Endoscopic full thickness resection using surgical compression clips

Abstract

A system including surgical compression clips is described and used for endoscopic full thickness resection. Similarly, methods for endoscopic full thickness resection using the described system are also discussed. Surgical compression clips using shape-memory elements are discussed. These clips are advanceable to the site of suspect tissue to be resected through a lumen of a multi-lumen sleeve encasing an endoscope. At the site of the tissue, the compression clip is opened and operated to circumscribe the suspect tissue. Grasper assemblies, advanceable through an endoscope, are also described. These latter grasp and bring the suspect tissue to the open clip. The clip is then closed and the tissue resected. The clip effects necrosis and healing at the resected site.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more fully understood and its features and advantages will become apparent to those skilled in the art by reference to the ensuing description, taken in conjunction with the accompanying drawings, in which:

FIG. 1A is an overall isometric view of an endoscopic system constructed according to the present invention;

FIG. 1B is an enlarged view of the distal end of the endoscopic system shown in FIG. 1A;

FIG. 1C is an enlarged view of the proximal end of the endoscopic system shown in FIG. 1A;

FIG. 2 shows an isometric view of the compression clip constructed according to a first embodiment in its closed position;

FIGS. 3A and 3B show isometric top and bottom views of the compression clip shown in FIG. 2 in its open position;

FIGS. 4A, 4B and 4C show isometric views of different configurations of spring elements constructed according to various embodiments of the present invention;

FIG. 5 is an isometric view of a clip applier constructed according to one embodiment of the present invention, the applier in its closed position;

FIG. 6 is an isometric view of the clip applier in FIG. 5, the applier in its open position;

FIG. 7 is an isometric view of the clip applier in FIG. 5 without its base element, the applier in its open position;

FIG. 8 is an isometric view of the clip applier of FIG. 5 used to position the clip in FIG. 2, the clip being attached to the applier and in its closed position;

FIG. 9 is an isometric view of a clip applier used to position the clip in FIG. 2, the clip being attached to the applier and in its open position;

FIG. 10 is an isometric view of a clip applier constructed according to a second embodiment of the present invention, the applier in its closed position;

FIG. 11 is an isometric view of the clip applier in FIG. 10, the applier in its open position;

FIG. 12 is an isometric view of the clip applier of FIG. 10, attached to a clip constructed as in FIG. 2, the clip being attached to the applier and in its closed position;

FIG. 13 is an isometric view of the clip applier of FIG. 10, attached to a clip constructed as in FIG. 2, the clip being attached to the applier and in its open position;

FIGS. 14 and 15 show isometric views of a second embodiment of a surgical compression clip constructed according to the present invention, wherein FIG. 14 and FIG. 15 show the clip in its closed and open positions, respectively;

FIG. 16 shows an exploded view of the clip in FIGS. 14 and 15;

FIGS. 17 and 18 show isometric partially cut-away views of the compression clip shown in FIGS. 14 and 15, respectively;

FIGS. 19 and 20 show isometric views of a clip applier used with the clip shown in FIGS. 14-18, FIG. 19 showing the applier engaged to the clip and FIG. 20 disengaged from the clip;

FIG. 21 shows an isometric view of the applier in FIGS. 19 and 20;

FIG. 22 shows a partially exploded view of the applier in FIGS. 19 and 20;

FIG. 23 shows a cross-sectional view of the applier shown in FIGS. 19 and 20;

FIG. 24A shows an exploded view of a third embodiment of a compression clip constructed according to the present invention;

FIG. 24B shows an isometric partially cut-away view of the clip shown in FIG. 24A;

FIGS. 25A and 25B are an isometric top and bottom view of a clip constructed according to a fourth embodiment of the present invention, the clip being in its closed position;

FIGS. 26A and 26B are an isometric top and bottom view of a clip constructed according to the embodiment of FIGS. 25A and 25B, the clip being in its open position;

