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, over 30 million musculoskeletal injuries are registered worldwide, nearly half of which involve tendons and ligaments. Common tendon injuries are most commonly associated with the Achilles tendon and the rotator cuff tendons of the shoulder. Over the past few years, an increasing number of scaffolding devices, such as extracellular matrices or synthetic grafts, have been used to mechanically and / or biologically reinforce the repair site to prevent suture pullout or elongation, which can lead to failure. Sutures are essential for medical procedures to ensure tissue regeneration. The type of suture used can vary depending on the surgical site and target tissue. Not only the mechanical properties of the suture, but also the knotting technique is crucial for achieving a good outcome. Early failure of tendon and ligament repairs is particularly caused by suture or knot failure, where the suture pulls out of the tendon or through the bone. For optimal soft tissue repair, high initial fixation strength to minimize gap formation and mechanical stability to allow for robust healing should be achieved.

[0004] 2. Related technical description

[0005] A medical implant for repairing tendons and ligaments is known from US 2008 / 0188936 A1 [Ball et al.]. This known medical implant comprises an anchor structure that can be attached to bone via a bone anchor and a tension member made of a patch material (e.g., 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 the anchor structure under tension. A disadvantage of this known medical implant is that the implant is only attached to soft tissue and / or bone at each of its ends, so that a mechanical connection between the implant and 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 of the fibers of the felt patch are pushed or pulled through the second surface into the soft tissue by a needle, pin, or blade comprising 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, engraved, 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 the felt patch or mat are pushed or pulled to penetrate the second surface in the entire region covered by the second surface. Felt patch or mat and soft tissue can be interwoven in the entire region covered by the second surface, thereby forming a firm mechanical connection between felt patch or mat and soft tissue. Felt patch or mat can withstand high loads in the axial direction, i.e. in the direction parallel to the second surface, but can be peeled off if felt patch or mat are loaded in a mode perpendicular to soft tissue. In this way, if necessary or beneficial, felt patch or mat 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 the application, the felt patch or mat can be configured as a flat, connected area, or as a tubular structure with longitudinal gaps, such as for application to blood vessels.

[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 force 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 thereby is that, by having higher tensile strength or having additional fibers of 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 that is 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 can be added that provides an anchoring function for the component, or a second layer, for example in the form of a woven structure (mesh or net) can be added to reinforce or strengthen 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 for the formation of minimal gaps and mechanical stability that allows for the firm healing of soft tissues (e.g., tendons or ligaments).

[0019] In another embodiment, the felt material is additionally modified with sutures arranged in a diagonal suture pattern before being attached to the soft tissue. In this way, better mechanical properties can be achieved because a higher stiffness of the mat 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 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, thereby not damaging 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, one or more sutures protrude from the felt patch or pad to form an anchoring member before the felt patch or pad is attached to the soft tissue. In order to allow the felt patch to be directly anchored to another member such as bone or cartilage, the patch-suture structure can be equipped with one or more anchoring elements that are connected to the felt patch by sutures or other connecting elements.

[0023] In another embodiment, before attaching the felt patch or pad to the soft tissue, one end of the woven textile, preferably one end of a suture, is unraveled and reconstructed 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 conventional felt materials having randomly arranged fibers.

[0025] In another embodiment, the fibers of the felt material comprise 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 the side of the suture, for example at a 30° angle. These double-angled barbs allow the suture to pass smoothly through soft tissue in one direction, but prevent it from sliding back through the soft tissue and making it more likely to become entangled and stuck with other fibers.

[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 mat to the soft tissue, the needle is guided at an angle other than 90° relative to the second surface of the felt patch or mat. By guiding the needle to push or pull the fibers of the felt patch or mat 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 that allows for secure healing of the soft tissue (e.g., a 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 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 engage soft tissue;

[0038] the first jaw being of a frame-like configuration 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 mat, the gripping device being adapted to grip the felt patch or mat;

[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 the tip portion of the needle to penetrate the first jaw within the confines of the first surface of the felt patch or mat.

[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, which allows 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 guide 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 a device for adjusting the amplitude of the needle's forward and backward motion. This advantageously allows the needle to penetrate felt patches and soft tissue to varying depths, depending on size and application. This is particularly useful in conjunction with a needle that has a defined delivery distance for the fibers being pushed into the tissue, particularly when the needle has only a single series of hooks near its tip.

