Prosthesis heart valve fixturing device

• US 8,021,421 B2
• Filed: 08/22/2003
• Issued: 09/20/2011
• Est. Priority Date: 08/22/2003
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Guiterrez, Federico, Holmgren, Neil, Drews, Michael J., Lane, Ernest, Fogarty, Thomas J.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US10/646,639
• Publication Number:
  US 20050043760A1
• Time in Patent Office: 2,951 Days
• Field of Search: 623 236- 241
• US Class Current: 623/2.38
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A biologically implantable prosthesis is disclosed. The prosthesis can have a circumferentially expandable wall and elements that prevent the wall from collapsing once the wall is expanded. Methods of making and using the prosthesis are also disclosed.

Claims

1. A heart valve device for connection to a first mass comprising:

a gasket body comprising an annular wall defining a gasket radius around a longitudinal axis central to the gasket body, the wall defining first and second edges, the gasket body further comprising a sewing ring including a skirt extending radially outwardly from the first edge and a complementary attachment device in the sewing ring, and

an elongate attachment device comprising one or more digitations, detents, or pawls located at an intermediate location between opposite ends of the elongate attachment device, the elongate attachment device having sufficient length such that the gasket body can be parachuted down the elongate attachment device to an implantation site,

wherein the complementary attachment device comprises an inner attachment radius and an outer attachment radius,

wherein the gasket radius, the inner attachment radius and the outer attachment radius are measured from the longitudinal axis, and wherein the outer attachment radius is greater than the gasket radius, and

wherein the complementary attachment device comprises a receptacle, the receptacle comprising a ratchet tooth for self-ratchetedly engaging the one or more digitations, detents, or pawls on the elongate attachment device received therethrough.

2. The device of claim 1, wherein the inner attachment radius is greater than the gasket radius.

3. The device of claim 1, wherein the inner attachment radius is substantially equal to the outer gasket radius.

4. The device of claim 1, wherein the inner attachment radius is less than the outer gasket radius.

5. The device of claim 4, wherein the inner attachment radius is greater than the inner gasket radius.

6. The device of claim 1, wherein the complementary attachment device is resilient.

7. The device of claim 1, wherein the complementary attachment device is deformable.

8. The device of claim 1, wherein the complementary attachment device comprises an internal obstacle.

9. The device of claim 1, wherein the sewing ring comprises a fabric.

10. The device of claim 1, wherein the receptacle comprises a can.

11. The device of claim 10, wherein the can is deformable.

12. The device of claim 10, wherein the can is resilient.

14. The device of claim 10, wherein the can comprises solid walls.

15. The device of claim 10, wherein the can comprises a wireframe.

16. The device of claim 10, wherein the can comprises a wrapped plate.

18. The device of claim 1, wherein the complementary attachment device is integral with the gasket body.

19. The device of claim 1, wherein the complementary attachment device comprises a first cam.

20. The device of claim 19, wherein the first cam is rotatably attached to the gasket body.

21. The device of claim 19, wherein the complementary attachment device comprises a second cam.

22. The device of claim 1, wherein the complementary attachment device further comprises a first fenestration.

23. The device of claim 22, wherein the complementary attachment device further comprises a first end, a second end, and a second fenestration between the first fenestration and the second end,

wherein the first fenestration is between the first end and the second end,

and wherein the complementary attachment device further comprises a first length between the first fenestration and the second fenestration.

24. The device of claim 23, wherein the elongate attachment device is configured to pass through the first fenestration.

25. The device of claim 24, wherein the device is configured for the attachment device to pass through the first length.

26. The device of claim 25, wherein the device is configured for the attachment device to pass through the second fenestration.

27. The device of claim 1, further comprising a mechanical valve attached to the gasket body.

28. The device of claim 1, further comprising a biological valve attached to the gasket body.

29. The device of claim 1, further comprising a leaflet attached to the gasket body.

30. The device of claim 1, wherein the attachment device is knotless.

31. The device of claim 1, wherein the attachment device comprises a suture.

13. A heart valve device for connection to a first mass comprising:

a gasket body comprising an annular wall defining a gasket radius around a longitudinal axis central to the gasket body, the wall defining first and second edges, the gasket body further comprising a sewing ring including a skirt extending radially outwardly from the first edge and a complementary attachment device, and

an elongate attachment device comprising a plurality of digitations, detents, or pawls located at an intermediate location between opposite ends of the elongate attachment device, the elongate attachment device having sufficient length such that the gasket body can be parachuted down the elongate attachment device to an implantation site,

wherein the complementary attachment device comprises an inner attachment radius and an outer attachment radius,

wherein the gasket radius, the inner attachment radius and the outer attachment radius are measured from the longitudinal axis, and wherein the outer attachment radius is greater than the gasket radius, and

wherein the complementary attachment device further comprises a can and the can is fixedly attached to the gasket body, the can comprising a ratchet tooth for self-ratchetedly engaging the digitations, detents, or pawls on the elongate attachment device when the elongate attachment device is received through the can.

