Patent Application
20190021749
The present disclosure generally relates to endoscopic devices and methods of use. More particularly, and without limitation, the disclosed embodiments relate to devices and methods for removing undesirable objects, such as obstructions, from body lumens.
The presence of objects in the lumen of a patient, such as kidney stones, biliary stones, gallstones, and the like may pose a health risk. Accordingly, removal of such objects is, when indicated, desirable. Tools have been devised to assist surgeons to accomplish this removal. In the case of biliary or pancreatic ductal systems, there are, generally speaking, two classes of tools available for removal of objects during an Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedure: retrieval balloons and retrieval baskets.
An exemplary catheter-mounted retrieval balloon may be mounted on an endoscope. The retrieval balloon is inserted into a patient while deflated, and navigated within the lumen to a position past the object to be removed. Once the balloon has been properly positioned in the lumen with respect to the object, the clinician will inflate the balloon. The inflation and expansion of the balloon presses the outer surface of the balloon against the walls of the lumen, forming a sliding seal, allowing the target objects, e.g., bile stones, to be swept out or the lumen along with the balloon as the catheter is withdrawn. Generally, balloons are effective for smaller stones of a diameter less than about 1 cm.
In situations where the target object is relatively large or of a shape rendering it difficult for balloon retrieval, a basket may be employed. A basket is essentially an expandable wire enclosure connected to a shaft configured for catheter delivery. In a delivery state, the basket resides in a collapsed configuration within the lumen of the delivery catheter. The end of the catheter is positioned proximate to the target object, and the shaft carrying the basket is urged distally with respect to the catheter end. The collapsed basket expands upon emerging from the catheter. Once expanded, the clinician maneuvers the device in an effort to capture the target object inside of the basket. Upon such entrapment, the shaft is withdrawn proximally with respect to the catheter, drawing the basket into the lumen and collapsing the basket's wire frame around the target object. Once collapsed, the catheter is withdrawn and the object is removed. Clinicians not infrequently experience difficulty entrapping objects in a basket, often requiring multiple attempts, which lead to prolonged procedure time. Additionally, smaller objects may easily become dislodged from the basket thus requiring the clinician to recapture the object.
Therefore, an improved system or apparatus is needed that allows for the universal retrieval of target objects from anatomical ducts or lumens, regardless of the size or shape. Such apparatus or system may be capable of reducing the time taken for a clinician to perform an endoscopic procedure and increasing the effectiveness of the procedure.
The embodiments of the present disclosure include devices and methods for retrieving objects in an endoscopic procedure, for example an ERCP procedure. Advantageously, the exemplary embodiments allow for a single instrument to be capable of quickly and effectively retrieving target objects of various sizes and shapes from a body duct or lumen, thereby improving the efficiency and effectiveness of the endoscopic procedure. In some embodiments, the devices and methods disclosed herein allow for the simultaneous retrieval of multiple objects.
According to an exemplary embodiment of the present disclosure, a retrieval device is described. The retrieval device includes a catheter, a strut shaft, a basket, and a device control portion. In some embodiments, the catheter has at least one lumen, a proximal end and a distal end. In some embodiments, the strut shaft has a proximal end and a distal end, and the catheter substantially surrounds the strut shaft. In some embodiments, the catheter can move axially relative to the strut shaft. In some embodiments, the basket is configured to be axially insertable into the catheter lumen. In some embodiments, the basket includes a plurality of struts, each having a proximal and distal end, where the proximal end of each strut is attached to the distal end of the strut shaft and the distal ends form a frame, and a collapsible pouch, where the collapsible pouch is flexibly connected to the distal end of each of the struts. In some embodiments, the device control portion has a proximal end and a distal end, where the distal end is connected to the proximal end of the catheter.
According to a further exemplary embodiment of the present disclosure, a method for retrieving one or more objects from a lumen of a patient is described. The method includes providing a retrieval device, inserting the retrieval device into the lumen of the patient, moving the catheter in a proximal direction, entrapping one or more objects in the collapsible pouch, optionally moving the catheter in a distal direction, and withdrawing the retrieval device from the lumen of the patient. In some embodiments, the retrieval device includes a catheter, a strut shaft, a basket, and a device control portion. In some embodiments, the catheter has at least one lumen, a proximal end and a distal end. In some embodiments, the strut shaft has a proximal end and a distal end, and the catheter substantially surrounds the strut shaft. In some embodiments, the catheter can move axially relative to the strut shaft. In some embodiments, the basket is configured to be axially insertable into the catheter lumen. In some embodiments, the basket includes a plurality of struts, each having a proximal and distal end, where the proximal end of each strut is attached to the distal end of the strut shaft and the distal ends form a frame, and a collapsible pouch, where the collapsible pouch is flexibly connected to the distal end of each of the struts. In some embodiments, the device control portion has a proximal end and a distal end, where the distal end is connected to the proximal end of the catheter.
