Sutures with external filaments containing medication

Abstract

The present invention is directed to a suturing system having a needle, an elongated flexible suture having a connecting end attached to the needle and an opposite free end, and at least one elongated external beneficial filament attached to the needle or to the suture at the connecting end, the beneficial filament having a smaller cross-sectional area and lower mechanical strength than the suture, and containing a drug.

Description

Technical Field

[0001] The technical field related to the present invention is absorbent medical devices or non-absorbent medical devices such as monofilament sutures or braided multifilament sutures, and more specifically, surgical sutures with beneficial filaments containing releasable drugs attached externally.

Background Art

[0002] It is well known in the art that surgical sutures and attached surgical needles are used in various conventional surgical procedures. For example, such sutures can be used to access tissues around incisions or lacerations in the epidermal layer and the underlying fascia layer, join the ends of blood vessels, attach tissues to medical devices such as heart valves, repair body organs, and repair connective tissues. Conventional surgical sutures can be made from known biocompatible materials, particularly synthetic and natural biocompatible polymer materials, which can be either non-absorbent or absorbent. Examples of synthetic non-absorbent polymer materials useful for manufacturing non-absorbent sutures include polyester, polyolefin, polyvinylidene fluoride, and polyamide. Further examples of non-absorbent materials are polyethylene, polypropylene, nylon, and similar polymers. Examples of synthetic absorbent polymer materials useful for manufacturing absorbent sutures include polymers and copolymers made from lactones such as lactide, glycolide, p-dioxanone, epsilon-caprolactone, and trimethylene carbonate. The term "absorbent" means a generic term that can also include implantable devices that are bioabsorbable, resorbable, bioreabsorbable, degradable, or biodegradable in the body or tissue. The term "non-absorbent" means an implantable device that is permanently placed in the body or tissue.

[0003] Sutures are preferred by surgeons for use in many surgical procedures due to several advantages and properties they possess. Absorbable sutures must be able to provide the desired biotensile strength for a sufficient period of time to allow for effective tissue healing. Wound healing depends not only on the properties of the specific tissue but also on the healing characteristics of the individual who has undergone the surgical procedure. For example, tissue that does not undergo successful angiogenesis takes longer to heal than tissue that does, and similarly, diabetic patients and the elderly also take longer to heal. Therefore, there is an opportunity to provide suture materials that match the healing characteristics of various wounds. Whatever is implanted, like sutures, appears as a foreign body to the patient's immune system. In addition, it is known that implantable medical devices, including sutures, can provide a platform for bacteria to attach and form biofilms.

[0004] Surgical sutures are designed to possess the physical properties necessary to ensure desirable and effective in vivo behavior. Absorbable sutures must maintain adequate tensile strength during the required healing period, which is typically characterized as breaking strength retention (BSR). To obtain the desired design properties, it is necessary to provide absorbable polymers and manufacturing processes that can produce absorbable sutures with the required properties.

[0005] Similarly, the ability to maintain mechanical properties, including tensile and nodal strength, after implantation is often a crucial and decisive characteristic for absorbable medical devices. The device must maintain mechanical integrity until the tissue has fully healed. Some body tissues take longer to heal and require longer maintenance of mechanical integrity. As mentioned earlier, this is often associated with tissues where angiogenesis is insufficient. Similarly, other circumstances exist, such as a given patient (e.g., a diabetic patient) who may tend to heal more slowly.

[0006] To reduce the possibility of postoperative infection, certain agents, such as antimicrobial agents, are known to be incorporated into or on top of sutures or other medical implants, such as hernia meshes, either for rapid release or for long-term retention in the body. However, the presence of such substances incorporated into or on top of the polymer material of the implant may adversely affect its processability and / or mechanical integrity. The presence of such substances may also adversely affect other suture parameters such as flexibility, bendability, surgical handling, knot strength, and knot sliding.

[0007] In particular, as mentioned above, the addition of large amounts of drugs required to provide sufficient antimicrobial properties to sutures, either by incorporating them into the suture material itself or through surface coating of the sutures, can adversely affect the properties of the sutures. Furthermore, such approaches to incorporating drugs may make application, processing, sterilization, and packaging difficult.

[0008] U.S. Patent No. 8097005, "Suture The "system" discloses a method for implanting a prosthesis device in the body, the method comprising: positioning a first suture strand through tissue to a first position using a first needle of a suture system having four or more needles connected by suture strands; positioning a second needle of the suture system in the tissue at a distance from the first position, wherein the second needle is attached to the first suture strand and the second suture strand has different indicators so as to be able to distinguish between the first and second strands, and the second needle has a needle diameter of at least the same size as the diameter of the first suture strand plus the diameter of the second suture strand; positioning an additional suture through tissue using an additional needle attached to the second needle; inserting the suture strand through the prosthesis device using four or more needles; and fixing the prosthesis device in place using a suture strand having indicators.

[0009] Japanese Patent Publication No. CN210204810U, "Double-strand surgical suture needle," discloses a double-strand surgical suture needle comprising a double-strand Phoenix Tail thread and a surgical needle. The double-strand Phoenix Tail thread consists of three double-strand absorbable sutures and one joint, the side of which is provided with a semicircular grooved ring, the left end of which the three double-strand absorbable sutures are fixedly connected. The surgical suture needle is crescent-shaped overall, the tail end of which is provided with a tail thread connection hole, the inner wall of which is provided with a semicircular projection ring, the connecting portion is inserted into the tail wire connection hole, and a circular card slot combined with the semicircular projection connects the double-strand Phoenix Tail thread and the surgical needle together. The double-strand Phoenix Tail thread is used to wrap fracture wounds requiring double-strand sutures.

[0010] International Publication No. 2019 / 045303(A1), “Coupling Structure Of Multifilament Polydioxanone Suture And Needle Tube,” discloses a suture formed of polydioxanone that is inserted into the stomach and absorbed by the body, the suture comprising a needle tube that is coupled and inserted into the body, and a sponge for fixing the needle tube and the suture, the suture being coupled and connected to a groove in the needle tube, the needle tube and the suture being inserted into and fixed within the sponge, the suture being a multifilament polydioxanone suture, the needle tube comprising a first suture coupled to a groove in the needle tube to form a ring, and a plurality of second sutures connected to the first suture in a folded shape on top of the combined structure of the first suture.

