method for forming an implantable device, and said device

专利摘要:
patent summary "frame of randomly uniform three-dimensional fabric of absorbable and non-absorbable materials". it is an implantable structure, a method for producing the structure and a method for using the structure, where the structure includes a combination of absorbable and non-absorbable components, and the implantable structure has a randomly uniform arrangement of materials. the resulting implantable structure provides better internal tissue growth and flexibility after implantation and after absorbing absorbable materials.
公开号:BR112015022772B1
申请号:R112015022772
申请日:2014-02-28
公开日:2020-05-19
发明作者:Smith Daniel；Dick Oliver；Landgrebe Susanne
申请人:Ethicon Inc；
IPC主号:

专利说明:

Invention Patent Descriptive Report for METHOD FOR FORMING AN IMPLANTABLE DEVICE, AND THE RELATED DEVICE.
FIELD OF THE INVENTION
[001] The present invention relates to an implantable scaffolding device for tissue repair and enlargement, the device including an exclusive three-dimensional arrangement of absorbable and non-absorbable materials. The materials used, the device structure and the method for producing the device provide enhanced benefits as an implantable device.
BACKGROUND OF THE INVENTION
[002] Implantable scaffolds can be used to repair injured or traumatized body tissue or to assist in supporting body tissue, such as cartilage, skin, muscle, bone, tendon and ligament. These implantable frameworks are intended not only to provide support for repaired tissue, but also to promote and encourage internal tissue growth so that repair can be sustained in the body over an extended period of time. Typical frameworks, however, include a large number of non-absorbable materials, which remain in the body for a significant period of time and can remain forever. Given the high content of non-absorbable materials, the framework can be felt by the user, or it can complicate movement or flexibility.
[003] Tissue scaffolds can be used in any of several applications, including, for example, repair applications, such as tendon repair, pelvic floor repair, stress urinary incontinence repair, hernia repair; supportive applications, such as support for the bladder or breast implant; formation of tissue volume; increased tissue; cosmetic treatments; therapeutic treatments; or, in general, as repair of
2/74 fabric or sealing device. A framework can be made of exclusively non-absorbable materials and will remain in place during and after the internal growth of the tissue. These frameworks will remain as part of the body in which they are implanted. Some frameworks are made of entirely bioabsorbable materials, and over time they will degrade and be absorbed by the body.
[004] While a certain degree of non-absorbable materials may be desired, framework devices including non-absorbable materials may be felt by the user long after implantation, or may restrict the user's movement or flexibility after implantation. The present invention seeks to provide an implantable device that maintains desirable characteristics and less sensation for an individual after implantation and absorption of certain components.
SUMMARY OF THE INVENTION
[005] The present invention is directed to an implantable device for repairing or augmenting tissue and a method for producing and using the device. The implantable device of the present invention is an exclusive three-dimensional arrangement of absorbable and non-absorbable materials to form a flexible three-dimensional material having a soft or rigid feel, which can be produced in a variety of thicknesses and densities. The design of the implantable device is initially uniform, but it appears random due to the manufacturing processes, which provide several benefits and allow greater and advantageous internal growth during absorption and after absorption is complete.
[006] In one embodiment of the present invention, a method is provided for forming an implantable device, including the steps of: forming a first yarn and a second yarn, wherein at least one of the first yarn and the second yarn includes a first filament does not absorb
3/74 viable and at least one of the first yarn and second yarn include a first absorbable filament, the first absorbable filament having a lower melting point than the first non-absorbable filament; forming an initial woven structure including the first yarn and the second yarn; subjecting the initial woven structure to a first heat treatment at a first temperature sufficient to cause shrinkage of the first absorbable filament, thereby bending at least the second yarn and forming an initial heated structure; heating the initial heated structure to a second temperature, the second temperature being higher than the first temperature, in which at least a portion of the first absorbable filament is melted; and allowing the web of loose knit fabric to cool to form a resulting implantable device.
[007] In another embodiment of the present invention, an implantable device is provided having a random orientation of a non-absorbable filament, formed by the method that includes the steps of: forming a first yarn and a second yarn, in which at least one of the first yarn and second yarn include a first non-absorbable thread and at least one of the first yarn and second thread include a first absorbable thread, the first absorbable thread having a lower melting point than the first non-absorbable thread; forming an initial woven structure including the first yarn and the second yarn; subjecting the initial woven structure to a first heat treatment at a first temperature sufficient to cause shrinkage of the first absorbable filament, thereby bending at least the second yarn and forming an initial heated structure; heating the initial heated structure to a second temperature, the second temperature being higher than the first temperature, in which at least a portion of the first absorbable filament is melted; and allow the loose knit fabric to cool to form a
4/74 resulting implantable device.
[008] In another embodiment, an implantable device is provided including a contiguous web of a deformed first non-absorbable filament and an absorbable first filament, in which the absorbable filament has been subjected to shrinkage in at least two dimensions, providing a random orientation of the non-absorbable filament.
[009] Other embodiments provide an implantable material including a random orientation of at least one first non-absorbable filament held in place by a first fused absorbable filament, in which the implantable material has a first level of elongation before hydrolysis of the first absorbable filament , where the second level of stretching is at least five times greater than the first level of stretching.
[0010] In yet another embodiment of the invention, a method for strengthening body tissue is provided, including the steps of: forming a first yarn and a second yarn, wherein at least one of the first yarn and the second yarn includes a first filament non-absorbable and at least one of the first yarn and the second yarn include a first absorbable filament, the first absorbable filament having a lower melting point than the first non-absorbable filament; forming an initial woven structure including the first yarn and the second yarn; subjecting the initial woven structure to a first heat treatment at a first temperature sufficient to cause shrinkage of the first absorbable filament, thereby bending at least one of the first or second strands and forming an initial heated structure; subjecting the initial heated structure to a second heating at a second temperature, wherein the second heating treatment at least partially melts the first absorbable filament, thereby forming a second heated structure; to allow
5/74 the second heated structure cools to form a resulting implantable device; attach the implantable device to an individual's body; and allowing internal tissue growth in the device. [0011] The device can be single layer or multiple layers, with one or more absorbable or non-absorbable components between the layers.
BRIEF DESCRIPTION OF THE FIGURES
[0012] The Figures included in the present invention are intended to be exemplary and not to limit the scope of the invention: [0013] Figure 1 is a representation of a filament useful in the present invention, the filament being a filament of multiple fibers. [0014] Figure 2 is a representation of a tightly woven mesh structure including a filament from Figure 1.
[0015] Figure 2A is an expanded view of a section of Figure 2. [0016] Figure 3 is a representation of an initial loose woven structure using yarns prepared from the mesh structure of Figure 2. [0017] Figure 3A is an expanded view of a section of Figure 3.
[0018] Figure 4 is a representation of an implantable device prepared from an initial loose woven structure of Figure 3, after heating.
[0019] Figure 4A is an expanded view of a section of Figure 4. [0020] Figure 5 is a representation of the device in Figure 4 after the absorbable components have been hydrolyzed and without internal tissue growth.
[0021] Figure 5A is an expanded view of a section of Figure 5. [0022] Figure 6 is a side view of an implantable device after hydrolysis, while maintaining its compacted shape, representing two hypothetical views of the device [A] without internal tissue growth (ie, bench hydrolysis) and [B] with internal tissue growth (ie, after implantation).
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[0023] Figure 6A is an expanded view of a section of section [B] of Figure 6.
DETAILED DESCRIPTION OF THE INVENTION
[0024] In treatments to repair or support various tissues, it is often useful to include a framework, which can serve to, in addition to sustaining the tissue being repaired, provide a means to allow and promote internal growth and tissue generation. The problem with most common network frameworks is that they are generally made from non-absorbable materials and, therefore, maintain their presence in the body long after implantation and after internal tissue growth. As used here, the term internal growth or internal tissue growth refers to the generation or development of various cells and tissues in the body that grow within or around an implanted device over time. Any tissue in the body can be generated depending on the implant site, including, for example, bone marrow, chondrocytes, westoblasts, fibroblasts, angioblasts, smooth muscle cells, myocytes, endothelial cells, epithelial cells, hepatocytes and Sertoli cells, among others. As used here, the terms, the terms bioabsorbable and absorbable are used interchangeably and refer to a material that is decomposed and absorbed by the body, and that can be metabolized or excreted by the body over a period of time, such as a period of minutes to at least one year.
[0025] The present invention provides a suitable implantable device, which has adequate physical characteristics in all three dimensions, both before implantation and after the internal growth of the tissue has begun. The present invention provides a framework that includes a low content of non-absorbable components, yet maintains desirable characteristics after the bioabsorbable components have been absorbed and the tissue has grown in the device.
7/74. The resulting implantable material is initially woven, but does not have a shaped structure after the absorbable material is hydrolyzed. In addition, given the exclusive structure and composition of the invention, the device is more similar to the tissue in its post-absorption state, allowing movement of the natural tissue and less of a noticeable sensation by the individual in which the device is implanted. [0026] The present invention provides an implantable device, method for producing the implantable device and method for using the implantable device. In preferred methods, the device is formed by initially selecting at least one, and more preferably, more than one polymeric fiber to form a filament, as will be explained in more detail below. An example of a filament structure including a plurality of fibers is shown in Figure 1. One or more filaments can then be used to form threads, which are generally described as twisted bundles of at least one filament. A filament can be turned into a spool for ease of use.
[0027] The one or more filaments can be twisted in any method, and in one method the filaments are used to form a tightly interwoven structure, such as a sock or blade. An example of a tightly woven structure can be seen in Figures 2 and 2A. If a sock or blade is formed first, the sock or blade is subsequently unwound, which results in a twisted bundle of fibers containing the individual filaments that are used to weave the sock or blade. Torsion can be achieved through other methods, such as crimping devices. The twisted filament is called a yarn. In some embodiments, each spool or filament can be made from its own filament bundle that can be turned into a yarn. The initial filament can be a monofiber or multifiber filament, and the resulting yarn can be similarly
8/74 and a monofilament or multifilament. Most desirably, the threads are formed through a plurality of filaments, each filament being twisted or crimped. Alternatively, the strands can be twisted or crimped after the filaments form a strand. Twisting or crimping the filaments provides an increase in the volume of components in the device.
[0028] The next step includes providing at least one yarn, and more desirably, more than one yarn, and intertwining these yarns to form a loose woven structure (called the initial woven structure). An example of an initial woven structure is seen in Figures 3 and 3A. The initial woven structure is then subjected to one or more heating processes described below, shrinking at least some of the filaments in the structure and forming a deformed and implantable structure, which can then be heat treated. The resulting structure is also known as the resulting implantable device, and refers to the final structure after being subjected to one or more heating steps. An example of a resulting implantable device can be seen in Figures 4 and 4A. Of course, there may be one or more intermediate structures between the initial woven structure and the resulting implantable device, for example, if multiple heating steps are used or during the heating process. After a first heating step, which shrinks at least some of the fibers in the initial woven structure, the resulting structure is called the initially heated structure. The initially heated structure can then be subjected to the additional heating step (s) to fuse some of the fibers and hold the shrunk and deformed structure in place. This forms the resulting implantable device. After the resulting implantable device is implanted in the user's body, it can be called an implanted device.
[0029] The present invention relates to an implantable device
9/74 which includes a combination of non-absorbable fibers and absorbable fibers. As will be described in more detail below, the device of the invention has a number of desirable physical characteristics, allowing it to serve as a viable and improved tissue repair device or support. For example, the device has a thickness in a desired range for the specific application for which it is being used. The thickness is such that the device adjoins the internal growth tissue after the internal growth has taken place and the absorbable material has been absorbed by the body. The device additionally has a mass that is of a sufficient level to allow the predominant composition of the new tissue to be either the body tissue generated. The device must also provide a suitable configuration in order to provide support while allowing growth, that is, the device has a suitable porous structure described below. In addition, at least the non-absorbable portion of the device should also be sufficiently interconnected, so as to avoid providing the device with fibers that may migrate after implantation. The device can also have a desirable physical strength, thus maintaining the integrity of the device after implantation, while preventing internal growth. In addition, the device must be flexible enough to allow the device to remain implanted and secured during normal body movement.
[0030] The device of the invention is a contiguous three-dimensional web of non-absorbable and absorbable fibers, forming a distinct orientation in all three dimensions. It is understood that the device has a randomly uniform non-structural matrix. As used here, the term randomly uniform non-structural matrix is used to describe the orientation of the final product, which is formed by providing an initial uniform weave, of at least two different fibers, one of which has a lower melting point than the or
10/74 tra, which are subsequently stretched together in all three dimensions, thus generating the appearance of a random non-oriented structure, even though the resulting structure has an underlying woven structure. The stretching step will be described in detail below and may include the step of raising the temperature to a level above the lowest melting point, but below the highest melting point. The resulting structure may appear random and not uniform, but it is actually uniform in its randomness. In other words, the resulting structure can be a uniform, flat, three-dimensional, tight heat-treated mesh, with undulating surfaces, which has the look and feel of a felt material. The resulting structure can be rigid or it can be somewhat flexible, depending on the amount of material, layers and density of the resulting structure. The details of the resulting implantable device can be better understood through the description below. The use of a randomly uniform non-structural matrix is important to provide a device that improves the growth and development of fibroblasts throughout and within the device over time. In addition, the resulting implantable device can be stretched with less effort than traditional non-absorbable scaffolds or screens. Additionally, the invention, when absorbed by the body, creates a tissue-like repair, allowing for more free tissue movement than conventional frameworks containing non-absorbable structural components.
[0031] In preferred embodiments, the device includes a filament web including non-absorbable and absorbable fibers, including at least one non-absorbable fiber and at least one absorbable fiber. These filaments form twisted threads, which are woven and subjected to the stretching steps described below. As used here, the filaments can be made of monofiber or multi-fiber filament materials, which can, for example, be braided or otherwise.
