Medical textile implants with variable gripping filaments
Medical textile implants with variable gripping filaments address the challenge of controllable friction in soft tissue reconstruction by using embroidery to form filaments that adjust their height and number with resorbable spacers, enhancing both initial placement and long-term stability.
Patent Information
- Application Number
- PCT/US2024/058980
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-06
- Filing Date
- 2024-12-06
- Publication Date
- 2025-06-12
AI Technical Summary
Current medical textiles for soft tissue reconstruction lack controllable friction characteristics, which can lead to issues such as pain, infection, hernia recurrence, and instability during the healing process.
The development of medical textile implants with variable gripping filaments, which are formed through embroidery and can adjust their frictional properties by changing the effective height and number of gripping filaments using resorbable spacers, allowing for controlled peel and shear resistance at different stages of implantation.
This solution provides improved initial placement and long-term stability of medical textiles by adjusting friction levels in response to the implantation phase, reducing adverse events such as pain, infection, and recurrence.
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Abstract
Description
MEDICAL TEXTILE IMPLANTS WITH VARIABLE GRIPPING FILAMENTSCLAIM OF PRIORITY
[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 606,986, titled “MEDICAL TEXTILE IMPLANTS WITH VARIABLE GRIPPING FILAMENTS,” and filed on December 6, 2023, which is herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD
[0003] The apparatuses and methods described herein relate generally to the field of surgical grafts and medical textiles useful for soft tissue reconstruction, regeneration, or repair. More particularly, described herein are medical and / or biotextile implants with gripping elements that have varying heights.BACKGROUND
[0004] Soft tissues within a body may benefit from repair or reinforcement due to a variety of reasons such as disease, enhancement, or trauma. An implant or medical textile may be used to repair or reinforce a soft tissue such as an unhealthy or modified tissue in the body. The tissue may be, for example, tissue that is no longer able to maintain its shape or physiological function such as a hernia or a tissue for which a shape or size change is desired such as breast size or shape change due to breast enhancement or breast reconstruction. A hernia is a condition in which part of an organ or fatty tissue protrudes through the wall of a surrounding tissue. Abdominal wall hernia surgery is one of the most common surgical procedures, and according to the U.S. Food and Drug Administration, more than 1 million hernia repairs are performed in the United States alone. Common adverse events associated with hernia repair surgery include pain, infection, hernia recurrence, adhesion formation, obstruction, bleeding, and fluid build-up. Breast reconstruction may be performed to reconstruct a breast after a mastectomy has been performed to remove a diseased tissue due to cancer or as a prophylactic measure to prevent cancer.
[0005] The successful application and use of implants and / or medical textiles may depend, among other things, on the friction characteristics associated with the selected surgical material. The friction characteristics can affect initial placement of the medical textile by the surgeon as well as the ability for the textile to remain in position during the healing of the patient.
[0006] Thus, there is a need for surgical repair textiles with controllable friction characteristics.SUMMARY OF THE DISCLOSURE
[0007] Described herein are apparatuses, systems, and methods to create one or more griping implants. A gripping implant can be an implant that includes a plurality of gripping filaments. The gripping filaments may extend from the surface of the implant to engage with tissue, and / or with a second implant material. The gripping implant may be (or may be part of) a medical textile implant. In general, the gripping filaments may provide friction and / or mechanical adhesion between the implant and a patient’s tissue or any other feasible substrate.
[0008] The gripping implants described herein may be specifically configured to include or modify a medical, and in particular a biotextile, implant so that one or more sets of gripping filaments extending beyond a surface of the implant. The one or more sets of gripping filaments may be formed from embroidery (stitching) and / or may be an element of a textile that is incorporated in the implant. For example, the one or more gripping filaments may be formed of a filament or filaments (e.g., yarn, fiber, strand, etc.) and may be formed of a polymer. The one or more plurality of gripping filaments may extend from a substate to which the gripping filaments are attached. The substrate may be, e.g., a medical textile to which the material forming the gripping filaments is embroidered (sewn), or in some examples, the filament(s) (e.g., yam, fibers, etc.) forming the gripping filaments may form all or a portion of the substrate. The gripping filaments may generally include an arm extending from the substrate. The arm is formed of the filament(s), and may include a distal end region (e.g., tip region) that is configured to engage with the tissue or other target in a predictable manner. For example, the distal end region may be enlarged as compared with the shaft of the arm region extending from the substrate.
[0009] In general, these apparatuses (e.g., devices, systems, etc., including in particular implants) and methods may provide one or more pluralities of gripping filaments that are configured to change their frictional properties during different phases of implantation. This may be achieved by including two or more distinct populations of gripping filaments thatmay be configured specifically to engage with the tissue (or other target) in a defined manner during implantation, when controlling peel resistance is most useful, vs. following implantation, when controlling shear resistance may be more important. In some cases, this may be achieved by adjusting the effective heights of the one or more sets of gripping filaments so that the gripping filaments have a first length (or sets of lengths) during implantation that may be different following completion of the implantation.
[0010] In some examples, the methods and apparatuses described herein may include gripping implants that are present on both sides of the implant and / or may have different effective lengths (heights) of gripping elements on one side or both sides of the implant. The use of different sets of gripping filaments (arms) having different height ranges may offer different degrees and / or type of friction (e.g., peel vs shear) at different stages of implantation (surgical positioning, possible repositioning during same procedure, surgical closing of the wound, healing, long-term residence, etc.). Thus, the apparatuses and methods described herein may be configured to adjust the balance (the “friction balance”) of the implant during various stages of the implant use.
[0011] In some examples the one or more sets of gripping filaments may be configured to adjust the effective height and / or number of the gripping filaments by the use of one or more spacers, and in particular the use of one or more controllably resorbable spacers that may provide an initial effective height for the gripping filaments in a first, e.g., implantation, configuration, but may, following a predetermined and relatively short time period after implantation, adjust the effective height of the gripping filaments (and / or may expose a set of gripping filaments) by resorbing the spacer. Thus, described herein are apparatuses including a resorbable spacer. The resorbable spacer may be a resorbable textile material (e.g., which may be coupled to the substrate, such as to an outer surface of the substrate) and / or may be an embroidered material (e.g., a resorbable filament), and / or a coating on the substate. For example, a resorbable fabric may be secured to the substrate. The spacers described herein can also enhance friction balance by changing effective distance between substrate and grip head. In some examples the spacer can be configured to be resorbed (e.g., completely or nearly completely, such as more than 75% resorbed, more than 80% resorbed, more than 85% resorbed, more than 90% resorbed, more than 95% resorbed, etc.) in as little to an hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 10 hours, 12 hours, 24 hours, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, one month, etc.), changing the friction of the device over time and / or at two different time periods (e.g., during implantation and after implantation (e.g., postoperatively).
