SELF-RETENTION SUTURE SYSTEM AND METHOD FOR MANUFACTURING A SELF-RETENTION SUTURE SYSTEM

专利摘要:
self-retaining suture and method for fabricating a self-retaining suture system. the present invention relates to a suture having a first end for penetration into the tissue, an elongated suture body having a periphery; a plurality of retainers at the periphery, and a second end having a variable loop of varying circumference, wherein the variable loop includes a fixed loop that slidably engages the elongated body to slide the circumference of the variable loop, and in that the first end can pass through the variable loop to hold the tissue as an anchor, the anchor preventing movement of the suture in the direction of positioning the first end.
公开号:BR112013024303B1
申请号:R112013024303-1
申请日:2012-03-23
公开日:2020-12-15
发明作者:Jeffrey M. Gross；Lev Drubetsky；William L. D'agostino；William L. Hunter
申请人:Ethicon Llc；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED ORDER
[0001] This application claims the benefit over 35 USC §119 (e) of Provisional Patent Application No. US 61 / 466,924, filed on March 23, 2011, whose application is hereby incorporated by reference, in its entirety . FIELD OF THE INVENTION
[0002] The present invention relates, in general, to sutures, including self-retaining sutures and unidirectional self-suturing sutures, suture manufacturing methods, and their use in wound repair and surgical procedures. BACKGROUND OF THE INVENTION
[0003] Wound closure devices, fittings, staples and pins have been widely used in superficial and deep surgical procedures in humans and animals for wound closure, repair of traumatic injuries or defects, joining tissues together (bringing together the separate tissues, closing an anatomical space, fixing layers of single or multiple tissues, creating an anastomosis between two hollow / luminous structures, adjacent tissues, fixation or fixation of tissues in their correct anatomical location), fixation of foreign elements to the tissues (apposition of medical implants, devices, prostheses and other functional or supportive devices), and for repositioning tissues in new anatomical locations (repairs, tissue elevations, tissue grafting and related procedures), to name just a few examples.
[0004] Sutures are often used as devices for closing wounds. Sutures typically consist of a filamentary suture thread attached to a needle with a sharp tip. Suture threads can be made from a wide variety of materials including bioabsorbable materials (which decompose completely in the body over time) or non-absorbable materials (permanent, non-degradable). It has been observed that absorbable sutures are particularly useful in situations where suture removal could impair repair or when the natural healing process makes the support provided by the suture material unnecessary after the wound has completed healing; as, for example, when finishing a skin closure without complications. Non-degradable (non-absorbable) sutures are used on wounds where healing can be expected to take a long time or where suture material is needed to provide physical support to the wound over long periods of time; such as, for example, deep tissue repairs, high-tension wounds, many orthopedic repairs and some types of surgical anastomoses. Also, a wide variety of surgical needles is available; the shape and size of the needle body and the needle tip configuration are typically selected based on the needs of the particular application.
[0005] To use a simple suture, a suture needle is advanced through the desired tissue on one side of the wound and then through the adjacent side of the wound. The ends of the sutures are then placed in close proximity to each other and then fastened together, for example, by tying a knot in the suture to keep the wound closed. Tying the knot takes time and causes a number of complications, including, but not limited to (i) squirt, a condition in which the suture, usually a knot, pushes the skin after a subcutaneous closure), ( ii) infection (bacteria are often able to attack and grow in spaces created by a node), (iii) batch / mass (a significant amount of suture material left in a wound is the portion that comprises the node), (iv) slip (the knots may slip or come loose), and (v) irritation (knots serve as a "foreign body" mass in the wound). The suture ties associated with knot tying can lead to ischemia (the knots can create tension points that can strangle the tissue and limit blood flow to the region) and increase the risk of dehiscence or rupture in the wound. Tying the knot is also labor intensive and can comprise a significant percentage of the time it takes to close a surgical wound. Additional operating procedure time is not only bad for the patient (complication rates increase with time spent on anesthesia), but also contributes to the total cost of the operation (many surgical procedures are estimated at between $ 15 and $ 30 per minute of operating time).
[0006] Self-retaining sutures (including barbed sutures) differ from conventional sutures in that self-retaining sutures have numerous tissue retainers (such as splinters) that anchor the self-retaining suture in a tissue after positioning and resist movement of the suture in the direction opposite to the ones that the retainers are facing, thus eliminating the need to tie the knots to fix the adjacent fabrics together (a "knotless" closure). Knotless tissue approximation devices that have splinters have previously been described in, for example, US Patent No. 5,374,268, featuring reinforced anchors that have splinter-like projections, while sets of sutures that have barbed side members have been described. in US Patent Nos. 5,584,859 and 6,264,675. Sutures that have a plurality of barbs positioned along a larger portion of the suture are described in US Patent No. 5,931,855, which features a unidirectional barbed suture, and US Patent No. 6,241,747, which features a bidirectional barbed suture. . Barb splitting methods and apparatus have been described in, for example, US Patent No. 6,848,152. Self-retaining systems for wound closure also result in a better approximation of the wound ends, evenly distributes the tension along the length of the wound (reducing the areas of tension, which can break or cause ischemia), decrease most of the wound material. suture that remains in the wound (eliminating the knots) and reduces spitting (the extrusion of a suture material - typically knots - across the surface of the skin). All of these features are designed to reduce the formation of scars, improve cosmesis, and increase wound resistance in relation to wound closure with simple sutures or staples. Thus, self-retention of sutures, since such sutures prevent knot tying, allows patients to experience a better clinical outcome, and also saves time and costs associated with prolonged surgery and follow-up treatments. It is noted that all patents, patent applications and patent publications identified throughout the present description are hereby incorporated by reference in their entirety.
[0007] The ability of the self-retaining sutures to anchor and fix the tissues in place, even in the absence of tension applied to the suture by a knot, is a feature that also provides superiority over simple sutures. When closing a wound that is under tension, this advantage manifests itself in several ways: (i) self-retaining sutures have a multiplicity of fasteners, which can dissipate the tension along the entire length of the suture (providing hundreds of " anchor points "that produce a superior cosmetic result and decrease the chance that the suture will" slide "or be pulled through) as opposed to sutures interrupted by a knot that concentrate tension at different points; (ii) complicated wound geometries can be closed (circles, arcs, uneven edges) evenly with more precision and accuracy than those obtained with interrupted sutures; (iii) self-holding sutures eliminate the need for a "third hand", which is often necessary to maintain tension throughout the wound during traditional suturing and knot tying (to prevent "slipping" when the tension is released momentarily during mooring); (iv) self-retaining sutures are superior in procedures where knot tying is technically difficult, such as, for example, in deep wounds or laparoscopic / endoscopic procedures; and (v) self-retaining sutures can be used to approximate and fix the wound before definitive closure. As a result, self-retaining sutures provide easier handling in anatomically tight or deep locations (such as the pelvis, abdomen and chest) and facilitate the approximation of tissues in laparoscopic / endoscopic and minimally invasive procedures; all without having to hold the knot closed. Greater precision allows the self-retaining sutures to be used in more complex closure systems (such as those with unpaired diameters, larger defects or pouch thread sutures) that can be performed with simple sutures.
[0008] The self-retaining suture can be unidirectional, which has one or more retainers oriented in one direction along the length of the suture; or bidirectional, typically having one or more retainers oriented in one direction along one portion of the thread, followed by one or more retainers oriented in another (often opposite) direction over a different portion of the thread (as described in relation to the retainers barbed wire in US Patent Nos. 5,931,855 and 6,241,747). While any number of sequential or intermittent retainer configurations is possible, a common form of self-retaining suture involves a needle at one end of a suture thread that has barbed ends that project "in the opposite direction" of the needle. Projecting "in the opposite direction" of the needle means that the tip of the retainer is farthest from the needle and the portion of the suture comprising the suture can be pulled more easily through the tissue in the direction of the needle than in the opposite direction. Examples of various retainer configurations are described, for example, in US patent application publications No. 20040060409, 20040060410, 20080255611 and 20100087855. In addition, self-retaining sutures having high density retainer configurations are described in the patent application. US serial number 61 / 329,436.
[0009] Unidirectional self-retaining sutures and their uses have been described in several publications as mentioned above. Various unidirectional sutures with anchors having loop elements have been described in, for example, patent application publications No. 20050267531, 20040060410, 20080255611 and 20100063540. SUMMARY
[00010] It is desirable in some applications to use unidirectional sutures that, at their rear ends, have anchors configured to resist tensions more effectively and effectively prevent movement when the suture is installed in the tissue. It is also desirable, in some applications, to provide unidirectional sutures with anchors that, when installed in the fabric, have a minimum amount of anchor material entering the fabric in addition to a minimum amount of anchor material remaining outside the fabric. As such, it is desirable to provide improved unidirectional self-retaining sutures that have a better ability to anchor the surrounding tissue, improved tissue holding capacity, enhanced maximum load and improved clinical performance.
[00011] The present invention provides improved unidirectional self-retaining sutures that have a better ability to anchor the surrounding tissue, improved tissue holding capacity, improved maximum load and improved clinical performance.
[00012] In some embodiments of the present invention, a self-retaining suture is provided that has a first end for penetrating the tissue, an elongated suture body that has a periphery, a first plurality of retainers on the periphery of the elongated and oriented body first end, in which the first plurality of retainers yield towards the suture body during movement of the suture through the tissue in a direction of positioning the first end and resist the movement of the suture, when in the tissue, in a direction substantially opposite to the direction of placement of the first end, and a second end that has a variable loop of varying circumference. The variable loop includes a fixed loop slidably interconnected to the elongated body so that the circumference of the variable loop can be changed by sliding the fixed loop along the elongated body and the first end can pass through the variable loop to secure the fabric as a anchor, where the anchor prevents movement of the suture in the direction of positioning the first end.
[00013] In some of these modalities, at least one of the retainers of the first plurality may be different in configuration from other retainers of the first plurality.
[00014] In some of these modalities, the cross section of the elongated suture body may be non-circular. In some modalities in which the elongated suture body has non-circular cross sections, the cross section can be polygonal.
[00015] In some of these modalities, the first end is adapted to penetrate the tissue, while in other of these modalities the first end is attached to a needle.
[00016] In some of these modalities, the suture may have a surface feature in at least part of the elongated body periphery between the fixed loop and the first plurality of retainers, in which the surface feature resists the sliding of the fixed loop in relation to the surface feature. In some modalities including surface features, the surface feature is arranged at least on the circumference of the variable loop.
[00017] In some modalities that have surface features, the suture feature may include sanding, corrugation, corrugations, grooves or other textures, while in other modalities, the surface feature may include a second plurality of retainers that are oriented in the opposite direction of the first end and thus provide resistance to sliding of the fixed loop in relation to them. In some of these embodiments in which the surface features include a second plurality of retainers, at least some of the second plurality retainers may be different in configuration from the first plurality retainers.
