Intragastric implant devices

• US 8,821,429 B2
• Filed: 09/29/2009
• Issued: 09/02/2014
• Est. Priority Date: 03/29/2007
• Status: Expired due to Fees

• Current Assignee: Ibis Medical, Inc.
• Original Assignee: Ibis Medical, Inc.
• Inventors: Vargas, Jaime
• Primary Examiner(s): MARCETICH, ADAM M
• Application Number:
  US12/568,899
• Publication Number:
  US 20100049224A1
• Time in Patent Office: 1,799 Days
• Field of Search: 604/8, 604/9, 604/264, 604/265, 604/270, 604/93.01, 604/104, 604/105, 604/106, 604/107, 604/108, 604/109, 623/11.11, 623/23.64, 623/23.65, 623/23.67, 623/23.68, 623/23.7, 623/9, 606/108
• US Class Current: 604/8
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• 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 5/0036 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: A61M 2210/1042 Alimentary tract A61M2210/0618 takes precedence
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 2210/1057 Duodenum
• CPC Class Codes: A61M 2210/106 Small intestine
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

An intragastric implant comprises an anchor and a therapeutic device or a diagnostic device. The anchor is adapted to extend between the fundus and the pyloric valve of a stomach, to be retained without attachment to the stomach wall, and to anchor the device within the stomach with a relatively stable position and orientation. The therapeutic or diagnostic device is adapted to extend from the esophagus or stomach to the intestines or stomach. The therapeutic or diagnostic device, when extending into the esophagus, will be slidably received through the gastroesophageal junction and, when extending into the intestines, will be slidably received in the pyloric valve.

Claims

1. An intragastric implant for use in a patient, the patient having an esophagus leading to a stomach, the stomach in communication with intestines through a pyloric valve, the intestines adjacent the pyloric valve including a duodenum with a duodenal bulb and bends, the intragastric implant comprising:

an intragastric anchor adapted to extend from the fundus toward the pyloric valve in the patient when deployed within the patient'"'"'s gastrointestinal tract, the anchor comprising a rigid or semi-rigid elongate element having a width dimension and a length dimension, the width dimension being less than the length dimension, the elongate element being dimensioned sufficiently small to pass through the esophagus into the stomach and the length dimension being sufficiently long such that the length dimension inhibits passage of the anchor beyond the bends of the duodenum so that the anchor provides non-penetrating anchoring within the gastrointestinal tract; and

an intestinal bypass sleeve coupled to the anchor, the intestinal bypass sleeve having a central passage extending from a proximal opening to a distal outlet, the distal outlet configured to be positioned in the intestines while the intragastric anchor maintains the proximal opening adjacent the stomach so that food passes through the intestinal bypass sleeve.

2. An intragastric implant as in claim 1, wherein the intragastric anchor and intestinal bypass sleeve are configured to be free from attachment to the gastric wall so that the proximal opening of the sleeve sealingly and slidably engages surrounding tissue when the intragastric anchor is disposed within the gastrointestinal tract.

3. An intragastric implant as in claim 1, wherein the intragastric anchor comprises opposing atraumatic ends including an upper atraumatic end and a lower atraumatic end when deployed within the patient'"'"'s gastrointestinal tract, the rigid or semi-rigid elongate element extending along a longitudinal axis between the upper and lower atraumatic ends.

4. The intragastric implant of claim 3, wherein a diameter of one or both of the upper and lower traumatic ends is greater than a middle portion of the intragastric anchor extending therebetween.

5. An intragastric implant as in claim 3, wherein at least one of the atraumatic ends has an expandable structure that is wider than the rigid or semi-rigid elongate element when expanded so as to distribute forces exerted by longitudinal movement of the anchor.

6. An intragastric implant as in claim 1, wherein the elongate element of the anchor is rigid.

7. An intragastric implant as in claim 6, wherein the intragastric anchor is straight.

8. An intragastric implant as in claim 6, wherein the intragastric anchor is bent or curved.

9. An intragastric implant as in claim 1, wherein the intestinal bypass sleeve has a sliding seal at its proximal end supportably attached to the elongate element, wherein the sliding seal comprises a reduced friction interface adapted to slidably engage an inner wall of the gastrointestinal tract.

10. An intragastric implant as in claim 9, wherein the sliding seal is inflatable, flared, or stented.

11. An intragastric implant as in claim 9, wherein the intestinal bypass sleeve slidably extends through the pyloric valve.

