• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    system and method for making braided barbed sutures the present invention relates to a system (50) for making braided barbed sutures which includes a set of winding filaments, and a guide set which includes an opening for dispensing at least one element of winding barbed insert (100 and 304) that defines a passage to guide a barbed insert. the guide assembly is adapted to dispense at least one barbed insertion element from the dispenser opening into the winding filament array to wrap a plurality of filaments (284 and 308) around said at least one insertion element to make a braided barbed suture. the passage of the dispenser opening is adapted to allow a longitudinal movement of the barbed insertion element in relation to the passage and simultaneously to prevent a twisting movement of the barbed insertion element in relation to the passage. as the barbed insertion element is dispensed, the opening of the barbed insertion dispenser is rotated selectively to give rotation to the barbed insertion element as the filaments are wound around the barbed insertion element. the passage may be an elongated slit wider than the height.
    公开号:BR112012004305B1
    申请号:R112012004305-6
    申请日:2010-08-27
    公开日:2020-01-07
    发明作者:David C. Lindh；Jason T. Perkins；Krasimira Hristov；Jesse G. Nawrocki；Robert J. Tannhauser
    申请人:Ethicon, Inc；
    IPC主号:
    专利说明:

    Invention Patent Specification Report for
    SYSTEM AND METHOD FOR MAKING BARBED SUTURES
    BRAIDED.
    BACKGROUND OF THE INVENTION
    FIELD OF THE INVENTION [0001] The present invention relates, in general, to surgical sutures, and more specifically it relates to automated systems and methods for producing braided barbed sutures.
    DESCRIPTION OF THE RELATED TECHNIQUE [0002] Surgical sutures are used to close wounds and surgical incisions, and to repair damaged muscles, vessels and tissues. Typically, a needle is attached to one end of the surgical suture, and the needle is pulled through the tissue to form one or more loops that hold said tissue together. The suture is subsequently tied with one or more knots so that the tissue remains joined.
    [0003] There are several attempts aimed at improving the sutures.
    For example, U.S. Patent No. 4,546,769 to Planck et al. it features a suture including a wrapper produced from a tubular braided structure, such as unruffled threads, and a core located within the wrapper containing ruffled fibers. The wrapper is formed by the braiding of unruffled threads around the core, which provides a suture that is easier to flex, easier to handle and that makes better knots.
    [0004] Although sutures are very effective in closing wounds, there are numerous challenges associated with the use of conventional sutures. Many of these challenges are directly related to the knots used to hold 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. Beyond
    Petition 870190080823, of 8/20/2019, p. 14/49
    2/36 of this, the use of knots to secure sutures can distort tissues, restrict blood flow, increase scarring, prevent wound healing, and result in infection.
    [0005] In response to the deficiencies noted above associated with conventional sutures, sutures with splinters were 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 without the use of knots. American patent No. 5,931,855 features sutures with splinters that are used for cosmetic procedures such as lifting the eyebrows and lifting the face. 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.
    [0006] A problem associated with barbed sutures is that the splinters can slide off or separate from the suture core, which can lead to device failure. In response to the problems encountered with the barbed sutures, barbed sutures braided with more durable barbs were developed. In an embodiment of the publication of the US patent application assigned to the same applicant No. 2007/0005110, its description being incorporated herein by reference, at least one barbed filament element is interlaced along its length with a plurality of non barbed filament elements, and the plurality of barbs extends beyond the non-barbed filament elements. In one embodiment, a braided barbed suture made using the methods presented in publication '110 had a 96% improvement in resistance retention compared to a barbed monofilament. Thus, a
    Petition 870190080823, of 8/20/2019, p. 15/49
    3/36 resistance to upper fixation was obtained without requiring the use of knots.
    Other efforts to produce braided, barbed sutures include manually supplying a barbed filament within a filament winding assembly. This approach requires an operator to follow a complex series of steps including operating a strand to form a first length of non-barbed suture, disconnecting the strand, placing a barbed filament in the hole of the strand where the strands curl, then reconnecting the strand and let the winding filaments pull the braided filament into the braid. This approach provides very little control over the interlacing of the barbed filament, as it is pulled into the braid, which commonly results in an unwanted braiding quality. This approach is also extremely labor intensive because an operator is required to continuously turn the braiding equipment on and off while adjusting the position of the barbed filament. In addition, the barbed insertion material being braided is greatly affected by the winding filaments themselves or by the vibration created as a result of the winding. The vibration generated by the braiding equipment can result in the wires being wound, interlaced, immobilized in the filaments, or in the accumulation of undesirable rotation.
    [0007] Despite the advances above, there remains a need for improved systems and methods for producing braided, barbed sutures, including automated systems and methods for producing braided, barbed sutures. There is still a need for improved systems and methods that consistently produce braided barbed sutures that meet exact standards, and that transform barbed barbed inserts in a single plane into barbed barbed sutures with multiple planes.
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    SUMMARY OF THE INVENTION [0008] In one embodiment, a system for producing braided barbed sutures includes a filament winding set adapted to wrap a plurality of filaments around an object, such as a barbed insert, and a guide set including at least one opening the barbed insertion dispenser defining a passage to guide a barbed insertion. In one embodiment, the passageway is an elongated slit that has a width greater than the height. The guide assembly is preferably adapted to dispense at least one barbed insert from the dispenser opening and within the filament winding assembly so that the plurality of filaments can be wound around the barbed insert. The passage of the dispenser opening is preferably adapted to allow the longitudinal movement of at least one barbed insertion in relation to the passage while simultaneously preventing the twisting movement of at least one barbed insertion in relation to the passage. In other words, the passageway is sized and modeled to allow the barbed insert to move freely along its longitudinal axis in relation to the passageway. However, the passage has a size and shape that substantially adapts to the size and shape of the barbed insertion so that the barbed insertion is constrained to rotate about its longitudinal axis in relation to the passage when the barbed insertion is passing through the passage.
    [0009] Although the present invention is not limited by any particular theory of operation, it is believed that providing a passage, such as an elongated slit, to dispense with a barbed insertion provides improved control of the orientation and configuration of the barbed insertion as it is introduced within the filament winding assembly. During a braiding operation,
    Petition 870190080823, of 8/20/2019, p. 17/49
    5/36 a barbed insert can twist, form a loop and / or rotate uncontrollably around its longitudinal axis as it is introduced into the filament winding assembly, which can result in the formation of twisted barbed sutures of inconsistent quality . The present invention seeks to reduce the number of uncontrollable variables found in conventional braiding systems by more direct control of the orientation and configuration of the barbed insert as it is introduced into the filament winding assembly. The present invention also provides an automated system that does not require continuous human supervision.
    [00010] In one embodiment, a barbed insert includes an elongated core that has a main end, an end end and a longitudinal axis extending between the main and end ends thereof. The barbed insert preferably includes at least one splinter, and preferably a plurality of splinters extending outside the core. In one embodiment, the plurality of barbs includes a first set of barbs extending in a first direction, and a second set of barbs extending in a second opposite direction. In one embodiment, at least one set of barbs may narrow outward between a first end and a second end, which preferably facilitates the passage of the barbed suture through the tissue.