[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 spirally inserted needle can be used in a variable rotational 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 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 surface of the soft tissue; 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 felt material according to the present invention during its fixation to a tendon by means of needles;

[0053] Figures 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 shows a perspective view of 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 Shown Figure 3 A cross-sectional view of a jaw of a clamping device of an embodiment of a set of surgical instruments.

[0057] Figure 6 shows a perspective view of 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 from 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 reinforcement of the rotator cuff tendon.

[0060] Specific embodiments of the invention

[0061] Figure 1 An embodiment of a felt material 1 comprising a plurality of fibers 2 in a method for repairing or reinforcing a soft tissue 3 of a human or animal 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 secured to the soft tissue (e.g., a tendon or ligament) by applying a method for repairing or reinforcing a soft tissue 3 of a human or animal comprising the steps of: A) positioning a felt material 1 in the form of a cushion or felt patch 9, 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, onto the soft tissue 3 of the patient; and B) repeatedly advancing a needle 10 through the felt patch 9 or cushion so that some of the fibers 2 of the felt patch or cushion are pushed or pulled by the needle 10 arrangement through the second surface into the soft tissue 3, thereby creating a secure connection between the felt material 1 and the soft tissue 3.

[0062] The above-mentioned method of using the felt patch 9 or pad can be used to strengthen the surrounding soft tissue as a preparation for suturing (tendon patch) using conventional sutures. Alternatively, it can also be used to fasten the 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 the felt patch 9, which includes sutures and / or anchoring elements for further fixing to a second structure such as soft tissue (tendon-patch and sutures) or bone (tendon-patch and sutures-bone anchors).

[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 mat for soft tissue fixation or reinforcement can have different shapes, material compositions, or even structures or composites of different materials or devices (for example, a patch interwoven with mesh 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., metal (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 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 and 20 mm, preferably 0.5 and 3 mm, and most preferably 1 and 2 mm. The felting fibers 2 may be randomly arranged (as is done in conventional felt production), or the fibers 2 may be arranged to obtain the unidirectional stiffness characteristics of the felt material 1. To improve the felting effect, the fibers 2 may be modified with barbs; and

[0067] The fibers 2 of the felt material 1 can have variable lengths ranging from 2 to 500 mm, and the thickness of the mixture of fibers 2 can be between 1 and 1000 μm, preferably between 5 and 200 μm. The length, thickness, coating, and manufacturing of the fibers 2 influence the internal structure of the felt material 1 and ultimately the reinforcing effect. Changing these parameters and the felting needle and pattern during the production of the felt patch 9 can affect, for example, the force required to peel the felt patch 9 from the soft tissue 3 or the variable directional stiffness of the felt patch 9. This allows the fineness of the fibers 2 to range from 0.9 to 17 dtex and the fiber length to vary from 1 to 90 mm.

[0068] In order 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 mat 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 subsequent permanent connection to the soft tissue 3 to 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 and 2D), the felt patch 9 or mat may have a specific configuration, 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 geometries, 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 for reinforcement of the structure, for example, when sutures are sutured through the gaps in 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 anchoring the felt patch 9 or mat directly 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 the felt patch 9 or mat.

[0071] Figure 2G Another alternative embodiment is shown in which the felt patch 9 or mat 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 stitch distance of 2 mm, to contribute to a higher structural stiffness (>100 N / mm). Depending on the stitching / sewing pattern, different stiffness characteristics can be achieved. If diagonal stress is applied, the diagonal pattern increases stability, which is beneficial for strengthening 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 The 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 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 overall structure better mechanical properties and preventing the 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 the additional long, systematically stitched threads or sutures 7 make 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 penetrated 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 gripping device 20 configured in the form of pliers and comprising a first gripping member 25a and a second gripping member 25b each having a proximal end and a distal end, wherein the distal end forms facing first and second jaws 21a, 21b adapted to abut against the soft tissue 3.

[0077] The first jaw 21 is a frame-like structure 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 mat, and the gripping device 28 is used to grip the felt patch 9 or mat. 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 mat.

[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 against the felt patch 9.

