KR20150131039A - Silk medical device for use in breast augmentation and breast reconstruction - Google Patents

Abstract

Dimensional fabric structure in the form of pockets for use in breast reconstruction procedures such as single-stage or two-stage breast reconstruction. The silk scaffold utilizes a knit pattern that substantially prevents unwinding and, in particular, preserves the stability of the mesh or scaffold device when the mesh or scaffold device is cut. An exemplary scaffold device employs a knitted mesh that includes at least two chambers laid in the knitting direction and meshes with each other to define a plurality of nodes.

Description

[0001] DESCRIPTION [0002] SILK MEDICAL DEVICE FOR USE IN BREAST AUGMENTATION AND BREAST RECONSTRUCTION [

Cross-reference to related applications

This application is a continuation-in-part of U.S. Patent Application No. 13 / 306,325, filed November 29, 2011, which is a continuation-in-part application of U.S. Patent Application No. 13 / 186,151 filed on July 19, 2011, Is a continuation-in-part of U.S. Patent Application No. 13 / 156,283, filed June 8, 2011, which is a continuation-in-part of U.S. Patent Application 12 / 680,404 filed on September 19, 2011, This application is a national phase application of PCT patent application PCT / US09 / 63717 filed on November 9, 2008, which claims priority and benefit of U.S. patent application 61 / 122,520, filed December 15, 2008, All of which are expressly incorporated herein by reference in their entirety.

The present invention relates generally to a prosthetic device for tissue reconstruction and more particularly to a surgical silk mesh or scaffold device that utilizes a stable knit structure and to a method of breast shaping and surgery such as in breast augmentation and / To a method of using the same in procedures.

Surgical meshes used initially for hernia and abdominal wall defects are currently being used for revascularization, muscle dysfunction, and reconstruction of other types of tissue, such as reconstruction or plastic surgery. In 2010, it is predicted that there will be more than 8 million hernia operations, 800,000 revolving revitalization, 3 million muscle dehydration recovery, 600,000 urinary incontinence recovery, and 1.5 million reconstructive or aesthetic plastic surgery. Most of these surgeries are C.R. Bard mesh (polypropylene); Dexon (polyglycolic acid) by Saisoner / US Surgery; W.L. Gore-Tex by Gore (polytetrafluoroethylene); (Polypropylene), propylene soft (polypropylene), mercylene mesh (polyester), guinea mesh (polypropylene), noncruritic mesh (polyglactin 910), TVT ); Spark Tape by American Medical Systems (polypropylene); There is a possibility to use implantable surgical mesh devices in the current industry, including IVS tapes (polypropylene) by TYCO Healthcare International.

Surgical mesh devices are generally suitable for the living body and may be formed of biodegradable and / or non-biodegradable materials. For example, polypropylene, polyester, and polytetrafluoroethylene (PTFE) are biocompatible and non-bio-soluble, while polyglycine 910 and polyglycolic acid are biocompatible and bio-soluble.

Currently, surgical mesh devices are formed of different materials, but have a variety of similar physical and mechanical characteristics that are beneficial for tissue repair. However, despite the benefits provided by current surgical mesh devices, its use may be accompanied by various complications. Such complications may include, for example, scar tissue and tissue erosion, persistent infection, pain, and difficulties associated with reoperation. Moreover, the use of absorbable materials can result in a rapid reabsorption of the injected material and a recurrence due to loss of strength.

While polypropylene single fibers may be a highly contemplated material for surgical mesh devices, polypropylene mesh devices are capable of inducing strong irritation, and even over the years after implantation, the chronic external Body reaction can be generated. Minor complaints of serous species, discomfort, and reduced wall mobility are frequently observed in half of the patients injected with polypropylene mesh devices. Moreover, polypropylene can not normally be placed next to the sheet due to the tendency of the adhesive composition.

Although the use of multi-fiber polyesters can improve coincidence with the abdominal wall, this is also associated with a variety of disadvantages. For example, higher incidences of infection, fistula fistula formation, and small bowel obstruction have been reported with the use of multifiber polyester compared to other materials. Moreover, the small cracks in the multi-filament yarn can make it more susceptible to the occurrence of the infection, so multifiber polyester is not commonly used in the United States.

The use of polytetrafluoroethylene (PTFE) may be advantageous to minimize adhesion to the sheet. However, host tissues encapsulate the PTFE mesh, resulting in weak growth in the abdominal wall and poorer hernia recovery. Although these materials do not have a good mesh material on their own, they have found their place as an adhesion barrier.

Absorbable materials such as Bicryl and Dexon used for hemihydrate recovery have the advantage of being placed in the bowel without adhesive or fistula formation. Studies have shown that bicryl has a comparable intensity to the nonabsorbable mesh at 3 weeks, but is significantly weaker at 12 weeks due to the faster absorption rate. On the other hand, Dexon observed that the growth of 12 weeks was due to less absorption of the mesh. Considerations for absorbable mesh are that the rate of uptake is variable, possibly leading to a herniated recurrence if the proper amount of new tissue does not withstand the physiological stress placed on the hernia defect.

A significant feature of biomaterials is their porosity, since porosity is a major determinant of tissue response. The size of the pores less than 500-600 [mu] m permits the growth of soft tissues; The size of the pores of less than 200-300 [mu] m favored neovascularization, allowing single-morphological restoration of bone defects; A pore size of &lt; 200 [mu] m is considered to be nearly water resistant, thereby preventing liquid circulation at physiological pressures; Pores of <100 μm result only in the growth of a single cell type instead of building a new tissue. Finally, a pore size of < 10 [mu] m prevents any growth and increases the chance of infection, copper formation, and encapsulation of the mesh. Bacteria with an average size of 1 [mu] m can be hidden in small gaps in the mesh and are spiked while being protected from the neutrophil granules 10-15 [mu] m on average.

Other important physical features for surgical mesh devices include thickness, burst strength, and material stiffness. The thickness of the surgical mesh devices varies with specific recovery procedures. For example, current surgical mesh devices, hernias, muscle dysfunction, and reconstruction / plastic surgery have a range of thicknesses of approximately 0.635 mm to 1.1 mm. For rotation near recovery, a thickness of 0.4 mm to 5 mm is generally used.

Inner abdominal pressure of 10-16 N has an average swelling of 11-32%, leading to the need for a surgical mesh with burst strength that can withstand the stresses of the internal abdomen before it becomes healthy tissue.

Material stiffness is an important mechanical feature for surgical meshes, especially when used for muscle dysfunction, because material stiffness is associated with the possibility of tissue erosion. For example, surgical mesh devices formed from TVT, IVS, mersylene, prolene, guinea mesh, spark tapes currently have a maximum tensile strength (UTS) in excess of the force exerted by the internal abdominal pressure of 10-16N. Through low forces in the abdomen, the initial stiffness of the material is an important consideration. Moreover, stiffness can most likely exhibit non-linear behavior due to changes in the fabric structure, such as, for example, loosening of knits, weaves, and the like. Surgical mesh devices of lower stiffness can help reduce tissue erosion and can more efficiently follow the contours of the body.

There are also considerations related to surgical procedures for breast reconstruction. Following a mastectomy, a woman may choose to have reconstruction using her own tissue (self-reconstructing) or breast implants. The autologous tissue may closely resemble the appearance and feel of the original breast; However, some women may want to avoid scar and donor site morbidity associated with this procedure, and other women simply do not have enough tissue to perform self-reconstruction. Therefore, an increasing number of women choose to undergo transplant reconstruction.

In Europe, one-stage immediate breast transplantation or direct transplantation (DTI) reconstruction has been performed, and this approach is advantageous in that it can reduce the number of hospitalizations and reduce the cost of surgery associated with multiple stage reconstruction . Studies by plants and others have suggested that single-stage reconstruction can be as efficient as two-stage reconstruction. These single-stage infusions are generally followed by skin-protective and nipple-protective mastectomies, often using the patient's autologous tissue to fix and support the breast implants. Single-stage surgery using autologous tissue generally results in few graft-related complications, low spherical build grading, and good aesthetic results. Two-stage reconstruction is also performed.

In transplant reconstruction, the tissue expander (TE) is positioned after the mastectomy and is inflated until the desired pocket size is obtained. The tissue expander is then removed, and a permanent implant is inserted. Recent advances in this procedure are the addition of materials to support the implant formulation by providing a framework to control the space or position of the tissue expander. A &quot; scaffold &quot; is sutured to the chest wall and anterior repositioning fascia to create a pocket or hammock for subsequent tissue expander or implant positioning. The superior part of the material is sealed to the inner aspect of the pectoral muscle to cover the tissue expander. These grafts can act as protective barriers between the implant and the skin, can control the position of the implant, and can reduce the transfer of force to the implant itself. Advantages of using this technique include effective &quot; extension &quot; of the tissue inflator's chest muscle coverage without compromising low extreme expansion, precise control of breast-down wrinkles and lateral breast boundaries, and greater initial fill-volume allowance. Additionally, the graft can allow the skin envelope to be used before shrinking, which can produce more natural aesthetic results.

Alordeum, an allogeneic dermal cell dermal matrix (ADM), was often used as a scaffold during breast reconstruction. When used to create complete coverage of the tissue expander, Alord can allow for a higher initial filling volume of the tissue expander, faster expansion, improved confinement of the breast-wrinkles, less post-operative pain, And no difference in initial filling volume or rate of expansion between the alodoma breast reconstruction group and the control group.

The results and shrinkage rates of the acellular dermis in stage reconstruction were examined by Bindingnavele et al. The rate of contraction in 65 breasts is 4.6% for serous, 3.1% for infection, 1.5% for inflator removal and 1.5% for hematoma. Four of the five patients underwent unplanned radiation therapy after reconstruction with an acellular dermis. One in five developed wound infections that required tissue culture of tissue expanders.

Shrinkage rates were higher in alordes than in the control group in some studies as well as others. Chun et al. Found a shrinkage of 14% for serous, 9% for infection and 23% for necrosis in a comparable study of alordes with similar allogenic dermal dermal tissue (DermaMatrix) Serum and one infected / cellulitis are 4% in 50 breasts (25 per group). The only significant difference found between the two matrices is that the patient is on average days with drains in place (11 for Alodom, 13 for DermaMatrix, p = 0.02). Other studies have found 5.85% of patients using AlloDerm without the use of 5% postoperative infection and AlloDerm. In a study of 96 women who underwent two-stage reconstruction with ADM, serous (7.2%) were identified in 11 patients and 9 of them undergo aspiration.

The 58 breasts undergoing reconstruction with crescent - shaped tissue swelling were evaluated by Buck et al. Overall, five complications (8.6%); Two infected tissue expanders, one patient with flap necrosis, one patient with hematoma development, and one with hematoma development. Patients were satisfied with the results.

Logistics using alordes can be a problem (for example, having a shelf life of two years and requiring rehydration for at least 30 minutes prior to application). Moreover, it has been recommended to undergo two saline baths, and the cost of the ADM can be substantial. Other ADMs have appeared in the industry. In a small study, Neoform was evaluated for safety and efficacy. Complications related to Neoform were not found in 22 patients, and tissue expansion procedures were performed as planned. Although some improvements in the logistics can be found in Neoform (ie, 5 years of shelf life and 3 to 5 minutes of refrigeration for rehydration), the average follow-up of these patients is quite short (10.2 months).

In particular, with respect to the disadvantages of current surgical mesh devices in breast reconstruction procedures, there is a continuing need for biomedical and absorbable surgical meshes, the ability to withstand the physiological stresses placed on the host collagen phase, Or adhesion. Accordingly, embodiments in accordance with aspects of the present invention provide a biocompatible surgical silk mesh prosthetic device for use in soft and hard tissue recovery. Examples of soft tissue repair include breast applications such as breast reconstruction and enlargement, hernia repair, rotator cuff repair, plastic surgery, bladder sling implementation, and the like. Examples of hard tissue repair, such as bone repair, include reconstructive plastic surgery, or trauma.

Advantageously, the open structure of these embodiments allows for tissue growth while the mesh device is degraded at a rate that allows smooth delivery of mechanical properties from the silk scaffold to the new tissue. In accordance with certain aspects of the present invention, embodiments utilize a knit pattern, which is referred to as a &quot; node-lock &quot; design. The &quot; node-lock &quot; design substantially prevents unwinding and preserves the stability of the mesh device, particularly when the mesh device is incised.

The present invention includes a method of using a knitted silk fabric in a breast reconstruction procedure. The method includes the step of embodying (placing the knitted silk fabric completely within the body of the patient) in a patient in a patient's vicinity of the reconstructed or reconstructed breast (at or near the anatomical location of the breast reconstruction) . Generally, the silk fabric will be attached to the patient by being sutured in place. The method may further include inserting (i. E., Injecting) a tissue expander and removing the tissue expander later. Breast implants can also be inserted.

In a particular embodiment, the prosthetic device includes at least two chambers laid down in the knitting direction and includes a knitted mesh meshing with each other to define a plurality of nodes, the at least two chambers having a first chamber extending therebetween, Wherein the first room comprises a second room and forms loops around the two nodes, the second room having a higher tension at two nodes than the first room, And substantially prevents the knitted mesh from unwinding at the nodes.

In the example of this embodiment, the first and second chambers are formed of different materials. In another example of this embodiment, the first and second chambers have different diameters. In a further embodiment, the first and second seals have different elastic properties. In another example of this embodiment, at least two chambers are formed of silk.

In another example of this embodiment, the first length of the first chamber extends between two nodes, the second length of the second chamber extends between the two nodes, and the first length is greater than the second length. For example, a first room forms an intermediate loop between two nodes, and a second room does not form a corresponding intermediate loop between the two nodes. The first length of the first chamber is larger than the second length of the second chamber.

In another example of this embodiment, the first seal is included in the first set of seals, the second seal is included in the second set of seals, the first set of seals is applied in the first wale direction, Each of the first set of loops forming a first series of loops in each of a plurality of courses for a knitted mesh and the second set of yarns being applied in a second wale direction, Each second set of threads forming a second series of loops with each other in a plurality of courses for a knitted mesh and a first set of threads forming a second series of loops on a course for each knitted mesh, And the second set of threads has a greater tension than the first set of threads and the difference in tension substantially prevents the knitted mesh from unwinding at the nodes.

In another example of this embodiment, the first seal is included in the first set of seals, the second seal is included in the second set of seals, the first set of seals and the second set of seals comprise a staggered loop Wherein the first set of threads interlaces with the second set of threads to define nodes for the knitted mesh and the second set of threads alternates between the first set of threads and the second set of threads The application of the first set of threads has a different tension on the second set of threads at the nodes and the difference in tension substantially prevents the knitted mesh from unwinding at the nodes.

In another example of this embodiment, a first set of yarns is included in a first set of yarns, a second set of yarns is included in a second set of yarns, and a first set of yarns Thereby forming a series of jersey loops and a second set of yarns forming a second series of alternating tucked loops and blocking loops along each second set of courses for the knitted mesh , The second set of courses alternating with the first set of courses, the second set of threads having a greater tension than the first set of threads, and the second set of threaded loops of threads having knit- Engages the first set of seal loops to define the nodes for the seal, and the tuck loops substantially prevent the knitted mesh from unwinding at the nodes.

In another specific embodiment, a method of making a knitted mesh for a prosthetic device comprises applying a first set of threads in a first wale direction on a single needle bed machine, each first set of threads having a knitted mesh Forming a first series of loops in each of the plurality of courses for the first set; Applying a second set of threads in a second wale orientation on a single needle bed machine, wherein the second wale orientation is opposite to the first wale orientation, each second set of threads having a plurality of A second set application step of forming a second series of loops; And applying a third cent of threads in all predetermined numbers of courses for the knitted mesh, wherein the first set of threads includes a second set of threads and a second set of threads per course to define nodes for the knitted mesh, The second set of threads has a greater tension than the first set of threads and the difference in tension substantially prevents the knitted mesh from unwinding at the nodes.