[00018] In some embodiments of the invention, the fixed loop has an internal cross-sectional length that is at least about the same cross-sectional length as the suture cross-section and can be up to ten times the cross-sectional length of the suture cross-section. In some of these modalities, the internal cross-sectional length of the fixed loop can be up to four times the cross-sectional length of the suture cross-section, while in other of these modalities it can be up to ten times the cross-sectional length of the suture cross-section. In most other of these modalities, the internal cross-sectional length of the fixed loop can be about one and a half times the cross-sectional length of the suture cross-section at about ten times the cross-sectional length of the suture cross-section, while in others it can be about one and a half times the cross section of the suture cross section at about four times the cross section of the suture cross section. In others, it may be about twice the cross-sectional length of the suture cross section to about three times the cross-sectional length of the suture cross section.
[00019] In some embodiments of the invention, the fixed loop may include a domain engaging element or a visible or tactile marking.
[00020] In some embodiments of the present invention, a self-retaining suture is provided that has a first end for penetrating the tissue; an elongated suture body having a periphery and a cross section, the cross section having a transverse length; a first plurality of retainers on the periphery of the elongated body and which is oriented towards the first end, the first plurality of retainers facing the suture body during movement of the suture through the tissue in a direction of positioning the first end, and resists the movement of the suture, when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; a second end that has a variable loop of varying circumference. The variable loop includes a fixed loop slidably interconnected to the elongated body so that the circumference of the variable loop can be changed by sliding the fixed loop along the elongated body and the first end can pass through the variable loop to secure the fabric as a third anchoring loop in the tissue, where the anchoring loop prevents movement of the suture in the direction of positioning the first end.
[00021] In some embodiments of the present invention, a self-retaining suture is provided that has a first end for penetrating the tissue; an elongated suture body having a periphery and a cross section, the cross section having a transverse length; a first plurality of retainers on the periphery of the elongated body and which is oriented towards the first end, the first plurality of retainers facing the suture body during movement of the suture through the tissue in a direction of positioning the first end, and resists the movement of the suture, when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; a second end that has a sliding knot, which includes a loop of variable circumference so that the loop circumference can be changed by sliding the sliding knot and the first end can pass through the variable loop to secure the fabric as an anchor to prevent the movement of the suture in the direction of positioning the first end.
[00022] In some embodiments of the present invention, a self-retaining suture is provided that includes a first end for penetrating the tissue; an elongated suture body having a periphery and a cross section, the cross section having a transverse length; a first plurality of retainers on the periphery of the elongated body and oriented towards the first end, the first plurality of retainers facing the suture body during the movement of the suture through the tissue in a positioning direction of the first end and resists the movement of the suture. suture when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; and a second end having a sliding knot, wherein the sliding knot includes a loop of variable circumference. Sliding the sliding knot changes the circumference of the loop and the first end can pass through the loop to secure the tissue, thus creating an anchoring loop in the tissue to prevent movement of the suture in the direction of positioning the first end.
[00023] In some embodiments of the present invention, a self-retaining suture is provided that includes a first end to penetrate the tissue; an elongated suture body that has a periphery and a cross section, the cross section having a transverse length (tl); a first plurality of retainers on the periphery of the elongated body and oriented towards the first end, the first plurality of retainers facing the suture body during the movement of the suture through the tissue in a positioning direction of the first end and resists the movement of the suture. suture when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; and a second end that has a variable loop of variable circumference, where the variable loop includes a fixed loop that has an internal transverse length (TL) and is slidably interconnected to the elongated body, so that the loop circumference can be changed by sliding the sliding knot. The TL: tl ratio is about 1: 1 to about 10: 1. The first end can pass through the variable loop to secure the tissue as an anchor to prevent movement of the suture in the direction of positioning the first end.
[00024] In any embodiments of the invention's self-retaining suture, the suture may additionally include a therapeutic agent.
[00025] The present invention further provides clinical methods and procedures activated by these improved small diameter self-retaining sutures.
[00026] In one embodiment, a method for suturing tissue is presented, in which the method comprising (a) providing a suture attached to a suture needle, in which a portion of the suture forming a loop has a circumference adjustable; (b) placing the thread on the needle through the loop; and (c) positioning the needle through a patient's tissue and bringing the tissue closer to the suture thread. Optionally, one or more of the following statements may also describe this modality: the loop comprises the suture and a fixed loop, in which the fixed loop has an opening through which the suture passes to form the loop that has an adjustable circumference; the fixed loop and any means by which the fixed loop is formed or attached to the suture, all placed on a surface of the tissue after the tissue has been completely brought together; the loop circumference is adjusted to a desired value before placing the thread on the needle through the loop; the loop circumference is adjusted to a desired value after placing the thread on the needle through the loop; the loop circumference is adjusted to a desired value in the range of 1.27 to 7.62 cm (0.5 to 3 inches); the loop circumference is reduced to a desired value; the needle is passed through and then removed from the fabric at the first and second locations, respectively, before being threaded through the loop; the suture thread comprises tissue retainers; the suture comprises cuts in the suture, where the cuts form the tissue retainers where optionally a cut is in a single plane or in two planes; a cut in the suture provides a barb in which the barb is a tissue retainer and there are a plurality of cuts in the suture; tissue retainers are present in a portion of the suture that forms the loop that has an adjustable circumference; tissue retainers are absent in a portion of the suture that forms the loop that has an adjustable circumference.
[00027] In another embodiment, a method of anchoring a suture in a patient's tissue location is presented, in which the method comprises: (a) providing a suture with an eyelet, the suture attached to a suture needle at a positioning end of the suture; (b) implant the suture needle into the tissue at the site, and then remove the suture needle from the tissue at an exit point; (c) crossing the needle through a loop comprising suture, the loop having a variable circumference; (d) applying tension to the suture by pulling on the positioning end of the suture; (e) thus providing an anchor at the top of the fabric, where the anchor comprises the eyelet, the loop and a portion of the suture, where the anchor resists the movement of the suture towards the positioning end of the Suture thread.
[00028] Details of one or more modalities are presented in the description below. Other characteristics, objectives and advantages will be apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS
[00029] The characteristics of the invention, and the nature of the various advantages of it, will be apparent from the accompanying drawings and the detailed description below of the various modalities of the invention.
[00030] Figures 1A and 1C are seen from a variable loop self-retaining suture according to an embodiment of the present invention.
[00031] Fig. 1B is a cross-sectional view of the naFig suture. 1A, taken along the line in Fig. 1A which is marked "1B".
[00032] Fig. 2 is a view of a variable loop self-retaining suture according to another embodiment of the present invention.
[00033] Fig. 3 is a view of a variable loop self-retaining suture according to another embodiment of the present invention, which has a needle at its positioning end.
[00034] Figures 4A and 4B are a method of using a variable loop self-retaining suture according to an embodiment of the present invention.
[00035] Fig. 5A is a view of the variable loop portion of a self-retaining suture according to an embodiment of the invention, illustrating a visible demarcation of the fixed loop.
[00036] Fig. 5B is a view of the variable loop portion of a self-holding suture according to a modality of the invention, illustrating a surface feature of the modality.
[00037] Fig. 5C is a view of the variable loop portion of a self-holding suture according to a modality of the invention, illustrating a surface feature of that modality.
[00038] Fig. 5D is a view of the variable loop portion of a self-retaining suture according to one embodiment of the invention, illustrating a surface feature of that embodiment.
[00039] Fig. 6A is a view of the variable loop portion of a self-holding suture according to one embodiment of the invention, illustrating a visible demarcation of the fixed loop of that embodiment.
[00040] Fig. 6B is a view of the variable loop portion of a self-retaining suture according to another embodiment of the invention, illustrating a domain engaging element of that embodiment.
[00041] Fig. 6C is a view of the variable loop portion of a self-holding suture in accordance with yet another embodiment of the invention, illustrating a domain engaging element of that embodiment.
[00042] Fig. 7 is a view of the variable loop portion of a self-holding suture in accordance with yet another embodiment of the invention, illustrating a fixed loop configuration of that embodiment.
[00043] Fig. 8 is a view of the variable loop portion of a self-retaining suture according to yet another embodiment of the invention, illustrating another configuration of a fixed loop of this embodiment.
[00044] Fig. 9 is a view of the variable loop portion of a self-holding suture according to yet another embodiment of the invention, illustrating yet another configuration of a fixed loop of this embodiment. DETAILED DESCRIPTION DEFINITIONS
[00045] Definitions of certain terms that can be used in the present invention include the following.
[00046] The term "armed suture" refers to a suture that has a suture needle in at least one suture positioning end.
[00047] "Braided suture" refers to a suture comprising a multifilament suture. The filaments in these sutures are typically twisted, twisted, or woven together.
[00048] "Degradable suture" (also called "biodegradable suture" or "bioabsorbable suture") refers to a suture that, after being introduced into a tissue, is decomposed and absorbed by the body. Typically, the degradation process is at least partially mediated by, or performed in, a biological system. The term "degradation" refers to a chain-splitting process by which a polymeric chain is cleaved into oligomers and monomers. Chain splitting can occur through a variety of mechanisms, including, for example, by chemical reaction (for example, hydrolysis, oxidation / reduction, enzymatic mechanisms or a combination of these) or by a thermal or photolytic process. The degradation of the polymer can be characterized, for example, using gel permeation chromatography (GPC), which monitors changes in the molecular weight of the polymer during erosion and degradation. The degradable suture material may include polymers such as polyglycolic acid, copolymers of glycolide and lactide, copolymers of trimethylene carbonate and glycolide with diethylene glycol (eg MAXON ™, Tyco Healthcare Group), terpolymer composed of glycolide, trimethylene carbonate and dioxanone (eg BIOSYN ™, [glycolide (60%), trimethylene carbonate (26%) and dioxanone (14%)], Tyco Healthcare Group), glycolide copolymers, caprolactone, trimethylene carbonate and lactide (eg CAPROSYN ™, Tyco Healthcare Group). These sutures can be either in a braided multifilament form or in a monofilament form. The polymers used in the present invention can be linear polymers, branched polymers or multiaxial polymers. Examples of multiaxial polymers used in sutures are described in US Patent Application Publications No. 20020161168, 20040024169 and 20040116620. Sutures produced from degradable suture material lose tensile strength as the material degrades.
[00049] The term "medical device" or "implant" refers to any object placed on the body for the purpose of restoring physiological function, reducing / relieving symptoms associated with a disease, and / or repairing / replacing organs and tissues damaged or diseased. While normally composed of biologically compatible synthetic materials (for example, medical grade stainless steel, titanium and other metals: polymers such as polyurethane, silicon, PLA, PLGA and other materials) that are exogenous, some medical devices and implants include materials derived from animals (e.g. "xenografts" as whole animal organs; animal tissues such as heart valves; naturally occurring or chemically modified molecules such as collagen, hyaluronic acid, proteins, carbohydrates and others), human donors ( for example, "allografts" as whole organs; tissues such as bone grafts, skin grafts and others), or from the patients themselves (for example, "autografts" such as saphenous vein grafts, skin grafts, tendon / ligament / muscle transplants) ). Medical devices that can be used in procedures in connection 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 (arterial vascular grafts and hemodialysis access grafts); both autologous and synthetic), skin grafts (autologous, synthetic), tubes, drains, volume forming agents for implantable tissue, pumps, taps, sealants, surgical nets (for example, hernia repair nets, tissue supports) , fistula treatments, spinal implants (for example, artificial intervertebral discs, spinal fusion devices, etc.).
