Cardiac Valve Downsizing Device And Method

• US 20100331971A1
• Filed: 12/20/2008
• Published: 12/30/2010
• Est. Priority Date: 12/21/2007
• Status: Active Grant

• Current Assignee: Medtentia International Ltd. Oy
• Original Assignee: Medtentia International Ltd. Oy
• Inventors: Antonsson, Per, Keränen, Olli
• Granted Patent: US 9,867,702 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

A device for repairing a heart valve comprises a medical device (10). The medical device (10) comprises an element in order to downsize the annulus upon insertion and allow the leaflets to open and close properly. The medical device (10) provides a temporary or permanent downsizing of the heart valve. An annuloplasty implant and/or heart valve prosthesis is in embodiments releasably attached to the medical device for insertion to the annulus and permanent fixation of the latter in a desired shape.

Claims

1. A medical device (10, 300, 310) for facilitating a repair and/or replacement of a defective heart valve of a heart of a patient, said device comprising

a loop shaped downsizing element devised to automatically provide downsizing of an annulus of said heart valve upon insertion of said downsizing element into said heart, wherein said downsizing element has a first shape to facilitate access to circumflex substantially all chordae (26, 28) of said heart valve, and a second shape to reposition said chordae (26, 28) towards a centre of said valve upon said insertion to provide said downsizing.

2. The medical device according to claim 1, wherein the downsizing element has a helical structure that is arranged on an imaginary cylinder and where a defined distance is kept between subsequent turns of its helix, such that said medical device comprises a hollow centre and a free space between each turn of said helical structure.

3. The medical device according to claim 2, wherein said helix comprises a single turn arranged to be introduced to the cardiac chamber side of the valve.

4. The medical device according to claim 2 or 3, wherein a distal tip of the medical device is arranged with a larger diameter than the subsequent part of the helix that is adapted to circumflex the chordae.

5. The medical device according to claims 2 to 4, wherein the helix has a blunt tip in order to not harm the anatomical structure of the heart.

6. The medical device according to any of preceding claims 1-5, wherein the device is adapted to be inserted through either commissure at said heart valve.

7. The medical device according to any of preceding claims 2-5, wherein said helix is adapted to circumflex said chordae by said helical structure as the device is inserted continuously, and wherein said medical device is adapted to pass through a commissure at said heart valve upon further insertion.

8. The medical device according to any of preceding claims 2-5 and 7, wherein a diameter of the imaginary cylinder, is smaller than corresponding diameter value of the valve, such that said medical device is adapted to downsize said valve as the helix is inserted and circumflexes said the chordae.

9. The medical device according to any of preceding claims 2-5 and 7-8, wherein said medical device comprises a proximal end 104 for releasably attaching a detachable delivery unit.

10. The medical device according to any of preceding claims 2-5 and 7-9, wherein said helical structure comprises a second loop shaped element that is connected to a first loop shaped element to form a the helical structure as a coiled configuration, wherein said second loop shaped element is configured to be positioned on a second, opposite side oriented towards an atrium of the area of the valve tissue to thereby arrange the valve tissue between the first loop shaped element and the second loop shaped element.

11. The medical device according to claim 10, wherein the second loop shaped element comprises at least one fixation element for releasable attachment of an annuloplasty implant and/or a heart valve prosthesis.

12. The medical device according to any of preceding claims 10-11, wherein said first loop shaped element is devised to be positioned within a cardiac chamber adjacent to, or in the vicinity of tissue of said valve;

and wherein said second loop shaped element has at least partly a larger circumference than said first loop shaped element and is devised to be positioned in an atrial side of said valve, adjacent to, or in the vicinity of an annulus of said valve.

13. The medical device according to any of preceding claims 1-12, wherein the medical device has a distal end (101) that is shaped in such a manner, that it catches the chordae (26, 28) by advancing between the chordae and the opposite cardiac muscle tissue (12).

14. The medical device according to claim 13 dependent on claims 10-12, wherein said distal end (101) is arranged radially outwards or axially downwards from a diametric plane of the second helical element 103.

15. The medical device according to any of preceding claims 10-14, wherein a proximal end (104) of said medical device is arranged substantially perpendicular to a plane diametric to loops shaped elements of the medical device (10).

16. The medical device according to claim 15, wherein said proximal end (104) is arranged along a longitudinal axis imaginary arranged perpendicular to the plane diametric to the loops and off-center of the loops.

17. The medical device according to any of preceding claims 10-16, wherein said medical device is provided with a connection interface for releasably attaching a delivery device at a proximal end thereof.

18. The medical device according to any of preceding claims 10-17, wherein said medical device comprises at least one helical element having at least partly a non circular form, whereby said medical device is adapted to provide a variable downsizing effect depending on a degree of rotation upon introducing said medical device.

19. The medical device according to any of preceding claims 10-18, wherein said medical device comprises a first helical element (102) having a plurality of interconnected segments (312) arranged to allow a change of shape of the first helical element (102).

20. The medical device according to claim 1 or 2, wherein said downsizing element comprises:

a first loop shaped element (43, 102, 301) configured to be positioned on a first side of an area of valve tissue oriented towards a cardiac chamber of said heart comprising a plurality of chordae (26, 28), and

wherein said first loop shaped element (43, 102, 301) is arranged to at least temporary circumflex substantially all said chordae (26, 28) and to re-arrange a position of said chordae (26, 28) upon said insertion thereof to provide said downsizing.

