Intragastric implant devices

• US 8,597,224 B2
• Filed: 03/28/2011
• Issued: 12/03/2013
• Est. Priority Date: 03/26/2010
• Status: Expired due to Fees

• Current Assignee: Ibis Medical, Inc.
• Original Assignee: Ibis Medical, Inc.
• Inventors: Vargas, Jaime
• Primary Examiner(s): Deak, Leslie
• Assistant Examiner(s): SASS, SARA A
• Application Number:
  US13/073,762
• Publication Number:
  US 20120004676A1
• Time in Patent Office: 981 Days
• Field of Search: 604/8, 604/909
• US Class Current: 604/8
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

An intragastric anchor implant device is provided with a substantially rigid member having proximal and distal ends and atraumatic tips or features disposed near the proximal and distal ends. The atraumatic features prevent damage to the tissues of the stomach and the gastrointestinal track and may help to anchor the device in the stomach, while the substantially rigid member resists bending so as to engage a tissue of the stomach or the gastrointestinal tract to prevent passage through the stomach. The anchor implant device is coupled with a therapeutic device, typically a sleeve, such as an intestinal bypass sleeve. Ideally, the device includes a sliding seal to direct a flow of food particles from the stomach through the sleeve, so as to be useful in treating a disorder, including obesity and diabetes. Methods of deploying the anchor implant devices are also disclosed.

Claims

1. A method for treating a patient having a metabolic related disorder, said method comprising:

deploying an implant within a gastrointestinal tract of the patient so that a proximal end of an anchor of the implant is disposed within a stomach of the patient while a distal end of the anchor is disposed distal of a pyloric valve of the gastrointestinal tract, the anchor having a proximal atraumatic feature at the proximal end and a distal atraumatic feature at a distal end with an elongate element extending therebetween, wherein the distal atraumatic feature comprises a distal portion that engages against a mucosal surface of the duodenum and remains entirely distal of the pyloric valve so as to maintain the distal end within the duodenum distal of the pyloric valve when the implant is deployed;

supporting a sleeve of the implant with the anchor so that the sleeve extends along an intestine of the patient, and so that a flow including ingested matter enters a lumen of the sleeve from the stomach, the flow being in contact with a wall of the stomach;

inhibiting advancement of the anchor around a bend of the intestine near the stomach by engaging a proximal portion of the anchor against a surface area of a mucosa of the stomach, by engaging the distal portion of the distal feature of the anchor against a mucosal surface area of the duodenum, and by resisting bending of the elongate element between the proximal and distal ends; and

advancing the flow along the intestine within the lumen of the sleeve, the ingested matter comprising ingested nutrients and particles of food.

2. The method of claim 1, wherein the flow further comprises stomach secretions.

3. The method of claim 1, wherein the proximal portion of the anchor comprises the proximal atraumatic feature.

4. The method of claim 1, wherein engagement of the surface areas with the proximal and distal portions of the anchor substantially limits the displacement of a longitudinal axis of the anchor so as to maintain a position of the anchor across the pyloric valve thereby preventing passage of the anchor through the gastrointestinal tract.

5. The method of claim 1, wherein the sleeve comprises an intestinal bypass sleeve having a lumen extending between a proximal opening and a distal opening, wherein the sleeve comprises a material substantially impenetrable to the flow of the ingested matter advancing therethrough when the ingested matter enters the sleeve from within the stomach and advances along the lumen of the sleeve so as to inhibit contact of the flow with an intestinal wall along the sleeve such that the disorder is mitigated, wherein the proximal opening is distal of the pyloric valve when the implant is fully deployed.

6. The method of claim 5, wherein the disorder comprises diabetes, and wherein the sleeve is substantially impenetrable to chyme advanced through the lumen of the sleeve so as to inhibit production of a hormone affecting the diabetes.

7. The method of claim 5, wherein deploying the implant is performed such that the elongate element of the anchor remains extended across the pyloric valve, the distal end of the anchor remains positioned entirely distal of the pyloric valve in the duodenum and the proximal end of the anchor remains positioned in the stomach while deployed, the gastrointestinal surface area comprising a lumenal area of the duodenum.

