Suture Device
20230099945 · 2023-03-30
Assignee
Inventors
- David John LINDEN (North Yorkshire, GB)
- Matthew John RAVENSCROFT (Cheshire, GB)
- Thomas Dooney, JR. (Naples, FL, US)
Cpc classification
International classification
A61B17/06
HUMAN NECESSITIES
Abstract
A suture device comprises at least one weft strand interwoven with a plurality of warp strands to define a body region. The body region has a substantially open mesh construction and at least a first elongate end region axially extending from and being one part with the body region having a substantially closed mesh construction. The width of the end region is substantially less than a width of the body region.
Claims
1. A suture device (100) comprising: a body region (102) including at least one weft strand (252) interwoven with a plurality of warp strands (250) in a leno weave, wherein the at least one weft strand (252) has a thickness larger than each of the plurality of warp strands (250); and at least one elongate end region (104) axially extending from and being one part with the body region (102) and having a width less than a width of the body region (102), wherein the at least one weft strand (252) interwoven with the plurality of warp strands (250) define a first body region (102) having a substantially open mesh construction and at least a first elongate end region (104) axially extending from and being one part with the body region (102) having a substantially closed mesh construction and a width substantially less than a width of the body region (102), and wherein the at least one elongate end region (104) comprises at least one of the at least one weft strand (252).
2. A suture device (100) comprising: a body region (102) including at least one weft strand (252) interwoven with a plurality of warp strands (250) in a leno weave, wherein the at least one weft strand (252) has a thickness larger than each of the plurality of warp strands (250); and at least one elongate end region (104) axially extending from and being one part with the body region (102) and having a width less than a width of the body region (102), wherein an average pore size of the body region (102) is larger than an average pore size of the at least one elongate end region (104).
3. A suture device (100) comprising: a body region (102) including at least one weft strand (252) interwoven with a plurality of warp strands (250) in a leno weave, wherein the at least one weft strand (252) has a thickness larger than each of the plurality of warp strands (250); at least one elongate end region (104) axially extending from and being one part with the body region (102) and having a width less than a width of the body region (102); and at least one tapered transition region (108, 110) defined between and being one part with the body region (102) and/or an end region (104, 106), wherein at least one of the plurality of warp strands (250) and at least one weft strand (252) are joined to form an elongate end region (104).
4. The suture device (100) according to claim 1, wherein the substantially open mesh construction has an average pore size of more than 100 μm, and the substantially closed mesh construction has an average pore size of less than 100 μm.
5. The suture device (100) according to claim 2, wherein the average pore size of the body region (102) is at least 100 μm and/or the average pore size of the at least one elongate end region (104) is less than 100 μm.
6. The suture device (100) according to claim 1, wherein the leno weave includes at least a first and a second warp strand twisted in a series of figure eights around at least one weft strand, wherein the first warp strand passes under the weft strand and over the second warp strand and the second warp strand passes over the weft strand.
7. The suture device (100) according to claim 3, wherein the at least one weft strand (252) is a suture and the at least one tapered transition region (108, 110) includes at least one of the plurality of warp strands (250) spliced into the suture strand (252).
8. The suture device (100) according to claim 1, wherein a second elongate end region (106) axially extends from the body region (102) and is provided in an opposed direction to the first end region (104) and is one part with the body region (102) and at least one elongate end region (104) has no undulations and has a constant width.
9. The suture device (100) according to claim 1, wherein the plurality of warp strands (250) comprises sets of at least two warp strands (250), wherein any set of warp strands (250) comprises groups of adjacent pairs of warp strands (250) and the sets of warp strands (250) of the body region (102) are parallel and spaced apart.
10. The suture device (100) according to claim 1, wherein a first warp strand (250) of a set of warp strands (250) is planar and a second warp strand (250) of a set is interwoven with the at least one weft strand (252), and any set of warp strands (250) comprises a greater number of said first warp strands (250) than said second warp strands (250) and a thickness of said first warp strand (250) may be greater than a thickness of said second warp strand.
11. The suture device (100) according to claim 1, wherein at least one end portion of the body region (102) comprises the plurality of weft strands (252) whereas a central portion of the body region (102) comprises a single weft strand (252).
12. The suture device (100) according to claim 11, wherein at least one of the weft strands (252) of the at least one end portion of the body region (102) are stiffer than the weft strand (252) of the central portion of the body region (102), and wherein the stiffer weft strands (252) comprises a braided cord and the weft strand (252) of the central portion of the body region (102) comprises at least one filament.