12. The intragastric implant of claim 1, wherein the elongate element is dimensioned to facilitate passage through the esophagus into the stomach when rigid or semi-rigid.

13. The intragastric implant of claim 1, wherein the length dimension is sufficient to inhibit passage of the entire intragastric anchor beyond the duodenal bulb when the intragastric anchor passes through the pyloric valve.

14. The intragastric implant of claim 1, wherein the intragastric anchor is configured such that the anchor provides anchoring within the gastro-intestinal tract without penetration of or fixed attachment to tissues of the gastrointestinal tract.

15. An intragastric implant for use in a patient, the patient having an esophagus leading to a stomach, the stomach in communication with intestines through a pyloric valve, the intestines adjacent the pyloric valve including a duodenum with a duodenal bulb and bends, the intragastric implant comprising:

an intragastric anchor comprising a rigid or semi-rigid elongate element having a width dimension less than a length dimension, wherein the elongate element is dimensioned sufficiently small to pass through the esophagus into the stomach and the length dimension is sufficiently long such that the length dimension inhibits passage of the anchor beyond the bends of the duodenum so as to provide non-penetrating anchoring within the gastrointestinal tract when deployed therein without attachment to a luminal wall of the gastrointestinal tract; and

a compliant cylindrical member with a distal end configured to be positioned adjacent the stomach or intestines and a proximal end configured to be positioned adjacent the stomach or esophagus.

16. An intragastric implant as in claim 15, wherein the compliant cylindrical member is a hollow tube.

17. An intragastric implant as in claim 16, wherein the hollow tube comprises a proximal opening supported by the anchor and a smooth flexible sealing surface adapted to provide a slidable seal when apposed with a mucosal wall of the gastrointestinal tract.

18. An intragastric implant as in claim 17, wherein the hollow tube comprises a gastric inflow regulator, an intestinal bypass sleeve or gastric outflow regulator and the mucosal wall comprises the esophagus, pylorus or duodenum.

19. An intragastric implant as in claim 17, wherein the slidable seal comprises a radiused or outwardly curved edge of the proximal opening to allow proximal and distal sliding when apposed against the mucosal wall.

20. An intragastric implant as in claim 17, wherein the slidable seal of the proximal opening comprises a tapered edge that tapers radially outward to allow proximal and distal sliding when apposed against the mucosal wall.

21. An intragastric implant as in claim 17, wherein the slidable seal is supported within by an expandable scaffold so as to exert an outward radial force against the mucosal wall with the smooth surface when expanded.

22. An intragastric implant as in claim 17, wherein the smooth surface comprises a hydrophilic coating to facilitate sliding against the mucosal wall.

23. An intragastric implant as in claim 17, wherein the hollow tube has an uncompressed diameter of approximately 15 mm to 35 mm to facilitate sealing by maintaining apposition between the mucosal wall and the smooth surface of the hollow tube adjacent the pylorus.

24. An intragastric implant as in claim 23, wherein the hollow tube is sized to fill an open pyloric valve.

25. An intragastric implant as in claim 16, wherein the elongate element has a length dimension sufficiently small to allow passage through the esophagus and into the stomach and sufficiently long to inhibit passage of the element beyond the duodenal bulb or through the tight bends of the relatively fixed duodenum.

26. An intragastric implant as in claim 25, wherein the length of the elongate element is between about 5 cm and about 20 cm.

27. An intragastric implant as in claim 25, wherein the length of the elongate element is about 10 cm.

28. An intragastric implant as in claim 16, the hollow tube comprises a bypass sleeve extending distally from the pylorus within the intestines.

29. An intragastric implant as in claim 28, wherein the hollow tube comprises a jejunal bypass sleeve extending from the pylorus into the jejunum.

30. An intragastric implant as in claim 16, wherein the hollow tube has proximal and distal open ends.

31. An intragastric implant as in claim 16, wherein the hollow tube is sealed closed on the proximal end so as to prevent passage of stomach contents therethrough.

32. An intragastric implant as in claim 16, wherein the hollow tube comprises a tubular braid coated with elastomer.

33. An intragastric implant as in claim 15, wherein the compliant cylindrical member is solid.

34. An intragastric implant as in claim 33, wherein the compliant cylindrical member is sized to fill an open pyloric valve.

