WO2014149096A1 - Dispositif médical en soie destiné à être utilisé en augmentation mammaire et en reconstruction mammaire - Google Patents

Dispositif médical en soie destiné à être utilisé en augmentation mammaire et en reconstruction mammaire Download PDF

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Publication number
WO2014149096A1
WO2014149096A1 PCT/US2013/075053 US2013075053W WO2014149096A1 WO 2014149096 A1 WO2014149096 A1 WO 2014149096A1 US 2013075053 W US2013075053 W US 2013075053W WO 2014149096 A1 WO2014149096 A1 WO 2014149096A1
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WO
WIPO (PCT)
Prior art keywords
mesh
breast
fabric
panel
tissue
Prior art date
Application number
PCT/US2013/075053
Other languages
English (en)
Inventor
Enrico Mortarino
Original Assignee
Allergan, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/843,519 external-priority patent/US20130304098A1/en
Application filed by Allergan, Inc. filed Critical Allergan, Inc.
Priority to CA2900682A priority Critical patent/CA2900682A1/fr
Priority to EP13826905.5A priority patent/EP2967837A1/fr
Priority to AU2013383409A priority patent/AU2013383409A1/en
Priority to KR1020157025057A priority patent/KR20150131039A/ko
Priority to BR112015021365A priority patent/BR112015021365A2/pt
Publication of WO2014149096A1 publication Critical patent/WO2014149096A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses and implants

Definitions

  • the present invention generally relates to a prosthetic device for tissue repair, and, more particularly, to a surgical silk mesh or scaffold device employing a stable knit structure and a method of using the same in breast cosmetic and surgical procedures, such as in breast augmentation and/or breast reconstruction procedures.
  • Surgical mesh initially used for hernia and abdominal wall defects are now being used for other types of tissue repair, such as rotator cuff repair, pelvic floor dysfunction, and reconstructive or cosmetic surgeries. It is projected that in 2010, there will be more than 8 million hernia procedures, 800,000 rotator cuff repairs, 3 million pelvic prolapse repairs, 600,000 urinary incontinence repairs, and 1.5 million reconstructive or aesthetic plastic surgeries. Most of these procedures will likely employ implantable surgical mesh devices currently on the market, including: Bard Mesh (polypropylene) by C. R. Bard; Dexon (polyglycolic acid) by Syneture/US Surgical; Gore -Tex (polytetrafluoroethylene) by W.L.
  • Bard Mesh polypropylene
  • Dexon polyglycolic acid
  • Gore -Tex polytetrafluoroethylene
  • Surgical mesh devices are typically biocompatible and may be formed from bioresorbable materials and/or non-bioresorbable materials.
  • polypropylene, polyester, and polytetrafluoroethylene (PTFE) are biocompatible and non-bioresorbable, while polyglactin 910 and polyglycolic acid are biocompatible and bioresorbable.
  • current surgical mesh devices may be formed from different materials, they have various similar physical and mechanical characteristics beneficial for tissue repair.
  • their use may be accompanied by a variety of complications.
  • Such complications may include scar encapsulation and tissue erosion, persistent infection, pain, and difficulties associated with revision surgery.
  • the use of an absorbable material may result in reoccurrence due to rapid resorption of the implant material and loss of strength.
  • polypropylene monofilament may be a highly regarded material for surgical mesh devices
  • polypropylene mesh devices can induce intense scar formations and create a chronic foreign body reaction with the formation of a fibrous capsule, even years after implantation. Minor complaints of seromas, discomfort, and decreased wall mobility are frequent and observed in about half of the patients implanted with polypropylene mesh devices.
  • polypropylene generally cannot be placed next to the bowel due to the propensity of adhesion formation.
  • multifilament polyester may improve conformity with the abdominal wall, it is also associated with a variety of disadvantages. For example, higher incidences of infection, enterocutaneous fistula formation, and small bowel obstruction have been reported with the use of multifilament polyester compared to other materials. Indeed, the small interstices of the multifilament yarn make it more susceptible to the occurrence of infection, and thus multifilament polyester is not commonly used within the United States.
  • PTFE polytetrafluoroethylene
  • Absorbable materials such as Vicryl and Dexon, used for hernia repair have the advantage of being placed in direct contact with the bowel without adhesion or fistula formation.
  • Vicryl has comparable burst strength to nonabsorbable mesh at three weeks but is significantly weaker at twelve weeks due to a quick absorption rate.
  • Dexon has more in-growth at twelve weeks with less absorption of the mesh.
  • the concern with absorbable meshes is that the rate of absorption is variable, possibly leading to hernia recurrence if the proper amount of new tissue is not there to withstand the physiologic stresses placed on the hernia defect.
  • a significant characteristic of a biomaterial is its porosity, because porosity is the main determinant for tissue reaction. Pore sizes of >500-600 ⁇ permit in-growth of soft tissue; pore sizes of >200-300 ⁇ favor neo-vascularisation and allow mono-morphological restitution of bony defects; pore sizes of ⁇ 200 ⁇ are considered to be almost watertight, hindering liquid circulation at physiological pressures; and pores of ⁇ 100 ⁇ only lead to in-growth of single cell types instead of building new tissues. Finally, a pore size of ⁇ 10 ⁇ hinders any in-growth and increases the chance of infection, sinus tract formation, and encapsulation of the mesh. Bacteria averaging 1 ⁇ in size can hide in the small interstices of the mesh and proliferate while protected from neutrophilic granulocytes averaging 10-15 ⁇ .
  • surgical mesh devices Other important physical characteristics include thickness, burst strength, and material stiffness.
  • the thickness of surgical mesh devices vary according to the particular repair procedure. For example, current surgical mesh device hernia, pelvic floor dysfunction, and reconstructive/cosmetic procedures range in thickness from approximately 0.635 mm to 1.1 mm. For rotator cuff repair, a thickness of 0.4 mm to 5 mm is typically employed.