[0011] U.S. Patent Application Publication No. 20180221021 by H. Scalzo, L.B. Kriksunov, R.J. Tannhauser, and E.R. Skula, “Braided Suture With Filament Containing A Medicant,” discloses a braided suture made from a filament bundle and formed using at least two different filamentous materials, a majority of at least first variety of filaments, and a small portion of second variety of filaments incorporating a biomedically useful agent. [Overview of the Initiative] [Problems that the invention aims to solve]

[0012] Despite recent advances, there remains an unmet need in this field to deliver drugs to medical devices such as sutures while maintaining their mechanical strength and long-term integrity. [Means for solving the problem]

[0013] An implantable medical device, such as a surgical suture, is presented, which is attached to a needle for insertion into tissue and for passing through the tissue with a suture, and which contains a drug that releases beneficial filaments, the beneficial filaments being positioned parallel to the suture and attached to the same needle, or attached to the suture proximal to the needle.

[0014] The present invention relates to a suturing system comprising a needle, an elongated flexible suture having a connecting end attached to the needle and a free end on the opposite side, and at least one elongated external beneficial filament attached to the needle or attached to the suture at the connecting end. The beneficial filament has a smaller cross-sectional area and lower mechanical strength than the suture and contains a drug. The suture may be nonabsorbable, while the beneficial filament may be absorbable or soluble after placement in mammalian tissue. Alternatively, the suture may be absorbable, while the beneficial filament may be absorbable or soluble after placement in mammalian tissue. The beneficial filament may contain at least 20% by weight of a drug. The suture may be barbed or knotless, while the beneficial filament may be neither barbed nor knotless. The suture may be a braided filament construct, while the beneficial filament is a monofilament. Beneficial filaments can be shorter than sutures.

[0015] In one embodiment, the suture has a recess configured to receive at least a portion of the beneficial filament. The beneficial filament may be attached to the needle or not attached to the suture along its length. Alternatively, the beneficial filament may be fixed to the suture at any point along its length, or intermittently.

[0016] The beneficial filament may be capable of expanding its cross-section by at least 25% within 60 minutes of placement in mammalian tissue. Preferably, the mechanical properties of the suture system are within 5% of the mechanical properties of the suture without the beneficial filament. For example, the suture system may have a Breaking Strength Retention (BSR) that is substantially the same as that of the suture without the beneficial filament one week after placement. The beneficial filament may be configured to dissolve completely or be completely reabsorbed within approximately 168 hours of placement in mammalian tissue. Alternatively, the beneficial filament may be configured to release at least 10% of the agent within 24 hours of placement in mammalian tissue. The agent may include chlorhexidine, polyhexamethylene biguanide, octenidine, silver particles, silver salts, triclosan, and combinations thereof. The beneficial filament may be sterilized separately and differently from the suture and / or needle, or separately and in the same manner as the suture and / or needle.

[0017] The present invention also relates to a method for suturing mammalian tissue, comprising: passing the suture system described herein through the tissue and bringing it close to the tissue area to establish support for the tissue by the suture; pulling beneficial filaments parallel to the suture through the tissue; optionally fixing the suture system by knots; and leaving the beneficial filaments parallel to the suture within the tissue to allow the release of a drug into the tissue.

[0018] The present invention also relates to a kit for assembling the suture system described herein before implantation, comprising an elongated flexible suture attached to a needle, and at least one elongated external beneficial filament, which is detached and stored in another form, and configured to be attached to the needle or to the suture at its connecting end. The external beneficial filament can be sterilized separately from the suture attached to the needle.

[0019] The present invention also relates to a method for producing a suture system as described herein by attaching the connecting end of a suture to a needle and attaching a useful filament to the needle or to the suture at the connecting end. [Brief explanation of the drawing]

[0020] While various modifications and alternative forms are possible with respect to this disclosure, specific exemplary implementations are shown in the drawings and described in detail herein. However, it should be understood that the description herein of specific exemplary implementations is not intended to limit this disclosure to the specific forms disclosed herein.

[0021] This disclosure covers all modifications and equivalents as defined by the appended claims. It should also be understood that the drawings are not necessarily to a fixed scale, but rather focus on clearly illustrating the principles of exemplary embodiments of the invention. Furthermore, certain dimensions may be exaggerated to help visually convey such principles. Furthermore, where appropriate, reference numbers may be repeated between drawings to indicate corresponding or similar elements. Additionally, two or more blocks or elements shown separately or distinctly in the drawings can be combined into a single functional block or element. Similarly, a single block or element shown in the drawings can be implemented as multiple processes or by multiple cooperating elements.

[0022] The forms disclosed herein are illustrated in the accompanying drawings as examples, not as limitations, and similar reference numerals refer to similar elements. [Figure 1a] A schematic representation of a side cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 1b] A schematic representation of a side cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 1c] A schematic representation of a side cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 1d] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 1e] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 2] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 3] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 4] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 5] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 6] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 7] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 8] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 9] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 10] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 11] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 12a] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 12b] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 12c] Shows a schematic representation of a side cross-sectional view of an embodiment of a suture system according to the present invention. [Figure 13a] Shows a schematic representation of a perspective view of an embodiment of a suture system according to the present invention. [Figure 13b]A schematic representation of an embodiment of the suture system according to the present invention is shown in a perspective view. [Figure 14a] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 14b] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 14c] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 14d] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 14e] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 14f] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 15a] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 15b] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 15c] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 15d] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 16a] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 16b] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 16c] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 16d] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 16e] A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 16f]A schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention is shown. [Figure 17a] This shows a schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention, as shown in a state where it is placed in mammalian tissue. [Figure 17b] This shows a schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention, as shown in a state where it is placed in mammalian tissue. [Figure 17c] This shows a schematic representation of an axial cross-sectional view of an embodiment of the suture system according to the present invention, as shown in a state where it is placed in mammalian tissue. [Modes for carrying out the invention]

[0023] In short, the suture system of the present invention advantageously allows for the delivery of drugs, such as antimicrobial agents and / or healing-promoting agents and / or swelling agents, or additional or increased amounts of drugs, to a sutured wound or tissue using any surgical suture (monofilament, braided, absorbable, non-absorbable, etc.) without altering the material, coating, and properties of the primary surgical suture. Delivery is provided by having at least one beneficial filament and / or sensing element containing the additional drug and / or swelling material, and by having a smaller cross-section than the primary surgical suture, and further by having weaker mechanical properties (tensile strength, breaking strength, BSR, etc.), and by having a faster dissolution or absorption profile compared to the primary surgical suture. The beneficial filament is attached to the same suture needle as the primary suture or attached to the primary suture proximal to the needle. The beneficial filament is positioned along the primary surgical suture and placed in the tissue parallel to the primary surgical suture. Therefore, the overall strength of wound closure and suture knots has a basic level defined by the surgical suture, while beneficial filaments placed in the tissue parallel to the surgical suture provide additional agents such as antimicrobial agents or wound healing agents, and / or a useful bulging effect to close suture holes (e.g., for high-pressure vascular occlusion). Since the main surgical suture remains the same, the sensory handling of the surgical suture is unaffected. In some embodiments, the presence of beneficial filaments increases knot strength.