FIGS. 27A and 27B are isometric views of a clip applier constructed according to another embodiment of the present invention, the applier shown in its closed and open position, respectively;

FIGS. 27C and 27D are cross-sectional views of the clip applier shown in FIGS. 27A and 27B, the applier shown in its closed and open position, respectively;

FIGS. 28A and 28B are isometric views of the clip applier shown in FIGS. 27A and 27B constructed in its closed and open position, respectively, when attached to and operating the clip shown in FIGS. 25A-26B;

FIG. 29 is an exploded view of another embodiment of a clip applier for use with the clips in the specification herein;

FIGS. 30A and 30B are isometric views of the clip applier shown in FIG. 29 in its closed and open position, respectively;

FIG. 30C is a revealed inner view of FIG. 30B;

FIG. 31A is a cross-sectional view of a surgical compression clip constructed according to a fifth clip embodiment of the present invention, the clip being in its open position and attached to its associated applier;

FIG. 31B is an enlarged view of a portion of the distal end of the clip shown in FIG. 31A;

FIGS. 32 and 33 are different partially exploded views of the surgical compression clip and applier in FIG. 31A;

FIG. 34 shows different views of the shape-memory spring element of the clip in FIG. 31A;

FIG. 35 shows different views of the latch arm of the clip presented in FIG. 31A;

FIG. 36 shows an isometric view of the clip's spring element at the hinge region of the clip shown in FIG. 31A;

FIG. 37 shows an isometric front side view of the clip in FIG. 31A, the clip in its open position;

FIGS. 38 and 39 show different views of the clip in FIG. 31A where the wire of the clip has been drawn taut;

FIG. 40 shows an enlarged view of the clip shown in FIG. 31A including the clip's distal end and its locking process;

FIG. 41 shows an enlarged cross-sectional view of the distal end of the clip shown in FIG. 31A, the clip in its latched position;

FIGS. 42 and 43 show additional enlarged views of the distal end of the clip shown in FIG. 31A, the clip being in its closed position;

FIG. 44 shows an isometric view of the clip shown in FIG. 31A, the clip in its closed position and ready for insertion into a clip applier;

FIG. 45 is an isometric view of an endoscope body encased in a multi-lumen sleeve, the sleeve having collapsed secondary lumens;

FIGS. 46-49 show various configurations of multi-lumen sleeves with collapsed secondary lumens;

FIGS. 50-53 show several configurations of the multi-lumen sleeves in FIGS. 46-49 with their secondary lumens distended;

FIG. 54 shows a grasper assembly constructed according to one embodiment of the present invention, the assembly being in its open position;

FIG. 55 shows a grasper assembly constructed according to another embodiment and in its closed position;

FIG. 56 shows additional details of the grasper assembly in FIG. 55 in its partially opened position;

FIG. 57 shows an endoscope prior to insertion into a multi-lumen sleeve;

FIG. 58 shows the endoscope of FIG. 57 being inserted into a multi-lumen sleeve;

FIG. 59A shows the endoscope after insertion into the multi-lumen sleeve;

FIG. 59B shows an enlarged view of the distal end of the endoscope in FIG. 59A;

FIG. 60 shows the sleeve-encased endoscope as it approaches a polyp in the gastrointestinal tract;

FIG. 61 shows a view of a surgical clip attached to an applier being advanced to the site of the polyp through a secondary lumen of the sleeve;

FIG. 62 shows a top side view of the surgical clip attached to an applier being positioned proximate to the polyp;

FIG. 63 shows a top side view of a surgical clip and applier positioned proximate to a polyp and a grasper assembly being positioned proximate to the polyp after advancing through a working channel of the endoscope;

FIG. 64 shows a top side view of the opened clip proximate to the polyp;

FIG. 65 shows a top view of the grasper of the grasper assembly beginning to pull the polyp through the opened clip shown in FIG. 64;

FIG. 66 shows a top side view of the grasper of the grasper assembly grasping the polyp;

FIG. 67 shows a top side view of the grasper continuing to pull the polyp through the opened surgical clip;

