The field relates to endoscopic procedures and tools.
An endoscope is an known instrument inserted into a body cavity to view the cavity and to carry out certain surgical, or other medical, procedures. Food impaction in the esophagus is a common gastrointestinal emergency in which food gets stuck and must be dislodged using a surgical procedure. There are several tools for removal of impacted food. The procedure for food removal can be tedious and several tools may be utilized. Cutting the food bolus into smaller pieces has proven to be a generally safe method to relieve the impaction. With current tools, this process may be laborious. Regular snares are not often unsuccessful. Worse still, the instruments may cause damage to surrounding tissues. Another use of an endoscopic snare is removal of unwanted tissue within the gastrointestinal tract such as polyps or other growths. Known tools have difficulty accessing and removing polyps or residual tissue that is not readily accessible.
It is known to use controls at the proximal end of the instrument may control the instrument's tip through cables or filaments running through the endoscope's tubular structure. These controls provide some modest control over the disposition of the distal tip of an instrument, often resulting in a laborious trial and error effort to position the instruments correctly within a cavity in order to perform a desired surgical procedure.
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a procedure that combines the use of an endoscope and radiographically guided instruments to reach the ampulla and selectively cannulate the common bile duct, pancreatic duct, or both. Frequently, the patient's indications require only cannulation of the common bile duct without cannulation of the pancreatic duct. Achieving selective cannulation into the bile duct generally provides a higher overall success rate and shortened procedure time as well as lower unintended complications. Chief among these complications is pancreatitis. The major difficulty encountered involves the ability to direct the cannula in the necessary upward direction from the tip of the endoscope to engage the common bile duct and not enter or damage the pancreatic duct.
Current tools used for selective cannulation of the common bile duct utilize methods of wire insertion and catheter insertion as well as contrast injection and depend primarily on the skills of the person operating the endoscope. Endoscopic Retrograde Cholangiopancreatography (ERCP) is typically carried out with a side-view endoscope, such as illustrated in
Existing tools don't have a distal end that can be readily guided to the papilla so that the instrument can engage the opening and assist in teasing it partially open. The problem is that known instruments cannot obtain the proper angle to engage the common bile duct directly without unintentionally entering the pancreatic duct. This can lead to unwanted complications and unsatisfactory outcomes.
An endoscopic tool comprises a proximal end having a manipulator for manipulating an instrument disposed at a distal end. The tool having a filament such as a cable or wire connecting the proximal end to the distal end such that manipulating the manipulator operates the instrument at the distal end. Herein, the term “filament” is used as a broad term to mean any type of wire, cable or other flexible shaft that may be inserted through a tubular lumen to push or pull the instrument using the manipulator. In one example, a more rigid filament may be used to push and pull. in an alternative example, a filament may be more flexible and may be capable of only pulling against the tool (but not capable of pushing the instrument). A spring-like resilience may act to pull the instrument back into place after being pulled by a highly flexible filament into an arcuate shape, for example, even though the flexible filament would not be able to push the tool back to its original shape.
The instrument at the distal end may be used for probing, cutting and/or removing an object or orifice in a body cavity. For example, the body cavity may be an intestinal tract or an esophagus or the like. For example, the tool may be inserted through an endoscope, the endoscope having a means, as is well known in the art, for viewing inside of the body cavity.
For example, the instrument may have a flexible end with a snare disposed within a tubular lumen of the tool. The tubular lumen may have a soft tip extending distally from the tubular lumen, and the snare may comprise a loop that extends transversely to the shaft of the tubular lumen when the loop extends from an orifice in a side of the tubular lumen or a side of the soft tip extending from the tubular lumen. Herein “transverse” and “transversely” mean perpendicularly or obliquely extending from the longitudinal axis of the tubular lumen (as directed by the manipulator and the orifice, when extended from the orifice). “Soft” means a degree of softness capable of reducing damage to tissues when a soft component is pressed against mucous membranes and internal body cavities, as this would be understood by one of ordinary skill in the art. For example, a silicone rubber coating is soft, as are other elastomeric materials.
The loop, prior to extension from the orifice, is directed along the longitudinal axis, but as the loop is directed by the orifice, the loop may extend transversely from the side of the tubular lumen. The loop may be constructed from a flexible wire or a shape memory alloy. The loop may be coupled to a distal end of a cable, and a proximal end of the cable may be coupled to the manipulator of the tool.