  • Intra-abdominal pressures of 10-16 N, with a mean distension of 11-32% results in the need for a surgical mesh with a burst strength that can resist the stress of the inner abdomen before healthy tissue comes into being.
  • Material stiffness is an important mechanical characteristic for surgical mesh, especially when used for pelvic floor dysfunction, because material stiffness has been associated with the likelihood of tissue erosion.
  • UTS ultimate tensile strength
  • the initial stiffness of the material is an important consideration.
  • the stiffness may exhibit non-linear behavior most likely due to changes in the fabric structure, e.g., unraveling of the knit, weave, etc.
  • a surgical mesh device of lesser stiffness may help reduce tissue erosion and may conform to the contours of the body more effectively.
  • one-stage immediate breast implant or Direct-to-Implant (DTI) reconstructions have been performed and are considered beneficial in that this approach can reduce the number of hospitalizations and the surgical costs associated with multiple stage reconstructions.
  • DTI Direct-to-Implant
  • a tissue expander (TE) is placed after mastectomy and expanded until the desired pocket size has been attained. The tissue expander is then removed, and a permanent implant is inserted.
  • a recent advancement to this procedure is the addition of material to support implant reconstruction by providing a framework to control the space or position of the tissue expander.
  • a "scaffold" is sutured to the chest wall and anterior rectus abdominus fascia, creating a pocket or hammock for subsequent tissue expander or implant placement.
  • the superior portion of the material is sutured to the inferior aspect of the pectoralis muscle in order to cover the tissue expander.
  • This graft can serve as a protective barrier between the implant and the skin, it can control the position of the implant, and it can decrease the force transmission to the implant itself.
  • Advantages of using this technique include effectively "lengthening" the pectoralis muscle coverage of the tissue expander without compromising lower pole expansion, precise control of the inframammary fold and lateral breast border, and allowance of greater initial fill-volumes. Additionally, grafts can allow the skin envelope to be used before it becomes contracted, which may yield a more natural aesthetic outcome. [0017] AlloDerm, an allogenic acellular dermal matrix (ADM) has been frequently used as the scaffold during breast reconstruction.
  • ADM acellular dermal matrix
  • AlloDerm When used to create complete coverage of the tissue expander, AlloDerm may allow higher initial fill volumes of tissue expanders, more rapid expansion, improved definition of inframammary folds, and may result in less postoperative pain, though Preminger et al. did not find differences in initial fill volume or rate of expansion between an AlloDerm breast reconstruction group and a control group.
  • AlloDerm can be an issue (e.g., it has a shelf-life of only 2 years and requires at least 30 minutes of rehydration before application). In addition, it has been recommended to undergo two saline baths, and costs of ADM may be significant. Other ADMs have appeared on the market. In a small study, NeoForm was evaluated for safety and effectiveness. No complications related to NeoForm were found in 22 patients, and the tissue expansion procedures went as planned. Although some improvement in the logistics may be found with NeoForm (i.e., no need for refrigeration, 5 year shelf-life, and 3 to 5 minutes for rehydration), average follow-up of these patients was relatively short (10.2 months).
  • embodiments according to aspects of the present invention provide a biocompatible surgical silk mesh prosthetic device for use in soft and hard tissue repair.
  • soft tissue repair include breast applications such as breast reconstruction and augmentation, hernia repair, rotator cuff repair, cosmetic surgery, implementation of a bladder sling, or the like.
  • hard tissue repair such as bone repair, involve reconstructive plastic surgery, ortho trauma, or the like.
  • the open structure of these embodiments allows tissue in-growth while the mesh device degrades at a rate which allows for a smooth transfer of mechanical properties to the new tissue from the silk scaffold.
  • embodiments employ a knit pattern, referred to as a "node-lock" design.
  • the "node-lock" design substantially prevents unraveling and preserves the stability of the mesh device, especially when the mesh device is cut.
  • the present invention includes a method of using a knitted silk fabric in a breast reconstruction procedure.
  • This method can comprise the step of implanting (that is placing entirely within the patient's body) a knitted silk fabric in a patient in the vicinity (that is at or adjacent to the anatomical location of the breast reconstruction) of a reconstructed or a to be reconstructed breast of the patient.
  • the silk fabric will be attached to the patient by being sutured in place.
  • the method can further comprising inserting (i.e. implanting) a tissue expander and later the step of removing the tissue expander A breast implant can also be inserted.
  • a prosthetic device includes a knitted mesh including at least two yarns laid in a knit direction and engaging each other to define a plurality of nodes, the at least two yarns including a first yarn and a second yarn extending between and forming loops about two nodes, the second yarn having a higher tension at the two nodes than the first yarn, the second yarn substantially preventing the first yarn from moving at the two nodes and substantially preventing the knitted mesh from unraveling at the nodes.
  • the first yarn and the second yarn are formed from different materials.
  • the first yarn and the second yarn have different diameters.
  • wherein the first yarn and the second yarn have different elastic properties.
  • the at least two yarns are formed from silk.
  • a first length of the first yarn extends between the two nodes and a second length of the second yarn extends between the two nodes, the first length being greater than the second length.
  • the first yarn forms an intermediate loop between the two nodes and the second yarn does not form a corresponding intermediate loop between the two nodes.
  • the first length of the first yarn is greater than the second length of the second yarn.
  • the first yarn is included in a first set of yarns and the second yarn is included in a second set of yarns, the first set of yarns being applied in a first wale direction, each of the first set of yarns forming a first series of loops at each of a plurality of courses for the knitted mesh, the second set of yarns being applied in a second wale direction, the second wale direction being opposite from the first wale direction, each of the second set of yarns forming a second series of loops at every other of the plurality of courses for the knitted mesh, the first set of yarns interlacing with the second set of yarns at the every other course to define the nodes for the knitted mesh, the second set of yarns having a greater tension than the first set of yarns, the difference in tension substantially preventing the knitted mesh from unraveling at the nodes.
