CATHETER DELIVERY SYSTEM FOR INTRODUCING AN EXPANDABLE HEART VALVE PROSTHESIS AND MEDICAL DEVICE FOR THE TREATMENT OF A HEART VALVE DEFECT

• US 20150148894A1
• Filed: 04/10/2013
• Published: 05/28/2015
• Est. Priority Date: 05/16/2012
• Status: Active Grant

• Current Assignee: Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forsching E.V., JenaValve Technology, Inc.
• Original Assignee: Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forsching E.V., JenaValve Technology GmbH (JenaValve Technology, Inc.)
• Inventors: Damm, Christoph, Litzenburger, Michael, Tllner, Thomas, Kamm, Andreas
• Granted Patent: US 9,878,127 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

The invention relates to an operating handle (10-1, 10-2) for manipulating a catheter tip (80-1, 80-2) of a catheter delivery system. The operating handle (10-1, 10-2) comprises a hand grip (11) designed to be held by a user, and a manipulating part (12) axially aligned with the hand grip (11). The manipulating part (12) is rotatable relatively to the hand grip (11) about a longitudinal axis (L) defined by the operating handle (10-1, 10-2). The operating handle (10-1, 10-2) comprises at least one sliding member (30, 40) operatively linked with the manipulating part (12) by means of a cam mechanism (50) such that, upon rotation of the manipulating part (12) relative to the hand grip (11), the at least one sliding member (30, 40) moves axially in the direction of the longitudinal axis (L).

Claims

1. Operating handle (10-1, 10-2) for manipulating a catheter tip (80-1, 80-2) of a catheter delivery system, the operating handle (10-1, 10-2) comprising:

a hand grip (11) designed to be held by a user, and

a manipulating part (12) axially aligned with the hand grip (11),

wherein the manipulating part (12) is rotatable relatively to the hand grip (11) about a longitudinal axis (L) defined by the operating handle (10-1, 10-2), and wherein the operating handle (10-1, 10-2) comprises at least one sliding member (30, 40) operatively linked with the manipulating part (12) via a cam mechanism (50) such that, upon rotation of the manipulating part (12) relative to the hand grip (11), the at least one sliding member (30, 40) moves axially in the direction of the longitudinal axis (L).

2. Operating handle (10-1, 10-2) according to claim 1,

wherein the cam mechanism (50) is integrated into the operating handle (10-1, 10-2) and is configured to transform a rotary motion of the manipulating part (12) relative to the hand grip (11) into a linear motion of the at least one sliding member (30, 40) relative to the hand grip (11).

3. Operating handle (10-1, 10-2) according to claim 1 or 2,

wherein the manipulating part (12) is a rotating wheel designed to be gripped by a user with one of its hands, whereas the other hand holds the hand grip (11).

4. Operating handle (10-1, 10-2) according to one of the claims 1 to 3,

wherein the cam mechanism (50) comprises a cylindrical member (51) connected with the manipulating part (12), the cylindrical member (51) comprising at least one cam groove (31, 41), and

wherein the cam mechanism (50) further comprises at least one pin member (32, 42) having a first end portion connected with the at least one sliding member (30, 40), and a second end portion opposite to the first end portion, the second end portion of the at least one pin member (32, 42) engaging the at least one cam groove (31, 41) such that, upon rotation of the manipulating part (12) relative to the hand grip (11), the at least one pin member (32, 42) follows a cam profile defined by the at least one cam groove (31, 41).

5. Operating handle (10-1, 10-2) according to claims 3 and 4,

wherein the rotating wheel has a diameter greater than the diameter of the cylindrical member (51) of the cam mechanism (50).

6. Operating handle (10-1, 10-2) according to claim 4 or 5,

wherein the hand grip (11) is formed as a jacket,

wherein the cylindrical member (51) of the cam mechanism (50) is at least partly disposed concentrically and coaxially with the hand grip (11), and wherein the cylindrical member (51) of the cam mechanism (50) is rotatable relatively to the hand grip (11).

7. Operating handle (10-1, 10-2) according to one of the claims 4 to 6,

wherein the cylindrical member (51) of the cam mechanism (50) is at least partly hollow, and

wherein the cam mechanism (50) further comprises a body member (52) disposed concentrically and coaxially with the hollow cylindrical member (51), wherein the body member (52) comprises a cylindrical portion (52a) having a diameter less than an inner diameter of the hollow cylindrical member (51), the cylindrical portion (52a) being at least partly received in the interior of the hollow cylindrical member (51) such that the hollow cylindrical member (51) is rotatable relatively to the body member (52).