17. A heart valve device for connection to a first mass comprising:

a gasket body comprising an annular wall defining a gasket radius around a longitudinal axis central to the gasket body, the wall defining first and second edges, the gasket body further comprising a sewing ring including a skirt extending radially outwardly from the first edge and a complementary attachment device, and

an elongate attachment device comprising a plurality of digitations, detents, or pawls located at an intermediate location between opposite ends of the elongate attachment device, the elongate attachment device having sufficient length such that the gasket body can be parachuted down the elongate attachment device to an implantation site,

wherein the complementary attachment device comprises an inner attachment radius and an outer attachment radius,

wherein the gasket radius, the inner attachment radius and the outer attachment radius are measured from the longitudinal axis, and wherein the outer attachment radius is greater than the gasket radius, and

wherein the complementary attachment device further comprises a can and the can comprises a plurality of ratchet teeth for self-ratchetedly engaging the digitations, detents, or pawls on the elongate attachment device when the elongate attachment device is received through the can.

32. A heart valve device for connection to a first mass comprising:

a gasket body comprising an annular wall covered by fabric,

a leaflet attached to the gasket body,

an elongate attachment device comprising a plurality of digitations, detents, or pawls located at an intermediate location between opposite ends of the elongate attachment device, the elongate attachment device having sufficient length such that the gasket body can be parachuted down the elongate attachment device to an implantation site, and

a discrete receptacle attached to the gasket body for receiving the elongate attachment device therethrough, the receptacle comprising teeth elements comprising shelves and slopes for self-fixturingly ratcheting the attachment device through the receptacle.

33. A heart valve device for connection to a first mass, comprising:

an annular body comprising a wall defining a circumference;

a plurality of receptacles spaced apart around the circumference of the wall, each receptacle comprising an element defining a shelf and a slope; and

a plurality of elongate attachment devices receivable through the receptacles, each attachment device comprising a detent for self-fixturingly ratcheting through a respective receptacle, the elongate attachment devices having sufficient length such that the annular body can be parachuted down the elongate attachment devices to an implantation site;

wherein each attachment device comprises a plurality of detents spaced apart along a length of the attachment device at an intermediate location between opposite ends of the respective attachment device.

34. The device of claim 33, wherein each detent comprises an angled tab.

35. The device of claim 33, further comprising a heart valve attachable to the annular body.

36. The device of claim 35, wherein the heart valve comprises a leaflet gasket holding leaflets.

37. The device of claim 35, wherein the heart valve comprises a biological valve.

38. The device of claim 33, wherein the wherein the annular body is covered by fabric.

39. The device of claim 33, wherein the annular body comprises a gasket body, the gasket body comprising an annular wall and a sewing ring attached to the annular wall.

40. The device of claim 39, wherein the sewing ring comprises a skirt extending radially outwardly from an edge of the wall.

41. The device of claim 40, wherein the skirt extends radially outwardly from a bottom edge of the wall.

42. The device of claim 39, wherein the sewing ring comprises a flare extending radially outwardly from a bottom edge of the wall.

43. The device of claim 33, wherein the receptacles comprise cans.

44. The device of claim 33, wherein each receptacle comprises a plurality of shelves and slopes.

45. A heart valve assembly for implantation within a biological annulus, comprising:

a heart valve assembly comprising a crown carrying leaflets;

a gasket body comprising an annular wall and a sewing ring attached to the annular wall, the sewing ring comprising a skirt extending radially outwardly from an edge of the wall;

a plurality of fixturing devices for attaching the gasket body to the biological annulus; and

a plurality of elongate attachment devices receivable through respective fixturing devices and having sufficient length such that the gasket body can be parachuted down the elongate attachment devices to an implantation site,

wherein each attachment device comprises a plurality of detents spaced apart along a length of the attachment device at an intermediate location between opposite ends of the respective attachment device.

