MATERIAL REMOVAL FROM WITHIN A PATIENT

TECHNICAL FIELD

Certain embodiments described herein relate generally to devices for removing unwanted materials from within patients, and further embodiments relate more particularly to devices, systems, and methods for removing material to treat pancreatitis.

BACKGROUND

Unwanted material within the body, such as may be found in blockages, can take various forms. For example, esophageal food impactions are a common and dangerous emergency in gastroenterology, with an annual incidence rate of at least 13/100,000 population (Longstreth, GIE; 2001); moreover, the incidence has been increasing in recent years due to a rise in eosinophilic esophagitis (Desai, GIE; 2005). Food impactions can occur when a bolus of swallowed food becomes lodged in the esophagus and is unable to pass spontaneously into the stomach. This occurs either when the swallowed bolus is too large or when there are diseases of the esophagus that narrow the esophageal lumen, such as GE reflux with a stricture or ring, an esophageal food allergy such as eosinophilic esophagitis with stricture or stenosis of the esophagus, a Schatzki's ring, esophageal webs, or esophageal cancer. Motility disorders of the esophagus typically do not cause impactions.

Food impactions present acutely and dramatically, with patients noting chest pain or pressure, inability to swallow, painful swallowing, a sensation of choking, and neck or throat pain. Retching and vomiting are also common, and patients can also experience breathing problems due to tracheal or airway compression, with stridor, coughing or wheezing being noted. Known devices, systems, and methods for treating food impactions suffer from one or more drawbacks that can be resolved, remedied, ameliorated, or avoided by certain embodiments described herein.

A variety of other conditions can give rise to and/or result from problematic undesirable material, which material may cause occlusions or blockages, within a patient. For example, in some instances, gallstones or tumors can become lodged in the biliary tree (i.e., in the common bile duct and/or in peripheral ducts). A variety of known methods are used to remove the gallstones or tumors from the bile ducts.

Moreover, gallstones or tumors lodged in bile ducts can cause chronic and/or acute pancreatitis, which can be treated by removal of unwanted material that collects within the pancreas. The term “pancreatitis,” as used herein, can include one or both of acute pancreatitis and chronic pancreatitis. Pancreatitis can result from other conditions as well, although gallstones are the most frequent cause in at least the western population. Pancreatitis is a serious disease resulting in significant morbidity and mortality. The two types of acute pancreatitis are interstitial edematous pancreatitis and necrotizing pancreatitis. With respect to necrotizing pancreatitis, necrosis develops as collections (e.g., fluid collections) in one or more of the pancreatic parenchyma or peripancreatic tissue. The collections are caused by inflammation and include acute peripancreatic fluid collections, pancreatic pseudocysts, acute necrotic collections, and walled-off necrotic collections. Collections usually remain sterile. While most resolve on their own, some can become pseudocysts, and a smaller portion can turn into walled-off necroses. Pseudocysts are collections in peripancreatic tissue that mostly contain solid material. In some instances, the pseudocysts can be blockages that occlude or partially occlude the main pancreatic duct or branches thereof. Walled-off necroses consist of mature necrotic material (both fluid and solid) completely encapsulated and demarcated inside a thickened wall of tissue lacking an epithelial lining. These usually develop about four weeks after onset of necrotizing pancreatitis.

Sterile necrotic collections often do not require any invasive intervention and resolve over time. In some instances, however, sterile necrotizing pancreatitis can occlude the gastric, intestinal, or biliary outlets due to size, and can benefit from intervention. Infection of pancreatic necrotic material is associated with significantly higher mortality than sterile necrosis and usually requires invasive or minimally invasive intervention. Infection of sterile necrotic tissue may, for example, be caused by movement of bacteria from the gastrointestinal tract to nearby necrotic pancreatic tissue.

Accordingly, undesirable materials (e.g., material that causes and/or results from one or more blockages within a patient), may desirably be removed from the patient. Such material can include, for example, food impactions within the esophagus. In further examples, the material can include gallstones and/or tumors that at least partially occlude bile ducts and/or debris (e.g., blockages) associated with pancreatitis, as well as other materials associated with pancreatitis, including fluid collections, pseudocysts, and/or walled-off necrotic collections. Other examples of materials can include gastric obstructions, such as stool impactions, blood (e.g., pooled blood and/or blood clots) within the gastrointestinal tract, bezoars in the gastrointestinal tract, and/or blood and/or mucous in the pulmonary tree. Known devices, systems, and methods for removing such undesired materials from within a patient suffer from one or more drawbacks that can be resolved, remedied, ameliorated, or avoided by certain embodiments described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:

FIG. 1 depicts a side elevation view of an illustrative embodiment of a catheter for clearing a blockage from within a body of a patient;

FIG. 2 depicts a side elevation view of an illustrative embodiment of a system for clearing a bolus of food or other debris or foreign body lodged within an esophagus of a patient, the system including the catheter of FIG. 1;

FIG. 2A is an end-on plan view of a distal tip of an embodiment of an endoscope that is compatible with the system of FIG. 2;

FIG. 3 depicts a portion of the system of FIG. 2 with the bolus of food or other debris being partially cored;

FIG. 4 depicts an illustrative embodiment of a distal end of the catheter for coring the bolus of food or other debris shown in FIG. 1;

FIG. 5 depicts another illustrative embodiment of a distal end of a catheter for coring the bolus of food or other debris, such as that shown in FIG. 1;

FIG. 6 depicts an illustrative embodiment of a proximal end of a catheter tube of FIG. 1 coupled to an embodiment of a syringe;

FIG. 7 depicts a side elevation view of an illustrative embodiment of a stylet that is compatible with the system of FIG. 2;

FIG. 8 depicts a side elevation view of the stylet of FIG. 7 positioned within the catheter of FIG. 1;

FIG. 9 depicts a schematic side elevation view of another embodiment of a catheter having a Y-fitting for removing a bolus of food or other debris lodged within an esophagus;

FIG. 10 is a perspective view of the catheter of FIG. 9;

FIG. 11 is a perspective view of a proximal portion of the catheter of FIG. 9 with a stylet advanced fully therethrough;

FIG. 12 shows another perspective view of the proximal portion of the catheter of FIG. 9;

FIG. 13 shows another view of the proximal portion of the catheter of FIG. 9 with the stylet partially removed therefrom;

FIG. 14 shows an enlarged view of the proximal portion of the catheter of FIG. 9;

FIG. 15 shows another view of the proximal portion of the catheter of FIG. 9 with a cap of the suction port removed;

FIG. 16 shows a distal end of the catheter of FIG. 9;

FIG. 17 shows the distal end of the catheter of FIG. 9;

FIG. 18 shows another example embodiment of a stylet for removing a bolus of food or other debris lodged within an esophagus;

FIG. 19 shows an end portion of the stylet of FIG. 18;

FIG. 20 shows another example embodiment of a system for removing a bolus of food or other debris lodged within an esophagus;

FIG. 21 shows a portion of the device of FIG. 20;

FIG. 22 shows another example embodiment of a system for removing a bolus of food or other debris lodged within an esophagus;

FIG. 23 shows a cross-sectional view of a portion of the device of FIG. 22;

FIG. 24 shows another cross-sectional view of a portion of the device of FIG. 22;

FIG. 25 is an exploded elevation view of another embodiment of a blockage clearing system;

FIG. 26 is a side elevation view of a proximal end of an embodiment of a sheath assembly that may be used with the system of FIG. 25;

FIG. 27 is a cross-sectional view of a sheath portion of the sheath assembly of FIG. 26 taken along the view line 27-27 in FIG. 26;

FIG. 28A is an elevation view of a distal end of the sheath assembly that includes a positioning element in an undeployed state;

FIG. 28B is an elevation view of the distal end of the sheath assembly that depicts the positioning element in a deployed state;

FIG. 29 is an elevation view of a proximal end of an embodiment of a catheter assembly that may be used with the system of FIG. 25;

FIG. 30 is a cross-sectional view of a catheter portion of the catheter assembly of FIG. 29 taken along the view line 30-30 in FIG. 29;

FIG. 31 is an elevation view of a distal end of the catheter of FIG. 29;

FIG. 32A is an early stage in an illustrative method of using the system of FIG. 25 in which the sheath is inserted into the esophagus of a patient;

FIG. 32B is a subsequent stage in the illustrative method in which the distal end of the sheath contacts an impacted bolus of food;

FIG. 32C is a subsequent stage in the illustrative method in which the positioning element is deployed into contact with the esophagus;

FIG. 32D is a subsequent stage in the illustrative method in which the distal tip of the catheter is advanced through the sheath and brought into contact with a proximal end of the food bolus;

FIG. 32E is a subsequent stage in the illustrative method in which a morsel of food from the food bolus is cut or, more specifically, cored by the distal tip of the catheter and is drawn into a lumen of the catheter;

FIG. 32F is a subsequent stage in the illustrative method in which the morsel of food has detached from the food bolus and is suctioned through the lumen of the catheter;

FIG. 32G is a subsequent stage in the illustrative method in which the catheter is withdrawn into or from the sheath;

FIG. 32H is a subsequent stage in a further illustrative method in which further coring of the food bolus is desired, wherein in the depicted stage, the positioning element is returned to the undeployed configuration to permit ready movement of the sheath relative to the esophageal wall;

FIG. 32I is a subsequent stage in the further illustrative method in which the distal end of the sheath has been advanced to a more distal position, wherein the proximal end of the cored food bolus has been reshaped in the absence of the suctioned-off food morsel;

FIG. 32J is a subsequent stage in the further illustrative method in which the positioning element is deployed again into contact with the esophagus;

FIG. 32 K is a subsequent stage in the further illustrative method in which the distal tip of the catheter is again brought into contact with the proximal end of the food bolus for further coring of the food bolus;

FIG. 33A is an elevation view of a distal end of another embodiment of a sheath assembly that includes a differently shaped positioning element in an undeployed state;

FIG. 33B is another elevation view of the distal end of the sheath assembly of FIG. 33A that depicts the positioning element in a deployed state in which the positioning element is substantially shaped as a frustocone;

FIG. 34 is an elevation view of a proximal end of another embodiment of a sheath assembly that includes a pressure regulation valve;

FIG. 35A is an elevation view of a distal end of the sheath assembly of FIG. 34 that depicts a positioning element in an undeployed state;

FIG. 35B is a further elevation view of the distal end of the sheath assembly of FIG. 34 that depicts the positioning element in a deployed state;

FIG. 35C is a further elevation view of the distal end of the sheath assembly of FIG. 34 that depicts the positioning element in a further state of operation in which the positioning element has been maintained in the deployed state at a substantially constant pressure via the pressure regulation valve of FIG. 34, despite attempts to further pressurize the positioning element;

FIG. 36 is an elevation view of a proximal end of another embodiment of a catheter assembly that, in some instances, may be used with a system such as that depicted in FIG. 25, or in other instances, may be used without a sheath;

FIG. 37 is a cross-sectional view of a catheter portion of the catheter assembly of FIG. 36 taken along the view line 37-37 in FIG. 36;

FIG. 38A is an elevation view of a distal end of the catheter assembly of FIG. 36 in which a positioning element is depicted in an undeployed state;

FIG. 38B is another elevation view of the distal end of the catheter assembly in which the positioning element is depicted in a deployed state;

FIG. 39A is an elevation view of a distal end of another embodiment of a catheter assembly that includes a differently shaped positioning element that is depicted in an undeployed state;

FIG. 39B is another elevation view of the distal end of the catheter assembly of FIG. 39A that depicts the positioning element in a deployed state;

FIG. 40A is an elevation view of a distal end of another embodiment of a catheter assembly that includes a differently shaped and differently oriented positioning element that is depicted in an undeployed state;

FIG. 40B is another elevation view of the distal end of the catheter assembly of FIG. 40A that depicts the positioning element in a deployed state;

FIG. 41 is an elevation view of a distal end of another embodiment of a catheter assembly that depicts a distal tip of a catheter that includes an internal bevel;

FIG. 42 is an elevation view of a distal end of another embodiment of a catheter assembly that depicts a distal tip of a catheter that is substantially flat and that includes a cutting element recessed from the distal tip within a lumen of the catheter;

FIG. 43 is a cross-sectional view of the catheter assembly of FIG. 42 taken along the view line 43-43 in FIG. 42;

FIG. 44 is an elevation view of a distal end of another embodiment of a catheter assembly that depicts a distal tip of a catheter that is substantially rounded and that includes a cutting element recessed from the distal tip within a lumen of the catheter;

FIG. 45 is an elevation view of another embodiment of a blockage clearing system in an assembled, pre-use, undeployed, packaged, or insertion state;

FIG. 46 is an elevation view of an embodiment of a sheath assembly of the blockage clearing system of FIG. 45, the sheath assembly being shown in a deployed state;

FIG. 47 is a cross-sectional view of a hub of the sheath assembly of FIG. 46;

FIG. 48 is a partial cross-sectional view of a portion of the sheath assembly that includes the hub, when the assembly is in an assembled state;

FIG. 49 is a cross-sectional view of a sheath of the sheath assembly of FIG. 46 taken along the view line 49-49 in FIG. 46 (not necessarily to scale);

FIG. 50 is an enlarged elevation view of a distal end of the sheath assembly of FIG. 46, which includes a positioning element that is depicted in a deployed state;

FIG. 51 is an elevation view of an embodiment of a catheter assembly that is compatible with the blockage clearing system of FIG. 45 and/or, in other or further embodiments, is compatible for use with an endoscope;

FIG. 52 is a cross-sectional view of a catheter of the catheter assembly of FIG. 51 taken along the view line 52-52 in FIG. 51 (not necessarily to scale);

FIG. 53 is an enlarged elevation view of a distal end of the catheter;

FIG. 54 is a perspective view of an embodiment of a spacer compatible with the system of FIG. 45;

FIG. 55 is an elevation view of an embodiment of a kit that includes the system of FIG. 45;

FIG. 56 is an elevation view of another embodiment of a kit that includes an embodiment of the catheter assembly of FIG. 51;

FIG. 57A is an elevation view of another embodiment of a sheath assembly, which can be used with embodiments of systems previously disclosed, the sheath assembly being shown in an undeployed state;

FIG. 57B is another elevation view of the sheath assembly of FIG. 57A shown in a deployed state;

FIG. 58A is an elevation view of another embodiment of a sheath assembly, which can be used with embodiments of systems previously disclosed, the sheath assembly being shown in an undeployed state;

FIG. 58B is another elevation view of the sheath assembly of FIG. 58A shown in a deployed state;

FIG. 59A is an elevation view of another embodiment of a sheath assembly, which can be used with embodiments of systems previously disclosed, the sheath assembly being shown in an undeployed state;

FIG. 59B is another elevation view of the sheath assembly of FIG. 59A shown in a deployed state;

FIG. 60A illustrates a stage of illustrative methods for removing material from a pancreas to treat pancreatitis, wherein a portion of the gastrointestinal tract is shown in cross-section and an embodiment of an endoscope is shown in elevation;

FIG. 60B illustrates another stage of certain of the illustrative methods in which a coring catheter is being inserted through the endoscope to core and suction away necrotic material, wherein a proximal end of the endoscope and a proximal end of the coring catheter are shown;

FIG. 60C illustrates another stage of certain of the illustrative methods in which a distal end of the coring catheter has been inserted past a distal end of the endoscope to core and suction away necrotic material;

FIG. 60D illustrates another stage of certain of the illustrative methods in which the endoscope and the coring catheter are inserted through a stent;

FIG. 61A illustrates a stage of further illustrative methods for removing material from a pancreas to treat pancreatitis, wherein a portion of the gastrointestinal tract is shown in cross-section and an embodiment of an endoscope is shown in elevation;

FIG. 61B illustrates another stage of certain of the illustrative methods of FIG. 61A in which a coring catheter has been inserted through the endoscope to core and suction away necrotic material;

FIG. 61C illustrates another stage of certain of the illustrative methods of FIG. 61A in which the endoscope and the coring catheter are inserted through a stent;

FIG. 62A is a perspective view of an embodiment of a material-disrupting device that may be used to cut, dislodge, or otherwise disrupt undesired material, and may be used independently or in conjunction with independently or in conjunction with a coring catheter for removal of the material from a patient;

FIG. 62B is an exploded perspective view of a manual driver portion of the material-disrupting device of FIG. 62A;

FIG. 63 is an elevation view of another embodiment of a material disrupting device;

FIG. 64 is an elevation view of another embodiment of a material disrupting device;

FIG. 65 is an elevation view of another embodiment of a material disrupting device; and

FIG. 66 is an elevation view of a distal end of an embodiment of a coring catheter.

DETAILED DESCRIPTION

The present disclosure relates generally to devices, systems, and methods for removing undesired materials from within a patient, such as by addressing a blockage within a lumen of a patient. While specific examples of such devices, systems, and methods are discussed with respect to esophageal food impactions, the disclosure is not limited to this specific application. For example, other foreign bodies positioned within the esophagus and/or blockages within other body lumens or other regions of the body may be cleared in manners such as disclosed herein. Certain embodiments described herein can be used to clear, remove, break up, or otherwise treat other blockages within the body, such as those in the lungs. Moreover, additional examples are provided, including examples for the removal of necrotic material to treat pancreatitis.

With respect to food impactions, most food impactions clear spontaneously, but a significant fraction (20%) will not and have traditionally required emergent endoscopic intervention to clear the blocked food. This can be dangerous, since typical emergency endoscopy with removal of food can result in serious complications including aspiration pneumonia, laceration of the esophagus with bleeding, or esophageal perforation, which can result in sepsis and death. The complication rate of endoscopic clearance of a food impaction is approximately 3-5% and the mortality rate is unknown but several deaths have been reported (Simic, Am J Forensic Med Path; 1988).

Various endoscopic tools may be used to clear impactions, but all have flaws and there is no prior technique that is demonstrably better than any other. Food can sometimes be pushed blindly through the esophagus and into the stomach using the tip of the endoscope, but this technique is performed without vision of the more distal esophagus, so the endoscopist cannot observe, via the endoscope, what the esophagus looks like distal to the obstruction or what abnormalities exist. This technique can work well in some patients (Vicari, GIE; 2001), but because the technique is blind, can often result in esophageal laceration or perforation. Indeed, there is a significant risk the distal tip of the endoscope and/or a sharp surface within the bolus will be deflected toward the esophagus wall during blind pushing of this sort, resulting in laceration or perforation. Many endoscopists avoid blind pushing for this reason.

Some endoscopic techniques employ forceps that include “rat-tooth” type designs, snares, or variable wire basket designs to break up food into smaller pieces for extraction. Such techniques are laborious, time-consuming, and often fail.

Other extraction techniques can also be tried, particularly when the food bolus is not tightly wedged and is firm, or if the food contains bone or sharp surfaces. In this regard, baskets, snares, graspers, “pelican” forceps with longer arms, nets, etc., can be used to remove food in whole or in pieces, but these techniques also frequently fail, and the patient is at risk for aspiration pneumonia if the pieces fall into the hypopharynx or mouth during the extraction attempts. If the food bolus is lodged proximally, then most of the above techniques will fail or are too dangerous to try. Endoscopic suction cannot be used for impactions, since a food bolus cannot be effectively suctioned through an endoscope. Moreover, if suction is used in an attempt to hold the food bolus against a distal tip of the endoscope, and the suction fails at some point to hold a bolus against the tip of the scope, the patient is at high risk for aspiration as the scope is withdrawn through the hypopharynx or mouth. Overtubes for endoscopes can be used if repeated endoscopic intubation is needed, but overtubes are uncomfortable, require deeper sedation, and can be dangerous in and of themselves with risk of esophageal laceration and perforation.

Certain embodiments disclosed herein can resolve, remedy, ameliorate, and/or avoid one or more of the limitations of known techniques for treating a patient who suffers from an esophageal food impaction, such as those just described, and/or can be advantageous over such techniques for other reasons, as will be apparent from the present disclosure.

In certain embodiments, a device is configured to clear a bolus of food impacted within an esophagus. The device can include a catheter tube having a hollow interior and a distal end configured to core the bolus of food and can include a proximal end configured to be coupled to a source of suction to clear the core. Certain systems described herein assist in resolving the buildup of pieces of food in the esophagus while minimizing the risk of aspiration. The systems are further designed in an atraumatic manner, helping to avoid esophageal laceration and perforation. In some embodiments, an inner region of a food impaction that is spaced from the esophageal wall (e.g., the mid-region or center of the food impaction) is cored out.

For example, in one embodiment, the system includes a catheter (e.g., hollow tube) with a distal end that is delivered to the site of the blockage. The distal end of the catheter is used to core out portions of the blockage until the blockage is reduced in volume in a piecemeal manner. The smaller volume blockage can then pass through the esophagus spontaneously and/or be more easily removed. In some embodiments, the catheter can be delivered to the blockage site through an endoscope (e.g., through the instrument channel of the endoscope) or other similar device.

In other or further embodiments, the catheter can be delivered to the blockage site through a dedicated or specialized sheath, which may include a positioning element to prevent the catheter tip from contacting the esophageal wall. In some instances, the dedicated sheath may permit the catheter to define a larger internal lumen, as compared with catheters that are deployed through the instrument or working channel of a standard endoscope, which can facilitate and/or increase a rate of blockage clearance. The dedicated sheath may permit the catheter to be used in a blind procedure, such as in an emergency room setting, without endoscopic or other visualization of the impaction during the procedure. In some embodiments, the sheath includes a positioning element that spaces the distal tip of the catheter away from the esophageal wall to prevent laceration or perforation of the esophagus.

In still other or further embodiments, the catheter itself may include a positioning element to prevent the catheter tip from contacting the esophageal wall. In some instances, the catheter may be used without an endoscope or other sheathing element.

In certain examples, suction can be provided to remove the cored portions of the blockage. The suction can be provided at the proximal end of the catheter to assist with the coring and/or to cause the cored portions to be suctioned from the site of the blockage and passed through the catheter and discarded, thus minimizing a risk of food aspiration. In some instances, suctioning arrangements can preserve endoscopic visualization. Stated otherwise, a coring aspiration catheter may be deployed through the working channel of an endoscope to remove portions of a food bolus without blocking a viewing lens at a distal end of the endoscope and/or without obscuring, or without significantly or fully obscuring, a field of view of the lens. For example, the impacted food bolus and the coring aspiration catheter may be viewed via the viewing lens at the distal end of the endoscope throughout at least a portion of the clearing procedure.

Certain embodiments can include features that allow cored portions of the food to be cleared, should the portions become caught in the catheter while being suctioned away from the blockage site. In one example, a source of compressed air, such as a syringe, can be placed at the proximal end of the catheter, and air can be passed through the catheter to clear any portions caught in the catheter, via the distal end. In other or further embodiments, a stylet can be passed through the interior of the catheter to clear any portions of food caught therein. The stylet can also perform other or further functions, such as providing stiffness for the catheter during delivery of the catheter to the blockage site. Further, the stylet can be configured to assist in the manipulation of the blockage, such as by advancing the stylet into the blockage one or multiple times to create a nidus for coring and suctioning.

One or more of the foregoing advantages and/or one or more other or further advantages will be apparent from the discussion that follows.

Referring now to FIG. 1, an example catheter 100, which may also be referred to as a catheter assembly 100, is shown. The catheter 100 includes a hollow catheter tube 102 that generally can be used to core out a portion of a blockage. Specifically, the catheter tube 102 includes a distal end 104 that is configured to contact and core the blockage one or more times. As the blockage is cored by the distal end 104 of the catheter tube 102, the volume of the blockage is reduced until the blockage is able to be passed through the esophagus spontaneously and/or removed.

The catheter assembly 100 includes a proximal end 106 configured to be coupled to various devices. For example, as described further below, the proximal end 106 of the catheter assembly 100 is configured to be coupled to a source of suction to allow the cored food portions to be suctioned and/or removed through the catheter tube 102. In another example, the proximal end 106 of the catheter tube 102 is configured to be coupled to a source of pressurized air, such as a syringe, to allow any cored food stuck within the catheter tube 102 to be cleared. Other configurations are possible. In the illustrated embodiment, the proximal end 106 is formed as a tapered connector that can be directly connected to a standard vacuum tubing arrangement, such as in a hospital setting, as discussed further below with respect to FIG. 2.

