Intragastric implant devices

• US 9,173,734 B2
• Filed: 09/26/2012
• Issued: 11/03/2015
• Est. Priority Date: 09/29/2009
• Status: Expired due to Fees

• Current Assignee: Ibis Medical, Inc.
• Original Assignee: Ibis Medical, Inc.
• Inventors: Vargas, Jaime
• Primary Examiner(s): Wiest, Philip R
• Assistant Examiner(s): KLEIN, BENJAMIN JACOB
• Application Number:
  US13/627,627
• Publication Number:
  US 20130079603A1
• Time in Patent Office: 1,133 Days
• Field of Search: 604/8, 604/9, 606/191
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 2560/066 catheters therefor
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6884 Clamps or clips
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• 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: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

An intragastric anchor implant device with an elongate member having proximal and distal ends with atraumatic features disposed thereon is described herein. The atraumatic features inhibit damage to the tissues of the stomach and the gastrointestinal tract and help anchor the device. The elongate member may be substantially rigid to resist bending and engage a tissue of the stomach or gastrointestinal tract to prevent passage therethrough and may include one or more bends to conform to the shape of the tract. The anchor implant device may be coupled with a therapeutic device, such as an intestinal bypass sleeve with a sliding seal, such as an expandable structure, that secures the sleeve to direct a flow of food particles from the stomach therethrough, for use in treating various disorders, including obesity and diabetes. Methods of deploying the anchor implant devices are also disclosed.

Claims

1. A method for treating and/or diagnosing a patient, said method comprising:

providing an anchor having a proximal atraumatic feature at a proximal end and a distal atraumatic feature at or adjacent a distal end with an elongate element extending therebetween, wherein the anchor includes a first radially expandable structure between the proximal and distal end of the elongate element and proximal of the distal atraumatic feature;

positioning the anchor within the gastrointestinal tract such that the distal atraumatic feature is within or adjacent the duodenum;

deploying the anchor within a gastrointestinal tract of the patient, by expanding the first radially expandable structure; and

inhibiting advancement of the deployed anchor around a bend of the gastrointestinal tract by engaging a proximal portion of the anchor against a first surface area of a mucosa of the gastrointestinal tract and by engaging a distal portion of the anchor against a second surface area of a mucosa of the gastrointestinal tract distal of the first mucosal surface area, and by resisting bending of the elongate element extending between the proximal and distal ends such that the distal atraumatic feature is maintained within the duodenum; and

supporting an intestinal bypass sleeve of the implant with the anchor so that the sleeve extends along an intestine of the patient while a proximal opening of the intestinal bypass sleeve is maintained within the duodenum so that a flow including ingested matter enters a lumen of the sleeve from a stomach of the patient, the flow being in contact with a wall of the stomach of the patient.

2. The method of claim 1, the method further comprising:

directing the flow of ingested matter into the sleeve by radially supporting a proximal opening of the sleeve with the first radially expandable structure and circumferentially engaging a wall of the sleeve against an inner wall of the gastrointestinal tract with the radially expandable structure of the anchor.

3. The method of claim 2, wherein the first radially expandable structure comprises a slidable seal that is slidable within the gastrointestinal tract in or adjacent a duodenal bulb of the gastrointestinal tract.

4. The method of claim 2, wherein the distal atraumatic feature comprises a second radially expandable support structure.

5. The method of claim 2, wherein the distal atraumatic feature comprises the first radially expandable support structure.

6. The method of claim 3, wherein supporting the proximal opening of the sleeve comprises expanding the first expandable structure within the gastrointestinal tract within the duodenum in or adjacent the duodenal bulb.

7. The method of claim 6, wherein directing a flow through the sleeve further comprises:

urging the proximal opening of the sleeve toward a pyloric valve of the gastrointestinal tract by supporting the proximal opening of the sleeve with a circumferential seal biased in the proximal direction.

8. The method of claim 7, wherein urging the proximal opening of the sleeve toward the pyloric valve comprises supporting the proximal opening with a proximal portion of the first expandable member while a distal portion of the expandable member engages a distal portion of the duodenal bulb.

9. The method of claim 6, wherein anchoring the sleeve further comprises:

expanding a second radially expandable structure proximal of the first radially expandable structure so as to engage a tissue proximal of a pyloric valve of the gastrointestinal tract to inhibit distal movement of the anchor along the gastrointestinal tract of the patient.

10. The method of claim 2, wherein when the first expandable structure is expanded in a duodenal bulb of the gastrointestinal tract, the second expandable structure is positioned adjacent the first expandable structure proximal of a pyloric valve of the gastrointestinal tract.

11. The method of claim 2, wherein the first expandable support structure is disposed on the elongate element of the anchor between proximal and distal ends.

12. The method of claim 11, wherein the elongate element includes a flexible portion and/or a curved portion between proximal and distal ends.

13. The method of claim 1, wherein the anchor comprises one or more sensors attached thereto, the method further comprising:

sensing a property of the gastrointestinal tract with the one or more sensors.

14. The method of claim 13, wherein the anchor comprises two or more separable segments, the method further comprising:

de-anchoring the anchor by separating the at least two separable segments thereby allowing one or more of the separable segments to pass distally through the gastrointestinal tract.

15. The method of claim 14, wherein de-anchoring further comprises selectively timing the de-anchoring of the at least two separable segments through electrolytic erosion.

