ENDOSCOPIC IMPLANT SYSTEM AND METHOD

• US 20100280529A1
• Filed: 05/04/2009
• Published: 11/04/2010
• Est. Priority Date: 05/04/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Barosense, Inc. (Boston Scientific Corporation)
• Inventors: England, Justen, Swope, Brett, Crews, Samuel T.
• Granted Patent: US 8,961,539 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

Abstract

A system, device, device and method for implanting a food restrictor in a patient'"'"'s stomach, by coupling the restrictor to a plurality of tissue-plication anchors already placed in the stomach, are disclosed. The device includes an elongate shaft assembly for accessing the stomach transorally, and on which the restrictor can be carried, and a plurality of cable members mounted on the shaft assembly. The cable members are disposed on the shaft assembly along a distal section thereof, and releasably attached to the shaft assembly'"'"'s distal end. After a cable member engages a tissue-plication anchor, retracting the cable is operable to first release the member from a holder at the the distal end of the shaft assembly, then pull a portion of the anchor through an aperture in the restrictor. This process is repeated for each anchor in the stomach for attaching the restrictor to the stomach.

Claims

1. A device for engaging a plurality of spaced tissue targets within a hollow organ of a subject, comprising

an elongate shaft assembly having a proximal section terminating at a proximal end and a distal section terminating at a distal end, where the shaft assembly comprises

a cable holder carried at the shaft assembly'"'"'s distal end,

a plurality of cable members extending along the shaft assembly, each cable member including (i) a cable whose axial position can be manipulated from the proximal end of the assembly and (ii) a distal-end tool for engaging a selected tissue target within the hollow organ,

for each cable member, a release structure for releasably attaching that cable member to the distal-end holder, and

a steering mechanism by which the cable holder can be manipulated from the proximal end of the assembly, to place a selected cable member tool whose cable member is attached to the holder adjacent a selected target within the organ,

wherein, with a selected cable-member tool positioned adjacent a selected tissue target and its tool manipulated to engage that selected target, axial movement of the tissue-engaged cable with respect to the holder and/or release of the cable from the holder allows the holder and its remaining attached cable members to be repositioned to place the tool of another selected cable member in position for engaging another selected tissue target.

2. The device of claim 1, which further includes an endoscope extending along the shaft assembly and being independently movable with respect to the cable holder at the distal end of the shaft assembly.

3. The device of claim 1, wherein a proximal portion of each cable member is disposed within a shaft assembly casing extending along the proximal section of the shaft assembly, and an exposed distal portion is disposed outside the shaft assembly along the distal section thereof, which is substantially less than proximal portion.

4. The device of claim 3, wherein the portion of each cable member disposed within the shaft assembly casing is housed within a cable sheath.

5. The device of claim 4, wherein the exposed portion of each cable member disposed outside the shaft assembly casing is housed within an axially compressible sheath that allows that distal end of the cable to be retracted, shortening the length of the exposed portion of the cable member.

6. The device of claim 5, wherein the distal sheath of each cable member has axially extending slots, to enhance the axial compressibility of the sheath.

7. The device of claim 5, wherein the release structure for each cable member includes a distal-end fitting that is carried at the distal end of the cable-member sheath and that is releasably attached to the holder by friction fit, and the distal-end fixture is dimensioned to block the cable tool and attached tissue target, such that retracting the cable and engaged target against the fixture is effective, with further retraction, to release the cable member and engaged tissue from the holder.

8. The device of claim 1, wherein the holder includes, for each cable member, an axially extending slot and the release structure includes a passive capture member adapted to releasably hold the cable assembly within the slot, for axial movement therein, but deform when the tool and an engaged tissue target are pulled away from the slot, to release the cable member and engaged tool from the holder.

9. The device of claim 1, wherein the holder includes, for each cable member, an axially extending slot and the release structure includes an active capture member whose operation can be controlled between a capture position, in which the cable assembly is supported within the slot, for axial movement therein, and a release position in which the cable member and engaged tissue target are released from the holder.

10. The device of claim 1, wherein the cable in each cable member includes an inner wire that is axially shiftable within the cable, and the cable-assembly tool includes a pair of clamp arms carried at the distal end of the wire, such that movement of the wire within the cable in distal and proximal directions is effective to open and close the clamp arms, respectively.

11. The device of claim 1, for use in attaching a restrictor within a subject'"'"'s stomach to a plurality of tissue targets having anchors fastened to tissue plications within the stomach, where the restrictor includes a proximal opening and a plurality of apertures spaced about the proximal opening, each for engaging an anchor to attach the restrictor within the stomach, wherein the shaft assembly includes a distal-section restrictor mount for holding the restrictor releasably on the shaft assembly, with the cable members received through said apertures, and said cable-member tools are adapted to clamp the anchors, such that withdrawing a cable of a selected cable member, after clamping a selected anchor, is effective to release the cable member from its release structure in the distal-end holder, allowing the tool and engaged anchor to be retracted distally until a cap portion of the anchor is pulled through the associated aperture in the restrictor.