The catheter or catheter assembly 100 can include a strain relief sleeve 53 of any suitable variety. The strain relief sleeve 53 can inhibit kinking or other undesirable deformation of the catheter tube 102 during use of the catheter tube 102. In some embodiments, the catheter 100 includes a shoulder 55 at a proximal end of the strain relief sleeve 53. The shoulder can define a larger diameter than the strain relief sleeve 53. The catheter 100 can further include a handle 57 via which a user may manipulate the proximal end of the catheter 100.

Referring now to FIGS. 2 and 3, the catheter 100 is shown within an example system 200 configured to remove a blockage 202 positioned within an esophagus 204 of a patient. In this example, the blockage 202 (generally food or other debris, but could also be other blockages like blood or blood clots, mucus, etc.) has become caught within the esophagus 204.

In the embodiment shown, the catheter 100 is delivered to the blockage 202 using an endoscope 210. The endoscope 210 can be of any suitable variety, including those presently in use and/or those yet to be devised. For example, the endoscope can be any of a variety of standard endoscopes typically used for upper GI tract endoscopy. As shown in FIG. 2A, the endoscope 210 contains a working channel 260 that is generally hollow and allows the catheter 100 to be delivered through the endoscope 210 to the blockage 202. The endoscope 210 may generally be referred to as a tubular member that defines a channel—specifically, the working channel 260.

In various embodiments, the endoscope 210 can include one or more additional ports having a variety of additional functions. For example, in the illustrated embodiment, the endoscope 210 includes a viewing port 262, which may include a lens, via which a region beyond the distal tip of the endoscope 210 can be viewed. The endoscope 210 can further include a light guide that terminates at a light port 264 for illuminating the region beyond the distal tip of the endoscope 210. The endoscope 210 can include a water jet 266 and/or can include an air and/or water nozzle 268. Various embodiments of endoscopes can include more or fewer features.

With continued reference to FIGS. 2 and 3, once the distal end 104 of the catheter tube 102 is in position, the endoscope 210 can be withdrawn or can remain in place as the blockage 202 is manipulated. In many methods, the endoscope 210 remains in close proximity to the blockage 202 during coring via the catheter tube 102 to permit visualization of the coring. In particular, the endoscope 210 can be positioned such that the region that is illuminated by the light port 264 and that is within the field of view of the lens of the viewing port 262 includes both the proximal end of the blockage 202 and the distal end of the catheter tube 102 as the catheter tube 102 is used to core pieces out of the blockage 202.

The catheter tube 102 of the catheter 100 is configured to be advanced so that the distal end 104 impacts the blockage 202 so as to reduce the volume of the blockage 202, such as by repetitively coring the food. As the volume is reduced (such as is shown in FIG. 3), the blockage 202 can be naturally passed through the esophagus 204 and into a stomach 206 of the person.

In example embodiments, the catheter tube 102 is at least semi-rigid but flexible, which allows the catheter tube to flex and/or bend during delivery through the endoscope, as the endoscope flexes and bends. This allows the catheter tube 102 to be directed more precisely as it is inserted to a desired location. For example, in some instances, the endoscope is introduced into the patient through the nose of the patient—or stated otherwise, is introduced into the patient via transnasal endoscopy—such that the endoscope defines a curved route through the upper respiratory tract of the patient. In other instances, the endoscope is introduced into the patient through the mouth, such that the endoscope defines a curved route from the mouth to the esophagus, in manners such as described elsewhere herein. The catheter tube 102 may be sufficiently flexible to pass through the curved portion of the endoscope, or more specifically, pass through the curved portion of the working channel 260.

In some examples, the distal end 104 of the catheter tube 102 is configured to assist in the coring of the blockage 202. For example, as shown in FIG. 4, the distal end 104 of the catheter tube 102 is tapered. Specifically, the distal end 104 includes an inner diameter 402 that is smaller than an inner diameter 404 of a more proximal portion 406 of the catheter tube 102. In one example, the difference in diameters can be less than one-hundredth of a millimeter. Other sizes are possible. In addition, the walls of the catheter tube 102 can be thinned as the walls extend to the distal end 104, as depicted.

This tapering of the distal end 104 can allow a core 410 of the blockage 202 that is formed by the distal end 104 to be more easily suctioned through the catheter tube 102. Since the cores formed by the distal end 104 will typically have a diameter smaller than that of the portion 406, the cores can be more easily suctioned through the catheter tube 102 for evacuation, as is illustrated by Poiseuille's law.

In another depiction shown in FIG. 5, the catheter tube 102 is formed of a first portion 502 at the distal end 104 having a smaller diameter, and a second portion 504 extending along a remainder of the catheter tube 102 having a larger diameter. This again allows the cores of the blockage 202 that are created by the first portion 502 to be smaller in diameter so that the cores can more easily pass through the remainder of the catheter tube 102 (i.e., the second portion 504).

In some examples, a tip 508 of the distal end 104 of the catheter tube 102 can be beveled and/or serrated. The tip 508 can take multiple forms, including a serrated edge, to cut (e.g., saw) or shave bits of the blockage 202 off of the bolus to better aid suctioning. The tip 508 can help core the blockage. For example, in some instances, the catheter tube 102 may be rotated relative to the working channel of the endoscope, whether in a single direction or back and forth, as the tip 508 contact the blockage 202. In some instances, this rotation, coupled with a serrated or otherwise configured tip can assist in coring the blockage 202. This technique may be used with other embodiments as well, including those in which a catheter is inserted through a sheath assembly, rather than an endoscope.

For example, referring again to the system 200 depicted in FIG. 2, a source of suction can be applied to the proximal end 106 of the catheter 100 to allow the cores of the blockage 202 to be removed through the catheter tube 102. Specifically, in the example provided, a vacuum line 220 can be coupled to the proximal end 106 of the catheter tube 102. In particular, the vacuum line 220 can include a suction line fitting 221 that is connected to the proximal end 106 of the catheter 100. The vacuum line 220 can be coupled to a collection canister 222 of any suitable variety, including those presently known or those yet to be devised, and the collection canister 222 is coupled to a suction line 224. The suction line 224 is coupled to a source of suction, such as a hospital vacuum source. In this configuration, pieces of the blockage 202 that are cored or otherwise dislodged by the catheter tube 102 can thereupon be sucked up the catheter tube 102, through the vacuum line 220, and collected in the collection canister 222.

As described previously, it is possible for one or more cores of the blockage 202 to become stuck within the catheter tube 102. In such a scenario, various devices can be used to clear the stuck cores.

For example, referring now to FIG. 6, an example syringe 602 is coupled to the proximal end 106 of the catheter 100 using, for example, a suction line fitting or Luer-lock style connection. In this embodiment, the syringe 602 can be a typical 60 cc syringe that is used to deliver air into the catheter tube 102 during coring of the blockage 202 to dislodge and/or remove portions of the blockage 202 that are in the catheter tube 102.

In this instance, a plunger of the syringe 602 is actuated to displace air within the syringe 602 into and through the catheter tube 102. This air can be used to dislodge obstructions within the tube. Other configurations are possible. For example, other types of fluids, such as a jet spray of water, could be used to help clear the tube or break up food.

In other instances, different devices can be used to clear the catheter 100. For example, referring now to FIG. 7-8, a stylet 700 is shown that is sized to fit through the hollow interior of the catheter tube 102. Generally, the stylet 700 can be used to perform various functions.

For example, the stylet 700 can be used to stiffen the catheter 100 during delivery to the blockage 202. Further, the stylet 700 can be introduced through the catheter tube 102 to clear the catheter tube 102 when one or more cores get stuck, performing a function of a pusher rod. In other or further instances, the stylet 700 can be used to pierce the blockage 202 to start a nidus for coring and suctioning. In various examples, the stylet 700 can be solid or hollow.

In the illustrated example, the stylet 700 further includes a stylet knob 702 that is configured to be engaged with the proximal end 106 of the catheter 100. The proximal end 106 can be configured to include a Luer taper that allows the proximal end 106 to engage the stylet knob 702 of the stylet 700. Other coupling arrangements, such as a threaded engagement, for example, can be used.

As shown in FIG. 8, the stylet knob 702 is coupled to the proximal end 106 of the catheter tube 102. In this configuration, the catheter 100 can be delivered to the desired location within the esophagus 204. At that time, the stylet knob 702 can be disengaged from the proximal end 106 to free the stylet 700 for movement. This movement can include the caregiver pushing the stylet 700 into and out of the catheter tube 102 to generally disrupt the blockage 202 and/or removal of the stylet 700 completely from the catheter tube 102.

When the stylet 700 is removed from the catheter tube 102, the vacuum line 220 can be connected to the proximal end 106 of the catheter tube 102 for suctioning, as described previously.

In this example shown in FIG. 8, the catheter tube 102 is approximately 80.5 inches in length and the stylet 700 is approximately 84 inches in length, although many different lengths can be provided such as, for example, shorter lengths for children and longer lengths for adults or to accommodate different length endoscopes, bronchoscopes or colonoscopes. The example catheter tube 102 has an outer diameter of 0.135 inches and an inner diameter of 0.115 inches. The stylet 700 has an outer diameter of 0.105 inches. Other sizes can be used.

In other embodiments, the catheter tube 102 can be variable in length and diameter, or stated otherwise, a variety of lengths and diameters are contemplated. For example, another embodiment of the catheter tube 102 measures 0.093 inches in outer diameter and 0.082 for the inner diameter, allowing for easy introduction and sliding within the working channel of any of a variety of endoscopes. The catheter tube 102 is long enough to extend through an endoscope. In some embodiments, the catheter tube 102 is at least 120 cm in length, but it can be longer in other embodiments.

The stylet 700 can vary in diameter, but in the preferred embodiment measures 0.070 inches in outer diameter to allow easy introduction and sliding within the catheter tube 102, and is slightly longer than the catheter tube 102 to allow the stylet 700 to extend beyond the distal end 104 of the catheter tube 102 to clear the catheter tube 102 and extend further into the blockage 202, if desired.

The catheter tube 102 can be made from a thin-walled extruded tube sized to fit the working channel (e.g., biopsy channel) of any commercially available endoscope. One example material is PEBAX® 7233 SA, available from Arkema, or any other suitable thermoplastic elastomer. Another possible material is an extrusion grade of PETG (glycol-modified polyethylene terephthalate). Other suitable materials include polyamide or extrusion grade Nylon or DEL_RIN® (acetal homopolymer resin, an engineering thermoplastic, available from DuPont), such as Nylon 10 or Nylon 12.

The stylet 700 could be made of the same or similar material. For example, the catheter tube 102 and the stylet 700 can be made of the same material to allow the stylet 700 to fit within the catheter tube 102 while minimizing friction. However, other materials and different materials for each can be used.

The above materials would clear food, but would not seriously damage the walls of the esophagus should they inadvertently contact the walls of the esophagus.

Referring now to FIGS. 9-17, another example device 900 is shown. The device 900 includes the catheter tube 102 with a suction port 902 at the proximal end 106 and with the distal end 104 that is designed (e.g., beveled) to be advanced through the biopsy channel of any commercial endoscope and that can accommodate the stylet 700 to clear any food that may stick in the catheter tube 102 after removal from the esophagus.

As shown in FIG. 9, the catheter tube 102 is designed to fit through the biopsy channel of an endoscope positioned within the esophagus to reach a food blockage, but can also be advanced adjacent to an endoscope and can also be advanced orally without the aid of an endoscope. The catheter tube 102 is also bendable and maneuverable as the endoscope bends and maneuvers, yet is rigid enough to withstand kinking. The catheter tube 102 is also sufficiently rigid to withstand suction forces that are sufficient to remove cored portions of a food or other blockage through the lumen of the catheter tube 102.

In this example (see FIGS. 9 and 15), there is a Y-fitting 904 wherein one arm 906 of the Y is attached to and forms the suction port 902, and another arm 908 of the Y accommodates the stylet 700.

There is also a compression seal 910, or rubber stopper, at the proximal end of the arm 908 that accommodates the stylet 700, so that any air escaping the proximal end—or entering through the proximal end—is minimized when the stylet 700 is in the catheter tube 102, so that suction and stylet clearance of the vacuum tube can occur simultaneously. When the compression seal 910 is loosened, the stylet 700 can be easily advanced into and out of the catheter tube 102 using a handle 912 of the stylet 700. The compression seal 910 can also secure the stylet 700 in any location along the shaft of the catheter tube 102.

In this example, a cap 914 is threaded onto the proximal end 916 of the arm 908 to retain the compression seal 910 in place. Upon removal of the stylet 700 from the catheter tube 102, the compression seal 910 is configured, in some embodiments, to close the proximal end 916 so that suction can be performed through the catheter tube 102 and the suction port 902.

In the example shown, the catheter tube 102 can work with the stylet 700 completely removed; the stylet 700 can also be introduced as needed, and advanced any distance in the catheter tube 102.

As with previous embodiments, the distal end 104 of the catheter tube 102 can disrupt food, core food, shave food and suction food. The catheter tube 102 wall could be thin and rigid to better accommodate a larger lumen of the tube. The stylet 700 can help support the catheter tube 102 to help prevent kinking, in some embodiments. Thus, in some instances, the stylet 700 can both help clear the suction tube and act as a stylet to stiffen the catheter tube 102.

Many alternative designs are possible. For example, in another design shown in FIGS. 18-19, a stylet 1800 could have a spline shape 1802 with splines 1804 formed along the stylet to better accommodate suction when the stylet in is the catheter tube. In other words, spaces 1806 are formed between the splines 1804 to allow suction to be provided through the catheter tube 102 even with the stylet 1800 in place within the catheter tube 102. Other configurations are possible.

Referring now to FIGS. 20-21, another example of a stylet 2000 is shown. In this example, the stylet 2000 is a wire 2002 with a piston 2004 positioned at an end 2006 thereof. The piston 2004 can be automatically (and/or manually) actuated intermittently or at regularly intervals (such as by a motor) to drive the stylet 2000 through the catheter tube 102 to engage the blockage in the esophagus. Other configurations are possible.

Referring now to FIGS. 22-24, another example device 2200 is shown. The device 2200 is similar to the embodiment of FIGS. 20-21, except that the device 2200 does not necessarily need suction. Instead, the device 2200 includes a handle 2202 and a tube 2204. The handle 2202 includes an actuator member 2206 that can be moved (e.g., by the caregiver's finger or thumb) in a direction 2208 in or out.

The actuator member 2206 is coupled to a wire 2210 that runs through the tube 2204 to an ejector piston 2402. The ejector piston 2402 is positioned within a cavity 2404 formed in a distal end 2406 of the tube 2204. The distal end 2406 of the tube 2204 forms an opening 2408 sized to core or otherwise carve the obstruction as the caregiver moves the handle 2202 and the tube 2204 attached thereto. This is accomplished, for example, by the pieces of the obstruction being carved by the distal end 2406 of the tube 2204 and received in the cavity 2404.

As the cavity 2404 is filled, the caregiver can move the actuator member 2206 to cause the ejector piston 2402 to be moved by the wire 2210 through the cavity 2404 towards the distal end 2406 of the tube 2204 to eject food out of the opening 2408. This process can be done multiple times until the obstruction is cleared. The actuator member 2206 can be biased to return to the retracted position and/or simply be moved in the opposite direction 2208 by the caregiver's finger to return the ejector piston 2402 to the retracted position.

In some examples, the distal end 2406 of the tube 2204 can be configured to more easily core the obstruction. For example, the distal end can be thinned or serrated so as to be sharper. In other examples, additional features, such as a stainless steel tip, can be added to the distal end 2406 of this (or any other embodiment disclosed herein) to enhance the coring impact of the device 2200.

In some examples, the inner surface of the tubes can be configured to more easily allow cores of the obstruction to pass therethrough. For example, the inner surface of a tube can be coated with a low friction or lubricious material to encourage passage and discourage clumping of the cores. Examples of such low friction materials include, without limitation, polyvinyl pyrrolidone and hyaluronic acid. Such materials can be typically bonded using heat or ultraviolet light. The external surface of the catheter 102 can optionally also be coated with low friction materials to enable passage through the endoscope. Other mechanisms, such as differing tapers and/or channeling of the inner surface, can also be used.

Further embodiments of blockage clearing systems are disclosed hereafter. The systems can resemble systems described above in certain respects. Specific features of these further systems may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments herein (whether discussed above or below) and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the following systems. Any suitable combination of the features and variations of the same described with respect to any of the systems and their components can be employed with any of the remaining systems and their components, and vice versa. Moreover, with respect to certain embodiments described hereafter, similar components among various embodiments may be identified with similar numbering, wherein the initial numerals may be incremented in subsequently disclosed embodiments.

FIG. 25 depicts an exploded view of an embodiment of a blockage clearing system 3000 that includes a sheath assembly 3002 and a catheter assembly 3004. The sheath assembly 3002 is configured to be coupled with the catheter assembly 3004 during use, as further discussed below. Moreover, the catheter assembly 3004 is configured to be coupled with a suction system 3006 during use.

The sheath assembly 3002 extends between a proximal end 3010 that is configured to remain outside of the patient during use and a distal end 3012 that is configured for insertion into the esophagus of a patient. The illustrated sheath assembly 3002 includes a hub 3014, a sheath 3016, and a positioning element 3018. As further discussed below, the hub 3014 of the sheath assembly 3002 can be configured to direct a catheter 3026 of the catheter assembly 3004 into a lumen of the sheath 3016. The catheter 3026 may also be referred to as a catheter tube, or more generally, as a tube, cannula, cutting member, cutting-and-suction member, or coring member. In further instances, the catheter 3026 may be referred to as an aspiration catheter, aspiration cannula, or aspiration tube.

At least a proximal portion of the sheath 3016 may define a preformed curve region 3017. In some embodiments, the curved region 3017 is sized and oriented to facilitate introduction of the sheath 3016 into the esophagus of a patient. The curved region 3017 may additionally or alternatively enhance the patient's comfort during use of the sheath 3016, such as when the curved portion 3017 extends through the mouth, against or adjacent to the soft palate, and through the hypopharynx. The curved portion 3017 may be pre-formed to correspond to a natural curvature of a patient's anatomy. In some embodiments, different sized sheath assemblies 3002 may be used for different sized patients to adjust to their differently sized anatomies, which may enhance comfort of the patients. In other embodiments, the curved region 3017 may be sufficiently flexible to adjust to different patient anatomies. A variety of configurations and alterations are contemplated. For example, in other embodiments, the sheath 3016 may be devoid of a curved region 3017. As can be appreciated from the foregoing, in such embodiments that lack a pre-formed curved region 3016, the sheath 3016 may be substantially linear prior to insertion into the patient, and can be sufficiently flexible to follow, deflect, adjust, and/or conform to a curvature of the patient's anatomy as the sheath 3016 is advanced through the mouth, against or adjacent to the soft palate, and through the hypopharynx of the patient. In other or further embodiments, the sheath 3016 may be advanced through the nose and through at least a portion of the upper respiratory tract and into the esophagus of the patient.

As further discussed below, the positioning element 3018 can assist in centering or otherwise positioning a distal tip 3023 of the catheter 3026 relative to the esophagus to prevent the distal tip 3023 from contacting or damaging the esophagus. In the illustrated embodiment, the positioning element 3018 is formed as an inflatable balloon 3019. Other or further varieties of positioning elements 3018 are also contemplated, illustrative examples of which are discussed further below. In various embodiments, the positioning element 3018 may also or instead be referred to as a centering element, anchoring element, contact element, expansion element, spacing element, and/or as a centering, anchoring, contact, expansion, and/or spacing member.

With continued reference to FIG. 25, the catheter assembly 3004 extends between a proximal end 3020 that is configured to remain outside of the patient during use and a distal end 3022 that is configured for insertion into the esophagus of a patient. As further discussed below, the distal end 3022 of the catheter 3026 can include a distal tip 3023 that is capable of coring an impacted food bolus. The distal tip 3023 may be sharp, and may be referred to as one or more of a cutting tip or a coring tip. In some embodiments, the distal tip 3023 can cut into the food bolus on its own and/or in combination with suction provided by the suction system 3006. In further embodiments, the distal tip 3023 can cooperate with the suction provided by the suction system 3006 to core the food bolus, e.g., as the suction tears from the food bolus a morsel that has been cut by the distal tip 3023.

The illustrated catheter assembly 3004 includes a hub 3024 attached to a proximal end of the catheter 3026. As further discussed below, the catheter hub 3024 can be configured to selectively couple with the suction system 3006. In the illustrated embodiment, the catheter hub 3024 includes a connector 3028 for establishing a fluid connection to the suction system 3006. In the illustrated embodiment, the connector 3028 is formed as a Christmas tree fitting or connector 3029. Any other suitable connection interface is contemplated. For example, the connector 3028 may instead define a substantially smooth outer surface, such as a smooth conical surface similar to that of the connector at the proximal end 106 of the catheter assembly 100 depicted in FIG. 1, rather than a ribbed outer surface of multiple stacked conical surfaces, such as depicted in FIGS. 25 and 29.

In the illustrated embodiment, the catheter hub 3024 includes a handle 3040 and a suction port 3042 positioned thereon. The handle 3040 can be of any suitable configuration. In many embodiments, the handle 3040 is sized and shaped to rest or be gripped comfortably within a single hand of a practitioner. For example, in some embodiments, the handle 3040 can be gripped with four fingers of a hand of a practitioner, and the port 3042 can be operated with the thumb of the same hand of the practitioner. In some embodiments, the port 3042 can be left open to prevent suction from being applied, or to significantly reduce an amount of suction being applied, through the catheter 3026. Conversely, the port 3042 can be closed, such as by placing a thumb or other finger thereon, to permit or increase an amount of suction to be applied through the catheter 3026. In other embodiments, such as in the catheter assembly 100 discussed above, the handle 3040 can be devoid of a suction port 3042. In such embodiments, suction through the catheter assembly 3004 can be continuous when the connector 3028 is coupled with the suction system 3006.

In the illustrated embodiment, the suction system 3006 includes a suction tube 3044, a container or suction trap 3046, and a suction, aspiration, or vacuum source 3048. The suction tube 3044 may be of any suitable variety, and may be configured to couple with the connector 3028 of the catheter assembly 3004. For example, in some embodiments, the suction tube 3044 may include a suction fitting 3045, such as the suction fitting 221 discussed above. The suction trap 3046 can be configured to permit air to pass through, but may be configured to retain therein pieces of a food bolus that are removed from a patient via the system 3000. The suction trap 3046 may include any suitable filters or other arrangements, including those known in the art or those yet to be devised. For example, the suction trap 3046 can comprise a collection cannister, such as the collection cannister 222 disclosed above. The vacuum source 3048 may be of any suitable variety. For example, in some embodiments, the vacuum source 3048 can be a dedicated vacuum line or vacuum system of a hospital.

With reference to FIG. 26, the proximal end 3010 of the sheath assembly 3002 is shown in greater detail and from a viewpoint that is rotated 90 degrees about a vertical axis relative to the view of FIG. 25. In the illustrated embodiment, the sheath hub 3014 includes a housing element 3050 that defines an entry passage or guide 3052. In the illustrated embodiment, the guide 3052 is substantially funnel shaped, which can facilitate insertion of the distal end 3022 of the catheter 3026 into a lumen 3054 of the sheath 3016.

