Method and apparatus for improving mitral valve function

• US 7,179,291 B2
• Filed: 07/19/2004
• Issued: 02/20/2007
• Est. Priority Date: 05/27/2003
• Status: Expired due to Fees

• Current Assignee: Guided Delivery Systems, Inc.
• Original Assignee: Viacor, Inc.
• Inventors: Taylor, Daniel C., Barnes, Terrence G., Blacker, Steven J., Rourke, Johnathan M.
• Primary Examiner(s): Pellegrino; Brian E.
• Application Number:
  US10/894,676
• Publication Number:
  US 20050070998A1
• Time in Patent Office: 946 Days
• Field of Search: 623/2.37, 623/2.36, 600/585, 604/524, 604/525
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility

Abstract

A method and apparatus for reducing mitral regurgitation. The apparatus is inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

Claims

1. An assembly for reducing mitral regurgitation, the assembly comprising:

an elongated carrier sufficiently flexible to assume a first configuration generally conforming to a coronary sinus upon insertion of said carrier into the coronary sinus, and to assume a straighter second configuration when biased toward the straighter configuration, said carrier having a lumen extending lengthwise therethrough; and

an elongated rod comprising five segments disposed end-to-end, said segments comprising a central segment provided with a selected first degree of flexibility which provides rigidity sufficient to reconfigure the mitral annulus, a pair of intermediate segments, one disposed at each end of said central segment, said intermediate segments each being provided with a selected second degree of flexibility which provides more rigidity to said intermediate segments than the rigidity of said central segment, and a pair of outer segments, each disposed at the end of an intermediate segment remote from said central segment, said outer segments each being provided with a third degree of flexibility exceeding the flexibility of said central segment and said intermediate segments, said rod being adapted to be received by the lumen in said carrier;

whereby to urge said carrier from the first configuration to the second configuration, to straighten a natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

2. An assembly according to claim 1 wherein said carrier is of a circular cross-section in at least a portion thereof.

3. An assembly according to claim 1 wherein said rod is selectable from a kit comprising a plurality of rods having different degrees of stiffness.

4. An assembly according to claim 1 wherein said rod is selectable from a kit comprising a plurality of rods having different lengths.

5. An assembly according to claim 1 wherein the assembly further comprises a guidewire, and said carrier is provided with an opening through which said guidewire is movable.

6. An assembly according to claim 1 wherein said carrier is provided with a second lumen extending lengthwise through said carrier;

and

said assembly comprises a second elongated rod of a material less flexible than said carrier and adapted to be received by the second lumen;

whereby to further urge said carrier from the second configuration to a still straighter configuration.

7. An assembly according to claim 6:

wherein said second rod comprises five segments disposed end-to-end, said segments comprising a central segment provided with a selected first degree of flexibility which provides rigidity sufficient to reconfigure the mitral annulus, a pair of intermediate segments, one disposed at each end of said central segment, said intermediate segments each being provided with a selected second degree of flexibility which provides more rigidity to said intermediate segments than the rigidity of said central segment, and a pair of outer segments, each disposed at the end of an intermediate segment remote from said central segment, said outer segments each being provided with a third degree of flexibility exceeding the flexibility of said central segment and said intermediate segments;

and further wherein the first rod central segment is of a stiffness different from the central segment stiffness of said second rod.

8. An assembly according to claim 6 wherein said second rod is selectable from a kit comprising a plurality of rods having different lengths.

9. An assembly according to claim 1 wherein said elongated rod is substantially straight in an unstressed condition.

10. An assembly according to claim 1 wherein said elongated rod is substantially curved after insertion into the coronary sinus.

11. An assembly according to claim 1 wherein said elongated rod central segment and said outer segments are substantially curved after said elongated rod is inserted into the coronary sinus, and said intermediate segments are substantially straight after the elongated rod is inserted into the coronary sinus.

12. An assembly according to claim 11 wherein said central segment, said outer segments and said intermediate segments have a length such that said elongated rod applies an anteriorly-directed force to the walls of the coronary sinus substantially adjacent to the posterior leaflet of the valve, and applies a posteriorly-directed force to the walls of the coronary sinus substantially adjacent to commissures of the valve.