    [00011] In one embodiment, the passage of the barbed insert dispenser opening desirably controls and / or prevents the rotation of a barbed insert in relation to the passage when the barbed insert is in contact with the passage and as the barbed insert is inserted into of the filament winding assembly. In one embodiment, the opening of the barbed insert dispenser can be rotated as the barbed insert is dispensed
    Petition 870190080823, of 8/20/2019, p. 18/49
    6/36 of this to give rotation to the section of the barbed insert in contact with the passage. Thus, although the barbed insert does not rotate about its longitudinal axis in relation to the passage, the barbed insertion can be rotated through the passage to provide a twist to the barbed insertion. In one embodiment, the passageway is rotated as the barbed insert is dispensed so that the filaments are wound helically around the barbed insert which, in turn, can result in the transformation of a barbed insert with barbs in a single plane within of a braided barbed suture that has splinters projecting in multiple planes, such as approximately 360 ° around the perimeter of the nucleus.
    [00012] The system described here is preferably automated so that braided sutures with consistent characteristics and quality can be produced. In one embodiment, the system preferably includes a system controller that has a central processing unit to control the operation of the system. In one embodiment, the system controller controls the operation of the filament winding assembly and the guide assembly. The system controller can have a first state in which the opening of the dispenser is stationary as a barbed insert is dispensed within the filament winding assembly. The system controller may have a second state in which the dispenser opening is rotated as the barbed insert is dispensed within the filament winding assembly to provide a twist to the barbed insert as the filaments are wound around the core of the barbed insert.
    [00013] In one embodiment, a plurality of barbed inserts with finite lengths are introduced in series in the filament winding assembly. In this embodiment, the guide assembly preferably comprises a plurality of cartridges, each
    Petition 870190080823, of 8/20/2019, p. 19/49
    7/36 one of the cartridges including one of the dispenser openings defining a passage (for example, an elongated slot) to guide one of the barbed inserts. Each of the barbed inserts is preferably loaded in one of the cartridges, so that a leading end of each barbed insertion protrudes from the opening of the barbed insertion dispenser opening associated with it.
    [00014] In one embodiment, the guide assembly also includes a deposit to hold the cartridges and the system controller includes a subroutine to introduce the cartridges one at a time into the filament winding assembly. In one embodiment, a first loaded cartridge is inserted into the filament winding assembly so that the barbed insert loaded therein can be pulled into the filament winding assembly to produce a first braided barbed suture. After the barbed insert has been pulled from the first cartridge, the cartridge can be automatically removed from the system. A second cartridge including a barbed insert loaded there may then be advanced in alignment with the filament winding assembly so that the second barbed insert in the second cartridge cartridge can be pulled into the braid to form a second braided barbed suture. The second empty cartridge is then dispensed, and the process is repeated to supply a series of loaded cartridges to the filament winding assembly and to remove the empty cartridges from the system.
    [00015] In one embodiment, each of the cartridges preferably includes an optical window to provide visual access to the barbed inserts loaded there. The system controller preferably includes an optical sensor and / or optional equipment to determine whether barbed inserts are present in the cartridges.
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    8/36
    In one embodiment, after a barbed insert has been pulled from a cartridge, the optical sensor determines that the barbed insert has been removed and the cartridge is empty. At this point, the optical sensor transmits a signal to the system controller, which in turn generates one or more signals to remove the empty cartridge from the system and advance the next loaded cartridge in alignment with the filament winding assembly.
    [00016] In one embodiment, each cartridge includes an external surface and the guide assembly preferably includes a cartridge insertion rod that engages the external surfaces of the respective cartridges to control the movement of the cartridges. In one embodiment, each cartridge includes a lower end that is engaged and the cartridge insertion rod includes an upper end that is engaged to engage with the lower end of the cartridge. In one embodiment, the opposed engaged ends allow the cartridge insertion rod to prevent the cartridge from rotating around its longitudinal axis as the barbed insert loaded there is pulled into the filament winding assembly. In one embodiment, the cartridge insertion rod can rotate under the command of the system controller to rotate the cartridge and the dispenser opening associated with the cartridge, which in turn provides a twist to the barbed insertion as the insertion element is pulled from the cartridge dispenser opening.
    [00017] In one embodiment, a system for producing braided barbed sutures includes a filament winding assembly that has a plurality of filaments, and a guide assembly to guide at least one barbed insert towards the filament winding assembly. The guide assembly desirably has a barbed insert dispenser opening, like a slit
    Petition 870190080823, of 8/20/2019, p. 21/49
    9/36 elongated, adapted to allow longitudinal movement of the barbed insert through the opening of the barbed insert dispenser while at the same time preventing the twisting movement of at least one barbed insert in relation to the opening of the barbed insert dispenser. In one embodiment, the filament winding assembly desirably includes a hole in the strand for directing the plurality of filaments toward a strand zone. The guide assembly is adapted to direct a leading end of at least one barbed insert within the braiding zone to wrap the plurality of filaments around at least one barbed insert to produce a braided barbed suture.
    [00018] In one embodiment, at least one barbed insert has a longitudinal axis, and the barbed insert dispenser opening is rotatable as the barbed insert is dispensed from the barbed insert dispenser opening to rotate the barbed insert around its axis longitudinal according to the plurality of filaments are wound around the barbed insertion.
    [00019] In one embodiment, a method for producing braided barbed sutures includes a filament winding set that has a plurality of filaments, and provides at least one barbed insert for insertion into the filament winding set. The method preferably includes providing an opening of the barbed insert dispenser adjacent to the filament winding assembly to dispense at least one barbed insert into the filament winding assembly. The opening of the barbed insert dispenser is preferably adapted to allow the longitudinal movement of at least one barbed insert in relation to the opening of the barbed insert dispenser while at the same time preventing the twisting movement of at least one
    Petition 870190080823, of 8/20/2019, p. 22/49
    10/36 barbed insertion in relation to the opening of the barbed insertion dispenser. The method desirably includes dispensing at least one barbed insert from the barbed insert dispensing opening and into the filament winding assembly. A plurality of filaments is preferably wound around the barbed insert as it is dispensed from the opening of the barbed insert dispenser.
    [00020] In one embodiment, the at least one barbed insert includes a core and at least one barb protruding out of the core. In one embodiment, the opening of the barbed insert element dispenser defines an elongated slot that has a size and shape that substantially conforms to the size and shape of said at least one barbed insert element. In one embodiment, by dispensing at least one barbed insert, the opening of the barbed insert dispenser is preferably rotated to twist at least one barbed insert as the plurality of filaments are wound around at least one barbed insert. This particular modality preferably transforms a barbed insert with barbs that are in a single plane within a braided barbed suture that has barbs protruding 360 ° around the perimeter of the nucleus.
    [00021] In an embodiment of the present invention, systems and methods are adapted to consistently incorporate insertion materials into a multifilament suture during braiding, which produces resulting device designs with insert elements that are fully contained within the multifilament braid, or designs of resulting devices with protrusions extending out of the multifilament strand in a single plane or in multiple planes. In one embodiment, the barbed inserts of various sizes, shapes,
    Petition 870190080823, of 8/20/2019, p. 23/49
    11/36 materials or variations thereof can be incorporated into multifilament sutures of various sizes and materials, including absorbable and non-absorbable materials. New braiding technologies, such as those described here, provide a wide range of next generation suture-based devices. In one embodiment, the present invention provides for the fabrication of twisted barbed devices in a large-scale manufacturing environment with consistent and repeatable results. The fully automated features of the present invention eliminate the hassle of providing each barbed insert within the braid manually.