The sheath hub 3014 further includes an actuator 3060 via which the positioning element 3018 can be deployed. In particular, in the illustrated embodiment, the actuator 3060 is configured as an inflation port 3060 via which the balloon 3019 can be selectively inflated or deflated. Stated otherwise the actuator 3060 is communicatively coupled with the balloon 3019, and, in this instances, the communication comprises fluid communication. The illustrated inflation port 3060 includes a connector 3062, such as a Luer fitting 3063, via which any suitable inflation device can be connected thereto. In various embodiments, the inflation device can be an air-, gas- liquid-, or other fluid-filled syringe or other medical fluid delivery device. In various embodiments, saline, air, nitrogen, or any other suitable fluid may be used to inflate the balloon 3019. In some embodiments, the inflation device may have its own pressure controls, such as to ensure that the fluid is delivered to the balloon 3019 within an acceptable range, or stated otherwise, does not exceed a predetermined limit. Any suitable inflation device, including any known in the art or any yet to be devised, is contemplated.

The sheath hub 3014 can further include a stopcock 3064 that can be selectively opened and closed via a handle or lever 3065. The stopcock 3064 can be opened to permit inflation or deployment of the balloon 3019, and can be closed maintain the balloon 3019 in an inflated or deployed state. In particular, the stopcock 3064 can be in an open configuration to permit passage of inflation fluid therethrough for inflation of the balloon 3019, and once the balloon 3019 has been filled to a desired amount and/or the fluid pressurized to a desired or predetermined level, the stopcock 3064 can be closed to prevent passage of the fluid back through the stopcock and thus maintain the balloon 3019 in a filled, inflated, and/or pressurized state.

The inflation port 3060 can be in fluid communication with an inflation lumen 3066, which may also be referred to as an inflation passageway, channel, etc. Stated otherwise, and is apparent from at least the foregoing, the connector 3062 is in fluid communication with the stopcock 3064, and the stopcock 3064 is in fluid communication with the inflation lumen 3066. When the stopcock 3064 is in the open state, the connector 3062 is in fluid communication with the inflation lumen 3066, and when the stopcock 3064 is in the closed state, the connector 3062 no longer fluidly communicates with the inflation lumen 3066. The stopcock 3064 may be said to be in line with, between, or fluidly coupled with the connector 3062 and the inflation lumen 3066. In the illustrated embodiment, the housing 3050 defines a proximal end of the inflation lumen 3066, and the inflation lumen 3066 extends through a sidewall of the sheath 3016. As shown in FIG. 26, an extender 3067 of any suitable variety may extend between the housing 3050 and the stopcock 3064 to establish fluid communication between the inflation port 3060 and the inflation lumen 3066. For example, the extender 3067 can comprise tubing (e.g., flexible tubing) of any suitable variety.

The extender 3067 may alternatively be referred to as an extension line. Further, the extender 3067 and the inflation port or actuator 3060 may be referred to, collectively, as an actuation branch 3068 of the sheath assembly 3002.

With reference to FIG. 27, the inflation lumen 3066 and the instrument delivery lumen 3054 of the sheath 3016 are shown in greater detail. Any suitable arrangement of the lumens 3054, 3066 is contemplated. In various embodiments, more than one inflation lumen 3066 may be present. For example, in some embodiments, one or more additional inflation lumens may be present in the sheath 3016 for redundancy in the event that one of the lumens is inadvertently blocked, such as due to kinking of the sheath 3016. The sheath 3016 may generally be referred to as a tubular member that defines a channel through which the catheter 3026 can be advanced. In particular, the sheath 3016 defines the working channel or lumen 3054.

In various embodiments, the sheath 3016 may be formed of a material and/or a thickness of the sidewall may be sufficient to provide the sheath 3016 with desirable amounts of columnar or other strength. For example, in various embodiments, the sheath 3016 can resist compression, crushing, kinking, and/or other deformation that could undesirably alter the shape of the lumen 3054 in a manner that could interfere with insertion therein and/or removal therefrom of the catheter 3026. As previously noted, the material may also be flexible so as to permit the sheath 3016 to conform to the anatomy of a patient. For example, the material may be sufficiently flexible to permit the sheath 3016 to be bent from a substantially linear arrangement to a curved arrangement as the sheath 3016 is inserted through the mouth of the patient into the esophagus, all while maintaining the lumen 3054 sufficiently patent to permit ready passage therethrough of the catheter 3026. Various suitable materials for a catheter are disclosed above, and in many instances, these and/or other suitable materials for the sheath are contemplated. For example, in various embodiments, the sheath 3016 comprises any suitable thermoplastic elastomer, such as any suitable variety of PEBAX®, available from Arkema. Moreover, in some embodiments, a lubricious layer or coating may be provided at the inner surface of the sheath 3016, which could facilitate insertion of the catheter 3026 into the lumen 3054 and/or removal of the catheter 3026 from the lumen 3054.

Any suitable size of the sheath 3016 for insertion into the esophagus is contemplated. For example, in various embodiments, the sheath 3016 (i.e., the outer diameter thereof) can be no larger than 7, 10, 15, 20, 25, or 30 French. In some embodiments, the sheath 3016 is between 7 and 30 French, between 7 and 25 French, between 7 and 20 French, or between 7 and 15 French. In some embodiments, the lumen 3054 is sized to receive a catheter 3026 that is only slightly smaller, which can allow a lumen of the catheter 3026 to be relatively large and permit ready passage therethrough of cored pieces of blockage material (e.g., food). For example, in some embodiments, the sheath 3016 is 12 French, which can be fairly easy for many patients to swallow, and the catheter 3026 can be as large as 10 or 11 French. In various embodiments, the catheter 3026 can be no less than 4, 6, 8, 10, or 12 French, or may be between 4 and 12 French.

FIG. 28A depicts the distal end 3012 of the sheath assembly 3002 when the positioning element 3018 is in the undeployed state. As can be seen, the balloon 3019 can define an outer diameter that may be only slightly greater than an outer diameter of more proximal portions of the sheath 3016 when in the undeployed state. In other embodiments, the outer diameter of the undeployed balloon 3019 may be the same as or slightly smaller than that of an adjacent portion of the sheath 3016. In the illustrated embodiment, the instrument delivery lumen 3054 extends through an axial center of the balloon 3019. Stated otherwise, the balloon 3019 encompasses a longitudinal axis of the sheath 3016.

FIG. 28B depicts the distal end 3012 of the sheath assembly 3002 when the positioning element 3018 has been transitioned to the deployed state, such as by introduction of an inflation fluid into the balloon 3019 via the inflation channel or inflation lumen 3066 (see FIG. 27). For example, as is clear from the foregoing disclosure, the inflation fluid can be introduced into the balloon 3019 by coupling a fluid-filled syringe or other medical fluid delivery device with the connector 3062, ensuring that the stopcock 3064 is in the opened state, and delivering fluid from the medical fluid delivery device through the connector 3062, through the stopcock 3064, through the inflation lumen 3066, and into the balloon 3019. Moreover, the balloon 3019 can be maintained in the deployed state by closing the stopcock 3064. As can be seen in FIG. 28B, the balloon 3019 can define an outer diameter that is significantly greater than an outer diameter of more proximal portions of the sheath 3016 when in the deployed state.

In certain embodiments, the balloon 3019 can be rotationally symmetrical when inflated. In further instances, the balloon 3019 can be configured to be rotationally symmetrical throughout inflation. Certain of such arrangements can substantially center the lumen 3054 relative to the esophagus. The inflated balloon 3019 also can anchor the lumen 3054 relative to the esophagus, or stated otherwise, the inflated balloon 3019 can stabilize the lumen 3054 relative to the esophagus to ensure the catheter tip 3023 does not come into contact with the esophageal wall. In certain embodiments, such an arrangement can ensure that the distal tip 3023 of the catheter 3026 does not come into contact with, or otherwise remains distanced from, the esophageal wall when the distal tip 3023 is advanced past the distal tip of the sheath 3016. Other arrangements are also contemplated. For example, in some embodiments, the lumen 3054 may not be centered relative to the esophagus. For example, in some embodiments, the positioning element 3018 may anchor the sheath 3016 such that a longitudinal axis thereof runs parallel to a central longitudinal axis of the esophagus. However, it may be desirable for the lumen 3054 to be centered relative to the esophagus to minimize the chances of contacting the esophagus wall with the distal tip 3023 of the catheter 3026 in any or all radial directions.

In some embodiments, the balloon 3019 is semi-compliant or non-compliant. For example, the balloon 3019 may expand to a predetermined size via application of a first amount of pressure therein, and thereafter may either expand only minimally or not at all upon further addition of pressure therein. In other or further embodiments, a portion of the balloon 3019 may be semi-compliant or non-compliant and another portion thereof can be compliant. For example, in some embodiments, a central portion of the balloon 3019 can be semi-compliant or non-compliant and one or more of a proximal or distal end of the balloon may be compliant. When the balloon 3019 is inflated to a predetermined pressure, the semi- or non-compliant portion defines a predetermined diameter, and if further pressure is applied, the proximal and/or distal ends may expand (e.g., longitudinally) to preserve the predetermined diameter of the balloon. Any suitable configuration of the balloon 3019 is contemplated. In some instances, it can be desirable for the balloon 3019 to not expand to a circumference or diameter that would damage the esophagus of the patient. On the other hand, it can be desirable for the balloon to expand by a sufficient amount to securely position the cutting distal tip 3023 of the catheter 3026 away from the esophageal wall. In some instances, the balloon can press against the esophageal wall around a full periphery of the balloon and/or around a full periphery of the inner surface of the esophageal wall.

FIG. 29 depicts the proximal end 3020 of the catheter assembly 3004 in greater detail than is shown in FIG. 25. As previously discussed, the catheter hub 3024 includes a handle 3040 and a suction port 3042. In the illustrated embodiment, the suction connector 3028 is positioned at a proximal end of the handle 3040. Other positions for the suction connector 3028 are contemplated.

FIG. 30 is a cross-sectional view of the catheter 3026. In the illustrated embodiment, the catheter 3026 includes a body 3070 and a lubricious layer 3072 at an internal surface thereof. The lubricious layer 3072 can define a lumen 3074 through which morsels of food that are removed from an impacted food bolus can pass.

The body 3070 can be formed of a material and/or can have a sidewall thickness that is sufficient to provide the catheter 3026 with desirable amounts of columnar or other strength. For example, in various embodiments, the catheter 3026 can resist compression, crushing, kinking, and/or other deformation that could undesirably alter the shape of the lumen 3074 in a manner that could interfere with passage therethrough of food morsels. Various suitable materials for the catheter 3026 are disclosed above. These and or other suitable materials are contemplated. For example, in some embodiments, the material comprises a relatively hard durometer. In other or further embodiments, the material may comprise a braided configuration. In some embodiments, the catheter 3026 may be more compliant than the sheath 3016. For example, in some embodiments, the sheath 3016 can protect the catheter 3026 from kinking or other undesired deformation. In some embodiments, the body 3070 can maintain its shape when significant suction forces are present within the lumen 3074.

The lubricious layer 3072 can be formed of any suitable material, and may have a low coefficient of friction or exhibit other physical properties that permit food morsels to pass readily by without sticking, adhering, or otherwise being stopped. In various embodiments, the lubricious layer 3072 can include one or more of PTFE or HDPE. In other embodiments, the lubricious layer 3072 may be omitted. For example, in some embodiments, the lumen 3074 is sufficiently large to reduce the chances of food morsels being stuck thereto during use. Stated otherwise, the lumen 3074 is sufficiently large to inhibit the food morsels from being stuck thereto during use.

In certain embodiments, an outer diameter of the body 3070 is sufficiently smaller than an inner diameter of the sheath 3016 to permit the body 3070 to readily pass through the sheath 3016. In some embodiments, the outer and inner diameters are sufficiently similar, however, such that the sheath 3016 can significantly limit lateral movement of the catheter 3026.

FIG. 31 depicts the distal end 3022 of the catheter assembly 3020 in greater detail than is shown in FIG. 25. In the illustrated embodiment, an inner diameter of the lumen 3074 is substantially constant along a full length of the catheter 3026. In other embodiments, such as those described in detail above, a diameter of the catheter 3026 may be narrower near the distal tip 3023 than it is along a proximal length thereof. An enlarged diameter along the proximal length may facilitate suctioning of food morsels through the catheter 3026 after those morsels are cored from the food bolus via the tip 3023.

In the illustrated embodiment, the distal tip 3023 defines a sharp edge. The edge is formed in part by a back bevel 3076 at an outer surface of the catheter 3026. Other cutting arrangements are contemplated, including those discussed further below.

FIG. 32A is an early stage in an illustrative method of using the system 3000. In the illustrated stage, the distal end 3012 of the sheath assembly 3002 is inserted into the esophagus 3090 of a patient. For example, the distal end 3012 of the sheath assembly 3002 can be inserted through the mouth of the patient and into the esophagus, as disclosed elsewhere herein. The distal tip of the sheath 3016 is advanced toward a foreign body 3092 that is lodged in the esophagus 3090. In the illustrated method, the foreign body 3092 is an impacted bolus of food, and will be referred to as such hereafter.

FIG. 32B is a subsequent stage in the illustrative method. In the illustrated stage, the sheath 3016 has been advanced distally a sufficient distance to bring the distal tip of the sheath assembly 3002 into contact with a proximal end 3098 of the food bolus 3092. In some instances, the procedure is performed blind. As apparent from the present disclosure, performing a procedure “blind” means that the procedure is not visualized, such as via a camera of an endoscope, under fluoroscopy, etc. The practitioner may be able to discern this contact with the food bolus 3092 via tactile feedback. For example, the practitioner can sense that the food bolus 3092 has been reached by a sudden increase in resistance to distal advancement of the sheath 3016.

FIG. 32C is a subsequent stage in the illustrative method. In the illustrated stage, the positioning element 3018 is deployed into contact with the esophagus 3090. For example, as apparent from other disclosures herein, an inflation device (e.g., a syringe) can be coupled with the inflation port 3060 and, with the stopcock 3064 in the open state, an inflation fluid (e.g., air) can be delivered from the inflation device into the balloon 3019 to deploy the balloon 3019. Once the balloon 3019 has been deployed, the stopcock 3064 can be closed to maintain the balloon 3019 in the deployed state. In the illustrated embodiment, the positioning element 3018, or balloon 3019, substantially centers the lumen 3054 relative to the esophagus 3090.

FIG. 32D is a subsequent stage in the illustrative method in which the distal tip 3023 of the catheter 3026 is advanced through the sheath 3016 and brought into contact with the proximal end 3098 of the food bolus 3092. In some instances, suction may be applied via the catheter 3026 throughout advancement of the catheter 3026 toward the food bolus 3092. In other instances, the practitioner may utilize tactile feedback to determine that contact has been made with the food bolus 3092, and may then instigate suction. The suction can draw a portion of the food bolus 3092 into the lumen 3074

FIG. 32E is a subsequent stage in the illustrative method in which a morsel of food 3094 from the food bolus 3092 is cut, or cored, by the distal tip 3023 of the catheter 3026 and is drawn into the lumen 3074 of the catheter 3026. In some embodiments, the catheter 3026 defines a length that is only slightly longer than a length of the sheath 3016. This maximum advanced length of the catheter 3026 may be delimited to reduce the chances of the distal tip 3023 coming into contact with the esophageal wall. In various embodiments, the distal tip 3023 is limited from moving past the distal tip of the sheath 3016 by a distance of no greater than 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, or 2.0 inches. Stated otherwise, movement of the catheter 3026 relative to the sheath 3016 is delimited to inhibit the distal tip of the catheter 3026 from coming into contact with the esophageal wall when the distal end of the catheter 3026 is extended to its distalmost orientation relative to the sheath 3016.

In view of at least the foregoing disclosure and the drawings, it is apparent that delimitation of the maximum advanced length can be due to interaction of the proximal end 3020 of the catheter assembly 3004 and the proximal end 3010 of the sheath assembly 3002. For example, in the illustrated embodiment, the distal end of the catheter 3026 is attached to the catheter hub 3024, which defines an enlarged diameter, as compared with a diameter of the catheter 3026, at the distal end of the catheter hub 3024. The catheter hub 3024 can interact with the sheath hub 3014 to delimit the maximum advanced length to which the catheter 3026 can extend past the distal end of the sheath 3016. In particular, the catheter 3026 of the catheter assembly 3004 can be advanced distally through the guide 3052 of the sheath hub 3014 of the sheath assembly 3002, whereas the distal face of the catheter hub 3024 can interfere with a proximal face of the sheath hub 3014 or with the tapered surface of the guide 3052 to delimit the distal movement of the catheter 3026.

More generally, the catheter assembly 3004 can define a stopping region 3047 (see FIG. 29) having an enlarged diameter, relative to a diameter of a working length of the catheter 3026. This stopping region 3047 can, for example, be defined at least in part by the catheter hub 3024. In the illustrated embodiment, the stopping region 3047 is defined entirely by a distal end of the catheter hub 3024. The stopping region 3047 can interfere with a portion of the sheath hub 3014 to delimit distal movement of the catheter 3026. In the illustrated embodiment, the portion of the sheath hub 3014 with which the stopping region 3047 (e.g., the distal end of the catheter hub 3014) can interfere is the proximal face of the sheath hub 3014 or a proximal end of the guide 3052.

FIG. 32F is a subsequent stage in the illustrative method in which the morsel of food 3094 has detached from the food bolus 3092 and is suctioned through the lumen 3074 of the catheter 3026.

FIG. 32G is a subsequent stage in the illustrative method in which the catheter 3026 is withdrawn from the sheath 3016. In some instances, the catheter 3026 is only partially withdrawn into the lumen 3054 so as not to inadvertently contact the esophagus. In other instances, the catheter 3026 may be fully withdrawn.

In some instances, a sufficient amount of material from the food bolus may have been withdrawn at this point for at least a portion of the food bolus to collapse by an amount sufficient to allow the food bolus to pass naturally into the stomach of the patient. Such passage may result in sudden relief to the patient, which can indicate that no further coring or clearing is needed. In some instances, the sheath 3016 and the catheter 3026 may be withdrawn together, or one after the other.

In other instances, it may be desirable to continue coring the food bolus 3092. Accordingly, in some instances, the procedure may continue, such as by positioning the system 3000 more distally within the esophagus 3090.

In some instances, the system 3000 can clear the food bolus 3092 without passing any portion of the system 3000 beyond a distal end of the food bolus 3092. In other or further instances, the system 3000 can clear the food bolus 3092 without passing any portion of the system 3000 completely through the food bolus 3092.

FIG. 32H is a subsequent stage in one such further illustrative method in which further coring of the food bolus is desired. In the depicted stage, the positioning element 3018 is returned to the undeployed configuration to permit ready movement of the sheath 3016 relative to the esophageal wall.

FIG. 32I is a subsequent stage in the further illustrative method in which the distal end of the sheath 3016 has been advanced to a more distal position within the esophagus 3090. The proximal end 3098 of the cored food bolus has been reshaped in the absence of the suctioned-off food morsel 3094.

FIG. 32J is a subsequent stage in the further illustrative method in which the positioning element 3018 is deployed again into contact with the esophagus 3090. Such repositioning can, in certain instances, permit further coring of the food bolus 3092 with little or no risk of the distal end of catheter coming into contact with the esophagus.

FIG. 32K is a subsequent stage in the further illustrative method in which the distal tip 3023 of the catheter 3026 is again brought into contact with the proximal end 3098 of the food bolus 3092 for further coring thereof.

When coring is completed, the catheter 3026 can be drawn into the sheath 3016 to shield the sharpened distal end of the catheter 3026, or may be fully withdrawn from the sheath assembly 3002. The balloon 3019 can be deflated out of contact with the esophagus and fully or partially returned to the undeployed state. For example, the stopcock 3064 can be opened to release inflation fluid (e.g., air) from the balloon 3019. The sheath 3016 may then be withdrawn from the patient.

FIG. 33A is an elevation view of a distal end of another embodiment of a sheath assembly 3102 that includes a differently shaped positioning element 3118 in an undeployed state. In some embodiments, the positioning element 3118 comprises a balloon that is compressed, folded, or otherwise formed into a low-profile arrangement such as that depicted in FIG. 33A so as to have a substantially cylindrically shaped outer surface that may be only slightly larger than a cylindrical outer surface of the sheath to which it is attached.

FIG. 33B is another elevation view of the distal end of the sheath assembly 3102 that depicts the positioning element 3118 in a deployed state in which the positioning element 3118 is substantially shaped as a frustocone. Other configurations of the deployed positioning element 3118 are contemplated. As with the positioning element 3018 described above, in certain embodiments, the positioning element 3118 can be radially symmetrical.

FIGS. 34, 35A, and 35B depict various views of another embodiment of a sheath assembly 3202 that includes a pressure regulation valve 3211. The pressure regulation valve 3211 can regulate a pressure within a positioning member 3218, such as an inflation balloon 3219. For example, the pressure regulation valve 3211 can ensure that a pressure within the inflation balloon 3219 does not exceed a preset maximum value. Such an arrangement may be configured to ensure that excess pressure that might injure or otherwise negatively impact the esophagus is not applied to the esophagus. As indicated in FIG. 34, the sheath assembly 3202 can be a component in another embodiment of a blockage clearing system 3200, such as the blockage clearing system 3000 described above.

The pressure regulation valve 3211 is depicted in fluid communication with a pressurization port 3260, which may also be referred to as an inflation port 3260. The pressure regulation valve 3211 is also depicted in fluid communication with an inflation lumen 3266. The pressure regulation valve 3211 is operationally positioned between the inflation port 3260 and the portion of the inflation lumen 3266 that is defined by a sheath 3216. Stated otherwise, the pressure regulation valve 3211 is in line with inflation port 3260 and is in line with the portion of the inflation lumen 3266 defined by the sheath 3216. In particular, in the illustrated embodiment, the pressure regulation valve 3211 is in line with each of the inflation port 3260 and the inflation lumen 3266, and further, is positioned between the inflation port 3260 and the inflation lumen 3266. The pressure regulation valve 3211 is coupled with a hub 3214. In particular, the pressure regulation valve 3211 is coupled to the hub 3214 via an extender 3267.

FIG. 35A depicts the positioning element 3218 in an undeployed state. FIG. 35B depicts the positioning element 3218 in a deployed state. FIG. 35C depicts the positioning element 3218 in a further state of operation in which the positioning element has been maintained in the deployed state at a substantially constant pressure via the pressure regulation valve 3211, despite attempts to further pressurize the positioning element via the pressurization port 3260.

FIG. 36 is an elevation view of a proximal end of another embodiment of a catheter assembly 3304 that, in some instances, may be used with a system such as the system 3000 discussed above; in other or further instances, may be used with an endoscope; or in still other instances, may be used without a sheath or endoscope. The catheter assembly 3304 can include a hub 3324 similar to the hub 3024 discussed above. For example, the catheter assembly 3304 includes a handle 3340 having a different gripping arrangement (more akin to a gun or drill) and a similar suction port 3342. The hub 3324 can further include an actuator or inflation port 3360, such as the inflation port 3060 discussed above with respect to the sheath assembly 3002.

FIG. 37 is a cross-sectional view of a catheter 3326 of the catheter assembly 3304. The catheter 3326 can resemble the catheter 3026 described above in many respects, but may further include an inflation channel or inflation lumen 3366, such as the like-numbered lumen 3066 discussed above with respect to the sheath 3016.

FIG. 38A is an elevation view of a distal end of the catheter assembly 3304 in which a positioning element 3318 is depicted in an undeployed state. The positioning element 3318 can function in the same manner as other positioning elements described above, and may be in fluid communication with the inflation lumen 3366. The positioning element 3318 can distance a distal tip 3323 of the catheter 3326 from the esophagus wall when deployed. For example, the positioning element 3318 may be symmetrical and/or may center the distal tip 3323 from the esophagus. In the illustrated embodiment, the distal tip 3323 is positioned at a distance distally from the distal end of the positioning element 3318.

FIG. 38B is another elevation view of the distal end of the catheter assembly 3304 in which the positioning element 3318 is depicted in a deployed state, such as described with respect to various other embodiments above.

