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1. (WO2019122944) DELIVERY DEVICE, DELIVERY SYSTEM, STENT GRAFT AND A SUPPORT STRUCTURE
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Claims

Delivery device (1) for an endoprosthesis (2), preferably an endoprosthesis for treating an aneurysm, comprising

_ an outer sheath (3) ,

- an inner tube (4) being arranged within the outer sheath (3) and

- at least one restraining tube (5) for holding the endoprosthesis in a compressed configuration being arranged between the outer sheath (3) and the inner tube (4),

- wherein the outer sheath, the inner tube and the at

least one restraining tube are coaxial,

characterized in that, the restraining tube (5) includes at least one axial elongation (6) extending from a distal end portion of the restraining tube (5), the at least one axial elongation being adapted to be laced through portions (23) of the endoprosthesis (2) .

Delivery device (1) according to claim 1, characterized in that at least one restraining tube (5, 30) includes multiple elongations (6) extending from the distal end portion of the restraining tube (5), preferably two or three or four or five or more elongations (6) .

Delivery device (1) according to claim 1 or 2, further comprising a distal tip (8) attached to a distal end (9) of the inner tube (4), wherein the distal tip (8) comprises at least one recess (10) , which preferably extends circularly around the distal tip (8), wherein the at least one recess is adapted to receive at least one of the elongation (s) of a restraining tube (5, 30) .

Delivery device (1) according to claim 3, characterized in that the at least one restraining tube (5) is releasably engageable to the distal tip (8) by engagement of at least one its elongation (s) (6) in one of the at least one recess (10) of the distal tip (8) .

Delivery device (1) according to claim 3 or 4, characterized in that the device comprises a first and a second restraining tube (5, 30) and in that the distal tip (8) comprises a first recess (10) and a second recess (29) , which preferably extend circularly around the distal tip (8) , wherein the first recess is adapted to receive at least one of the elongation (s) of the first restraining tube (5) and wherein the second recess is adapted to receive at least one of the elongation (s) of the second restraining tube (30).

Delivery device (1) according to one of the preceding claims, characterized in that at least one of the elongations (6), preferably each elongation, includes at least one attachment element (11) , preferably a slot (12) , adapted to be engaged with a corresponding element of the endoprosthesis, in particular with an anchor pin (13) .

Delivery device (1) according to one of the preceding claims, characterized in that a first restraining tube (5) is adapted to be laced through a proximal portion, in particular proximal arches, of the endoprosthesis (2) .

Delivery device (1) according to one of the preceding claims, characterized in that a second restraining

tube (30) is adapted to be laced through a distal portion of the endoprosthesis (2) .

Delivery device (1) according to one of the preceding claims, characterized in that the device comprises a first and second restraining tube (5, 30), preferably only a first and a second restraining tube (5, 30) .

10. Delivery device (1) according to claim 9, wherein each re- straining tube includes multiple elongations (6) extending from their respective distal end portions, wherein the elongations of the second restraining tube (30) are longer in an axial direction of the restraining tubes than the elongations of the first restraining tube (5) .

11. Delivery device (1) according to claim 9 or 10, characterized in that the first restraining tube (5) is at least partially arranged within the second restraining tube (30) .

12. Delivery device (1) according to one of the preceding

claims, characterized in that the elongation (s) (6) comprise or are made of a biocompatible material, preferably metal and/or plastic, particularly preferred stainless steel or nitinol or PEEK.

13. A delivery system comprising a delivery device (1) according to one of the claims 1 to 12 and an endoprosthesis (2), wherein the endoprosthesis (2) comprises a stent (22) characterized in that the elongation (s) (6) of the at least one restraining tube (5, 30) are laced through portions (23) of the endoprosthesis.

14. Delivery system according to claim 13, characterized in

that the stent comprises arches formed by struts (23) , preferably at a proximal end (24), wherein elongations of a first restraining tube (5) are laced through the arches of the stent (22) .

15. Delivery system according to claim 13 or 14, characterized in that the endoprosthesis (2) comprises a graft, wherein elongations of a second restraining tube (30) are laced through the graft of the endoprosthesis (2) .

16. Delivery system according to one of the claims 13 to 15, characterized in that the elongations of a first and/or second restraining tube (5, 30) are laced through struts of the stent forming a ring.