[00050] "Monofilament suture" refers to a suture comprising a monofilament suture.
[00051] "Needle fixation" refers to the fixation of a needle in a suture that requires the same placement in the fabric, and can include methods such as crimping, stranding, use of adhesives, and so on. The connection point between the suture and the needle is known as pinching.
[00052] "Needle diameter" refers to the diameter of a positioning needle in the suture at a point wider than the needle. Although the term "diameter" is often associated with a circular periphery, it should be understood in the present invention as indicating a cross-sectional dimension associated with a periphery of any shape. The dimension is the longest dimension between two points on the periphery of the shape, that is, the distance between the two points on the periphery that are farthest from each other.
[00053] The term "non-degradable suture" (also called "non-absorbable suture") refers to a suture that comprises material that is not degraded by chain splitting, such as chemical reaction processes (for example, hydrolysis, oxidation / reduction, enzymatic mechanisms or a combination of these) or by a thermal or photolytic process. Non-degradable suture materials include polyamide (also known as nylon, such as nylon 6 and nylon 6.6), polyester (eg, polyethylene terephthalate), polytetrafluoroethylene (eg, expanded polytetrafluoroethylene), polyether as a polybutester (block copolymer) of butylene terephthalate and polytetra methylene ether glycol), polyurethane, metal alloys, metal (for example, stainless steel wire), polypropylene, polyethylene, silk, and cotton. Sutures produced from non-degradable suture material are particularly suitable for applications where the suture is intended to be permanent or to be physically removed from the body.
[00054] The term "retainer configurations" refers to fabric retainer configurations and may include characteristics such as size, shape, surface characteristics and so on. They are sometimes called "barbed configurations".
[00055] The term "self-retaining suture" refers to a suture that does not require a knot or anchor on at least one of its ends in order to maintain the position in which it was installed during a surgical procedure. These can be monofilament sutures or braided sutures and are positioned in the tissue in two stages, namely, positioning and fixation, and include at least one tissue retainer.
[00056] The term "self-holding system" refers to a self-holding suture together with means for positioning the suture in the tissue. Such positioning means include, but are not limited to, suture needles and other positioning devices as well as sufficiently rigid and pointed ends on the suture itself to penetrate tissue.
[00057] The term "end for positioning the suture" refers to an end of the suture to be positioned in the tissue. A positioning means such as a suture needle can be located at the positioning end of the suture, or the suture thread can be formed in a sufficiently sharp and rigid structure to penetrate the tissue itself, where that acute and rigid structure is located at the positioning end of the suture.
[00058] The term "suture diameter" refers to the diameter of the suture body when viewed in cross section. Although the term "diameter" is often associated with a circular periphery, it should be understood in the present invention as indicating a cross-sectional dimension (or distance, or length) associated with a periphery of any shape. For a non-circular shape, the diameter is the longest distance between any two points on the periphery of a cross section, which can also be called the distance in cross section. The cross-sectional shape of the suture body or thread is seen at a location along the suture where there are no splinters, or the splinters that are present are pushed against the suture body so that they are level with the surface of the suture body. In one embodiment, the suture or thread body has a generally circular shape in cross section. While the suture body can have a circular or generally circular cross-sectional shape, the cross-sectional shape can be non-circular, for example, it can be polygonal, for example, with 3 (triangular), 4, 5 or 6 sides ( hexagonal). The cross section of the suture body may have an oval, ellipsoidal, oblong or semicircular appearance. The size of the suture is based on the diameter. The American Pharmacopoeia ("USP") designation of the suture size ranges from 0 to 7 in the largest range and from 1-0 to 11-0 in the smallest range; in the shortest interval, the higher the value that precedes the hyphenated zero, the smaller the suture diameter. According to the USP nomenclature system, the actual diameter of a suture will depend on the material of the suture, so that, for example, a suture of size 5-0 and produced from collagen will have a diameter of 0.15 mm, while sutures having the same USP size designation but made of an absorbable synthetic material or non-absorbable material will each have a diameter of 0.1 mm. The selection of the suture size for a specific purpose depends on factors such as the nature of the tissue to be sutured and the importance of cosmetic care; while smaller sutures can be more easily manipulated through restricted surgical sites and are associated with less scarring, the tensile strength of the suture made from a given material tends to decrease with decreasing size. It should be understood that the sutures and methods for making the sutures presented herein are suitable for a variety of 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.It should be understood that a variety of lengths of suture can be used with the sutures described here.
[00059] "Suture needle" refers to needles used to position the sutures in the fabric, which are available in many formats, shapes and compositions. There are two main types of needles, traumatic needles and atraumatic needles. Traumatic needles have perforated grooves or ends (ie, holes or eyes) that are supplied separately from the suture and are threaded in place. Atraumatic needles have no holes and are attached to the suture at the factory by pinching, in which the suture material is inserted into a channel at the blind end of the needle which is then deformed to a final shape that holds the suture and needle together. In this way, atraumatic needles do not require additional time at the site to pass the thread and the end of the suture at the needle fixation site is smaller than the needle body. In the traumatic needle, the thread exits the needle hole on both sides and the suture often tears the tissue to a certain extent when it passes through it. More modern sutures are embedded with atraumatic needles. Atraumatic needles can be permanently embedded in the suture or can be designed to come out of the suture in a straight, sharp motion. These "pop-offs" are commonly used for interrupted sutures, where each suture is only passed once and then tied. For barbed sutures, which are uninterrupted, these atraumatic needles would be ideal. Suture needles can also be classified according to their stitch geometry. For example, needles can be (i) "tapered" so that the needle body is round and tapers slightly to a point; (ii) "cut" so that the needle body is triangular and has a sharp cutting edge inside; (iii) "Reverse cut" so that a cutting edge is on the outside; (iv) "trocar point" or "narrow cut" so that the needle body is round and tapered, but ends at a small triangular cut point; (v) "Blind" stitches for sewing friable fabrics; (vi) "Side cut" or "Spatula points" so that the needle is horizontal at the top and bottom with the cut end along the front to one side (These are typically used in eye surgery). Suture needles can also be of various shapes including, (i) straight, (ii) half curved or ski, (iii) 1/4 circle, (iv) 3/8 circle, (v) 1/2 circle , (vi) 5/8 circle, (v) and compound curve. Suture needles are described, for example, in US patents 6,322,581 and 6,214,030 (Mani, Inc., Japan); and 5,464,422 (W.L. Gore, Newark, DE, USA); and 5,941,899; 5,425,746; 5,306,288 and 5,156,615 (US Surgical Corp., Norwalk, CT, USA); and 5,312,422 (Linvatec Corp., Largo, FL, USA); and 7,063,716 (Tyco Healthcare, North Haven, CT, USA). Other suture needles are described, for example, in US Patent Nos. 6,129,741; 5,897,572; 5,676,675; and 5,693,072. The sutures described here can be installed with a variety of types of needles (including without limitation curved, straight, long, short, micro, and so on), the needle cutting surfaces (including without limitation, cut, tapered, and and so on), and needle fixation techniques (including without limitation, pierced, crimped ends, and so on). In addition, the sutures described herein may include ends that are sufficiently rigid and sharp to dispense the need for positioning the needles together.
[00060] The term "suture thread" refers to the filamentous body component of the suture and, for sutures that require needle placement, does not include the suture needle. The suture may be monofilamentous, that is, formed of a single filament, or multifilamentous, that is, formed of a combination of two or more filaments, for example, three filaments arranged in a braided manner. The terms "filament" and "filamentous" are used in the common sense, to refer to a long, thin structure, so in many instances of the present invention the suture is also identified as the elongated body or elongated suture body, where these terms are interchangeable. The filamentary suture has a length that is often its diameter, and in various embodiments the suture has a length that is at least 5 times, or at least 10 times, or at least 20 times, or at least 30 times , or at least 40 times, or at least 50 times the wire diameter. In fact, the length of the suture may even be at least 100 times the diameter of the suture. In addition to being filamentous, the suture is highly flexible. In other words, the thread will flex in any direction as the surgeon moves the suture through the patient's tissue. The yarn may have some memory of its storage condition, for example, if the yarn has been stored for a long period in a rolled-up circular shape, it may tend to return to that shape even after it has been released from its storage container and unrolled. However, the thread will always follow the needle to which it is attached along any path that the needle goes through and around the tissue or an injury. The yarn can therefore be described as flexible or malleable. Put another way, any two adjacent segments of the suture can be placed, in relation to each other, at any angle from essentially or close to 0 (where the two segments are bent backwards, one over the other) at 180 degrees (where the two segments go together along a single straight line). The suture thread has a length, in which that length is typically at least 12.7 cm, or at least 25.4 cm, or at least 38.1 cm or at least 50.8 cm (5 inches, or minus 10 inches, or at least 15 inches, or at least 20 inches). The suture typically will have two ends, which can be described as a positioning end and / or an end end. In this case, the positioning end of the suture is the end that will first enter the tissue, usually being in a position adjacent to a needle, while the end end of a suture would be the end of the thread that is not the positioning end. .
[00061] "Tissue lifting procedure" refers to a surgical procedure to reposition the tissue from a lower height to a higher height (that is, moving the tissue in a direction opposite to the direction of gravity). The retention ligaments of the face support the soft tissue of the face in a normal anatomical position. However, with age, the gravitational effects pull that tissue down and the underlying ligaments, and the fat descends to the plane between the superficial and deep facial fascia, thus allowing the tissue to arch. Facial plastic surgery procedures (face-lift) are designed to lift flabby tissues, and are yet another example of a class of medical procedures commonly known as tissue elevation processes. More generally, a tissue elevation procedure reverses the change in appearance resulting from the effects of gravity over time, and other temporal effects that cause the tissue to become limp, such as genetic effects. It should be noted that the fabric can also be repositioned without lifting; in some procedures, the tissues are repositioned laterally (away from the midline), medially (towards the midline) or lower (lowered) in order to restore symmetry (that is, repositioned so that the left and right sides) right of the body "coincide").
[00062] The term "tissue retainer" or simply "retainer" refers to a suture element having a retaining body that protrudes from the suturing body and a retaining end adapted to penetrate the tissue; an example of a tissue retainer is a splinter. Each retainer is adapted to resist movement of the suture in a direction other than the direction in which the suture is installed in the tissue by the physician, and is substantially oriented in the direction of positioning (that is, they flatten when pulled in the direction of positioning, and open or "spread out" when pulled in a direction contrary to the positioning direction). As the penetrating end of the fabric of each retainer points away from a positioning direction when moving through the fabric during placement, the fabric retainers must not grab or grip the fabric during this phase. Once the self-holding suture has been positioned, a force exerted in another direction (often substantially opposite the positioning direction) causes the retainers to be displaced from their positioning position (that is, toward or resting substantially along suture body), forces the ends of the retainer to open (or "spread") from the suture body in a way that grabs, penetrates the surrounding tissue and results in the tissue getting trapped between the retainer and the suture, "anchoring" or affixing the self-holding suture in place.
