Gastrointestinal implants and fixation therefor - Patents.com

Abstract

The present invention relates to an anchor (14) for an implant (20) for use in the gastrointestinal tract. The anchor (14) comprises a tissue contacting portion (16) having an embedding region (16a) configured to at least partially integrate or promote integration with the wall of the gastrointestinal tract.

Description

[Technical field]

[0001] The present invention relates to the field of implants for insertion into the gastrointestinal tract and anchors therefor. In some non-limiting aspects, the implant is a bypass sleeve for bypassing a portion of the intestine. [Background technology]

[0002] Various surgical techniques and implants have been proposed to treat obesity and diabetes.Surgical techniques include the creation of a gastric pocket and gastric bypass of a portion of the stomach, duodenum and jejunum.Implants such as bypass sleeves or liners have been proposed for insertion into the gastrointestinal tract to bypass the duodenum and possibly a portion of the jejunum.

[0003] Technical challenges remain for many of these techniques. For example, endoscopic placement and fixation of the bypass sleeve remains difficult. One proposed technique is to fix the sleeve in the vicinity of the pylorus. However, the stomach and intestines undergo significant movement in normal bodily functions. Muscular contractions of the stomach, including the pyloric antrum, and significant intestinal motility, both antegrade and retrograde, complicate maintaining the sleeve in place. Muscular contractions on the gastric side and retrograde motility on the intestinal side can become extreme, for example, when the patient vomits. Dislodgement either toward the duodenum or into the stomach may require medical intervention to correct the position or to retrieve the bypass sleeve. Many existing proposals are compromised by the apparently conflicting requirements of secure fixation, atraumatic engagement with body tissue, and allowing removal of the sleeve. One proposed approach uses a sleeve device with an integral crush-resistant gastric anchor with a smooth, atraumatic surface. The crush resistance prevents dislodgement from the stomach. The surface reduces mucosal engagement and allows for easy removal of the sleeve and anchor when the sleeve is no longer needed or is replaced. Summary of the Invention [Problem to be solved by the invention]

[0004] It would be desirable to address and / or alleviate one or more of the above problems. [Means for solving the problem]

[0005] Broadly speaking, a first aspect of the invention provides an anchor for an implant (e.g., a sleeve) for use in the gastrointestinal tract, the anchor comprising a tissue contacting portion having an embedding region, the embedding region configured to at least partially integrate with or promote integration with a wall of the gastrointestinal tract.

[0006] The wall of the gastrointestinal tract may be the stomach wall, optionally in the region of the antrum, although the invention may also be used in other regions of the gastrointestinal tract, such as the esophagus. As described below, the anchor may comprise or be a stent.

[0007] As used herein, the term "integrate" means that the implanted region becomes part of the wall of the vessel by tissue growth into and / or around the implanted region, either immediately after implantation or within a predetermined period of time after implantation. The implanted region may be incorporated into the tissue lining or mucosa of the vessel wall. The predetermined period of time may be less than about 4 months, optionally less than about 3 months, optionally less than about 2 months, and optionally less than about 1 month.

[0008] In general, integration of the implant region into tissues, such as the wall of the gastrointestinal tract, depends on several factors, e.g. - Rough outer surface of the implanted area; The embedding region of the anchor comprises a plurality of openings; the implanted region having a substantially open exterior; the embedded region comprises a lattice structure of struts; the struts have a small circumferential (e.g., circumferential) width; the struts have a small radial thickness; the tissue contacting portion comprises one or more protrusions (e.g., barbs or spikes); can be influenced and promoted by

[0009] It will be appreciated that the above factors may individually cause tissue integration and may be combined, for example for faster or further integration. No single factor is necessarily required for tissue integration, but any factor may be substituted for another depending on the application.

[0010] The use of anchors having an embedded region is a distinct approach from the prior art of anchors that are not embedded within a tissue wall, but are configured only for atraumatic, temporary engagement with the tissue wall.

[0011] By embedding into the tissue wall, the anchor can provide strong and reliable fixation without relying on high crush resistance which would affect the ability of the tissue wall to move normally, and without the risk of long-term irritation of the wall due to repeated relative motion between the anchor and the tissue wall.