17. Delivery system according to one of the claims 13 to 16, characterized in that the elongations of a second restraining tube (5, 30) are laced through a distal part of the endoprosthesis (2) .

18. Delivery system according to one of the claims 13 to 17, characterized in that the stent (22) includes at least one anchor pin (13) and the delivery device (1) includes at least one elongation (6), wherein at least one of the elon- gation(s) (6), preferably each elongation (6), comprises one or more slots (12), wherein at least one slot (12) is operatively engaged or engageable with the at least one anchor pin (13) .

19. Delivery system according to claim 18, characterized in

that characterized in that one or more anchor pins (13) are arranged on an apex, preferably a proximal apex (24), of the arches.

20. Delivery system according to one of the claims 13 to 19, characterized in that the endoprosthesis (2) includes an outer cover (36) covering a part of a stent ring and the stent ring comprises at least one repositioning opening (47), preferably disposed at a proximal part of the cover (36), wherein an elongation (s) of at least one restraining tube (5, 30) is laced through the at least one repositioning opening (47) .

21. Delivery device (1) for an endoprosthesis, preferably an endoprosthesis for treating an aneurysm, preferably a device or system according to one of the preceding claims, comprising a handle portion (14) with

a body (46),

a first gripping portion (15) for retracting an outer sheath (3) ,

the first gripping portion (15) having a ring , said ring being rotatable around a longitudinal axis (L) of the body (46) such that upon rotation of the ring the outer sheath is withdrawn, and

a separate second gripping portion (16) for retracting the outer sheath, the second gripping portion being axi ally connected or connectable to the outer sheath (3), the second gripping portion (16) being slidable relatively to the body (46) along the longitudinal axis (L) of body (46) such that the outer sheath (3) is retracta ble by pulling the second gripping portion (16) longitu dinally.

22. Delivery device (1) according to claim 21, wherein the handle portion (14) comprises an inner connecting member (48), which is rotatabiy connected or connectable to the second gripping portion (16) and connected or connectable to the outer sheath (3) .

23. Delivery device (1) according to claim 22, wherein the inner connecting member (48) comprises one or two or more cam(s) (55), which extend (s) radially outwardly and wherein the cam(s) (55) is/are engageable in a circumferential recess (56) of the second gripping portion (16) or wherein the one or two or more cam(s) extend (s) radially inward from the second gripping portion and is/are engageable in a circumferential recess of the inner connecting member (48) .

24. Delivery device (1) according to claim 22 or 23, wherein the inner connecting member (48) is rotatably connected or connectable to the outer sheath.

25. Delivery device (1) according to claim 24, wherein the inner connecting member (48) is tubular with an inner lumen (57) and comprises a circumferential recess (58) in the inner lumen (57) for receiving a cam of the outer sheath (3) or wherein one or two or more cams extend into the inner lumen for rotatably attaching the outer sheath to the inner connecting member (48) .

26. Delivery device (1) according to one of the claims 21 to 25, wherein the second gripping portion (16) comprises a tubular outer connecting member (49), wherein the outer connecting member (49) is slidably arranged on a, preferably threaded, tube (18) .

27. Delivery device (1) according to one of the claims 21 to 26, wherein the handle portion (14) comprises a threaded tube (18), which is disposed between the second gripping portion (16) , in particular a tubular outer connecting member (49), and an inner connecting member (48), wherein the second gripping portion (16) is connected or connectable to the inner connecting member (48) through axially extending slotted holes (41) in the threaded tube (18) .

.Delivery device (1) according to one of the claims 21 to 27, characterized in that the second gripping portion (14) comprises :

a selection mechanism with a selection element, preferably a button (20) , which is moveable between an open position and a locked position, the selection element preferably being biased towards the locked position, wherein in the locked position the second gripping portion (16) is directly or indirectly engaged to the first gripping portion (15) , such that the outer sheath (3) is retractable by rotating of the first gripping portion (15) and

in the open position the second gripping portion (15) is released from the first gripping portion, such that the outer sheath (3) is retractable by pulling the second gripping portion (16) longitudinally relatively to the body (46) .

