DEVICE FOR COLLAPSING AND LOADING A HEART VALVE INTO A MINIMALLY INVASIVE DELIVERY SYSTEM

• US 20120083874A1
• Filed: 08/17/2011
• Published: 04/05/2012
• Est. Priority Date: 08/17/2010
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Chalekian, Aaron J., Glazier, Valerie J., Wang, Huisun, Dale, Theodore Paul
• Granted Patent: US 9,021,670 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: Y10T 29/49927 Hollow body is axially joined cup or tube
• CPC Class Codes: Y10T 29/53657 to apply or remove a resilient article [e.g., tube, sleeve, etc.]
• CPC Class Codes: Y10T 29/53796 Puller or pusher means, contained force multiplying operator
• CPC Class Codes: Y10T 29/53843 Tube, sleeve, or ferrule inserting or removing
• CPC Class Codes: Y10T 29/53852 C-frame
• CPC Class Codes: Y10T 29/539 Plier type means

Abstract

A device is provided for collapsing a stented bioprosthetic valve, including first section and second sections, each spanning between first and second ends of the device. The second section of the device is associated with the first section to at least partially enclose an internal cavity formed by the first and second sections, the internal cavity tapering from an open insertion portion at a first end of the device to an open exit portion at a second end of the device. The insertion portion has a larger dimension than the exit portion. When the first section and second section are substantially enclosing the internal cavity, a stented bioprosthetic valve may be inserted into the insertion portion and collapsed as it is moved toward and through the exit portion. The valve may then be loaded on an apparatus for insertion into the body.

Claims

1. A device for collapsing a stented bioprosthetic valve, the device comprising:

a first end and an opposed second end;

a first section spanning between said first and second ends;

a second section spanning between said first and second ends, the second section associated with the first section to at least partially enclose an internal cavity formed by the first and second sections, the internal cavity tapering from an open insertion portion at a first end of the device to an open exit portion at a second end of the device, the insertion portion having a larger dimension than the exit portion;

wherein when the first section and second section are substantially enclosing the internal cavity, a stented bioprosthetic valve may be inserted into the insertion portion and collapsed as it is moved towards the exit portion.

2. The device of claim 1, wherein the first section and second section fully enclose the internal cavity.

3. The device of claim 1, further comprising a tether or pusher adapted to associate with the stented bioprosthetic valve to enable the valve to travel from the insertion portion to the exit portion via the tether or the pusher.

4. The device of claim 1, wherein the first section and the second section are movable between a first position at least partially enclosing the internal cavity and a second position wherein the cavity is fully exposed.

5. The device of claim 1, further comprising a collar adapted to fit around at least a portion of the collapsed stented bioprosthetic valve.

6. The device of claim 5, wherein said collar comprises an orientation portion to align said collar on a second device.

7. The device of claim 1, wherein the first section is filled with a heat retaining gel.

8. The device of claim 1, further comprising insulation associated with the first section.

9. The device of claim 1, wherein the first section is manufactured from a high heat capacity metal.

10. The device of claim 1, further comprising a sleeve insertable into the internal cavity to reduce the volume thereof.

11. A method of loading a stented bioprosthetic valve onto a minimally invasive delivery system comprising:

crimping the stented bioprosthetic valve from a first condition having a first diameter to a second condition having a second diameter, the second diameter smaller than the first diameter, the crimping being achieved by advancing the stented bioprosthetic valve through a device having a tapered internal cavity, the taper advancing from a first dimension to a second dimension, the second dimension being smaller than the first;

inserting the stented bioprosthetic valve into a collar;

and loading the collar and the bioprosthetic valve onto a minimally invasive delivery system by threading at least a portion of the system into the collar.

12. The method of claim 11, wherein inserting of the stented bioprosthetic valve into a collar is performed after crimping.

13. The method of claim 12, wherein inserting of the stented bioprosthetic valve into a collar is performed simultaneously with at least a portion of the crimping.

14. The method of claim 11, further comprising cooling the device.

15. The method of claim 11, wherein the device is comprised of an outer structural shell filled with a cold-sustaining gel.

16. The method of claim 11, wherein the device includes an insulating exterior component.

17. A device for collapsing a stented bioprosthetic valve, the device comprising a cavity shaped as a frustoconical funnel spilling into a cylinder, wherein a stented bioprosthetic valve may be passed through the device to collapse the valve.

18. The device of claim 17, wherein the device is configured from high heat capacity metal.

19. The device of claim 17, wherein the device includes a cold-retaining gel core.

20. The device of claim 17, further comprising a pusher for pushing the stented bioprosthetic valve through the device or tethers for pulling the stented bioprosthetic valve through the device.