[00063] The term "unidirectional suture" refers to a suture having a positioning end, a final end and retainers oriented towards the positioning end. The final end can be used to prevent the suture from moving out of the tissue in the direction of positioning, having a knot tied to it or having an anchoring element that remains out of the point on the tissue where the suture tipping end was initially inserted. In contrast, a bidirectional suture has retainers oriented in one direction at one end and retainers oriented in the other direction at the other end. A bidirectional suture is typically armed with a needle at each end of the suture. The bidirectional suture may have a retainer-free transition segment located between the two orientations of the retainer.
[00064] "Closure of injury" refers to a surgical procedure to close a wound. An injury, specifically one where the skin or other internal or external surface is cut, torn, punctured, or otherwise broken is known as an injury. An injury usually occurs when the integrity of all tissue is compromised (for example, skin cut or burns, muscle lacerations, or bone fractures). An injury can be caused by an act, such as a gunshot wound, a fall, or a surgical procedure; by an infectious disease; or because of an underlying medical condition. The surgical closure of the wound facilitates the biological healing event by joining, or approaching the edges of, those wounds where the tissue has been torn, cut or otherwise separated. The surgical closure of the wound directly opposes or approximates the tissue layers, which serves to minimize the volume of new tissue formation needed to fill the gap between the two edges of the wound. The closure can serve both aesthetic and functional purposes. These purposes include eliminating dead spaces by approaching subcutaneous tissues, minimizing the formation of scars by careful epidermal alignment, and avoiding deep scarring by precisely eversing the edges of the skin. UNIDIRECTIONAL SELF-RETENTION SUTURES
[00065] Self-retaining sutures (including barbed sutures) differ from conventional sutures in that they have numerous small tissue retainers (such as splinters) that anchor in the tissue after placement and resist movement of the suture in a direction opposite to that for which the retainers are facing, thus eliminating the knots that would otherwise have to be tied around the positioning end of the suture, to fix the tissues adjacent to each other (a "knotless" closure), at the location where the positioning the suture leaves the tissue. By eliminating the knot tying, the associated complications are eliminated including, but not limited to (i) squirt (a condition in which the suture (usually a knot) pushes the skin after a subcutaneous closure), (ii) infection ( bacteria are often able to settle and grow in spaces created by a knot), (iii) batch / mass (a significant amount of suture material left in a wound is the portion that comprises the knot), (iv) slip (the knots may slip or come loose) and (v) irritation (the knots serve as a "foreign body" mass in the wound). Suture ties in the tissue that are created by the knots tied during a surgical procedure can lead to ischemia (they create tension points that can strangle the tissue and limit blood flow to the region) and increase the risk of dehiscence or rupture in the surgical wound. . Tying the knot is also labor intensive and can comprise a significant percentage of the time it takes to close a surgical wound. Additional operating procedure time is not only bad for the patient (complication rates increase with time spent on anesthesia), but also contributes to the total cost of the operation (many surgical procedures are estimated at between $ 15 and $ 30 per minute of operating time). Thus, knotless sutures not only allow patients to experience a better clinical outcome, but also save time and costs associated with prolonged surgery and follow-up treatments.
[00066] Self-retaining sutures for wound closure also result in a better approximation of the wound edges, evenly distribute the tension along the length of the wound (reducing the areas of tension that can break or lead to ischemia), decrease the volume of suture material remaining in the wound (by eliminating the knots) and reduce expulsion (the extrusion of suture material - typically knots - across the skin surface. All of these features are designed to reduce the formation of scars, improve cosmesis and increase wound resistance compared to wound closure with simple sutures or staples.
[00067] Self-retaining sutures are also suitable for a variety of specialized indications; for example, they are suitable for the tissue lifting procedure where the tissue is moved from its previous location and repositioned in a new anatomical location (this is typically performed in cosmetic procedures where the "pending" tissue is raised and fixed in a more "young"; or where the tissue "out of position" is moved back to its correct anatomical location). Such procedures include lifting the face, forehead, breasts, buttocks and so on.
[00068] Unidirectional self-retaining sutures and their uses have been described in several publications mentioned above. While the segment of the suture in a position adjacent to the positioning end of a unidirectional self-holding suture is provided with tissue retainers to prevent the suture from sliding in a direction substantially opposite to the positioning direction, the end end may be provided with a anchor to prevent sliding in the positioning direction (and to avoid the potential undesirable effects of requiring a knot to be tied during a surgical procedure at the final end of a unidirectional suture). Various unidirectional sutures with anchors, including anchors having loop elements, have been described, for example, in US Patent Application publications. 20050267531, 20040060410, 20080255611, and 20100063540.
[00069] Several problems common to existing unidirectional self-retaining sutures having loop anchors can be addressed by the modalities of this invention. For example, unidirectional sutures with fixed loop anchors, such as those described in some of the publications mentioned above, have several disadvantages, the first of which is that the size of the fixed loop should typically be reasonably small (that is, not much larger than the size of the first stitch that the clinician would like to make with the same stitch), which requires the clinician to make some effort (and therefore spend precious time from the surgery) finding the loop and passing the suture placement end through it. As the suture of the present invention includes a variable loop anchor, the clinician is presented with a large loop through which he can easily pass the positioning end of the suture; this is particularly beneficial in laparoscopic procedures. So, when this suture is pulled through the tissue, if the first stitch made is greater than the longest internal dimension of the fixed loop after the suture body has been extracted through it and tensioned, then the base of the loop (ie , where the loop joins the suture body) can be pulled into the tissue, resulting in potential problems such as those described above in connection with the knot tying. On the other hand, if the first stitch is smaller than the longest internal dimension of the fixed loop after the suture body has been extracted through it and tensioned, then the excess loop material remains at the tissue site, an axiomatically undesirable condition which could also cause surgical instruments to become trapped in excess material during the procedure. In the case of the present invention, the adjustable nature of the variable loop anchor allows the physician to avoid these difficulties.
[00070] In addition, there are physical problems of the loop integrity associated with a fixed loop anchor. For example, fixed loop attachment problems are avoided by the variable loop suture of the present invention. Where the loop of a fixed loop suture is welded or otherwise attached to the suture body, either as a separate structure attached at its base to the suture or as an end of the suture turned and attached to the suture to create a loop portion, the base of the loop (where it joins the suture body) is the attachment region and is also where the suture is pulled into the tissue. Thus, it is subject to tissue drag and potentially to rupture or detachment in the attachment region. While this can be treated by increasing the length of the attachment region and / or by providing a taper or chamfer, this can be totally avoided by the sutures of the present invention, as the variable loop eyelet will remain superficially on the fabric. if approaching, it will not be necessary to pass through the fabric, and it is not subject to dragging the fabric. Furthermore, in the sutures of the present invention, the main load when tensioning the fabric is carried by the variable loop instead of the eyelet. As a result, the eyelet does not hold the primary tension when the first stitch is made, and the weld length can be shortened, thereby reducing the local biomaterial effects (inflammation and / or risk of infection) in healing the wound.
[00071] Unidirectional self-retaining sutures of the present invention are provided with a loop configuration of variable length at one end and a positioning end at the other. The wound is closed by starting one end of the wound containing tissue to be approached, passing the positioning end through both edges of the tissue, pulling the end of the suture containing the needle through the tissue until the loop segment is close to the first edge of the fabric, and passing the needle end back through the variable loop portion of the device. The tension is pulled until the loop rests on the fabric and the desired firmness is obtained. The positioning end is now passed repeatedly through the tissue in a pattern determined by the physician to facilitate the start of the wound closure process at the newly landed end by moving in one direction to the other end of the tissue to be approached. A "J point" can be used to complete the process and the needle is removed similarly to the procedure used with bidirectional configurations.
[00072] Referring now to Figures 1A, 1B and 1C, a suture 100 is illustrated having a positioning end 101 on an elongated body 102 which is alternatively referred to in the present invention as suture thread, the body of which (or thread) has a cross section length (the longest cross dimension in a cross section). This cross-sectional length is illustrated in Fig. 1B, where Fig. 1B is a cross-sectional view of the suture in Fig. 1A, taken along the line in Fig. 1A which is marked "1B" where this length in cross section is denoted by "tl" in Fig. 1b, and Fig. 1B also shows a cross section of the suture body 102 and three retainers each identified as 104 which are shown in a darker tone to make it clear that they are not equally distant from the observer located in position 1B. It should be understood that the cross-sectional shape of the suture is not limited to circular, but can also be non-circular (as in the shape of an ellipse, triangle, square, other polygons, etc.).
[00073] Continuing with Figures 1A to 1C, the body 102 supports a plurality of retainers 104 oriented towards the positioning end 101, and an eyelet 112 through which the suture body passes, thus forming the variable loop 108. The eyelet it is, in essence, a fixed loop, which in the tissue is outside the tissue in which the suture is positioned. The presence of the variable loop as part of the anchoring structure ensures that all the force exerted on the anchor is not only exerted on the fixed loop. This is advantageous because the force is therefore distributed over a larger structure and the fixed loop (eyelet) or portions thereof, for example, the attachment region as discussed below in the present invention, are not guided to the fabric. One benefit is that the anchor can be more readily accessed and then cut away from the suture, allowing for easier removal of the suture after it is considered that the healing process no longer requires the presence of the suture. Absent the variable loop, the anchor would be composed only of the eyelet or eyelet in combination with a portion of the suture thread that passes through the eyelet but does not form a variable loop. An anchor that is formed only from a fixed loop, or is formed from a fixed loop in combination with a suture thread passing through the fixed loop but not forming a variable loop, is observed to tighten the fabric at the anchoring point and can lead to undesirable side effects, for example, tissue necrosis. An anchor formed from a fixed loop (eyelet) and a variable loop and an elongated body portion (suture) tightens the tissue less and thus provides less opportunity for unwanted tissue necrosis.
[00074] As shown in Fig. 1C, the positioning end 101 can be passed through variable loop 108. As positioning end 101 continues to be guided through variable loop 108, and tension is applied to suture 102 from the direction of the positioning end 101, more and more of the suture 102 will be guided or threaded through the variable loop. In practice, the positioning end 101 will pass through a patient's tissue before passing through variable loop 108, and therefore, as suture 102 passes through variable loop 108, eyelet 112 will be pulled onto a surface of the patient's tissue and will eventually be firmly attached to that tissue by the tension or force exerted on the positioning end 101. With the continuous pull, force or tension, the circumference of the variable loop will tend to decrease, until the moment the doctor determines that the variable loop has a desired circumference, at that moment the doctor will stop pulling at the positioning end and the anchor is thus formed. After that, the doctor will continue to sew the patient's tissue with the now anchored suture.