13. An assembly according to claim 1 wherein said elongated rod is formed at least in part out of a resilient material.

14. An assembly according to claim 13 wherein said elongated rod effects valve remodeling on a continuous basis over a prolonged period of time.

15. An assembly according to claim 14 wherein said elongated rod is formed in part of a superelastic material.

16. An assembly according to claim 1 wherein said assembly further comprises a stabilizing scaffold engaging to said elongated carrier.

17. An assembly according to claim 1 wherein at least a portion of said elongated carrier is configured to facilitate tissue in-growth.

18. An assembly for reducing mitral regurgitation, the assembly comprising:

an elongated carrier of material sufficiently flexible to assume a first configuration generally conforming to a coronary sinus upon insertion of said carrier into the coronary sinus, and to assume a straighter second configuration when biased toward the straighter configuration, said carrier having a plurality of lumens extending lengthwise therethrough; and

a plurality of elongated rods each comprising five segments disposed end-to-end, said segments comprising a central segment provided with a selected first degree of flexibility which provides rigidity sufficient to reconfigure the mitral annulus, a pair of intermediate segments, one disposed at each end of said central segment, said intermediate segments each being provided with a selected second degree of flexibility which provides more rigidity to said intermediate segments than the rigidity of said central segment, and a pair of outer segments, each disposed at the end of an intermediate segment remote from said central segment, said outer segments each being provided with a third degree of flexibility exceeding the flexibility of said central segment and said intermediate segments, said rods being adapted to be received by the lumens in said carrier;

whereby to urge said carrier from the first configuration to the second configuration, to straighten a natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

19. An assembly for reducing mitral regurgitation, the assembly comprising:

a carrier sufficiently flexible to assume a first configuration generally conforming to a coronary sinus upon insertion of said carrier into the coronary sinus, and to assume a straighter second configuration when biased toward the straighter configuration, said carrier having a plurality of first lumens extending lengthwise therethrough;

a catheter shaft having a plurality of first lumens extending lengthwise therethrough, each alignable with one of the carrier first lumens, a distal end of said catheter shaft being engageable with a proximal end of said carrier;

a plurality of straightening rods, each adapted to be received by the catheter shaft first lumens and by the carrier first lumens, said rods comprising five segments disposed end-to-end, said segments comprising a central segment provided with a selected first degree of flexibility which provides rigidity sufficient to reconfigure the mitral annulus, a pair of intermediate segments, one disposed at each end of said central segment, said intermediate segments each being provided with a selected second degree of flexibility which provides more rigidity to said intermediate segments than the rigidity of said central segment, and a pair of outer segments, each disposed at the end of an intermediate segment remote from said central segment, said outer segments each being provided with a third degree of flexibility exceeding the flexibility of said central segment and said intermediate segments; and

a push rod adapted to be received by at least the catheter shaft first lumens and engageable with one of said straightening rods and operable to push an engaged straightening rod into one of the carrier first lumens in alignment with one of the catheter shaft lumens in which said push rod is disposed;

whereby to bias said carrier from the first configuration to the second configuration.

20. An assembly according to claim 19 wherein said rod is selectable from a kit comprising a plurality of rods having different lengths.

21. An assembly according to claim 19 wherein the assembly further comprises a guidewire adapted for insertion into the coronary sinus, and said carrier and said catheter shaft are movable along said guidewire.

22. An assembly according to claim 19 wherein said push rod is adapted to connect to a selected straightening rod end-to-end, and to be disconnected therefrom.

23. An assembly according to claim 19 wherein said carrier and said catheter shaft are each provided with second lumens of smaller diameter than the first lumens.

24. An assembly according to claim 23 wherein tether lines are fixed in the carrier second lumens, and extend proximally from a proximal end of said catheter shaft, the tether lines being drawable through said catheter shaft to urge said catheter shaft and said carrier into abutting relationship.

