IMPLANTABLE SUSPENSION DEVICE, ASSEMBLY DEVICE AND METHOD FOR ASSEMBLING AN IMPLANTABLE SUSPENSION DEVICE
20220354482 · 2022-11-10
Assignee
Inventors
Cpc classification
A61B2017/0438
HUMAN NECESSITIES
A61B2017/0053
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
A61B17/0485
HUMAN NECESSITIES
International classification
Abstract
The invention relates to an implantable suspension device (1) for fixing an elongated flexible implant (G) in a desired position, comprising a suspension plate (100) and a suture element (200) engaging with the suspension plate (100), the suture element (200) comprising a first end section (201) and a second end section (202), wherein the second end section (202) comprises a connecting section (240) configured to be connected to said implant (G) or a medical textile (500).
The invention further relates to an assembly device (2) comprising a holder (400) configured to hold said suspension plate (100) and a guiding rope (300) configured to be moved together with said suture element (200) relative to the holder (400) resulting in the suture element (200) engaging with the suspension plate (100) to assemble said implantable suspension device (1) and a method for assembling an implantable suspension device (1).
Claims
1. An implantable suspension device (1) for fixing an elongated flexible implant (G) in a desired position, comprising: a suspension plate (100) and a suture element (200) engaging with the suspension plate (100), wherein the suture element (200) comprises a first end section (201) extending from said suspension plate (100) to a first end (201a) of said suture element (200) and a second end section (202) extending from said suspension plate (100) to a second end (202a) of said suture element (200), wherein the second end section (202) comprises a connecting section (240) configured to be connected to said implant (G) or to a medical textile (500).
2. The implantable suspension device (1) according to claim 1 characterized in that said connecting section (240) is positioned at the second end (202a) of the suture element (200).
3. The implantable suspension device (1) according to claim 1 or 2, characterized in that the suture element (200) comprises a needle (250) attached to the suture element (200), particularly to the first end (201a) or the second end (202a).
4. The implantable suspension device (1) according to claim 1 or 2, characterized in that said suture element (200) comprises or consists of a plurality of fibers (203), wherein the fibers (203) are separated from each other in the connecting section (240), particularly wherein each of the separated fibers (203) comprises a fiber end (204) or a fiber loop positioned at the second end (202a) of the suture element (200).
5. The implantable suspension device (1) according to claim 4, characterized in that said connecting section (240) forms a fan-like structure extending in a plane parallel to an extension direction of the suture element (200).
6. The implantable suspension device (1) according to one of the preceding claims, characterized in that the suture element (200) forms a first locking loop (41) for pressing the first end section (201) of the suture element (200) against the suspension plate (100) and thereby locking the first end section (201) with respect to the suspension plate (100).
7. The implantable suspension device (1) according to one of the preceding claims, characterized in that the second end section (202) comprises an adjustable first suspension section (231) between said suspension plate (100) and said connecting section (240), wherein the first suspension section (231) is configured to be shortened by pulling on the first end section (201) of the suture element (200), wherein particularly said first end section (201) protrudes out of said first locking loop (41).
8. The implantable suspension device (1) according to one of the preceding claims, characterized in that the suspension plate (100) comprises a front side (100a) and a rear side (100b), which rear side (100b) faces away from the front side (100a).
9. The implantable suspension device (1) according to claim 8, characterized in that the suspension plate (100) comprises a plurality of through-holes (11, 12, 13, 14, 15, 16), each through-hole (11, 12, 13, 14, 15, 16) extending from the front side (100a) to the rear side (100b) of said suspension plate (100), wherein said suture element (200) extends through said through-holes (11, 12, 13, 14, 15, 16).
10. The implantable suspension device (1) according to claim 9, characterized in that said plurality of through-holes (11, 12, 13, 14, 15, 16) is formed by at least three through-holes (11, 12, 13), particularly 3, 4, or 6 through-holes.
11. The implantable suspension device (1) according to claim 9 or 10, characterized in that the suture element (200) extends through a first-through-hole (11) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the rear side (100b) to the front side (100a) of the suspension plate (100), with the first end (201a) ahead, particularly such that the adjustable first suspension section (231) is formed on the rear side (100b) of the suspension plate (100).
12. The implantable suspension device (1) according to claim 11, characterized in that the suture element (200) extends through a second through-hole (12) of said plurality of through-holes from the front side (100a) to the rear side (100b) of the suspension plate (100), with the first end (201a) ahead, particularly such that the first locking loop (41) is formed on the front side (100a) of the suspension plate (100), wherein the suture element (200) further extends through a third through-hole (13) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the rear side (100b) to the front side (100a) of the suspension plate (100) with the first end (201a) ahead, wherein particularly the first end section (201) of the suture element (200) further extends through the first locking loop (41) for clamping the first end section (201) to the front side (100a) of the suspension plate (100) by means of the first locking loop (41) with a locking force (F.sub.L).