16. An implant for use in a gastrointestinal tract of a patient, said implant comprising:

an anchor having a proximal atraumatic feature at the proximal end, a distal atraumatic feature at the distal end, and an elongate element extending therebetween;

wherein the proximal and distal atraumatic features are configured to inhibit tissue trauma when urged against a surface area along a mucosa in the gastrointestinal tract of the patient, and wherein flexibility of the elongate element is limited so as to resist bending between the proximal and distal ends so as to inhibit advancement of the anchor around a bend of the gastrointestinal tract,

wherein the anchor include a first radially expandable structure between the proximal and distal ends and proximal of the distal atraumatic feature, the first radially expandable structure being dimensioned to sit within the duodenum within or adjacent a duodenal bulb of the gastrointestinal tract when expanded therein so as to maintain the distal atraumatic feature within the duodenum; and

an intestinal bypass sleeve supported with the anchor so that the sleeve extends along an intestine of the patient while a proximal opening of the intestinal bypass sleeve is maintained within the duodenum so that a flow including ingested matter enters a lumen of the sleeve from a stomach of the patient.

17. The implant of claim 16, wherein the first radially expandable structure is dimensioned to substantially fill a duodenal bulb of the gastrointestinal tract when expanded therein.

18. The implant of claim 16,

wherein the intestinal bypass sleeve is coupled to the first expandable structure so as to extend at least partially through the gastrointestinal tract.

19. The implant of claim 18, wherein the sleeve comprises a material substantially impenetrable to a flow including ingested matter when passed through the lumen, the flow of matter being in contact with a wall of a stomach of the patient.

20. The implant of claim 16, wherein the distal atraumatic feature comprises the first radially expandable structure and the anchor comprises a second radially expandable structure proximal of the first radially expandable structure, the second radially expandable structure dimensioned so as to engage a tissue proximal of a pyloric valve of the gastrointestinal tract when expanded so as to inhibit distal movement of the anchor along the gastrointestinal tract of the patient.

21. The implant of claim 16, wherein the elongate element comprises at least two bends so as to conform to a shape of the gastrointestinal tract.

22. The implant of claim 18, wherein the distal atraumatic feature comprises the first radially expandable structure.

23. The implant of claim 18, wherein the elongate element is substantially rigid and comprises one or more bends so as to further anchor and conform to a shape of the gastrointestinal tract.

24. The implant of claim 18, wherein the first radially expandable structure comprises a circumferential seal supporting a proximal opening of an intestinal bypass sleeve while maintained within the duodenum so as to allow a flow of ingested materials from a stomach of the patient to pass therethrough.

25. The implant of claim 24, wherein the circumferential seal is disposed on a proximal portion of the first radially expandable structure so as to position the proximal opening of the sleeve nearest a pyloric valve when the first expandable structure is expanded within the duodenal bulb.

26. The implant of claim 25, wherein the first expandable structure comprises space-filling struts extending along a distal portion of the first expandable structure so as to position the circumferential seal nearest the pyloric valve when expanded within the duodenal bulb.

27. The implant of claim 25, wherein the circumferential seal comprising a sinusoidal member of the expandable structure.

28. The implant of claim 25, wherein the circumferential seal comprises any of a ziz-zag member, a diamond shaped member, a multi-link structure, a plurality of flexible arms, or an expandable ring configuration suitable for supporting the proximal opening of the sleeve.

29. The implant of claim 24, wherein the circumferential seal comprises a sliding seal that circumferentially engages an outer wall of the sleeve against an inner wall of the duodenal bulb so as to maintain the seal while allowing slight movement of the first expandable structure along the gastrointestinal tract.

30. The implant of claim 24, wherein the first expandable structure comprises a proximal portion and a distal portion, wherein the proximal portion comprises the circumferential seal nearest a pyloric valve of the gastrointestinal tract when the first expandable structure is expanded within the duodenal bulb.

31. The implant of claim 24, wherein the circumferential seal is configured so as to urge the circumferential seal in the proximal direction when the first expandable structure is under radial compression.

32. The implant of claim 31, wherein the circumferential seal is supported with curved struts.

33. The implant of claim 32, wherein the curved struts are curved such than an apex of curvature points in a proximal direction such that radial compression of the expandable structure urges the circumferential seal in the proximal direction.

34. The implant of claim 24, wherein the distal atraumatic feature comprises a second expandable structure.

35. The implant of claim 34, wherein the first and second expandable structure are axially spaced apart by a distance sufficiently large enough to accommodate a pyloric valve of the gastrointestinal tract and sufficiently small enough that the first expandable structure engages a tissue adjacent the pyloric valve so as to inhibit distal movement of the implant while the expanded second expandable structure is disposed within the duodenal bulb.

36. The implant of claim 16, wherein the elongate element comprises a flexible portion so as to allow the anchor to accommodate a curvature of the gastrointestinal tract.

37. The implant of claim 16, wherein the elongate element comprises at least three elongate members attached in series in a shape corresponding to different portions of the gastrointestinal tract, wherein the at least three elongate members includes a first elongate member corresponding to an antrum and proximal duodenum of the gastrointestinal tract, a second elongate member attached thereto and corresponding to a descending portion of the duodenum and a third elongate member attached thereto and corresponding to a third portion of the duodenum.

38. The implant of claim 16, further comprising:

an intestinal bypass sleeve coupled to the first expandable anchor, wherein the sleeve extends at least partially through the gastrointestinal tract, the intestinal bypass sleeve having a lumen extending therethrough from a proximal opening to a distal opening.

39. The implant of claim 16, further comprising:

one or more sensors attached to the anchor, the one or more sensors configured to sense a property of the gastrointestinal tract when disposed therein.

40. The implant of claim 39, wherein the anchor comprises two or more separable segments, at least one of the separable segments sized so as to be passed through the gastrointestinal tract of the patient and wherein the two or more separable segments are coupled so as to be selectively de-coupled from outside a body of the patient.