11/74 interlaced mode. The term filament can include monofiber or multifiber filaments. As explained above, a yarn is formed from one or more filaments, which is twisted. The figures presented here show multifiber filaments, but it will be understood that the filaments may be monofiber.
[0032] The non-absorbable fibers of the present invention can be made of any stable non-absorbable material. Suitable materials include, for example, polymers, such as polypropylene (such as that sold under the PROLENE suture trade name, Ethicon, Inc., Somerville, NJ, USA), PVDF / HFP blends (such as a polyvinylidene fluoride polymer blend and poly (vinylidene-cohexafluoropropylene fluoride) sold under the brand name of PRONOVA suture, with Ethicon, Inc., Somerville, NJ, USA), polyester, nylon, polyacrylate, polymethacrylate, cellulose acetates, non-biodegradable polyurethanes, polystyrenes, polyvinyl chloride, polyvinyl fluoride, polyvinyl imidazole, polyolefins, polytetrafluoroethylene (PTFE), silicone and styrene butadiene block and combinations thereof. Other suitable non-absorbable materials include metals, such as stainless steel, cobalt-chromium, titanium and titanium alloys, and bioinert ceramics such as alumina, zirconia and calcium sulfate and combinations thereof. The non-absorbable filaments of the present invention can include more than one non-absorbable fiber, which can be the same or different. Preferred non-absorbable fibers of the present invention include polypropylene, blends of PVDF / HFP, polyesters and nylon. The non-absorbable fibers of the invention can be of any size to serve the function of the implant and particularly provide filaments that have a size between about 10 deniers and about 100 deniers, and more preferably, from about 25 deniers to about 60 deniers. As used here, the term denier has the understood meaning of a unit of measurement and is intended to be a unit of
12/74 filament fineness (either monofiber or multifiber filament), which is equal to the fineness of a filament that weighs one gram for every 9000 meters of filament.
[0033] The absorbable fibers of the present invention can similarly be made of any stable non-absorbable material. Bioabsorbable polymers include synthetic polymers, such as polyesters and biopolymers, such as polypeptides, polysaccharides and their derivatives. Examples of suitable biocompatible bioabsorbable polymers include, but are not limited to, aliphatic polyesters (amino acids), copoly (ether-esters), poly (alkylene oxalates), polyamides, polyacetals, polyetals, polycarbonates, polyortocarbonates, polyurethanes, poly (alkylene succinates) ), polymalealic acid, poly (methyl vinyl ether), poly (maleic anhydride), tyrosine-derived polycarbonates, poly (iminocarbonates), polyorthoesters, polyoxaesters, polyamide esters, polyoxaesters, containing amine groups, poly (anhydrides), polyphosphates, biopolymers (by example, collagen, gelatin, alginate, pectin, starch, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid and mixtures thereof) and mixtures thereof. Aliphatic polyesters can include, but are not limited to, lactide homopolymers and copolymers (which includes lactic acid, D-L- and meso lactide); glycolide (including glycolic acid); epsilon-caprolactone; p-dioxanone (1,4dioxan-2-one); trimethylene carbonate (1,3-dioxan-2-one); alkyl derivatives of trimethylene carbonate; delta-valerolactone; betabutyrolactone; gamma-butyrolactone; epsilon-decalactone; hydroxybutyrate; hydroxyvalerate; 1,4-dioxepan-2-one (including its 1,5,8,12tetraoxyclotetradecane-7,14-dione dimer); 1,5-dioxepan-2-one; 6,6-dimethyl1,4-dioxan-2-one; 2,5-dicetomorpholine; pivalolactone; gamma, gamma-diethylpropiolactone; ethylene carbonate; ethylene oxalate; 3-methyl-1,4dioxane-2,5-dione; 3,3-diethyl-1,4-dioxan-2,5-dione; 6,8-dioxabicycloctane7-one and polymer blends thereof. Poly (alkyl oxalates)
13/74 no) include those described in US Patent No. 4.2 08,511; 4,141,087; 4,130,639; 4,140,678; 4,105,034; and 4,205,399, each of which is incorporated herein by reference. The bioabsorbable materials useful in this invention further include polyglycolate, copolymer of poly (lactic acid-ethylene co-oxide), polyphosphester, polyamino acids, poly (lactic acid) (PLA), poly (glycolic acid) (PGA), polycaprolactone ( PCL), polydioxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), copolymers or blends thereof. Polyphosphazenes, co-, terpolymers and of greater magnitude based on monomers produced from L-lactide, D, L-lactide, lactic acid, glycolide, glycolic acid, para-dioxanone, trimethylene carbonate and epsilon-caprolactone are also useful . Poly-anhydrides include derivatives of diacids of the form HOOC - C ₆ H ₄ --O “(CH ₂ ) _m --O - C ₆ H ₄ --COOH, where m is an integer in the range of 2 to 8, and copolymers of them with alpha-omega aliphatic diacids of up to 12 carbons. Useful polyoxaesters, polyoxa-amides and polyoxa-esters containing amine and / or amide groups are described in one or more of the following US Patent Nos. 5,464,929; 5,595,751; 5,597,579; 5,607,687; 5,618,552; 5,620,698; 5,645,850; 5,648,088; 5,698,213; 5,700,583; and 5,859,150, each of which is incorporated herein by reference. Other useful materials may include poly (Llactide) (PLA), poly (d, l-lactide) (PDLA), poly (glycolide) (PGA), polycaprolactone, copolymers, terpolymers, polymers of larger polymers of the same, or combinations or mixtures thereof of the same.
[0034] The fibers or filaments can be colored, as through biologically stable dyes, or they can be non-colored. In some embodiments, at least one of the materials used in the resulting implantable device is provided with a color, such as through the use of a dye, in order to allow a user to view the different fibers in the device. Additionally, the use of a dye can provide a manufacturing benefit and / or store
14/74 as adding a dye to a material can make the material less sensitive to ultraviolet light. For example, a material in the device can be dyed with a blue or purple dye.
[0035] Most desirably, the absorbable fiber or fibers include one or more polymers selected from the group consisting of polymers produced from glycolide and / or lactide, polyglactin 910 (sold under the trade name VICRYL suture by Ethicon, Inc., Somerville, NJ, USA), and polymers made from poly (glycolic acid), poly (p-dioxanone) (such as the one sold under the PDS suture name, Ethicon, Inc., Somerville, NJ, USA), caprolactone , trimethylene carbonate and combinations thereof. If synthetic absorbable polymers are used, the desired polymers must be biocompatible and have degradation products that are low molecular weight compounds, such as lactic acid and glycolic acid, that enter normal metabolic pathways. The bioabsorbable fibers in the present invention can be used to prepare filaments that have a size of about 10 deniers to about 100 deniers and more particularly about 28 deniers to about 56 deniers. There may be one or more of a bioabsorbable fiber in the present invention, and, if multiple absorbable fibers are used, they can be prepared from the same material or they can be prepared from different materials. In addition, each fiber can have a different melting point than the other fibers in the present invention.
[0036] In one embodiment, the present invention includes at least one non-absorbable fiber and at least one absorbable fiber, wherein the fibers have different melting points. In another embodiment, the present invention includes at least one non-absorbable fiber and at least two absorbable fibers, each of which has a different melting point than the other. Any of the absorbable and non-absorbable fibers can have the lowest melting point of the device.
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In embodiments including at least one non-absorbable fiber and at least one absorbable fiber, the percentage weight of the non-absorbable fibers for the weight of the total fiber is between about 5% to about 50% by weight, and most desirably, from about 10% to about 25% by weight. Preferably, there is a higher level (by weight) of absorbable fibers than of non-absorbable fibers in the device.
[0037] The device has a randomly uniform non-structural matrix that describes the orientation of the filaments in the device, particularly in all three dimensions. The device can be formed by any means desired and, in one embodiment, the device is formed by the following methods. Initially the fibers are selected to form the device and can include combinations of absorbable and non-absorbable fibers. These fibers are used to form individual filaments that can include a fiber (monofiber) or can include a plurality of fibers (multifibers). As can be seen in Figure 1, a filament 10 includes a plurality of individual fibers 12, 14, 16. The filament in Figure 1 shows a filament including three types of fibers: a first absorbable fiber 12, a first non-absorbable fiber (14 ) and a second absorbable fiber 16. As will be discussed in more detail below, there may be several different types of fibers in the filament for different reasons. In that figure, for example, the filament 10 on the left side of Figure 1 demonstrates a filament that has a first absorbable fiber 12, a first non-absorbable fiber (14) and five second absorbable fibers 16, but any types and numbers of fibers can be used as desired. The filament 10 on the left side of Figure 1 shows four second absorbable fibers 16, a first absorbable fiber 12 and a first non-absorbable fiber 14. Other different amounts of material can be used, and the amount can be measured by weight or by a number of fiber strands.
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[0038] The yarns are formed of several filaments, which may include the selected non-absorbable and absorbable fibers discussed above. The threads can be formed by any desired thread forming means, and in some embodiments, the threads are formed through the formation of a tightly woven initial mesh structure, such as a sock or blade. One embodiment of a tightly interwoven structure can be seen in Figures 2 and 2A. Figure 2 shows a mesh structure 100 including a filament 10. The mesh structure 100 can include any number of different filaments 10, as desired. The selected filaments 10 can be tightly interwoven to form the initial tightly woven structure 100, which can be of any desired size and shape. The resulting structure 100 can form a continuous stocking or blade, which can be of any desired length and diameter. For example, a sock can have a diameter of about 1.27 centimeters to about 25.4 centimeters (from 0.5 inches to about 10 inches) and more desirably from about 3.81 centimeters to about 12.7 centimeters (from 1.5 inches to about 5 inches). A blade can be a substantially flat structure, having any desired length and width. The width can be, for example, from 1.27 cm to about 91.44 centimeters (0.5 inches to about 36 inches), and the length can be defined (for example, at least about 30.48 centimeters) (12 inches)) or can be extended to more than 1,524 meters (5 inches), more than 3,048 meters (10 feet), more than 6,096 meters (20 feet), or even more, allowing for a continuous blade. If a sock or blade is formed first, the sock or the blade can then be unwound to provide a twisted strand of materials. Any number of wires can be formed and used to form the implantable device. There must be enough thread formed to weave the
17/74 device to your desired size and shape.
[0039] In some embodiments, the initial fibers can be contained as an initial fiber spool, which can be extruded from a homogeneous material and rolled up. It is clear that a fiber can be homogeneous or can be produced from multiple materials, if desired. In some embodiments, there may be a bundle of very small fibers creating a small bundle of fibers. The fiber spool is used to prepare the filaments, which can then be used to prepare a yarn. If desired, a plurality of spools of the same or different fibers can be taken, which can form a filament or a portion of bundles of fiber. Yarns can be formed from any number of filaments (and thus any number of fibers), and it is possible for a yarn to be formed from a single fiber. For example, yarns can be formed of filaments made of a plurality (for example, from about 3 to about 7) of fibers from a first absorbable material, such as polyglactin 910, an optional second absorbable fiber, such as PDS, and at least a non-absorbable fiber, such as polypropylene. Various combinations will be described below. The fiber combination can be used to form an initial mesh stocking or blade, or the combination can be assembled and / or twisted and / or crimped by any desired means. If a sock or blade is formed first, when the plurality of fibers are pulled together out of the sock or blade of mesh, the resulting yarn resembles a twisted bundle of fibers. Optionally, one or more yarns from two different knit socks or sheets may be required to create the initial loose woven structure. As described here, each yarn in the initial woven structure may contain several filament ratios having several ratios of individual absorbable and non-absorbable fibers, and it is preferred that at least one yarn contains a bundle strand of a non-absorbable fiber and at least one
18/74 thread contains a string of bundles of absorbable fiber.
[0040] After the thread or threads are obtained, a structure is initially formed with the thread or threads loosely weaving the threads through any known method. A representation of an initial loose woven structure can be seen in Figures 3 and 3A. The initial loose woven structure is referred to in this document as the initial woven structure. As shown in Figure 3, an initial woven structure 200 is made of a weft of at least one yarn 210, which can be made of a plurality of individual fibers 212, 214, 216. The initial woven structure 200 can be made of one type of yarn 210 or may be made of multiple yarns 210, each of which may be the same or may be different. Figure 3 shows multifiber yarns 210, but it is understood that yarns 210 may be monofiber yarns. As can be seen in Figure 3, the wires 210 have a twisted structure.
[0041] The initial woven structure 200 may be of any desired shape, including, for example, rectangular, oval, or may even be tubular or tapered. The initial woven structure 200 can have any desired thickness, and is preferably between about 0.1 mm and about 5 mm thick, more desirably about 2 mm thick. Of course, the thickness can be modified depending on the intended use and location of the implantation. The initial woven structure 200 can be any desired length or width and can form a large sheet of material. If the initial woven structure 200 forms a large blade, the resulting implantable device made therefrom may be longer and wider than desired, and the user can trim the device to the size and shape to be implanted. In some embodiments, the initial woven structure 200 itself can be implanted. The initial woven structure 200 will disperse the non-absorbable and absorbable fibers throughout the structure, desirably supplying each measurable section of the structure with some of the absorbable and non-absorbable materials present. The initial woven structure 200 has a substantially uniform appearance in all three dimensions. As used here, a loose weave is intended to refer to a woven structure in which the ratio between rows and rows is from about 8 to 1 to about 1.5 to 1, and more preferably from about 5 to 1 to about 2 to 1. In some embodiments, however, the ratio between ranks and careers can be from about 5 to 1 to about 1.5 to 1, and more preferably from about 5 to 1 about 2 to 1.
