WO2022159654A1 - Prosthetic surgical sling - Google Patents
Prosthetic surgical sling Download PDFInfo
- Publication number
- WO2022159654A1 WO2022159654A1 PCT/US2022/013233 US2022013233W WO2022159654A1 WO 2022159654 A1 WO2022159654 A1 WO 2022159654A1 US 2022013233 W US2022013233 W US 2022013233W WO 2022159654 A1 WO2022159654 A1 WO 2022159654A1
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- WO
- WIPO (PCT)
- Prior art keywords
- surgical implant
- ptfe
- fibrils
- article
- nodes
- Prior art date
Links
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims abstract description 67
- 239000004810 polytetrafluoroethylene Substances 0.000 claims abstract description 67
- 238000000034 method Methods 0.000 claims abstract description 52
- 229920002313 fluoropolymer Polymers 0.000 claims abstract description 22
- 239000004811 fluoropolymer Substances 0.000 claims abstract description 22
- -1 e.g. Polymers 0.000 claims abstract description 16
- 239000011347 resin Substances 0.000 claims abstract description 11
- 229920005989 resin Polymers 0.000 claims abstract description 11
- 238000003490 calendering Methods 0.000 claims abstract description 9
- 239000007943 implant Substances 0.000 claims description 67
- 239000000463 material Substances 0.000 claims description 31
- 238000001125 extrusion Methods 0.000 claims description 18
- 239000011148 porous material Substances 0.000 claims description 17
- 241000894006 Bacteria Species 0.000 claims description 16
- 238000001035 drying Methods 0.000 claims description 11
- 230000003319 supportive effect Effects 0.000 claims description 7
- 239000000155 melt Substances 0.000 claims description 5
- 230000010512 thermal transition Effects 0.000 claims description 5
- 230000001580 bacterial effect Effects 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 230000035515 penetration Effects 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 claims description 3
- 238000003303 reheating Methods 0.000 claims description 3
- 230000000452 restraining effect Effects 0.000 claims description 3
- 230000008569 process Effects 0.000 abstract description 10
- 238000001816 cooling Methods 0.000 abstract 1
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 description 14
- 210000001519 tissue Anatomy 0.000 description 14
- 239000004743 Polypropylene Substances 0.000 description 11
- 229920001155 polypropylene Polymers 0.000 description 11
- 230000006378 damage Effects 0.000 description 6
- 238000001000 micrograph Methods 0.000 description 6
- 239000000314 lubricant Substances 0.000 description 5
- 231100000241 scar Toxicity 0.000 description 5
- 208000015181 infectious disease Diseases 0.000 description 4
- 229910052500 inorganic mineral Inorganic materials 0.000 description 4
- 239000011707 mineral Substances 0.000 description 4
- 235000015096 spirit Nutrition 0.000 description 4
- 238000001356 surgical procedure Methods 0.000 description 4
- 239000007787 solid Substances 0.000 description 3
- 230000008901 benefit Effects 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 239000008188 pellet Substances 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 230000000451 tissue damage Effects 0.000 description 2
- 231100000827 tissue damage Toxicity 0.000 description 2
- 210000003708 urethra Anatomy 0.000 description 2
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 208000000094 Chronic Pain Diseases 0.000 description 1
- 206010021639 Incontinence Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 206010067268 Post procedural infection Diseases 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000008952 bacterial invasion Effects 0.000 description 1
- 238000006065 biodegradation reaction Methods 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 230000028709 inflammatory response Effects 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000005245 sintering Methods 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
- 230000009772 tissue formation Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/146—Porous materials, e.g. foams or sponges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
- A61F2/0045—Support slings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
Definitions
- the disclosed embodiments relate generally to the field of prosthetic medical devices. More specifically, the field relates to the development of prosthetic medical slings implemented for supporting internal body structures.
- Pubovaginal sling procedures are very prevalently used to offer support needed to stabilize a patient’s urethra or bladder.
