Percutaneous atrioventricular valve and method of use

• US 20070156233A1
• Filed: 08/24/2006
• Published: 07/05/2007
• Est. Priority Date: 08/25/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Yadav, Jay, Kapadia, Samir, Tuzcu, E.
• Granted Patent: US 7,611,534 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid

Abstract

An apparatus for percutaneously replacing a diseased cardiac valve includes an expandable support member for positioning in an atrial chamber. The expandable support member includes at least one anchoring portion for anchoring in at least one opening that extends from the atrial chamber and a main body portion located adjacent the at least one anchoring portion. The main body portion has a cage-like structure and is adapted to conform to a size and shape of the atrial chamber. An expandable ring is selectively connected to the main body portion. The expandable ring is adapted to engage an annulus of the diseased cardiac valve. A prosthetic valve is attached to the expandable ring. The prosthetic valve is adapted to replace the diseased cardiac valve. A method for percutaneously replacing a diseased cardiac valve is also described.

Claims

1. An apparatus for percutaneously replacing a diseased cardiac valve, the apparatus comprising:

an expandable support member for positioning in an atrial chamber, the expandable support member including at least one anchoring portion for anchoring in at least one opening that extends from the atrial chamber and a main body portion located adjacent the at least one anchoring portion, the main body portion having a cage-like structure and being adapted to conform to a size and shape of the atrial chamber;

an expandable ring selectively connected to the main body portion, the expandable ring being adapted to engage an annulus of the diseased cardiac valve; and

a prosthetic valve attached to the expandable ring, the prosthetic valve being adapted to replace the diseased cardiac valve.

2. The apparatus of claim 1, wherein at least a portion of the apparatus is formed from a biodegradable material.

3. The apparatus of claim 1, wherein at least a portion of the apparatus is adapted to elute a therapeutic agent.

4. The apparatus of claim 1, wherein the prosthetic valve is attachable to the annulus of the diseased cardiac valve.

5. The apparatus of claim 4, wherein the prosthetic valve is attachable to the annulus of the diseased cardiac valve with a plurality of barbs at least partially encased in a biodegradable material.

6. The apparatus of claim 1, wherein at least one anchoring portion is a first anchoring portion for anchoring in a first opening that extends from the atrial chamber, and an oppositely disposed second anchoring portion is provided for anchoring in a second opening that extends from the atrial chamber, the main body portion being intermediate the first and second anchoring portions.

7. The apparatus of claim 1, wherein the expandable ring is adapted to support the prosthetic valve in the annulus of the diseased cardiac valve when the main body portion is detached from the expandable ring.

8. The apparatus of claim 1, wherein the main body portion includes a plurality of strut members having a three-dimensional cage-like structure.

9. The apparatus of claim 1, wherein the at least one anchoring portion has a cage-like structure, the cage-like structure of the at least one anchoring portion having a different configuration from the cage-like structure of the main body portion.

10. The apparatus of claim 1, wherein a biocompatible material extends between the expandable ring and the main body portion, the biocompatible material being adapted to release the expandable ring from the main body portion after a predetermined time has elapsed.

11. A method for percutaneously replacing a diseased cardiac valve, the method comprising the steps of:

providing an apparatus including an expandable support member having at least one anchoring portion, a cage-like main body portion located adjacent the at least one anchoring portion, an expandable ring selectively connected to the main body portion, and a prosthetic valve attached to the expandable ring;

introducing the apparatus into a patient'"'"'s vasculature;

positioning at least a portion of the apparatus within the patient'"'"'s atrial chamber;

deploying the apparatus in the atrial chamber with the at least one anchoring portion of the expandable support member being anchored in an opening extending from the atrial chamber;

positioning the expandable ring of the expandable support member adjacent the annulus of the diseased cardiac valve; and

engaging the expandable ring of the expandable support member with the annulus of the diseased cardiac valve to position the prosthetic valve of the apparatus within the annulus of the diseased cardiac valve.

12. The method of claim 11, wherein at least a portion of the apparatus is formed from a biodegradable material.

13. The method of claim 11, wherein at least a portion of the apparatus is adapted to elute a therapeutic agent.

14. The method of claim 11, wherein the step of engaging the expandable ring of the expandable support member with the annulus of the diseased cardiac valve includes the step of attaching the expandable ring to the annulus of the diseased cardiac valve with a plurality of barbs at least partially encased in a biodegradable material.

15. The method of claim 11, wherein the step of deploying the apparatus in the atrial chamber with the at least one anchoring portion of the expandable support member being anchored in an opening extending from the atrial chamber includes the steps of:

anchoring a first anchoring portion in a first opening that extends from the atrial chamber;

providing an oppositely disposed second anchoring portion with the main body portion being intermediate the first and second anchoring portions; and

anchoring the second anchoring portion in a second opening that extends from the atrial chamber.