[0042] The initial woven structure is then subjected to an increase in energy, such as heat, radiation, vibration, increased electrical current, radiofrequency or other types of energy, designed to shrink the structure and treat the structure with heat. In some embodiments, the initial woven structure 200 can be subjected to a first heating, which can be done together with other energy variations, such as vibration or radiation exposure. The initial woven structure is first heated, as by placing it in a defined heating space, such as a heating device or other space to provide heat to the initial woven structure 200. In some embodiments, the initial woven structure 200 is placed inside the oven. heating or in other modalities it can be placed between the first and the second heating surfaces or plates. Desirably, the entire initial woven structure 200 is enclosed within the boundaries of the heating surface or surfaces, either inserted in an oven or placed between heating surfaces, but only if a certain region of the initial woven structure 200 is to be heated, that region can be placed within the heating limits. Additionally, in some embodiments, the initial woven structure 200 may form a tubular shape, such as by rolling in the machine direction or not in the machine direction, and placed within a space of
20/74 tubular heating.
[0043] If the initial woven structure 200 is placed in a heat source with defined surfaces, it is desired that the gap between these surfaces is at least slightly greater than the thickness of the initial woven structure 200, to ensure adequate heating throughout the initial woven structure 200. Desirably, the gap between the surfaces is about 0.5 mm to about 5 mm, and more desirably about 1.5 mm and about 3.0 mm. Of course, the size of the gap between the heating elements may depend on the thickness and density of the initial woven structure 200, or the type of material used in the initial woven structure 200. If the initial woven structure 200 is about 0.1 mm around 1.0 mm thick, for example, then the span should be about 1.5 mm to about 3.0 mm. If the initial woven structure 200 has a smaller thickness, a smaller gap can be used, and vice versa. The span size can be from 0.1 mm to about 2.0 mm greater than the thickness of the initial woven structure 200.
[0044] In this method of forming the implantable device, the initial loose woven structure 200 is subjected to at least one temperature, where the temperature is related to the melting point of the material having the lowest melting point in the structure. The material with the lowest melting point can be an absorbable material or it can be a non-absorbable material. The description below refers to the material having the lowest melting point as being an absorbable material, but it should be understood that that material having the lowest melting point may be a non-absorbable material.
[0045] For that first heating of the initial woven structure 200, the temperature of the heating device is set at a level which is: (1) at, (2) slightly above or (3) slightly below the initial melting temperature of the material that has the lowest melting point in the initial woven structure (this material is called the first
21/74 fiber in the device). This initial rise in temperature is the first warm-up. As used here, the term slightly above is about 0.1 ° C to about 10 ° C higher than the initial melting temperature, or about 0.1 ° C to about 5 ° C greater than initial melting temperature, and most desirably from about 0.1 ° C to about 2 ° C higher. Similarly, as used here, the term slightly above is about 0.1 ° C to about 10 ° C less than the initial melting temperature, or about 0.1 ° C to about 5 ° C lower than the initial melting temperature, and more desirably from about 0.1 ° C to about 2 ° C lower.
[0046] As an example, the initial woven structure can include two fibers, the first fiber having an initial melting point of 100 ° C and the second fiber having an initial melting point of 150 ° C. In this embodiment, the initial woven structure can be placed in a heating device and exposed to a first temperature, the first temperature being about 100 ° C (for example, at the melting point of the fiber, which has the lowest melting point). Alternatively, the first temperature can be from about 99.9 ° C to about 95 ° C, more desirably from about 99.9 ° C to about 98 ° C (for example, slightly below the melting point of the fiber that has the lowest melting point). Or alternatively, the first temperature can be from about 100.1 ° C to about 105 ° C, more desirably from about 100.1 ° C to about 102 ° C (for example, slightly below the melting of the fiber that has the lowest melting point). The first temperature is intended to cause shrinkage. Fusion of the fiber having the lowest melting point in the initial woven structure (for example, the first fiber or if the fiber is an absorbable fiber, can be called the first absorbable fiber) is not the goal in this step, instead, the goal is to shrink the first material.
[0047] In some modalities, the first fiber is an ab fiber
22/74 sorbible, which has an initial melting point of about 1Ü5 ° C, and the first heating step is conducted from about 1ÜÜ ° C to about 1Ü3 ° C.
[ÜÜ48] Additionally, it is desirable that the lowest melting point of the first fiber be at least 1Ü ° C lower than the temperature of the material that has the second lowest melting point in the initial woven structure. That is, the second fiber must have a melting point at least 1 ° C higher than the first fiber.
[ÜÜ49] For purposes of this description, the first fiber (for example, the fiber that has the lowest melting point in the device) will be described as being absorbable and can be called the first absorbable fiber. The first heating is continuous for long enough to cause the first absorbable fiber to shrink (which has the lowest melting point in the device). The shrinkage of a material, as used here, refers to the restructuring of molecules in that material, but that is not enough to melt the material. Shrinkage can be achieved, for example, by heating the material to its glass transition temperature. The fusion of the first absorbable fiber is not the goal, although a slight fusion may occur. Instead, the heating step is intended to cause an initial shrinkage of the first absorbable fiber. Shrinkage, rather than fusion, is preferred because shrinkage allows the first absorbable fiber to retain some of its strength and pull the other fibers into the device, while melting a material reduces the extraction force of that material. Typically, this first heating step should take about 1Ü to about 6Ü seconds, and more particularly about 2Ü to about 45 seconds, but it can vary depending on the material or materials used in the initial woven structure. The shrinkage of the first absorbable fiber causes a deformation of the resulting fibers in the initial tissue device.
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[0050] The resulting structure after the first heating stage is a device that has a woven pattern of at least one thread, which has fibers that have been deformed due to the shrinkage of fibers that have a lower melting point. Due to the deformation, however, the structure appears to have a non-uniform layout, since the degree of shrinkage is random. The resulting material is called an initially deformed structure or an initially heated structure.
[0051] The initially deformed structure can then be subjected to an optional energy boost or heating step (second heating), if desired, for heat treatment of the device. A second heating step is preferred, but is not necessary. This second heating can take place on the same heating device described above or it can be on a separate heating device and can include additional sources of increased energy, such as vibration or radiation, or other energy sources described above. The second heating is desirably at a temperature of or above the temperature of the first heating and, preferably, above the melting point of the first fiber (which has the lowest melting point in the device). The second heating can be at a temperature of about 2 ° C to about 25 ° C greater than the temperature of the first heating.
[0052] The second heating step aims to fuse the first fiber that has the lowest melting point in the structure, thus stabilizing the structure and dimensions of the initially deformed structure. The second heating step should be substantially quick, but it may be slightly longer than the first heating, for example, from about 60 seconds to about 120 seconds and more particularly from about 60 seconds to about 90 seconds. A longer second warm-up time can be
24/74 necessary if, for example, a thicker device is desired. Optionally, the second heating step can include additional steps, such as a compression step, in which the initially deformed structure is compacted between heating elements during the heating stage. Compression may be desired, for example, if the shape of the initially deformed structure is to be changed to form the final implantable device. It may be desirable, for example, to level the initially deformed device at about 25% to about 75% of its thickness, and more desirably about 50% of its thickness (for example, from about 2 mm of thickness to about 1 mm thick). The size of the gap between the heating elements can be adjusted to the desired thickness, and the pressure can be additionally exerted, if desired.
[0053] After being subjected to the first heating stage and the optional second heating stage, the initially deformed structure is removed from the heating device and left to cool, which can occur at room temperature or in a temperature-controlled environment (for example, example, either above room temperature or below room temperature). In some embodiments, a heating device that has a cooling capacity can be used, which allows for quick cooling after heating is obtained. The resulting structure is a solidified three-dimensional implantable tissue device, in which at least some of the filaments have been randomly deformed due to the shrinkage of some filaments. This is called the resulting implantable device. The resulting implantable device maintains its final shape due to the subsequent fusion and solidification of some fibers, forming connection points. The resulting implantable structure thus appears to have a random orientation in all three dimensions, in
25/74 although the unfused filaments have, in fact, an original uniform weave. The resulting implantable device is in a woven / non-woven state and has the look and feel of a felt-like material. The resulting implantable device, therefore, has a randomly uniform non-structural matrix in all three dimensions of thickness, length and width. Additionally, with the random deformation of the fused filaments, the resulting implantable device appears to have a non-structural matrix of fibers.
[0054] One embodiment of a final implantable device is seen in Figures 4 and 4A, which show a resulting implantable device 300. The resulting implantable device 300 includes a shrunken web of threads 310, where each thread 310 can be made in one plurality of fibers 312, 316. Twisted yarn 310 is essentially a twisted and shrunk version of yarn 210 of Figure 3. As explained above, there may be more than one type of yarn 310 used in device 300 and each yarn 310 can be monofiber or multifiber. As can be seen in Figure 4A, one of the fibers was fused to form connection points 314 in device 300. The fusion is achieved during the second heating step, in which the fiber is fused and cooled to a degree sufficient to form connection 314 on device 300. The resulting implantable device 300 is thus shrunk in at least two directions (for example, length and width) and is held in place by connection points 314. Shrinkage can result in increased thickness, or, if shrinkage is done in a compacted environment, the thickness can be reduced or remain substantially constant. Desirably, the connection points 314 are formed of an absorbable fiber, for example, the first absorbable fiber.
[0055] If desired, the final product to be implanted may include more than one layer of a resulting implantable device.
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More than one initial woven structure or initial deformed structure can be layered, one on top of the other, and subjected to the heating step (or steps) simultaneously, thus having multiple layers of implantable material resulting in a uniform transverse pattern of random orientation that are merged. Alternatively, each layer can be subjected to its own heating step, forming a plurality of resulting implantable devices and then layered and attached to each other. The layers can simply be attached to each other directly, that is, without any component interfering, or they can include material between them to improve fixation. Fixation can be achieved through physical means, such as heat fusing the components, or it can be achieved through chemical or physical means, such as through adhesive or by sewing the layers together. If desired, a film or films made of the material having the lowest melting point in the device (or alternatively, another absorbable material with a low melting point) can be placed between layers. A film used to arrange the device between layers can be absorbable. The layers can be placed in a heating device, allowing the film to melt, thereby increasing the bond between the layers. The layers can be identical to each other if desired; however, it is important to note that the various layers in the device do not have to be identical or even be of the same materials. Although each layer may include similar or overlapping materials, the exact compositions of each layer need not be the same. Alternatively, the materials in each layer can be totally different, without overlapping materials.
[0056] In some embodiments, there may be multiple layers of the implantable device of the invention by pressing a layer of canvas or a non-absorbable frame material. In these modalida
27/74 d, the layered material can be prepared by placing a mesh layer or framework material between a first layer of the initial woven device and a second layer of the initial woven device and then subjecting the sandwich structure to heating steps , as described above. Layers of adhesive or film material can be placed between any layers to assist in preparing the layered structure. The sandwich structure can then be subjected to the heating steps, as explained above, resulting in a layered heat-treated implantable device. In some embodiments, the layers may initially be made of a layer of canvas or framework material arranged between a first layer of an initially deformed structure and a second layer of an initially deformed structure, and then the sandwich structure can be subjected to the heat as described above. Any number of layers of material can be placed over the others, if desired, forming the device in layers. The edges of the layers may be flush with each other or at least one of the edges of a first layer may extend beyond the edge of a second layer, or vice versa.
[0057] The final device to be implanted can be produced from multiple layers of the resulting implantable device, which can be arranged in the same, different or alternating directions. Since the resulting implantable device has different stretching properties in perpendicular directions, layer formation of the layers of the individual resulting device can create a device that has similar stretching properties in all directions. In some embodiments, depending on the direction of the layers, the layered implantable device may be more capable of being stretched in a first direction and less capable of being stretched
28/74 in a second direction. The formation of multiple layers can create a very strong implantable device for various uses, for example, for tendon repair, as opposed to soft tissue repair. Adding a layer of film between the layers of the resulting woven device, as described above, can serve to increase the bonding of the layers, and can be pressed to a thickness less than the initial thickness.
[0058] In some embodiments, the material that has the lowest melting point in the device (the first fiber) is an absorbable fiber and may include poly (p-dioxanone) (including that sold under the brand name PDS suture by Ethicon , Inc., Somerville, NJ, USA). In that embodiment, the first heating temperature can be about 100 ° C to 103 ° C and the second heating temperature can be about 105 ° C to about 120 ° C. Of course, the first and second heating temperatures can be varied depending on the material or materials used in the device. In some embodiments, a second higher heating temperature can result in a greater level of flexibility and less tensile strength in the resulting final device. If used, poly (p-dioxanone) can be used in combination with non-absorbable material and optionally other absorbable materials.
[0059] In one embodiment, the device can be produced from three different fibers. The first fiber may be a non-absorbable fiber, such as polypropylene. The second fiber can be a first absorbable fiber, such as polydioxanone, and the third fiber can be a second absorbable fiber, such as polyglactin 910. Each fiber forms a filament or can be joined into a filament including multiple different fibers, and each fiber or filament can have its own denier. For example, the polyglactin fiber can have the smallest denier, and it can be about 28. The polydioxanone fiber can have a slight denier
29/74 larger, such as about 30. The non-absorbable fiber may have the largest denier, such as about 60. The filament may be made of several fibers, and the resulting filament may have a desired denier. The torsion and deformation level of the final implantable device can be modified depending on the material or materials forming the filaments. Other materials may be included, as desired, or varied non-absorbable and / or absorbable materials may be used. Desirably, the device is produced from at least one non-absorbable component (fiber) and at least one absorbable component (fiber).
[0060] In a multimaterial modality, each material can be included in any desired quantity or ratio. It is preferred, however, that absorbable fiber (s) is present in greater quantity than the non-absorbable fiber (s) in the device. For example, in one embodiment, the woven structure includes filaments of a first absorbable fiber and a first non-absorbable fiber, and the materials are present in amounts of about 1 to 7 parts (by weight) of the first absorbable fiber to about 1 part of the first non-absorbable fiber and more desirably from about 3 to 5 parts (by weight) of the first absorbable fiber to about 1 part of the first non-absorbable fiber. The reasons need not be in weight and can be for individual fiber or strand of yarn, regardless of the denier of the fiber. That is, there can be about 1 to 7 strands of the first absorbable fiber to about 1 strand of the first non-absorbable fiber. In this embodiment, the first absorbable fiber may have a lower melting point than the first non-absorbable fiber, where the difference in the melting point is at least about 10 ° C. Any materials can be used for this composition, including, for example, polyglactin 910 or poly (p-dioxanone) as the first absorbable fiber and polypropylene as the first non-absorbable fiber.