[0024] Structures Referring to Figures 1A to 1E, which show schematic side cross-sectional views, in one embodiment, the suture system 1 of the present invention comprises an elongated flexible string, filament, thread, bundle of filaments, or braid, comprising a suture 10 having a connecting end 10b and a free end 10a on the opposite side, the connecting end 10b of the suture 10 being connected to a suture needle 100 at a needle connecting end 100b. The needle 100 comprises an elongated straight or curved member having a sharp end 100a on the opposite side of the needle connecting end 100b. As shown, and further referring to Figure 2, the connecting end 10b of the suture 10 is typically inserted into an opening 102 of the needle connecting end 100b. The connecting end 10b of the suture 10 can be fixed in the opening 102 by means of a swaging needle 100, the use of adhesive, etc. The free end 10a may optionally have a fastener or tab (not shown) to fix the free end 10a in tissue.

[0025] The suture 10 may be any suture known in the art, including monofilament, multifilament, or braided sutures made from any biocompatible material, including synthetic or natural materials, or absorbable, non-absorbable, or partially absorbable sutures, and combinations thereof. In some embodiments, the polymer material of the suture 10 includes bioreabsorbable polyester or non-bioreabsorbable polypropylene. Particularly preferred sutures 10 include, for example, VICRYL® (Polyglutin 910) sutures, coated VICRYL® (Polyglutin 910) sutures; coated VICRYL® + antimicrobial (Polyglutin 910) sutures; VICRYL RAPIDE® (Polyglactin 910) sutures; MONOCRYL® (Polygrecapron 25) sutures; PDS® (Polydioxanone) sutures; PDS® + Antibacterial (Polydioxanone) sutures; ETHILON® nylon sutures; ETHIBOND® polyester sutures; MERSILENE® polyester fiber sutures; PRONOVA® poly(hexafluoropropylene-VDF) sutures; PROLENE® polypropylene sutures; NUROLON® nylon sutures, etc. are sutures approved for use in surgical procedures and are sold by Ethicon, Inc. under various brand names, for example. The suture 10 may optionally be a barbed or knotless suture such as STRATAFIX® Spiral Knotless Tissue Control Device; STRATAFIX® Symmetric Knotless Tissue Control Device; or a similar suture. The suture 10 may be an antimicrobial suture.

[0026] Needle 100 can be any surgical suture needle known in the art, including straight or curved needles, needles having bodies and tips or sharp ends of various geometric shapes, needles coated or uncoated with a lubricating coating, and needles made of metals such as steel or tungsten alloy, or needles made of polymer materials. Examples include suture needles sold by Ethicon, Inc. under various trademark names such as EVERPOINT® cardiovascular needles; ETHALLOY® needle alloy-based needles; HEMO-SEAL® needle sutures; ETHIGUARD® blunt-edge needles; MULTIPLASS® needles; and VISI-Black® surgical needles. Tapered point needles, tapered cut needles, cutting edge needles, etc., and similar designs can be used. In one embodiment, the suture system of the present invention may be double-armed (not shown) so that a second needle (not shown) is attached to the free end 10a.

[0027] As shown in Figures 1 and 2, the suture system 1 of the present invention has at least one external beneficial string, thread, or filament 20 positioned parallel to the suture 10 and attached to the same needle as the main suture 10. In the shown embodiment, the filament 20 is fixed together with the suture 100 within the opening 102 by means of a swaging needle 100, the use of an adhesive, etc.

[0028] Referring to Figure 1A, the filament 20 is positioned parallel to the suture 10 and has the same length as the suture 10. Figure 1B shows the filament 20 attached to the needle 100, positioned in a free shape, not coupled parallel to the suture 10, and having the same length as the suture 10. In some embodiments, as shown in Figure 1C, the filament 20 is shorter than the suture 10, for example, having a length that is 5, 10, 15, 20, 30, and 50% shorter as a percentage of the length of the suture 10, respectively. In some embodiments, the filament 20 is shorter than the suture 10 by only 5, 10, 15, 20, 30, 50, and 100 mm, measured in mm, respectively.

[0029] Referring to Figures 1D and 1E, in some embodiments the suture 10 is a barbed suture having barbs 13, but in any embodiment the filament 20 does not have barbs. As shown in Figure 1E, if the suture 10 is a barbed suture, the filament 20 can be attached to the suture 10 at several points along the suture 10, or it may not be attached anywhere other than near the connecting end 10b.

[0030] In the embodiment shown in Figure 3, the filament 20 is not attached to the needle 100 by insertion into the opening 102, as seen in Figures 1 and 2. In this embodiment, the filament 20 is fixed to the connecting end 10b of the suture 10 by adhesive 30a disposed between the connecting end 10b of the suture 10 and the filament 20. As shown in Figure 4, the adhesive 30b can also extend around the connecting end 10b and the filament 20. As shown in Figure 5, the adhesive 30c can also extend around the connecting end 10b and the filament 20 and further contact the needle connecting end 100b.

[0031] In the embodiment shown in Figure 6, the filament 20 is fixed to the connecting end 10b of the suture 10 by spot welding or melting, and represents a melted or fused region 32.

[0032] In the embodiment shown in Figure 7, the beneficial filament 20 is secured to the connecting end 10b of the suture 10 by a sleeve 34, such as a heat-shrinkable or adhesive sleeve. In the embodiment shown in Figure 8, the filament 20 is secured to the connecting end 10b of the suture 10 by a sleeve 36, such as a heat-shrinkable or adhesive sleeve 36, which also overlaps the needle connecting end 100b.

[0033] In the embodiments shown in Figures 1 to 8, the filament 20 is positioned parallel to the suture 10 and is fixed to the connecting end 10b of the suture 10 by attaching it to the suture 10, or to the needle 100, or both. In further embodiments, the beneficial filament 20 is also fixed to the suture 10 at any point along the length of the suture 10, or intermittently, along the length of the suture 10, along at least 30% of the length of the suture 10, for example, along 30, 50, 75, and 100% of the length of the suture 10. Referring to Figure 9, the filament 20 is fixed to the suture 10 along the entire length of the suture 10 by intermittent spot welds or adhesive spots 33. The intermittent spot welds or adhesive spots 33 may be 0.5 to 15 mm in length, for example, about 1, 2, 3, and 5 mm in length, and may be separated by gaps of about 2 to 50 mm, for example, gaps of 2, 3, 5, 10, 20, and 30 mm. Referring to Figure 10, the filament 20 is fixed to the suture 10 along its entire length by continuous welding or adhesive 35. Referring to Figure 11, the beneficial filament 20 is fixed to the suture 10 at the connecting end 10b and also at the opposite free end 10a by intermittent spot welding or adhesive spots 33.