8. Operating handle (10-1, 10-2) according to claim 7,

wherein the body member (52) is provided with at least one flange (53) for preventing axial movement of the manipulating part (12) relative to the body member (52).

9. Operating handle (10-1, 10-2) according to claim 7 or 8,

wherein the body member (52) is at least partly hollow, and

wherein the at least one sliding member (30, 40) is received within the body member (52) such that the at least one sliding member (30, 40) is axially movable relatively to the body member (52).

10. Operating handle (10-1, 10-2) according to claims 4 and 8,

wherein the body member (52) is provided with at least one elongated hole (33, 43) parallel to the longitudinal axis (L) of the operating handle (10-1, 10-2), wherein the at least one pin member (32, 42) extends through the at least one elongated hole (33, 43).

11. Operating handle (10-1, 10-2) according to one of the claims 7 to 10,

wherein the body member (52) further comprises a portion (52b) fixed to the hand grip (11).

12. Operating handle (10-1, 10-2) according to claim 11,

wherein the portion (52b) fixed to the hand grip (11) is cylindrical and has a diameter equal to or substantially equal to the outer diameter of the hollow cylindrical member (51),

wherein the hand grip (11) is at least partly disposed around the cylindrical portion (52b) of the body member (52) such as to be concentrically and coaxially with the cylindrical portion.

13. Operating handle (10-1, 10-2) according to one of the claims 7 to 12,

wherein guiding means are provided for guiding an axial movement of the at least one sliding member (30, 40) relative to the body member (52).

14. Operating handle (10-1, 10-2) according to one of the claims 1 to 13,

wherein the operating handle (10-1, 10-2) is provided with a locking mechanism (70) for subdividing a maximal available turning movement of the manipulating part (12) when rotated relatively to the hand grip (11).

15. Operating handle (10-1, 10-2) according to one of the claims 7 to 13 and claim 14, wherein the locking mechanism (70) comprises at least one locking recess (71-1, 71-2) provided in the cylindrical member (51) of the cam mechanism (50), and further comprises at least one engaging piece (72) operatively connected with the body member (52), the at least one engaging piece (72) being adapted to releasably engage with the at least locking recess (71-1, 71-2) thereby preventing continuous rotation of the cylindrical member (51) relative to the body member (52).

16. Operating handle (10-1, 10-2) according to claim 15,

wherein the locking mechanism (70) comprises operating means for disengaging the engaging piece (72) when the engaging piece (72) engages with the at least one locking recess (71-1, 71-2).

17. Operating handle (10-1, 10-2) according to claim 16,

wherein the engaging piece (72) is spring-loaded, and

wherein the operating means comprises a spring-loaded push-button (73) operatively connected with the engaging piece (72), the push-button (73) being designed to be pushed by the user for disengaging the engaging piece (72).

18. Operating handle (10-1, 10-2) according to claim 17,

wherein the operating means further comprises a lever (74) connected with the push-button (73) for pressing the engaging piece (72) down when the push-button (73) is pushed down by the user.

19. Operating handle (10-1, 10-2) according to claim 18,

wherein the operating means further comprises a driving piece (75) having a first end section coupled to the lever (74) by means of a pin (76) such as to be pivotable in a plane perpendicular to the direction of pushing of the push-button (73), and further having a second end section for pressing the engaging piece (72) down when the push-button (73) is pushed down by the user.

20. Operating handle (10-1, 10-2) according to claim 19,

wherein the driving piece (75) is coupled to the lever (74) such that the driving piece (75) swings out relatively to the lever (74) when the push-button (73) is pushed down by the user and when the cylindrical member (51) is simultaneously rotated relatively to the body member (52), wherein the second end section of the driving piece (75) loses contact with the engaging piece (72) when the driving piece (75) swings out relatively to the lever (74).

21. Operating handle (10-1, 10-2) according to claim 20,

wherein the operating means further comprises centering means (77) for returning the driving piece (75) when the push-button (73) is released.

22. Operating handle (10-1, 10-2) according to one of the claims 15 to 21,

wherein the locking mechanism (70) comprises a plurality of locking recesses (71-1, 71-2) provided in the cylindrical member (51) of the cam mechanism (50) such as to a subdivide the maximal available turning movement of the manipulating part (12) into a plurality of consecutive indexing turning movements of the manipulating part (12).

23. Operating handle (10-1, 10-2) according to one of the claims 15 to 22,

wherein the locking mechanism (70) comprises a first locking recess (71-1) provided in the cylindrical member (51) such that the at least one pin member (32, 42) of the cam mechanism (50) is at the beginning of the at least one cam groove (31, 41) when the engaging piece (72) of the locking mechanism (70) engages with the first locking recess (71-1).

