• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
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  • 优先权
    • 专利摘要:
    FARPED SUTURES HAVING COMPRESSION STOPS AND METHODS TO PRODUCE THEM The present invention relates to a surgical suture (100) that includes an elongated core (106) that has a first dressing (102) and a second leg (104), the first set of barbs (108) protruding from the first core leg, and a second set of splinters (110) protruding from the second core leg. The suture has a stop (114) that protrudes from the core that is located between the first and second sets of splinters, and a braid (450) that surrounds the elongated core and the stop to reinforce the suture. The suture includes a compress (440) that has a first (438A) and a second (438B) openings that extend through it, the first leg extending through the first opening of the compress, the second leg extending through the second compress opening, the second leg extends through the second compress opening, and the stop extends between the first and second compress openings.
    公开号:BR112012004312B1
    申请号:R112012004312-9
    申请日:2010-08-24
    公开日:2020-10-27
    发明作者:David C. Lindh, Sr.；Jesse G. Nawrocki；Dennis L. Furman；Krasimira Hristov；Jason T. Perkins
    申请人:Ethicon, Inc；
    IPC主号:
    专利说明:

    CROSS REFERENCE TO RELATED ORDERS
    [0001] The present application relates to the patent application assigned to the same applicant, serial number US 12 / 548,984, entitled "Automated Systems and Methods for Making Braided Barbed Sutures", (ETH5439USNP) filed on the same date as this application, being its description incorporated herein by reference. BACKGROUND OF THE INVENTION Field of the Invention
    [0002] The present invention relates, in general, to surgical sutures, and more specifically it relates to sutures used to fix prosthetic devices to the tissue. Description of the Related Art
    [0003] Surgical sutures are used to close wounds and surgical incisions, and to repair damaged or cut muscles, vessels and tissues. Typically, the suture is attached at one end to a needle, and the needle is pulled through the fabric to form one or more loops that hold the fabric together. The suture is subsequently tied with one or more knots so that the tissue remains joined.
    [0004] Although sutures are very effective in closing wounds, there are numerous issues associated with the use of conventional sutures. Many of these issues are directly related to the use of knots to keep the sutures in place. If the knots are not properly tied, defects such as slip, tearing of the knots and reopening of the wound may arise.
    [0005] In response to the obstacles associated with conventional sutures, barbed sutures have been developed. Unlike conventional sutures, barbed sutures have protruding splinters that allow the suture to be used to close wounds, bring tissues together, tighten tissues and fix prosthetic devices - all without the use of knots. Fixing conventional sutures with knots requires the knots to be pushed down towards the tissue to ensure proper tension and fixation of the sutures. In contrast, barbed sutures achieve adequate tensioning and fixation by applying tension to the suture. For example, US patent No. 5,931,855 features sutures with splinters that are used for cosmetic procedures such as lifting the eyebrows and lifting the face.
    [0006] In some procedures, it is desirable to use barbed sutures to fix prosthetic devices, such as bioprosthetic heart valves. For example, in certain modalities of the publication of a patent application assigned to the same US applicant No. 2007/0005110, the description of which is incorporated by reference, braided barbed sutures are arranged in the suture ring of the heart valve first sutures through a ring and then passing the sutures through the valve suture ring. The first and second ends of the barbed suture can be passed through the openings of a compress to securely seat the suture against the valve suture ring. The compress is typically positioned in a central region of the barbed suture, which is located between opposing splinter groups. Approximately 12 to 20 groups of braided barbed sutures are used around the perimeter of the valve to hold the valve in place. The valve suture ring is then lowered through the barbed suture sets and housed in place within the ring. After the suture ring has lowered in a downward direction, the splinters prevent the suture ring from moving in the opposite upward direction. The splinters keep the suture ring in place without using knots.
