1. A prosthesis for receiving a valve prosthesis, comprising:
an annular member advanceable into a tissue annulus;
a sewing cuff extending radially from the annular member; and
a plurality of receivers secured to the sewing cuff, each receiver comprising a pair of legs defining a pocket, the legs being deflectable away from one another to accommodate receiving an engagement member from a valve prosthesis in the pocket, the legs being resiliently deflectable towards one another after an engagement member is received in the pocket for securing the engagement member to the receiver,
wherein each receiver comprises at least one hole extending through a leg of the receiver to receive a portion of an engagement member therein.
2. The prosthesis of claim 1, wherein the sewing cuff comprises a core to which the receivers are secured, the sewing cuff further comprising a layer of fabric overlying the core.
3. The prosthesis of claim 2, wherein the layer of fabric comprises an opening overlying each receiver for receiving an engagement member therethrough.
4. A prosthetic heart valve, comprising:
a gasket member comprising an annular member advanceable into a tissue annulus, and a sewing cuff extending radially from the annular member;
a valve member comprising a frame carrying a plurality of valve elements;
a plurality engagement members extending from one of the gasket member and the valve member; and
a plurality of receivers on the other of the gasket member and the valve member, each receiver comprising a pair of legs defining a pocket, the legs being deflectable away from one another to accommodate receiving a respective engagement member in the pocket, the legs being resiliently deflectable towards one another after the engagement member is received in the pocket for securing the engagement member to the receiver, thereby securing the valve member relative to the gasket member,
wherein each engagement member comprises at least one detent, and each receiver comprises at least one hole extending through a leg for receiving the respective detent therein when the engagement member is received in the pocket.
5. The prosthetic heart valve of claim 4, wherein the engagement members extend from the frame of the valve member, and the receivers are attached to the gasket member.
6. The prosthetic heart valve of claim 4, wherein the engagement members are integrally formed with the frame.
7. The prosthetic heart valve of claim 4, wherein each engagement element comprises a tapered or rounded first edge to guide the engagement element into the respective pocket, and a substantially blunt second edge to prevent the engagement element from being removed subsequently from the respective pocket.
8. The prosthetic heart valve of claim 7, wherein each engagement element comprises a pair of detents including tapered or rounded first edges and substantially blunt second edges.
9. The prosthetic heart valve of claim 8, wherein the detents are disposed opposite one another on the engagement element.
10. A method for implanting a prosthetic valve within a biological annulus within a patient’s body, the prosthetic valve comprising a gasket member including an annular ring advanceable into a tissue annulus and a sewing cuff extending radially from the annular ring, and a valve member comprising a frame carrying a plurality of valve elements, the method comprising:
introducing the gasket member into the biological annulus such that the annular ring is disposed within the biological annulus and the sewing cuff is disposed supra-annularly above the biological annulus;
securing the gasket member relative to the biological annulus;
after securing the gasket member, introducing the valve member into the patient’s body toward the biological annulus; and
securing the valve member relative to the gasket member by engaging a plurality of engagement members extending from one of the gasket member and the valve member to a plurality of receptacles on the other of the gasket member and the valve member, each engagement member comprising one or more tabs including tapered first edges and substantially blunt second edges, each receptacle comprising a pocket for receiving a respective engagement member therein and one or more tapered surfaces for guiding a respective engagement member into the receptacle, the substantially blunt second edges preventing removal of the engagement member from the receptacle.
11. The method of claim 10, wherein the gasket member is introduced into the patient’s body in a radially compressed configuration, the method further comprising expanding the gasket member such that the annular ring to direct tissue surrounding the biological annulus radially outwardly.
12. The method of claim 10, wherein the frame of the valve member has a multiple lobed shape, and wherein the valve member is oriented within the patient’s body to align the engagement members with the receptacles.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
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.