[0012] In some embodiments, the anchor and / or tissue contact portion and / or embedded region have a tubular shape for engaging around the tract. The anchor may comprise or take the form of a stent. For example, in the case of a gastric anchor for fitting near the pyloric antrum and / or pylorus, the anchor and / or tissue contact portion and / or embedded region may have a circumferential dimension (e.g., circumference) of about 50 mm to about 80 mm, at least in the full-size and / or implanted state. An implant (e.g., sleeve) may optionally pass within the interior space of the tubular space and / or the tubular space may allow the passage of material passing through the gastrointestinal tract.

[0013] At least the embedded region of the anchor can comprise a plurality of openings to allow tissue growth through the openings. The anchor can have a generally open outer surface. The embedded region can have a ratio of open to non-open space of at least 2:1, optionally at least 3:1, optionally at least 4:1, optionally at least 5:1, optionally at least 10:1, optionally at least 100:1, optionally at least 200:1, optionally at least 500:1, optionally at least 1000:1.

[0014] The anchors and / or tissue contacting portions and / or embedded regions may comprise a lattice structure of struts defining openings therebetween. The openings may be open cells of a cellular lattice defined by the struts. The struts may be optionally coated (e.g., to protect the anchors from the corrosive effects of digestive fluids). Preferably, the coating is very thin and does not substantially block the openings between the struts.

[0015] The struts can have a circumferential (e.g., circumferential) width of about 0.5 mm to about 2 mm, optionally about 1 mm. Additionally or alternatively, the struts can have a radial thickness of about 0.2 mm to about 0.5 mm, optionally about 0.3 mm. Such relatively thin struts can promote cell growth around the struts to integrate the struts into the wall of the gastrointestinal tract.

[0016] The surface (e.g., at least the outer surface) of the tissue contact portion and / or the implantation region may optionally be non-smooth, e.g., roughened. The rough surface may be provided on the struts of the anchor (e.g., a stent) and / or on a covering of the struts. The rough surface may enhance frictional engagement between the anchor and the tissue wall until the implantation region is sufficiently integrated with the wall by tissue in-growth. For example, a rough outer surface may promote frictional engagement between the anchor and the mucosa of the vessel wall. Additionally or alternatively, contacting the tissue wall with a rough surface, optionally with limited friction while the implantation portion is implanted, may stimulate a healing response of the tissue wall and increase tissue in-growth, thereby aiding in the desired implantation into the wall.

[0017] Additionally or alternatively, the tissue contacting portion may further comprise one or more protrusions (e.g., barbs or spikes) for penetrating and / or puncturing the wall tissue. Such protrusions may increase frictional engagement between the anchor and the tissue wall until the implanted region is sufficiently integrated with the wall tissue by tissue growth. Optionally, the one or more barbs or spikes may have an undercut shape to help hook into the tissue wall. The protrusions (e.g., barbs or spikes) may also stimulate a healing response, as described above.

[0018] Additionally or alternatively, the projections may be implemented as extensions of the anchor at at least one axial end of the anchor, preferably both ends. Additionally or alternatively, the projections may be implemented as spikes, preferably as spikes extending radially outward of the tissue contact portion. The spikes may have a length of 1 mm to 10 mm. The spikes may extend from at least one of the struts, preferably from all of the struts of the strut lattice structure.

[0019] Additionally or alternatively, the prongs may have an at least partial hook-shaped configuration for penetrating into tissue.

[0020] At least some of the protrusions (e.g., barbs and / or spikes) may be long enough to penetrate at least the mucosal lining of the duct wall, e.g., the gastric mucosa of the stomach wall. At least one, optionally some, of the protrusions (e.g., barbs and / or spikes) may be long enough to penetrate the submucosal layer of the duct wall, e.g., the muscularis layer of the stomach wall. In some embodiments, the protrusions (e.g., barbs or spikes) have a length of about 1 mm to about 3 mm, optionally about 2 mm to about 3 mm. Additionally or alternatively, the protrusions may be configured as surface structures of the struts, e.g., by the placement of small barbs relative to the strut structure.

[0021] In some embodiments, the struts have a length of from about 1 mm to about 3 mm, optionally from about 2 mm to about 3 mm.