    [0007] Despite the advances above, there remains a need for sutures, suture systems and suturing methods that more securely and reliably secure the sutures in place and minimize the slip of the sutures and / or compresses used in combination with the sutures. sutures. In addition, there remains a need for suture systems that simplify surgical procedures and minimize the likelihood of surgical error. There is still a need for sutures that are able to pass more easily through suture rings and tissues without causing damage. SUMMARY OF THE INVENTION
    [0008] In one embodiment, a surgical suture includes an elongated core that has a first leg and a second feather, and a stop protruding from the elongated core between the first and second legs. The suture may include a first set of splinters protruding from the first leg, and a second set of splinters protruding from the second leg, so that the stop protrudes from a central region of the elongated core, which is preferably located between the first and second sets of barbs. In one embodiment, the first set of barbs protrudes in a first direction and the second set of barbs protrudes in a second direction that is opposite to the first direction. In one embodiment, the barbs of the first and second barbs are desirably flexible, and the stop is preferably less flexible than the barbs of the first and second barbs.
    [0009] In one embodiment, the barbed suture can be braided as by winding a plurality of filaments wrapped around the elongated core and the anvil. The wound filaments desirably form a braid that extends along the length of the elongated core which adds resistance to the suture, particularly by instances where the suture is under tension. In one embodiment, the barbs preferably protrude through the interstices of the braid.
    [00010] In one embodiment, the stop is integrally formed with the core. The stop is preferably fixed in place between the opposite sets of barbs. The stop preferably defines the largest cross-sectional dimension of the core. In one embodiment, the stop includes at least one concave part that protrudes from the core. The at least one concave part may have a longitudinal axis that extends along the longitudinal axis of the core. The at least one concave part may have a concave side surface. In one embodiment, the term "concave lateral surface" describes a surface that extends along the length of the nucleus. In one embodiment, the stop has two concave parts including a first concave part that protrudes from a first side of the core and a second concave part that protrudes from a second side of the core. The first and second concave parts of the anvil can be coplanar.
    [00011] In one embodiment, the suture includes a compress that has the first and second openings extending through it. The barbed suture can be assembled with the dressing by passing the first leg through the first dressing opening and the second leg through the second dressing opening. After the first and second legs have passed through the compress openings, the stop preferably extends between the first and second compress openings. In one embodiment, the stop has a length that generally corresponds to the spacing between the first and second openings of the compress. In one embodiment, the spacing between the first and second compress openings is measured from the inner edge of one opening to the inner edge of the other opening. In one embodiment, when the barbed suture is assembled with the compress, the compress is positioned between the first and the second barbed legs, and a main face of the anvil is opposite the main face of the compress.
    [00012] In one embodiment, a surgical suture includes an elongated core including a first leg, a second leg and a central region located between the first and second legs. The suture preferably includes a first set of splinters protruding from the first leg of the nucleus, a second set of splinters protruding from the second leg of the nucleus, and a stop protruding from the central region of the nucleus.
    [00013] The suture may include a braid formed around the elongated core and the stop to reinforce the suture, particularly by instances where the suture is under tension. The suture may include a compress with the first and second openings extending through it, so that the first leg desirably extends through the first opening of the compress, the second leg desirably extends through the second opening of the compress, and the stop extends between the first and second openings of the compress.
    [00014] In one embodiment, a surgical suture preferably includes an elongated core that has a first leg and a second leg, a first set of splinters protruding from the first leg, a second set of splinters protruding from the second leg, a stop protruding from the core and located between the first and second sets of barbs, and a braid surrounding the elongated core and the stop to reinforce the suture. The braid desirably includes a plurality of filaments wrapped around the elongated core, and the stop, so that the splinters of the first and second sets of splinters extend through the interstices of the braid.
    [00015] In one embodiment, the suture can be used in conjunction with a compress with the first and second openings extending through it, so that the first leg of the suture extends through the first opening of the compress, the second leg extends through the second opening of the pad, and the stop extends between the first and second openings of the pad.
    [00016] In one embodiment, the stop may include a double concave end stop extending from the core of a suture. In one embodiment, the stop may include a single concave end stop projecting from the core of a suture. In yet another embodiment, the stop preferably includes a flap protruding from the core of a suture. The stop is preferably fixed to the core and is adapted to remain stationary in relation to the core. The anvil can be used with barbed and non-barbed sutures, and braided or non-braided sutures.
