Self-retaining sutures with bi-directional retainers or uni-directional retainers

Technical field of self-retaining suture thread with two-way retainer or one-way retainer

[0001] The present invention generally relates to self-retaining sutures for surgical procedures, methods of manufacturing self-retaining sutures for surgical procedures, and their use.

Background technique

[0002] Sutures are commonly used to close or glue wounds in human or animal tissues such as skin, muscles, tendons, internal organs, nerves, and blood vessels. The suture thread can be formed of a non-absorbable material, such as silk, nylon, polypropylene or cotton, or alternatively, the suture thread can be formed of a bioabsorbable material, such as but not limited to: glycolide, lactide , Poly-dioxanone (p-dioxanone) and ε-caprolactone homopolymer and/or copolymer.

[0003] Sutures usually include filamentous sutures with needles (the needles have a pointed end). The installation of sutures and surgical needles is described in US Patent Nos. 6163948 and U.S. Patent Application Publication No. 2004/0088003).

[0004] The difference between self-retaining sutures (often called "barbed sutures") and ordinary sutures is that they have a large number of tiny retainers (usually barbs) that are anchored in the surrounding area after deployment. In tissues, there is no need for tether knots to fix adjacent tissues together, and is described in, for example, US Patent No. 6848152 and European Patent 1075843. These retainers protrude from the periphery of the suture and are arranged to allow the self-retaining suture to pass when pulled through the tissue in one direction (with respect to the direction of the retainer's protrusion), but prevent the self-retaining suture when pulled in the opposite direction movement. The retainer can reduce the slippage of the suture thread along at least one direction of the suture thread, and can selectively avoid knotting of the suture thread.

[0005] Self-retaining sutures may be unidirectional, having one or more retainers oriented in one direction along the length of the suture thread; or bidirectional, usually having one or more retainers oriented in one direction along a portion of the thread. One retainer, and then one or more retainers oriented in another direction (usually the opposite direction) on the remainder of the thread (such as the barbed retainers described in U.S. Patent Nos. 5,931,855 and 6,241,747). Although the retainer can have any number of continuous or discontinuous structures, the most common form consists of a needle at one end, followed by barbs protruding "away" from the needle until it reaches the suture transition point (usually the midpoint). ); At this transition point, the structure of the barbs reverses itself 180 along the remaining length of the suture thread before reaching the second needle at the opposite end. (That is, the barbs are facing the opposite direction at this time). All patents and patent applications mentioned here are incorporated by reference.

[0006] The unidirectional self-retaining suture may include: a pointed end so that it can penetrate and pass through tissue when pulled by the end; and an opposite end that includes an anchor for initial insertion The point engages with the tissue in order to limit the movement of the suture. Alternatively, the bidirectional self-retaining suture may include grouped retainers extending in one direction along a part of the suture and grouped opposed retainers extending in the opposite direction along the other part of the suture. When implanted, both sets of retainers are engaged with the tissue, and the retainers can prevent movement of the suture thread through the tissue in either direction.

[0007] The surgeon may use a surgical needle attached with a suture (the suture may be a smooth monofilament or a multifilament) to optionally pierce the tissue on the opposite side of the wound in order to suture the wound. Techniques for arranging self-retaining sutures in tissues to close or glue wounds together can include making self-retaining sutures in linear patterns (such as zigzags) and curved patterns (such as alpha, sinusoidal, and spiral shapes). ) Thread the thread. Surgeons can also use self-retaining sutures to locate and support tissues that have not been injured during treatment, such as the face, neck, abdomen, or chest area

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And so on cosmetic surgery.

[0008] More specifically, for example, self-retaining sutures can be used to close wounds, repair wounds or defects, connect tissues together (make cut tissues close to , Close the anatomical space, fix single or multiple tissue layers together, produce anastomosis between two hollow (lumen) structures, and abut the tissue; fix or re-fix the tissues in their appropriate anatomical positions), and attach foreign elements Attached to tissues (fixed medical implants, devices, prostheses, and other functional or supporting devices), and used to reposition tissues in new anatomical locations (repair, tissue elevation, tissue transplantation, and related procedures).

[0009] Sutures usually include a filiform suture thread attached to a needle (the needle has a pointed end) (the connection of the suture and the surgical needle is described in US Patent Nos. 3981307, 5084063, 5102418, 5123911, 5509991, 5722991, 6012216 And 6163948 and U.S. Patent Application Publication No. 2004/0088003). Typically, the needle is advanced through the appropriate tissue on one side of the wound and then through the adjacent side of the wound to form a "loop", which is then completed by tying a knot in the suture.

[0010] Suture materials are broadly classified into degradable or bioabsorbable (that is, they will completely decompose in the body over a period of time) and non-absorbable (permanent; non-degradable). The degradable or bioabsorbable suture The thread material is composed of, for example, the following materials: catgut, acetic acid polymers and copolymers, lactic acid polymers and copolymers, and polybromide-based copolymers such as polyglycolide or lactide and polyglycol or Polypropylene copolymer; non-absorbable suture material (permanent; non-degradable) composed of, for example, the following materials: polyamide, polytetrafluoroethylene, polyethylene terephthalate, polyurethane, based on polyamide- Copolymers of esters, such as copolymers of polybutene or polyethylene terephthalate and polyglycol or polybromide, metal alloys, metals (such as stainless steel wire), polypropylene, polyethylene, silk, and cotton. In the case where the removal of the suture thread may be harmful to repair, or when the wound is completely healed and the natural healing process makes it unnecessary to provide support by the suture material, the degradable (bioabsorbable) suture thread is particularly advantageous, for example When completing a simple skin closure. Non-degradable (non-absorbable) sutures are used for healing wounds that may be expected to extend or require suture materials to provide physical support for the wound for a long time, such as deep tissue repair, high-stretch wounds, many plastic surgery repairs and some types The surgical anastomosis is in progress.

[0011] The bioabsorbable suture may be made of a material that decomposes in the tissue after a given time has elapsed, and the given time depending on the material may be from 10 days to 8 weeks. Therefore, sutures are used in many internal tissues of the body. In most cases, 3 weeks is enough to close the wound firmly. The suture will no longer be needed at this time, and it will be advantageous to disappear because no foreign material remains in the body and the patient does not need to remove the suture. In rare cases, bioabsorbable sutures may cause inflammation and rejection by the body rather than absorption. Bioabsorbable sutures were first made from the intestines of mammals. For example, visceral sutures can be made from specially prepared cattle or sheeps intestines, and can be untreated (ordinary catgut), made with salt in order to increase the retention time of the suture in the body (intestine), or heat-treated for Produce faster absorption (fast gut). For fear of spreading diseases (such as mad cow disease), the internal organs are obtained from materials that have been tested to ensure that the natural polymer used for the suture material does not carry viral diseases. The bioabsorbable suture can be made of synthetic polymer fibers, which can be monofilament or woven.

[0012] The self-retaining suture is designed to engage with tissue when the suture is pulled in a direction different from the direction in which it was originally placed in the tissue. A cordless knot tissue access device with barbs has been introduced, for example, in U.S. Patent No. 5,374,268, which discloses arm anchors with barbed protrusions and sutures with barbed transverse members The components have been disclosed in U.S. Patent Nos. 5584859 and 6264675. An earlier patent that introduced barbed sutures is U.S. Patent No. 3716058, which discloses sutures with one or more relatively rigid barbs at opposite ends

Line; the presence of barbs just at the end of the suture will limit the effectiveness of the barbs. Sutures with multiple barbs arranged along a larger portion of the suture are described in US Patent No. 5931855 (which discloses a unidirectional barbed suture) and US Patent No. 6241747 (which discloses a two-way There are barbed sutures) introduced in. Methods and devices for forming barbs on a suture thread by cutting the barbs in the suture thread body have been introduced in, for example, US Patent Nos. 6848152 and 7225512. Methods of manufacturing sutures with truncated cone retainers have also been introduced in European Patent 1075843 and US Patent Document No. 2007/0038429.