[0012] In general, the use of embroidery to form the implants, and in particular, the use of embroidery to form the gripping filaments, and in some cases the substrate and / or spacer(s) may allow control of the mechanical properties of the implant, including (but not limited to) the compliance. In some examples the gripping implants may be fabricated by knitted and / or embroidered techniques. In some cases, the methods of fabricating the gripping implants described herein may include knitting and / or embroidering to form the different griping filament heights. Compliance-control stitching may also be used to improve implant characteristics. Embroidery offers unique fabrication methods and property control that cannot otherwise be created with traditional technology.
[0013] In some examples, the gripping implant can include one or more plurality of gripping filaments, such as a first group of gripping filaments and a second group of gripping filaments. Each group of gripping filaments may be associated with a distinct length. For example, a first group of gripping filaments may be associated with a first length and a s second group of gripping filaments may be associated with a second length, different than the first length. Different lengths of gripping filaments may be associated with different friction characteristics and therefore may be selected and employed to control the frictional properties of the apparatus.
[0014] In some aspects, the length of the gripping filaments may be associated with a peel friction. Peel friction may be related to an initial friction force of placing a gripping implant into a position. In some aspects, the length of the gripping filaments may be associated with a shear friction. Shear friction may be related to a friction force of moving a gripping implant particularly moving the gripping implant lateral or sideways after initial placement
[0015] Any of the apparatuses described herein may be configured as a surgical implant. The surgical implant may include a substrate comprising a first side and a second side, and a first group of gripping filaments coupled to the first substrate and extending from the first side, wherein each end of the first group of gripping filaments is configured to engage with a first surface of the body into which the implant is implanted and / or a first surface of another implant that may engage with the gripping implant.
[0016] In any of the apparatuses described herein, the first surface may include a patient’s tissue and a region receiving the surgical implant. In general, the first surface may generally be associated with any location where the surgical implant is being used. Further, the first surface may be another biomedical textile.
[0017] In any of the apparatuses described herein, each end of the first and / or second group of gripping filaments may include an enlarged distal end region (e.g., a mushroom orbutton tip feature) configured to provide a resistance force against pulling the surgical implant away from the first surface. In general, the distal end region may perform as a hook or barb restricting motion of the gripping filament.
[0018] In any of the apparatuses described herein, the first surface may include at least one a human tissue, a biologic textile, or a combination thereof. Furthermore, in any of the apparatuses, the first substrate may include a polymer compound.
[0019] Any of the apparatuses described herein may also include a second group of gripping filaments extending from the first side of the substrate, where the second group of gripping filaments are configured to engage with the first surface. Thus, in some examples, a surgical implant can include two different groups (sets) of gripping filaments. In some examples, the second group of gripping filaments may be separate from the first group of gripping filaments, e.g., may have a separate vertex from which the gripping filaments leave the sub state.
[0020] For example, an implant (e.g., a gripping implant) as described herein may include: a sheet of substrate material having a first side and a second side; a first plurality of gripping filaments extending proud of the first side of the sheet of substrate material by a first height, hi, wherein each gripping filament of the first plurality of gripping filaments comprises an arm extending from a first vertex; and a second plurality of gripping filaments extending proud of the first side of the sheet of substrate material by a second height, I12, wherein the first height is less than the second height (hi < fe). Any of these implants may include one or more resorbable spacers on the first side of the sheet having an offset height, hs, so that the effective height of the first plurality of gripping filaments and the second plurality of gripping filaments is reduced by the offset height (e.g., hi -hs, h2-hi) while the implant is in a pre-implantation configuration, and further wherein the effective height of the first plurality of gripping filaments is converted to the first height, and the height of the second plurality of gripping filaments is converted to the second height in an implanted configuration. In any of these examples the spacer may be approximately the same height or higher than the height of the second set of gripping filaments, therefore preventing them from engaging until the resorbable spacer is resorbed.
[0021] The resorbable spacer may be any appropriate resorbable spacer. In some examples the resorbable spacer comprises a resorbable embroidered material that embroidered to the first surface. In some examples the resorbable spacer comprises a resorbable textile. The resorbable material may be any appropriate resorbable material, and may be configured or selected to be resorbed quickly, e.g., as a fast resorbing spacer formed from a material configured to be resorbed in 72 hours or less (e.g., withing 1 hour or less,within 2 hours or less, within 3 hours or less, between 1 and 3 hours, between 1-4 hours, within 4 hours or less, within 5 hours or less, within 6 hours or less, within 10 hours or less, within 12 hours or less, within 16 hours or less, within 20 hours or less, within 24 hours or less, within 30 hours or less, within 36 hours or less, within 48 hours or less, within 72 hours or less, within 4 days or less, within 5 days or less, within 6 days or less, within 7 days or less, etc.). The dissolving material may be a resorbable polymers, such as, but not limited to, lactic acid, glycolic acid (e.g., polylactic acid (PL A), polygly colic acid (PGA), poly-L-lactide (PLLA), poly-DL-lactide (PDLLA), copolymers of PLA and PGA (PLGA), copolymers of PLLA and PDLLA, etc.), hydrogels, including resorbable hydrogels of polyethylene oxide), as well as methyl cellulose, hyaluronic acid, chitosan, collagen, gelatin, fibrin, dextran, agarose and carboxy methyl cellulose. The resorbable material can also be a composite of resorbable polymers with calcium sulfate, calcium phosphate, calcium phosphate cements, hydroxyapatite, beta-tri calcium phosphate and bioactive glass and glass ceramics.Different resorbable materials have different rates of resorption, allowing the spacer to be designed for a particular application requirement. For example, the resorbable spacer may comprise a fast-resorbing material configured to be resorbed in 24 hours or less.
