Endovascular aortic valve replacement

• US 8,915,959 B2
• Filed: 10/23/2001
• Issued: 12/23/2014
• Est. Priority Date: 07/16/1991
• Status: Expired due to Fees

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Stevens, John H.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US10/047,581
• Publication Number:
  US 20020058995A1
• Time in Patent Office: 4,809 Days
• Field of Search: 623/2.1, 623 212- 219, 623/1.26, 623/2.11, 623/2.35, 623/2.36
• US Class Current: 623/2.17
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0125 Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

The subject invention relates to a valve replacement system together with methods of preparation and use, are provided for endovascular replacement of a heart valve in a host. The valve replacement system includes up to five components: a prosthetic valve device, a valve introducer device, an intraluminal procedure device, a procedure device capsule, and a tissue cutter. The system provides for endovascular removal of a malfunctioning valve and subsequent replacement with a permanent prosthetic heart valve.

Claims

1. A valve for implantation at a desired location within a mammal, comprising:

a flexible sleeve having a proximal end, a distal end and an outside surface;

at least one cusp secured to the sleeve and configured to permit blood flow through the at least one cusp in a single direction;

at least one ring attached to the outside surface at only the proximal end of the sleeve, the at least one ring being attached to a portion of the sleeve that is not everted, wherein the ring is expandable from a first diameter to a larger, second diameter; and

at least one fastener connected to the at least one ring, the at least one fastener extending in a direction radially outward with respect to the sleeve and including at least one leg.

2. The valve of claim 1, wherein the at least one ring has a height that is less than the distance measured from the proximal end of the sleeve to the distal end of the sleeve.

3. The valve of claim 2, wherein the at least one cusp comprises three cusps attached to the sleeve, the three cusps being configured to open to permit blood to flow through the distal end when subjected to blood flow through the sleeve from the proximal end to the distal end.

4. The valve of claim 3, wherein the three cusps are configured to close to prevent blood flow through the sleeve from the distal end to the proximal end.

5. The valve of claim 3, wherein the valve is configured to have an open position that permits blood to flow through the distal end when blood flows through the sleeve from the proximal end to the distal end and a closed position to prevent blood from flowing from the distal end to the proximal end of the sleeve.

6. The valve of claim 5, wherein each of the three cusps has at least one side and each of the three cusps are configured to mate along the at least one side with a side of a cusp located adjacent to each of the three cusps when the valve is in the closed position.

7. The valve of claim 1, wherein the ring is compressible.

8. The valve of claim 1, wherein the at least one fastener is for attaching at least the sleeve at a desired location.

9. The valve of claim 8, wherein the at least one fastener comprise a series of legs arranged circumferentially about the ring.

10. The valve of claim 8, wherein the ring has a longitudinal axis and the at least one fastener comprises at least one mounting pin attached to the ring, the mounting pin having two ends offset from one another in the longitudinal direction.

11. The valve of claim 10, wherein the two ends of the at least one mounting pin extend radially outward from the mounting ring.

12. The valve of claim 1, wherein the ring is balloon expandable.

13. The valve of claim 1, wherein the sleeve and cusp are formed of different materials.

14. The valve of claim 1, wherein the at least one cusp comprises one of a homogenic material, an allogenic material and a xenogenic material.

15. The valve of claim 1, wherein the at least one cusp comprises a synthetic material.

16. The valve device of claim 1, wherein the ring has a transport configuration for transporting the valve device to the desired location and a fasten configuration for fastening the valve device at the desired location, and comprising at least one fastener extending from the ring in a direction radially outward with respect to the sleeve when the ring is in the fasten position.

17. The valve device of claim 16, wherein the at least one fastener includes at least one leg having a sharpened distal end.

18. The valve device of claim 17, wherein the sharpened distal end is configured to pierce tissue when the valve device is in the fasten configuration at the desired location.