[0013] Despite the advantages of existing self-retaining sutures, there is still a need for new and preferably improved self-retaining sutures and methods of manufacturing them.

Summary of the invention

[0014] There is provided a suture thread for use in a treatment process applied to the tissue, as well as a method for forming the suture thread. According to one embodiment, the suture includes an elongate suture body and a plurality of retainers that are spaced apart from each other and extend from the elongate suture body between the first and second ends of the suture body. In a special embodiment, the holder is a bidirectional holder.

[0015] According to an embodiment of the present invention, each bidirectional retainer can be deployed through the tissue in two directions substantially opposite to each other, but once deployed in one direction, it will prevent movement in substantially opposite directions. Preferably, this makes it possible to quickly determine the number of bidirectional retainers deployed in one direction and the number of bidirectional retainers deployed in substantially opposite directions during the surgical procedure. In other words, how many sutures are deployed through the tissue in one direction and how many sutures are deployed through the tissue in the other direction can be determined during the surgical procedure because the sutures have no predetermined transition sections or transition points.

[0016] According to an embodiment of the present invention, each bidirectional holder can be contracted in any one of two directions according to the direction in which the holder is deployed through the tissue. According to one embodiment, each retainer is retracted in a direction opposite to the direction in which the retainer is deployed through the tissue. Once the retainer is contracted due to deployment through the tissue in the first direction, the retainer will substantially yield to the movement of the elongated suture body within the tissue when the elongated suture body is pulled in the first direction, and will prevent the elongated suture The wire body moves in a second direction substantially opposite to the first direction.

[0017] According to an embodiment of the present invention, the shape of each retainer can be transformed in either of two ways according to the direction in which the retainer is deployed through the tissue. Once the retainer transforms its shape due to deployment through the tissue in the first direction, the retainer will substantially yield to the movement of the elongate suture body within the tissue when the elongate suture body is pulled in the first direction, and will prevent the elongated suture body from moving within the tissue. The long suture body moves in a second direction substantially opposite to the first direction. Once the retainer transforms its shape due to deployment through the tissue in the second direction, the retainer will substantially yield to the movement of the elongate suture body within the tissue when the elongate suture body is pulled in the second direction, and will prevent the elongated suture body from moving within the tissue. The body of the long suture moves along the first direction.

[0018] According to an alternative embodiment of the present invention, the suture includes an elongated suture body and a plurality of tapered-shaped retainers, which are spaced apart from each other and are located at the first and second ends of the suture body. Between the elongated suture thread body protrudes. In addition, the tissue engaging protrusion protrudes from the edge of the tapered holder and/or the inclined wall of the tapered holder.

[0019] One or more embodiments are described in detail below. Other features, objectives and advantages can be made clear from the drawings and claims. In addition, all patents and patent applications described herein will be incorporated by reference in their entirety.

[0020] One or more aspects or embodiments are described in detail below. Other features, objectives and advantages can be made clear from the drawings and claims. In addition, all patents and patent applications mentioned here will be passed through

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Cited to join.

Description of the drawings

[0021] FIG. 1 is a perspective view of a portion of a self-retaining suture according to an embodiment of the present invention, which includes a bidirectional retainer.

[0022] FIGS. 2A-2C are front views of the bidirectional holder of FIG. 1 according to various embodiments of the present invention.

[0023] FIGS. 3A-3H are cross-sectional views of grooves in the bidirectional holder of FIGS. 2A-2C according to various embodiments of the present invention.

[0024] FIG. 4A is a perspective view of a portion of the self-retaining suture of FIG. 1 before being deployed through the tissue of the patient.

[0025] FIG. 4B is a perspective view of the self-retaining suture of FIG. 1 (and FIG. 4A) when it is initially deployed through the patient's tissue.

[0026] FIG. 4C is a perspective view of the self-retaining suture of FIG. 1 (and FIGS. 4A, 4B) after it is deployed through the patient's tissue.

[0027] FIG. 5 shows that the bidirectional holder of FIGS. 1-4C can be deployed through the tissue of the patient in different directions.

[0028] FIGS. 6A and 6B are front views of a bidirectional holder according to an embodiment of the present invention, the bidirectional holder including protrusions protruding from the edge of the holder.

[0029] FIG. 6C is a perspective view of a suture including a bidirectional retainer of FIGS. 6A and 6B after the retainer is deployed through patient tissue.

[0030] FIGS. 6D and 6E are front views of a bidirectional holder including protrusions protruding from the edge of the holder according to other embodiments of the present invention, wherein the protrusions are corners of a quadrilateral face.

[0031] FIG. 7 is a front view of a bidirectional holder including a vent that prevents air from being captured by the holder.

[0032] FIG. 8 shows an example extrusion and sizing machine according to an embodiment of the present invention, which can be used for manufacturing reference drawings

The sutures described in 1-7.

[0033] FIG. 9 shows an example filament that can be manufactured using the machine of FIG. 8.

[0034] Figures 10A70C show how a mold or die can be used to make the suture described with reference to Figures 1-7 from the filament shown in Figure 9.

[0035] FIG. 11A shows a self-retaining suture according to an embodiment of the present invention, which includes a unidirectional retainer.

[0036] FIGS. 11B-11E show an alternative retainer embodiment for the self-retaining suture of FIG. 11A.

Detailed ways

[0037] Before introducing the present invention, it is first proposed that the definitions of certain terms used in the following may be beneficial to the understanding of the present invention.

[0038] "Self-retaining system" refers to a self-retaining suture and a device for deploying the suture in tissue. The deployment device includes, but is not limited to: suture needles and other deployment devices, and a sufficiently rigid and sharp end on the suture itself for penetrating tissue.

[0039] "Self-retaining suture" refers to a suture that does not require knotting or suture anchors at its ends to keep it in place during a surgical procedure. They can be monofilament sutures or braided sutures and are positioned in the tissue in two stages, namely deployment and fixation, and include at least one tissue retainer.

[0040] "Tissue retainer" (or simply "retainer" or "barb") refers to a suture element having a retainer body protruding from the suture body and a retainer end for penetrating tissue . Each retainer is used to prevent movement of the suture in a direction other than the direction in which the suture is deployed into the tissue by the surgeon by being oriented substantially facing the deployment direction. When deploying

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When the tissue penetrating end of each retainer that passes through the tissue movement during the process deviates from the deployment direction (the deployment direction is the direction through which the suture thread passes during the deployment process), the tissue retainer does not jam or grasp the tissue in this stage. Once the self-retaining suture has been deployed, applying a force in the other direction (which is usually substantially opposite to the deployment direction) to hold the suture in place will cause the retainers to leave their deployed position that is substantially stationary along the suture body. And make the end of the retainer penetrate into the tissue, causing the tissue to be stuck between the retainer and the suture body.

[0041] "Retainer structure" refers to the structure of a tissue retainer, which may include features such as size, shape, surface features, and the like. These are sometimes called "barb structures".

[0042] "Bidirectional suture" refers to a self-retaining suture having a retainer oriented in one direction at one end and a retainer oriented in the other direction at the other end. Bidirectional sutures are usually equipped with needles at each end of the suture thread. Many bidirectional sutures have a transition section between the two barb directions.

[0043] "Transition section" refers to the gap between a first set of retainers (barbs) oriented in a first direction and a second set of retainers (barbs) oriented in the other direction of the bidirectional suture. Retainer (no barb) part.

[0044] "Suture thread" refers to the monofilament body part of a suture thread, and suture needles will not be included for sutures that require needle deployment. The suture thread can be monofilament or multifilament.

[0045] A "monofilament suture" refers to a suture including a suture thread of monofilament.

[0046] "Knitted suture" refers to a suture including multifilament suture threads. The filaments in such suture threads are usually woven, twisted, or woven together.