For example, a distal tip of the tool may be comprised of soft blunt tip. A side opening in the tubular member or the soft blunt tip may be disposed proximate to the distal soft blunt tip. The soft blunt tip may be used to probe an orifice in order for the tool to enter the orifice, for example. The orifice in the body cavity may be a duct, such as a bile duct, for example.
For example, the orifice may be from 2 to 3 mm from a distal end of the soft blunt tip. In one example, the loop may extend from the orifice perpendicularly to the longitudinal axis of the tubular lumen. In some procedures, the transversely directed loop greatly improves the ability of a surgeon to quickly and accurately grasp, under direct visualization, an impacted bolus or polyp or the like, for example, while the soft blunt tip prevents inadvertent damage to mucus membranes, ducts, and other tissues within the body cavity. A loop may be used to dissect the bolus for its removal or to remove an impaction lodged in the body cavity, for example.
In another example, the tool may be used for cannulating a duct, such as a common bile duct, for example. The instrument at the distal end of the tool may be flexible and may allow for accurate positioning within the ampulla of Vater proximate the sphincter of oddi. A distal end of the instrument may probe and facilitate entry of a wire or cannula into an orifice. In one example, a secondary filament redirects the tip greater than 90 degrees from the longitudinal axis of the endoscope allowing the instrument to gently traction on the ampulla's upper rim, stabilizing and straightening the lumen for insertion of the wire or cannula.
For example, the instrument comprises grasping jaws coupled with the manipulator such that the grasping jaws engage a portion or papilla of the sphincter of oddi, teasing the papilla at least partially open for insertion of a wire or cannula. The wire or cannula may extend through an orifice extending longitudinally or transversely to the longitudinal axis of the tubular lumen of the tool, such that the wire or cannula is directed into the duct.
For example, the grasping jaws of the instrument may be made of a soft and slip resistant material, such as an elastomer or an elastomerically coated rigid material, allowing a firm grasp without cutting or otherwise tearing the tissue being grasped. For example, a non-slip silicone polymer may be used for coating a metal grasper. Grasping jaws may be coated with a silicone or other elastomeric polymer, for example. The grasping jaws may be made with one or both grasping jaws movable from an open position to a grasping position with a scissor mechanism or any other mechanism capable of closing the jaws in a grasping motion.
In one example, the tool further comprises a secondary filament coupled at one end near the tip of the tools distal end and coupled at the other end to the manipulator such that the secondary filament may be pulled by the manipulator such that the movement or bending of the distal tip arcuately disposes the distal end for accurately positioning the instrument within the body cavity. In this example, the secondary filament may be any material compatible with the instrumentation and its internal use and includes materials from the group consisting of a metal such as a wire or cable, fiber materials, and polymer materials. In one example, a titanium metal wire is selected.
By combining grasping jaws and a secondary filament the tip of the instrument extending from the endoscope is positioned independent of the endoscope in an orientation more favorable for delivering a wire or a cannula from the tip of the instrument through the papilla teased open by the grasping jaws and into the common bile duct. For example, an orifice in a soft tip may be directionally angled for easy entry and extension of a wire or a cannula into the common bile duct, without inadvertently entering any other duct, such as the pancreatic duct. Alternatively, the wire or the cannula may be reoriented to direct the wire or cannula safely into the pancreatic duct, if desired, for diagnostic or corrective surgical procedures.
The following drawings are illustrative examples and do not further limit any claims that may eventually issue.
When the same reference characters are used, these labels refer to similar parts in the examples illustrated in the drawings.
In one example, an endoscopic tool may comprise an instrument for use in existing endoscopes by inserting the instrument through a tubular channel of the endoscope and controlling the instrument using a manipulator as described in more detail elsewhere.
For example, the tool may comprise a tubular lumen and various instruments that may be disposed within the tubular lumen, such as a wire, cannula, catheter or sphincterotome, for example, as illustrated in
The filament 44 may be coupled to a manipulator at a proximal end of the tool for a surgeon to activate the manipulator to pull the filament, bending die bending section 40 at any desired angle relative to the longitudinal axis of the endoscope. Tension pulling on the filament 44 may be controlled to adjust flexure of the bending section 40, as shown for the sphincterotome in
Filament 44 may have a portion extending externally to a tubular member of the bending section. Internal to the flexible end is an instrument 12, such as a wire, cannula, snare loop or catheter.