  • the first yarn is included in a first set of yarns and the second yarn is included in a second set of yarns, the first set of yarns and the second set of yarns being alternately applied in a wale direction to form staggered loops, the first set of yarns interlacing with the second set of yarns to define the nodes for the knitted mesh, the alternating application of the first set of yarns and the second set of yarns causing the first set of yarns to have different tensions relative to the second set of yarns at the nodes, the difference in tension substantially preventing the knitted mesh from unraveling at the nodes.
  • the first yarn is included in a first yarns and the second yarn is included in a second set of yarns, the first set of yarns forming a series of jersey loops along each of a first set of courses for a knitted mesh, the second set of yarns forming a second series of alternating tucked loops and jersey loops along each of a second set of courses for the knitted mesh, the second set of courses alternating with the first set of courses, the second set of yarns having a greater tension than the first set of yarns, the tucked loops of the second set of yarns engaging the jersey loops of the first set of yarns to define nodes for the knitted mesh, the tucked loops substantially preventing the knitted mesh from unraveling at the nodes.
  • a method for making a knitted mesh for a prosthetic device includes: applying a first set of yarns in a first wale direction on a single needle bed machine, each of the first set of yarns forming a first series of loops at each of a plurality of courses for a knitted mesh; applying a second set of yarns in a second wale direction on the single needle bed machine, the second wale direction being opposite from the first wale direction, each of the second set of yarns forming a second series of loops at every other of the plurality of courses for the knitted mesh; and applying a third set of yarns in every predetermined number of courses for the knitted mesh, the application of the third set of yarns defining openings in the knitted mesh, wherein the first set of yarns interlaces with the second set of yarns at the every other course to define nodes for the knitted mesh, and the second set of yarns has a greater tension than the first set of yarns, the difference in tension substantially
  • a method for making a knitted mesh for a prosthetic device includes: applying a first set of yarns to a first needle bed of a double needle bed machine in a wale direction; applying a second set of yarns to a second needle bed of the double needle bed machine in a wale direction; and applying a third set of yarns in every predetermined number of courses for the knitted mesh, the application of the third set of yarns defining openings in the knitted mesh, wherein the first set of yarns and the second set of yarns are alternately applied to form staggered loops at the first needle bed and the second needle bed, respectively, and the first set of yarns interlaces with the second set of yarns to define nodes for the knitted mesh, the alternating application of the first set of yarns and the second set of yarns causing the first set of yarns to have a different tension relative to the second set of yarns at the nodes, the difference in tension substantially preventing the knitted mesh from unraveling at the nodes
  • a method for making a knitted mesh for a prosthetic device includes: forming, on a flat needle bed machine, a first series of jersey loops along each of a first set of courses for a knitted mesh; and forming, on the flat needle bed machine, a second series of alternating tucked loops and jersey loops along each of a second set of courses for the knitted mesh, the second set of courses alternating with the first set of courses; wherein the second set of courses has a greater tension than the first set of courses, and the tucked loops along the second set of courses engage the jersey loops of the first set of courses and substantially prevents the knitted mesh from unraveling at the tucked loops.
  • a continuous yarn forms the first set of courses and the second set of courses.
  • the first set of courses and the second set of courses are formed by different yarns.
  • the first set of courses and the second set of courses are formed by different yarns having different diameters.
  • an implantable prosthesis for breast augmentation or reconstruction procedures comprising, a biocompatible and biodegradable fabric structure comprising one or more individual yarns comprised of sericin-extracted native fibroin fibers, wherein the yarn(s) are intertwined to produce the fabric structure, the fabric structure extending in a first dimension and having a first surface adapted to engage and support natural breast tissue or a prosthetic breast implant in a patient.
  • the fabric structure includes a portion adapted to be fastened to tissue surrounding the chest cavity of the patient.
  • the fabric structure includes a portion adapted to be fastened to soft tissue surrounding the breast tissue or the prosthetic breast implant.
  • the fabric structure includes a portion adapted to be fastened to a boney structure adjacent to the breast tissue or the prosthetic breast implant.
  • the fabric structure is formed in a predefined shape adapted to conform to at least a portion of a region of natural breast tissue or a breast implant.
  • the predefined shape selected from the group consisting of a circular shape, an oval shape, a crescent shape, a cup shape and an elongated strip.
  • the fabric structure includes factors for promoting in-growth of breast tissue.
  • the fabric structure when implanted, at least partially replaces breast connective tissue.
  • the fabric structure is formed in an sling shape to provide support for a breast or a breast implant when the fabric structure is implanted in a patient.
  • the fabric structure is formed in an elongated shape to provide support in an inframammary region of a breast when the fabric structure is implanted in a patient.
  • the fabric structure is formed in a cup shape to provide inferior support in an inframammary region of a breast when the fabric structure is implanted in a patient.
  • the fabric structure is formed in a cup shape to provide medial or lateral support for the breast when the fabric structure is implanted in a patient.
  • the fabric structure is selected from the group consisting of twisted, braided, knitted, stitch bonded, and combinations thereof.
  • aspects of the present invention relate to a method of supporting breast tissue or a breast implant in a patient comprising, providing a biocompatible and biodegradable fabric structure comprising one or more individual yarns comprised of sericin-extracted native fibroin fibers, wherein the yarn(s) are intertwined to produce the fabric structure, and inserting the fabric structure between the skin of the patient and the breast tissue or the breast implant.
  • the method further comprises fastening the fabric structure to tissue surrounding the chest cavity of the patient.
  • the method further comprises fastening the fabric structure to soft tissue surrounding the breast tissue or the prosthetic breast implant.