46. The heart valve assembly of claim 45, wherein each detent comprises an angled tab.

47. A heart valve assembly for implantation within a biological annulus, comprising:

a heart valve assembly comprising a crown carrying leaflets;

a gasket body comprising an annular wall and a sewing ring attached to the annular wall, the sewing ring comprising a skirt extending radially outwardly from an edge of the wall;

a plurality of fixturing devices for attaching the gasket body to the biological annulus; and

a plurality of elongate attachment devices receivable through respective fixturing devices, the elongate attachment devices having sufficient length such that the gasket body can be parachuted down the elongate attachment devices to an implantation site,

wherein each fixturing device comprises an element defining a shelf and a slope located at an intermediate location between opposite ends of the respective attachment device, the fixturing devices configured for receiving respective elongate attachment devices therethrough, each attachment device comprising a detent for self-fixturingly ratcheting through a respective fixturing device; and

wherein each fixturing device comprises teeth elements for engaging the detent on the respective attachment device.

48. A heart valve assembly for implantation within a biological annulus, comprising:

a heart valve assembly comprising a crown carrying leaflets;

a gasket body comprising an annular wall and a sewing ring attached to the annular wall, the sewing ring comprising a skirt extending radially outwardly from an edge of the wall;

a plurality of fixturing devices for attaching the gasket body to the biological annulus; and

a plurality of elongate attachment devices receivable through respective fixturing devices, the elongate attachment devices having sufficient length such that the gasket body can be parachuted down the elongate attachment devices to an implantation site,

wherein each fixturing device comprises an element defining a shelf and a slope, the fixturing devices configured for receiving respective elongate attachment devices therethrough, each attachment device comprising a detent located at an intermediate location between opposite ends of the respective attachment device for self-fixturingly ratcheting through a respective fixturing device; and

wherein each fixturing device comprises a plurality of shelves and slopes.

49. The heart valve assembly of claim 48, wherein each attachment device comprises a plurality of detents spaced apart along a length of the attachment device.

50. A heart valve device for connection to a first mass, comprising:

an annular body comprising a wall defining a circumference;

a plurality of receptacles spaced apart around the circumference of the wall, each receptacle comprising an element defining a shelf and a slope; and

a plurality of elongate attachment devices receivable through the receptacles and having sufficient length such that the annular body can be parachuted down the elongate attachment devices to an implantation site, each elongate attachment device comprising a plurality of digitations, detents, or pawls at an intermediate location between opposite ends of the respective attachment device for self-fixturingly ratcheting through a respective receptacle.

51. The device of claim 50, further comprising leaflets attached to the annular body.

52. The device of claim 50, wherein the attachment devices comprise sutures.

53. The device of claim 50, wherein the attachment devices comprise filaments.

54. The device of claim 50, wherein the plurality of digitations, detents, or pawls are fixedly attached to the elongate attachment device.

55. The device of claim 50, wherein the element comprises teeth internal to the receptacles.

56. A heart valve assembly for implantation within a biological annulus, comprising:

a heart valve assembly comprising a crown carrying leaflets;

a gasket body comprising an annular wall and a sewing ring attached to the annular wall, the sewing ring comprising a skirt extending radially outwardly from an edge of the wall;

a plurality of fixturing devices on the gasket body for attaching the gasket body to the biological annulus; and

a plurality of elongate attachment devices receivable through respective fixturing devices and having sufficient length such that the gasket body can be parachuted down the elongate attachment devices to an implantation site, each elongate attachment device comprising a plurality of digitations, detents, or pawls at an intermediate location between opposite ends of the respective attachment device for self-fixturingly ratcheting through a respective fixturing device.

57. The heart valve assembly of claim 56, wherein the plurality of fixturing devices comprise a plurality of receptacles spaced apart around the circumference of the wall, each receptacle comprising an element defining a shelf and a slope, the receptacles configured for receiving respective elongate attachment devices therethrough.

58. The heart valve assembly of claim 57, wherein the element comprises teeth internal to the receptacles.

59. The heart valve assembly of claim 56, wherein the attachment devices comprise sutures.

60. The heart valve assembly of claim 56, wherein the attachment devices comprise filaments.

61. The heart valve assembly of claim 56, wherein the plurality of digitations, detents, or pawls are fixedly attached to the elongate attachment device.