[0022] Any appropriate substate material may be used, including one or more sheets, fabric, mesh, etc. In some examples a substrate may be formed of a knit, woven, and / or braided material (e.g., filament(s), including the same filament(s) used for forming the gripping filament(s). In some examples the sheet of substrate material comprises a mesh. The second plurality of gripping filaments may comprise a second arm extending from a second vertex. In some examples the first plurality of gripping filaments may be formed of a grid pattern of filament that is stitched through the sheet of substrate material.
[0023] The first plurality of gripping filaments may comprise a first filament of material extending adjacent to the first side of the sheet of substrate material. The first plurality of gripping filaments may comprise an enlarged distal end at the ends of each of the arms. In some examples, as mentioned above, the enlarged distal end comprises a mushroom head. Similarly, the second plurality of gripping filaments may each comprise an enlarged distal end at the ends of each of the gripping filaments of the second plurality of gripping filaments.
[0024] Any of these implants may include a third plurality of gripping filaments extending proud of the second side of the sheet of substrate material by a third height, hs. Any of these implants may include a fourth plurality of gripping filaments extending proud of the second side of the sheet of substrate material by a fourth height, Av, which is less than the third height, hs .
[0025] The first plurality of gripping filaments may be formed of a material that is different from the second plurality of gripping filaments. Alternatively, the first plurality of gripping filaments may be formed of a material that is the same from the second plurality of gripping filaments.
[0026] Any appropriate substrate may be used. For example, the substrate may comprise at least one of a human tissue, a biologic textile, or a combination thereof. The first plurality of gripping filaments may comprise a polymeric material. The first plurality of gripping filaments may be associated with a peel friction between the implant and a first surface and wherein the second plurality of gripping filaments is associated with a shear friction between the implant and the first surface.
[0027] For example, a method of fabricating an implant may include: embroidering a first material onto a sheet of substrate material having a first side and a second side; embroidering a second material onto the sheet of substrate material; forming the first material into a first plurality of gripping filaments extending proud of the first side by a first height, h , and forming the second material into a second plurality of gripping filaments extending proud of the first side of the sheet of substrate material by a second height, I12, wherein the first height is less than the second height (hi < A?).
[0028] Any of these methods may include embroidering a resorbable material to the first surface so that the effective height of the first plurality of gripping filaments and the effective height of the second plurality of gripping filaments is reduced by an offset height while the implant is in a pre-implantation configuration, and further wherein the effective height of the first plurality of gripping filaments is converted to the first height, and the height of the second plurality of gripping filaments is converted to the second height in an implanted configuration in which the resorbable material is absorbed. For example, embroidering the resorbable material to the first surface may comprise embroidering with a resorbable filament. In some examples embroidering the resorbable material to the first surface comprises embroidering a resorbable sheet of material onto the first surface.
[0029] Forming the first material into the first plurality of gripping filaments and forming the second material into the second plurality of gripping filaments may comprise cutting a plurality of interconnecting filaments between the first surface of the sheet of substrate material and a second sheet of material embroidered to the first sheet of substrate material. Any of these methods may include forming an enlarged distal end on a distal end of each end of the first plurality of gripping filaments. Any of these methods may include forming an enlarged distal end on a distal end of each end of the second plurality of gripping filaments.
[0030] In some cases, embroidering the first material onto the sheet of substrate material may comprise embroidering through the sheet of substrate material and a second sheet of material. The method of fabricating may further comprise compressing the sheet of substrate material and the second sheet of material prior to embroidering the second material onto the sheet of substrate material, wherein second material onto the sheet of substrate material comprises embroidering through the sheet of substrate material and the second sheet of material. Forming the first material into the first plurality of gripping filaments and forming the second material into the second plurality of gripping filaments may comprise passing a heated cutter between the sheet of substrate material and the second sheet of material.
[0031] Also described herein are methods of treating a patient using any of the apparatuses (e.g., implants) described herein. For example, a method of treating a patient may include: engaging a tissue of the patient with a first level of friction from an implant comprising a sheet of substrate material having a first plurality of gripping filaments extending proud of a first side of the sheet of substrate material by a first height and a second plurality of gripping filaments extending proud of the first side of the sheet of substrate material by a second height, wherein the first height is greater than the second height, wherein the first plurality of gripping filaments extend from the implant by a first effective height that is less than the first height and the second plurality of gripping filaments extend from the implant by a second effective height that is less than the second height; and increasing the friction between the first implant and the tissue after implantation as a resorbable material on the first side of the sheet of substrate material is resorbed so that the first effective height of the first plurality of gripping filaments increases toward the first height and the second effective height of the second plurality of gripping filaments increases towards the second height. The resorbable material may comprise a sheet of resorbable material and / or may be resorbed over a period of, e.g., 24 hours or less, e.g., 36 hours or less, 48 hours or less, 72 hours or less, etc. For example, the resorbable material may be resorbed over a period of 24 hours or less. Any of these methods may include implanting the implant into the tissue.
[0032] In general, different groups of gripping filaments may each have a different length. For example, the first group of gripping filaments may be longer than the second group of gripping filaments. In some examples, a surgical implant can include more than two groups of gripping filaments. For example, a surgical implant can also include a third group of gripping filaments. The third group of gripping filaments may be configured to engage with a second surface.
[0033] In general, different groups of gripping filaments may be associated with different friction. For example, the first group of gripping filaments may be associated with a peel friction between the surgical implant and the first surface, and the second group of gripping filaments may be associated with shear friction between the surgical implant and the first surface.In any of the apparatuses described herein, may include dissolvable spacer, e.g., dissolvable layer, dissolvable embroidery, etc., disposed on the first substate and configured to temporarily reduce a length of any of the first group of gripping filaments. In some examples, the dissolvable embroidery disposed on the first substate and configured to temporarily reduce a length of any of the first group of gripping filaments. In some examples, the dissolvable embroidery may be disposed on the first side of the first substrate. In some aspects, the dissolvable embroidery may be configured to contact the first surface. In any of the apparatuses described herein, the dissolvable embroidery is dissolved by a patient in less than sixty minutes (e.g., 1 hour or less, 2 hours or less, 3 hours or less, etc.). In some cases, the dissolvable embroidery (e.g., dissolvable spacer) may be dissolved by a patient in less than three hours. In some examples, the surgical implant may include a spacer textile disposed against the first side of the first substrate, where the spacer textile is attached to the first substrate by dissolvable embroidery.
[0034] In any of the apparatuses described herein, the first group of gripping filaments may be configured to limit stretching, deformation, displacement, or a combination thereof in response to an applied force.
