Heart valve prosthesis and suturing assembly and method of implanting a heart valve prosthesis in a heart

• US 3,997,923 A
• Filed: 04/28/1975
• Issued: 12/21/1976
• Est. Priority Date: 04/28/1975
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Possis, Zinon C.
• Primary Examiner(s): Frinks, Ronald L.
• Application Number:
  US05/572,001
• Time in Patent Office: 603 Days
• Field of Search: 3/1, 3/1.5, 3/1.912-1.913, 3/13, 128/334 R, 128/334 C
• US Class Current: 623/2.4
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2424 Ball valves

Abstract

A heart valve prosthesis removably mounted on a suturing assembly. The suturing assembly has an annular sleeve carrying a fabric collar. Sutures secure the collar to heart tissue. The heart valve has a base that is removably mounted on the annular sleeve. The suturing assembly is initially secured to the heart tissue. The heart valve base is then attached to the sleeve and locked in place. If a replacement valve is necessary, the heart valve prosthesis is removed from the sleeve without detaching the suturing assembly from the heart tissue. A new heart valve prosthesis is then mounted on the suturing assembly.

Claims

1. A heart valve prosthesis and suturing means adapted to be attached to heart tissue and support the heart valve prosthesis in the heart comprising:

an annular base having a passage for carrying blood, said base having a cylindrical outside wall, an outside threaded section and an outside shoulder between the outside wall and the outside threaded section, valving means movable relative to the base to a first position to allow blood to flow in one direction through the passage and to a second position to restrict the flow of blood through the passage in the direction opposite the one direction, means retaining the valving means in operative movable relation with the base, suturing means attachable to heart tissue, said suturing means including a sleeve having a cylindrical inside wall, an inside threaded section and an inside shoulder between the inside wall and inside threaded section, said inside and outside walls, threaded sections and shoulders engaging each other when the base is mounted on the sleeve, said sleeve having an outside annular channel, a suturing collar located in the channel adapted to be secured to heart tissue, and releasable lock means mounted on the sleeve and engageable with the base to fix the position of the base on the sleeve, said lock means having a lock position to fix the location of the base on the sleeve and a release position allowing the heart valve prosthesis to be mounted on and removed from the suturing means after the suturing means is attached to the heart tissue.

2. The structure of claim 1 wherein:

the lock means has a body and means to hold the body in assembled relation with the sleeve whereby the lock means is retained on the sleeve in both the lock position and release position of the lock means.

3. The structure of claim 1 wherein:

said inside and outside threads have a plurality of starts.

4. The structure of claim 1 wherein:

the lock means comprises a body located in a bore in the sleeve, a head attached to the body, said head having a portion engageable with the base when the base is mounted on the sleeve, and means engageable with the body and sleeve to hold the body in assembled relation with the sleeve whereby the lock means is retained on the sleeve in both the lock position and release position of the lock means.

5. The structure of claim 1 wherein:

the suturing collar includes a porous fabric and means holding the fabric on the sleeve.

6. The structure of claim 5 wherein:

the sleeve has grooves open to the channel for accommodating parts of the fabric, and said means holding the fabric on the sleeve includes cord means holding the parts of the fabric in the grooves.

7. The structure of claim 1 wherein:

the valving means is a ball.

8. The structure of claim 1 wherein:

the valving means is a disc.

9. The structure of claim 1 wherein:

the valving means is a discoid valve poppet.

10. The structure of claim 1 wherein:

the valving means is a member that moves angularly relative to the base.

11. Means for supporting a heart valve prosthesis in a heart, said heart valve having a base, said base having a passage for carrying blood, valving means for controlling one-way flow of blood through the passage, and means retaining the valving means in moving operative relation with the base comprising:

first means attachable to heart tissue, second means associated with the first means and a base to releasably support the base on the first means whereby the heart valve prosthesis can be mounted on and removed from the first means after the first means is attached to the heart tissue, and lock means mounted on the first means, said lock means movable to a release position to allow the heart valve prosthesis to be removed from and mounted on the first means and movable to a lock position to hold the heart valve prosthesis in a fixed position relative to the first means.

12. The means of claim 11 wherein:

the first means includes an annular sleeve and the second means includes means on the sleeve for releasably attaching the base to said sleeve.

13. The means of claim 11 wherein:

said second means comprises screw threads.

14. The means of claim 11 wherein:

said lock means has a body and means to hold the body in assembled relation with the first means when the lock means is in either the release position or the lock position.

15. The means of claim 11 wherein:

the first means includes an annular sleeve, a collar surrounding the sleeve, said collar including a porous fabric and means holding the fabric on the sleeve.

16. The means of claim 11 wherein:

the second means includes first screw threads on the base and second screw threads on the first means, said first and second threads cooperating with each other to hold the base on the first means.

17. The means of claim 16 wherein:

the first and second screw threads have a plurality of starts.

18. A suturing assembly attachable to heart tissue for releasably holding a heart valve prosthesis, comprising:

an annular member having means for releasably holding the heart valve prosthesis cover means surrounding the annular member, means holding the cover means on the annular member and lock means movably mounted on the annular member locatable in a release position to allow the heart valve prosthesis to be mounted on and removed from the annular member and locatable in a lock position to hold the heart valve prosthesis in a fixed position relative to the annular member.

19. The suturing assembly of claim 18 wherein:

the means for releasably holding the heart valve prosthesis includes screw threads cooperating with a portion of the heart valve prosthisis.