    [00022] In one embodiment, an individual barbed insert, having a distinct finite length, is placed inside a cartridge and fed into a filament winding set during braiding. The result is a suture-based device with finite braided suture sections interposed between the finite lengths of braided suture. In another embodiment, a continuous length of suture material with a braided profile, such as that of individual barbed inserts, can be continuously fed from a spool through a guide and subsequently incorporated into the winding filaments during braiding, which provides a suture-based device comprising a continuous length of braided barbed suture.
    [00023] In one embodiment, the automated braiding equipment provides for braiding the winding filaments around a barbed insertion with the desired protrusion of the multifilament suture barbs. The automated braiding equipment allows for a manufacturing method that consistently produces braiding quality satisfactory to the
    Petition 870190080823, of 8/20/2019, p. 24/49
    12/36 while significantly reducing the work involved in obtaining such devices. In one embodiment, a system operator can fill a tank with loaded cartridges, program the desired braiding cycle parameters and allow the automated braiding equipment to perform the braiding operation. Or, in the case of a continuous length of suture material having a barbed profile, the person operating the system can thread the guide end of a barbed material spool through the guide and allow the suture filaments to coil around the material barbed until the barbed material comes out.
    [00024] In one embodiment, the present invention also allows for the manufacture of barbed suture devices with helically shaped cores. The innovative aspect of this resulting design is that the helical shape of the core can be controlled using automated braiding equipment to create a fixture that provides 360 ° fixation resistance around the core.
    [00025] In one embodiment, a magazine loaded with a plurality of cartridges is locked in place below a braider with the use of a magazine tool. The strand is then turned on and a PLC-controlled cycle begins to distribute stranded cartridge inserts into the strand. At a suitable time, a retractable gate is retracted and an air cylinder pushes the stack of cartridges towards the chamber to load a guide cartridge into the chamber. The retractable gate then closes, isolates the guide cartridge loaded in the chamber. A two-stage lifting sequence can be started. During a first stage, a motorized support shelf moves upwards, and then stops. During a second stage, the lift sequence allows a push rod to engage the bottom of the cartridge
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    13/36 guides and initiates the upward movement of the stem and cartridge.
    [00026] In one embodiment, as the cartridge approaches its maximum displacement towards the winding filaments, however before the cartridge stops completely, the barbed insert is pulled out of the cartridge by the winding filaments. A fiber optic sensor detects when the barbed insert has been pulled out of the cartridge at which point the empty cartridge starts to move downwards. When the empty cartridge returns to the cartridge chamber, it is ejected and transported to a collection area through a cartridge ejection tube.
    [00027] In one embodiment, a continuous length of suture material that has a barbed profile is distributed through a guide and within a set of winding filaments. The guide is adapted to distribute the barbed material to the set of winding filaments. The guide end of the continuous length of the barbed suture material is threaded through the guide and incorporated within the winding suture filaments. In one embodiment, the guide can be rotated as the continuous length of the suture material is fed into the guide, so that the resulting braided barbed suture will have a helical shape that is permanently deformed by the braid itself. The present invention allows barbed sutures braided with barbs or other protuberances to be presented in a single plane or in multiple planes, including a 360 ° helical design.
    [00028] In one embodiment, a system for producing braided barbed sutures includes a projectile-type cartridge adapted to receive barbed inserts that are finite in length. In this modality, the cartridge is adapted to act as a vehicle for the distribution of a barbed insert in a braided multifilament suture. The projectile-type cartridge includes a slot fitted to the bottom
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    14/36 of the cartridge that prevents the unwanted twisting movement of the barbed insert to allow braiding. The cartridge is fixed and does not allow free movement of the insertion element, since it is incorporated into the strand.
    [00029] In one embodiment, the braiding system includes a controller with timers, sensors and cartridge distribution devices. The controller described above is preferably combined with conventional braiding technology, so that timers and sensors allow a fully automated repeatable braiding cycle, which allows for the consistent formation of barbed, braided sutures. The cartridge dispensing apparatus preferably allows the physical delivery of the cartridge, which contains a barbed insert, to the suture filaments at the desired suture length intervals. As the cartridge approaches its maximum displacement towards the winding filaments, however before the cartridge stops completely, the barbed insert is desirably pulled out of the cartridge by the winding filaments itself.
    [00030] In one embodiment, the control system provides control over variable movement / rotation, braiding speed and cartridge distribution speed. In one embodiment, the controlled rotation of the barbed insertion during distribution within the suture filaments allows for a resulting helical device, so that the braid of the suture adapts the twist of the barbed insertion core through the rotation of the cartridge.
    [00031] In one embodiment, the braiding system includes a cartridge tank with a retractable gate and ejection tube. The cartridge tank with retractable gate and ejection tube preferably allows a side loading and bottom ejection device that allows the distribution of a loaded cartridge within the filaments of
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    15/36 suture for braiding and ejecting an empty cartridge after the barbed insertion has been distributed within the braid.
    [00032] In one embodiment, a braiding system produces twisted barbed sutures with a helical-shaped core with barbs projecting 360 ° around the core. The helical design preferably allows the barbs to engage 360 ° around the core rather than in a single plane. The 360 ° positioning of the splinters preferably increases the fixation strength of the resulting device. The braiding system of the present invention preferably allows an operator to transform a flat, barbed insert with barbs in a single plane into a device with multiple planes. So far, such a device with multiple planes has only been obtainable through methods, such as cutting monofilament sutures and braiding the resulting device or through injection molding.
    [00033] In one embodiment, a braiding system includes a rotatable guide for barbed inserts that accommodate a continuous length of suture material with a barbed profile, so that the continuous length of the suture material is fed from a spool and incorporated into a braided. In one embodiment, a continuous length of suture material with a barbed profile can be fed through the rotating guide, incorporated into the braid and collected on a collection spool. The guide is desirably attached to the equipment by an appropriate substructure. The guide is preferably rotatable as the continuous barbed material is fed through it to create a periodic helical design of the resulting device, so that the suture filaments define the orientation of the continuous length of the barbed suture material.
    [00034] These and other preferred embodiments of the present invention will be described in detail later in this document.
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    16/36
    BRIEF DESCRIPTION OF THE DRAWINGS [00035] Figure 1 shows an automated system for producing braided barbed sutures, according to an embodiment of the present invention.
    [00036] Figure 2 shows a barbed insert used to produce a braided barbed suture, according to an embodiment of the present invention.
    [00037] Figure 3 shows a cartridge used to produce braided barbed sutures, according to an embodiment of the present invention.
    [00038] Figure 4A shows a top view of the cartridge shown in figure 3.
    [00039] Figure 4B shows a top perspective view of the cartridge shown in figures 3 and 4A.
    [00040] Figure 5A shows a cross-sectional view of a cartridge used to produce braided barbed sutures, according to an embodiment of the present invention.
    [00041] Figure 5B shows another cross-sectional view of the cartridge shown in figure 5A.
    [00042] Figure 5C shows a perspective view of the cartridge shown in figure 5B.
    [00043] Figure 6A shows the barbed insertion of figure 2 loaded in the cartridge shown in figures 5A to 5C.
    [00044] Figure 6B shows a leading end of the cartridge shown in figure 6A.
    [00045] Figure 6C shows an end end of the cartridge shown in figure 6A.
    [00046] Figure 6D shows a cross-sectional view of the cartridge shown in figure 6A.
    [00047] Figure 7A shows a side view of the cartridge in figure 3
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    17/36 loaded with the barbed insert in figure 2.