According to a further exemplary embodiment of the present disclosure, a retrieval device is described. The retrieval device includes a catheter, a strut shaft, a basket, and a device control portion, wherein axial movement of the catheter in a proximal direction relative to the strut shaft causes the plurality of struts to spread apart until the collapsible pouch is taut when the basket exits from the distal end of the catheter. In some embodiments, the catheter has at least one lumen, a proximal end, and a distal end. In some embodiments, the strut shaft has a proximal end and distal end, where the catheter substantially surrounds the strut shaft, and where the catheter can move axially relative to the strut shaft. In some embodiments, the basket is configured to be axially insertable into the catheter lumen, and includes a plurality of struts and a collapsible pouch. In some embodiments, each of the plurality of struts has a proximal end and a distal end, where the proximal end of each strut is attached to the distal end of the strut shaft, and the distal ends form a frame. In some embodiments, the collapsible pouch is flexibly connected to the distal end of each of the struts. In some embodiments, the device control portion has a proximal end and a distal end, where the distal end is connected to the proximal end of the catheter.
According to a further exemplary embodiment of the present disclosure a retrieval device is described. The retrieval device includes a catheter having a proximal end and a distal end, a strut shaft having a proximal end and a distal end, a basket, and a device control portion. In some embodiments, the catheter substantially surrounds the strut shaft. In some embodiments, the catheter can move axially relative to the strut shaft. In some embodiments, the basket is configured to be axially insertable into the catheter. In some embodiments, manipulation of the device control portion may result in deployment of the basket. In some embodiments, the basket includes a plurality of struts and a collapsible pouch. In some embodiments, each of the plurality of struts has a proximal end and a distal end, and the proximal end of each strut is attached to the distal end of the strut shaft and the distal ends form a frame. In some embodiments, the collapsible pouch is flexibly connected to the distal end of each of the struts.
Additional features and advantages of the disclosed embodiments will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the disclosed embodiments. The features and advantages of the disclosed embodiments will be realized and attained by the elements and combinations particularly pointed out in the appended claims.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the disclosed embodiments as claimed.
The accompanying drawings constitute a part of this specification. The drawings illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the disclosed embodiments as set forth in the accompanying claims.
The disclosed embodiments relate to devices and methods for efficient and effective object removal from an anatomical duct or lumen. Advantageously, embodiments of the present disclosure allow retrieval of one or more objects of various sizes and shape to be removed from a body duct or lumen with a single device.
As used herein, a proximal end may refer to a point or a location along the length of the device of the present disclosure closer to a clinician, e.g., closer to the handle. A distal end may refer to a point or location along the length of the device of the present disclosure further away from a clinician.
According to an aspect of the present disclosure, a retrieval device may comprise a catheter having a proximal and distal end. The catheter may substantially surround a strut shaft, which has a proximal and distal end. In some embodiments, the strut shaft may be sufficiently flexible. In some embodiments, the strut shaft can move axially with respect to the catheter.
In some embodiments, the catheter may have a length ranging from about 150 cm to about 250 cm. In some embodiments, the catheter may have a length of about 200 cm. In some embodiments, the catheter has an outer diameter ranging from about 4 F (about 1.3 mm) to about 12 F (about 4 mm). In some embodiments, the outer diameter of the catheter is about 9 F (about 3 mm). In some embodiments, the catheter has an inner diameter ranging from about 1 mm to about 3.5 mm. In some embodiments, the inner diameter of the catheter is about 2.6 mm. In some embodiments, the catheter is sufficiently flexible such that it may contort to navigate tortuous body lumen. In some embodiments, the catheter may be made of one or more materials chosen from polyurethane, pebax, and polyethylene.
