CATHETER DELIVERY SYSTEM FOR INTRODUCING AN EXPANDABLE HEART VALVE PROSTHESIS AND MEDICAL DEVICE FOR THE TREATMENT OF A HEART VALVE DEFECT
First Claim
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, anda 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).
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Accused Products
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).
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Citations
58 Claims
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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:
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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). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58)
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).
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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).
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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).
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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).
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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® - .
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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.
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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:
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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.
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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.
Specification