    [00017] In one embodiment, a barbed suture may have a plurality of splinters including a main splinter that has a more gradual outward slope than trailing splinters. The main splinter can have an arrowhead shape that provides a smoother transition from the suture core to the full size splinters that pull the main splinter. The main arrowhead barb can have a longitudinal length that is greater than the longitudinal length of one or more of the drag barbs. In one embodiment, the main splinter has a length that is about 3 to 4 times greater than the length of the drag splinters. As used above, the term "term" means a length measured along the longitudinal axis of the suture. In one embodiment, a barbed suture that has a main arrowhead-shaped barb can include an untwisted barbed insert. In one embodiment, a barbed suture having an arrowhead-shaped main barb can be a braided barbed suture including a barbed insert and filaments wrapped around the barbed insert to form a braid. As such, the term "core" can be used to describe the elongated core of a barbed insertion element or the elongated non-barbed filament positioned along the longitudinal axis of a barbed insertion element.
    [00018] These and other preferred embodiments of the present invention will be described in detail later in this document. BRIEF DESCRIPTION OF THE DRAWINGS
    [00019] Figure 1A shows a front elevation view of a barbed suture including a compress.
    [00020] Figure 1B shows a central region of the barbed suture shown in figure 1 A.
    [00021] Figures 2A-2B show a plurality of barbed sutures used to attach a prosthetic device to the tissue.
    [00022] Figures 3A and 3B show a barbed suture that has a plug in a central region thereof, according to an embodiment of the present invention.
    [00023] Figure 4 shows a barbed suture that has a plug in a central region thereof, according to another embodiment of the present invention.
    [00024] Figure 5 shows a barbed suture that has a plug in a central region thereof, in accordance with yet another embodiment of the present invention.
    [00025] Figure 6 is a graphical representation showing the results of the load test on the braided sutures shown in Figures 3B, 4 and 5, respectively.
    [00026] Figure 7A shows a braided barbed suture that has a tampon that is used in conjunction with a compress, according to an embodiment of the present invention.
    [00027] Figure 7B shows an enlarged view of the braided barbed suture and the compress shown in figure 7A.
    [00028] Figure 8A shows a perspective view of the braided barbed suture and the compress of Figure 7A assembled together.
    [00029] Figure 8B shows a bottom view of the braided barbed suture and the compress shown in figure 8A.
    [00030] Figure 9 shows a suture that has a plug in a central region thereof, according to another embodiment of the present invention.
    [00031] Figure 10 shows a suture that has a plug in a central region of the same, according to another embodiment of the present invention.
    [00032] Figure 11 shows a suture that has a plug in a central region thereof, according to yet another embodiment of the present invention.
    [00033] Figure 12 shows a barbed suture that has a main arrow-shaped barb, according to an embodiment of the present invention. DETAILED DESCRIPTION
    [00034] With reference to figures 1A and 1B, a bidirectional barbed suture 20 includes a first leg 22 having a first set of barbs 24 and a first suture needle 26 provided at the distal end of the first leg. The bidirectional barbed suture 20 includes a second leg 28 having a second set of splinters 30 and a second suture needle 32 provided at the distal end of the second leg. The first set of barbs 24 extends in an opposite direction from the second set of barbs 30. Barbed suture 20 includes a core 34, and the first and second sets of barbs 24, 30 protrude out of the core 34. The core 34 has a central region 36 that is located and extends between the first and second sets of splinters 24, 30. Before or during a surgical procedure, the first and second legs 22, 28 of the bidirectional barbed suture 20 pass through the respective first and second openings 38A, 38B of a dressing 40. In one embodiment, the first needle of suture 26 passes through the first opening 38A of dressing 40 and the second needle of suture 32 passes through the second opening 38B of dressing 40. The first and the second legs 22, 28 are pulled through the pad openings so that the pad 40 is positioned within the central region 36 of the core 34, which is between the first set of barbs 24 and the second set of barbs 30.