21. The medical device according to claim 20 further comprising a second loop shaped element (41, 103) connected to said first loop shaped element to form a coiled configuration,

wherein said second loop shaped element (41, 103) is configured to be positioned on a second, opposite side oriented towards an atrium of the area of the valve tissue to thereby arrange the valve tissue between said first loop shaped element (43, 102) and said second loop shaped element (41, 103), and wherein said second loop shaped element comprises at least one fixation element for releasable attachment of an annuloplasty implant or a heart valve prosthesis.

22. The medical device according to any of preceding claims 20-21, wherein at least said first loop shaped element is formed from a flat plate material having a varying cross section.

23. The medical device according to any of preceding claims, wherein said downsizing element comprises at least a portion of a shape memory material.

24. The medical device according to claim 23, wherein said first loop shaped element has a first shape configured to facilitate easy access of said chordae (26, 28) and a second shape, obtained by a change of shape of said portion of said shape memory material, configured to reposition said chordae (26, 28) to achieve said downsizing.

25. The medical device according to claim 21, wherein said first loop shaped element is radially moveable with respect to said second loop shaped element to achieve said downsizing.

26. The medical device according to any one of the preceding claims, wherein said downsizing element is adjustable in a diameter thereof to provide adjustment of said annulus for said downsizing.

27. The medical device according to claim 20, wherein said first loop shaped element is arranged to be turned into position in said cardiac chamber for said circumflexing.

28. The medical device according to claim 20 or 27, comprising a proximal end (301) and wherein a transition section between said first loop shaped element (302) and said proximal end (302) comprises a gradually decreasing diameter, such that said downsizing achievable by the medical device is controllable depending on how far it is rotated into said cardiac chamber.

29. The medical device according to claim 1 or 20, further comprising two support rings configured to be arranged on opposite sides of the valve annulus and arranged to provide a releasable pinch between each other.

30. A kit for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the kit comprising:

a medical device according to any of claims 1-29 for facilitating a repair and/or replacement of a defective heart valve of a heart of a patient, said device comprising a downsizing element devised to automatically provide downsizing of an annulus of said heart valve upon insertion of said downsizing element into said heart; and

an annuloplasty implant adapted to be attached to the heart valve annulus in order to reshape the annulus and allow the leaflets to open and close properly, and/or a valve prosthesis adapted to be attached to the heart valve annulus or said annuloplasty implant in order to allow the heart valve to open and close properly.

31. The kit according to claim 30, wherein said annuloplasty implant and/or said valve prosthesis is arranged movable along said medical device upon said downsizing and into position for fixation to said annulus, and arranged releasably to said medical device for said fixation.

32. The kit according to claim 31, comprising a delivery device (11), wherein said kit is adapted to provide downsizing and positioning of an annuloplasty prosthesis with said delivery device (11), wherein an annuloplasty prosthesis (400) is arranged longitudinally movable along an elongated section of said delivery device (11) for lowered into position and fixation to the valve annulus and subsequent release from the delivery device (11).

33. The kit according to any of claims 30-32, wherein the annuloplasty implant and/or valve prosthesis is releasably attached to said medical device by means of sutures, clips or staples.

34. The kit according to any of claims 30 to 33, wherein said downsizing device, annuloplasty implant and/or valve prosthesis are patient configured.

35. The kit according to any one of claims 30-34, wherein the device is arranged to be withdrawn from the patient after the annuloplasty implant and/or valve prosthesis has been fixated to the valve tissue.

43. The method according to any of claims 36-41, wherein said medical device is a medical device according to any of claims 1-34.

36. A method for repairing and/or replacing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, said method comprising:

inserting a medical device for automatically downsizing said annulus of said heart valve upon insertion of said medical device and prior to fixating an annuloplasty implant and/or valve prosthesis to said heart valve.

37. The method according to claim 36 comprising accomplishing said automatically downsizing by means of a downsizing element of said medical device devised to provide said automatically downsizing of an annulus of said heart valve upon insertion of said downsizing element into said heart.

38. The method according to claim 37 comprising accessing and circumflexing substantially all chordae (26, 28) of said heart valve by said downsizing element and temporary repositioning said chordae (26, 28) of said heart valve by said downsizing element upon insertion thereof.

39. The method according to claim 38, wherein said reposition said chordae (26, 28) comprises repositioning the latter towards a centre of said valve upon said insertion of said medical device to provide said downsizing.

40. The method according to any of claims 36 to 39, wherein said inserting comprises inserting a distal end of said medical device through a portion of the valve tissue, rotating the medical device to position the distal end on a first side of the valve, and downsizing said annulus from said first side of the valve.

41. The method according to any of claims 36-40, wherein said inserting comprises a inserting via a ventricular access path.

42. The method according to any of claims 36-41, comprising providing downsizing, and positioning of an annuloplasty prosthesis with a single delivery device (11), said method comprising arranging an annuloplasty prosthesis (400) is longitudinally movable along an elongated section of said delivery device (11), and lowering said annuloplasty prosthesis (400) into position and fixation to the valve annulus, and subsequent releasing said annuloplasty prosthesis (400) from said delivery device (11).