[0034] One further technique that can be used to fix the beneficial filament 20 to the suture 10 is to expose the beneficial filament 20, which is positioned parallel to the suture 10, to a liquid such as water, aqueous solution, pure solvent (such as ethanol), solution in a non-aqueous solvent, or vapor (such as water vapor, ethanol vapor, or the like) by immersion, spraying, vapor cabinet exposure, or similar means. By exposing the beneficial filament 20 to water, solvent, solution, or vapor while pressing it against the suture 10, the beneficial filament 20 adheres to the suture 10. Subsequent drying removes the solvent or moisture, while leaving the beneficial filament 20 attached to the suture 10 in the area where they were pressed together. In such embodiments, the presence of liquid softens the beneficial filament 20, partially and temporarily solubilizing it, causing it to stick and adhere. In another embodiment, adhesion between the suture 10 and the beneficial filament 20 is achieved by using a soluble absorbent material such as polyethylene glycol (PEG), polysaccharides such as CMC or polyester, or the like. After the evaporation of the solvent during drying forms such a solution, the remaining absorbent material plays a role in attaching the beneficial filament 20 to the suture 10.

[0035] An embodiment of the suture system 1 of the present invention is further schematically shown in Figure 12 in a side view. Figure 12A shows a beneficial filament 20 fixed to the suture 10 only proximal to the connecting end 10b. Figure 12B shows a beneficial filament 20 fixed to the suture 10 at the connecting end 10b, as well as at intermediate spots 10i along the length of the suture 10, and at the free end 10a. Figure 12C shows a beneficial filament 20 fixed to the suture 10 along the entire length of the suture 10.

[0036] Figures 13A and 13B schematically show perspective views of the positioning of beneficial filaments 20 along the suture 10. Figure 13A shows one embodiment in which the beneficial filaments 20 are positioned side-by-side with the suture 10 by means of attaching or fixing them to the suture 10 not only in the area of ​​the connecting end 10b of the suture 10 but also along its entire length, via means such as adhesive, welding, sleeves, etc. (not shown in Figure 13A). Figure 13B shows one embodiment in which the beneficial filaments 20 and the suture 10 are attached only in the area of ​​the connecting end 10b of the suture 10.

[0037] Figure 14 shows a schematic axial cross-sectional view showing the arrangement of beneficial filaments 20 parallel to the suture thread 10. Figure 14A shows a schematic diagram, while Figure 14B shows one embodiment in which both the beneficial filaments 20 and the suture thread 10 are monofilaments, i.e., made from a string of a single material. Figure 14C shows one embodiment in which the beneficial filaments 20 are monofilaments, while the suture thread 10 is braided, i.e., made from a bundle of multiple threads braided together, and such bundles are braided together to form a stable interwoven structure or frame. Figure 14D shows one embodiment in which the beneficial filaments 20 are braided, i.e., made from multiple threads braided together, while the suture thread 10 is monofilament. Figure 14E shows one embodiment in which both the beneficial filaments 20 and the suture thread 10 are braided. Figure 14F shows one embodiment in which the suture 10 is a barbed suture having outwardly projecting barbs 17, similar to the STRATAFIX® Symmetric Knotless Tissue Control Device available from Ethicon, Inc. Advantageously, beneficial filaments 20 are positioned between the barbs 17 so as not to interfere with them.

[0038] Figure 15 shows a schematic axial cross-sectional view showing the arrangement of beneficial filaments 20 parallel to the suture 10. Figure 15A shows an adhesive 30a or molten or melted area 32, or intermittent spot welding or adhesive spots 33, or continuous welding or adhesive 35, which are disposed between the beneficial filaments 20 and the suture 10 and fix the beneficial filaments 20 to the suture 10. Figure 15B shows an adhesive 30a, 33, or 35, which are disposed between the beneficial filaments 20 and the suture 10 and fix the beneficial filaments 20 to the suture 10. Figure 15C shows an adhesive 30b, which extends around the beneficial filaments 20 and the suture 10 and fixes the beneficial filaments 20 to the suture 10. Figure 15D shows a sleeve 34, such as a heat-shrinkable or adhesive sleeve, which extends around the beneficial filaments 20 and the suture 10 and fixes the beneficial filaments 20 to the suture 10.

[0039] Advantageously, sutures 10 and beneficial filaments 20 of any cross-sectional shape can be utilized. While the preferred embodiments shown utilize a substantially round or circular cross-sectional shape, alternative cross-sections of any preferred geometric shape can be used. Figure 16 shows schematic axial cross-sectional views with several exemplary geometric shapes, illustrating the arrangement of beneficial filaments 20 parallel to the suture 10. Figure 16A shows arcuate or hollow semicircular beneficial filaments 20 anchored parallel to a substantially circular suture 10, resulting in a compact structure for easy placement within the tissue. Figure 16B shows ribbon shapes of beneficial filaments 20 and suture 10, both positioned parallel to each other, resulting in a compact structure for easy placement within the tissue. Figure 16C shows circular beneficial filaments 20 parallel to a ribbon-shaped suture 10. Figure 16D shows a circular suture 10 having a recess or flat portion 11a, thereby positioning a circular beneficial filament 20 parallel to the suture 10 within the recess 11, resulting in a compact structure for easy placement in tissue. Figure 16E shows a circular suture 10 having a semicircular cut portion or hollow 11b molded to accommodate at least a portion of the beneficial filament 20, thereby positioning the circular beneficial filament 20 parallel to the suture 10 within the hollow 11b, resulting in a compact structure for easy placement in tissue. Figure 16F shows two beneficial filaments 20 attached parallel to a substantially circular suture 10. In most embodiments, at least one beneficial filament 20 is shown, but two, three, four, or more beneficial filaments 20 may be used, and the most preferred system comprises one or two beneficial filaments 20 parallel to the suture 10. The two different beneficial filaments 20 may contain different types of drugs.

[0040] Figure 17 shows a schematic axial cross-sectional view of a suture system placed within tissue T. Figures 17A and 17B show a useful filament 20 parallel to a substantially circular suture 10 within an opening 40 in tissue T. The tissue opening 40 is formed so that a needle 100 (not shown) can penetrate tissue T during the placement of the suture 10.