In yet another embodiment, a method of making a knitted mesh for a prosthetic device includes applying a first set of threads to a first needle bed of a dual needle bed machine in a wale direction; Applying a second set of threads to a second needle bed of a dual needle bed machine in a wale direction; Applying a third set of threads in all predetermined numbers of courses for a knitted mesh, the application of the third set of threads defining an opening in the knitted mesh, The second set is alternately applied to form a staggered loop in the first needle bed and the second needle bed, respectively, and the first set of chambers is used to define the nodes for the knitted mesh, The alternating application of the first set of seals and the second set of seals allows the first set of seals to have different tensions for the second set of seals at the nodes and the difference in tension to be a knitted Thereby substantially preventing the mesh from unwinding at the nodes.

In a further particular embodiment, a method of making a knitted mesh for a prosthetic device includes forming a first series of blocking loops along each of the first set of courses for a knitted mesh on a flat needle bed machine ; On a flat needle bed machine, forming a second series of alternating tubular loops and a blocking loop along each of the second set of courses for the knitted mesh, wherein the second set of courses comprises a first set of courses Wherein the second set of courses has a greater tension than the first set of courses and the tufted loops along the second set of courses comprise a first set of course loops of the course, And substantially prevents the knitted mesh from unwinding in the tubular loop. In the example of this embodiment, the continuous chamber forms a first set of courses and a second set of courses. In another example of this embodiment, the first set of courses and the second set of courses are formed by different seals. In another example of this embodiment, the first set of courses and the second set of courses are formed by different chambers having different diameters.

Aspects of the present invention relate to implantable prostheses for breast augmentation or reconstruction procedures that include a biocompatible biodegradable fabric structure comprising one or more individual threads comprised of sericin-extracted natural fibroin fibers , The thread (s) are twisted together to create a fabric structure, the fabric structure extends to a first dimension and has a first surface adapted to engage and support natural breast tissue or prosthetic breast implants in the patient. In one embodiment, the fabric structure includes a portion adapted to be secured to tissue surrounding the patient &apos; s pleural cavity. In one embodiment, the fabric structure includes a portion adapted to be secured to a soft tissue surrounding the breast tissue or prosthetic breast implant. In one embodiment, the fabric structure includes a portion adapted to be secured to a bony structure adjacent to the breast tissue or prosthetic breast implant. In one embodiment, the fabric structure is formed in a predefined form adapted to conform to at least a portion of the area of a natural breast tissue or mammography. In one embodiment, the predefined shapes have been selected from the group consisting of a circular shape, an oval shape, a crescent shape, a cup shape, and an elongated strip. In one embodiment, the fabric structure includes factors to promote growth of the breast tissue. In one embodiment, the fabric structure at least partially replaces the breast connecting tissue when implanted. In one embodiment, the fabric structure is formed in a sling shape to provide a support for the breast or breast implant when the fabric structure is implanted in a patient. In one embodiment, the fabric structure is formed in an elongated form to provide a support in the sub-breast region of the breast when the fabric structure is implanted in a patient. In one embodiment, the fabric structure is formed in the form of a cup to provide an internal support in the submammary region of the breast when the fabric structure is implanted in a patient. In one embodiment, the fabric structure is formed in a cup shape to provide a medical or side support for the breast when the fabric structure is implanted in a patient. In one embodiment, the fabric structure is selected from the group consisting of twist, twist, knit, stitch bonded, and combinations thereof.

Aspects of the present invention relate to a method of supporting breast tissue or breast implants in a patient, which method comprises providing a biodegradable fabric structure comprising one or more individual threads comprising sericin-extracted natural fibroin fibers, Wherein the thread (s) are twisted together to create a fabric structure, and inserting the fabric structure between the skin of the patient and the breast tissue or breast implant. In one embodiment, the method further comprises securing the fabric structure to tissue surrounding the patient &apos; s pleural cavity. In one embodiment, the method further comprises securing the fabric structure to a soft tissue surrounding the breast tissue or prosthetic breast implant. In one embodiment, the method further comprises securing the fabric structure to a bone structure adjacent to the breast tissue or prosthetic breast implant. In one embodiment, the method further comprises forming the fabric structure in a predefined fashion adapted to conform to at least a portion of the area of the natural breast tissue or mammary gland. In one embodiment, the predefined shape is selected from the group consisting of a circular shape, an oval shape, a crescent shape, a cup shape, and an elongated strip. In one embodiment, the method further comprises treating the fabric structure with factors to promote growth of the breast tissue. In one embodiment, the fabric structure is inserted into the submammary region of the breast to provide vertical positioning of the breast and reduce vertical internal displacement of the breast. In one embodiment, the fabric structure is inserted into the medical side of the breast to provide medical positioning of the breast and to reduce the medical displacement of the breast. In one embodiment, the fabric structure is inserted into the lateral side of the breast to provide medical positioning of the breast and reduce lateral displacement of the breast. In one embodiment, the fabric structure is selected from the group consisting of twist, twist, knit, stitch bonded, and combinations thereof.

Aspects of the present invention are biocompatible and biodegradable fabrics comprising one or more individual threads comprised of sericin-extracted natural fibroin fibers, wherein the yarn (s) are twisted, twisted, knitted, stitched , &Lt; / RTI &gt; and combinations thereof. In one embodiment, the fabric is homogeneous. In one embodiment, the fabric has one or more biomechanical properties of the connective tissue of the female breast. In one embodiment, the one or more biomechanical properties are selected from the group consisting of ultimate tensile strength, linear stiffness, calculated point, percent elongation at break, and combinations thereof. In one embodiment, the fabric is a two-dimensional mesh. In one embodiment, the connective tissue is the epidermal fascia or muscle fascia of the subcutaneous myofascial system of the female breast. In one embodiment, the fabric is heterogeneous. In one embodiment, the fabric includes a two-dimensional mesh having one or more additional structures therein. In one embodiment, the two-dimensional mesh has one or more biomechanical properties of the connective tissue of the female breast. In one embodiment, the connective tissue is the epidermal fascia or muscle fascia of the subcutaneous myofascial system of the female breast. In one embodiment, the additional structure (s) is selected from the group consisting of a twisted structure, an equilibrium structure, and a twisted structure. In one embodiment, the additional structure (s) have one or more biomechanical properties of the connective tissue of the female breast. In one embodiment, the connective tissue is selected from the group consisting of a fascia breast, a dry bough, and a transverse fibrous layer. In one embodiment, the connective tissue is a mammary gland. In one embodiment, the one or more biomechanical properties are selected from the group consisting of ultimate tensile strength, linear stiffness, calculated point, percent elongation at break, and combinations thereof. In one embodiment, the fabric has one or more biomechanical properties of the soft tissue in the breast. In one embodiment, the fibroin fibers contain less than 20% by weight of sericin. In one embodiment, the fibroin fibers contain less than 10% by weight sericin. In one embodiment, the fibroin fibers contain less than 1% by weight of sericin. In one embodiment, the at least one thread comprises fibrous fibers that are parallel or twisted together. In one embodiment, the at least one yarn is a braid, a textured yarn, a twisted yarn, a cable-like yarn, or a combination thereof. In one embodiment, the at least one yarn has a single-level hierarchical organization comprising a group of parallel or twisted fibers to form the yarn (s). In one embodiment, the one or more yarns have a two-level hierarchical organization comprising a bundle of twisted groups, the groups comprising parallel or twisted fibers. In one embodiment, the at least one yarn has a three-level hierarchical organization comprising strands of twisted bundles, the bundles comprising twisted groups, and the groups comprise parallel or twisted fibers. In one embodiment, the one or more yarns have a four-level hierarchical organization comprising code of twisted strands, the strands comprising twisted bundles, the bundles comprising twisted groups, the groups being parallel or twisted Fibers. In one embodiment, the at least one yarn comprises a complex of sericin-extracted fibroin fibers and at least one degradable polymer, wherein the at least one degradable polymer is selected from the group consisting of collagen, polylactic acid or a copolymer thereof, polyglycolic acid or a copolymer thereof, Polyanhydrides, elastin, glycosaminoglycans, and polysaccharides. In one embodiment, the fabric is coated, subtly, laminated, or a combination thereof. In one embodiment, the fabric further comprises a medicament. In one embodiment, the fabric further comprises a cell-attaching factor. In one embodiment, the cell-adhesion factor is RGD. In one embodiment, the at least one chamber is treated with a gas plasma. In one embodiment, the fabric further includes biological cells seeded therein.

Aspects of the present invention are directed to a method of creating connective tissue in an individual's breast comprising applying the fabric disclosed therein having one or more biomechanical properties of the connective tissue to a suitable Implanting to an individual in an anatomical location within the breast of an individual providing a physiological environment, the fabric comprising one or more individual threads comprising sericin-extracted natural fibroin fibers. In one embodiment, the connective tissue is selected from the group consisting of epidermal fascia, muscle fascia, breast fascia, dry fibers, and transverse fibrous layers. In one embodiment, the fabric is implanted in an individual to replace or to reverse the damaged tissue. In one embodiment, the anatomical site is a surgical incision site or tissue reconstruction site. In one embodiment, the fabric is homogeneous. In one embodiment, the fabric is heterogeneous. In one embodiment, one or more of the individual rooms may comprise a hierarchical organization selected from the group consisting of a single-level hierarchical organization, a two-level hierarchical organization, a three-level hierarchical organization, and a four- .

Aspects of the present invention further relate to a method of supporting a breast structure in an individual comprising implanting a fabric disposed therein within a breast of an individual in a support position with respect to the breast structure. In one embodiment, the breast structure comprises natural breast tissue. In one embodiment, the breast structure comprises a breast prosthesis. In one embodiment, the breast structure comprises a tissue expander. In one embodiment, the fabric comprises a two dimensional mesh. In one embodiment, the fabric further comprises one or more additional structures therein. In one embodiment, the fabric has at least one biomechanical property of the connective tissue that naturally exists in the breast at such a support position. In one embodiment, the connective tissue is selected from the group consisting of epidermal fascia, muscle fascia, breast fascia, dry fibers, and transverse fibrous layers.

The invention also includes a method of using a silk scaffold in thoracic reconstruction, the method comprising the steps of sewing a knitted silk scaffold to the chest wall and creating a pocket for positioning the tissue expander or breast implant . The method includes inserting a tissue expander; Removing the tissue expander; Inserting a breast implant; And inserting the breast implant without a tissue expander. Additionally, the method may also include the step of incising the silk scaffold to a size for restoring voids in the breastfold zone. The scaffold may be pre-cleaned with antibiotic solution prior to suturing.

The invention also includes a method of using a silk scaffold in a breast reconstruction, the method comprising: obtaining a knitted scaffold comprising at least two chambers laid in the knitting direction; Wherein the at least two chambers include a first chamber and a second chamber extending between two nodes, wherein the second chamber includes a higher tension at two nodes than the first chamber, The second chamber substantially preventing the first chamber from moving at the two nodes and substantially preventing the knitted scaffold from unwinding at the nodes; A knitted silk scaffold is sealed to the chest wall to create a pocket for positioning the tissue expander or breast implant. The first and second chambers may be formed of different materials. The first and second chambers may have different diameters, and the first and second chambers may have different elastic properties. In an embodiment of the invention, the first length of the first chamber extends between two nodes, the second length of the second chamber extends between the two nodes, and the first length is greater than the second length. In addition, the first chamber may form an intermediate loop between the two nodes, the second chamber does not form a corresponding intermediate loop between the two nodes, and the first length of the first chamber may be the same Is greater than the second length. Furthermore, the first seal may be included in the first set of seals, the second seal is included in the second set of seals, the first set of seals is applied in the first wale direction, Forming a first series of loops in each of a plurality of courses for the mesh, the second set of chambers being applied in a second wale direction, the second wale direction being opposite to the first wale direction, The first set of yarns interlaces with the second set of yarns per course to define nodes for the knitted mesh, and the first set of yarns interlaces with the second set of yarns for each course to define nodes for the knitted mesh, The second set of threads has a greater tension than the first set of threads and the difference in tension substantially prevents the knitted mesh from unwinding at the nodes. Moreover, the first seal may be included in the first set of seals, the second seal is included in the second set of seals, the first set of seals and the second set of seals may be included in the wale direction Wherein the first set of threads interlaces with the second set of threads to define nodes for the knitted mesh and the alternate application of the first set of threads and the second set of threads is applied alternately, The first set of threads has a different tension on the second set of threads in the nodes and the difference in tension substantially prevents the knitted mesh from being unwound from the nodes. Finally, a first chamber may be included in the first set of chambers, a second chamber is included in the second set of chambers, and a first set of chambers may be formed in each of the stop loops along the first set of courses for the knitted mesh And the second set of threads forms a second series of alternating tubular loops and blocking loops along each of the second set of courses for the knitted mesh, A second set of tubular loops having a tension greater than one set, the tubular loops of the thread engaging a first set of seal loops of the thread to define nodes for the knitted mesh, Thereby substantially preventing unwinding at the nodes. The two chambers can be formed of silk, can be about 20 to 1000 microns in diameter, and can have a substantially constant diameter.

The present invention also includes a method of using a silk scaffold in a breast augmentation procedure, the method comprising: (a) implanting a breast prosthesis into a patient; (b) implanting a knitted silk scaffold adjacent to the breast prosthesis to support the breast prosthesis and to facilitate tissue growth at the site of the knitted silk scaffold, or contacting the breast prosthesis.

