Fixation band for affixing a prosthetic heart valve to tissue

• US 9,539,088 B2
• Filed: 10/01/2009
• Issued: 01/10/2017
• Est. Priority Date: 09/07/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Woolfson, Steven B., Streeter, Richard B., Taylor, Daniel C., Liddicoat, John R.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US12/587,041
• Publication Number:
  US 20100030244A1
• Time in Patent Office: 2,658 Days
• US Class Current: 1/1
• 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 having proximal and distal annular portions positionable relative to one another, the proximal and distal annular portions each having a proximal and distal sides, 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; staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device operative between the proximal and distal annular portions for selectively positioning the proximal and distal annular members toward one another for compressing the staples therebetween and deploying the staples into tissue so as to affix the prosthetic heart valve to tissue.

Claims

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

positioning a fixation band having the prosthetic heart valve attached thereto adjacent to the tissue; and

actuating a compression device that is operatively attached to the fixation band for moving a proximal annular portion and a distal annular portion of the fixation band toward one another, and thereby deforming and deploying at least one staple that is supported between the proximal and distal annular portions into the tissue;

wherein the proximal annular portion and the distal annular portion each define an arcuate surface for deforming the at least one staple.

2. The method according to claim 1 wherein each staple has first and second ends that are movable with respect to one another.

3. The method according to claim 2 wherein after the step of actuating the compression device, both of the first and second ends of each staple engage the tissue.

4. The method according to claim 2 wherein the step of deforming and deploying at least one staple includes compressing the first and second ends of each staple with the compression device.

5. The method according to claim 1 wherein each staple is C-shaped after being deformed.

6. A method for affixing a prosthetic heart valve to tissue, the method comprising:

positioning a fixation band adjacent to tissue;

after the step of positioning the fixation band, actuating a compression device that is operatively attached to the fixation band for moving a proximal annular portion and a distal annular portion of the fixation band toward one another, and thereby deforming and deploying at least one staple that is supported between the proximal and distal annular portions into the tissue; and

after the step of actuating the compression device, attaching the prosthetic heart valve to the fixation band.

7. The method according to claim 6 wherein each staple has first and second ends that are movable with respect to one another.

8. The method according to claim 7 wherein after the step of actuating the compression device, both of the first and second ends of each staple engage the tissue.

9. The method according to claim 7 wherein the step of deforming the at least one staple includes compressing the first and second ends with the compression device.

10. The method according to claim 6 wherein each staple is C-shaped after being deformed.

11. A method for affixing a prosthetic heart valve to tissue, the method comprising:

providing 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, each of the plurality of staples having two ends; 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 portion and the distal annular portion toward one another so as to compress the two ends of each of the plurality of staples therebetween so as to deform and deploy the plurality of staples into tissue so as to affix the prosthetic heart valve to the tissue;

positioning the fixation band adjacent to the tissue; and

actuating the compression device so as to move the proximal annular portion and the distal annular portion toward one another so as to deform at least one of the plurality of staples and to deploy the deformed staple into the tissue.

12. A method according to claim 11 further comprising the step of removing the compression device from the proximal annular portion and the distal annular portion.

13. The method according to claim 11 wherein the proximal annular portion and the distal annular portion each define an arcuate surface for deforming the plurality of staples during the step of actuating the compression device.

14. The method according to claim 11 wherein after the step of actuating the compression device, both of the first and second ends of each respective staple engage the tissue.

15. The method according to claim 11 wherein each of the plurality of staples is C-shaped after being deformed.

16. The method according to claim 11 wherein, during the step of actuating the compression device, the proximal annual portion and the distal annular portion each shape one respective first and second end of each of the plurality of staples.