[0022] The anchor may be made of any suitable biocompatible material, including, for example, metals, metal alloys, and / or polymers. Exemplary materials include shape memory materials, such as alloys including at least nickel and titanium, such as Nitinol. Optionally, the anchor may be made of or include a bioabsorbable material, such as magnesium or poly-L-lactic acid. Anchors made of bioabsorbable materials biodegrade into the tissue wall after the expected life of the anchor, leaving little or no persistent material embedded in the tissue wall.

[0023] The anchors can be expandable from a first, e.g., low-profile, undeployed configuration suitable for intraluminal delivery to the gastrointestinal tract, to a second, e.g., expanded, deployed configuration for engaging the wall of the tract. The anchors can be self-expanding (e.g., made of a shape-memory material) or plastically expandable (e.g., made of a material that can be forced to expand). The anchors can also use a combination of both self-expanding and plastic expansion.

[0024] In addition to or in place of any of the above, the anchor may further comprise at least one fastener that protrudes relative to the tissue contacting portion and / or the embedded region. The fastener may protrude axially and / or radially inward relative to the tissue contacting portion and / or the embedded region. The fastener may facilitate attachment of an implant (e.g., a sleeve) to the anchor. By providing a protruding fastener, the fastener may remain exposed to the tissue wall even after the embedded portion is at least partially integrated into the vessel wall.

[0025] In addition to or in place of any of the above, a second aspect of the invention provides a modular sleeve device for the gastrointestinal tract comprising an anchor configured to engage wall tissue of the gastrointestinal tract and a sleeve extending or extendable from the anchor, the sleeve and anchor being configured as different modules.

[0026] The sleeve may be connectable to the anchor so as to extend from the anchor. As used herein, the term "modular" means that the sleeve and anchor are designed such that they can be assembled together as distinct units to form a device and / or disassembled from one another as distinct units.

[0027] In some embodiments, the modular components may be introduced to the target site in separate stages. The anchor may be introduced and implanted in a first stage, followed by the sleeve in a second stage. The first and second stages may be performed during the same procedure, or the first and second stages may be performed in different procedures, for example, separated by at least one day, optionally at least one week, optionally at least two weeks, optionally at least three weeks, optionally at least four weeks.

[0028] Additionally or alternatively, whether the anchor and sleeve are introduced together or in separate steps, in some embodiments the sleeve may be separable from the anchor for removal of the sleeve, optionally leaving the anchor attached and / or embedded in the vessel wall. For example, a retrieval tool may be inserted into the gastrointestinal tract to remove the sleeve, which can then be removed (e.g., pulled) outside the body.

[0029] The anchor and sleeve may comprise complementary fasteners. The fasteners may be engageable in the case of modular devices that can be assembled and / or disengageable in the case of modular devices that can be disassembled. Exemplary complementary fasteners may include one or more of male and female parts, interlocking male-male parts, interlocking female-female parts, snap-fit ​​parts, one of more mushroom head fasteners, one part that hooks onto a complementary part, a magnetic fastener, an adhesive fastener (e.g., at least one part carrying a releasable pressure sensitive adhesive).

[0030] In some embodiments, at least the fastening portion of the anchor is reusable, allowing either the same sleeve or a replacement sleeve to remain fastened to an existing anchor, so the anchor can act as a reusable dock for the sleeve, without the need to remove and replace the anchor with each new sleeve arrangement.

[0031] In addition to or instead of any of the above, a third aspect of the invention provides a sleeve suitable for use with the anchor of the first aspect and / or for use in the sleeve device of the second aspect, the sleeve comprising a sleeve fastener portion mateable with a complementary fastener portion of the anchor.

[0032] In some embodiments, the sleeve may be placed in the gastrointestinal tract uncoupled from an anchor and coupled to an anchor already in place in the gastrointestinal tract.

[0033] The sleeve may be free of anchors for securing the sleeve directly to tissue and / or anatomical structures of the gastrointestinal tract.

[0034] Additionally or alternatively to any of the above, a fourth aspect of the invention may provide an anchor for an implant (e.g. a sleeve) for use in the gastrointestinal tract, the anchor comprising a tissue contacting portion optionally having an embedded region, the tissue contacting portion comprising or further comprising at least one deployable protrusion for penetrating tissue, the protrusion having a generally flat configuration when the anchor is in a first, e.g. low profile, undeployed configuration, and the protrusion bending outwardly to a protruding configuration when the anchor is in a second, e.g. deployed configuration.