These and other aspects of the present invention will become more apparent from the following detailed description of preferred embodiments of the present invention when taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1A shows a technical rear view of an example of a mesh created on a single needle bed warp knitting machine in accordance with aspects of the present invention.
Fig. 1B shows the technical front of the example of the mesh shown in Fig. 1A.
Figures 2a and 2b illustrate examples of meshes produced on a dual needle bed warp knitting machine in accordance with aspects of the present invention.
Figure 3 shows an example of a mesh created with a single filament yarn yarn in accordance with aspects of the present invention.
Figure 4 illustrates an example of a mesh created on a single needle bed warp knitting machine in accordance with aspects of the present invention.
5A shows an example of a mesh created on a dual needle bed warp knitting machine, with an example of a mesh having parallelogram holes with sections describing the flush design in accordance with aspects of the present invention.
Figure 5b shows an example of a mesh created on a dual needle bed warp knitting machine, an example of a mesh having hexagon holes according to aspects of the present invention.
6A and 6B illustrate an example of a narrow mesh fabric of varying stitch densities incorporating flush deformation according to aspects of the present invention.
Figure 7 shows an example of a mesh merging a loop file according to aspects of the present invention.
Figure 8 shows an example of a narrow mesh fabric having a hole design achieved through variations in actual feed rates in accordance with aspects of the present invention.
Figure 9a shows an example of a collapsed mesh fabric having holes in the shape of a hexagon according to aspects of the present invention.
Figure 9b shows an example of an open mesh fabric having holes in the shape of a hexagon according to aspects of the present invention.
Figure 10 shows an example of a stable, non-collapsible, hexagonal porous mesh fabric in accordance with aspects of the present invention.
11A shows an example of a three dimensional mesh with the same technical forward and technical rear according to aspects of the present invention.
FIG. 11B shows a 2.55 mm thick example of the three-dimensional mesh of FIG. 11A.
Figure 12 shows an example of a three dimensional mesh with a thickness of 3.28 mm according to aspects of the present invention.
Figure 13A illustrates the technical front of an example of a non-porous mesh in accordance with aspects of the present invention.
Figure 13b shows the technical back of the example of the non-porous mesh of Figure 13a.
Figure 13c shows a 5.87 mm thickness of the example of the non-porous mesh of Figure 13a.
14A shows an example of a three dimensional mesh with the same technical forward and technical rear according to aspects of the present invention.
Fig. 14B shows the 5.36 mm thickness of the three-dimensional mesh example of Fig. 14A.
Figure 15a illustrates the technical front of an example of a three dimensional mesh fabric in accordance with aspects of the present invention.
Figure 15b shows the technical back of the example of the three dimensional mesh fabric of Figure 15a.
Figure 16 illustrates an example of a mesh created on a dual needle bed weft knitting machine that illustrates the forming of a mesh for breast support applications in accordance with aspects of the present invention.
Figure 17 illustrates another example of a mesh created on a dual needle bed weft knitting machine that illustrates the forming of a mesh for breast support applications in accordance with aspects of the present invention.
Figure 18 shows another example of a mesh created on a dual needle bed weft knitting machine that illustrates the forming of a mesh for breast support applications in accordance with aspects of the present invention.
Figure 19 shows an additional mesh created on a dual needle bed weft knitting machine that describes the forming of a mesh for breast support applications in accordance with aspects of the present invention.
Figure 20 shows another example of a mesh created on a dual needle bed weft knitting machine that illustrates the forming of a mesh for breast support applications in accordance with aspects of the present invention.
Figure 21a shows a full thickness rat abdominal defect created using a custom designed 1-cm stainless steel punch, wherein the defect is an oval in shape due to the applied body wall tension.
Figure 21B shows an example of a 4 cm x 4 cm implant held in place with a single interrupted polypropylene stitch (arrow) through the implant and muscle centered on the top of the open defect of Figure 21A.
FIG. 21C shows a sample that was eaten out in a post-implantation of 94 days as shown in FIG. 21B.
Figure 21d illustrates a ball burst test performed with a 1-cm diameter ball pushed through a reinforced defect region with a mesh in accordance with aspects of the present invention.
Figure 22 illustrates an example of a pattern layout for a single needle bed mesh in accordance with aspects of the present invention.
Figure 23 shows an example of a pattern layout for a single needle bed mesh in accordance with aspects of the present invention.
Figure 24 shows an example of a pattern layout for a single needle bed mesh in accordance with aspects of the present invention.
Figure 25 illustrates an example of a pattern layout for a single needle bed mesh in accordance with aspects of the present invention.
Figure 26 illustrates an example of a pattern layout of a dual needle bed mesh in accordance with aspects of the present invention.
Figure 27 illustrates an example of a pattern layout for a dual needle bed weft knitting machine in accordance with aspects of the present invention.
28A and 28B show the positioning of the silk scaffold according to the present invention.
Figure 29 illustrates a pocket or sling formed by a scaffold at a stomach muscle that is suitable for maintaining a felon inflator or breast implant in accordance with the present invention.
30A and 30B are photographs of exemplary breast reconstruction procedures in accordance with the present invention.
Figures 31A, 31B, 31C and 31D are photographs of representative breast augmentation procedures in accordance with the present invention.
32 illustrates a three dimensional mesh having a pocket shape for positioning and securing the breast implant against the chest wall in accordance with aspects of the present invention.
Figure 33 illustrates a breast implant external to a pocket in accordance with aspects of the present invention.
Figure 34 illustrates a breast implant placed in a pocket according to aspects of the present invention.
Figure 35 illustrates a three dimensional mesh with pocket implants and breast implants according to aspects of the present invention.
Figure 36 illustrates a breast implant that is external to a pocket having a low elongation on top in accordance with aspects of the present invention.
Figure 37 shows a breast implant that is external to a pocket having a high elongation on top in accordance with aspects of the present invention.
Figure 38 shows a breast implant placed in a pocket according to aspects of the present invention.
Figure 39 illustrates a three dimensional mesh having a pocket shape referencing a transition between a pocket and a non-pocket configuration in accordance with aspects of the present invention.
Figure 40 illustrates a three dimensional mesh with breast implants referencing a transition between a pocket and a non-pocket configuration in accordance with aspects of the present invention.
Figure 41 illustrates a template for dissecting mesh shapes in accordance with aspects of the present invention.
Figure 42 shows a breast implant.
Figure 43 shows a three dimensional mesh panel according to aspects of the present invention.
Figure 44 illustrates a trimmed three dimensional mesh panel according to aspects of the present invention.
Figure 45 shows a template for cutting open taps in accordance with aspects of the present invention.
Figure 46 shows a three dimensional mesh panel with open tabs cut in accordance with aspects of the present invention.
Figure 47 illustrates a second partial structure seamed to the chest wall in accordance with aspects of the present invention.
Figure 48 shows a breast implant insertion in a pocket formed by two structures in accordance with aspects of the present invention.
Figure 49 illustrates forming two symmetrical pockets in accordance with aspects of the present invention.
Figure 50 is a photograph of an open template on a Ceres &lt; RTI ID = 0.0 &gt; CAP &lt; / RTI ^&gt; mesh panel according to aspects of the present invention.
Figure 51 shows a three dimensional mesh cut in a form according to aspects of the present invention.
Figure 52 shows two partial structures sealed together in accordance with aspects of the present invention.
Figure 53 shows two partial structures with a breast implant inserted according to aspects of the present invention.
54A shows a mesh template according to aspects of the present invention.
Figure 54B shows another mesh template according to aspects of the present invention.
Figure 55 shows another mesh template according to aspects of the present invention.
Figure 56a is a photograph of a pattern layout for a silk-based scaffold design in accordance with the present invention.
Figures 56b and 56c show an example of a pattern layout for the silk-based scaffold design of Figure 56a according to the present invention, including all patterns and ground bars according to aspects of the present invention.
Figs. 56D and 56E are enlarged views of the pattern layout and the ground bars of Fig. 56B. Fig.
Figures 57A and 57B illustrate an example of a pattern layout for a dual needle bed scaffold or mesh according to aspects of the present invention from Figure 56B for ground bar # 2.
Figs. 57C and 57D are enlarged views of the pattern layout and the ground bars of Fig. 56B. Fig.
Figures 58A and 58B are diagrams illustrating pattern layouts for a double needle bed mesh or scaffold according to aspects of the present invention from Figure 56 for pattern bar # 4.
Figs. 58C and 58D are enlarged views of the pattern layout and the ground bars of Fig. 56B.
59A and 59B are diagrams showing examples of pattern layouts for a double needle bed mesh or scaffold in accordance with aspects of the present invention from FIG. 56B for pattern bar # 5.
Figs. 59C and 59D are enlarged views of the pattern layout and the ground bars of Fig. 7B. Fig.
Figs. 60A and 60B are diagrams showing examples of pattern layouts for a dual needle bed mesh or scaffold in accordance with aspects of the present invention from Fig. 56B for pattern bar # 7.
Figs. 60C and 60D are enlarged views of the pattern layout and the ground bars in Fig. 56B.
Fig. 61 is a diagram showing an example of pattern simulation for the double needle bed mesh described in Fig. 56B according to aspects of the present invention. Fig.
62 is a photograph of a mesh pattern of a mesh according to aspects of the present invention.
63 is a photograph of a mesh pattern of a mesh according to aspects of the present invention.
64 is a photograph of a mesh pattern of a mesh according to aspects of the present invention.
65 is a photograph of a mesh pattern of a mesh according to aspects of the present invention.
66 is a photograph of a mesh pattern of a mesh according to aspects of the present invention.
67 is a photograph of a mesh pattern of a mesh according to aspects of the present invention.
68 is a photograph of a mesh pattern of a mesh according to aspects of the present invention.
Figure 69 is a photograph showing positioning of three fabric formation measurements (horizontal measurements) and positioning of three fabric width measurements (vertical measurements) in accordance with aspects of the present invention.

Within the scope of the present invention, all silk fabrics are knit silk fabrics intended for implantation in the human body. The word &quot; knit &quot; is synonymous with the word &quot; knitted &quot;, so that the knitted silk fabric is the same as the knitted silk fabric. Within the scope of the present invention, the silk fabric may be a warp knit or a weft knitted silk fabric. Preferably, the silk fabric of the present invention is a warp knit, multi-fiber silk fabric suitable for the living body. Woven (woven) silk fabrics, woven textiles and woven fabrics are not within the scope of the present invention. The woven material or fabric is made as a weave, which is a needleless process and results in a fabric having different characteristics. In particular, woven fabrics are made by a non-needle process using multiple yarns interlacing at right angles to form a structure, one set of yarns being parallel to the direction of fabric formation. On the other hand, the knitted fabric may be fabricated using a needle (such as a needle of a single or double bed knitting machine) to pull the thread through a preceding thread formed by a loop in the needle To produce a knitted fabric (to be described in more detail later). In particular, knitted fabrics are made using needles to have a fabric with one or multiple thread intermeshing (also referred to as interleaving). In addition, nonwoven fabrics are also not within the scope of the present invention. Nonwovens (also referred to as bonded) fabrics are formed by having multiple fabrics chemically or physically bonded together without the use of needles.

Embodiments in accordance with aspects of the present invention provide a biocompatible surgical silk mesh device for use in soft or hard tissue recovery. Examples of soft tissue restoration include hernia recovery, rotator cuff repair, plastic surgery, bladder sling implementation, and the like. Examples of hard tissue repair, such as bone repair, include reconstructive plastic surgery, or trauma.

Advantageously, the open structure of these embodiments allows for tissue growth while the mesh bio-absorbs at a rate that allows smooth delivery of mechanical properties from the silk scaffold to the new tissue. Moreover, the embodiment utilizes a knit pattern that substantially prevents unwinding, especially when the mesh device is cut. In particular, embodiments can preserve the stability of the mesh device by utilizing a knit pattern that utilizes variations in tension between at least two chambers laid in the knitting direction. For example, the first and second chambers may be laid in the knit direction to form &quot; nodes &quot; for the mesh device. For example, the knitting direction for at least two yarns may be vertical during warp knitting, or may be horizontal during wet knitting. The nodes of the mesh device, also known as intermeshes, are referred to as intersections in mesh devices where two yarns form loops around the knitting needles. In some embodiments, the first chamber is adapted to include a slack greater than the second chamber such that when the load is applied to the mesh device, the first chamber is under lower tension than the second device. A load that places at least two yarns under tension can result, for example, when the mesh device is stitched or pulled on the mesh device. The slack in the first chamber causes the first chamber to be more efficiently larger in diameter than the second chamber such that the first chamber experiences greater frictional contact with the second chamber at the node and is unable to move relative to the second chamber, Locked ". Thus, this particular knit design can be referred to as a &quot; node-lock &quot; design.

Generally, a node-lock design in accordance with aspects of the present invention utilizes at least two threads under different tension, wherein the thread of higher tension constrains the lower tension chamber at the mesh nodes. To achieve variation in tension between the seals, other node-lock designs may vary the yarn diameter, yarn material, yarn elastic properties, and / or knit pattern. For example, the knit pattern described above applies yarns to varying lengths to create slack in some yarns to experience low tension. Because the lower tension chambers are constrained by the higher tension chambers, the node-lock design substantially prevents unwinding of the mesh when the mesh is cut. As such, the embodiments allow the mesh device to be cut to any shape or size while maintaining the stability of the mesh device. Moreover, the node-lock design provides stability that facilitates passage through the mesh device through the cannula for laparoscopic or arthroscopic surgery without damaging the material.

Although the node-lock design can utilize a variety of polymeric materials, mesh devices that utilize silks in accordance with aspects of the present invention are capable of delivering load-bearing reactivity slowly to natural tissue while allowing bioabsorption at a rate sufficient to allow tissue growth. can do. Certain embodiments may be formed of spring bix moly silk worm silk fibroin. The one-silk fabric may have a native spherical protein coating known as sericin, which may have antigenic properties and should be depleted prior to implantation. Thus, the thread is taken through the depletion process. The depletion of sericin is described, for example, in Gregory H. Altman et al., "Silk matrix for tissue engineered anterior cruciate ligaments," 2002, Eng. 23, pp. 4131-4141, the contents of which are incorporated herein by reference. As a result, the silk materials used in the device embodiments are substantially free of photosensitizing agents, as long as they can be measured or predicted by standardized biomaterial testing methods.

A surgical mesh device according to aspects of the present invention may be created on a single needle bed Comez Acotronic / 600-F or Comez 410 ACO by the use of three movements as shown in pattern layout 2200 in Figure 22; Two movements in the wale direction, one in the vertical direction in the fabric, and one in the course direction, the horizontal direction of the fabric. Movements in the wale direction go in the opposite direction; The first room moving in one direction loops for each course, while the second room moving in the opposite direction loops all other courses. The yarns follow a repeating pattern of 3-1 and 1-1 / 1-3 on a 20 gauge knitting machine using only half of the needles available on the needle bed. Interlacing of the loops within the fabric keeps one thread under stress under more tension than the other, locking it around the thread receiving less tension, and maintaining the loose state when the fabric is incised. Other movements within the fabric occur on every few courses that create openings in the mesh. These rooms follow the pattern of 1-9 / 9-7 / 7-9 / 9-1 / 1-3 / 3-1. These threads create tension in the fabric when under stress, locking the threads in the fabric, and preventing the fabric from unwinding.

The surgical mesh device according to aspects of the present invention may be created on a double needle bed Comez DNB / EL-800-8B knitting machine by use of three movements as shown in pattern layout 2600 in Figure 26; Two movements in the wale direction, and one move in the course direction. Two movements in the wale direction occur on separate needle beds with alternating chambers; Loops arising from all course moves are staggered within the loop. Actually, it follows the repeated pattern of 3-1 / 1-1 / 1-3 / 3-3 and 1-1 / 1-3 / 3-3 / 3-1. The third movement occurs in the yarn across the width of the fabric. Actually, the pattern of 9-9 / 9-9 / 7-7 / 9-9 / 7-7 / 9-9 / 1-1 / 1-1 / 3-3 / 1-1 / 3-3 / 1-1 . The fabric is also made in half gauge on a 20 gauge knitting machine and prevents unwinding due to tension created between the seals when stressed. The repetition of the yarn following the pattern is shown in Fig.

According to the pattern layouts 2300, 2400, and 2500 shown in FIGS. 23, 24, and 25, respectively, the variation of the surgical mesh pattern is accomplished by a single needle including knitting using the added warp bar, Bed. These changes include knitting using the node lock room while moving it vertically to one or more wales. These variations include, but are not limited to, knitting chain stitches that are open or blocked on all or alternate courses. Using the third warp bar in contrast to the Weft bar insertion can also be applied to a double needle warp knitting machine.

A surgical mesh device according to aspects of the present invention may be formed on a Shima Seiki flat needle bed machine as shown in pattern layout 2700 in Fig. The knit may include a continuous thread or at least two different thread sizes, and one of the at least two different thread sizes may be a different material, but is not limited thereto. The knitted mesh is formed by a regular jig knit on a first row with loops formed by a continuous thread or a thread of a certain thread size while a loop in the second row is formed by a jig knit loop of the same continuous thread, Are formed by alternately occurring turret loops. The mesh is a stitch that increases or decreases; And is molded during knitting by use of a conventional technique.