- the most common device used in executing such a process is an elongated flexible strip constructed of a nonabsorbable polypropylene mesh material, the ends of which can be anchored elsewhere in the patient’s body, and support is offered to prevent incontinence.
- a medical support device includes an elongated body comprised of an expanded fluoropolymer.
- the device is used to support a body component, e.g., in embodiments, can be used as a urethral sling or for other like applications.
- the elongated expanded fluoropolymer is expanded polytetrafluoroethylene (ePTFE).
- ePTFE expanded polytetrafluoroethylene
- the ePTFE can, in embodiments, be formed into an elongated sheet.
- the techniques described herein relate to a surgical implant including: an elongated body configured to support a body tissue, the elongated body including and a first end and a second end, the elongated body formed of a biocompatible, bacteria-resistant fluoropolymer material, wherein the biocompatible, bacteria-resistant fluoropolymer material includes a plurality of nodes and a plurality of fibrils, the plurality of fibrils interconnecting the plurality of nodes.
- the techniques described herein relate to a surgical implant, wherein the biocompatible, bacteria-resistant fluoropolymer material includes Polytetrafluoroethylene (PTFE).
- PTFE Polytetrafluoroethylene
- the techniques described herein relate to a surgical implant, wherein the biocompatible, bacteria-resistant fluoropolymer material includes expanded PTFE (ePTFE).
- ePTFE expanded PTFE
- the techniques described herein relate to a surgical implant, wherein the elongated body is substantially planar.
- the techniques described herein relate to a surgical implant, wherein the surgical implant is substantially microporous.
- the techniques described herein relate to a surgical implant, wherein the body is multiaxially expanded such that the plurality of fibrils radiate between the plurality of nodes to define a plurality of pores.
- the techniques described herein relate to a surgical implant, wherein the plurality of fibrils are about .5 to about 3 microns in length.
- the techniques described herein relate to a surgical implant, wherein the plurality of pores defined between the plurality of nodes and fibrils are less than or equal to 2 by 1 microns in size.
- the techniques described herein relate to a surgical implant, wherein the elongated body is uniaxially expanded such that the plurality of fibrils extend substantially longitudinally between the plurality of nodes to define a plurality of elongated pores.
- the techniques described herein relate to a surgical implant, wherein the plurality of fibrils are about 0.5 to about 3.0 microns in length. [0016] In some aspects, the techniques described herein relate to a surgical implant, wherein the plurality of pores defined between the plurality of nodes and the plurality of fibrils have widths which are less than about 3 microns.
- the techniques described herein relate to a surgical implant, wherein the elongated body has a thickness of about 0.60 mm.
- the techniques described herein relate to a surgical implant, wherein the surgical implant is configured for use as a pubovaginal sling.
- the techniques described herein relate to a surgical implant, wherein the first end is configured to receive a first surgical placement aid, and the second end is configured to receive a second surgical placement aid.
- the techniques described herein relate to a surgical implant, wherein the biocompatible, bacteria-resistant fluoropolymer material includes a microporous structure which is relatively closed to ingrowth and bacterial penetration.
- the techniques described herein relate to a method for producing a supportive surgical implant device, the method including: mixing a PTFE resin paste with an extrusion aid; configuring the PTFE resin paste and the extrusion aid into a pre-extrusion form; calendaring the pre-extrusion form to make a PTFE article; drying the extrusion aid from the PTFE article; reheating the PTFE article at a temperature higher than a drying temperature used in the drying step, but lower than a melt temperature of the PTFE article; expanding the PTFE article to create a node/fibril structure; restraining the PTFE article in an expanded state and heating the PTFE article to a temperature above a thermal transition temperature for the PTFE article to lock the node/fibril structure in place; allowing the PTFE article to cool; and configuring the PTFE article for use as the supportive surgical implant device.
- the techniques described herein relate to a method, including: forming the PTFE article into a sheet; and causing at least a portion of the sheet to have an elongated body and two ends.
