Fixation band for affixing a prosthetic heart valve to tissue

• US 20020055774A1
• Filed: 09/07/2001
• Published: 05/09/2002
• Est. Priority Date: 09/07/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Liddicoat, John R.
• Granted Patent: US 6,846,325 B2
• Time in Patent Office: Days
• US Class Current: 623/2.4
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A novel fixation band for affixing a prosthetic heart valve in position within the heart. In one preferred form of the invention, the fixation band generally comprises a tubular frame having a distal end and a proximal end, and a tube having a distal end and a proximal end. The tubular frame comprises a plurality of longitudinally-extending members each having a hook on its distal end and fixation means on its proximal end. The tubular frame also comprises at least one laterally-extending member for stabilizing the longitudinally-extending members relative to one another so as to form the complete tubular frame. The tube is positioned inside the longitudinally-extending members, with the distal end of the tube being everted back over the aforementioned hooks. A sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members. In use, a standard prosthetic valve is secured to the distal end of the fixation band by suturing the prosthetic valve'"'"'s sewing cuff to the fixation band'"'"'s sewing cuff. Next, the prosthetic valve, with fixation band attached, is advanced to the valve'"'"'s seat. Then the fixation band'"'"'s tubular frame is pulled proximally slightly. This action causes the ends of the hooks to pass through the side wall of the everted tube and into the surrounding tissue at the valve'"'"'s seat, whereby the fixation band, and hence the prosthetic valve, will be fixed against further proximal movement. Next, the fixation band'"'"'s fixation means are deployed so as to secure the proximal end of the fixation band to the surrounding tissue, whereby the fixation band, and hence the prosthetic valve, will be fixed against distal movement.

Claims

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

a body;

a sewing cuff for securing the prosthetic heart valve to the fixation band, said sewing cuff being attached to said body; and

a plurality of radially-expanding members for securing said fixation band to tissue, said plurality of radially-expanding members being attached to said body.

2. A fixation band according to claim 1 wherein said plurality of radially-expanding members comprise at least one hook disposed at a distal end of said body.

3. A fixation band according to claim 1 wherein said plurality of radially-expanding members comprise fixation means disposed at said proximal end of said body.

4. A fixation band according to claim 3 wherein said fixation means are actuated by bending the same radially outwardly so as to engage the surrounding tissue.

5. A fixation band according to claim 3 wherein said fixation means are adapted to be deployed by removing a restraining device, whereby the fixation means will automatically deploy against the surrounding tissue.

6. A fixation band for affixing a prosthetic heart valve to tissue, said fixation band comprising:

a tubular frame having a distal end and a proximal end, said tubular frame comprising a plurality of longitudinally-extending members each having a hook on its distal end and fixation means on its proximal end, and at least one laterally-extending member for stabilizing the longitudinally-extending members relative to one another so as to form the complete tubular frame; and

a tube positioned inside said longitudinally-extending members, with the distal end of said tube being everted back over said hooks, and with a sewing cuff being formed in said tube distal to the distalmost end of said longitudinally-extending members.

7. A fixation band according to claim 6 wherein said fixation means are actuated by bending the same radially outwardly so as to engage the surrounding tissue.

8. A fixation band according to claim 6 wherein said fixation means are adapted to be deployed by removing a restraining device, whereby the fixation means will automatically deploy against the surrounding tissue.

21. A fixation band according to claim 6 wherein said tube is flared outwardly at said distal end of said tube.

22. A fixation band according to claim 6 wherein said tube comprises a radially-extending flange at its distal end.

9. A prosthetic heart valve assembly comprising:

a prosthetic heart valve comprising a frame, at least one leaflet adapted to open and close relative to said frame, and a sewing cuff attached to said frame;

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

a body;

a sewing cuff for securing said prosthetic heart valve to said fixation band, said sewing cuff being attached to said body; and

a plurality of radially-expanding members for securing said fixation band to tissue, said plurality of radially-expanding members being attached to said body;

said prosthetic heart valve being secured to said fixation band by suturing the sewing cuff of said prosthetic heart valve to the sewing cuff of said fixation band.