13. The implantable suspension device (1) according to claim 12, characterized in that the suture element (200) further extends through a fourth through-hole (14) of said plurality of through-holes from the front side (100a) to the rear side (100b) of the suspension plate (100) with the first end (201a) ahead.
14. The implantable suspension device (1) according to claim 12, characterized in that the suture element (200) further extends through a fourth through-hole (14) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the rear side (100b) to the front side (100a) of the suspension plate (100) with the second end (202a) ahead, particularly such that the suture element (200) forms a second suspension section (232) between said connecting section (240) and said suspension plate (100), wherein said suture element (200) further extends through a fifth through-hole (15) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the front side (100a) to the rear side (100b) of the suspension plate (100) with the second end (202a) ahead, particularly such that a second locking loop (42) is formed, wherein the suture element (200) further extends through a sixth through-hole (16) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the rear side (100b) to the front side (100a) of the suspension plate (100) with the second end (202a) ahead, wherein particularly the second end section (202) of the suture element (200) further extends through said second locking loop (42) for clamping the second end section (202) of the suture element (200) to the front side (100a) of the suspension plate (100) by means of the second locking loop (42) with a locking force (F.sub.L).
15. The implantable suspension device (1) according to claim 14, characterized in that the suture element (200) comprises an adjustable second suspension section (232) between said connecting section (240) and said suspension plate (100), wherein the second suspension section (232) is configured to be shortened by pulling on the second end section (202) of the suture element (200), wherein particularly said second end section (202) protrudes out of said second locking loop (42).
16. The implantable suspension device (1) according to one of the preceding claims, characterized in that the suspension plate (100) is connected to or integrally formed with a screw (3) or an anchor (4) configured to be inserted into a bone.
17. A medical implant (6) comprising the implantable suspension device (1) according to one of the claims 1 to 16 and a medical textile (500), particularly comprising or consisting of a felt material, wherein the connecting section (240) of the suture element (200) is connected to the medical textile (500), wherein the medical textile (500) is configured to be connected to said implant (G).
18. The medical implant (6) according to claim 17, characterized in that the connecting section (240) is connected to the medical textile (500) by stitches (S).
19. The medical implant (6) according to claim 17, characterized in that the suture element (200) comprises or consists of a plurality of fibers (203), wherein the fibers (203) are separated from each other in the connecting section (240), and wherein the separated fibers (203) of the connecting section (240) extend into and/or through the medical textile (500) to connect the suture element (200) of the implantable suspension device (1) to the medical textile (300).
20. The medical implant (6) according to claim 19, characterized in that the medical textile (500) extends along a plane, wherein particularly the medical textile (500) comprises a flat shape, wherein particularly the connecting section (240) of the suture element (200) forms a fan-like structure extending in a plane parallel to an extension direction of the suture element (200), and wherein the suture element (200) is connected to the medical textile (500), such that the first medical implant (130) extends from the medical textile (500) parallel to the plane of the medical textile (500).
21. The medical implant (6) according to one of the claims 17 to 19, characterized in that the medical textile (500) comprises a tubular shape, wherein the medical textile (500) comprises an inner surface configured to be connected to said implant (G).
22. An assembly device (2) for assembling the implantable suspension device (1) according to one of the claims 1 to 16, comprising a holder (400) configured to hold said suspension plate (100), a guiding rope (300) configured to be moved together with said suture element (200) relative to the holder (400) resulting in the suture element (200) engaging with the suspension plate (100) to assemble said implantable suspension device (1).
23. The assembly device (2) according to claim 22, characterized in that the assembly device (2) is configured to assemble the implantable suspension device (1) according to any one of the claims 6 to 14, wherein said guiding rope (300) extends through at least one through-hole (11, 12, 13, 14, 15, 16) of said plurality of through-holes (11, 12, 13, 14, 15, 16) of said suspension plate (100) held by said holder (400), such that the guiding rope (300) can be moved through said at least one through-hole (11, 12, 13, 14, 15, 16) together with the suture element (200), resulting in the suture element (200) engaging with the suspension plate (100).
24. The assembly device (2) according to claim 22 or 23, characterized in that said assembly device (2) comprises a first pin (P1) and a second pin (P2), wherein said holder (400) is configured to hold the suspension plate (100) between said first pin (P1) and said second pin (P2), and wherein the assembly device (2) is configured such that the guiding rope (300) can be moved around the first pin (P1) and the second pin (P2) together with the suture element (200) resulting in the suture element (200) engaging with the suspension plate (100), particularly wherein the holder (400) is configured to hold the suspension plate (100) between the first pin (P1) and the second pin (P2) such that said first pin (P1) faces said front side (100a) of the suspension plate (100) and said second pin (P2) faces said rear side (100b) of the suspension plate (100).
