Methods and systems for cardiac valve delivery

• US 8,790,396 B2
• Filed: 07/24/2006
• Issued: 07/29/2014
• Est. Priority Date: 07/27/2005
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Inventors: Bergheim, Bjarne, Cuevas, Walter, DuMontelle, Jeffrey P.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): Templeton, Christopher L
• Application Number:
  US11/492,486
• Publication Number:
  US 20070027534A1
• Time in Patent Office: 2,927 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.11, 606/108, 606/200, 606191-199, 604/104, 604/509, 604/96.01, 604/528, 604/141, 604/142, 604/912, 604915-919, 604/103.07, 604/95.03, 60410101-10105, 604/103, 600/138, 600/144
• US Class Current: 623/2.11
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

The present invention provides systems and methods for the repair, removal, and/or replacement of heart valves. The methods comprise introducing a delivery system into the heart, wherein a prosthesis is disposed on the delivery member attached to the delivery system, advancing the prosthesis to the target site, and disengaging the prosthesis from the delivery member at the target site for implantation. The present invention also provides implant systems for delivering a prosthesis to a target site in or near the heart. In one embodiment of the present invention, the implant system comprises a delivery system, an access system, and a prosthesis.

Claims

1. A delivery system comprising:

an elongated, rigid, rod-shaped support structure;

a balloon delivery member coupled to the support structure at a distal portion of the support structure;

a valve replacement detachably positioned about the balloon delivery member and structured to be collapsed to temporarily reduce a valve diameter, said valve replacement comprising a pliant prosthetic valve having an inlet end, an outlet end, a plurality of leaflet portions and a plurality of commissural tabs positioned at the outlet end and integrally formed with said leaflet portions; and

a collapsible stent positioned about an exterior of the valve, the collapsible stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal support posts, said commissural tabs operably coupled to said longitudinal support posts,

wherein said rigid support structure is configured to transmit longitudinal and rotational motion along its length without twisting or bending along its length,

wherein the balloon delivery member comprises a perfusion tube connecting a distal end and a proximal end of the balloon delivery member and structured to allow blood flow through the balloon delivery member, and

wherein the rigid support structure terminates between a proximal end of a balloon of the balloon delivery member and a distal end of the balloon of the balloon delivery member.

2. The delivery system of claim 1 wherein the stent is made of stainless steel.

3. The delivery system of claim 1 wherein the stent has three parallel support posts attached to the circular inflow and outflow rims at about 120°

intervals,

4. The delivery system of claim 1 wherein the rigid support structure is selected from the group consisting of a solid rod, a hollow rod, a catheter with a guide stick, and a catheter with a guide sleeve.

5. The delivery system of claim 4 wherein the hollow rod includes one or more lumens therewithin.

6. The delivery system of claim 1, wherein the rigid support structure is fabricated from the group consisting of stainless steel and a polymer.

7. The delivery system of claim 1 wherein the longitudinal support posts are adapted to align with the commissural attachments of a diseased heart valve.

8. The delivery system of claim 1 wherein said balloon delivery member includes a first inflatable balloon delivery portion positioned at a distal end of the valve, which in an inflated configuration has a diameter larger than a diameter of the valve;

and a second inflatable balloon delivery portion positioned about the rigid support structure at a proximal end of the valve, which in the inflated configuration has a diameter larger than the diameter of the valve.

9. The delivery system of claim 8 wherein the perfusion tube is positioned about the rigid support structure and within the first inflatable balloon delivery portion, the perfusion tube being operably connected to one or more holes in the first inflatable balloon delivery portion, wherein said perfusion tube is structured to allow blood flow through the perfusion tube.

10. The delivery system of claim 8 wherein said first and second balloon delivery portions comprise separate balloon delivery portions.

11. The delivery system of claim 8 wherein the balloon delivery member further includes a middle portion that is disposed within the valve and connects said first and second balloon delivery portions.

12. The delivery system of claim 11 wherein the first and second inflatable balloon delivery portions have a larger coefficient of friction than the balloon delivery member middle portion.

13. The delivery system of claim 11 wherein the perfusion tube is positioned about the rigid support structure and is operably connected to the first balloon delivery portion, the second balloon delivery portion and the middle connecting portion, wherein the perfusion tube is structured to allow blood flow through the perfusion tube.

14. The delivery system of claim 11 wherein a balloon inflation device, adapted to inflate the first and second inflatable balloon delivery portions and the balloon delivery middle portion, is secured to an exterior of the rigid support structure at a plurality of locations.

15. The delivery system of claim 14 wherein said first balloon delivery portion, said second delivery portion and said middle portion are integrally formed.

16. The delivery system of claim 1 wherein the valve replacement is structured to be folded to temporarily reduce the valve diameter by up to about 90%.

17. The delivery system of claim 1 wherein the stent is fabricated from a shape memory alloy having an Af temperature between about 0°

C. and about 30°

C.

18. The delivery system of claim 17 wherein the shape memory alloy is Nitinol.

19. The delivery system of claim 1, wherein the rigid support structure is further structured and arranged to deliver the valve replacement during a beating heart procedure.

20. The delivery system of claim 1, wherein the rigid support structure is coupled to an exterior surface of the perfusion tube.

21. The delivery system of claim 1, wherein the support structure cannot be bent by forces imposed by blood flow and a beating heart.

22. The delivery system of claim 1, wherein the support structure provides rigid support between a proximal portion of the support structure and the distal portion of the support structure located in the heart during a beating heart procedure.

23. A delivery system comprising:

an elongated, rigid, rod-shaped support structure having a proximal end and a distal end;

a balloon delivery member positioned about the support structure at a distal portion of the support structure;

a valve replacement detachably positioned about the balloon delivery member and structured to be collapsed to temporarily reduce a valve diameter; and

a collapsible stent positioned about an exterior of the valve, the collapsible stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal support posts,

wherein the proximal and distal ends of the support structure maintain longitudinal and rotational position and orientation with respect to each other,

wherein the balloon delivery member comprises a perfusion tube connecting a distal end and a proximal end of the balloon delivery member and structured to allow blood flow through the balloon delivery member, and

wherein the support structure terminates between a proximal end of a balloon of the balloon delivery member and a distal end of the balloon of the balloon delivery member.

24. The delivery system of claim 23, wherein the support structure provides rigid support between the proximal end of the support structure and the distal end of the support structure located in the heart during a beating heart procedure.

25. A scapus delivery system comprising:

an elongated, rigid scapus;

a balloon delivery member positioned about the scapus;

a heart valve replacement detachably positioned about the balloon delivery member and structured to be collapsed to temporarily reduce a valve diameter; and

a collapsible stent positioned about an exterior of the valve, the collapsible stent having a circular inflow nm and a circular outflow rim connected by a plurality of longitudinal support posts,

wherein said rigid scapus is structured to precisely longitudinally and rotationally position said valve replacement in an aorta transapically,

wherein the scapus is configured to resist bending and torsion,

wherein the balloon delivery member comprises a perfusion tube connecting a distal end and a proximal end of the balloon delivery member and structured to allow blood flow through the balloon delivery member, and

wherein the scapus terminates between a proximal end of a balloon of the balloon delivery member and a distal end of the balloon of the balloon delivery member.

26. The delivery system of dam 25, wherein the scapus provides rigid support between a proximal portion of the scapus and a distal portion of the scapus located in the heart during a beating heart procedure.