[0041] Figure 17C shows the inflatable beneficial filament 25 parallel to the substantially circular suture 10 within the opening 40 of tissue T after it has been placed and expanded. The expansion of the inflatable beneficial filament 25 fills the space within the tissue opening 40, at least partially closing the tissue opening 40 and thus preventing or reducing bleeding through the tissue opening 40.

[0042] Characteristics of structures In a preferred embodiment, the suture 10 comprises any commercially available suture approved for use by the relevant regulatory authority. Thus, the suture 10 maintains the desirable mechanical properties, handling properties, knot strength, and absorbability properties corresponding to the approved commercially available suture.

[0043] The suture 10 itself can incorporate an antimicrobial agent or any other medically beneficial property (e.g., an agent to aid or stimulate wound healing), or an expandable coating and / or an antimicrobial agent or expandable component, or alternatively, the suture 10 may not incorporate any antimicrobial or expandable coating, or any antimicrobial or expandable component. Advantageously, the suture system 1 of the present invention provides further antimicrobial activity or expandability compared to commercially approved sutures due to the presence of beneficial filaments 20.

[0044] In one embodiment, the beneficial filament has little or no effect on the mechanical properties of the suture system 1 of the present invention during or after installation, and thereby, due to the smaller cross-section and weaker construction material, the mechanical strength of the beneficial filament may be lower.

[0045] Dimensionally, the cross-sectional area of ​​the beneficial filament 20 is less than 25% of the cross-sectional area of ​​the suture 10. Alternatively, for circular or rounded cross-sectional shapes, the dimensional relationship can be expressed relative to the diameter of the beneficial filament 20 when it is 50% or less of the diameter of the suture 10, resulting in the cross-sectional area of ​​the beneficial filament 20 being 25% or less of the cross-sectional area of ​​the suture 10. Most preferably, the diameter of the beneficial filament 20 is 50%, 40%, 30%, 20%, 10%, or 5% of the diameter of the circular suture 10. Alternatively, more generally, the cross-sectional area of ​​the beneficial filament 20 is 25%, 20%, 15%, 10%, 5%, 4%, 3%, 2%, or 1% of the cross-sectional area of ​​the suture 10. The same ratio of cross-sectional area relationships can be applied to non-rounded / uncircular cross-sectional geometric shapes.

[0046] The mechanical properties of the suture system of the present invention, comprising a combination of suture 10 and at least one beneficial filament 20, such as tensile strength, and / or elongation under load, and / or fracture strength, and / or knot strength, and / or knot sliding, are the same as, or very close to, those of suture 10 alone, before placement and after exposure to tissue, in vivo or in a tissue model simulating placement in tissue, such as a water system with temperature / buffering agents that simulates a tissue environment. As outlined in Table 1, the mechanical properties of the suture system 1 of the present invention in Embodiment A1 are the same as those of suture 10 alone, within the range of measurement error, measured 24 hours in tissue or a tissue model, 48 hours in tissue or a tissue model, and 72 hours in tissue or a tissue model, before placement in tissue or a tissue model. In Embodiment B1, the mechanical properties of the suture system 1 of the present invention, measured before placement in tissue or a tissue model and 24 hours later in the tissue or tissue model, are within 5% of those of the suture 10 alone. The mechanical properties of the suture system 1 of the present invention, measured 48 hours and 72 hours later in the tissue or tissue model, are the same as those of the suture 10 alone, within the range of measurement error. In Embodiment C1, the mechanical properties of the suture system 1 of the present invention, measured before placement in tissue or a tissue model and 24 hours and 48 hours later in the tissue or tissue model, are within 10% of those of the suture 10 alone. The mechanical properties of the suture system 1 of the present invention, measured 72 hours later in the tissue or tissue model, are the same as those of the suture 10 alone, within the range of measurement error.

[0047] The mechanical properties of the suture system 1 are similar to, or the same as, those of the suture 10 alone, for the following reasons: ● The beneficial filament 20 has a smaller cross-section than the suture 10. ● The beneficial filament 20 has lower mechanical strength than the suture 10. ● Beneficial filaments 20 have faster dissolution and / or absorption in tissue compared to sutures 10.

[0048] [Table 1]

[0049] material Materials for suture thread 10 The material of the suture 10 can be any suture material known in the art, in particular commercially available and approved suture materials such as synthetic and natural biocompatible polymer materials, which may be non-absorbable or absorbable. Examples of synthetic non-absorbable polymer materials useful for producing non-absorbable sutures include polyester, polyolefin, polyvinylidene fluoride, and polyamide. Further examples of non-absorbable materials are polyethylene, polypropylene, nylon, and similar polymers. Examples of synthetic absorbable polymer materials useful for producing absorbable sutures include polymers and copolymers made from lactones such as lactide, glycosides, p-dioxanone, epsilon-caprolactone, and trimethylene carbonate. Suitable biocompatible, biodegradable polymers may be synthetic or natural polymers. Suitable synthetic biocompatible and biodegradable polymers include polymers selected from the group consisting of aliphatic polyesters, poly(amino acids), copolymers (ether-esters), polyalkylene oxalates, tyrosine-derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamide esters, polyoxaesters containing amine groups, poly(acid anhydrides), polyphosphazenes, and combinations thereof. For the purposes of the present invention, aliphatic polyesters include, but are not limited to, lactides (including lactic acid, D-, L-, and meso-lactides), glycolides (including glycolic acid), epsilon-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), alkyl derivatives of trimethylene carbonate, and homopolymers and copolymers of mixtures thereof.The polymer can be selected from poly(lactic acid) (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polylactide-glycolic acid (PLGA), polypropylene (PP), polyethylene (PE), polydioxanone (PDS), or combinations or copolymers thereof of their monomers.Suitable bioabsorbable and biocompatible elastomer copolymers include, but are not limited to, epsilon-caprolactone and glycolide copolymers (the molar ratio of epsilon-caprolactone to glycolide is preferably about 30:70 to about 70:30, preferably 35:65 to about 65:35, more preferably 45:55 to 35:65); epsilon-caprolactone and L-lactide, D-lactide, and their formulations. Elastomer copolymers of lactide containing epsilon-caprolactone or lactic acid copolymer (the molar ratio of epsilon-caprolactone to lactide is preferably about 35:65 to about 65:35, more preferably 45:55 to 30:70); elastomer copolymers of p-dioxanone (1,4-dioxan-2-one) and lactide containing L-lactide, D-lactide and lactic acid (the molar ratio of p-dioxanone to lactide is preferably Examples include: elastomer copolymers of epsilon-caprolactone and p-dioxanone (the molar ratio of epsilon-caprolactone to p-dioxanone is preferably about 30:70 to about 70:30); elastomer copolymers of p-dioxanone and trimethylene carbonate (the molar ratio of p-dioxanone to trimethylene carbonate is preferably about 30:70 to about 70:30); copolymers of trimethylene carbonate and glycolide (the molar ratio of trimethylene carbonate to glycolide is preferably about 30:70 to about 70:30); elastomer copolymers of trimethylene carbonate and lactide including L-lactide, D-lactide, their formulations, or lactide copolymers (the molar ratio of trimethylene carbonate to lactide is preferably about 30:70 to about 70:30); and their formulations. In one embodiment, the elastomer copolymer is a copolymer of glycolide and epsilon-caprolactone. In another embodiment, the elastomer copolymer is a copolymer of lactide and epsilon-caprolactone. Examples of non-absorbable, i.e., bio-durable suture materials include nylon, polyethylene, polypropylene, or their monomers or copolymers.Suitable bio-durable polymers include, but are not limited to, polyurethane, polypropylene (PP), polyethylene (PE), polycarbonate, polyamide (e.g., nylon), polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), polystyrene (PS), polyester, polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PTFCE), polyvinyl fluoride (PVF), fluorinated ethylene propylene (FEP), polyacetal, polysulfone, silicon, and combinations thereof.