In certain embodiments, the retrieval device may also comprise a basket. This basket may be configured to be axially insertable into a lumen of the catheter. In some embodiments, the basket may comprise a plurality of struts. This plurality of struts forms a frame. In some embodiments, the basket may comprise a collapsible pouch. This collapsible pouch may reside on the frame. The plurality of struts may each have a proximal and distal end, where the proximal end is attached to the distal end of the strut shaft, and the distal end is attached to the collapsible pouch. The distal end of the strut shafts may be attached to the collapsible pouch by a weld, an adhesive, a crimp, a fastener, a rivet, and the like.
In some embodiments, the length of the strut may range from about 10 mm to about 75 mm. In some embodiments, the length of the strut may be about 40 mm. In some embodiments, the width of the strut may range from about 0.25 mm to about 1.25 mm. In some embodiments, the width of the strut may be about 0.75 mm. In some embodiments, the strut may be made of one or more materials chosen from a group including nitinol, surgical grade stainless steel, and titanium.
In some embodiments, the length of the strut shaft may range from about 10 mm to about 75 mm. In some embodiments, the length of the strut shaft may be about 40 mm. In some embodiments, the outer diameter of the strut shaft may range from about 0.75 mm to about 5 mm. In some embodiments, the outer diameter of the strut shaft may be about 1.5 mm. In some embodiments, the strut shaft may have a hollow structure. In some embodiments, the inner diameter of the hollow portion of the strut shaft may range from about 0.5 mm to about 4.75 mm. In some embodiments, the inner diameter of the hollow portion of the strut shaft may be about 1.25 mm. In some embodiments, the strut shaft may be made of one or more materials chosen from a group including nitinol, surgical grade stainless steel, and the like.
In some embodiments, the collapsible pouch has a diameter ranging from about 5 mm to about 50 mm. In some embodiments, the diameter may be about 20 mm. In some embodiments, the depth of the pouch may range from about 1 mm to about 15 mm. In some embodiments, the depth of the pouch may be about 7 mm.
In some embodiments, the collapsible pouch may be a film, mesh, netting, or other suitable structure. In some embodiments, the collapsible pouch may be a biocompatible film. In some embodiments, the film may be made of one or more biocompatible materials chosen from polyurethane, polypropylene, and polyethylene. In some embodiments, the collapsible pouch may be a mesh. In some embodiments, the mesh may be made of one or more materials chosen from nitinol, surgical grade stainless steel, and polyester.
In certain embodiments, the collapsible pouch has a guidewire port. The guidewire port may, in some embodiments, facilitate use of the device for object retrieval of the present disclosure in cooperation with a guidewire. In some embodiments, the guidewire port may have a diameter ranging from about 0.025″ (about 0.63 mm) to about 0.050″ (about 1.27 mm). In some embodiments, the guidewire port may have a diameter of about 0.040″ (about 1.0 mm).
In other embodiments, the retrieval device may also comprise a device control portion. The device control portion may have a proximal end and a distal end, where the distal end is attached to the proximal end of the catheter. In some embodiments, the device control portion is chosen from a handle, robotic driver, and the like. In some embodiments, the device control portion further comprises an actuation mechanism. In some embodiments, the actuation mechanism may control deployment and retraction of the basket. Exemplary actuation mechanisms include, e.g., a thumb slide, lever, ratchet, rotatable knob or collar, finger rings, etc.
In certain embodiments, an exemplary device control portion is a handle. In some embodiments, the handle may further comprise a stationary handle piece. The stationary handle piece may have a proximal end and a distal end. In some embodiments, the handle may have one or more finger rings, for example, one, two, three, four, or five finger rings. In certain embodiments, the handle may have one finger ring. In other embodiments, the handle may further comprise a moveable handle piece. In some embodiments, the moveable handle piece may have one or more finger rings, for example, one, two, three, four, or five finger rings. In some embodiments, the moveable handle piece may have two finger rings.
In some embodiments, the handle may have an overall length ranging from about 4″ (about 10 cm) to about 12″ (about 30 cm). In some embodiments, the handle has an overall length of about 9″ (about 23 cm). In some embodiments, the handle has an outer diameter ranging from about 0.4″ (about 1.0 cm) to about 1″ (about 2.5 cm). In some embodiments, the handle has an outer diameter of about 0.63″ (about 1.65 cm). In some embodiments, the handle may be made of one or more materials chosen from a group including ABS, polypropylene, and polyethylene.