24. Operating handle (10-1, 10-2) according to one of the claims 15 to 23,

wherein the locking mechanism (70) comprises at least one second locking recess (71-2) provided in the cylindrical member (51) such that the at least one pin member (32, 42) of the cam mechanism (50) is in a central portion of the at least one cam groove (31, 41) when the engaging piece (72) of the locking mechanism (70) engages with the at least one second locking recess (71-2).

25. Operating handle (10-1, 10-2) according to one of the claims 15 to 24,

wherein the locking mechanism (70) comprise a third locking recess provided in the cylindrical member (51) such that the at least one pin member (32, 42) of the cam mechanism (50) is at the end of the at least one cam groove (31, 41) when the engaging piece (72) of the locking mechanism (70) engages with the third locking recess.

26. Operating handle (10-1, 10-2) according to one of the claims 1 to 25,

wherein the operating handle (10-1, 10-2) further comprises decoupling means (20) for selectively separating an operative linkage between the at least one sliding member (30, 40) and the manipulating part (12).

27. Operating handle (10-1, 10-2) according to claim 26,

wherein the cam mechanism (50) comprises a cylindrical member (51) connected with the manipulating part (12), the cylindrical member (51) comprising at least one cam groove (31, 41),

wherein the cam mechanism (50) further comprises at least one pin member (32, 42) having a first end portion connected with the at least one sliding member (30, 40), and further having a second end portion opposite to the first end portion, the second end portion of the at least one pin member (32, 42) engaging with the at least one cam groove (31, 41) such that, upon rotation of the manipulating part (12) relative to the hand grip (11), the at least one pin member (32, 42) follows a cam profile defined by the at least one cam groove (31, 41), and

wherein the decoupling means (20) comprises at least one pin member manipulating element (21) operatively connected with the at least one pin member (32, 42), the at least pin member manipulating element (21) being drivable from a first position, in which the at least one pin member (32, 42) engages with the at least one cam groove (31, 41), into a second position, in which the at least one pin member (32, 42) is disengaged from the at least one cam groove (31, 41).

28. Operating handle (10-1, 10-2) according to claim 27,

wherein the first end portion of the at least one pin member (32, 42) is at least partly received in a recess (22) provided in the at least one sliding member (30, 40) such that the at least one pin member (32, 42) is movable relatively to the sliding member (30, 40) in a longitudinal direction defined by the recess (22).

29. Operating handle (10-1, 10-2) according to claim 27 or 28,

wherein the at least one pin member manipulating element (21) comprise a lever arm (23) having a first end section operatively connected with the at least one pin member (32, 42), in particular with the first end portion of the at least one pin member (32, 42), and further having a second end section opposite to the first end section, the second end section of the lever arm (23) being operatively connected with an operating bar (24) for moving the lever arm (23) with the at least one sliding member (30, 40) connected thereon.

30. Operating handle (10-1, 10-2) according to one of the claims 27 to 29,

wherein the cylindrical member (51) of the cam mechanism (50) is at least partly hollow,

wherein the cam mechanism (50) further comprises a body member (52) disposed concentrically and coaxially with the at least partly hollow cylindrical member (51), wherein the body member (52) comprises a cylindrical portion having a diameter less than an inner diameter of the at least partly hollow cylindrical member (51), the cylindrical portion being at least partly received in the interior of the at least partly hollow cylindrical member (51) such that the at least partly hollow cylindrical member (51) is rotatable relatively to the body member (52), and

wherein the at least one pin member (32, 42) is movable by means of the operating bar (24) and the lever arm (23) connected therewith from a coupled state, in which the second end portion of the at least one pin member (32, 42) engages with the at least one cam groove (31, 41), into an uncoupled state, in which the second end portion of the pin member (32, 42) disengages the at least one cam groove (31, 41) and in which the lever arm (23) engages with a recess (49) provided in the body member (52) of the cam mechanism (50) thereby blocking a rotation movement of the at least one sliding member (30, 40) relative to the body member (52) upon rotation of the manipulating part (12) of the operating handle (10-1, 10-2) relative to the hand grip (11).

31. Catheter delivery system for introducing an expandable heart valve prosthesis (150) into the body of a patient, the catheter delivery system comprising:

at least one sleeve-shaped member (81, 82) at a distal end portion of the catheter delivery system, the at least one sleeve-shaped member (81, 82) being part of a catheter tip (80-1, 80-2) of the catheter delivery system and capable of receiving an at least partly a compressed heart valve prosthesis (150); and

an operating handle (10-1, 10-2) according to one of the claims 1 to 30, the operating handle (10-1, 10-2) being disposed at the proximal end portion of the catheter delivery system,

wherein the at least one sliding member (30, 40) of the operating handle (10-1, 10-2) is operatively connected with the at least one sleeve-shaped member (81, 82) of the catheter tip (80-1, 80-2).

