METHODS AND DEVICES FOR INTRA-ATRIAL SHUNTS HAVING SELECTABLE FLOW RATES

• US 20130184634A1
• Filed: 12/24/2012
• Published: 07/18/2013
• Est. Priority Date: 12/22/2011
• Status: Active Grant

• Current Assignee: DC Devices Inc.
• Original Assignee: DC Devices Inc.
• Inventors: McNamara, Edward, Sutherland, Michael W., Finch, Matthew J., Forcucci, Stephen J., Mitzel, John
• Granted Patent: US 9,642,993 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. The devices are adapted to permit fluid flow across the membrane in which the device is implanted at first rate, and at a second rate, wherein a difference between the first rate and the second rate is not solely dependent upon variations in blood pressure differential across the membrane due to the heart'"'"'s pumping cycle.

Claims

1. A device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising anchors which are adapted to hold the device in place within the aperture, and a shunting section connected to the anchors and adapted to permit fluid flow across the membrane at first rate, and at a second rate, wherein a difference between the first rate and the second rate is not solely dependent upon variations in blood pressure differential across the membrane due to the heart'"'"'s pumping cycle.

2. The device of claim 1, wherein the first rate is less than the second rate.

3. The device of claim 1, wherein the second rate is less than the first rate.

4. The device of claim 1, wherein at least a portion of the shunting section is biased to cause the shunting section to have a first hydraulic diameter.

5. The device of claim 4, wherein the shunting section is adapted to have a second hydraulic diameter upon removal of at least portion of the bias.

6. The device of claim 1, wherein at least one of the shunting section and the pair of anchors comprises a shape memory material.

7. The device of claim 1, wherein the shunting section is adapted to change from the first flow rate to the second flow rate automatically.

8. The device of claim 1, wherein the shunting section is adapted to permit fluid flow across the membrane at a third rate, wherein the third rate is not solely dependent upon variations in blood pressure differential across the membrane due to the heart'"'"'s pumping cycle.

9. The device of claim 8, wherein the third rate is greater than at least one of the first and second rates.

10. The device of claim 8, wherein the third rate is less than at least one of the first and second rates.

11. The device of claim 8, wherein the shunting section is adapted to change from the second rate to the third rate automatically.

12. An expandable device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising:

first and second anchors adapted to contact, respectively, a first side and a second side of the membrane; and

a shunt connected to the first and second anchors and having a bio-resorbable material, the shunt being adapted to permit blood to flow across the membrane at a first flow rate;

wherein the shunt is adapted to permit blood to flow across the membrane at a second flow rate upon absorption of at least a portion of the bio-resorbable material.

13. The device of claim 12, wherein at least a portion of the shunting section is biased by the bio-resorbable material to cause the shunting section to have a first hydraulic diameter.

14. The device of claim 12, wherein the first flow rate is greater than the second flow rate.

15. The device of claim 12, wherein the second flow rate is greater than the first flow rate.

16. The device of claim 12, wherein the shunt is further adapted to permit blood to flow across the membrane at a third flow rate upon further absorption of at least a portion of the bio-resorbable material.

17. The device of claim 16, wherein the third flow rate is greater than at least one of the first and second flow rates.

18. The device of claim 16, wherein the third flow rate is less than at least one of the first and second flow rates.

19. The device of claim 12, further comprising a protruding member adapted to be engaged by a percutaneous retrieval device.

20. The device of claim 12, wherein each of the first and second anchors comprises a plurality of segments.

21. The device of claim 12, wherein the first anchor, the second anchor, and the shunt are integrally connected.

22. The device of claim 12, wherein the absorption of the bio-resorbable material occurs at a pre-determined rate.

23. An expandable device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising:

first and second anchors adapted to contact, respectively, a first side and a second side of the membrane; and

a shunt having a first dimension and connected to the first and second anchors and having a first bio-resorbable material, the shunt being adapted to permit blood to flow across the membrane at a first flow rate corresponding to the first dimension and comprising a frame having a plurality of struts,

wherein at least a set of the struts are interconnected by the first bio-resorbable material,

wherein the shunt has a first dimension when the interconnection is intact and a second dimension when the inter-connection is not intact, and

wherein the shunt is adapted to permit blood to flow across the membrane at a second flow rate corresponding to the second dimension.

24. The device of claim 23, wherein each of the first and second anchors comprises a plurality of segments.

25. The device of claim 23, wherein the first anchor, the second anchor, and the shunt are integrally connected.

26. The device of claim 23, wherein the absorption of the first bio-resorbable material occurs at a pre-determined rate.

27. The device of claim 23, further comprising a sheath situated within and attached to the frame.

28. The device of claim 23, wherein at least some of the struts are arranged in diamond-pattern sets, each of the diamond-pattern sets having a first and a second diagonal.

29. The device of claim 28, wherein at least some of the struts in the diamond-pattern sets are interconnected by the first bio-resorbable material to restrain the diamond-pattern sets to which the interconnected struts belong from changing the length of their respective first diagonals.

30. The device of claim 29, wherein the shunt has a longitudinal axis and at least some of the first diagonals are aligned parallel to the shunt'"'"'s longitudinal axis.

31. The device of claim 29, further comprising a sheath situated within and attached to the frame.

32. The device of claim 23, wherein the shunt has a first end and a second end and at least one of the first and second ends is adapted to have a contracted configuration and a expanded configuration and the first bio-resorbable material interconnection is adapted to releasably maintain at least one of the first and second ends in at least one of its respective contracted and expanded configurations.

