US 20090024143 A1
Disclosed is a system for endoscopically implanting a medical implant within a body cavity such as a human stomach. The system includes one or more anchors positionable within one or more openings formed in tissue within the body cavity, such as cutouts formed in plicated body tissue. Tools are disclosed for positioning the anchors within the openings, and for coupling the implant to the anchors.
1. A method of coupling an implant to tissue having an opening formed therein, the method comprising:
providing an anchor having a head and a base;
drawing the head through the opening in the tissue to position the head on a first side of the plication and the base on a second side of the plication, and
coupling an implant to the anchor.
2. The method of
3. The method of
4. The method of
coupling the anchor to a first tool;
advancing the first tool into a body cavity;
advancing a second tool into the body cavity and passing the second tool through the opening;
after passing the second tool through the opening, engaging the anchor using the second tool;
withdrawing the second tool from the opening to draw the head through the opening; and
releasing the anchor from the first tool.
5. The method of
6. The method of
7. The method of
8. The method of
9. The method of
10. The method of
11. The method of
12. The method of
providing the anchor includes providing the head to include a laterally-extending loop
the method further includes positioning the anchor within the tissue opening such that the loop extends generally away from the most proximate second of the tissue wall.
13. The method of
providing the anchor further includes providing the base to include a first edge having a first curvature and a second edge having a second, flatter curvature, the loop extending laterally in a direction opposite to the second edge of the base, and
positioning the anchor includes positioning the anchor with the second edge in contact with the wall to cause the loop to extend generally away from the most proximate section of the tissue wall.
14. The method of
15. The method of
16. The method of
forming a plication in the wall of the stomach;
forming an opening in the plication.
17. The method of
18. The method of
19. A medical implant system for coupling an implant to an opening formed in body tissue, comprising:
an anchor comprising a head coupled to a base, the head having a first, natural, position in which the head has a diameter larger than a diameter of the opening, and a second, elongated, position in which the head is deformed for passage through the opening; and
an implant having an opening, the opening of the implant proportioned to allow passage of the head when the head is in the second position, and to resist passage of the head when the head is in the first position.
20. The medical implant system of
21. The medical implant system of
22. The medical implant system of
23. The medical implant system of
24. The medical implant system of
25. The medical implant of
26. The medical implant system of
27. The medical implant system of
28. The medical implant system of
29. The medical implant system of
30. The medical implant system of
31. The medical implant system of
32. The medical implant system of
33. The medical implant system of
34. The medical implant system of
35. The medical implant system of
the system includes a plurality of the anchors;
the implant includes a plurality of openings; and
the system includes a plurality of tools each transorally insertable into the stomach and extendable through separate openings formed in stomach tissue, each tool engageable with the head of a corresponding one of the anchors to deform the head into the second position, the opening of the implant slidable over the plurality of tools into engagement with the anchors.
36. The medical implant system of
37. The medical implant system of
38. The medical implant system of
39. The medical implant system of
40. The medical implant system of
41. The medical implant system of
an implant pusher having at least one engaging pin on a distal portion of the implant pusher, the implant pusher proportioned for transoral advancement into the stomach with the implant coupled to the engaging pin.
42. The medical implant system of
coupling the anchor to the tool;
transorally advancing the tool into the stomach;
advancing a second tool into the stomach and passing the second tool through the tissue opening;
after passing the second tool through the opening, engaging the anchor using the second tool;
withdrawing the second tool from the opening to draw the head through the opening;
releasing the anchor from the first tool; and
passing the implant over the second tool and over the head.
43. A restrictive stomach implant, comprising:
a wall including a plurality of anchor points and compliant sections between the anchor points.