FIG. 39A is an elevation view of a distal end of another embodiment of a catheter assembly 3404 that includes a differently shaped positioning element 3418 that is depicted in an undeployed state. FIG. 39B is another elevation view of the distal end of the catheter assembly 3404 that depicts the positioning element 3418 in a deployed state. In some embodiments, the catheter assembly 3404 is used to clear an impacted food bolus in manners such as described above, but without a sheath. In other embodiments, the catheter assembly 3404 is used with a sheath, such as the sheath 3016, in manners such as described above. For example, both the sheath 3016 and the catheter assembly 3404 can include inflatable positioning members that inhibit contact between the esophagus and the catheter. In still other or further embodiments, the catheter assembly 3404 can instead be inserted into the esophagus of a patient through the working channel of an endoscope. The positioning element 3418 can be advanced past a distal end of the endoscope and deployed into contact with the esophagus to prevent inadvertent contact of the distal tip of the catheter to the esophageal wall.

FIG. 40A is an elevation view of a distal end of another embodiment of a catheter assembly 3504 that includes a differently shaped and differently oriented positioning element 3518 that is depicted in an undeployed state. FIG. 40B is another elevation view of the distal end of the catheter assembly 3504 that depicts the positioning element in a deployed state. When deployed, the positioning element 3518 is substantially donut-shaped. The positioning element 3518 is also closer to the distal end of the catheter assembly 3504. In some embodiments, the catheter assembly 3504 can be particularly well-suited for use with a sheath and/or an endoscope, such as, for example, those previously described. The positioning element 3518 may be advanced just beyond a distal tip of the sheath or endoscope before being deployed, in some instances.

FIG. 41 is an elevation view of a distal end of another embodiment of a catheter assembly 3604 that depicts a distal tip 3623 of a catheter 3626 that includes an internal bevel 3676. For example, the internal bevel 3676 may be formed as a conical chamfer.

FIGS. 42 and 43 depict a distal end of another embodiment of a catheter assembly 3704 that includes a catheter 3726 that has a distal tip 3723 that is substantially flat. The catheter assembly 3704 includes a cutting element 3775, such as a blade, that is recessed from the distal tip 3723 within a lumen of the catheter 3726. The cutting element 3775 includes a cutting edge 3777, which is substantially circular in the illustrated embodiment. The cutting element 3775 is attached to the catheter 3726 via a plurality of brackets or supports 3779. A cutting area of the cutting edge 3777 can be smaller than an inner diameter of a lumen of the catheter 3726.

FIG. 44 is an elevation view of a distal end of another embodiment of a catheter assembly 3804 that depicts a distal tip 3823 of a catheter 3826 that is substantially rounded and that includes a cutting element 3875 that is recessed from the distal tip 3823 within a lumen of the catheter. The catheter assembly 3804 further includes a positioning element or centering balloon 3819, which can function similarly to other embodiments described herein. The rounded tip 3823 may be substantially atraumatic to the esophagus. The recessed cutting element 3875 may further aid in preventing inadvertent damage to the esophagus. The centering balloon 3819 may likewise prevent inadvertent damage to the esophagus when deployed. As with other embodiments described herein, the catheter assembly 3804 may be used with or without a sheath or endoscope, in various embodiments. Catheter assemblies such as the assembly 3804 may also be referred to as catheter systems.

FIG. 45 is an elevation view of another embodiment of a blockage clearing system 4000 that can resemble blockage clearing systems described above (e.g., the systems 3000, 3200) in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to “40.” Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the system 4000 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the system 4000 and components thereof. Any suitable combination of the features and variations of the same described with respect to the systems 3000, 3200 can be employed with the system 4000, and vice versa. More generally, any suitable combination of like-numbered components herein is contemplated. Thus, for example, any of the positioning element arrangements 3018, 3118, 3218, 3318, 3418, 3518, 3819 disclosed above, and the positioning element arrangements described hereafter, may be used in place of any of the other positioning elements, mutatis mutandis. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter, wherein the leading digits may be further incremented.

The system 4000 is shown in a pre-use, undeployed, packaged, or insertion state. In particular, the system 4000 is shown in a state in which it may be packaged, or stated otherwise, in a state in which it exists when removed from packaging by a user (e.g., medical practitioner) for insertion into a patient. The system 4000 can include a sheath assembly 4002 and a catheter assembly 4004, such as like-numbered features previously disclosed. The sheath assembly 4002 is discussed further below with respect to at least FIGS. 46-50, and the catheter assembly 4004 is discussed further below with respect to at least FIGS. 51-53.

The system 4000 further includes a retainer or spacer 4080 that can maintain a fixed relative orientation of the sheath assembly 4002 and the catheter assembly 4004. Stated otherwise, the spacer 4080 can maintain a fixed longitudinal relationship, such as a fixed longitudinal separation, between hubs of the sheath assembly 4002 and the catheter assembly 4004. Maintenance of such a fixed relationship between the hubs can likewise maintain a fixed longitudinal relationship between the distal tips of the sheath assembly 4002 and the catheter assembly 4004. For example, as further discussed below, the spacer 4080 can ensure that a distal tip of the catheter assembly 4004, which may comprise a sharpened cutting tip, is positioned at an interior of the sheath assembly 4004 (e.g., is proximally recessed relative to a distal tip of the sheath assembly 4004) when the spacer 4080 is in place. Such an arrangement may be useful to ensure that the cutting surface of the catheter does not inadvertently come into contact with the anatomy of a patient as the system 4000 is being introduced into the patient (e.g., into the esophagus of the patient). Accordingly, in some instances, the system 4000 may be provided in the assembled state shown with the spacer 4080 in place. For example, the system 4000 may be packaged with the spacer 4080 positioned in engagement with the sheath assembly 4002 and the catheter assembly 4004.

In the illustrated embodiment, the spacer 4080 is formed as a clip 4082 that is selectively attachable to and detachable from specific regions of the sheath assembly 4002 and the catheter assembly 4004. In other embodiments, the clip 4082 may only be selectively detachable from the sheath assembly 4002 and the catheter assembly 4004. For example, in some embodiments, portions of the clip 4082 may be permanently attached to the sheath assembly 4002 and the catheter assembly 4004, respectively, and a further portion of the clip 4082 may permanently detach from the portions that are attached to the sheath assembly 4002 and the catheter assembly 4004 to permit relative movement of the sheath assembly 4002 and the catheter assembly 4004. In some instances, the clip 4082 may be provided with the system 4000 in an initial or pre-deployment state (e.g., a packaged state), and may be used during an initial insertion of the system 4000 into the patient and into contact with a blockage, such as a food impaction. The detachable portion of the clip 4082 (e.g., the clip 4082 in its entirety or a detachable portion thereof) may then be removed to permit relative longitudinal movement of the sheath assembly 4002 and the catheter assembly 4004, as discussed further below.

FIG. 46 is an elevation view of the sheath assembly 4002 in a deployed state. As with other sheath assemblies previously discussed (e.g., the sheath assemblies 3002, 3202), the sheath assembly 4002 can include an inflation port 4060, which can include a connector 4062, such as a luer fitting 4063. The inflation port 4060 can further include a stopcock 4064, which can be transitioned between open and closed states via a knob or lever 4065. The inflation port 4060 can be formed of any suitable materials. For example, in some embodiments, the inflation port 4060 comprises polycarbonate.

As with other embodiments described herein, the inflation port 4060 can be coupled with a sheath hub 4014 in any suitable manner. In the illustrated embodiment, the inflation port 4060 is coupled to an extender 4067, such as tubing of any suitable construct, and the extender 4067 is coupled to the hub 4014. The extender tubing can comprise any suitable material. For example, in some embodiments, the tubing comprises TYGON®, available from Saint-Gobain Performance Plastics. The extender 4067 can be attached to a connector portion of the stopcock 4064 in any suitable manner.

The hub 4014 can include a housing 4050, which is discussed further below with respect to FIGS. 47 and 48. In some embodiments, a pressure regulation valve 4011 is coupled with the housing 4050. In particular, in the illustrated embodiment, the pressure regulation valve 4011 is directly connected to the housing 4050. The hub 4014 can further be coupled with a sheath 4016 and a strain relief sleeve 4015. The pressure regulation valve 4011 may also be referred to as a pressure regulator.

As with other embodiments disclosed herein, the sheath 4016 can be coupled with a positioning element 4018, such as an inflatable balloon 4019. In some embodiments, the sheath 4016 can include a soft or atraumatic distal tip 4013.

As with the inflation port 3060 discussed above, the inflation port 4060 may also be referred to as an actuator. As further discussed below, the inflation port 4060 is configured to be actuated to achieve deployment of the positioning element 4018, and can be further actuated to achieve retraction of the positioning element 4018.

With reference again to FIG. 45, in some embodiments, the sheath 4016 can include one or more depth indicia or indicators 4084. The indicators 4084 can comprise any suitable marking or other signaling element to provide a visual cue to a user to indicate a depth to which the distal tip of the sheath assembly 4002 has been inserted into a patient. For example, the one or more indicators 4084 can be printed or may be formed as laser markings. In some embodiments, one of the indicators—for example, the distalmost indicator 4084—may indicate a minimum depth to which the distal tip of the sheath assembly 4002 should desirably be inserted prior to deployment of the positioning element 4018. For example, in some embodiments, the minimum depth indicator 4084 is positioned, e.g., 25 centimeters from the distal tip of the sheath 4016. A practitioner may use the minimum depth indicator 4084 to ensure that the distal tip of the sheath 4016 has been inserted to a sufficient depth past the incisors of the patient, which can ensure that the positioning element 4018 is not deployed within the pharynx of the patient. In various embodiments, the minimum depth indicator 4084 may be closer to or further from the distal tip of the sheath 4016 than 25 centimeters. In some instances, the minimum depth indicator 4084 is selected to ensure that the pharynx of any patient, regardless of patient size or anatomy variation, will be avoided when the positioning element 4018 is deployed.

With reference to FIGS. 47 and 48, the hub 4014 can include a housing 4050, which can be formed in any suitable manner. For example, the housing 4050 may be an injection-molded plastic component. In some embodiments, the housing 4050 comprises polycarbonate.

The housing 4050 can define a connector 4055 at a proximal end thereof. For example, in some embodiments, the connector 4055 comprises a luer fitting 4056. The connector 4055 can permit selective coupling with any suitable medical device to provide the medical device with access to an instrument delivery lumen 4054 defined by the sheath 4016 (see FIG. 49). For example, if a practitioner desires to flush the instrument delivery lumen 4054 of the sheath 4016, a flushing syringe could be coupled with the connector 4055 and fluid dispensed through the instrument delivery lumen 4054.

The connector 4055 portion of the housing 4050 can define an entry passage or guide 4052. In the illustrated embodiment, the guide 4052 is substantially funnel shaped, which can facilitate insertion of a distal end of a catheter portion of the catheter assembly 4004 into the instrument delivery lumen 4054 of the sheath 4016. In particular, in the illustrated embodiment, the guide 4052 defines a luer taper that decreases in diameter in the distal direction.

The housing 4050 can further define a connector 4057, such as a flanged or ribbed post, or the like, to which the extender 4067 can be attached in any suitable manner. Similarly, the housing 4050 can define a connector 4058, such a flanged or ribbed post, or the like, to which the strain relief sleeve 4015 can be attached in any suitable manner. For example, as shown in FIG. 48, in the illustrated embodiment, the extender 4067 is fitted over the connector 4057 and the strain relief sleeve 4015 is fitted over the connector 4058 to achieve said attachments.

The housing 4050 can define a sheath receptacle 4059 into which a proximal end of the sheath 4016 can be received. The sheath 4016 can be inserted into the sheath receptacle 4059 until the proximal end contacts a ledge at the proximal end of the receptacle. The proximal end of the sheath 4016 thus may be at or slightly below a distal end of the guide 4052 when the sheath 4016 has been secured to the housing 4050.

The housing 4050 can further define an inflation channel or lumen 4066a that extends through the connector 4057 and that terminates at and is in fluid communication with the sheath receptacle 4059. The housing 4050 can further define an inflation channel or lumen 4066b that extends from a valve receptacle 4069 to the lumen 4066a. In particular, the lumen 4066b intersects the lumen 4066 at a junction 4061. Stated otherwise, fluid communication between the lumens 4066a, 4066b is established at the junction 4061. The lumens 4066a, 4066b are in fluid communication with each other and define separate branches of a unitary fluid passageway defined by the housing 4050. Stated otherwise, the channels 4066a, 4066b may be considered to be, and may also be referred to as, separate branches of a unitary inflation passageway or inflation lumen 4066, of which a proximal end is defined by the housing 4050 and a distal end is defined by the sheath 4016. That is, as with other embodiments herein, and as previously noted, the sheath assembly 4002 can include multiple lumens for expanding the balloon 4019, including one or more lumens that extend through the sheath 4016. All of the lumens may be interconnected or in fluid communication with each other, and may collectively define the fluid passageway or inflation lumen 4066.

With reference to FIG. 49, in the illustrated embodiment, the sheath 4016 defines two separate inflation lumens 4066c, 4066d that are each in fluid communication with the inflation lumen 4066a defined by the housing 4050 at or near their proximal ends, and further, are in fluid communication with an interior of the balloon 4019 at or near their distal ends. The inflation lumens 4066c, 4066d define the distal end of the inflation passageway or inflation lumen 4066 of the sheath assembly 4002. As previously noted, in some embodiments, it can be advantageous for the sheath 4016 to define two or more inflation lumens, such as, for example, for purposes of redundancy in the event that one of the lumens 4066c, 4066d is inadvertently blocked (e.g., due to kinking of the sheath 4016). Thus, even if one lumen 4066c, 4066d becomes obstructed, the other can permit inflation or deflation of the balloon 4019.

Again, as previously mentioned, the inflation lumen 4066 can be a unitary lumen or fluid pathway or passageway that includes a plurality of interconnected lumens or branches 4066a, 4066b, 4066c, 4066d. In the illustrated embodiment, the inflation lumens 4066a, 4066b are connected and in fluid communication with each other at the junction 4061. Further, the inflation lumens 4066c, 4066d are in fluid communication with the distal end of the inflation lumen 4066a at their proximal ends, and are in fluid communication with an interior of the balloon 4019 at their distal ends. In this manner, a pressure within the balloon 4019 and within any of the inflation lumens 4066a, 4066b, 4066c, 4066d can be substantially the same at any given time. Stated otherwise, the inflation lumens 4066a, 4066b, 4066c, 4066d and the balloon 4019 can be pressurized substantially in unison, or may increase in pressure substantially concurrently and/or substantially at the same rate during deployment of the balloon 4019.

For example, in some instances, an air-filled syringe can be coupled with the connector 4062. The stopcock 4064 can be oriented in an open state (e.g., the lever 4065 can be rotated to the open state). To deploy the balloon 4019, a plunger of the syringe can be depressed. This can cause air to flow from the syringe, through the stopcock 4064, through the extender 4067, into the inflation lumen 4066a, and from the inflation lumen 4066a into the inflation lumen 4066b, and further, into the inflation lumens 4066c, 4066d of the sheath 4016 and from thence into the balloon 4019. Once air has passed into all of these cavities, pressurization in each of the branches of the inflation lumen 4066 and within the balloon 4019 can proceed substantially in unison as more air is urged from the syringe and, after full deployment of the balloon 4019 (which, in some embodiments, may be non-compliant or semi-compliant) is compressed within a fixed-volume inflation fluid receptacle defined by the inflation lumen 4066 and the expanded balloon 4019.

With reference again to FIGS. 47 and 48, the pressure regulation valve 4011 is attached to the housing 4050 within the valve receptacle 4069. In some instances, the pressure regulation valve 4011 may be secured in place via an adhesive. The pressure regulation valve 4011 can be of any suitable variety. For example, the pressure regulation valve 4011 can comprise a check valve that is configured to permit passage therethrough of a fluid (e.g., air) at or above a cracking pressure. Any suitable commercially available or other variety of check valve is contemplated. For example, in some embodiments, a commercially available cartridge check valve or pressure relief valve is used. The check valve 4011 is positioned such that an entry port thereof 4017a is in fluid communication with the inflation channel 4066b, and hence with the inflation channel 4066a. More generally, the entry port 4017a of the check valve 4011 is in fluid communication with the inflation passageway or inflation lumen 4066 of the sheath assembly 4002. Further, in the illustrated embodiment, the pressure regulation valve 4011 is oriented such that an exit port 4017b thereof is in fluid communication with an environment external to the housing 4014. The pressure regulation valve 4011 thus can leak inflation fluid (e.g., air) to the environment when a threshold pressure—i.e., the cracking pressure—is reached or exceeded within the inflation lumen 4066 and within the balloon 4019.

Accordingly, the pressure regulation valve can regulate a pressure within the balloon 4019. For example, the pressure regulation valve 4011 can ensure that a pressure within the inflation balloon 4019 does not exceed a preset maximum value, which corresponds with the cracking pressure of the valve. Such an arrangement may be configured to ensure that excess pressure that might injure or otherwise negatively impact the esophagus is not applied to the esophagus.

The pressure regulation valve 4011 is depicted as being in fluid communication with the pressurization or inflation port 4060. In particular, with reference to FIGS. 46 and 48, the pressure regulation valve 4011 is in fluid communication with the inflation lumen 4066 (FIG. 48), the inflation lumen 4066 is in fluid communication with the tubing 4067 (FIG. 48), and the tubing 4067 is in fluid communication with the inflation port 4060 (FIG. 46). The pressure regulation valve 4011 is operationally positioned between the inflation port 4060 and the portion of the inflation lumen 4066 defined by the sheath 4016 (e.g., the inflation lumens 4066c, 4066d, as shown in FIG. 49). Stated otherwise, the pressure regulation valve 4011 is in line with the inflation port 4060 and is in line with the portion of the inflation lumen 4066 defined by the sheath 4016 (e.g., the inflation lumens 4066c, 4066d). In particular, in the illustrated embodiment, the pressure regulation valve 4011 is fluidly coupled to the inflation lumen 4066 at a position that is in line with or is between the inflation port 4060 and the portion of the lumen 4066 that is defined by the sheath 4016 (e.g., the inflation lumens 4066c, 4066d).

The pressure regulation valve 4011 is coupled with the hub 4014. In particular, in the illustrated embodiment, the pressure regulation valve 4011 is directly attached to the hub 4014.

Any suitable cracking pressure of the pressure regulation valve 4011 is contemplated. The cracking pressure may be relatively low to ensure that the balloon 4019 does not deform the esophagus, does not significantly deform the esophagus, or does not deform the esophagus beyond an acceptable amount (e.g., an amount less than that at which injury might occur). In various embodiments, the cracking pressure, which may also be referred to as the threshold pressure, is no greater than 3 psi, 4 psi, or 5 psi. In one embodiment, the cracking pressure is about 4.5 psi (e.g., may be set at 4.56 psi). In other embodiments, higher cracking pressures may be used, such as cracking pressures no greater than 6, 7, or 8 psi.

One or more of the connections previously described with respect to the sheath assembly 4002 may be further secured with adhesive. For example, any suitable light curing adhesive is contemplated, including, without limitation, MD 204-CTH-F flexible catheter-bonding adhesive, available from Dymax. For example, adhesive may be used to bond the connections between the extender 4067 and each of the stopcock 4060 and the housing 4050, between the sheath 4016 and the housing 4050, between the valve 4011 and the housing 4050, etc.

With reference to FIGS. 46 and 48, the strain relief sleeve 4015 can be positioned over a proximal portion of the sheath 4016 and over the connector 4058 at the distal end of the housing 4050. In some embodiments, the strain relief sleeve 4015 may be heat shrunk in place. Any suitable material for the strain relief sleeve 4015 is contemplated. For example, in some embodiments, the strain relief sleeve 4015 can comprise a polyolefin.

The strain relief sleeve 4015 can reinforce a proximal end of the sheath 4016. For example, in some instances, the strain relief sleeve 4015 can contribute to a columnar strength of the sheath 4016 and can stiffen the sheath 4016. In some embodiments, this stiffening can facilitate insertion of the sheath 4016 into the esophagus of the patient, such as in instances where the sheath 4016 is relatively compliant. In other or further instances, the strain relief sleeve 4015 can inhibit or prevent kinking of the sheath 4016, such as kinking that might otherwise close one or more of the inflation lumens 4066a, 4066b. In some instances, the sheath 4016 is sufficiently long to cover and reinforce regions of the sheath 4016 that may be most prone to bending or kinking, such as a region at or near the connector 4058 and/or a region (which may be the same or a different region) at or near a portion of the sheath 4016 that undergoes maximum bending during insertion of the sheath 4016 into the esophagus, such as to conform to the anatomy between the mouth and the esophagus.

With reference to FIG. 49, the sheath 4016 can be formed in any suitable manner. For example, in some embodiments, the sheath 4016 comprises a tri-lumen extrusion. The sheath 4016 can comprise any suitable material, as previously discussed. In the illustrated embodiment, the sheath 4016 comprises a thermoplastic elastomer, such as PEBAX®. For example, in some embodiments, the sheath 4016 comprises PEBAX® 5533 SA 01 MED. In other or further embodiments, the sheath 4016 can comprise nylon 12 or PEBAX® 7233.

With reference to FIG. 50, the atraumatic tip 4013 can be formed in any suitable manner. The tip 4013 can be formed of a material that is softer than the remainder of the sheath 4016. For example, in some embodiments, the sheath 4016 comprises a thermoplastic elastomer, such as PEBAX®, which could be a softer version than is used for the remainder of the shaft, such as, for example, PEBAX® 3533 SA 01 MED. Any suitable manufacturing techniques for forming the tip 4013 are contemplated, such as, for example, reflowing and tipping.

With reference again to FIGS. 47 and 48, the proximal end of the sheath 4016 can be positioned within the receptacle 4059 such that both lumens 4066c, 4066d are oriented toward the inflation lumen 4066a defined by the housing 4050. One or more openings 4090 can be formed through the sidewall of the sheath 4016 into the lumens 4066c, 4066d in a region that aligns with the inflation lumen 4066a of the housing to fluidly couple the lumen 4066a with the lumens 4066c, 4066d. The one or more openings 4090 can be formed in any suitable manner. For example, in some instances, a fixture that includes one or more blades can retain the unfinished sheath 4016 therein and slice through a portion of the sidewall of the sheath 4016 to provide access to each lumen 4066c, 4066d individually (e.g., by forming two longitudinal slices) or to provide access to both of the lumens 4066c, 4066d collectively, such as via a single cut through the sidewall that provides fluid communication into each of the lumens 4066c, 4066d.

As previously discussed, in some embodiments, the sheath 4016 is formed as a thin-walled triple-lumen extrusion having a cross-section such as that depicted in FIG. 49. In some embodiments, the lumens 4066c, 4066d are closed at their proximal and distal ends in any suitable manner, thus permitting the lumens 4066c, 4066d to hold a fluid (e.g., air) therein and withstand pressure increases, such as previously discussed. The proximal and distal ends of the lumens 4066c, 4066d can be closed or sealed, e.g., so as to be fluid-tight and pressure-resistant, in any suitable manner. For example, in some embodiments, the sidewall of the extrusion in the region of the proximal and distal ends of the lumens 4066c, 4066d is heated or reflowed and reshaped to close off the proximal and distal ends of the lumens 4066c, 4066d.

With reference to FIG. 50, one or more openings (not shown) can be formed through the sidewall of the sheath 4016 into the lumens 4066c, 4066d in a region that is internal to an inflatable portion of the balloon 4019. The one or more openings can be formed in manners such as discussed above with respect to the one or more openings 4090 (FIG. 48). Accordingly, the interior of the balloon 4019 can be in fluid communication with the lumens 4066c, 4066d of the sheath 4016, with the lumens 4066a, 4066b of the housing, with the pressure regulation valve 4011, and with the inflation port 4060. The stopcock 4064 of the inflation port can selectively be opened and closed to selectively establish and terminate, respectively, fluid communication between the connector 4063 and the balloon 4019.

