Low Profile Delivery System for Transcatheter Heart Valve

• US 20090281619A1
• Filed: 10/08/2008
• Published: 11/12/2009
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Tran, Tri, Le, Thanh H., Vidal, Antonio, Cayabyab, Ronaldo, Taylor, David, Bowes, Robert
• Granted Patent: US 9,061,119 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• 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: A61M 25/1011 Multiple balloon catheters

Abstract

A heart valve delivery apparatus includes a valve carrying member. A prosthetic valve is crimped onto the valve carrying member at a location that is distal or proximal to the balloon member, thereby providing a smaller profile delivery apparatus.

Claims

1. An apparatus for delivering a prosthetic valve through the vasculature of a patient comprising:

a main catheter, the main catheter comprising an elongated shaft;

a balloon catheter comprising an elongated shaft and a balloon connected to a distal end portion of the shaft, the shaft of the balloon catheter being capable of moving longitudinally within the shaft of the main catheter; and

a valve carrying member, the valve carrying member having a mounting surface for receiving a crimped valve for insertion into the vasculature of the patient, the balloon being positioned distal or proximal to the mounting surface, the balloon being configured to be movable relative to the mounting surface, or vice versa, to position the balloon at a location extending through the crimped valve after the valve is inserted into the patient'"'"'s vasculature.

2. The apparatus according to claim 1, the apparatus further comprising a nose piece, wherein the valve carrying member extends between a proximal end of the nose piece and a distal end of the shaft of the main catheter.

3. The apparatus according to claim 2, wherein the valve carrying member comprises two or more strip members, the strip members being attached to the proximal end of the nose piece and the distal end of the shaft of the main catheter.

4. The apparatus according to claim 3, wherein a proximal end of the nose piece comprises one or more slits and the distal end of the shaft of the main catheter comprises one or more slits.

5. The apparatus according to claim 1, wherein the valve carrying member comprises an elongated shaft that extends coaxially with respect to the shaft of the main catheter.

6. The apparatus according to claim 5, wherein the shaft of the valve carrying member has a distal end portion that extends beyond the distal end of the shaft of the main catheter, the distal end portion of the shaft of the valve carrying member comprising the mounting surface of the valve carrying member.

7. The apparatus according to claim 6, wherein the prosthetic valve is connected to the distal end of the shaft of the main catheter using a temporary connecting device.

8. The apparatus according to claim 6, wherein the temporary connecting device comprises suture connected to the valve and a wire that is connected to the shaft of the main catheter and the suture.

9. The apparatus according to claim 6, wherein the shaft of the valve carrying member comprises a Nitinol braid.

10. The apparatus according to claim 6, the apparatus further comprising a nose piece, wherein the shaft of the valve carrying member extends between a proximal end of the nose piece and a distal end of the shaft of the main catheter.

11. The apparatus according to claim 10, wherein the distal end of the shaft of the valve carrying member is attached to an inside surface of the nose piece, and a portion of the shaft of the valve carrying member is disposed within the shaft of the main catheter.

12. The apparatus according to claim 10, wherein a proximal end of the nose piece comprises one or more slits and a distal end of the shaft of the main catheter comprises one or more slits.

13. The apparatus according to claim 12, wherein the distal end of the shaft of the main catheter further comprises a flex adapter disposed at the location of the slits, the flex adaptor having two or more fingers that are configured to maintain the slits in a radially expanded position in the absence of an inwardly directed force.

14. The apparatus according to claim 12, wherein the nose piece further comprises a polymer jacket surrounding at least a portion of the slits on the nose piece.

15. An apparatus for delivering a prosthetic valve through the vasculature of a patient comprising:

a main catheter, the main catheter comprising an elongated shaft; and

a balloon catheter comprising an elongated shaft, a balloon connected to a distal end portion of the shaft, and an extension portion, the balloon catheter being capable of moving longitudinally within the shaft of the main catheter;

wherein the extension portion of the balloon catheter is located between the balloon and the elongated shaft and is configured to receive a prosthetic valve in a crimped state on an outer surface of the extension portion.

16. The apparatus according to claim 15, wherein the extension portion of the balloon catheter is formed of the same material as the balloon.

17. The apparatus according to claim 15, the apparatus further comprising a nose piece, wherein a distal portion of the balloon is attached to the nose piece.

18. The apparatus according to claim 17, wherein the distal portion of the balloon is attached at approximately the mid-point of the nose piece.

19. The apparatus according to claim 17, wherein the nose piece is configured to move relative to the crimped prosthetic valve, so that the nose piece can be moved adjacent to the crimped prosthetic valve while the crimped prosthetic valve is in the vasculature of the patient.

20. The apparatus according to claim 19, wherein the nose piece has a substantially hourglass shape with a proximal concave portion, wherein the proximal concave portion of the nose piece is configured to receive at least a portion of the balloon when the nosepiece is moved adjacent to the crimped prosthetic valve.