Prosthetic heart valve holder

• US 5,531,785 A
• Filed: 05/06/1994
• Issued: 07/02/1996
• Est. Priority Date: 05/06/1994
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Autogenics, Inc.
• Inventors: Hudak, Philip J., Suggitt, Robert W., Love, Jack W., Love, Charles S.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): FOSSUM, LAURA J
• Application Number:
  US08/239,345
• Time in Patent Office: 788 Days
• Field of Search: 623/2, 623/900, 606/1, 606/99, 606/108, 606/113
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

The present invention provides a prosthetic heart valve holder specifically configured to hold a prosthetic heart valve comprised of a stent. The heart valve holder assembly has three main components: a handle, a valve capture loop assembly and a valve retainer. The prosthetic heart valve is secured to the valve retainer by a loop of suture as the surgeon sutures or attaches the valve to the annulus of the heart. Thus, the valve holder assembly facilitates attachment of the prosthetic valve to the annulus so that the procedure may be performed in a time and labor efficient manner.

Claims

1. A valve holder for holding a prosthetic heart valve having an inflow portion and an outflow portion so that the valve is (i) accurately positioned at an annulus of a patient'"'"'s heart remaining after removal of a patient'"'"'s diseased heart valve, (ii) temporarily held in place without substantially obstructing the valve while a surgeon or technician attaches the valve within the patient'"'"'s heart while said valve is temporarily held in place by the holder, and (iii) quickly and easily removed after the prosthetic heart valve has been permanently attached at said annulus, said valve holder comprising:

a cup shaped retainer defining an inner cavity, said retainer having an open receiving end configured to accept said outflow portion of said prosthetic heart valve within said cavity;

a valve capture loop assembly comprising a base, a loop of suture attached to said base, and a spring for biasing said base and its attached loop of suture; and

a rod member inserted through said base and said spring and attached to said cup shaped retainer opposite its open receiving end, said rod member serving (i) as a handle for the surgeon or technician attaching said valve, (ii) for slidably mounting said base member, and (iii) for retaining said spring between said cup shaped retainer and said base of said valve capture loop assembly;

said holder configured to capture said prosthetic heart valve to the holder with said loop of suture so that (i) only a very minimal area of said valve is obstructed when said valve is held in place within said patient'"'"'s heart, and (ii) configured such that said prosthetic heart valve is very easily removed from said holder after its attachment within said heart by simply cutting said loop of suture to completely release said prosthetic heart valve from said holder.

2. A valve holder assembly having a length of monofilament line for securing and precisely positioning a prosthetic heart valve having an outflow portion and a base during the implantation of said valve into the annulus of the heart of a patient, comprising:

a handle having a distal and a proximal end, said distal end having external threads;

a valve capture assembly including a cylindrical base piece having a first ring located at a distal end of said base piece and including a plurality of holes, a second ring located proximally from said first ring on said base piece, and a hollowed-out portion extending through said base piece along its longitudinal axis, said valve capture assembly further including a length of monofilament line attached to said first ring where said length of monofilament line is configured to be looped over said base of said valve, said valve capture assembly further including a spring engaging said distal end of said base piece, said handle inserted into said hollowed-out portion of said cylindrical base piece; and

a valve holder having a cup portion defining an inner cavity, said holder, specifically configured to hold said outflow portion of said valve within said valve and an internally threaded attachment portion for threadable engagement with said distal end of said handle, said cup portion connected to said handle and said attachment portion registering against a distal end of said valve capture assembly spring so that said spring applies tension to said monofilament line.

3. The valve holder assembly of claim 2, wherein said handle is straight.

4. The valve holder assembly of claim 2, wherein said handle has a bend located near its distal end.

5. The valve holder assembly of claim 2, wherein said handle has a malleable middle section.

6. The valve holder assembly of claim 2, wherein said handle is made of an autoclavable material.

7. The valve holder assembly of claim 2, wherein said handle is disposable.

8. The valve holder assembly of claim 2, wherein said valve holder is made of a semi-transparent plastic.

9. The valve holder assembly of claim 2, wherein said monofilament line is made of a lubricous material.

10. The valve holder assembly of claim 2, wherein said valve retainer is a protective cover which prevents moisture from evaporating from prosthetic heart valve leaflets.

11. The valve holder assembly of claim 2, wherein said valve retainer is a protective shield for an outer stent of the prosthetic heart valve.

12. The valve holder assembly of claim 2, wherein said monofilament line has a first end and a second end and is secured to said base piece by tying together the ends of said monofilament line, thereby creating a knot which resides between said first ring and said second ring of said base piece.

13. The valve holder assembly of claim 2, wherein said monofilament line is secured to said base piece by molding said monofilament line into said base piece.

14. The valve holder assembly of claim 2, wherein said monofilament line is secured to said base piece by epoxy.

15. A valve holder assembly for precisely positioning a prosthetic heart valve having a base and an outflow portion during implantation of said valve into the heart of a patient, comprising:

a cup defining an inner cavity configured to retain the outflow portion of said prosthetic heart valve;

a valve capture assembly having a base piece, a segment of line attached to said base piece, and a spring having a first and a second end, said line configured to hold said base of said valve in said cup during implantation of said valve, said first end of said spring engaging said base piece and said second end of said spring engaging said cup, whereby said spring biases said base piece away from said cup for supplying tension to said line during the implantation of said valve; and

a handle having a threaded distal end, said handle threadably engageable with said cup.

16. A valve holder assembly for precisely positioning a prosthetic heart valve, having an outflow portion and a base, during the implantation of said valve into an annulus of the heart of a patient, comprising:

a handle having a distal and a proximal end,

a valve capture assembly including a cylindrical base piece having a first ring located at the distal end of said base piece and including a plurality of holes, a second ring located proximally from said first ring on said base piece, and a hollowed-out portion extending through said base piece along its longitudinal axis, said valve capture assembly further including a length of monofilament line attached to said first ring where said length of monofilament line is configured to be looped over the base of said valve, said valve capture assembly further including a spring, said handle inserted into said hollowed-out portion of said cylindrical base piece; and

a valve holder having a cup portion defining an inner cavity, said holder specifically configured to hold the outflow portion of said valve within said cavity and an attachment portion for attachable engagement with said distal end of said handle, said cup portion connected to said handle and said attachment portion registering against said spring.