MEDICAL IMPLANT, MEDICAL DEVICE, SEPARATION DEVICE, FELTING DEVICE AND METHODS
20230329702 · 2023-10-19
Assignee
Inventors
Cpc classification
International classification
Abstract
The invention relates to a medical implant (100) extending between a first end (103) and a second end (104), wherein the medical implant (100) comprises or consists of a plurality of fibers (101), the medical implant (100) comprising a main section (105) and a first connecting section (110) configured to be connected to soft biological tissue (500) or to a medical textile (300), particularly comprising or consisting of a felt material, wherein the first connecting section (110) extends towards the first end (103), and wherein the fibers (101) are connected in the main section (105) and separated from each other in the first connecting section (110). Furthermore, the invention relates to a medical device (600) comprising the medical implant (100), a felting device (700) and a separation device (800), methods for producing a medical implant (100) and a medical device (600), and a method for biological soft tissue repair.
Claims
1. A medical implant (100) extending between a first end (103) and a second end (104), wherein the medical implant (100) comprises or consists of a plurality of fibers (101), characterized in that the medical implant (100) comprises a main section (105) and a first connecting section (110) configured to be connected to soft biological tissue (500) or to a medical textile (300), particularly comprising or consisting of a felt material, wherein the first connecting section (110) extends towards the first end (103), and wherein the fibers (101) are connected, particularly braided, twisted, knitted or felted, in the main section (105) and separated from each other in the first connecting section (110).
2. The medical implant (100) according to claim 1, characterized in that the medical implant (100) comprises a second connecting section (120) configured to be connected to soft biological tissue (500) or to a medical textile (300), particularly comprising or consisting of a felt material, wherein the second connecting section (120) extends towards the second end (104), wherein the fibers (101) are separated from each other in the second connecting section (120).
3. The medical implant (100) according to claim 1, characterized in that each of the separated fibers (101) comprises a fiber end (106) or a fiber loop positioned at the first end (103) or the second end (104) of the medical implant (100).
4. The medical implant (100) according to claim 1, characterized in that the main section (105) and the first connecting section (110) and/or second connecting section (120) of the medical implant (100) each comprise an area perpendicular to an extension direction of the medical implant (100), wherein the area of the first connecting section (110) and/or second connecting section (120) is greater than the area of the main section (105).
5. The medical implant (100) according to claim 1, characterized in that the first connecting section (110) or the second connecting section (120) forms a fan-like structure extending in a plane parallel to an extension direction of the medical implant (100), or the first connecting section (110) or the second connecting section (120) forms a tubular structure, particularly comprising a circular or oval-shaped cross-sectional contour perpendicular to an extension direction of the medical implant (100), wherein particularly a width of the cross-sectional contour increases, particularly monotonously, towards the first end (103) of the medical implant (100).
6. The medical implant (100) according to claim 1, characterized in that the fibers (101) each comprise a plurality of barbs (102).
7. The medical implant (100) according to claim 1, characterized in that the fibers (101) comprise or consist of a biocompatible polymer, particularly polyethylene, polytetrafluorethylene, polyethylene terephthalate, poly(glycolide), poly(lactic-co-glycolic acid), poly (L-lactic acid), polycaprolactone, 1,2-propanediol, or 1,3-propanediol.
8. A medical device (600) comprising at least one medical implant (100) according to claim 1, characterized in that the medical device (600) further comprises a medical textile (300), particularly comprising or consisting of a felt material, wherein the separated fibers (101) of the first connecting section (110) and/or the second connecting section (120) of the medical implant (100) extend into or through the medical textile (300) to connect the medical implant (100) to the medical textile (300).
9. The medical device (600) according to claim 8, characterized in that the medical textile (300) extends along a plane, wherein particularly the medical textile (300) comprises a flat shape.
10. The medical device (600) according to claim 9, comprising two medical implants characterized in that the medical device (600) comprises a first medical implant (130), wherein the first connecting section (110) and/or the second connecting section (120) of the first medical implant (130) forms a fan-like structure extending in a plane parallel to an extension direction of the first medical implant (100), and wherein the first medical implant (130) is connected to the medical textile (300), such that the first medical implant (130) extends from the medical textile (300) parallel to the plane of the medical textile (300), and the medical device comprises a second medical implant (140), wherein the first connecting section (110) or the second connecting section (120) of the second medical implant (140) forms a tubular structure, particularly comprising a circular or oval-shaped cross-sectional contour perpendicular to an extension direction of the second medical implant (140), wherein particularly a width of the cross-sectional contour increases, particularly monotonously, towards the first end (103) of the second medical implant (140) wherein the second medical implant (140) is connected to the medical textile (300), such that the second medical implant (140) extends from the medical textile (300) perpendicular to the plane of the medical textile (300).