25. The assembly device (2) according to claim 23 or 24 when referring to claim 16, characterized in that the assembly device is configured to assemble the implantable suspension device (1) according to one of the claims 9 to 12 or claim 13 or 14 when referring to one of the claims 9 to 12, wherein said guiding rope (300) extends successively through said first through-hole (11) or said fourth through-hole (14) from said rear side (100b) to said front side (100a) of the suspension plate (100), around said first pin (P1), through said second through-hole (12) or said fifth through-hole (15) from said front side (100a) to said rear side (100b) of the suspension plate (100), around said second pin (P2) and through said third through-hole (13) or said sixth through-hole (16) from said rear side (100b) to said front side (100a) of the suspension plate (100).
26. The assembly device (2) according to one of the claims 22 to 25, characterized in that said guiding rope (300) forms a loop (303) configured to enlace said suture element (200), such that said loop (303) can be moved together with the suture element (200) relative to the holder (400) resulting in the suture element (200) engaging with the suspension plate (100).
27. The assembly device (2) according to one of the claims 22 to 26, characterized in that said guiding rope (300) comprises an inner volume (305) extending between a first end (301) and a second end (302) of the guiding rope (300), wherein the guiding rope (300) is configured to receive said suture element (200) in said inner volume (305), such that the guiding rope (300) can be moved together with the suture element (200) disposed in the inner volume (305) relative to the holder (400) resulting in the suture element (200) engaging with the suspension plate (100), wherein particularly said guiding rope (300) forms a funnel (306) at the first end, wherein said funnel (306) defines an opening (307) for receiving said suture element (200) in said inner volume (305), wherein particularly the funnel (306) is characterized by an expanded state and a collapsed state, wherein said opening (307) has a first diameter in the expanded state and a second diameter in the collapsed state, wherein the first diameter is larger than the second diameter.
28. The assembly device (2) according to one of the claims 22 to 27, characterized in that the assembly device (2) comprises a holding part (21) comprising said holder (400) and a casing part (22) comprising a wall (22c) configured to encase said holder (400) when the holding part (21) and the casing part (22) are assembled, wherein particularly the wall (22c) comprises an opening (22d) for inserting and/or extracting the suture element (200) by means of the guiding rope (300), particularly the first end (201a) and/or the second end (202a) of the suture element (200), wherein particularly said holding part (21) comprises said first pin (P1) and said second pin (P2), wherein said casing part comprises a first hole (22a) configured to receive the first pin (P1) of the holding part (21) and a second hole (22b) configured to receive the second pin (P2) of the holding part (21) to assemble the holding part (21) and the casing part (22).
29. The assembly device (2) according to one of the claims 22 to 28, characterized in that the assembly device (2) comprises a tool (5) for implanting said implantable suspension device (1), wherein the tool (5) comprises a guide bar (23) extending along a first axis (A1), wherein the guide bar (23) comprises a slot (23a) extending along said first axis (A1) for receiving said guiding rope (300) and/or said suture element (200), particularly said first end (201a) or said second end (202a) of said suture element (200).
30. The assembly device (2) according to claim 29 and claim 24 or one of the claims 25 to 28 when referring to claim 24, characterized in that said guide bar (23) comprises a recess (23b) for receiving said first pin (P1) or said second pin (P2).
31. The assembly device (2) according to claim 30 or claim 29 and claim 24 or one of the claims 25 to 28 when referring to claim 24, characterized in that said guide bar (23) comprises a tip (23d) comprising a notch (23c) for receiving said suspension plate (100).
32. The assembly device (2) according to claim 30 or 31, characterized in that said tool (5) comprises a handle (24a) for holding said tool (5), wherein said handle (24a) is connected to said guide bar (23), wherein particularly said handle (24a) comprises a groove (24b) for inserting said guiding rope (300) and/or said suture element (200) when at least a part of said guiding rope (300) and/or said suture element (200) is arranged in the slot (23a).
33. The assembly device (2) according to claim 32, characterized in that the tool (5) is separable into a handle part (24) comprising said handle (24a) and a tip part (25) comprising at least a part of said guiding bar (23), wherein particularly said handle part (24) and said tip part (25) comprise an inner thread (26) and an outer thread (27) corresponding to the inner thread (26).
34. The assembly device (2) according to one of the claims 30 to 33, characterized in that said assembly device (2) is configured to clamp the suture element (200) in the slot (23a).
35. The assembly device (2) according to claim 34, characterized in that said assembly device (2) comprises an actuating element (28) that can be actuated to clamp the suture element (200) in the slot (23a).
36. The assembly device (2) according to claim 34, characterized in that said assembly device (2) comprises a self-locking clamp for clamping the suture element (200) when the suture element (200) is received in the slot (23a).
37. The assembly device (2) according to one of the claims 22 to 27, characterized in that said assembly device comprises a first part (30) comprising a fixing element (31) for attaching the guiding rope (300) to the first part (30), and a second part (50) comprising said holder (400), wherein said second part (50) is rotatable about a rotation axis (R) relative to said first part (30), such that the guiding rope (300) can be moved together with said suture element (200) relative to the holder (400) when said second part (50) is rotated relative to said first part (30), resulting in the suture element (200) engaging with the suspension plate (100).