    [00035] Referring to Figure 1 A, the bidirectional barbed suture 20 can be used to attach a suture ring from valve 42 to tissue T. The suture ring from valve 42 is positioned adjacent to the tissue. First needle of suture 26 is pulled through the T fabric and the valve suture ring 42 so that at least some of the first splinters 24 in the first leg 22 extend from the top surface 44 of the valve suture ring 42. The second suture needle 32 is pulled through the T fabric and the valve suture ring 42 so that at least some of the second splinters 30 on the second leg 28 extend from the top surface 44 of the valve suture ring 42.
    [00036] Referring to figure 2A, a plurality of bidirectional barbed sutures and compresses are used around the perimeter of the valve suture ring 42 to secure a prosthetic device 46, such as a heart valve, to the T tissue. As shown in the figure 2A, the compress 40 is preferably aligned with the central region 36 (figure 1B) of the barbed suture core 20. With reference to figure 2B, the first and second legs 22, 28 of each bidirectional barbed suture extend to the along the axes that are substantially parallel to each other. The spacing between the first and second legs 22, 28 of the suture is controlled by the spacing between the openings 38A, 38B in the dressing 40. Some of the barbs 40 in the legs 22, 28 engage the top surface 44 of the suture ring 42 to secure the suture ring to T tissue.
    [00037] With reference to figure 3A, in one embodiment, a bidirectional barbed suture 100 has a first end 102 and a second end 104. The first and second ends 102, 104 of the barbed suture can be connected to the respective hooks, needles or perforating fabric elements to pass the respective first and second ends 102, 104 through the openings of the dressing, tissue and / or prosthetic devices. The bidirectional barbed suture 100 preferably includes an elongated core 106 that extends between the first and second ends 102, 104, and a plurality of barbs 148 projecting outwardly from the core 106.
    [00038] In one embodiment, the bidirectional barbed suture 100 includes a first set of barbs 108 projecting from the core 106 and a second set of barbs 110 projecting from the core 106. The first and second sets of barbs 108, 110 desirably project in opposite directions. The core 106 of the bidirectional barbed suture 100 preferably includes a central region 112 that extends between the first and second opposing sets of barbs 108, 110.
    [00039] With reference to figures 3A and 3B, in one embodiment, the bidirectional barbed suture includes a stop 114 located within the central region 112 of the core 106. The stop preferably projects outwardly from the core. In one embodiment, the stop 114 is desirably integrally formed with the core. In one embodiment, the stop 114 preferably includes a first concave part 116 which has a first end 118 and a second end 120, and a concave top surface 122 which extends between the first and second ends 118, 120. The stop 114 preferably includes a second concave part 124 having a first end 126 and a second end 128, and a concave surface 130 extending between the first end 126. In one embodiment, the first and second concave parts 116, 124 protrude from opposite sides of the nucleus and are coplanar. The first and second concave parts 116, 124 can be integrally formed with the core.
    [00040] In one embodiment, the stop 114 is preferably incorporated into the bidirectional barbed suture 100 within a central region of the suture 100 in order to limit the mobility of a compress and / or to optimize the performance of the suture. Although the present invention is not limited by any particular theory of operation, it is believed that providing a bidirectional barbed suture with a stop located between the first and the second set of opposing barbs improves the holding strength of the barbed suture and prevents unwanted movement of the compress after the sutures have been stretched. Yours, during a surgical procedure, one leg of a conventional barbed suture is over-insulated while attaching a prosthetic device, there is the possibility of pulling the splinters on the second opposite leg through a compress hole, causing the barbed suture to come out of the compress and potentially fail. The present invention seeks to minimize these risks by providing a barbed suture that has a stop located between the first and the second opposite barbed sections. The centrally located stop cooperates with the compress to form an improved tissue support that essentially decouples each leg from the suture from each other, allowing each leg of the suture to be placed independently of one another to reduce the potential for device failure. In one embodiment, the anvil can be used as a tissue support itself without requiring a compress, thus eliminating the need to use a compress with the barbed suture. Arrangements using the stop as a supportive tissue support along may also eliminate the potential for the suture to return outward because the stop is preferably a fixed part of the suture.