    [00048] Figure 7B shows a top perspective view of the cartridge and the barbed insert shown in figure 7A.
    [00049] Figure 7C shows a section of the middle of the cartridge of figure 3 with the barbed insert visible through an optical window, according to an embodiment of the present invention.
    [00050] Figure 8A shows a perspective view of a lower end of the cartridge of figure 3, according to an embodiment of the present invention.
    [00051] Figure 8B shows a side view of the lower end of the cartridge in figure 8A.
    [00052] Figure 8C shows a view of the perspective end of the lower end of the cartridge shown in figures 8A and 8B.
    [00053] Figure 9 shows a deposit holding a plurality of cartridges, according to an embodiment of the present invention.
    [00054] Figure 10 shows the tank and cartridges of figure 9 positioned below a braiding plate of the system shown in figure 1, according to an embodiment of the present invention.
    [00055] Figures 11A to 11E show a method of loading a cartridge into a system to produce braided barbed sutures, according to an embodiment of the present invention.
    [00056] Figure 12 shows the system of figure 1 during the step of the method shown in figure 11E, according to an embodiment of the present invention.
    [00057] Figure 13 shows a cartridge guide tube and a filament winding assembly, according to an embodiment of the present invention.
    [00058] Figures 14A and 14B show a method of advancing an upper end of a cartridge towards a set of
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    18/36 filament winding according to an embodiment of the present invention.
    [00059] Figure 14C shows filaments being wound around a barbed insert to form a braided barbed suture, according to an embodiment of the present invention.
    [00060] Figure 15 shows a braided barbed suture, according to an embodiment of the present invention.
    [00061] Figure 16 shows a braiding pin positioned downstream of the filament winding assembly shown in figure 14C, according to an embodiment of the present invention.
    [00062] Figure 17 shows an enlarged view of the braiding pin shown in figure 16.
    [00063] Figure 18 shows a suture collection spool located downstream of the braiding pin shown in figures 16 and 17, according to an embodiment of the present invention.
    [00064] Figure 19 shows an empty cartridge being dispensed from the system after a barbed insert has been pulled out of the cartridge, according to an embodiment of the present invention.
    [00065] Figures 20A to 20D show a method of removing an empty cartridge from the system shown in figure 1, according to an embodiment of the present invention.
    [00066] Figure 21 shows an automated system for producing braided barbed sutures, according to an embodiment of the present invention.
    [00067] Figure 22 shows a barbed suture braided with splinters projecting in multiple planes around a nucleus, according to one embodiment of the present invention.
    DETAILED DESCRIPTION [00068] With reference to figure 1, in an embodiment of the present invention, an automated system 50 for producing barbed sutures
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    Braided 19/36 includes a system controller 52 to control system operation. The automated system 50 preferably includes a closed area 54 which houses a braiding assembly 56 adapted to wrap filaments around barbed inserts to form braided barbed sutures, as will be described in detail below. Braiding assembly 56 preferably includes a braiding plate 58 and spools 60 that contain multifilaments that are positioned around braiding plate 58. Braiding assembly 56 desirably includes a hole in braiding 62 to direct the filaments towards a zone of central braiding, a cartridge guide tube 63, a braiding pin 64 and a suture collection spool 66. The braiding system preferably also includes an air cylinder 68 located under the braiding plate 58 and a tank 70 to hold a plurality of cartridges that are pre-loaded with barbed inserts. In one embodiment, the air cylinder preferably serves as an actuator to move the cartridges.
    [00069] With reference to figure 1, the automated braiding system 50 preferably also includes a fiber optic sensor screen 72 and a cartridge insertion rod 74 to advance the loaded cartridges, one at a time, within the area circled 54. The automated braiding system 50 also desirably includes a lift shelf 76 which is movable in a first direction (for example, upwards) to advance a loaded cartridge towards the hole of the braider 62, and in a second direction (for example) , down) to dispense an empty cartridge from the automated system. The air cylinder can be coupled with the lift shelf.
    [00070] The braiding system 50 also desirably includes a cartridge ejection tube 78 to dispense empty cartridges from the system after barbed inserts have been removed from the cartridges
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    20/36 by the braiding system, and preferably after the cartridges have returned to a position below the braiding plate 58 by the riser shelf 76. The braiding system also desirably includes a suture core 80, which provides increased tensile strength and controls stretching of the braided suture.
    [00071] In an embodiment of the present invention, the barbed inserts are loaded into the cartridges and the loaded cartridges are advanced in the closed area 54 of the automated braiding system. Once the barbed inserts advance into the enclosed area, filaments are preferably wound around the barbed inserts to produce braided barbed sutures. Barbed inserts and filaments can be produced from absorbable biocompatible materials, non-absorbable materials and combinations of absorbable and non-absorbable materials. Preferred non-absorbable materials suitable for both barbed inserts and filaments are polypropylene, a polymer blend of polyvinylidene fluoride and polyvinylidene-cohexafluorpropylene fluoride, polyethylene, polyvinylidene fluoride (PVDF), polyesters, polyethylene terephthalate, terephthalate, polyethylene terephthalate, terephthalate with glycol, ethylene polytetrafluorine, 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 modality
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    21/36 preferred, the preferred material is a polymer blend of polyvinylidene fluoride and polyvinylidene-cohexafluorpropylene fluoride. In a highly preferred embodiment, the filament material is polyethylene terephthalate. In addition, any of these materials can have conventional surface modifications that include coatings, plasma, therapeutic and similar treatments.
    [00072] With reference to figure 2, in one embodiment, a barbed insert 100 includes a core 102 extending between a first end 104 and a second end 106 of the barbed insert. In one embodiment, the barbed insert 100 includes a first set of barbs 108 extending in a first direction and a second set of barbs 110 extending in a second direction that is opposite the first direction, thereby producing a bidirectional barbed insert. In one embodiment, the barbed insert 100 preferably includes a compress plug 112 located between the first set of splinters 108 and the second set of splinters 110. The compress plug preferably prevents the barbed insert from being pulled too far in one direction.
    [00073] With reference to the figure. 3, in one embodiment, the barbed insert shown in figure 2 is preloaded in a cartridge 200. In one embodiment, the cartridge 200 is produced from a durable material, such as metal. In one embodiment, cartridge 200 is preferably made from stainless steel. Preferred materials for the cartridge include stainless steel, polyvinyl chloride, nylon and polyethylene methylene (eg DELRIN thermoplastic acetal resin). In one embodiment, the cartridge 200 has an upper end 202, an intermediate section 204 and a lower end 206. The upper end 202 of the cartridge preferably defines a main point or tip 208. As will be
    Petition 870190080823, of 8/20/2019, p. 34/49
    22/36 described in more detail below, the main point 208 at the upper end 202 of the cartridge 200 desirably includes an opening or passageway for receiving the barbed insert 100 shown in figure 2. The cartridge 200 preferably includes an optical window 210 extending through the cartridge. The optical window 210, which can be located in the intermediate section 204 of the cartridge 200, preferably provides visual access to the barbed insert loaded in the cartridge. The lower end 206 of the cartridge 200 preferably has a nested end 212, which allows the lower end 206 to be connected with the cartridge insertion rod 74 (figure 1), as will be described in more detail below.