13. The suture device (100) according to claim 11, wherein a first weft strand (252) of the plurality of weft strands (252) is thicker than a second weft strand (252) of the plurality of weft strands (252).
14. The suture device (100) according to claim 13, wherein the at least one weft strand (252) extends longitudinally from a portion of the body region (102) and wherein the at least one weft strand (252) extends along at least one edge of a central portion of the body region (102), and wherein the at least one weft strand (252) extends along opposed edges of a central portion of the body region (102) and wherein the at least one weft strand (252) of the at least one end region (104, 106) comprises at least one corded construction.
15. The suture device (100) according to claim 14, wherein at least an end portion of the at least one corded construction is hollow and wherein free ends of the warp strands (250) of the at least one end region (104, 106) may be located inside the at least one corded construction by one or more splices to define at least one corded end region (104, 106).
16. A method of manufacturing a suture device, comprising: interweaving at least one weft strand (252) with a plurality of warp strands (250) to define an open mesh construction; and applying a tension to the at least one weft strand (252) to urge the warp strands (250) together and define a body region (102) having an open mesh construction and at least a first elongate end region (104, 106) axially extending from and being one part with the body region (102) having a closed mesh construction and a width less than a width of the body portion.
Description
DESCRIPTION OF DRAWINGS
[0050] In the following the invention will be described by way of example, without limitation of the general inventive concept, on examples of embodiment with reference to the drawings.
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DETAILED DESCRIPTION
[0075] As illustrated in
[0076] Aptly, the body region 102 and the at least one end region 104,106 include a textile fabric. A textile fabric may include a selection of constructions, interlaced and non-interlaced, whether made by braiding, weaving, knitting, crocheting, plaiting, twisting, plying, embroidery, bonding, laminating, non-woven or other processes and combinations thereof. The textile constructions may be fabricated from strands. The term ‘strands’ is intended to include fiber, monofilament, multi-filament yarns that may or may not be twisted, textile constructions such as braids, or a combination of these. Strands may have uniform or varying shape or size. Strands may consist of uniform material, or a combination of various materials. The discrete strands may be the same material or different materials. Variations between strands in terms of construction, shape, size, material, coating, or mechanical properties, may be equally geometrically arranged, or irregularly spaced.
[0077] As illustrated in
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[0079] As illustrated in
[0080] The tapered transition 308 located between the body region 302 and the end region 304 is created by pulling the weft cord (i.e. applying a tension to the weft cord) in substantially the longitudinal direction and out of the construction to provide a run which locks the warp strands and draws them towards the central axis. The weft cord is oriented substantially parallel with the warp strands. Loose strands adjacent to the taper are aptly placed inside the longitudinally orientated hollow weft cord via a single or series of splices, residing throughout the inside of the length of the end regions 304, 306, or terminating at a distance from the ends.
[0081] The regions 312 and 314 are the weft cord after being repositioned into the warp direction. The free ends of the mesh of body region 302 are then pulled inside this hollow tubular weft cord. As illustrated in
[0082] The run causes the weft cord to lock the warps at the taper whilst providing the taper itself. This arrangement also allows for easier splicing, provides a smooth tapered transition from the body region 302 to the end region 306 which allows for easy passage through tissue, and provides a thin dense cord end for ease of threading through surgical instruments and creating a fixation mechanism.
[0083] According to an alternative embodiment, the surgical device may include an open mesh construction which allows a relatively wide profile to be created from a similar quantity of material. This provides an increased footprint to enhance engagement with adjacent tissue and also facilitates tissue ingrowth and postsurgical repair.
[0084] As illustrated in
[0085] As illustrated in
[0086] As illustrated in
[0087] Aptly, as illustrated in
[0088] Preferably, the parallel warp strands 751 have a larger diameter than the binding warp strands 753. This allows a particularly desirable fabric to be created having a relatively high strength (greater number of warps), relatively high stiffness (parallel warps), and optimum pore size for tissue incorporation.
[0089] Alternatively, one or more binding warp strands may have a similar, larger or smaller diameter to the other strands. One or more parallel warp strands may have a similar, larger or smaller diameter to the other strands. One or more weft strands may have a similar, larger or smaller diameter to the other strands. One or more warp and/or weft strands may be equally or not equally spaced. For example, as illustrated in
[0090] According to an alternative embodiment, the body region of the device may include an open mesh construction and the at least one end region may be of a thinner construction to facilitate threading through tissue and eyelets in surgical instruments. The thinner end region/s may be formed by a series of tapers, binding and/or splicing, as previously described.