32. Catheter delivery system according to claim 31,

wherein the catheter delivery system further comprises at least one catheter tube (91, 92) having a distal end connected with the at least one sleeve-shaped member (81, 82), and further having a proximal end connected with the at least one sliding member (30, 40).

33. Catheter delivery system according to claim 31 or 32,

wherein the catheter tip (80-1, 80-2) comprises:

a first sleeve-shaped member (81) operatively connected with a first sliding member (30, 40) of the operating handle (10-1, 10-2); and

a second sleeve-shaped member (82) operatively connected with a second sliding member (30, 40) of the operating handle (10-1, 10-2),

wherein the first and second sliding members (30, 40) are both operatively linked with the manipulating part (12) of the operating handle (10-1, 10-2) by means of the cam mechanism (50) such that, upon rotation of the manipulating part (12) relative to the hand grip (11), the first and second sliding members (30, 40) move independently from each other axially in the direction of the longitudinal axis (L).

34. Catheter delivery system according to claim 33,

wherein the cam mechanism (50) of the operating handle (10-1, 10-2) comprises a cylindrical member (51) connected with the manipulating part (12) of the operating handle (10-1, 10-2), the cylindrical member (51) comprising a first cam groove (31, 41) and a second cam groove (31, 41), wherein the cam mechanism (50) further comprises a first pin member (32, 42) having a first end portion connected with the first sliding member (30, 40), and further having a second end portion opposite to the first end portion, the second end portion of the first pin member (32, 42) engaging with the first cam groove (31, 41) such that, upon rotation of the manipulating part (12) relative to the hand grip (11), the first pin member (32, 42) follows a cam profile defined by the first cam groove (31, 41), and

wherein the cam mechanism (50) further comprises a second pin member (32, 42) having a first end portion connected with the second sliding member (30, 40), and further having a second end portion opposite to the first end portion, the second end portion of the second pin member (32, 42) engaging with the second cam groove (31, 41) such that, upon rotation of the manipulating part (12) relative to the hand grip (11), the second pin member (32, 42) follows a cam profile defined by the second cam groove (31, 41).

35. Catheter delivery system according to claim 34,

wherein the cam profiles defined by the first and second cam grooves (31, 41) are respectively chosen such that a rotary motion of the manipulating part (12) relative to the hand grip (11) is transformed into a linear motion of the first sliding member (30, 40) and, independently therefrom, into a linear motion of the second sliding member (30, 40), thereby allowing a predetermined sequence of axial movements of the first and second sleeve-shaped members (81, 82) of the catheter tip (80-1, 80-2) relative to each other.

36. Catheter delivery system according to one of the claims 33 to 35,

wherein the first sleeve-shaped member (81) and the second sleeve-shaped member (82) of the catheter tip (80-1, 80-2) constitute a seat portion adapted to receive a heart valve prosthesis (150),

wherein the catheter tip (80-1, 80-2) further comprises a stent holder (85) capable of releasably fixing a heart valve prosthesis (150) received in the seat portion.

37. Catheter delivery system according to claim 36,

wherein the first sleeve-shaped member (81) and the second sleeve-shaped member (82) are axially movable relatively to each other and relatively to the stent holder (85).

38. Catheter delivery system according to claim 36 or 37,

wherein the stent holder (85) comprises a crone having stent retaining means (86) for releasably connecting with catheter retaining means (123) provided at a heart valve prosthesis (150) to be introduced into the patient'"'"'s body by means of the catheter delivery system.

39. Catheter delivery system according to one of the claims 36 to 38,

wherein the stent holder is operatively connected with an anchorage (45) of the operating handle (10-1, 10-2).

40. Catheter delivery system according to claim 39 in connection with one of the claims 7 to 13, wherein the anchorage (45) of the operating handle (10-1, 10-2) is affixed to the body member (52) of the cam mechanism (50).

41. Catheter delivery system according to one of the claims 36 to 40,

wherein the catheter delivery system comprises:

a first catheter tube (91) defining a first lumen and having distal end connected with the first sleeve-shaped member (81), and further having a proximal end connected with the first sliding member (30, 40);

a stent holder tube (93) defining a passageway and having a distal end connected with the stent holder (85), and further having a proximal end connected to an anchorage (45) of the operating handle (10-1, 10-2), and

a second catheter tube (92) defining a second lumen and having a distal end connected with the second sleeve-shaped member (82), and further having a proximal end connected with the second sliding member (30, 40).