In some embodiments, the actuation mechanism, e.g., a moveable handle piece, advantageously controls movement of the catheter and the wedge shaft. In some embodiments, the actuation mechanism, e.g., a moveable handle piece, advantageously controls movement of the strut shaft. As the skilled artisan will appreciate, the moveable handle piece could be replaced with, for example, a lever, a slide, a button, a switch, a knob, or the like.
Movement of the moveable handle piece from the distal position to the proximal position may sequentially cause the catheter to move in a proximal direction, thereby exposing the collapsed basket and allowing it to expand, and, in some embodiments, moving the wedge shaft in a proximal direction, thereby jamming the wedge against the proximal end of each strut causing the collapsible pouch to achieve a maximum pouch diameter and forcing the struts apart to maximize the space in between each of them, known as an expanded position. Without being bound by any theory, the jamming of the wedge against the proximal end of each strut to achieve a maximum pouch diameter may aid in maximizing the number of objects collected in the collapsible pouch. In other embodiments, movement of the moveable handle piece from the proximal position to the distal position may sequentially cause the wedge shaft to move in a distal direction, and the catheter to move in a distal direction, thereby collapsing and then substantially surrounding the basket, known as a collapsed position. However, this description is merely exemplary and the skilled artisan will appreciate that any configuration may be suitable, for example, the catheter may remain stationary and the strut shaft may move axially relative to the catheter in a distal direction, thereby exposing the collapsed basket and allowing it to expand.
In some embodiments, the retrieval device may further comprise a wedge shaft, having a proximal end and a distal end. In some embodiments, the wedge shaft may be configured to be substantially surrounded by the strut shaft. In some embodiments, the wedge shaft may be configured to be partially surrounded by the strut shaft. In other embodiments, the retrieval device may further comprise a wedge. In some embodiments, the wedge may be attached to the distal end of the wedge shaft.
In some embodiments, the wedge may be spherical. In some embodiments, the wedge may be rectangular. In some embodiments, the wedge may be conical. In some embodiments, the wedge may have a width ranging from about 0.040″ (about 1 mm) to about 0.120″ (about 3 mm). In some embodiments, the wedge may have a width of about 0.075″ (about 1.9 mm). In some embodiments, the wedge may have a length ranging from about 0.040 (about 1 mm) to about 0.160″ (about 4 mm). In some embodiments, the wedge may have a length of about 0.060″ (about 1.5 mm). In some embodiments, the wedge may have a hollow structure. In some embodiments, the hollow portion of the wedge may be configured to receive a guidewire. In some embodiments, the inner diameter of the wedge having a hollow structure may have a range from about 0.075 mm (about 0.030″) to about 1.5 mm (about 0.060″). In some embodiments, the inner diameter of the wedge having a hollow structure may be about 1 mm (about 0.040″). In some embodiments, the wedge may be made of one or more materials chosen from polyimide, peek, and polyethylene.
In some embodiments, the wedge shaft may have a length ranging from about 150 cm to about 250 cm. In some embodiments, the wedge shaft may have a length of about 200 cm. In some embodiments, the wedge shaft may have a solid structure with an outer diameter ranging from about 0.25 mm (about 0.010″) to about 0.75 mm (about 0.030″). In some embodiments, the wedge shaft may have an outer diameter of about 0.4 mm (about 0.016″). In some embodiments, the wedge shaft may have a hollow structure. In some embodiments, the inner-diameter of the wedge shaft having a hollow structure may range from about 0.75 mm (about 0.030″) to about 1.5 mm (about 0.060″). In some embodiments, the inner-diameter of the wedge shaft having a hollow structure may be about 1.1 mm. In some embodiments, the outer diameter of the wedge shaft having a hollow structure may range from about 0.9 mm (about 0.35″) to about 2 mm (about 0.080″). In some embodiments, the wedge shaft may be made of one or more materials chosen from polyimide, peek, and polyethylene. In some embodiments, the wedge shaft may be reinforced with, e.g., a stainless steel wire braid or coil. In some embodiments, friction reducing linings, e.g., PTFE, may be applied on the inside and outside surfaces.
In some embodiments, the catheter may further comprise a guidewire lumen. The guidewire lumen is configured to receive a guidewire. For example, guidewire lumen may extend over a predetermined length of the catheter. A guidewire may be inserted and passed through guidewire lumen. In some embodiments, the guidewire lumen may have a slit extending over at least a portion of its length.
