PRE-SIZED PROSTHETIC CHORDAE IMPLANTATION SYSTEM

• US 20100249919A1
• Filed: 03/31/2010
• Published: 09/30/2010
• Est. Priority Date: 03/31/2009
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Gillinov, A. Marc, Hemingway, Jeremy, Bauer, Jonathan, Banbury, Michael K., Berky, Craig B.
• Granted Patent: US 8,439,969 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A pre-sized prosthetic chordae assembly includes a male attachment unit and a female securing member. The male attachment unit includes a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to the at least one male attachment member. The female securing member is for receiving the papillary penetration member.

Claims

1. A pre-sized prosthetic chordae assembly comprising:

a male attachment unit comprising a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to said at least one male attachment member; and

a female securing member for receiving said papillary penetration member.

2. The pre-sized prosthetic chordae assembly of claim 1, wherein said male attachment unit further comprises first and second male attachment members, each of said first and second male attachment members having oppositely disposed first and second surfaces, said papillary muscle penetration member extending substantially axial to said first and second surfaces of each of said first and second male attachment members.

3. The pre-sized prosthetic chordae assembly of claim 2, wherein said papillary muscle penetration member includes a proximal end and a sharpened distal tip, said proximal end being securely connected to said first male attachment member.

4. The pre-sized prosthetic chordae assembly of claim 2, wherein each of said pre-sized prosthetic chordae is fixedly connected to said first surface of said second male attachment member.

5. The pre-sized prosthetic chordae assembly of claim 1, wherein each of said pre-sized prosthetic chordae further comprises:

a continuous first strand of a material having an arcuate first end portion and a second end portion that is formed into a knot; and

at least one rung that is axially spaced between said first and second end portions, said at least one rung including first and second ends that are securely connected to said first strand by first and second knots.

6. The pre-sized prosthetic chordae assembly of claim 2, wherein said second surface of said first male attachment member includes a backing for supporting said papillary muscle penetration member.

7. The pre-sized prosthetic chordae assembly of claim 2, wherein each of said second male attachment member and said female securing member include at least one channel extending therethrough.

8. The pre-sized prosthetic chordae assembly of claim 1, wherein said female securing member includes a protective member to prevent said distal tip of said papillary muscle penetration member from damaging a cardiac structure.

9. The pre-sized prosthetic chordae assembly of claim 1, wherein each of said at least one male attachment member and said female securing member comprises a pledget.

10. An apparatus for implanting a pre-sized prosthetic chordae assembly in a subject, said apparatus comprising:

a proximal handle;

a distal applicator end operably linked to said proximal handle via an intermediate portion that defines a longitudinal axis, said distal applicator end comprising opposable first and second jaw members, each of said first and second jaw members including a port for receiving the pre-sized prosthetic chordae assembly; and

an actuating mechanism that extends between said proximal handle and said distal applicator end, said actuating mechanism for actuating said second jaw member.

11. The apparatus of claim 10, wherein said port of each of said first and second jaw members is defined by an opening in fluid communication with opposing longitudinal slots that extend along a portion of each of said first and second jaw members.

12. The apparatus of claim 10, wherein said proximal handle includes an adjustment mechanism for controlling rotation of said distal applicator end about said longitudinal axis.

13. The apparatus of claim 10, wherein each of said first and second jaw members includes a proximal end and a distal end, said distal end of each of said first and second jaw members including first and second ports, respectively, for receiving a female securing member and a male attachment unit of the pre-sized prosthetic chordae assembly.

14. The apparatus of claim 13, wherein each of said first and second ports are defined by first and second openings, respectively, each of said first and second openings being in fluid communication with said opposing longitudinal slots, each of said opposing longitudinal slots extending along a portion of said distal end of each of said first and second jaw members.

15. A method for implanting a pre-sized prosthetic chordae assembly in a subject, said method comprising the steps of:

providing a pre-sized prosthetic chordae assembly, the pre-sized prosthetic chordae assembly including a male attachment unit comprising a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to the at least one male attachment member;

providing an apparatus for implanting the pre-sized prosthetic chordae assembly, the apparatus comprising a proximal handle, a distal applicator end operably linked to the proximal handle and comprising opposable first and second jaw members, and an actuating mechanism that extends between the proximal handle and the distal applicator end;

loading the female securing member and the male attachment unit onto the first and second jaw members, respectively;

positioning the distal applicator end about a papillary muscle so that the first and second jaw members are disposed about opposite sides of the papillary muscle;

operating the proximal handle to actuate the second jaw member such that the papillary penetration member pierces the papillary muscle and is received by the female securing member; and

retracting the distal applicator end so that the female securing member and the male attachment unit are slidably removed from the first and second jaw members, respectively, and remain implanted in the subject.

16. The method of claim 15, wherein said step of providing a pre-sized prosthetic chordae assembly further comprises providing a male attachment unit including first and second male attachment members, the plurality of pre-sized prosthetic chordae being fixedly sandwiched between the first and second male attachment members and the papillary penetration member extending substantially axial to the first and second male attachment members.

17. The method of claim 16, wherein said step of providing an apparatus for implanting the pre-sized prosthetic chordae assembly further comprises providing a distal applicator end that includes first and second jaw members that each have a proximal end and a distal end, the distal end of each of the first and second jaw members including first and second ports, respectively, each of the first and second ports being defined by first and second openings, respectively, each of the first and second openings being in fluid communication with opposing longitudinal slots, each of the opposing longitudinal slots extending along a portion of the distal end of each of the first and second jaw members.

18. The method of claim 17, wherein said step of loading the female securing member and the male attachment unit further comprises the steps of:

sliding the first male attachment member and the papillary muscle penetration member into the second opening and the longitudinal slot, respectively; and

sliding the female securing member into the first opening of the first jaw member.

19. The method of claim 15, wherein said step of operating the proximal handle further includes the step of depressing a movable lever of the proximal handle.

20. The method of claim 17, wherein said step of retracting the distal applicator end further comprises manipulating the apparatus so that the first male attachment member slides out of the longitudinal slot through the second opening and the female securing member simultaneously slides out of the first opening.