[0050] 20 Useful Filament Materials The beneficial filament 20 incorporates a certain amount of drug, and can contain up to 80% of the drug, for example, 5, 10, 20, 30, 40, 50, 60, 70, 75, or 80% by weight. Advantageously, such a large amount of drug results in a mechanically weak filament that is faster / more rapidly soluble / absorbent to the suture 10.

[0051] Preferably, the drug is synthesized into the material of the beneficial filament 20, where the beneficial filament 20 imparts a mixture of the drug and a polymer binder, and such mixture is extruded to form an elongated beneficial filament 20.

[0052] In one embodiment, the beneficial filament 20 is configured to rapidly release the drug after being placed in tissue. As shown in Table 2 for embodiments D1, E1, and F1, the beneficial filament 20 is configured to release at least 5, 10, and 20% of the drug within 24 hours in tissue or tissue model, at least 10, 25, and 50% of the drug within 48 hours in tissue or tissue model, and at least 20, 50, and 90% of the drug within 72 hours in tissue or tissue model.

[0053] [Table 2]

[0054] In some embodiments, the beneficial filaments are configured to dissolve and / or be reabsorbed substantially within 24 hours, 48 ​​hours, 72 hours, 96 hours, 120 hours, or 168 hours after tissue exposure, either in vivo or in a tissue model simulating placement within a tissue, such as in a water system with temperature / buffering agents that simulates the tissue environment.

[0055] The beneficial filament 20 comprises at least one agent and at least one absorbable and / or soluble filament-forming material, the filament-forming material being mixed with the agent, bound to the agent, or containing or retaining the agent throughout the matrix of the filament-forming material, enabling the formation of an elongated string via melt extrusion, solvent extrusion, casting, drawing, or any available technique.

[0056] Preferably, the filament-forming material for the beneficial filament 20 is a natural or synthetic polymer or a mixture of polymers. Suitable natural polymers include, but are not limited to, collagen, gelatin, elastin, polymerized hyaluronic acid, cellulose, oxidized cellulose, or any naturally derived polymer, or combinations thereof with natural or synthetic polymers. Suitable synthetic polymers include, but are not limited to, biocompatible polymers selected from the group consisting of polyacrylamide, polyvinylpyrrolidone, polyvinyl alcohol, polyvinyl methyl ether, polyethylene oxide, polyethylene glycol, and any combination thereof.

[0057] The release of antimicrobial agents or drugs from the beneficial filaments 20 may be a substitute for or in addition to any antimicrobial agents / drugs released by the suture 10 itself.

[0058] medication Suitable antimicrobial agents may be those that can be uniformly dispersed throughout the polymer matrix of the abrasive coating. For example, the antimicrobial agent may be any agent having antibiotic or antimicrobial properties, including chlorhexidine, polyhexamethylene biguanide (PHMB), octenidine, silver particles, silver salts, triclosan, and combinations thereof. Suitable antimicrobial agents may be selected from, but are not limited to, halogenated hydroxy ethers, acyloxydiphenyl ethers, or combinations thereof. In particular, the antimicrobial agent may be halogenated 2-hydroxydiphenyl ether and / or halogenated 2-acyloxydiphenyl ether, with acetate esters, chloroacetates, methyl or dimethylcarbamates, benzoates, chlorobenzoates, methylsulfonicates, and chloromethylsulfonicates being particularly suitable. Some particularly advantageous antimicrobial agents are 2,4,4'-trichloro-2'-hydroxydiphenyl ether, commonly referred to as triclosan, chlorhexidine gluconate, and combinations thereof.

[0059] In one embodiment, a material having a high affinity for an antimicrobial agent, or particles of such a material, can be distributed throughout the polymer matrix of the beneficial filament 20. For example, polycaprolactone and polycaprolactone copolymers have a high affinity for triclosan. Therefore, when triclosan is selected as the antimicrobial agent, (co)polymers of polycaprolactone or particles of polycaprolactone itself can be included in the beneficial filament 20. The beneficial filament 20 may contain a material having high solubility for a biomedically useful agent, for example, at least about 30% by weight of polycaprolactone, where the biomedically useful agent is triclosan. Triclosan is known to vaporize under relatively mild temperature and / or low pressure conditions and is preferentially absorbed into the polycaprolactone-containing polymer.

[0060] In one embodiment, particles such as silver particles having a size of approximately 0.1 microns to approximately 300 microns, such as approximately 10, approximately 50, approximately 100, and even approximately 150 microns, are incorporated into a useful filament 20 at a concentration of approximately 1 to approximately 75 volume%, such as 2, 3, 5, 10, 15, 20, 30, or 50 volume%. In some embodiments, silver salts such as carbonates, lactides, nitrates, or analogues can be used.

[0061] In addition to the antimicrobial agents described herein, beneficial filament agents 20 include, but are not limited to, alcohols such as ethanol and isopropanol; aldehydes such as glutaraldehyde and formaldehyde; anilides such as trichlorocarbanilide; biguanides such as chlorhexidine; chlorine-releasing agents such as sodium hypochlorite, chlorine dioxide and sodium acidite; iodine-releasing agents such as povidone-iodine and poloxamer-iodine; metals such as silver nitrate, silver sulfadiazine, other silver compounds, copper-8-quinolate and bismuththiol; peroxygen compounds such as hydrogen peroxide and peracetic acid; phenols; and quaternary ammonium compounds such as benzalkonium chloride, cetrimide and ionene-polyquaternary ammonium compounds. These may also be biocides, disinfectants and / or preservatives.