[0035] Any of the methods described herein may include methods for fabricating a surgical implant. The methods may include obtaining or receiving a substrate material, where the spacer comprises a knit material includes a first surface, a second surface, and a plurality of interconnecting filaments configured to couple the first surface to the second surface. The method may also include cutting the plurality of interconnecting filaments to separate the first surface from the second surface, wherein the plurality of interconnecting filaments form a first group of gripping filaments of the surgical implant.
[0036] In any of the methods described herein may further include cutting the plurality of interconnecting filaments includes forming a button feature on a distal end of each cut end of the interconnecting filaments. In general, the button feature may act as a barb or hook and can increase resistance to pulling the surgical implant away from another substrate or surface.
[0037] Any of the methods described herein may include compressing the substrate material with embroidery stitching between the first surface to the second surface prior to cutting the plurality of interconnecting filaments. In some examples, cutting the plurality ofinterconnecting filaments further comprises cutting the embroidery stitching between the first surface to the second surface. Furthermore, the cut embroidery stitching may form a second group of gripping filaments of the surgical implant. In some cases, the embroidery stitching can decrease a distance between the first surface and the second surface.
[0038] In any of the methods described therein, cutting the plurality of interconnecting filaments includes passing a heated knife to partially melt the plurality of interconnecting filaments.
[0039] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS
[0040] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:
[0041] FIG. 1 A shows a simplified isometric view of a substrate configured as a knit material.
[0042] FIG. IB shows a side view of the knit material of FIG. 1A.
[0043] FIG. 1C shows an example gripping implant that may be formed by cutting the knit material of FIGS. lA and IB.
[0044] FIG. ID shows a side view of the gripping implant of FIG. 1C.
[0045] FIGS. 2A-2D show another example gripping implant.
[0046] FIG. 3 A shows an isometric view of the double knit material that may be used to form a substate as described herein.
[0047] FIG. 3B shows a side view of the double knit material of FIG. 3 A.
[0048] FIG. 3C shows the side view of the double knit material in relation to a first cut line and a second cut line.
[0049] FIG. 4 shows a side view of example gripping implants that may be formed from a double knit material, such as the double substrate knit material of FIGS. 3A-3C
[0050] FIGS. 5A-5C show various examples of double-sided gripping implants.
[0051] FIGS. 6 A and 6B illustrate example gripping implant textiles with and without resorbable spacer embroidery.
[0052] FIG. 7A shows another example gripping implant including a resorbable spacer (e.g., spacer textile).
[0053] FIG. 7B shows the gripping implant with a resorbable spacer including a spacer embroidery.
[0054] FIGS. 8A-8C illustrate possible steps associated with forming a double-gripping implant (e.g., a gripping implant having a pair of sets of gripping filaments having two different average lengths).
[0055] FIG. 9 is a flowchart depicting an example of one method for forming a gripping implant.DETAILED DESCRIPTION
[0056] Medical substrates and textiles are used in a variety of surgeries and other medical procedures. Depending on the particular application, some substrates / textiles may need varying amounts of friction for placement during implantation and / or for long-term healing. For example, a surgeon may need to contend with at least two distinct types of friction with respect to substrates and textiles.
[0057] A first type of friction may be referred to as peel friction. This type of friction affects placement and repositioning of the substate or textile within a treatment area. For example, as a substrate is placed into position, the surgeon may need to lift and reposition the substrate (overcoming peel friction) several times. Thus, the peel friction may affect how easily the substrate can be moved and repositioned.
[0058] A second type of friction may be referred to as shear friction. This type of friction may be related to the ability of the substrate or textile to remain in place and resist sideways or shearing motion. Thus, shear friction may affect substrate stability and, in some cases, compliance of the substrate with respect to other materials or patient anatomies.
[0059] Often, a desired peel friction may be different than a desired shear friction. Thus, a user or surgeon may find it useful and / or desirous to control or select distinct levels or amounts of peel and shear friction.
[0060] Disclosed herein are substrates and textiles that include various gripping filaments to control and / or affect levels of peel and shear friction between the substrates / textiles and a patient’s anatomy or other surfaces. The gripping filaments may be formed from a polymer material, although other materials are feasible. Various methods for forming gripping filaments are also disclosed herein.
[0061] FIG. 1 A shows a simplified isometric view of a substrate material 100. In this example the substrate is shown as a double layer that may be cut to form the substate of the implant. The substrate may be a fabric. In some examples the substrate is a knit substrate, however any appropriate substrate may be used. The substrate material 100 may be composedof fibers or filaments and may be used to separate two or more elements. For example, the substrate material 100 can separate an anatomical implant from a patient’s tissue. The substrate material 100 may include a first side (or surface) 101 and a second side (or surface) 102. Generally, the first side 101 may be parallel to the second side 102. The substrate material 100 may have a thickness D that separates the first side 101 from the second side 102. The first side 101 may be connected to the second side 102 with a plurality of interconnecting filaments 103.
[0062] FIG. IB shows a side view of the substrate material 100. As shown, the first side 101 is separated from the second side 102 by the distance D. The substrate material 100 may be formed from any feasible material such as hypoallergenic and / or bioabsorbable polymers. Interconnecting filaments 103 may connect the first side 101 to the second side 102.
[0063] In some examples, a gripping implant may be formed from a substrate material, such as the substrate material 100. A gripping implant may be substrate that includes one or more groups of gripping filaments that engage with and provide varying amounts of friction between the substrate and a target surface, such as a cavity, tissue, or region within a patient. Returning to FIG. 1 A, the substrate material 100 may be cut in the direction shown by arrow 110. Cutting the substrate material 100 through the interconnecting filaments 103 in this manner can form two gripping implants.
[0064] FIG. 1C shows an example gripping implant 120 that may be formed by cutting the substrate material 100. If the substrate material 100 was generally cut in the center of the thickness D, then the gripping implant 120 may have a thickness of D / 2. As shown, the gripping implant 120 may include a plurality of gripping filaments 121. Each gripping filament 121 may include a button feature 122 formed during the cutting process. For example, if the cutting process includes the use of a heated cutting element (heated knife), then the heated cutting element may cause the formation of one or more button features 122 on distal ends of the gripping filaments 121. The button feature 122 may help anchor or lock the gripping implant 120 to any other adjacent substrate or anatomical body part (tissue, lining, cavity, or the like). For example, the button feature 122 may operate as a barb or latch that provides an added resistance against pulling the gripping filament 121 out from the adjacent substrate, tissue, or body part. In this manner, the gripping filaments 120 may control or affect friction between the gripping implant 120 and other surfaces or substrates by engaging with the other surfaces and / or substrates.