  • the method further comprises fastening the fabric structure to a boney structure adjacent to the breast tissue or the prosthetic breast implant.
  • the method further comprises forming the fabric structure into a predefined shape adapted to conform to at least a portion of a region of natural breast tissue or a breast implant.
  • 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.
  • the method further comprises treating the fabric structure with factors for promoting in-growth of breast tissue.
  • the fabric structure is inserted in an inframammary region of the breast to provide vertical positioning of the breast and reduce vertical inferior displacement of the breast.
  • the fabric structure is inserted in a medial side of the breast to provide medial positioning of the breast and reduce medial displacement of the breast.
  • the fabric structure is inserted in a lateral side of the breast to provide lateral positioning of the breast and reduce lateral displacement of the breast.
  • the fabric structure is selected from the group consisting of twisted, braided, knitted, stitch bonded, and combinations thereof.
  • aspects of the present invention relate to a biocompatible and biodegradable fabric comprising one or more individual yarns comprised of sericin-extracted native fibroin fibers, wherein the yarn(s) are intertwined to produce a fabric structure selected from the group consisting of twisted, braided, knitted, stitch bonded, and combinations thereof.
  • the fabric is homogeneous.
  • the fabric has one or more biomechanical properties of connective tissue of the female breast.
  • the one or more biomechanical properties is selected from the group consisting of ultimate tensile strength, linear stiffness, yield point, percent elongation at break, and combinations thereof.
  • the fabric is a 2-dimensional mesh.
  • the connective tissue is superficial fascia or muscular fascia of the female breast subcutaneous fascial system.
  • the fabric is heterogeneous.
  • the fabric comprises a 2- dimensional mesh with one or more additional constructs therein.
  • the 2- dimensional mesh has one or more biomechanical properties of connective tissue of the female breast.
  • the connective tissue is superficial fascia or muscular fascia of the female breast subcutaneous fascial system.
  • the additional construct(s) is selected from the group consisting of a twisted construct, a parallel construct, and a braided construct.
  • the additional construct(s) has one or more biomechanical properties of connective tissue of the female breast.
  • the connective tissue is selected from the group consisting of fascia mammae, retinaculum fibrosa, and transverse fibrous lamella. In one embodiment, the connective tissue is inframammary retinaculum. In one embodiment, the one or more biomechanical properties is selected from the group consisting of ultimate tensile strength, linear stiffness, yield point, percent elongation at break, and combinations thereof. In one embodiment, the fabric has one or more biomechanical properties of soft tissue within the breast. In one embodiment, the fibroin fibers contain less than 20% sericin by weight. In one embodiment, the fibroin fibers contain less than 10% sericin by weight. In one embodiment, the fibroin fibers contain less than 1% sericin by weight.
  • one or more of the yarns comprise fibroin fibers that are parallel or intertwined.
  • one or more of the yarns is a braid, textured yarn, twisted yarn, cabled yarn, or combinations thereof.
  • one or more of the yarns has a single-level hierarchical organization comprising a group of parallel or intertwined fibers to form the yarn(s).
  • one or more of the yarns has a two-level hierarchical organization comprising a bundle of intertwined groups, wherein a group comprises parallel or intertwined fibers.
  • one or more of the yarns has a three-level hierarchical organization comprising a strand of intertwined bundles, wherein a bundle comprises intertwined groups, wherein a group comprises parallel or intertwined fibers.
  • one or more of the yarns has a four-level hierarchical organization comprising a cord of intertwined strands, wherein a strand comprises intertwined bundles, wherein a bundle comprises intertwined groups, wherein a group comprises parallel or intertwined fibers.
  • one or more of the yarns comprise a composite of the sericin-extracted fibroin fibers and one or more degradable polymers selected from group consisting of collagens, polylactic acid or its copolymers, polyglycolic acid or its copolymers, polyanhydrides, elastin, glycosamino glycans, and polysaccharides.
  • the fabric is coated, dobby, laminated, or combinations thereof.
  • the fabric further comprises a drug.
  • the fabric further comprises a cell-attachment factor.
  • the cell- attachment factor is RGD.
  • one or more of the yarns is treated with gas plasma.
  • the fabric further comprises biological cells seeded therein.
  • aspects of the present invention related to a method for generating connective tissue in the breast of an individual comprising implanting a fabric disclosed herein, wherein the fabric has one or more biomechanical properties of connective tissue, into the individual at an anatomical location within the breast of the individual that provides the appropriate physiologic environment for the development of the connective tissue from the implanted fabric, wherein the fabric is comprised of one or more individual yarns comprised of sericin-extracted native fibroin fibers.
  • the connective tissue is selected from the group consisting of superficial fascia, muscular fascia, fascia mammae, retinaculum fibrosa, and transverse fibrous lamella.
  • the fabric is implanted into the individual to replace or repair damaged tissue.
  • the anatomical location is a site of a surgical incision or of tissue reconstruction.
  • the fabric is homogeneous.
  • the fabric is heterogeneous.
  • one or more of the individual yarns has a hierarchical organization selected from the group consisting of single-level hierarchical organization, two-level hierarchical organization, three-level hierarchical organization, and four-level hierarchical organization.
  • aspects of the present invention further relate to a method for supporting a breast structure in an individual comprising implanting a fabric disclosed herein within the breast of the individual in a supporting position relative to the breast structure.
  • the breast structure comprises native breast tissue.
  • the breast structure comprises a breast prosthesis.
  • the breast structure comprises a tissue expander.
  • the fabric comprises a 2-dimensional mesh.
  • the fabric further comprises one or more additional constructs therein.
  • the fabric has one or more biomechanical properties of a connective tissue present naturally in the breast at such a supporting position.
  • the connective tissue is selected from the group consisting of superficial fascia, muscular fascia, fascia mammae, retinaculum fibrosa, and transverse fibrous lamella.