42. Catheter delivery system according to claim 41,

wherein the second catheter tube (92) has a cross-sectional diameter less than a cross-sectional diameter of the first catheter tube (91), and wherein the first catheter tube (91) is disposed concentrically and coaxially with the second catheter tube (92).

43. Catheter delivery system according to claim 41 or 42,

wherein the third lumen defined by the second catheter tube has a diameter sufficient to accommodate a guidewire (180).

44. Catheter delivery system according to one of the claims 41 to 43,

wherein the first catheter tube (91) terminates at its distal end in a flared section (83), the flared section (82) defining a transition to the first sleeve-shaped member (81).

45. Catheter delivery system according to claim 44,

wherein the flared section (83) is preferably formed integrally with a distal end portion of the first catheter tube (91).

46. Catheter delivery system according to one of the claims 41 to 45,

wherein the stent holder tube (93) has a cross-sectional diameter less than a cross-sectional diameter of the first catheter tube (91) and greater than a cross-sectional diameter of the second catheter tube (92),

wherein the first catheter tube (91) is disposed concentrically and coaxially with the stent holder tube (93) thereby accommodating the stent holder tube (93) such that the first catheter tube (91) is axially movable relatively to the stent holder tube (93), and wherein the passageway defined by the stent holder tube (93) has a diameter sufficient to accommodate the second catheter tube (92) such that the second catheter tube (92) is axially movable relatively to the stent holder tube (93).

47. Catheter delivery system according to one of the claims 42 to 46,

wherein the stent holder tube (93) is rotatable relatively to the first and second catheter tubes (91, 92).

48. Catheter delivery system according to one of the claims 41 to 47,

wherein the first catheter tube (91) and/or the second catheter tube (92) are/is made from a bendable material adapted to transfer compression and tension forces, and wherein at least a proximal end section of the first catheter tube (91) and/or at least a proximal end section of the second catheter tube (92) are/is preferably made of a braided wire construction.

49. Catheter delivery system according to claim 48,

wherein the bendable material include polyurethane, silicone, polyvinylchlorid (PVC), nylon and/or polyether-block-amide, in particular Pebax®

.

50. Catheter delivery system according to one of the claims 41 to 49,

wherein a catheter end tip (94) is connected to the distal end section of the second catheter tube (92) distal to the second sleeve-shaped member (82) in order to ease entry of the catheter tip (80-1, 80-2) into the patient'"'"'s body.

51. Catheter delivery system according to claim 50,

wherein the catheter end tip (94) preferably is a soft catheter end tip, more preferably a soft polymeric catheter end tip having an atraumatic shape.

52. Catheter delivery system according to one of the claims 41 to 51,

wherein the first catheter tube (91) and/or the second catheter tube (92) are/is at least partly made of a braided wire construction.

53. Catheter delivery system according to one of the claims 31 to 52, further comprising a guidewire (180) suited for guiding at least the distal end portion of the catheter delivery system to an implantation side, the guidewire (180) being designed to be advanced into a patient'"'"'s vasculature independently from the catheter delivery system and, in particular, independently from the distal end portion of the catheter delivery system.

54. Medical device for the treatment of a heart valve defect, in particular a heart valve failure or a heart valve stenosis in a patient, wherein the medical device comprises:

a catheter delivery system in accordance with one of the claims 31 to 53; and

an expandable heart valve stent (100) accommodated in the catheter tip (80-1, 80-2) of the catheter delivery system.

55. Medical device according to claim 54,

wherein the expandable heart valve stent (100) comprises catheter retaining means (85, 86) configured to engage with stent retaining means (123) of the catheter tip (80-1, 80-2) for releasably connecting the expandable heart valve stent (100) with the catheter tip (80-1, 80-2).

56. Medical device according to claim 54 or 55,

wherein the expandable heart valve stent (100) comprises a plurality of positioning arches (115, 115a, 115b, 115c) configured to be positioned within a plurality of pockets (T) of the patient'"'"'s native heart valve and to be positioned on a first side of a plurality of native heart valve leaflets (V), and further comprises a plurality of retaining arches (116, 116a, 116b, 116c) configured to be positioned on a second side of the plurality of native heart valve leaflets (V) opposite the first side.

57. Medical device according to one of the claims 54 to 56

wherein a valvular prosthesis (200) is connected to the expandable heart valve stent (100).

58. Medical device according to claim 57,

wherein the valvular prosthesis (200) is made from pericardium.