[0065] In some examples, the gripping filaments 121 can increase compliance of the underlying gripping implant 120. As used herein, compliance may refer to effectuating one or more of control, modulation, influence, or regulation of one or more of the strength,stretching, deformation, displacement, elasticity, flexibility, and resilience of an object, for example, a substrate or an implant, under applied force(s). In this case, compliance of the gripping implant 120 is improved by the gripping filaments 121 providing anchoring support and resistance to movement.
[0066] FIG. ID shows a side view of the gripping implant 120. In particular, FIG. ID shows and example height D / 2 of the gripping filaments 121. Other heights are possible based on where the substrate material 100 is sliced or cut.
[0067] FIGS. 2A-2D show another example gripping implant 200. In particular, FIG. 2A shows a simplified side view of the gripping implant 200. The gripping implant 200 may include first group of gripping filaments 210 and second group of gripping filaments 211.The height of the first group of gripping filaments 210 may be different from the height of the second group of gripping filaments 211. For example, the first group of gripping filaments 210 may have an associated height of D2 and the second group of gripping filaments 211 may have an associated height of D3. The height of the first group of gripping filaments 210 may be the same as or different than the height of the second group of gripping filaments 211.
[0068] In some examples, different heights of the different groups of gripping filaments may be associated with different amounts of friction or grip. For example, longer (taller) gripping filaments may engage, contact, and / or interact with another surface (which can be a patient’s anatomy) or textile sooner than a shorter gripping filament. Therefore, controlling the number (density) of longer gripping filaments with respect to shorter gripping filaments may control how a textile reacts to an initial peel friction in contrast to a shear friction. In some cases, gripping filaments with a relatively longer height may be responsible for a peel friction and gripping filaments with a relatively shorter height may be responsible for a shear friction. As a surgeon places a substrate or textile within a patient, the surgeon may want to reposition the substrate / textile. In this example, initial resistance (peel friction) may be an important friction component. After placement (and after surgery), the substrate or textile should be relatively motionless with respect to the treatment region. Under these circumstances, shear friction may be an important friction component. Thus, selecting the amount or levels of the different types of friction associated with a substrate may affect surgical outcomes associated a textile.
[0069] As described above, the relatively longer gripping filaments may be associated with peel friction and the relatively shorter gripping filaments may be associated with shear friction. Furthermore, the number (density) and length of the longer gripping filaments may affect the amount or level of peel friction. In a similar manner, the number (density) and length of the shorter gripping filaments may affect the amount or level of shear friction.
[0070] In some examples, relatively longer grip filaments may require relatively low compressive forces to engage with a patient’s tissue or other substrates. The longer grip filaments may be engaged a tissue or other substrate during an initial placement. The longer grip filaments may provide light (low) peel friction (resistance) and light (low) shear friction. Thus, the long grip filaments may enable a substrate to be repositioned more easily during surgery. In some embodiments, the long grip filaments may be fabricated through an embroidery process after shorter grip filaments are in-place or already formed.
[0071] In some examples, relatively shorter grip filaments may engage with a tissue or substrate with additional compressive force (for example, after the long grip filaments have already been engaged with a tissue or other substrate). In some cases, after placement of the substate, the surgeon can provide pressure to selected regions of the substrate or textile with the shorter grip filaments to increase friction and / or enhance positioning. This may make the associated substrate or textile more stable after surgery (for example, after wound closure). In some embodiments, the short grip filaments may be fabricated through embroidery or from a substrate textile as described in FIGS. 1 A-1D.
[0072] In some examples, the multiple types (lengths) of gripping filaments may enhance compliance of the gripping implant. In some cases, not only does an increased density of gripping filaments improve the anchoring of the gripping implant, but the differing lengths of the groups of gripping filaments may also provide increased resistance to move in response to stretching or deformation forces. Furthermore, each gripping filament may each include a button feature or other similar feature (barb, hook, or the like) that enable the first group of gripping filaments 210 and the second group of gripping filaments 211 to engage with, and remain attached to, other substrates or anatomical tissues.
[0073] FIG. 2B shows an isometric view of the gripping implant 200. As shown, the first group of gripping filaments 210 and the second group of gripping filaments 211 may each include a button feature or other similar feature (barb, hook, or the like) that enable the first group of gripping filaments 210 and the second group of gripping filaments 211 to engage with, and remain attached to, other substrates or anatomical tissues. FIG. 2C shows an isometric view of another example gripping implant 250. The gripping implant 250 may include first group of gripping filaments 260 and second group of gripping filaments 261. In some examples, the first group of gripping filaments 260 may be longer than the second group of gripping filaments 261. The second group of gripping filaments 261 may be part of an integral part of a substrate while the first group of gripping filaments 260 may be added to the substrate through an embroidery process. Each gripping filament may include a button feature or other similar feature to provide enhanced friction. FIG. 2D shows an isometricview of another example gripping implant 270. The gripping implant 270 can include first group of gripping filaments 280 which may be longer than second group of gripping filaments 281.
[0074] In some applications, a double-sided gripping implant may be desired. Forming a double-sided gripping implant may begin with a double substrate material as described below in conjunction with FIGS. 3 and 4.
[0075] FIG. 3A shows an isometric view of the double substrate material 300. The double substrate material 300 may be similar to (formed from similar materials) as described with respect to the substrate material 100 of FIGS. 1A-1D. The double substrate material 300 may include a first side (or surface) 301, a second side (or surface) 302 and an intermediate layer 303. The first side 301 may be substantially parallel to the second side 302. In addition, the intermediate layer 303 may be substantially equidistant from the first side 301 and the second side 302. A plurality of interconnecting filaments 304 may couple the first side 301 to the intermediate layer 303. In a similar manner, another plurality of interconnecting filaments 305 may couple the intermediate layer 303 to the second side 302.
[0076] FIG. 3B shows a side view of the double substrate material 300. The first side 301, the second side 302, the intermediate layer 303, the interconnecting filaments 304, and the interconnecting filaments 305 are also shown. The distance between the first side 301 and the intermediate layer 303 can be E. The distance between the second side 302 and the intermediate layer 303 can be F.
