Articulated gastric implant clip

• US 8,920,447 B2
• Filed: 10/12/2011
• Issued: 12/30/2014
• Est. Priority Date: 10/19/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Inventors: Dominguez, Zachary
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US13/272,083
• Publication Number:
  US 20120095484A1
• Time in Patent Office: 1,175 Days
• Field of Search: 606/151, 606/157, 606/153, 606/120, 606/136, 606/142, 606/154, 606/158, 606/201, 606/213, 606/214, 606/215, 600/37, 623/23.65, 244/95, 245/17, 245/21, D28/10, D28 39- 43, 604/250
• US Class Current: 606/157
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0033 with more than one chamber
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0073 in the abdominal cavity, e.g. not attached to the stomach
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: Y10T 24/44342 having rigid linking arm pivotally connected to each gripping member
• CPC Class Codes: Y10T 24/4453 with position locking-means for gripping members
• CPC Class Codes: Y10T 24/44564 having specific surface material or irregularity on or along engaging face

Abstract

Intragastric implant devices for obesity treatment are disclosed. The device is passive and does not autonomously change shape, but instead reacts to movement of the stomach to induce satiety. The device includes a series of connected, articulated clips that plicate the stomach wall nondestructively (no puncturing through the gastric wall) such that the overall volume of the stomach is reduced. Cam-shaped clamping surfaces prevent slippage of the stomach tissue from within the clips. Methods of implant are disclosed including delivering the device through a transoral delivery tube and advancing the device through the esophagus to be deployed within the stomach. Removal of the device occurs in the reverse.

Claims

1. An intragastric obesity treatment implant, comprising:

a gastric clip comprising a plurality of solid articulated links including two equal rows of links joined by a hinge link, wherein latching members are provided on the links on the free ends of the gastric clip opposite the hinge link so as to form two parallel rows joined at both ends by, respectively, the hinge link and the latching members, the two parallel rows being parallel to a longitudinal axis, each articulated link being pivotally connected to an adjacent link so as to prevent relative rotation from linear alignment in a direction away from the longitudinal axis, but permit relative rotation from linear alignment in a direction toward the longitudinal axis, each link further including a cam rotatably mounted therein, each cam rotating about a longitudinal axis relative to the row of links in which the cam is mounted, and opposed cams being configured to non-destructively clamp tissue therebetween,

the implant being capable of being unfolded open about the hinge link into a substantially linear delivery configuration and being formed of a material that will resist degradation over a period of at least six months within the stomach.

2. The implant of claim 1, wherein each of the cams has a substantially D-shaped cross-section with a flat side facing the opposite row of links.

3. The implant of claim 2, wherein the flat side of each cam has a track-like texture.

4. The implant of claim 1, wherein each cam is made of an elastomeric material that is softer than the material of the remainder of the corresponding articulated link.

5. The implant of claim 1, wherein the parallel rows of links are arranged such that when the latching members are engaged opposed cam members are spaced apart a distance between about 4 and 10 mm.

6. The implant of claim 1, wherein each of the cams is mounted for rotation within a housing, and each of the housings is pivotally connected to either an adjacent housing or the hinge link, and wherein the substantially linear delivery configuration defines a longitudinal direction along the series of articulated links with the axes of rotation of the cams being parallel to the longitudinal direction.

7. The implant of claim 1, wherein each of the cams is mounted for rotation within a housing, and each of the housings is pivotally connected to either an adjacent housing or the hinge link, and wherein each housing includes a protrusion or recess on an outer side that nests within a corresponding protrusion or recess within an outer side of an adjacent housing, and wherein the adjacent housings pivot about hinge pins connecting the corresponding protrusions and recesses.

8. The implant of claim 1, wherein each of the cams is mounted for rotation within a housing such that the cams face inward and the housings face outward, and wherein the housings have smooth convex exteriors.