    [00074] Referring to figures 4A and 4B, in one embodiment, the cartridge 200 includes an opening 214 at the main end 202 thereof which defines a passageway to guide a barbed insertion. In one embodiment, the passageway preferably defines an elongated slot that is sized and shaped to exactly conform to the cross-sectional shape of the barbed insert 100 shown in figure 2. The elongated slot 214 desirably has a dimension that allows the insertion barbs barbed wire from sliding into the slot, while preventing the barbed insert from rotating around its longitudinal axis in relation to the longitudinal axis of the cartridge 200.
    [00075] In one embodiment, the barbed insert has barbs that are oriented 180 degrees from each other. This orientation lends itself to having the opening of the cartridge to accommodate barbs 180 degrees from each other by having a cartridge opening that is modeled as an elongated slot (with a width greater than its height). However, the orientation of the barbed inserts is not limited to having barbs that are 180 degrees opposite each other. An example would be a barbed insert with three sets of barbs, so that each set of
    Petition 870190080823, of 8/20/2019, p. 35/49
    23/36 barbs are oriented 120 degrees from each other around the core axis. In this embodiment, the opening of the cartridge barbed insertion dispenser may have a cross section that accommodates this arrangement in order to maintain the rotational alignment and prevent unwanted rotation of the barbed insertion around its core while allowing the longitudinal movement of the insertion element. as it is pulled into the winding filaments. In one embodiment, systems and methods for producing braided barbed sutures include loading a barbed insert into an opening of the barbed insert dispenser in preparation for its distribution within the winding filaments. In one embodiment, however, a single cartridge can have multiple openings / cross sections to accommodate a barbed insert per cartridge opening or multiple barbed inserts in a single cartridge opening.
    [00076] With reference to figure 5A, in one embodiment, the cartridge 200 includes an elongated first half 216A and an elongated second half 216B which are adapted to be assembled together. The outer surfaces of the first and second elongated halves 216A, 216B define at least one annular groove 218 formed therein, and a C-shaped ring 220 is positionable in at least one annular groove 218 to hold the first and second elongated halves 216A , 216B joined. The elongated halves 216A, 216B have opposite grooves formed therein. When assembled together, the opposite grooves of the first and second elongated halves 216A, 216B cooperatively define an elongated slit 214. In one embodiment, the elongated slit has a width W of about 0.76-2.03 mm (0.030 - 0.080 inch) and a Hi height of about 0.191-0.318 mm (0.0075 - 0.0125 inch).
    [00077] Figure 5B shows the elongated second half 216B of
    Petition 870190080823, of 8/20/2019, p. 36/49
    24/36 cartridge 200 shown in figure 5A. As noted above, the second elongated half 216B is assembled to the first elongated half 216A (figure 5A). During the assembly of the first and second halves in combination, the first and second halves are held together by positioning C 220 shaped rings, shown in figure 5A, within 218A-218D annular grooves provided along the length of the elongated halves . In the embodiment shown in Figure 5B, the second half of the cartridge 216B includes pin openings 222A, 222B adapted to receive opposite pins protruding from the first elongated half of the cartridge. The elongated second half 216B of the cartridge 200 includes an upper end 202 which has a main tip 208, an intermediate section 204 and a lower end 206 which has an engaged end 212.
    [00078] The second elongated half 216B of the cartridge 200 has one of the opposite grooves formed there that defines the elongated slot 214. In one embodiment, the opposite groove that defines the elongated slot 214 preferably extends from the main end 202 of the cartridge to the fitted end 212 of cartridge 200. In one embodiment, the groove defining slot 214 includes a narrower rod-shaped section 226 that accommodates the core of the barbed insert at the second end 104 of the barbed insert. A main section 228 of the slot 214 is wider than the rod-shaped section 226 and is sized and shaped to accommodate the barbs in the first and second barbed sections of the barbed insert.
    [00079] Figure 5C shows a perspective view of the elongated second half 216B of the cartridge 200 shown in figure 5B. The elongated second half 216B includes the main end 202 having the main end 208 with the slit-shaped opening 214 being accessible at the main end. The elongated slit 214 of
    Petition 870190080823, of 8/20/2019, p. 37/49
    25/36 preferably extends between the main end 202 of the cartridge and the rod 226. In one embodiment, the groove that defines the elongated slot 214 desirably has a shape that adapts to the shape of the barbed insert 100 shown in Figure 2. is noted above, a groove that defines the elongated slot 214 is also preferably formed in the first elongated half 216A of the cartridge 200 shown in figure 5A. The elongated slot 214 formed in the cartridge preferably allows the barbed insert to move in relation to the cartridge along its longitudinal axis as it is pulled from slot 214. However, since the shape of the slot adapts perfectly to the shape of the insert barbed, the slot prevents the section of the barbed insert in contact with the slot from rotating or twisting around its longitudinal axis in relation to the slot.
    [00080] With reference to figure 6A, in one embodiment, a barbed insert 100, like the one shown and described above in figure 2, is preloaded in the cartridge shown and described above in figures 5A to 5C. Cartridge 200 includes elongated slot 214 which has a wider main section 228 adapted to accommodate the first and second barbed sections 108, 110 of the barbed insert 100 and a narrower rod-shaped section 226 adapted to accommodate the insert core barbed wire 100 located at the second end 106 of the barbed insert.
    [00081] With reference to figure 6B, in one embodiment, the leading end 104 of the barbed insert 100 protrudes from the slot-shaped opening 214 at the leading end 202 of the cartridge 200. The barbs of the first barbed section 108 are desirably arranged within the plus wider section 228 of slot 214. In one embodiment, the barbed insert 100 is loaded into a cartridge 200 by moving the barbed insert in an indicated direction D1. During a braiding operation, the
    Petition 870190080823, of 8/20/2019, p. 38/49
    26/36 barbed insert 100 can move in direction D2 as it is removed from slot 214 at the main end 202 of cartridge 200.
    [00082] With reference to figure 6C, in one embodiment, the end end of the elongated groove 222 tapers inward to exactly match and adapt to the barb configuration of the second barbed section 110 of the barbed insert 100. The core at the second end 106 of the barbed insert 100 fits within the narrowest rod-shaped groove 226 formed adjacent the lower end 206 of the cartridge 200.
    [00083] Figure 6D shows the elongated slot opening 214 provided at the main end 208 of the cartridge 200. As shown in figure 6D, the size and shape of the elongated slot opening exactly matches the size and shape in cross section of the barbed insert 100. The barbs in the barbed insert 100 preferably have a wing span that fits exactly the width W1 of the slot 214. The core 102 of the barbed insert 100 is desirably centered inside the slot 214. Since the dimensions of the elongated slot 214 exactly match the external dimensions of the barbed insert 100, the barbed insert is prevented from rotating around its longitudinal axis in relation to the slot by the internal surfaces of the slot 214. As such, the barbed insert 100 is only capable of to move longitudinally in relation to the longitudinal axis of the cartridge. Although the present invention is not limited by any particular theory of operation, it is believed that providing a narrow, elongated slot opening 214 at the leading end of cartridge 200 better controls the movement and orientation of the barbed insert 100 relative to cartridge 200. As a result, the unwanted twisting and bending of the barbed insert 100 can be eliminated.
    [00084] With reference to figure 7A, in one modality, the
    Petition 870190080823, of 8/20/2019, p. 39/49
    27/36 barbed insert 100 is loaded into the elongated slot opening 214 at the main end 202 of the cartridge 200 so that the first end 102 of the barbed insert 100 protrudes from the elongated slot. In figure 7A, the first barbed section 108 of the barbed insert 100 protrudes from the main tip 208 of the cartridge 200. In at least one embodiment, however, the barbs of the first barbed section 108 are preferably fully inserted into the elongated slot of the cartridge, so that only the rod or core at the first end 102 of the barbed insert is exposed.