[0077] FIG. 3C shows the side view of the double substrate material 300 in relation to a first cut line 310 and a second cut line 320. In some examples, the first cut line 310 may cut the interconnecting filaments 304 between the first side 301 and the intermediate layer 303 and the second cut line 320 may cut the interconnecting filaments 305 between the second side 302 and the intermediate layer 303. Cutting the double substrate material 300 as indicated by the first cut line 310 and the second cut line 320 may create three different gripping implants as described below in FIG. 4. The length of the gripping elements of the three gripping implants may be based on a position of the first cut line 310 with respect to the distance E and a position of the second cut line 320 and the distance F.
[0078] FIG. 4 shows a side view of example gripping implants that may be formed from a double substrate material, such as the double substrate material 300 of FIGS. 3A-3C. A first gripping implant 400 may be created from the double substrate material 300 and the first cut line 310. As shown, the first gripping implant 400 may include a substrate 405 and gripping filaments 409. The substrate 405 may be the first side 301 of the double substrate material 300 of FIGS. 3A-3C. Each of the gripping filaments 409 may include a button features 402 toassist in anchoring (engaging) the first gripping implant 400 to any other feasible surface or material.
[0079] A second gripping implant 410 may include a substrate 415, a first group of gripping filaments 418, and a second group of gripping filaments 419. The substrate 415 may be formed from the intermediate layer 303 of the double substrate material 300. Similar to the first gripping implant 400, the first group of gripping filaments 418 can include button features 412 and the second group of gripping filaments 419 can include button features 413. The second gripping implant 410 may advantageously include gripping filaments disposed on either side of the substrate 415. Therefore, the second gripping implant 410 may be used to anchor (engage) two separate items (surfaces, tissues, materials) to each other.
[0080] A third gripping implant 420 may include a substrate 425 and third gripping filaments 429. Each of the gripping filaments 429 may include button features 422 to grip or anchor the substrate 425 to any feasible surface or material. The third knit 420 may be similar to the first gripping implant 400.
[0081] FIGS. 5A-5C show various examples of double-sided gripping implants. The double-sided gripping implants shown here are meant to be exemplary and not limiting. FIG. 5A is a first double-sided gripping implant 500. The first double-sided gripping implant 500 can include a substrate 510, a first group of gripping filaments 511, a second group of gripping filaments 513, and a third group of gripping filaments 515. Each group of gripping filaments can include a button feature configured to engage, grip, and / or anchor the substrate510 to a surface, tissue, or other material. For example, the first group of gripping filaments511 may include button features 512, the second group of gripping filaments 513 can include button features 514, and the third group of gripping filaments 515 can include button features 516.
[0082] Although the first double-sided gripping implant 500 shows equal numbers of gripping elements in the first group of gripping filaments 511, the second group of gripping filaments 513, and the third group of gripping filaments 515, in other examples, each group of gripping filaments may have different numbers of individual gripping filaments. In some examples, the number of gripping filaments within any one group may vary with respect to any other group. For example, the density of filaments of the first group of gripping filaments 511 may be higher or lower than the density of filaments of the second group of gripping filaments 513.
[0083] As described above with respect to FIGS. 2A-2D, different heights (or lengths) of gripping filaments may contact a surface, anatomy, textile, or the like during different times as gripping implant is positioned during a surgery. Thus, controlling the density of any of thegroups of gripping filaments can affect how a gripping implant reacts to peel friction and / or shear friction.
[0084] Returning to FIG. 5A, a first side of the first double-sided gripping implant 500 may include two groups of gripping filaments while a second side of the gripping implant 500 may have a single group of gripping filaments. As shown, the first side of the gripping implant 500 may have long and short gripping filaments that provide different peel and shear friction. The second side of the gripping implant 500 may have relatively longer gripping filaments, therefore friction associated with the second side may be a peel friction.
[0085] FIG. 5B shows a second double-sided gripping implant 520. The second doublesided gripping implant 520 can include a substrate 530, a first group of gripping filaments 531, a second group of gripping filaments 533, and a third group of gripping filaments 535. Each group of gripping filaments can include a button feature to engage, grip, and / or anchor the second double-sided gripping implant 520 to a surface, tissue, or other material. For example, the first group of gripping filaments 531 may include button features 532, the second group of gripping filaments 533 can include button features 534, and the third group of gripping filaments 535 can include button features 536.
[0086] A first side of the second double-sided gripping implant 520 may include two groups of gripping filaments while a second side of the second double-sided gripping implant 520 may include a single group of gripping filaments. In the example of second double-sided gripping implant 520, the second group of gripping filaments 533 may be longer than the first group of gripping filaments 531 and the third group of gripping filaments 535. In contrast to the second double-sided gripping implant 500 of FIG. 5 A, the second side may only have relatively short gripping filaments. Thus, the friction for the second side may generally be shear friction. The friction associated with the first side may be both shear and peel friction.
[0087] FIG. 5C shows a third double-sided gripping implant 540. The second doublesided gripping implant 540 can include a substrate 550, a first group of gripping filaments551, a second group of gripping filaments 553, a third group of gripping filaments 555, and a fourth group of gripping filaments 557. Each group of gripping filaments can include a button feature to grip or anchor the double-sided gripping implant 540 to a surface, tissue, or other material. For example, the first group of gripping filaments 551 may include button features552, the second group of gripping filaments 553 can include button features 554, the third group of gripping filaments 555 can include button features 556, and the fourth group of gripping filaments 557 can include button features 558.
[0088] In contrast to both the first double-sided gripping implant 500 and the second double-sided gripping implant 520, the third double-sided gripping implant 540 can havegripping filaments of different lengths on both sides of the substrate 550. Thus, both the first side and the second side can have different peel and shear friction.
[0089] In some examples, a spacer embroidery may be used in conjunction with a gripping implant. A spacer embroidery can be a resorbable material that is quickly absorbed by the body. In some examples, the spacer embroidery may shorten an effective length of a gripping filament as an associated gripping implant is first introduced and placed into a patient. Then, as the spacer embroidery is absorbed, the effective length of the gripping filaments increase. As the effective length of the gripping filaments changes, the associated friction and / or adhesion also changes. In some examples, the double-sided gripping implants described herein can enhance compliance by including gripping filaments on two sides of implant textile.
