Biologically implantable heart valve system

• US 8,025,695 B2
• Filed: 01/31/2003
• Issued: 09/27/2011
• Est. Priority Date: 12/20/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Drews, Michael J., Holmgren, Neil, Modesitt, D. Bruce, Fogarty, Thomas J.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US10/355,429
• Publication Number:
  US 20040122514A1
• Time in Patent Office: 3,161 Days
• Field of Search: 623/2.13, 623/2.14, 623/2.38, 623/2.4, 623/2.41, 623/2.15, 623/2.18, 623/2.19
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10S 623/91 Heart

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 biologically implantable system for a heart valve, comprising:

a first prosthesis comprising an annular ring implantable directly and independently into an annulus of a heart, the first prosthesis comprising a circumference and a fabric covering, the annular ring having a circular latitudinal cross-section perpendicular to a central longitudinal axis;

a second prosthesis comprising a heart valve crown, the second prosthesis further comprising a circumference including a fabric covering thereon, the crown comprising an annular frame carrying leaflets, the frame having a latitudinal cross-section in a plane perpendicular to the central longitudinal axis defining multiple lobes separated by scallops, the scallops being disposed closer to the central longitudinal axis within the plane than the lobes; and

at least one engagement element disposed on the circumferences of the first and second prostheses that self-engage one another when the second prosthesis is inserted into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart.

2. The system of claim 1, further comprising cooperating elements on the first and second prostheses that angularly align the second prosthesis with the first prosthesis when the second prosthesis is inserted into engagement with the first prosthesis.

3. The system of claim 2, wherein the cooperating elements comprise a rib and groove on the first and second prostheses, the rib fitting within the groove when the second prosthesis is inserted into engagement with the first prosthesis.

4. The system of claim 1, wherein the at least one engagement element comprises a plurality of lips disposed around the circumference of the first prosthesis and a plurality of spring lock tabs disposed around the circumference of the second prosthesis.

5. The system of claim 1, wherein the first prosthesis comprises a tapered wall to guide the second prosthesis during insertion into the first prosthesis.

6. The system of claim 1, wherein the circumference of the second prosthesis defines a shape including three lobes.

15. The system of claim 1, wherein the annular ring has a tapered wall configured to push back the annulus when the first prosthesis is inserted into the annulus.

16. The system of claim 1, wherein the first prosthesis comprises a top segment, a bottom segment, and a longitudinal axis substantially perpendicular to the circumference, at least one of the top and bottom segments defining an angle with the longitudinal axis such that the top segment has an outer circumference larger than the bottom segment.

17. The system of claim 16, wherein the first prosthesis comprises a joint angle between the top segment and the bottom segment.

18. The system of claim 16, wherein the top segment defines an angle with the longitudinal axis that is greater than the bottom segment.

19. The system of claim 1, further comprising a plurality of fixturing devices configured to be inserted through a portion of the first prosthesis for securing the first prosthesis to the annulus before the second prosthesis is introduced into the annulus.

20. The system of claim 1, wherein the at least one engagement element comprises means for snap-fitting the second prosthesis to the first prosthesis.

21. The system of claim 1, wherein the at least one engagement element comprises a plurality of connectors for snap-fitting the second prosthesis to the first prosthesis.

33. The system of claim 1, wherein the annular ring is foldable into an unexpanded state during delivery and is resiliently expandable radially for engaging the tissue annulus.

34. The system of claim 2, wherein the cooperating elements on the first and second prostheses are separate from the plurality of engagement elements.

7. A biologically implantable system for a heart valve, comprising:

a first prosthesis implantable within an annulus of a heart, the first prosthesis comprising a circumference;

a second prosthesis comprising a heart valve crown, the second prosthesis comprising a circumference;

a plurality of engagement elements disposed around the circumference of the second prosthesis, the engagement elements comprising angled distal surfaces;

a plurality of elements disposed around the circumference of the first prosthesis that contact the angled distal surfaces of the engagement elements when the second prosthesis is inserted into the annulus into engagement with the first prosthesis to accommodate the engagement elements self-engaging with the plurality of elements on the first prosthesis; and

cooperating elements on the first and second prostheses that angularly align the second prosthesis with the first prosthesis when the second prosthesis is inserted into engagement with the first prosthesis,

wherein the engagement elements comprise tabs extending from the second prosthesis at an angle to defined the angled distal surfaces, the tabs being deflectable when the angled distal surfaces contact the plurality of elements on the first prosthesis to accommodate the tabs self-engaging with the plurality of elements on the first prosthesis,

wherein the plurality of elements on the first prosthesis comprise a plurality of lips for slidably engaging the angled distal surfaces of the plurality of tabs, the lips defining pockets for receiving the plurality of tabs therein to prevent separation of the first and second prostheses.

8. The system of claim 7, wherein the cooperating elements comprise a rib and groove on the first and second prostheses, the rib fitting within the groove when the second prosthesis is inserted into engagement with the first prosthesis.

9. The system of claim 7, wherein the cooperating elements comprise a plurality of magnets disposed around the circumferences of the first and second prostheses.

10. The system of claim 7, wherein the first prosthesis comprises a tapered wall to guide the second prosthesis during insertion into the first prosthesis.

11. The system of claim 7, wherein the second prosthesis further comprises three lobes, and wherein the circumference of the second prosthesis comprises a fabric covering extending around the circumference.

