Pyloric anchors and methods for intestinal bypass sleeves

• US 9,622,897 B1
• Filed: 03/03/2016
• Issued: 04/18/2017
• Est. Priority Date: 03/03/2016
• Status: Active Grant

• Current Assignee: MetaModix, Inc.
• Original Assignee: MetaModix, Inc.
• Inventors: Ziebol, Mathew, Stangenes, Todd, Schwarz, Werner, Belhe, Kedar R., Anderson, Edward
• Primary Examiner(s): Deak, Leslie
• Assistant Examiner(s): WENG, KAI H
• Application Number:
  US15/060,418
• Time in Patent Office: 411 Days
• 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 5/0036 Intragastrical devices
• 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: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A gastrointestinal device for implanting within a patient'"'"'s gastrointestinal tract, the device having a central axis and a first expandable portion comprising a hollow tubular braided structure of wire and having a first cylinder extending parallel to the central axis, the first cylinder having a length and a first face; a neck portion extending from the first face of the first expandable portion parallel to the central axis, the neck portion having a first end, a second end, a wall extending between the first end and second end, and a diameter sized to fit within a pylorus; and a second expandable portion comprising a hollow tubular braided structure of wire and having a second cylinder extending parallel to the central axis, the second cylinder having a second face located at the proximal end of the second cylinder and oriented transverse to the central axis.

Claims

1. A gastrointestinal implant for use within a pylorus, a duodenal bulb, and a duodenum of a patient, the implant having an expanded configuration and a contracted configuration and comprising:

a proximal portion comprising a hollow tubular braided structure of wire shaped to form a cylinder having a proximal end, a distal end, and a proximal wall extending radially inward from the proximal portion distal end, wherein the proximal wall has an outer circumference and an inner circumference and is configured with a first bias such that the inner circumference is located closer to the proximal portion proximal end than the proximal portion outer circumference;

a neck portion comprising a cylinder having a proximal end and a distal end and extending distally from the inner circumference of the proximal portion, the neck portion having a length greater than a width of a pylorus;

a distal portion comprising a hollow tubular braided structure of wire shaped to form a cylinder extending distally from the neck portion and having a proximal end, a distal end, an outer wall extending between the proximal end and distal end, and a distal wall extending radially inward from the distal portion proximal end, wherein the distal wall has an outer circumference and an inner circumference and is configured with a second bias such that the inner circumference is located closer to the distal portion distal end than the distal portion outer circumference; and

a structural element including a plurality of rings attached to the hollow tubular braided structure, wherein each ring of the plurality of rings has at least a first section coupled to the distal portion distal wall and at least a second section coupled to the distal portion outer wall, and wherein each ring of the plurality of rings is oriented in a plane, and wherein the plane of each ring intersects the plane of each of the other rings between the first section of each ring and the second section of each ring, the structural element configured to resist circumferential compression along a portion of the outer wall.

2. The gastrointestinal implant of claim 1, wherein upon implantation within a patient'"'"'s pylorus the proximal wall first bias defines a gap between the proximal wall inner circumference and the patient'"'"'s pylorus.

3. The gastrointestinal implant of claim 1, wherein upon implantation within a patient'"'"'s pylorus the distal wall second bias defines a gap between the distal wall inner circumference and the patient'"'"'s pylorus.

4. The gastrointestinal implant of claim 1, wherein the structural element includes at least three rings, wherein each ring is attached along a circumference of the outer wall at a location about 120 degrees apart from each of the other rings.

5. The gastrointestinal implant of claim 4, wherein the structural element comprises a shape that consists of a round shape, a rectangular shape, a square shape or an elliptical shape.

6. The gastrointestinal implant of claim 1, wherein the proximal portion includes a drawstring.

7. The gastrointestinal implant of claim 1, wherein the proximal portion includes a structural element comprising a substantially circular main body and a plurality of loops extending from the main body in the proximal direction.