In embodiments using silk yarns, the silk yarns may be twisted from yarns made by 20-22 denier circular silk fabrics at approximately 40 to 60 탆 diameters. Preferably, circular silk fibers in the range of 10 to 30 denier may be used; However, any fiber diameter that allows the device to provide sufficient intensity in the intended area is acceptable. Advantageously, the constant thread size can maximize the uniformity of the surgical mesh mechanical properties, such as stiffness, elongation, etc., and physical and / or biological properties. However, the thread size can be varied in the section of the surgical mesh to achieve different mechanical, physical, and / or biological characteristics in the desired surgical mesh locations. Factors that can influence the size of the yarn are the ultimate tensile strength (UTS); The output strength, ie, the point at which the yarn is permanently deformed; Percentage extension; Fatigue and dynamic relaxation (creep); Bioabsorption rate; And delivery of cells / nutrients to and from the mesh. The knit pattern layouts 2200, 2300, 2400, 2500, and 2600 shown in Figures 22-26, respectively, can be knitted to any width defined by the knitting machine width, and various knit pattern layouts, Lt; RTI ID = 0.0 &gt; gauges &lt; / RTI &gt; Table 2 discloses fabric widths that can be achieved using different numbers of needles on different gauge machines. It is understood that the dimensions in Table 1 are approximated due to the stitch design, the stitch density, and the contraction factor depending on the yarn size used.

gauge Needle coat Knitting width 48 2-5,656 0.53-2,997.68mm 24 2-2,826 1.06-2,995.56mm 20 2-2,358 1.27-2,994.66 mm 18 2-2,123 1.41-2,993.43mm 16 2-1,882 1.59-2,992.38mm 14 2-1,653 1.81-2,991.93 mm 12 2-1,411 2.12-2,991.32 mm 10 2-1,177 2.54-2,989.58 mm 5 2-586 5.08-2.976.88mm

Examples of prosthetic devices according to the present invention can be knitted on a fine gauge crochet knitting machine. A non-limiting list of crochet machines that can produce surgical meshes in accordance with aspects of the present invention is available from Changde Textile Machinery Co., Ltd .; Ltd; Comez; China Textile Machinery Co., Ltd .; Huibang Machine; Jakob Muller AG; Jingwei Textile Machinery Co., Ltd .; Zhejiang Jingyi Textile Machinery Co., Ltd .; Dongguan Kyang the Delicate Machine Co., Ltd .; Karl Mayer; Sanfang Machine; Sino Techfull; Suzhou Huilong Textile Machinery Co., Ltd .; Taiwan Giu Chun Ind. Co., Ltd .; Zhangjiagang Victor Textile; Liba; Lucas; Muller Frick; and Texma.

Embodiments of the prosthetic device according to the present invention can be knitted on a micro gauge warp knitting machine. A non-limiting list of warp knitting machines that can produce surgical meshes in accordance with aspects of the present invention is described in &lt; RTI ID = 0.0 &gt; Comez &lt; / RTI &gt;Diba; Jingwei Textile Machinery; Liba; Lucas; Karl Mayer; Muller Frick; Runyuan Warp Knitting; Taiwan Giu Chun Ind .; Fujian Xingang Textile Machinery; And the Yuejian Group.

Embodiments of the prosthetic device according to the present invention can be knitted on a micro gauge flatbed knitting machine. A non-limiting list of flat bed machines capable of manufacturing surgical meshes in accordance with aspects of the present invention includes Around Star; Boosan; Cixing Textile Machine; Fengshen; Flying Tiger Machinery; Fujian Hongqi; G &P;Gortex;Jinlong;JP; Jy Leh; Kauo Heng Co., Ltd .; Matsuya; Nan Sing Machinery Limited; Nantong Sansi Instrument; Shima Seiki; Nantong Tianyuan; And Ningbo Yuren Knitting.

Figures 1 to 20 illustrate examples of meshes generated in accordance with aspects of the present invention. Referring to FIGS. 1A and 1B, an example of a mesh 100 is created on a single needle bed warp knitting machine in accordance with aspects of the present invention. FIG. 1A shows the technical back 100A of the mesh 100 and FIG. 1B shows the technical front 100B of the mesh 100. FIG.

Referring to Figures 2A and 2B, an example of a mesh 200 is created on a dual needle bed warp knitting machine in accordance with aspects of the present invention. Figure 2A shows the technical front 200A of the mesh 200 and Figure 2B shows the technical back pressure 200B of the mesh 200. [

Figure 3 illustrates an example of a mesh 300 produced with a single fiber silk yarn in accordance with aspects of the present invention.

Figure 4 illustrates an example of a mesh 400 created on a single needle bed warp knitting machine in accordance with aspects of the present invention.

Figure 5A shows an example of a mesh 500A created on a dual needle bed warp knitting machine. Mesh 500A has parallelogram holes with sections that illustrate the flush design in accordance with aspects of the present invention. On the other hand, FIG. 5B shows an example of the mesh 500B created on a double needle bed warp knitting machine. An example of mesh 500B has hexagon holes according to aspects of the present invention.

Figures 6A and 6B illustrate examples of narrow mesh fabrics 600A and 600B in accordance with aspects of the present invention. The mesh fabrics 600A and 600B have varying stitch densities that merge the flush changes.

Referring to FIG. 7, an example of a mesh 700 merges loop files according to aspects of the present invention. Figure 8 illustrates an example of a narrow mesh fabric 800 having a hole design achieved through variations in actual feed rates in accordance with aspects of the present invention.

9A illustrates an example of a collapsed mesh fabric 900A having a hexagon-shaped aperture in accordance with aspects of the present invention. On the other hand, Fig. 9B shows an example of an open mesh fabric 900B having a hexagonally shaped hole in accordance with aspects of the present invention.

As shown in FIG. 10, an example of a stable non-collapsible mesh fabric 1000 includes hexagonal-shaped holes in accordance with aspects of the present invention.

11A shows an example of a three dimensional mesh 1100 having the same technical forward and technical rear according to aspects of the present invention. FIG. 11B shows the 2.55 mm thick of the three-dimensional mesh 1100. Fig. 12 shows another example of a three-dimensional mesh 1200 having a thickness of 3.28 mm according to aspects of the present invention.

Figures 13A-13C illustrate examples of non-porous meshes 1300 in accordance with aspects of the present invention. 13A shows the technical front 1300A of the non-porous mesh 1300. FIG. FIG. 13B shows the technical back 1300B of the non-porous mesh 1300. FIG. 13C shows that the non-porous mesh 1300 has a thickness of 5.87 mm.

14A shows an example of a three dimensional mesh 1400 having the same technical forward and technical rear according to aspects of the present invention. 14B shows that the 3D mesh 1400 has a thickness of approximately 5.36 mm. 15A and 15B illustrate another example of a three dimensional mesh fabric 1500 in accordance with aspects of the present invention. Figure 15A shows the technical front 1500A of the fabric 1500 and Figure 15B shows the technical back 1500B of the fabric 1500. [

FIGS. 16-20 illustrate examples of meshes 1600, 1700, 1800, 1900, and 2000 generated on a dual needle bed weft knitting machine. The meshes 1600, 1700, 1800, 1900, and 2000 illustrate the shaping of the mesh for breast support applications in accordance with aspects of the present invention.

The test method was developed to check the curvature of the surgical mesh formed in accordance with aspects of the present invention. In the test method, the surgical mesh is assessed according to the number needed to incise the mesh with the surgical margin. The mesh was found to have excellent incision because it takes one scissor stroke to incise it. The mesh was also cut diagonally and in circular patterns to determine how easily the mesh was released and once it was dissected. The mesh is not released in one or more modes after being incised in both directions. To further determine if the mesh is loosened, the suture passes through the hole closest to the cut edge and is pulled out. This adjustment does not loosen the mesh. Thus, the surgical mesh can be easily dissected and not released after conditioning.

Embodiments can be treated with a surface treatment, which increases the material hydrophilicity, biocompatibility, physical and mechanical properties such as anti-bacterial and antimicrobial coatings as well as management for ease of dissection and graft tugging. Specific examples of surface treatments are:

● Plasma deformation

Including, but not limited to, proteins such as, but not limited to, fibronectin, denatured collagen or gelatin, collagen gels and hydroformin by a shared link or other chemical or physical method

Peptides with hydrophilic and hydrophobic ends

• Tappha contains one silk-binding sequence and one biologically active sequence-biodegradable cellulose

● Surface sulfonation

● Ozone gas treatment

Physical binding and chemically stabilized peptides

● DNA / RNA plasmid

● Peptide nucleic acid

● Abbimer

● Modified and unmodified polysaccharide coatings

● Carbohydrate coating

● Anti-bacterial coating

● Antimicrobial coating

● Phosphoryl chloride coating

A method for assessing the ease of delivery through the cannula was performed to ascertain whether the surgical mesh could be used as a laparoscopy. The various lengths were rolled and pulled through two different standard size cannulas using a surgical grasper. The mesh was evaluated to determine if there was any damage to the mesh. The mesh pulled through the cannula was found to have some distortion in the corners maintained by the grasper. The 16 cm and 18 cm lengths of the rolled and pulled mesh through the 8 mm cannula each have minimal wear and one distorted hole. It has also been found that no damage has been done to the cannula or diaphragm in any test. It has been found that an appropriately sized surgical mesh has successfully passed through a laparoscopic can- press without damage, enabling efficient use during the laparoscopic procedure.

The surgical mesh device according to aspects of the present invention was found to be bioabsorbed by approximately 100 days to 50%. In studies by Horan et al., Sprague-Dawley rats were used to compare the bio-reabsorption of the examples according to the invention with the Mersilene (TM) mesh (Ethicon, Somerville, N.J.). The histological report from the paper mentions that after 94 days, 43% of the initial mesh of the Examples remained relative to 96% of the Mersilene ™ mesh. It was also reported that the growth was more uniform in the meshes of the Examples than the Mersilene ™ Mesh. Mersilene ™ was found to have less growth in the defect area than along the abdominal wall.

Physical properties include thickness, density, and hole size. Thickness was measured using a J100 keeper dial thickness gauge. The Mitsuto digimatic caliper was used to find the length and width of the samples; It is used to calculate the density. Density was found by multiplying the mesh length, width and thickness, and dividing the result by mass. The hole size was found by photographing the mesh with an Olympus SZX7 dissecting microscope at 0.8x magnification. Measurements were taken using Image Pro 5.1 software and values were averaged over several measurements. The physical characteristics of the sample meshes, including embodiments according to the present invention, are provided in Table 2.

device Physical Characterization Thickness (mm) Hole size (mm ² ) Density (g / cm ³⁾ Mersilene mesh 0.31 ± 0.01 0.506 + 0.035 0.143 + - 0.003 Bard Mesh 0.72 ± 0.00 0.465 + 0.029 0.130 0.005 Non-crylike mesh 0.22 ± 0.01 0.064 0.017 0.253 + 0.014 Current embodiments - Single needle bed (SB) 1.0 + 0.04 0.640 0.409 0.176 ± 0.002 Current Embodiments - Dual Needle Bed (DB) 0.80 ± 0.20 1.27 0.135 - 0.165

All devices were cut to the dimensions specified in Table 3 for each type of mechanical analysis. Samples were incubated in phosphate buffered saline (PBS) for 3 ± 1.25 hours at 37 ± 2 ° C prior to mechanical analysis to provide characteristics in a wet environment. Samples were removed from the solution and immediately tested.

Test form Length (mm) Width (mm) Tensile force 60 10 Burst 32 32 Pulled suture 40 20 Ripped 60 40 Tension fatigue 60 40

Ball burst test samples were reduced due to limitations in material dimensions. The test fixture used was a reduced (1: 2.5) version of what was recommended by ASTM standard D3787. The samples were centered in a fixture and a burst with a 10 mm diameter ball running at a displacement rate of 60 mm / min. The maximum stress and stiffness were determined from burst sets. The results are shown in Table 4.

device Burst strength Stress (MPa) Stiffness (N / mm) Mersilene mesh 0.27 ± 0.01 13.36 + - 0.85 Bard Mesh 0.98 + 0.04 38.28 ± 1.49 Non-crylike mesh 0.59 ± 0.05 32.27 ± 1.86 Fibitex polypropylene mesh 0.59 + 0.04 29.78 ± 1.33 Fermat Cole biologic implant 1.27 + - 0.27 128.38 + - 22.14 Current Embodiments (SB) 0.76 + 0.04 46.10 ± 2.16 Current Embodiments (DB) 0.66 40.9

Tensile testing was pre-performed along the fabric formation and width axes of each device. A 1 cm length of mesh on each end of the device was inserted between parts of a 3.0 mm thick silicone and mounted on a pneumatic fabric clamp with a clamping pressure of 70-85 psi. The samples were loaded with controlled displacement by testing at failure rates of 100% / s (2400 mm / min) and / or 67% / s (1600 mm / min) The ultimate tensile strength (UTS), linear stiffness and percent elongation at failure are shown in the following tables. The results can be found in Tables 5-8. The input of &quot; NT &quot; indicates that the data has not yet been tested.

device Tensile strength SPTF (fabric forming axis-1600mm / min) century
(N) stress
(MPa) Stiffness
(N / mm) % Elong. @
damage Mersilene mesh 46.14 ± 3.15 10.04 + - 0.71 0.90 + 0.06 132.1% ± 9.3% Bard Mesh 30.90 ± 2.0 16.64 ± 1.16 3.32 ± 0.26 106.5% ± 3.2% Non-crylike mesh 35.69 ± 3.30 35.89 + - 4.48 2.59 ± 0.33 89.0% ± 7.3% Current Embodiments (SB) 76.72 + - 4.36 10.06 + - 0.38 7.13 + - 0.50 41.5% ± 2.3% Current Embodiments Mesh (DB) NT NT NT NT

device Tensile strength SPTF (fabric forming axis-2400 mm / min) century
(N) stress
(MPa) Stiffness
(N / mm) % Elong. @
damage Mersilene mesh 43.87 ± 5.19 14.15 ± 1.68 2.18 ± 0.3 56.6% ± 3.5% Bard Mesh 35.29 ± 5.69 4.90 ± 0.79 0.80 + - 0.23 177.3% ± 13.2% Non-crylike mesh 30.88 + - 3.30 14.04 1.50 0.76 + 0.17 191.9% ± 14.2% Belt-in polypropylene mesh 23.05 ± 3.75 5.36 ± 0.87 0.57 + 0.07 110.0% ± 13.6% Fermat Cole biologic implant 164.52 ± 30.58 13.71 + - 2.55 23.94 + - 2.7 23.5% ± 3.3% Current Embodiments (SB) 72.31 + - 7.80 6.95 + - 0.75 4.31 ± 0.3 45.5% ± 5.2% Current Embodiments (DB) 74.62 ± 2.70 8.68 ± 0.31 4.25 + 0.13 48.3% ± 2.1%

device Tensile strength SPTF (fabric width axis-2400mm / min) century
(N) stress
(MPa) Stiffness
(N / mm) % Elong. @
damage Mersilene mesh 31.14 ± 2.21 10.04 + - 0.71 0.90 + 0.06 132.1% ± 9.3% Bard Mesh 119.80 + - 8.36 16.64 ± 1.16 3.32 ± 0.26 106.5% ± 3.2% Non-crylike mesh 78.96 ± 9.86 35.89 + - 4.48 2.59 ± 0.33 89.0% ± 7.3% Current Embodiments (SB) 104.58 ± 3.96 10.06 + - 0.38 7.13 + - 0.50 41.5% ± 2.3% Current Embodiments (DB) NT NT NT NT

device Tensile strength SPTF (fabric width axis-2400mm / min) century
(N) stress
(MPa) Stiffness
(N / mm) % Elong. @
damage Mersilene mesh 28.11 + - 2.93 28.11 + - 2.93 1.05 + 0.13 128.2% ± 23.6% Bard Mesh 103.53 + - 8.92 14.38 ± 1.24 3.43 ± 0.5 94.0% ± 8.4% Non-crylike mesh 106.65 ± 8.46 48.48 ± 3.85 5.08 ± 0.1 58.6% ± 8.4% Belt-in polypropylene mesh 30.24 + - 5.77 7.03 + - 1.34 1.48 ± 0.1 89.6% ± 9.6% Fermat Cole biologic implant 67.71 + - 13.36 5.64 ± 1.11 8.56 ± 2.0 27.4% ± 4.2% Current Embodiments (SB) 98.84 + - 4.79 9.50 + - 0.46 8.48 ± 0.3 39.0% + - 4.1% Current Embodiments (DB) 70.08 + - 2.55 8.15 0.30 5.87 ± 0.22 33.6% ± 2.0%