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[0061] In another embodiment, the woven structure may include filaments of a first absorbable fiber and a second non-absorbable fiber, with the materials present in quantities of about 1 to 7 parts (by weight) of the first absorbable fiber at about 1 part of the second absorbable fiber, and more desirably about 3 to 5 parts (by weight) of the first absorbable fiber to about 1 part of the second absorbable fiber. Again, these reasons do not have to be in weight and can be per individual fiber or yarn strand, regardless of the denier of the fiber. That is, there can be about 1 to 7 strands of the first absorbable fiber to about 1 strand of the second absorbable fiber. In this embodiment, the first absorbable fiber may have a lower melting point than the second absorbable fiber, where the melting point of the first absorbable fiber is at least about 10 ° C less than the melting point of the second absorbable fiber. . Alternatively, the second absorbable fiber in the device may have a lower melting point than the first absorbable fiber. There may be a greater amount of this first absorbable fiber (for example, the material with the lowest melting point) than the second absorbable fiber, or vice versa. Any material can be used for this modality, including, for example, poly (p-dioxanone) as the first absorbable fiber and polyglactin 910 as the second absorbable fiber.
[0062] In yet another embodiment, the structure may include three fibers, such as a first absorbable fiber, a second absorbable fiber and a first non-absorbable fiber or alternatively a first absorbable fiber, a first non-absorbable fiber and a second non-absorbable fiber. This embodiment can include a first absorbable fiber in an amount of about 1 to 7 parts (by weight), a first non-absorbable fiber in an amount of about 1 part (by weight) and a second absorbable fiber or second non-absorbable fiber in an amount of 1 part (by weight). Again, es
31/74 These reasons do not need to be in weight and can be per individual fiber or wire strand, regardless of the fiber denier. That is, there may be about 1 to 7 strands of the first absorbable fiber, about 1 cord of the first non-absorbable fiber and about 1 cord of the second absorbable and non-absorbable fiber.
[0063] The three modalities described above are exemplary and are not intended to limit. The implantable device can include alternative or additional absorbable and / or non-absorbable fibers, as desired. For example, it can be larger than the three materials in the implantable device, including various combinations of absorbable and non-absorbable fibers. The starting materials can be used to form monofiber or multifiber filaments, and the filaments, in turn, are used to form yarns.
[0064] The individual yarns used to make the woven device can include any of the fibers described above and can be prepared in any desired way. In one embodiment, the wires are formed first by making firm meshes of the selected filaments, such as a sock or blade, or by crimping the filaments. The initial tightly woven structure may include a filament including a first absorbable fiber and a first non-absorbable fiber, or alternatively, a filament including a first absorbable fiber and a second absorbable fiber, or alternatively, a filament including a first absorbable fiber, a second absorbable fiber and a first non-absorbable fiber. The yarn or threads can be formed by unwinding the tightly woven structure, which results in a twisted bundle of filaments containing the individual fibers. Of course, more than one sock or blade can be formed and more than one thread can be formed from the prepared sock or blade. The yarns may include absorbable fibers, non-absorbable fibers and combinations thereof.
[0065] After the wires are formed, the wires can be used
32/74 to form an initial woven structure. The initial woven structure can include wefts of any combination of yarns, including those described above. In one embodiment, the initial woven structure may include a weft of only one type of yarn, for example, a yarn having a first absorbable fiber and a first non-absorbable fiber or a yarn having a first absorbable fiber, a second absorbable fiber and a first non-absorbable fiber. In alternative embodiments, the initial woven structure may include wefts of at least two different types of yarn. For example, the initial woven structure may include a weft of a first yarn and a second yarn, where the first and second yarns are different from each other. The first yarn can be, for example, (a) a yarn having a first absorbable fiber and a first non-absorbable fiber or (b) a yarn having a first absorbable fiber and a second absorbable fiber or (c) a yarn that has a first absorbable fiber, a second absorbable fiber and a first non-absorbable fiber, and the second yarn can be, for example, (a) a yarn having a first absorbable fiber and a first non-absorbable fiber or (b) a yarn which has a first absorbable fiber and a second absorbable fiber or (c) a thread that has a first absorbable fiber, a second absorbable fiber and a first non-absorbable fiber, wherein the first and second threads are made of different fibers. It is desired that the initial woven device includes at least one absorbable fiber and at least one non-absorbable fiber.
[0066] As an example, the initial woven structure may include a weft of a first yarn and a second yarn, in which the first yarn is made of a first absorbable fiber and a second absorbable fiber and a second thread is made of a first absorbable fiber, second absorbable fiber and first non-absorbable fiber. The specific absorbable and non-absorbable fibers in each yarn can be the same or they can be different. For example, in this modality, the first
33/74 yarn can be made of polyglactin 910 and poly (p-dioxanone) and the second yarn can be made of polyglactin 910, poly (p-dioxanone) and polypropylene. [0067] Another example is an initial woven structure including a weft of a first yarn and a second yarn, in which the first yarn is made of a first absorbable fiber and a second absorbable fiber and the second yarn is made of a first fiber absorbable and a first non-absorbable fiber. The specific absorbable and non-absorbable fibers in each yarn can be the same or they can be different. For example, in this embodiment, the first yarn can be made of polyglactin 910 and poly (p-dioxanone), and the second yarn can be made of polyglactin 910 and polypropylene.
[0068] These modalities aim to exemplify the various possible combinations with the understanding that any of the absorbable and non-absorbable fibers identified above can be used. Alternative materials can be used, if desired, including, for example, blends of various absorbable polymers, in order to provide the resulting implantable structure with a longer or shorter absorption profile. The absorption profile can be adjusted through post-manufacture steps, such as sterilization, as well as through exposure to gamma rays to reduce the absorption profile. The presence of a non-absorbable component in the final implantable device can be useful, for example, to retain a presence in the body after absorbing the absorbable components. If absorption is desired and desired, however, a device including only absorbable fibers can be used.
[0069] The initial shape or structure of the initial woven structure, before being subjected to any heating step, can be a loose, flat woven structure, as described above. Other formats can be useful, including, for example, spherical, conical, cylindrical and the like. It can be in the form of a microsphere or a set
34/74 or chain of microspheres that can be connected through an absorbable and non-absorbable filament material. Preferred modalities are flat structures, with flat structures having a substantially rectangular or elliptical shape. The corners of the initial woven structure can be rounded, if desired. The resulting implantable device can be cut or trimmed by a user before implantation. As explained above, the final device to be implanted can include any number of layers of the resulting implantable devices as desired, but the initial woven structures are typically formed as a single layer. If a multilayer device is desired, the single layers can be combined with each other before, during or after the various heating steps and using physical or chemical means of attachment between the layers. In addition, the layered device may include additional elements, such as a mesh or non-absorbable frame sandwiched between the layers.
[0070] The resulting implantable device, after all the heating steps, can have any desired length or width, depending on the intended use. In some embodiments, the resulting implantable device may be in the form of a blade, which can be trimmed to the size and shape desired by a user prior to implantation. In some embodiments, the device may be in the form of a material strip, so that it can be used to wrap or modify a stress urinary incontinence (SUI) brace, or in other embodiments, it may be square in shape. The device can be any desired length and width, from 0.0254 centimeters (0.01 inches) to greater than 30.48 centimeters (12 inches). For example, if used as an IUE strap (sling), the width can be from about 0.762 to about 1.778 centimeters (from 0.3 to about 0.7 inches), and the length can be
35/74 from about 5.08 to about 10.16 centimeters (from 2 to about 4 inches), as measured below the urethra. In other embodiments, the device may be circular or tubular in shape and may have a diameter of 0.127 cm to about 25.4 centimeters (0.05 inches to about 10 inches). In elliptical configurations, the device can have a greater radius of about 0.254 cm to about 12.7 centimeters (from 0.1 inch to about 5 inches) and a smaller radius of about 0.0254 centimeters to about 7 62 centimeters (from 0.01 inches to about 3 inches). In still other embodiments, the implantable device may have an indefinite shape, such as a type of amorphous or cotton ball configuration, which can be used as packaging or filling material, such as to fill a hole or empty space created by removing tissue in a patient.
[0071] The initial thickness of the initial woven structure can be from about 0.127 cm to about 1.27 cm (from 0.05 inches to about 0.4 inches) thick, while the initial deformed structure, after the first the heating step described above can be from about 0.0508 centimeters to about 0.64 centimeters (from 0.02 inches to about 0.25 inches) thick, and the final implantable device, after all the heating steps and optional compression described above, can be from about 0.03 centimeters (0.01 inches) thick to about 0.318 centimeters (0.125 inches) thick. In some embodiments, each heating step can reduce the thickness of the device, as if compression is used.
[0072] The resulting implantable device has a distinctive appearance when viewed by a user. The resulting implantable device is a narrowly constructed material mat, which has no or only visual acuity, depending on thickness and density
36/74 of the construct. The external texture of the resulting implantable device is felt-like in nature. A felt-like material is composed of short fibers intertwined together, while the device of the invention was initially loosely woven, and when an internal fiber connected to all other fibers was shrunk (through the first heating) to contract and deform the material in a compacted state of a connected but non-structural matrix of non-absorbable fibers. However, due to post-shrinkage processing (for example, a second heating step), the complete fiber matrix in the resulting implantable device is interwoven through an absorbable fiber that has fused and solidified. This gives the resulting implantable device a three-dimensional surface texture in a microscale. The resulting implantable device has a woven / non-woven structure, which has a degree of porosity depending on the material and the density of that material. It may be desired that the porosity of the resulting implantable device may not be able to be seen with the naked eye by the user, as with wefts and screens, while in other embodiments, a user can see the porosity of the device with the naked eye. The pore sizes will be from about 4 microns to about 300 microns, if compacted, but can be much larger (for example, greater than 300 microns), if desired, for example, without compression.
[0073] The resulting implantable device may have a desired hardness. Hardness can be measured by known tests, such as a bending test described in the examples below. The force required to flex the device of the invention can be from about 1 N to about 1.5 N and more specifically from about 1.25 N to about 1.50 N. The resulting implantable device can have a resistance to about 5 N to about 4000 N and more preferably between about 50 N and 500 N. The resulting implantable device may have
37/74 a desired level of stretch when pulled in a first direction. The preferred elastic modulus of the resulting implantable device can be from about 100 N / m to about 300 N / m, and more particularly from about 150 N / m to about 200 N / m.
[0074] After the resulting implantable device is prepared, it can be implanted. Over time, hydrolysis of the absorbable fiber in the device results in a final hydrolyzed structure including only non-absorbable fibers. One embodiment of a hydrolyzed structure can be seen in Figures 5 and 5A, which show a hydrolyzed structure 400 including only non-absorbable fibers 410. Figure 6 is a cross-sectional view showing two hypothetical final results of a device: the section [A ] shows a hydrolyzed portion of a device including only 410 non-absorbable fibers. This would be the result, for example, in experimental or bench use, where there is no internal tissue growth, and this section represents the structure of the polypropylene remaining in the same compressed state after hydrolysis. It is understood that the polypropylene structure may lose compression after hydrolysis and may not have a compressed appearance. The section [B] of Figure 6 shows a hydrolyzed portion after the internal growth of the tissue, in which there is a combination of non-absorbable fibers 410 and the tissue 420, which can be better seen in the expanded view of Figure 6A.
[0075] It is understood, of course, that sections [A] and [B] in Figure 6 are probably not the end result after implantation, but instead these two sections are a side-by-side comparison between two possible outcomes after bench or experimental hydrolysis [A] and [B] internal tissue growth. After implantation and absorption of the absorbable components by the body, it is understood that the entire device includes the internal growth of the tissue through it (for example, section [B] of Figure 6).
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[0076] The present invention can provide multiple levels of elasticity for the device: a first level before any hydrolysis of the components and a second level after the hydrolysis of the components. The implantable device (for example, 300) has a first level of elasticity before hydrolysis of the absorbable material (s) in the device and formation of a hydrolyzed structure (for example, 400). The first level of elasticity can be measured by any desired means, including a tensile test in one or more directions. It is understood, of course, that the device may be more elastic in a first direction (for example, along its length) than a second direction (for example, along its width). After the hydrolysis of the absorbable material in the device, as after the bench hydrolysis, the absorbable material in the device will be totally or substantially totally removed from the device, leaving only the non-absorbable material (hydrolyzed structure 400). In that state, that is, after hydrolysis, the device has a second level of elasticity, which is greater than the level of elasticity of the implantable device before hydrolysis. In some embodiments, the elasticity level of the post-hydrolysis device is at least twice the elasticity level of the device before hydrolysis, and more desirably, at least 3 times the elasticity level of the device before hydrolysis or at least 5 times the level of elasticity or at least 10 times the level of elasticity. Any method for measuring elasticity can be used, but the method used must be the same for prehydrolysis and posthydrolysis. After implantation in a patient's body, and subsequent absorption of the absorbable components of the device, there is internal growth of the tissue into the device, which can restrict the elasticity of the post-implantation device. The resulting device, with internal tissue growth, is more elastic and flexible than the structured screen or the frames made from the structured screens.
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Increased flexibility and elasticity are a significant benefit over mesh implants.