    [00085] Figure 7B shows the opening of the elongated slot 214 at the main end 202 of the cartridge 200. The opening of the elongated slot 214 preferably accommodates the barbs in the barbed insert 100. The opening of the elongated slot 214 is sized and shaped to receive the barbs and be in relatively close conformation to the outer perimeter of the barbed insert 100 to prevent the barbed insert from rotating or twisting around its longitudinal axis with respect to the cartridge when the barbed insert is loaded into cartridge 200.
    [00086] With reference to figure 7C, in one embodiment, the cartridge 200 includes an optical window 210 that provides a view of the barbed insertion 100 when the insertion element is disposed in the cartridge. the optical window can be located in the intermediate section 204 of the cartridge 200. As will be described in more detail here, the automated braiding system of the present invention preferably includes an optical sensor adapted to determine when the barbed insert has been completely dispensed with from the cartridge 200 In one embodiment, once the barbed insertion has been completely dispensed with, the optical sensor will send at least one signal to a system controller indicating that the barbed insertion has been dispensed with. In response, the system controller will
    Petition 870190080823, of 8/20/2019, p. 40/49
    Preference to issue commands to retract the empty cartridge 200 below the braiding plate and unload the empty cartridge from the system, so that another cartridge loaded with a barbed insert can advance into place for braiding.
    [00087] With reference to figure 8A, in one embodiment, the lower end 206 of the cartridge 200 has an embedded end 212 formed therein. In one embodiment, the fitted end 212 preferably includes a first projection 230, a second projection 232 spaced from the first projection 230, and a central span 234 extending between the first and second projections 230, 232. In one embodiment , the engaged end 212 allows the lower end 206 of the cartridge 202 to be engaged by an upper end of the cartridge insertion rod 74 (figure 1). The upper end of the cartridge insertion rod can also be engaged to intertwine with the engaged lower end 212 of the cartridge 200. Interlacing the upper end of the cartridge insertion rod with the lower end of the cartridge preferably provides better cartridge control. For example, in one embodiment, it may be desirable to avoid rotating the cartridge around its longitudinal axis during a filament winding operation. In other embodiments, however, it may be desirable to rotate the cartridge around its longitudinal axis during a filament winding operation. For example, the cartridge can be rotated about its longitudinal axis as the filaments are wound around a barbed insert. As the cartridge rotates around its longitudinal axis, the barbed insert loaded in the cartridge will also rotate around its longitudinal axis, so that the filaments are helically wound around the core of the barbed insert so that the barbs are project 360 ° around the longitudinal axis of the insert
    Petition 870190080823, of 8/20/2019, p. 41/49
    29/36 braided barbed.
    [00088] Figure 8B shows a side view of the bottom end 206 of the cartridge 200. The bottom end 212 includes the first projection 230 spaced from the second projection 232 to define the central gap 234. The bottom end 212 desirably allows the end bottom 206 of cartridge 200 intertwines with an upper end of a cartridge insertion rod.
    [00089] Figure 8C shows a view of the end of the bottom engaged end 212 of the cartridge 200. Although a particular engaged structure is shown in figures 8A-8C, the present invention contemplates that other structures or connecting structures can be used. Although the present invention is not limited by any particular theory of operation, it is believed that providing a structure fitted to the lower end 206 of a cartridge 200 allows for better control of the cartridge. In one embodiment, the embedded structure is used to prevent rotation of the cartridge around its longitudinal axis so that the cartridge only moves in the axial direction along its longitudinal axis, which, in turn, prevents the barbed insertion loaded there rotate around its longitudinal axis. In one embodiment, the embedded structure allows the cartridge to be rotated around its longitudinal axis, which in turn rotates the barbed insert around its longitudinal axis to form braided barbed sutures that are wound in a helical shape with the barbs that project 360 ° around the longitudinal axis of the suture. In these latter embodiments, the embedded structure allows the cartridge to be simultaneously rotated about its longitudinal axis while moving in axial directions along its longitudinal axis.
    [00090] With reference to the figure. 9, in one modality, one
    Petition 870190080823, of 8/20/2019, p. 42/49
    The automated system includes a tank 70 with an elongated slot 240 adapted to secure a plurality of cartridges 200 pre-loaded with barbed inserts. In one embodiment, the cartridges 200 are loaded into the deposit 70 so that the lower ends of the cartridges are positioned within the elongated slot 240 of the deposit 70 and the upper ends of the cartridge are in substantial alignment with each other and spaced from the elongated slot 240 .
    [00091] With reference to figure 10, in one embodiment, the tank 70 has a plurality of cartridges 200 loaded there and is positioned below the braiding plate 58. The system includes a cartridge chamber 250 that is adapted to receive a main cartridge. The cartridge chamber 250 preferably has an opening which is sized and shaped to fit the outer surface of the cartridge 200 when the cartridge is received therein. when the guide cartridge advances into the opening of the cartridge chamber 250, the cartridge chamber 250 is preferably adapted to position the main cartridge in alignment with the cartridge insertion rod 74 (figure 1). The braiding system also desirably includes a retractable gate 252 that is movable between the open and closed positions. When the retractable gate 252 is in the open position, a main cartridge can be loaded into the cartridge chamber 250. When the retractable gate 252 is in a closed position, the gate prevents any cartridges from advancing into the cartridge chamber 250.
    [00092] With reference to figure 11A, in one embodiment, the deposit 70 preferably signs a plurality of cartridges 200 that have barbed inserts 100 preloaded in each of the respective cartridges. The tank 70 has a main end 90 that can be aligned with the opening of the cartridge chamber 250.
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    31/36
    The braiding assembly desirably includes a deposit advance that selectively pushes one of the main cartridges 200 into the cartridge chamber 250.
    [00093] The braiding system includes the retractable gate 252 that selectively opens and closes the chamber of the cartridge 250. In figure 11A, the retractable gate 252 is in a closed position so that a guide cartridge 200 may not advance into the chamber of the cartridge by the tank advance 92. With reference to figure 11B, the retractable gate 252 can move to an open position, so that the guide cartridge 200 can advance into the chamber of the cartridge 250.
    [00094] Figure 11C shows the tank forwarder 92 moving to the right in relation to the tank 70 to advance the guide cartridge 200 into the chamber of the cartridge 250. Referring to figure 11D, after the guide cartridge 200 advances to inside the cartridge chamber 250, the retractable gate 252 returns to the closed position.
    [00095] Referring to figure 11E, after the guide cartridge has advanced into the cartridge chamber 250 and the retractable gate 252 is closed, the cartridge insertion rod 74 preferably engages the cartridge to advance the preloaded cartridge through the braiding plate 58 and into the closed area 54 (figure 1) of the automated system.
    [00096] With reference to figure 12, in one embodiment, the cartridge insertion rod 58 advances the preloaded cartridge into the closed area 54 of the automated braiding system 50, so that filaments can be wound around the barbed insertion loaded into the cartridge to form a braided barbed suture.