The test intensity was found by a method involving incising a 10 mm &quot; tear &quot; to the edge, perpendicular to the long axis edge and centered along the length of the mesh. The mesh was mounted on pneumatic fabric clamps as described above in the tensile test methods. The samples were loaded through a displacement controlled test at a strain rate of 100% / s (2400 mm / min) until failure. Loads in failure and failure mode are shown in Table 9.

device Tear strength Century (N) Failure mode Mersilene mesh 110.30 ± 5.63 Tear failure: 6/6 Bard Mesh 181.70 ± 12.33 Tear failure: 6/6 Non-crylike mesh 109.35 + - 4.85 Tear failure: 6/6 Fibitex polypropylene mesh 108.14 + - 6.95 Tear failure: 4/6 Fermat Cole biologic implant 273.79 ± 65.57 Tear failure: 6/6 Embodiments (SB) 194.81 ± 9.12 Tear failure: 6/6 Embodiments (DB) NT NT

Tensile fatigue testing was performed on surgical mesh devices according to aspects of the present invention and represents pruned types including non-crryl mesh and bard mesh. The samples were loaded into pneumatic fabric clamps as described above in the above tensile test methods. Samples were immersed in PBS at room temperature during circulation. The sinusoidal load-controlled circulation was pre-performed at 60% of the ultimate tensile strength of the mesh. The number of cycles for failure was determined during the cyclic study and is shown in Table 10, where failures were indicated by bursts or permanent deformation exceeding 200%.

device Tension fatigue
Circulation, 60% UTS Bard Mesh 6994 ± 2987 Non-crylike mesh 91 ± 127 Embodiments (DB) 1950 ± 1409

The method has been developed to compare suture pulling strength of surgical mesh devices according to aspects of the present invention to other surgical meshes in the industry. The tested mesh was sutured through three 3.5 mm diameter suture anchors (Florida, Naples, Atrex) and secured to a rigid polyurethane foam with 15 pcf solids. Each device was centered 20 mm across the center anchor with a 3 mm suture byte distance used during mesh suture to the three anchors. The serrate bone was mounted and offset on the low bonded fabric clamp to provide loading along the axis of the device when the device was centered under the load cells. The free end of the mesh was inserted between the silicon parts and placed in the upper fabric clamp with a clamping force of 85 +/- 5 psi. The test was pre-performed under displacement control at a strain rate of 100% / s (1620 mm / min). The maximum load in the failure and failure mode is shown in Table 11.

device Pulled suture Century / Suture [N] Failure mode Mersilene mesh 13.50 ± 1.65 Mesh failure: 6 of 6 Bard Mesh 28.80 ± 3.39 Mesh failure: 6 of 6 Non-crylike mesh 12.90 ± 1.30 Mesh failure: 6 of 6 Fibitex polypropylene mesh 18.29 ± 4.04 Mesh failure: 6 of 6 Fermat Cole biologic implant 47.36 + - 7.94 Mesh failure: 6 of 6 Embodiments (SB) 41.00 ± 2.98 Mesh failure: 6 of 6 Embodiments (DB) 32.57 ± 2.30 Mesh failure: 6 of 6

By using a pattern for a dual needle bed mesh and modifying yarn size, yarn feed rate and / or needle bed width, the surgical mesh device according to aspects of the present invention can be adapted to the physical and mechanical properties Lt; / RTI &gt; Such properties include hole size, thickness, ultimate tensile strength, stiffness, burst strength, and pulled stitching. The pore size can be varied according to the feed rate to produce more open fabric and the thickness can range from 0.40 mm to as wide as 19.0 mm. Through variations on hole size and thickness, UTS, stiffness, burst strength, and grabbed stitches all have been modified to best accommodate variations in pore size and / or thickness to meet specific mechanical demands.

Such meshes created on a flat knitting machine are made in such a way as to increase or decrease the hole size and / or thickness by changing the yarn size and / or by changing the loop length found within the knitting setting. Loop positioning in combination with the node lock design allows changes to the shape and / or mechanical properties of the mesh. A thread suitable for a living body having elasticity such as a highly twisted silk can be used for molding.

Implantation and subsequent testing of the mesh in accordance with aspects of the present invention is illustrated in Figures 21A-21D. Figure 21a shows the full-thickness mouse abdominal defects created using a custom designed 1-cm stainless steel punch. The defect is oval in shape due to the applied body wall tension. Figure 21b shows a 4 cm x 4 cm implant centered on the top of the open defect and held in place with a single interrupted polypropylene suture (arrow) through the implant and muscle. Figure 21c shows a 94 day post-transplantation of the denatured specimen. 21D shows a ball burst test performed with a 1-cm diameter ball pulled through a mesh-reinforced defect site.

While the invention has been described in conjunction with a number of exemplary embodiments and implementations, the invention is not so limited, but rather covers various modifications and equivalent arrangements. For example, a knitted mesh according to aspects of the present invention can be used in a fill material. In one application, the knitted mesh may be cut into 1 mm x 1 mm sections to separate one or more nodes, e.g., three nodes. The sections may be added to the adipose tissue or hydro-gel to form a solution that can be injected into the defect area. Advantageously, the filler material may provide the desired texture, but will not dissolve.

In another aspect of the invention, a knitted silk mesh or scaffold is used in the breast reconstruction procedure. Thus, the present invention relates to a method (s) of using a knitted silk scaffold in single-stage or two-stage breast reconstruction. The method includes sealing a knitted silk scaffold to the chest wall that creates a pocket for positioning a tissue expander or breast implant. 28A and 28B illustrate the positioning of the silk scaffold according to the method of the present invention. Figure 29 shows a pocket or sling formed by a scaffold at a stomach muscle suitable for holding a tissue expander or breast implant.

In another preferred aspect of the present invention, the silk scaffold is a node-lock configuration, wherein the knitted mesh or scaffold comprises at least two chambers, at least two chambers are laid in the knitting direction, And wherein the at least two chambers include a first chamber and a second chamber extending between the two nodes, the second chamber having a higher tension at two nodes than the first chamber, Substantially prevents movement at these two nodes and substantially prevents the knitted mesh from unwinding at the nodes. Knitted silk scaffolds have other characteristics discussed herein that are particularly desirable in breast reconstruction procedures.

The fabrics described herein may be designed for use as implantable prostheses in surgical procedures performed to alter the size, shape, location, or contour of a patient &apos; s breast mound. In one embodiment, the fabric described herein is used as an implantable prosthetic device for supporting surrounding tissue while acting as a scaffold for the in vivo production of such supporting tissue within the patient &apos; s breast.

As such, the fabrics described herein are useful for implantation in procedures such as breast augmentation, breast augmentation, and breast reconstruction post-mastectomy.

In one embodiment, the fabric further provides a site for in vivo growth of new breast tissue.

In one embodiment, the fabric also acts as a scaffold for tissue production in the breast at the implant site. The new tissue created to replace the fabric can serve as an integral component of breast recovery / enlargement and / or can help recover from incisions made during surgery (e.g., breast reconstruction, breast augmentation, mastectomy) have. The particular size, shape and fiber organization of the fabric will vary with the type of procedure and the particular use of the fabric in such procedures, and may be determined by the technician for each individual patient. In one embodiment, the fabric is designed to at least partially replace the breast connective tissue (e.g., tissue lost or otherwise damaged due to surgical removal) in the patient.

The fabric may take the form of one or more components that are similar to, and designed to replicate, natural tissue components within the breast, as described herein. The fabric may be designed to replicate a particular tissue structure or may be designed to resemble a plurality of tissue structures (e. G., Normally closely associated or interconnected with the breast).

In one embodiment, the fabric is designed to replace or replicate connective tissues (e.g., connective tissue, breast fascia, fibrous layer) that rotate the breast region and connect the fascia and / or skin. In one embodiment, the fabric is a two-dimensional web or mesh. The web or mesh may be designed to have one or more biomechanical properties of the fascia of the breast (e.g., epidermal, myofascial).

The fabric in the form of a web or mesh may further comprise one or more components similar to natural tissue components in the breast (e.g., ligament or ligament-like structures). For example, a web or mesh with thicker ligament-like structures is inserted through the body of the mesh. Such thicker structures may follow the length of the web through the center of the web and may be dispersed in various patterns, for example in radial straight and / or branch lines from the center. They may have circular / elliptical shapes (e.g., circles of different sizes arranged to have the same center). In one embodiment, the structures are arranged in a pattern over a web similar to the connective tissue of the breast. Such structures may be designed and created as integral components of the web or mesh, or they may be generated separately and may be additional post-generation of the web or mesh by attachment. Such structural components of the breast are known in the prior art.

The fabrics are composed of interwoven yarns (for example, woven together by weaving, knitting, or stitching bonding). The yarns are made of the sericin-extracted fibroin fibers described herein. Fibroin fibers can be threaded by 1, 2, 3 or 4 level hierarchical organization, as described herein. For example, parallel or interwoven fibers are grouped together to form a thread in a single-level hierarchical organization. The second level of hierarchical organization is added when a plurality of groups are interwoven together to form one or more bundles that are present in the rooms. A third level of hierarchical organization is added when a plurality of bundles are interwoven together to form one or more strands present in the chambers. The fourth level of hierarchical organization is added when a plurality of strands are interwoven together to form one or more codes present in the chambers. The interweaving consists of being randomly aligned with each other through parallel spiral organization. Such organization may occur at any hierarchical level to produce a fabric having the desired properties (biomechanical, porosity, etc.). Those skilled in the art will recognize that various combinations of these levels of hierarchical organization can be used to create fabrics having different overall structures (e.g., twisted, braided, knit, stitched). Additionally, fabrics having any combination of these structures may be produced.

In one embodiment, the fabric is designed and implanted to support the prosthetic and / or breast structure located within the breast. The structure of the fabric has at least one surface (first surface) that extends into at least one dimension (first dimension) and is adapted to engage the resulting breast (including natural breast tissue and / or prosthetic breast implants) . By proper positioning of the fabric within the patient, the resulting breast structure is molded by the fabric.

The fabric may be designed to have a variety of different overall shapes (e.g., to conform to the breast tissue when implanted). For example, fabrics that are webs or meshes may be flat or concave. The fabric may have a predefined shape within the patient that is adapted to conform to at least a portion of a region of natural breast tissue or breast implant. In one embodiment, the fabric has a crescent shape or an oval shape. Circular, semi-circular, elliptical, cup-shaped, or half-circular forms may also be used. Extended strips may also be used. In one embodiment, the fabric is sufficiently large to fully or partially cover the lower and / or side sections of the breast prosthesis or breast tissue. Such a configuration allows the fabric to support the lower pole of the breast prosthesis and / or the natural breast tissue, for example, to emulate the inner and lateral breast folds. However, the positioning of the fabric will not be limited to any particular place or arrangement within the breast, but will depend on the specific purposes of the procedure and organization. In one embodiment, the fabric is formed in a sling shape (e.g., providing a support for the breast or breast implants in the patient). In one embodiment, the fabric is formed in an elongated form (e. G., Providing support in the submammary region of the breast, within the patient). In one embodiment, the fabric is formed in a cup shape (e.g., providing a mid or side support for the breast in a patient).

The fabric may further include portions adapted to be secured to the tissue of the patient. This will facilitate implantation. The structure of the adapted portion will depend on the attachment to the patient and / or the means of the attachment site. In one embodiment, the attachment is tissue surrounding the patient &apos; s pleural cavity. In one embodiment, the attachment is a soft tissue that surrounds the breast tissue or surrounds the prosthetic breast implant. In one embodiment, the attachment is a bone structure adjacent to the breast tissue or adjacent to the prosthetic breast implant.

The fabric may further comprise one or more drugs that promote the growth of cells to produce new breast tissue. Such agents include, without limitation, the cell adhesion factors, growth factors, adhesion promoters, agents, and chymotry tracers described herein.

Breast Anatomy

The breast-folded part is the natural boundary of the breast from below the point where the breast and chest meet. The submerged folds are located on the 15-16 ribs. The lowest part extends into six intercostal spaces. This folded portion has a constant position.

The submammary region contains a large number of thick collagen fibers stretched between the epidermal fascia and the deep fascia. The epidermal fascia consists of both collagen and elastic fibers. The epidermal fascia of the female breast subcutaneous epidermal system is exceptionally thick. The epidermal fascia is connected to the deep fascia (muscle fascia) through a thick support along the dress bone. The connecting band known as the anterior breast capsule (fascia breast) is separated from the epidermal fascia. These fascia and the fascia in the subclavian region support the streamline by supporting fibers (Cooper's ligaments). Cooper's ligaments and also the fascia breast are separated from the epidermal fascia and connect to the skin (dermis). The submammary support is derived from the epidermal fascia and consists of merging with a dense connection support. The epidermal fascia is separated from the muscle fascia through a thin, deep subcutaneous layer with a connection support almost horizontal. They are also joined by elastic diaphragms, including the lipid lobes. In dry women, only a few of these are present and they are fixed in the small, deeper muscle fascia. Along the dressing bone, the epidermal fascia with deeper fascia is melted. Inside, the epidermal fascia is merged into the anterior membrane of the appendage bone, and consists of fibers from the sternocleidomandibular and tendon devices of the large chest muscles.

The transverse fiber layer emerges from the fascia almost at the 6.sup.th rib and extends the entire length of the breast-fold. This structure has a more dense consistency and a different texture from the epidermal fascia. Between the epidermis and dermis, there is a layer composed of fibrous tissue and often fibrous tissue. In the breast area, the tissue has more fiber in the 6th rib-6th intercostal space. The epidermal fascia is connected to the deeper muscle fascia by a thicker support at the deep submucosal layer. Here, the epidermal fascia adheres to a deep plane (muscle fascia) and is more resistant to traction. Adhesion is made histologically with multiple short fiber connections that do not pass through the myofiber plane.

Breast ligaments form circumferential ligaments to the breast to form a circumferential fusion between the epidermal fascia and the deep fascia. These connective ligaments, which completely surround the breast to form a circular border between the epidermal fascia and the deep fascia, are often referred to as circumferential breast ligaments. Circumferential breast ligaments form a natural boundary connecting the two tissue layers that can be used by a physician who cuts between the layers to define and limit the degree of incision. These limited layers also provide areas for tissue growth as disclosed in U.S. Patent Application Publication No. 2008/0300681.

Use of Fabrics in Breast Surgery

Fabrics designed to act as tissue supports and / or scaffolds for breast reconstruction may be used in a wide variety of procedures involving, for example, breast augmentation procedures, breast augmentation procedures, breast augmentation including post-mastectomy reconstruction, or mastectomy Can be used.

