Method and systems for sizing, folding, holding, & delivering a heart valve prosthesis

• US 20060287718A1
• Filed: 06/19/2006
• Published: 12/21/2006
• Est. Priority Date: 06/21/2005
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: Bicer, Demetrio
• Granted Patent: US 7,842,084 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument

Abstract

A folding device used to fold a cardiac valve is disclosed. Also shown are methods and system for holding and delivering a cardiac valve during implantation. The folding device facilitates folding either a stented or unstented prosthetic valve prior to insertion into a valve annulus. A delivery system is provided to allow a user to measure the patient annulus to select the prosthetic valve size and insert a folded prosthetic valve into a target site. Methods for using the folding device and delivery system are also disclosed.

Claims

1. A method of folding a stented heart valve comprising the steps of

placing a stented heart valve within a flexible folding device;

and

pushing the exposed side walls of the stented valve towards the center of the folding device;

while simultaneously compressing the sides of the folding device.

2. The method claimed in claim 1, further comprising the step of inserting the folded folding device and valve into a retainer ring.

3. The method claimed in claim 1, further comprising the step of disposing the folded folding device into a valve receptacle.

4. The method claimed in claim 2, further comprising the step of disposing the folded valve into a valve receptacle.

5. A method of folding a stented heart valve comprising:

placing a stented, foldable heart valve within a flexible, semi-cylindrical folding device;

pushing the exposed side walls of the stented, foldable heart valve toward the center of the flexible, semi-cylindrical holding device and, simultaneously, compressing the sides of the flexible, semi-cylindrical folding device thereby folding the stented heart valve therebay reducing the diameter of the stented valve by up to 50 percent;

inserting the flexible, semi-cylindrical folding device and stented, foldable heart valve into a retainer ring; and

positioning the flexible folding device, stented, foldable heart valve and retainer ring into a valve receptacle.

6. A valve folding assembly for folding a stented heart valve, the device comprising

a stented valve;

and

a folding device in intimate contact with the stented valve.

7. The valve folding assembly of claim 6, further comprising sutures tied between suture holes on opposite sides of the folding device to retain the stented valve positioned within the folding device.

8. The valve folding assembly of claim 6, further comprising a stopper ring attached to the folding device.

9. The valve folding assembly of claim 6, wherein the folding device made out of a flexible material

10. The valve folding assembly of claim 6, wherein the folding device reduces the diameter of said valve by 1 to 50%. when the folding device is folded.

11. A valve folding device for folding a stented heart valve, the device comprising a

generally semi-cylindrical flexible receptacle whose curvature and length generally matches that of a heart valve prosthesis;

and

one or more suture slots located at the distal end of the valve folding device.

12. The valve folding device of claim 11, wherein the folded folding device includes locking bars attached to the sides of the folding device.

13. A valve folding assembly for folding a stented heart valve comprising:

a stented, foldable heart valve;

a flexible, semi-cylindrical foldable device, the flexible semi-cylindrical folding device having suture holes on the sides;

at least two locking bars attached to the exterior of the flexible, semi-cylindrical folding device;

a stopper ring positioned about the exterior of the flexible semi-cylindrical folding device; and

a guide rail valve receptacle adapted to be positioned about the stented, foldable heart valve, the guide rail valve receptacle having at least two guide rails adapted to engage the locking bars of the flexible, semi-cylindrical folding device.

14. A valve holder and delivery assembly comprising a

stented valve disposed within a valve receptacle;

and

a valve receptacle adapted to receive a handle.

15. The valve holder and delivery assembly of claim 14, further comprising a plunger loosely disposed within the handle.

16. A valve holder and delivery assembly comprising a

stented valve disposed within a folding device;

and a

a folding device adapted to receive a handle.

17. A heart valve and delivery assembly comprising:

a stented, foldable valve adapted to reduce the valve diameter up to about 50 percent when folded;

a heart valve receptacle disposed around the stented, foldable heart valve, the heart valve receptacle having a retainer ring positioned about the heart valve receptacle and adapted to receive a handle and a retractable plunger disposed within the handle for implanting the stented, foldable heart valve and for releasing and unfolding the stented, foldable heart valve upon retraction of the plunger.

18. A method of delivering and unfolding a stented heart valve comprising the steps of

placing a distal end of a valve holder and delivery assembly containing a folded heart valve and a plunger at a target site for implanting the valve;

and

retracting the delivery system in relation to the plunger thereby releasing the valve which unfolds at the target site.

19. A method of delivering and unfolding a stented heart valve comprising the steps of

placing the distal end of a valve holder and delivery assembly containing a folded heart valve and a plunger at the target site for implanting the valve;

and

moving the plunger relative to the delivery system thereby releasing the valve at the target site.