Accordingly, when the stopcock 4064 is open, a fluid delivery device (e.g., an air-filled syringe) coupled with the connector 4063 can urge fluid into the balloon 4019 to deploy the balloon 4019. The fluid can fully deploy the balloon 4019. Whether concurrently upon reaching the fully deployed state of the balloon 4019, or whether at some point thereafter due to continued addition of fluid into the balloon 4019, a pressure within the balloon 4019 can reach the threshold value. At this point, if attempts to pressurize the balloon 4019 above the threshold value, the pressure regulation valve 4011 will permit fluid to escape to the environment to maintain the balloon 4019 at the threshold value of pressure. Accordingly, the valve 4011 can maintain the balloon 4019 in the deployed state at a substantially constant pressure, despite attempts to further pressurize the balloon 4019 via the inflation or pressurization port 4060. The stopcock 4064 can be closed to maintain the fluid within the sheath assembly 4002 and maintain the balloon 4019 in the deployed state.

The term “fluid” can refer herein to one or more gases, one or more liquids, or a combination thereof. For example, an inflation fluid used with the balloon 4019 can comprise one or more of air, nitrogen, water, saline solution, etc. In some embodiments, the fluid is air.

In the illustrated embodiment, the balloon 4019 includes a proximal sleeve or extension 4019p and a distal sleeve or extension 4019d. The extensions 4019p, 4019d can be attached to the sheath 4016 in any suitable manner. For example, in some embodiments, the extensions 4019p, 4019d are bonded or otherwise secured to the sheath 4016 to form fluid tight seals at the proximal and distal ends of the balloon 4019.

As previously discussed, in various embodiments, the balloon 4019 is semi-compliant or non-compliant. For example, the balloon 4019 may expand to a predetermined size via application of a first amount of pressure therein, and thereafter may either expand only minimally or not expand at all upon further addition of pressure therein. Stated otherwise, the balloon 4019 may define a preformed shape, such as the shape depicted in FIG. 50, to which it is inflated when deployed.

For example, with reference to FIG. 45, during manufacture, after the balloon 4019 has been secured to the sheath 4016, the balloon 4019 may be deflated (e.g., via application of a vacuum at the inflation port 4060) or otherwise transitioned to a compressed, deflated, retracted, undeployed, wrapped, folded, or packaged state, as shown. A protective sleeve 4098 or other suitable cover may be placed over the balloon 4019 for packaging. When the sheath assembly 4002 is ready for use, the protective sleeve 4098 can be removed and the balloon 4019 can be advanced to the desired position within the esophagus. The balloon 4019 may maintain its low-profile configuration throughout insertion, such as may result from having been contained within the protective sleeve 4098 for an extended period.

The balloon 4019 can then be inflated into contact with the esophagus, in manners such as previously discussed. Throughout the inflation, the balloon 4019 may undergo little or no stretching. Rather, the balloon 4019 may be flexible so as to be compacted or compressed into its pre-use state, and then can be inflated to its preformed shape without, or substantially without, stretching the material of which the balloon 4019 is formed. Any suitable material is contemplated for the balloon 4019. For example, in some embodiments, the balloon 4019 comprises a thermoplastic polyurethane elastomer, such as PELL_ETHANE®, which is available from Lubrizol. In particular, in some embodiments, the balloon 4019 comprises PELL_ETHANE® having a Shore A hardness 90. Other materials are also contemplated. In some embodiments, the balloon 4019 may be more compliant and may be configured to stretch into a desired shape when a predetermined pressure is applied therein.

With reference again to FIG. 46, the balloon 4019 can define any suitable shape and configuration. As with other embodiments disclosed herein, the illustrated balloon 4019 is substantially cylindrical with curved edges. The balloon 4019 defines a length L_Band a width W_B, which may also be referred to as the diameter of the balloon 4019. In the illustrated embodiment, the length L_Bis greater than the width W_B. In various embodiments, the length L_Bis within a range of from about 1 to about 5 centimeters, from about 2 to about 4 centimeters, or from about 2.5 to about 3.5 centimeters; is no less than about 2, 2.5, 3, 3.5, 4, 4.5 or 5 centimeters; is no greater than about 2, 2.5, 3, 3.5, 4, 4.5, or 5 centimeters; or is about 2, 2.5, 3, 3.5, 4, 4.5, or 5 centimeters. In other or further embodiments, the width W_Bis within a range of from about 1.5 to about 3.5 centimeters or from about 2 to about 3 centimeters; is no less than about 1.5, 2, 2.5, 3, or 3.5 centimeters; is no greater than 1.5, 2, 2.5, 3, or 3.5 centimeters; or is about 1.5, 2, 2.5, 3, or 3.5 centimeters. For example, in the illustrated embodiment, the length L_Bis 3 centimeters and the width W_Bis 2.5 centimeters.

The sheath assembly 4002 can define a total length L_Tbetween its proximal and distal tips, and can further define a working length L_W, which may represent a portion of the sheath assembly 4002 that can generally be manipulated for insertion into a patient. The working length L_Wmay, in some embodiments, desirably be sufficiently long to permit the distal, atraumatic tip 4013 to be inserted sufficiently deep into the esophagus of any of a variety of patients, including those having the largest anatomies, to be able to access a food impaction situated at or near the bottom of the esophagus. In various embodiments, the working length L_Wis no less than about 50, 55, 60, 65, or 70 centimeters; is no greater than about 50, 55, 60, 65, or 70 centimeters; or is about 50, 55, 60, 65, or 70 centimeters. In the illustrated embodiment, the total length L_Tis 64.5 centimeters and the working length L_Wis 60 centimeters.

As previously discussed, a variety of sizes are contemplated for the sheath 4016. In the illustrated embodiment, the sheath 4016 is 12 French. Similarly, a variety of sizes are contemplated for the instrument delivery lumen 4054 of the sheath 4016. In the illustrated embodiment, the minimum inner diameter of the delivery lumen 4054 (e.g., along the horizontal dimension in FIG. 49) is 0.133 inches.

FIG. 51 depicts a catheter assembly 4004 that can be well suited for use with the sheath assembly 4002. Other embodiments of catheter assemblies disclosed herein are also possible. In the illustrated embodiment, the catheter assembly 4004 includes a catheter hub 4024 that is fixedly secured to a proximal end of a catheter 4026, and is further connected to a proximal end of a strain relief sleeve 4025.

The catheter hub 4024 includes a suction connector 4028 at a proximal end thereof. The suction connector 4028 can be a tapered suction fitting 4029 of any suitable variety, including those presently in use and suitable for connection to a variety of different sizes and constructions of vacuum line tubing. For example, the connector 4028 can be configured for slip fit connection to the vacuum system of a hospital via any suitable tubing. The hub 4024 can further include a handle 4040, which may include grips 4041 for increased traction. The hub 4024 may define a distally projecting connector 4043, similar to the connector 4058 of the sheath hub 4014 (see FIG. 47), through which the catheter 4026 is inserted for connection to an interior of the hub 4014 and over which the strain relief sleeve 4025 is secured.

The various components of the catheter assembly 4004 can be formed of any suitable materials. In the illustrated embodiment, the hub 4024 comprises polycarbonate and the strain relief sleeve 4025 comprises a heat shrink polyolefin.

With reference to FIG. 52, the catheter 4026 can include a lubricious inner layer 4072 of any suitable variety. In the illustrated embodiment, the layer 4072 comprises a PTFE liner. The catheter 4026 can further include a body 4070 that includes a braided material and a polymeric material. In particular, the body 4070 includes a braided layer 4073 and an outer layer 4075 of polymeric material, which can extend into the braided layer 4073. In the illustrated embodiment, the braided layer 4073 comprises a layer of braided 304 stainless steel, and the outer layer 4075 comprises nylon 12. The illustrated embodiment also includes a distal tip 4023, which may include one or more different and/or additional materials from other portions of the catheter. For example, in the illustrated embodiment, the tip may be formed of or include polyethylene terephthalate (PET). Any other suitable composition of the catheter 4026 is contemplated.

Standard methods may be used to manufacture the catheter 4026. For example, the catheter 4026 may be formed via a “stick build” in which the PTFE liner 4072 is placed over a mandrel, the stainless steel is braided over the PTFE liner 4072 to form the braided layer 4073, a single-lumen extrusion of nylon 12 is slid over the braid, and then the materials are heated and reflowed.

With reference again to FIG. 51, the catheter 4026 can include a depth indicator 4027, which can provide information regarding a position of the distal tip 4023 of the catheter 4026 within the sheath assembly 4002. In the illustrated embodiment, the depth indicator 4027 comprises a transition line 4026t between a proximal portion 4026p and a distal portion 4026d of the catheter 4026. In some embodiments, the proximal and distal portions 4026p, 4026d of the catheter are different colors to provide a readily observable visual cue. For example, in one embodiment, the proximal portion 4026p is white and the distal portion 4026d is gray. Any other suitable indicium for the depth indicator 4027 is contemplated. For example, in other or further embodiments, the critical depth can be identified with a printed or laser marking. In the illustrated embodiment, the catheter 4026 can be formed in manners such as previously disclosed, but utilizing two different single-lumen extrusions of nylon 12 each having different colorants. The extrusions can be situated end-to-end over the braided layer 4073 prior to reflowing.

The distal portion 4026d of the catheter 4026 may define a retraction length L_Rthat is slightly shorter than the total length L_Tof the sheath assembly 4002 (see FIG. 46). In this manner, a practitioner may have a visual cue that the distal tip 4023 of the catheter 4026 is safely withdrawn within an interior of the sheath 4016 when, for example, a proximal end of the gray distal portion 4026d of the catheter 4026 is visible outside of the proximal end of the sheath assembly 4002. It can be desirable for the distal tip 4023 to be within the sheath 4016 prior to insertion or repositioning of the system 4000 into or within the patient to ensure that the atraumatic tip 4013 of the sheath 4016 is the leading tip of the system 4000, rather than the sharper coring tip 4023 of the catheter 4026. In various embodiments, the retraction length L_Ris shorter than the total length L_Tof the sheath assembly 4002 by no less than about 0.4, 0.5, 0.6, 0.7, 0.8 centimeters. For example, in the illustrated embodiment, the retraction length L_Ris shorter than the total length L_Tof the sheath assembly 4002 by about 0.6 centimeters. In some instances, such an arrangement can ensure that the distal tip 4023 of the catheter 4026 is safely stowed in the sheath 4016 (e.g., is proximally recessed relative to the distal tip of the sheath 4016), while permitting the catheter 4026 to support (e.g., inhibit the kinking or other undesired deformation of) nearly an entire length of the sheath 4016.

Similarly, the proximal portion 4026p of the catheter 4026 and the strain relief sleeve 4025 can define an exposed length L_Eof which an entirety should be visible beyond the proximal end of the sheath assembly 4002 to ensure that the distal tip 4023 of the catheter 4026 is safely retracted within the sheath 4016. The exposed length L_Eat the proximal end of the catheter 4026 can be slightly longer than an exposable length of the distal end of the catheter 4026 that is permitted to extend past the distal tip 4013 of the sheath 4016 during coring and suctioning. In particular, in some embodiments, the exposed length L_Eat the proximal end of the catheter 4026 is longer than the exposable length at the distal end of the catheter 4026 by the same distance to which the distal tip 4023 of the catheter 4026 is retracted from the distal tip 4013 of the sheath 4016 when the interface of the proximal and distal portions 4026p, 4026d of the catheter 4026 is flush with the proximal tip of the sheath assembly 4002.

As discussed elsewhere herein, in some instances, it can be desirable for the exposable length at the distal end of the catheter 4026 to be relatively short to ensure that the distal tip 4013 of the catheter does not inadvertently come into contact with the esophagus. For example, in various embodiments, the exposable length may be no greater than 0.75, 1.0, 1.25, 1.5, or 2.0 inches. In some embodiments, such as illustrated, the exposed length L_Ecan include at least a portion of a length of the strain relief sleeve 4025. In other embodiments, a proximal end of the exposed length L_Eterminates substantially at a proximal end of a portion of the catheter 4026 that is not covered by the strain relief sleeve 4025.

As with other embodiments disclosed herein, the catheter assembly 4004 can include a stopping region 4047, which can interact with the sheath hub 4014 to delimit an amount of distal movement of the catheter 4026 beyond the distal tip 4013 of the sheath 4016. In the illustrated embodiment, the stopping region 4047 is the diametrically or laterally expanded region defined by the connector 4043 portion of the catheter hub 4024 and the expanded portion of the strain relief sleeve 4025 that is connected thereto. The stopping region 4047 can interfere with a proximal end of the connector 4055 or may enter into and interfere with a proximal portion of the guide 4052 within the connector 4055, each of which is defined by the housing 4050 (see FIG. 47), as the catheter assembly 4004 is advanced distally through the sheath assembly 4002.

The catheter assembly can define a total length L_Tand a working length L_W. In the illustrated embodiment, which is merely one illustrative example, the total length L_Tis 77.5±1 centimeters and the working length L_Wis 72.8±1 centimeters. The exposed length L_Eis 8.9±0.05 centimeters. Other dimensions are possible and are contemplated by the present disclosure.

With reference to FIG. 53, an outer diameter OD of the illustrated catheter 4026 is 0.124±0.005 inches and an inner diameter ID of the catheter 4026 is 0.105±0.005 inches. The outer diameter OD may also be referred to as a maximum diameter of the catheter 4026. A height H_BEVof the bevel at the distal tip 4023 is 0.025±0.005 inches. An angle a defined by the bevel, relative to an axial or longitudinal dimension of the catheter 4026, is 20.0±0.05 degrees. Other dimensions are possible and are contemplated by the present disclosure. For example, the angle a can be greater than or less than that of the illustrated embodiment. In various embodiments, the angle a is no greater than 15, 20, 25, 30, or 35 degrees. The other dimensions may similarly be altered in other emboidments.

FIG. 54 depicts the spacer 4080 in greater detail. As previously discussed, the spacer 4080 is configured to maintain a predetermined relative position of the sheath assembly 4002 and the catheter assembly 4004 during insertion and/or manipulation of the system 4000 in the patient, such as during introduction of the system 4000 into the esophagus and into contact with an impacted food bolus. In particular, the spacer 4080 can be configured to maintain a relative orientation in which the distal tip 4023 of the catheter 4013 is retracted within the instrument delivery lumen 4054 of the sheath 4016, or stated otherwise, is retracted relative to the distal tip 4013 of the sheath 4016.

The illustrated spacer 4080 is an elongated clip 4082 that includes a proximal fastener 4086 and a distal fastener 4088. The proximal fastener 4086 is configured to selectively attach to and detach from the connector 4043 portion of the catheter hub 4024 (see FIGS. 45 and 51). The distal fastener 4088 is configured to selectively attach to and detach from the connector 4055 portion of the sheath hub 4014 (see FIGS. 45 and 47). The fasteners 4086, 4088 can be of any suitable variety. In the illustrated embodiment, the fasteners 4086, 4088 are spring clips with resiliently flexible arms.

In some embodiments, the spacer 4080 is attached to the system 4000 during manufacture and packaging of the system 4000. Accordingly, when a user removes the system 4000 from the packaging, the spacer 4080 may already be in place. In other embodiments, the spacer 4080 may come separately within the packaging, and instructions for use can indicate that the user can attach the spacer 4080 to the assemblies 4002, 4004 prior to insertion of the system 4000 into the esophagus of the patient.

In some embodiments, such as the illustrated embodiment, the spacer 4080 can be configured to be selectively detached from the assemblies 4002, 4004 and selectively reattached to the assemblies 4002, 4004. For example, in some instances, a user may deploy the positioning element 4018 into contact with the esophageal wall and core through a portion of the blockage using the catheter assembly 4004, such as by moving the catheter assembly 4004 longitudinally back and forth relative to the sheath assembly 4002, which sheath assembly 4002 remains in a substantially fixed orientation relative to the esophagus and the blockage (e.g., food impaction) during thie initial phase of coring.

In some instances, after the initial coring, the user may wish to advance the sheath assembly 4002 to a more distal position within the esophagus, such as to be able to core deeper into the blockage. Accordingly, a user may wish to contract the positioning element 4018 (e.g., deflate the balloon 4019) or otherwise transition the positioning element 4018 to a lower profile and then move the system within the esophagus. In some instances, in order to protect the esophagus from inadvertent contact with the esophageal wall, it may be desirable for a user to reattach the spacer 4080 to the specified attachment regions of the assemblies 4002, 4004 to reestablish the fixed longitudinal relationship between the assemblies the ensures the distal tip of the catheter 4026 is retracted within the lumen of the sheath 4016. Thus, in some instances, instructions for use may recommend or require that a user reattach the spacer 4080 prior to any movement within the esophagus when the positioning element 4018 is in the contracted state.

As a further example, the spacer 4080 can be reattached prior to removal of the system 4000 from the esophagus. In other instances, a user may not use the spacer 4080 during retraction. In certain of such instances, the user may fully retract the catheter assembly 4004 from the sheath assembly 4002 (e.g., pull proximally out of the sheath assembly 4002), may then subsequently contract the positioning element 4018 to a low profile, and then may remove the sheath assembly 4002 from the esophagus.

The system 4000 may be used in any of the manners disclosed herein, as suitable. For example, the various methods and/or portions (e.g., a subset of steps) thereof discussed with respect to, e.g., the systems 200, 3000, 3200 can be performed with the system 4000.

With reference to FIG. 55, any of the systems or components thereof described herein may be provided in a kit 5000. In some embodiments, the kit 5000 is particularly well suited for use in an emergency room setting. The kit 5000 may be used in blind procedures, such as those in which no direct or indirect visualization of the blockage is performed during the procedure. Accordingly, in some instances, the kit 5000 may be used by practitioners who are not specialized endoscopists, etc.

In the illustrated embodiment, the kit 5000 includes an embodiment of the system 4000. The kit 5000 can further include instructions 5002 for using the embodiment of the system 4000. For example, the instructions for use 5002 may provide directions with respect to any of the methods or processes disclosed herein. By way of further example, the instructions for use 5002 may recite any method and/or other portion of the present disclosure.

The kit 5000 can further include packaging 5004. The system 4000 can be contained within the packaging 5004, and the instructions 5002 can be contained within, printed on, or otherwise made accessible via the packaging 5004.

In various embodiments, the kit 5000—and, in particular, the system 4000 and the instructions for use 5002 thereof—can be approved of or authorized by a regulating body of a particular jurisdiction. For example, the kit 5000, and the instructions 5002 for use thereof, may be approved of or authorized by the Food and Drug Administration of the United States of America and/or may comply with the regulations of other jurisdictions, such as by qualifying for CE marking in the European Union.

The instructions 5002 can provide directions with respect to any of the methods or processes disclosed herein. That is, the instructions 5002 can provide directions for using the system 4000, or components thereof, in accordance with any of the methods or processes disclosed herein. One illustrative example of a set of instructions 5002 for use with one embodiment of the system 4000 is provided below. Other instructions may include more, fewer, and/or different directions than those provided in the illustrative example, and other embodiments of the system 4000 may include more, fewer, and/or different features than those discussed in the instructions.

EXAMPLE 1

An embodiment of the system 4000 is designed to core and aspirate food impactions. It is comprised of the sheath assembly 4002 and the catheter assembly 4004. The sheath assembly 4002 is a 12 Fr OD with a 0.133″ ID, 62 cm in usable length, has a soft, atraumatic tip. It is designed to connect to a standard 10 cc-20 cc syringe for inflation of the balloon 4019. The sheath assembly 4002 uses the low-pressure balloon 4019 to stabilize and center the aspiration catheter 4026 in the esophagus.

The catheter assembly 4004 is used through the working channel 4054 (FIG. 49) of the sheath assembly 4002. The catheter assembly 4004 has a molded tapered handle that is a slip fit connection to the vacuum system in the emergency room of a hospital. It has a beveled distal tip to aid in coring through food impactions. The catheter assembly 4004 extends approximately 2.00″ outside the tip of the sheath assembly 4002 during full insertion. In this example, the proximal portion 4026p of the catheter 4026 is colored white, and the distal portion 4026d is colored gray (see FIG. 51).

The system 4000 can be packaged with instructions for use 5002, which instructions may recite some or all of the following directions. The instructions detail illustrative examples of using the system 4000.

The system 4000 is indicated for removal of food blockage and impaction in the esophagus. The system 4000 may desirably be used by a health care professional with adequate training in the use of the device. The catheter assembly 4004 moves freely through the sheath assembly 4002. Do not remove system 4000 assembly clip 4082 until the sheath assembly 4002 is in final position within the esophagus, which may also be referred to as an anchored position in which the balloon 4019 is fully deployed. Do not use if the system 4000 cannot be advanced to at least 25 cm past the incisors as indicated by the relevant markings.

When repositioning or withdrawing the system 4000, always withdraw the catheter assembly 4004 until the white proximal portion 4026p of the catheter 4026 is visible outside the sheath. This will ensure the atraumatic tip of the sheath assembly 4002 is always the leading edge during positioning.

Open the package and carefully remove balloon protector sleeve 4098 from the sheath assembly 4002. Verify that the distal tip of the aspiration catheter is contained within the sheath and does not extend beyond the tip of the sheath.

Introduce the system 4000, into the mouth and then advance beyond the cricopharyngeus into the esophagus.

Advance the system 4000 at least 25 cm from the incisors. Verify the depth by the marking on the external surface of the sheath. Insertion of the system 4000 to a depth of less than 25 cm from the incisors could lead to inadvertent balloon inflation within the pharynx.

Advance the system 4000 to the level of the food impaction as indicated by resistance to further passage of the system 4000.

Withdraw the system 4000 approximately 1-2 cm (e.g., a short distance) from the point of contact of the food impaction. This will allow proper positioning, (i.e., centering) and inflation of the balloon.

Inflate the balloon to its full diameter by attaching a standard 10 cc or 20 cc syringe to the luer lock inflation port and injecting 20 cc's of air into the balloon. Once balloon has been inflated close the stopcock 4064 to seal air within the system. Gently pull on the balloon sheath to confirm the balloon is fully inflated and secured within the esophagus.

Remove the assembly clip 4082 from the system 4000. This will allow free movement of the catheter assembly 4004 relative to the anchored sheath assembly 4002.

Attach standard suction tubing of a suction system to the catheter assembly 4004 handle by pressing tubing firmly onto the handle. Attach the suction system to the wall suction of the hospital in any suitable manner. For example, press fit tubing of the suction system over a wall-mounted nozzle in a hospital room that is connected to the hospital suction source.

Turn on the wall suction. Adjust wall suction to its highest power setting.

The aspiration catheter, attached to suction, will then be employed to core pieces of the food impaction and suction the pieces as cored. The aspiration catheter will be advanced into the food to core pieces of food and then be withdrawn to allow suction. This process will be repetitively performed (coring and suctioning) as needed to clear the impaction. Repeat this action until food impaction is clear. The food impaction may naturally pass into the stomach once a sufficient portion thereof has been cored away.

If necessary or desired, the sheath balloon can be deflated by opening the stopcock and pulling a vacuum on the inflation syringe and re-inflated in order to advance, withdraw or reposition the sheath to optimize clearance of the impaction.

The aspiration catheter should be safely withdrawn into the sheath, and the balloon can be partially or completely deflated to allow free motion of the sheath, to allow advancement of the sheath into any remaining impaction to push any remaining food distally into the stomach. Advancement of the sheath should not be attempted until the aspiration catheter is contained within the confines of the sheath (e.g., the gray distal portion 4026d of the aspiration catheter 4026 is visible outside of sheath assembly 4002).

After the food impaction is cleared, withdraw the catheter assembly 4004 until the gray distal portion 4026d is visible outside the sheath assembly 4002, open the stopcock and completely deflate the balloon by pulling a vacuum on the inflation syringe.

Withdraw the system 4000 from the esophagus.

With reference again to FIGS. 51 and 53, in some embodiments, the catheter assembly 4004 is particularly well suited for use with any of a variety of standard or otherwise commercially available endoscopes. In some embodiments, the catheter assembly 4004 may be better suited for use with such endoscopes than with certain embodiments of dedicated sheaths. For example, the catheter assemblies can be deployed through a standard working channel of an endoscope. In certain of such instances, the food bolus and progress of the procedure can be visually monitored via the endoscope by a professional during certain uses of the catheter assemblies.