[0035] Such an arrangement can enhance engagement between the anchor and the wall of the gastrointestinal tract while still providing a low profile and / or flat configuration for delivery to a target site. In the flat configuration, the projections retract into the plane of the anchor or wall. In the deployed configuration, the projections can provide directional penetration of the wall tissue to resist movement in a particular direction. For example, the projections can resist antegrade movement of the anchor, for example proximally.

[0036] Additionally or alternatively to any of the above, a fifth aspect of the invention provides a method of securing an implant to the gastrointestinal tract, the method comprising: inserting at least one delivery device into the gastrointestinal tract to access a target location; using at least one delivery instrument to deploy anchors for the implant, the delivery instrument including deploying a tissue contacting portion of the anchor into contact with a wall tissue of the gastrointestinal tract, the tissue contacting portion having an embedding region configured to at least partially integrate with or promote integration with the wall of the gastrointestinal tract; Includes.

[0037] Inserting may include inserting at least one delivery instrument through a natural body orifice, such as the patient's mouth.

[0038] The method may further include allowing and / or causing the implanted region to at least partially integrate with the wall of the gastrointestinal tract, and optionally to become substantially completely integrated with the wall.

[0039] The anchor may comprise an expandable stent, and deploying may include causing expansion of the stent from an undeployed configuration for delivery to a deployed configuration in contact with the wall of the gastrointestinal tract.

[0040] The method may optionally include using a delivery instrument to introduce an implant (e.g., a sleeve) along with the anchor as an integrated device. Alternatively, the method may include attaching an implant (e.g., a sleeve) to the deployed anchor after deploying the anchor.

[0041] Additionally or alternatively to any of the above, a sixth aspect of the invention provides a method of performing a follow-up procedure on a gastrointestinal tract in which an implant device (e.g., a sleeve device) has already been implanted, the implant device optionally being according to any preceding aspect, the method comprising: inserting at least one tool into the gastrointestinal tract to access the implant device; operating at least one tool device to detach an implant component of the implant device from an anchor of the implant device, the anchor including a tissue contacting portion having an embedded region at least partially integrated with a wall of the gastrointestinal tract; removing the detached implant component from the gastrointestinal tract using at least one tool, leaving the anchor in place within the gastrointestinal tract; Includes.

[0042] The implant device may be a sleeve device and the implant component may be a sleeve of the sleeve device.

[0043] Optionally, the method may further include inserting at least one delivery instrument into the gastrointestinal tract to introduce a follow-up implant component and manipulating the at least one instrument to attach the follow-up component to the anchor. The follow-up component may be a replacement component, such as an exchange sleeve, although a different type of implant component than the removed component may also be envisioned.

[0044] Inserting may include inserting at least one tool and / or delivery instrument (if used) through a natural body orifice, such as the patient's mouth.

[0045] The above description highlights certain aspects, features and advantages of the invention, but is intended merely to illustrate the particular ideas and principles employed and is not intended to limit the scope of the invention. Protection is claimed for any novel features or ideas disclosed in the specification and / or drawings, whether or not emphasis is placed on them.

[0046] Non-limiting embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0047] [Figure 1] FIG. 2 is a schematic side view of the anchor of the first embodiment. [Diagram 2] FIG. 2 is a plan view of the anchor of FIG. 1. [Diagram 3] 13 is a schematic side view of a second embodiment of a sleeve that can be used with the anchor of the first embodiment. FIG. [Figure 4] 13 is a schematic side view of a third embodiment of a sleeve that can be used with the anchor of the first embodiment. FIG. [Diagram 5] 1 is a schematic cross-sectional view illustrating placement of an anchor and sleeve within the gastrointestinal tract of a patient. [Figure 6] 13 is a schematic side view of a further embodiment of an anchor having barbs in a deployed configuration. [Figure 7] FIG. 7 is an end view of the anchor of FIG. 6. [Figure 8] FIG. 8 is a schematic cutaway view of a cell of a variant embodiment similar to that of FIGS. 6 and 7; [Figure 9] FIG. 9 is a schematic cutaway view similar to FIG. 8, showing a further modified embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] With reference to the drawings, the embodiments show the invention in the form of a duodenal sleeve device 10 implantable to extend from the antrum of a patient's stomach 12, through the pylorus 12a, into the duodenum, and optionally at least partially into the jejunum. However, similar principles may be used to implant other types of implants and / or at other locations within the gastrointestinal tract.