[0047] "Degradable (also referred to as "biodegradable" or "bioabsorbable") suture thread" refers to a suture thread that is broken down and absorbed by the body after being introduced into a tissue. Generally, the degradation treatment is performed at least locally in the biological system. "Degradation" refers to chain scission treatment by which polymer chains are cleaved into oligomers and monomers. Chain scission can be produced through various mechanisms, For example, it includes treatment by a chemical reaction (for example, hydrolysis, oxidation/reduction, enzymatic mechanism, or a combination thereof), or by heat or photolysis. The characteristics of polymer degradation can be determined, for example, using gel permeation chromatography (GPC), which monitors changes in polymer molecular weight during corrosion and decomposition. The degradable suture material may include polymers, such as catgut, polyglycolic acid, lactic acid polymer, polybromide-ester (such as a copolymer of polyglycolide and polyglycol, a copolymer of polyglycolide and polyglycolide) , Copolymers of polylactide acid and polyglycol, or copolymers of polylactide acid and polyol), copolymers of glycolide and lactide, cyclopropane carbonate and glycolide and diethylene glycol Copolymers (such as MAXONTM, Tyco Healthcare Group)> terpolymers of glycolide and cyclopropane carbonate and dioxycyclohexanone (such as BI0SYNTM: glycolide (60%), cyclopropane carbonate ( 26%) and dioxanone (14%)], TycoHealthcare Group) >Copolymer of glycolide and caprolactone, cyclopropane carbonate and lactide (such as CAPROSYNTM, Tyco Healthcare Group)_oThese sutures can be in the form of woven multifilaments or monofilaments. The polymer used in the present invention may be a linear polymer, a branched polymer, or a multiaxial polymer. Examples of multiaxial polymers used for sutures are disclosed in U.S. Patent Application Publication Nos. 20020161168, 20040024169 and 20040116620. The degradable suture may also include a soluble suture made of a soluble polymer, such as, but not limited to: a partially deacetylated polymer of polyvinyl alcohol. Sutures made of degradable suture materials lose their tensile strength when the material degrades.

[0048] "Non-degradable (also referred to as "non-absorbable") sutures" are meant to include those that cannot be processed by chain scission, such as chemical reactions (such as hydrolysis, oxidation/reduction, enzymatic mechanisms, or combinations thereof), or through heat or photolysis. Sutures of materials that have been processed and degraded. Non-degradable suture materials include polyamide (also known as nylon, such as nylon 6 and nylon 6.6), polyethylene terephthalate, polytetrafluoroethylene, poly-ester (such as polybutene or Polyethylene terephthalate-based copolymers with polyglycol or polybromide), polyurethane, metal alloys, metals (such as stainless steel wire), polypropylene, polyethylene, silk and cotton. by

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Sutures made of non-degradable suture materials are suitable for applications where the suture is to be permanently maintained or to be physically removed from the body.

[0049] "Suture diameter" refers to the diameter of the suture body. It should be understood that various suture lengths can be used for the sutures described herein, and the term "diameter" is generally associated with the circumference of a circle. It should be understood that this refers to the cross-sectional dimensions associated with the circumference of any shape. The size of the suture is based on the diameter. The United States Pharmacopoeia ("USP") suture size label ranges from 0 to 7 in a larger range, and 1-0 to 11-0 in a smaller range. In this smaller range, the higher the value before zero, The smaller the diameter of the suture. The actual diameter of the suture will depend on the material of the suture, such that, for example, the diameter of a suture made of collagen with a size of 5-0 is 0.15mm, while the same USP size designation but made of synthetic absorbable or non-absorbable materials The manufactured sutures will each have a diameter of 0.1 lmni. For special purposes, the choice of suture size depends on many factors, such as the characteristics of the tissue to be sutured and the importance of cosmetic issues; smaller sutures can be operated more easily through tight surgical sites, and scars are smaller , And the tensile strength of a suture made of a given material will decrease as the size decreases. It should be understood that the suture thread and the method of making the suture thread described here are also suitable for various diameters, including but not limited to: 7, 6, 5, 4, 3, 2, 1, 0, 1-0, 2-0 , 3-0, 4-0, 5-0, 6-0, 7-0, 8-0, 9-0, 10-0 and 11-0.

[0050] "Suture deployment end" refers to the end of the suture that is to be deployed into the tissue; one or both ends of the suture may be the suture deployment end. The suture deployment end may be mounted on a deployment device such as a suture needle, or it may be sharp and rigid enough to penetrate tissue by itself.

[0051] "Equipped suture" refers to a suture with a suture needle on at least one suture deployment end.

[0052] "Needle connection" is the connection of the pointer head to the suture that needs to be deployed into the tissue, and may include methods such as crimping, elbows, use of adhesives, and the like. The point where the suture is attached to the needle is called the elbow.

[0053] "Suture needle" refers to a needle used to deploy suture into tissue, and it can have many different shapes, forms, and components. There are two main types of needles: traumatic needles and atraumatic needles. The wound needle has a channel or a drilled end (that is, a hole or eye), which is provided separately from the suture thread and threaded on site. The atraumatic needle is eyeless and is attached to the suture thread by molding at the factory. Therefore, the suture material is inserted into the channel at the blunt end of the needle. Keep the needles together. In this way, the atraumatic needle does not require extra time to thread the needle on site, and the suture end at the connection site of the needle is smaller than the needle body. In wound needles, the silk thread comes out of the needle holes on both sides, and the suture usually tears the tissue to some extent as it passes through the tissue. More modern sutures are molded with atraumatic needles. The atraumatic needle can be permanently molded to the suture or it can be designed to leave the suture by a sharp straight pull. These "sudden departures" are usually used to interrupt sutures, where each suture passes only once and then knots. For uninterrupted barbed sutures, these atraumatic needles are ideal.

[0054] Suture needles can also be classified according to their tip geometry. For example, the needle can be "tapered", so the needle body is round and tapered smoothly toward the tip; (ii) "cut", so the needle body is triangular with a sharpened cutting edge on the inside ; (Iii) "reverse cut", so the cutting edge is on the outside; (iv) "trocar tip" or "conical cut", so the needle body is round and tapered, but ends in a smaller triangular cut Tip; (ν) "Blunt" tip, used to suture fragile tissue; (vi) "Side cut" or "scraper tip", so the top and bottom of the needle are flat, with a front to one side Cutting edge (usually used in eye surgery).

[0055] The suture needle can also be in various shapes, including: straight shape; (ii) semi-curved or sliding plate shape; (iii) 1/4 circle; (iv) 3/8 arc shape; (ν) 1/2 arc shape; (vi) 5/8 arc shape; (ν) and compound curve shape.

[0056] Suture needles, such as those in U.S. Patent Nos. 6322581 and 6214030 (issued to Mani, Inc. in Japan), 5464422 (issued to WL Gore, Newark, Germany), 5941899, 5425746, 5306288, and 5156615 (issued to

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US Surgical Corp., Norwalk, CT)>5312422 (granted to Linvatec Corp., Largo, FL) and 7063716 (granted to TycoHealthcare, North Haven, CT). Other suture needles are described in, for example, US Patent Nos. 6129741, 5897572, 567675, and 5,693,072. The suture thread described here can pass through various needle types (including but not limited to: curved, straight, longer, shorter, micro, etc.), needle cutting surfaces (including but not limited to: cutting, Taper, etc.) and needle connection technology (including but not limited to: drill end, crimping, etc.) to deploy. Moreover, the sutures described herein may themselves include sufficiently rigid and sharp ends to be distributed to meet the needs of deployment with the needle.

[0057] "Needle diameter" refers to the diameter of the suture deployment needle at the widest point of the needle. Although the term "diameter" is usually associated with a circular perimeter, it should be understood that this refers to the cross-sectional dimensions associated with an arbitrary shaped perimeter.