    [00097] With reference to figure 13, in one embodiment, the braiding system includes a filament winding set including a
    Petition 870190080823, of 8/20/2019, p. 44/49
    32/36 strand hole 62 and a cartridge guide tube 63 that preferably aligns the top end of the cartridge with the strand hole 62. The strand system includes a fiber optic sensor 282 that detects the presence or absence of a barbed insert in the cartridge. The braiding system includes a plurality of suture spools that provide filaments 282 that are wound around the barbed insert to form a braided barbed suture. The braiding system preferably also includes a rotating spool 286 that guides downward the downward advance of the braided barbed sutures after the filaments have wound around the barbed insert.
    [00098] With reference to figure 14A, in one embodiment, the cartridge insertion rod advances the cartridge 200 through the cartridge guide tube 63 so that the main end 202 of the cartridge 200 advances from the top end of the cartridge guide tube 63 and in alignment with the hole of the braid 62.
    [00099] With reference to figure 14B, the cartridge insertion rod continues to advance the cartridge 200 upwards until the main end 202 of the cartridge engages with the hole of the strand 62. With reference to figure 14C, the winding filaments 284 they pull the barbed insert 100 from the elongated slot at the main end of the cartridge 200 and the filaments 284 are wound around the barbed insert 100.
    [000100] With reference to figure 15, in one embodiment, filaments 284 are wound around the core (not shown) of the barbed insert 100 to form a braided barbed suture. In the braided barbed suture of Figure 15, a plurality of filaments 284 are wound around the suture along its length. The barbs 108 preferably project through the plurality of filaments 284 so that the barbs remain exposed. The barbs 108 are preferably in a single
    Petition 870190080823, of 8/20/2019, p. 45/49
    33/36 plane, which preferably results from the barbed insert being kept in a single plane by the cartridge as the barbed insert is removed from the cartridge.
    [000101] With reference to figure 16, in one embodiment, the braiding system includes a pair of braiding pins 64A, 64B located downstream in the process of the braiding orifice 62 and the rotating reel 286. Each of the braiding pins 64A, 64B has preferably, a helical groove 65 formed therein which is adapted to receive the braid 75 and the barbed sutures braided therein. Figure 17 shows a braided barbed suture arranged within a helical groove 65 of the first twist pin 64A. Although the present invention is not limited by any particular theory of operation, it is believed that the pair of twist pins 64A, 64B effectively maintain tension in strand 75 as the strand moves downstream. In one embodiment, the two pins 64A, 64B are spaced and offset from each other so that the suture progressively advances to the next groove as the suture passes back and forth between the two pins 64A, 64B.
    [000102] With reference to figure 18, in one embodiment, the braiding system 50 includes the suture collection spool 66 which is adapted to collect the braid 75 and the barbed sutures braided therein. The suture collection spool 66 preferably rotates to collect the braid 75 and the barbed sutures braided therein for later handling and use.
    [000103] Referring to figure 19, in one embodiment, after the barbed insert has been removed from cartridge 200, optical sensor 282 detects the absence of the barbed insert. In response, the system controller retracts the cartridge insertion rod, which in turn retracts the empty cartridge 200 into the cartridge guide tube 63.
    Petition 870190080823, of 8/20/2019, p. 46/49
    34/36 [000104] Referring to figure 20A, in one embodiment, the cartridge insertion rod 74 is retracted below the braiding plate 58 to remove the empty cartridge from the closed area of the braiding system. As the cartridge insertion rod 74 is retracted, the retractable gate 252 that colors the cartridge chamber 250 preferably remains closed. Figure 20B shows the braiding system with the cartridge insertion rod retracted, so that the empty cartridge 200 has returned to the cartridge chamber 250. Retractable gate 252 remains closed to separate the empty cartridge 200 from the loaded cartridges positioned inside the tank 70.
    [000105] With reference to the figure. 20C, in one embodiment, the empty cartridge shown in figure 20B is preferably removed from the system via the cartridge ejection tube 78 shown in figure
    1. Referring to figure 20D, after the empty cartridge has been removed through the cartridge ejection tube, the next guide cartridge 200 in tank 70 is prepared to be loaded into the cartridge chamber 250 to repeat the process described here. This process is continuously repeated by the system controller to advance loaded cartridges into the filament winding apparatus to form braided barbed sutures, and to remove empty cartridges from the system.
    [000106] Referring to figure 21, in one embodiment, an automated braiding system 300 includes a rotating reel 302 that has a continuous length of the barbed insert material 304 provided therein. The braiding system 300 includes a guide 306 through which the barbed insert material 304 is passed. The guide 306 preferably has an opening or passage, such as a slit-shaped opening, which is adapted to fit exactly with the shape of the barbed suture material 304. The opening or passage preferably allows the insertion material barbed wire moves axially in relation to the guide, but that
    Petition 870190080823, of 8/20/2019, p. 47/49
    35/36 prevents the barbed insertion material 304 from rotating or braiding around its longitudinal axis in relation to the 306 guide. In one embodiment, the guide can be selectively rotatable to rotate and / or selectively braid the continuous length of the insertion material barbed wire 304 as filaments 308 are wound around the barbed insertion material. As noted above, in one embodiment, the barbed insertion material 304 is preferably a continuous length of material that can be initially fed into the filament winding assembly to produce braided barbed sutures. In one embodiment, if certain actions are not taken, an undesirable entanglement can form in the continuous length of the barbed insertion material 304 before it reaches the 306 guide. There are at least two ways to avoid this undesirable entanglement: 1) provide a mechanism to rotate the entire reel of continuous barbed insertion material in conjunction with any rotation of the guide 306 and / or 2) the guide 306 can quickly reverse the rotation to its starting point once it reaches 180 degrees of rotation (for barbed inserts that have barbs oriented 180 degrees apart) or 360 degrees (for barbed inserts that have barbs on one side only), or other degrees of rotation based on the number of barbs opposite the barbed insert (for example, for equidistant barbs , the degrees of reverse rotation would be 360 divided by the number of equidistant splinters).
    [000107] The automated system 300 shown in figure 21 preferably includes winding filaments 308 which are wound around the barbed insertion material 304 in a hole in the braid 310. In one embodiment, as the barbed insertion material 304 advances towards the orifice of the strand 310, the guide 306 is preferably rotated about its longitudinal axis which, in turn, rotates the barbed insert 304 about its longitudinal axis. As the rotating guide 306 rotates the
    Petition 870190080823, of 8/20/2019, p. 48/49
    36/36 barbed insertion, filaments 308 are helically wound around barbed insertion material 304 to form braided barbed sutures. In another embodiment, the guide can be locked in position so that it does not rotate around its longitudinal axis which, in turn, will not rotate the barbed insert as it is inserted into the filament winding assembly.
    [000108] Figure 22 shows a braided barbed suture 400 that is formed using the system 300 shown in figure 21, so that the guide 306 is rotated as the barbed insert is dispensed from the guide 306, which in turn , rotates the barbed insert around its longitudinal axis as the filaments are wound around the barbed insert. The braided barbed suture 400 has filaments 484 wound in a helical shape around the core of the barbed insert. As a result of the helical winding, the barbs 408 are arranged in a helical 360 ° pattern. Although the present invention is not limited by any particular theory of operation, it is believed that providing splinters in a 360 ° pattern provides a braided barbed suture with greater resistance to fixation.
    [000109] 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 trademark Ethibond Excel by Ethicon, Inc., with surgical needles attached to both ends of the suture . A pad, like a Teflon pad, can be positioned in the middle of the polymeric anchoring section.
