The invention relates to methods, devices, and systems for an improved high strength sutures. More specifically, the invention relates to methods, devices and systems for high strength sutures with a portion of a rigid or substantially rigid materials to improve structural support.
Arthroscopic suturing techniques and instruments have been developed to facilitate the suturing of tissue during arthroscopic surgical procedures. In arthroscopic surgery, access to a surgical work site within a patient's body is normally provided through one or more cannulas inserted into a patient's body through one or more cannulas inserted into the patient's body through small incisions. Since the work site is only accessible through the one or more cannulas, it is very difficult to for the surgeon to pass the sutures through the lumens of the cannulas to reach the desired site, tie sutures around or through tissue with shuttle sutures arthroscopically and/or keep sutures from sticking together making it difficult to use during surgical procedures. The sutures usually do not have any structural strength and cannot push through lumens or tissues, as well as hold radial hoop strength when forming a looped suture.
In one embodiment, a rigid composite suture comprises: a monofilament suture, the monofilament suture comprising a monofilament material; and a multifilament suture sheath, the multifilament suture sheath comprising a multifilament material, the multifilament braided suture formed or constructed over at least a portion of the monofilament suture to position the monofilament suture at or near the center. The multifilament material comprises ultra-high weight molecular polyethylene (UHWMPE) and the monofilament material comprises Nylon or Polypropylene.
In another embodiment, a rigid composite suture comprising: a multifilament suture, the multifilament suture comprises a first yarn and a second yarn, the first yarn comprising a first yarn material, first direction, and a first plurality of filaments, the second yarn comprising a second yarn material, a second direction and a second plurality of filaments, the first yarn being positioned in the first direction and the second yarn being interlaced or interlocked with the first yarn in the second direction into a weave pattern; and one or more monofilament sutures, the one or more monofilament sutures comprising a one or more monofilament materials, a first yarn or second yarn comprise the one or more monofilament sutures. The multifilament material comprises ultra-high weight molecular polyethylene (UHWMPE) and the monofilament material comprises Nylon or Polypropylene.
In another embodiment, a method of forming the rigid composite suture comprises the steps of: creating a textile with monofilament; selecting or identifying one or more portions of the Monofilament to be removed; extracting the selected or identified one or more portions of monofilament; and forming desired shape with remaining monofilament. The method of forming a rigid composite textile further comprises the step of: locking or securing desired shape with remaining monofilament.
In another embodiment, a method of forming the rigid composite suture comprises the steps of creating a textile; selecting or identifying at least one portion of a strand of the textile to be removed; extracting the selected or identified at least one portion of the strand to create at least one void; and inserting at least one portion of a monofilament into the at least one void. The method may further comprise the step of locking or securing desired shape with monofilament.
Accordingly, it would be desirable to provide an improved rigid composite textile or suture that would help provide the surgeon when pushing/passing a suture, making looped sutures, and/or any other procedural steps requiring higher strength sutures with structural support. The following detailed description is of the best currently contemplated modes of carrying out the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims.
Although the invention is often referred to herein as a rigid composite suture, it is understood that such description is not limiting. Such that the technology in this invention may be applied in numerous other textile structures, such as but not limited to a wide variety of medical textiles, including implantable textiles and/or devices incorporating medical textiles, may benefit from the various marking techniques described herein. Such products can include, but should not be limited to, implantable medical textiles, non-implantable medical textiles, extracorporeal medical textiles and/or healthcare and hygienic medical textiles such as cardiovascular and vascular grafts and implants, artificial ligaments and tendons, sutures, patches or meshes, soft tissue implants, dialysis devices, ophthalmologic materials, dental materials, gauzes, crepe bandages, bed linens, surgical masks, etc.
The processes described herein constitute a method of fabricating a rigid composite textile suture in such a way to improve structural strength of a textile in desired regions of the textile when forming or creating desired structures that will be helpful in during surgery. The invention applies state-of-the-art materials and processes to a medical textile, while at the same time should not impact medical textile performance or size.