44. The restrictive stomach implant of
45. The restrictive stomach implant of
46. The restrictive implant of
47. The restrictive implant of
48. The restrictive implant of
49. The restrictive implant of
50. The restrictive implant of
51. The restrictive implant of
52. The restrictive implant of
53. The restrictive implant of
54. A medical implant system for use in a patient comprising:
an anchor configured to be coupled to tissue within a body cavity;
a first tool having a proximal portion, a distal portion, and a shaft between the proximal and distal portions, the distal portion including a coupling element operable to couple the first tool to the anchor, the first tool proportioned such that when the coupling element is coupled to the anchor within the body cavity, the proximal portion of the first tool extends out of the patient; and
an implant having an opening proportioned to slide over the shaft and distal end of the first tool and into engagement with the anchor.
55. The medical implant system according to
56. The medical implant system according to
57. The medical implant system according to
58. The medical implant system according to
59. The medical implant system according to
60. The medical implant system according to
61. The medical implant system according to
This is application claims priority to U.S. Provisional Application No. 60/950,584, filed Jul. 18, 2007, and U.S. Provisional Application No. 61/042,862, filed Apr. 7, 2008.
The present invention relates to the field of systems for use in endoscopically implanting devices within the gastrointestinal system.
An anatomical view of a human stomach S and associated features is shown in
Stomach S includes a fundus F at its proximal end and an antrum A at its distal end. Antrum A feeds into the pylorus P which attaches to the duodenum D, the proximal region of the small intestine. Within the pylorus P is a sphincter that prevents backflow of food from the duodenum D into the stomach. The middle region of the small intestine, positioned distally of the duodenum D, is the jejunum J.
Several prior applications, including U.S. Publication No. US 2007/0276432 having a priority date of Oct. 8, 2004 and U.S. Publication No. US 2008/0065122, filed May 23, 2006 describe methods according to which medical implants are coupled to tissue structures, such as plications or folds, formed within the stomach. Examples of methods and devices for forming such tissue structures are described in U.S. Publication No. US 2007/0219571 (entitled ENDOSCOPIC PLICATION DEVICES AND METHOD), filed Oct. 3, 2006, U.S. application Ser. No. 11/900,757 (entitled ENDOSCOPIC PLICATION DEVICE AND METHOD), filed Sep. 13, 2007, and U.S. application Ser. No. 12/050,169 (entitled ENDOSCOPIC STAPLING DEVICES AND METHODS), filed Mar. 18, 2008. Each of the referenced publications and applications is incorporated herein by reference.
As disclosed in these prior applications, more robust and long lasting coupling between the implant and the surrounding stomach wall tissue is achieved when the plications/folds are formed by retaining regions of serosal tissue (i.e., the tissue on the exterior surface of the stomach) in contact with one another. Over time, adhesions form between the opposed serosal layers. These adhesions help to create strong bonds that can facilitate retention of the plication/fold over extended durations, despite the forces imparted on them by stomach movement and implanted devices
Several of the disclosed methods for forming tissue plications include a step in which a hole or cut is formed in the plication, using the plication device or other devices. An example of this type of plication is shown in
An anchor hand-off 16 delivers the anchors into the stomach, and anchor graspers 18 (one shown) are used to position the anchors within the tissue openings and also to guide the restrictor 14 to the implanted anchors. A restrictor guide 20 is provided for advancing the restrictor into position in the stomach. An endogastric overtube 22 is provided for establishing a working channel between the mouth and the stomach. Other tools shown elsewhere in the drawings, such as a multi-lumen guide 24 (
One embodiment of an anchor 12 is shown in
Head 32 includes a ring 34 and a plurality of struts 36 coupling the ring 34 to the stem 30, and an elongate loop 38 extending from the ring 34. The anchor is elastically deformable to an elongated shape (see
Referring to the top view of the anchor 12 shown in
Referring again to
Anchor hand-off 16 is an instrument used to deliver individual anchors to the implantation site, and to hand-off each anchor to an anchor grasper which pulls the anchor through an opening in a plication.