38. The assembly device (2) according to claim 37 and claim 24 or one of the claims 25 to 27 when referring to claim 24, characterized in that said first pin (P1) and said second pin (P2) are comprised in said second part (50), wherein said assembly device (2) further comprises a third pin (P3) and a fourth pin (P4) comprised in said second part (50), the third pin (P3) being arranged between the first pin (P1) and the second pin (P2) along a periphery around the holder (400) and the fourth pin (P4) being arranged between the first pin (P1) and the second pin (P2) and opposite the third pin (P3) along said periphery, wherein said guiding rope (300) is arrangeable along said periphery around said first pin (P1), said second pin (P2), said third pin (P3) and said fourth pin (P4) when said second part (50) is rotated relative to said first part (30).
39. The assembly device (2) according to claim 38, characterized in that said assembly device (2) further comprises a fifth pin (P5) for guiding said guiding rope (300) and/or said suture element (200) from the holder (400) towards the fixing element (31), wherein the fifth pin (P5) is arranged on said second part (50) adjacent to said first pin (P1) radially outward from said first pin (P1) with respect to said rotation axis (R).
40. The assembly device (2) according to claim 39, characterized in that said assembly device (2) further comprises a sixth pin (P6) arranged on said second part (50), wherein the fifth pin (P5) and the sixth pin (P6) are arranged such that the guiding rope (300) and/or the suture element (200) can be guided from the holder (400) towards the fixing element (31) between the fifth pin (P5) and the sixth pin (P6) when said second part (50) is rotated relative to said first part (30).
41. The assembly device (2) according to one of the claims 37 to 40, characterized in that said assembly device (2) comprises a lid part (60) comprising a first handle (61), wherein the lid part (60) is configured to be coupled to said second part (50), wherein said first part (30) comprises a second handle (32), such that the second part (50) can be rotated relative to said first part (30) by moving said first handle (61) relative to said second handle (32), wherein particularly said lid part (60) comprises at least a first hole (62) and a second hole (63), wherein the first hole (62) and the second hole (63) are each configured to receive one of said first pin (P1), said second pin (P2), said third pin (P3), said fourth pin (P4), said fifth pin (P5) or said sixth pin (P6) to couple the lid part (60) to the second part (50).
42. A method for assembling an implantable suspension device (1), particularly according to one of the claims 1 to 16, wherein a suspension plate (100) and a suture element (200) are provided, wherein the suture element (200) is engaged with the suspension plate (100), such that a first end section (201) of the suture element (200) extends from said suspension plate (100) to a first end (201a) of said suture element (200) and a second end section (202) extends from said suspension plate (100) to a second end (202a) of said suture element (200).
43. The method according to claim 42, wherein a connecting section (240) comprised in the second end section (202) is connected, particularly stitched, to an elongated flexible implant (G).
44. The method according to claim 42 or 43, wherein a first locking loop (41) is formed from the suture element (200), wherein the first locking loop (41) presses the first end section (201) of the suture element (200) against the suspension plate (100), thereby locking the first end section (201) with respect to the suspension plate (100).
45. The method according to one of the claims 42 to 44, wherein an adjustable first suspension section (231) of said suture element (200) between said suspension plate (100) and said connecting section (240) is shortened by pulling on the first end section (201) of the suture element (200), wherein particularly said first end section (201) protrudes out of said first locking loop (41).
46. The method according to one of the claims 42 to 45, wherein said suture element (200) is inserted into a plurality of through-holes (11, 12, 13, 14, 15, 16) of said suspension plate (100), particularly at least three through-holes (11, 12, 13), more particularly 3, 4 or 6 through-holes, extending from a front side (100a) of the suspension plate (100) to a rear side (100b) of the suspension plate (100) facing away from the front side (100a).
47. The method according to claim 46, wherein the suture element (200) is inserted into a first-through-hole (11) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the rear side (100b) to the front side (100a) of the suspension plate (100) with the first end (201a) ahead, particularly such that the adjustable first suspension section (231) is formed on the rear side (100b) of the suspension plate (100).
48. The method according to claim 47, wherein the suture element (200) is inserted into a second through-hole (12) of said plurality of through-holes from the front side (100a) to the rear side (100b) of the suspension plate (100) with the first end (201a) ahead, particularly such that the first locking loop (41) is formed on the front side (100a) of the suspension plate (100), wherein the suture element (200) is further inserted into a third through-hole (13) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the rear side (100b) to the front side (100a) of the suspension plate (100) with the first end (201a) ahead, wherein particularly the first end section (201) of the suture element (200) is further inserted into the first locking loop (41) for clamping the first end section (201) to the front side (100a) of the suspension plate (100) by means of the first locking loop (41) with a locking force (F.sub.L).