One aspect of the invention relates to the use of the fabrics described herein in a method for supporting the breast structure in a patient. The method involves positioning the fabric within the patient (e.g., as a scaffold for support and configured as a new growth tissue) in a support position relative to the breast structure. The breast structure may include natural breast tissue (e. G., Wired), or breast prosthesis (e. G., Breast implants), or combinations thereof. In general, this entails implanting the fabric structure at the anatomical location between the skin covering the breast tissue and the breast tissue to be supported within the patient and / or the breast implant. The particular location (e.g., depth) between the skin and the supported tissue will vary according to the actual procedure and may be determined by the skilled artisan. In one embodiment, locating the fabric includes covering the lower and side sections of the breast region. In one embodiment, the fabric is inserted into the inner side of the breast and / or implant and reduces the inner displacement of the breast and / or implant. In one embodiment, the fabric is inserted into the lateral side of the breast to support lateral positioning of the breast and / or implant and / or to reduce lateral displacement of the breast and / or implant. In one embodiment, the fabric includes one or more biomechanical properties of tissue naturally present in the breast at such a support position. Such organizations are described herein.

Methods of using support matrices as surgical instruments are well known in the art and can be applied to the fabrics described herein by the skilled artisan. Implanting the fabric generally involves inserting the fabric structure and fixing the matrix in the desired location. Such methods generally include fixation of the matrix to a desired location (e.g., across the lower and side sections to support the lower pole of the breast prosthesis / breast tissue, or along the sides or sides of the breast to prevent lateral or inward displacement) On the inner side). Fixing or attachment may be accomplished, for example, by positioning the stitching or staples, or using any suitable method known in the art through the use of adhesive devices. Appropriate methods for attachment of the fabrics described herein during the implantation procedure will be determined by the skilled artisan. The fabrics described herein can be attached to a bone (e.g., one or more ribs), muscle, or soft tissue. In one embodiment, the fabric is attached to one or more soft tissues within the breast region, as described herein. Various attachment methods are known in the art and include, without limitation, stitching, stapling, gluing, and layering in situ. Various attachment methods are described in U.S. Patent No. 5,584,884.

The exact location of the attachment will vary according to the particular procedure being performed and may be determined by the skilled artisan. In one embodiment, the attachment for securing the fabric is tissue surrounding the patient &apos; s pleural cavity. In one embodiment, the attachment or fixation is a soft tissue that surrounds the breast tissue and / or prosthetic implants within the patient. The fabric may alternatively be attached or fixed to the bony structure adjacent to the breast tissue and / or prosthetic implants in the patient.

It may be advantageous or necessary for the skilled artisan to form the fabric structure in a predefined fashion adapted to conform to the area of the natural breast tissue and / or prosthesis implant within the patient, or at least a portion thereof. Such useful forms include, without limitation, a circular shape, an oval shape, a crescent shape, a cup shape, and an elongated strip.

As described herein, it may be advantageous to treat the fabric structure with one or more drugs that promote cell growth.

Breast enlargement

In one embodiment, the fabric described herein is used as a surgical tool in breast enlargement. The term &quot; breast augmentation &quot; as used herein generally refers to increasing the size of the breast, such that prosthetic implants are achieved by insertion.

The fabric of the present invention can be used to promote wound healing and soft tissue reconstruction by providing strength and covering it at the site of the surgical incision (e. G., The breast implantation site). Provide instant intensity to the site or incision site of soft tissue reconstruction / enlargement, and provide a base for new tissue growth. In one embodiment, the fabric includes interconnecting the cells or the fibrous network to an intensity sufficient to provide interception and protection of the incision sites.

In one embodiment, the fabric described herein is used to position or reposition the breast prosthesis. For example, the fabric may be used to support the lower pole position of the breast implants, or may be used as a partial or complete covering of the breast implants. Covering the implants in the fabric provides an advantageous interface with the host tissue and reduces the potential for misplacement or capsule buildup. The covering of the implant also reduces or prevents tissue adhesion to the implant. Ultimately, the fabric can be absorbed and replaced by the infected tissue. As such, the fabric can provide temporary scaffolding and a well defined structure until it is no longer needed.

The fabric of the present invention may be used to reposition the breast implants in subsequent corrective surgery or may be used to prevent placement of the initial implants to prevent displacement. The fabric may be configured and implanted to position the breast implant at a desired location within the atom (e.g., under complete muscle, partial muscle, or subjacent positioning).

Implants are generally located within the thorax in one of three locations: (1) transplants under the large chest roots and below the breast tissue (subjacent); (2) implants partially under the muscles (partial muscles); (3) Transplants that are completely under the muscles (muscles). Postboard positioning implants the implant immediately behind the breast tissue and the submandibular ligament and in front of the large breast muscle. This positioning requires minimal complex surgery and results in the fastest recovery. Disadvantages of this positioning are increased opportunity for capsule building and greater visibility and vulnerability for implantation. This is because skin and breast tissue isolates the implant from the outside world. Depending on the amount of breast tissue available, the implant can see &quot; rippling &quot; through the skin.

Partial intramuscular positioning involves placing the implant under the large chest muscles. Because of this muscle structure, the implant is only partially covered. These alternatives reduce the risk of capsule buildup and visual implant replenishment, but the recovery time from this positioning is generally longer and more painful because the physician must regulate muscle during surgery. Also, due to increased swelling, the implant may no longer fall into its natural position after surgery. Complete sub-muscle positioning places the implant firmly behind the thoracic muscle wall. The implant is located behind the large breast muscle and is located behind both the supporting fascia (connective tissue) and non-pectoral muscle groups. This positioning is accompanied by more trauma surgical procedures, with longer recovery times and potential losses of internal bloat.

Regardless of the implant site, in the case of breast enlargement, the surgery is performed through an incision that is positioned to minimize long-term scarring. The incision is made in one of three areas: (1) a peripheral incision in the areola; (2) an incision underneath the breast, and (3) an incision in the armpit. The area around the areola allows the surgeon to position the implant in a submerged, partial muscle, or fully submuscular position, and the implant is inserted or removed through the incision. Like the circumference of the areola, the submerged folds provide all these types of positioning and provide both insertion and removal of the implant through the incision. An incision is made in the gap under the breast, allowing the scar to be carefully removed. Once the incision is made, the implant is inserted and acts perpendicular to the site.

Currently, there are very few techniques for reliably maintaining the position of implants positioned as part of an aesthetic or reconstructive surgical procedure. The wrong location of the implant is poor surgical technique, ie the implant pocket is too large or too low; Weight of graft; Or lack of soft tissue support. Moreover, in reconstructive patients, cancer therapy, such as anticancer therapy, weakens soft tissue, and surgery usually stops the natural anatomical plane of soft tissue. These factors are more severe in patients who have lost an excessive amount of weight. Such situations generally provide the inability of the general support structures within the breast, such as the breasts underneath to support the weight of the implant, and the excessively poor soft tissue support.

In one embodiment, the fabric described herein is implanted within the patient for initial positioning of the breast implant within the patient. In such an embodiment, the fabric may be configured to form a receiving region for receiving the breast implant. The fabric may further comprise at least one region for tissue attachment. One of the regions may be adapted to attach the fabric to the soft tissue or bone structure surrounding the breast implant within the patient, such as the periosteum of the thoracic cavity, via a first suture, or by conventional or endoscopic tacking.

During the implant placement or repositioning procedure, the physician utilizes an initial incision made to insert the fabric, provided that the initial incision is in the periphery or breast-folded area to access and position the implant with the fabric . However, in certain situations, it may be necessary to create a new incision, such as the initial incision is in the armpit position. Once the incision is made, the fabric (e. G., Rolled) can be inserted into the body through the incision. The fabric may include sutures or tees at the distal end that may be removed so that the ends are once unwound at the desired location for implantation.

The fabric of the present invention may be configured to be implanted in a patient in a variable orientation according to the particular situation to be resolved or prevented. For example, when used to compensate for the internal displacement of the implant (mammography) or side displacement, the fabric is each placed in a substantially vertical position on the inside or lateral side of the implant. The fabric is placed in a substantially horizontal position to support the implant from below (otherwise known as a hairming out in the prior art), where the fabric will be used to compensate for the internal displacement of the implant. Proper positioning of the fabric during the initial implant location procedure depends on the desired location of the implant within the patient and the tissue structure surrounding the implant.

Fixation of the fabric is accomplished by positioning the incision, for example, by positioning a permanent seal at critical locations through tissue attachment areas, or through the use of a conventional or endoscopic tagging device. A submucosal folding incision may require proper suturing of the fabric, while a peripheral incision may enable the use of an endoscopic tagging device.

When the fabric is oriented in a vertical position to fix or prevent the inner displacement of the implant, the fabric may be secured in the tissue attachment area to one or more of the following structures and soft structures: 1) the posterior to the periosteum of the chest wall Wall, 2) upper crossover of the first and second portions to the sternal border of the chest wall, 3) lower crossover of the first and second portions to the periosteum of the chest wall, and 4) posterior aspect of the large thoracic fascia Anterior wall for.

Figures 31A, 31B, 31C, and 31D are photographs of exemplary breast augmentation (correction) surgical procedures in accordance with the present invention. FIG. 31A is a photograph showing the breast of an open-cut patient, the breast implant was removed, and the ceress cavity 100 was placed in the breast. FIG. 31B is a photograph of FIG. 31A showing a cerise capillary 100 additionally positioned within the breast. 31C is a photograph of the breast of FIG. 31B showing the cerise canal 100 in its final position in a place ready to support a new enlarged breast implant to be placed in place E. Figure 31d shows a photograph of the breast (both breasts now shown) of Figure 31c, and a very positive breast enlargement result after the wound has been occlusion-sealed (on the breast implants supported by the ceres fold 100) Show.

Breast Lift (Breast Lift)

Mastectomy, or breast lift, is a procedure designed to improve the appearance of a sagging or dehydrating breast. Mastectomy is one of the biggest challenges for breast physicians. While many techniques offer this improvement in the form of breasts, aesthetic improvements come at the cost of scars. Moreover, the use of implants in mammography provides specific risk and complexity. There are four main types of breast lifts: crescent breast fixation, donut breast fixation, lollipop or vertical breast fixation and anchor breast fixation based on the type of incision and the resulting scar.

Crescent breast fixation is for patients with excessive breast skin with soft sagging in the upper half of the breast and normal normal skin in the lower half, and a semi-circular incision is made on the upper part of the areola. The crescent-shaped portion of the skin is removed, and when the skin edges are woven together, the nipples and areola are slightly elevated (1-2 inches). Crescent breast fixation is best for women with soft breast pouches (sagging).

Because the incision is made around the circumference of the areola, donut breast fixation, called Benelli Breast Fixation or Canine Incision Breast Fixation, removes the ring of skin from the outside of the areola. The sutures are then positioned around the areola, and the skin is tightened as a pouch suture to lift the breast. The wrinkling of the skin can occur and usually resolve itself within a few months. Donut breast anchoring is also useful for women with a protruding teat / Areola complex (often referred to as a toe or missile breasts) and can also be used to simultaneously reduce the size of the areola.

Lollipop or vertical breast fixation is when the incision for lollipop breast anchoring is made around the areola and under the center of the breast for the breast-folded, as the name implies. This technique is used to soften the average breast ptosis. The size of the areola can be reduced at the same time, such as in a foliar incision or a donut lift.

In addition, anchor breast anchoring, referred to as a wise pattern (or often a wise pattern) breast anchoring, whole breast lift, or inverted-T incision, is considered to be a typical technique for breast lifting. The incision is made around the areola, beneath the center of the lower part of the breasts, and then across the breasts at the breasts. Like donut and lollipop incisions, areola can be made smaller at the same time. The resulting scar is in the form of an anchor. Despite the wise pattern or anchor breast fixation used as a standard, only those that are appropriate for serious breast sagging are now generally preserved.

Breast fixation may be performed with or without a corresponding change in breast size (breast reduction or breast enlargement).

The fabrics described herein can be used in any of these types of procedures. In one embodiment, the fabrics described herein are used in procedures to promote wound healing and / or tissue support. The fabric may also be used to enlarge or replace pre-existing breast tissue.

In one embodiment, the fabric is used in a method of reducing breast volume. As a non-limiting example, the method can be performed as follows:

1. Create four points on the breast around the areola to determine the amount of skin needed for both the excess skin in the surrounding area and the external skin lining of the new breast for the flap to be used for internal skin lining.

2. De-epithelium flap to maintain center pedicle.

3. Displacement of the subcutaneous breast below the level of the pectoral muscle fascia.

4. Cut the skin based on the upper hemisphere to gradually increase the thickness of subcutaneous fat close to the skin.

5. Re-incision the mid-wedge of the tissue and shorten the upper hemisphere.

6. Incision of the skin from the tissue-diseased tissue in the lower hemisphere of the breast.

7. Optionally re-incision the second central wedge of tissue at the lower hemisphere.

8. Apply a properly shaped fabric over the skin flap in the lower hemisphere to sling the underside of the breast.

9. Seal the fabric on the pectoral fascia to promote the elevation and shape of the cone under the breast.

10. Areola cuts the outer skin lining while securing the skin to the outer skin lining.

11. Dressing the breast in a supportive manner that allows multiple drainage.

In another embodiment, the fabric is used in a method of lifting breast tissue. As a non-limiting example, the method can be performed as follows:

1. Create four points on the breast around the areola to determine the amount of skin needed for both the excess skin in the surrounding area and the external skin lining of the new breast for the flap to be used for internal skin lining.

2. De-epithelium flap to maintain center pedicle.

3. Displacement of the subcutaneous breast below the level of the pectoral muscle fascia.

4. Cut the skin based on the upper hemisphere to gradually increase the thickness of subcutaneous fat close to the skin.

5. Incision of the skin from the tissue-diseased tissue in the lower hemisphere of the breast.

6. Apply a properly shaped fabric over the skin flap in the lower hemisphere to sling the underside of the breast.

7. Suture the fabric in the pectoral fascia to promote the rise and shape of the cone under the breast.

8. Arreola sutures to block outer skin lining while securing skin to outer skin lining.

9. Dressing the breast in a supporting manner that allows drainage of the effluent.

In another embodiment, the fabric is used in a breast fixation method using breast augmentation. As a non-limiting example, the method can be performed as follows:

1. If the implant is large and sagging is larger, or if the implant is small, insert a breast implant under the muscle in the subcutaneous pocket below the mammary line in the granulation pocket.

2. Create four points on the breast around the areola to determine the amount of skin needed for both the excess skin in the surrounding area and the external skin lining of the new breast for the flap to be used for internal skin lining.

3. De-epithelium flap to maintain center pedicle.

4. Displacement of the subcutaneous breast below the level of the pectoral muscle fascia.

5. Cut the skin based on the upper hemisphere to gradually increase the thickness of subcutaneous fat close to the skin.

6. Incision of the skin from the tissue-diseased tissue in the lower hemisphere of the breast.

7. Apply breast augmentation on the skin flap in the lower hemisphere to sling the other underside of the breast.

8. Suture the fabric in the pectoralis fascia to promote the rise and shape of the submandibular cone.

9. Arreola sutures to block outer skin lining while securing skin to outer skin lining.

10. Dressing the breast in a supportive manner that allows multiple drainage.

Breast reconstruction

Breast reconstruction is the regeneration of the breast fixation following the breast. Breast fixation is the most common treatment for localized breast cancer. Breast reconstruction can be performed at breast fixation, but better candidates are often confirmation of cancer removal as a graft material, and reconstruction will interfere with detection of recurrence. Reconstruction generally involves, in the first series of surgeries, two partial processes in which a tissue expander is inserted under the skin and large chest muscles. An inflator is an air or saline-filled balloon that is periodically inserted over several months with additional saline to progressively stretch the skin and muscles. When the skin and muscles are long enough, the implant (saline or silicone) is inserted to reposition the natural breast structure. However, to properly maintain the implant, an additional section of the patient's tissue, autograft, should be used along the lateral side of the breasts, typically a wide isometric or rectal muscle along the dog. The autograft tissue has the risk of total coverage and support and tissue mobility of the implant, or an expander having muscular tissue in the breast fixation pocket is challenged. Without proper coverage, the implant can be exposed and reduce aesthetic outcomes.