[0049] 1 and 2, the sleeve device 10 comprises an anchor 14 in the form of a stent. The anchor comprises a tubular tissue contacting portion 16 from which extends at least one, and optionally a plurality of fasteners 18, in this example three.

[0050] The tissue contacting portion 16 has an embedded region 16a. In this example, the embedded region 16a corresponds to substantially the entire tissue contacting portion 16, although in other embodiments the embedded region 16a may be smaller. The embedded region 16a has a lattice structure with open openings or cells, which in this example have an open mesh design. The embedded region 16a is configured to promote at least partial, and preferably substantially complete, integration of the embedded region into the wall of the gastrointestinal tract by tissue growth around the openings and / or struts of the embedded region 16a.

[0051] The anchors 14 may be made of any suitable biocompatible material, including any one or more of metals, alloys, and polymers. The anchor struts 14 may be bare or may be covered with a protective coating to protect the struts from the corrosive effects of digestive fluids, for example, in the gastrointestinal tract. In some embodiments, the anchors 14 may be made of a shape memory material. Additionally or alternatively, the material may be bioabsorbable.

[0052] By at least partially integrating with the gastrointestinal wall tract, the anchor 14 can be at least semi-permanently integrated and provide secure fixation of the implant without having to rely on large external forces or high crush resistance to form a frictional and / or interlocking fixation. If the anchor 14 is made of a bioabsorbable material, the anchor may biodegrade after its intended useful life. Alternatively, a non-biodegradable anchor 14 may be removed in a subsequent removal procedure using appropriate tissue cutting or tissue grinding tools to expose and allow the anchor to be extracted.

[0053] Although not explicitly shown in the first embodiment, as will be shown below, anchor 14 may also include one or more protrusions, such as spikes or barbs, to increase grip and / or friction between anchor 14 and the wall tissue of the gastrointestinal tract until embedded region 16a is at least partially embedded. Additionally or alternatively, at least the outer surface of embedded region 16a may also have a roughened surface to increase frictional contact with the wall tissue.

[0054] The fastener portions 18 protrude axially and / or radially inward relative to the tissue contacting portion 16, thereby allowing the fastener portions 18 to remain exposed even after the embedded portion 16a has integrated with the wall of the gastrointestinal tract. The fastener portions 18 serve as attachment points for the implant 20.

[0055] With reference to Figures 3 and 4, two exemplary embodiments of an implant 20 in the form of a sleeve or sleeve component are shown. The sleeve 20 is made of a flexible polymeric material intended to extend into at least the duodenum of a patient (see, for example, Figure 5). The sleeve 20 has a proximal end 26 defining an entrance for placement near or at the pylorus and a distal end 28 for placement distally in the intestine. The proximal end 26 includes a plurality of sleeve fasteners 24 for cooperatively engaging with the fasteners 18 of the anchor 14. In the illustrated example, the sleeve fasteners 24 are female parts for mating engagement with the male high-speed parts 18 of the anchor 14, although many other types of cooperating fasteners are envisioned, including mechanical, magnetic, and adhesive fasteners. The sleeve 20 is optionally provided with a reinforcing band 22 at the proximal end 26 to distribute loads and avoid high stress concentrations in the sleeve material around individual fasteners 24.

[0056] The embodiment of Figure 4 is similar to that of Figure 3, but further includes a duodenal anchor 30 for engaging the duodenal side of the pylorus. The duodenal anchor 30 can function to prevent migration through the pylorus and / or provide a sealing contact with the duodenal wall to reduce the risk of leakage of chyme around the outside of the sleeve 20. The duodenal anchor 30 can comprise, for example, a self-expanding stent on or attached to the sleeve 20. Alternatively, the duodenal anchor 30 may comprise an expandable cuff.

[0057] 5 illustrates placement of an implant device 10, including an anchor 14 and a sleeve 20, within a patient's gastrointestinal tract. The anchor 14 is deployed in the antrum of the stomach 12, on the gastric side of the pylorus 12a. The sleeve 20 extends distally through the pylorus into at least the duodenum.