49. The method according to claim 48, wherein the suture element (200) is further inserted into a fourth through-hole (14) of said plurality of through-holes from the front side (100a) to the rear side (100b) of the suspension plate (100) with the first end (201a) ahead.
50. The method according to claim 48, wherein the suture element (200) is further inserted into a fourth through-hole (14) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the rear side (100b) to the front side (100a) of the suspension plate (100) with the second end (202a) ahead, particularly such that the suture element (200) forms a second suspension section (232) between said connecting section (240) and said suspension plate (100), wherein said suture element (200) is further inserted into a fifth through-hole (15) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the front side (100a) to the rear side (100b) of the suspension plate (100) with the second end (202a) ahead, particularly such that a second locking loop (42) is formed, wherein the suture element (200) is further inserted into a sixth through-hole (16) of said plurality of through-holes (11, 12, 13, 14, 15, 16) from the rear side (100b) to the front side (100a) of the suspension plate (100) with the second end (202a) ahead, wherein particularly the second end section (202) of the suture element (200) is further inserted into said second locking loop (42) for clamping the second end section (202) of the suture element (200) to the front side (100a) of the suspension plate (100) by means of the second locking loop (42) with a locking force (F.sub.L).
51. The method according to claim 50, wherein an adjustable second suspension section (232) of said suture element (200) between said connecting section (240) and said suspension plate (100) is shortened by pulling on the second end section (202) of the suture element (200), wherein particularly said second end section (202) protrudes out of said second locking loop (42).
52. The method according to one of the claims 42 to 51, wherein the connecting section (240) is connected to the elongated flexible implant (G) by means of a needle (250) attached to the suture element (200), particularly to the first end (201a) or the second end (202a).
53. The method according to one of the claims 42 to 52, wherein a guiding rope (300) is moved together with said suture element (200) resulting in the suture element (200) engaging with the suspension plate (100) to assemble said implantable suspension device (1).
54. The method according to claim 53 when referring to one of the claims 45 to 51, wherein said guiding rope (300) is inserted into at least one through-hole (11, 12, 13, 14, 15,
16. of said plurality of through-holes (11, 12, 13, 14, 15, 16) of said suspension plate (100), and wherein the guiding rope (300) is subsequently moved through said at least one through-hole (11, 12, 13, 14, 15, 16) together with the suture element (200), resulting in the suture element (200) engaging with the suspension plate (100).
55. The method according to claim 53 or 54, wherein the guiding rope (300) is moved around a first pin (P1) and a second pin (P2) together with the suture element (200) during engagement of the suture element (200) with the suspension plate (100), particularly wherein the suspension plate (100) is arranged between the first pin (P1) and the second pin (P2), such that said first pin (P1) faces said front side (100a) of the suspension plate (100) and said second pin (P2) faces said rear side (100b) of the suspension plate (100).
56. The method according to one of the claims 53 to 55, wherein said guiding rope (300) is successively inserted into said first through-hole (11) or said fourth through-hole (14) from said rear side (100b) to said front side (100a) of the suspension plate (100), around said first pin (P1), into said second through-hole (12) or said fifth through-hole (15) from said front side (100a) to said rear side (100b) of the suspension plate (100), around said second pin (P2) and into said third through-hole (13) or said sixth through-hole (16) from said rear side (100b) to said front side (100a) of the suspension plate (100).
57. The method according to one of the claims 53 to 56, wherein said guiding rope (300) forms a loop (303) enlacing said suture element (200), wherein said loop (303) is moved together with the suture element (200) resulting in the suture element (200) engaging with the suspension plate (100).
58. The method according to one of the claims 53 to 57, wherein said suture element (200) is received in an inner volume (305) of the guiding rope (300) extending between a first end (301) and a second end (302) of the guiding rope (300), wherein the guiding rope (300) is moved together with the suture element (200) disposed in the inner volume (305) resulting in the suture element (200) engaging with the suspension plate (100), wherein particularly said suture element (200) is received in said inner volume (305) through an opening (307) of a funnel (306) formed by the guiding rope (300) at the first end (301) of the guiding rope (300), wherein particularly the funnel (306) is collapsed from an expanded state to a collapsed state during engagement of the suture element (200) with the suspension plate (100), wherein said opening (307) has a first diameter in the expanded state and a second diameter in the collapsed state, wherein the first diameter is larger than the second diameter.
59. The method according to one of the claims 42 to 58, wherein after assembly of said implantable suspension device (1), said implantable suspension device (1) is mounted, particularly automatically, on a tool (5) for implanting said implantable suspension device (1).
60. The method according to one of the claims 53 to 59, wherein the guiding rope (300) is attached to a fixing element (31), wherein the fixing element (31) is moved along a periphery around the suspension plate (100), such that the guiding rope (300) together with the suture element (200) is moved relative to the suspension plate (100) resulting in the suture element (200) engaging with the suspension plate (100).