8. The method of claim 7, wherein the elongate element between the ends has a profile smaller than the sleeve, and further comprising radially supporting an inside surface of the sleeve with the distal feature of the anchor, wherein the distal feature extends laterally from the elongate element of the anchor to the sleeve so that a majority of the flow advances around the elongate element and through the pyloric valve, and enters the proximal opening and advances within the sleeve.

9. The method of claim 8, wherein the distal feature comprises a radial array of projections extending radially from the elongate element toward the inside surface of the sleeve when deployed, and wherein the projections compliantly deflect within the gastrointestinal tract so as to engage the surrounding surface area of the duodenum and spread anchoring loads across the area of the duodenum.

10. The method of claim 9, wherein the anchoring loads are forces exerted on the anchor by a tissue of the stomach or gastrointestinal tract substantially imparted by gastric motility.

11. The method of claim 8, wherein the distal feature comprises a plurality of flexible struts in a radial array, and wherein the struts compliantly deflect within the gastrointestinal tract while urging the inside surface of the sleeve radially outwardly toward the surrounding duodenum.

12. The method of claim 5, wherein deploying the implant is performed such that a distal end of the anchor is positioned entirely within the proximal portion of the duodenum distal of the pyloric valve and the proximal end of the anchor is positioned in the stomach while deployed.

13. The method of claim 12, further comprising:

expanding the distal atraumatic feature within the duodenum distal of the pyloric valve so as to increase a profile of the distal feature so as to prevent passage of the distal feature across the pyloric valve.

14. The method of claim 5, wherein supporting the sleeve comprises axially restraining the sleeve with a flexible connector extending distally from the anchor toward the sleeve, and radially supporting the proximal opening of the sleeve with a compliant coupling support extending laterally from the flexible connector, and wherein deploying the implant comprises positioning the sleeve so that the proximal opening is located in the duodenum.

15. The method of claim 5, wherein the implant includes a sliding seal circumscribing the proximal opening of the sleeve, and wherein positioning the sleeve comprises positioning the sliding seal in a proximal portion of the duodenum of the patient to sealingly engage an inner wall of the duodenum, wherein the anchor supports the sliding seal such that, when deployed, the anchor maintains the sliding seal within the proximal portion of the duodenum so as to direct the flow from the stomach through the proximal opening into the lumen of the sleeve.

16. The method of claim 5, wherein the implant includes a sliding seal circumscribing the proximal opening of the sleeve, and wherein positioning the proximal opening comprises positioning the sliding seal in the antrum of the stomach to sealingly engage an inner wall of the antrum, wherein the anchor supports the sliding seal such that, when deployed, the anchor maintains the sliding seal at the antrum of the stomach so as to direct a fluid or solid flowing from the stomach through the proximal opening into the lumen of the implant.

17. The method of claim 1, further comprising radially constraining at least one of the proximal feature or the distal feature in a small profile configuration and releasing the at least one feature to expand elastically radially outwardly into a large profile configuration for use of the implant within the gastrointestinal tract.

18. An implant for treating a patient having a metabolic related disorder, said implant comprising:

an anchor having an elongate element extending between a proximal end and a distal end, a proximal atraumatic feature disposed near the proximal end, and a distal atraumatic feature disposed near the distal end;

the proximal atraumatic feature configured to inhibit tissue trauma when urged against a surface area along a mucosa of a stomach of the patient, the distal atraumatic feature configured to inhibit tissue trauma when urged against a surface of a duodenum of a gastrointestinal tract of the patient, wherein the distal atraumatic feature comprises a plurality of flexible struts arranged in a radial array and is adapted to engage a surrounding mucosal surface within the duodenum so as to maintain the distal end of the anchor entirely distal of the pyloric valve while the proximal end remains disposed within the stomach when the implant is deployed, and the elongate element being substantially rigid so as to resist bending between the proximal and distal ends and sufficiently long so that the anchor is configured to inhibit advancement of the anchor around a bend of the intestine near the stomach when under the anchoring loads; and

an intestinal bypass sleeve having a lumen extending between a proximal opening and a distal opening, 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 the stomach, the proximal opening supported distally of the proximal end of the anchor and remaining distal of the proximal end of the anchor when deployed so that the flow flows from within the stomach into the lumen.