In one exemplary embodiment, the combination of a multi-filamented suture (e.g., the flexibility, easily shaped, high load capacity) and the monofilament suture (e.g., its rigidity, its elasticity and shape memory) provides a formed structure capable of pushing linearly or transversely and/or maintain hoop strength or hoop memory to allow a surgeon to be more efficient during arthroscopic procedures. Furthermore, integrating the monofilament into the weaving pattern during the weaving process allows the monofilament to be strategically placed or positioned into the textile to achieve the desired mechanical characteristics, maintain textile integrity (e.g., textile would not be damaged) and reduce or eliminate potential migration of the monofilament.
The first and second yarn material comprises ultra-high weight molecular polyethylene (UHWMPE) and the monofilament material comprises Nylon or Polypropylene. The weave pattern may comprise a woven pattern or a braid pattern. The first direction may comprise a warp or a vertical strand, and the second direction may comprise a weft or a horizontal strand. The third direction may comprise an axial strand. Alternatively, the first direction may comprise a first angled orientation, the second direction may comprise a second angled orientation, and the third direction may comprise an axial orientation.
In another embodiment, the rigid composite textile 40 comprises a monofilament 10 that is co-braided with the multifilament textile 15 as an additional strand. The rigid composite suture 40 comprising: a multifilament suture 15, the multifilament suture 15 comprises a first yarn 25, a second yarn 30, a third yarn and a monofilament 10, the first yarn 25 comprising a first yarn material and a first plurality of filaments, the second yarn 30 comprising a second yarn material and a second plurality of filaments, the third yarn comprising a third yarn material and a third plurality of filaments, the monofilament including a monofilament material, the first yarn, second yarn and third yarn being interlaced or intersected at an angled orientation to form a braided weave pattern, at least a portion of the monofilament being interlaced or interlocked into the weave pattern in a desired direction. The first and second yarn material comprises ultra-high weight molecular polyethylene (UHWMPE) and the monofilament material comprises Nylon or Polypropylene. The desired direction may be the same or different as the angled orientation. The desired direction may comprise an axial direction, a vertical direction and/or a warp direction.
In one embodiment, the textile comprises a suture, the suture comprises a monofilament suture. Monofilaments sutures comprise a single filament, and can easily pass from tissues due to its smooth surface resulting in low friction. Monofilament sutures also contain elasticity and/or memory, or prefer to spring back to the way they were packaged (e.g., memory). The monofilament suture may further comprise a round monofilament suture, a flat monofilament suture, and/or a round-to-flat monofilament suture.
In another embodiment, the textile comprises a multifilament suture, the multifilament suture comprises a plurality of yarns. Yarn, as used herein is a strand of textile fiber made up of one or more filaments or one or more fibers. The plurality of yarns may include a single filament (monofilament), multiple or plurality of filaments (multifilament), staple fibers, wire and/or any other material capable of being woven or knitted. The plurality of yarns may be textured or flat, and may be of any opacity, including bright, semi-dull, full-dull and/or any combination thereof. Multifilament sutures generally pliable or flexible, contain better knot security and strength. The multifilament suture may comprise a round multifilament suture, a flat multifilament suture, and/or a flat-to-round multifilament suture. The multifilament suture may comprise a cored or coreless suture.
In another embodiment, the suture comprises a textile structure or weave pattern that includes a woven medical textile, a knitted medical textile and/a braided medical textile. In a preferred embodiment, the medical textile comprises a woven medical textile. A woven textile involves the interlacing of two or more yarns in right angles to create a fabric or fabric textile. The woven medical textile includes a first yarn and a second yarn. The first yarn may be woven into a first desired direction, the desired direction includes a warp direction, weft direction or a first angled orientation. The second yarn may be woven in a second desired direction, the second desired direction also includes a warp, weft direction or a second angled orientation.