[0058] "Wound closure" refers to a surgical procedure used to close a wound. Wounds (especially wounds when the skin or other external or internal surfaces are cut, torn, punctured, or otherwise destroyed) are called wounds. Wounds usually occur when the integrity of any tissue is impaired (for example, skin breaks or burns, muscle tears, or fractures). Wounds can be caused by actions (such as shooting, falling, or surgical procedures), infections, or through underlying medical conditions. Surgical wound closure facilitates biological healing by adjoining or closely drawing the edges of these wounds where the tissue has been torn, cut, or otherwise separated. Surgical wound closure directly juxtaposes or draws the tissue layer, which is used to reduce the volume of new tissue that needs to be formed to bridge the gap between the two edges of the wound. The closure can also be used for functional and aesthetic purposes. These goals include the elimination of dead zones by drawing the subcutaneous tissue, the reduction of scar formation by careful epidermal alignment, and the avoidance of sunken scars by precisely flipping the edges of the skin.

[0059] "Tissue raising process" refers to a process used to reposition the tissue from a lower height to a higher height (that is, to make the tissue move in a direction opposite to the direction of gravity). The retaining ligaments of the face support the soft tissues of the face in a normal anatomical position. However, as we age, gravity acts on the tissue and the bottom ligament to produce a downward pull, and the fat drops to the plane between the surface and the deep facial fascia, causing the facial tissues to sag. The face raising procedure is designed to raise these sagging tissues and is an example of a more common type of medical procedure called the tissue raising procedure. Generally, the tissue raising process reverses the appearance change (the appearance change is caused by the effect of gravity over a period of time) and the time effect (the time effect causes the tissue to sag, such as a genetic effect). It should be understood that the tissue can also be repositioned without raising it. In some treatments, the tissue can be repositioned laterally (away from the midline), toward the middle (toward the midline), or downward (lower) in order to restore symmetry (Ie repositioning so that the left and right sides of the body are "symmetrical").

[0060] "Medical device" or "implant" refers to any object arranged in the body for the purpose of restoring physiological functions, reducing/alleviating conditions associated with diseases, and/or repairing/replacement of damaged or diseased organs and tissues. Although biocompatible synthetic materials (such as medical grade stainless steel, titanium and other metals, polymers such as polyurethane, silicon, PLA, PLGA, and other materials) are usually included on the outside, some medical devices and implants include animal sources (E.g. "xenografts" such as whole animal organs; animal tissues such as heart valves, naturally occurring or chemically changed molecules such as collagen, hyaluronic acid, proteins, carbohydrates, etc.), human donors (e.g. "heterologous "Transplant" such as whole organs, tissues such as bone grafts, skin grafts, etc.), or materials from the patient himself (eg, "autologous grafts" such as saphenous vein grafts, skin grafts, tendon/ligament/muscle grafts). Medical devices that can be used in the treatment process combined with the present invention include, but are not limited to: orthopedic implants (artificial joints, ligaments and tendons; screws, plates and other implantable hardware), dental implants, intravascular Implants (artery and vein vascular bypass grafts, hemodialysis access implants; autologous and synthetic), skin grafts (autologous, synthetic), tubes, drainage channels, implantable tissue fillers , Pump, bypass, sealant, surgical net (example Such as hernia repair nets, tissue stents), fistula treatment, spinal implants (such as simulated intervertebral discs, spinal fusion devices, etc.)

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and many more.

[0061] Self-retaining suture

[0062] The difference between self-retaining sutures (including barbed sutures) and ordinary sutures is that they have a large number of tissue retainers (such as barbs) that are anchored in the tissue after deployment and prevent the sutures It moves in the opposite direction to the direction of the holder, so no tether knot is needed to hold adjacent tissues together ("tetherless knot" closure). By eliminating tether knots, associated complications can be eliminated, including but not limited to: (i) spitting (a symptom when sutures (usually knots) are pushed through the skin after being closed under the skin) (Ii) Infection (bacteria can usually attach to and grow in the space created by the knot); (iii) Volume/mass (at the part including the knot, a large amount of suture material remains in the wound; (Iv) Slippage (the knot may slip or untie); and (ν) irritation (the knot acts as a large "exosome" in the wound). The suture loop associated with the tether knot may cause local defects Blood (they create stretch points that may constrict the tissue and restrict blood flow to the area) and increase the risk of cracking or rupture at the surgical wound. Tether knots are also very labor intensive, and This may include a significantly larger percentage of the time spent closing surgical wounds. The additional surgical treatment time is not only detrimental to the patient (the incidence of complications varies with the It also increases the overall cost of the operation (many surgical procedures are estimated to cost between $15 and $30 per minute of operation time. Therefore, cordless sutures can not only improve the clinical outcome of the patient, It also saves time and costs associated with prolonged surgery and subsequent treatment.

[0063] The self-retaining system used for wound closure also leads to better access to the edges of the wound, so that the stretching force is evenly distributed along the length of the wound (reducing stretch areas that may rupture or cause ischemia), reducing retention in The volume of suture material in the wound (by eliminating knots) and reducing splashing (the suture material (usually knots) is squeezed out through the surface of the skin). All of these features are believed to reduce scar formation, improve beauty, and increase wound strength compared to wound closure by ordinary sutures or nails.

[0064] The ability of self-retaining sutures to anchor and hold tissue in place even when no stretch is applied to the sutures is also a feature that is superior to ordinary sutures. When the wound is closed under stretching, this advantage itself proves in many ways: (i) A large number of retainers can spread the stretching force along the entire length of the suture (providing hundreds of "anchor" points, and intermittent In contrast to knotted sutures, the intermittently knotted sutures allow the stretching force to be concentrated at discrete points; this produces good cosmetic results and reduces the possibility of sutures "slipping" or pulling over); (ii) ) It is possible to close complex geometrical wounds (circular, arc, zigzag edges) in a uniform manner, which is more accurate and correct than the results obtained by intermittent sutures; (iii) They do not require a "third hand", in ordinary The process of stitching and tethering knots usually requires a "third hand" to maintain the stretching force across the wound (in order to prevent "slipping" when the stretch is temporarily released during the knotting process); (iv) they are used in the tethering technique It is advantageous in difficult treatments, such as deep wounds or laparoscopic treatments; and (ν) they can be used to close and maintain the wound before the final closure. Therefore, self-retaining sutures make it easier to handle anatomically tighter or deeper locations (such as the pelvis, abdomen, and chest), and it is easier to draw tissues closer during laparoscopic and minimally invasive procedures; all of these It is not necessary to use a knot to fix the closure. Compared with ordinary sutures, greater precision makes self-sustaining sutures The thread can be used for more complex closures (such as closures with diameter mismatches, larger defects, or purse-string sutures).

[0065] Self-retaining sutures themselves are also beneficial for various professional applications: for example, they are suitable for tissue raising treatments, in which the tissue leaves its previous position and is repositioned in a new anatomical position (this is usually used in cosmetic treatments). During the process, the "sagging" tissue is raised and fixed in a more "younger" position; or when the "off-position" tissue is returned to its correct anatomical position). Such treatments include raising the face, raising the eyebrows, raising the chest, raising the buttocks, and so on.

[0066] The self-retaining suture may be unidirectional, having one or more oriented in one direction along the length of the suture thread

Retainer; or bidirectional, usually one or more retainers oriented in one direction along a part of the thread, and then one or more retainers oriented in the other direction (usually the opposite direction) on the remaining part of the thread (As described in U.S. Patent Nos. 5931855 and 6241747 with barbed retainers).

[0067] Although the retainer can have any number of continuous or discontinuous structures, the most common form consists of a needle at one end, followed by barbs protruding "away" from the needle until it reaches the suture transition point (usually in the middle). Point); at this transition point, the structure of the barbs along the remaining length of the suture thread is reversed by 180° before reaching the second needle at the opposite end (that is, the barbs are facing the opposite direction at this time) (so in the suture The barb on this part is also away from the nearest needle). In other words, the barbs on both "halves" of the two-way self-retaining suture point point to the middle, the transition section (without retainer) is placed between them, and the needle is installed at each end.