9. An intragastric obesity treatment implant, comprising:

a gastric clip comprising a plurality of solid articulated links including two equal rows of links joined by a hinge link, wherein latching members are provided on the articulated links on the free ends of the gastric clip opposite the hinge link so as to form two parallel rows joined at both ends by, respectively, the hinge link and the latching members, each link further including a cam rotatably mounted therein about longitudinal axes aligned with the rows of links, each of the cams has a substantially D-shaped cross-section with a flat side facing the opposite row of links, and opposed cams being configured to non-destructively clamp tissue therebetween,

the implant being capable of being unfolded open about the hinge link into a substantially linear delivery configuration and being formed of a material that will resist degradation over a period of at least six months within the stomach.

10. The implant of claim 9, wherein the flat side of each cam has a track-like texture.

11. The implant of claim 9, wherein the parallel rows of links are arranged such that when the latching members are engaged opposed cam members are spaced apart a distance between about 4 and 10 mm.

12. The implant of claim 9, wherein each of the cams is mounted for rotation within a housing, and each of the housings is pivotally connected to either an adjacent housing or the hinge link, and wherein the substantially linear delivery configuration defines a longitudinal direction along the series of articulated links with the axes of rotation of the cams being parallel to the longitudinal direction.

13. The implant of claim 9, wherein each of the cams is mounted for rotation within a housing, and each of the housings is pivotally connected to either an adjacent housing or the hinge link, and wherein each housing includes a protrusion or recess on an outer side that nests within a corresponding protrusion or recess within an outer side of an adjacent housing, and wherein the adjacent housings pivot about hinge pins connecting the corresponding protrusions and recesses.

14. The implant of claim 9, wherein each of the cams is mounted for rotation within a housing such that the cams face inward and the housings face outward, and wherein the housings have smooth convex exteriors.

15. The implant of claim 9, wherein each cam is made of an elastomeric material that is softer than the material of the remainder of the corresponding articulated link.

16. A method of plicating an inner stomach wall, comprising:

providing a gastric clip including a plurality of articulated links hingedly connected and forming two rows of the same number of links joined by a hinge link, the gastric clip further including latching members on the free ends of the two rows of links opposite the hinge link so as to form two parallel rows joined at both ends by, respectively, the hinge link and the latching members, the two parallel rows being parallel to a longitudinal axis, each articulated link being pivotally connected to an adjacent link so as to prevent relative rotation from linear alignment in a direction away from the longitudinal axis, but permit relative rotation from linear alignment in a direction toward the longitudinal axis, each link further including a cam rotatably mounted therein, each cam rotating about a longitudinal axis relative to the row of links in which the cam is mounted, and opposed cams being configured to non-destructively clamp tissue therebetween;

unfolding the gastric clip about the hinge link into a substantially linear delivery configuration;

delivering the unfolded gastric clip transorally through a delivery tube into a patient'"'"'s stomach;

expelling the gastric clip from the delivery tube;

folding the gastric clip about the hinge link and encompassing a portion of the inner stomach wall between the two rows of links; and

engaging the latching members to plicate the portion of the inner stomach wall between the two parallel rows of links, the rotatably mounted cams permitting some relatively movement of stomach tissue between the two parallel rows of links.

17. The method of claim 16, wherein each articulated link in the two parallel rows of links is pivotally connected to an adjacent link so as to permit rotation in only one direction relative to the adjacent link and create two parallel jaws that won'"'"'t bow apart.

18. The method of claim 16, wherein each of the cams has a substantially D-shaped cross-section with a flat side facing the opposite row of links.

19. The method of claim 16, wherein each of the cams is mounted for rotation within a housing such that the cams face inward and the housings face outward, and wherein the housings have smooth convex exteriors.

20. The method of claim 19, wherein each cam is made of an elastomeric material that is softer than the material of the remainder of the corresponding articulated link.

21. An intragastric device for treatment of obesity, comprising:

a clip comprising a plurality of articulated links including a plurality of rows of links joined by a hinge link, wherein latching members are provided on the links on the free ends of the clip opposite the hinge link so as to form a plurality of rows joined at both ends by, respectively, the hinge link and the latching members, the rows spaced from each other and a longitudinal axis therebetween, each articulated link being connected to an adjacent link so as to prevent relative rotation from linear alignment away from the longitudinal axis, but permit relative rotation from linear alignment toward the longitudinal axis, each link further including a cam rotatably mounted therein, the implant being capable of being unfolded open about the hinge link into a substantially linear configuration.