The fabrics described herein can be used in procedures to promote wound healing and / or tissue support. The fabric may also be used to enlarge or replace pre-existing breast tissue. The fabric may additionally be used to position implants described herein in the breast reconstruction procedure. In one embodiment, the fabric described herein is used in conjunction with, or instead of, a breast reconstruction procedure (e. G., Covering and / or supporting the implant or inflator in the lower breast pole) with self-implanted knitting.

In one embodiment, the fabric of the present invention is used to provide strength to weakened fascia and / or soft tissue by breast anchoring surgery. During breast fixation, the epidermal myofascial system in the submerged fold is preserved as much as possible. Generally, Cooper's ligaments are incised during surgery. In one embodiment, the fabric of the present invention is used to regenerate the submucosal folds following breast fixation. In one embodiment, the fabric of the present invention is designed to have one or more biomechanical properties of a submerged folded tissue that is damaged during the breast fixation process. This fabric can be implanted in a damaged tissue site. Such implanted tissue supports the reconstructed breast and also acts as a scaffold for the creation of new tissue at that site in the body.

In one embodiment, the fabric of the present invention may be used in place of or in combination with a net flap in breast reconstruction after breast anchoring. One such procedure is described by Goes and Macedo (The Surgery of the Breast, Principles and Art, Lippincott Williams & Wilkins, Second Edition, Chapter 52, pp. 786-793, 2006).

Mesh  Pockets and templates

32 illustrates a three dimensional mesh having a pocket shape for positioning and securing the breast implant against the chest wall in accordance with aspects of the present invention.

32, the silk fibroin pocket or pouch 3200 is formed in a three-dimensional structure having the shape of a granular pouch type pouch. The structure allows for the insertion and placement of the breast implant 3210 within the pocket 3200 . The pocket structure permits stitching of one of the structural surfaces 3220 with respect to the chest wall, thereby positioning the pocket 3200 and the relative breast implant 3210 at the desired location. The knitted mesh of the pocket structure (represented by the cross-hatch) has a physical and mechanical property to keep the breast implant 3210 in place during pocket biodegradation while the newly formed tissue supports increasing the breast graft load Respectively. According to a particular aspect of the invention, the knitted mesh is in a pattern referred to as a &quot; node-lock &quot; design. The &quot; node-lock &quot; design substantially prevents unwinding and preserves the stability of the mesh device, particularly when the mesh device is incised.

Additional advantages may include preventing or correcting for the following surgical complications: erroneous positioning inside; Low pole enhancement to allow larger implants at primary expansion; Enlargement - strengthening the implant location during breast fixation; Excessive procedure - lateral / inward misalignment correction without neo-pockets or suture lines; Capsule build-up due to capsule formation.

32 is made with a seam 3230 ; It is well known that the two parts are laid together and interwoven together. 33 is a photograph of a breast implant on the exterior of a Cerris Cavity ^™ mesh pocket made according to FIG. 32; Figure 34 is a picture breast implants seriseu cache placed on the fold ^™ mesh pocket made in accordance with Figure 32.

In another aspect of the invention, the pocket 3500 may have two different structural surfaces 3520A and 3520B that are characterized by varying physical and mechanical properties. Figure 35 illustrates a three dimensional mesh with pocket implants and breast implants according to aspects of the present invention. 35 illustrates a pocket having two sides 3520A and 3520B . In a preferred aspect of the invention, one of the faces of the pocket is a knitted mesh having a lower elongation capability than the other face. In another preferred aspect of the present invention, one of the faces of the pocket is a knitted mesh having a higher elongation capability than the other face. For example, one side may have a low elongation to preserve the bottom-out breast implant while allowing positioning by suturing the thoracic wall, while the other side may have more High elongation. Pocket 3500 is made with no seams (such as folding) or with seams in any one case made up of two different fabric structures (represented by cross-hatches). The fabric of the sides is a knit with a double needle bed or a single needle bed, or a tubular knit. In a preferred aspect of the present invention, the structure is seamless to allow better and uniform bioresorption of the pouch or pouch with the joint. In addition, stimulation of surrounding tissue is minimized by using seamless design.

Figure 36 illustrates a breast implant that is external to a pocket having a low elongation on top in accordance with aspects of the present invention. Figure 37 shows a breast implant that is external to a pocket having a high elongation on top in accordance with aspects of the present invention. Figure 38 shows a breast implant placed in a pocket according to aspects of the present invention.

Another aspect of the present invention is shown in Fig. Figure 39 illustrates a three dimensional mesh with dotted and pocket shapes that refer to the transition 3900 between the pocket 3910 and the non-pocket 3920 in accordance with aspects of the present invention. Figure 40 illustrates a three dimensional mesh with a breast implant that refers to a transition between pocket 4000 and non-pocket 4010 in accordance with aspects of the present invention. 40 shows a non-pocket region 4010 that can be cut for molding. The structure is formed in a process that defines the incision area by knitting the non-pocket 4010 configuration only within the incision area for molding. The warp knit Jacquard machine is the preferred apparatus for making the pouch described herein. When cutting along the transition 4030 between the pocket 4000 and the non-pocket 4010 structure, the pocket is still sealed within the cutting edge by the non-pocket structure.

In another aspect of the present invention, a template 4100 is provided for dissecting the mesh shape. Figure 41 illustrates a template for dissecting mesh shapes in accordance with aspects of the present invention.

The first portion of the structure is shown in Figure 41 as a dimension proportional to the size of the breast implant 4200 for adoption as shown in Figure 42 compared to the three dimensional mesh panel 4300 shown in Figure 43 Lt ; RTI ID = 0.0 &gt; 4120 &lt; / RTI &gt; After opening the template with the surgical marker, the panel 4400 preferably has the sealing tabs 4410 shown in FIG. 44 and is trimmed to the desired shape. The sealing tabs 4410 are incorporated into the shape of the trimmed panel. The second portion of the structure is formed by introducing a template having open taps 4500 as shown in Fig. 45, with dimensions proportional to the size of the breast implant to be received, as compared to the mesh panel shown in Fig. After opening the template with the surgical marker, the slots 4610 are formed as shown in Fig.

Figure 47 illustrates a second portion of the structure sealed to the chest wall in accordance with aspects of the present invention. As shown in Figure 47, the second portion of the structure is sutured to the patient's chest at the position desired by the physician. Figure 48 shows a breast implant insertion into a pocket formed by two structures. The ribs of the first portion of the structures are inserted into and sealed in the slots of the second structure, and the breast implant is inserted into the pocket formed as shown in Fig.

In another aspect of the invention, the surgeon may position two first structures 4900A and 4900B with symmetrical, and thus symmetrical, two breast implants 4910A and 4910B , There is a second structure 4900B . Figure 49 shows forming two symmetrical pockets.

Figure 50 is a photograph showing an open template on a Cerescapold ^™ mesh panel in accordance with aspects of the present invention. Figure 51 is a photograph illustrating a Cerris café ^™ cut in a form according to aspects of the present invention. Figure 52 is a photograph illustrating a two part sericeous folded ^™ mesh structure sealed in accordance with aspects of the present invention. Figure 53 is a graph showing the breast implant 2 seriseu cache fold ^™ mesh structure of the portion with the water inserted in accordance with aspects of the present invention picture.

54A shows another mesh template 5400 in accordance with aspects of the present invention. In Fig. 54A, the template 5400 includes a first panel 5410A and a second panel 5410B . As shown in Fig. 54A, the first panel 5410A has mainly a round shape, and the second panel 5410B has mainly a half-circular shape. As shown in Fig. 54A, the panel is composed of a single knitted mesh. Preferably, the knitted mesh is in a node-lock pattern. Examples of sealing locations 5420 are shown for illustrative purposes. In accordance with the present invention, the first panel 5410A is sealed to the chest wall and the second panel 5410B is folded over the fold line 5430 to form a pocket or pouch suitable for insertion of the mammary graft.

Fig. 54B shows another embodiment of the mesh template 5400. Fig. 54B, the first panel 5410A is comprised of different knitted meshes, and the different knitted mesh may be both a node-lock design, but different mesh features than the 5410B and / . The panels of panels 5410A and 5410B preferably have variable elongation. More preferably, panel 5410B has a greater elongation than panel 5410A .

Figure 55 illustrates another mesh template 5500 in accordance with aspects of the present invention. As shown in FIG. 55, the mesh template 5500 includes a first panel 5510 and a second panel 5520 . The second panel 5520 is rectangular in shape. The first panel 5510 has a rectangular shape. As shown in FIG. 55, the second panel 5520 is larger in size than the first panel 5510 . Fold line 5540 is also shown for illustrative purposes, but may or may not be visible on the actual mesh template. Although the first and second panels may be meshes having the same characteristics and knit pattern, the first and second panels may optionally have different characteristics and / or different characteristics as indicated in Figure 55 by differences in the cross- &Lt; / RTI &gt; Suitable dimensions and ratios are shown in FIG.

In accordance with aspects of the present invention, examples of meshes or scaffolds having elongation properties suitable for use in the fabric structures of the present invention are shown in Figures 56a-61. Referring to the drawings, Figure 56A is a photograph of a pattern layout for a silk-based scaffold design in accordance with the present invention. 56A, item 130 is a mesh or a scaffold. This modification of the scaffold according to the present invention is preferably accomplished by the use of four movements as shown in the pattern layout in Figures 56b and 56c and 56d and 56e by the use of Comez DNB / EL 800 It is created on a rasping machine such as the -8B setting; Two movements in the wale direction, a vertical direction in the fabric, and a course direction, two movements in the vertical direction of the fabric. Movements in the wale direction occur on separate needle beds with alternating chambers; Loops that occur every course are staggered in the iteration. Actually, one of the repeating patterns of 3 / 1-1 / 1-1 / 3-3 / 3 is applied to one of the wale-direction movements as shown in FIGS. 57A to 57D, and as shown in FIGS. 60A to 60D 1 / 1-1 / 3-3 / 3-3 / 1 for other wale movement. The interlacing of the loops in the fabric keeps one thread under more stress than the other, locking it around the thread receiving the less tension, and keeping the loosening as the fabric is cut. 58A to 58D, one of the other two movements in the course direction creates a porous design of the scaffold and occurs in a small number of courses. These rooms are located at 3 / 3-3 / 3-7 / 7-7 / 7-3 / 3-3 / 3-5 / 5-5 / 5-1 / 1-1 / 1-5 / 5-5 / 5-3 / 3-3 / 3-5 / 5-5 / 5-3 / 3-3 / 3-5 / 5-5 / 5. 59A to 59D, other movements in the course direction generate openings in the scaffold and occur in a small number of courses. These rooms are located at 3 / 3-3 / 3-5 / 5-5 / 5-1 / 1-1 / 1-5 / 5-5 / 5-3 / 3-3 / 3-7 / 7-7 / 7-3 / 3-3 / 3-5 / 5-5 / 5-3 / 3-3 / 3-5 / 5-5 / 5-3 / 3. The pattern simulation layout of this pattern considers a yarn design made up of two ends of Td 20/22 circular silk twisted together in the S direction to form a ply with 6 tpi, The resulting three plies are combined and rendered with the ComezDraw 3 software in FIG. The same yarn design is used for movements that occur in the wale and course directions. The stitch density or peak count for the scaffold design in FIG. 61 is 39 peaks per centimeter, taking into account the total peak counts for the technical forward and the technical rear faces of the fabric, or 19.5 peaks per cm, taking into account only one side of the fabric . The operating parameters are not limited to those described in Figs. 56B to 56E, and are not limited to optimal values for the specific room design used in the pattern simulation layout of Fig.

The following are non-limiting examples of methods of use of the knitted silk scaffold of the present invention, which method is not limited to the silk scaffold of the node-lock design in breast reconstruction procedures.

61 illustrates a process improvement for a fabrication process of a scaffold having a pattern layout in Figs. 56B-56E. The improvement consists of a separation area 36-1 between two individual scaffolds 36-2 and 36-3. The advantage of the separation area is that it provides a guide for the tools needed to separate the two individual scaffolds and provides a guide for the exact length the scaffold needs to measure. For example, in order to achieve a length of 5 cm + - 0.4 cm, the pattern in Figures 56b-56e repeats pattern line 1 to pattern line 16 for 112 times, followed by pattern line 17, To the pattern line 20, as shown in FIG.

Examples

In the breast reconstruction procedure, a knitted silk scaffold with a node-lock design is used. The scaffold is draped and made into a sling or pocket for insertion of the breast implant. Physician observations may include that the scaffolds used are easier to use than existing FLEX HD products. It is possible to see through the preferred scaffold. It is noted that when in place, the scaffold is well drained and can be implanted as a preferred and useful breast support sling.

Example 1: silk - Induced medical use Device  Features

Silk-derived medical devices (silk-derived bioresorbable scaffold or &quot; SBS &quot;) suitable for use as support scaffolds in human breast reconstruction surgery, among other uses, Respectively. An embodiment of such a medical device has the trade name CERIS CAFFOLD (TM). Desired characteristics (features) of the medical device (i.e., SBS) include long term bioabsorbability; As a surgical scaffold; Easy to use and seal without loosening during trimming; No side specificity; No swelling / shrinkage with hydratable properties; And internal-sample consistency. Additionally, the pore size of the fabric or material making up such a desired medical device should facilitate the delivery of fluids and cells to permit a natural recovery of tissue defects. CERIS CAFFOLD ™ is an example of an embodiment of the noted SBS developed to provide a soft tissue support and having all the features described in this paragraph.

Were determined the characteristics of the particular SBS seriseu cache fold ™, which contains a dry and a thickness of the hydrated sample and density, the hole area (measured using the Image Pro ^® software), cutting ability, draping ability / compatibility capability, and laparoscopic insertion do. Thus, it was determined that the final preparation using these SBD samples in the dry state had a thickness of 0.9 +/- 0.0 mm (mean + -standard deviation) and a density of 0.16 +/- 0.01 mg / mm &lt; ^{3 &} gt ;. At hydration (SBS is hydrated by incubation in saline phosphate buffered saline for 2 hours at 37 ° C), SBS keeps its dimensions constant, only the excess increases in length, width and thickness. The SBS hole area was 1.3 ± 0.1 mm ² . The opposite sides of SBS were identical, and all dimensions were constant across multiple manufacturing lots. In addition, the SBS is incised in a single stroke of standard surgical scissors, and remains through the immediate perforation area or thread without any observed prying or loosening. The SBS was determined to be drapeable and conformable in its basic solid form and can be rolled along a length allowing a successful passage through the 7/8 laparoscopic cannula following a brief soak in the saline bath.

Thus, SBS has features that are easy to use as a surgical scaffold for soft tissue support, including, for example, porosity with low density and ease of incision, drapeability, compatibility, and correction to laparoscopic insertion . SBS dimensions are precisely matched, consistent between lots, and do not change significantly through hydration. The area of SBS holes is conductive to supporting tissue growth. These features combined with the bioresorption profile make SBS suitable for providing soft tissue support.