    [000110] 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 (22)
    [1]
    1. System (50,300) for making braided barbed sutures (400) characterized by the fact that it comprises:
    a filament winding assembly; and a guide assembly that includes at least one opening of the barbed insertion dispenser (214) defining a passageway to guide a barbed insertion element (100,304), the guide assembly being adapted to dispense at least one insertion element from the opening of the dispenser (214) into the filament winding assembly, wherein the passage of the dispenser opening (214) is adapted to allow a longitudinal movement of the at least one barbed insertion element (100,304) with respect to the passage while preventing simultaneously the twisting movement of the at least one insertion element (100,304) in relation to the passage.
    [2]
    2. System according to claim 1, characterized in that the filament winding assembly comprises a plurality of filaments (284.308) to wrap around at least one barbed insertion element (100.304) dispensed in the winding assembly of filaments to make a braided barbed suture (400).
    [3]
    3. System according to claim 1, characterized by the fact that the passage has a size and shape that conform to the size and shape of at least one barbed insertion element (100,304).
    [4]
    4. System according to claim 3, characterized by the fact that at least one barbed insertion element (100,304) comprises:
    a core (102) that has an anterior end, an end end, and a longitudinal axis that extends between the
    Petition 870190080823, of 8/20/2019, p. 7/49
    2/6 anterior and final extremities; and at least one splinter (110) extending outwardly from the core (102).
    [5]
    5. System according to claim 4, characterized by the fact that the passage controls the rotation of at least one barbed insertion element (100,304) in relation to the passage when the at least one barbed insertion element (100,304) is in contact with the passage.
    [6]
    6. System according to claim 5, characterized by the fact that the opening of the barbed insertion element dispenser (214) is selectively rotatable to rotate a section of at least one barbed insertion element (100,304) in contact with the passage.
    [7]
    7. System according to claim 6, characterized by the fact that it still comprises a system controller (52) that has a central processing unit to control the operation of the filament winding assembly and the guide assembly.
    [8]
    8. System according to claim 7, characterized by the fact that the system controller (52) has a first state in which the opening of the dispenser (214) is stationary as the barbed insert (100,304) is dispensed in the filament winding assembly and a second state in which the opening of the dispenser (214) rotates as the barbed insert (100,304) is dispensed in the filament winding assembly.
    [9]
    9. System according to claim 8, characterized in that the at least one barbed insertion element (100,304) comprises a plurality of barbed insertion elements (100,304), and in which the guide assembly comprises
    Petition 870190080823, of 8/20/2019, p. 8/49
    3/6 additionally a plurality of cartridges (200), at least one of the cartridges (200) including one of the dispenser openings (214) defining a passageway to guide at least one of the barbed inserts (100,304).
    [10]
    10. System according to claim 9, characterized in that at least one of the plurality of barbed inserts (100,304) is loaded in one of the plurality of cartridges (200) so that an anterior end of the at least one insertion element of the plurality of barbed insertion elements (100,304) protrudes from the passage of the opening of the barbed insertion element dispenser (214) associated with it.
    [11]
    11. System according to claim 10, characterized by the fact that the guide assembly still comprises a compartment (70) for holding the cartridges (200), and in which the system controller includes a subroutine for introducing the cartridges, one at a time, in the filament winding assembly.
    [12]
    12. System according to claim 11, characterized by the fact that each of the cartridges (200) comprises an optical window (210) to provide visual access to the barbed insertion elements (100,304) loaded in them, and in which the controller The system sensor further comprises an optical sensor (282) to determine the presence of the insertion elements in the cartridges (200).
    [13]
    13. System according to claim 9, characterized by the fact that each of the cartridges (200) includes an external surface, and in which the guide assembly still comprises a rod for inserting the cartridge (74) that engages the surfaces to move the cartridges (200).
    [14]
    14. System according to claim 1,
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    4/6 characterized by the fact that the passage comprises an elongated crack with a width greater than the height.
    [15]
    15. System according to claim 1, characterized by the fact that the filament winding assembly comprises a braiding eyelet (62,310) to direct the plurality of filaments (284,308) towards the braiding zone, and in which the guide assembly is adapted to direct an anterior end of at least one barbed insertion element (100.304) into the braiding zone to wrap the plurality of filaments around the at least one barbed insertion element (100.304) to make a braided barbed suture (400).
    [16]
    16. System according to claim 15, characterized by the fact that the dispenser opening (214) has a size and shape that conforms to the size and shape of at least one barbed insertion element (100,304).
    [17]
    17. System according to claim 16, characterized by the fact that the at least one barbed insert element (100,304) has a longitudinal axis, and in which the barbed insert element dispenser opening (214) is rotatable as the at least one insertion element is dispensed from the barbed insertion dispenser opening (214) to rotate the at least one barbed insertion element (100,304) around its longitudinal axis according to the plurality of filaments (284,308 ) is wrapped around at least one barbed insert (100.304).
    [18]
    18. Method for making a braided barbed suture (400) characterized by the fact that it comprises the steps of:
    providing a filament winding assembly that includes a plurality of filaments (284,308);
    provide at least one barbed insert
    Petition 870190080823, of 8/20/2019, p. 10/49
    5/6 (100.304) for introduction into the filament winding set;
    providing an opening of the barbed insert dispenser (214) adjacent to the filament winding assembly to dispense at least the barbed insertion element (100,304) in the filament winding assembly, the opening of the barbed insert element dispenser (214 ) being adapted to allow longitudinal movement of at least one barbed insertion element (100,304) in relation to the opening of the barbed insertion element dispenser (214) while simultaneously preventing the twisting movement of at least one barbed insertion element (100,304) in relation to the opening of the barbed insert dispenser (214);
    dispensing the at least one barbed insert (100,304) from the opening of the barbed insert dispenser (214) and into the filament winding assembly; and winding the plurality of filaments around the at least one barbed insertion element (100,304) as the at least one barbed insertion element (100,304) is dispensed from the barbed insertion dispenser opening (214).
    [19]
    19. Method according to claim 18, characterized in that the at least one barbed insertion element (100,304) comprises a core (102) and at least one barb (110) projecting outwardly from the core (102), and in which the opening of the barbed element dispenser (214) conforms to the size and shape of the at least one barbed insert element (100,304).
    [20]
    20. Method, according to claim 19, characterized by the fact that the opening of the barbed insert element dispenser (214) defines an elongated slot that
    Petition 870190080823, of 8/20/2019, p. 11/49
    6/6 has a size and shape that conforms to the size and shape of at least one barbed insert (100,304).
    [21]
    21. Method, according to claim 19, characterized by the fact that it still comprises:
    during the dispensing step of at least one barbed insertion element (100,304), rotate the barbed insertion element dispenser opening (214) to rotate the at least one barbed insertion element (100,304) according to the plurality of filaments (284,308 ) is wrapped around at least one barbed insert (100,304).
    [22]
    22. Method according to claim 18, characterized by the fact that it still comprises wrapping the plurality of filaments (284,308) around a filament core.
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    公开号 | 公开日
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    JP2013503008A|2013-01-31|
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-07-02| B06T| Formal requirements before examination|
    2019-11-05| B09A| Decision: intention to grant|
    2020-01-07| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/08/2010, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US12/548,984|US8210085B2|2009-08-27|2009-08-27|Automated systems and methods for making braided barbed sutures|
    US12/548,984|2009-08-27|
    PCT/US2010/046927|WO2011025926A1|2009-08-27|2010-08-27|Automated systems and methods for making braided barbed sutures|
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