- the techniques described herein relate to a method, including: configuring the ends of the at least a portion of the sheet to attach to one or more surgical placement aids. [0024] In some aspects, the techniques described herein relate to a method, wherein the expanding step is a substantially unidirectional expansion resulting in a plurality of elongated fibrils, each fibril in the plurality being substantially parallel relative to the others.
- the techniques described herein relate to a method, wherein the expanding step is a multiaxial expansion resulting in a plurality of fibrils which radiate between a plurality of nodes.
- the elongated medical support device can have first and second ends both receivable by a placement tool designed to aid with implanting the device into the human body in a supporting capacity regarding an internal structure.
- the device is a sling.
- FIG. 1 A shows an overall view for a first embodiment
- FIG. IB shows a cross sectional view taken from line 1B-1B in FIG. 1A;
- FIG. 1C depicts the article (shown in FIGs. 1 A-B) as it might be attached to placement aids used for implant;
- FIG. 2 is a micrograph taken of the material manufactured according to the process steps expressed herein where a single axis expansion is executed.
- FIG. 3 a micrograph taken of the material manufactured according to the process steps expressed herein where a multiaxial expansion is executed.
- references to “one embodiment,” “an embodiment,” or “embodiments” mean that the feature or features being referred to are included in at least one embodiment of the technology.
- references to “one embodiment,” “an embodiment,” or “embodiments” in this description do not necessarily refer to the same embodiment and are also not mutually exclusive unless so stated and/or except as will be readily apparent to those skilled in the art from the description.
- a feature, structure, act, etc. described in one embodiment may also be included in other embodiments, but is not necessarily included.
- the technology can include a variety of combinations and/or integrations of the embodiments described herein.
- Synthetic slings have been available for implant procedures for many decades.
- the most common form of sling is constructed of polypropylene, which is typically comprised of woven or knit filaments.
- a polypropylene sling presents open structure which allows bacteria to penetrate. This can lead to postoperative infection.
- these devices have been implanted in many thousands of patients, there remain many post-implantation problems that have yet to be resolved. Most of these problems are clinically significant, and can end with surgical retrieval of the devices, which can lead to internal tissue damage.
- any limited damage created upon implant of the polypropylene sling is not necessarily considered a bad thing, in that the damage causes an immediate inflammatory response, which ultimately helps incorporate the device structurally. But this damage can compromise tissues in undesirable ways also.
- Another problem is that of infection.
- the vulnerability of the polypropylene to infection is due in large part to the nature of the mesh material.
- the invention disclosed herein is a prosthetic medical sling made of a novel synthetic material, in embodiments, a relatively closed expanded Polytetrafluoroethylene structure.
- the inventive design of the medical device provides for a strong, supportive, biocompatible sling that resists bacterial invasion and disintegration.
- the embodiments described herein comprise a novel synthetic prosthetic medical sling that is biocompatible, resists bacterial infection, exhibits significant long-term strength to support tissues, does not promote massive scar tissue, and will not deteriorate over time. Further, the sling embodiments exhibit strength adequate for intended use, are supple and tissue compliant to minimize scar tissue formation, and are durable, as PTFE, a fluoropolymer, is known to be resistant to biodegradation.
- Embodiments are comprised of a processed fluoropolymer, such as Polytetrafluoroethylene (PTFE).
- PTFE Polytetrafluoroethylene
- Embodiments disclosed in the figures herein incorporate expanded PTFE, or “ePTFE” which is formed by expansion under heat.
- An ePTFE article can be manufactured to have fibril lengths such that the article is a relatively closed structure to prevent the infiltration of bacteria, yet supple for tissue compliance, and adequately strong for its intended use as a tissue support device. And of course, as ePTFE, it is fully biocompatible and will not degrade.
- the microporous structure of known ePTFE articles is characterized by a plurality of nodes that are connected together by a plurality of fibrils.
- the nodes are essentially solid PTFE, having a density of between about 2.0 grams to about 2.2 grams per cubic centimeter, whereas the density of the expanded material is less than about 2.0 grams per cubic centimeter.