19. The implant of claim 18, wherein the flow comprises chyme including stomach secretions, ingested nutrients and food particles, wherein the disorder comprises diabetes, and wherein the sleeve is further substantially impenetrable to the flow and is configured so as to inhibit production of a hormone affecting diabetes within the intestine.

20. The implant of claim 18, wherein the distal feature is sized and configured to be advanced through a pyloric valve of the patient such that, when implanted, the distal end of the anchor remains within the duodenum entirely distal of the pyloric valve and the proximal end of the anchor remains within the stomach, the distal surface area comprising a lumenal area of the duodenum.

21. The implant of claim 20, wherein the elongate element between the ends has a profile smaller than the sleeve, the distal feature of the anchor radially supporting an inside surface of the sleeve, wherein the distal feature extends laterally from the elongate element of the anchor to the sleeve so that a majority of the ingested matter that advances around the elongate element and through the pyloric valve enters the proximal opening and advances within the sleeve.

22. The implant of claim 21, wherein the distal feature comprises a radial array of projections extending radially between the elongate element and the inside surface near the proximal opening, and wherein the projections compliantly deflect under the anchoring loads so as to distribute the anchoring loads across the area of the duodenum.

23. The implant of claim 21, wherein the plurality of flexible struts extend from the elongate element toward the inside surface of the sleeve, wherein the struts compliantly deflect under the anchoring loads so as to urge the inside surface of the sleeve radially outwardly toward the surrounding duodenum.

24. The implant of claim 18, wherein the distal feature is constrainable in a small profile configuration suitable for advancement of the implant through the esophagus and expands elastically radially outwardly into a large profile configuration when released within the gastrointestinal tract.

25. The implant of claim 24, wherein the distal feature in the large profile configuration is sufficiently large to distribute the anchoring loads when the anchoring loads are imparted by gastric motility on the implant, and wherein the elongate element between the ends has a profile smaller than the distal feature.

26. The implant of claim 24, wherein the distal feature comprises a looped structure, and wherein in the expanded configuration, the looped structure has a profile sufficiently larger than the pyloric valve to prevent proximal passage of the anchor across the pyloric valve when deployed thereacross and to distribute anchoring loads.

27. The implant of claim 26, wherein the loop structure is operatively attached to a drawstring such that movement of the drawstring expands the loop structure from the collapsed configuration to the expanded configuration.

28. The implant of claim 18, wherein the distal atraumatic feature has a profile sufficiently large to substantially fill the duodenal bulb and prevent passage of the distal feature across a pyloric valve of the patient after deployment of the anchor within the gastrointestinal tract.

29. The implant of claim 28, wherein the distal atraumatic feature has a profile of approximately 25 mm in diameter.

30. The implant of claim 24, wherein the distal feature comprises an expandable sinusoidal-type structure.

31. The implant of claim 30, wherein the expandable sinusoidal-type structure circumscribes the proximal opening of the sleeve so as to support the proximal opening and to direct the ingested matter from the stomach through the central passage into the lumen.

32. The implant of claim 18, wherein the elongate element is of sufficient length to prevent end-to-end rotation of the member within the stomach.

33. The implant of claim 18, wherein the length of the elongate element is at least about 10 cm.

34. The implant of claim 18, wherein the elongate element comprises a portion that is substantially rigid and substantially straight when deployed as the anchor in the gastrointestinal tract.

35. The implant of claim 18, wherein the elongate element is substantially rigid and is curved when deployed as the anchor in the gastrointestinal tract.

36. The implant of claim 18, wherein the sleeve comprises a braided material embedded in an elastomer so as to provide radial compliance and resistance to twisting.

37. The implant of claim 18, wherein the sleeve has a length within a range of about 40 cm to about 80 cm.

38. The implant of claim 18, further comprising a flexible connector coupling the distal feature of the anchor with the sleeve so as to accommodate lateral movement therebetween.

39. The implant of claim 38, wherein the flexible connector extends distally from the anchor toward the sleeve, and further comprising a compliant coupling support extending laterally from the flexible connector radially outwardly to compliantly support the proximal opening of the sleeve when the proximal opening is located in the duodenum.

40. The implant of claim 38, wherein the flexible connector comprises a tether.

41. The implant of claim 18, wherein the proximal opening of the sleeve is fixedly attached to the distal feature of the anchor such that ingested matter passes from the stomach across the pyloric valve and through the proximal opening of the sleeve.

