BALLOON VALVULOPLASTY DELIVERY SYSTEM

• US 20160220367A1
• Filed: 02/04/2015
• Published: 08/04/2016
• Est. Priority Date: 02/04/2015
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: BARRETT, DONNA
• Application Number:
  US14/613,851
• Publication Number:
  US 20160220367A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A balloon dilation and valve prosthesis delivery device is provided to treat a stenosed valve through balloon dilation and to deliver a valve prosthesis. The device includes an inner shaft assembly including an intermediate portion providing a coupling structure configured to selectively engage a prosthetic valve, and an outer shaft assembly including a delivery sheath capsule, and an expandable balloon attached to a distal end of the outer shaft assembly, and an inflation lumen extending along the length of the outer shaft assembly.

Claims

1. A balloon dilation and valve prosthesis delivery device comprising:

an inner shaft assembly including an intermediate portion providing a coupling structure configured to selectively engage a prosthetic heart valve; and

an outer shaft assembly including;

a delivery sheath capsule at a distal end of the outer shaft assembly, the capsule being slidably disposed over the inner shaft assembly and configured to compressively contain a prosthetic heart valve engaged with the coupling structure,

an expandable balloon removeably coupled to a distal end of the outer shaft, and

an inflation lumen extending along the length of the outer shaft assembly, configured to transmit fluid into the balloon for expansion.

2. The device of claim 1, wherein the prosthetic heart valve is self-expanding.

3. The device of claim 1, wherein the capsule is configured to compressively contain the prosthetic heart valve within an interior area of the capsule.

4. The device of claim 1, wherein the prosthetic heart valve includes a frame and a plurality of valve leaflets, the frame being configured to engage the coupling structure.

5. The device of claim 1, wherein the balloon has first and second opposing ends and an intermediate section disposed therebetween, at least one of the first and second ends of the balloon removeably coupled to the distal end of the outer shaft assembly.

6. The device of claim 5, wherein at least one of the first and second ends of the balloon is fluidly connected to the inflation lumen.

7. The device of claim 1, wherein the balloon is removeably coupled to a base tip on the distal end of the outer shaft.

8. The device of claim 7, wherein the base tip has a collet portion extending distally therefrom.

9. The device of claim 8, wherein the collet portion includes a plurality of fingers which are deformable in a radial direction when either an axial or radial force is applied to the fingers.

10. The device of claim 8, wherein one end of the balloon is disposed between the outer shaft assembly and the collet portion.

11. The device of claim 10, wherein a collet sleeve is removably coupled to the collet portion to secure one end of the balloon to the base tip.

12. The device of claim 8, wherein a tip end is disposed over collet portion and removeably coupled to the base tip.

13. An balloon dilation and valve prosthesis delivery device comprising:

an inner shaft including a valve prosthesis assembly including an intermediate portion providing a coupling structure configured to selectively engage a prosthetic heart valve; and

an outer shaft assembly including;

a delivery sheath capsule at a distal end of the outer shaft assembly, the capsule being slidably disposed over the inner shaft assembly and configured to compressively contain a prosthetic heart valve engaged with the coupling structure,

an expandable balloon removeably coupled to a distal end of the outer shaft, and

an inflation lumen extending along the length of the outer shaft assembly, configured to transmit fluid into the balloon for expansion, the inner shaft telescopically slidable within the inflation lumen of the outer shaft assembly, such that a distal end of the inner shaft is extendible forwardly past the distal end of the outer shaft to dispose the inner member within the balloon.

14. The device of claim 13, wherein the balloon has first and second opposing ends and an intermediate section disposed therebetween, the first end of the balloon removeably coupled to the distal end of the outer shaft.

15. The device of claim 14, wherein the distal end of the inner member is removeably coupled to the second end of the balloon.

16. The device of claim 15, wherein the distal end of the inner member is secured to the second end of the balloon with a cap.

17. The device of claim 14, wherein the balloon is collapsible in a axial direction when the inner member is retracted rearwardly within outer shaft.

18. The device of claim 13, further comprising a handle coupled to a proximal end of the outer sheath, wherein an inner member handle is disposed exterior to the handle at a proximal end thereof, inner member handle allows for telescopic manipulation of inner member forwardly and rearwardly within outer sheath.