DUODENAL LINER DEVICE

• US 20110040232A1
• Filed: 01/22/2009
• Published: 02/17/2011
• Est. Priority Date: 04/23/2008
• Status: Abandoned Application

• Current Assignee: Duocure, Inc.
• Original Assignee: Duo-Cure Incorporated
• Inventors: Magal, Elad
• Application Number:
  US12/988,971
• Publication Number:
  US 20110040232A1
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/004 remotely adjustable
• 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

Abstract

Disclosed are tethered duodenal liner devices as well as methods of transcutaneously deploying and removing the tethered duodenal liner devices.

Claims

1-25. -25. (canceled)

26. A device comprising:

a liner tube,

wherein the liner tube comprises walls of a flexible material defining a liner lumen, a proximal end defining a proximal lumen opening, and a distal end defining a distal lumen opening, and

wherein the liner tube is sufficiently designed so as to be capable of residing inside a duodenum of a human subject;

an expandable balloon component,

wherein the expandable balloon component is functionally associated with the proximal end of the liner tube; and

a tether,

wherein the tether comprises an elongated flexible material having one or more lumens, a proximal end, and a distal end,

wherein one lumen of the tether is in fluid communication with the expandable balloon component,

wherein the proximal end of the tether engages an anchor, and

wherein the distal end of the tether engages at least one of the liner tube or the expandable balloon component,

wherein the anchor is sufficiently designed so as to be securable to a surface of the human subject for securing the liner tube inside the duodenum.

27. The device of claim 26 wherein the anchor is a tether anchor.

28. The device of claim 26 wherein the distal end of the tether engages the liner tube.

29. The device of claim 26 wherein the distal end of the tether engages the liner tube at multiple locations.

30. The device of claim 26 wherein the distal end of the tether engages the expandable balloon component.

31. The device of claim 26 wherein the distal end of the tether engages the liner tube and the expandable balloon component.

32. The device of claim 26 wherein the proximal end of the tether passes through a gastric wall of the human subject, and the anchor is secured to an outer surface of the gastric wall.

33. The device of claim 26 wherein the proximal end of the tether passes through a gastric wall as well as other tissue of the human subject, and the anchor is secured to the surface of a muscle layer.

34. The device of claim 26 wherein the proximal end of the tether passes through a gastric wall as well as other tissue to emerge through skin of the human subject, and the anchor is secured to an outer surface of the skin

35. The device of claim 26 wherein the expandable balloon component is sufficiently designed so as to be deployable in the duodenal bulb to sufficiently pass chyme from a stomach of the human subject through the proximal lumen opening.

36. The device of claim 26 wherein one lumen of the tether is in fluid communication with a composition-administration component to facilitate administration of a composition in the duodenum.

37. The device of claim 37 wherein the composition-administration component is associated with the liner tube.

38. The device of claim 37 wherein the composition-administration component is associated with the expandable balloon component.

39. A device comprising:

a liner tube,

wherein the liner tube comprises walls of a flexible material defining a liner lumen, a proximal end defining a proximal lumen opening, and a distal end defining a distal lumen opening, and

wherein the liner tube is sufficiently designed so as to be capable of residing inside a duodenum of a human subject;

an expandable balloon component,

wherein the expandable balloon component is functionally associated with the proximal end of the liner tube,

wherein the expandable balloon component has a collapsed configuration and an expanded deployed configuration, and

wherein the expandable balloon component is sufficiently designed so as to be capable of residing completely in a duodenal bulb of the human subject;

a percutanous endoscopic gastrostomy tube,

wherein the percutanous endoscopic gastrostomy tube comprises a channel-defining component and a percutanous endoscopic gastrostomy anchor; and

a tether,

wherein the tether comprises an elongated flexible material having one or more lumens, a proximal end, and a distal end,

wherein one lumen of the tether is in fluid communication with the expandable balloon component,

wherein at least a portion of the tether passes through the channel-defining component of the percutanous endoscopic gastrostomy tube,

wherein the proximal end of the tether engages the percutanous endoscopic gastrostomy anchor, and

wherein the distal end of the tether engages at least one of the liner tube or the expandable balloon component,

wherein the percutanous endoscopic gastrostomy anchor is sufficiently designed so as to be securable to an outer skin surface of the human subject for securing the liner tube inside the duodenum.

40. The device of claim 39 wherein the distal end of the tether engages the liner tube.

41. The device of claim 39 wherein the distal end of the tether engages the liner tube at multiple locations.

42. The device of claim 39 wherein the distal end of the tether engages the expandable balloon component.

43. The device of claim 39 wherein the distal end of the tether engages the liner tube and the expandable balloon component.

44. The device of claim 39 wherein the proximal end of the tether passes through a gastric wall of the human subject, and the percutanous endoscopic gastrostomy anchor is secured to an outer surface of the gastric wall.

45. The device of claim 39 wherein the proximal end of the tether passes through a gastric wall as well as other tissue of the human subject, and the percutanous endoscopic gastrostomy anchor is secured to the surface of a muscle layer.

46. The device of claim 39 wherein the proximal end of the tether passes through a gastric wall as well as other tissue to emerge through skin of the human subject, and the percutanous endoscopic gastrostomy anchor is secured to an outer surface of the skin

47. The device of claim 39 wherein the expandable balloon component is sufficiently designed so as to be deployable in the duodenal bulb to sufficiently pass chyme from a stomach of the human subject through the proximal lumen opening.

48. The device of claim 39 wherein one lumen of the tether is in fluid communication with a composition-administration component to facilitate administration of a composition in the duodenum.

49. The device of claim 48 wherein the composition-administration component is associated with the liner tube.

50. The device of claim 48 wherein the composition-administration component is associated with the expandable balloon component.

51. A device comprising:

a liner tube,

wherein the liner tube comprises walls of a flexible material defining a liner lumen, a proximal end defining a proximal lumen opening, and a distal end defining a distal lumen opening, and

wherein the liner tube is sufficiently designed so as to be capable of residing inside a duodenum of a human subject; and

an expandable balloon component,

wherein the expandable balloon component is functionally associated with the proximal end of the liner tube,

wherein the expandable balloon component has a collapsed configuration and an expanded deployed configuration, and

wherein the expandable balloon component is sufficiently designed so as to be capable of residing completely in a duodenal bulb of the human subject,

wherein a smooth outer surface of the expandable balloon component is sufficiently designed so as to be deployable in the duodenal bulb so as to sufficiently contact luminal walls of the duodenal bulb to anchor the liner tube inside the duodenum.

52. The device of claim 51 further comprising a tether, wherein the distal end of the tether engages at least one of the liner tube or the expandable balloon component.

53. The device of claim 51 wherein the expandable balloon component is manufactured from a compliant material.

54. The device of claim 51 wherein the compliant material is polyurethane.

55. The device of claim 51 wherein the expandable balloon component is sufficiently designed so as to be deployable in the duodenal bulb to sufficiently pass chyme from a stomach of the human subject through the proximal lumen opening.