42. The implant of claim 18, further comprising a sliding seal coupled to the proximal opening of the sleeve.

43. The anchor implant of claim 42, wherein the sliding seal is adapted to slidably and circumferentially engage an inner wall of the duodenum of the gastrointestinal tract while the elongate element extends through the pyloric valve when the anchor is deployed.

44. The anchor implant of claim 43, wherein the sliding seal is coupled to the intestinal bypass sleeve near the proximal end of the sleeve.

45. The anchor implant of claim 44, wherein the sliding seal is expandable into an expanded configuration from a collapsed configuration, wherein in the expanded configuration, the sliding seal has a diameter at least greater than that of the proximal opening of the sleeve, and wherein in the collapsed configuration, the sliding seal has a diameter at least less than that of a delivery tube through which the sliding seal is delivered through the stomach.

46. The anchor implant of claim 42, wherein the sliding seal comprises any of an inflatable portion, a flared portion, and a stent portion adapted for slidably engaging an inner wall of the duodenum of the gastrointestinal tract of the patient.

47. The implant of claim 42, wherein the sliding seal comprises a compliant cylinder or ring having an outward expansive strength so as to exert an outward force towards an inner wall of the duodenum of the gastrointestinal tract or the stomach of the patient so as to maintain a sufficient seal against the inner wall so as to direct a majority of the flow of ingested matter through the lumen.

48. The implant of claim 38, wherein the sliding seal comprises a diameter greater than a diameter of the sleeve, and wherein the sliding seal circumscribes the proximal opening of the sleeve so as to seal the sleeve within the duodenum of the gastrointestinal tract of the patient.

49. The implant of claim 44, wherein the intestinal bypass sleeve extends through the pyloric valve when the sliding seal is slidably and sealingly engaged with an inner wall of a proximal portion of the duodenum.

52. The anchor implant of claim 42, wherein the sliding seal is adapted to slidably and circumferentially engage an inner wall of the gastrointestinal tract while the elongate element extends through the pyloric valve when the anchor is deployed, wherein the sliding seal is supported by the anchor so as to remain proximal of the distal feature.

53. The anchor implant of claim 42, wherein the sliding seal is adapted to slidably and circumferentially engage an inner wall of the duodenum while the elongate element extends through the pyloric valve when the anchor is deployed, wherein the sliding seal is supported by the anchor so as to remain distal of the distal feature.

54. The anchor implant of claim 42, wherein the sliding seal is adapted to slidably and circumferentially engage an inner wall of the duodenum while the elongate element extends through the pyloric valve when the anchor is deployed, wherein the sliding seal is supported circumferentially by the distal feature near the proximal opening so as to remain co-located with the distal feature within the duodenum.

50. An implant for treating a patient having a metabolic related disorder, said implant comprising:

an anchor having an elongate element extending between a proximal end and a distal end, a proximal atraumatic feature disposed near the proximal end, and a distal atraumatic feature disposed near the distal end;

the proximal atraumatic feature configured to inhibit tissue trauma when urged against a surface area along a mucosa of a stomach of the patient, the distal atraumatic feature configured to inhibit tissue trauma when urged against a mucosal surface of a duodenum of a gastrointestinal tract of the patient, and the elongate element being substantially rigid so as to resist bending between the proximal and distal ends and sufficiently long so that the anchor is configured to inhibit advancement of the anchor around a bend of the intestine near the stomach when under the anchoring loads, wherein the distal atraumatic feature comprises a plurality of flexible struts arranged in a radial array and is adapted to reside within the duodenum by engagement with the mucosal surface area of the duodenum so as to maintain the distal end of the anchor entirely distal of the pyloric valve while the proximal atraumatic feature remains disposed within the stomach when the implant is deployed; and

a therapeutic device supported by the anchor within the gastrointestinal tract such that the therapeutic device resides in the gastrointestinal tract distal of the pyloric valve.

51. The implant of claim 50, wherein the therapeutic device has a proximal end and a distal end, and wherein the proximal end of the therapeutic implant is supported by the anchor so as to remain downstream of the pyloric valve of the gastrointestinal tract of the patient after deployment.