Method and device for treatment of mitral insufficiency

• US 7,192,442 B2
• Filed: 02/05/2001
• Issued: 03/20/2007
• Est. Priority Date: 06/30/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Berger, Erwin, Schwager, Michael, Solem, Jan O, Kimblad, Per O
• Primary Examiner(s): Isabella; David J.
• Application Number:
  US09/775,677
• Publication Number:
  US 20010018611A1
• Time in Patent Office: 2,234 Days
• Field of Search: 623/11.11, 623/23.7, 623/1.1, 623/1.15, 623/1.16, 623/1.18, 623/1.2, 623/1.3, 623/1.31, 623/2.36, 623/2.37, 623/1.36, 600 16- 18, 600/108, 606191-195, 606/198, 128/898
• US Class Current: 623/1.31
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A device for treatment of mitral annulus dilatation comprises an elongate body having two states. In a first of these states the elongate body is insertable into the coronary sinus and has a shape adapting to the shape of the coronary sinus. When positioned in the coronary sinus, the elongate body is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

Claims

1. A device for treatment of mitral annulus dilatation, comprising an elongate body having such dimensions as to be insertable into the coronary sinus and having two states, in a first of which the elongate body has a shape that is adaptable to the shape of the coronary sinus, and to the second of which the elongate body is transferable from said first state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus is reduced as well as the circumference of the mitral valve annulus, when the elongate body is positioned in the coronary sinus, said elongate body comprising at least one stent section at a distance from each end of the elongate body, said at least one stent section providing a reduction of its length when expanded in situ in the coronary sinus, whereby the elongate body is shortened and bent to a smaller radius of curvature, wherein the at least one stent section is a central stent section of the elongate body, the central stent section located between a distal stent section and a proximal stent section of the elongate body, the distal and proximal stent sections being expandable prior to the central stent section.

2. The device of claim 1, wherein the distal and proximal stent sections are expandable without substantial length reduction.

3. The device of claim 1, wherein a memory material is used as stent material.

4. A medical device for remodeling an extravascular tissue structure adjacent to a vessel in a patient, comprising:

an elongate body adapted to be fixed to the vessel, the elongate body extending between a proximal end and a distal end, and that is adjustable from a first configuration having a first shape such that the elongate body is adapted to be delivered at least in part into the vessel to a second configuration having a second shape such that the elongate body is adapted to be fixed to the vessel, and to a third configuration having a third shape such that the elongate body is adapted to exert a force from within the vessel onto the extravascular tissue structure in order to remodel the extravascular tissue structure, and

wherein the elongate body is adapted to be positioned in the first configuration at least in part within a coronary sinus and is adapted to remodel a mitral valve annulus adjacent to the coronary sinus after it is fixed to the coronary sinus;

wherein the distal end of the elongate body is spaced distally from the proximal end of the elongate body in the first and third configurations;

wherein, in at least one of the second configuration and the third configuration, the proximal and distal ends of the elongate body have a greater cross-sectional profile than a central section of the elongate body.

5. A medical device as in claim 4, wherein the elongate body within the coronary sinus comprises a substantially similar length between the first and third configurations.

6. A medical device as in claim 4, wherein the elongate body within the coronary sinus is relatively non-expandable while the elongate body is adjusted between the first and third configurations.

7. A medical device as in claim 4, wherein the elongate body within the coronary sinus is relatively non-compressible while the elongate body is adjusted between the first and third configuration.

8. A medical device as in claim 4, wherein in the third configuration the third shape for the elongate body at least in part within the coronary sinus defines an arc.

9. A medical device as in claim 4, further comprising an anchor for retaining the elongate body at least in part within the coronary sinus.

10. A medical device as in claim 9, wherein the anchor comprises a region along a distal portion of the elongate body.

11. A medical device as in claim 9, wherein the anchor comprises a friction enhancing surface for engaging a wall of the coronary sinus.

12. A medical device as in claim 9, wherein the anchor comprises at least one barb for piercing a wall of the coronary sinus.

13. A medical device as in claim 9, wherein the anchor is located at least in part at the proximal end of the elongate body.

14. A medical device as in claim 4, wherein the mitral valve annulus has a wall that circumscribes a space having a diameter, and the elongate body when adjusted from the first configuration to the third configuration within the coronary sinus is adapted to compress the mitral valve annulus to thereby reduce the diameter of said space.

16. A medical device of claim 4, wherein the elongate body is adjusted to the third configuration without fully encircling the mitral valve annulus.

17. The medical device of claim 4, wherein the elongate body comprises a memory material.

18. The medical device of claim 4, wherein the elongate body is adapted to be fixed to the vessel at least at one of the proximal end and the distal end of the elongate body.

15. A medical system for remodeling an extravascular tissue structure adjacent to a vessel in a patient, comprising:

an elongate body adapted to be fixed to the vessel, the elongate body extending between a proximal end and a distal end, and that is adjustable from a first configuration having a first shape such that the elongate body is adapted to be delivered at least in part into the vessel to a second configuration having a second shape such that the elongate body is adapted to be fixed to the vessel, and to a third configuration having a third shape such that the elongate body is adapted to exert a force from within the vessel onto the extravascular tissue structure in order to remodel the extravascular tissue structure,

wherein the elongate body is adapted to be positioned in the first configuration at least in part within the coronary sinus and is adapted to remodel a mitral valve annulus adjacent to the coronary sinus after it is fixed to the coronary sinus, and

a deployment system cooperating with the elongate body and which is adapted to at least in part deliver the elongate body in the first configuration at least in part into the coronary sinus;

wherein the distal end of the elongate body is spaced distally from the proximal end of the elongate body in the first and third configurations;

wherein, in at least one of the second configuration and the third configuration, the proximal and distal ends of the elongate body have a greater cross-sectional profile than a central section of the elongate body.

19. A medical system as in claim 15, wherein the deployment system comprises a delivery member that is coupled to the elongate body and is adapted to advance the elongate body into the coronary sinus.

21. A medical system as in claim 19, wherein the elongate body is pre-formed into an arcuate shape in the third configuration such that when advanced by a delivery member into the coronary sinus it assumes its pre-formed arcuate third configuration to apply force to remodel the mitral valve annulus.

20. A medical device for remodeling a tissue structure adjacent to a body space that is defined at least in part by a tissue wall in a patient, comprising:

an elongate body adapted to be fixed to the body space, the elongate body extending between a proximal end portion and a distal end portion and that is adjustable from a first configuration having a first shape that is adapted to be delivered at least in part into the body space to a second configuration having a second shape that is adapted to be fixed to the vessel, and to a third configuration having a third shape such that the elongate body is adapted at least in part to exert a force from within the body space onto the adjacent tissue structure in order to remodel the adjacent tissue structure, wherein the elongate body is adapted to be positioned in the first configuration at least in part within a coronary sinus and is adapted to remodel a mitral valve annulus adjacent to the coronary sinus after it is fixed to the coronary sinus;

wherein the distal end of the elongate body is spaced distally from the proximal end of the elongate body in the first and third configurations;

wherein, in at least one of the second configuration and the third configuration, the proximal and distal ends of the elongate body have a greater cross-sectional profile than a central section of the elongate body.