    [00041] The barbed sutures with a stop shown in this application can be used in a wide variety of surgical procedures, where fixation is necessary. In one embodiment, the present invention can be used for heart valve attachment procedures. The present invention can also be used for other medical applications such as hernia repair, anastomoses, wound closure, organ support (for example, pexi procedures, for example, with pelvic organ support or tongue support for the treatment of obstructive sleep apnea), trauma repair (where rapid tissue repair is required), cosmetic procedures and other surgical procedures that require the distribution of forces along the tissue surface to minimize pressure on the direct suture in the tissue. The barbed sutures shown in the present invention can also be used for wound closure. In one embodiment, an incision can be closed using a barbed suture. In one embodiment, a surgical method includes passing a suture through both sides of the initial end of an incision, tying a knot at the initial end of the incision, and then going through a suture to the opposite end of the incision, then going through a suture to the opposite end of the incision and place a suture in the opposite direction. Another technique involves starting the suture a short distance from the initial end of the incision, suturing back to the beginning of the incision, and then going through the suture to the opposite end of the incision, then going through a suture to the opposite end of the incision and put a suture in the opposite direction.
    [00042] With reference to figure 4, in one embodiment, a bidirectional barbed suture 200 includes an elongated core 206, a first set of barbs 208 and a second set of barbs 210 that project in an opposite direction from the first set of barbs 208 The elongated core 206 includes a central region 212 that extends between the first and second sets of barbs 208, 210. Suture 200 preferably includes a stop 214 projecting from the region of the central core. The stop 214 preferably includes a single concave part 216 having a first end 218, a second end 220 and a concave surface 222 extending between the first and second ends 218, 220. The stop 214 is preferably , permanently attached to and / or integrally formed with the core 206 to remain within the central region 212 of the barbed suture 200.
    [00043] Referring to figure 5, in one embodiment, a bidirectional barbed suture 300 includes a core 306, a first set of barbs 308 and a second set of barbs 310. The first and second set of barbs preferably extend in opposite directions. The core 306 desirably includes a central region 312 extending between the first and second sets of barbs 308, 310. The central region 312 of the core 306 preferably includes a flap-shaped stop 314 projecting from the region of the core central 312. The flap-shaped stop 314 is preferably positioned between the first set of barbs 308 and a second set of barbs 310.
    [00044] In one embodiment, providing a compress stop on a barbed suture allows a compress to function as a more effective tissue support. Bench testing was performed to quantify the average maximum load required to pull a barbed device with a compress plug through a compress hole when attaching an individual suture leg during surgery. An Instron test device with a load capacity cell of 89.0 Newton (20 lb) was used to test at a crosshead speed of 12.7 cm / min (5 in / min). The needle at one end of the barbed suture was manually passed through a hole in a blade of compress material to a point where the barbed insertion section was just below the plane of the compress material. The end of the suture that passed through the compress hole was attached to the handle of the upper Instron and the crosshead movement was initiated to pull through. The end of the test criterion for pulling through was approximately the point at which the entire barbed insertion section passed through the compress hole. Therefore, the first splinter section flattened in the preferred direction as it passed through the compress hole while the opposite splinter set was curved back on itself. Different designs of compress plugs have been incorporated between these opposite barbed sections for evaluation. A design that requires greater force to pull the compress plug through the compress hole will be more effective in protecting against excessive stretching of the device that could occur during cardiac valve seating during surgery.
    [00045] The table below summarizes the average maximum loads recorded on the stop for the respective modalities of compress buffer shown in figures 3A, 4 and 5. In a preferred embodiment, the compress comprises a TEFLON® compress material, however, others biocompatible materials can also be used. Ten devices were tested for each of the compress plug designs shown in the present invention. They were compared with a control suture, namely, a barbed suture that does not have a compress plug. Table I: Average maximum load (Newton (Ibf)) for each compress plug design.