Yes 2: 2 - Stage  Breast reconstruction

Ceres CAFOLD ™ surgical scaffolds (warp knit, multi-fiber, bioengineering, silk mesh or fabric with "node lock" need patterns or structures) are available from Allergan Medicla (Santa Barbara, Calif., And Medford, Mass.). Lt; / RTI &gt; The CeresCafold ™ surgical scaffold is a temporary scaffold for soft tissue support and recovery in two-stage breast reconstruction to enhance the lightness of the presence of vulnerability or voids, which requires the addition of material to obtain the desired surgical outcome . The Ceres CAFOLD ™ surgical scaffold is an appendix supplied in a single use 10 cm x 25 cm size, with one device per breast. The surgical scaffold is positioned during Stage I breast reconstruction of each subject with a tissue expander positioning procedure.

The procedure following this example is in stage I-tissue expander, and the Ceres CAFOLD ™ surgical scaffold positioning is as follows. Ceres CAFOLD ™ surgical scaffolds are prepared and used in accordance with the package insert and treatment standards supplied for the breast reconstruction procedure. Following breast fixation (immediate or delayed), the surgical site is prepared for tissue expander insertion under pectoral muscle according to standard surgical procedures. Allergan Natrelle ^® Style ™ 133V tissue expanders and seriseu caviar fold serial / lot number of a surgical scaffold are recorded. The tissue expander is washed in an antimicrobial solution (according to treatment standard) and inserted into a pocket under the pectoral muscle. The CeresCafford ™ surgical scaffold is incised (prior to, during, and / or after suturing) to restore pore space between the large breast muscle and the thoracic wall (ie, the breast-folded area). The Ceres Caffold ™ surgical scaffold is cleaned with an antimicrobial solution and is sealed with 3 mm of the material or with a minimum suture bite of one entire row. If any incision is performed naturally, washing of the implant site is performed. Intra-action pictures take the scaffold positioning prior to interception. Tissue expanders are filled with appropriate drains located according to common treatment criteria and the number and location of known drain (s). A standard wash of the surgical site and occlusion is performed. Profile lactin antimicrobial use and duration is documented.

The surgical drain (s) are removed when considered appropriate. Tissue expansion is performed according to treatment standards as appropriate for each subject. The timing, volume, and number of fillings of the tissue expander fill are recorded at all swell visits.

Stage II for breast implants exchange - The procedure following tissue expander is as follows. In the second surgical procedure, the tissue expander is removed and replaced with a breast implant. Since this procedure is performed as appropriate for each subject, the duration of the elapsed time since the cericafold (TM) surgical scaffold positioning is varied from subject to subject. Standard surgical approaches are used to remove tissue expanders. The implant placement is a large chest muscle, and the pockets are prepared according to treatment standards. The breast implants are washed in an antimicrobial solution and placed in a pocket. Therapeutic criteria are performed.

The Ceres Capold ™ surgical scaffold incorporation is assessed by: (1) scaffold-capsule adhesion to the tissue expander surface and (2) angiogenesis of the area. The evaluations are recorded during stage II surgery. Scaffold-capsule adhesion to the tissue expander surface, and tissue expander adhesion to the large breast muscle, respectively, was determined during removal of the tissue expander device according to the following scale: 0, no adhesion; 1 minimum adhesion (<50% surface area); 2, normal adhesion (50-79% surface area); And 3, fully bonded (80-100% surface area). Capsule angiogenesis surrounding the biopsy site from the CeresCafford (TM) surgical scaffold is visually assessed.

30A and 30B are photographs showing a tissue expander for an implant exchange performed in a two-stage breast reconstruction procedure according to the present invention. Transplant replacement was performed after 11 weeks. The scaffold was integrated and not detectable. The capsule was flexible and vascularized. The scaffold accommodated the expansion to create the ideal breast shape. As a result, the patient has properly positioned and proportioned breasts with a normal breast appearance and feel. 30A is a photograph of the breast area tissue of the open incised patient, the tissue expander is removed, ready to receive the final breast implant, and the support ceric fiber is already shown in place. The cerise cloth fabric is shown in Figure 30A at the appropriate location on the inner surface of the skin flap held open by two tongs. 30B is a photograph of FIG. 30A showing a very positive final surgical outcome with the patient after implantation of a breast implant supported by a ceric fiber and the reconstruction of each reconstructed mammary wound is blocked.

To summarize the results obtained in this Example 2 study, physicians in breast reconstruction used an acellular dermis to maintain the location of the large breast muscle and to strengthen the lower pole of the breast mound. These cell dermis products are catheter or genotype tissue-based, and there is an open report of the increased risk of complications through its use. For the soft tissue support in patients undergoing tissue expander-based breast reconstruction, CERIS CAFFOLD ™ devices, a unique silk-derived bioresorbable scaffold (SBS), have been developed and clinically tested.

Ceres CAPAD ™ is an FDA-510 (k) approved, silk-derived, bioresorbable scaffold (SBS) developed to provide soft tissue support. This Example 2 study (a multicenter clinical trial of a promising single-arm patient ["subject"] without pre-operative or planned post-operative radiotherapy] was performed at the breast fixation as follows: Subjects undergoing sternocuffal positioning of a tissue expander with SBS used to maintain muscle position. In stage 2, tissue expanders were replaced by breast implants and tissue samples of the integrated scaffold were obtained for histology These results of the use of non-Qadeba and non-Xenograft-derived SBS in two-stage breast reconstruction showed a high degree of investigator and subject fulfillment, and SBS was found to be easy to use.

Example 3: Single stage  Breast reconstruction

CERIS CAFOLD ™ Silk Scaffold is obtained from Allergan Medical for use in breast reconstruction for tissue support and recovery in direct-transplant breast reconstruction surgery. In this example, Ceres CAFOLD ™ is used as a surgical scaffold in direct-implant (DTI), or single-stage, soft tissue support and breast reconstruction for recovery. The CeresCafold (TM) surgical scaffold is used as a temporary scaffold for soft tissue support and recovery to strengthen the presence of weaknesses or voids that require the addition of material to obtain the desired surgical outcome.

The Ceres CAFOLD ™ surgical scaffold is an appendix supplied in a single use 10 cm x 25 cm size, with one device per breast. The device is implanted in an immediate posterior breast fixation during a mammogram placement, during a direct-implantation breast reconstruction procedure. In this example, a CeresCafford (TM) surgical scaffold in DTI breast reconstruction is used.

Ceres CAFOLD ™ surgical scaffolds are prepared and used in accordance with the package insert and treatment standards supplied for the breast reconstruction procedure. Following breast fixation, the surgical site is prepared for breast implants under the sternotomy according to standard surgical procedures. The breast implants are washed in an antimicrobial liquid and inserted into pockets under the pectoral muscle. The CeresCafford ™ surgical scaffold is incised (prior to, during, and / or after suturing) to restore pore space between the large breast muscle and the thoracic wall (ie, the breast-folded area). The Ceres Caffold ™ surgical scaffold is cleaned with an antimicrobial solution and is sealed with 3 mm of the material or with a minimum suture bite of one entire row. If any incision is performed naturally, washing of the implant site is performed. The drains are located according to general treatment criteria and the number and location of known drain (s). The surgical site is cleaned and blocked using an antimicrobial solution. The surgical drain (s) are removed when considered appropriate. As a result, the patient has properly positioned and proportioned breasts with a normal breast appearance and feel.

Example 4: Surgery Mesh  Elongation physical characteristics

The series of meshes were made to have a knit pattern as shown in Figs. 56A to 56E. The meshes were evaluated for height for use in breast reconstruction. The amount and orientation of the elongation was measured and sampled at varying amounts of elongation both in fabric formation and in the fabric width direction.

According to the procedure, the two marks were placed on fresh, undivided mesh portions spaced 10 cm apart. Whenever possible, an attempt was made to keep marks at a minimum value of centimeters from the edge to allow the tester to fully hold the fabric. The fabric was pulled with a continuous force, and the elongation percentage (%) level corresponding to the new distance between the dots was recorded. This procedure was repeated in the direction of the vertical fabric, and the elongation level was recorded. The evaluation results are illustrated in Tables 12-18 for each of the meshes shown in Figures 62-68.

Referring to the table on the number of island yarns, the island yarn refers to one individual yarn yarn material. Multiple indexes are combined to achieve real properties for the desired mesh application. For example, nine yarn yarns were produced by combining three yarns in the first stage to produce ply, and in a subsequent operation, three ply were combined to produce yarns (three yarns x 3 ply = 9 islands). The average length referred to as the measurements was made at three different locations along the upper, middle and lower portions of the scaffold (along the fabric formation (FF) direction; parallel to the fabric wales). Length measurements were taken per course in the scaffold sample vignette, excluding any protrusions, incised wales through these courses. The average width referred to as the measurements was made at three different locations (parallel to the fabric courses along the fabric width (FW) direction) in the left, center and right locations of the scaffold.

FIG. 69 shows three fabric formation measurements (positioning of horizontal measurements and positioning of three fabric width measurements (vertical measurements), showing the placement of each measurement in the enlarged images of fabric formation and fabric width edges End points.

The evaluation results are shown in Table 12-18 below.

(Fig. 62) Average Length (mm) 97.39 Average width (mm) 261.48 Average thickness (mm) 0.96 Mass (mg) 310.28 Density (mg / mm ³ ) 0.012620 Surface density (mg / mm ² ) 0.012184 Number of islanders (high twisted silk room) 9 % Elongation in Wales 60 % Elongation in the course direction 32

(Fig. 63) Average Length (mm) 245.74 Average width (mm) 97.33 Average thickness (mm) 0.96 Mass (mg) 342.08 Density (mg / mm ³ ) 0.014586 Surface density (mg / mm ² ) 0.014303 [Pseudo] Number of Islands (High Twisted Silky Seal) 9 % Elongation in Wales 80 % Elongation in the course direction 35

(Fig. 64) Average Length (mm) 236.54 Average width (mm) 109.30 Average thickness (mm) 0.91 Mass (mg) 281.86 Density (mg / mm ³ ) 0.011994 Surface density (mg / mm ² ) 0.010902 [Pseudo] Number of Islands (High Twisted Silky Seal) 9 % Elongation in Wales 40 % Elongation in the course direction 35

(Fig. 65) Average Length (mm) 209.14 Average width (mm) 113.18 Average thickness (mm) 0.91 Mass (mg) 277.89 Density (mg / mm ³ ) 0.012753 Surface density (mg / mm ² ) 0.011740 [Pseudo] Number of Islands (High Twisted Silky Seal) 9 % Elongation in Wales 65 % Elongation in the course direction 30

(Fig. 66) Average Length (mm) 248.66 Average width (mm) 103.14 Average thickness (mm) 0.97 Mass (mg) 301.74 Density (mg / mm ³ ) 0.011989 Surface density (mg / mm ² ) 0.011765 [Pseudo] Number of Islands (High Twisted Silky Seal) 9 % Elongation in Wales 50 % Elongation in the course direction 35

(Fig. 67) Average Length (mm) 175.46 Average width (mm) 91.03 Average thickness (mm) 0.77 Mass (mg) 162.7 Density (mg / mm ³ ) 0.013113 Surface density (mg / mm ² ) 0.010186 Number of island yarns (low twisted silk yarn) 6 % Elongation in Wales 65 % Elongation in the course direction Not Available

(Fig. 68) Average Length (mm) 204.39 Average width (mm) 81.95 Average thickness (mm) 0.80 Mass (mg) 170.41 Density (mg / mm ³ ) 0.012956 Surface density (mg / mm ² ) 0.010173 Number of island yarns (low twisted silk yarn) 6 % Elongation in Wales 80 % Elongation in the course direction 40

Claims (35)

A three-dimensional fabric structure for use in breast surgery, including silk, knitted seamless mesh in the form of pockets for insertion and placement of breast implants or tissue expanders. The three-dimensional fabric structure of claim 1, wherein the fabric structure comprises at least two sides. The three-dimensional fabric structure of claim 1, wherein the faces have a node-lock configuration. The three-dimensional fabric structure of claim 1, wherein the mesh is bioresorbable. The three-dimensional fabric structure of claim 1, wherein the first side is a knitted mesh having a lower elongation capability than the second side. The three-dimensional fabric structure of claim 1, wherein the faces are a double needle bed, a single needle bed, or a tubular knit. A three-dimensional fabric structure for use in breast surgery, comprising: a three-dimensional fabric structure having a silk knitted mesh with a pocket knit configuration and a non-pocket knit configuration, wherein a transition exists between the pocket configuration and the non- . 8. The three-dimensional fabric structure of claim 7, wherein the non-pocket knit configuration is incisionable for molding. 8. The three-dimensional fabric structure of claim 7, wherein the fabric structure is knitted on a warp knit jacquard machine. The three-dimensional fabric structure of claim 7, wherein the surfaces are node-lock configurations. 8. The three-dimensional fabric structure of claim 7, wherein the mesh is bioabsorbable. 8. The three-dimensional fabric structure of claim 7, wherein the pocket configuration has two sides. The three-dimensional fabric structure of claim 12, wherein the first side is a knitted mesh having a lower elongation capability than the second side. 13. The three-dimensional fabric structure of claim 12, wherein the second side is a knitted mesh having a higher elongation capability than the first side. 9. The three-dimensional fabric structure of claim 7, wherein the faces are double needle beds, a single needle bed, or tubular nitrone. A fabric template for use in a breast surgery procedure, the template comprising a predominantly semi-circular shaped silk knitted mesh with one or more tabs on a semicircular shaped circumference. 17. The fabric template of claim 16, wherein the tabs correspond to one or more slots in a knitted silk mesh panel for attaching the semi-circular shaped mesh to the knitted silk mesh panel. 17. The fabric template of claim 16, wherein the semi-circular shaped mesh forms a pocket having two sides upon attachment to the knitted silk mesh panel. 17. The fabric template of claim 16, wherein the faces have a node-lock configuration. 17. The fabric template of claim 16, wherein the mesh is bioresorbable. 19. The fabric template of claim 18, wherein, among the faces, the first face is a knitted mesh having a lower extensibility than the second face. 17. The fabric template of claim 16, wherein the faces are a double needle bed, a single needle bed, or tubular nitrone. 10. A fabric template for use in a breast surgery procedure, the template comprising a pair of silk knit-like meshes in a predominantly semi-circular shape having one or more tabs on the circumference of each of the semicircular shaped meshes. A fabric template for use in a breast surgery procedure, the template comprising a knitted silk mesh having a first panel section and a second panel section, the first panel section having a predominantly rounded shape, Having a generally semi-circular shape. 27. The fabric template of claim 24, wherein the first panel and the second panel comprise a single knit mesh. 27. The fabric template of claim 24, wherein the first panel and the second panel are node-locked configurations. 27. The fabric template of claim 24, wherein the first panel and the second panel have meshes with different physical properties. 27. The fabric template of claim 24, wherein the first panel and the second panel have different knit patterns. 27. The fabric template of claim 24, wherein the first panel has a different elongation capability than the second panel. 10. A fabric template for use in a breast surgery procedure, the template comprising a knitted silk mesh having a first panel section and a second panel section, the first panel section having a rectangular shape, Wherein the second panel is larger than the first panel. 32. The fabric template of claim 30, wherein the first panel and the second panel comprise a single knitted mesh. 32. The fabric template of claim 30, wherein the first panel and the second panel are node-lock configurations. 32. The fabric template of claim 30, wherein the first panel and the second panel have meshes with different physical properties. 32. The fabric template of claim 30, wherein the first panel and the second panel have different knit mesh patterns. 32. The fabric template of claim 30, wherein the first panel has a different elongation capability than the second panel.

Images