FIG. 68 shows a top side view of the grasper and grasper transporting element rotating and wrapping the pulled polyp around the grasper transporting element;

FIG. 69 shows a cross-sectional view along line AA′ of FIG. 68 of the grasper and grasper transporting element rotating and wrapping the pulled polyp around the grasper transporting element;

FIG. 70 shows a top side view of the surgical clip closing around the wrapped polyp;

FIG. 71 shows a top side view of the closed surgical clip and polyp without the applier that has been withdrawn through a secondary lumen from the region of the resected polyp;

FIG. 72 shows a top side view of the closed surgical clip and polyp with a severing device approaching the rotated polyp for severing;

FIG. 73 shows a top side view of the tissue held by the clip at the resection site;

FIGS. 74A and 74B show two side views of the tissue held by the clip at the resection site;

FIG. 75 shows a schematic overall view of a vacuum-based tissue grasper assembly of the present invention;

FIG. 76 shows an exploded view of the distal portion of the vacuum-based tissue grasper assembly in FIG. 75;

FIGS. 77A and 77B show a schematic view and a cut-away view, respectively, of the distal end of the vacuum-based tissue grasper assembly in FIG. 75;

FIGS. 78A and 78B show two schematic views of a vacuum u from the distal end of the vacuum-based tissue grasper assembly with FIG. 78B showing the cup being turned toward a lesion (not shown);

FIG. 78C shows a schematic view of the vacuum cup extending even further from the distal end of the vacuum-based tissue grasper assembly;

FIG. 79A shows a schematic view of the vacuum cup of the vacuum-based tissue grasper assembly shown in FIG. 75;

FIG. 79B shows a schematic view of a ribbed embodiment of the vacuum cup of the vacuum-based tissue grasper assembly shown in FIG. 75;

FIG. 79C shows a schematic view of the vacuum cup of the vacuum-based tissue grasper assembly shown in FIG. 75 supported by a stent-like structure;

FIG. 80 shows a top side view of a surgical clip attached to an applier being positioned proximate to the polyp;

FIG. 81 shows a top side view of a surgical clip and applier positioned proximate to a polyp and a vacuum-based tissue grasper assembly being positioned proximate to the polyp after advancing through a secondary lumen of a multi-lumen sleeve;

FIG. 82 shows a top side view of the vacuum cup of the vacuum-based tissue grasper assembly pulling the polyp through the opened clip shown in FIG. 81; and

FIG. 83 shows a top side view of the surgical clip closed around the polyp, the polyp being pulled by the vacuum cup of the vacuum-based tissue grasper assembly.

Claims

1. For use with a surgical compression clip comprising a pair of compression elements and at least one force applier element formed of a shape memory material, the clip having an open position and a closed position and configured to receive a full thickness of an organ wall portion therethrough when in its open position, the force applier element operative for providing a force to said compressing elements, and the compressing elements operative to apply a compression force to a full thickness of an organ wall portion when the clip is closed thereabout, so as to cause organ wall closure after resection of a portion thereof, a system for performing a full thickness resection of a portion of an organ wall comprising: an endoscope having an insertion shaft having at least one channel;a multi-lumen sleeve having a primary lumen encasing said endoscope insertion shaft, and at least one secondary lumen;a clip applier for advancing the clip through a working conduit and for positioning the clip near the tissue to be resected, wherein said working conduit is a preselected one of (i) said at least one channel of said insertion shaft and (ii) said at least one secondary lumen of said multi-lumen sleeve;a severing element for resecting tissue, selectably extendable through said working conduit so as to be brought into a position of operational proximity to tissue extending through the compression clip; anda grasper assembly selectably extendable through said working conduit, for engaging and pulling the full thickness of an organ wall portion through the clip when the clip is in its open position,wherein said severing element is operable to resect the full thickness of the portion of the organ wall extending through the clip.