61. The method according to claim 60 and claim 55 or one of the claims 56 to 59 when referring to claim 55, wherein said guiding rope (300) is moved along said periphery around said first pin (P1), said second pin (P2), a third pin (P3) and a fourth pin (P4), the third pin (P3) being arranged between the first pin (P1) and the second pin (P2) along said periphery and the fourth pin (P4) being arranged between the first pin (P1) and the second pin (P2) and opposite the third pin (P3) along said periphery.
62. The method according to claim 61, wherein said guiding rope (300) is further moved around a fifth pin (P5), wherein the fifth pin (P5) guides said guiding rope (300) and/or said suture element (200) towards the fixing element (31), wherein the fifth pin (P5) is arranged adjacent to said first pin (P1).
63. The method according to claim 62, wherein said guiding rope (300) is further moved around a sixth pin (P6), wherein said guiding rope (300) and/or the suture element (200) is guided towards the fixing element (31) between the fifth pin (P5) and the sixth pin (P6).
64. A method for assembling a medical implant (6) according to one of the claims 17 to 21, comprising the steps of a. providing a suture element (200) comprising a connecting section (240), b. providing a medical textile (500), particularly comprising or consisting of a felt material, c. connecting the connecting section (240) of the suture element (200) to the medical textile (500), d. providing a suspension plate (100), e. engaging the suture element (200) with the suspension plate (100), particularly by the method according to one of the claims 42 to 63.
65. The method according to claim 64, wherein the connecting section (240) of the suture element (200) is connected to the medical textile (500) by stitching.
66. The method according to claim 64, wherein the suture element (200) comprises or consists of a plurality of fibers (203), wherein the fibers (203) are separated from each other in the connecting section (240), and wherein the separated fibers (203) of the connecting section (240) are advanced into and/or through the medical textile (500) to connect the suture element (200) of the implantable suspension device (1) to the medical textile (300).
67. The method according to claim 66, wherein the connecting section (240) of the suture element (200) is connected to the medical textile (500) by repeatedly advancing a needle comprising at least one barb through the connecting section (240) and the medical textile (500) to advance the separated fibers (203) of the connecting section into and/or through the medical textile (500).
68. The method according to one of the claims 64 to 67, wherein, after connecting the connecting section (240) of the suture element (200) to the medical textile (500), the medical textile (500) and/or the suture element (200) is connected to an elongated flexible implant (G), particularly outside of a human or animal body.
69. The method according to claim 68, wherein the medical textile (500) and/or the suture element (200) is stitched to the implant (G).
70. The method according to claim 68, wherein the medical textile (500) is connected to the implant (G) by repeatedly advancing a needle comprising at least one barb through the medical textile (500) and the implant (G) and/or wherein the suture element (200) is connected to the implant (G) by repeatedly advancing a needle comprising at least one barb through the connecting section (240) of the suture element (200) and the implant (G).
71. The method according to one of the claims 68 to 70, wherein the medical textile (500) is at least partially wrapped around the implant (G) prior to connecting the medical textile (500) to the implant (G), particularly wherein the medical textile (500) is wrapped around the implant (G), such that the medical textile (500) assumes a tubular shape, wherein said implant (G) is connected to an inner surface of the medical textile (500).
Description
[0131] Further features and advantages of the invention shall be described by means of detailed descriptions of embodiments with reference to the Figures, wherein
[0132]
[0133]
[0134]
[0135]
[0136]
[0137]
[0138]
[0139]
[0140]
[0141]
[0142]
[0143]
[0144]
[0145]
[0146]
[0147]
[0148]
[0149]
[0150] As shown in
[0151] The first end 201a is then advanced through a first through-hole 11 of the suspension plate 100 from a rear side 100b (not shown in
[0152] Subsequently, the first end 201a of the suture element 200 is inserted into a second through hole 12 of the suspension plate 100 from the front side 108 to the rear side 100 B (
[0153] In the next step which is shown in
[0154] The final assembly with a tightened first locking loop 41 pressing the first end section 201 against the front side 100a of the suspension plate 100 is shown in
[0155] Furthermore, a first suspension section 231 is formed between the rear side 100b of the suspension plate 100 and the connecting section 240 stitched to the implant G (
[0156] As illustrated in
[0157] In particular, in order to achieve a friction coefficient which is sufficient to provide a self-locking mechanism, the suture element 200 may be braided from an ultra-high molecular weight polyethylene or co-braided from an ultra-high molecular weight polyethylene and polypropylene, polyester or polyamide, and the front side 100a and/or the rear side 100b of the suspension plate may have a surface roughness of at least 0.6 μm. For example, the suture element 200 may have a diameter of about 0.5 to 0.7 mm, and the first through-hole 11, the second through-hole 12 and/or the third through-hole may have a diameter of about 1.1 mm.