  • the present invention also includes a method of using a silk scaffold in breast reconstruction, the method comprising the steps of suturing a knitted, silk scaffold to a chest wall creating a pocket for placement of a tissue expander or a breast implant.
  • This method can further comprise the steps of: inserting the tissue expander; removing the tissue expander; inserting the breast implant, and; inserting the breast implant without a tissue expander.
  • the method can also have the step of cutting the silk scaffold to a size to repair a void in an inframammary fold region.
  • the scaffold can be pre-rinsed with antibiotic solution prior to suturing.
  • the present invention also includes a method of using a silk scaffold in breast reconstruction, the method comprising the steps of: obtaining a knitted scaffold including at least two yarns laid in a knit direction and engaging each other to define a plurality of nodes, the at least two yarns including a first yarn and a second yarn extending between two nodes, the second yarn having a higher tension at the two nodes than the first yarn, the second yarn substantially preventing the first yarn from moving at the two nodes and substantially preventing the knitted scaffold from unraveling at the nodes, and; suturing the knitted, silk scaffold to a chest wall creating a pocket for placement of a tissue expander or a breast implant.
  • the first yarn and the second yarn can be formed from different materials.
  • the first yarn and the second yarn can have different diameters and the first yarn and the second yarn can have different elastic properties.
  • a first length of the first yarn extends between the two nodes and a second length of the second yarn extends between the two nodes, the first length being greater than the second length.
  • the first yarn can form an intermediate loop between the two nodes and the second yarn does not form a corresponding intermediate loop between the two nodes, the first length of the first yarn being greater than the second length of the second yarn.
  • the first yarn can be included in a first set of yarns and the second yarn is included in a second set of yarns, the first set of yarns being applied in a first wale direction, each of the first set of yarns forming a first series of loops at each of a plurality of courses for the knitted mesh, the second set of yarns being applied in a second wale direction, the second wale direction being opposite from the first wale direction, each of the second set of yarns forming a second series of loops at every other of the plurality of courses for the knitted mesh, the first set of yarns interlacing with the second set of yarns at the every other course to define the nodes for the knitted mesh, the second set of yarns having a greater tension than the first set of yarns, the difference in tension substantially preventing the knitted mesh from unraveling at the nodes.
  • the first yarn can be included in a first set of yarns and the second yarn is included in a second set of yarns, the first set of yarns and the second set of yarns being alternately applied in a wale direction to form staggered loops, the first set of yarns interlacing with the second set of yarns to define the nodes for the knitted mesh, the alternating application of the first set of yarns and the second set of yarns causing the first set of yarns to have different tensions relative to the second set of yarns at the nodes, the difference in tension substantially preventing the knitted mesh from unraveling at the nodes.
  • the first yarn can be included in a first set of yarns and the second yarn is included in a second set of yarns, the first set of yarns forming a series of jersey loops along each of a first set of courses for a knitted mesh, the second set of yarns forming a second series of alternating tucked loops and jersey loops along each of a second set of courses for the knitted mesh, the second set of courses alternating with the first set of courses, the second set of yarns having a greater tension than the first set of yarns, the tucked loops of the second set of yarns engaging the jersey loops of the first set of yarns to define nodes for the knitted mesh, the tucked loops substantially preventing the knitted mesh from unraveling at the nodes.
  • the two yarns can be formed from silk, can be approximately 20 to 1000 ⁇ in diameter, and can be substantially constant in diameter.
  • the present invention also includes a method of using a silk scaffold in a breast augmentation procedure, the method comprising the steps of: (a) implanting a mammary prosthesis into a patient, and; (b) implanting a knitted, silk scaffold adjacent to or abutting the mammary prosthesis in order to support the mammary prosthesis and to facilitate tissue ingrowth at the location of the knitted, silk scaffold.
  • FIG. 1A illustrates the technical back of an example mesh produced on a single needle bed warp knitting machine according to aspects of the present invention.
  • FIG. IB illustrates the technical front of the example mesh illustrated in FIG. 1A.
  • FIGS. 2A and 2B illustrate an example mesh produced on a double needle bed warp knitting machine according to aspects of the present invention.
  • FIG. 3 illustrates an example mesh produced with single filament silk yarn according to aspects of the present invention.
  • FIG. 4 illustrates an example mesh produced on a single needle bed warp knitting machine according to aspects of the present invention.
  • FIG. 5A illustrates an example mesh produced on a double needle bed warp knitting machine, the example mesh having a parallelepiped pore with a section demonstrating a plush design according to aspects of the present invention.
  • FIG. 5B illustrates an example mesh produced on a double needle bed warp knitting machine, the example mesh having a hexagonal pore according to aspects of the present invention.
  • FIGS. 6A and 6B illustrate example narrow mesh fabrics of varying stitch densities incorporating a plush variation according to aspects of the present invention.
  • FIG. 7 illustrates an example mesh incorporating loop pile according to aspects of the present invention.
  • FIG. 8 illustrates an example narrow mesh fabric with pore design achieved through variation in the yarn feed rate according to aspects of the present invention.
  • FIG. 9A illustrates an example collapsed mesh fabric with hexagonal shaped pores according to aspects of the present invention.
  • FIG. 9B illustrates an example opened mesh fabric with hexagonal shaped pores according to aspects of the present invention.
  • FIG. 10 illustrates an example of a stable, non-collapsible, hexagonal-shaped porous mesh fabric according to aspects of the present invention.
  • FIG. 11 A illustrates an example of a three-dimensional mesh with the same technical front and technical back according to aspects of the present invention.
  • FIG. 11B illustrates the 2.55 mm thickness of the example three-dimensional mesh of FIG. 11A.
  • FIG. 12 illustrates an example of a three-dimensional mesh with a thickness of 3.28 mm according to aspects of the present invention.