[0077] The present invention can be useful as an implantable device for supporting or treating body tissue. The implantable device can be used as a tissue framework implant, which can be used to reinforce tissue structures or to stimulate new internal tissue growth to increase the presence of volumetric tissue in a specific region of the body. In some embodiments, the implantable device can be attached to a specific body tissue surface, including, for example, the pelvic floor, one or more tendons, bladder or breast, or it can be used to help treat illnesses, such as urinary incontinence. exertion, hernia and other similar illnesses involving injured or compromised tissue. The implantation of the implantable device can be achieved through any standard and desirable means, including, for example, through the use of adhesive fixation, such as fibrin, or surgical fixation, such as by suturing or stapling. In some embodiments, the implantable device can be attached in a location without any external means of attachment, such as when used as a packaging material in a confined space or pocket where friction holds the device in place. The implantable device must be secured sufficiently so that it remains implanted in the intended location for a period of time sufficient to allow the internal growth of the tissue to develop throughout the device, in which the internal growth helps or ensures that the device is well stuck. The fixation must be sufficient to keep the implantable device implanted at the implantation site for at least one week, at least two weeks, at least one month, at least two months, at least six months or at least one year.
[0078] After implantation, fibrin fixation and growth
40/74 internal of the actual fibroblast can begin within seven to about fourteen days. Over time, the absorbable components will biodegrade and be absorbed by the body and the areas that contained these absorbable components will be filled with new internal tissue growth. Since the resulting non-absorbable components have an undiscernable configuration and are present in such a small amount in the implantable device, as the absorbable components disappear, the remaining materials in the device are not substantially felt by the user. This results in a resulting implantable device that provides support and a place for internal growth, but which is also comfortable for the user and provides a tactile sensation similar to the most natural tissue.
[0079] The mass of the implantable device can be any level that is sufficient to allow the internal growth of the tissue in the device and, thus, results in the predominant composition being newly formed tissue. In some embodiments, the weight of the area before absorbing the absorbable materials in the implantable device can be from about 47 g / m2 to about 152 g / m2, and the weight of the resulting area after absorbing the absorbable materials in the device can be from about 12 g / m2 to about 40 g / m2. In modalities in which there is a greater amount of absorbable material than non-absorbable material (for example, about 10x both absorbable material and non-absorbable material in the device, by weight), the ratio between the weight of the area before absorption and the weight of the area after absorption can increase significantly. It is desired that the weight of the area after absorption is about 25% or less than 25% of the weight of the area before absorption. This is a marked improvement over other devices in which there is a higher amount of structured non-absorbable material in the implant.
[0080] The implantable device must also have a porosity
41/74 adequate to allow the initial internal growth of the tissue after implantation, and the implantable device must be a breathable material that allows air to pass through your body. Pores can extend over the entire thickness of the device, if necessary. The porosity of the resulting implantable material can be changed depending on the density of the starting material and how loose the initial weave is in the initial woven structure. In general, the looser the initial weave (for example, the greater the spaces between rows and rows), the lower the density of the resulting implantable device. It is understood that areas where absorbable materials have been contained will be at least partially filled with newly developed tissue during and after the absorption of absorbable materials in the device. [0081] The implantable device may include additional components, such as assets dispersed over or within the device, or the device may also be a drug carrier, coagulant or cell release / growth. The active components can be useful in treating illnesses or in releasing these active components for general healing. Radio-opaque elements or markers can be included in the non-absorbable components of the implantable device to assist with implantation and placement of the implantable device. The implantable device may additionally include one or more markers for identification, such as stained sections or other symbols to assist with implantation. The implantable device can include one or more additives that accelerate or delay the degradation and absorption of absorbable materials in the implantable device and can include encapsulation materials. Other useful and known components can be included in the implantable device, including, for example, nutrients, proteins, growth factors, body cells and tissues, immunomodulators, inflammation inhibitors, regression factors, components to increase or restrict growth of
42/74 fabric and other substances.
[0082] The present invention also relates to methods of tissue repair and augmentation using the implantable device described above. The implantable device described above is prepared and can then be implanted in the body by a user. The implantation site is any desired site on the body, including, but not limited to, tendon repair sites, pelvic floor repair, stress urinary incontinence repair or hernia repair. The implantation site can be a site for providing supportive applications, such as bladder support or breast implantation. Alternatively, the implantation site can be a site to provide any tissue volume formation, tissue augmentation, cosmetic treatments, therapeutic treatments or in general as a tissue seal or support device.
[0083] The method of repair or augmentation of body tissue can be obtained during surgery to repair or augment tissue. The implantation site is first determined, and based on the site and access to the site, the size and shape of the implantable device to be used can be determined. The implantable device could be sized and shaped to suit the specific geometry and dimensions of the tissue portion to be treated, and it should also be sized and shaped to allow access through a surgical opening or other body opening. The implantable device can optionally be sized and shaped by a user before implantation, such as by cutting, flexing or otherwise manipulating the implantable device before implantation.
[0084] After access to the desired anatomical site is obtained (whether by injury, surgical technique or any other means to provide access), the implantable device can be attached to the desired location. The implantable device can be attached through which
43/74 either by desired means, such as by means of chemical or mechanical fixation. Chemical media can include adhesives, such as glue or fibrin clot or other biologically compatible adhesives. Mechanical fixing means include, for example, sutures, staples, fabric tacks, anchors, darts, screws, pins and arrows. Combinations of chemical or mechanical attachment means may be useful, if desired. In some cases, the implantable device may fit into an opening, so that friction is used to hold the implanted device in place. For example, in embodiments where the device has an amorphous shape and configuration, such as a loading material, the device can be fitted into an opening to fill the opening.
[0085] After implanted in a safe and adequate way, the surgical site can be closed, if it is necessary to close. If necessary, the implantable device can be removed and replaced at a different site, for example, if it is determined that the implantable device has been improperly implanted. Once implanted in the site and allowed to begin absorption within the body, as a result of the normal healing process of the body, the body tissue grows in and around the implantable device, and matures to form a tissue with mechanical properties similar to those of native tissue. The mechanical nature of the implantable device also serves as a guide for tissue regeneration after implantation. In tissue augmentation methods, for example, the presence of an implantable device guides the new tissue to growth and development sites. The new tissue grows around the periphery of the implantable device, but it also grows within the open pores of the implantable device in order to fully incorporate the implant.
[0086] As the implantable device includes absorbable materials, and, in particular, includes more absorbable material than non-absorbable material
44/74 absorbable (by weight), after implantation, the absorbable material in the implantable device begins to degrade and is absorbed by the body in which it is implanted. Although the absorption process begins immediately after implantation, the absorbable material in the device begins to degrade noticeably and is absorbed by the body after a desired period of time, for example, after about a day, after about a week , after about two weeks, after about a month, after about two months, after about six months or after about 1 year. The rate of degradation depends on the materials used in the device and the amount / density of those materials in the resulting implantable device. Methods to increase the rate of degradation, such as radiation exposure, can be used after implantation to increase the rate of absorption. As used here, the term perceptibly degrade refers to the material being degraded and absorbed to a sufficient extent that the level of degradation would be detectable. The speed and level of degradation of the implantable device can be determined by bench hydrolysis testing (laboratory) or can be determined using invasive or non-invasive means after the device is implanted.
[0087] After the desired period of time and after the noticeable degradation has occurred, the implantable device includes a certain degree of structure and mechanical strength, but a portion of the absorbable material has been replaced with new tissue. Due to the unique three-dimensional orientation of the absorbable and non-absorbable fibers revealed above, after noticeable degradation and absorption, the implantable device results in a material having a continuous surface, thus causing fibroblasts and other tissues to develop differently from the that they would develop into a typical canvas construct. In a typical open weft product,
45/74 fibroblasts grow along each fiber of the mesh and then through the pores of the mesh before growing through the thickness of the mesh. As body tissues grow, they can reach short distances and create a fibrous layer on either side of a mesh implant. This can be seen in animal studies where typical mesh implants are extracted during initial time points, such as 7, 14, or 21 days. On the other hand, in the device of the invention, the connection and integration of the tissue along the pores of the mesh and the thickness of the mesh are greater as the time period increases, providing improved internal tissue growth and sustainability and allowing a more effective implant over time.
[0088] At the time of implantation, the implantable device has a contiguous web of a thread or threads, including at least one non-absorbable fiber and at least one absorbable fiber, in which the initial contiguous web extends across all three planes. In the resulting implantable device, the thread (s) including a non-absorbable fiber has (have) a first orientation, which is described as being a randomly uniform non-structural matrix. The first orientation is caused due to the deformation and shrinkage (and heat conformation) of the melted absorbable material, thus creating the appearance of an unoriented random structure. As the body begins to heal, new tissue begins to grow in and around the device. At the same time, the absorbable filament of the implanted device begins to degrade and be absorbed by the body. After this degradation and absorption of the absorbable fibers, the implanted device will develop open spaces due to the empty space created by the degradation and absorption. Simultaneously, during the curing process, spaces that have been filled with absorbable material are filled with new tissue.
[0089] During the early stages of internal tissue growth
46/74 of the initial absorption of the absorbable fibers, the implanted device substantially maintains the first orientation of the non-absorbable fibers. The implanted device substantially maintains the first orientation of the non-absorbable fibers for at least about a week, two weeks, a month, six months or a year. In some embodiments, due to the internal growth of the tissue, the implanted device will substantially maintain the structure and orientation of the non-absorbable fibers as they were present in the resulting implantable device. In some embodiments, due to the internal growth and the concomitant absorption of the absorbable fibers, the resulting orientation of the non-absorbable fibers can be random and they can be compacted or expanded due to the forces conferred by the new tissue.
[0090] As the internal growth of the tissue continues, and the absorbable fibers continue to be absorbed and degraded, the new tissue can begin to move. This movement of the tissue is due to normal physiological conditions. Due to this movement and stretching, the initially hydrolyzed implanted device (which now has fewer absorbable fibers than when it was implanted due to hydrolysis and absorption) may begin to adopt a second orientation. The second orientation is due to the movement of the fabric, forcing the non-absorbable fibers to be displaced. In this second orientation, the non-absorbable fibers provide little or no resistance to the movement of the fabric, which is due to the random matrix of the permanent non-structural material. As absorbable fibers begin to be absorbed, the possible reconformation of the implanted device occurs due to tissue contraction and / or tissue remodeling. The contraction of the tissue occurs during the healing period and may be due to the safety of the implant in the implantation or growth of the fibroblast on the surface that was observed in some animal tests
4ΊΠ4 for test and control articles. Tissue remodeling takes place over a longer period (for example, around 6 months). Tissue remodeling is a weakening or a return of the newly formed scar tissue to a state similar to that before the injury or surgical intervention. If the implanted device includes only absorbable fibers, remodeling the tissue may result in a need for future tissue repair in the same area. However, due to the addition of non-absorbable materials to the device of the invention, tissue remodeling does not occur due to the presence of a foreign body (i.e., remaining non-absorbable fibers). For this reason, the device of the invention includes at least some non-absorbable fibers, but the level of non-absorbable fibers is minimal and non-structural, in order to allow for the desired internal growth and flexibility.
[0091] Over time, the implanted device may adopt additional guidelines due to the continued growth and stretching of the new tissue, depending on the strength of the tissue. If a non-absorbable fabric material is used in a layered configuration with the implantable material of the invention, there may be less flexibility after absorbing the absorbable materials. In cases where there is no additional mesh material and the implant includes only the implantable device of the invention described here, there will be greater flexibility and movement after absorption, and the resulting site will be more similar to the tissue. Because natural body growth and movement inherently result in tissue movement and tissue growth, the random, unaligned, non-structural deformed orientation of the fibers in the implant provides a more flexible and tissue-like environment than an implant constructed from a non-mesh absorbable or containing a mesh, even if the component of that mesh initially had the ability to flex. In short, the device of the invention provides a significantly improved im48 / 74 plant over time, allowing not only enhanced internal strength and growth, but also added flexibility and a feeling of greater comfort.
[0092] After a desired period of time post-implantation (depending on the specific absorbable fibers used in the implantable device), which can be at least about a week, at least about two weeks, at least about a month, at at least about two months, at least about six months, at least about 9 months or at least about 1 year, the absorbable fibers in the implanted device are substantially degraded and absorbed by the body. After the desired period of time after implantation, such as at least about three months, at least about six months, or at least about one year, the implanted device is substantially free of absorbable fibers and consists essentially of non-absorbable fibers and new tissue growth in it. Although complete absorption of absorbable fibers is desired, minimal amounts of absorbable fibers may remain (for example, less than about 1% of their initial amount, less than about 2% of their initial amount or less than about 5% of their initial amount). initial amount), but the device essentially consists of non-absorbable materials and new tissue.
[0093] The device can remain in the body for any desired period of time and can remain in the body for the life of the user. It is understood that the remaining portion of the device is integrated into the user's body to a sufficient degree so that it can remain within the body, making removal unnecessary. The newly grown tissue in and around the device's non-absorbable fibers provides desired support and resistance to the implantation site.
[0094] In summary, as explained above, in general, the device
49/74 implantable is a woven device that includes non-woven features and is a non-woven device that is unique in that it is a felt-like material. The invention features a structural device having a reasonably uniform appearance upon implantation and prior to degradation of absorbable components, however, it is constructed so that the non-absorbable component initially loosely woven is non-structural and expandable (ex vivo) after the fibers absorbable parts of the device have been hydrolyzed. However, after the absorption is complete and the tissue grows in and around the device, the non-absorbable component is similar to the tissue.
[0095] This exclusive device can be created through the processes presented above and, in a specific modality, training is a multi-step process. First, the user selects the blend of absorbable and non-absorbable fibers from which to form the filaments in the device. The filaments can include only one fiber, or they can include several bonded fibers, where each fiber can be the same or can be different. The device must include at least one absorbable fiber and at least one non-absorbable fiber, although individual fibers forming the device may be solely absorbable or non-absorbable. For example, useful materials include polypropylene fibers, PDS and polyglactin 910. The number or weight of the specific fibers used in each yarn and the number of yarns used to make the final resulting device can be modified, as desired, and in preferred embodiments, the device includes at least one polypropylene fiber, at least one PDS fiber and at least one to about 15 polyglactin 910 fibers. Various combinations of materials and ratios can be used, as explained above.
