Surgical device with blunt-tipped felt needles

Abstract

The present invention relates to a surgical device (1) for attaching a nonwoven fabric to human or animal soft tissue by conveying individual fibers of the nonwoven fabric to the soft tissue. The device includes a holder (3, 5) and a felting needle (2, 31, 51, 61, 71, 81, 91). The holder holds the felting needle. The felting needle is reciprocable relative to the holder between a first position and a second position. The felting needle has a longitudinal axis, a proximal end, and a distal end. The felting needle is configured to push the individual fibers of the nonwoven fabric into the soft tissue. The distal end of the felting needle has a blunt tip, and the blunt end surface captures and pushes out new fibers of the nonwoven fabric.

Description

[Technical Field]

[0001] The present application relates to a surgical device for attaching a nonwoven fabric to the soft tissue of a human or animal by delivering individual fibers of the nonwoven fabric to the soft tissue of a human or animal. The invention also relates to a set including the surgical device, and to a method for attaching a nonwoven fabric to the soft tissue of a human or animal by delivering individual fibers of the nonwoven fabric to the soft tissue of a human or animal. [Background technology]

[0002] The present applicant recently disclosed Surgical FiberLock Technology (see, e.g., PCT / CH2019 / 000015) as a method and device for implanting a specialized biocompatible implant made of nonwoven microfibers using a specialized device. This innovative technology allows for the distribution of microfibers throughout soft tissue to enhance tissue repair, while minimizing the occurrence of suture breaks, a common issue that necessitates revision of repairs using traditional sutures. Furthermore, this technology has the potential to reinforce and repair severely damaged or weakened tissue that cannot be repaired with traditional sutures.

[0003] The Surgical FiberLock Technology implantation process involves the use of a radiofrequency reciprocating needle. The needle is designed with features that enable it to penetrate both the implant, including the nonwoven fabric, and the soft tissue of the human or animal, delivering the implant fibers into the soft tissue. As a result, the implant is securely and evenly fixed within the tissue.

[0004] Previously described needles have barbs located at the end of the needle body, which are intended to hook onto the microfibers of the implant. However, one limitation of these barbs is the distance from the fiber-carrying portion to the needle tip. As a result, the needle must penetrate tissue beyond the depth required for fiber delivery. This creates a risk, especially in situations where the soft tissue is in close proximity to sensitive areas, such as nerves or major circulatory organs in cardiovascular tissue.

[0005] The process of felting individual fibers in nonwoven fabrics is known in other technical fields, such as the textile industry. There, felting needles typically have barbs along the needle's circumference that are used to capture fibers and draw them into other fibers. Such felting needles allow for consistent felting, particularly for the consistent felting of two fabrics over large areas with an even distribution of the fibers being conveyed. While felting needles used in the textile industry may have a similar general shape, they differ in many aspects. Felting nonwoven fabrics to biomedical tissues presents a different set of challenges. In particular, human or animal soft tissues are often close to hard tissues, so only relatively small areas can be felted, and smaller areas require more fibers to be felted. Furthermore, traditional felting needles are complex to manufacture, requiring penetration beyond the two tissues being felted together to push the fibers far enough. Summary of the Invention [Problem to be solved by the invention]

[0006] It is an objective technical problem to overcome one or more of the above-mentioned drawbacks of the prior art. In particular, it is an objective technical problem to provide a surgical device for attaching nonwoven fibers to soft tissue of a human or animal, which brings individual fibers of the nonwoven fabric into the soft tissue of a human or animal, thereby creating a strong bond between the fibers and the tissue. [Means for solving the problem]

[0007] This objective problem is solved by the features of the independent claims. One aspect of the invention relates to a surgical device for attaching a nonwoven fabric to human or animal soft tissue by conveying individual fibers of the nonwoven fabric to the soft tissue. The device includes a holder and a felting needle. The holder holds the felting needle. The felting needle is reciprocable relative to the holder between a first position and a second position. The felting needle has a longitudinal axis, a proximal end, and a distal end. The felting needle is configured to push the individual fibers of the nonwoven fabric into the soft tissue. The distal end of the felting needle has a blunt tip for capturing and pushing out fibers of a novel fabric having a distal end surface with the blunt tip.

[0008] Unlike conventional felting needles, the independently claimed felting needle is configured to extrude fibers with its distal end rather than with a proximal barb. This allows the felting needle to extrude fibers as far as it penetrates. The applicant has found that such felting needles provide better adhesion than conventional felting needles for the same needle penetration depth when attaching nonwoven fabrics to human or animal soft tissue. Traditional felting needles known from the textile industry have sharp tips. While the sharp tips enable conventional felting needles known from the textile industry to penetrate nonwoven fabrics, the sharp tips do not support fibers at their distal end portions. Furthermore, the sharp tips may reduce the penetration force into the fabric. In contrast, the tips of the felting needles disclosed herein are blunt and include a distal end surface that captures at least one fiber as it passes through the nonwoven fabric.

[0009] A further advantage is that the felt needle does not need to penetrate as far, potentially reducing tissue damage. Additionally, the distance between the first and second positions is reduced, reducing the amplitude of the reciprocating motion, which may allow for a higher frequency and / or lower needle speed during reciprocating motion.

[0010] Felting as used herein may be understood as the intertwining and / or entangling of tissue fibers and implant fibers, which is achieved, for example, by forcing individual or a small number of fibers of a nonwoven fabric into human or animal soft tissue with felting needles.

[0011] Reciprocating motion can be understood as a back-and-forth motion. For example, moving a needle along a line or rotating around an axis at an angle. The nonwoven material is part of or forms part of an implant. The implant is equipped with a surgical device. Exemplary materials and exemplary implants are shown, for example, in PCT / CH2019 / 000015, PCT / EP2020 / 081887, PCT / EP2020 / 081891, EP22177290.8, and PCT / EP2020 / 081881. The implant may contain a drug, such as that described in EP22177290.8.

[0012] The holder may have a tubular member that guides the felting needle along the reciprocating motion. The surgical device may also include a drive member for reciprocating the felting needle between the first and second positions. The distance between the first and second positions may be 1 to 30 mm, more preferably 6 to 15 mm. In particular, the distance may be 6.5 mm, 8.5 mm, or 12 mm. At least one felting needle may have a length at least the thickness of the implant. In some embodiments, the needle may have a length of at least 4 mm, 6 mm, 8 mm, or 10 mm. The motor may operate the needle at a frequency of 1 to 200 Hz, preferably 10 to 100 Hz, most preferably 20 to 80 Hz, and in one embodiment, 40 Hz. In general, the holder may be designed as shown in any of the following applications: PCT / CH2019 / 000015, PCT / EP2020 / 081887, PCT / EP2020 / 081891, EP22177290.8, and PCT / EP2020 / 081881

[0013] As used herein, "blunt tip" may refer to a tip having at least some region at its distal end suitable for pushing individual or several fibers from the nonwoven into soft tissue. This region may be oriented normal to the longitudinal axis or may be at an angle of 45° or less to the longitudinal axis.

[0014] In a preferred embodiment, the distal end face is flat and extends substantially perpendicular to the longitudinal axis of the felting needle. A perpendicular end face is particularly suitable for carrying fibers, since the fibers tend to grip the surface well without slipping off.

[0015] In a particularly preferred embodiment, the felting needle has the shape of a flat-head screwdriver. This embodiment is particularly simple and easy to manufacture, and allows for strong interlacing between the fibers of the soft tissue and the fibers of the nonwoven fabric. Other shapes with blunt tips are also suitable, such as a blunt Phillips screwdriver (cross-shaped), a Torx® screwdriver (star-shaped), or a hexagonal screwdriver.

[0016] In further embodiments, the distal end surface is flat and extends at an angle of greater than 45°, 60°, 70°, or 80° relative to the longitudinal axis of the felting needle. Thus, the flat surface can also be angled. Applicant has recognized that angled surfaces can also carry fibers. In particular, the distal end surface can have a roughness that allows for fiber carrying, as described below.

[0017] In preferred embodiments, the blunt tip is round, rectangular, cross, star, eight, or oval, which refer to the shape of the distal tip when viewed from the distal or normal to the distal end surface.

[0018] In a preferred embodiment, the distal end surface includes one, two, three, or more notches. The notches can have a width of 0.005 to 0.1 mm. The notches serve to grasp and convey individual fibers and convey these fibers to the soft tissue. Individual fibers may mean that one or a small number (e.g., two, three, or four) of fibers are conveyed. The notches may be parallel to each other or disposed at any angle to each other. The notches may be straight, wavy, angled, or curved. The notches may extend across the width or depth of the distal end surface, or anything in between. For example, the notches may extend along a direction parallel or perpendicular to the longest dimension of the distal end surface. The notch depth may be up to 0.005 to 0.1 mm. The notches may be tapered, particularly semicircular, V-, or U-shaped.

[0019] In a preferred embodiment, the blunt distal end has a first width perpendicular to the longitudinal axis of the felting needle of at most 1 mm. In a preferred embodiment, the first width is at most 0.5 mm. Particularly preferred, the first width is at most 0.4 mm. Most preferred, the first width is at most 0.3 mm. These dimensions are particularly suitable for capturing fibers of nonwoven fabrics and transporting the fibers into soft tissue. As mentioned above, these fibers become entangled with the soft tissue. If the distal end of the felting needle is too large, too many fibers will be captured at the same time and pushed toward the soft tissue. This will push too many fibers and cause damage to the soft tissue, compared to capturing only a few fibers or a single fiber that can be pulled from the felt alone.

[0020] In further embodiments, the first width is at least 0.02 mm, at least 0.03 mm, at least 0.04 mm, or at least 0.05 mm. These minimum widths ensure that the fibers are caught by the blunt end. If the first width is small, the felting needle may penetrate the felt without catching anything or only catching a few fibers, resulting in no or poor adhesion. Furthermore, if the first width is below these values, the felting needle may cut the fibers.

[0021] The blunt end may also have a second width perpendicular to the longitudinal axis of the felting needle and perpendicular to the first width. The second width may be at least 0.01 mm, at least 0.02 mm, at least 0.03 mm, at least 0.04 mm, or at least 0.05 mm. Similar considerations apply as for the first width.

[0022] In a preferred embodiment, the felting needle comprises a distal end portion. A blunt tip may form the distal end of the distal end portion. The distal end portion comprises a blunt tip. The distal end portion may be tapered towards the distal end. The distal end portion may be conical. In a preferred example, the distal end portion is frustoconical. A tapered shape, particularly a conical shape, may help the distal end portion of the felting needle to move through the nonwoven and / or soft tissue and capture only individual fibers.

[0023] In preferred embodiments, the distal end portion has a mean linear roughness of 3.2 μm or more, 2.5 μm or more, 2.0 μm or more, 1.5 μm or more, or 1.0 μm or more. Mean linear roughness can be understood as the deviation of the surface from the average height. The roughness may be the arithmetic mean value of the roughness profile determined from the deviation around the centerline within the evaluation length. The roughness of the distal end portion, especially the roughness of the distal end surface, allows individual fibers to be captured and transported.

[0024] In a preferred embodiment, the felting needle does not include a barb. In particular, the barbs may be absent along the outer surface of the felting needle. The felting needles described herein carry individual fibers by the blunt distal end surface. Therefore, the felting needle does not need to comprise a barb. This allows for simpler and easier felting needle manufacturing.

[0025] In a preferred embodiment, the distal end face is particularly rounded and recessed in the proximal direction to capture fibers, which allows for efficient capture of not just one fiber, but multiple fibers at once.

[0026] In a further embodiment, the apparatus further comprises a motor configured to drive the felting needle back and forth between the first position and the second position, thereby providing reciprocating motion of the felting needle.

[0027] A further aspect of the present invention is directed to a set, which includes the surgical device described above and an implant comprising a nonwoven fabric.

[0028] A further aspect of the present invention relates to a method for attaching an implant comprising a nonwoven fabric to soft tissue of a human or animal by delivering individual fibers of the nonwoven fabric to the soft tissue of a human or animal, the method comprising: -preparing the set as described above; - positioning the nonwoven fabric adjacent to the soft tissue; - actuating the felting needles by moving them back and forth between the first and second positions so that the felting needles move through the nonwoven fabric and into the soft tissue. - pushing the fibers of the nonwoven fabric through the soft tissue with the blunt end; Contains: [Brief explanation of the drawings]

[0029] Non-limiting embodiments of the present invention are illustrated by way of example only in the accompanying drawings, in which: [Figure 1]FIG. 1 shows a surgical device known in the art. [Figure 2] FIG. 2 shows the felting needle used in the surgical instrument of FIG. [Figure 3A] FIG. 3A shows a first embodiment of a felting needle according to the invention in a top view. [Figure 3B] FIG. 3B shows a first embodiment of a felting needle according to the invention in a top view. [Figure 4A] FIG. 4A shows a first embodiment of a felting needle according to the invention in a perspective view. [Figure 4B] FIG. 4B shows a first embodiment of a felting needle according to the invention in a side view. [Figure 5A] FIG. 5A shows a second embodiment of a felting needle according to the invention. [Figure 5B] FIG. 5B shows a second embodiment of a felting needle according to the invention. [Figure 6A] FIG. 6A shows a third embodiment of a felting needle according to the invention. [Figure 6B] FIG. 6B shows a third embodiment of a felting needle according to the invention. [Figure 7A] FIG. 7A shows a further embodiment of a felting needle according to the present invention. [Figure 7B] FIG. 7B shows a further embodiment of a felting needle according to the present invention. [Figure 7C] FIG. 7C shows a further embodiment of a felting needle according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0030] FIG. 1 shows a perspective view of a surgical device 1 as disclosed in WO 2022 / 100833 (ZURIMED TECHNOLOGIES AG). The surgical device 1 comprises a holder with a housing 5 and a guide tube 3 extending from the housing 5. A felting needle 2 is disposed within the guide tube 3 and extends from the distal end of the guide tube 3. The felting needle 2 can be reciprocated back and forth along its axis and the axis of the guide tube 3. The surgical device 1 includes a handle 9 with a trigger lever 6. Furthermore, the surgical device 1 is connected to an energy source with a power cord 8 that connects to the surgical device 1. An actuator (here, an electric motor 7) is disposed within the housing 5 of the surgical device 1. The motor 7 drives the reciprocating movement of the needle 2. When a user pulls the trigger lever 6, the electric motor 7 moves the felting needle 2. The felting needle moves back and forth along its longitudinal axis, in this particular embodiment, with an amplitude of 12 mm and a frequency of approximately 40 Hz (other frequencies and amplitudes are possible). Such a surgical device is disclosed in detail in WO2022 / 100833.

[0031] Felting needle 2 of surgical device 1 is shown in Figure 2. Felting needle 2 has a barrel portion 21 and a tip portion 22. Tip portion 22 tapers conically to a sharp point 23. Barb portion 21 includes barbs 24a-b and 25a-b. Barbs 24a-b and 25a-b capture fibers of the nonwoven fabric as the felting needle moves through the fibers.

[0032] Instead of using a felting needle with a sharp tip, as shown in FIG. 2, the present invention is directed to providing a felting needle with a blunt tip. An example of such a felting needle is shown in FIGS. 3A-4B. FIGS. 3A-4B all show a felting needle 31 that can replace the felting needle 2 in the surgical device 1. The felting needle 31 has a cylindrical portion 33 and a tip portion 32. The tip portion 32 tapers conically. In the illustrated embodiment, the cylindrical portion 33 is cylindrical, but it may also be rectangular, square, hexagonal, elliptical, trapezoidal, or any other cylindrical shape. Unlike the felting needle 2, the cylindrical portion 33 does not include a barb. Rather, the tip portion 32 is blunt and includes a flat distal end surface 34. The felting needle also includes a flat, inclined surface 35 extending from the cylindrical portion to the distal end surface 34. The flat, inclined surface 35 may be at an angle of approximately 5° relative to the longitudinal axis of the felting needle 31. The beveled surface 35 extends to the tip, similar to the cylindrical portion 33. The flat beveled surface 35 and the conical taper at the tip 32 result in a rectangular tip surface 34 (see the perspective view of FIG. 4A). As a result, the felting needle 31, as shown in FIGS. 3A-4B, generally has the shape of a flathead screwdriver. The rectangular distal end surface captures individual fibers 36 and pushes them into soft tissue, as shown in FIG. 3B.

[0033] In the illustrated embodiment, the end face 34 is rectangular and may have a first width of 0.13 mm along a first width direction 36 (see FIG. 4A). The rectangular end face may have a second width of 0.05 mm along a second width direction 37 (see FIG. 4B). The second width direction 37 is perpendicular to the first width direction 36. As noted above, width measurements may vary.

[0034] 5A and 5B show a second embodiment of a felting needle 51 according to the present invention. The felting needle 51 is substantially similar to the felting needle 31 shown in FIGS. 3A to 4B. Furthermore, the felting needle 51 has a notch 52 on its distal end surface. The notch extends along the second width direction and is substantially V-shaped. The V-shaped notch 52 is typically adapted to the width of the fibers to be felted. Such fibers may have a width between 5 and 200 μm. The notch has approximately the same or slightly larger dimensions. In particular, the width of the notch is between 5 and 100 μm.

[0035] 6A and 6B show a third embodiment of a felting needle 61 according to the present invention. The felting needle 61 is substantially similar to the felting needle 51 shown in FIGS. 5A and 5B. Instead of only one notch, the felting needle 61 includes multiple notches 62 on its distal end surface. This allows the felting needle to more reliably capture multiple fibers 36, as shown in FIG. 6B. Like the notch 52, the notch 62 extends generally in the direction of the second width. Any of the other illustrated embodiments can further include one or more notches. In other embodiments, the notches can extend along the first width. The first width can be greater than the second width.

[0036] 7A shows a fourth embodiment of a blunt-tipped felting needle 71. Like the previously described felting needles, the felting needle 71 comprises a cylindrical portion 73 and a tapered portion 72. The tapered portion 72 has a frustoconical shape such that a flat distal end surface 74 is formed at the tip. The distal end surface is substantially perpendicular to the longitudinal axis of the felting needle.

[0037] Figure 7B shows a fifth embodiment of a blunt-tipped felting needle 81. Felting needle 81 is similar to felting needle 71 shown in Figure 7A, having a cylindrical portion 83, a tapered portion 82 having a frusto-conical shape, and a flat distal end surface 84. Unlike the fourth embodiment, flat distal end surface 84 extends at an angle of 80° relative to the longitudinal axis of the felting needle.

[0038] 7C shows a sixth embodiment of a felting needle 91. In contrast to the previously shown felting needles, the felting needle 91 includes only a cylindrical portion 92 and no tapered portion. The cylindrical portion 92 has a distal end surface 93. The distal end surface may extend at a 90° angle relative to the longitudinal axis of the felting needle 91. The felting needle 91 then forms a stamp that drives individual fibers into the soft tissue. In the illustrated embodiment, the distal end surface 93 extends at a 70° angle relative to the longitudinal axis of the felting needle 91 and has an average roughness of 1.5.

[0039] The felting needles shown herein are manufactured similarly to known needles, for example those shown in WO 2022 / 100833, but instead of forming a barb the sharp tip may be removed using, for example, EDM (electrical discharge machining), micromachining techniques, grinding, electrogrinding or laser grinding.

Claims

1. A surgical device (1) for attaching a nonwoven fabric to soft tissue of a human or animal by carrying individual fibers of the nonwoven fabric to the soft tissue of a human or animal, comprising: The device includes a holder (3, 5) and felting needles (2, 31, 51, 71, 81, 91), and the felting needles (2, 31, 51, 71, 81, 91) are held by the holder (3, 5), the felting needles (2, 31, 51, 71, 81, 91) are reciprocally movable relative to the holder between a first position and a second position; the felting needles (2, 31, 51, 71, 81, 91) have a longitudinal axis, a proximal end, and a distal end, and the felting needles (2, 31, 51, 71, 81, 91) are configured to press individual fibers of the nonwoven fabric into human or animal soft tissue; A surgical device in which the distal end of the felting needle (2, 31, 51, 71, 81, 91) has a blunt tip, and the fibers of the nonwoven fabric are captured and pushed in by the distal end surface (34, 74, 84, 93) on the blunt tip side.