[00075] As shown in Figures 1A and 1C, the region of the suture body next to which a plurality of retainers is provided may be larger than the region of the suture body that is used in forming an eyelet. In addition, the eyelet does not necessarily contain any retainers, although retainers of a type may be present to assist in securing the suture body within the eyelet. The retainers may be missing from the variable loop portion of the suture, as shown in Figures 1A and 1C, or the retainers may be present in that portion of the suture as shown in the following figures.
[00076] As can be seen in Fig. 2, suture 200 has retainers 204 on suture body 202, which run along most of the length of suture body 202 including the variable loop 208 formed from suture body 202, to approach eyelet 212. Since retainers 204 are oriented to positioning edge 201 of suture 200, eyelet 212 easily passes through suture 202 and retainers 204 located when the suture is pulled through eyelet 212 ( or eyelet 212 is pulled over the suture body 202) in the direction of positioning to decrease the circumference of the variable loop 208.
[00077] As illustrated by the comparison of Fig. 2 and Fig. 3, the positioning end of a suture 200 and 300, respectively, can be pointed. As shown in Fig. 2, the positioning end 201 can be pointed by converting the end of the suture body 202 into a sharp and rigid structure. Or, as shown in Fig. 3, positioning end 301 can become pointed as a result of attaching a needle 303 to a tip of suture 302. Fig. 3 shows needle 303 at positioning end 301 of the suture variable loop 300.
[00078] In one embodiment, the invention features a self-holding system comprising a self-holding suture as described herein, including a positioning means. The self-retaining suture comprises a suture thread with a plurality of tissue retainers and one or more (usually only one is required) eyelets. The eyelet can have a circular or generally circular shape, and in that shape the diameter of the eyelet can be measured in the common way according to the distance between any two opposite points (two points on the opposite sides of the circle) on the inner side of the eyelet. The needle diameter can be selected in view of the eyelet diameter. For example, the diameter of the needle may be greater than the diameter of the eyelet, for example, the diameter of the needle may be at least 5% greater, or at least 10% greater, or at least 15% greater or at least 20% greater than the diameter of the eyelet. In this example, a fixed loop is formed when the positioning end of the suture body passes through the eyelet and then the positioning end of the suture is attached to a suture needle. Since the suture needle has a diameter that is greater than the diameter of the eyelet, the positioning end of the suture cannot return through the eyelet without breaking the eyelet and / or the needle, unless the eyelet is made of a material flexible that can be stretched. The suture body of the invention typically does not stretch to any significant extent. In this way, the loop can be seen as a fixed loop. In another example, the diameter of the needle is approximately equal to the diameter of the eyelet, in other words, the diameter of the needle is plus / minus 5% of the diameter of the eyelet, or in another embodiment, plus / minus 10% of the diameter of the eyelet. eyelet. In this case, the diameter of the needle and the diameter of the eyelet are approximately equal, and it will be difficult or impossible to pull the positioning end of the suture back through the eyelet after the positioning end has been attached to a needle. In another example, the diameter of the needle is chosen to be less than the diameter of the eyelet, such as where the diameter of the needle is less than 90% of the diameter of the eyelet, or less than 80%, or less than 70% or less than 60% or less than 50% of the eyelet diameter. In that case, the positioning end can be attached to a needle, and then the needle can be threaded through the eyelet. This option provides greater flexibility in forming the variable loop suture.
[00079] The diameter of the needle is typically chosen to be at least equal to the diameter of the suture, and in various embodiments the diameter of the needle is at least 110%, or at least 120%, or at least 130%, or at least 140 %, or at least 150% of the suture thread diameter.
[00080] The use of variable loop self-retaining sutures of the present invention is illustrated in Figures 4A and 4B. In these drawings, suture 400 is guided at a first point through the fabric (indicated in the hatched region, "T"), and then the elongated body 402 is guided through variable loop 408. When suture 400 is then pulled in the direction of positioning end 401 (indicated with an arrow), suture body 402 continues to pass through loop 408, tensioning the variable loop and decreasing its size as it passes through eyelet 412. The suture is thus anchored and ready for continued positioning through the fabric.
[00081] In one embodiment, the invention features a suture method, where that method comprises: (a) providing a self-holding system comprising a suture needle attached to one end of a self-holding suture, in which a self-holding suture it comprises a suture that has a thread diameter, a plurality of fabric retainers and an eyelet, where the suture passes through the eyelet to form a variable loop that has an original diameter; (b) inserting the needle into a patient's tissue in a first tissue site; (c) removing the needle from the patient's tissue at a second tissue site; (d) passing the needle and at least part of the suture through the variable loop; and (e) inserting the needle into the patient's tissue at a third tissue site. Optionally, one or more of the following statements can be used in combination with a statement providing a suture method as provided here: the suture is passed through the variable loop while simultaneously the variable loop diameter decreases where optionally the decrease is greatest that 50% of the original variable loop diameter; the diameter of the variable loop decreases to provide a variable loop diameter which is less than 10 times the wire diameter; the diameter of the variable loop decreases until the variable loop fits perfectly around the suture; the suture is passed through the variable loop until the eyelet, the variable loop and the suture body together form an anchor in the tissue, and where the additional movement of the suture in the direction of the suture needle is resisted by the anchor.
[00082] In another embodiment, the invention features a method for suturing the tissue, in which the method comprises: (a) providing a suture thread attached to a suture needle, a portion of the suture thread that forms a loop that has an adjustable circumference; (b) placing the thread on the needle through the loop; and (c) positioning the needle through a patient's tissue and bringing the tissue closer to the suture thread. Optionally, one or more of the following statements can be used in combination with a statement that provides a suture method as provided here: the loop comprises the suture and a fixed loop (also called an eyelet), where the fixed loop has an opening through which the suture passes through to form the loop that has an adjustable circumference; the fixed loop (also called the eyelet in the present invention) and any means by which the fixed loop is formed or attached to the suture, all placed on a surface of the tissue after the tissue has been completely approached; the circumference of the variable loop is adjusted to a desired value before placing the thread at the positioning end or needle through the variable loop; the circumference of the variable loop is adjusted to a desired value after placing the thread at the positioning end or needle through the variable loop; the loop circumference is adjusted to a desired value in the range, where that desired range can be 1.27 to 7.62 cm or 1.27 to 5.08 cm, or 1.27 to 2.54 cm (0.5 to 3 inches or 0.5 to 2 inches, or 0.5 to 1 inch), depending on the doctor's fit and the nature of the wound being stitched; the circumference of the loop is reduced to a desired value, that is, a value desired by the physician as appropriate for your comfort and for the wound to be sewn; the needle is passed through and then removed from the fabric at the first and second locations, respectively, before being threaded through the variable loop; the suture thread comprises tissue retainers; the suture comprises cuts in the suture, the cuts forming the tissue retainers, in other words, the cut provides a separation between the suture material on either side of the cut, where the material portion of the suture more close to the periphery of the suture, it can be pulled up and away from the suture on the other side of the cut, in order to form a structure that is a tissue retainer; a cut made in the suture remains in a single plane, or in two planes such as where the angle of the cut is changed during the process of forming the cut in the suture, for example, the first cut within the suture is relatively deep, while the cut after the first cut is not (or not very) deep; a cut is made in the suture to provide a splinter; tissue retainers are present in the portion of the suture that forms the loop that has an adjustable circumference; tissue retainers are absent in a portion of the suture that forms the loop that has an adjustable circumference.
[00083] In another embodiment, the invention provides a method for suturing that includes forming an anchor at a location in a patient's tissue, wherein the method comprises: (a) providing a suture with an eyelet, the thread suture attached to a suture needle at an end positioning the suture thread; (b) implant the suture needle into the tissue at the site, and then remove the suture needle from the tissue at an exit point; (c) crossing the needle through a loop comprising suture, the loop having a variable circumference; (d) applying tension to the suture by pulling on the positioning end of the suture; (e) thus providing an anchor at the top of the fabric, where the anchor comprises the eyelet, the loop and a portion of the suture, where the anchor resists the movement of the suture towards the positioning end of the Suture thread. Optionally, one or more of the following statements can be used in combination with a statement that provides a suture method as provided here: the loop comprises the suture and a fixed loop (also called an eyelet), where the fixed loop has an opening through which the suture passes through to form the loop that has an adjustable circumference; the fixed loop (also called the eyelet in the present invention) and any means by which the fixed loop is formed or attached to the suture, all placed on a surface of the tissue after the tissue has been completely approached; the circumference of the variable loop is adjusted to a desired value before placing the thread at the positioning end or needle through the variable loop; the circumference of the variable loop is adjusted to a desired value after placing the thread at the positioning end or needle through the variable loop; the loop circumference is adjusted to a desired value in the range, where that desired range can be 1.27 to 7.62 cm or 1.27 to 5.08 cm, or 1.27 to 2.54 cm, or at least 1.27 cm, or at least 2.54 cm, or at least 3.18 cm (0.5 to 3 inches or 0.5 to 2 inches, or 0.5 to 1 inch, or at least 0.5 inch , or at least 1 inch, or at least 1.5 inch), depending on the doctor's fit and the nature of the wound being stitched; the circumference of the loop is reduced to a desired value, that is, a value desired by the physician as appropriate for your comfort and for the wound to be sewn; the needle is passed through and then removed from the fabric at the first and second locations, respectively, before being threaded through the variable loop; the suture thread comprises tissue retainers; the suture comprises cuts in the suture, the cuts forming the tissue retainers, in other words, the cut provides a separation between the suture material on either side of the cut, where the material portion of the suture more close to the periphery of the suture, it can be pulled up and away from the suture on the other side of the cut, in order to form a structure that is a tissue retainer; a cut made in the suture remains in a single plane, or in two planes such as where the angle of the cut is changed during the process of forming the cut in the suture, for example, the first cut within the suture is relatively deep, while the cut after the first cut is not (or not very) deep; a cut is made in the suture to provide a splinter; tissue retainers are present in the portion of the suture that forms the loop that has an adjustable circumference; tissue retainers are absent in a portion of the suture that forms the loop that has an adjustable circumference.
[00084] To serve the purpose of allowing a doctor to identify and differentiate the eyelet, a marker can be placed next to the eyelet. The marker must be readily recognized and distinguished by the doctor under the conditions in which the suture will be used. For example, in microsurgery, markers can be used so that they are visible under the microscope, but not necessarily visible to the naked eye. Similarly, in endoscopies, the markers must be used in such a way that they are visible through the endoscope and on the associated monitor. If the suture is used with fluoroscopic visualization, then the markers may include radiopaque markers. If the suture is used with ultrasound visualization, then the markers may include echogenic markers. Thus, different markers and different types of markers may be suitable under different circumstances depending on the circumstances of the procedure and the scanning / imaging / visualization technology used in the procedure.
[00085] Markers can include different colors such as red, green, orange, yellow, green, blue etc. In some cases, it may be desirable to use a marker color that is unusual in the operating environment. For example, it may be desirable to use green markers because green is not common in the human body. In endoscopies, the use of green is advantageous because the video system can be programmed to emphasize green and accentuate the visualization of the marker without interfering with the rest of the image.