The warp and/or weft or angled directions used in weaving are used to describe the direction of the yarn compared the weaving machines. The warp yarns are positioned vertically, lengthwise or longitudinally and are held stationary in tension on a frame or loom-they act as the beam or center that the weft is interlaced through. The weft is positioned horizontal, latitudinally or transverse and is drawn through and inserted over-and-under the warp in a variety of weave patterns. The warp may be a strong material to be held under high tension during the weaving process, unlike the weft which carries almost no tension. The weft or woof crosses the warp, binding the warp threads at either side to form the selvage. Accordingly, a braid weave pattern allows the interweaving or interlacing of three or more separate strands that intersect at an angled orientation to create a textile. The one or more strands comprise of one or more materials.
In one embodiment, the rigid composite textile 5, 20, 35, 40, 45, 95, 100, 105 comprises a braided weave pattern. The carriers on a braiding machine hold the materials or strands being braided and move in a specific pattern to create a braid. The braided weave pattern may comprise at least 12 strands or greater or at least 12 carriers or greater; the braided weave pattern may comprise at least 14 strands or greater or at least a 14 carrier or greater. The braided weave pattern may comprise at least 16 strands or greater or a 16 carrier or greater. The braided weave pattern may comprise at least a range of 12 to 20 strands or greater or 12 to 20 carriers. Alternatively, the rigid composite textile 5, 20, 35, 40, 45, 95, 100, 105 comprises a woven or knitted weave pattern.
The rigid composite textile 5, 20, 35, 40 may comprise weave pattern having a picks per inch (PPI). A picks per inch is a measurement of the weft in woven pattern and/or it is a measurement of braid density in a braided pattern. The PPI may comprise at least 10 PPI or greater; the PPI may comprise at least 20 PPI or greater; the PPI may comprise at least 25 PPI or greater; the PPI may may comprise at least 30 PPI or greater; the PPI may may comprise at least 35 PPI or greater; and/or the PPI may comprise at least 40 PPI or greater. Alternatively, the PPI may comprise 20 PPI to 50 PPI; the PPI may comprise 20 PPI to 40 PPI; the PPI may comprise 25 PPI to 35 PPI; and/or the PPI may comprise 25 PPI to 30 PPI.
The rigid composite textile 5, 20, 35, 40 may comprise an overall denier (D). The overall denier of the rigid composite textile 5, 20, 35, 40 can vary from 50 to 4000 D; the overall denier may comprise 50 D to 2000 D; and/or the overall denier may comprise 50 D to 1000 D. Within this range, the ranges of the overall denier may comprise 50 to 250 D; the overall denier may comprise 50 to 225 D; the overall denier may comprise 50 to about 200 D; overall denier may comprise 50 to 150 D; the overall denier may comprise at least 50 to 100 D; the overall denier may comprise 50 to 75 D; and/or the overall denier may comprise 70 to 85 D. Alternatively, the overall denier may comprise at least 70 D or greater.
In another embodiment, the textile, monofilament suture, multifilament suture, the first and second yarns, and/or the one or more filaments comprises a material. The material comprises absorbable or non-absorbable materials. The absorbable materials comprise synthetic or natural materials. The synthetic materials may include Vicryl, Monocryl, PDS, and/or any combination thereof. The natural materials may comprise collagen, surgical gut and/or any combination thereof. The non-absorbable materials comprise synthetic and natural materials. The non-absorbable synthetic materials comprises Nylon, polyethylene terephthalate (PET), polyurethane (PU), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (PTFE), polycarbonates (“PC”), ABS, polypropylene (PP), polystyrene, polyethylene (PE), polyester, polyacetal, elastomers, thermoplastic polyurethane (“TPU”), polyvinyl chloride (“PVC”) and/or any combination thereof, as well as other medical grade materials known by those of ordinary skill in the textile art. The polyethylene (PE) comprises ultra-high molecular weight polyethylene (UHMWPE), low density polyethylene (LDPE), medium density polyethylene (MDPE) and/or any combination thereof. The first yarn and the second yarn may be the same or different materials.