    [00046] Figure 6 represents the data above in a graphical representation format. From the data in figure 6, it is evident that the two-concave stopping mode of figure 3A requires the greatest load to pull the stopper through a compress hole. The stop mode of the single concave part of figure 4 required the second load, and the flap-shaped stop mode shown in figure 5 required less load than the modes of figures 3A and 4. However, all three of the modes stopper shown in figures 3A, 4 and 5 provided significantly improved results over a bidirectional barbed suture that does not have a localized lock between opposite sets of barbs.
    [00047] In one embodiment, the bidirectional barbed sutures shown in figures 3A to 3B, 4 and 5 can be braided as presented in one or more modalities of the US patent application assigned to the same applicant serial number 12 / 548,984, entitled " Automated Systems and Methods for Making Braided Barbed Sutures ", filed on the same date as this application (ETH5439USNP), its description being incorporated herein by reference in the present invention.
    [00048] Referring to figure 7A, in one embodiment, a bidirectional barbed suture 400 like that shown in figures 3A and 3B, passes through a braiding system to wrap the filaments around the suture core to form a braid 450. The braided barbed suture 400 includes a first end 402, a second end 404 and an elongated core 406 that extends between the first and second ends. The braided barbed suture 400 preferably includes a first set of barbs 408 and a second set of barbs 410 that extend in an opposite direction from the first set of barbs 408. The first and second set of barbs preferably project to outside from the core 406. The elongated core 406 includes a central region 412 and a lock 414 projecting outwardly from the core 406 into the central region 412. The braided barbed suture 400 preferably includes a plurality of filaments wrapped around the elongated core 406 and the stop 414. The braid 450 preferably extends beyond the first and second ends of the barbed suture 400. Although the present invention is not limited by any particular theory of operation, it is believed that the wrapping a plurality of filaments around the elongated core 406 reinforces the barbed insert and provides a braided barbed insert that has optimum durability and / or resistance used. In one embodiment, braiding can be useful when the braided barbed suture is under tension. The barbs 448 of the first and second barbs 408, 410 preferably protrude through the interstices of the braid 450.
    [00049] In one embodiment, the barbed suture is made using a non-absorbable polymeric material and a non-absorbable multifilament polyester suture commonly sold under the ETHIBOND EXCEL polyester suture trademark by Ethicon, Inc., with surgical needles attached to both the ends of the suture. A compress, such as a Teflon® compress, can be positioned in the middle of the polymeric anchoring section.
    [00050] The barbed suture and the filaments wrapped around the suture to make the braid can be produced from conventional, biocompatible, non-absorbable materials and combinations of absorbable and non-absorbable materials. Preferred non-absorbable materials suitable for both barbed inserts and filaments include polypropylene, a polymer blend of polyvinylidene fluoride and polyvinylidene-co-hexafluorpropylene fluoride, polyethylene, polyvinylidene fluoride (PVDF), polyesters, polyethylene terephthalate and tethylene terephthalate. modified with glycol, polytetrafluoro ethylene, fluoropolymers, nylon, etc. and the like, or copolymers of combinations thereof. Preferred absorbable polymeric materials suitable for both barbed inserts and filaments include polydioxanone, polyglactin, polyglycolic acid, glycolide and lactide copolymers, polyoxaesters and polyglecaprone. In certain preferred embodiments, these may include combinations of both absorbable and non-absorbable materials, specifically for the filaments. In addition, metals or ceramics may be suitable for certain applications, such as instances where specific resistance or corrosion resistance is required. In a preferred embodiment, the insertion element preferably includes a polymer blend of polyvinylidene fluoride and polyvinylidene-co-hexafluorpropylene fluoride material, and the braid preferably includes a polyethylene terephthalate material. In addition, any of these materials may have conventional surface modifications that include coatings, plasma, therapeutic and similar treatments.
    [00051] With reference to figure 7B, in one embodiment, the filaments are wrapped around the core and the stop 414. The barbs of the first and second barbs 408, 410 desirably project between the interstices of the braid 450. In one embodiment, the braided barbed suture 400 is used in conjunction with a compress 440, as a compress produced from TEFLON® material, which has a first opening 438A and a second opening 438B spaced from the first opening system. In one embodiment, the distance D 1 between the spaced openings of the pad 438A, 438B preferably correspond to the length Li of the stop 414. In one embodiment, the end walls of the stop can adapt to the shape of the openings that extend through the pad.