[0158] After adjusting the length of the first suspension section 231, the first end section 201 may be shortened, e.g., by cutting, resulting in the configuration shown in
[0159]
[0160] To form the assembly shown in
[0161] Subsequently, the second end section 202 is advanced through a fifth through-hole 15 from the front side 100a to the rear side 100b of the suspension plate 100 with the second end 202a ahead, thereby forming a second locking loop 42 on the front side 100a of the suspension plate 100 (
[0162] The second end section 202 is then inserted into a sixth through-hole 16 from the rear side 100b to the front side 100a of the suspension plate 100 with the second end 202a ahead and advanced through the second locking loop 42 on the front side 100a of the suspension plate 100 (
[0163] Thereby, a first suspension section 231 of the suture element 200 protruding from the rear side 100b of the suspension plate 200 is formed between the first through-hole 11 and the implant G, and a second suspension section 232 of the suture element 200 protruding from the rear side 100b of the suspension plate 200 is formed between the implant G and the fourth through-hole 14.
[0164] In the final assembly depicted in
[0165] The length of the first and second suspension strand 231, 232 can then be adjusted independently of each other by pulling on the first end section 201 or the second end section 202, respectively (see arrow in
[0166] The self-locking mechanism of the first locking loop 41 and the second locking loop 42 functions in the same way as described above for the embodiment shown in
[0167]
[0168] As depicted in
[0169] The first free end 201a of the suture element 200 is inserted into the first through-hole 11 of the suspension plate 100 from the rear side 100b to the front side 100a (
[0170] Thus, the first suspension section 231 extending between the implant G and the first through-hole 11 and the first end section 201 protruding from the fourth through-hole 14 are both arranged on the rear side 100b of the suspension plate 100, which allows to adjust the length of the first suspension section 231 from the rear side 100b by pulling on the first end section 201. This is advantageous for some applications of the implantable suspension device 1, where the rear side 100b of the suspension plate 100 can be more easily accessed than the front side 100a of the suspension plate 100.
[0171] The self-locking mechanism of the first locking loop 41 according to
[0172]
[0173] The screw 3 shown in
[0174] The suspension plate 100 integrally formed with the screw 3 comprises a first through-hole 11, a second through-hole 12, a third through-hole 13 and a fourth through-hole 14, each extending between the front side 100a and the rear side 100b of the suspension plate 100. To access the front side 100a of the suspension plate 100, a lateral opening 3c is provided (
[0175]
[0176] The suspension plate 100 integrally formed with the anchor 4 comprises a first through-hole 11, a second through-hole 12, a third through-hole 13 and a fourth through-hole 14, each extending between the front side 100a and the rear side 100b of the suspension plate 100. To access the front side 100a of the suspension plate 100, a lateral opening 4c is provided (
[0177] As indicated in
[0178] A needle 250 is attached to the second end 202a of the suture element 200 as shown in
[0179] For example, the implantable suspension device 1 according to
[0180]
[0181] The guiding rope 300 extends from a first end 301 successively through the third through-hole 13 or sixth through-hole 16, the second through-hole 12 or fifth through-hole 15, and the first through-hole 11 or fourth through-hole 14, forms a loop 303 and extends back through the first through-hole 11 or fourth through-hole 14, the second through-hole 12 or fifth through-hole 15 and the third through-hole 13 or the sixth through-hole 16 towards a second end 302. An additional first loop L1 or bend is formed between the first or fourth through-hole 11, 14 and the second or fifth through-hole 12, 15 and a further second loop L2 or bend is formed between the second or fifth through-hole 12, 15 and the third or sixth through-hole 13. 16.
[0182] When the suture element 200 is inserted into the loop 303 of the guiding rope 300 as shown in
[0183]
[0184] The guiding rope 300 according to
[0185] Hereafter, an assembly device 2 for assembling the implantable suspension device 1 according to the present invention is described with reference to
[0186]
[0187] The holding part 21 comprises a holder 400 formed as a slot for insertion of the suspension plate 100, a first pin P1 and a second pin P2, wherein the first pin P1 and the second pin P2 are arranged on opposite sides of the holder 400. The holder 400 is arranged between the pins P1, P2 such that the first pin P1 faces the front side 100a of the suspension plate 100 and the second pin P2 faces the rear side 100b of the suspension plate 100. In
[0188] As shown in
[0189]
[0190] In
[0191]
[0192]
[0193] The casing part 22 comprises a first hole 22a and a second hole 22b for receiving the first pin P1 and the second pin P2 of the holding part 21, respectively, and connect the casing part 22 to the holding part 21, and a wall 22c encasing the holding part 21 and comprising an opening 22d for receiving the guide bar 23 (see also
[0194]
[0195] By pulling the guiding rope 300 through the assembly device 2 along the slot 23a of the guide bar 23 and through the groove 24b of the handle 24a, the suture element 200 may be assembled and engaged with the suspension plate 100 held by the holding part 21, resulting in the first end 201a of the suture element 200 protruding from the groove 24b of the handle 24a and the second end 202a of the suture element 200 protruding from the opening 22d of the casing part 22 opposite the tip of the guide bar 23, resulting in the setup shown in
[0196] As depicted in
[0197] The second end 202a of the suture element 200 may then be attached to an implant G (see
[0198] The tool 5 may further comprise an actuating element 28 that can be actuated to clamp the suture element 200 in the slot 23a of the guide bar 23 or release a clamping mechanism.