2. A system for performing a full thickness resection of a portion of an organ wall according to claim 1, wherein said clip applier includes: two arm elements selectably engageable with the compression clip, each arm element having a slot and a pin hole;a position controlling element in mechanical communication with said arm elements, said position controlling element including a first and second pin, where said first pin passes through said position controlling element and said pin hole on each of said two arm elements and said second pin passes through said position controlling element and said slot on each of said arm elements; andan activating element in mechanical communication with and operable to move said pins in said position controlling element,thereby to produce substantially scissor-like motion of said arm elements bringing them from their closed adjacent position to their open spaced apart position and vice versa; andthereby to cause the compression clip to move from its open position to its closed position and vice versa in tandem with the motion of said arm elements of said clip applier.

3. A system for performing a full thickness resection of a portion of an organ wall according to claim 1, wherein the compression clip includes a threaded bolt inside a compression element, the threaded bolt having a receiving aperture, and said clip applier comprising: a head element mateably insertable into the receiving aperture on the threaded bolt inside the compression element of the compression clip; andan activator for rotating said head element,thereby to cause the threaded bolt to rotate and the clip to move from its open position to its closed position and vice versa depending on the direction of rotation.

4. A system for performing a full thickness resection of a portion of an organ wall according to claim 1, wherein the compression clip includes a compression element and at least one connector element on each of two force applier elements, and wherein said clip applier includes: two wires each connected to a connector element on a different one of the two force applier elements; anda pin passing through an anchor positioned in the compression element, one of said wires being wound around said pin,whereby the compression clip moves from its closed position to its open position when said wires are pulled and moves to its closed position from its open position when said wires are released.

5. A system for performing a full thickness resection of a portion of an organ wall according to claim 1, wherein said grasper assembly is comprised of: a grasper having a closed and an open position, said grasper comprised of: forceps arms for grasping and pulling the portion of the organ wall to be resected; anda wire in mechanical connection with and for controlling and maneuvering said forceps arms and for bringing said forcep arms from their closed position to their open position and vice versa; anda grasper transporting element for transporting said grasper in its closed position to a location near the portion of the organ wall to be resected whereat said grasper is ejected from said transporting element allowing said forcep arms to open to their open position.

6. A system for performing a full thickness resection of a portion of an organ wall according to claim 5, wherein at least one of said wire and said forceps arms includes a bend, said bend facilitating grasping and pulling the organ wall to be resected through the clip.

7. A system for performing a full thickness resection of a portion of an organ wall according to claim 5, wherein at least one of said wire and said forceps arms is formed at least partially of a shape memory material.

8. A system for performing a full thickness resection of a portion of an organ wall according to claim 1, wherein said grasper assembly comprises: a flexible resilient vacuum cup having a closed and an open position;a suction source for generating negative pressure;a conduit joining said vacuum cup to said suction source;a grasper transporting element for transporting said vacuum cup in its closed position to a location near the portion of the organ wall to be resected where said vacuum cup is ejected from said transporting element allowing said vacuum cup to open to its open position; andarticulation means for bringing said vacuum cup to the portion of the organ wall to be resected for engaging the tissue under a suction force, and for subsequently pulling the tissue through the surgical clip.

9. A system for performing a full thickness resection of a portion of an organ wall, which comprises: an endoscope having an insertion shaft having at least one channel;a multi-lumen sleeve having a primary lumen encasing said endoscope insertion shaft, and at least one secondary lumen;a compression clip having an open position and a closed position, said clip configured to receive a full thickness of an organ wall portion therethrough when in its open position, and operative to apply a compression force thereto when closed thereabout, so as to cause organ wall closure after resection of a portion thereof;a clip applier for advancing said clip through a working conduit and for positioning said clip near the tissue to be resected, wherein said working conduit is a preselected one of (i) said at least one channel of said insertion shaft and (ii) said at least one secondary lumen of said multi-lumen sleeve;a severing element for resecting tissue, selectably extendable through said working conduit so as to be brought into a position of operational proximity to tissue extending through said compression clip; anda grasper assembly selectably extendable through said working conduit, for engaging and pulling the full thickness of an organ wall portion through said clip when said clip is in its open position,wherein said severing element is operable to resect the full thickness of the portion of the organ wall extending through said clip.