[0058] The anchor 14 and sleeve 20 may be implanted as a combined unit, with the sleeve pre-attached to the anchor 14 by cooperating fasteners 18 and 24. Such a technique allows for the implantation of the complete device in a single procedure.

[0059] Alternatively, anchor 14 may be implanted in a first stage of a procedure and sleeve 20 may be inserted in a second stage after the first stage. The first and second stages may be part of the same procedure on a patient or may be separated in time by, for example, at least one day, optionally at least one week, optionally at least two weeks, optionally at least three weeks, optionally at least four weeks.

[0060] If it is desired to remove the sleeve 20 after a period of use, a tool can be used to access the sleeve 20 and remove the cooperating fasteners 18 and 24 to remove the sleeve 20 while leaving the anchor 14 in place. The protruding fasteners 18 can allow access even if the embedded portion 16a of the anchor has already become integrated into the wall of the gastrointestinal tract. If desired, a replacement sleeve 20 or a different implant (not shown) can be placed and attached to the existing anchor 14 to continue treatment of the patient.

[0061] Figures 6-9 show examples of barbs 32 implemented as part of the stent structure of anchor 14. In the examples of Figures 6 and 7, barbs 32 are implemented as extensions of the stent structure at at least one axial end (optionally both ends) of the stent. When anchor 14 expands upon deployment, barbs 32 bend at an angle of at least 90°, optionally at least 100°, optionally about 180° to provide at least a partial hook shape for penetrating into tissue and opposing movement in the direction of the tip of the hook shape.

[0062] 8 and 9 show cutaway views of a single cell of anchor stent 14. When deployed, the anchor can have a funnel configuration similar to that of FIGS.

[0063] In the example of Figure 8, barbs 32 are mounted within internal openings of protruding paddles at at least one axial end (optionally both ends) of the stent. In an undeployed configuration of anchor 14 (e.g., a low-profile configuration for delivery), the barbs are folded to lie generally in the plane of the paddles. Upon deployment, barbs 32 bend outward, angled away from the plane of the paddles, penetrating the tissue wall and resisting movement in the direction of the barb tips.

[0064] 9 is similar to FIG. 8, but illustrates a further example in which the barbs are implemented within internal openings or cells of the anchor structure 14. In the undeployed configuration of the anchor 14 (e.g., a low-profile configuration for delivery), the barbs are folded so that they lie generally within the walls of the anchor 14. Upon deployment, the barbs 32 bend outwardly, similar to the embodiment of FIG.

[0065] In the illustrated embodiment, the barbs 32 are implemented at a narrow portion or distal end of the anchor 14 configured for placement near the pylorus. The barbs 32 are configured to resist migration in a proximal direction. The funnel or wedge shape of the anchor (e.g., FIG. 5) provides a natural resistance to migrating distally through the narrow pylorus, and the barbs provide resistance to proximal migration. If desired, barbs may also be provided at the opposite end of the anchor 14, or at any point along the length of the anchor. The barbs may optionally be configured to resist migration in a distal direction, or the barbs may be provided to resist migration in either direction (e.g., individually or collectively).

[0066] It is emphasized that the foregoing is merely illustrative of exemplary forms of the invention, and that many modifications and equivalents may be used without departing from the scope and / or principles of the invention.

Claims

1. An anchor (14) for an implant (20) for use in the gastrointestinal tract, said anchor (14) comprising a tissue contacting portion (16) having an embedding region (16a), said embedding region (16a) configured to at least partially integrate with or promote integration with a wall of the gastrointestinal tract.

2. The anchor (14) of claim 1, wherein the anchor (14) and / or the tissue contacting portion (16) and / or the embedding region (16a) have a tubular shape for engaging around the tube.

3. 10. The anchor (14) of any one of the preceding claims, wherein the anchor (14) comprises or takes the form of a stent.

4. 10. The anchor (14) of any one of the preceding claims, wherein at least the embedding region (16a) comprises a plurality of openings for allowing tissue in-growth therethrough.

5. The anchor (14) according to any one of the preceding claims, wherein the anchor (14) and / or the tissue contacting portion (16) and / or the embedded region (16a) comprises a lattice structure.