[0091] As illustrated in
[0092] As illustrated in
[0093] According to an alternative embodiment, as illustrated in
[0094] According to an alternative embodiment, the wefts in the end portions 1103,1105 of the body region 1102 are continuous, with one or more wefts 1152 running at least partially along the edge of a central portion 1101 the body region and substantially parallel to the longitudinal axis. This arrangement provides a soft and pliable middle portion to the body region 1102 for enhanced tissue ingrowth, while the edge portions of the body region have increased strength provided by the second weft.
[0095] According to an alternative embodiment, multiple sets of wefts may be used. In a first example, as illustrated in
[0096] Weft 1204 penetrates opposing weft 1205, entering at point 1208 and residing along the interior lumen of the opposing weft 1205, and exiting the weft 1205 at point 1210 thereby creating a loop which is adjustable in length when free end of cord 1211 is pulled, and locked in length when the loop 1207 is under load. Similarly, weft 1205 penetrates opposing weft 1204 at point 1213, passes within weft 1204, and exits weft 1204 at point 1215 to create free end of cord 1217. Alternatively, any weft cord may form a discrete adjustable loop by passing within itself. Alternatively, a button may be attached to one or more loops to aid fixation.
[0097] According to an alternative embodiment, the device is aptly configured to facilitate cutting away surplus material following implantation. Typically, such open mesh constructions are unstable when cut to length, with the strands at the end of the device fraying and splaying with the textile construction becoming unraveled. A method is described by which the device 1300 is cut to a first length (
[0098] According to an alternative embodiment, one or more warp cords may be used. In a first example, as illustrated in
[0099] In
[0100] The construction of any region of the device in regards to width, length, cross sectional shape, density, pore size, material type and mechanical properties may be adapted for its function, whereby the mechanical properties may include one or a combination of; strength, stiffness, wettability, flexibility and rate of absorption, and any region may have, for example, a variance in any one or a combination of the above mentioned physical or mechanical properties. Variations in the properties of the warp or weft strands may be substantially equally or unequally spaced relative to one another. One or more of the warp strands may include a different cross-sectional size to other warp strands. The warp strands may be equal to, greater than and/or smaller than the denier of the weft strands. The body region of the device may have undulations in the surface to provide increased frictional resistance to aid knot tying. One or more of the warp strands may include a larger cross-sectional area to create one or more ridges. One or more of the weft strands may include a larger cross-sectional area to create one or more ridges. The body region may be planer or tubular in cross section.
[0101] The suture material may include a single or a blend of materials. The materials that create the textile fabric may include bioabsorbable or non-bioabsorbable substances from natural or artificial sources including for example, gut, silk, cotton, ultra-high molecular weight polyethylene (UHMWPE) polyamide (Nylon), polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), polydioxanone polyetheretherketone (PEEK), polyetherketoneketone (PEKK), graphene, or bioabsorbable materials whether as a single material or as a blend of materials. A combination of ultra-high molecular weight polyethylene (UHMWPE) and polyethylene terephthalate (PET) may be used to provide strength and improved knotting characteristics respectively. Pairs of warp strands may be used where one of the strands is UHMWPE and one PET. Preferably the UHMWPE has a larger cross-sectional area, in effect a greater denier, and is substantially parallel to transmit the load, where the smaller denier PET strand acts to bind the UHMWPE strand to the weft strands. Colored strands may be incorporated to enhance visibility during use. Colored strands are aptly fashioned from dyed fibres of UHMWPE, PET or nylon. Different colors or patterns of color may be used in different regions for identification.
[0102] Embodiments provide a suture device that provides improved utility for a range of surgical applications, whilst allowing the device to be used with existing surgical instrumentation. The device is configured to improve pressure distribution to adjacent tissue during and after a surgical repair and to reduce/eliminate any undesirable contact forces which could result in cutting of the adjacent tissue. The device is configured to provide improved strength and optimized coupling with bone, soft tissue or fixation devices. The device includes a relatively wide and open mesh main body region to create a large footprint resistant to tissue pull-through and to encourage tissue interaction. The relatively thin end regions are adapted to pass through relatively small eyelets in standard surgical instruments to facilitate efficient transit through tissue during surgical procedures.
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[0104] A preferred definition is as shown in
[0105] If the weft strands have a distance larger than the warp strands, then the diameter of the circle is mainly determined by the distance of the warp strands. This is shown in