[0068] Although self-retaining sutures have multiple advantages, there is still a need and desire to improve the design of the sutures so that various common limitations can be eliminated.

[0069] B. Bidirectional retainer

[0070] FIG. 1 shows a perspective view of a part of a self-retaining suture 100 according to an embodiment of the present invention. The self-retaining suture 100 includes an elongated linear suture body 102 and a suture body 102 protruding from the Multiple holders 104. The suture body 102 may include two ends, or more than two ends (ie, three ends, four ends or more). The self-retaining suture 100 shown in Figure 1 has not yet been deployed through the patient's tissue.

[0071] As shown in FIG. 1, the retainer 104 (eg, during a surgical procedure) is generally flat before being deployed through the tissue. As shown in FIG. 1, the retainer may be substantially perpendicular to the suture body 102 before being deployed through the tissue. The holders 104 can be called bidirectional holders 104 because they can be deployed in two directions, but once deployed in one direction will prevent movement in the opposite direction, as described later. Advantageously, this enables the number of bidirectional retainers 104 to be deployed in one direction and the number of bidirectional retainers 104 to be deployed in the opposite direction to be determined during the surgical procedure. More specifically, before being deployed through the tissue, each bidirectional retainer 104 may be deployed through the tissue in a first direction and a first direction substantially opposite to the first direction. However, once the bidirectional retainer 104 is deployed through the tissue in one of the first direction and the first direction, the bidirectional retainer 104 will be pulled when the elongated suture body 102 is pulled in one of the first direction and the second direction. Substantially yielding to the movement of the elongated suture body 102 within the tissue will prevent the elongated suture body 102 from moving in the other of the first direction and the second direction.

[0072] As shown in the front views of FIGS. 2A and 2B, the holder 104 may have a circular shape (FIG. 2A), or may have other shapes, such as but not limited to: octagonal (FIG. 2B), hexagonal , Square, etc. Each holder 104 includes a groove 106 that extends radially from the center toward the outer periphery or edge of the holder. The groove 106 may be continuous from the center to the outer edge, or may be discontinuous or discontinuous (similar to how perforations include discontinuous holes). The groove 106 may be cut into the holder 104 (and therefore scored), or formed as part of molding and/or thorough processing, for example at the same time as the holder 104 is formed. More or fewer slots 106 than shown in Figures 2A-2C can be used. Also, as described below, the grooves shown in FIGS. 2A-2C may be replaced by multiple pairs of side-by-side grooves or three or more side-by-side grooves.

[0073] FIGS. 3A-3F show various embodiments of the groove 106, and FIGS. 3A-3F show alternative cross-sectional portions of the retainer 104. Each holder 104 has two substantially planar sides, and these two sides may be referred to as a first side and a second side, a left side and a right side, and so on. As shown in FIGS. 3A and 3D, only one side of the holder 104 may include the groove 106, or as shown in FIGS. 3C and 3F, only the other side of the holder 104 may include the groove 106. Alternatively, as shown in FIGS. 3B and 3E, both sides of the holder 104 may include grooves 106. When both sides of the holder 104 include grooves, the groove 106 on one side may be a mirror image of the groove on the other side. Alternatively, the groove 106 can be on both sides of the holder 104, and they do not mirror each other.

For example, as shown in FIG. 2C, the solid line 106 represents the groove on one side, and the dashed line 106 represents the groove on the other side. It should be understood that the shape of the groove 106 in FIGS. 3A-3C is different from the shape of the groove 106 in FIGS. 3D-3F. A pair of grooves can be side by side, as shown in Figure 3G, or three or more grooves can be side by side, so as to form a sinusoidal wave of grooves, as shown in Figure 3H. In certain embodiments, the groove may have a uniform thickness and/or depth. In another embodiment, the grooves may have varying thickness and/or depth to allow greater deformation near the center of each retainer 104. For a more specific example, each groove may have the greatest thickness and/or depth in the center of the holder or near the opening 116, and be the narrowest and/or shallowest at the outer edge of the holder. Although the groove 106 is shown as a substantially triangular shape in FIGS. 3A-3H, it can also have other shapes, such as but not limited to: square, U-shaped, and the like.

[0074] As shown in FIGS. 1 and 4A, the sides of the retainer 104 are first substantially perpendicular to the suture body 102. This also means that the groove 106 is generally perpendicular to the suture body 102 at first. However, once the suture is used in a surgical procedure and passes through the patient's tissue, the resistance provided by the patient's tissue will cause the retainer 104 to contract, as shown in Figures 4B and 4C. Figure 4B shows the retainer 104 when it initially begins to contract. Figure 4C shows that the retainer 104 is in its retracted position after it has been retracted. The groove 106 serves as a folding line or a shrinking line, so that the holder 104 shrinks in a controlled manner. The contraction can be produced in the form of a slightly accordion, where the folds alternate back and forth along the groove 106.

[0075] Depending on the direction in which the retainers are deployed through the tissue, each retainer 104 can be contracted in either of two directions. The holder 104 may shrink in the direction of the groove, but may also shrink in the direction opposite to the groove. In other words, when the slot is on the right side of the retainer 104 and the suture body 102 with the retainer is pulled through the tissue in the left direction (ie, deployed), the retainer 104 will contract to the right, as shown in Figures 4B and 4C Shown in. However, when the same suture body 102 is initially pulled through the tissue in the right direction (ie, deployed), the retainer 104 will retract to the left, even though the groove is only on the right side of the retainer 104. In other words, each retainer 104 contracts in a direction opposite to the direction in which the retainer is deployed through the tissue.

[0076] Once in the retracted position (e.g., as shown in FIG. 4C), the retainer 104 will substantially yield to the elongated suture body 102 in the tissue when the suture 100 is pulled in the suture deployment direction that causes the retainer to contract. When the suture thread 100 is pulled in a direction opposite to the direction in which the suture thread is deployed, the movement is prevented. For example, it can be seen from FIG. 4C that the retracted retainer 104 can easily pull through the tissue in the direction of the arrow, but will prevent movement in the direction opposite to the arrow. More generally, once the bidirectional retainer 104 is contracted due to the retainer being deployed through the tissue in the first direction, the retainer 104 will substantially yield to the elongated suture when the elongated suture body 102 is pulled in the first direction. The movement of the body 102 within the tissue will prevent movement of the elongated suture body 102 in a second direction that is substantially opposite to the first direction. More generally, each bidirectional retainer 104 can be deployed in either direction, and once deployed, will succumb to movement in the direction that allows the retainer to be deployed through the tissue, and prevent movement in the direction opposite to the deployment direction. exercise.

[0077] The self-retaining suture 100 including the bidirectional retainer 104 can be used unidirectionally or bidirectionally. When it is to be used unidirectionally, the self-retaining suture may include: a pointed end or an end with a needle to allow passing through and passing through the tissue when pulled by the end; and an opposite end, which is at a certain end. Some embodiments include anchors that are used to engage the tissue at the initial insertion tip to limit the movement of the suture. When it is to be used bidirectionally, more than one end of the suture may include a tip or needle for tissue penetration. In other words, the bidirectional suture thread can be equipped with needles at each end of the suture thread.

[0078] Generally, a bidirectional self-retaining suture includes a set of retainers extending along a part of the suture toward one deployment direction and a group of opposing retainers that extend along another part of the suture toward the opposite deployment direction. Also, generally, the bidirectional self-retaining suture includes a transition section between the two sets of retainers. The problem with such common bidirectional self-retaining sutures is that the surgeon needs to recognize the position of the transition section when deploying the suture. Moreover, when the transition section is in the middle of the suture, in some cases, the length of the suture on one side of the transition section can be shorter than the surgeon hopes.