    [00052] With reference to figure 8A, in one embodiment, the first and second ends 402, 404 of the braided barbed suture 400 of figure 7A pass through the first and second openings (not shown) of the compress 440 so that the stop 414 within the central region 412 of the suture core is positioned between the first and second openings of the dressing 440. In one embodiment, a main face of the stop 414 is preferably placed against an opposite main face of the dressing 440.
    [00053] Figure 8B shows the compress stop 414 positioned between the first and second openings 438A, 438B of the compress 440. The first and second legs of the braided barbed suture and the braid formed around the legs desirably extend through the first and second compress openings 438A, 438B. In one embodiment, the plurality of filaments are preferably wound around the suture core and the compress stop 414 to reinforce the insertion element. In one embodiment, the filaments can reinforce and / or add strength to the braided barbed suture, particularly when the braided barbed suture is under tension.
    [00054] The stops in the form of an entire concave part, half of the concave part and flap described above can also be supplied in sutures without barb. Such sutures can be braided and / or unraveled. With reference to figure 9, in one embodiment, a suture 500 includes an elongated core 506 having a stop 514 which is similar to the stop of two concave parts shown in the embodiments of figures 3A and 7A.
    [00055] With reference to figure 10, in one embodiment, a suture 600 has an elongated core 606 and a single concave part stop 614 similar to that shown in the embodiment of figure 4.
    [00056] With reference to figure 11, in one embodiment, a suture 700 has an elongated core 706 and a flap-shaped stop 714 similar to that shown in the embodiment of figure 5. The stop 714 is preferably centrally located in the core 706 of the suture. In one embodiment, the stop preferably has a length that substantially corresponds to the spacing between the first and second openings in a compress used therewith. In one embodiment, the sutures with stops shown in the embodiments of figures 9 to 11 can be used without a compress. In these modalities, the stop can, in itself, function as a support for the suture.
    [00057] With reference to the figure. 12, in one embodiment, a barbed suture 800 includes an arrowhead main barb 815A that precedes a series of drag barbs 815B-815E. The main arrowhead barb 815A has a length l_2 that is greater than the length l_3 of the trailing barbs 815B-815E. In one embodiment, the length l_2 of the main barb 815A is about 2.54 mm (0.1 inch) and the lengths l_3 of the respective drag barbs 815B-815E are about 0.76 mm (0.03 inch). In one embodiment, the main barb 815A has a length that is about 4X greater than the length of the trailing barbs 815B-815E. Since the length of the main barb is longer than the length of the drag barbs, the 815A main arrowhead bar tapers out at an angle ai which is less than the a2 angle of the barks 815B- 815E . In one embodiment, a tangent line that extends along the taper of the main barb 815A extends to the outer edge of the trailing barb 815B, which additionally extends to the outer edge of the trailing barb 815D. In one embodiment, main splinter 815A tapers away from core 806 at an angle of about 10 to 20 ° and trailing splinters 815B-815E taper outward at an angle of about 50 to 60 °. The more gradual tapering out of the main arrowhead barb 815A preferably allows a smoother transition from the suture core 806 to the 815B-815E drag as the suture is pulled by the fabric or a suture ring. In this way, the main arrowhead barb 815A is preferably adapted to gradually distribute the traction force necessary to pass the splinters through the fabric or a suture ring as opposed to a more abrupt angular transition from the 806 core to the trailing barbs 815B-815E, and as found with the barbs of the barbed sutures of the prior art. Although figure 12 shows an untwisted barbed suture, the main arrowhead barb of figure 12 can also be incorporated into a braided barbed suture.
    [00058] In one embodiment, the barbs have a width (that is, from one end of the barb to the other end of the same barb) that is large enough to extend beyond the braid when a barbed insert is combined with a braided structure to allow the splinters to engage the tissue or engage the tissue of an implant.
