Fixation band for affixing a prosthetic heart valve to tissue

• US 7,097,659 B2
• Filed: 04/16/2003
• Issued: 08/29/2006
• Est. Priority Date: 09/07/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Liddicoat, John R., Streeter, Richard B., Taylor, Daniel C., Woolfson, Steven B.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H
• Application Number:
  US10/414,766
• Publication Number:
  US 20040044406A1
• Time in Patent Office: 1,231 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.38
• US Class Current: 623/2.4
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising: a structure having a proximal end and a distal end in opposition to one another, and a lateral region between the proximal end and the distal end, wherein the prosthetic heart valve is attached to one of the proximal end and the distal end of the structure; a plurality of barbs selectively configurable between a first position and a second position, the barbs being contained within a peripheral boundary of the lateral region of the structure in the first position, and the barbs being extended from the peripheral boundary of the lateral region of the structure in the second position; and an actuator for selectively moving the plurality of barbs between the first position and the second position. A fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising: a proximal annular portion and a distal annular portion selectively positioned relatively to one another, the proximal annular portion and the distal annular portion each having a proximal side and a distal side, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and the prosthetic heart valve being attached to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion; a plurality of staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device in attachment to the proximal annular portion and the distal annular portion, the compression device being configured to selectively position the proximal annular member and the distal annular member toward one another so as to compress the plurality of staples therebetween and deploy the plurality of staples into tissue so as to affix the prosthetic heart valve to the tissue.

Claims

1. A fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising:

a proximal annular portion and a distal annular portion selectively positionable relative to one another, the proximal annular portion and the distal annular portion each having a proximal side and a distal side, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and a prosthetic heart valve being attachable to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion;

a plurality of staples operatively supported between the proximal annular portion and the distal annular portion; and

a compression device operatively positioned between the proximal annular portion and the distal annular portion, the compression device for selectively relatively moving the proximal annular member and the distal annular member toward one another so as to compress the plurality of staples and to deform the plurality of staples and thus deploy the staples into tissue for affixing a prosthetic heart valve to tissue.

2. A fixation band according to claim 1 wherein at least one of the proximal annular member and the distal annular member forms an anvil so as to bend a portion of the staples toward the tissue.

3. A fixation band according to claim 1 wherein the proximal annular member and the distal annular member form a first anvil and a second anvil so as to bend a first portion of the staples and a second portion of the staples, respectively.

4. A fixation band according to claim 3 wherein the first anvil and the second anvil form an opened curve with respect to one another so as to form a “

C”

shaped staple therebetween.

5. A fixation band according to claim 1 wherein the plurality of staples have a first end and a second end.

6. A fixation band according to claim 1 further comprising a band connecting together the plurality of staples.

7. A fixation band according to claim 1 wherein the compression device comprises a support engaging the proximal annular portion and a plurality of cables connected to the distal annular portion, and further wherein the plurality of cables are configured to be drawn through the support so as to move the proximal annular portion and the distal annular portion toward one another.

8. A fixation band according to claim 7 wherein the plurality of cables are selectively attached to the distal annular portion so as to disconnect the compression device after the staples are deployed into the tissue.

9. A fixation band according to claim 1 wherein the compression device is selectively attached to the proximal annular portion and the distal annular portion so as to disconnect the compression device after the staples are deployed into the tissue.

10. A prosthetic heart valve assembly comprising:

a prosthetic heart valve comprising a frame, and at least one leaflet adapted to open and close relative to the frame; and

a fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising;

a proximal annular portion and a distal annular portion selectively positionable relative to one another, the proximal annular portion and the distal annular portion each having a proximal side and a distal side, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and the prosthetic heart valve being attached to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion;

a plurality of staples operatively supported between the proximal annular portion and the distal annular portion; and

a compression device operatively positioned between the proximal annular portion and the distal annular portion, the compression device for selectively relatively moving the proximal annular member and the distal annular member toward one another so as to compress the plurality of staples and to deform the plurality of staples and thus deploy the staples into tissue so as to affix the prosthetic heart valve to tissue.