[0079] In addition, the marking of the transition point of a common bidirectional self-retaining suture is not always satisfactory. The disadvantage of the current two-way self-retaining sutures is that there are additional manufacturing and technical obstacles to achieve effective marking of the transition point. Moreover, the transition point is not always in the position desired by some doctors and/or the position suitable or optimal for certain procedures.

[0080] The bidirectional self-retaining suture 100 including the bidirectional retainer 104 overcomes the aforementioned shortcomings of the conventional bidirectional self-retaining suture. This is because the bidirectional self-retaining suture 100 including the bidirectional retainer 104 can be deployed in any direction, and once deployed, it will prevent movement in the direction opposite to the deployment direction. For example, when the suture includes N spaced apart retainers 104, any number of retainers 104 from all to zero (ie, M, 0WMWN) can be passed through the patient by pulling all or part of the suture in the first direction. The tissue is contracted in one direction, and the remaining retainer 104 (ie, N-M) can be contracted in the opposite direction by pulling the remaining part of the suture through the patient's tissue in the second direction. Then, once contracted, each retainer 104 will prevent movement in the direction opposite to its deployment direction. For example, M holders 104 can prevent movement in a first direction, and N-M holders 104 can prevent movement in a second direction opposite to the first direction, where the variable M can be selected quickly. In other words, the number of bidirectional retainers 104 deployed in one direction and the number of bidirectional retainers 104 deployed in the opposite direction may be determined during the surgical procedure. This can be shown in Figure 5. Moreover, compared with ordinary two-way self-retaining sutures (wherein, two sets of retainers that can be deployed in opposite directions are usually The bidirectional self-retaining suture 100 including the bidirectional retainer 104 does not need to include the transition section. In addition, regardless of the desired and/or optimal transition point, the same bidirectional self-retaining suture 100 including the bidirectional retainer 104 can be used efficiently and effectively. In addition, when the suture includes needles at both ends of the suture body, the doctor can change the transition point at any time during the treatment. For example, the doctor can sew through a needle, and then, no matter how many sutures have been used at this time, when he does so, the doctor can start to sew the remaining sutures with another needle. This is better than a suture with a fixed symmetrical or asymmetrical transition section, because the transition section can be any position the doctor chooses for any procedure at any time during the procedure.

[0081] FIGS. 6A and 6B show that the holder 104 may include protrusions 108 along the outer edge of the holder. The protrusion 108 is used to increase the engagement of the retainer 104 with the tissue. Figure 6C shows a retainer 104 of Figure 6A after it has been deployed through the tissue and contracted. It can be seen from FIG. 6C that when the suture thread body 102 is pulled in the direction opposite to the arrow, the protrusion will penetrate into the tissue of the patient, thereby further preventing movement in the direction opposite to the arrow. As shown in FIGS. 6D and 6E, the protrusion 108 may be part of a quadrilateral face 610. The quadrilateral surface 610 may be an ideal rhomboid, as shown in FIG. 6E. By changing the size of each quadrilateral (and possibly rhomboid) face 610, different final geometric shapes can be obtained.

[0082] FIG. 7 shows that the retainer 104 may include one or more vent holes 110 that prevent air from being captured by the retainer 104 when the retainer is deployed through the patient's tissue. This is advantageous because it is believed that the tissue will heal faster when air is not trapped behind the retainer 104. Moreover, the vent is used for further anchoring with the patient's tissue.

[0083] The retainers 104 may be pre-formed and then attached to the suture body 102 ±. In one embodiment, each bidirectional retainer 104 includes an opening 116 therethrough. The suture body 102 may pass through the opening 116 of the holder 104, and the holder 104 may be connected to the suture body 102 such that the holders 104 are spaced apart from each other. In one embodiment, the retainer 104 may be attached to the suture body 102 using an adhesive. Exemplary adhesives that can be used include, but are not limited to: oxyacrylates (such as octyl oxyacrylate), fibrin sealants, animal glues, synthetic N-succinimide-based adhesives, and acrylic adhesives. Alternatively, externally activated adhesives can be used, such as materials from the polymerizable group, such as acrylic and methacrylic functionalities, acrylamide, methacrylamide, itcon and styrene groups, They will have adhesive properties through exposure to high-frequency radiation (such as ultraviolet light or other high-frequency waves). Other adhesives that can be used include permanent silicon room temperature vulcanization adhesives, free radical generating adhesives such as peroxy

Benzoyl and so on. In other embodiments, the retainer 104 is connected to the suture body 102 by melting the retainer 104 on the suture body 102 ±o. In other words, the retainer may be thermally bonded to the suture body 102 ±o. In an embodiment, the holder 104 may be connected to the suture body 102 by fusing the holder 104 to the suture body 102 by welding (such as but not limited to ultrasonic welding or laser welding). In other words, the holder 104 can be welded and adhered to the suture body 102. Alternatively, the retainer 104 may be connected to the suture body 102 using a solvent, for example, by partially or completely dissolving a part of the retainer 104 in the suture body 102 and/or vice versa. In other words, the retainer may be solvent-attached to the suture body 102.

[0084] Alternatively, the retainer 104 may be formed as an integral part of the suture body 102 (ie, an integral structure with the suture body), for example, using extrusion, molding, and/or thorough processing. 8, 9 and 10A-10C will be used to explain example methods that can be used to manufacture the self-retaining suture 100 including the bidirectional retainer 104.

[0085] Referring to FIG. 8, the monofilament 220 may be formed by extrusion and sizing. As shown in FIG. 8, the extruder 210 receives pellets of polymer 212 in a hopper 214. The polymer is melted and pushed through the extrusion die 218 by the screw conveyor 216 to form a filament 220 of molten polymer 212. The filament 220 initially has a uniform cross-section in the shape of the hole in the extrusion die 218. The extruded filament passes through an air gap 219 in which the filament cools and the polymer 212 solidifies slightly. The extruded filament 220 passes through a sizing machine 230 in which the filament 220 passes between two carts 232,234. Before and/or after the sizing treatment, the wire can be optionally quenched, drawn and/or tempered. The roller 232.234 has a patterned surface that presses the material of the wire 220 into the proper shape shown in FIG. 9. The sizing treatment can be carried out at a temperature between 20-80% of the melting point of the polymer. In a preferred embodiment, the sizing treatment is performed at a temperature higher than the glass transition temperature of the polymer and lower than the temperature at the beginning of melting. In the structure shown in FIG. 8, each roller 232.234 has a hemispherical concave portion 236 on its outer surface, so that when the wire 220 passes through the roller, it acquires the shape shown in FIG.

[0086] As shown in FIG. 9, the formed wire 220 has intermittent hemispherical knots 230. As shown in FIGS. 10A-10C, the mold or mold 250 can be used to form, sizing or otherwise manufacture the bidirectional holder 104 described above with reference to FIGS. 1-7 in molding and/or thorough processing. The groove 106 in the holder 104 may be produced using a mold or a mold 250, or later cut or machined into the holder 104, for example, using a blade or the like.

[0087] The aforementioned FIGS. 2A, 2B, 6A, and 6B show alternative shapes of the bidirectional holder 104. They are only used for some possible shapes of the bidirectional holder 104, not for limitation. In other words, other shapes of the bidirectional holder 104 are also possible and within the scope of the present invention.

[0088] The self-retaining suture 100 may include bidirectional retainers 104 of different sizes, which are used for various surgical purposes. For example, different holders 104 may have different diameters. A relatively larger holder is suitable for connecting fat and soft tissues, while a relatively smaller holder is suitable for connecting fibrous tissues. The use of a combination of larger, medium, and/or smaller retainers on the same suture line helps to ensure maximum anchoring properties when the retainers are sized for each tissue layer. The periodicity of the holder 104 may be random or organized. The order of appearance and the size of the group can be changed to maximize the strength of the tissue joint.