In some instances, the catheter assembly 4004 for use with an endoscope may vary from certain embodiments configured for use with a sheath assembly 4002. For example, in some instances, the catheter assembly 4004 may be devoid of a depth indicator 4027. By way of further example, rather than having differently colored proximal and distal portions 4026p, 4026d, the shaft of the catheter 4026 may be a uniform color along a full length thereof.

In some embodiments, various dimensions of the catheter assembly 4004 can be optimized for use with endoscopes. In some illustrative examples, the total length L_Tof the catheter assembly 4004 may be relatively longer, whereas the outer diameter OD and the inner diameter ID are smaller. For example, in one illustrative example, the total length L_Tis 128.7±1 centimeters, the outer diameter OD is 0.107±0.005 inches and the inner diameter ID is 0.096±0.005 inches. The remaining dimensions (e.g., the bevel angle and bevel height) may be as previously identified. Other values of the various dimensions are possible and are contemplated by the present disclosure.

With reference to FIG. 56, any of the catheter assemblies disclosed herein may be provided in a kit 6000. In certain embodiments, the kit 6000 is particularly well suited for use with a standard or otherwise commercially available endoscope. For example, the kit 6000 may be used by an endoscopist or other similarly trained practitioner. In the illustrated embodiment, the kit 6000 includes an embodiment of the catheter assembly 4004. The kit 6000 can further include instructions 6002 for using the embodiment of the catheter assembly 4004. In particular, the instructions 6002 can provide directions to carry out any procedure, procedural step, or other action disclosed herein. By way of further example, the instructions for use 6002 may recite any method and/or other portion of the present disclosure

The kit 6000 can further include packaging 6004. The catheter assembly 4004 can be contained within the packaging 6004, and the instructions 6002 can be contained within, printed on, or otherwise made accessible via the packaging 6004.

In various embodiments, the kit 6000—and, in particular, the catheter assembly 4004 and the instructions for use 6002 thereof—can be approved of or authorized by a regulating body of a particular jurisdiction. For example, the kit 6000, and the instructions for use 6002 thereof, may be approved of or authorized by the Food and Drug Administration of the United States of America and/or may comply with the regulations of other jurisdictions, such as by qualifying for CE marking in the European Union.

The instructions 6002 can provide directions with respect to any of the methods or processes disclosed herein. That is, the instructions 6002 can provide directions for using the catheter assembly 4004 in accordance with any of the methods or processes disclosed above. One illustrative example of a set of instructions 6002 for use with one embodiment of the catheter assembly 4004 is provided below. Other instructions may include more, fewer, and/or different directions than those provided in the illustrative example, and other embodiments of the catheter assembly 4004 may include more, fewer, and/or different features than those discussed in the instructions.

EXAMPLE 2

The catheter assembly 4004 is designed to be used in the esophagus to remove food blockages. It is an 8 Fr OD with a 0.090 inch max ID, 124 cm useable length, single-lumen, braided biocompatible catheter with a sharp distal tip for cutting through the food impaction. The catheter assembly 4004 has a molded, tapered handle that is a slip fit connection to the vacuum system in the hospital.

The catheter assembly 4004 is designed to be used through the working channel (>2.7 mm ID) of a standard endoscope. It is designed to connect to extend outside the distal end of an endoscope by approximately 1 inch when fully inserted.

The catheter assembly 4004 can be packaged with instructions for use 6002, which instructions may recite some or all of the following directions. The instructions detail illustrative examples of using the catheter assembly 4004.

The catheter assembly 4004 is indicated for removal of food blockage/impaction in the esophagus.

The catheter assembly 4004 should be used by a health care professional with adequate training in the use of the device.

Do not use if the device is kinked or damaged in any way.

Do not use if the catheter assembly 4004 does not move freely through the working channel of a standard endoscope with a working channel ID of 2.7 mm or greater.

Following standard practices, introduce a standard endoscope (e.g., through the mount of the patient) to the level of the food impaction.

Insert the catheter assembly 4004 through the working channel of the endoscope until the aspiration catheter is visible through the distal end of the endoscope.

Once positioned in the endoscope, attach standard suction tubing to the catheter handle by pressing tubing firmly onto the handle. Attach the suction system to the wall suction of the hospital in any suitable manner. For example, press fit tubing of the suction system over a wall-mounted nozzle in a hospital room that is connected to the hospital suction source.

Deliver a plurality of (e.g., 4 to 5) drops of water through the irrigation lumen of the endoscope. This will help saturate the food impaction making it easier to aspirate.

The aspiration catheter, attached to suction, will then be employed to core pieces of the food impaction and suction the pieces as cored. The aspiration catheter will be advanced into the food to core pieces of food and then be withdrawn to allow suction. This process will be repetitively performed (coring and suctioning) as needed to clear the impaction. Repeat this step until food impaction is clear (e.g., until food impaction is naturally passed out of the esophagus and into the stomach by the patient).

When the impaction has been cleared, detach the vacuum from catheter handle and remove the catheter assembly 4004 from the endoscope.

FIGS. 57A and 57B depict another embodiment of a sheath assembly 7002 in an undeployed state and in a deployed state, respectively. The sheath assembly 7002 can be used with embodiments of catheter assemblies disclosed herein in manners such as are also disclosed herein.

The sheath assembly 7002 can function similarly to other sheath assemblies disclosed herein. In general, the sheath assembly 7002 includes a positioning element 7018 and an actuator 7060 via which the positioning element 7018 can be deployed and retracted.

As with other embodiments disclosed herein, the sheath assembly 7002 includes hub 7014 that is coupled with a sheath 7016 in any suitable manner. The sheath 7016 defines an instrument deployment lumen 7054 within which a catheter can be positioned, and through which the catheter can be advanced and/or retracted. The sheath 7016 can further define an actuation channel or lumen 7066, which can resemble the inflation channels or lumens 3066, 3266, 4066 described above. All such lumens can allow movement therethrough of an actuation element (such as fluid or, as discussed further hereafter for the present case, an actuation wire or rod) to effect actuation or retraction of a positioning element.

In the illustrated embodiment, the positioning element 7018 comprises an expandable member 7019 of any suitable variety. The expandable member 7019 can, for example, comprise a braided or other configuration of wires or other materials that can be selectively expanded to a larger profile configuration or retracted to a lower profile configuration. For example, the expandable member 7019 can resemble or be formed as a selectively expandable and retractable stent, such as, for example, a braided stent.

With reference to FIGS. 58A and 58B, in other instances, rather than defining a braided sleeve, an expandable member, or positioning element, can define a series of longitudinally extending wires or other elongated elements that are predisposed to flare outwardly when compressed and can assume a low-profile configuration when placed under tension. In still other embodiments, an expandable member, or positioning element, can define a plurality of resilient arms (e.g., FIGS. 59A and 59B) configured to press outwardly into contact with the esophagus. Any other suitable system for expanding into contact with the esophagus and retracting away from contact with the esophagus is contemplated.

In various embodiments, the expandable member 7019 is resiliently flexible and/or comprises a shape-memory material. In various embodiments, the expandable member 7019 may be biased toward a retracted orientation (FIG. 57A), such that the bias must be overcome to deploy the expandable member 7019. The expandable member 7019 may readily return to the retracted orientation under influence of the bias, when so permitted. In other embodiments, the expandable member 7019 may be biased toward the deployed orientation (FIG. 57B), such that actuation of the expandable member 7019 includes permitting the bias to naturally deploy the expandable member 7019. The expandable member 7019 may be returned to the retracted orientation by overcoming the bias. In other embodiments, the expandable member 7019 is not subject to internal or other biases when positioned in either of the retracted or deployed orientations.

A distal end of the expandable member 7019 can be fixed relative to the sheath 7016. A proximal end of the expandable member 7019 can be movable relative to the sheath 7016. For example, the proximal end of the expandable member 7019 can be permitted to translate longitudinally relative to the sheath 7016.

The proximal end of the expandable member 7019 can be coupled with a mechanical linkage 7091 of any suitable variety, such as a wire or rod 7093. The mechanical linkage 7091 can further be coupled with an actuation interface 7095 of any suitable variety, such as a button, lever, switch, slider, etc. The actuation interface 7095 can move the mechanical linkage 7091 so as to effect actuation and retraction of the expandable member 7019. Accordingly, the actuator 7060 can be communicatively coupled with the positioning element 7018. In particular, the actuation interface 7095 is configured to directly, mechanically communicate with the expandable member 7019 via the mechanical linkage 7091.

For example, in the illustrated embodiment, the actuation interface 7095 comprises a switch that is translatable relative to the housing 7014. By urging the switch distally from the proximal position shown in FIG. 57A to the distal position shown in FIG. 57B, the mechanical linkage 7091 is likewise urged distally, which likewise urges the proximal end of the expandable member 7019 distally. Due to the fixed relationship of the distal end of the expandable member 7019 relative to the sheath 7016, the expandable member 7019 can deploy outwardly to the configuration depicted in FIG. 57B. Similarly, urging the switch proximally from the distal position shown in FIG. 57A to the proximal position shown in FIG. 57B can return the expandable member to the retracted orientation shown in FIG. 57A.

FIGS. 58A and 58B depict another embodiment of a sheath assembly 8002 in an undeployed state and in a deployed state, respectively. The sheath assembly 8002 can closely resemble the sheath assembly 7002 just described, but may include a different expandable member 8019 that includes a plurality of longitudinally extending wires or elongated elements 8095. The expandable member 8019 can perform substantially as previously described with respect to the expandable member 7019.

FIGS. 59A and 59B depict another embodiment of a sheath assembly 9002 in an undeployed state and in a deployed state, respectively. The sheath assembly 9002 can closely resemble the sheath assemblies 7002, 8002 just described, but may include a different expandable member 9019 that includes a plurality of resiliently expandable arms 9097. In the illustrated embodiment, the arms 9097 are configured to rotate outward into contact with the esophageal wall when deployed. In particular, in the illustrated embodiment, the arms 9097 are deployed when proximal portions thereof are advanced distally so as to no longer be restrained in a low-profile orientation by a retainer element 9099.

Although various embodiments are described herein, the embodiments are only examples and should not be construed as limiting. The examples described above generally refer to food impactions in the esophagus. However, many other similar impactions can be addressed using the systems and methods described herein. For example, embodiments of the systems may be used with any suitable anatomical tube (e.g., the esophagus, a bronchus, a vessel).

For example, a person can choke while eating, and food can get aspirated and lodge in the trachea, or can also lodge in the lung, specifically any portion of the bronchial tree. Mucus can also become trapped anywhere in the bronchial tree, causing mucus plugging. When this occurs, one or more of the embodiments described herein can be used to core and suction said food or mucus, such as by placing the device, for example, through the working channel of a flexible or rigid bronchoscope as opposed to an endoscope.

One or more of the embodiments described herein can also be used to core, suction and remove trapped blood or blood clots anywhere in the GI tract, specifically the esophagus, stomach, small intestine or large intestine.

One or more of the embodiments described herein can also be used to core, suction and remove trapped food, blood or blood clots, or mucus or mucus plugs, anywhere in the pulmonary organ system, i.e., the trachea or lung i.e. anywhere in the bronchial tree.

One or more of the embodiments described herein can be used to core and remove blood or blood clots, or atheroma or atheromatous plaque anywhere in the vasculature system, i.e. great arteries or veins, or peripheral vasculature i.e. the peripheral arteries or veins. To core harder materials such as calcified plaque, a stainless steel tip can be attached to the end of the suction catheter.

One or more of the embodiments described herein can also be used to core and remove blood or blood clots, or atheroma or atheromatous plaque anywhere in the heart or coronary arteries. To core harder materials such as calcified plaque, a stainless steel tip can be attached to the end of the suction catheter.

In another example, one or more of the embodiments described herein can be used to core and suction kidney stones from the urinary system, specifically the ureters, bladder and kidneys. To core harder materials such as calcified, struvite, oxalate or uric acid kidney stones a stainless steel tip can be attached to the end of the suction catheter.

In yet another example, one or more of the embodiments described herein can be used to core and remove gallstones or tumors lodged in the biliary tree (common bile duct or peripheral ducts). Harder materials can be cored by attaching a stainless steel tip to the end of the suction catheter.

For example, in some embodiments, an endoscope 210 of any suitable variety, such as a duodenoscope, is inserted into and advanced through the upper gastrointestinal tract of a patient. The duodenoscope can be advanced through the mouth, esophagus, and stomach and into the duodenum. A distal end of the duodenoscope can be brought to the level of, or stated otherwise, can be positioned near (e.g., adjacent to), the major duodenal papilla.

In various embodiments, a device is advanced through the working channel of the duodenoscope to assist in positioning a catheter assembly (e.g., an embodiment of the catheter assembly 4004) within the biliary tree to core and remove the undesired material, such as a gallstone or tumor. For example, in some embodiments, a guidewire is advanced through the working channel of the duodenoscope and, while the distal end of the duodenoscope remains positioned adjacent to the major duodenal papilla, the guidewire can be advanced out of a distal end of the working channel, through the major duodenal papilla, then through the common bile duct or the pancreatic duct to a location of the gallstone, tumor, or any other undesired material. For example, a distal end of the guidewire may be placed just proximal to the gallstone or tumor, in contact with the gallstone or tumor, or may be advanced by or through the gallstone or tumor so as to extend distally beyond (from the perspective of the practitioner) the undesired material. Any suitable imaging technique may be used in delivering the guidewire to the desired locations, such as, e.g., fluoroscopy.

With the guidewire in place, the catheter assembly may subsequently be advanced through the working channel of the duodenoscope and over the guidewire. The catheter assembly may further be advanced out of the duodenoscope over the guidewire and into proximity to the gallstone or tumor. In some instances, the guidewire may then be removed. Suction and coring of the undesired material may take place in manners such as previously described.

In some instances, different apparatus and/or techniques may be used to achieve the desired positioning of the guidewire and/or the catheter assembly. For example, in some instances, any suitable cholangioscopy procedure (e.g., endoscopic retrograde cholangiopancreatography) may be employed to position an embodiment of the catheter assembly 4004 for coring and removal of, e.g., a gallstone, tumor, blood clot, or other lesion or material. In some instances, an imaging probe of any suitable variety may be used in conjunction with or instead of fluoroscopic imaging. Any suitable imaging probe is contemplated. For example, in some instances, a direct-visualization probe of any suitable variety may be used. By way of illustration, and without limitation, the SpyGlass® Direct Visualization System, available from Boston Scientific, may be used. The imaging probe, such as, for example, the SpyScope® Access and Delivery Catheter, can be inserted through the working channel of the duodenoscope and out of the distal end of the duodenoscope, through the major duodenal papilla, and can be controlled (e.g., via proximally located actuators of the probe) so as to advance through the biliary tree to a desired position. For example, the desired position may place the distal end of the probe at a position just proximal to (from the perspective of the practitioner) the gallstone or tumor.

In some instances, a guidewire may then be advanced through a working channel of the imaging probe. As with other procedures previously described, the distal end of the guidewire may be placed just proximal to the gallstone or tumor (or other material), in contact with the gallstone or tumor, or may be advanced by or through the gallstone or tumor so as to extend distally beyond (from the perspective of the practitioner) the undesired material. In some instances, the imaging probe is removed proximally over the guidewire. The catheter assembly may then be advanced over the guidewire and into contact with the undesired material for coring and removal. In some instances, the guidewire is removed prior to coring and suctioning.

In other instances, the imaging probe may be used without a guidewire. For example, once the imaging probe has been advanced through the duodenoscope and is in place, the catheter assembly may be advanced through a working channel of the imaging probe and into contact with the gallstone or tumor. Imaging (e.g., direct visualization) of the target site or working area may be maintained via the imaging probe as the catheter assembly is repeatedly advanced and retracted to core and/or suction away pieces of the undesired material. The imaging probe can provide continuous or substantially continuous viewing of the target region during the coring procedure.

In still other instances, the catheter assembly (e.g., an embodiment of the catheter assembly 4004) can be advanced through the working channel of the duodenoscope and into a desired position within the biliary tree without assistance from additional devices deployed through the endoscope, such as a guidewire or a separate imaging probe.

As can be appreciated from the foregoing, the catheter assembly (e.g., embodiments of the catheter assembly 4004) can be used to remove undesired material—such as gallstones, tumors, or other undesired material—from within, e.g., the pancreas. For example, the material may be removed from one or more ducts that pass through the pancreas. Various embodiments may be used to remove other types of undesired material from these and/or other regions of the pancreas and/or to remove undesired material from the pancreas in other manners, or stated otherwise, via other approaches or procedures.

In some procedures, an embodiment of a catheter assembly (e.g., an embodiment of the catheter assembly 4004) is used in an endoscopic transmural necrosectomy (ETN) procedure for the treatment of pancreatitis. Such a procedure may also be referred to as a direct endoscopic necrosectomy (DEN). Endoscopic transmural necrosectomy can be performed via the gastric lumen or the duodenal lumen and involves transmural puncture from the gastric or the duodenal lumen into a target region, such as a necrotic cavity, within the pancreas.

With reference to FIGS. 60A and 61A, in various embodiments, any suitable endoscope 9100, such as a gastroscope or a duodenoscope, is inserted through the mouth of a patient and advanced until positioned inside the stomach S (FIG. 60A) or the duodenum D (FIG. 61A) of the patient. In particular, the endoscope 9100 can be advanced until a distal end thereof is positioned near or in the vicinity of a target region 9102 of the pancreas P. The target region 9102 may be located on or within the pancreas. Stated otherwise, the distal end of the endoscope 9100 is brought into proximity to the target region 9102, but is separated therefrom by at least the wall of the stomach S or the wall of the duodenum D, depending on the location of the target region 9102 within the pancreas. In some instances, the target region 9102 may be beneath an outer surface of the pancreas P, such that healthy pancreatic tissue is also positioned between the distal end of the endoscope 9100 and the target region 9102.

The following discussion will first focus on procedures that involve a transmural puncture from the gastric lumen to the pancreas, with particular reference to FIGS. 60A-60D. Such procedures may also be referred to as endoscopic transgastric necrosectomies. Similar procedures that instead involve transmural punctures into through the duodenal wall will subsequently be discussed with reference to FIGS. 61A-61C.

With reference to FIGS. 60A-60D, the target region 9102 can comprise any undesirable or problematic material 9104. For example, in various embodiments, the undesirable material 9104 can comprise one or more collections (e.g., fluid or necrotic tissue) in the pancreatic parenchyma or peripancreatic tissue. Such collections may be caused by inflammation, and may include one or more of acute peripancreatic fluid collections, pancreatic pseudocysts, acute necrotic collections, and walled-off necrotic collections. Acute collections may typically remain sterile, and may resolve on their own. However, some collections can become pseodocysts, which may turn into walled-off necrotic collections. Pseudocysts are collections in peripancreatic tissue that mostly contain solid material. These can cause occlusion of the main pancreatic duct or branches. Walled-off necrotic collections consist of mature necrotic material (fluid and/or solid) that can be completely encapsulated and demarcated inside a thickened wall of tissue lacking an epithelial lining. Such can develop about four weeks after the onset of necrotizing pancreatitis. For endoscopic transmural necrosectomy procedures, the undesirable material 9104 typically includes necrotic material, such as the necrotic material in walled-off necrotic collections. Accordingly, hereafter the undesirable material 9104 may also be referred to as necrotic material 9104, and the target region 9102 may also be referred to as a necrotic target 9102. Despite these appellations for purposes of convenience, it should be understood that in some instances, the undesirable material 9104 may not be necrotic. For example, the undesirable material 9104 may be of a variety that may become necrotic or that may contribute to necrosis elsewhere.

With reference to FIG. 60A the target region 9102 may be identified via the endoscope 9100 (e.g., a gastroscope). For example, in some instances, the target region 9102 may give rise to a visible bulge of the gastric wall, which can be visually identified via an endoscope 9100 that includes a visual imaging system. In some instances, the endoscope 9100 may comprise a forward-viewing therapeutic gastroscope. In other or further instances, the endoscope 9100 may include ultrasonic imaging capabilities. For example, the endoscope 9100 can additionally or alternatively include an endoscopic ultrasound (EUS) system of any suitable variety. In some instances, such as when the endoscope 9100 is configured for EUS, the target region 9102 can be identified, even in the absence of a visual bulge. In some instances, EUS can advantageously help identify blood vessels that may desirably be avoided during puncture and expansion of a tract through the gastric wall to the target region 9102. In various embodiments, fluoroscopic and/or ultrasonic (e.g., EUS) imaging may be used in positioning the endoscope 9100 and/or in subsequent stages of the procedure, such as forming a puncture site through the gastric wall.

After identification of the target region 9102, a transmural puncture may be made through the gastric wall and to or into the pancreas. Any suitable technique is contemplated for the puncture. In various embodiments, any suitable needle or needle knife apparatus may be advanced through the working channel of the endoscope 9100 and advanced through the posterior gastric wall to form an opening therethrough. The cutting or puncturing apparatus can be advanced through the gastric wall and into the target region 9102, such as into a necrotic cavity. The puncturing or cutting apparatus can fully perforate the stomach wall.

In some embodiments, a guidewire may be passed through the puncture site into the necrotic cavity, after which the perforating device may be removed. In some instances, it may be desirable for the guidewire to be inserted so as to have a relatively stable and straight (rectilinear) approach through the gastric wall and into the necrotic cavity.

The puncture tract through the gastric wall can then be dilated. In some instances, this can be accomplished by advancing a balloon catheter over the guide wire and expanding the balloon, in any suitable manner. The balloon catheter may have a relatively large balloon, which can ultimately facilitate passage of the distal end of the endoscope through the puncture tract. In some embodiments, stepwise dilatation may be performed. For example, in some instances the tract may be expanded from approximately 12 millimeters in diameter up to 15 millimeters.

In some instances, the balloon may be advanced distally through the tract, with the distal end of the endoscope 9100 trailing behind. Stated otherwise, the distal end of the endoscope 9100 may be passed through the tract into the target region 9102 (e.g., the necrotic cavity). In some instances, once the distal end of the endoscope 9100 is in place, the necrotic cavity can be insufflated. For example, in some instances, carbon dioxide may be passed through the endoscope into the necrotic cavity. The balloon may be deflated and removed through the endoscope 9100.

In other or further embodiments, prior to the initial insertion of the endoscope 9100 through the tract, a large-diameter stent (e.g., metal or plastic stent) may be positioned within the tract and expanded to facilitate passage of the endoscope. In other instances, the stent may instead be placed in the tract after the endoscope has first been advanced through the tract (in manners such as previously disclosed), kept in place during removal of necrotic tissue, and subsequently removed from the tract. The stent may maintain a passage through which one or more subsequent endoscopic transgastric necrosectomies may be performed, thus permitting omission of many of the early steps of the initial necrosectomy (e.g., puncture, tract expansion) in subsequent procedures. Moreover, the stent may permit drainage into the stomach when not actively in use during a necrosectomy. In some instances, the stent may ultimately be removed or, in some instances, permitted to biodegrade/bioresorb in any suitable manner at the completion of all desired necrosectomies.

FIG. 60B illustrates a stage of certain procedures in which the distal end of the endoscope 9100 has been advanced through the stomach wall and near or into a necrotic cavity. The balloon catheter has been removed from a working channel 9110 of the endoscope 9100. Once the endoscope 9100 is in a desired position, a catheter assembly 9120, which may also be referred to as a coring catheter 9120, is advanced through the working channel 9110. The coring catheter 9120 can resemble, as suitable for the present application, any of the catheter assemblies described elsewhere herein, such as, for example, the catheter assemblies 100, 900, 3004, 3604, 3704, 3804, 4004. In some embodiments, a length of the coring catheter 9120 can be selected to ensure that the coring catheter 9120 can extend past a distal end of the endoscope 9100, when the endoscope 9100 is positioned as previous described (e.g., with the distal tip thereof at or near the target region 9102). An outer diameter of the coring catheter 9120 can be sufficiently small to readily pass through the working channel 9110 of the endoscope 9100.