25. An assembly for reducing mitral regurgitation, the assembly comprising:

an elongated carrier of material sufficiently flexible to assume a first configuration generally conforming to a coronary sinus upon insertion of said carrier into the coronary sinus, and to assume a straighter second configuration when biased toward the straighter configuration, said carrier having a plurality of first lumens extending lengthwise therethrough and a plurality of second lumens, smaller in diameter than the first lumens, extending therethrough;

a catheter shaft having a plurality of first and second lumens extending lengthwise therethrough and alignable with the respective first and second lumens of said carrier, a distal end of said catheter shaft being engageable with a proximal end of said carrier;

a plurality of straightening rods adapted to be received by the catheter shaft first lumens and by the carrier first lumens said straightening rods comprising five segments disposed end-to-end, said segments comprising a central segment provided with a selected first degree of flexibility which provides rigidity sufficient to reconfigure the mitral annulus, a pair of intermediate segments, one disposed at each end of said central segment, said intermediate segments each being provided with a selected second degree of flexibility which provides more rigidity to said intermediate segments than the rigidity of said central segment, and a pair of outer segments, each disposed at the end of an intermediate segment remote from said central segment, said outer segments each being provided with a third degree of flexibility exceeding the flexibility of said central segment and said intermediate segments;

a plurality of push rods adapted to be received by at least the catheter shaft first lumens; and

a tether fixed in at least one carrier second lumen and extending through the catheter shaft second lumen and manipulatable to draw said carrier into abutting engagement with said catheter shaft;

wherein at least one selected stiffening rod is insertable into at least one selected catheter shaft first lumen, and at least one push rod is insertable into the selected catheter shaft lumen and into engagement with the selected stiffening rod to push the selected stiffening rod into one of the carrier first lumens, to bias the carrier from the first configuration towards the second configuration.

26. An assembly for reducing mitral regurgitation, the apparatus comprising:

a tubular flexible carrier adapted for insertion into a coronary sinus proximate a posterior leaflet of the mitral valve;

an elongated body comprising five segments disposed end-to-end, said segments comprising;

a central segment of sufficient rigidity to reconfigure a mitral annulus;

a pair of intermediate segments, one disposed at each end of said central segment, said intermediate segments each being of a rigidity greater that the rigidity of said central segment; and

a pair of outer segments, each disposed at an end of an intermediate segment, said outer segments each being of less rigidity than the rigidity of said central segment and the rigidity of said intermediate segments;

such that upon insertion of said body into the carrier, said central segment serves to reconfigure the mitral annulus, said intermediate segments serve to transfer the load of reconfiguring the mitral annulus to said outer segments, and said outer segments serve to dissipate the load to side walls of the coronary sinus;

wherein said elongated body segments are of a length such that forces applied to walls of the coronary sinus improve leaflet coaptation by reducing a distended mitral valve anterior-to-posterior dimension without increasing the heart valve commissure-to-commissure dimension, whereby to minimize creation of commissure side jets.

27. An assembly for reducing mitral regurgitation, the assembly comprising:

an elongated carrier sufficiently flexible to assume a first configuration generally conforming to a coronary sinus upon insertion of said carrier into the coronary sinus, and to assume a straighter second configuration when biased toward the straighter configuration, said carrier having a lumen extending lengthwise therethrough; and

an elongated rod having at least three different degrees of flexibility, each degree of flexibility corresponding to one or more predetermined portions of said elongated rod adapted to be received by the lumen in said carrier;

whereby upon insertion of said elongated rod into said lumen of said carrier, the elongated rod urges said carrier from the first configuration to the second configuration resulting in a straightening of a natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve when the carrier is inserted into the coronary sinus, wherein said elongated rod comprises a central segment provided with a selected first degree of flexibility which provides rigidity sufficient to reconfigure the mitral annulus, a pair of intermediate segments, one disposed at each end of said central segment, said intermediate segments each being provided with a selected second degree of flexibility which provides more rigidity to said intermediate segments than the rigidity of said central segment, and a pair of outer segments, each disposed at the end of an intermediate segment remote from said central segment, said outer segments each being provided with a third degree of flexibility exceeding the flexibility of said central segment and said intermediate segments.

28. An assembly according to claim 27 wherein said elongated rod central segment and said outer segments are substantially curved after said elongated rod is inserted into the coronary sinus, and intermediate segments are substantially straight after the elongated rod is inserted into the coronary sinus.

29. An assembly according to claim 28 wherein said central segment, said outer segments and said intermediate segments have a length such that said elongated rod applies an anteriorly-directed force to the walls of the coronary sinus substantially adjacent to the posterior leaflet of the valve, and applies a posteriorly-directed force to the walls of the coronary sinus substantially adjacent to commissures of the valve.