20. The suturing assembly of claim 19 wherein:

the threads have a plurality of starts.

21. The suturing assembly of claim 18 wherein:

the annular member has outwardly directed flanges and grooves adjacent said flanges, said cover means having portions located in the grooves, said means holding the cover means including cord means holding the portions in the grooves.

22. The suturing assembly of claim 18 wherein:

the annular member is a sleeve, said means for releasably holding the heart valve prosthesis comprising thread means on part of the sleeve that cooperate with portions of the heart valve prosthesis to releasably hold the heart valve prosthesis in assembled relation with the sleeve.

23. The suturing assembly of claim 18 wherein:

the lock means has a body and means to hold the body in assembled relation with the annular member when the lock means is in either the release position or the lock position.

24. The suturing assembly of claim 18 wherein:

the heart valve prosthesis has a base with a cylindrical outside wall, a threaded section and a shoulder between the outside wall and threaded section, said annular member including a cylindrical inside wall, a threaded section, and a shoulder between the inside wall and threaded section, said inside and outside walls, threaded sections and shoulders engaging each other when the heart valve prosthesis is mounted on the suturing assembly.

25. A method of implanting a heart valve prosthesis and suturing assembly in a heart, said prosthesis having a base and said suturing assembly having a sleeve accommodating the base, coacting means on the base and sleeve to mount the base on the sleeve, and releasable lock structure movable to a lock position to hold the base on the sleeve and movable to a release position to allow the base to be mounted on the sleeve, comprising:

exposing the heart, opening the exposed heart, removing the defective natural heart valve, placing the suturing assembly in the opening formed by the removed natural heart valve, attaching the suturing assembly to the heart tissue with the lock structure located in the release position, attaching the heart valve prosthesis to the suturing assembly by positioning the base in assembled relation with the sleeve, moving the lock structure to the lock position to fix the position of the base on the sleeve, and closing the heart.

26. The method of claim 25 wherein:

the suturing assembly is attached to the heart tissue with stitches.

27. The method of claim 25 including:

circumferentially orientating the heart valve prosthesis on the suturing assembly when the heart valve prosthesis is being attached to the suturing assembly.

28. A method of replacing a first heart valve prosthesis located in a heart with a second heart valve prosthesis in a suturing assembly attached to heart tissue without removing the suturing assembly from the heart tissue, each prosthesis having a base, said suturing assembly having a sleeve accommodating each base, coacting means on each base and the sleeve to mount each base on the sleeve, and releasable lock structure movable to a lock position to hold each base on the sleeve and movable to a release position to allow each base to be mounted on and removed from the sleeve, comprising:

exposing the heart, opening the exposed heart, moving the lock structure to the release position, removing the first heart valve prosthesis from the suturing assembly without separating the suturing assembly from the heart tissue, mounting the second heart valve prosthesis on the suturing assembly by positioning the base of the second heart valve prosthesis in assembled relation with the sleeve, moving the lock structure to the lock position to fix the position of the base of the second heart valve prosthesis on the sleeve, and closing the heart.

29. The method of claim 28 including:

circumferentially orientating the second heart valve prosthesis on the sleeve when the second heart valve prosthesis is being mounted on the sleeve.

30. A heart valve prosthesis and suturing means adapted to be attached to heart tissue and support the heart valve prosthesis in the heart comprising:

a heart valve prosthesis having an annular base having an inside wall forming a passage for carrying blood and an outside wall, valving means movable relative to the base to a first position to allow blood to flow in one direction through the passage and movable to a second position to restrict the flow of blood through the passage in the direction opposite the one direction, means retaining the valving means in operative movable relation to the base, suturing means attachable to heart tissue, said suturing means including a sleeve having an inside wall and means surrounding the sleeve attachable to heart tissue, coacting means on the outside wall of the base and the inside wall of the sleeve to releasably mount the base on the sleeve whereby the heart valve prosthesis can be mounted on and removed from the suturing means after the suturing means is attached to the heart tissue, and releasable lock means cooperating with the sleeve and the base to hold the base on the sleeve, said lock having a lock position to fix the location of the base on the sleeve and a release position allowing the base to be mounted on and removed from the sleeve.

31. The structure of claim 30 wherein:

said lock means has a body and means to hold the body in assembled relation with the sleeve whereby the lock means is retained on the sleeve in both the lock position and the release position of the lock means.

32. The structure of claim 30 wherein:

the lock means comprises a body located in a bore the sleeve, a head attached to the body, said head having a portion engageable with the base when the base is mounted on the sleeve, and means engageable with the body and sleeve to hold the body in assembled relation with the sleeve whereby the lock means is retained on the sleeve in both the lock position and release position.

33. The structure of claim 30 wherein:

the coacting means includes an outside threaded portion on the base and an inside threaded portion on the sleeve, said inside and outside threaded portions cooperating with each other to mount the base on the sleeve.

34. The structure of claim 33 wherein:

said inside and outside threaded portions have threads with a plurality of starts.

35. The structure of claim 30 wherein:

the base has a cylindrical outside wall, said sleeve has a cylindrical inside wall adapted to engage the outside wall of the base when the base is mounted on the sleeve, said outside wall of the base and inside wall of the sleeve including cooperating shoulders which engage each other when the coacting means cooperates to mount the base on the sleeve.