In one embodiment, the multifilament strands made from UHMWPE may constitute less than 95%, or less than 90%, or less than 85%, or less than 80%, or less than 75%, or less than 70%, or less than 65%, or less than 60%, or less than 55%, or less than 50% of the number of strands. As for a minimum number of UHMWPE strands, in various embodiments the sleeve contains at least 25%, or at least 30%, or at least 35%, or at least 40%, or at least 45%, or at least 50%, or at least 55%, or at least 60%, or at least 65%, or at least 70%, or at least 75%, or at least 80% UHMWPE multifilament strands. Suitable exemplary ranges include 50-75% of the strands used to form the textile weave pattern are made from UHMWPE, or 50-85% of the strands to form the textile weave pattern are made from UHMWPE.
In another embodiment, the first embodiment of a method of forming the rigid composite textile 20, 35, 40, 45, 95, 100, 110a, 110b comprises the steps of: creating the textile with a monofilament; selecting one or more portions of the monofilament to be removed at one or more locations from the textile; extracting selected one or more portions of the monofilament at the one or more locations from the textile; forming desired shape with a remaining monofilament portions. The method may further comprise the step of: locking or securing the desired shape.
In another embodiment, the first embodiment of a method of forming the rigid composite textile 20, 35, 40, 45, 95, 100, 110a, 110b comprises the steps of: creating a textile 15 that comprises a monofilament 10; identifying a first portion of the monofilament at a first location 55 and a second portion of the monofilament at a second location 50; extracting the first portion of the monofilament from the textile at the first location 55; and forming a desired shape with the second portion of the monofilament at the second location 50. The method may further comprise the step of: locking or securing the desired shape 85. The desired shape may comprise a shuttle loop 60 with a shuttle loop opening 65, a first free end 75 and/or a second free end 85. Alternatively, the desired shape may comprise a shuttle loop 60 with a shuttle loop opening 65, at least one free end.
The step of forming a multifilament suture that includes a monofilament suture or the step of creating a textile with a monofilament suture may comprise an overweave and/or a co-weave. An over-weave is a weaved pattern (e.g., woven, braid or knitted) sheath that is positioned over a portion of the monofilament. A co-weave pattern is weaved pattern (e.g., woven, braided or knitted) that is integrated, integrated or interlaced with a portion of monofilament. In one exemplary embodiment, the step of forming a multifilament suture that includes monofilament or the step of creating a textile with a monofilament suture to form a co-weaved braiding pattern. In another exemplary embodiment, the step of forming a multifilament suture that includes monofilament or the step of creating a textile with a monofilament suture to form an overbraiding structure.
The step of forming a multifilament suture that includes monofilament or the step of creating a textile with a monofilament suture comprises the following: a multifilament suture, the multifilament suture comprising a first strand having a first material and a first orientation, a second strand having a second material and a second orientation, the first strand being interconnected with the second strand to create a weave pattern, at least a portion of the first strand comprises a monofilament, the monofilament comprises a monofilament material.
Alternatively, step of forming a multifilament suture that includes monofilament or the step of creating a textile with a monofilament suture to form comprises the following: a multifilament suture, the multifilament suture comprising a first strand having a first material and a first orientation, a second strand having a second material and a second orientation; and a monofilament suture, the monofilament sutures comprising a monofilament material and a third orientation, the first yarn, the second yarn and the monofilament being interconnected together to create a weave pattern.
In another embodiment, the step of forming a multifilament suture that includes monofilament or the step of creating a textile with a monofilament suture further comprises the steps of: interconnecting a first strand having a first material and a first orientation, a second strand having a second material and a second orientation, to create the textile sheath with weave pattern; positioning the weave pattern sheath over the monofilament (as shown in
In another embodiment, the step of forming a textile that includes monofilament or the step of creating a textile with a monofilament suture comprises the step of: interconnecting a first strand having a first material and a first orientation, a second strand having a second material and a second orientation, to create a weave pattern, at least a portion of the first or second strand comprises a monofilament (see
In another embodiment, In another embodiment, the step of forming a step of forming a textile that includes monofilament or the step of creating a textile with a monofilament suture comprises the step of: interconnecting a first strand having a first material and a first orientation, a second strand having a second material and a second orientation, and a third strand having a third strand material and a third orientation, to create a weave pattern, at least a portion of the third strand comprises a monofilament (see
The textile may comprise a suture, graft or a mesh. The weave pattern may comprise a woven pattern, a braided pattern and/or a knitted pattern. The first strand orientation may comprise a warp strand or vertical strand and the second strand orientation may comprise a weft or horizontal strand. The third strand orientation may comprise vertical strand or a horizontal strand. Accordingly, the first strand orientation and the second strand orientation comprise an angled orientation. Alternatively, the first strand orientation, the second strand orientation and a third strand orientation comprise an angled orientation. The first strand orientation and the second orientation comprise the same angled orientation or different angled orientation. The first and second strand orientation may be the same or different angled orientation compared to the third strand orientation. The angled orientation may include a range of 5 degrees to 85 degrees. The angled orientation may include 90 degrees or right angles. The monofilament is interconnected, integrated and/or interlaced throughout an entire length of the multifilament suture. Alternatively, the monofilament is interconnected, integrated and/or interlaced in a portion of the length of the multifilament textile.
