Source: https://patents.google.com/patent/US20060155312A1/en
Timestamp: 2019-04-24 16:44:59+00:00

Document:
2006-03-21 Assigned to GI DYNAMICS, INC. reassignment GI DYNAMICS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MEADE, JOHN C., CVINAR, JOHN F., MELANSON, DAVID A., LEVINE, ANDY H.
2010-06-01 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46323358&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20060155312(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Methods and apparatus for delivering an implant device within the digestive system of an animal are presented. An delivery device includes an outer sheath, or container, for storing a proximal portion of the implant device. The outer sheath is moveable relative to the stored portion of the implant device to release the proximal portion from within the outer sheath. The delivery device also includes an inner sheath defining a lumen therein that extends distal to the outer sheath, a moveable element adapted to secure the distal end of the implant to the inner sheath, and a release mechanism coupled to the moveable element for releasing the distal end of the implant. The device also includes a atraumatic tip, or ball, coupled at its distal end to facilitate guiding the delivery device through the gastrointestinal tract.
This application is a continuation-in-part of U.S. application Ser. No. 10/999,846, filed Nov. 30, 2004, which is a divisional of U.S. application Ser. No. 10/339,786, filed Jan. 9, 2003, which claims the benefit of U.S. Provisional Application No. 60/430,321, filed on Dec. 2, 2002. The entire teachings of the above applications are incorporated herein by reference.
The present invention provides methods and apparatus for implanting a device within the gastrointestinal tract of an animal. More particularly the methods and apparatus of the invention provide for implanting a device through the nose or mouth of a patient and into the intestine.
A delivery system for placing a gastrointestinal implant device in a body includes an outer sheath, or container, for storing a proximal portion of the implant device, and an inner sheath within the outer sheath, and an atraumatic feature such as a ball coupled to the distal end of the inner sheath to guide the delivery system through the alimentary canal. The ball can be dimensioned to permit it to be pulled-back through a central lumen of the implant device. The outer sheath is moveable relative to the stored portion of the implant device to release the proximal portion of the device from within the outer sheath.
The inner sheath defines a lumen therein and extends distal to the outer sheath. The delivery system also includes a moveable element, such as an elongated wire moveable within the lumen of the inner sheath. The moveable element is adapted to secure the distal end of the implant, such as a sleeve, to the inner sheath. A release mechanism is coupled to the moveable element for releasing the distal end of the implant. In some embodiments, the inner sheath of the delivery system defines a second lumen for passing the outer sheath over a guidewire.
The delivery system can be used to implant a device, such as an elongated sleeve having a collapsible sleeve anchor coupled to its proximal end. In some embodiments, the sleeve, or liner, is open at both ends and adapted to extend into the duodenum. In some embodiments, the sleeve is extended to a length of about 1 foot or more when implanted. The desired result using the implanted sleeve can include one or more of: limiting the absorption of nutrients; delaying the mixing of chyme with digestive enzymes; providing negative feedback; reducing hormone triggers; and treating diseases, such as diabetes.
The sleeve anchor is adapted to be retained within the digestive system and can include a stent having a network of struts. In some embodiments, the delivery system is used to anchor the implant device distal to the pylorus. In other embodiments, the delivery system can be used to anchor the implant within the pyloric orifice or proximal to the pylori orifice, such as in the stomach.
In operation, the anchor release mechanism pulls the outer sheath toward the proximal end of the delivery system to remove the outer sheath from the sleeve anchor. Similarly, the sleeve release mechanism pulls the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the sleeve anchor has been released. The moveable element can be a sleeve retention wire, exiting the lumen of the inner sheath and piercing the distal end of the sleeve. Alternatively, the moveable element can be a snare wire capturing the distal end of the sleeve.
FIGS. 29A-C are a series of sequential diagrams illustrating the delivery of a gastrointestinal implant using an alternative embodiment of a delivery device.