[0199]
[0200] As shown in
[0201]
[0202] As depicted in
[0203] The first part 30 comprises a fixing element 31 for fixing the guiding rope 300 to the first part 30. In the embodiment shown in
[0204] As shown in
[0205] The first part 30 further comprises a second handle 32 and a further handle 33 opposite the second handle 32.
[0206]
[0207] When the lid part 60 is coupled to the second part 50 and the first handle 61 of the lid part 60 is moved relative to the second handle 32 of the first part 30, the second part 50 is rotated about the rotation axis R with respect to the first part 30. Thereby, the fixing element 31 with the ends of the guiding rope 300 attached revolves around the second part 50 and the loop 303 of the guiding rope 300 is drawn around the pins P1, P2 and through the through-holes 11, 12, 13 of the suspension plate 100 in the holder 400, resulting in an engagement of the suture element 200 with the suspension plate 100 similar to the procedure shown in
[0208] Due to the rotary motion of the guiding rope 300, the assembly advantageously requires less space than in case of a linear motion. In addition, uncontrollable movements during the mechanism due to different forces acting during different stages of assembly, are avoided by the rotary assembly procedure. Furthermore, by using sufficiently long handles, the force applied to the handles can be amplified (e.g. by a factor of about 3), resulting in less force applied by the user. The pins P1, P2, P3, P4 ensure that the guiding rope 300 and the suture element 200 do not entangle and the pins P5, P6, P7 serve to guide the guiding rope towards the fixing element 31.
[0209]
[0210] As shown in
[0211] Next, as illustrated in
[0212] Subsequently, the medical textile 500, which is now attached to the suture element 200, is connected to a flexible implant G, e.g., a soft tissue such as a tendon (
[0213]
[0214] Finally,
[0215] During a typical surgical procedure, the bone tunnel 601 is first introduced into the bone 600 using a surgical drill. Subsequently, the suspension plate 100 with the attached suture element 200 is introduced into the first segment 602 of the bone tunnel 601 and then moved through the second segment 603 of the bone tunnel 601 to the outside of the bone 600. The suspension plate 100 is then flipped to be arranged perpendicular to the bone tunnel 601. Next, the first suspension section 231 is shortened by pulling on the first end section 201, which results in the medical textile 500 with the attached flexible implant G being pulled into the first segment 602 of the bone tunnel 601. After tightening the first suspension section 231, the first end section 201 of this is suture element 200 may be cut, resulting in the configuration shown in
[0216]
[0217] As shown in
[0218]
[0219] Finally, as illustrated in
[0220] The assembled medical implant 6 is then inserted into a bone tunnel 601 as described above for the example shown in
LIST OF REFERENCE NUMERALS
[0221]
TABLE-US-00001 1 Implantable suspension device 2 Assembly device 3 Screw 3a Tip 3b Cutting thread 3c Lateral opening 4 Anchor 4a Tooth 4b Groove 4c Lateral opening 5 Tool 6 Medical implant 11 First through-hole 12 Second through-hole 13 Third through-hole 14 Fourth through-hole 15 Fifth through-hole 16 Sixth through-hole 21 Holding part 22 Casing part 22a First hole 22b Second hole 22c wall 22d opening 23 Guide bar 23a Slot 23b hole 23c Notch 23d Tip 24 Handle part 24a Handle 24b Groove 25 Tip part 26 Inner thread 27 Outer thread 28 Actuating element 30 First part 31 Fixing element 32 Second handle 33 Further handle 34 Brace 41 First locking loop 42 Second locking loop 50 Second part 60 Lid part 61 First handle 62 First hole 63 Second hole 64, 65, 66, 67 Further hole 68 Further handle 100 Suspension plate 100a Front side 100b Rear side 200 Suture element 201 First end section 201a First end 202 Second end section 202a Second end 203 Fiber 204 Fiber end 231 First suspension section 232 Second suspension section 240 Connecting section 250 Needle 300 Guide rope 301 First end of the guiding rope 302 Second end of the guiding rope 303 Loop 305 Inner volume 306 Funnel 307 Opening of the funnel 400 Holder 500 Medical textile 600 Bone 601 Bone tunnel 602 First segment 603 Second segment P1 First pin P2 Second pin P3 Third pin P4 Fourth pin P5 Fifth pin P6 Sixth pin P7 Seventh pin d diameter L Longitudinal axis L1 First loop L2 Second loop R Rotation axis A1 First axis F.sub.L Locking force G Implant S Stitches