[0096] After the polymers that form the fibers are selected and the quantities of each fiber are selected, the individual filaments (monofiber or multifiber) form a yarn, which is desirable
50/74 a twisted filament, which may be a twisted bundle of fibers. The yarn can be formed by any desired means, including simple crimping steps, or alternatively the filaments can be woven into a tightly woven sock or blade using a round weaving operation, and then the mesh sock or blade can be unwound to supply the twisted filaments (threads). Each yarn can include several combinations or components, as explained above, for example, each yarn can include more than one type of filament, and each filament can include more than one type of fiber. Multiple socks or blades or threads may be used in forming the device, and each sock or blade or thread may include combinations of absorbable and non-absorbable components. It is also desirable that at least one thread be used to form the device, and it is additionally desirable that at least one absorbable fiber and at least one non-absorbable fiber be used.
[0097] From the threads, an initial loose mesh or weft structure is prepared. The initial loose structure can be of any size or shape, as explained earlier. The initial loose structure is then subjected to at least one heating step and most desirably two heating steps. The first heating step is at a temperature that is at or slightly below the melting point of the fiber that has the lowest melting point in the device (the first fiber or first absorbable fiber. The first heating step shrinks the first fiber, causing deformation of the remaining fibers and forming an initially deformed structure (for example, a thermal shrinking step). After this first heating, the initially deformed structure is subjected to a second heating step, which is at a temperature at or above the point melting of the first fiber in the structure. The second heating step is described in more detail above, and is
51/74 sufficient (both in temperature and duration) to melt the first fiber to a degree sufficient to cause the melted portions to bond with the remaining fibers in the structure. The resulting material is cooled, either in the same device used to heat the structure or after removing the heating structure, forming the resulting implantable device. The resulting implantable device can be implanted as desired.
[0098] The size of the heated space defined, particularly, during the first heating step, is related to the type of absorbable fiber, quantity or number of fibers combined and denier of the fibers used in the loose weave. The size of the defined heating space can be another factor in determining the final density of the resulting material as well as the flexibility of the resulting material. In general, a wider defined space allows more freedom in the movement of the material, allowing the shrink fibers captured in the weave to have a greater possibility of contraction (reducing the frictional resistance) and, thus, pulling larger amounts of absorbable and non-absorbable fibers to within the defined heated space. In contrast, a smaller defined heated space will increase the frictional resistance to movement, thus restricting contraction and resulting in less fibers being pulled and reducing the density of the resulting material. The size of the heating space defined in the first heating step can thus be modified to provide different levels of shrinkage and ultimately consistency in density and flexibility of the resulting implantable device.
[0099] The second heating step can be modified to increase or reduce the material's resistance properties, such as by applying compression during the second heating step. Not using compression can provide a softer, more flexible semi-structural material that may be suitable for densification
52/74 or filling the space within the body where minimal strength of the structure is required. However, compression during the second heating step can be used to compress the material during the heat forming stage and give it a defined structure and orientation. Compression offers at least two benefits: first, it fuses at least one fiber or bundle to connect all adjacent fibers through fusion and pressure trapping; and second, it can create any desired shape by compressing the material into a defined cavity under heat and pressure for a defined heating and / or cooling cycle. The resulting implantable device may have a range of tensile strength and flexural strength, as well as defined shapes that, when stored in a controlled environment, such as in a sterile package or under nitrogen, will retain their material properties.
[00100] The resulting implantable device can be used immediately after formation or can be stored in a sterile environment. The device can be sterilized before packaging or before implantation. In addition, the implantable device can be sized and shaped to a desired size and shape and packaged in a larger size to allow the end user to scale and conform to the device, as needed. The sterile and substantially fluid and air proof packaging is important to prevent premature hydrolysis of the absorbable fiber (s) in the device. When the device is ready to be implanted, the user, typically a doctor or assistant, opens the sterile and fluid-proof package and sizes and / or deploys the device, as explained above. In modalities in which the device is a semi-structural, flexible, softer material, which may be suitable for densifying or filling the space within the body where minimal resistance or structure is required, the user can remove only the
53/74 amount needed to fill the empty space inside the patient's body.
[00101] As explained earlier, the device of the invention can be used for any number of uses and any number of formats, including, for example, repair applications such as tendon repair, pelvic floor repair, stress urinary incontinence repair hernia repair; supportive applications, such as support for the bladder or breast implant; formation of tissue volume or general tissue filling; increased tissue; cosmetic treatments; therapeutic treatments; as a device to control uterine bleeding; or generally as a tissue repair or sealing device.
[00102] In one embodiment, the device can be used to control uterine bleeding. In this use, the invention can be used to create adhesions within the uterus, which results in the closure of the lower part of the uterus and ends with monthly bleeding. The method includes providing an instrument to prepare the area for implantation, how to increase it to a suitable diameter and activate the endometrium. The method, then, includes providing an implantation of an implantable device in the upper cervical / lower uterus area. The device of the invention, as explained above, includes a combination of absorbable and non-absorbable components, can be used as the implant and, in particular, the device of the invention can be prepared in a cylindrical shape having a diameter related to the size of the neck of the uterus in which it will be implanted. The cylinder can be formed by rolling a flat ribbon of the material of the invention and then pressing to obtain the desired density to create the necessary compression forces to remain as positioned and be effective or simply by preparing a cylindrical shaped device. The device may include a suture or sutures that
54/74 extend along the axial length of the cylinder, where the cylinder has at least one slot, and may include two slots, four slots or more and pulling the filament or filaments compresses the cylinder (for example, pulling a first end towards to a second end) after implantation to provide a firmer fit. A disk or plate can be attached to counter upward movements. An applicator can be used to implant the device.
[00103] The resulting device can be used to create a urethral brace that has an immediate effect when placed, thus reducing the risk of perforation of the bladder and having less foreign material left behind. In this modality, the implantable device can be placed in the connective tissue of the urogenital diaphragm or internal muscle for a strong initial fixation of the implant. The cross-sectional area can be circular or rectangular or elliptical and can change along the length of the implant. The implant part in the area below the urethra can be flat. The ends of both ends can be stiffened by pressing or melting the fleece material with heat. A suture can be fixed inside the fused tip, inside the fleece cylinders or it can be fixed to the insertion instrument. The insertion sticks or applicator can also be used so that the device reaches the implantation site effectively. The applicator can retain the device internally or externally through a variety of application means. This would allow the implant to be pulled back. The ends of the implant can be very rigid and can be drilled or cut to any shape necessary to increase initial fixation to the tissue. The implant aims to penetrate the connective tissue of the urogenital diaphragm or the complex obturator, which includes the external, internal obturator and membrane. It can alternatively be located near or in contact
55/74 with the pubic bone. Fixation can be achieved by using a means of affixing, such as paste, adhesives, anchors or compression on the connective tissue in that area. The application of adhesives can be performed through a lumen inside the device, applied or expelled through an opening or through pores in the implant. The patch, if used, can be permanent or absorbable.
[00104] The device can be used as a barrier between a mesh implant and tissue, as an implant for SUI or any other device using a mesh implant. The device thus creates a new layer of tissue that serves as a barrier between the mesh and the wall of the vagina. This can limit or prevent erosion or exposure of the network, reduce future pain and post-operative corrective surgery. In addition, it may be useful to implant the material of the invention between a mesh or the outer wall of the vagina and the urethra to allow more pressure to be applied to the urethra. It can be a separate device positioned by hand, it can be pre-attached to the mesh device prior to implantation or it can simply be applied with tweezers placed under the tissue before suturing the mesh in place.
[00105] The device can be used as a preformed implantable external device for moderate SUI, such as external volume formation. This modality places the volume formation externally to the urethral muscle and has a compressed nature in the middle urethra. The implant can be used in such a way that it does not penetrate the urogenital diaphragm, but is instead placed below and / or around the middle urethra using only the surrounding tissue as an initial support to maintain the torsion effect or external volume formation. In some embodiments, the material of the invention can be used in an implant, the implant having a first end, a second end, a central section in which the first and second end or the central section can be made of the material of the
56/74 invention. In this embodiment, the first and second ends can be sized and shaped to be suitable for implantation on either side of the urethra to provide support for the urethra. The immediate correction of SUI is created by compression of the urethra due to the volume formation device of the external urethra, while the internal growth of the final tissue will create the permanent structure supporting the urethra. In this modality, both terminal zones of the device can be placed, or affixed, in contact with the lower edge of the pubic bone to create new strips of permanent tissue for the long-term correction of SUI. The preformed external device for IUE can be formed in a V or U shape, and the first and / or second ends can have a smooth or textured surface. The cross-sectional area can be circular or rectangular or elliptical and can change along the length of the implant. In addition, the implant center can be flattened, if desired. The implant can be applied between the middle urethra and about one third of the distance from the bladder neck.
[00106] In some embodiments, a method for treating stress urinary incontinence may be provided, which may include the steps of making an incision in the anterior wall of the vagina and placing the material of the invention in a location between the outside of the urethra and the outer surface of the vaginal canal. In these embodiments, the material can be in a folded or elongated shape, or it can be in an undefined amorphous shape, or it can be in a spiral shape before or after insertion. The incision can be made at any desired location and proximal to the location of the middle urethra. A small degree of dissection of the tissue plane can be done at the place where the material of the invention is to be placed.
[00107] The implantable device can be used for plastic surgery, for example, to fill defects, such as cavities under the
57/74 skin created by natural or surgical removal of tissue. This creates a permanent filler to correct the defect initially and with soft natural visual properties with a long-term effect. This modality additionally provides for the use of a cosmetic adjustment to increase facial cheeks, remove expression lines or other cosmetic needs in the form of a strip, ball, spring, tampon, or particle, in which the particle shape is created by cutting the material from the resulting invention in small pieces, so that the cut material is extremely formable under the skin to eliminate visualization of the outline of the implant. Due to the dry nature of the particles and the adhesive properties of the material, the internal growth of the fabric binds the particles, thus reducing the spread of the charge beyond the placement site, which often happens with liquid or gel fillers.
[00108] The implantable device can be used for the treatment of SUI, where during surgical treatment with the brace, some patients with SUI are not cured because they are completely dry, and therefore a secondary treatment, such as volume formation is necessary . The device of the invention can be used for secondary treatment instead of swelling to make external compression in the urethra by compacting the material in the area between the urethra and the previously placed brace. Due to the linear construction of the material, it is less likely to migrate. The material can be compacted into the fabric or removed if necessary for immediate suitable result. The device may be in the form of strips, and held on a spool. The device can be pressed to a desired opening by hand or by forceps.
[00109] If the device is used to repair the pelvic floor, for example, the vaginal canal can be opened and the device of the invention inserted. For vaginal prolapse, the material of the invention can
58/74 be installed between the outer wall of the vagina and the surrounding structures. The device can be used as the material of the invention or in conjunction with a net. A vaginal splint or other fixation device can be used to hold the vagina in its anatomical position until sufficient internal growth has occurred.
[00110] If used for repair or breast augmentation, for example, a bag similar to a lightweight flexible pouch can be used to allow insertion of the implant. The effect is to reduce or eliminate the movement of the breast implant during the healing and contraction phases of normal tissue in this surgery. Similarly, a bag can be used to repair and / or support soft organs, such as the bladder. In addition, due to its non-structural matrix of contiguous non-absorbable fibers, the device of the invention may be suitable for tissue repair in children who are not yet fully developed.
[00111] In another embodiment, with the application of a film or barrier on one side of the implantable device, such as PDS, the invention can be used with or without biological agents for hemostatic control or as a tissue repair device that has properties of tissue separation to prevent unwanted adhesion of the repair site to the surrounding tissue. The device can be formed in various shapes or configurations to serve as a separating fabric to prevent unwanted adhesions to the surrounding fabric.
[00112] Other modalities include the use of implantable material in a straw-like form having a central lumen, which can be reformatted secondarily to close the ends or create openings.
Examples
Example 1 - Testing the material after implantation in 7, 14 and 28 days [00113] A study was conducted to test the extraction force of the material of the invention after implantation in rabbits. Samples of
59/74 material of the invention (including polypropylene fibers, polyglactin 910 and polydioxanone processed using a 2.35 mm heating span) and a control material (Gynemesh ®, a soft non-absorbable polypropylene mesh implant) were implanted in rabbits. Two implants of different sizes were used for each of the inventive material and the control. The small implant was a 1.5 cm x 1.0 cm slide covered by a 1.0 cm x 1.4 cm polyethylene sheath so that a 0.5 cm x 1.0 cm section was uncovered. The large implants were 2.0 cm x 1.0 cm in size covered by a 1.0 cm x 1.4 cm polyethylene sheath so that a 1.0 cm x 1.0 cm section was uncovered. The sheath and implant materials were ultrasonically welded. The sheath blocked or limited internal tissue growth above the plane of the tissue and provided a place to hold the construct for testing after in vivo exposure. Two rabbits were assigned to each of the three time points and six implants were made in each rabbit in the paravertebral musculature on each side of the back. The control implant was placed on the left side and the implant of the invention was placed on the right side.
[00114] After the desired post-implantation time, the extraction test was performed using forceps to hold the lung and a 10 lb (50N) force gauge. The results are shown in Table 1, below: I - large is the sample of the invention, large size; Big C is the control sample, big size; I - small is the sample of the invention, small size; and C - small is the control of the invention, small size.