35. An intragastric implant as in claim 15, wherein the anchor comprises a rigid element.

36. A method for treating a metabolic disorder, said method comprising:

providing an intragastric anchor coupled with an intestinal bypass sleeve, the anchor comprising an elongate element that is rigid or semi-rigid and the intestinal bypass sleeve extending from a proximal opening to a distal outlet, the proximal opening being supported by the anchor;

inserting the intragastric anchor having the rigid or semi-rigid elongate element into a stomach of a patient through an esophagus leading to the stomach, the rigid or semi-rigid elongate element being sufficiently small to facilitate passage through the esophagus into the stomach;

positioning the anchor in the stomach of the patient, the stomach being in communication with intestines through a pyloric valve, the intestines adjacent the pyloric valve including a duodenum with a duodenal bulb and bends, wherein the anchor is positioned so that the elongate element extends from the pyloric valve toward the fundus, the elongate element having a width dimension and a length dimension, the width dimension being less than the length dimension, wherein the width dimension is sufficiently small enough to pass through the esophagus into the stomach and the length dimension is sufficiently long such that the length dimension inhibits passage of the anchor beyond the bends of the duodenum so that the positioned anchor provides non-penetrating anchoring within the gastrointestinal tract without attachment to the gastrointestinal tract; and

positioning a distal portion of the intestinal bypass sleeve within the duodenum so that at least a portion of the intestinal bypass sleeve extends distally from the pylorus through the duodenum.

37. A method for treating a metabolic disorder, said method comprising:

providing an intragastric anchor coupled with a hollow tube, the anchor comprising an elongate element that is rigid or semi-rigid and the hollow tube extending from a proximal opening to a distal outlet;

introducing a catheter with an internal guidewire into the stomach via the esophagus and advancing a distal atraumatic tip of the catheter through the stomach and into the duodenum;

advancing the intragastric anchor having the rigid or semi-rigid elongate element into the stomach through the esophagus within the catheter, the elongate element being rigid or semi-rigid and dimensioned sufficiently small to facilitate passage through the esophagus into the stomach;

positioning the anchor in the gastrointestinal tract of a patient so that the elongate element extends from the pyloric valve toward the fundus, wherein the elongate element has a width dimension less than a length dimension, the length dimension being sufficiently long such that the length dimension inhibits passage of the anchor beyond the bends of the duodenum providing anchoring within the gastrointestinal tract without attachment to the stomach wall; and

deploying the hollow tube through the duodenum so that a proximal opening of the hollow tube is supported by the intragastric anchor and the distal opening is disposed within the intestines.

38. The method of claim 37, further comprising:

limiting absorption of food with the hollow tube by slidably sealing a smooth outer surface of the hollow tube against a mucosal wall adjacent the pylorus.

39. The method of claim 38, wherein deploying the hollow tube comprises using an intestinal bypass sleeve or gastric outflow restrictor.

40. The method of claim 38, wherein the proximal opening of the hollow tube is supported by the anchor and comprises a smooth flexible sealing surface that provides a slidable seal when apposed with a mucosal wall of the gastrointestinal tract.

41. The method of claim 40, wherein the hollow tube comprises a gastric inflow regulator, an intestinal bypass sleeve or gastric outflow regulator and the mucosal wall comprises the esophagus, pylorus or duodenum.

42. An intragastric implant for use in a patient, the patient having an esophagus leading to a stomach in communication with intestines within a gastrointestinal tract, the intragastric implant comprising:

an intragastric anchor providing anchoring within the gastrointestinal tract;

an intestinal bypass sleeve coupled to the intragastric anchor, the sleeve having a central passage extending from a proximal opening to a distal outlet, the distal outlet configured to be positioned in the intestines while the intragastric anchor maintains the proximal opening adjacent the stomach so that food passes through the intestinal bypass sleeve; and

a sliding seal supportably attached to a proximal portion of the intestinal bypass sleeve so that food passes into the intestinal bypass sleeve through the proximal opening, wherein the sliding seal is adapted to slidably engage an inner wall of the gastrointestinal tract with a reduced-friction interface that facilitates sliding along the inner wall of the gastrointestinal tract and inhibiting damage thereto.

43. The intragastric implant of claim 42, wherein the sliding seal is coupled to the intragastric anchor through one or more semi-flexible struts.

44. The intragastric implant of claim 42, wherein the slidable seal comprises an expandable stent-like structure urging a slidable sealing surface radially outward against a mucosal wall of the gastrointestinal tract, wherein the slidable sealing surface comprises the reduced-friction interface.

45. The intragastric implant of claim 42, wherein the slidable seal comprises a proximal leading edge that curves radially inward so as to facilitate sliding of the sliding seal along the reduced-friction interface and inhibit trauma to the gastrointestinal tract.