12. A biologically implantable system for a heart valve, comprising:

a first annular prosthesis implantable within an annulus of a heart, the first prosthesis comprising an annular ring having a circular latitudinal cross-section perpendicular to a central longitudinal axis and a fabric covering;

a second prosthesis separate from the first prosthesis and comprising a heart valve crown, the crown comprising an annular frame carrying leaflets, the frame having a latitudinal cross-section in a plane perpendicular to the central longitudinal axis defining multiple lobes separated by scallops, the scallops being disposed closer to the central longitudinal axis within the plane than the lobes;

a plurality of engagement elements disposed around the circumferences of the first and second prostheses that self-engage one another when the second prosthesis is inserted into engagement with the first prosthesis; and

cooperating elements on the first and second prostheses separate from the plurality of engagement elements, said cooperating elements capable of angularly aligning the second prosthesis with the first prosthesis and preventing rotation of the second prosthesis with respect to the first prosthesis as the second prosthesis is inserted into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart.

14. The system of claim 12, wherein the circumference of the second prosthesis defines a multiple lobed shape in a latitudinal cross-section perpendicular to a central longitudinal axis including three lobes.

22. The system of claim 12, wherein the first prosthesis comprises a top segment, a bottom segment, and a longitudinal axis substantially perpendicular to the circumference, at least one of the top and bottom segments defining an angle with the longitudinal axis such that the top segment has an outer circumference larger than the bottom segment.

23. The system of claim 12, wherein the cooperating elements comprise a plurality of connectors for snap-fitting the second prosthesis to the first prosthesis.

35. The system of claim 12, wherein the first prosthesis comprises a wall defining the circumference and a central longitudinal axis substantially perpendicular to the circumference, the wall having a circular latitudinal cross-section perpendicular to the central longitudinal axis and being foldable into an unexpanded state during delivery and resiliently expandable radially for increasing the circumference for engaging the tissue annulus.

36. The system of claim 12, wherein the cooperating elements are configured to longitudinally align the second prosthesis with the first prosthesis as the second prosthesis is inserted into engagement with the first prosthesis in a predetermined angular orientation.

13. A biologically implantable system for a heart valve, comprising:

a first annular prosthesis implantable within an annulus of a heart, the first prosthesis comprising a circumference and a fabric covering;

a second prosthesis separate from the first prosthesis and comprising a heart valve crown, the second prosthesis comprising a circumference;

a plurality of engagement elements disposed around the circumferences of the first and second prostheses that self-engage one another when the second prosthesis is inserted into engagement with the first prosthesis; and

cooperating elements on the first and second prostheses separate from the plurality of engagement elements, said cooperating elements capable of angularly aligning the second prosthesis with the first prosthesis and preventing rotation of the second prosthesis with respect to the first prosthesis as the second prosthesis is inserted into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart,

wherein the cooperating elements comprise a rib and groove on the first and second prostheses, the rib fitting within the groove as the second prosthesis is inserted into engagement with the first prosthesis in a predetermined angular orientation to longitudinally align the second prosthesis with the first prosthesis.

24. A biologically implantable system for a heart valve, comprising:

a first annular prosthesis implantable into an annulus within a heart, the first prosthesis including a wall defining a circumference and a central longitudinal axis substantially perpendicular to the circumference, at least a portion of the wall being angled away from the longitudinal axis, the wall having a circular latitudinal cross-section perpendicular to the central longitudinal axis and being foldable into an unexpanded state during delivery including one or more folds and resiliently expandable radially for increasing the circumference and for engaging the tissue annulus;

a second annular prosthesis comprising a valve;

at least one engagement element on the first and second prostheses that engage one another when the second prosthesis is inserted into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart;

wherein the at least one engagement element comprises means for snap-fitting the second prosthesis to the first prosthesis.

25. The system of claim 24, the first prosthesis comprising a top annular segment and a bottom annular segment, at least one of the top and bottom segments defining an angle with the longitudinal axis such that the top segment has an outer circumference larger than the bottom segment.

26. The system of claim 25, wherein the first prosthesis comprises a joint angle between the top segment and the bottom segment.

27. The system of claim 25, wherein the top segment defines an angle with the longitudinal axis that is greater than the bottom segment.

28. The system of claim 24, wherein the second prosthesis comprises a circumferential multiple lobed shape in a latitudinal cross-section perpendicular to the central longitudinal axis that includes a scallop between adjacent lobes.

29. The system of claim 28, wherein the circumferential shape of the second prosthesis has three lobes.

30. The system of claim 24, further comprising a plurality of fixturing devices configured to be inserted through a portion of the first prosthesis for securing the first prosthesis to the annulus before the second prosthesis is introduced into the annulus.

31. The system of claim 24, wherein the at least one engagement element comprises a plurality of connectors for snap-fitting the second prosthesis to the first prosthesis.

32. The system of claim 24, wherein the first annular prosthesis comprises a metal ring.

37. A biologically implantable system for a heart valve, comprising:

a first prosthesis comprising an annular ring implantable directly and independently into an annulus of a heart and a fabric covering, the annular ring having a circular latitudinal cross-section perpendicular to a central longitudinal axis and being foldable into an unexpanded state during delivery including one or more folds and resiliently expandable radially for increasing the circumference and for engaging the tissue annulus;

a second prosthesis comprising a heart valve crown comprising an annular frame carrying leaflets, the frame having a latitudinal cross-section in a plane perpendicular to the central longitudinal axis defining multiple lobes separated by scallops, the scallops being disposed closer to the central longitudinal axis within the plane than the lobes; and

a plurality of engagement elements spaced apart from one another about a circumference of the first prosthesis and a corresponding plurality of engagement elements spaced apart from one another about a circumference of the frame of the crown that self-engage one another when the second prosthesis is inserted into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart.