Felt material for use in method of repairing or strengthening human or animal soft tissue

Abstract

A felt material (1) comprising a plurality of fibres (2) for a method of repairing or reinforcing human or animal soft tissue (3) wherein the felt material (1) is in the form of a mat or felt patch (9) comprising a first surface (5) and a second surface (6) arranged opposite to the first surface for contacting the surface of the soft tissue (3), wherein some of the fibres (2) of the felt patch (9) are pushed or pulled through the second surface (6) into the soft tissue (3) by means of a needle (10) device, thereby creating a connection between the felt material (1) and the soft tissue (3). Furthermore, the invention provides an instrument kit comprising a needle (10), a suturing device (30) and a gripping device (20) comprising a first jaw (21a) and a second jaw (21b), the first jaw (21a) being frame-like configured to allow the tip portion (10) of the needle to penetrate through the first jaw (21a), the second jaw having a cavity (29) configured to receive the tip portion of the needle (10).

Description

Background of the Invention 1. Field of the Invention

[0002] The present invention relates to a felt material comprising a plurality of fibers, a surgical instrument kit for attaching the felt material to soft tissue, and a method of repairing or reinforcing human or animal soft tissue.

[0003] Every year, more than 30 million musculoskeletal injuries are registered worldwide, of which nearly half involve tendons and ligaments. Common tendon injuries are mostly related to the Achilles tendon and the rotator cuff tendons of the shoulder. In the past few years, more and more scaffold devices, such as extracellular matrices or synthetic grafts, have been used to mechanically and / or biologically reinforce the repair site to avoid suture pull-out or elongation that could lead to failure. To date, sutures are indispensable for medical procedures to ensure tissue regeneration. The threads used for suturing may vary, depending on the surgical site and the target tissue. Not only the mechanical properties of the suture, but also the knotting technique are crucial to achieve a good result. In particular, early failure of repaired tendons and ligaments is caused by failure of the suture or knot, where the suture pulls out of the tendon or passes through the bone. For an ideal repair of soft tissue, a high initial fixation strength should be achieved to allow minimal gap formation and mechanical stability to allow solid healing.

[0004] 2. Related technical description

[0005] A medical implant for repairing tendons and ligaments is known from US2008 / 0188936 A1 [Ball et al.]. This known medical implant comprises an anchor structure that can be attached to the bone by means of a bone anchor and a tension member made of a patch material (such as a woven mesh, a fabric made of woven, knitted, braided or felted fibers). During surgery, one end of the tension member is attached to the tendon, and tension is then applied to the other end of the tension member, which then engages with the anchor structure under tension. A disadvantage of this known medical implant is that the implant is only attached to the soft tissue and / or bone at each of its ends, so that a mechanical connection of the implant to the soft tissue or bone is achieved only in a small area. Summary of the invention

[0006] It is an object of the present invention to provide a strong and durable mechanical connection between the felt material and the soft tissue to be treated therewith over an extended area of ​​the contact interface between the felt material and the soft tissue to be treated therewith.

[0007] The present invention solves the technical problem by a felt material comprising a plurality of fibers, a surgical instrument kit for attaching the felt material to soft tissue, and a method for repairing or reinforcing human or animal soft tissue.

[0008] An advantage of a felt material comprising a large number of fibers for use in a method for repairing or reinforcing human or animal soft tissue is that a strong mechanical connection between the soft tissue and the felt material can be achieved over a wide area of ​​the contact surface, thereby achieving an optimal stress distribution.

[0009] Other advantageous embodiments of the present invention can be reviewed as follows:

[0010] In a specific embodiment, some fibers of the felt patch are pushed or pulled through the second surface into the soft tissue by a needle, pin or blade including barbs. The barbs grab the fibers of the felt patch or mat and push them through the second surface into the soft tissue. The barbs can be stamped, carved or cut into the needle, pin or blade.

[0011] In another embodiment, the barbs are spaced apart at intervals along the needle, pin or blade.

[0012] In another embodiment, the needle includes a tip portion, and the barbs face alternately forward and rearward relative to the tip portion. An advantage of this configuration is that the fibers of the felt patch can be pushed or pulled through the second surface into the soft tissue.

[0013] In another embodiment, some fibers of felt patch or pad are pushed or pulled to penetrate the second surface in the whole area covered by the second surface.Felt patch or pad and soft tissue can be interwoven in the whole area covered by the second surface, thereby forming a firm mechanical connection between felt patch or pad and soft tissue.Felt patch or pad can withstand high loads in the axial direction, i.e. in the direction parallel to the second surface, but if felt patch or pad are loaded in a mode perpendicular to the soft tissue, then can be peeled off.In this way, if necessary or beneficial, felt patch or pad can be repositioned or removed.

[0014] In yet another embodiment, the second surface of the felt patch or mat is a continuous area, preferably a continuous and flat area. In this way, the felt patch or mat is configured to extend continuously over a large contact area. Depending on its application, the felt patch or mat can be configured as a flat connection area, or can be configured as a tubular structure with a longitudinal gap to apply the structure to, for example, a blood vessel.

[0015] In another embodiment, in addition to the fibers of the felt material, the felt material also includes fibers or lines of monofilament or multifilament properties, which have higher tensile strength or have a larger diameter, wherein the ratio of the tension applied to the additional fibers or lines and the fibers of the felt material is at least 1.5, preferably 2.0. The advantage that can be achieved is that, by having higher tensile strength or having additional fibers with a larger diameter, higher tensile forces can be applied to the felt patch or mat, thereby significantly improving stiffness and patch stability. In addition, if the suture is sutured through the felt patch, the complete structure can be strengthened. Another advantage is that a nonlinear stiffness more similar to the natural behavior of tendons and ligaments can be achieved.

[0016] In another embodiment, the additional fibers or threads are in the form of monofilaments, webs, fans, or fabrics.

[0017] In yet another embodiment, the felt patch or mat additionally comprises at least a second layer, wherein the at least one second layer is constructed differently from the felt patch or mat, or comprises a different material than the felt patch or mat. This configuration allows the advantage that a layer providing an anchoring function for the assembly can be added, or a second layer in the form of a woven structure (mesh or net) can be added to strengthen or reinforce the felt patch.

[0018] In another embodiment, the felt material is pre-stretched in at least one direction along the first and second surfaces of the felt patch or cushion before being attached to the soft tissue. The advantage of this embodiment is that better mechanical properties can be achieved because the stiffness of the cushion or felt patch is higher. In addition, the initial fixation strength can be improved to allow the formation of minimum gaps and the mechanical stability of the firm healing of soft tissues (e.g., tendons or ligaments) to allow for.

[0019] In another embodiment, the felt material is additionally modified by sutures arranged in a diagonal suture pattern before being attached to the soft tissue. In this way, better mechanical properties can be achieved, since a higher stiffness of the cushion or felt patch can be achieved.

[0020] In another embodiment, the felt patch or mat comprises one or more reinforcement areas, each reinforcement area comprising fibers or threads of a monofilament or multifilament nature and having a higher tensile strength or having a larger diameter, or a second layer, or at least one suture arranged in a diagonal suture pattern. This configuration allows the advantage that the attachment of the felt patch or mat can be achieved in an unreinforced area, for example not directly on the reinforced second layer or suture pattern, so as not to damage the fibers or sutures in the reinforced area.

[0021] In another embodiment, the felt patch or pad additionally includes one or more sutures incorporated into the felt material prior to attachment to the soft tissue.

[0022] In yet another embodiment, before the felt patch or pad is attached to the soft tissue, one or more sutures protrude from the felt patch or pad to form an anchoring member. For the function of the felt patch directly anchored to another member such as bone or cartilage, the patch-suture structure can be equipped with one or more anchoring elements, which are connected to the felt patch by sutures or other connecting elements.

[0023] In another embodiment, prior to attaching the felt patch or pad to the soft tissue, one end of the woven textile, preferably one end of a suture, is untied and reassembled into a felt textile and attached to the felt patch or pad to form a second layer.

[0024] In another embodiment, the fibers of the felt material are aligned. This allows the felt patch or mat to achieve the advantage of higher unidirectional stiffness properties compared to ordinary felt materials with randomly arranged fibers.

[0025] In another embodiment, the fibers of the felt material include barbs arranged along the fibers, wherein the barbs are preferably formed integrally with the fibers of the felt material. In this way, an improved felting effect can be achieved. If larger monofilament fibers or more likely sutures are used They can be modified by cutting on the side of the suture, for example at a 30° angle. Those created double angle barbs allow the suture to pass smoothly through the soft tissue in one direction, but prevent it from sliding back through the soft tissue and making it more likely to intertwine and get stuck with other fibers of the same type.

[0026] In yet another embodiment, the felt material is covered or impregnated with a drug or chemical agent such as an antibiotic, a biocompatible glue, or collagen.

[0027] In another embodiment, the felt patch or pad comprises an additional layer of a biocompatible self-adhesive film.This configuration allows for a first mechanical connection or a subsequent permanent connection of the felt patch or pad to the soft tissue to which it is attached.

[0028] In another embodiment, during attachment of the felt patch or pad to the soft tissue, the needle is guided at an angle other than 90° relative to the second surface of the felt patch or pad. By guiding the needle to push or pull the fibers of the felt patch or pad through the second surface at an angle other than 90° toward the surface of the soft tissue, a high initial fixation strength can be applied to allow for minimal gap formation and mechanical stability to allow for secure healing of the soft tissue (e.g., tendon or ligament).

[0029] In another embodiment, during attachment of the felt patch or pad to the soft tissue, the needle is subsequently or alternately directed at an angle other than 90° relative to the second surface of the felt patch or pad. The fibers of the felt material are cross stitched obliquely to the soft tissue surface.

[0030] In another embodiment, more than one felt patch or pad is attached to the soft tissue.Multiple felt patches can be used to connect two tendon ends (eg, at the top and bottom).

[0031] In another embodiment, more than one needle is used to move some of the fibers of the felt patch or mat to penetrate the second surface into the soft tissue simultaneously, preferably from two or more directions.

[0032] In another embodiment, one or more rotating needles are used to move some of the fibers of the felt patch or mat helically across the second surface and into the soft tissue.

[0033] According to another aspect of the present invention, there is provided an instrument kit for attaching a felt material to a soft tissue, wherein the instrument kit comprises:

[0034] - a needle having a barb and a pointed portion;

[0035] - a suturing device comprising a device for fixing a needle and a tubular member surrounding the needle;

[0036] - a gripping device in the form of pliers comprising:

[0037] a first clamping member and a second clamping member each having a proximal end and a distal end, wherein the distal end forms first and second facing jaws adapted to abut against soft tissue; wherein

[0038] the first jaw is of frame-like construction that allows the tip portion of the needle to penetrate the first jaw within the confines of the first surface of the felt patch or pad, the grasping device to grasp the felt patch or pad; wherein

[0039] The second jaw includes a cavity opening toward the first jaw to receive the tip portion of the needle.

[0040] In a further embodiment, the suturing device includes a drive mechanism, wherein the tubular member has a longitudinal axis and the drive mechanism is configured to move the needle back and forth along the longitudinal axis of the tubular member.

[0041] In another embodiment, the first jaw includes an opening, wherein the opening allows a tip portion of the needle to penetrate the first jaw within the confines of the first surface of the felt patch or pad.

[0042] In another embodiment, the second jaw comprises a mesh covering the cavity, wherein the mesh has an opening to allow the needle to pass through.

[0043] In another embodiment, the second jaw includes a plurality of brush fibers disposed in the cavity that allow the needle to pass between the brush fibers.

[0044] In yet another embodiment, the clamping device includes a grasper adapted for attachment to a suturing device, wherein the grasper is configured to grasp the felt patch or pad and direct the needle at a selectable angle.

[0045] In another embodiment, the drive mechanism may be attached to an electric, pneumatic or hydraulic drive unit.

[0046] In another embodiment, the drive mechanism includes means for adjusting the amplitude of the needle's forward and backward movement. The advantage that can be achieved in this way is that the different depths of needle penetration into felt patches and soft tissues can be adjusted by the user, depending on the size and application. This is particularly useful in combination with a needle that has a defined delivery distance for the fibers to be pushed into the tissue, especially when there is only a single series of hooks near the tip of the needle.

[0047] In another embodiment, the drive mechanism or drive unit attached to the suturing device includes a device for rotating the needle around the longitudinal axis of the tubular member. In this way, during insertion or extraction, the rotating or spiral piercing needle can be used in a variable rotation mode of the needle.

[0048] In another embodiment, the tubular element comprises a hollow spherical front end.This configuration allows the advantage of obtaining a better contact surface at the front end, which in particular allows preventing the tubular element from tilting or falling when contacting the surface of the felt patch or mat.

[0049] In another embodiment, the barb of the needle is rounded. In this way, the cleaning, washing and sterilization process of the needle is improved, thereby providing a needle that is particularly suitable for surgical use.

[0050] According to another aspect of the present invention, a method for repairing or strengthening human or animal soft tissue is provided, wherein the method comprises the following steps: A) positioning a felt material in the form of a pad or a felt patch on the soft tissue of a patient to be treated, the felt material comprising a first surface and a second surface arranged opposite to each other for contacting the soft tissue surface; and B) repeatedly advancing a needle through the felt patch or pad so that some fibers of the felt patch or pad are pushed or pulled through the second surface into the soft tissue by the needle, thereby creating a connection between the felt material and the soft tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Several embodiments of the present invention are described below by way of example only with reference to the accompanying drawings, in which:

[0052] Figure 1 shows a side view of an embodiment of a felt patch or pad made of a felt material according to the invention during its fixation to a tendon by means of needles;

[0053] Figure 2A-2Gperspective views showing respectively different configurations of felt patches or mats made from the felt material according to the present invention;

[0054] Figure 3 A perspective view showing an embodiment of a set of surgical instruments for use with the felt material according to the present invention in a method of repairing or reinforcing human or animal soft tissue;

[0055] Figure 4A , 4B Shown according to Figure 3 A set of side views of different embodiments of a needle of an embodiment of a surgical instrument;

[0056] Figure 5 Shows Figure 3 A cross-sectional view of the jaws of a clamping device of an embodiment of a set of surgical instruments.

[0057] Figure 6 A perspective view showing another embodiment of a set of surgical instruments for use with the felt material according to the present invention in a method of repairing or reinforcing human or animal soft tissue;

[0058] Figure 7 a schematic diagram showing a first example of the use of an embodiment of a felt patch or cushion made of a felt material according to the present invention in the context of soft tissue repair / reconstruction; and

[0059] Figure 8 A schematic diagram showing a second example of the use of an embodiment of a felt patch or pad made of a felt material according to the invention in the context of reinforcing a rotator cuff tendon. DETAILED DESCRIPTION

[0061] Figure 1 An embodiment of a felt material 1 comprising a plurality of fibers 2 in a method for repairing or reinforcing a human or animal soft tissue 3 according to the present invention is shown. The felt material 1 is in the form of a cushion or felt patch 9 comprising a first surface 5 and a second surface 6 arranged oppositely for contacting the surface of the soft tissue 3. In use, the felt patch 9 or cushion is fixed to the soft tissue (e.g., a tendon or ligament) by applying the method for repairing or reinforcing a human or animal soft tissue 3, which comprises the following steps: A) positioning a felt material 1 in the form of a cushion or felt patch 9 onto the patient's soft tissue 3, the felt material 1 comprising a first surface 5 and a second surface 6 arranged oppositely for contacting the surface of the soft tissue 3; and B) repeatedly advancing a needle 10 through the felt patch 9 or cushion so that some fibers 2 of the felt patch or cushion are pushed or pulled through the second surface into the soft tissue 3 by the needle 10 device, thereby creating a firm connection between the felt material 1 and the soft tissue 3.

[0062] The above-mentioned method of using felt patch 9 or pad can be used to strengthen surrounding soft tissue as preparation for suturing (tendon patch) using conventional sutures. Alternatively, it can also be used to fasten felt patch 9 to connect it directly to a second target organ (e.g. tendon-patch-tendon or tendon-patch-bone). Another application is to fasten felt patch 9, which includes sutures and / or anchoring elements for further fixing to a second structure such as soft tissue (tendon-patch and suture) or bone (tendon-patch and suture-bone anchor).

[0063] The felt material 1 applied according to the above method can be used for the repair, reinforcement or fixation of anatomical structures, such as: suturing of collagenous tissues, such as tendons or fascia, ligament reconstruction (collateral ligaments, cruciate ligaments, etc.), subcutaneous sutures, skin closures, skeletal muscles, myocardium and valves, and conventional suturing of hollow organs (large blood vessels, bladder, esophagus, and possibly small intestine).

[0064] According to its application:

[0065] -like Figure 1 As shown, the felt patch 9 or pad for soft tissue fixation or reinforcement can have different shapes, material compositions, or even structures or composites of different materials or devices (for example, the patch is interwoven with mesh materials and sutures). The fibers 2 can be from natural sources (natural fibers, cotton, silk, etc.), synthetic [polypropylene (PP), polyamide (PA), polytetrafluoroethylene (PTFE), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE, UHMW), polyethylene terephthalate (PET)] fibers or other high-strength fibers, etc., metals (stainless steel wool, titanium wool, magnesium wool) or combinations thereof. The fibers 2 can be permanent implants or biodegradable materials [poly-L-lactic acid (PLLA), polyglycolic acid (PGA), etc.)], combinations thereof, or can be combined with non-degradable fibers 2. The felt patch 9 can partially or completely contain fibers 2 of biological origin, such as collagen fibers or hair;

[0066] - the thickness of the felt patch 9 or mat may be between 0.2-20 mm, preferably 0.5-3 mm, most preferably 1-2 mm. The felting fibres 2 may be randomly arranged (as is done in conventional felt production), or the fibres 2 may be arranged to obtain the unidirectional stiffness characteristics of the felt material 1. To improve the felting effect, the fibres 2 may be modified with barbs; and

[0067] - The fibers 2 of the felt material 1 may have a variable length of 2-500 mm and the thickness of the mixture of fibers 2 is between 1-1000 μm, preferably 5-200 μm. The length, thickness, coating and manufacturing of the fibers 2 affect the internal structure of the felt material 1 and ultimately the reinforcing effect. Changing these parameters and the felting needles and patterns during the production of the felt patch 9 affects, for example, how much force is required to peel the felt patch 9 from the soft tissue 3, or the variable directional stiffness of the felt patch 9. This enables the fineness range of the fibers 2 to be between 0.9-17 dtex and the fiber length to be varied between 1-90 mm.

[0068] To obtain better mechanical properties in terms of higher stiffness of the structure, the felt patch 9 can be pre-stretched and / or additionally modified with a diagonal stitching pattern. Furthermore, the felt patch 9 or pad can be covered or impregnated with a drug or chemical agent such as an antibiotic, a biocompatible glue, collagen or a layer of a biocompatible self-adhesive film to allow a first mechanical connection or a later permanent connection to the soft tissue 3 on which it is felted.

[0069] like Figure 2A –2G, in addition to the basic geometric shapes of the felt patch 9 or mat such as circular or rectangular patches ( Figure 2A , 2C In addition to 2D), the felt patch 9 or mat may have a specific structure, such as Figure 2D The ring shown (e.g. for heart valve repair) or Figure 2E The tube shown includes a longitudinal gap 14 (similar to a catheter) that can be used to repair a hollow organ such as a blood vessel. Alternatively, other geometric shapes, such as concave and convex surfaces, can also be used.

[0070] according to Figure 2B and 2F In the alternative embodiment shown, the felt patch 9 includes a second layer 15 to form an assembly of different layers, which improves the felt patch 9 or mat and increases the anchoring function. Alternatively, in order to increase the stiffness and patch stability, stronger fibers 2 or threads of a monofilament or multifilament nature can be integrated into the felt patch 9 or mat in the form of single fibers, meshes, fans or fabrics or similar shapes. For this effect, the ratio of the tension applied to the additional fibers or threads to the tension on the fibers 2 of the felt material 1 is at least 1.5, preferably at least 2.0. This also allows the structure to be strengthened, for example, when sutures are sutured through the gaps of the felt patch 9 or mat. Similarly, sutures (round or flat) can be integrated into the felt patch 9 or mat. Alternatively, in order to achieve the function of directly anchoring the felt patch 9 or mat to another structure such as bone or cartilage, the patch-suture structure can be equipped with one or more anchoring elements (not shown), which are connected to the felt patch 9 or mat by sutures or other connecting elements. Alternatively or in addition, as Figure 2FAs shown, one end of a woven textile (eg, stitching 12) is untied, reshaped into a felt textile 13 and attached as a second layer 15 to a felt patch 9 or mat.

[0071] Figure 2G Another alternative embodiment is shown, in which the felt patch 9 or pad includes an additional stitching pattern, such as a zigzag stitch, with the yarn or suture 7 having an exemplary diameter of 0.1 mm and a stitching distance of 2 mm, to contribute to a higher structural body stiffness (>100 N / mm). Depending on the stitching / sewing pattern, different stiffness characteristics can be obtained. If diagonal stress is applied, the diagonal pattern increases stability, which is beneficial for the reinforcement of the suture bridge in rotator cuff surgery. The diagonal stitching pattern makes the structure stronger and resists shear stresses that may occur, such as when the shoulder is rotated.

[0072] Figure 2B , 2F Embodiments of 2G and 2G are configured to reinforce the stiffness of the felt patch 9 or mat by one or more additional reinforcing second layers 15 or by using additional stitching of the sutures 7 (e.g., an X-shaped pattern or stitching of the outer edges). The long, nearly endless threads, sutures 7, or additional fibers provide structure to the felt patch 9 or mat, giving the entire structure better mechanical properties and preventing individual fibers 2 of the felt material 1 from being pulled apart. The combination of individual filaments that are felted but weak in the structure and additional long, systematically stitched threads or sutures 7 that can be pierced with needles 10 makes the felt patch 9 a useful implant. In various embodiments, the felt patch 9 or mat may include unreinforced areas and other areas that are reinforced (e.g., by additional second layers 15 or stitching). The reinforced areas are not pierced by the needles 10, while the non-reinforced areas are used to attach the felt patch 9 or mat to the soft tissue 3.

[0073] Figure 3-5 An embodiment of a set of instruments according to the invention for attaching a felt material 1 to a soft tissue 3 is shown. The set of instruments comprises:

[0074] - a needle 10 having a pointed portion 16;

[0075] - a suturing device 30 comprising means for fixing the needle 10, a tubular member 32 surrounding the needle 10, and a drive mechanism 31; and

[0076] A clamping device 20 configured in the form of forceps and comprising a first clamping member 25a and a second clamping member 25b each having a proximal end and a distal end, wherein the distal end forms facing first and second jaws 21a, 21b suitable for abutting against the soft tissue 3.

[0077] The first jaw 21 is a frame-like configuration that allows the tip portion 10 of the needle to penetrate the first jaw 21a within the scope of the first surface 5 of the felt patch 9 or cushion, and the gripping device 28 to grip the felt patch 9 or cushion. The second jaw 21b includes a cavity 29 that opens toward the first jaw 21a to receive the tip portion of the needle 10. The tubular member 32 has a longitudinal axis 33 and the drive mechanism 31 is configured to move the needle 10 back and forth along the longitudinal axis 33 of the tubular member 32. The frame-like first jaw 21a includes an opening 24 that allows the tip portion of the needle 10 to penetrate the first jaw 21a within the scope of the first surface 5 of the felt patch 9 or cushion.

[0078] In addition, the tubular member 32 has a hollow spherical front end 40 (eg, with a diameter between 2 and 10 mm). In this way, a better contact surface can be achieved and the tubular member 32 can be prevented from tilting or falling when it is close to the felt patch 9.

[0079] In various embodiments, the drive mechanism 31 of the suturing device 30 can be triggered manually, electrically, or by pneumatic, magnetic, or hydraulic assistance. Alternatively, the suturing device 30 can be plugged into a motorized power source. The suturing device 30 is configured as a single needle device, but can alternatively be a multi-needle consistent device.

[0080] In another embodiment, the drive mechanism 31 or a drive unit (not shown) attached to the suturing device 30 comprises means for rotating the needle 10 about the longitudinal axis 33 of the tubular member 32. Thus, a rotating or spiral insertion needle can be used with variable rotation of the needle 10 during insertion or withdrawal.

[0081] In another embodiment, the drive mechanism 31 includes a device (not shown) for adjusting the amplitude of the forward and backward movement of the needle 10, so that different depths of needle penetration into the felt patch 9 or pad and soft tissue 3 can be adjusted by the user, depending on the size and application. This is particularly useful in combination with a needle 10 that has a limited delivery distance for the fibers 2 to be pushed into the soft tissue 3, especially when there is only a single series of hooks near the tip of the needle 10. In another embodiment, if multiple needles are used, a pair or series of needles can suture continuously. A parallel suture pattern or a cross pattern can be achieved.

[0082] The shape of the needles 10 and the orientation of the felting barbs 11 may be configured to push the fibers 2 of the felt material 1 through the second surface 6 ( Figure 4A ), or is configured to pull the fibers 2 of the felt material 1 through the second surface 6 of the felt patch or mat ( Figure 4B ).

[0083] In addition, based on preventing tissue damage, flat or round needles 10 can be used. The felting barbs 11 can be oriented in one direction or in two linear (circular) directions. This will allow the fibers 2 of the felt material 1 to be pushed and / or pulled in two directions (for example, in a configuration using a felt patch 9 on the top and bottom of the soft tissue 3). The felting barbs 11 can be oriented side by side in a gradient or circumferential pattern.

[0084] The suturing technique can be perpendicular to the soft tissue 3 so that the guidance of the needle is parallel. In another embodiment, the guidance of the needle is at an angle to the surface of the soft tissue. In another embodiment, a cross suturing is performed oblique to the surface. In one embodiment, several felt patches 9 are used to connect two tendon ends (e.g., at the top and bottom), and multiple needles 10 can be sutured from two or more directions simultaneously, each needle 10 is equipped with a barb 11.

[0085] like Figure 3 and 5 As shown, the first jaw 21a includes an opening 24, wherein the opening 24 allows the tip portion of the needle 10 to penetrate the first jaw 21a within the first surface 5 of the felt patch 9 or pad. In addition, the second jaw 21b includes a covering cavity 29 ( Figure 3 ) of a mesh material 34, wherein the mesh material 34 has an opening that allows the needle 10 to pass through. Alternatively, the second jaw 21b may include a plurality of brush fibers 35 ( Figure 5 ) to allow the needle 10 to pass between the brush-like fibers 35. The surface of the second jaw 21b facing the first jaw 21a is provided with a tooth structure 38 to achieve a better grip of the soft tissue 3 ( Figure 5 Alternatively, both facing surfaces of the first and second jaws 21a, 21b may be provided with tooth structures 38.

[0086] like Figure 4A , 4BAs shown, the needle 10 includes barbs 11 oriented in one direction, which makes them catch and push or pull the fibers 2 in the suturing direction of the needle 10. The soft tissue 3 (in this case, the two torn ends of the tendon 4) is grasped together by a surgical or special clamp 20. The surgical clamp 20 has two jaws 21a, 21b, each of which has a tip, and the tip of the first jaw 21a grasps the felt patch 9 [flexible member] in place. A net or one or more brushes 22 are straddled on the second jaw 21b of the surgical clamp 20, and the brush 22 is pressed down and thus wrapped around the tendon 4. The brush structure allows the needle 10 to pass through the bristles while keeping the tendon 4 in place. Thin metal wires can be used instead of nets, which are arranged in parallel at a certain distance. The purpose of the brush 22, net or wire structure is to constrain the soft tissue 3 while allowing the needle 10 to pass through the soft tissue 3. The second jaw 21b of the surgical clamp 20 has a space 23 to allow the needle 10 to penetrate deeply and protect the surrounding soft tissue 3 from being penetrated by the needle. When the needle 10 penetrates the felt patch 9 [flexible member] comprising [or made of] a large number of loose fibers 2, the needle 10 pushes or pulls a large number of these fibers 2 into [another] soft tissue 3, such as a tendon 4. The deeper the needle 10 penetrates the soft tissue 3, the higher the probability that many fibers 2 (also from the barbs 11 farther away from the needle 10) penetrate the soft tissue 3. If this process is repeated (twice per second, preferably five times per second), the felt patch 9 and the soft tissue 3 will be intertwined and a strong mechanical connection will be achieved.

[0087] The needles 10 are exemplarily (but not limited to) equipped with specific rounded barbs 11 which allow improved post-processing (cleaning, washing, sterilization) after the mechanical production of these needles 10. This configuration is therefore particularly suitable for medical applications.

[0088] Alternative embodiments of the clamping device 20 for arthroscopic indication are as follows Figure 6 As shown. The clamping device 20 includes a positioning device 39 for the suturing device 30 (e.g., a guide tube for more easily positioning the suturing device 30). In addition, the first and second jaws 21a, 21b of the clamping device 20 are small enough to be delivered through a surgical body opening with a diameter of 20 mm. Alternatively, the diameter of the surgical body opening can be 10 mm or 6 mm.

[0089] During the attachment of the felt patch 9 or mat, for example but not limited to, more than 2000 fibers / cm 2through the soft tissue 3. The stress applied to the felt structure will be evenly distributed across the 2000 fibers, which is very attractive for better healing and preventing suture strain. In terms of stress distribution of the suture / fibers, the felting method according to the present invention has a stress distribution that is nearly 1000 times better than traditional suturing methods. Differently oriented felt fibers 2 (isotropic or orthotropic) may facilitate cell ingrowth, mimicking the underlying soft tissue 3. A layer of parallel longitudinal fibers 2 promotes ingrowth of tendon cells, while the orthotropic structure promotes ingrowth of cardiomyocytes.

[0090] Example 1 (soft tissue repair / reconstruction):

[0091] exist Figure 7 In the illustrated embodiment, tendon ends 17 are attached to sutures 12 as a preparatory step prior to surgical attachment of the graft to the body (e.g., ACL reconstruction, semitendinosus tendon graft preparation, or biceps tenodesis):

[0092] A felt patch 9 of dimensions L×W (e.g. 40×40 mm) and thickness of 3 mm is tightly wrapped / wrapped around the tendon end 17 and clamped at its end. The polyethylene terephthalate (PET) fibers 2 of the felt patch 9 are a mixture of different fiber lengths (20-60 mm) and have a thickness of 5 μm. The patch / suture structure has a tear strength of 250 N when fully hydrated. The felt patch 9 is made of PET yarn 19 Enhance the stitching pattern and sew in the stitching line 12 ( Figure 7 ).

[0093] Afterwards, the still loose tendon-patch structure is placed on a brush mattress and felted with a suturing device that allows 2500 suturings per minute. Now, the felt patch 9 is sewed to the tendon 4 by moving the suturing device over the upper surface of the felt patch 9 and tilting it for 30 seconds. Afterwards, the tendon 4 is turned 180° and the process is repeated for the bottom surface of the felt patch 9. This will result in a 380° penetration of the needle 10 and the delivery of more than 10,000 fibers 2 into the tendon 4.

[0094] The felted tendon-patch-suture structure can now be implanted, for example, in a bone tunnel, and the suture can be wrapped and tied to a cortical fixation device or suture anchor. The felting method takes 60 seconds, avoids the time-consuming suturing of the tendon ends 17 (e.g., Mason-Allan suture), and minimizes the risk of pulling the suture out of the tendon.

[0095] Embodiment 2 (Strengthening of rotator cuff tendon):

[0096] In Example 2, Figure 8As shown, a felt patch 9 with dimensions w×l (20 mm wide and 25 mm long) and a thickness of 2 mm is used. The felt patch 9 consists of polyethylene terephthalate (PET) fibers 2 of different fiber lengths (about 40 mm) and has a thickness of 10 μm.

[0097] The felt patch 9 has two perforations 18 with a diameter of 1 mm, and the outer edges of the perforations 18 are directly covered with PET yarn 19. Reinforced in a zigzag pattern, circular and concentric with the perforation 18. This strengthens the felt patch 9 (if only a felt consisting of dense loose fibers is used, it cannot withstand a larger force [about 50N]). By using yarn 19 to reinforce in a stitching pattern, the felt patch 9 obtains a higher stiffness (about 200N / mm when fully hydrated). In the next step, the felt patch 9 is placed on top of the rotator cuff tendon 41 and fixed to the rotator cuff tendon 41 by a clamp device. A three-sided felt needle (the cross section looks like a triangle) is used, with a length of 0.5mm on each side. The total penetration depth of the needle is 20mm. The needle has a total of 6 barbs, the distance between each barb is 1mm, and the barb depth is 0.1mm. The suturing device used allows 2500 suturings per minute. Now, by moving the suturing device in a circular manner around the perforations 18, the felt patch 9 is felted onto the rotator cuff tendon 41, while avoiding to proceed on an enhanced zigzag pattern (otherwise the barbs of the needle may damage the yarn). This operation lasts for 30 seconds, with a total of approximately 1250 stitches. Assuming that more than one fiber 2 is pushed down into the soft tissue 3 by the needle device, a variety of 1250 fibers are pushed into the soft tissue (5×1250≥6000 fibers). In the last step, two USP 2 sutures 42 with suture needles and including suture anchors 43 (e.g., anchored in the humeral head 44) ​​are used by suturing needles penetrating each perforation 18.