[00086] Markers can be formed by several conventional methods. For example, markers can be coated, sprayed, glued, dyed, stained or otherwise affixed to the self-holding suture systems or components thereof. Traditional dye application processes include, but are not limited to, dipping, spraying (by, for example, an ink jet), painting, printing, applying and / or coating dyes on the suture section of interest. Critical fluid extraction (such as carbon oxide) can also be used to add dye locally to all or part of the section to be marked. Alternatively, the dye (s) for the suture section of interest can be included in a portion of the suture material that is used to form the suture body, that portion being in the section of interest of the manufactured suture.
[00087] Additionally, the suture section of interest can be demarcated using an energy activated dye. For example, when a laser-activated dye (that is, a pigment or dye that permanently changes the color after being exposed to laser energy) is used to color the suture, then the eyelet or other suture section of interest can be marked by the use of laser energy to permanently change the suture lining in the suture section of interest. This also applies to the use of other energy activated dyes that are activated by other energy sources such as, but not limited to, heat, chemicals, microwaves, ultraviolet light or X-rays. For example, bleaches such as sodium hypochlorite or hydrogen peroxide will permanently change the color of the dye, which allows the demarcation of the eyelet or other suture region.
[00088] Additionally, the dye (s) used to demarcate the suture section of interest can be included in a biocompatible plastic material that is applied to the suture in the section of interest. Such a layer may be absorbable, such as a polyglycolide coating that has a dye to mark the suture section of interest, or it may be a non-absorbable material, such as silicone. The colored material can be synthetic or it can be derived from a natural source (either the modified or unmodified material), such as collagen. The biocompatible plastic material can be applied to the suture before or after the retainers are formed in the suture body.
[00089] Alternatively, the eyelet or other suture region can be inversely marked, so that where the suture body is already visibly colored, the dye may be missing from all or part of the suture section of interest, so that at least at least a portion of the section of interest is optically distinguishable by the surgeon from the rest of the suture. Such a suture can be manufactured by including a dye-free portion of suture material in the suture section of the area of interest during fabrication of the suture body (for example, by extrusion) or by removing dye from the suture section of interest after the suture body has been manufactured, before or after the retainers have been formed in the suture body. The dye can be removed locally, for example, by extraction of critical fluid such as (for example, carbon oxide). It is not necessary to remove all dye from the suture section of interest as long as there is a difference detectable by a surgeon between the section of interest and the rest of the suture.
[00090] Another example of an inversely marked suture is one that lacks a colored layer that is present in the rest of the suture body. A biocompatible plastic material that carries a dye can be applied to the other sections of the suture, and at least where the other sections delimit the section of interest. Examples of such materials are discussed above. As in the previously mentioned examples, demarcating the suture section of interest can be carried out in the suture manufacturing process before or after the formation of retainers.
[00091] Another example of an inversely marked suture is one that has a coaxial structure in which each coaxial layer that has a different color, and a portion of the outermost layer (s) is removed to visually expose a layer below. For example, a double layer monofilament polypropylene suture can be produced with a white inner core (intercoaxial layer) with a blue outer coaxial layer, and portions of the outer layer can be removed to visually expose the white inner monofilament to mark the section. suture of interest.
[00092] Yet another example of an inversely marked suture is one in which an outer covering is removed (or partially removed) from the suture in the suture section of interest, and where the base covering or suture has a contrasting color difference. This technique of removing (or partially removing) material in the suture section of interest can also create a tactile demarcation of the suture section of interest.
[00093] The marking may include a radio-detectable compound or magnetic resonance detectable compound. For example, the suture section of interest with barium sulfate (BaSO4), as by impregnating the suture with barium sulfate or adding a coating containing barium sulfate, will be detectable by electromagnetic energy. In the case of X-ray detection, the section marked with barium sulfate of interest would be radio-opaque. Similarly, computed tomography (CT) or computed axial tomography (CAT) can be used to detect the radio-detectable section of interest. The use of electromagnetic energy for radio detection of the transition section is not limited to the use of X-ray wavelengths, as other radio frequencies can be used. Similarly, gadolinium (Gd) or gadolinium compounds can be used to mark the suture section of interest, specifically when detection is made using magnetic resonance imaging (MRI). The use of radio-detectable or magnetic resonance marking may be useful for the surgeon during laparoscopic procedures.
[00094] The region of the variable loop at the base of the eyelet can be marked to increase its visibility to the doctor, either for the purpose of indicating where he is during the positioning of the suture, or to allow the doctor to identify where the anchor is to cut it for the purpose of removing the positioned suture from the tissue. Figures 5A, 5B, 5C and 5D illustrate the rear ends of the variable loop sutures having such markings. In Fig. 5A, variable loop 508 of suture 500 includes eyelet 512, which is marked on its base 514. Suture 520 of Fig. 5B includes a variable loop 528 having a demarcation 534 next to eyelet 532 in addition to a feature surface 536 adjacent to the base of eyelet 534 where feature 536 provides a different tactile feel to suture 520 compared to other locations in the suture, while suture 540 in Fig. 5C has a variable loop 548 having a marking 554 next to eyelet 552 , and suture 560 of Fig. 5D shows a variable loop 568 having two demarcations 534 next to eyelet 572 and demarcation 576 located elsewhere in variable loop 568.
[00095] In some embodiments, the suture may additionally be provided with a surface feature for a portion of the suture body adjacent to the fixed loop, to provide some resistance, perceptible to the physician, for the variable loop being pulled up to the fixed loop. While in some of these modalities it is not necessary for the surface feature to prevent the variable loop from being tightened to the fixed loop, in most other modalities the surface feature may work to do this. Some examples, without limitation, of suitable surface resources are curling, curling, corrugating, sanding, sawing, ridges, filaments and so on. In this connection, Fig. 5B includes the surface feature 536 next to the eyelet 532. Of course, these surface features can also take the form of short segment retainers oriented in the opposite direction from the positioning end of the suture, which would resist the movement of the suture. suture body through the eyelet, the latter may be of the same pattern as the suture balance or may be different, that is, a short segment of retainers having the same or different configuration of the plurality of barbs oriented towards the positioning end.
[00096] In Fig. 5C, the retainers 544 oriented towards the positioning end of the suture pass easily through the eyelet 552, while the retainers 558 are oriented in the opposite direction and thus somehow resist having the eyelet guided in relation to them. Similarly, suture 560 of Fig. 5D is provided with retainers 564 oriented for positioning and retainers 578, which are oriented in the opposite way. Suture 560 is also provided with an additional marking 576 between the two sets of retainers, to allow the physician to identify the region between the two sets.
[00097] Referring now to Fig. 6A, this provides a view of the variable loop portion 608 of a self-holding suture 600 according to an embodiment of the invention, illustrating a visible demarcation 614 of the fixed loop of that embodiment. In other words, the fixed loop (alternatively called the eyelet) has a different surface appearance or a different surface tactile feel compared to the adjunct suture. In Fig. 6A, eyelet 612 is constructed of a darker colored material than the material that forms the adjunct suture 602. Alternatively, the eyelet could be formed of a lighter colored material, or of a totally different colored material. the adjunct suture. The eyelet can be formed of material having a matte finish, while the adjunct suture has a natural or shiny appearance. The eyelet may also, or alternatively, be formed from materials containing grooves or other indentations or ridges that are not present in the adjunct suture, which provides a tactile distinction between the region of the eyelet and the adjunct suture. With this visible demarcation between the eyelet and the adjunct suture, the doctor who uses the suture, or perhaps a robot handling the suture, can more readily see the eyelet and distinguish the eyelet from the adjunct suture.
[00098] Now with reference to figures 6B and 6C, the eyelet may be provided with or be in combination with a domain engagement element to facilitate removal of the suture anchor if it is decided that the suture should be removed from the tissue. As shown in Fig. 6B, suture 620 having variable loop 628 with eyelet 632 and attachment region 634 has a flap 636 as the domain engaging element, while suture 640 in Fig. 6C includes a length of non-barbed suture 656 as a domain hitch element located on or as part of the integrally formed eyelet 652 of variable loop 648. Domain hitch elements 636 and 656 illustrate two options for a feature that is part of, or is attached to, the eyelet and is of a size and orientation that can be readily understood, secured, tightened or maintained by the health care professional as a means of lifting the eyelet and the associated anchor in the opposite direction to the fabric. A domain coupling element is an optional feature of each of the variable loop sutures described here.
[00099] The domain coupling element can be produced from absorbable or non-absorbable materials. For example, a non-absorbable domain hitch element produced from polyester felt or polytetrafluoroethylene can be used to allow the surgeon to gently find and pull the eyelet to facilitate removal of the suture body anchor if and when desired. remove the suture from the tissue (by detaching the anchor and then pulling the suture out of its positioning end). Examples of absorbable materials include glycolide and glycolide-lactide polymers. The use of an absorbable domain engaging element can be especially useful for closing deep cavity tissue where the surgeon wishes to have a choice of whether or not to leave the domain engaging element within the body. In addition, the domain hitch element can be colored (as shown by the shading of tab 636 of Fig. 6B) to optimize the visibility of the element. This includes, but is not limited to, the use of fluorescent dyes, radio-detectable compounds or magnetic resonance-detectable compounds. MANUFACTURE AND MATERIALS
[000100] The suture threads described herein can be produced by any suitable method including, without limitation, injection molding, stamping, cutting, laser, extrusion, and so on. With respect to the cut, thread or polymeric filaments can, in some embodiments, be manufactured or purchased for the suture body, and the retainers can be subsequently cut on or within the suture body; they can be cut manually, laser or by mechanical machining using blades, cutting discs, grinding discs and so on. Sutures can be manufactured from any suitable biocompatible material, and can additionally be treated with any suitable biocompatible material, whether to enhance strength, resilience, longevity, or other qualities of the suture, or to equip the sutures to fulfill additional functions in addition joining fabrics, repositioning fabrics, or fixing different elements to fabrics. As they are suitable for indicating or using the suture in question, the sutures can be provided with retainers of various configurations, dispositions, densities and so on, such as those taught in several publications mentioned here.
[000101] Variable loops for sutures of the present invention can be formed in several ways. With reference to suture 700 shown in Fig. 7, variable loop 708 includes eyelet 712 through which suture body 702 passes. Eyelet 712 is formed by passing what would otherwise be the non-positioned side 791 of suture body 702 around and back around itself and attaching externally to suture body 702 in attachment region 714. In this case, the attachment region 714 is adjacent to eyelet 712. In contrast, and with reference to suture 800 shown in Fig. 8, which illustrates eyelet 812 of variable loop 808 formed from the end end (alternatively called the non-positioning end) 891 of the body suture 802 in an internal attachment, that is, the attachment region 814 is inside and is part of the structure that forms the eyelet. The attachments mentioned in reference to these figures can be made to have a permanent nature, by welding, gluing and so on.
