MEMBRANE AUGMENTATION, SUCH AS OF FOR TREATMENT OF CARDIAC VALVES, AND FASTENING DEVICES FOR MEMBRANE AUGMENTATION

• US 20090188964A1
• Filed: 05/21/2007
• Published: 07/30/2009
• Est. Priority Date: 06/01/2006
• Status: Abandoned Application

• Current Assignee: Mor Research Applications Ltd. (Clalit Health Services)
• Original Assignee: Mor Research Applications Ltd. (Clalit Health Services)
• Inventors: Orlov, Boris
• Application Number:
  US12/302,900
• Publication Number:
  US 20090188964A1
• Time in Patent Office: Days
• US Class Current: 227/175.300
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity

Abstract

Disclosed are methods for augmenting tissue, for example membranes such as cardiac leaflets and tissue surrounding a cardiac valve, which in embodiments improve leaflet coaptation. Also disclosed are devices useful for augmenting tissue.

Claims

1. A surgical fastening device useful for securing a cardiac valve to an implant, comprising:

a) a device body comprising a fastener magazine having a fastener ejection ring configured to project a plurality of tissue-piercing elements of one or more fasteners in the shape of a closed curve from said fastener magazine; and

b) an anvil configured to act as a counterpoise during said projection of said tissue-piercing elements which comprises an anvil head including an anvil head top surface having a shape of a closed-curve and a size substantially similar to that of said fastener ejection ring, said anvil configured to be reversibly secured to said device body through a stem surrounded by said fastener ejection ring, so that when secured, said anvil head surface is opposite said fastener ejection ring

wherein said anvil head comprises at least two mateable anvil head parts, wherein each said mateable anvil head part spans a sector of said closed curve of said anvil head.

2. The device of claim 1, wherein said one or more fasteners are selected from the group consisting of staples, cotter pins, studs, rivets, and two-part rivets.

3. An anvil for a surgical fastening device useful for securing a cardiac valve to an implant, comprising at least two mateable anvil head parts that when mated said anvil head parts constitute an anvil head that is substantially a closed curve including an anvil head top surface, wherein each said mateable anvil head part spans a sector of said closed curve, and a width of said mateable anvil head part is less than half of a radius of said closed curve.

4. The anvil of claim 3, comprising two mateable anvil head parts, a first anvil head part and a second anvil head part, when mated together spanning the entire circumference of said closed curve.

5. The anvil of claim 4, wherein said first anvil head part spans a sector of between about 120°

and about 240°

of said closed curve.

6. The anvil of claim 3, each said anvil head part comprising crosspiece extending toward a center of said closed curve.

7. The anvil of claim 6, a said crosspiece spanning no greater than about 45°

.

8. The anvil of claim 3, further comprising a stem attached to at least one said anvil head part through a crosspiece.

9. The anvil of claim 8, said stem attached to only one said anvil head part.

10. The anvil of claim 8, said stem split into a plurality of mateable parts, said parts attached to different said anvil head parts, configured so that when said anvil head parts are properly mated said stem parts are properly mated.

11. The anvil head of claim 3, said top surface comprising a tray for presenting locking components to engage fasteners projected from the surgical fastening device.

12. The anvil head of claim 3, said top surface comprising features for facilitating deformation of fasteners projected from the surgical fastening device.

60. The anvil of claim 3, configured so that at least one of the anvil head parts is shaped to pass between the cardiac valve chord and a ventricle wall.

61. The anvil of claim 60, configured so that when mated said closed curve is sized to go around the chordae of the cardiac valve.

62. The anvil of claim 3, configured so that at least one of the anvil head parts is shaped to pass between the cardiac valve chord and a ventricle septum.

63. The anvil of claim 62, configured so that when mated said closed curve is sized to go around the chordae of the cardiac valve.

13-37. -37. (canceled)

38. A lockable fastener useful for securing the periphery of a cardiac valve to an implant material comprising:

a) a loop-shaped body with a bottom side defining a lumen and describing at least a 320°

sector about an axis; and

b) at least three elongated piercing elements protruding from said bottom side substantially parallel to said axis.