Within the implant device 200 at the proximal end including the first proximal opening 204 is a collapsible self-expanding stent 208. The stent 208 includes a plurality of opposed barbs 210 for anchoring the implant device 200 to the muscular pylorus in the stomach 102. The diameter of the stent 208 is dependent on the diameter of the pyloric orifice 108 (FIG. 1) about 0.8″ to 1.1″ based on human anatomy variations. In one embodiment, the length l of the stent 208 is selected to extend through the pylorus 108 and keep the pylorus 108 permanently open to induce “dumping syndrome.” In an alternate embodiment, a stent with a shorter length l allows the pylorus 108 to open and close normally.
The covered stent 208 can be collapsed into a sheath having a diameter less than ¼ inches to enable endoscopic delivery. Covering the exterior surface of the stent 208 with the first outer layer of the sleeve 202 permits endoscopic removal of the implant device 200 by preventing tissue in-growth on the exterior surface of the stent 208.
FIG. 5A is a sectional view of a body showing one embodiment of the gastrointestinal implant device 200 implanted in the digestive system. The first proximal end 204 of the implant device 200 is anchored to muscle in the pyloric portion of the stomach 102. The barbs 210 grip onto the muscle to anchor the implant device 200 in place so that the implant device 200 can not be dragged into the stomach or down into the intestines with movement of the stomach and the intestines. FIG. 5B is a sectional view of a body showing an alternative embodiment of the gastrointestinal implant device 200′ implanted distal to the pylorus 108.
FIG. 6 is a perspective view of a collapsible self-expanding stent 600 in the gastrointestinal implant device 200 shown in FIG. 2 when expanded. The stent 600 is non-woven, collapsible and self-expanding, allowing endoscopic insertion and removal of the implant device 200. The stent 600 includes a plurality of flat struts 602 forming an open space pattern to ease collapsing while ensuring self-expansion. The open space pattern allows for collapsing into a catheter for endoscopic delivery and removal. The struts 602 may be manufactured from heat-treated spring steel, or from an alloy such as a nickel-titanium, a shape-memory alloy commonly referred to as nitinol. Other alloys include nickel-cobalt-chromium-molybdenum alloys possessing a unique combination of ultrahigh tensile strength, such as MP35N, available from Asahi Intecc Co., Ltd. of Newport Beach, Calif.
The sleeve 202 is secured temporarily outside the inner sheath 1226 allowing for proper positioning of the gastrointestinal implant device and then for release. As shown, the sleeve 202 is secured by the sleeve retention wire 1210 using a dead-bolt mechanism 1206. Non-stick coatings such as Teflon on the sleeve retention wire 1210 are preferred to make release easier to accommodate tortuous anatomical pathways. The sleeve retention wire 1210 extends through the second inner lumen from the release mechanism 1214 of the catheter system 1200 to the dead-bolt mechanism 1206. The dead-bolt mechanism 1206 is described later in conjunction with FIG. 13A. The sleeve retention wire 1210 holds the sleeve in position. The distal end of the folded sleeve is released by the release mechanism 1214 by pulling the sleeve retention wire 1210 backward from the proximal end 1208 of the catheter.
FIG. 26C is a cross-sectional view taken along line DD of FIG. 26A through the outer sheath 2600 showing the inner sheath 2650 within the outer sheath 2600. The outer sheath has an inner diameter of about 0.1 inches and an outer diameter of about 0.143 inches. The open space inside the outer sheath can be used for passing a drawstring through the outer sheath.
FIG. 28 is a perspective view of a gastrointestinal implant device with another embodiment of a collapsible self-expanding anchoring device. The gastrointestinal implant device 2800 includes a sleeve 202 and an anchoring device, or sleeve anchor, for anchoring the gastrointestinal implant 2800 device within the gastrointestinal tract. In some embodiments, the implant device 2800 includes a wave anchor 2810 coupled to a proximal portion of the sleeve 202. Wave anchors are described in more detail in co-pending U.S. patent application Ser. Nos. 10/858,851 and 10/858,852, both filed on Jun. 1, 2004, both claiming priority to U.S. Provisional Application Nos. 60/528,084 filed on Dec. 9, 2003 and 60/544,527 filed on Dec. 13, 2003; U.S. patent application Ser. No. 11/229,352, filed on Sep. 16, 2005, which claims priority to U.S. Provisional Application No. 60/611,038, filed on Sep. 17, 2004; and U.S. patent application Ser. No. 11/147,992, filed on Jun. 8, 2005, all incorporated herein by reference in their entirety.
The wave anchor 2810 includes a compliant, radial spring 2900 shaped into an annular oscillating pattern. For example, the pattern is a wave pattern, such as a sinusoidal pattern formed about a central axis. The anchor provides an outward radial force, while allowing substantial flexure about its perimeter. Such flexure is advantageous as it allows for minimally-invasive delivery and ensures that the device will substantially conform to the surrounding anatomical structure when implanted.
The annular wave element 2900 can be formed from one or more elongated resilient members radially-disposed about a longitudinal axis and joined together defining a lumen along its central axis formed between two open ends. When implanted, the central axis 2815 of the anchor is substantially aligned with the central axis of the lumen 2820 (e.g., duodenum 104), allowing chyme to pass through the interior of the device 2800. Additionally, the compliant wave anchor 2810 minimizes trauma to the tissue by providing sufficient flexibility and compliance, while minimizing the likelihood of tissue erosion and providing a solid anchoring point to the tissue.
In some embodiments, the wave anchor is adapted for placement within a region of the proximal duodenum referred to as the duodenal bulb 500 (FIG. 5B). For these applications, the axial extent of the anchor is preferably less than the distance between the pyloric sphincter and the ampulla of Vater. Exemplary relaxed lengths can range from about 20 to 50 mm (i.e., from less than 1 to about 2 inches). The diameter of the wave anchor 2900 can have an initial installed diameter within the range of about 20-40 millimeters (i.e., between about ¾ and 1¾ inches).
The compliance of the anchor 2900, allows it to flex radially over a wide range according to natural contractions and expansions of the duodenum 104. In some embodiments, the relaxed diameter of the wave anchor 2900 can be about 50 mm (i.e., about 2 inches). In other embodiments, the relaxed diameter can exceed 50 mm, being up to 60 mm (i.e., 2.5 inches) or even more. In either case, the wave anchor 2900 can be temporarily collapsed to about 12 mm (i.e., about 0.5 inches) for endoscopic placement.
In some embodiments, the implant device includes a retrieval/repositioning feature. For example, the implant device 2800 includes a drawstring 2825. The drawstring 2825 can be selectively woven around the perimeter of the anchor 2900 through openings of opportunity in the anchor 2900. Alternatively or in addition, the drawstring 2825 can be selectively woven through dedicated openings, such as eyelets provided on the anchor 2900 or in the proximal sleeve 202. In operation, the drawstring 2825, when pulled, contracts about the perimeter of the anchor 2900 to reduce the diameter of the anchor 2900. Collapsing the anchor 2900 in this manner before removing or repositioning the anchor 2900 is advantageous in avoiding tissue damage, particularly when the implant device 2800 includes barbs.
In some embodiments, the gastrointestinal implant device 2800 can be inserted endoscopically in combination with a delivery catheter, such as any of the delivery catheters described herein (FIGS. 12 and 17) or any of the delivery catheters described in U.S. patent application Ser. No. 10/999,846, filed on Nov. 30, 2004, which is a divisional of U.S. patent application Ser. No. 10/339,786, filed on Jan. 9, 2003, which claims the benefit of U.S. Provisional Application No. 60/430,321 filed on Dec. 2, 2003; any of the delivery catheters described in U.S. patent application Ser. No. 10/726,011, filed on Dec. 2, 2003, which claims the benefit of U.S. Provisional Application No. 60/512,145, filed on Oct. 17, 2003; or any of the delivery catheters described in U.S. patent application Ser. No. 11/057,861, filed on Feb. 14, 2005, which claims the benefit of U.S. Provisional Application Nos. 60/586,521, filed on Jul. 9, 2004 and 60/610,614, filed on Sep. 19, 2004, all incorporated herein by reference in their entirety.