[000102] It is important to note that the non-positioning end of the suture need not have any specific shape or appearance or function when it is located in the attachment region. Since neither the eyelet nor the adjacent attachment region of the variable loop sutures of the present invention are made to enter the fabric, there is no need to facilitate entry, for example, of the attachment region by providing any particular shape that would facilitate this entry. For example, the end or tip of the non-positioning end of the sutures of the present invention may be square in comparison to the sides of the adjacent suture, rather than having an angle or inclination that would facilitate entry into the tissue. The positioning end may, in fact, be designed or adapted to delay the entry of the attachment region into the fabric. This is particularly relevant when the eyelet is formed with the attachment region located adjacent to the eyelet. This same problem is not relevant if the attachment region is part of the material that forms the eyelet.
[000103] Alternatively, eyelet 912 can be integral with suture body 902 as shown by suture 900 illustrated in Fig. 9, in which eyelet 912 of variable loop 908 is continuous with suture body 902. Thus, in this modality, there is no attachment region.
[000104] As yet another alternative modality, the eyelet can be formed independently of the suture, and then the eyelet is joined to the suture in a suitable location. For example, the non-positioning end of the suture can be attached to an eyelet, in the same way that the end of a rope can be tied to a ring. In this alternative modality, it is desirable that the suture is connected to the eyelet in a safe way, so that the eyelet does not separate from the suture at an inappropriate time. A secure connection of the eyelet and the suture may be made, for example, by welding the knot that is used to tie the eyelet to the suture. As another example, the eyelet can take the form of a ring (or polygon or other suitable shape defining a hole through which the suture can pass or be threaded) where the ring has a hole through which the suture can pass to secure the ring to the suture thread. For example, after passing through this hole, the non-positioning end of the suture may be formed into a knot of a size that cannot easily pass through the hole. In this way, the suture thread is attached to an eyelet. As a final example, the eyelet can be firmly attached to a resource where it is readily attached to the suture thread. For example, two rings joined together in the shape of figure 88, the two rings not necessarily being of the same diameter, provide a structure where the suture can be tied to a ring, while the adjunct ring is available to serve as an eyelet. Instead of having the eyelet attached to a ring, the eyelet can be attached to a flap that can be folded and crimped around the suture. The eyelet can alternatively be attached to a hollow cylinder, where the non-positioning end of the suture can be inserted into the cylinder, and then the cylinder is crimped to secure the suture to the cylinder (in a similar way to the known shape in which the positioning end of a suture is attached to a needle, but in this case the non-positioning end of a suture would be attached to an eyelet). Having the eyelet formed separately from the suture provides greater flexibility (ie independence) when selecting materials from which to form the suture and eyelet.
[000105] The dimensions of the eyelet can be varied; for example, the internal cross-sectional length of the eyelet (that is, the longest internal dimension crossing the eyelet) may be small as the cross-sectional length of the suture cross-sectional body (that is, the longest dimension crossing the cross-sectional body suture, regardless of the shape of a cross section) and as large as four times or even ten times the cross-sectional length of the suture cross-section body. Other bands of internal cross-section that may be suitable are one and a half times the cross-sectional length of the suture cross-section at about ten times the cross-sectional length of the suture cross-section, one and a half times the cross-sectional length of the suture cross-section about four times the cross-sectional length of the suture cross-section, or about twice the cross-sectional length of the suture cross-section at about three times the cross-sectional length of the suture cross-section.
[000106] After preparation, the self-holding suture system can be packaged for ease of storage, handling and use. Suitable packaging systems are known in the art, where exemplary suture packages are described in US Patent Nos. 20110056859 and 20100230300. Before, but preferably after the packaging process, the suture can be sterilized by radiation, for example.
[000107] In one embodiment, a method of manufacturing a self-holding suture system is presented, in which the method comprises (a) providing a suture, in which the suture comprises a positioning end, and comprising or be attached to an eyelet, (b) forming a plurality of cuts in the suture thread to provide a plurality of fabric retainers; (c) thread the positioning end of the suture through the eyelet to thereby form a loop of variable circumference; (d) thread the positioning end of the suture through the loop of variable circumference to provide a suture ready for packaging; (e) placing the ready-made suture in suitable packaging to store the suture and suitable to allow a healthcare professional to have quick access to the packaging-ready suture. One or more of the following statements can be used in combination with the description of a method for making a self-holding suture system, to further describe and declare the invention: the method further comprises fixing the suture needle to one end of the thread suture, where the needle is optionally attached to the suture after the end of the suture thread has been threaded through the eyelet or the needle is attached to the suture thread after the end of the suture thread has been threaded through the circumference loop variable; the suture is sterilized; the eyelet is integrally formed with the suture thread; the eyelet is attached to the suture; the eyelet is formed by (a) folding the non-positioning end of the suture, also called the final end of the suture, back to a portion of the suture to provide an attachment region, where the end of non-positioning of the suture is in contact with the portion of the suture in the attachment region; and (b) adhere the non-positioning end and the suture portion to the attachment region, where in this case, adhesion can be obtained by welding with the non-positioning end and the suture portion in the attachment region or it can be obtained by gluing the non-positioning end and the suture portion in the attachment region; the eyelet comprises the attachment region that will occur in the event that the positioning end is bent back to a portion of the suture that forms part of the eyelet; the eyelet is adjacent to the attachment region that will occur in the event that the positioning end is bent back to a portion of the suture that is not part of the eyelet but is adjacent to the eyelet at the base of the eyelet.
[000108] The self-retaining sutures described here can also incorporate materials that additionally promote tissue engagement. In addition to attaching the tissue to the retainers, the use of materials promoting the attachment of the tissue to at least part of the suture bodies (such materials may or may not include all or part of the retainers) can enhance the ability of the sutures to remain in place. This class of tissue engagement promoting materials is porous polymers that can be extruded to form suture bodies, including both microporous polymers and polymers that can be extruded with bubbles (whether bioabsorbable or non-bioabsorbable). A suture synthesized with such materials can have a three-dimensional lattice structure that increases the surface area of the tissue engagement and allows the tissue to infiltrate the suture body itself, thus having a primary structure that promotes the successful use of suture . In addition, by optimizing the pore size, the formation of fibroblasts can be encouraged, making it easier for the suture to be anchored in the tissue.
[000109] One of these microporous polymers is ePTFE (expanded polytetrafluoroethylene). EPTFE incorporating self-holding (and related microporous materials) are suitable for uses that require a permanent and resistant lift (such as lifting the breasts, face and other tissue repositioning procedures) , because the infiltration of the suture in the tissue results in the improvement of the fixation and graft of the suture and the surrounding tissue, thus providing superior firmness and greater lifting longevity.
[000110] Additionally, the self-retaining sutures described in this document can be provided with compositions to promote healing and avoid undesirable effects such as scar formation, infection, pain and so on. This can be accomplished in a variety of ways, including for example: (a) fixing a formulation directly to the suture (for example, by spraying the suture with a polymer / drug film, or by immersing the suture in a polymer / drug solution), (b) coating the suture with a substance such as a hydrogel that, in turn, will absorb the composition, (c) inserting the coated thread with formulation (or the polymer itself formed in a thread) in the suture structure in the case of multifilament sutures, (d) insert the suture into a glove or mesh that is comprised of, or coated with, a formulation, or (e) build the suture itself with a composition. Such compositions may include, but are not limited to, antiproliferative agents, anti-angiogenic agents, anti-infective agents, fibrous agents, scar-creating anti-forming agents, lubricating agents, echo-generating agents, anti-inflammatory agents, cell cycle inhibitors, analgesics and antimicrotubule agents. For example, a composition can be applied to the suture before the retainers are formed, so that when the retainers engage, the engagement surface is substantially free of the coating. In this way, the fabric being sutured comes into contact with a coated suture surface as the suture is introduced, but when the retainer engages an uncoated surface, the retainer comes into contact with the tissue. Alternatively, the suture can be coated after or during the formation of retainers in the suture if, for example, a fully coated suture instead of a selectively coated suture is desired. In yet another alternative, a suture can be selectively coated during or after formation of retainers by exposing only selected portions of the suture to the coating. The specific purpose for which the suture is to be placed or the composition can determine whether a fully coated or selectively coated suture is suitable; for example, with slippery coatings, it may be desirable to selectively coat the suture, leaving, for example, the tissue engaging surfaces of the uncoated sutures to prevent the tissue engaging function of those surfaces from being impaired. On the other hand, coatings such as those comprising such compounds as anti-infectious agents can be applied appropriately to the entire suture, although coatings such as those comprising fibrosis inducing agents may be properly applied to all or part of the suture (such as surfaces coupling). The purpose of the suture can also determine the type of coating that is applied to the suture; for example, self-retaining sutures that have antiproliferative coatings can be used to close tumor excision sites, while self-retaining sutures with fibrous coatings can be used in tissue repositioning procedures, and those having scar antiforming agents can be used to close injuries on the skin. In addition, the structure of the suture can influence the choice and extent of the lining; for example, sutures that have an expanded segment may include a fibrosis-inducing composition on the expanded segment to further secure the segment in position in the tissue. The coatings may also include a plurality of compositions together or in different portions of the suture, where multiple compositions can be selected for different purposes (such as combinations of painkillers, anti-infective and anti-scarring agents) or for synergistic effects. CLINICAL USES
[000111] In addition to the general applications for wound closure and soft tissue repair, described in the preceding sections, self-retaining sutures can be used in several other indications.
[000112] Self-retaining sutures described here can be used in various dental procedures, that is, oral and maxillofacial surgical procedures. The aforementioned procedures include, without limitation, oral surgery (for example, removal of impacted or broken teeth), surgery to provide bone augmentation, surgery to repair dentofacial deformities, repair after trauma (for example, fractures of facial bone injuries), treatment surgical treatment of odontogenic and non-odontogenic tumors, reconstructive surgery, repair of the cracked lip or palate, congenital craniofacial deformities and aesthetic facial surgery. Dental self-retaining sutures can be degradable or non-degradable, and can typically range in size from USP 2-0 to USP 6-0.
[000113] The self-retaining sutures described here can also be used in surgical tissue repositioning procedures. Such surgical procedures include, but are not limited to, face, neck, forehead, thigh and breast lift. The self-retaining sutures used in tissue repositioning procedures may vary depending on the tissue being repositioned; for example, sutures with larger and additionally spaced retainers can be used appropriately with relatively soft fabrics such as fatty fabrics.
[000114] The self-retaining sutures described here can also be used in microsurgical procedures that are performed under a surgical microscope (and thus can be called "self-retaining microsutures"). Such surgical procedures include, but are not limited to, rewiring and repair of peripheral nerves, spinal microsurgery, hand microsurgery, various plastic microsurgical procedures (for example, facial reconstruction), microsurgery of the male or female reproductive system and various types of microsurgery reconstruction. Microsurgical reconstruction is used for complex reconstructive surgery problems, when other options, such as primary closure, healing by second intention, skin grafting, local flap transfer and distant flap transfer are not suitable. Self-retaining microsutures have a very small caliber, often as small as USP 9-0 or USP 10-0, and can have a fixed needle of corresponding size. They can be degradable or non-degradable.
