IMPLANTABLE VASCULAR DEVICE

• US 20100057191A1
• Filed: 10/07/2009
• Published: 03/04/2010
• Est. Priority Date: 06/02/1999
• Status: Active Grant

• Current Assignee: Andrew K. Hoffa, Brian C. Case, Darin G. Schaeffer, Dusan Pavcnik, Jacob A. Flagle, Michael L. Garrison, Ram H. Paul Jr, Raymond B. Leonard II, Richard B. Sisken, Thomas A. Osborne
• Original Assignee: Andrew K. Hoffa, Brian C. Case, Darin G. Schaeffer, Dusan Pavcnik, Jacob A. Flagle, Michael L. Garrison, Ram H. Paul Jr, Raymond B. Leonard II, Richard B. Sisken, Thomas A. Osborne
• Inventors: HOFFA, ANDREW K., FLAGLE, JACOB A., CASE, BRIAN C., LEONARD, RAYMOND B. II, GARRISON, MICHAEL L., SISKEN, RICHARD B., PAVCNIK, DUSAN, PAUL, RAM H. JR., SCHAEFFER, DARIN G., OSBORNE, THOMAS A.
• Granted Patent: US 8,382,822 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/0021 square
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

An valve prosthesis, such as an artificial venous valve, having a support frame and leaf structure comprising one or more leaflets in which the outer edge of each leaflet engages the inner circumference of the bodily passageway along a serpentine path urged against the passageway by an expandable frame, while the inner edges move in response to fluid to restrict retrograde flow. Optionally, one or more elements can extend from the support frame/leaf structure to provide centering support and/or protection from the leaflet adhering to the vessel wall. In one embodiment, the centering support structure comprises a second or third expandable frames attached to and extending from the proximal and/or distal ends of main valve structure and support frame. In another embodiment, one or more support elements extend outward from the valve support frame to engage the vessel wall to provide greater longitudinal stability.

Claims

1-39. -39. (canceled)

40. A valve prosthesis for implantation within a vascular vessel, comprising:

a support frame having a lengthwise axis and comprising a leaflet support portion and a circumferential centering support element disposed adjacent the leaflet support portion on the lengthwise axis;

the leaflet support portion comprising a plurality of struts interconnected by bends and configured for expansion to conform to a wall of the vascular vessel and having a first end with two bends and a second, opposite end with two bends, the bends of the first end disposed on a first transverse axis and the bends of the second end disposed on a second transverse axis, the first transverse axis oriented approximately orthogonally with the second transverse axis;

the circumferential centering support element comprising a ring-shaped frame having a plurality of struts interconnected by bends to define a zig-zag pattern with a third end and a fourth opposite end, two of the bends at the fourth end of the circumferential centering support element connected with the bends of the first end of the leaflet support portion and all ends at the third end of the circumferential centering support element extending away from the leaflet support portion and configured to provide outwardly-directed radial force for expansion of the circumferential centering support element to anchor the support frame to the wall of the vascular vessel;

a covering attached to the leaflet support portion and adapted to move between a first position in which a passageway in said vascular vessel is open to fluid flow and a second position that closes the passageway in said vascular vessel.

41. The valve prosthesis of claim 40, wherein the leaflet support portion and the circumferential centering support element are formed from a single cannula.

42. The valve prosthesis of claim 41, wherein the two bends at the fourth end of the centering support element are integral with the bends of the first end of the leaflet support portion.

43. The valve prosthesis of claim 41, wherein the cannula comprises one of stainless steel and Nitinol.

44. The valve prosthesis of claim 40, wherein at least one of the leaflet support portion and the centering support element are formed from wire.

45. The valve prosthesis of claim 40, wherein the leaflet support portion is formed from a first wire;

and

wherein the centering support element is formed from a second wire; and

wherein the the two bends at the fourth end of the centering support element are attached to the bends of the first end of the leaflet support portion.

46. The valve prosthesis of claim 40, wherein the leaflet support portion and the centering support element are formed from a single wire.

47. The valve prosthesis of claim 40, wherein the covering comprises a biomaterial.

48. The valve prosthesis of claim 47, wherein the covering comprises a collagen material.

49. The valve prosthesis of claim 47, wherein the covering comprises an extracellular matrix material.

50. The valve prosthesis of claim 47, wherein the covering comprises small intestine submucosa.

51. The valve prosthesis of claim 47, wherein the covering comprises one of pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa, and dura mater.

52. The valve prosthesis of claim 47, wherein the covering has remodelling properties.

53. The valve prosthesis of claim 40, wherein the covering comprises a synthetic material.

54. The valve prosthesis of claim 53, wherein the covering comprises one of DACRON and expanded polytetrafluorethylene.

55. The valve prosthesis of claim 40, wherein the covering has a multilaminate construction.

56. The valve prosthesis of claim 40, wherein the covering comprises a xenogenic material with respect to the host animal of said vascular vessel.

57. The valve prosthesis of claim 40, wherein the covering comprises autologous tissue with respect to the host animal of said vascular vessel.

58. The valve prosthesis of claim 40, wherein the covering comprises harvested native valve tissue.

59. The valve prosthesis of claim 40, wherein the covering comprises at least first and second valve leaflets.

60. A valve prosthesis for implantation within a vascular vessel, comprising:

a support frame formed from a cannula, the support frame having a lengthwise axis and comprising a leaflet support portion and a circumferential centering support element disposed adjacent the leaflet support portion on the lengthwise axis;

the leaflet support portion comprising a plurality of struts interconnected by bends and configured for expansion to conform to a wall of the vascular vessel and having a first end with two bends and a second, opposite end with two bends, the bends of the first end disposed on a first transverse axis and the bends of the second end disposed on a second transverse axis, the first transverse axis oriented approximately orthogonally with the second transverse axis;

the circumferential centering support element comprising a ring-shaped frame having a plurality of struts interconnected by bends to define a zig-zag pattern with a third end and a fourth opposite end, two of the bends at the fourth end of the circumferential centering support element integral with the bends of the first end of the leaflet support portion and all ends at the third end of the circumferential centering support element extending away from the leaflet support portion and configured to provide outwardly-directed radial force for expansion of the circumferential centering support element to anchor the support frame to the wall of the vascular vessel;

a covering attached to the leaflet support portion and adapted to move between a first position in which a passageway in said vascular vessel is open to fluid flow and a second position that closes the passageway in said vascular vessel.

61. A valve prosthesis for implantation within a vascular vessel, comprising:

a support frame formed from a cannula, the support frame having a lengthwise axis and comprising a leaflet support portion and a circumferential centering support element disposed adjacent the leaflet support portion on the lengthwise axis;

the leaflet support portion comprising a plurality of struts interconnected by bends and configured for expansion to conform to a wall of the vascular vessel and having a first end with two bends and a second, opposite end with two bends, the bends of the first end disposed on a first transverse axis and the bends of the second end disposed on a second transverse axis, the first transverse axis oriented approximately orthogonally with the second transverse axis;

the circumferential centering support element comprising a ring-shaped frame having a plurality of struts interconnected by bends to define a zig-zag pattern with a third end and a fourth opposite end, two of the bends at the fourth end of the circumferential centering support element integral with the bends of the first end of the leaflet support portion and all ends at the third end of the circumferential centering support element extending away from the leaflet support portion and configured to provide outwardly-directed radial force for expansion of the circumferential centering support element to anchor the support frame to the wall of the vascular vessel;

a covering attached to the leaflet support portion, the covering comprising at least two leaflets that cooperatively form a valve opening that extends between the two bends at the first end of the leaflet support portion and the two bends at the fourth end of the circumferential centering support element.