FIG. 60C illustrates a stage of certain procedures in which the coring catheter 9120 has been advanced past the distal end of the endoscope 9100 into the target region 9102. In the illustrated embodiment, the coring catheter 9120 has been brought into contact with the necrotic material 9104. The coring catheter 9120 can be used to debride the necrotic material 9104. In particular, coring of the necrotic material 9104 can be achieved in manners such as previously described with respect to other unwanted materials. For example, the distal tip of the coring catheter 9120 can be advanced into the necrotic material 9104. Suction can be applied at a proximal end of the coring catheter 9120 to suction cored pieces and/or to assist in coring the pieces and suctioning the cored pieces away from the target region 9102. The coring catheter 9120 can also or alternatively suction blood and/or pancreatic fluids away from the target site. Visualization of at least a portion of the target region 9102 can be maintained by the endoscope 9100 during suctioning. Suctioning of the various material from the target site or field can leave this region clear for good visualization via the endoscope.

The coring catheter 9120 can suction multiple cores of necrotic material 9104 through a lumen 9122 thereof and away from the target region 9102. In some instances, the coring catheter 9120 is advanced substantially in a straight line, and multiple cores are suctioned away as the catheter is advanced distally. In other or further instances, a back-and-forth motion may be used along the linear path to achieve coring and suctioning. For example, the coring catheter 9120 can be repeatedly advanced and retracted, or moved forward and backward (distally and proximally), to suction the cores. The coring catheter 9120 can be moved in any desired direction to remove as much of the necrotic material 9104 as desired, such as all or substantially all of the necrotic material 9104. The endoscope 9100 can be repositioned as desired to direct the coring catheter 9120 along a path that will achieve the desired coring. For example, in some embodiments, the coring catheter 9120 can extend substantially rectilinearly from the working channel 9110. The endoscope 9100 can be moved so as to permit the coring catheter 9120 to extend therefrom along a line that will bring the distal tip of the coring catheter 9120 into contact with a desired portion of the necrotic material 9104 for coring and removal. It can be desirable to debride the necrotic tissue until the cavity is lined with healthy granulation tissue.

In other instances, the coring catheter 9120 includes a pre-curved distal end, which may facilitate manipulation within the target. For example, as illustrated in FIG. 66, in some embodiments, the coring catheter 9120 can include a distal end that is curved to define an angle β relative to a central longitudinal axis A_Lof the coring catheter 9120. The preformed or natural bend or pre-curve can be formed in any suitable manner. The distal end of the coring catheter 9120 can be flexible such that the distal end may be retained within the working channel of the endoscope in a less curved shape, which may be substantially rectilinear or which may be closer to rectilinear than when in the pre-curved orientation. As the distal end is advanced out of the endoscope, the distal end of the catheter 9120 can naturally or automatically (e.g., resiliently) return to the pre-curved orientation. The pre-curved shape may, in some instances, facilitate reaching portions of the target region 9102 that might otherwise be difficult to reach by pointing the distal end of the endoscope toward the hard-to-reach area and advancing a rectilinear coring catheter thereat. In other or further instances, the pre-curved coring catheter can facilitate a procedure by permitting a certain orientation of the endoscope to remain substantially fixed (e.g., without manipulation of deflection controls at a distal end of the endoscope) while the coring catheter 9120 is advanced therefrom and positioned at various portions of the target region 9102. In some instances, the user can rotate the coring catheter 9120 within the working channel of the endoscope to access multiple regions that are positioned off-axis relative to the distal end of the endoscope. The coring catheter 9120 thus may be advanced and/or retracted longitudinally relative to the endoscope and/or may be rotated relative to the endoscope to reach a larger volume of space than may otherwise be achieved by a substantially linear ended coring catheter, without deflection of the distal tip of the catheter. In some instances, similar advantages may be achieved in other contexts, such as in positioning the coring catheter 9120 into portions of a food impaction within the esophagus, advancing the coring catheter 9120 down branches of the bronchial or biliary trees, etc.

In various embodiments, the angle β may be no greater than 15, 30, 45, 60, 90, 180, or 270 degrees; may be no less than 15, 30, 45, 60, 90, 180, or 270 degrees; may be within a range of from about 15 to 30, 45, 60, 90, 180 or 270 degrees, from about 30 to 45, 60, 90, 180, or 270 degrees, from about 45 to 60, 90, 180, or 270 degrees, from about 60 to 90, 180, or 270 degrees, from about 90 to 180 or 270 degrees, or from about 180 to 270 degrees; or may be about 15, 30, 45, 60, 90, 180, or 270 degrees.

With reference again to FIG. 60C, after debridement is complete, the coring catheter 9120 can be removed from the endoscope 9100. In some instances, one or more nasocystic catheters may then be placed for drainage and lavage between necrosectomy sessions. In other instances, the stent may merely be left in place without any instruments positioned therein to permit drainage of necrotic material into the stomach. In other or further instances, multiple transmural stents may be placed (e.g., a multiple-gateway approach) to facilitate drainage during necrosectomy.

In some instances, aggressive lavage of the necrotic cavity may be used prior to or during the coring to facilitate the necrosectomy. For example, lavage may be achieved via a fluid delivery lumen of the endoscope 9100 before, during, and/or after the coring catheter 9120 is used for debridement of the necrotic material. Ultimately, the endoscope 9100 is removed from the patient.

With reference to FIG. 60D, in some instances, a stent 9130 can be placed in the transmural tract to facilitate passage of the endoscope 9100. In some instances, the stent 9130 is placed prior to the initial introduction of the endoscope 9100 through the stomach wall. In other instances, the stent 9130 is placed at the end of a procedure to maintain patency of the tract and provide a passageway for the endoscope 9100 for subsequent necrosectomies. Any suitable stent is contemplated. For example, in some embodiments, the stent 9130 comprises an AXIOS™ stent available from Boston Scientific. FIG. 60D depicts a stage of a procedure in which the endoscope 9100 passes through the stent 9130 and the coring catheter 9120 passes through the endoscope 9100 to debride the necrotic material 9104. The debridement (e.g., coring and suctioning of cores) of the necrotic material 9104 can proceed in manners such as previously discussed. Upon completion of debridement, the coring catheter 9120 and the endoscope 9100 can be removed from the patient. The stent 9130 can be left in place for further debridement, in manners such as just discussed, at later times, e.g., over the course of days or weeks.

FIGS. 61A-61C depict additional procedures similar to those of FIGS. 60A-60C. In these procedures, the location of the target region 9102 is in the head of the pancreas P (rather than in the tail, as in FIG. 60A), and is accessible by forming a passageway through the duodenum D. In certain embodiments, the endoscope 9100 can be a duodenoscope. Embodiments of the coring catheter 9120 can be the same as or different from that used in the procedures of FIGS. 60A-60C. For example, in some instances, the coring catheter 9120 depicted in FIGS. 61B and 61C can be relatively longer to account for a longer pathway through the digestive tract of the patient. Accordingly, various procedures can be identical to those described above with respect to the stomach S, other than they are performed via the duodenum D. Thus, the foregoing disclosures discussed in the context of passing through the stomach wall will not be repeated, but are incorporated here with all appropriate replacements of the term “stomach” with “duodenum.”

Procedures such as just described can have a number of advantages, in various instances. For example, in certain instances, the procedures can be “truly minimally invasive,” in that they do not require abdominal puncture, as is generally the case for videoscopic-assisted retroperitoneal debridement (VARD) or laparoscopic necrosectomy. This can avoid the potential for scarring, hernia, or pancreatico-cutaneous fistula. Furthermore, in some instances, the procedures can be performed under conscious sedation, rather than general anesthesia. General anesthesia can, in some instances, cause long-term systemic inflammation in patients that are already seriously ill.

The coring catheter 9120 can be used in other procedures, such as VARD or laparoscopic necrosectomy. Additionally or alternatively, the coring catheter 9120 can be used effectively in various open surgery procedures.

Necrotic collections located in the tail of the pancreas, small collections, and collections in patients with low serum albumin levels may not produce a visible bulge and may desirably be accessed under EUS guidance to ensure proper positioning and avoid major vessels. In some instances, necrotic collections that are not close to the stomach or bowel (e.g., within a few centimeters), are extremely large, are dissociated, or are located in distant areas, such as the pelvis may, in some instances, but better treated with procedures other than endoscopic transmural necrosectomy. Further, in some instances, it may be desirable to treat collections that are not walled off with procedures other than endoscopic transmural necrosectomy to reduce chances of spreading necrotic tissue during gas insufflation.

In various instances, multiple necrosectomy procedures may be performed over a number of days via a placed stent. For example, in some instances, no fewer than 2, 3, 4, 5, or 6 necrosectomy procedures are achieved through the placed stent to ultimately obtain complete or substantially complete removal of the necrotic tissue. In other instances, even more sessions may take place (e.g., no less than 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, or 18). The repeated sessions may take place over a period of no less than 3, 4, 5, or 6 days or no less than 1, 2, 3, or 4 weeks. Further, in some methods, a necrosectomy procedure is performed directly after placement of a transmural stent, whereas in other methods, a waiting period may follow placement of the stent prior to the (e.g., first) necrosectomy procedure.

In some instances, it can be desirable to drain portions of the pancreas prior to proceeding with endoscopic transmural necrosectomies, such as those previously described. For example, in some instances, endoscopic transmural or transpapillary drainage may be conducted prior to any endoscopic transmural necrosectomies.

With reference again to FIGS. 9-16, in certain embodiments, a device 900 can include a coring catheter, or catheter tube 102 of any suitable variety discussed herein for purposes of coring and suctioning material from a patient. The device 900 can include a Y-fitting 904, which can include a suction port 902 for application of suction to the catheter tube 102, and can further include an arm 908 that defines an access channel into the catheter tube 102. The arm 908 can, such as in the illustrated embodiment, extend rectilinearly from a proximal end of the catheter tube 102. The arm 908 can accommodate insertion therethrough of any suitable elongated element. The elongated element can be advanced through the catheter tube 102 and, in some embodiments, can extend past a distal end of the catheter tube 102 to manipulate or otherwise disrupt material thereat. For example, as discussed previously with respect to the arm 908, in the illustrated embodiment, the stylet 700 can be passed through the arm 908 and through the catheter tube 102 and the distal end thereof can contact and disrupt problematic material, such as, e.g., impacted food within the esophagus or any other problematic material discussed herein. That is, the stylet 700 can be referred to as an elongated element, elongated member, or elongated disrupting element or member.

In some embodiments, the Y-fitting 904 includes a valve of any suitable variety, such as a Tuohy-Borst valve or adapter. The functioning of an embodiment of such a valve, which can include the compression seal 910 and the threaded cap 914, has previously been described.

In other embodiments, a different elongated member can be inserted through the Y-fitting 904 and through the catheter tube 102 of the device 900 to disrupt target material (e.g., problematic or undesired material) positioned distally past a distal tip of the catheter tube 102. For example, in various embodiments, any suitable variety of the disruptive (e.g., macerating) devices disclosed in the following U.S. patents and patent application publications is contemplated: U.S. Pat. No. 8,845,621, titled APPARATUS FOR ROTATING MEDICAL DEVICES, SYSTEMS INCLUDING THE APPARATUS, AND ASSOCIATED METHODS, issued Sep. 30, 2014; U.S. Pat. No. 9,107,691, titled APPARATUS FOR ROATATING MEDICAL DEVICES, SYSTEMS INCLUDING THE APPARATUS, AND ASSOCIATED METHODS, issued Aug. 18, 2015; U.S. Pat. No. 10,352,411 titled ROTATIONAL DRIVE APPARATUS WITH RATCHETING MECHANISM, issued Jul. 16, 2019; U.S. Pat. No. 10,376,278, titled TISSUE RESECTORS WITH CUTTING WIRES, HAND OPERATED TISSUE RESECTING SYSTEMS AND ASSOCIATED METHODS, issued Aug. 13, 2019; U.S. Patent Application Publication No. 2014/0142594, titled APPARATUS FOR ROTATING MEDICAL DEVICES, SYSTEMS INCLUDING THE APPARATUS, AND ASSOCIATED METHODS, published May 22, 2014; U.S. Patent Application Publication No. 2017/0189046, titled TISSUE RESECTORS, HAND OPERATED TISSUE RESECTING SYSTEMS, AND ASSOCIATED METHODS, published Jul. 6, 2017; and U.S. Patent Application Publication No. 2018/0228509, titled TISSUE PIERCING ASSEMBLIES, published Aug. 16, 2018. The entire contents of each of the foregoing patents and patent application publications are hereby incorporated by reference herein and form a part of the present disclosure.

By way of example, with reference to FIGS. 62A, in some instances, a manually operated, material-disrupting device 9200 can be formed by combining the disclosures pertinent to at least FIGS. 9 and 16 of U.S. Patent Application Publication No. 2014/0142594. The device 9200 may also be referred to as a system; in some embodiments, certain components of the device 9200 may be fully separable from each other and/or selectively adjustable relative to each other. The material-disrupting device 9200 can include a driver 9204 that includes a manually operable actuation handle 9205 of any suitable variety, such as disclosed in the aforementioned patents and published patent applications. In the illustrated embodiment, the driver 9204 is manually manipulable, or stated otherwise, is a manual driver. In other embodiments, as discussed below, an automated or power driver may be used.

In some embodiments, the actuation handle 9205 can include two handle elements 9206, 9207, and manual contraction or approximation of at least a portion of the two handle elements toward each other causes rotation of an elongated member 9210 portion of the system or device 9200 in a first direction, and separation or distancing of the two handle elements from each other causes rotation of the elongated member 9210 in a second direction opposite the first direction. For example, the device 9200 can include a helically threaded rotational member 9208 that converts translational motion of one or more of the handle elements (e.g., back and forth movement of an upper end of the forward handle element 9207 relative to the back handle element 9206) into rotational motion of the elongated member 9210. In some embodiments, separation of the two handle elements 9206, 9207 after an approximation event may occur automatically due to internal biasing of the driver 9204, such as may be provided by a compression spring 9209. Any suitable disclosures of the foregoing patents and patent application publications are contemplated with respect to the actuation handle 9205 and the elongated member 9210. Further details regarding the illustrated driver 9204 will now be provided.

With continued reference to FIGS. 62A and 62B, the illustrated embodiment includes the back and forward handle elements 9206, 9207, which can be gripped by a single hand of a user. In some instances, the back handle element 9206 remains relatively stationary relative to the hand during use, whereas the forward handle element 9207 is repeatedly squeezed to alternatingly approximate and move away from the back handle element 9206. The forward handle element 9207 can be coupled to the back handle element 9206 at a pivot 9232. Any suitable pivot arrangement is contemplated. In the illustrated embodiment, the forward handle element includes one or more inward protrusions that are received within an opening of the back handle element 9206 and are rotatable therein.

At an upper end of the illustrated back handle element 9206 is a housing 9230 that defines an open chamber with an opening (not shown) at a back end or base thereof. A proximal end of the he compression spring 9209 can be received into the chamber of the housing. A proximal end of the rotational member 9208 can extend through the chamber, through the opening at the base of the housing 9230. A ledge 9242 can be sized to not pass through the back opening so as to maintain the rear end of the rotational member 9208 in the chamber. In some embodiments, a cap 9220 is coupled to (e.g., screwed onto) the proximal end of the rotational member 9208 so as to be fixed relative thereto. Accordingly, as the rotational member 9208 spins, the cap 9220 may spin in unison therewith.

In the illustrated embodiment, the rotational member 9208 includes a thread 9244 that can interact with a shuttle 9250, which reciprocates back and forth as the forward handle member 9207 is squeezed and released, to impart rotation to the rotational member 9208. The rotational member 9208 can further include a forward ledge or shelf 9246 and a post 9248, which are further discussed hereafter.

The shuttle 9250 can be received within a barrel 9270, and the barrel 9270 can be secured to the housing 9230 in any suitable manner. The illustrated barrel 9270 includes linear slots 9272 that run parallel to a longitudinal axis of the driver 9204 and are diametrically opposed. The shuttle 9250 includes diametrically opposed slide protrusions 9250 that fit within the slots. The slide protrusions 9252 are elongated so as to prevent rotation of the shuttle 9250 within the barrel 9270. The shuttle 9250 further includes pivot protrusions 9254 that fit within openings 9260 defined at an upper end of the forward grip, or forward handle member 9207. As the bottom end of the forward handle member 9207 rotates about the pivot 9232, the upper end of the forward handle member 9207 rotates about the pivot protrusions 9254 as the shuttle 9250 moves longitudinally backward (i.e., proximally) and forward (i.e., distally) within the barrel 9270. Stated otherwise, repeated squeezing and releasing of the forward handle member 9207 can cause linear back-and-forth motion of the shuttle 9250. Backward motion of the handle element 9207 urges the shuttle 9250 backward, which compresses the spring 9209. Upon release of the handle element 9207, the spring 9209 urges the shuttle 9250 and the handle element 9207 forward again.

The shuttle 9250 can include any suitable interface for interacting with the thread 9244 of the rotational member 9208 to convert the linear motion of the shuttle 9250 into rotational motion of the rotational member 9208. For example, the shuttle 9250 can include an internally threaded track 9256 that is complementary to and interfaces with the thread 9244. In other embodiments, the thread 9244 and the track 9256 can be reversed relative to the components. Each mechanism involving one or more of a thread or track (e.g., helically arranged) may be referred to as a threaded arrangement. Any other suitable rotation-imparting mechanism or system is contemplated.

The post 9248 of the rotational member 9208 can extend through a distal opening 9274 defined by the barrel 9270. The ledge 9246 can be larger than the opening 9274 and can interface with an inner surface of the barrel 9270 to retain the rotational member 9208 within the barrel 9270. A distal cap 9280 can be attached to the post 9248 in any suitable manner. For example in some embodiments the distal cap 9280 is secured to the post 9248 via threading, adhesives, and/or welding. The distal cap 9280 can rotate in unison with the rotational member 9208.

With reference to FIG. 62A, the elongate member 9210 can include a distal portion or distal end 9218 and a proximal portion or proximal end 9219. The distal end 9218 can be inserted into the patient (e.g., through an endoscope and/or through a coring catheter), as discussed further below. The proximal end 9219 can remain at an exterior of the patient (and at an exterior of the endoscope and/or coring catheter) during use. The proximal end 9219 may be fixedly secured to the driver 9204 in any suitable manner. For example, in some embodiments, the proximal end 9219 of the elongated member 9210 can be adhered to one or more of the proximal and distal caps 9220, 9280. In other embodiments, the proximal end 9219 may be selectively secured via one of more of the caps 9220, 9280, such as via a tightening and/or loosing threaded collet. In certain of such embodiments, a length to which the distal end 9218 of the elongate member 9210 extends past the distal cap 9280 may be selected by a user.

The distal end 9218 of the elongated member 9210 can include an agitator 9215. In the illustrated embodiment, the agitator 9215 is a compressible component that can selectively be compressed to a low-profile state for advancement through, e.g., a working channel of an endoscope or a lumen of a catheter. In some embodiments, the agitator 9215 is resilient so as to naturally assume the expanded shape shown. In the illustrated embodiment, the agitator 9215 defines an empty basket shape when in an expanded state. For example, the agitator 9215 includes a plurality (four, in the illustrated embodiment, although other numbers are contemplated) of disruption elements. The disruption elements, when expanded, extend outwardly away from a longitudinal axis A of the elongated member 9210. Each disruption element defines an arc (more easily seen in other embodiments—see, e.g., FIGS. 63, 64, 65). Stated otherwise, each disruption element may be preformed to define a curve that extends outwardly away from the longitudinal axis A. In the illustrated embodiment, no portion of the elongated member is oriented along the longitudinal axis A in the region of the agitator 9215.

The agitator 9215 may be introduced through an endoscope or other elongated device with a lumen in a compressed or low-profile state. The agitator 9215 can, in some embodiments, naturally enlarge to the expanded state when advanced past the distal end of the endoscope or other device.

In various embodiments, a full stroke (e.g., squeeze) of the handle element 9207 of the actuation handle 9205 may effect 1, 2, 3, 4, 5, 6, 7 or more rotations of the elongated member 9210. In further instances, the return stroke may effect the same number of rotations, but in the opposite direction. A user may control how quickly or slowly the elongated member 9210 rotates by controlling the rate at which the actuation handle 9205 is squeezed and released. In various embodiments, by rapidly and repeatedly squeezing and releasing, a user may achieve a total number of rotations at a rate of up to, about, or greater than 500, 600, 700, 800, 900 or 1,000 rotations per minute. In some instances, an instantaneous rate of rotation of the elongated member 9210 may exceed the rate of total rotations achievable due to the back and forth motion exhibited in the latter instance. In various embodiments, an instantaneous rate of rotation of greater than about 1,000 or 1,500 rotations per minute may be achieved. Other rates of rotation are contemplated.

The elongated member 9210 portion of the device 9200 can be inserted through the Y-fitting 904 and through the lumen of the catheter tube 102 (see FIG. 9), with the expandable agitator 9215 portion of the elongated member 9210 in a compressed state. The agitator 9215 may also be referred to as a cutter, cutting element, scraper, scraping wire or wires, basket, macerator, resector, agitator, disruptor, etc. The agitator 9215 can be positioned at a distal end of a stem or shaft 9217.

The agitator 9215 can be expanded and rotated to cut, macerate, dislodge, or otherwise agitate or disrupt the undesired or problematic material. The disrupted material can be suctioned through the catheter tube 102. In some instances, the disrupted material is suctioned while the elongated member 9210 remains in place within the catheter tube 102. In other instances, the elongated member 9210 is removed from the catheter tube 102, and in further instances, is also removed completely from the Y-fitting 904, prior to suctioning. In some instances, the agitator 9215 may cut or otherwise disrupt one or more individual or separated pieces of material and, while the agitator 9215 remains at a position distal to the distal tip of the coring catheter 102, the distal tip of the coring catheter may core or cut the one or more pieces into smaller pieces for suctioning through the catheter 102. In other or further instances, the agitator 9215 may alter a state of the material, such as from a relatively solid or viscous state to a relatively liquified, slurry-like, or less viscous state and, while the agitator 9215 remains at a position distal to the distal tip of the coring catheter 102, the coring catheter 102 can apply suction (e.g., relatively high suction) to remove the altered material.

In some embodiments, a user may sese, feel, or otherwise receive tactile feedback from the agitator 9215, and thus from the conditions that the agitator 9215 encounters, as the agitator 9215 rotates. For example, a user may sense when rotation is relatively easy or relatively difficult, or even when binding of the agitator 9215 has occurred. This can enable the user to react quickly (e.g., terminate rotation, speed up or slow down rotation, torque, and/or oscillation, move the agitator longitudinally back and forth with or without rotating the agitator) in a manner that will reduce potential for damage or harm to the patient and/or that will enhance effectiveness of a procedure.

In other embodiments, an automated or powered driver may be used in place of the illustrated manual driver. For example, in some embodiments a handheld power drill of any suitable variety may be coupled with and rotate the elongated member 9210. The power drill may achieve any of the rotational rates (absolute and/or instantaneous) previously described. In some instances, the powered driver may provide less or even no tactile feedback to a user with respect to conditions encountered by the agitator 9215.

In some embodiments, the coring and suctioning device 900 and the agitating device 9200 may be used in an alternating or serial fashion. For example, in some instances, an endoscope may be positioned adjacent to the target material for removal from the patient, such as necrotic material in the pancreas (e.g., from pseudocysts and/or pancreatic ducts), stool impaction within the bowel, mucous or other blockages within the trachea and/or bronchial tree, blood clots (e.g., within the gastrointestinal tract), esophageal food impactions, etc. In various of such instances, specialized endoscopes may be used, depending on the region of the body being accessed. For example, in various instances, the devices 900, 9200 may be passed through the working channel of a gastroscope, a duodenoscope, a sigmoidoscope, or a colonoscope, or a bronchoscope.