  • FIG. 13A illustrates the technical front of an example non-porous mesh according to aspects of the present invention.
  • FIG. 13B illustrates the technical back of the example non-porous mesh of FIG. 13 A.
  • FIG. 13C illustrates the 5.87 mm thickness of the example non-porous mesh of FIG. 13 A.
  • FIG. 14A illustrates an example of a three-dimensional mesh with the same technical front and technical back according to aspects of the present invention.
  • FIG. 14B illustrates the 5.36 mm thickness of the example three-dimensional mesh of FIG. 14A.
  • FIG. 15A illustrates the technical front of an example three-dimensional mesh fabric according to aspects of the present invention.
  • FIG. 15B illustrates the technical back of the example three-dimensional mesh fabric of FIG. 15 A.
  • FIG. 16 illustrates an example mesh produced on a double needle bed weft knitting machine demonstrating shaping of the mesh for a breast support application according to aspects of the present invention.
  • FIG. 17 illustrates another example mesh produced on a double needle bed weft knitting machine demonstrating shaping of the mesh for a breast support application according to aspects of the present invention.
  • FIG. 18 illustrates yet another example mesh produced on a double needle bed weft knitting machine demonstrating shaping of the mesh for a breast support application according to aspects of the present invention.
  • FIG. 19 illustrates a further mesh produced on a double needle bed weft knitting machine demonstrating shaping of the mesh for a breast support application according to aspects of the present invention.
  • FIG. 20 illustrates another example mesh produced on a double needle bed weft knitting machine demonstrating shaping of the mesh for a breast support application according to aspects of the present invention.
  • FIG. 21 A illustrates a full-thickness rat abdominal defect created using a custom designed 1-cm stainless steel punch, the defect appearing oval in shape due to body wall tension applied.
  • FIG. 2 IB illustrates a 4 cm x 4 cm example implant centered on top of the open defect of FIG. 21 A, and held in place with single interrupted polypropylene sutures (arrow) through the implant and muscle.
  • FIG. 21C illustrates an explanted specimen 94 days post implantation as shown in FIG. 21B.
  • FIG. 2 ID illustrates ball burst testing performed with a 1-cm diameter ball pushed through the defect site reinforced with the mesh according to aspects of the present invention.
  • FIG. 22 illustrates an example pattern layout for a single needle bed mesh according to aspects of the present invention.
  • FIG. 23 illustrates an example pattern layout for a single needle bed mesh according to aspects of the present invention.
  • FIG. 24 illustrates an example pattern layout for a single needle bed mesh according to aspects of the present invention.
  • FIG. 25 illustrates an example pattern layout for the single needle bed mesh according to aspects of the present invention.
  • FIG. 26 illustrates an example pattern layout of the double needle bed mesh according to aspects of the present invention.
  • FIG. 27 illustrates an example pattern layout for the double needle bed weft knitting machine according to aspects of the present invention.
  • FIGS. 28A and 28B illustrate placement of a silk scaffold in accordance with the present invention.
  • FIG. 29 illustrates a pocket or sling formed by the scaffold at the pectoralis muscle suitable to hold a tissue expander or breast implant in accordance with the present invention.
  • FIGS. 30A and 30B are photographs of representative breast reconstruction surgical procedures in accordance with the present invention.
  • FIGS. 31 A, 3 IB, 31C and 3 ID are photographs of a representative breast augmentation surgical procedure in accordance with the present invention.
  • FIG. 32 illustrates a three-dimensional mesh with a pocket shape to position and secure a breast implant against a chest wall according to aspects of the present invention.
  • FIG. 33 illustrates a breast implant outside of the pocket according to aspects of the present invention.
  • FIG. 34 illustrates a breast implant seated in the pocket according to aspects of the present invention.
  • FIG. 35 illustrates is a three-dimensional mesh with a pocket shape and breast implant according to aspects of the present invention.
  • FIG. 36 illustrates a breast implant outside of the pocket with low stretch face on top according to aspects of the present invention.
  • FIG. 37 illustrates a breast implant outside of the pocket with high stretch face on top according to aspects of the present invention.
  • FIG. 38 illustrates a breast implant seated in the pocket according to aspects of the present invention.
  • FIG. 39 illustrates a three-dimensional mesh with a pocket shape referencing the transition between the pocket and non-pocket construction according to aspects of the present invention.
  • FIG. 40 illustrates a three-dimensional mesh with breast implant referencing the transition between the pocket and non-pocket construction according to aspects of the present invention.
  • FIG. 41 illustrates a template for cutting a mesh shape according to aspects of the present invention.
  • FIG. 42 illustrates a breast implant
  • FIG. 43 illustrates a three-dimensional mesh panel according to aspects of the present invention.
  • FIG. 44 illustrates a trimmed three-dimensional mesh panel according to aspects of the present invention.
  • FIG. 45 illustrates a template for cutting an opening tab according to aspects of the present invention.
  • FIG. 46 illustrates a three-dimensional mesh panel with cut opening tab according to aspects of the present invention.
  • FIG. 47 illustrates a sutured second part structure to the chest wall according to aspects of the present invention.
  • FIG. 48 illustrates a breast implant insertion in the pocket formed by the two structures according to aspects of the present invention.
  • FIG. 49 illustrates forming two symmetrical pockets according to aspects of the present invention.
  • FIG. 50 is a photograph of an outlined template on a SeriScaffold TM mesh panel according to aspects of the present invention.
  • FIG. 51 illustrates a three-dimensional mesh cut to shape according to aspects of the present invention.
  • FIG. 52 illustrates a two part structure sutured together according to aspects of the present invention.
  • FIG. 53 illustrates a two part structure with breast implant inserted according to aspects of the present invention.
  • FIG. 54A illustrates a mesh template in accordance with aspects of the present invention.
  • FIG. 54B illustrates another mesh template in accordance with aspects of the present invention.