- the shape, size, and orientation of the nodes and fibrils within the structure can be controlled by varying the expansion rate, expansion ratio, number of expansion axes, and other processing parameters to yield many different structures. It is also known that properties such as the expandability and microstructure of the expanded article vary with the molecular weight, particle size, and other physical characteristics of the PTFE resin.
- An embodiment of the ePTFE article useable as an implant device is configured as a flat (roughly/substantially planar) elongated sheet embodiment as seen in FIGs. 1 A and IB.
- the body is made of a relatively closed structure, high strength, expanded fluoropolymer.
- FIG. IB shows a cross section taken at 1B-1B in FIG. 1A.
- the article 100 usable as a surgical supporting device includes a first end 102, a second end 104, and a substantially flat elongated body 106 (configured of a fluoropolymer in embodiments).
- the substantially flat elongated body 106 of the first version 100 is, in embodiments, comprised of multiaxially expanded PTFE that will ultimately reflect a node/fibril structure that can be made according to the practices discussed hereinafter.
- the article is made, in embodiments, according to a process. More specifically, the article is produced by expanding PTFE in one dimension (i.e., uniaxially). Alternatively, the article can be expended in multiple dimensions (i.e., multiaxially). Beforehand, a resin paste can be mixed with an extrusion-aid such as mineral spirits, and then that paste can be compressed at relatively low pressures into a pre-extrusion form, e.g., as a pellet.
- an extrusion-aid such as mineral spirits
- the material is extruded as a substantially flat article.
- the PTFE article is then calendered while wet to a desired thickness. Because the article will be partially wet with mineral spirits, the process then moves on to a drying step where the lubricant is removed by subjecting it to a temperature slightly above the boiling point of the lubricant (e.g., about 150° C), and far below the sintering or coalescing temperature of the polymer, generally at about 327° C in embodiments.
- a temperature slightly above the boiling point of the lubricant e.g., about 150° C
- far below the sintering or coalescing temperature of the polymer generally at about 327° C in embodiments.
- the article in embodiments, is reheated at a temperature higher than the drying temperature, but below the melt temperature, e.g., above 240° C, in embodiments, or about 250° C in more specific embodiments.
- the article is expanded in one or more dimensions.
- the process will result in unidirectional elongated fibrils (which are substantially parallel) extending between nodes. These fibrils will have, in embodiments, lengths of about 0.5 microns to about 3 microns. In embodiments, the resulting pores will have approximate lengths of about 3 microns or less, and widths of about 1 microns or less. This pore sizes will not allow for ingrowth, and the article will have good strength.
- the extent of expansion of the PTFE makes the material softer, and here, that softness makes the ultimate device perform well.
- the process may result in fibril lengths of between about 0.5 microns to about 3.0 microns.
- the resulting pore size is about less than or equal to 3.0 by 1.0 microns. Again here, these pore sizes will not allow for ingrowth, and the multiaxial expansion gives great strength. Also with the multiaxial arrangement, the extent of expansion of the PTFE makes the material softer, and here, that softness makes the ultimate device perform well.
- the article is subjected to a final heat- treating step.
- the material is restrained in its expanded state and heated above the thermal transition temperature at about 350° C to lock the structure in place.
- the ePTFE article is allowed to cool over a period of time at a lower temperature, e.g., at ambient.
- the article can be presented for use along with existing implant systems and/or methods.
- the article can also be configured for use as a surgical implant.
- the article can also be cut into desired sections or otherwise configured in ways making each section able to function as an individual sling.
- an antimicrobial coating can be applied to the PTFE strip.
- the ends of the cut strips can be configured for attachment to placement aids (e.g., needles) at each end of the article 100.
- placement aids e.g., needles
- FIG. 1C shows the PTFE article 100 attached to each of the placement aids 126 and 128.