2. 2. The surgical device of claim 1, wherein the distal end face (34, 74, 84, 93) is flat and extends substantially perpendicular to the longitudinal axis of the felting needle (2, 31, 51, 61, 71, 81, 91).

3. 3. A surgical device according to claim 2, wherein said felting needles (2, 31, 51, 61, 71, 81, 91) have the shape of a flat-head screwdriver.

4. 2. The surgical device of claim 1, wherein the distal end surface (34, 74, 84, 93) is flat and extends at an angle of 45° or more, 60° or more, 70° or more, or 80° or more relative to the longitudinal axis of the felting needle (2, 31, 51, 61, 71, 81, 91).

5. The surgical device according to any one of claims 1 to 4, wherein the blunt end is circular, rectangular, cross-shaped, figure-eight-shaped, or oval.

6. The surgical device of any one of claims 1 to 5, wherein the distal end face (34, 74, 84, 93) includes one, two, three or more notches.

7. 7. The surgical device according to any one of claims 1 to 6, wherein the blunt end of the distal end has a first width perpendicular to the longitudinal axis of the felting needle (2, 31, 51, 61, 71, 81, 91), said width being at most 3 mm, at most 1 mm, preferably at most 0.5 mm, at most 0.4 mm, more preferably at most 0.3 mm or at most 0.2 mm.

8. 8. The surgical device according to any one of claims 1 to 7, wherein the blunt end has a first width perpendicular to the longitudinal axis of the felting needle (2, 31, 51, 61, 71, 81, 91), said width being at least 0.02 mm, or at least 0.03 mm, preferably at least 0.04 mm, at least 0.05 mm.

9. A surgical device according to any one of claims 1 to 8, wherein the distal end has a second width perpendicular to the longitudinal axis of the felting needle (2, 31, 51, 61, 71, 81, 91) and perpendicular to the first width, the width being at least 0.01 mm, preferably at least 0.02 mm, at least 0.03 mm, at least 0.04 mm or 0.05 mm.

10. 10. A surgical device according to any one of claims 1 to 9, wherein the felting needle (2, 31, 51, 61, 71, 81, 91) comprises a distal end portion including a blunt tip, said distal end portion tapering towards said blunt tip, said distal end portion preferably being conical.

11. The surgical device of any one of claims 1 to 10, wherein the distal end portion has an average line roughness of 3.2 μm or more, 2.5 μm or more, 2.0 μm or more, 1.5 μm or more, or 1.0 μm or more.

12. A surgical device according to any one of claims 1 to 11, wherein the felting needles (2, 31, 51, 61, 71, 81, 91) do not include barbs.

13. 13. The surgical device according to any one of claims 1 to 12, wherein the device additionally comprises a motor (7), the motor (7) being configured to drive the felting needles (2, 31, 51, 61, 71, 81, 91) back and forth between a first position and a second position.

14. A set comprising a surgical instrument (1) according to any one of claims 1 to 13 and an implant comprising a nonwoven fabric.

15. 1. A method of attaching an implant comprising a nonwoven fabric to soft tissue of a human or animal by delivering individual fibers of said nonwoven fabric to the soft tissue of a human or animal, comprising: - providing a set according to claim 14, - positioning the nonwoven fabric adjacent to soft tissue; - actuating the felting needles (2, 31, 51, 61, 71, 81, 91) by moving them back and forth between a first position and a second position so that said felting needles (2, 31, 51, 61, 71, 81, 91) pass through said nonwoven fabric into the soft tissue; and - pushing fibers of the nonwoven fabric through the nonwoven fabric into the soft tissue with a blunt end. A method comprising:

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