Table 1
Extraction Force (N (lbs)) Time after implantation Dice I - great C - large I - small C - small 7 days Average 4.85 (1.09) 2.4 (0.53) 1.5 (0.34) 0.62 (0.14)Standard deviation 2.2 (0.49) 1.6 (0.35) 1.0 (0.23) 0.2 (0.05) 14 days Average 10.0 (2.25) 9.83 (2.21) 6.63 (1.49) 5.29 (1.19)Standard deviation 5.38 (1.21) 4.2 (0.95) 1.5 (0.33) 0.3 (0.07) 28 days Average 2.6 (0.59) 10.5 (2.37) 1.5 (0.34) 4.0 (0.91)Standard deviation 0.53 (0.12) 0.89 (0.20) 0.62 (0.14) 0.67 (0.15)
60/74
[00115] 7 days after implantation, the material of the invention exhibited greater internal growth / fixation compared to the control for both sizes, as reflected in a resistance force twice greater to extract the test articles. All tested articles were extracted intact from the tissue during the test. The initial differences in the extraction / fixation force of the fabric can be explained by the area of surface contact with the fabric being greater for the material of the invention than the control due to the textured contour of the former and the open weft structure of the latter. In addition, it appears that there was equivalent structural stability at the time of implantation between the material of the invention and the material of the control (not shown in Table 1, but based on the other tensile test results showing similarity in profile by design), and yet there was twice as much tissue fixation providing resistance to movement between I (large) and C (large) in 7 days.
[00116] At 14 days after implantation, the force values obtained within the Large and Small article groups were closer to each other than at 7 days. This comparable apparent resistance to extract could indicate an acceleration of internal tissue growth for control. However, the behavior of the different articles during the test suggests that the material of the invention actually had a better integration at that point in time. The material of the invention was either extended during testing or completely separated at the tissue interface, leaving behind the internal growth portion of the test article in the tissue. All control articles were completely extracted from the tissue (after attenuation) at the same strength value.
[00117] Beginning 14 days after implantation, the strength of the internal growth was greater than the structural intensity of the absorbable test materials as expected, therefore, the separation of the material
61/74 al during the test. The extraction force aspect is used for relative measurement of the degree of internal tissue growth instead of an extraction resistance measurement from a performance perspective as this material / device would never be extracted from the fabric in this way.
[00118] Within 28 days after implantation, all structural components of the fibers of the material of the invention were degraded above the fabric plane and integrated into the fabric below the fabric plane. Large control articles broke at an average force comparable to the force to separate large I articles in 14 days and not significantly greater than the extraction force of large control articles in 14 days. All the materials of the invention in both animals were worn or separated at the sheath / tissue interface resulting in lower extraction values than in 14 days. The test behavior indicates that the portion not protected by the sheath was well integrated into the tissue.
[00119] It is believed that the material of the invention (large) is a more representative test model than the small test. As can be seen in Table 1, material I (large) obtained 48% (4.85 N (1.09 lbs)) of its final 10.0 N (2.25 lbs) in 7 days compared to 14 days , while the control network C (large) only obtained 24% (2.4 N (0.53 lbs)) of its final 9.83 N (2.21 lbs) in 7 days compared to 14 days. The material of invention I (large) obtained 98.2% (10.0 N (2.25 lbs)) of extraction force in 14 days compared to 10.5 N (2.37 lbs) obtained by control C (large) in 28 days.
[00120] As can be seen in the table above, the insertion and extraction values after 28 days of the material of the invention (large I) demonstrate a lower extraction force. This demonstrates the non-structural nature of the implantable device after the absorbable fibers are degraded after 28 days. There is less extraction force
62/74 or equal to the 7-day control (using Gynemesh as an implant). These data demonstrate that when degradation occurs and absorbable materials are replaced by tissue fiber, the implant is stable and, if degradation should occur without tissue integration, the implant must not have structural integrity and the resulting hydrolyzed material would have a expansion profile larger than the initial non-hydrolyzed implantable device. This further separates the material of the invention from the devices that use or integrate a network in which the network itself provides the structure to the implanted region.
Example 2 - Test of area weight, amount of non-absorbable material and strength of materials
Preparation of the initial woven structures
[00121] Three implantable materials were prepared, each with varying amounts of absorbable and non-absorbable materials. The entire mesh was produced using the Alveolar Buffering processing parameters, except the updated loop sizes for determined pre-tests of flat interlacing and shown below. For Alveolar Tamponamento, two of the same interlaced tubes (socks) were produced first. Both tubes were then deinterlaced in parallel and the resulting twisted filament yarn was flatly interwoven like a loose initial woven structure. The filaments used to produce the materials included Vicryl®, which was dyed to show a purple color, PDS and polypropylene. Sock A was produced with a first absorbable material and a second absorbable material. Sock B was produced with a first absorbable material, a second absorbable material and a first non-absorbable material. Sock C was produced with a first absorbable material and a second non-absorbable material. Each tube was produced using one of the three material ratios, shown in Table 2:
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Table 2 - Material ratios in knitted socks
Half A Sock B Half C 5 parts Vicryl®, 28 denier 5 parts Vicryl®, 28 denier 5 parts Vicryl®, 28 denier 1 part PDS, 30 denier 1 part PDS, 30 denier Without PDS Polypropylene free 1 part polypropylene, 60 denier 1 part polypropylene, 60 denier
[00122] Knitted stockings were then unrolled providing filaments of twisted yarn. The threads were prepared from these filaments. Threads A, B and C, each included the materials and ratios shown in Table 2 above. Using these three threads, three different loose initial weft structures (wipes) were prepared. The interweaving parameters of the initial woven structures 1, 2 and 3 are shown in Table 3 below. The raw material content of the three initial woven structures is shown in Table 4 below. Finally, the raw material ratio is shown in Table 5 below. Table 3 - Interweaving parameters of the initial woven structures 1, 2 and 3
Structure No. First wire Second wire Flat interlace loop size Minimum scarf length Initial Woven Structure 1 Reason A Reason B 12.5 350 mm Initial Woven Structure 2 Reason B - 12.5 400 mm Initial Woven Structure 3 Reason A C ratio 14 350
Table 4 - Raw material content of Initial woven structures 1,2 and 3
Structure No. No. of Vicryl fibers (28 denier) No. of PDS fibers(30 denier) No. of polypropylene fibers (60 denier) Initial Woven Structure 1 10 (280 denier) 2 (60 denier) 1 (60 denier) Initial Woven Structure 2 5 (140 denier) 1 (30 denier) 1 (60 denier) Initial Woven Structure 3 10 (280 denier) 1 (30 denier) 1 (60 denier)
Table 5 - Raw material ratio of the initial woven structures 1, 2 and 3
Structure No. Absorbable to non-absorbable ratio Total Denier Initial Woven Structure 1 5.7: 1 400 Initial Woven Structure 2 2.8: 1 230 Initial Woven Structure 3 5.2: 1 370
[00123] As can be seen, the Initial Woven Structure 1,
64/74 includes a combination of two different threads: Thread A (a first and second absorbable material) and Thread B (a first and second absorbable material and a first non-absorbable material). Initial Woven Structure 2 includes a thread: Thread B (a first and second absorbable material and a first non-absorbable material). Initial Woven Structure 3, includes a combination of two different threads: Thread A (a first and second absorbable material) and Thread C (a first absorbable material and a first non-absorbable material). The number of fibers in each material is varied, and the resulting ratio of the absorbable and non-absorbable material is presented above. Structure Woven Initial 1 includes the highest amount of absorbable material compared to non - absorbable material and two times the PDS ratio used to shrink / twisting loose knitting in one heating step as compared to the woven structure Initial 3, and Initial Woven Structure 2 includes the least amount of absorbable material compared to non-absorbable material.
Heating of the initial woven structures
[00124] The Initial Woven Structures, as prepared above, were made on three 130 mm x 130 mm sheets submitted to the first heating step of 103 ° C and the second heating step to 105-120 ° C, and each sheet was then cut into 6 strips to test the density consistency for each sheet. Each sheet was then evaluated according to the protocol, including thickness measurements taken at 3 locations on each strip to assess shrinkage consistency in several spans away from the first heating, in which the first heating was conducted in approximately 103 ° C for about 20 seconds. Shrinkage was achieved by placing slides of Initial Woven Structures between two plates at a predetermined span size between plates. The test was conducted in different span sizes: 2.35 mm, 1.85 mm and 1.35 mm. The
65/74 resulting materials are called Initial Heated Structures. Subsequently, after shrinking, the Initial Heated Structures were then subjected to a second heating. The second heating was obtained using plates heated to a span distance of 0.9 mm, for about 120 seconds and at temperatures of 105 ° C or 120 ° C.
Weight of the resulting heated structures
[00125] Using the final resulting strips, the average weight measurements were determined for each slide and are reproduced in Tables 6A, 6B and 6C below.
Table 6A - Measured weight of the strips of the resulting structure 1
Gap: 2.35 mm Span: 1.85 mm Span: 1.35 mm Blade No. Weight (g) after second heating (105 ° C) Weight (g) after second heating (120 ° C) Weight (g) after second heating (105 ° C) Weight (g) after second heating (120 ° C) Weight (g) after second heating (105 ° C) Weight (g) after second heating (120 ° C) 1 0.642 0.683 0.525 0.533 0.452 0.462 2 0.692 0.653 0.537 0.547 0.470 0.453 3 0.642 0.627 0.540 0.542 0.462 - Weight (g / m ² ) 274.31 272.69 222.45 225.23 192.13 190.63
Table 6B - Measured weight of the strips of the resulting structure 2
Gap: 2.35 mm Span: 1.85 mm Span: 1.35 mm Blade No. Weight (g) after second heating (105 ° C) Weight (g) after second heating (120 ° C) Weight (g) after second heating (105 ° C) Weight (g) after second heating (120 ° C) Weight (g) after second heating (105 ° C) Weight (g) after second heating (120 ° C) 1 0.382 0.375 0.325 0.323 0.268 0.265 2 0.363 0.375 0.318 0.317 0.250 0.255 3 0.355 - 0.320 - 0.257 - Weight (g / m ² ) 152.78 156.25 133.80 133.33 107.64 108.33
66/74
Table 6C - Measured weight of the strips of the resulting structure 3
Gap: 2.35 mm Span: 1.85 mm Span: 1.35 mm Blade No. Weight (g) after second heating (105 ° C) Weight (g) after second heating (120 ° C) Weight (g) after second heating (105 ° C) Weight (g) after second heating (120 ° C) Weight (g) after second heating (105 ° C) Weight (g) after second heating (120 ° C) 1 0.433 0.477 0.400 0.387 0.342 0.343 2 0.445 0.455 0.380 0.378 0.347 0.348 3 0.427 0.447 0.393 0.395 0.345 0.345 Weight (g / m ² ) 181.25 192.82 162.96 161.11 143.52 143.98
[00126] As can be seen, there was a statistical difference in the weights of the blade when compared by type of material and size of the span of the heating plates. The weight of the blades was lower in Resultant Structure 2, then increased in Resultant Structure 3, and finally, it was higher in Resultant Structure 1. This was expected due to the content of the physical material and the ratio of the components. In addition, the weight of the strip increased as the gap size increased, which reflects more material fitting into the gap space during shrinkage. That is, with a larger span space, there is no more space for the material to accumulate. The impact of the temperature variation did not show a statistically significant difference for the sizes of the structures and spans.
Thickness of the resulting heated structures
[00127] Using the blades, as heated above, the blades were cut into 6 strips and each strip was measured at 3 locations; the average thickness measurements were determined and are reproduced in Tables 7A, 7B and 7C below.
67/74
Table 7A - Measured strip thickness of the resulting structure 1
Gap: 2.35 mm Span: 1.85 mm Span: 1.35 mm Blade No. Thickness (mm) after second heating (105 ° C) Thickness (mm) after second heating (120 ° C) Thickness (mm) after second heating (105 ° C) Thickness (mm) after second heating (120 ° C) Thickness (mm) after second heating (105 ° C) Thickness (mm) after second heating (120 ° C) 1 750.4 709.2 732.9 700.1 703.2 673.1 2 779.1 669.3 742.6 692.5 699.8 671.5 3 747.5 714.6 728.4 694.3 712.2 - Weight (g / m ² ) 759.0 707.7 734.6 695.6 705.1 672.3 Table 7B - Med thickness outward strips resulting texture 2
Gap: 2.35 mm Span: 1.85 mm Span: 1.35 mm Blade No. Thickness (mm) after second heating (105 ° C) Thickness (mm) after second heating (120 ° C) Thickness (mm) after second heating (105 ° C) Thickness (mm) after second heating (120 ° C) Thickness (mm) after second heating (105 ° C) Thickness (mm) after second heating (120 ° C) 1 638.7 628.5 597.5 593.7 552.1 538.2 2 653.1 608.7 591.2 584.1 533.7 534.2 3 640.6 - 574.4 - 553.3 - Weight (g / m ² ) 644.2 618.6 587.7 588.9 546.4 536.2 Table 7C - Med thickness outward strips resulting texture 3
Gap: 2.35 mm Span: 1.85 mm Span: 1.35 mm Blade No. Thickness (mm) after second heating (105 ° C) Thickness (mm) after second heating (120 ° C) Thickness (mm) after second heating (105 ° C) Thickness (mm) after second heating (120 ° C) Thickness (mm) after second heating (105 ° C) Thickness (mm) after second heating (120 ° C) 1 631.5 631.3 605.9 625.6 585.6 597.3 2 645.9 646.8 630.3 628.0 585.6 576.9 3 629.6 651.8 625.0 624.0 581.8 589.5 Total average (mm) 635.7 643.3 620.4 625.9 584.3 587.9
[00128] As can be seen, there was a statistical difference in thickness when the material is changed and the span size is changed. In general, the thickness of the material was the smallest with Resultant Structure 2 and then increased with Resultant Structure 3, and Resultant Structure 1 provided the largest thickness. This may be due to the increased content of physical material (mass). The thickness also increased with the increase in the span, probably because there is a larger space and allows more material to be contained within that space. A statistical difference in thickness by temper
68/74 ture was observed only in Resultant Structure_1. Based on the measurements taken, it is believed that there was a slight setback after pressing influenced by the mass of the material being handled, the shrinking span and the pressing temperature. The temperature and pressure were the same for all samples.