[0089] The holder 104 may be made of the same material as the suture body 102, or may be made of a different material. In a special embodiment, the retainer 104 is made of a material that has a higher spring constant (thus harder) and/or a larger plastic area (thus more permanently deformable) than the material from which the suture body 102 is made. Also, the suture body 102 may be made of a material that is more flexible and/or more elastic than the material from which the retainer 104 is made. Moreover, the retainers 104 can be made tougher than the suture body in order to withstand excessive bending forces applied to them. Alternatively, the retainer 104 and the suture body 102 can be made of the same type of material, but the retainer can be made at the time of formation.

It is rational to increase their hardness and strength, for example by a suitable annealing cycle of the holder 104 (heating to a specific temperature and cooling at a specific rate), for example using a technique similar to that described in U.S. Patent No. 5007922, which is here. Added by reference.

[0090] The retainer 104 and the suture body 102 may both be made of bioabsorbable materials, and examples of them are as described above. Alternatively, the retainer 104 and the suture body 102 may both be made of non-bioabsorbable materials, and their examples are as described above. In yet another embodiment, the retainer 104 may be bioabsorbable, while the suture body 102 is non-bioabsorbable, or vice versa. In another embodiment of the present invention, the retainer 104 and/or the suture body 102 may be partially bioabsorbable, or the plurality of retainers 104 may be bioabsorbable, and the remaining retainers 104 may not be bioabsorbable. In addition, the suture body 102 may be made of a material having a greater tensile strength than the material used to make the retainer 104, or vice versa.

[0091] C. One-way retainer

[0092] A protrusion similar to the protrusion 108 may also be arranged on the one-way holder, as shown in FIGS. 11A-11E. In FIG. 11A, the self-retaining suture 1100 includes a retainer 1104 that is tapered and includes protrusions 1108. In FIGS. 11A-11D, the protrusion 1108 protrudes from the end 1112 of the main body of the tapered holder 1104. The retainer 1104 yields to the movement of the elongated suture body in the tissue when the suture is pulled in the direction of suture deployment indicated by the arrow, and when the suture is in the direction opposite to the suture deployment direction (the direction opposite to the arrow) ) Stop movement while pulling. When the suture 1100 is pulled in the direction opposite to the arrow, the protrusion 1108 will penetrate into the patient's tissue, thereby preventing movement in the direction opposite to the arrow even further.

[0093] FIGS. 11B-11E show some variations of the holder 1104. The holder 1104 of FIG. 11B is similar to the holder 1104 of FIG. 8 but includes a larger number of protrusions 1108. FIG. 11C shows that the angle of the protrusion 1108 of the holder 1104 may be different from the angle of the wall 1114 of the tapered body of the holder 1104 (for example, approximately an obtuse angle). The holder 1104 of FIG. 11D is similar to the holder 1104 of FIG. 11C, but includes a larger number of protrusions 1108. Figure 11C also shows that the holder 1104 may include one or more vent holes 1110 in the inclined wall 1114, where the vent holes prevent air from being captured by the holder 1104 when the holder is used to pass through the patient's tissue. This is advantageous because it can be assumed that the tissue will heal faster when the air is not trapped behind the retainer 1104. Moreover, the vent is used for further anchoring with the tissue. The vent hole 1110 can be included in any holder 1104 of FIGS. 11A-11E. Ventilation can also be provided by making the tapered holder formed of a mesh, perforated or porous material. The holder 1104 of FIG. 11E includes a protrusion 1108 that protrudes from the inclined wall 1114 of the tapered body of the holder 1104. In various embodiments, the retainer 1104 yields to the movement of the elongated suture body in the tissue when the suture is pulled along the first suture deployment direction, and when the suture is drawn along the Prevent movement when pulled in a direction opposite to the suture deployment direction. When the retainers 1104 are pulled in the direction opposite to their deployment direction, the protrusions 1108 will penetrate into the patient's tissue, thereby preventing even further 35 watts in the universal direction opposite to the deployment direction).

[0094] Although the tapered holder 1104 may have a circular cross-section, the cross-section may be selected as an ellipse or some other shape. Also, it should be understood that instead of the curved inclined walls 1114, they may be polyhedral faces. Moreover, the term cone is meant to include truncated cones.

[0095] The retainers 1104 may be pre-formed and then attached to the suture body 1102 ±. In one embodiment, each retainer 1104 includes an opening 1116 therethrough. The suture body 1102 may pass through the opening 1116 of the holder 1104, and the holder 1104 may be connected to the suture body 1102 such that the holders 1104 are spaced apart from each other. The retainer may be connected to the suture body 1102 using an adhesive, thermal bonding, welding connection, solvent connection, or the like. and also

CN 102056552 Β

Optionally, the retainer 1104 may be formed as an integral part of the suture body 1102 (ie, a one-piece structure with the suture body), for example, using extrusion, molding, and/or thorough processing, for example, as described above with reference to FIGS. 8-10C Formed in a similar way to the above. [0096] The wall of the retainer 1104 is inclined, so that the retainer substantially yields to the movement of the elongated suture body in the tissue when the suture is pulled along a suture deployment direction, and when the suture is in the opposite direction to the suture deployment direction Stop movement when pulling in the direction of the direction. The self-retaining suture 1100 may be unidirectional or bidirectional. In the case of a unidirectional suture, the self-retaining suture may include: an end with a pointed tip or a needle so that it can penetrate and pass through tissue when pulled by the end; and an opposite end, which is implemented in some embodiments. Examples include anchors that are used to engage the tissue at the initial insertion point in order to limit the movement of the suture. When bidirectional, the self-retaining suture 1100 may include a group of retainers extending in one deployment direction along a part of the suture and a group of retainers extending in the opposite deployment direction along another part of the suture. Therefore, when such a two-way suture is implanted, both sets of retainers are engaged with the tissue, and the retainers can prevent movement of the suture through the tissue in either direction. Also, the bidirectional suture thread may be equipped with needles at each end of the suture thread. The bidirectional suture can also have a transition section between the two sets of retainers.

[0097] The self-retaining suture 1100 may also include retainers 1104 of different sizes, which are used for various surgical purposes. For example, different holders 1104 may have different cross-sectional diameters. A relatively larger holder is suitable for connecting fat and soft tissue, while a relatively smaller holder is suitable for connecting fibrous tissue. The use of a combination of larger, medium, and/or smaller retainers on the same suture line helps to ensure maximum anchoring properties when the retainers are sized for each tissue layer. The periodicity of the holder 104 may be random or organized. The order of appearance and the size of the group can be changed to maximize the strength of the tissue joint.

[0098] The holder 1104 may be made of the same material as the suture body 1102, or made of a different material. In a special embodiment, the retainer 1104 is made of a material that has a higher spring constant (thus harder) and/or a larger plastic area (thus more permanently deformable) than the material from which the suture body 1102 is made. Also, the suture body 1102 may be made of a material that is more flexible and/or more elastic than the material from which the holder 1104 is made. Moreover, the retainers 1104 can be made tougher than the suture body in order to withstand excessive bending forces applied to them. Alternatively, the retainer 1104 and the suture body 1102 can be made of the same type of material, but the retainer can be processed to increase their hardness and strength when formed, for example, through a suitable annealing cycle of the retainer 1104 (heated to a specific Temperature and cooling at a specific rate), for example using a technique similar to that described in U.S. Patent No. 5007922, which is hereby incorporated by reference.

[0099] The holder 1104 and the suture body 1102 may both be made of bioabsorbable materials, and examples of them are as described above. Alternatively, the retainer 1104 and the suture body 1102 may both be made of non-bioabsorbable materials, and their examples are as described above. In yet another embodiment, the retainer 1104 may be bioabsorbable, while the suture body 1102 is not bioabsorbable, or vice versa. In another embodiment of the present invention, the retainer 1104 and/or the suture body 1102 may be partially bioabsorbable, or multiple retainers 1104 are bioabsorbable, and the remaining retainers 1104 are not bioabsorbable. In addition, the suture body 1102 may be made of a material having greater tensile strength than the material used to make the holder 1104, or vice versa.