[0079] In various embodiments, the drive mechanism 31 of the suturing device 30 can be manually, electrically, or initiated 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 device.

[0080] In another embodiment, the drive mechanism 31 or a drive unit (not shown) attached to the suturing device 30 includes 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, thereby enabling the needle to penetrate the felt patch 9 or cushion and soft tissue 3 to varying depths, depending on the size and application. This is particularly useful in conjunction with a needle 10 having a defined transport distance for the fibers 2 to be pushed into the soft tissue 3, particularly 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 be used to perform continuous suturing. Parallel suturing patterns or cross-stitch patterns 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] Furthermore, based on the need to prevent 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 allows the fibers 2 of the felt material 1 to be pushed and / or pulled in two directions (e.g., in a configuration where a felt patch 9 is used 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 needle is guided parallel. In another embodiment, the needle is guided at an angle to the surface of the soft tissue. In another embodiment, a cross stitch is performed that is inclined to the surface. In one embodiment, several felt patches 9 are used to connect the two tendon ends (for example, at the top and bottom), and multiple needles 10 can be used to suturing from two or more directions simultaneously, each needle 10 being 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 scope of the first surface 5 of the felt patch 9 or mat. 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, needle 10 includes barbs 11 oriented in one direction, which allows them to catch and push or pull fibers 2 in the direction of the needle 10's suturing. Soft tissue 3 (in this case, the two torn ends of tendon 4) is grasped together using a surgical or specialized clamp 20. The clamp 20 has two jaws 21a and 21b, each with a sharp tip. The tip of the first jaw 21a holds the felt patch 9 (flexible member) in place. A mesh or one or more brushes 22 are placed across the second jaw 21b of the clamp 20. The brushes 22 are pressed down and thus wrapped around the tendon 4. The brush structure allows the needle 10 to pass through the bristles while holding the tendon 4 in place. Fine wires can be used in place of the mesh, arranged parallel to each other at a distance. The purpose of the brush 22, mesh, or wire structure is to constrain the soft tissue 3 while allowing the needle 10 to pass through it. The second jaw 21b of the clamp 20 has a space 23 to allow the needle 10 to penetrate deeply and protect the surrounding soft tissue 3 from being penetrated. When needle 10 penetrates felt patch 9 [a flexible member] comprising [or made of] a large number of loose fibers 2, needle 10 pushes or pulls a large number of these fibers 2 into [another] soft tissue 3, such as tendon 4. The deeper needle 10 penetrates soft tissue 3, the higher the probability that many fibers 2 (also from the more distal barbs 11 of needle 10) will penetrate soft tissue 3. If this process is repeated (twice per second, preferably five times per second), felt patch 9 and soft tissue 3 will become intertwined and a strong mechanical connection will be achieved.

[0087] The needles 10 are exemplarily (but not exclusively) 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 easier positioning of 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. The 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 embodiment shown, 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 x W (e.g. 40 x 40 mm) and 3 mm thick is tightly wrapped / wrapped around the tendon end 17 and clamped at its ends. The polyethylene terephthalate (PET) fibers 2 of the felt patch 9 are a mixture of different fiber lengths (20-60 mm) and are 5 μm thick. 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 using a suturing device capable of 2,500 stitches per minute. The felt patch 9 is now sutured to the tendon 4 by moving and tilting the suturing device over the upper surface of the felt patch 9 for 30 seconds. The tendon 4 is then rotated 180° and the process is repeated for the underside of the felt patch 9. This results in a 380° penetration of the needle 10 and the delivery of over 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 process takes 60 seconds, avoids the time-consuming suturing of the tendon ends 17 (e.g., Mason-Allan suturing), and minimizes the risk of pulling the suture out of the tendon.

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

[0096] In Example 2, Figure 8As shown, a felt patch 9 having 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 varying fiber lengths (approximately 40 mm) and has a thickness of 10 μm.

[0097] The felt patch 9 has two holes 18 with a diameter of 1 mm, and the outer edges of the holes 18 are directly covered with PET yarn 19. It is reinforced in a zigzag pattern, in a circular manner and concentrically with the perforations 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 clamping device. A three-sided felt needle is used (the cross section looks like a triangle), each side is 0.5mm long. 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 to the rotator cuff tendon 41, while avoiding to do so in 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, by penetrating the suture needles of each perforation 18, two USP 2 sutures 42 with suture needles and comprising a suture anchor 43 (e.g., anchored in the humeral head 44) ​​are used.