16. The method of claim 11, including the steps of:

maintaining the prosthetic valve within the annulus of the diseased cardiac valve; and

removing the main body portion and the at least one anchoring portion from the atrial chamber.

17. The method of claim 16, including the step of detaching the expandable ring from the main body portion.

18. The method of claim 16, wherein the step of removing the main body portion and the at least one anchoring portion from the atrial chamber includes the step of allowing the main body portion and the at least one anchoring portion to biodegrade within the atrial chamber.

19. The method of claim 11, wherein a biocompatible material extends between the expandable ring and the main body portion, and including the step of allowing the biocompatible material to release the expandable ring from the main body portion after a predetermined time has elapsed.

20. A method for percutaneously replacing a diseased cardiac valve, the method comprising the steps of:

determining at least one dimension of the diseased cardiac valve and an atrial chamber of a patient;

providing an apparatus in response to the at least one determined dimension, the apparatus including an expandable support member having at least one anchoring portion, a cage-like main body portion located adjacent the at least one anchoring portion, an expandable ring selectively connected to the main body portion, and a prosthetic valve operatively secured to the expandable ring;

inserting a first guidewire through the patient'"'"'s vasculature and into the atrial chamber;

providing a peelable catheter having longitudinally spaced proximal and distal end portions, the distal end portion including a slit having a predetermined length;

passing the peelable catheter over the first guidewire and positioning the distal end portion in the atrial chamber such that at least a portion of the slit is located in the atrial chamber;

inserting a second guidewire into the peelable catheter;

passing a distal end of the second guidewire out of the peelable catheter through the slit;

passing the distal end of the second guidewire through the diseased cardiac valve and into a ventricular chamber;

attaching the apparatus to a proximal end of the second guidewire;

introducing the apparatus into a patient'"'"'s vasculature;

passing the apparatus through the peelable catheter along the first guidewire;

positioning at least a portion of the apparatus within the atrial chamber;

actuating the second guidewire to remove at least a portion of the apparatus from the slit of the peelable catheter within the atrial chamber;

deploying the apparatus in the atrial chamber with the at least one anchoring portion of the expandable support member being anchored in an opening extending from the atrial chamber;

positioning the expandable ring of the expandable support member adjacent the annulus of the diseased cardiac valve; and

engaging the expandable ring of the expandable support member with the annulus of the diseased cardiac valve to position the prosthetic valve of the apparatus within the annulus of the diseased cardiac valve.

21. The method of claim 20, including the steps of:

passing the second guidewire through the ventricular chamber; and

removing the distal end of the second guidewire from the patient through the patient'"'"'s vasculature.

22. The method of claim 20, wherein the step of deploying the apparatus in the atrial chamber with the at least one anchoring portion of the expandable support member being anchored in an opening extending from the atrial chamber includes the steps of:

anchoring a first anchoring portion in a first opening that extends from the atrial chamber;

providing an oppositely disposed second anchoring portion with the main body portion being intermediate the first and second anchoring portions; and

anchoring the second anchoring portion in a second opening that extends from the atrial chamber.

23. The method of claim 20, wherein the step of positioning the expandable ring of the expandable support member adjacent the annulus of the diseased cardiac valve includes the steps of:

providing a plurality of strands operatively linking the expandable ring and the second guidewire; and

using the second guidewire to apply force to at least one strand which steers the expandable ring into position adjacent the annulus of the diseased cardiac valve.

24. The method of claim 20, wherein at least a portion of the apparatus is formed from a biodegradable material.

25. The method of claim 20, wherein at least a portion of the apparatus is adapted to elute a therapeutic agent.

26. The method of claim 20, wherein the step of engaging the expandable ring of the expandable support member with the annulus of the diseased cardiac valve includes the step of attaching the expandable ring to the annulus of the diseased cardiac valve with a plurality of barbs at least partially encased in a biodegradable material.

27. The method of claim 20, including the steps of:

maintaining the prosthetic valve within the annulus of the diseased cardiac valve; and

removing the main body portion and the at least one anchoring portion from the atrial chamber.

28. The method of claim 27, including the step of detaching the expandable ring from the main body portion.

29. The method of claim 27, wherein the step of removing the main body portion and the at least one anchoring portion from the atrial chamber includes the step of allowing the main body portion and the at least one anchoring portion to biodegrade within the atrial chamber.

30. The method of claim 20, wherein a biocompatible material extends between the expandable ring and the main body portion, and including the step of allowing the biocompatible material to release the expandable ring from the main body portion after a predetermined time has elapsed.

31. The method of claim 20, including the step of removing at least one of the peelable catheter, the first guidewire, and the second guidewire from the patient through the patient'"'"'s vasculature.