29. Delivery device (1) according to claim 28, wherein the han- die portion comprises a threaded tube (18) which is disposed radially inwardly in relation to the second gripping portion (16), wherein the threaded tube (18) is aligned co- axially with the body of the handle portion (14), and wherein the second gripping portion (16) is indirectly en- gaged to the first gripping portion (15) via the threaded tube (18) in the locked position and released from the threaded tube (18) in the open position.

.Delivery device (1) according to claim 29, wherein the threaded tube is fixedly connected the first gripping portion (15) or integral with the first gripping portion (15)

31. Delivery device (1) according to one of the claims 28 to 30, wherein the second gripping portion comprises one or two or more radially movable contact element (s) (50), wherein the threaded tube (18) comprises an outer threading and wherein the contact element (s) (50) is/are adapted to engage the outer threading in the locked position and released from the outer threading in the open position.

32. Delivery device according to claim 31, wherein the one or two or more contact element (s) (50) is/are made of wire, preferably plastic or metal wire, in particular a steel wire.

33. Delivery device according to claim 26 and claim 31 or 32, wherein the tubular outer connecting member (49) comprises one or two or more radially extending through hole(s) (64), wherein the one or two or more contact element (s) (50) is/are disposed at least partially in the one or two or more hole (s) (64) .

34. Delivery device according to one of the claims 31 to 33, wherein the selection element comprises a radially movable button (20), which is operatively attached to the movable contact element (s) (50), wherein the second gripping portion comprises a socket (53) for holding the button (20) , wherein the socket (60) comprises an inner cut-out for the button, and wherein the a length of the cut-out is shorter than a length of the button along an axial direction of the handle portion.

.Delivery device (1) according to one of the preceding claims, characterized in that a handle portion (14) com prises :

at least one release mechanism (19) for releasably fixing a restraining tube (5, 30) to the handle portion (14), wherein each release mechanism (19) comprises a release element (28), preferably a button or lever, which is moveable between an open position and a locked position, wherein the release element (28) is preferably biased towards the locked position, preferably by a release spring (33) and

wherein in the locked position the restraining tube (5, 30) is fixedly connected to the body (46) of the handle portion (14), and in the open position the restraining

tube (5, 30) is adapted to be axially slid longitudinally in relation to the body (46) of the handle portion (14) by retracting the restraining tube (5) .

36. Delivery device according to claim 35, wherein the handle portion (14) comprises two release mechanisms for releasably fixing a first and a second restraining tube (5, 30) .

37. Delivery device according to claim 35 or 36, characterized in that the handle portion (14) and a restraining

tube (5, 30) are connected by an actuation spring, which is pre-stressed in a longitudinal direction (L) of the handle portion (14), such that upon opening the release mechanism (19) the restraining tube (5) is retracted by the pre- stressed actuation spring (33) .

38. Delivery device (1) according to one of the claims 35 to

37, characterized in that the release mechanism (19) comprises a stopper, preferably a ring, arranged to prevent moving the release mechanism (19) from the locked position to the open position, wherein the ring is preferably dis- posed proximally to the release mechanism (19) .

39. Delivery device (1) according to one of the claims 21 to

38, wherein the second gripping portion (16) is disposed proximally of the first gripping portion (15) .

40. Delivery device (1) according to one of the claims 21 to

39, wherein the body (46) comprises a third gripping portion (51) .

41. Delivery device (1) according to claim 40, wherein along a longitudinal direction (L) of the handle portion (14) the third gripping portion (51) is disposed between the first and second gripping portions (15, 16) .

42. Delivery device (1) according to one of the claims 21 to 41, wherein the body (46) comprises one or two or more axi- ally extending slotted holes (54), wherein the second gripping portion is arranged slidably in the slotted hole(s).

43. Stent graft, preferably for treating an aneurysm, comprising

- a collapsible and re-expandable stent (22), preferably a vascular or a heart stent, the stent (22) comprising a distal and a proximal end and at least one hole to receive a wire (31) or elongation for loading the stent (22) into a delivery device, preferably a delivery device according to one of the claims 1 to 12 or 21 to 42, and

- an outer cover (36) covering a distal part of the

stent (22),

characterized in that the at least one hole (31) is disposed proximally of a proximal edge (37) of the cover (36) .