6. The anchor (14) of claim 5, wherein the lattice is a lattice of struts defining openings between the struts.

7. The anchor (14) of claim 6, wherein the struts have a width of between 0.5 mm and 2 mm, preferably about 1 mm.

8. An anchor (14) according to claim 6 or 7, wherein the struts have a radial thickness of between 0.2 mm and 0.5 mm, preferably about 0.3 mm.

9. 10. The anchor (14) of any one of the preceding claims, wherein the tissue contacting portion (16) further comprises at least one protrusion (32) for penetrating and / or piercing wall tissue.

10. 10. The anchor (14) of any one of the preceding claims, wherein the anchor (14) is deployable from a first configuration suitable for intraluminal delivery to the gastrointestinal tract to a second configuration for engaging the wall of the gastrointestinal tract.

11. The anchor (14) according to any one of the preceding claims, further comprising at least one fastening portion (18) projecting relative to the tissue contacting portion (16) and / or the embedding region (16a).

12. A modular sleeve device (10) for the gastrointestinal tract comprising an anchor (14) and a sleeve (20), the anchor (14) configured to engage wall tissue of the gastrointestinal tract, preferably the anchor (14) being an anchor as described in any one of the preceding claims, and the sleeve (20) being connectable to the anchor (14) so ​​as to extend therefrom.

13. The modular sleeve device (10) of claim 12, wherein the sleeve (20) is preferably separable from the anchor (14) for removal of the sleeve (20).

14. The modular sleeve device (10) of claim 12 or 13, wherein the anchor (14) and the sleeve (20) include complementary fastening portions (18, 24).

15. The modular sleeve device (10) of claim 14, wherein at least the fastening portion (18) of the anchor (14) is reusable.

16. A sleeve (20) suitable for use with an anchor (14) according to any one of claims 1 to 11 and / or for use in a modular sleeve device (10) according to any one of claims 12 to 15, the sleeve (20) comprising a sleeve fastening portion (24) mateable with a complementary fastening portion (18) of the anchor (14).

17. An anchor (14) for an implant (20), preferably for a sleeve (20), for use in the gastrointestinal tract, preferably an anchor (14) according to any one of claims 1 to 11, said anchor (14) comprising a tissue contacting portion (16), preferably having an embedded region (16a), said tissue contacting portion (16) comprising or further comprising at least one deployable protrusion (32) for penetrating tissue, said protrusion (32) having a substantially flat configuration when said anchor (14) is in a first, preferably low profile and undeployed configuration, said protrusion (32) bending outwardly to a protruding configuration when said anchor (14) is in a second, preferably deployed configuration.

18. A method for securing an implant (20) in the gastrointestinal tract, comprising: inserting at least one delivery device into the gastrointestinal tract to access a target location; using said at least one delivery instrument to deploy an anchor (14) for an implant (20), preferably an anchor according to any one of claims 1 to 11, comprising deploying a tissue contacting portion (16) of said anchor (14) into contact with wall tissue of the gastrointestinal tract, said tissue contacting portion (16) having an embedding region (16a) configured to at least partially integrate with or promote integration with the wall of the gastrointestinal tract; A method comprising:

19. 20. The method of claim 18, further comprising encouraging the embedded region (16a) to at least partially integrate with the wall of the gastrointestinal tract, preferably to integrate substantially completely with the wall.

20. 20. The method of fixation according to claim 18 or 19, comprising using the delivery instrument to introduce an implant (20) together with the anchor (14) as an integrated device.

21. 20. The method of fixation according to claim 18 or 19, comprising after said deploying said anchor (14), attaching an implant (20) to said deployed anchor (14).

22. A method for performing a follow-up procedure on a gastrointestinal tract in which an implant device (20) has already been implanted, said implant device (20) being preferably a device according to any one of claims 12 to 16, said method comprising the steps of: inserting at least one tool into the gastrointestinal tract to access the implant device (20); operating the at least one tool device to detach an implant component of the implant device (20) from an anchor (14) of the implant device (20), the anchor (14) including a tissue contacting portion (16) having an embedded region (16a) at least partially integrated with the wall of the gastrointestinal tract; removing the detached implant component from the gastrointestinal tract using the at least one tool, leaving the anchor (14) in place in the gastrointestinal tract; A method comprising:

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