The agitating device 9200 (i.e., the elongated member 9210 thereof) may initially be introduced through the working channel of the endoscope to the target material, and then actuated to rotate and macerate the material. The agitating device 9200 may be removed from the working channel while the endoscope remains in place. The coring and/or suctioning device 900 may then be inserted through the working channel and can core and/or suction away the disrupted material. In some instances, the disruption and suctioning stages can be repeated as necessary or desired. In some instances, each of the devices 900, 9200 are used under complete visualization provided by the endoscope. The device 900 and/or the device 9200 can, individually or in cooperation with each other, be used for effective treatment of pancreatitis (e.g., walled-off necroses), bowel impactions, tracheal or bronchial blockages, blood clots, esophageal food impactions, etc.

While the foregoing discussion focuses on the illustrative device 900, which includes the catheter tube 102, it is contemplated that appropriate features of any of the other catheter tubes and coring devices disclosed herein may be employed with the device 900, or stated otherwise, that any of the other disclosed coring catheters may be suitably adapted to accommodate the elongated member 9210 of the agitating device 9200 and to simultaneously provide suctioning through the catheter lumen within which the elongated member 9210 is positioned.

In still other or further instances, the elongated member 9210 of the agitating device 9200 can be selectively inserted through and removed from any of the catheter or catheter assemblies 100, 3004, 3304, 3404, 3504, 3604, 3704, 3804, 4004, 9120. For example, in some instances, the catheter or catheter assembly can be inserted into the patient, for example, such that the distal tip is at or near the target site. In some instances, the catheter or catheter assembly is inserted into the patient by being advanced through the working channel (or one of multiple working channels) of an endoscope. The elongated member 9210 of the agitating device 9200 can be inserted through a lumen of the catheter or catheter assembly, with the agitator 9215 in the low-profile state, before or after said insertion of the catheter or catheter assembly. The elongated member 9210 can be advanced past the distal end of the catheter and into the target site, can naturally transition to the expanded state, and can be rotated to agitate or disrupt the target site (e.g., problematic material). In further instances, the elongated member 9210 is then withdrawn from the catheter. The catheter may then be coupled to a source of suction. The catheter may then be used to core and/or suction the agitated material, in manners such as previously disclosed. The coring catheter may subsequently be removed from the patient. For example, the coring catheter may be withdrawn proximally from the endoscope and the endoscope may subsequently be removed, or both the catheter and the endoscope may be withdrawn simultaneously from the patient.

In some methods, the catheter may not be coupled to a source of suction and may not be used to core the material. For example, in some embodiments, the catheter or catheter assembly (100, 3004, 3304, 3404, 3504, 3604, 3704, 3804, 4004, 9120) may be used to reduce friction to facilitate longitudinal and/or rotational movement of the elongated member 9210 of the agitating device. As previously discussed, in some embodiments, an interior surface of the catheter may be lubricious. In various methods, the catheter or catheter assembly is inserted into the patient by being advanced through the working channel (or one of multiple working channels) of an endoscope. The elongated member 9210 of the agitating device 9200 can be inserted through a lumen of the catheter or catheter assembly before or after said insertion of the catheter or catheter assembly. The elongated member 9210 can be advanced past the distal end of the catheter and into the target site, and can be rotated to agitate or disrupt the target site (e.g., problematic material). The catheter may reduce friction for the spinning elongated member 9210, relative to friction that might otherwise be experienced between the elongated member 9210 and the endoscope in the absence of the catheter. In some embodiments, the catheter is not used to core or suction any of the disrupted material. The elongated member 9210 and the catheter may ultimately be removed from the endoscope. In some instances, at any appropriate stage of certain of these or other methods, standard suction may be applied to the disrupted material via the endoscope.

The foregoing methods may be incorporated, as appropriate, into any of the methods disclosed herein. For example, these methods may be used, whether alone or in conjunction with other methods disclosed herein, for treating pancreatitis, food impaction, blockages of the lungs, bowel impaction, etc.

In some methods, it may be advantageous to achieve rotation of the agitator 9215 prior to contacting the material that is to be disrupted. For example, with reference again to FIGS. 60C, 60D, 61B, and 61C, in some instances, the necrotic material 9104 may tend to bind the agitator 9215 when the agitator 9215 is positioned therein while stationary or moving slowly. For example, the consistency of the necrotic material 9104 may be similar to, e.g., peanut butter. With the agitator 9215 positioned in the necrotic material 9104, it may be difficult to start rotation of the agitator 9215, as a large amount of torque may be necessary to initiate movement of the agitator 9215. In some instances, the agitator 9215 is less prone to binding or sticking within the necrotic material 9104 and/or is more efficient at cutting or otherwise disrupting the necrotic material 9104 when the agitator 9215 rotates, e.g., rapidly, before contacting the necrotic material 9104. Accordingly, in some methods, it can be desirable to achieve rotation of the agitator 9215, such as relatively large rotational rates of the agitator 9215, prior to contacting the necrotic material 9104 with the agitator. In various methods, a rate of total rotations per minute and/or a maximum instantaneous rate of rotation of the agitator 9215 can be no less than 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1,000 rotations per minute prior to contacting the agitator 9215 to the necrotic material 9104.

In some embodiments, disruption of the target (e.g., problematic) material may be more efficient with introduction of water or other fluid (e.g., saline) to the material. In some embodiments, sterile water may be delivered to the target material prior to, concurrently with, and/or after cutting, agitation, or other disruption of the target material via the agitator 9215.

In some embodiments, disruption of the target (e.g., problematic) material may be more efficient with longitudinal (e.g., proximal and/or distal) movement of the agitator 9215. For example, in some embodiments, the elongated member 9210 may be longitudinally fixed relative to the handle 9205, and the user may urge the handle 9205 forward (distally) and/or backward (proximally) relative to the endoscope to dislodge material and/or to free the agitator 9215 from the material. In other or further instances, the user may advance and/or retract the elongated element 9210 relative to the handle 9205 while maintaining the handle 9205 substantially stationary. In other or further instances, the handle 9205 may be configured to achieve longitudinal movement (e.g., back-and-forth or hammering motion) of the elongated member 9210, such as in manners disclosed on one or more of the above-identified patents and patent application publications. Accordingly, various methods can include a step of moving the agitator 9215 longitudinally before, after, and/or concurrently with rotation of the agitator 9215.

The foregoing methods may be particularly useful in certain instances of clearing necrotic material from the pancreas, and thus may be readily incorporated into the various methods of treating pancreatitis disclosed herein. Moreover, methods involving other target materials (for example, food impactions, stool impactions, etc.) may similarly include various method steps disclosed above, such as rotating the agitator 9215 prior to contact with the material; introducing water to the material prior to, concurrently with, and/or after agitation of the material; and/or moving the agitator 9215 longitudinally.

With respect to necrosectomy procedures, some or all of the foregoing methods may assist in separating the necrotic material from healthy tissue, breaking down the necrotic material into smaller pieces, and/or forming a flowable slurry of the necrotic material. In some methods, the smaller pieces and/or slurry material may be cored and/or suctioned via, e.g., a coring catheter (e.g., those described elsewhere herein), endoscope suction, etc. In other or further methods, the smaller pieces and/or slurry material can drain naturally from the pancreas, through the stent, and into the stomach or duodenum, where it may then pass through the gastrointestinal tract and/or be expelled from the patient through natural processes.

FIG. 63 depicts another embodiment of a material-disrupting device 9300 such as those previously described (including those described in the above-mentioned patents and patent application publications), and which can be used in place of the device 9200 in any of the methods disclosed relative thereto. The device 9300 includes a handle 9305, which in certain embodiments may operate identically to the handle 9205. The handle 9305 can include comfort grip features. The device 9300 further includes an elongated element 9310 that includes a distal agitator 9315, a proximal agitator 9316, and a shaft 9317. The proximal agitator 9316 is positioned toward a distal end of the shaft 9317, and the distal agitator 9315 is at a distal end of the proximal agitator 9316. This arrangement can provide a dual-cutting, or dual-disruption feature. The arrangement may also be referred to as a dual-head agitator. In the illustrated embodiment, the distal and proximal agitators 9315, 9316 are differently sized, with the proximal agitator 9316 defining a greater diameter than that of the distal agitator 9315. In various embodiments, the agitators 9315, 9316 can be compressed or compressible to a size that is the same as or only slightly larger than a diameter of the shaft 9317. The agitators 9315, 9316 can expand into the configuration shown for rotational disruption of material.

In the illustrated embodiment, the shaft 9317 can comprise a wire of any suitable construction. The shaft 9317 can be relatively flexible in transverse directions or, stated otherwise, can be laterally flexible, while being longitudinally stiff. In various embodiments, the shaft 9317 comprises nitinol or stainless steel. In further embodiments, the agitators 9315, 9316 can be formed from the same material as the shaft 9317, and in further embodiments, a single unitary element may define each of the shaft 9317 and the agitators 9315, 9316. For example, in some embodiments, the expandable agitators 9315, 9316 may be formed by laser cutting a distal region of a wire.

In various embodiments, including those depicted in FIGS. 62-65, it may be desirable for the one or more agitators to be formed of nitinol. The thin strips of nitinol (i.e., the disruption elements), which expand into the illustrated basket or cage shape, can be very flexible. When rotating quickly, these flexible members can cut through or otherwise disrupt damaged or necrotic tissue (for example, in the pancreas), but may merely bend, flex, or deflect from healthy tissue. The flexible members thus may impart little or no damage to healthy tissue. Stated otherwise, the flexible members may pass through the necrotic tissue, thereby disrupting it, but may merely glide over, flex, or otherwise be moved out of the way by healthy tissue.

In the illustrated embodiment, the shaft 9317 comprises a nitinol wire having an outer diameter of 0.035 inches. The proximal agitator 9316 defines an outer diameter of 25 millimeters, and the distal agitator 9315 defines an outer diameter of 10 millimeters. Other shapes and sizes are contemplated.

In the illustrated embodiment, each agitator 9315, 9316 is formed from the single, unitary nitinol wire, through which two orthogonal planes of laser cuts have been made. Accordingly, in cross-section, each of the resulting four agitator members has a substantially 90-degree pie-piece shape, with the arc thereof being at the external surface of the cut member. Other shapes and configurations are contemplated.

In some arrangements, the elongated element 9310 can be advanced through the lumen of a coring catheter with the agitators 9315, 9316 in a low-profile state. The agitators 9315, 9316 can be advanced past the distal end of the coring catheter and expanded. The agitators 9315, 9316 can be actuated (e.g., rotated and/or moved axially/longitudinally) back and forth to disrupt material. In some instances, the disrupted material can be suctioned through the coring catheter while the shaft 9317 remains within the lumen of the coring catheter and/or after the elongated element 9310 has been removed from the coring catheter, in manners such as previously discussed.

In other instances, and as is true with other agitating devices disclosed herein, the agitating device 9300 may be used in a serial, alternating, or exchange manner with the coring catheter (as previously discussed), or may be used without the coring catheter. For example, in some methods, the agitators 9315, 9316 are inserted through the working channel of an endoscope to the target region and are used to disrupt the material. For example, in certain procedures for eliminating necrotic material from the pancreas, the disrupted necrotic material may be suctioned through the endoscope, may be pulled into the stomach or duodenum via some other instrument (e.g., a grasper) inserted through the working channel, or may be left to drain naturally (e.g., through a pre-placed stent) into the stomach or duodenum.

In various methods of using the device 9300 (as with other similar devices disclosed herein), two users control the endoscope, the coring catheter, and the material disruption device 9300, or in other methods, control the endoscope and the disruption device 9300. For example, a first user (e.g., a doctor or other practitioner) may control the endoscope and the coring catheter. In various instances, either the first user or a second user (e.g., a nurse, technician, or other practitioner) may advance the device 9300 through the coring catheter while the first user maintains the endoscope and coring catheter in a desired configuration within the patient. In further instances, the second user can actuate the handle of the device 9300 to disrupt material via one or more of the agitators 9315, 9316. For example, in some instances, substantially all control of an orientation and/or position of a distal tip of the endoscope, a distal tip of the coring catheter, and the agitators 9315, 9316 can be controlled by the first user, whereas the second user controls actuation of the agitators 9315, 9316. In other methods, a first user may similarly control just the endoscope, while a second user operates the agitating device 9300.

FIG. 64 depicts another embodiment of a material-disrupting device 9400 such as those previously described (including those described in the above-mentioned patents and patent application publications). The device 9400 includes an elongated element 9410 that includes an agitator 9415 at a distal end of a shaft 9417. In the illustrated embodiment, the shaft 9417 comprises a wire having an outer diameter of 0.035 inches. The agitator 9315 defines an outer diameter of 25 millimeters. Other shapes and sizes are contemplated.

FIG. 65 depicts another embodiment of a material-disrupting device 9500 such as those previously described (including those described in the above-mentioned patents and patent application publications). The device 9500 includes an elongated element 9510 that includes an agitator 9515 at a distal end of a shaft 9517. In the illustrated embodiment, the shaft 9517 comprises a wire having an outer diameter of 0.035 inches. The agitator 9515 defines an outer diameter of 10 millimeters. Other shapes and sizes are contemplated. For example, in various embodiments, the outer diameter of the expanded agitator 9515 is within a range of from about 10 to 30, 10 to 25, 10 to 20, 10 to 15, 15 to 30, 15 to 25, 15 to 20, 20 to 30, 20 to 25, or 25 to 30 millimeters, is no less than 10, 15, 20, 25, or 30 millimeters, or is no greater than 10, 15, 20, 25, or 30 millimeters. In various embodiments, the outer diameter of the expanded agitator 9515 is 15, 16, 17, 18, 19, or 20 millimeters.

A length of the elongated elements 9210, 9310, 9410, 9510 can be sufficient to permit the end agitators 9215, 9315, 9316, 9415, 9515 to pass through the endoscope (e.g., which may have been positioned transorally) and into the target region. Accordingly, for various pancreatitis applications, the length may be sufficient for the agitators to pass through the endoscope into a necrotic portion of the pancreas. In some embodiments, for other applications, the length may be longer or shorter, such as to be on the same general order (although longer than) a combined length of the endoscope with which the elongate element will be used and the driver.

Kits can include any suitable combination of the foregoing system components, such as a driver, a elongate member, a coring catheter, and/or an endoscope. The driver and elongate member may be preassembled in some instances, or may be assembled on site in other instances. The kits can include instructions for use, such as previously described (see, e.g., FIGS. 55 and 56 and associated discussion). The instructions may recite directions to achieve any of the methods disclosed herein using the various devices and components. Accordingly, any method disclosed herein may be recited as directions within a set of instructions for use.

EXAMPLES 3-29

Following are examples of illustrative methods, numbered 3 to 29.

Example 3. A method comprising:

advancing an endoscope to a site within a body of a patient at which problematic material is located, the endoscope defining a channel;

delivering a device through the channel of the endoscope to the site at which the problematic material is located, the device comprising a distal end configured to core the problematic material, a proximal end, and a tube that comprises a hollow interior;

coring from the problematic material, using the distal end of the device, a piece that is sized to pass through the hollow interior of the tube; and

applying suction to the device to pass the piece through the hollow interior of the tube and to move the piece out of the device.

Example 4. The method of example 3, wherein the site is within the pancreas of the patient.

Example 5. The method of example 3, wherein the site is in the biliary tree of the patient.

Example 6. The method of example 5, wherein the site is in the common bile duct of the patient.

Example 7. The method of example 5, wherein the site is in a peripheral duct of the patient.

Example 8. The method of example 3, wherein a gallstone comprises the problematic material.

Example 9. The method of example 8, wherein the gallstone is lodged in the biliary tree.

Example 10. The method of example 3, wherein a tumor comprises the problematic material.

Example 11. The method of example 10, wherein the tumor is lodged in the biliary tree

Example 12. The method of example 3, wherein a kidney stone comprises the problematic material.

Example 13. The method of example 12, wherein the kidney stone is within one of a ureter, the bladder, or a kidney of the patient.

Example 14. The method of example 3, wherein a blood clot comprises the problematic material.

Example 15. The method of example 3, wherein the endoscope is specialized for advancement through the patient to the site.

Example 16. The method of example 15, wherein the endoscope is a bronchoscope, and wherein the site is within the bronchial tree of the patient.

Example 17. The method of example 15, wherein the endoscope is a colonoscope, and wherein the site is within the colon of the patient.

Example 18. The method of example 3, wherein said delivering the device through the channel of the endoscope to the site at which problematic material is located comprises advancing the distal end of the device past a distal end of the endoscope into contact with the problematic material.

Example 19. A method comprising:

positioning an endoscope within a body of a patient such that a distal end of the endoscope is at a site within the body of the patient at which problematic material is located, the endoscope defining a channel;

delivering a catheter tube through the channel of the endoscope to the site at which the problematic material is located, the catheter tube defining a lumen;

advancing an elongated member that extends through the lumen of the catheter tube out of the catheter tube and into the problematic material to manipulate the problematic material; and

after said advancing the elongated member, applying suction to the catheter tube to remove a portion of the problematic material through the lumen of the catheter tube.

Example 20. The method of example 19, wherein said advancing the elongated member out of the catheter tube and into the problematic material comprises piercing and disrupting the problematic material via the elongated member.

Example 21. The method of example 20, wherein the elongated member comprises a stylet.

Example 22. The method of example 20, wherein the elongated member comprises a pointed distal tip.

Example 23. The method of example 19, wherein the elongated member remains within the lumen of the catheter tube during said applying suction to the catheter tube to remove the portion of the problematic material.

Example 24. The method of example 19, further comprising removing the elongated member from the catheter tube prior to said applying suction to the catheter tube to remove a portion of the problematic material.

Example 25. The method of example 24, further comprising introducing the elongated member into the lumen of the catheter prior to said advancing the elongated member out of the catheter tube and into the problematic material.

Example 26. A method of treating pancreatitis, the method comprising:

positioning a distal end of an endoscope adjacent to necrotic material within the pancreas of a patient, wherein the endoscope comprises a working channel;

advancing a coring catheter through the working channel of the endoscope and into contact with the necrotic material past the distal end of the endoscope; and

suctioning at least a portion of the necrotic material through the coring catheter.

Example 27. The method of example 26, further comprising:

advancing an agitator of a material-disrupting device through the working channel of the endoscope into contact with the necrotic material; and

actuating the agitator to disrupt the necrotic material.

Example 28. The method of example 27, wherein said advancing the agitator through the working channel of the endoscope comprises advancing the agitator through a lumen of the coring catheter while the coring catheter is positioned within the working channel of the endoscope.

Example 29. The method of example 27, further comprising removing the material-disrupting device from the working channel of the endoscope prior to said advancing the coring catheter through the working channel of the endoscope.

Although the foregoing detailed description contains many specifics for the purpose of illustration, a person of ordinary skill in the art will appreciate that many variations and alterations to the following details can be made and are considered to be included herein. Accordingly, the foregoing embodiments are set forth without any loss of generality to, and without imposing limitations upon, any claims set forth. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.

As used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a layer” includes a plurality of such layers.

In this disclosure, “comprises,” “comprising,” “containing” and “having” and the like can have the meaning ascribed to them in U.S. patent law and can mean “includes,” “including,” and the like, and are generally interpreted to be open ended terms. The terms “consisting of” or “consists of” are closed terms, and include only the component structures, steps, or the like specifically listed in conjunction with such terms, as well as that which is in accordance with U.S. patent law. “Consisting essentially of” or “consists essentially of” have the meaning generally ascribed to them by U.S. patent law. In particular, such terms are generally closed terms, with the exception of allowing inclusion of additional items, materials, components, steps, or elements, that do not materially affect the basic and novel characteristics or function of the item(s) used in connection therewith. For example, trace elements present in a composition, but not affecting the compositions nature or characteristics would be permissible if present under the “consisting essentially of” language, even though not expressly recited in a list of items following such terminology. When using an open ended term in the specification, like “comprising” or “including,” it is understood that direct support should be afforded also to “consisting essentially of” language as well as “consisting of” language as if stated explicitly and vice versa.

The terms “first,” “second,” “third,” “fourth,” and the like in the description and in the claims, if any, are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in sequences other than those illustrated or otherwise described herein. Similarly, if a method is described herein as comprising a series of steps, the order of such steps as presented herein is not necessarily the only order in which such steps may be performed, and certain of the stated steps may possibly be omitted and/or certain other steps not described herein may possibly be added to the method.

The terms “left,” “right,” “front,” “back,” “top,” “bottom,” “over,” “under,” and the like in the description and in the claims, if any, are used for descriptive purposes and not necessarily for describing permanent relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in other orientations than those illustrated or otherwise described herein. The term “coupled,” as used herein, is defined as directly or indirectly connected in any suitable manner. Objects described herein as being “adjacent to” each other may be in physical contact with each other, in close proximity to each other, or in the same general region or area as each other, as appropriate for the context in which the phrase is used. Occurrences of the phrase “in one embodiment,” or “in one aspect,” herein do not necessarily all refer to the same embodiment or aspect.

As used herein, the term “substantially” refers to the complete or nearly-complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, an object that is “substantially” enclosed would mean that the object is either completely enclosed or nearly completely enclosed. The exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context. However, generally speaking the nearness of completion will be so as to have the same overall result as if absolute and total completion were obtained. The use of “substantially” is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result. For example, a composition that is “substantially free of” particles would either completely lack particles, or so nearly completely lack particles that the effect would be the same as if it completely lacked particles. In other words, a composition that is “substantially free of” an ingredient or element may still actually contain such item as long as there is no measurable effect thereof.

As used herein, the term “about” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “a little above” or “a little below” the endpoint. Moreover, for references to approximations (which are made throughout this specification), such as by use of the terms “about” or “approximately,” or other terms, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about,” “substantially,” and “generally” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially perpendicular” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely perpendicular orientation.

As used herein, a plurality of items, structural elements, compositional elements, and/or materials may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member. Thus, no individual member of such list should be construed as a de facto equivalent of any other member of the same list solely based on their presentation in a common group without indications to the contrary.

Concentrations, amounts, and other numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “about 1 to about 5” should be interpreted to include not only the explicitly recited values of about 1 to about 5, but also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as 2, 3, and 4 and sub-ranges such as from 1-3, from 2-4, and from 3-5, etc., as well as 1, 2, 3, 4, and 5, individually.

This same principle applies to ranges reciting only one numerical value as a minimum or a maximum. Furthermore, such an interpretation should apply regardless of the breadth of the range or the characteristics being described.

References throughout this specification to “an example,” if any, mean that a particular feature, structure, or characteristic described in connection with the example is included in at least one embodiment. Thus, appearances of the phrases “in an example” in various places throughout this specification are not necessarily all referring to the same embodiment.

Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.

Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.

The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description. These additional embodiments are determined by replacing the dependency of a given dependent claim with the phrase “any of claims [x] through the claim that immediately precedes this one” where the bracketed term “[x]” is replaced with the number of the most recently recited independent claim. For example, for the first claim set that begins with independent claim 1, claim 3 can depend from either of claims 1 and 2, with these separate dependencies yielding two distinct embodiments; claim 4 can depend from any one of claim 1, 2, or 3, with these separate dependencies yielding three distinct embodiments; claim 5 can depend from any one of claim 1, 2, 3, or 4, with these separate dependencies yielding four distinct embodiments; and so on.

Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements specifically recited in means-plus-function format, if any, are intended to be construed in accordance with 35 U.S.C. § 112(f). Elements not presented in requisite means-plus-function format are not intended to be construed in accordance with 35 U.S.C. § 112(f). Embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows.

	Number	Date	Country
	62905369	Sep 2019	US
	62926517	Oct 2019	US

	Number	Date	Country
Parent	PCT/US2020/052594	Sep 2020	US
Child	17702427		US

MATERIAL REMOVAL FROM WITHIN A PATIENT

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