11. The medical device (600) according to claim 8, characterized in that the medical textile (300) comprises a tubular shape, wherein the medical textile (300) comprises an opening (304) configured for insertion of a soft biological tissue (500) into the medical textile (300), wherein particularly the first connecting section (110) or the second connecting section (120) of the medical implant (100) forms a tubular structure, wherein the tubular structure is arranged in the medical textile (300) contacting the inner circumference of the medical textile (300) or wherein the tubular structure is arranged at least partially around the outer circumference of the medical textile (300), wherein the separated fibers (101) of the tubular structure extend into or through the medical textile (300) to connect the medical implant (100) to the medical textile (300).
12. The medical device (600) according to claim 8, characterized in that the medical device (600) further comprises at least one anchoring element (610) configured to be inserted into a bone, wherein particularly the anchoring element (610) is connected to the medical implant (100).
13. A separation device (800) for producing a medical implant (100) according to claim 1, comprising a first roller (801) rotatably mounted on a first shaft (802) extending along a longitudinal axis (L) and a second roller (804), particularly rotatably mounted on a second shaft (805) parallel to the first shaft (802), wherein the first roller (801) comprises a plurality of spikes (803) extending radially with respect to the longitudinal axis (L), and wherein the second roller (804) comprises a plurality of grooves (806) extending in a circumferential direction around the second roller (804), wherein each groove (806) is aligned with a corresponding spike (803) of the first roller (801), such that the spikes (803) of the first roller (801) are able to insert into and move through the respective grooves (806) when the first roller (801) is rotated around the first shaft (802), and wherein the first roller (801) and the second roller (804) are separated by a gap (807) configured to receive a medical implant (100) comprising a plurality of braided or twisted fibers (101), and wherein the device (800) is configured to separate the fibers (101) of the medical implant (100) by means of the spikes (803) when the first roller (801) is rotated around the first shaft (802), thereby generating the first connecting section (110) or the second connecting section (120) of the medical implant (100).
14. A felting device (700) for producing a medical device according to claim 8, wherein the device (700) comprises a surface (701) for arranging a medical textile (300) and at least one needle (702) comprising at least one barb, wherein the device (700) is configured to repeatedly advance the needle (702) through the medical textile (300) arranged on the surface (701) and through the first connecting section (110) or the second connecting section (120) of a medical implant (100) which is arranged on the medical textile (300), such that the separated fibers (101) of the first connecting section (110) or the second connecting section (120) of the medical implant (100) are advanced into or through the medical textile (300) to connect the medical implant (100) to the medical textile (300).
15. A method for biological soft tissue (500) repair, wherein the method comprises providing a medical implant (100) according to claim 1 or a medical device (600) thereof, and wherein the first connecting section (110) or the second connecting section (120) of the medical implant (100) or the medical textile (300) of the medical device (600) is arranged on a soft biological tissue (500), and wherein a needle (200) comprising at least one barb is repeatedly advanced through the first connecting section (110) or the second connecting section (120) of the medical implant (100) and the soft biological tissue (500) or through the medical textile (300) and the soft biological tissue (500) to connect the medical implant (100) or the medical device (600) to the soft biological tissue (500), wherein particularly the method is performed outside of a human or animal body.
Description
[0100] The invention is further illustrated by the following examples and figures, from which further embodiments and advantages can be drawn. These examples are meant to illustrate the invention but not to limit its scope.
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[0111] Furthermore,
[0112] In summary,
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[0115] As shown in
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[0118] A number of further embodiments of the medical implant 100 and medical device 600 are shown in
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[0120] In contrast, the second medical implant 140 and the fourth medical implant 140a are formed as shown in
[0121] As is apparent from
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[0125] Rotator cuff tears are one of the most frequent tendon injuries with reported failure rates between 30 and 70%. Especially early failure of repaired tendons and ligaments are caused by suture or knot failure where the suture pulling out of the tendon or through the bone. To ideally repair a soft-tissue, high initial fixation strength should be achieved to allow minimal gap formation and mechanical stability to allow a solid healing.
[0126] The medical device 600 comprises a first medical implant 130 and a second medical implant 140 (here, first and second medical sutures) connected by felting to a planar medical textile 300 from a felt material. The medical textile 300 has been tightly connected by felting to the tendon 501. Furthermore, the medical device 600 comprises additional anchoring elements 610 (e.g., bone anchors 610), which are attached to the first medical implant 130 and second medical implant 140, respectively.