[0090] FIGS. 6 A and 6B illustrate example gripping implant textiles with and without spacer embroidery. In particular, FIG. 6A shows an example of gripping implant textile 600. The gripping implant textile 600 includes a first group of gripping filaments 610, a second group of gripping filaments 620 and a substrate 630. The effective length of the gripping filament is generally based on the distance between the substrate 630 to an end of a filament. For example, as shown here the effective length of a filament from the first group of gripping filaments 610 is distance A.
[0091] FIG. 6B shows another example gripping implant textile 650. The gripping implant textile 650 includes a first group of gripping filaments 660, a second group of gripping filaments 670, a substrate 680, and a spacer embroidery 690. The spacer embroidery 690 may increase an effective thickness of the substrate 680, thereby decreasing an effective length of any feasible gripping filament. For example, the thickness of the spacer embroidery 690 decreases the effective length of any filament in the first group of filaments 660 and / or the second group of filaments. Thus, the distance B shown here is less than the distance A of FIG. 6A. In some examples, the spacer embroidery 690 may be dissolvable or absorbable.
[0092] In some cases, the thickness of the spacer embroidery 690 may be different on each side of the substrate 680. In this manner, the effective length of filaments of each side of a double-sided gripping implant may be different. After a time period, the spacer embroidery 690 may be resorbed by the patient. In some cases, the time period may be as short as a few minutes or as long as a couple of hours. In this manner, the gripping implant textile 650 may have an initial friction that changes after the spacer embroidery 690 is absorbed or dissolved. Therefore, initial placement of the gripping implant textile may be based on an effective filament length of B, but after the spacer embroidery 690 is absorbed (dissolved), then the effective filament length may extend to length A.
[0093] FIG. 7A shows another example gripping implant 700. The gripping implant 700 may include a substrate 710, a first group of gripping filaments 720, a second group of gripping filaments 730, and a spacer textile 740. Use of the spacer textile 740 may reduce an effective length of any of the first group of gripping filaments 720 and the second group of gripping filaments 730. In some examples, the spacer textile 740 may be joined or attached to the substrate 710 by an embroidery as described below with respect to FIG. 7B
[0094] FIG. 7B shows the gripping implant 700 with an embroidery 750. In some examples, the embroidery 750 may assist in attaching the spacer textile 740 to the substrate 710. The embroidery 750 may be absorbed by the body after placement. Thus, the effective length of the first group of filaments 720 and the second group of filaments 730 may be modified as the embroidery 750 is resorbed by the patient’s body.
[0095] FIGS. 8A-8C illustrate possible steps associated with forming a double-gripping implant. FIG. 8A shows a substrate material 800. The substrate material 800 may be an example of the substrate material 100 of FIGS. 1A and IB. The substrate material 800 can have a first side 801 and a second side 802 that is spaced apart a distance X and connected together with interconnecting filaments 803.
[0096] FIG. 8B shows the substrate material 800 with embroidery stitching 810. The embroidery stitching 810 can draw the first side 801 towards the second side 802 with interconnecting filaments 811 such that the first side 801 are now spaced apart from the second side 802 by a distance Y. The distance Y is less than the distance X. Since the first side 801 is drawn toward the second side 802, the interconnecting filaments 803 of the substrate material 800 may become coiled or compressed.
[0097] After the embroidery stitching 810 has been applied, then the substrate material 800 may be cut at the cut line 820. By cutting the substrate material 800 at the cut line 820, two gripping implant substrates can be formed.
[0098] FIG. 8C shows a gripping implant 850 that may be formed by cutting the substrate material 800 along the cut line 820. The gripping implant 850 can include a first group of gripping filaments 860 and a second group of gripping filaments 861. The first group of gripping filaments 860 and the second group of gripping filaments 861 may be formed from the interconnecting filaments 803 and the interconnecting filaments 811. As described herein, both the first group of gripping filaments 860 and the second group of gripping filaments 861 may include button features that can assist the gripping filaments in sticking or adhering the gripping implant 850 to a tissue or other substrate. In some examples, the height (or length) of the first group of gripping filaments 860 may be X / 2 and the second group of gripping filaments 861 may be Y / 2.
[0099] FIG. 9 is a flowchart depicting an example of one method 900 for forming a gripping implant. Some examples may perform the operations described herein with additional operations, fewer operations, operations in a different order, operations in parallel, and some operations differently.
[0100] In FIG. 9, one example method 902 may begin as a substrate material is received or obtained (or in some examples, formed). The substrate material can be any suitable material. As illustrated above, in some examples two surfaces (a first surface and a second surface) connected together by interconnecting filaments. Examples of the substrate material can include the multiple layers of substrate material 100 of FIG. 1A, the double substrate material 300 of FIG. 3, and the substrate material 800 of FIG. 8.
[0101] In some examples, the substrate material may include a spacer embroidery, similar to the spacer embroidery 690 of FIG. 6B. In some aspects, the spacer embroidery may be absorbable.
[0102] Next, in block 904 embroidery stitching may be applied to the substrate material. This operation may be optional. The embroidery stitching may be used to draw the first surface of the substrate material closer to the second surface, for example as depicted in FIG. 8B. In this manner, the interconnecting filaments of the substrate material may be compressed, at least in part by the embroidery stitching.
[0103] Next, in block 906 the substrate material is cut. In some examples, cutting the substrate material can form one or more gripping implants, which may be similar to the gripping implant of FIG. 1C, ID, or FIG. 2A-2D. If embroidery stitching has been applied (as described in block 904), the cutting of the substrate material may form a gripping implant as depicted in FIG. 8C.
[0104] Alternatively, to the method described above, in any of these methods the material may be cut 906 before it is stitched to form the spacer 904.
[0105] If the substrate material is a double substrate material 300, then cutting the double substrate material 300 may form a gripping implant with gripping filaments that extend to both sides of the substrate as shown FIG 4. That is, the substrate material can become a first group of gripping filaments and the embroidery stitching of block 904 can become a second group of gripping filaments.
[0106] In some examples, cutting the substrate material may form button features on distal ends of gripping filaments. The button features may a resistance force against pulling the gripping implant away from a tissue or surface.It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutuallyinconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.
[0107] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.
[0108] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached, or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.
[0109] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".
[0110] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations ofthe device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
[0111] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.
[0112] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
[0113] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components, or sub-steps.