[000115] The self-retaining sutures described herein can be used at similarly small caliber intervals for ophthalmic surgical procedures and can therefore be referred to as "ophthalmic self-retaining sutures". Such procedures include, but are not limited to, surgical procedures for keratoplasty, cataracts, retinal and vitreous. Ophthalmic self-retaining sutures can be degradable or non-degradable, and have a fixedly small gauge needle attached.
[000116] Self-retaining sutures can be used in a variety of veterinary applications for a wide range of surgical and traumatic purposes in animal health.
[000117] Although the present invention has been shown and described in detail with respect to only a few exemplary embodiments of the invention, it should be understood by those skilled in the art that it is not intended to limit the invention to the specific embodiments presented. Various modifications, omissions, and additions can be made in the modalities presented without substantially departing from the innovative teachings and advantages of the invention, particularly in light of the aforementioned teachings. Consequently, it is intended to cover all these modifications, omissions, additions, and equivalents that may be included in the spirit and scope of the present invention, as defined by the following claims. Some specific embodiments of the invention are:
[000118] Self-retaining suture comprising: a first end to penetrate the tissue; an elongated suture body (which may alternatively be called a suture), having a periphery; a first plurality of retainers on the periphery of the elongated body (which may alternatively be called suture thread or suture body) and oriented to the first end, where the first plurality of retainers goes towards the suture body during the movement of the suture through the tissue in a direction of positioning the first end, and resisting the movement of the suture, when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; a second end having a variable loop of variable circumference, wherein the variable loop includes a fixed loop (which may alternatively be called an eyelet) slidably interconnected to the elongated body to slide the variable loop circumference slidingly, and in which the first end can pass through the variable loop to hold the tissue as an anchor, where the anchor prevents movement of the suture in the direction of positioning the first end. Optionally, one or more of the following statements can be used to better describe the self-holding suture provided here: the first end is adapted to penetrate the tissue; the first end is attached to a needle; the suture additionally comprises a surface feature in at least part of the elongated body periphery between the fixed loop (eyelet) and the first plurality of retainers, where the surface feature resists the sliding of the fixed loop over the surface feature, where optionally the surface feature comprises a second plurality of retainers, wherein the second plurality of retainers is oriented in the opposite direction to the first end and / or the surface feature is arranged on at least part of the circumference of the variable loop; the elongated body has a cross section having a transverse length (tl) and the fixed loop has an internal transverse length (TL) and where the ratio between TL: tl is from about 1: 1 to about 10: 1 or the TL: tl ratio is about 1: 1 to about 4: 1 or TL: tl ratio is about 1: 1 to about 3: 1 or TL: tl ratio is about 1 , 5: 1 to about 10: 1 or the TL: tl ratio is about 1.5: 1 to about 4: 1 or the TL: tl ratio is about 2: 1 to about 3 :1; the fixed loop is fixed to or additionally comprises a domain engaging element; at least one of the retainers of the first plurality differs in configuration from the other retainers of the first plurality; second plurality retainers differ in configuration from the first plurality retainers; the fixed loop additionally comprises a visible marking; a cross section of the elongated suture body (alternatively called the suture) is non-circular; the cross section of the elongated suture body is polygonal; the suture additionally comprises a therapeutic agent.
[000119] Self-retaining suture comprising: a first end to penetrate the tissue; an elongated suture body (alternatively called a suture) having a periphery and a cross section, the cross section having a transverse length (tl); the first plurality of retainers on the periphery of the elongated body (alternatively called the elongated suture body or suture thread) and oriented to the first end, where the first plurality of retainers go towards the suture body (alternatively called the suture thread) ) during the movement of the suture through the tissue in a direction of positioning the first end, and resisting the movement of the suture, when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; a second end having a variable loop of variable circumference, wherein the variable loop includes a fixed loop (alternatively identified as an eyelet) slidably interconnected the elongated body to slide the circumference of the variable loop slidingly, and where the first end it can pass through the variable loop to secure the tissue as a third anchoring loop in the tissue to prevent movement of the suture in the direction of positioning the first end.
[000120] Self-retaining suture comprising: a first end to penetrate the tissue; an elongated suture body having a periphery and a cross section, the cross section having a transverse length (tl); a first plurality of retainers on the periphery of the elongated body and oriented to the first end, wherein the first plurality of retainers goes to the suture body during movement of the suture through the tissue in a direction of positioning the first end, and resisting the movement the suture, when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; a second end having a sliding knot, wherein the sliding knot comprises a loop of variable circumference through which the first end can pass to secure the tissue as an anchor to prevent movement of the suture in the direction of positioning the first end.
[000121] Self-retaining suture comprising: a first end to penetrate the tissue; an elongated suture body having a periphery and a cross section, the cross section having a transverse length (tl); the first plurality of retainers on the periphery of the elongated body oriented to the first end, wherein the first plurality of retainers goes to the suture body during movement of the suture through the tissue in a direction of positioning the first end, and resisting the movement the suture, when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; a second end having a sliding knot, wherein the sliding knot comprises a loop of variable circumference through which the first end can pass to secure the tissue as an anchoring loop in the tissue to prevent movement of the suture in the direction of positioning the first end .
[000122] Self-retaining suture comprising: a first end to penetrate the tissue; an elongated suture body having a periphery and a cross section, the cross section having a transverse length (tl); a first plurality of retainers on the periphery of the elongated body and oriented to the first end, wherein the first plurality of retainers goes to the suture body during movement of the suture through the tissue in a direction of positioning the first end, and resisting the movement the suture, when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; a second end having a variable loop of variable circumference, wherein the variable loop includes a fixed loop having an internal transverse length (TL) and slidably interconnected the elongated body to slide the circumference of the variable loop, in which the TL: tl ratio is from about 1: 1 to about 10: 1; wherein the first end can pass through the variable loop to secure the tissue as an anchor to prevent movement of the suture in the direction of positioning the first end.

权利要求:
Claims (13)
[0001]
1. Self-holding suture system comprising a self-holding suture (100, 200, 300, 400, 500, 520, 540, 560, 600, 620, 640, 700, 800, 900) and a needle (303) having a diameter, the self-retaining suture comprising: a first end for penetration into the tissue (101, 201, 301, 401), where the first end is attached to the needle (303); an elongated suture body (102, 202, 302, 402, 602, 702, 802, 902) having a periphery; a first plurality of retainers (204, 544, 564) on the periphery of the elongated body and oriented towards the first end, the first plurality of retainers being in the direction of the suture body during the movement of the suture through the tissue in a direction of positioning of the first end, and resists the movement of the suture, when in the tissue, in a direction substantially opposite to the direction of positioning of the first end; a second end having a variable loop (108, 208, 408, 508, 528, 548, 568, 608, 628, 648, 708, 808, 908) of variable circumference, wherein a fixed loop (112, 212, 412, 512, 532, 552, 572, 612, 632, 652, 712, 812, 912) at one end of the elongated suture body slidably engages the elongated body to slidably vary the circumference of the variable loop. the fixed loop having a diameter; where the first end can pass through the variable loop to fix the tissue as an anchor, the anchor preventing movement of the suture in the direction of implantation of the first end; characterized by the fact that the needle diameter is larger than the diameter of the fixed loop .
[0002]
2. Suture system according to claim 1, characterized by the fact that it still comprises a surface feature (536, 558, 578) in at least part of the elongated body periphery between the fixed loop and the first plurality of retainers , and the surface feature resists the sliding of the fixed loop over the surface feature.
[0003]
3. Suture system according to claim 1, characterized by the fact that the elongated body has a cross section having a transverse length (tl) and the fixed loop has an internal transverse length (TL), and in which the TL ratio : tl is from 1: 1 to 10: 1.
[0004]
4. Suture system according to claim 1, characterized by the fact that the fixed loop still comprises a latching element for retention.
[0005]
5. Suture system, according to claim 1, characterized by the fact that the fixed loop also comprises a visible mark.
[0006]
6. Suture system, according to claim 1, characterized by the fact that the cross-section of the elongated suture body is non-circular.
[0007]
7. Method for making a self-holding suture system, comprising the steps of: providing a suture thread (102, 202, 302, 402, 602, 702, 802, 902), which comprises a first end to penetrate the tissue and either comprises or is attached to a fixed loop (112, 212, 412, 512, 532, 552, 572, 612, 632, 652, 712, 812, 912), the fixed loop having a diameter; forming a plurality of cuts in the suture to provide a plurality of tissue retainers (204, 544, 564); thread the first end (101, 201, 301, 401) of the suture through the fixed loop to form a variable loop of varying circumference (108, 208, 408, 508, 528, 548, 568, 608, 628, 648 708 , 808, 908); characterized by the fact that thread the first end of the suture through the variable loop to provide a suture (100, 200, 300, 400, 500, 520, 540, 560, 600, 620, 640, 700, 800, 900) ready for pack; placing the ready-to-pack suture in suitable packaging to store the suture and adequate to allow a clinician to quickly access the ready-to-pack suture; attach a needle (303) to the first end of the suture, where the diameter of the needle is greater than the diameter of the fixed loop.
[0008]
8. Method according to claim 7, characterized by the fact that the needle is attached to the suture line after the first end has been passed through the fixed loop.
[0009]
9. Method according to claim 7, characterized by the fact that the needle is attached to the suture line after the first end has been passed through the variable loop.
[0010]
10. Method, according to claim 7, characterized by the fact that the fixed loop is fixed to the suture thread.
[0011]
11. Method according to claim 7, characterized in that the fixed loop is formed by bending a second end of the suture again over a portion of the suture to provide a fixation region, in which the second end the suture is in contact with the suture portion in the fixation region; and adhering the second end and the suture portion in the attachment region to each other.
[0012]
12. Method according to claim 11, characterized by the fact that the fixed loop comprises the fixation region.
[0013]
13. Method according to claim 11, characterized by the fact that the fixed loop is adjacent to the fixation region.

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法律状态:
2017-07-11| B25A| Requested transfer of rights approved|Owner name: ETHICON ENDO-SURGERY LLC (US) |

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2017-07-18| B25F| Entry of change of name and/or headquarter and transfer of application, patent and certif. of addition of invention: change of name on requirement|Owner name: ETHICON ENDO-SURGERY LLC (US) |

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2017-07-25| B15G| Petition not considered as such [chapter 15.7 patent gazette]|

---

2017-08-08| B15G| Petition not considered as such [chapter 15.7 patent gazette]|

---

2017-12-12| B25D| Requested change of name of applicant approved|Owner name: ETHICON LLC (PR) |

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2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-09-15| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-15| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161466924P| true| 2011-03-23|2011-03-23|

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US61/466,924|2011-03-23|

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PCT/US2012/030441|WO2012129534A2|2011-03-23|2012-03-23|Self-retaining variable loop sutures|

---