In some embodiments, the wedge shaft may be solid. In some embodiments, the wedge shaft may have a hollow structure. In some embodiments, the hollow portion of the wedge shaft may be centered in the wedge shaft. In other embodiments, the hollow portion of the wedge shaft may be off-center in the wedge shaft. In some embodiments, the hollow portion of the wedge shaft may be configured to receive a guidewire.
If a clinician determines that a person may have an object in a lumen, they may use a retrieval device of the present disclosure. While the basket is in a collapsed position, the clinician may insert the retrieval device to the site of the object. This may be accomplished by use of a guidewire or use of another instrument to visualize the object, e.g., an endoscope. Upon reaching the site of the object, the clinician may then desire to deploy the basket. This may be achieved by manipulation of the actuation mechanism, e.g., a handle, by the clinician, e.g., by moving a moveable handle piece or a lever to a proximal position, which causes the basket (collapsible pouch and struts) to achieve an expanded position. A withdrawal motion of the retrieval device may cause the object to become entrapped in the collapsible pouch. In some embodiments, the clinician may opt to collapse the pouch to facilitate withdrawal by, e.g., manipulating the actuation mechanism. In other embodiments, the clinician may opt to partially withdraw the retrieval device with the basket in an expanded position, e.g., to attempt to retrieve more objects as the retrieval device is withdrawn.
Reference will now be made in detail to embodiments and aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Where possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
In some embodiments, manipulation of handle 100, e.g., by movement of moveable handle piece 104, e.g., from a distal position to a proximal position, may result in a compound action that results in deployment and expansion of basket 246.
In some embodiments, guidewire 202 may optionally be present. As shown in
Collapsible pouch 240 may assume a wide variety of geometric shapes. In some embodiments, e.g., as shown in
Moveable handle piece 104 moves axially along one or more cams 114 and is guided by one or more engagement blocks 112, resulting in deployment of a basket from the distal end of catheter 200. In one embodiment, axial movement of handle piece 104 in proximal direction causes catheter 200 to move in a proximal direction. When moveable handle piece 104 is moved to a cam transition point 116, engagement block 112 engages with wedge slide 110. Wedge slide 110 is coupled to wedge shaft 222. Upon engagement, axial movement in a proximal direction of moveable handle piece 104 causes axial movement in a proximal direction of wedge slide 110 and wedge shaft 222. This movement causes wedge 220 (not shown), located at the distal end of wedge shaft 222, to jam against the proximal end of the struts 230 (not shown), thus forcing them to spread apart.
Closing and retraction of basket 246 occurs in the opposite order of the aforementioned process. Axial movement of moveable handle piece 104 in a distal direction results in an unjamming of a wedge at the end of wedge shaft 222 by axial movement in a distal direction. Further axial movement in a distal direction of moveable handle piece 104 results in disengagement of engagement block 112 from wedge slide 110, followed by collapse of the basket 246 (not shown) and retraction of the basket 246 into the distal end of catheter 200 by axial movement of catheter 200 in a distal direction. The skilled artisan, will, however, appreciate that this configuration is merely exemplary and deployment of the basket can be effected by axial movement of strut shaft 232 while catheter 200 remains stationary.
The foregoing description has been presented for purposes of illustration. It is not exhaustive and is not limited to precise forms or embodiments disclosed. Modifications and adaptations of the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. For example, the described implementations include hardware and software, but systems and methods consistent with the present disclosure can be implemented as hardware alone. In addition, while certain components have been described as being coupled to one another, such components may be integrated with one another or distributed in any suitable fashion.
Moreover, while illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as nonexclusive. Further, the steps of the disclosed methods can be modified in any manner, including reordering steps and/or inserting or deleting steps.
The features and advantages of the disclosure are apparent from the detailed specification, and thus, it is intended that the appended claims cover all systems and methods falling within the true spirit and scope of the disclosure. As used herein, the indefinite articles “a” and “an” mean “one or more.” Similarly, the use of a plural term does not necessarily denote a plurality unless it is unambiguous in the given context. Words such as “and” or “or” mean “and/or” unless specifically directed otherwise. Further, since numerous modifications and variations will readily occur from studying the present disclosure, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure.
Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as example only, with a true scope and spirit of the disclosed embodiments being indicated by the following claims.