10. A system for performing a full thickness resection of a portion of an organ wall according to claim 9, said compression clip further comprising a pair of generally elongated compressing elements for compressing the site of the portion of the organ wall to be resected, said compressing elements formed and configured for being disengageably joined to said clip applier.

11. A system for performing a full thickness resection of a portion of an organ wall according to claim 10, wherein said compression clip includes at least one shape memory force applier element formed of shape memory material, said at least one force applier element operative for providing a force to said pair of compressing elements for compressing the portion of the organ wall to be resected held therebetween.

12. A system for performing a full thickness resection of a portion of an organ wall according to claim 11, wherein said compressing elements and said at least one shape memory force applier element form a planar configuration in both the clip's open and closed positions and said compressing elements of said surgical clip apply a compressive force to the portion of the organ wall to be resected, the compressive force acting in the plane of said clip and in a line between said compressing elements.

13. A system for performing a full thickness resection of a portion of an organ wall according to claim 11, wherein said system further includes a pair of generally elongated securing elements and wherein said at least one shape memory force applier element is positioned between, and in mechanical connection with, said operatively associated securing and compressing elements, and wherein said at least one shape memory force applier element and said pairs of securing and compressing elements all lie in substantially the same plane in both the first open and second closed positions of said clip and wherein a line of securing for holding the portion of the organ wall to be resected is formed by, and tangent to, said securing elements and a line of compression for compressing the portion of the organ wall to be resected is formed by, and tangent to, said compression elements, the lines of securing and of compression not being collinear lines.

14. A system for performing a full thickness resection of a portion of an organ wall according to claim 13, wherein said securing and compressing elements are generally linear elements.

15. A system for performing a full thickness resection of a portion of an organ wall according to claim 10, said clip further comprising a pair of generally elongated securing elements each having formed thereon a pair of mutually opposing gripping portions adapted to secure therebetween the portion of the organ wall to be resected, said securing elements operationally associated with said compressing elements, said securing elements formed and configured for being disengageably joined to said clip applier.

16. A system for performing a full thickness resection of a portion of an organ wall according to claim 15 wherein said gripping portions of said securing elements include toothed first edges which are in proximity to each other when said clip is in its closed position and wherein said toothed first edges of said securing elements are spaced apart from each other when said clip is in its open position.

17. A system for performing a full thickness resection of a portion of an organ wall according to claim 15, wherein said securing and compressing elements are substantially linear elements.

18. A system for performing a full thickness resection of a portion of an organ wall according to claim 9, wherein said grasper assembly is comprised of: a grasper having a closed and an open position, said grasper comprised of: forceps arms for grasping and pulling the portion of the organ wall to be resected; anda wire in mechanical connection with and for controlling and maneuvering said forceps arms and for bringing said forceps arms from their closed position to their open position and vice versa; anda grasper transporting element for transporting said grasper in its closed position to a location near the portion of the organ wall to be resected whereat said grasper is ejected from said transporting element allowing said forceps arms to open to their open position.

19. A system for performing a full thickness resection of a portion of an organ wall according to claim 18, wherein at least one of said wire and said forceps arms includes a bend, said bend facilitating grasping and pulling the organ wall to be resected through said clip.

20. A system for performing a full thickness resection of a portion of an organ wall according to claim 18, wherein at least one of said wire and said forceps arms is formed at least partially of a shape memory material.

21. A system for performing a full thickness resection of a portion of an organ wall according to claim 9, wherein said grasper assembly comprises: a flexible resilient vacuum cup having a closed and an open position;a suction source for generating negative pressure;a conduit joining said vacuum cup to said suction source;a grasper transporting element for transporting said vacuum cup in its closed position to a location near the portion of the organ wall to be resected where said vacuum cup is ejected from said transporting element allowing said vacuum cup to open to its open position; andarticulation means for bringing said vacuum cup, when in its open position, to the portion of the organ wall to be resected for engaging the tissue under a suction force, and for subsequently pulling the tissue through said surgical clip.