For example, a delivery device 2950 is directed into the duodenum, as illustrated in FIG. 29A. The leading or distal end of the delivery device 2950 includes an outer catheter 2955 that may include a capsule or container 2960. The capsule 2960 may be placed with the assistance of a guidewire (not shown) and its position confirmed within a desired location, such as partially or entirely through the pylorus 108 and into the small intestine, using fluoroscopy.
The container 2960 holds or houses parts or all of a gastrointestinal implant device (e.g., a gastrointestinal sleeve). The gastrointestinal implant device includes a distal portion and a proximal portion. The distal portion includes a gastrointestinal sleeve and the proximal portion of the device includes a collapsible sleeve anchor for securing the device within the gastrointestinal tract (e.g., in the proximal duodenum). In some embodiments, the container 2960 holds or houses at least the proximal portion of the gastrointestinal device. In other embodiments, the container 2960 holds or houses both the distal and proximal portions. In still further embodiments, the container 2960 holds or houses the entire gastrointestinal device. Some or all of the sleeve portion can be folded and stored in the container 2960 with the sleeve anchor.
After the container 2960 is positioned at the desired location, a distal portion 2965 of the sleeve is removed from the container and directed into a location in the gastrointestinal tract that is distal from the container, as illustrated in FIG. 29B. The outer catheter 2955 defines an inner catheter lumen (not illustrated) and an inner catheter (hidden under sleeve 2965) extending distal to the outer catheter 2955 or container 2960. The inner catheter can be advanced with respect to the container 2960 into locations of the gastrointestinal tract that are distal from container 2960 and pylorus 108.
The distal portion 2965 of the sleeve is releasably secured to the leading or distal portion of the inner catheter so that as the inner catheter is advanced through the intestine 112, distal portion 2965 is also advanced. In this manner, distal portion 2965 is directed to locations in the gastrointestinal tract that are distal from container 2960 and into the intestine 112 (e.g., into the jejunum). Throughout this procedure, the outer catheter 2955 is held in place to ensure that capsule 2960 remains in the duodenum and does not move proximally into the stomach.
The proximal portion of the gastrointestinal sleeve can be releasably secured within the container 2960 by a locking means (e.g., by an anchor locking wire) to ensure that the anchor does not emerge from container 2960 and deploy before the distal portion 2965 of the sleeve is extended to a desired location in the intestine 112.
In some embodiments, an atraumatic tip (e.g., atraumatic ball 2970) is attached to the distal end of the inner catheter, which minimizes or eliminates tissue trauma as the inner catheter is advanced into the intestine.
After the distal portion 2965 of the sleeve is advanced to a desired location in the intestine 112, the anchor is deployed from the container 2960 and secured to a desired position within the gastrointestinal tract, as illustrated in FIG. 29C. The anchor locking means (not shown) is released to allow the anchor to be subsequently removed from container 2960. For example, the anchor locking means can include a locking wire that releasably secures the anchor within container 2960 and pulling the locking wire proximally detaches the anchor so that the anchor can be removed from the container 2960 at some subsequent time.
Once the container 2960 is in the desired location, outer catheter 2955 is held in position and the inner catheter can be advanced further distally to pull the sleeve and anchor 2975 from container 2960. Optionally, the anchor 2975 is pushed out of the container 2960 using a means for displacing an anchor 2975 from the container assembly (e.g., an anchor plunger). In some embodiments, either the inner catheter or the means for displacing the anchor are used to hold the anchor 2975 in position, while the outer catheter 2955 is pulled proximally to release the anchor 2975 in place.
In some embodiments, the atraumatic tip or ball 2970 is dimensioned such that it can be pulled back through the sleeve. The inner catheter and outer catheter 2955 are removed by pulling the delivery device 2950 proximally, out of the patient.