[0100] D. Materials for manufacturing self-retaining sutures

[0101] The above-mentioned suture body and retainer can be made of any suitable biocompatible material, and can be further processed by any suitable biocompatible material, whether it is to increase the strength, elasticity, longevity of the suture or Other quality requirements still make sutures equipped to achieve additional functions (except for connecting tissues together, repositioning tissues or connecting foreign materials to tissues).

[0102] The above-mentioned retainer may further include a material that further promotes tissue bonding. For example, forming the retainer from tissue engagement promoting material can improve the ability to hold the suture in place. One type of such tissue engagement promoting material is a porous polymer that can be extruded to form a suture body, including a microporous polymer, and the polymer is extruded with bubbles (whether bioabsorbable or non-bioabsorbable). absorb). The holder composed of such a material can have a three-dimensional grid structure, which increases the area of the tissue joining surface and allows the tissue to penetrate into the suture body itself, thereby having a main structure that promotes the successful use of the suture. Moreover, by optimizing the size of the hole, the growth of fibroblasts can be promoted, which further facilitates the anchoring of the retainer in the tissue. Alternatively, a fibrophilic coating or agent can be used to encourage more fibrous tissue to surround the retainer, and therefore better engage. Exemplary fibrophilic materials that can be used to form the retainer 204 and/or can be applied to the retainer to promote tissue growth are described in US Patent No. 7166570, which is titled Medicalimplants and fibrosis-inducing agents , The document is added here by reference.

[0103] One such microporous polymer is ePTFE (expanded polytetrafluoroethylene). Self-retaining sutures including ePTFE (and related microporous materials) are ideal for applications that require strong and permanent elevation (such as breast elevation, face elevation, and other tissue repositioning processes) due to the tissue penetration of the suture As a result, the fixation and movement of the suture thread and surrounding tissues is improved, so that the elevation is well maintained and the life is longer.

[0104] In addition, the self-retaining sutures described herein may be provided with ingredients for promoting healing and preventing undesirable effects (such as scar formation, infection, pain, etc.). This can be achieved in various ways, including for example: (a) by fixing the formulation directly on the suture (for example by spraying a polymer/drug film on the suture, or by immersing the suture in a polymer/drug solution) (B) by coating the suture with a substance such as a hydrogel, which in turn will absorb the components; (c) in the case of a multifilament suture by applying a formulation-coated thread (or a polymer forming thread) (The object itself) is interwoven in the suture structure; (d) by inserting the suture into a sleeve or net that includes or is coated with a formula; or (e) the suture itself is composed of components. Such components may include, but are not limited to: anti-proliferative agents, anti-angiogenic agents, anti-infective agents, fiber attractants, anti-scarring agents, smoothing agents, echogenic agents [J, anti-inflammatory agents, cell cycle inhibitors , Analgesics and anti-microtubule agents. For example, the composition may be applied to the suture before forming the retainer, so that when the retainer is engaged, the engaging surface is substantially uncoated. Likewise, when the suture is introduced, the sutured tissue is in contact with the coated surface of the suture, but when the retainer is engaged, the uncoated surface of the retainer is in contact with the tissue. You can also choose when you want to coat completely instead of choosing When the suture is selectively coated, the suture may be coated after the retainer is formed on the suture or during the formation process. In yet another alternative embodiment, the suture thread may be selectively coated during or after the formation of the retainer by allowing only selected portions of the suture thread to be coated. The special purpose of the suture to be used or the special purpose of the components can determine whether full coating is appropriate or selective coating is appropriate: for example, for a smooth coating, it may be desirable to selectively coat the suture, for example to make stitching The tissue-engaging surfaces of the thread are uncoated in order to prevent damage to the tissue-engaging function of these surfaces. On the other hand, a coating including a component such as an anti-infective agent may be suitably applied on the entire suture, and a coating including a component such as a fiber forming agent may be suitably applied on all or part of the suture (such as tissue bonding surface). The purpose of the suture can also determine the type of coating applied to the suture: for example, a self-retaining suture with an anti-proliferation coating can be used to close the tumor resection, while a self-retaining suture with a fiber-forming coating can It is used in the tissue for repositioning processes, while self-retaining sutures with anti-scar coating can be used for wound closure on the skin. Also, the structure of the suture can affect the choice and scope of the coating; for example, a suture with an expanded section may include a fiber-forming attractant component on the expanded section to further fix the section in place in the tissue. The coating can also include multiple components, which These components together, or in different parts of the suture, where multiple components can be selected for different purposes (such as a combination of analgesics, anti-infectives, and anti-scarring agents), or for their synergistic effects .

CN 102056552 Β

[0105] Ε. Clinical use

[0106] In addition to the general wound closure and soft tissue repair applications described in the previous section, self-retaining sutures can be used for a variety of other indications.

[0107] The self-retaining sutures described herein can be used in various dental treatment processes, that is, oral and maxillofacial surgical treatments, so they can be referred to as "self-retaining dental sutures." The above-mentioned treatment procedures include but are not limited to: oral surgery (such as removal of impacted or damaged teeth), surgery to provide bone enlargement, surgery to repair tooth and face deformation, repair of underlying trauma (such as facial bone fractures and injuries) ), surgical treatment of dentin and non-dentin trauma, reconstructive surgery, repair of cleft lip or palate, congenital craniofacial deformation, and facial sensation surgery. Self-retaining dental sutures can be degradable or non-degradable, and the size range can generally be from USP 2-0 to USP 6-0.

[0108] The self-retaining sutures described herein can also be used in tissue repositioning surgical procedures, and therefore can be referred to as "self-retaining tissue repositioning sutures." Such surgical procedures include, but are not limited to: face lift, neck lift, eyebrow lift, thigh lift, and chest lift. The self-retaining sutures used in the tissue repositioning process may vary according to the repositioned tissue; for example, sutures with larger and more spaced retainers may be suitably used for relatively soft tissues, such as adipose tissue.

[0109] The self-retaining suture thread described herein can also be used for microsurgery procedures performed under a surgical operating microscope (hence it can be referred to as "self-retaining micro suture thread"). Such surgical procedures include but are not limited to: reattachment and repair of peripheral nerves, spinal microsurgery, hand microsurgery, various plastic microsurgery procedures (such as face reconstruction), male or female Microsurgery of the reproductive system and various reconstruction microsurgery. When other options (such as initial closure, auxiliary purpose healing, skin grafting, local flap delivery, and distal flap delivery) are inappropriate, microsurgical reconstruction is used to solve complex reconstructive surgical problems. The self-retaining micro suture thread has a very small caliber, usually as small as USP 9-0 or USP 10-0, and can be connected with a needle of a corresponding size. They can be degradable or non-degradable.

[0110] The self-retaining sutures described herein can be used in ophthalmic surgical procedures in a similarly small-caliber range, so they are called "eye self-retaining sutures." Such procedures include but are not limited to: keratoplasty, cataract and various vitreous retinal microsurgery procedures. The eye self-retaining suture can be degradable or non-degradable, and is connected with a corresponding small-diameter needle.

[0111] Self-retaining sutures can be used in various veterinary applications for many surgical and trauma treatment purposes for animal rehabilitation.

[0112] Although the embodiments of the present invention have been shown and described in detail through several exemplary embodiments of the present invention, those skilled in the art should know that it does not limit the present invention to the specific embodiments described herein. Without essentially departing from the novel teachings and advantages of the present invention, particularly in accordance with the foregoing teachings, various changes, omissions, and additions can be made to the described embodiments. Therefore, it will cover all these changes, omissions, additions and equivalents, which may be included in the scope of the present invention as determined by the following claims.