[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 load.

[0099] Although the present invention has been described in conjunction with the specific embodiments thereof, many alternatives, modifications and variations will be apparent to those skilled in the art. It is therefore 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 the sake of clarity, some features of the present invention described in the context of separate embodiments may also be combined and provided in a single embodiment. Conversely, various features of the present invention briefly described in the context of a single embodiment may also be provided individually or in any suitable subcombination or applicable to any other described embodiment of the present invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

Claims

1. 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), 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), Features 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), and the fibers are a combination of biodegradable fibers and non-degradable fibers.

2. The felt material (1) according to claim 1, wherein The biodegradable fiber is at least one of the following: polylactic acid, PLLA, polyglycolic acid, PGA, collagen fiber or hair.

3. The felt material (1) according to any one of claims 1 to 2, 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.

4. The felt material (1) according to claim 1 or 2, wherein: The fibers (2) are aligned, preferably unidirectionally.

5. Felt material according to any one of the preceding claims, wherein The fiber fineness is 0.9-17dtex and the fiber length is 1-90mm.

6. Felt material according to any one of the preceding claims, wherein The fibers (2) of the felt material (1) comprise barbs arranged along the fibers (2), wherein the barbs are preferably formed integrally with the fibers (2) of the felt material (1).

7. The felt material (1) according to any one of claims 1 to 2, 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.

8. The felt material (1) according to claim 7, wherein The additional fibers or threads are in the form of monofilaments, webs, fans or fabrics.

9. A felt material (1) according to any one of the preceding claims, wherein The felt patch (9) or mat comprises one or more reinforcement zones, each comprising fibres or threads of a monofilament or multifilament nature and having a higher tensile strength or having a larger diameter, or a second layer (15), or at least one stitching line (7) arranged in a diagonal stitching pattern.

10. The felt material (1) according to any one of claims 1 to 9, wherein: The felt patch (9) or pad additionally comprises one or more sutures incorporated into the felt material (1) prior to attachment to the soft tissue (3).

11. The felt material (1) according to claim 10, wherein Prior to attaching the felt patch (9) or pad to the soft tissue (3), one or more sutures (7) protrude from the felt patch (9) or pad to form an anchoring member.

12. The felt material (1) according to any one of claims 1 to 11, wherein: The felt material (1) is covered or impregnated with a drug or chemical agent such as an antibiotic, a biocompatible glue or collagen, and / or wherein the felt patch (9) or mat comprises an additional layer of a biocompatible self-adhesive film.

13. An instrument kit for attaching a felt material (1) according to any one of claims 1 to 12 to a soft tissue (3), wherein: The instrument kit includes: A) a needle (10) having a barb (11) and a tip portion (16); B) A suturing device (30) comprising a device for fixing the needle (10) and a tubular member (32) surrounding the needle.

14. The instrument kit according to claim 13, in, The suturing device (30) comprises a drive mechanism (31), wherein 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); and / or wherein the first jaw (21a) comprises an opening (24), wherein the opening (24) allows 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 / or wherein the second jaw (21b) comprises a mesh (34) covering the cavity (29), wherein the mesh (34) has an opening for allowing the needle (10) to pass through; and / or wherein the second jaw (21b) comprises a plurality of brush fibers (35) arranged in the cavity (29) to allow the needle (10) to pass between the brush fibers (35); and / or wherein the clamping device (20) comprises a gripper (36) adapted to be attached to the suturing device (30), wherein the gripper (36) is configured to grip the felt patch (9) or pad and guide the needle (10) at a selectable angle; and / or wherein the drive mechanism (31) is attached to an electric, pneumatic or hydraulic drive unit (37); and / or Wherein, the driving mechanism (31) includes a device for adjusting the amplitude of the forward and backward movement of the needle (10); and / or wherein a drive mechanism (31) or a 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); and / or wherein the tubular member (32) comprises a hollow spherical front end (40); and / or Wherein, the barb (11) of the needle (10) is circular.

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