In one embodiment, the anchor hand-off 16 has a horseshoe shaped form with an opening 45 that narrows to form a constriction 47. The stretchable nature of the anchor stem 30 allows it to be squeezed through the constriction 47 and thus held in place by friction. See
Shaft 46 is slidably disposed in an articulating guide 49 that will articulate in response to actuation using pull wires or other means known to those skilled in the art. The articulating guide 26 may be one with video capability, for example it might be an articulating endoscope. In one embodiment, wire element 48 is detachable from the shaft 46 of the anchor hand-off 16 to allow shaft 48 to pass through a small diameter tool channel in the articulating guide 26. Once the distal end of the shaft 46 reaches the distal end of the guide 26, the wire element 48 is coupled to the shaft 46.
Furthermore, the anchor hand-off tool 16 may be designed to hold the anchor behind (or axially off-set from) the distal tip of the articulating guide 26 with video capability. This facilitates greater visibility at the target site/plication by positioning the held anchor out of the endoscope's field of view as shown in
Anchor grasper 18 is designed to couple to or engage a portion of the head 32 of an anchor 12. It is used to pull the anchor 12 through an opening in a plication, and to pull the anchor through a corresponding opening in a restrictor that is to be implanted. The anchor grasper 18 may have a variety of designs that allow these functions to be carried out. One such design is shown in
A closure tube 56 is longitudinally slidable over the hook and gate to lock them in the closed position, thus preventing them from separating. The collar and associated features are proportioned to ensure that when the grasping element 50 is to be locked, bending of the shaft of the anchor grasper 18 does not cause the closure tube 56 to slide into a position that will release the grasping element 50 from the locked position.
Hypotube 64 is slidably and rotatably disposed within outer tubing 60, and includes a pin 66 disposed within the slot 62. Hypotube 64 is mounted to a tapered handle 68. A cable 70 has a distal end coupled to the grasping element 50 and a proximal end mounted to the handle 68.
To close and lock the grasping element, the outer tube 60 is advanced distally relative to the handle 68. Advancement of the outer tube 60 pushes the coil 58 and thus the closure tube 56 in a distal position until the closure tube 56 moves the grasping element 50 to the closed position shown in
The restrictor is an implant designed to slow the passage of food from the esophagus into the stomach. The illustrated embodiments, the restrictor is positioned in the stomach such that food enters the restrictor through a proximal opening and exits the restrictor through a distal opening. The restrictor and/or openings are proportioned to slow the rate at which food can move into or through the restrictor, and/or from the restrictor into the rest of the stomach.
A preferred restrictor is proportioned to be coupled to anchors that have been coupled to plications in the gastroesophageal junction region of the proximal stomach. In a preferred design, the restrictor 14 includes features that minimize pulling against the anchors when the restrictor encounters stress as a result of food moving through the restrictor and/or movement of the stomach. Minimizing pulling at the anchors is beneficial for minimizing stress on the stomach wall tissue coupled to the anchors. In general, the restrictor 14 is designed to have compliance between the anchor points (i.e., the points at which the implant is coupled to the tissue directly or using the anchors). This compliance may be achieved using the geometry of the restrictor 14 and/or using restrictor materials selected to give compliance between anchor points.
In a first embodiment shown in
Anchor openings 80 are positioned between the radial peaks 82. These openings may be positioned in the portion of the wall that is at the most radially inward position as on the restrictor 14 a of
Openings 80 may be surrounded by reinforced sections 92 formed using thicker regions of silicone, or a stronger material embedded in or attached to the silicone. Additional reinforcements such as ribs 94 a, 94 b may extend from the openings 80 towards the orifice 86 and/or from the proximal peaks 78 towards the orifice 86 and may be formed using similar techniques.
The edge of the wall defining the orifice 86 preferably includes folds or undulations 96, allowing the orifice to be compliant as well. In addition, small holes 98 are arranged around the orifice to allow the restrictor 14 to be coupled to the restrictor guide used to deliver the restrictor into the stomach.