[0098] If tension is now applied to the suture 42, the cutting of the soft tissue is now reduced due to the reinforced felt patch 9 distributing and absorbing the punctual loads.

[0099] Although the present invention has been described in conjunction with the specific embodiments of the present invention, many alternatives, modifications and variations will be apparent to those skilled in the art. Therefore, it is intended to include all such substitutions, modifications and variations that fall within the scope of the appended claims.

[0100] It should be understood that, for clarity, some features of the present invention described in the context of separate embodiments may also be combined in a single embodiment. Conversely, the features of the present invention briefly described in the context of a single embodiment may also be provided separately or in any suitable sub-combination or applicable to any other described embodiment of the present invention. Certain features described in the context of various embodiments should not be considered as essential features of these embodiments, unless the embodiment does not work without these elements.

Claims

1. An instrument kit for connecting felt material (1) to repair soft tissue, the instrument kit comprising: A) needle (10) and tip portion (16); as well as B) A suturing device (30), comprising a device for fixing a needle (10) and a tubular member (32) surrounding the needle (10) and a driving mechanism (31), wherein the driving mechanism is configured to move the needle (10) back and forth along the longitudinal axis (33) of the tubular member (32) so that some fibers (2) of the felt patch (9) are pushed or pulled through the surface (6) of the patch into the soft tissue (3), thereby establishing a connection between the felt material (1) and the soft tissue (3).

2. The instrument kit according to claim 1, wherein: The drive mechanism (31) is attached to an electric, pneumatic or hydraulic drive unit (37).

3. The instrument kit according to claim 1 or 2, wherein: The drive mechanism (31) is attached to an electric, pneumatic or hydraulic drive unit (37).

4. An instrument kit according to any one of the preceding claims, wherein: The driving mechanism (31) comprises a device for adjusting the amplitude of the back-and-forth movement of the needle (10).

5. An instrument kit according to any one of the preceding claims, wherein: A drive mechanism (31) or drive unit attached to the suturing device (30) comprises means for rotating the needle (10) about the longitudinal axis (33) of the tubular member (32).

6. An instrument kit according to any one of the preceding claims, wherein: The tubular member (32) includes a hollow spherical front end (40).

7. An instrument kit according to any one of the preceding claims, wherein: The needle comprises a barb, preferably a rounded barb.

8. The instrument kit according to one of the preceding claims, further comprising a clamping device (20) configured in the form of a forceps and comprising: A first clamping member (25a) and a second clamping member (25b), each having a proximal end and a distal end, wherein the distal end forms first and second facing jaws (21a; 21b) adapted to abut against the soft tissue (3); wherein the first jaw (21a) is of frame-like construction allowing the tip portion of the needle (10) to penetrate the first jaw (21a) within the confines of the first surface (5) of the felt patch (9) or mat, and a gripping device (28) to grip the felt patch (9) or mat; and wherein The second jaw (21b) includes a cavity (29) opening toward the first jaw (21a) to receive the tip portion of the needle (10).

9. The instrument kit according to one of the preceding claims, further comprising a felt material (1) comprising a plurality of fibers (2) for use in a method for repairing or reinforcing human or animal soft tissue (3), in, The felt material (1) is in the form of a pad or a felt patch (9) comprising a first surface (5) and a second surface (6) arranged opposite to the surface for contacting the soft tissue (3), Therein, some of the fibers (2) of the felt patch (9) are pushed or pulled through the second surface (6) into the soft tissue (3), thereby creating a connection between the felt material (1) and the soft tissue (3).

10. The instrument kit according to claim 9, wherein: The fibers are a combination of biodegradable fibers and non-degradable fibers.

11. The instrument kit according to claim 9 or 10, wherein: The felt patch (9) or mat additionally comprises at least one second layer (15), wherein the at least one second layer (15) is constructed differently than the felt patch (9) or mat or comprises a different material than the felt patch (9) or mat.

12. The instrument kit according to any one of claims 9 to 11, wherein: The second surface (6) of the felt patch (9) or mat is a continuous area, preferably a continuous and flat area.

13. The instrument kit according to any one of claims 9 to 12, wherein: In addition to the fibers (2) of the felt material (1), the felt material (1) also includes fibers or threads of a monofilament or multifilament nature, which have a higher tensile strength or have a larger diameter, wherein the ratio of the tension applied to the additional fibers or threads to the fibers (2) of the felt material (1) is at least 1.5, preferably at least 2.

0.

14. The instrument kit according to any one of claims 9 to 13, wherein: The fibers (2) of the felt material (1) are aligned.

15. The instrument kit according to any one of claims 9 to 14, wherein: The felt material (1) is covered or impregnated with drugs or chemical agents such as antibiotics, biocompatible glue or collagen, and / or wherein, The felt patch (9) or mat comprises an additional layer of biocompatible self-adhesive film.

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