In one exemplary embodiment, the weave pattern comprises a co-braided pattern, and the textile comprises a suture. The first and second strand orientation may comprise a different angled orientation compared to the third strand orientation. The first and second strand orientation comprises an angled orientation, and the third strand comprises an axial or vertical orientation.
As described herein, the multifilament suture can be formed over the monofilament in several techniques. These techniques include the multifilament suture being braided over the monofilament suture during braiding construction; the multifilament suture being positioned over the monofilament suture after braiding construction; the monofilament suture being co-braided, interlaced or interconnected to multifilament suture yarns during braiding construction; and/or any combination thereof.
The monofilament suture being co-braided, interlaced or interconnected to the multifilament suture yarns during braid construction allows the monofilaments to be integrated into the multifilament suture structure to create a composite or hybrid suture structure. The composite rigid core structure comprises a sleeve that includes a plurality of multifilament strands and monofilament strands braided together, the multifilament strands include a plurality of UHMWPE filaments and the monofilament strands comprises nylon or polypropylene. The multifilament strands may be twisted or non-twisted. The one or more monofilament sutures is positioned at or near the center of the multifilament strand. The one or more monofilament strands are positioned longitudinally or is parallel to the longitudinal axis of the multifilament suture. The monofilament may be positioned the entire length of the multifilament suture and/or at least one or more portions of the length of the multifilament suture. The more monofilament strands introduced, the stiffer or rigid the composite suture.
The step of selecting one or more regions of interest (ROI) of the monofilament the rigid composite suture 45, 95, 100 selecting one or more portions of the monofilament to be removed 55 at one or more locations from the rigid composite suture 45, 95, 100 may further comprise the steps of: identifying the desired structure that will be formed; and identifying the size of the structure; and identifying the one or more locations for the desired structure. In one exemplary embodiment, the identified structure that will be formed comprises a shuttle, the shuttle includes shuttle loop 60 having a shuttle loop opening 65 and a shuttle loop size (not shown). Identifying the size and locations to form the desired structure using acquired measurements, allows the user to understand how much of the monofilament should remain and how much monofilament should be extracted—thus identifying a first monofilament portion at a first location and a second monofilament portion at a second location.
The step of isolating one or more portions of the monofilament suture (or a first monofilament portion and a second monofilament portion) within the one or more ROIs extracting selected one or more portions of the monofilament at the one or more locations from the textile allows the removal of unnecessary or unwanted monofilament portions 55 from the weaved pattern of the textile using an appropriate tool 110, which leaves one or more remaining monofilament portions 50. More specifically, the removal of one or more unwanted monofilament portions 50 from the weaved textile pattern allows the tool 110 to extract or isolate the one or more remaining monofilament portions 50 from the interconnected strands that form the weaved pattern, and/or extract the one or more remaining monofilament portions 50 from the core of the over-weaved textile construct (as shown in
The step of creating the desired structure with the one or more portions of the monofilament suture and/or the remaining second monofilament portion comprises manipulating the textile into desired shape. In one exemplary embodiment, the step of creating or forming the desired structure comprises forming a shuttle loop 60 using the second monofilament portion at the second location, the shuttle loop 60 including a shuttle opening 65 and a shuttle size as shown in
In another embodiment, the formed textile comprises a suture, the suture includes a first free end, a second free end, a longitudinal axis. The second free end comprises a second monofilament portion. The second free end of the suture is folded to create a shuttle loop 65 with a shuttle loop opening 65 and a shuttle loop size. The second free end with the second monofilament portion pierces the first location or position to exit out a second location in a substantially transverse or transverse direction secure the shuttle loop 85 (see
The shuttle loop 65 comprises a hoop strength or hoop resistance, that if moved from a first position, the first position being a deflated or compressed hoop position with a first diameter, to a second position, the second position being a uncompressed hoop position with a second diameter, the second position allows the hoop to return to its original uncompressed position. The second diameter being larger than the first diameter. The shuttle loop comprises elasticity allowing the hoop to be compressed and return to its uncompressed, open loop position.