22. A system for performing a full thickness resection of a portion of an organ wall according to claim 9, wherein said clip further includes a pair of compressing elements and at least two shape memory force applier elements formed of shape memory material where one of said force applier elements is constructed as a latch which is operable to engage with an engagement means formed on one end of one of said pair of compressing elements, said latch thereby exerting a force on the portion of the organ wall to be resected when held between said compressing elements.

23. A system for performing a full thickness resection of a portion of an organ wall according to claim 22, wherein said clip further includes a wire snare.

24. A method for performing a full thickness resection of a portion of an organ wall employing an endoscope, said method comprising the steps of: placing the endoscope in a body cavity and advancing the endoscope to and positioning it near the site of the portion of the organ wall to be resected;positioning a compression clip near the site of the portion of the organ wall to be resected;extending a grasping instrument for grasping the site of the organ wall to be resected and then operating the grasping instrument to grasp and pull all tissue layers of the organ wall portion to be resected into and through the compression clip so that full thickness resection may be effected; andsevering the grasped tissue with a severing instrument while it is held by the compression clip.

25. A method according to claim 24, further including the step of opening the compression clip prior to said step of extending and also further including the step of closing the compression clip prior to said step of severing.

26. A method according to claim 24, further including the step of rotating the grasped and pulled portion of the organ wall to be resected over and around a working instrument extended from the endoscope, the working instrument configured, sized and positioned for having the tissue wrapped around it thereby ensuring that all tissue layers of the organ wall to be resected have been grasped.

27. A method according to claim 24, wherein said step of extending includes the step of grasping sufficient tissue to include large margins around the portion of the organ wall being resected.

28. A method according to claim 24, wherein said step of extending the grasping instrument is advanced and brought to the site of resection through a first secondary lumen of a multi-lumen sleeve and in said step of positioning the compression clip is advanced and brought to the site of resection through a second secondary lumen of the multi-lumen sleeve, wherein the primary lumen of the sleeve encases the endoscope and wherein the second secondary lumen is the secondary lumen closest to the portion of the organ wall to be resected.

29. A method according to claim 24, wherein said step of extending the grasping instrument and in said step of positioning the compression clip are both advanced and brought to the site of resection through the same secondary lumen of a multi-lumen sleeve wherein the primary lumen of the sleeve encases the endoscope and wherein the aforementioned secondary lumen is the secondary lumen closest to the portion of the organ wall to be resected.

30. A method according to claim 24, wherein said step of extending the grasping instrument is advanced and brought to the site of resection through a working channel of the endoscope and in said step of positioning the compression clip is advanced and brought to the site of resection through a secondary lumen of the multi-lumen sleeve, wherein the primary lumen of the sleeve encases the endoscope and wherein the aforementioned secondary lumen is the secondary lumen closest to the portion of the organ wall to be resected.

31. A method according to claim 24, further comprising the step of activating a vacuum source so as to effect the action of grasping in said step of extending by a suction operated grasping instrument.

32. A method according to claim 24, wherein the severing instrument in said step of severing is advanced through a secondary lumen of a multi-lumen sleeve proximate to the secondary lumen through which the surgical clip is advanced, thereby allowing the tissue to be severed a few millimeters from the closed clip.

33. A method according to claim 24, wherein the severing instrument in said step of severing is advanced through the same secondary lumen of a multi-lumen sleeve as the secondary lumen through which the clip is advanced.

34. A method according to claim 24, wherein the severing instrument in said step of severing is advanced through the a working channel of the endoscope, and the clip is advanced through a secondary lumen of a multi-lumen sleeve, the secondary lumen being adjacent to the working channel through which the severing device is advanced.