In one example, an instrument 12 is directed through the papilla of the sphincter of oddi and into the common bile duct as shown in
In one example of the method, the method comprises the following steps: placing the distal tip of the instrument within a patient's ampulla of Vater; disposing the grasping jaws in an open position at a location such that closing the grasping jaws will grasp a portion of the papilla proximate the lumen leading to the common bile duct; closing the grasping jaws such that a portion of the the upper rim of the papilla is grasped with the grasping jaws; applying traction to the portion of the papilla with the grasping jaws to position the orifice of the soft tip of the instrument adjacent to the papilla and teasing open the papilla and aligning the lumen of the papilla for insertion of the instrument into the lumen of the papilla; and advancing the instrument into the lumen of the papilla.
For example, the method may advance a cannula or catheter into the lumen of the papilla. In one example, the instrument comprises a bending section, and the bending section is arcuately bent by pulling on a filament coupled on a distal end adjacent to the tip of the instrument and on its opposite proximal end to a manipulator capable of applying and releasing tension on the filament. For example, a longitudinal axis of the tip may be directed at an angle such that the instrument extending along the longitudinal direction extends through the lumen of the papilla and into the common bile duct without damaging the pancreatic duct. Alternatively, an orifice may be disposed on a side of the tip such that the instrument extends transversely from the longitudinal axis of the tip and through the lumen of the papilla. In one example, the orientation of the orifice on the side of the tip may be arranged to either extend the instrument into the common bile duct or the pancreatic duct, without damaging the pancreatic duct.
In one example, the portion of the papilla grasped by the grasping jaws is the upper rim of the papilla. In one example, a method comprises: placing the distal tip of the instrument within a patient's ampulla of Vater; disposing the grasping jaws in an open position at a location such that closing the grasping jaws will grasp a portion of the papilla proximate the lumen leading to the common bile duct; closing the grasping jaws such that a portion of the the upper rim of the papilla is grasped with the grasping jaws; applying traction to the portion of the papilla with the grasping jaws to position the orifice of the soft tip of the instrument adjacent to the papilla and teasing open the papilla and aligning the lumen of the papilla for insertion of the instrument into the lumen of the papilla; applying tension to the filament of the bending portion of the instrument, arcuately bending the bending portion such that the longitudinal axis of the tip of the instrument is favorably angled for penetration into the lumen of the papilla; advancing the tip of the instrument into the lumen of the papilla; and advancing a wire, a cannula, a catheter or a loop along the longitudinal axis of the tip of the instrument through the papilla and into the common bile duct. For example, a cannula is inserted into the common bile duct.
In one example, during a cannulation procedure, involuntary movements occur within the intestinal tract, and the grasping jaws assist in at least partially anchoring the tip of the instrument such that the tip of the instrument remains in position relative to the the lumen through the papilla.
A primary control filament, such as a cable, is shown in
For example, the distal end of the tip 14 prevents damage to tissues of the patient. Since the snare loop 12 does not extend out of the tip 14, the tip may be made of any soft materials such as an elastomeric material. In one example, the tip is of a soft silicone rubber, which prevents damage to soft tissues, even when the tip is disposed between a bolus and a mucus membrane. This makes positioning of the snare loop 12 much easier and reduces unintended complications.
The tip of the tool is soft and blunt and capable of resting on the gastrointestinal wall to stabilize the instrument, such as during removal of a bolus impaction within the esophagus. In one example, a method comprises: endoscopically inserting an instrument having a soft blunt tip into an esophagus of a patient; disposing the soft blunt tip adjacent a bolus impaction; manipulating a manipulator such that a snare loop extends transversely relative to a longitudinal axis of the soft blunt tip, the snare loop extending from an orifice disposed on a side of a tubular lumen or the soft blunt tip or a combination of these; and using the snare loop to dislodge the bolus by dissection or removal of the bolus or both dissection and removal of the bolus.
This detailed description provides examples including features and elements of the claims for the purpose of enabling a person having ordinary skill in the art to make and use the inventions recited in the claims. However, these examples are not intended to limit the scope of the claims, directly. Instead, the examples provide features and elements of the claims that, having been disclosed in these descriptions, claims and drawings, may be altered and combined in ways that are known in the art.
This application is a 371 U.S. national phase application which claims priority to PCT/US2019/037076 filed Jun. 18, 2019 which claims priority to two U.S. provisional applications: provisional No. 62/743,226 filed Oct. 9, 2018 and provisional No. 62/684,396 filed Jun. 13, 2018, the disclosures of both herein being incorporated by reference in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2019/037076 | 6/13/2019 | WO | 00 |
Number | Date | Country | |
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62684396 | Jun 2018 | US | |
62743226 | Oct 2018 | US |