Area weight and amount of non-absorbable material in the resulting structures
[00129] For each of the three resulting heated structures formed as shown above, the weight of the area of the structure was obtained and the amount of the polypropylene (PP) content was obtained. Each measurement was taken for the different processing parameters, for example, changing the span size and changing the second heating from 105Ό to 120Ό. The results are shown in Table 8 below.
Table 8 - Area weight and non-absorbable content in the resulting structures
Resulting Structure 1 (2 tubes, 10x Vicrvl. 2x PDS, 1x Polypropylene)Gap size - 2.35 mm Span size -1.85 mm Span size -1.35 mmArea weight (g / m2) Quantity of PP (g / m ² ) Area weight (g / m ² ) Quantity of PP (g / m ² ) Area weight (g / m ² ) Quantity of PP (g / m ² ) 105 ° C 274.31 41.15 222.45 33.37 192.13 28.82 120 ° C 272.69 40.90 225.23 33.78 190.63 28.59 Resulting Structure 2 (1 tube, 5x Vicrvl, 1x PDS, 1x Polypropylene)Gap size - 2.35 mm Span size -1.85 mm Span size -1.35 mmArea weight (g / m2) Quantity of PP (g / m ² ) Area weight (g / m ² ) Quantity of PP (g / m ² ) Area weight (g / m ² ) Quantity of PP (g / m ² ) 105 ° C 152.77 39.85 133.80 34.90 107.64 28.08 120 ° C 156.25 40.76 133.33 34.78 108.33 28.26 Resulting Structure 3 (2 tubes, 10x Vicrvl, 1x PDS, 1x Polypropylene)Gap size - 2.35 mm Span size -1.85 mm Span size -1.35 mmArea weight (g / m2) Quantity of PP (g / m ² ) Area weight (g / m ² ) Quantity of PP (g / m ² ) Area weight (g / m ² ) Quantity of PP (g / m ² ) 105 ° C 181.25 29.39 162.96 26.43 143.52 23.27 120 ° C 192.82 31.27 161.11 26.13 143.98 23.35
[00130] The amount of Vicryl and PDS was also determined for each of the structures presented above, and the material ratios were determined. For Resultant Structure 1, it was observed that there was about 70% Vicryl, about 15% PDS and about 15%
69/74 polypropylene. For Resultant Structure 2, it was observed that there were about 60.9% Vicryl, about 13% PDS and about 26.1% polypropylene. For Resultant Structure 3, it was observed that there were about 75.7% Vicryl, about 8.1% PDS and about 16.2% polypropylene.
[00131] As can be seen, the area weights are less in Resultant Structure 2, followed by an increase in Resultant Structure 3, and the greater area weight can be seen in Resultant Structure 1. For all Resultant Structures, the amount polypropylene increased with increasing span size. The Structure with the lowest amounts of polypropylene was Resultant Structure 3. This is probably due to the fact that the structure has a lot of Vicryl in relation to a PDS strand contained in Resultant Structure 1. Since all strands are together, less PP is extracted for the first heating span. Similarly, Resultant Structure 2 and Resultant Structure 1 have equal material ratios (Vicryl and PDS) so that the percentage of PP is also equal, in general.
Tensile strength of the resulting structures
[00132] The three Resulting Structures were prepared, as explained above, each prepared in span sizes of 2.35mm, 1.85mm or 1.35mm and at second heating temperatures of 105 ° C or 120 ° C. Each resulting strip was measured with a ZWICK tester to assess any difference in tensile strength. The stress level (N) was measured at 1% effort and 10% effort.
[00133] It was found that there was a statistical difference in tensile strength for all three types of material when the temperature was changed, regardless of the span size. In general, it was observed that the lower temperature of the second heating
70/74 produces greater tensile strength and a shorter confidence interval (standard deviation) for each span size. Further melting of the PDS at higher temperatures can influence the result. There was a statistical difference in tensile strength due to the size of the span for the Resulting Structures formed in the second heating at 120 ° C. In general, when the second heating was at 120 ° C, as the span size increased, the tensile strength also increased. The Resulting Structures formed using the second lowest heating (105 ° C) did not show a significant change in tensile strength due to the change in span size. It has been shown that Resultant Structure 1 has a statistically greater tensile strength than Resultant Structures 2 and 3 formed at the same heating temperature and using the same span size. The amount of PDS content and the PDS melting level can provide a trigger for the tensile strength of the resulting material. Additional PDS can provide an increase in the shrinkage effect during the heating stages, thus providing an increase in tensile strength. In fact, PDS acts as a glue to bond materials. However, the reduction in tensile strength as the temperature increases demonstrates that the increased melting of the PDS can have a detrimental effect. [00134] In summary, it appears that Resultant Structure 1 provides a final product significantly different from Resultant Structures 2 and 3. It can also be seen that, in addition to the types and ratios of the materials present, the size of the gap during heating can provide an effect statistic in the weight, strength and thickness of the resulting final product. The increase in temperature had a noticeable effect on the tensile strength.
Example 3 - Porosity and hardness test
[00135] The structures of the invention were prepared and tested / 74 for porosity and resistance to flexion or hardness. The structure of the invention used in this example included vicryl, polypropylene and PDS in a ratio of 5 parts (by weight) of vicryl, 1 part of polypropylene (by weight) and 1 part of PDA (by weight). The loose initial woven structure was prepared and subjected to a first heating at 103 ° C in a span of 1.5 mm. The initial heated structure was then subjected to a second heating at 105 ° C in a 0.9 mm span providing the final resulting device. The resulting device was substantially flat and shaped like a plate.
[00136] The hardness of the device was measured using a flexural stiffness test, specifically using a Zwick Roell tensile test. For this test, a trapezoid-shaped indenter was pressed on the test section of the device of the invention, measuring about 50 mm x 50 mm, in which the device was placed over a 12.5 mm gap. The span allowed the test section to be pressed downward by the indenter as much as necessary to examine the maximum force the sample can withstand before starting to enter the span. Four samples of the device of the invention were tested. As a comparison, two known products (Ultrapro Mod®, a polypropylene / polyglecaprone 25 device, and Prolene Softmesh®, a polypropylene network) were tested using the same parameters. The four samples were each tested in both directions plus three repetitive measurements to test reproducibility. The hardness test resulted in a maximum force of 1.351 N for the device of the invention, while the standard deviation was 0.2789. This is significantly higher than the tested hardness for other known products (Ultrapro, 0.38 N; Prolene Softmesh, 0.25 N).
[00137] Porosity, which refers to the pore size distribution, was measured using a POROLUX 1000 device. To measure porosity, a circular section of the device of the invention having a
72/74 diameter of about 18 mm was embedded in Silpore, a high density liquid. The gas was then pushed through the sample, while a machine recorded the flow and pressure of the gas. Due to surface tension, the largest pores open first, followed by the next smallest pore to the smallest pore of all. The results are calculated on a gas flow chart in relation to the pore size.
[00138] Five samples of the device of the invention were tested and measured for the largest pore size and smallest pore size. The largest pore size of sample 1 was 218.1 microns, and the smallest pore size of sample 1 was 10.49 microns. The largest pore size of sample 2 was 254.2 microns, and the smallest pore size of sample 2 was 10.78 microns. The largest pore size of sample 3 was 246.0 microns, and the smallest pore size of sample 3 was 5.24 microns. The largest pore size of sample 4 was 21.38 microns, and the smallest pore size of sample 4 was 4.18 microns. The largest pore size of sample 5 was 236.1 microns, and the smallest pore size of sample 5 was 4.29 microns.
[00139] As can be seen, on average, the largest pore size was 233 microns in diameter, and the smallest pore size was about 6 microns in diameter. The pore size distribution was reasonably homogeneous across the five samples tested. Example 4 - Post-hydrolysis elongation test
[00140] Several structures, including the structure of the invention, have been tested for elongation properties. To obtain the elongation, several samples of the structure of the invention (both in the implantable state and after hydrolysis occurs), hydrolyzed VYPRO® (about 1.5 cm long x 2 cm wide), Ultrapro® hydrolyzed (about 5 cm long x 1 cm wide) and a non-absorbable polypropylene mesh product (Gynemesh®) (about 5 cm long x 2 cm wide) were provided. The measurements were
73/74 taken for a sample of implantable device prior to implantation (about 5 cm long x 2 cm wide), two samples of the invention device of the single layer hydrolyzate (about 5 cm long x 2 cm wide, about 1.5 cm long x 2 cm wide), a sample of the hydrolysed two-layer device of the invention (layers arranged at 90 ° each other) (about 1.5 cm long x 2 cm wide ), and a sample of the hydrolysed four-layer device of the invention (two layers arranged at 90 ° to each other) (about 1.5 cm long x 2 cm wide), Various weights were hung on the product, and the length resultant was measured. For some samples, only one or two weights were measured due to sample availability. In each case, the smallest weight (10 grams) was used for comparison purposes. The results are shown in Table 9, below.
Table 9 - Measurements of the length of various products
Material Original length Length with 10g weight Length with weight 20g Length with 50g weight Length with weight 200g Implantable device of the invention (without hydrolysis 5 cm 5 cm(1x stretch) 5 cm(1x stretch) 5.1 cm (~ 1x stretch) 5.4 cm(~ 1.1x elongation) Hydrolyzed device of the invention 5 cm 25 cm(5x stretching) 30 cm(6x stretching) 30 cm(6x stretching) 37.5 cm(7.5x stretching) Hydrolyzed device of the invention 1.5 cm 8.3 cm(5.5x stretch) - - - Hydrolyzed device of the invention with 2 layers 1.5 cm 3.0 cm(2x stretching) 3.6 cm(2.5x stretch) Hydrolyzed device of the invention with 4 layers 1.5 cm 1.8 cm(~ 1.2x stretch) 2.0 cm(~ 1.4x stretch) VYPRO® hydrolyzate 1.5 cm 2.0 cm(~ 1.4x stretch) - - - Ultrapro® hydrolyzate 5 cm 5 cm(1x stretch) 5.5 cm(1.1x stretch) 6.0 cm (1.2x elongation) 6.0 cm (1.2x elongation) Gynemesh 5 cm 5 cm(1x stretch) 5 cm(1x stretch) 5.1 cm (~ 1x stretch) 5.4 cm(~ 1.1x elongation)
74Π4
[00141] Several results can be observed from the tests above, specifically, that the material of the invention, in its implantable state (before hydrolysis), has significant strength and is comparable to the non-absorbable polypropylene material. After hydrolysis, however, the material of the invention is about 5 or 6 times more elastic, even when loaded with low weights (for example, 10 to 20 grams). With more weight, the level of stretching is higher, as demonstrated by a 7.5x stretch with 200 grams of weight. The level of elongation after hydrolysis is greater in the material of the invention than in other hydrolyzed materials, demonstrating the effectiveness and improvement of the material of the invention.

权利要求:
Claims (11)
[1]
1. Method for forming an implantable device, characterized by the fact that it comprises the steps of:
The. forming a first yarn and a second yarn, wherein at least one of said first yarn and second yarn includes a first non-absorbable filament and at least one of said first yarn and second yarn includes a first absorbable filament, said first filament absorbable has a lower melting point than said first non-absorbable filament;
B. forming an initial woven structure comprising a web of said first and second threads;
ç. subjecting said initial woven structure to a first heat treatment at a first temperature sufficient to cause said first absorbable filament to shrink, and thus deform at least the second yarn and form an initial heated structure;
d. heating said initial heated structure to a second temperature, said second temperature being higher than said first temperature, in which at least a portion of said first absorbable filament is melted; and
and. allowing said heated structure to cool to form a resulting implantable device.
[2]
Method according to claim 1, characterized in that it further comprises the step of twisting at least one of said first absorbable filament and said first non-absorbable filament before the formation of said first or second yarn.
[3]
Method according to claim 1 or 2, characterized in that it further comprises the step of compressing said initial woven structure mentioned during said heating step of said initial heated structure to a
Petition 870190105652, of 10/18/2019, p. 5/11
2/3 second temperature.
[4]
Method according to any one of claims 1 to 3, characterized in that said first yarn comprises a first non-absorbable filament and a first absorbable filament, and said second yarn comprises a second non-absorbable filament and a second absorbable filament.
[5]
Method according to claim 4, characterized by the fact that said first absorbable filament is polydioxanone and said first non-absorbable filament is polypropylene.
[6]
Method according to any one of claims 1 to 3, characterized in that said first yarn comprises a first non-absorbable filament, a first absorbable filament and a second absorbable filament, and said second yarn comprises a second filament non-absorbable and a third absorbable filament.
[7]
Method according to claim 6, characterized in that said first absorbable filament is polyglactin, said second absorbable filament is polydioxanone and said first non-absorbable filament is polypropylene.
[8]
Method according to any one of claims 1 to 7, characterized in that said step of subjecting said initial woven structure to a first heat treatment comprises placing said initial woven structure in a heat source that has a span that is at least as wide as said thickness of said initial woven structure.
[9]
Method according to any one of claims 1 to 8, characterized in that said step of subjecting said initial woven structure to a first heat treatment comprises subjecting said initial woven structure to a first temperature which
Petition 870190105652, of 10/18/2019, p. 6/11
3/3 is 0.1 to 2 ° C less than the melting point of the absorbable filament which has the lowest melting point in said initial woven structure.
[10]
Method according to any one of claims 1 to 9, characterized in that said second temperature is a temperature that is 0.1 to 20 ° C higher than the melting point of the absorbable filament that has the lowest melting point in said initial woven structure.
[11]
11. Implantable device, characterized by the fact that it has a random orientation of a non-absorbable filament, formed using the method as defined in any one of claims 1 to 11.

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法律状态:
2018-02-27| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

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2020-03-10| B09A| Decision: intention to grant|

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2020-05-19| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/02/2014, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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