[0062] Beneficial filaments 20 may incorporate antibiotics including, but not limited to, penicillins such as amoxicillin, oxacillin, and piperacillin; parenteral cephalosporins such as cefazolin, cefadroxyl, cefoxitin, cefprodil, cefotaxime, and cefdinir; monobactams such as aztreonam; β-lactamase inhibitors such as clavulanate sulbactam; glycopeptides such as vancomycin; polymyxins; quinolones such as nalidixic acid, ciprofloxacin, and revaquin; metranidazole; novobiocin; actinomycin; rifampin; aminoglycosides such as neomycin and gentamicin; tetracyclines such as doxycycline; macrolides such as chloramphenicol and erythromycin; sulfonamides such as clindamycin and sulfadiazine; trimethoprim; topical antibiotics; bacitracin; gramicidin; mupirocin; and / or fusidic acid.

[0063] In some embodiments, the agent further includes antibodies, growth factors, cytokines, chemokines, agents that enhance wound healing, therapeutic peptides, and combinations thereof.

[0064] One beneficial filament 20 may contain two or more different agents incorporated therein. If two or more different beneficial filaments 20 are used, each may incorporate the same agent, or each may contain different types of agents. Thus, the first beneficial filament 20 may incorporate a first agent, such as chlorhexidine gluconate or silver particles, and the second beneficial filament 20 may incorporate a second agent, such as polyhexamethylene biguanide or silver salt.

[0065] Sterilization and assembly In one embodiment, the suturing system 1 of the present invention is assembled and then sterilized and packaged, or packaged and then sterilized. In this embodiment, the sterilization of the beneficial filaments 20 fixed to the sutures 10 / needles 100 is performed together by the same sterilization technique (e.g., ethylene oxide-based, gamma irradiation-based, electron beam irradiation-based, thermal-based, etc.).

[0066] In an alternative embodiment, the beneficial filament 20 is supplied as part of a kit having sutures 10 and needles 100, rather than being attached. In this case, the beneficial filament 20 is attached to the sutures 10 and / or needles 100 that form the suture system 1 immediately before use on a patient, within 1 to 120 minutes before use, such as within 1 to 30 minutes before use. In this embodiment, sterilization of the beneficial filament 20 that is not attached to the sutures 10 / needles 100 can be performed simultaneously by the same sterilization technique (e.g., ethylene oxide-based, gamma irradiation-based, electron beam irradiation-based, thermal-based, etc.) or separately by different sterilization techniques. Advantageously, sterilization of the beneficial filament 20 by a suitable sterilization technique can be performed separately, without negatively affecting the drugs, while sterilizing the sutures 10 / needles 100 by another suitable sterilization technique; therefore, the sterilized beneficial filament 20 and sutures 10 / needles 100 can be provided as part of an unbound sterilization kit. In this embodiment, a medical professional attaches the beneficial filament 20 to the suture 10 / needle 100 in the operating room using a suitable sterile adhesive, a heat-shrinkable sleeve, or heat treatment, thereby joining the beneficial filament 20 to the suture 10 and / or needle 100, and thus forming the suture system 1 immediately before use on a patient.

[0067] Information transmission or sensor In some embodiments, the beneficial filament 20 includes sensors configured to indicate the state of tissue and / or wound. In particular, states indicating undesirable processes such as infection, the presence of infected organisms, and biomarkers indicating such things are sensed and detected. In one embodiment, an indicator reflecting the presence of cancer cells can be incorporated. Direct detection of bacteria is conceivable, as are biomarkers of inflammation and / or infection, such as antibodies, cytokines and chemokines, as well as bacterial antigens and metabolites. Detection of the physiological environment of the wound, which may indicate infection, such as specific pH, oxygen supply, and temperature, is also conceivable. Alternatively, sensing and detection of normal states indicating the absence of inflammation and / or infection is also conceivable.

[0068] Reporting and communicating information about the condition of the wound is achieved through the communication of information via a beneficial filament, such as a change in color. Alternatively, the beneficial filament can be removed and analyzed. Alternatively, the beneficial filament may contain an electronic microchip and sensor, as well as a wired conduit or antenna for wired or wireless reporting. When an electronic sensor is used, the beneficial filament can interact synergistically with the already implanted sensor to passively amplify the wireless signal from the already implanted sensor, i.e., to resonate, amplify, or transmit the signal via an antenna effect.

[0069] In alternative embodiments, the beneficial filament 20 is configured to carry signals from a sensor (not shown) placed within the tissue at the site of a wound, and the beneficial filament 20 acts as a transmitting antenna for carrying electrical signals, i.e., electric currents, or for communicating information to a receiver / recorder outside the tissue, via wired or wireless means. In this embodiment, a sensor that senses the state of the tissue and / or wound carries signals from the sensor to an external receiver (not shown) via the beneficial filament 20. Thus, information regarding the state of healing and / or infection is carried externally and communicated to hygiene workers and / or the patient, and such information is carried / transmitted to a receiver outside the wound / patient using the beneficial filament 20, and the beneficial filament 20 does not necessarily generate information or sense the wound environment. In some embodiments, the beneficial filament 20 is connected to an auxiliary intra-tissue sensor via a wired or wireless link after placement of the beneficial filament 20 in the tissue, and also connected to an external recorder, also via a wired or wireless link, after placement of the beneficial filament 20 in the tissue.

[0070] Expandable and beneficial filament In one embodiment, the beneficial filament 20 is expandable in response to moisture, body fluids, or exposure to tissue. Advantageously, upon use of the suture system 1 for suturing and placement of the suture 10 having the beneficial filament 20 into the tissue, the beneficial filament expands, thus facilitating the closure of the hole made in the tissue by the needle. The expansion and inflation of the beneficial filament 20a is configured to occur within less than 60 minutes after placement in the tissue, for example, within 1, 2, 3, 5, 10, 30, or 45 minutes. The expansion or inflation constitutes an increase in the cross-sectional area of ​​the beneficial filament by at least 10%, for example, 10, 20, 30, 50, 100, 200, 300, or 500%.

[0071] Figure 17C shows the inflatable beneficial filament 25 parallel to the substantially circular suture 10 within the opening 40 of tissue T after it has been placed and expanded. The expansion of the inflatable beneficial filament 25 fills the space within the tissue opening 40, at least partially closing the tissue opening 40 and thus preventing or reducing bleeding through the tissue opening 40.