An alternative restrictor 14 b shown in
Yet another alternative restrictor 14 c (
An additional restrictor 14 d is molded out of a combination of high and low compliance material (such as 50 shore A plus 40 shore 00 silicones) in different areas of the restrictor to achieve optimal performance. A rib structure 94 c (see
Restrictor guide 20 generally includes a tubular shaft 101, a distal portion comprising a coupling element/mount 102 and a proximal portion 104.
In a preferred restrictor guide, the mount 102 is designed to support the restrictor 14 during delivery of the restrictor into the stomach and coupling of the restrictor 12 to the stomach wall (directly or using anchors or other means as disclosed herein). In the illustrated embodiment, mount 102 includes a collar 103 on the distal end of the shaft 101. A pair of tubes 112 extend distally between the collar 103 and a ring 107. Ring 107 includes a plurality of distally extending pins 106 and a central opening 109. A tube 111 is positioned co-axially with the opening 109. A distal cap 108 is mounted to the distal end of the tube 111. Cap 108 includes an opening positioned in alignment with the opening of the ring 107 and the lumen of the tube 111. Bores 110 in the cap are positioned so that proximal advancement of the cap 108 relative to the ring 107 causes pins 106 to enter the bores 110.
Drive rods 112 a (
Proximal portion 104 of the restrictor guide 20 is a multi-lumen guide having a central lumen 114 through which the tubular shaft 101 extends, and a plurality of peripheral lumens 116 arranged around the central lumen. The peripheral lumens 116 are proportioned to accommodate the anchor graspers 18. Each of the peripheral lumens 116 has a proximal port fitted with a seal (which may be, for example, a duck bill seal) that will seal around the shaft of a grasper 18 positioned in the lumen, and that will self-seal when the grasper 18 is removed from the lumen.
Use of the system 10 to implant a restrictor 14 will next be described. According to one embodiment, the method is performed following an initial procedure in which a plurality of plications P having cutouts or other openings C are formed. In another embodiment, after each plication is formed, an anchor 12 is implanted in that plication's opening for the dual purpose of marking the location of the plication as well as ensuring that the opening does not close in the natural healing process of the tissue. The anchor implantation procedure may immediately precede restrictor implantation, or may instead be performed in advance of the restrictor implantation procedure to allow reinforcement of the plications through the body's healing process.
In the initial phase of the restrictor implantation procedure, anchors 12 are positioned in the openings of the plications P. Referring to
Outside the body, an anchor hand-off 16 is passed through a tool channel of an endoscope 26 such that the anchor engaging wire 48 extends from the endoscope lumen. With the engaging wire in this position, an anchor 12 is coupled to the engaging wire 48, and the endoscope 26, anchor hand-off 16, and anchor 12 are together passed through the central lumen 24 a of the multi-lumen guide tube 24 and into the stomach as shown in
Next, an articulating guide 25 is advanced through a peripheral lumen 24 b of the multi-lumen guide tube 24 and into the stomach. An anchor grasper 18 is positioned in the lumen of the guide 25. Under visualization using endoscope 26 (with anchor hand-off 18 retracted so that the anchor is out of view), guide 25 is articulated to orient the grasper 18 towards the opening C in the plication, and the grasper 18 is then advanced through the opening as also shown in
The endoscope 26 and anchor hand-off 16 are withdrawn from the guide tube 24 along with the multiple lumen guide and articulating guide. After another plication is created, the process is repeated for each anchor that is to be implanted. See
As each anchor is implanted, its corresponding anchor grasper is preferably left coupled to the ring of the anchor, although it may instead be withdrawn from the body. At the end of the anchor-positioning phase of the procedure, each anchor is positioned extending through a plication opening (
If the anchor graspers 18 are not left in place following implantation of the individual anchors 12, the graspers 18 are re-coupled to the anchors prior to the restrictor-positioning phase. Specifically, each of the graspers 18 is reintroduced into the stomach and endoscopically guided by its corresponding articulated guide 25 into engagement with the head 32 of one of the anchors. As discussed in the Anchors section above, orientation of the loop 38 to extend in a direction opposite to the asymmetrical base 28 helps to orient the loop 38 centrally within the stomach so that the loops 38 may be more easily seen and engaged by the graspers 18.