    [00059] One or more characteristics of any of the modalities presented in the present invention can be combined with one or more characteristics of any of the other modalities presented in the present invention and still be within the scope of the present invention. The present invention may also incorporate one or more of the modalities presented in patent application publications assigned to the same applicant No. US 2007/0005110 and US 2007/0257395, and to US patent applications assigned to the same applicant No. 12 / 135,176. 12 / 140,311; 12 / 177,947; and 12 / 340,829, the descriptions of which are incorporated herein by reference into the present invention.
    [00060] Although the above is directed to modalities of the present invention, other additional modalities and modalities of the invention can be developed without departing from its basic scope. Accordingly, the scope of the present invention is intended to be limited only as set out in the appended claims.
    权利要求:
    Claims (12)
    [0001]
    1. Surgical suture (100) comprising: an elongated core (106) that includes a first leg (102) and a second leg (104); and a first set of barbs (108) protruding from the first leg (102); and a second set of barbs (110) protruding from the second leg (102), in which the first and second sets of barbs (108,110) are flexible, characterized by the fact that it still comprises a stop (114) which it projects from the elongated core (106) between the first and second legs (102,104), in which the stop is integrally formed with the core (106) and projects from a central region (112) of the elongated core (106) located between the first and second sets of barbs (108,110), and where the stop (114) is less flexible than the first and second sets of barbs (108,110).
    [0002]
    2. Surgical suture, according to claim 1, characterized by the fact that the first set of splinters (108) protrudes in a first direction and the second set of splinters (110) protrudes in a second direction that is opposite to first direction.
    [0003]
    3. Surgical suture according to claim 1, characterized by the fact that it still comprises a plurality of filaments wrapped around the elongated core (106) and the stop (114) to form a braid (450) that extends along of the elongated core (106).
    [0004]
    4. Surgical suture, according to claim 1, characterized by the fact that the stop (114) defines the largest dimension in cross section of the nucleus.
    [0005]
    5. Surgical suture, according to claim 1, characterized by the fact that the stop (114) comprises at least one concave part (116,124) that protrudes from the core (106).
    [0006]
    6. Surgical suture, according to claim 4, characterized by the fact that the stop (114) comprises a first concave part (116) that protrudes from a first side of the core (106) and a second concave part ( 124) projecting from a second side of the core (106).
    [0007]
    7. Surgical suture, according to claim 6, characterized by the fact that the first and second concave parts (116,124) of the stop (114) are coplanar.
    [0008]
    8. Surgical suture, according to claim 1, characterized by the fact that it still comprises a compress (440) that has first and second openings (438A, 438B) that extend through it, in which the first leg (102) extends through the first compress opening, the second leg (104) extends through the second compress opening, and the stop (114) extends between the first and second compress openings.
    [0009]
    9. Surgical suture, according to claim 1 or 8, characterized by the fact that it still comprises a braid (450) formed around the elongated core (106) and the stop (114).
    [0010]
    10. Surgical suture according to claim 9, characterized by the fact that the stop (114,414) has a length that corresponds to the space between the first and second compress openings (438A, 438B).
    [0011]
    11. Surgical suture according to claim 1, characterized by the fact that at least one of the first and second legs (102,104) includes an anterior barb (815A) that has an inclination that projects more gradually outward than one second barb (815B) after the previous barb (815A).
    [0012]
    12. Surgical suture, according to claim 9, characterized by the fact that the braid (450) comprises a plurality of filaments wrapped around the elongated core (406) and the stop (414), and in which the barbs (448 ) of the first and second set of barbs extend through the braid (450).
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-07-28| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-10-27| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 27/10/2020, OBSERVADAS AS CONDICOES LEGAIS. |
    2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 24/08/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |
    优先权:
    申请号 | 申请日 | 专利标题
    US12/549,046|US9011487B2|2009-08-27|2009-08-27|Barbed sutures having pledget stoppers and methods therefor|
    US12/549,046|2009-08-27|
    PCT/US2010/046435|WO2011025760A1|2009-08-27|2010-08-24|Barbed sutures having pledget stoppers and methods therefor|
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