In some embodiments, the gastrointestinal implant device can be repositioned and/or removed endoscopically in combination with a repositioning/removal device, such as any of the repositioning/removal devices described herein (FIG. 19) or any of the repositioning/removal devices described in U.S. patent application Ser. No. 11/001,812, filed on Nov. 30, 2004, which is a divisional of U.S. patent application Ser. No. 10/339,786, filed on Jan. 9, 2003, which claims the benefit of U.S. Provisional Application No. 60/430,321 filed on Dec. 2, 2003; or any of the repositioning/removal devices described in U.S. Provisional Application No. 60/645,287, filed on Jan. 19, 2005, all incorporated herein by reference in their entirety.
Various embodiments of the gastrointestinal implant device have been described herein. These embodiments are given by way of example and are not intended to limit the scope of the present invention. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments.
The appended claims are of a scope that covers the embodiments disclosed in priority application U.S. patent application Ser. No. 10/858,852 referenced herein, and thus have the benefit of priority of that filing date. The claims are also of a sufficient scope to cover more recent embodiments, including those described above and those disclosed in U.S. patent application Ser. Nos. 11/229,352 and 11/147,992, also referenced herein.
a spherical element disposed at the distal portion of the delivery system.
2. The delivery system of claim 1, wherein the moveable element is a sleeve retention wire, which exits the lumen of the inner sheath and pierces the distal end of the sleeve.
3. The delivery system of claim 1, wherein the moveable element is a snare wire which captures the distal end of the sleeve.
4. The delivery system of claim 1, wherein the outer sheath is pulled toward a proximal end of the delivery system to remove the sleeve anchor from the outer sheath.
5. The delivery system of claim 4 wherein the sleeve release mechanism pulls the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the sleeve anchor has been released.
6. The delivery system of claim 1, wherein the gastrointestinal device is anchored in the stomach.
7. The delivery system of claim 1, wherein the gastrointestinal device is anchored distal to the pylorus.
8. The delivery system of claim 1, wherein the spherical element is coupled to the distal end of the inner sheath.
9. The delivery system of claim 1, wherein the spherical element is dimensioned to permit its retraction through a central lumen of the gastrointestinal implant device.
10. The delivery system of claim 1, wherein the inner sheath defines a second lumen to pass the outer sheath over a guidewire.
11. The delivery system of claim 1, wherein the sleeve anchor comprises a stent.
13. The delivery system of claim 12, wherein the outer sheath is pulled toward the proximal end of the delivery system to remove the sleeve anchor from the outer sheath.
14. The delivery system of claim 13, wherein the sleeve release mechanism pulls the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the sleeve anchor has been released.
16. The delivery system of claim 15, wherein the outer sheath is pulled toward the proximal end of the delivery system to remove the sleeve anchor from the outer sheath.
17. The delivery system of claim 16, wherein the sleeve release mechanism pulls the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the sleeve anchor has been released.
a sleeve release mechanism coupled to the moveable element to move the moveable element and thus release the distal end of the sleeve and a spherical element disposed at the distal portion of the delivery system.
19. The delivery system of claim 17, wherein the moveable element is a sleeve retention wire, which exits the lumen of the inner sheath and pierces the distal end of the sleeve.
20. The delivery system of claim 17, wherein the moveable element is a snare wire which captures the distal end of the sleeve.
21. The delivery system of claim 17, wherein the outer sheath is pulled toward a proximal end of the delivery system to remove the sleeve anchor from the outer sheath.
22. The delivery system of claim 20, wherein the sleeve release mechanism pulls the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the sleeve anchor has been released.
23. The delivery system of claim 17, wherein the gastrointestinal device is anchored distal to the pylorus.
24. The delivery system of claim 17, wherein the sleeve anchor comprises a stent.
25. The delivery system of claim 17, wherein the spherical element is coupled to the distal end of the inner sheath.
26. The delivery system of claim 17, wherein the spherical element is dimensioned to permit its retraction through a central lumen of the gastrointestinal implant device.
a ball disposed at the distal portion of the delivery system.
28. The delivery system of claim 26, wherein the ball is coupled to the distal end of the inner sheath.
29. The delivery system of claim 26, wherein the ball is dimensioned to permit its retraction through a central lumen of the gastrointestinal implant device.

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