A rigid composite suture comprising: a multifilament suture, the multifilament suture comprising a first strand having a first material and a first orientation, a second strand having a second material and a second orientation, the first strand being interconnected with the second strand to create a weave pattern, at least a portion of the first strand comprises a monofilament, the monofilament comprises a monofilament material. The monofilament material comprise nylon or polypropylene. The first strand material and the second strand material comprise ultra-high weight molecular polyethylene (UHWMPE). The weave pattern comprises a braided pattern. The multifilament suture comprises a round suture, a flat suture, and/or a round-to-flat suture. The monofilament suture comprises a round suture, a flat suture, and/or a round-to-flat suture. The first orientation is a warp or vertical direction, and the second orientation is a weft or horizontal orientation. The first orientation and second orientation are at an angled orientation, the angled orientation comprises 5 degrees to 85 degrees.
A rigid composite suture comprising: a multifilament suture, the multifilament suture comprising a first strand having a first material and a first orientation, a second strand having a second material and a second orientation; and a monofilament suture, the monofilament sutures comprising a monofilament material and a third orientation, the first yarn, the second yarn and the monofilament being interconnected together to create a weave pattern. The first strand material and second strand material comprise ultra-high weight molecular polyethylene (UHWMPE). The monofilament material comprises nylon or polypropylene. The weave pattern comprises a braided weave pattern. The first orientation and second orientation are interconnected in an angled orientation, the angled orientation comprises 5 degrees to 85 degrees. The third orientation comprises a vertical orientation or warp orientation.
A rigid composite suture shuttle comprising: a multifilament suture, the multifilament suture including a shuttle loop and a free end, the multifilament suture further comprising a first strand having a first material and a first orientation, a second strand having a second material and a second orientation, the first yarn and the second yarn being interconnected together to create a weave pattern; and a monofilament suture, the monofilament suture comprising a monofilament material, the monofilament being interconnected into the weave pattern in a third orientation within the shuttle loop. The first strand material and second strand material comprise ultra-high weight molecular polyethylene (UHWMPE). The monofilament material comprises nylon or polypropylene. The weave pattern comprises a braided weave pattern. The first orientation and second orientation are interconnected in an angled orientation, the angled orientation comprises 5 degrees to 85 degrees. The third orientation comprises a vertical orientation or warp orientation.
The method of making a rigid composite suture comprises the steps of: Creating a suture that comprises a monofilament; identifying a first portion of the monofilament at a first location and a second portion of the monofilament at a second location; extracting the first portion of the monofilament from the suture at the first location; forming a shuttle having a shuttle loop, the shuttle loop including a shuttle loop size and a shuttle loop resistance with the second portion of the monofilament at the second location;
This application claims the benefit of U.S. Provisional Application No. 63/612,647 entitled “Rigid Core Composite Textile” filed on Dec. 20, 2023, and U.S. Provisional Appl. No. 63/617,164, entitled “Rigid Core Composite Textile” filed on Jan. 3, 2024, the disclosures of which are both incorporated by reference herein in their entireties.
Number | Date | Country | |
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63612647 | Dec 2023 | US | |
63617164 | Jan 2024 | US |