33. The device of claim 32, wherein the shunt further comprises a sheath situated within and attached to the frame.

34. The device of claim 23, wherein the shunt has a first end having a first contracted configuration and a first expanded configuration and a second end have a second contracted configuration and a second expanded configuration, the first end being constrained by the first bio-resorbable material to releasably maintain either its first expanded configuration or its first contracted configuration, and wherein the shunt has a second end having a second contracted configuration and a second expanded configuration, the second end being constrained by a second bio-resorbable material to releasably maintain either its second expanded configuration or its second contracted configuration, wherein the absorption of the first bio-resorbable material occurs at a first pre-determined rate and the absorption of the second bio-resorbable material occurs at a second pre-determined rate that is different than the first pre-determined rate.

35. The device of claim 34, wherein the shunt further comprises a sheath situated within and attached to the frame.

36. An expandable device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising:

first and second anchors adapted to contact, respectively, a first side and a second side of the membrane; and

a shunt connected to the first and second anchors and comprising a passageway and one or more expandable folds extending into the passageway;

wherein at least one of the folds is constrained from expanding by a bio-resorbable material and the shunt is adapted to permit blood to flow across the membrane at a first flow rate when the constraint is intact, and

wherein the shunt is adapted to permit blood to flow across the membrane at a second flow rate when the constraint is not intact.

37. The device of claim 36, wherein each of the first and second anchors comprises a plurality of segments.

38. The device of claim 36, wherein the first anchor, the second anchor, and the shunt are integrally connected.

39. The device of claim 36, wherein the absorption of the bio-resorbable material occurs at a pre-determined rate.

40. An expandable device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising:

first and second anchors adapted to contact, respectively, a first side and a second side of the membrane;

a core segment interconnecting the first and second anchors, the core segment being adapted to permit blood to flow across the membrane at a first flow rate; and

a shunt disposed within the core segment and comprising a bio-resorbable material, the shunt adapted to permit blood to flow across the membrane at a first rate when the bio-resorbable material is intact, and at a second rate when the bio-resorbable material is not intact.

41. The device of claim 40, wherein the shunt and the core segment are integrally connected.

42. The device of claim 40, wherein the first flow rate is greater than the second flow rate.

43. The device of claim 40, wherein the second flow rate is greater than the first flow rate.

44. The device of claim 40, wherein shunt comprises a plurality of apertures adapted to influence the second flow rate.

45. The device of claim 44, wherein at least one of the apertures has associated with it a flap releasably secured in place with the bio-resorbable material so as to prevent blood flow through the at least one aperture until a time when the bio-resorbable material has become at least partially absorbed.

46. The device of claim 45, wherein at least one other of the apertures has no flap associated with it.

47. The device of claim 44, wherein at least one of the apertures has associated with it a flap releasably secured in place with the bio-resorbable material so as to permit blood flow through the at least one aperture until a time when the bio-resorbable material has become at least partially absorbed.

48. The device of claim 47, wherein at least one other of the apertures has no flap associated with it.

49. The device of claim 40, wherein the shunt comprises a plurality of first apertures, each of the first apertures being adapted to influence the second flow rate and having associated with it a first flap releasably secured in place with the bio-resorbable material.

50. The device of claim 49, wherein the bio-resorbable material securing at least one of the first flaps is adapted to release the at least one first flap at a preselected first time and the bio-resorbable material securing at least one other of the first flaps is adapted to release the at least one other of the first flaps at a preselected second time that is different than the preselected first time.

51. The device of claim 49, wherein at least one of the first flaps is secured in place so as to permit blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

52. The device of claim 51, wherein the shunt further comprises a plurality of second apertures, each of the second apertures being adapted to influence, respectively, the first and second flow rates and having associated with it a second flap releasably secured in place with the bio-resorbable material.

53. The device of claim 52, wherein at least one of the first flaps is secured in place so as to prevent blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed

54. The device of claim 53, wherein at least one of the second flaps is secured in place so as to permit blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

55. The device of claim 53, wherein at least one of the second flaps is secured in place so as to prevent blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

56. The device of claim 52, wherein at least one of the first flaps is secured in place so as to permit blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

57. The device of claim 56, wherein at least one of the second flaps is secured in place so as to permit blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

58. The device of claim 56, wherein at least one of the second flaps is secured in place so as to prevent blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

59. The device of claim 40, wherein the shunt is configured as a disk having at least one aperture adapted to permit blood to flow across the membrane at, respectively, the first or second flow rate.

60. The device of claim 40, wherein the shunt is configured as a cylinder having a first end, the first end having at least one aperture adapted to permit blood to flow across the membrane at, respectively, the first or second flow rate.

61. The device of claim 40, wherein the shunt comprises a frame having an first aperture situated therein and a plurality of flaps attached to the frame so as to at least partially close the first aperture.

62. The device of claim 61, wherein each of the flaps is releasably attached to at least one other of the flaps with the bio-resorbable material.

63. The device of claim 62, wherein the plurality of flaps form the rim of a second aperture.

64. The device of claim 40, wherein the shunt comprises a frame having a first aperture situated therein and the bio-resorbable material forming the rim of a second aperture, the bio-resorbable material being attached to the frame so as to at least partially close the first aperture.

65. The device of claim 64, wherein the bio-resorbable material has a first region having a first rate of bio-resorbability and a second region having a second rate of bio-resorbability that is different from the first rate of bio-resorbability.

66. The device of claim 64, wherein the first rate is greater than the second rate.

67. The device of claim 65, wherein the first region includes at least a portion of the rim of the second aperture.

68. The device of claim 67, wherein the first rate is greater than the second rate.