Method and system for cardiac valve delivery

• US 20050240200A1
• Filed: 04/23/2004
• Published: 10/27/2005
• Est. Priority Date: 04/23/2004
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Inventors: Bergheim, Bjarne
• Granted Patent: US 10,219,899 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2230/0006 circular

Abstract

The invention provides methods and systems for introducing a delivery device in the heart at or near the apex of the heart, wherein the delivery device includes a prosthesis, advancing the prosthesis to the target site, and disengaging the prosthesis from the delivery device at the target site for implantation. Specifically, the present invention provides valve replacement systems for delivering a replacement heart valve to a target site in or near a heart. The valve replacement system comprises a trocar or other suitable device to penetrate the heart at or near the apex of the heart, a delivery member that is movably disposed within the trocar, and a replacement cardiac valve disposed on the delivery member. The delivery member may further comprise mechanical or inflatable expanding members to facilitate implantation of the prosthetic valve at the target site.

Claims

1. A method for delivering a prosthesis to a target site in or near a heart, the method comprising:

introducing a delivery device into the heart at or near the apex of the heart, wherein the delivery device includes the prosthesis;

advancing the prosthesis to the target site; and

disengaging the prosthesis from the delivery device at the target site.

2. The method of claim 1 further comprising the step of imaging the heart during surgery.

3. The method of claim 2 wherein the step of imaging the heart is performed by an imaging system selected from the group consisting of:

an ultrasound viewing instrument, an intravascular ultrasound system, a transesophageal echo system, a transthoracic echo system, fluoroscopy, cinefluoroscopy, and an injectable radiopaque dye.

4. The method of claim 1 wherein the prosthesis is a temporary valve.

5. The method of claim 1 wherein the prosthesis is a distal embolic protection assembly.

6. The method of claim 1 wherein the prosthesis is a replacement cardiac valve.

7. The method of claim 6 wherein the target site is selected from a group consisting of an aortic valve and a mitral valve.

8. The method of claim 7 wherein the delivery device is introduced into the left ventricle of the heart.

9. The method of claim 6 wherein the target site is selected from the group consisting of a pulmonary valve and a tricuspid valve.

10. The method of claim 9 wherein the delivery device is introduced into the right ventricle of the heart.

11. The method of claim 6 wherein the replacement cardiac valve comprises a tissue valve secured to a support structure.

12. The method of claim 11 wherein the support structure is a radially collapsible and expandable cylindrical stent.

13. The method of claim 12 wherein the cylindrical stent is made of Nitinol.

14. The method of claim 6 further comprising the step of removing a dyfunctional or diseased native valve before disengaging the prosthesis from the delivery device.

15. The method of claim 14 further comprising the step of implanting a distal embolic protection assembly near the target site before the step of removing the native valve.

16. The method of claim 6 further comprising the step of cleaning the native valve area.

17. A valve replacement system for delivering a replacement valve to a target site in or near a heart, the system comprising:

a trocar for penetrating the heart at or near the apex of the heart;

a delivery member movably disposed within the trocar, the delivery member having distal and proximal ends and an expansion and contracting member; and

a replacement cardiac valve disposed on expansion and contracting member of the delivery member.

18. The system of claim 17 wherein the trocar comprises an inner lumen and a stop-valve disposed within the inner lumen.

19. The system of claim 17 wherein the delivery member is a hollow tube.

20. The system of claim 17 wherein the delivery member further comprises an ultrasound transducer.

21. The system of claim 20 where in the delivery member further comprises a first and second ultrasound transducers at both ends of the balloon.

22. The system of claim 17 wherein the catheter further comprises a tip attachment.

23. The system of claim 22 wherein the tip attachment is selected from a group consisting of:

a distal embolic protection system, a temporary valve, an imaging system, a valve removal system, and a valve cleaning system.

24. The system of claim 17 wherein the delivery member further comprises an inner element.

25. The system of claim 24 wherein the inner element is used for inserting a guide wire or a pulling wire for controlling the tip deflection.

26. The system of claim 25 wherein the inner element is a fluid infusion conduit for the expansion and contracting member.