- connection aids 126 and 128 are connected to ends 102 and 104 exist in the art, e.g., the ends can be: (i) secured into clamps existing on each placement aids 126 and 128 (ii) ends 102 and 104 can be apertured for receipt of snaps on each placement aid (126 and 128); (iii) the ends of the article 100 can be knotted and then secured into V-shaped grooves formed into each aid (126 and 128); (iv) the placement aids 126, 128 can be attached using sutures; (v) attached using trocars; or (vi) other methods.
- EXAMPLE 1 In an embodiment, a resin paste was formed by blending 100% PTFE fine powder with an extrusion-aid (e.g., mineral spirits). The resulting resin paste was then formed into an extrusion pellet.
- an extrusion-aid e.g., mineral spirits
- the PTFE article was extruded as a rectangular cross section, and calendered to a thinner cross section while wet.
- the ultimate thickness was about 0.60 mm after calendering.
- the lubricant was removed by subjecting the article to heat at a temperature of about 150° C in order to dry the article (remove the mineral spirits).
- the process moved on to an expansion step.
- the article was then reheated at about 250 °C but below the melt temperature and expanded uniaxially. This expansion was made by securing each end of the article and expanding the article in a single direction longitudinally.
- the ePTFE article was allowed to cool over a period of time at a lower temperature, e.g., at ambient.
- FIG. 2 is a micrograph taken of the material manufactured according to the processes discussed above. Referring to FIG. 2, it can be seen that the article has fibril lengths which are essentially less than about 3 micron. This size inhibits cells or bacteria from penetrating the material. Another noteworthy property is that the fibrils occupy limited space in the article, whereas the node sizes are relatively much larger. As can be seen from the FIG. 2 micrograph, more than about 80% of the area is comprised of solid nodes.
- Example 1 the same processes were followed as expressed above in Example 1 except that after calendering and lubricant removal, the article was multiaxially expanded. More specifically, the article was expanded in two dimensions, e.g., longitudinally and laterally (in directions offset by 90 degrees).
- FIG. 3 is a micrograph taken of the material manufactured according to the processes discussed in this example. Referring to the figure, it can be seen that the article has a fibril lengths which are, generally speaking, range from about 0.5 micron to about 1.0 micron.
- the uniaxial expansion creates elongated pores between the nodes which have widths that range in size, but are always lower than 2 micron. This size inhibits cells or bacteria from penetrating the material.
- fibrils occupy limited space in the article, and the node sizes are relatively larger.
- more than about 80% of the area is comprised of solid nodes.
- ePTFE articles as prosthetic slings to stabilize a patient’s urethra or bladder as described above, they could also be useful in providing support for other organs. Additionally, multiple strips could be used together for certain applications. Further, the articles could be used for the support of rectal muscles in other applications.
- a surgical implant including: an elongated body configured to support a body tissue, the elongated body including and a first end and a second end, the elongated body formed of a biocompatible, bacteria-resistant fluoropolymer material, the biocompatible, bacteria-resistant fluoropolymer material includes a plurality of nodes and a plurality of fibrils, the plurality of fibrils interconnecting the plurality of nodes.
- the biocompatible, bacteria-resistant fluoropolymer material includes Polytetrafluoroethylene (PTFE).
- the biocompatible, bacteria-resistant fluoropolymer material includes expanded PTFE (ePTFE).
- ePTFE expanded PTFE
- the elongated body is substantially planar.
- the surgical implant is substantially microporous.
- the elongated body is multiaxially expanded such that the plurality of fibrils radiate between the plurality of nodes to define a plurality of pores.
- the plurality of fibrils are about .5 to about 3 microns in length.
- the plurality of pores defined between the plurality of nodes and fibrils are less than or equal to 2 by 1 microns in size.
- the elongated body is uniaxially expanded such that the plurality of fibrils extend substantially longitudinally between the plurality of nodes to define a plurality of elongated pores.
- the plurality of fibrils are about 0.5 to about 3.0 microns in length.
- the plurality of pores defined between the plurality of nodes and the plurality of fibrils have widths which are less than about 3 microns.
- the elongated body has a thickness of about 0.60 mm.
