Fixation band for affixing a prosthetic heart valve to tissue

• US 20060271175A1
• Filed: 06/29/2006
• Published: 11/30/2006
• 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.
• Granted Patent: US 7,611,535 B2
• Time in Patent Office: Days
• US Class Current: 623/2.380
• 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 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.

2. A fixation band according to claim 1 wherein the structure comprises a proximal shell portion and a distal shell position.

3. A fixation band according to claim 2 wherein at least one of the proximal shell portion and the distal shell portion comprises a plurality of exit tracts for the barbs to pass through when moving between the first position and the second position.

4. A fixation band according to claim 3 wherein the actuator comprises at least one cog disposed between the proximal shell portion and the distal shell portion, the at least one cog comprising at least one spring being selectively configurable between a loaded state and an unloaded state, wherein the barbs are selectively positioned in the first position within the peripheral boundary of the lateral region of the structure when the at least one spring is configured in the loaded state, and the barbs are selectively positioned in the second position outside the peripheral boundary of the lateral region of the structure when the at least one spring is configured in the unloaded state.

5. A fixation band according to claim 4 further comprising an attachment between a portion of each one of the at least one spring and one of the proximal shell portion and the distal shell portion, and a selectively releasable attachment between the at least one cog and at least one of the proximal shell portion and the distal shell portion, wherein release of the selectively releasable attachment causes the spring to change from the loaded state to the unloaded state so as to move the at least one cog relative to the at least one of the proximal shell portion and the distal shell portion so as to move the barbs from the first position to the second position.

6. A fixation band according to claim 5 wherein the at least one cog forms at least one first pin hole therein, at least one of the proximal shell portions and the distal shell portions forms at least one second pin hole therein corresponding to the at least one first pin hole of the at least one cog, and wherein the fixation band further comprises at least one pin configured for selective placement within a set of the at least one first pin hole and the at least one second pin hole corresponding to one another so as to selectively maintain the at least one spring of the cog in the loaded state with the barbs at the first position.

7. A fixation band according to claim 6 wherein the at least one spring is configured in the loaded state by maintaining the at least one spring in tension with the at least one pin placed within the set of the at least one first pin hole and the at least second pin hole.

8. A fixation band according to claim 1 wherein the prosthetic heart valve and the fixation band are attached to one another during manufacture of the prosthetic band.

9. A fixation band according to claim 1 wherein prosthetic heart valve and the fixation band are attached to one another subsequent to manufacture of the fixation band.

10. A prosthetic heart valve assembly comprising:

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

a fixation band for affixing the 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.

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 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;

positioning the fixation band adjacent to the tissue; and

actuating the fixation band so as to affix the prosthetic valve to tissue.

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

positioning a fixation band adjacent to the tissue; and

removing a pin in engagement with a spring in a loaded configuration so as to release the spring, cause a cog to rotate, and deploy barbs through a lateral portion of the fixation band into the tissue surrounding the fixation band.

13-23. -23. (canceled)

24. 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; 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;

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 deploy the plurality of staples into the tissue

25. A method according to claim 24 further comprising the step of removing the compression device from the proximal annular portion and the distal annular portion.

26. 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 attached to the fixation band so as to move a proximal annular portion and a distal annular portion of the fixation band toward one another so as to deploy a plurality of staples into the tissue.

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

positioning a fixation band adjacent to tissue;

actuating a compression device attached to the fixation band to move a proximal annular portion and a distal annular portion of the fixation band toward one another so as to deploy a plurality of staples into the tissue; and

attaching the prosthetic heart valve to the fixation band.