  • FIG. 55 illustrates still yet another mesh template in accordance with aspects of the present invention.
  • FIG. 56A is a photograph of a pattern layout for a silk-based scaffold design in accordance with the present invention.
  • FIGS. 56B and 56C illustrate an example pattern layout for a silk-based scaffold design of FIG. 56A in accordance with the present invention including all pattern and ground bars according to aspects of the present invention.
  • FIGS. 56D and 56E are enlarged views of the example pattern layout and ground bars of FIG. 56B.
  • FIGS. 57A and 57B illustrate an example pattern layout for a double needle bed scaffold or mesh according to aspects of the present invention from FIG. 56B for ground bar #2.
  • FIGS. 57C and 57D are enlarged views of the example pattern layout and ground bars of FIG. 56B.
  • FIGS. 58A and 5B illustrate an example pattern layout for a double needle bed mesh or scaffold according to aspects of the present invention from FIG. 56 for pattern bar #4.
  • FIGS. 58C and 58D are enlarged views of the example pattern layout and ground bars of FIG. 56B.
  • FIGS. 59A and 59B illustrate an example pattern layout for a double needle bed mesh or scaffold according to aspects of the present invention from FIG. 56B for pattern bar #5.
  • FIGS. 59C and 59D are enlarged views of the example pattern layout and ground bars of FIG. 7B.
  • FIGS. 60A and 60B illustrate an example pattern layout for a double needle bed mesh or scaffold according to aspects of the present invention from FIG. 56B for ground bar #7.
  • FIGS. 60C and 60D are enlarged views of the example pattern layout and ground bars of FIG. 56B.
  • FIG. 61 illustrates an example pattern simulation for a double needle bed mesh demonstrated in FIG. 56B according to aspects of the present invention.
  • FIG. 62 is a photograph of a mesh pattern of a mesh in accordance with aspects of the present invention.
  • FIG. 63 is a photograph of a mesh pattern of a mesh in accordance with aspects of the present invention.
  • FIG. 64 is a photograph of a mesh pattern of a mesh in accordance with aspects of the present invention.
  • FIG. 65 is a photograph of a mesh pattern of a mesh in accordance with aspects of the present invention.
  • FIG. 66 is a photograph of a mesh pattern of a mesh in accordance with aspects of the present invention.
  • FIG. 67 is a photograph of a mesh pattern of a mesh in accordance with aspects of the present invention.
  • FIG. 68 is a photograph of a mesh pattern of a mesh in accordance with aspects of the present invention.
  • FIG. 69 is a photograph illustrating placement of three fabric formation measurements (horizontal measurements) and placement of the three fabric width measurements (vertical measurements) in accordance with aspects of the present invention.
  • All the silk fabrics within the scope of the present invention are knit silk fabrics intended for implantation in a human body.
  • the word "knit” is synonymous with the word “knitted”, so that a knit silk fabric is the same as a knitted silk fabric.
  • the silk fabrics within the scope of the present invention can be warp knit or they can weft knit silk fabrics.
  • the silk fabric of the present invention is a biocompatible, warp knit, multi-filament silk fabric.
  • Woven (weaved) silk fabric, woven textiles and woven fabrics are not within the scope of the present invention.
  • a woven material or fabric is made by weaving, which is a process that does not use needles, and results in a fabric with different characteristics.
  • a woven fabric is made by a non-needle process using multiple yarns that interlace each other at right angles to form a structure wherein one set of yarn is parallel to the direction of fabric formation.
  • a knit fabric is made by using needles (such as for example the needles of a single or double bed knit machine) to pull threads (yarn) up through the preceding thread formed into a loop by the needle, to thereby making the knit fabric (explained in more detail supra).
  • a knitted fabric is made using needles to have a fabric with one or multiple yarn intermeshing (also referred as interloping).
  • non- woven fabrics are also not within the scope of the present invention.
  • Non-woven (also refer to as bonded) fabrics are formed by having multiple fibers cohered together chemically or physically, without use of needles.
  • Embodiments according to aspects of the present invention provide a biocompatible surgical silk mesh device for use in soft or hard tissue repair.
  • soft tissue repair include hernia repair, rotator cuff repair, cosmetic surgery, implementation of a bladder sling, or the like.
  • hard tissue repair such as bone repair, involve reconstructive plastic surgery, ortho trauma, or the like.
  • the open structure of these embodiments allows tissue in-growth while the mesh bioresorbs at a rate which allows for a smooth transfer of mechanical properties to the new tissue from the silk scaffold.
  • embodiments employ a knit pattern that substantially prevents unraveling, especially when the mesh device is cut.
  • embodiments may preserve the stability of the mesh device by employing a knit pattern that takes advantage of variations in tension between at least two yarns laid in a knit direction. For example, a first yarn and a second yarn may be laid in a knit direction to form "nodes" for a mesh device.
  • the knit direction for the at least two yarns for example, may be vertical during warp knitting or horizontal during weft knitting.
  • the nodes of a mesh device also known as intermesh loops, refer to intersections in the mesh device where the two yams form a loop around a knitting needle.
  • the first yam is applied to include greater slack than the second yam, so that, when a load is applied to the mesh device, the first yam is under a lower tension than the second device.
  • a load that places the at least two yams under tension may result, for example, when the mesh device is sutured or if there is pulling on the mesh device.
  • the slack in the first yam causes the first yam to be effectively larger in diameter than the second yam, so that the first yam experiences greater factional contact with the second yam at a node and cannot move, or is "locked,” relative to the second yam. Accordingly, this particular knit design may be referred to as a "node-lock" design.
  • node-lock designs employ at least two yams under different tensions, where a higher tension yam restricts a lower tension yam at the mesh nodes.
  • other node-lock designs may vary the yam diameter, the yam materials, the yam elastic properties, and/or the knit pattern.