The restrictor-positioning phase of implantation begins with each anchor that is to be coupled to the restrictor having a separate anchor grasper 18 coupled to it. If the multi-lumen guide 24 is still in use at this point, with individual ones of the graspers 18 in the peripheral lumen 24 b, the guide 24 is withdrawn from the endogastric tube 22 and removed from the handles of the anchor graspers. The tapered proximal ends of the anchor graspers 18 allow the lumens 24 b of the guide 24 to pass easily over them. Before the multiple lumen guide is completely removed from the endogastric tube 22, the anchor grasper tool shafts are locked into a tool organizer 130 at the proximal end of the endogastric tube 22 as shown in
The restrictor 14 is prepared for implantation by threading anchor openings 80 in the restrictor over the tapered proximal ends of the anchor graspers 18, which at this point are still extending out of the endogastric tube 22.
Next, the restrictor guide 20 is advanced over the tapered proximal ends of the anchor graspers 18, which are still extending out of the endogastric tube 22. The restrictor guide 20 is positioned so that each of its peripheral lumens 116 advances over a separate one of the anchor graspers 18.
In a final step, the anchors 12 are pulled through the anchor openings 80 to couple the restrictor 14 to the anchors 12. In this step, distally-oriented pressure is applied to the restrictor guide 20 while the anchor graspers 18 are one-by-one pulled proximally, causing the anchors 12 to elongate sufficiently to pass through the openings 90. Coupling between each anchor and its corresponding opening 80 is confirmed visually and/or by tactile feedback reflecting the “pop” of the anchor moving through the opening 80. Once the restrictor 14 has been coupled to the anchors 12, the cap 108 of the restrictor guide 20 is advanced distally to release the restrictor as described in the Restrictor Guide section above. The anchor graspers 18 are unlocked and separated from the anchors. The restrictor guide 20, anchor graspers 18, guides, etc. are withdrawn from the body, leaving the restrictor 14 and anchors 12 in place as shown in
The system of
Use of one such tool is generally illustrated in
Although the disclosed system has been described in the context of implanting a restrictor implants implantable in the stomach for limiting limit intake of food by the patient, the systems and methods may be used to implant other types of implants for a variety of purposes. These implants include, but are not limited to obstructive gastric implants that obstruct flow of food into the stomach, gastric space occupiers for limiting effective stomach volume, prosthetic valves for the treatment of gastro-esophageal reflux disease, gastric stimulators, pH monitors and drug eluting devices that release drugs, biologics or cells into the stomach or elsewhere in the GI tract. Such drug eluting devices might include those which release leptin (a hormone which creates feelings of satiety), Ghrelin (a hormone which creates feelings of hunger), octreotide (which reduces Ghrelin levels and thus reduces hunger), Insulin, chemotherapeutic agents, natural biologics (e.g., growth factor, cytokines) which aid in post surgery trauma, ulcers, lacerations, etc. Still other implants might be of a type which might provide a platform to which specific cell types can adhere, grow and provide biologically-active gene products to the GI tract, and/or a platform for radiation sources that can provide a local source of radiation for therapeutic purposes, or provide a platform whereby diagnostic ligands are immobilized and used to sample the GI tract for evidence of specific normal or pathological conditions, or provide an anchor point for imaging the GI tract via cameras and other image collecting devices. Additionally, the disclosed anchors and restrictors are shown positioned and anchored near the gastro-esophageal junction region of the proximal stomach, but may be positioned and/or anchored elsewhere in the stomach or GI system.
It should also be recognized that a number of variations of the above-identified embodiments will be obvious to one of ordinary skill in the art in view of the foregoing description. Accordingly, the invention is not to be limited by those specific embodiments and methods of the present invention shown and described herein. Rather, the scope of the invention is to be defined by the following claims and their equivalents.
Any and all patents and patent applications referred to herein, including for purposes of priority, are incorporated herein by reference.