44. Stent graft according to claim 43, characterized in that the at least one hole (31) is disposed less than 2.5 mm proximally of the proximal edge of the cover (36) , preferably between 1 mm and 2 mm.

45. Stent graft according to claim 43 or 44, characterized in that the stent (22) includes at least one pair of

struts (39) having a common apex (40) and extending from the apex in a distal direction, wherein the hole (31) is disposed at the apex (40) of the struts (39) .

46. Stent graft according to claim 45, characterized in that the hole (31) is formed in between the pair of struts and includes an open end formed by the pair of struts (39) , and wherein the open end is on a distal side of the hole (31) .

.Stent graft according to one of the claims 43 to 46, char acterized in that the stent (22) comprises three or four five or more holes (31) .

48. Stent graft according to one of the claims 43 to 47, characterized in that the holes have a diameter of less than 1.5 mm, preferably less than 1 mm.

49. Stent graft according to one of the claims 43 to 48, characterized in that the proximal edge is undulating.

50.A support structure with thrombogenic elements for a stent graft, sized and shaped to be mounted on a stent graft, characterized in that the support structure comprises at least one strip of a fabric, wherein a plurality of elongated thrombogenic elements, preferably fibres, are at- tached to the at least one strip.

51. Support structure according to claim 50, characterized to in that the thrombogenic elements are sewn, in particular stitched, glued, welded or riveted to the at least one strip.

52. Support structure according to one of the claims 50 to 51, characterized in that the elongate thrombogenic elements comprise a first and a second end, which are attached to the strip, wherein the thrombogenic elements form a loop.

53. Support structure according to one of the claims 50 to 52, characterized in that the elongate thrombogenic elements comprise a first and a second end, wherein the first ends are connected to the strip and the second ends are releasa bly connected to one or two or more releasable secondary strips .

54. Support structure according to one of the claims 50 to 53, characterized in that the at least one strip, preferably all strips, is formed by threads or fibres.

55. Support structure according to one of the claims 50 to 54, characterized in that the strip or the strips, in particular the threads or fibres, are made of a synthetic fibre like a polyamide, PET, PE, PTFE, FEP or PFA.

56. Support structure according to one of the claims 50 to 55, characterized in that the support structure comprises only one primary strip, to which the thrombogenic elements are fixedly attached.

57. Support structure according to one of the claims 50 to 55, characterized in that the support structure comprises a plurality, preferably four, five, six, seven or more, of parallel strips which extend longitudinally are transversely spaced apart, wherein the longitudinal strips are interconnected by transversely extending strips, such that the longitudinal and the transverse strips form a mesh.

58. Support structure according to claim 57, characterized in that the support structure comprises a longitudinally extending membrane which is attached to the strips.

59. Support structure according to claim 58, characterized in that the membrane is made of or comprises a plastic, preferably FEP or PFA.

60. Support structure according to one of the claims 57 to 59, characterized in that the thrombogenic elements are attached to transversely outer strips, which extend longitudinally.

61. Stent graft, preferably a stent graft according to one of the claims 43 to 49, comprising one or more body parts with a graft, wherein one or two or more support structures according to one of the claims 50 to 60 are arranged on a radially outer surface of the graft.

62. Stent graft according to claim 61, characterized in that at least one support structure is sewn, glued or welded to the one or more body parts.

63. Stent graft according to claim 61 or 62, characterized in that at least one support structure is wound helically around the one or more body part.

64. Stent graft according to one of the claims 61 to 63, characterized in that a longitudinal direction of at least one support structure is parallel to a longitudinal axis of the one or more body parts.

65. Stent graft according to one of the claims 61 to 64, characterized in that at least one support structure is wound circumferentially around the one or more body parts.

66. Stent graft according to one of the claims 61 to 65, characterized in the stent graft comprises two or more body parts, wherein a first tubular body part includes a proximal opening and two distal openings and a second tubular body part is attached to one of the distal openings, and wherein one or two or more support structures are attached to the first and/or second body part.

67. Stent graft according to one of the claims 61 to 66, characterized in that that two or more support structures, preferably four to eight support structures, are arranged on the outer surface of the one or more body parts, particularly preferred on each of the body parts.