39. The fastener of claim 38, said piercing elements configured to deform upon sufficiently forceful contact with an anvil when projected from an appropriately configured surgical fastening device so as to lock in place.

40. The fastener of claim 38, a said piercing element configured to engage a discrete locking component.

41. A set of lockable fasteners, comprising at least two fasteners of claim 38 configured to be coaxially nestable, so that when coaxially nested, a coaxial gap between an outer edge of a said loop-shaped body of a smaller said fastener and an inner edge of a said loop-shaped body of a larger said fastener is at least 0.1 mm.

42. A method of augmenting a membrane, comprising:

a) slitting an in vivo membrane so as to produce a slit having a first slit edge and a second slit edge;

b) providing a patch of tissue having a periphery as a membrane augmenting implant;

c) placing said patch of tissue to define an overlap region comprising an overlap of a first portion of said periphery with said first slit edge and an overlap of a second portion of said periphery with said second slit edge; and

d) securing said patch to said membrane around a plurality of locations of said overlap region substantially simultaneously,

thereby augmenting said membrane by increasing a surface area of said membrane with said patch.

47. The method of claim 42, wherein said securing comprises:

i) piercing said patch and said membrane at said plurality of locations to make a plurality of holes in said overlap region substantially simultaneously;

ii) passing lockable fasteners through said holes; and

iii) locking said lockable fasteners so as to secure said patch to said first slit edge and said second slit edge through said overlap region.

48. The method of claim 42, wherein said in vivo membrane is a leaflet of a cardiac valve.

43-46. -46. (canceled)

49. A method of augmenting the tissue surrounding a cardiac valve, comprising:

a) excising leaflets of a cardiac valve with an incision having a shape of a closed curve so as to define a valve seat edge of said incision and a valve periphery edge of said incision;

b) providing an implant including a wall, the wall delimited by two edges each in the shape of a closed curve and defining a lumen as a cardiac valve augmenting implant;

c) placing said implant to define a proximal overlap region comprising an overlap of a first portion near a first edge of said implant with said valve seat edge

d) placing said implant to define a distal overlap region comprising an overlap of a second portion near a second edge of said implant with said valve periphery edge;

e) securing said first portion of said implant to said valve seat edge around a plurality of locations of said proximal overlap region; and

f) securing said second portion of said implant to said valve periphery edge around a plurality of locations of said distal overlap region, substantially simultaneously thereby augmenting a surface area of tissue surrounding said cardiac valve with said implant.

50. The method of claim 49, wherein said securing said first portion of said implant to said valve seat edge around a plurality of locations of said proximal overlap region is performed substantially simultaneously for said plurality of locations.

51. The method of claim 49, wherein:

said excising;

said placing said implant to define said proximal overlap zone; and

said securing said first portion of said implant to said valve seat edge are substantially simultaneous.

52. The method of claim 49, wherein:

said excising;

said placing said implant to define said distal overlap zone; and

said securing said second portion of said implant to said valve periphery edge are substantially simultaneous.

53. The method of claim 49, wherein:

said excising;

said placing said implant to define said proximal overlap zone;

said placing said implant to define said distal overlap zone;

said securing said first portion of said implant to said valve seat edge; and

said securing said second portion of said implant to said valve periphery edge are substantially simultaneous.

57. The method of claim 49, wherein said securing said first portion of said implant to said valve seat edge comprises:

i) piercing said implant and tissue surrounding said valve seat edge at said plurality of locations to make a plurality of holes in said proximal overlap region substantially simultaneously;

ii) passing lockable fasteners through said holes; and

iii) locking said lockable fasteners so as to secure said implant to said valve seat edge through said proximal overlap region.

58. The method of claim 49, wherein securing said second portion of said implant to said valve periphery edge comprises:

i) piercing said implant and tissue surrounded said valve periphery edge at said plurality of locations to make a plurality of holes in said distal overlap region substantially simultaneously;

ii) passing lockable fasteners through said holes; and

iii) locking said lockable fasteners so as to secure said implant to said valve periphery edge through said distal overlap region.

59. The method of claim 49, wherein said cardiac valve is a mitral valve.

54-56. -56. (canceled)