12. The device of claim 11, wherein the restrictor has a central distal opening, is adapted to be carried on the device with a distal portion of the shaft assembly inserted through the distal opening in the restrictor, and is forced into a collapsed condition when the cable members are attached to the distal-end holder.

14. The device of claim 1, wherein shaft assembly'"'"'s distal section is detachable from its proximal section.

13. The device of claim 13, which further includes a restrictor mount having a plurality of posts disposed about the shaft assembly at a position along the shaft assembly'"'"'s distal end section, for mounting the restrictor on the shaft assembly, with the posts received in apertures spaced about the restrictor'"'"'s distal opening, and wherein the restrictor can be disengaged from the device only when all of the cable members have been released from the holder.

15. A system for implanting in a patient'"'"'s stomach, adjacent the gastro-esophageal junction thereof, a restrictor of the type having a proximal opening for receiving food from the patient'"'"'s esophagus, and a plurality of apertures spaced about the opening, each for engaging an tissue-supported anchor, to attach the restrictor within the stomach, comprising

(A) an implantation device comprising an elongate shaft assembly having a proximal section terminating at a proximal end and a distal section terminating at a distal end, where the shaft assembly comprises

a cable holder carried at the shaft assembly'"'"'s distal end,

a plurality of cable members extending along the shaft assembly, each cable member including (i) a cable whose axial position can be manipulated from the proximal end of the assembly, and (ii) a distal-end tool for engaging a selected tissue supported-anchor within the stomach,

for each cable member, a release structure designed to releasably attach the associated cable on the holder,

a steering mechanism extending along the shaft assembly by which the cable holder can be manipulated from the proximal end of the assembly, to place a selected cable member tool adjacent a selected tissue-supported anchor the organ, and

a restrictor mount carried on the shaft assembly'"'"'s distal end section, for supporting the restrictor thereon,

wherein, with a selected cable-member tool positioned adjacent a selected tissue-supported anchor and its tool manipulated to engage that anchor, axial movement of the anchor-engaged cable with respect to the holder and/or release of the cable from the holder allows the holder and its remaining attached cable members to be moved to place the tool of another selected cable member in position for engaging another selected tissue-supported anchor, and

retracting the tool and engaged anchor is operable to successively (i) release the assembly tool and attached anchor from the holder, and (ii) pull a cap of the anchor through the restrictor aperture, to attach that anchor to the restrictor, and

(B) an overtube adapted for transoral placement in a patient, by which the device can be placed in the patient'"'"'s stomach.

16. The system of claim 15, wherein the restrictor mount in the device has a plurality of posts positioned about the shaft assembly, with the posts received in apertures spaced about the restrictor'"'"'s distal opening, and wherein the restrictor can be disengaged from the device only when all of the cable members have been released from the holder.

17. The system of claim 15, wherein the overtube is axially movable on the device shaft assembly between extended and retracted positions at which the overtube covers and exposes the restrictor mount and restrictor carried thereon, respectively.

18. A method for implanting in a patient'"'"'s stomach, adjacent the gastro-esophageal junction thereof, a restrictor of the type having a proximal opening for receiving food from the patient'"'"'s esophagus, and a plurality of apertures spaced about the opening, each for engaging an tissue-supported anchor to attach the restrictor within the stomach, comprising

(a) forming within the patient'"'"'s stomach, adjacent the gastro-esophageal junction, a plurality of tissue plications, each supporting an anchor that is in contact with opposite sides of the plication, and which provides a compressible cap for coupling to the restrictor;

(b) accessing the patient'"'"'s stomach with an endoscopic device comprising a shaft assembly having a distal-end holder that can be moved within the patient'"'"'s stomach to selected positions, and a plurality of cable members releasably attached to holder, for movement therewith, each cable member having a distal-end tool operable to engage an anchor cap, where the restrictor is carried on the distal section of the device with the plurality of cable members received through the plurality of restrictor apertures;

(c) manipulating the device to position the holder adjacent a selected plication anchor in the stomach;

(d) manipulating the tool of a selected cable member to engage the cap of the anchor at the selected plication anchor,

(e) repeating steps (c) and (d) until the tool of each a cable member has been attached to an associated anchor; and

(f) before or after repeating steps (c) and (d) for any selected anchor, pulling the selected cable member tool and engaged anchor cap in a proximal direction through the associated aperture in the restrictor; and

(g) before or after each step (f), releasing the engaged anchor caps from the associated cable-assembly tool, and withdrawing the device from the patient'"'"'s stomach.

19. The method of claim 18, wherein (f) includes retracting the cable member tool and engaged anchor cap to release the cable member from the distal-end holder.

20. The method of claim 18, wherein the restrictor has 4-6 apertures for attachment to 4-6 anchors, respectively, and steps (c), (d), and (f) are carried out a total of 4-6 times, respectively, until each plication anchor is attached to an associated restrictor aperture.

21. The method of claim 18, which further includes, at least prior to step (f) retracting an overtube on the device to expose the restrictor.