8. A gastrointestinal device for implanting within a pylorus, a duodenal bulb, and a duodenum of a patient'"'"'s gastrointestinal tract, the device having a central axis and comprising:

a first expandable portion comprising a hollow tubular braided structure of wire and having

a first cylinder extending parallel to the central axis, the first cylinder having a proximal end, a distal end, and a length; and

a first face located at the distal end of the first cylinder and oriented transverse to the central axis;

a neck portion extending from the first face of the first expandable portion parallel to the central axis, the neck portion having a first end, a second end, a wall extending between the first end and second end, and a diameter sized to fit within a pylorus; and

a second expandable portion comprising a hollow tubular braided structure of wire and having

a second cylinder extending parallel to the central axis, the second cylinder having a proximal end, a distal end, and a length;

a second face located at the proximal end of the second cylinder and oriented transverse to the central axis; and

a structural element coupled to the second face and the length of the second cylinder, the structural element including at least three rings, wherein each of the three rings is oriented in a plane and wherein the plane of each ring intersects the plane of each of the other two rings;

wherein the length of the second cylinder is greater than one centimeter.

9. The gastrointestinal device of claim 8, wherein the structural element comprises a plurality of circular rings arranged to provide structural support radially between the second face and the second cylinder.

10. The gastrointestinal device of claim 8, wherein the structural element is configured to deform independent of the hollow tubular braided structure in response to a compressive force.

11. The gastrointestinal device of claim 8, wherein the neck portion is configured to fit within the pylorus and has a through lumen that allows chyme to flow from a patient'"'"'s stomach to the duodenum.

12. The gastrointestinal device of claim 10, wherein the neck portion is compliant enough to allow opening and closure of the through lumen within the pylorus.

13. The gastrointestinal device of claim 8, wherein the neck portion is rigid enough to hold the pylorus open.

14. The gastrointestinal device of claim 8, wherein the second face is oriented transverse to the central axis at an angle less than 90 degrees.

15. The gastrointestinal device of claim 8, wherein the length of the second cylinder is sized to prevent rotation of the gastrointestinal device within the duodenal bulb.

16. The gastrointestinal device of claim 8, wherein the length of the second cylinder is from about 1.0 cm to about 10.0 cm.

17. The gastrointestinal device of claim 8, wherein the first face is oriented transverse to the central axis at an angle less than 90 degrees.

18. A gastrointestinal device for implanting within a pylorus, a duodenal bulb, and a duodenum of a patient'"'"'s gastrointestinal tract, the device comprising:

a first expandable portion comprising a hollow tubular braided structure of wire shaped to include a disk portion configured to be located on a stomach side of the pylorus, the first expandable portion including a first structural element configured to resist radial compression of the first expandable portion and having a ring that includes at least one node configured to bias the ring into a collapsed configuration upon application of a radial force on the first expandable portion;

a central cylinder portion having a first end, a second end, and a diameter that fits within the pylorus;

a second expandable portion comprising a hollow tubular braided structure of wire shaped to include a cylinder having a proximal end, and distal end, a length between the proximal end and distal end, and a disk portion to be located on an intestinal side of the pylorus, the second expandable portion including a second structural element configured to resist circumferential compression, wherein the second structural element includes a plurality of rings attached to the hollow tubular braided structure, each ring of the plurality of rings having at least a first section coupled to the disk portion of the second expandable portion and at least a second section coupled to the length of the second expandable portion, and wherein each ring of the plurality of rings is oriented in a plane, and wherein the plane of each ring of the plurality of rings intersects the plane of each of the other rings between the first section of each ring and the second section of each ring; and

an intestinal bypass sleeve comprising a sleeve portion, wherein the sleeve portion is configured to extend from the duodenal bulb into the duodenum.

19. The gastrointestinal device of claim 18, wherein the second structural element comprises a circular ring.

20. The gastrointestinal device of claim 18, wherein the second structural element comprises a plurality of substantially circular rings.

21. The gastrointestinal device of claim 18, further comprising a drawstring attached to the first expandable portion.

22. The gastrointestinal device of claim 18, further comprising a drawstring attached to the first expandable portion and configured to collapse the first expandable portion.