10. A fixation band according to claim 9 wherein said plurality of radially-expanding members comprise at least one hook disposed at a distal end of said body.

11. A fixation band according to claim 9 wherein said plurality of radially-expanding members comprise fixation means disposed at said proximal end of said body.

12. A fixation band according to claim 11 wherein said fixation means are actuated by bending the same radially outwardly so as to engage the surrounding tissue.

13. A fixation band according to claim 11 wherein said fixation means are adapted to be deployed by removing a restraining device, whereby the fixation means will automatically deploy against the surrounding tissue.

15. A fixation band according to claim 14 wherein said plurality of radially-expanding members comprise at least one hook disposed at a distal end of said body.

16. A fixation band according to claim 14 wherein said plurality of radially-expanding members comprise fixation means disposed at said proximal end of said body.

17. A fixation band according to claim 16 wherein said fixation means are actuated by bending the same radially outwardly so as to engage the surrounding tissue.

18. A fixation band according to claim 16 wherein said fixation means are adapted to be deployed by removing a restraining device, whereby the fixation means will automatically deploy against the surrounding tissue.

23. A prosthetic heart valve assembly according to claim 14 wherein said tube is flared outwardly at said distal end of said tube.

24. A prosthetic heart valve assembly according to claim 14 wherein said tube comprises a radially-extending flange at its distal end.

14. A prosthetic heart valve assembly comprising:

a prosthetic heart valve comprising a frame, at least one leaflet adapted to open and close relative to said frame, and a sewing cuff attached to said frame;

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

a tubular frame having a distal end and a proximal end, said tubular frame comprising a plurality of longitudinally-extending members each having a hook on its distal end and fixation means on its proximal end, and at least one laterally-extending member for stabilizing the longitudinally-extending members relative to one another so as to form the complete tubular frame; and

a tube positioned inside said longitudinally-extending members, with the distal end of said tube being everted back over said hooks, and with a sewing cuff being formed in said tube distal to the distalmost end of said longitudinally-extending members;

said prosthetic heart valve being secured to said fixation band by suturing the sewing cuff of said prosthetic heart valve to the sewing cuff of the fixation band.

19. A method for affixing a prosthetic heart valve to tissue, said method comprising:

providing a prosthetic heart valve comprising a frame, at least one leaflet adapted to open and close relative to said frame, and a sewing cuff attached to said frame; and

providing a fixation band for affixing the prosthetic heart valve to tissue, said fixation band comprising a body, a sewing cuff for securing the prosthetic heart valve to the fixation band, the sewing cuff being attached to the body, and a plurality of radially-expanding members for securing the fixation band to tissue, said plurality of radially-expanding members being attached to the body;

securing the prosthetic heart valve to the fixation band by suturing the sewing cuff of the prosthetic heart valve to the sewing cuff of the fixation band;

positioning the prosthetic heart valve at its valve seat; and

fixing the fixation band to tissue surrounding the valve seat.

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

providing a prosthetic heart valve comprising a frame, at least one leaflet adapted to open and close relative to said frame, and a sewing cuff attached to said frame; and

providing a fixation band for affixing the prosthetic heart valve to tissue, said fixation band comprising a tubular frame having a distal end and a proximal end, said tubular frame comprising a plurality of

longitudinally-extending members each having a hook on its distal end and fixation means on its proximal end, and at least one laterally-extending member for stabilizing the longitudinally-extending members relative to one another so as to form the complete tubular frame; and

a tube positioned inside said longitudinally-extending members, with the distal end of said tube being everted back over said hooks, and with a sewing cuff being formed in said tube distal to the distalmost end of said longitudinally-extending members;

securing the prosthetic heart valve to the fixation band by suturing the sewing cuff of the prosthetic heart valve to the sewing cuff of the fixation band;

positioning the prosthetic heart valve at its valve seat; and

fixing the fixation band to tissue surrounding the valve seat.