[0072] Expanding materials are any biocompatible materials that increase in volume or expand in response to water absorption, including superabsorbent polymers, hydrogels, i.e., hydrophilic three-dimensional networked materials capable of absorbing large amounts of water or biological fluids, gelatin, gelatin / polyvinylpyrrolidone hydrogel, hydroxypropyl methylcellulose, poly(ethylene oxide), sodium alginate, etc.

[0073] The expandable beneficial filament 20 may further have a releaseable active agent, such as an antimicrobial agent coated, impregnated, or compounded onto the filament 20.

[0074] While the present invention has been described herein with reference to specific embodiments thereof, it is evident that many changes, modifications, and variations are possible without departing from the concept of the invention disclosed herein. Accordingly, this shall encompass all such changes, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0075] [Implementation Method] (1) A suturing system, a) Needle and, b) An elongated flexible suture having a connecting end attached to the needle and a free end on the opposite side, c) comprising at least one elongated external useful filament attached to the needle or attached to the suture at the connecting end, The beneficial filament has a smaller cross-sectional area and lower mechanical strength than the suture, A suturing system in which the aforementioned beneficial filaments contain a drug. (2) The suture system according to Embodiment 1, wherein the suture is nonabsorbable, and the beneficial filaments are absorbable or soluble after being placed in mammalian tissue. (3) The suture system according to Embodiment 1, wherein the suture is absorbable, and the beneficial filaments are absorbable or soluble after being placed in mammalian tissue. (4) The suture system according to Embodiment 1, wherein the beneficial filament contains at least 20% by weight of the drug. (5) The suture system according to Embodiment 1, wherein the suture is barbed or knotless, and the beneficial filament is neither barbed nor knotless.

[0076] (6) The suture system according to Embodiment 1, wherein the suture is a braided filament structure and the beneficial filament is a monofilament. (7) The suture system according to Embodiment 1, wherein the beneficial filament is shorter than the suture thread. (8) The suture system according to Embodiment 1, wherein the suture has a recess configured to receive at least a portion of the beneficial filament. (9) The suture system according to Embodiment 1, wherein the beneficial filament is not attached to the suture along the length of the suture. (10) The suture system according to Embodiment 1, wherein the beneficial filaments are fixed to the suture at all points along the length of the suture, or intermittently along the suture.

[0077] (11) The suture system according to Embodiment 1, wherein the beneficial filament is capable of expanding its cross-section by at least 25% within 60 minutes after being placed in mammalian tissue. (12) The suture system according to Embodiment 1, wherein the mechanical properties of the suture system are within 5% of the properties of the suture without beneficial filaments during or after installation. (13) The suture system according to Embodiment 1, wherein the suture system has a BSR that is substantially the same as the BSR of the suture without beneficial filaments one week after placement. (14) The suture system according to Embodiment 1, wherein the beneficial filament is configured to dissolve completely or be completely reabsorbed within approximately 168 hours after being placed in mammalian tissue. (15) The suture system according to Embodiment 1, wherein the beneficial filament is configured to release at least 10% of the drug within 24 hours after being placed in mammalian tissue.

[0078] (16) The suture system according to Embodiment 1, wherein the drug comprises chlorhexidine, polyhexamethylene biguanide, octenidine, silver particles, silver salts, triclosan, and combinations thereof. (17) The suturing system according to Embodiment 1, wherein the beneficial filaments are sterilized separately and differently from the sutures and the needle, or the beneficial filaments are sterilized separately and in the same manner as the sutures and the needle. (18) A method for suturing mammalian tissue, The suture system described in Embodiment 1 is passed through the tissue and brought close to the tissue region to establish support for the tissue by the suture thread, Pulling the beneficial filament parallel to the suture through the tissue, Optionally, the suture system may be fixed by knots, To leave the beneficial filaments parallel to the suture in the tissue, A method comprising enabling the release of the drug into the tissue. (19) A kit for assembling the suture system described in Embodiment 1 before implantation, a) A long, slender, flexible suture attached to the needle, b) comprising at least one elongated external useful filament, separate from the suture and the needle, configured to be attached to the needle or to the suture at the connecting end, A kit in which the external beneficial filament is sterilized separately from the suture attached to the needle. (20) A method for producing the suture system described in Embodiment 1, Attaching the connecting end of the suture to the needle, A method comprising attaching the beneficial filament to the needle or to the suture at the connecting end.

Claims

1. A suturing system, a) Needle and, b) A long, slender, flexible suture having a connecting end attached to the needle and a free end on the opposite side, c) comprising at least one elongated external useful filament, separate from the needle and the suture, which is attached to the needle and separated from the suture, The beneficial filament has a smaller cross-sectional area and lower mechanical strength than the suture, A suturing system in which the aforementioned beneficial filaments contain a drug.

2. The suturing system according to claim 1, wherein the suture is non-absorbable, and the beneficial filaments are absorbable or soluble after being placed in mammalian tissue.

3. The suturing system according to claim 1, wherein the suture is absorbable, and the beneficial filaments are absorbable or soluble after being placed in mammalian tissue.

4. The suture system according to claim 1, wherein the beneficial filament contains at least 20% by weight of the drug.

5. The suturing system according to claim 1, wherein the suture is barbed or knotless, and the beneficial filament is neither barbed nor knotless.

6. The suturing system according to claim 1, wherein the suture is a braided filament structure, and the beneficial filaments are not braided into the filament structure.

7. The suture system according to claim 6, wherein the beneficial filament is a monofilament.

8. The suturing system according to claim 1, wherein the beneficial filament is shorter than the suture thread.

9. The suturing system according to claim 1, wherein the suture thread has a recess configured to receive at least a portion of the beneficial filament.

10. The suturing system according to claim 6, wherein the beneficial filaments are separated from the suture along the entire length of the suture.

11. The suturing system according to claim 6, wherein the beneficial filaments are fixed to the suture at multiple points along the length of the suture, or intermittently to the suture.

12. The suture system according to claim 11, wherein the beneficial filament is fixed to the suture by spot welding or adhesive spot welding.

13. The suture system according to claim 1, wherein the beneficial filament is expandable after placement in mammalian tissue to fill the space between a region extending circumferentially from at least a portion of the inner wall of a tissue opening and a region extending circumferentially from at least a portion of the outer wall of the suture.

14. The suture system according to claim 1, wherein the drug comprises chlorhexidine, polyhexamethylene biguanide, octenidine, silver particles, silver salts, triclosan, and combinations thereof.

15. A method for producing the suture system described in claim 1, Attaching the connecting end of the suture to the needle, A method comprising attaching the beneficial filament to the needle or to the suture at the connecting end.

16. The method according to claim 15, further comprising sterilizing the beneficial filaments separately and differently from the sutures and needles, or sterilizing the beneficial filaments separately and in the same manner as the sutures and needles.

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