[0127] A detailed view of the tendon 501 and medical device 600 is depicted in
[0128] In a typical method using the medical device 600 shown in
[0129] The lower portion of
[0130] For simplicity, the medical devices 600 used in rotator cuff repair and biceps tendon repair are illustrated on the same bone 502 in
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[0132] The separation device 800 comprises a first roller 801 rotatably mounted on a first shaft 802 extending along a longitudinal axis L and a second roller 804 rotatably mounted on a second shaft 805 which is parallel to the longitudinal axis L. The first roller 801 and the second roller 804 are separated by a gap 807 for receiving the medical implant 100. The first roller 801 comprises spikes 803 extending outward in a radial direction in respect of the longitudinal axis L, and the second roller 804 comprises corresponding grooves 806 extending around the circumference of the second roller 804 in a circumferential direction in respect of the second shaft 805. In the example shown in
[0133] The first roller 801 and the second roller 804 are aligned such that the spikes 803 protrude into and move through the grooves 806 when the first roller 801 is rotated around the first shaft 802. In this manner, the spikes 803 engage a medical implant 100 arranged in the gap 807 between the first roller 81 and the second roller 804 and disengage and separate the braided or twisted fibers 101 of the medical implant 100 to generate the first connecting section 110. Of course, the second connecting section 120 can be generated in a similar manner by providing the opposite end of the medical implant 100 in the gap 807 between the first roller 801 and the second roller 804. The first shaft 802 or the second shaft 805 or both the first shaft 802 and the second shaft 805 may be driven, e.g. by a motor.
[0134] The felting device 700 comprises a cube shaped bottom part 700a and a top part 703 configured to be arranged on the bottom part 700a. The bottom part 700a forms a slot 705 for receiving a medical textile 300 delimited by a surface 701 and side walls 706 on two opposite sides of the slot 705. The slot 705 is open towards the remaining two sides delimiting the surface 701.
[0135] The top part 703 comprises a plurality of felting needles 702 each comprising at least one barb, particularly each comprising a plurality of barbs, wherein the needles 702 are facing with their tips towards the surface 701 of the bottom part 700a when the top part 703 is arranged on the bottom part 700a. The surface 701 further comprises an array of holes 704 aligned with the needles 702 of the top part 703, such that each needles 702 is at least partially inserted into a corresponding hole 704 when the top part is placed on the bottom part 700a or moved towards the bottom part 700a.
[0136] To connect a medical implant 100 to a medical textile 300 from a felt material, the medical textile 300 is inserted into the slot of the bottom part 700a, the first connecting section 110 or the second connecting section 120 of the medical implant 100 is arranged on the medical textile 300, and the top part 703 is positioned on the bottom part 700a. Subsequently, the top part 703 with the attached needles 702 is moved up and down periodically through the connecting section 110, 120 and the medical textile 300, such that fibers 101 of the connecting section 110, 120 are moved into the felt material of the medical textile 300 to tightly connect the medical implant 100 to the medical textile 300.
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[0138] In a preferred method, the conveyor mechanism may be used as follows: a first end 103 of a medical implant 100 is inserted in the gap 810 between the third roller 808 and the fourth roller 809, and then pulled towards the fifth roller 811 and the sixth roller 812 and inserted in the gap 810 between the fifth roller 811 and the sixth roller 812 (either manually or by rotating the third roller 808 and/or the fourth roller 809). By rotating the third roller 808 counterclockwise, the fourth roller 809 clockwise, the fifth roller 811 counterclockwise and the sixth roller 812 clockwise, the first end 103 is then moved towards the gap 807 between the first roller 801 and the second roller 804 of the separation device 800. By separating the fibers 101 of the medical implant 100 on the first end 103 by means of the spikes 803 on the first roller 801, the first connecting section 110 is generated. Subsequently, a felt medical textile 300 is arranged on the surface 701 in the slot 705 of the felting device 700, and the third roller 808, the fourth roller 809, the fifth roller 811 and/or the sixth roller 812 are rotated in the opposite direction to move the first end 103 with the first connecting section 110 onto the medical textile 103 in the slot 705. The top part 703 is then closed, and the medical implant 100 is connected to the medical textile 300 by repeatedly advancing the needles 702.
TABLE-US-00001 List of reference signs Medical implant 100 Fiber 101 Barb 102 First end 103 Second end 104 Main section 105 Fiber end 106 First connecting section 110 Upper portion 110a Lower portion 110b Second connecting section 120 Upper portion 120a Lower portion 120b First medical implant 130 Second medical implant 140 Felting needle 200 Medical textile 300 First medical textile 301 Second medical textile 302 Fiber 303 Opening 304 Soft biological tissue 500 Tendon 501 Humerus bone 502 Bone tunnel 502a Medical device 600 Anchoring element 610 Felting device 700 Bottom part 700a Surface 701 Needle 702 Top part 703 Hole 704 Slot 705 Side wall 706 Separation device 800 First roller 801 First shaft 802 Spike 803 Second roller 804 Second shaft 805 Groove 806 Gap 807 Third roller 808 Third shaft 808a Fourth roller 809 Fourth shaft 809a Gap 810 Fifth roller 811 Fifth shaft 811a Sixth roller 812 Sixth shaft 812a System 900 Longitudinal axis L