[0114] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value unless the context indicates otherwise. Forexample, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
[0115] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
[0116] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of theabove embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
Claims
CLAIMSWhat is claimed is:
1. An implant, the implant comprising: a sheet of substrate material having a first side and a second side; a first plurality of gripping filaments extending proud of the first side of the sheet of substrate material by a first height, hi, wherein each gripping filament of the first plurality of gripping filaments comprises an arm extending from a first vertex; and a second plurality of gripping filaments extending proud of the first side of the sheet of substrate material by a second height, hi, wherein the first height is less than the second height (hi < A?).
2. The implant of claim 1, further comprising a resorbable spacer on the first side of the sheet having an offset height, hi, so that the effective height of the first plurality of gripping filaments and the second plurality of gripping filaments is reduced by the offset height while the implant is in a pre-implantation configuration, and further wherein the effective height of the first plurality of gripping filaments is converted to the first height, and the height of the second plurality of gripping filaments is converted to the second height in an implanted configuration.
3. The implant of claim 2, wherein the resorbable spacer comprises a resorbable embroidered material that embroidered to the first surface.
4. The implant of claim 2, wherein the resorbable spacer comprises a resorbable textile.
5. The implant of claim 2, wherein the resorbable spacer comprises a fast resorbing material configured to be resorbed in 72 hours or less.
6. The implant of claim 2, wherein the resorbable spacer comprises a fast resorbing material configured to be resorbed in 24 hours or less.
7. The implant of claim 1, wherein the sheet of substrate material comprises a mesh.
8. The implant of claim 1, wherein the second plurality of gripping filaments comprises a second arm extending from a second vertex.
9. The implant of claim 1, wherein the first plurality of gripping filaments are formed of a grid pattern of filament that is stitched through the sheet of substrate material.
10. The implant of claim 1, wherein the first plurality of gripping filaments comprises a first filament of material extending adjacent to a first side of the sheet of substrate material.
11. The implant of claim 1, wherein the first plurality of gripping filaments comprises an enlarged distal end at the ends of each of the arms.
12. The implant of claim 11, wherein the enlarged distal end comprises a mushroom head.
13. The implant of claim 1, wherein the second plurality of gripping filaments each comprises an enlarged distal end at the ends of each of the gripping filaments of the second plurality of gripping filaments.
14. The implant of claim 1, further comprising a third plurality of gripping filaments extending proud of the second side of the sheet of substrate material by a third height, hs.
15. The implant of claim 14, further comprising a fourth plurality of gripping filaments extending proud of the second side of the sheet of substrate material by a fourth height, Av, which is less than the third height, hs .
16. The implant of claim 1, wherein the first plurality of gripping filaments are formed of a material that is different from the second plurality of gripping filaments.
17. The implant of claim 1, wherein the substrate comprises at least one of: a human tissue, a biologic textile, or a combination thereof.
18. The implant of claim 1, wherein the first plurality of gripping filaments comprises a polymeric material.
19. The implant of claim 1, wherein the first plurality of gripping filaments is associated with a peel friction between the implant and a first surface and wherein the second plurality of gripping filaments is associated with a shear friction between the implant and the first surface.
20. A method of fabricating an implant, the method comprising:embroidering a first material onto a sheet of substrate material having a first side and a second side; embroidering a second material onto the sheet of substrate material; forming the first material into a first plurality of gripping filaments extending proud of the first side by a first height, h , and forming the second material into a second plurality of gripping filaments extending proud of the first side of the sheet of substrate material by a second height, h2, wherein the first height is less than the second height (hi < A?).
21. The method of claim 20, further comprising embroidering a resorbable material to the first surface so that the effective height of the first plurality of gripping filaments and the effective height of the second plurality of gripping filaments is reduced by an offset height while the implant is in a pre-implantation configuration, and further wherein the effective height of the first plurality of gripping filaments is converted to the first height, and the height of the second plurality of gripping filaments is converted to the second height in an implanted configuration in which the resorbable material is absorbed.
22. The method of claim 21 wherein embroidering the resorbable material to the first surface comprises embroidering with a resorbable filament.
23. The method of claim 21 wherein embroidering the resorbable material to the first surface comprises embroidering a resorbable sheet of material onto the first surface.
24. The method of claim 20, wherein forming the first material into the first plurality of gripping filaments and forming the second material into the second plurality of gripping filaments comprises cutting a plurality of interconnecting filaments between the first surface of the sheet of substrate material and a second sheet of material embroidered to the first sheet of substrate material.
25. The method of claim 20, further comprising forming an enlarged distal end on a distal end of each end of the first plurality of gripping filaments.
26. The method of claim 20, further comprising forming an enlarged distal end on a distal end of each end of the second plurality of gripping filaments.
27. The method of claim 20, wherein embroidering the first material onto the sheet of substrate material comprises embroidering through the sheet of substrate material and a second sheet of material.
28. The method of claim 27, further comprising compressing the sheet of substrate material and the second sheet of material prior to embroidering the second material onto the sheet of substrate material, wherein second material onto the sheet of substrate material comprises embroidering through the sheet of substrate material and the second sheet of material.
29. The method of claim 27, wherein forming the first material into the first plurality of gripping filaments and forming the second material into the second plurality of gripping filaments comprises passing a heated cutter between the sheet of substrate material and the second sheet of material.
30. A method of treating a patient, the method comprising: engaging a tissue of the patient with a first level of friction from an implant comprising a sheet of substrate material having a first plurality of gripping filaments extending proud of a first side of the sheet of substrate material by a first height and a second plurality of gripping filaments extending proud of the first side of the sheet of substrate material by a second height, wherein the first height is greater than the second height, wherein the first plurality of gripping filaments extend from the implant by a first effective height that is less than the first height and the second plurality of gripping filaments extend from the implant by a second effective height that is less than the second height; and increasing the friction between the first implant and the tissue after implantation as a resorbable material on the first side of the sheet of substrate material is resorbed so that the first effective height of the first plurality of gripping filaments increases toward the first height and the second effective height of the second plurality of gripping filaments increases towards the second height.
31. The method of claim 30, wherein the resorbable material comprises a sheet of resorbable material.
32. The method of claim 30, wherein the resorbable material is resorbed over a period 72 hours or less.- za -33. The method of claim 30, wherein the resorbable material is resorbed over a period of 24 hours or less.
34. The method of claim 30, further comprising implanting the implant into the tissue.
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