- the surgical implant is configured for use as a pubovaginal sling.
- the first end is configured to receive a first surgical placement aid
- the second end is configured to receive a second surgical placement aid
- the biocompatible, bacteria-resistant fluoropolymer material includes a microporous structure which is relatively closed to ingrowth and bacterial penetration.
- (Bl) A method for producing a supportive surgical implant device, the method including: mixing a PTFE resin paste with an extrusion aid; configuring the PTFE resin paste and the extrusion aid into a pre-extrusion form; calendaring the pre-extrusion form to make a PTFE article; drying the extrusion aid from the PTFE article; reheating the PTFE article at a temperature higher than a drying temperature used in the drying step, but lower than a melt temperature of the PTFE article; expanding the PTFE article to create a node/fibril structure; restraining the PTFE article in an expanded state and heating the PTFE article to a temperature above a thermal transition temperature for the PTFE article to lock the node/f
- (B2) For the method denoted as (Bl), including: forming the PTFE article into a sheet; and causing at least a portion of the sheet to have an elongated body and two ends.
- (B3) For the method denoted as (Bl) or (B2), including: configuring the ends of the at least a portion of the sheet to attach to one or more surgical placement aids.
- the expanding step is a substantially unidirectional expansion resulting in a plurality of elongated fibrils, each fibril in the plurality being substantially parallel relative to the others.
- the expanding step is a multiaxial expansion resulting in a plurality of fibrils which radiate between a plurality of nodes.
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP22703516.9A EP4281005A1 (en) | 2021-01-21 | 2022-01-21 | Prosthetic surgical sling |
BR112023014635A BR112023014635A2 (en) | 2021-12-15 | 2022-01-21 | SURGICAL IMPLANT AND METHOD FOR PRODUCING A SURGICAL IMPLANT SUPPORT DEVICE |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
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US202163140052P | 2021-01-21 | 2021-01-21 | |
US63/140,052 | 2021-01-21 | ||
US17/552,296 | 2021-12-15 | ||
US17/552,296 US20230066272A1 (en) | 2021-09-01 | 2021-12-15 | Verified transactions through integrations |
US17/580,434 | 2022-01-20 | ||
US17/580,434 US20220226093A1 (en) | 2021-01-21 | 2022-01-20 | Prosthetic surgical sling |
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Publication Number | Publication Date |
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WO2022159654A1 true WO2022159654A1 (en) | 2022-07-28 |
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PCT/US2022/013233 WO2022159654A1 (en) | 2021-01-21 | 2022-01-21 | Prosthetic surgical sling |
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WO (1) | WO2022159654A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023224844A1 (en) * | 2022-05-16 | 2023-11-23 | Ruefer Rebecca | Surgical implant for supporting tissue following pelvic organ prolapse |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5433909A (en) * | 1992-03-13 | 1995-07-18 | Atrium Medical Corporation | Method of making controlled porosity expanded polytetrafluoroethylene products |
US20120065649A1 (en) * | 2010-09-09 | 2012-03-15 | Towler Jeffrey C | Surgical Mesh |
US20130204355A1 (en) * | 2010-02-12 | 2013-08-08 | Spire Biomedical | Medical device made of eptfe partially coated with an antimicrobial material |
US20140142368A1 (en) * | 2005-02-04 | 2014-05-22 | Ams Research Corporation | Pelvic implants and related methods |
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2022
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US20140142368A1 (en) * | 2005-02-04 | 2014-05-22 | Ams Research Corporation | Pelvic implants and related methods |
US20130204355A1 (en) * | 2010-02-12 | 2013-08-08 | Spire Biomedical | Medical device made of eptfe partially coated with an antimicrobial material |
US20120065649A1 (en) * | 2010-09-09 | 2012-03-15 | Towler Jeffrey C | Surgical Mesh |
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WO2023224844A1 (en) * | 2022-05-16 | 2023-11-23 | Ruefer Rebecca | Surgical implant for supporting tissue following pelvic organ prolapse |
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