  • the knit pattern described previously applies yams in varying lengths to create slack in some yams so that they experience less tension. Because the lower tension yam is restricted by the higher tension yam, node-lock designs substantially prevent unraveling of the mesh when the mesh is cut.
  • the embodiments allow the mesh device to be cut to any shape or size while maintaining the stability of the mesh device.
  • node-lock designs provide a stability that makes it easy to pass the mesh device through a cannula for laparoscopic or arthroscopic surgeries without damaging the material.
  • a mesh device using silk can bioresorb at a rate sufficient to allow tissue in-growth while slowly transferring the load-bearing responsibility to the native tissue.
  • Particular embodiments may be formed from Bombyx mori silkworm silk fibroin.
  • the raw silk fibers have a natural globular protein coating known as sericin, which may have antigenic properties and must be depleted before implantation. Accordingly, the yam is taken through a depletion process. The depletion of sericin is further described, for example, by Gregory H. Altman et al, "Silk matrix for tissue engineered anterior cruciate ligaments," Biomaterials 23 (2002), pp.
  • a surgical mesh device may be created on a single needle bed Comez Acotronic/600-F or a Comez 410 ACO by the use of three movements as shown in the pattem layout 2200 in FIG. 22: two movements in the wale direction, the vertical direction within the fabric, and one in the course direction, the horizontal direction of the fabric. The movements in the wale direction go in opposing directions; a first yarn moving in one direction loops every course while the second yam moving in the opposite direction loops every other course.
  • the yarns follow a repeated 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.
  • the interlacing of the loops within the fabric allow for one yarn to become under more tension than the other under stress, locking it around the less tensioned yam; keeping the fabric from unraveling when cut.
  • the other movement within the fabric occurs in every few courses creating the openings in the mesh.
  • These yarns follow a pattern of 1-9/9-7/7-9/9-1/1-3/3-1. These yams create tension within the fabric when under stress, locking the yarns in the fabric; preventing the fabric from unraveling.
  • a surgical mesh device may be created on a double needle bed Comez DNB/EL-800-8B knitting machine by the use of three movements as shown in the pattem layout 2600 in FIG. 26: two movements in the wale direction and one in the course direction. The two movements in the wale direction occur on separate needle beds with alternate yarns; loops that occur in every course movement are staggered within the repeat. The yarns follow a repeated pattern of 3-1/1-1/1-3/3-3 and 1-1/1- 3/3-3/3-1. The third movement happens with the yarn that traverses the width of the fabric. The yarn follows the pattem 9-9/9-9/7-7/9-9/7-7/9-9/1-1/1-1/3-3/1-1/3-3/1-1. This fabric is also made at half gauge on a 20 gauge knitting machine and prevents unraveling due to the tension created between the yarns when stressed. The repeat the yam follows within the pattern is illustrated in FIG. 26.
  • a surgical mesh device may be formed on the Shima Seiki flat needle bed machine as shown in the pattern layout 2700 in FIG. 27.
  • This knit includes a continuous yarn or at least two different yarn sizes, one of which could be, though not limited to a different material.
  • the knitted mesh would be formed by a regular jersey knit on the first row with loops formed by either a continuous yarn or a yarn of a certain yarn size, while the loops in the second row are formed by tucked loops that occur alternately with jersey knit loops of the same continuous yarn or with a yarn of a different size.
  • the mesh would be shaped during knitting by use of increasing or decreasing stitches; a fashioning technique.
  • the silk yarn may be twisted from yarn made by 20-22 denier raw silk fibers approximately 40 to 60 ⁇ in diameter.
  • raw silk fibers ranging from 10 to 30 denier may be employed; however any fiber diameters that will allow the device to provide sufficient strength to the intended area are acceptable.
  • a constant yarn size may maximize the uniformity of the surgical mesh mechanical properties, e.g. stiffness, elongation, etc., physical and/or biological properties.
  • the yarn size may be varied in sections of the surgical mesh in order to achieve different mechanical, physical and/or biological characteristics in the preferred surgical mesh locations.
  • TABLE 1 outlines the fabric widths that may be achieved using different numbers of needles on different gauge machines. It is understood that the dimensions in TABLE 1 are approximate due to the shrink factor which depends on stitch design, stitch density, and yarn size used.
  • Embodiments of a prosthetic device according to the present invention may be knitted on a fine gauge crochet knitting machine.
  • a non-limiting list of crochet machines capable of manufacturing the surgical mesh according to aspects of the present invention are provided by: Changde Textile Machinery Co., 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; S rotating 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 a prosthetic device according to the present invention may be knitted on a fine gauge warp knitting machine.
  • warp knitting machines capable of manufacturing the surgical mesh according to aspects of the present invention are provided by: Comez; Diba; Jingwei Textile Machinery; Liba; Lucas; Karl Mayer; Muller Frick; Runyuan Warp Knitting; Taiwan Giu Chun Ind.; Fujian Xingang Textile Machinery; and Yuejian Group.
  • Embodiments of a prosthetic device according to the present invention may be knitted on a fine gauge flat bed knitting machine.
  • a non-limiting list of flat bed machines capable of manufacturing the surgical mesh according to aspects of the present invention are provided by: Around Star; Boosan; Cixing Textile Machine; Fengshen; Flying Tiger Machinery; Fujian Hongqi; G & P; Gorteks; Jinlong; JP; Jy Leh; Kauo Heng Co., Ltd.; Matsuya; Nan Sing Machinery Limited; Nantong Sansi Instrument; Shima Seiki; Nantong Tianyuan; and Ningbo Yuren Knitting.
  • FIGS. 1-20 illustrate example meshes produced according to aspects of the present invention.
  • an example mesh 100 is produced on a single needle bed warp knitting machine according to aspects of the present invention.
  • FIG. 1A shows the technical back 100A of the mesh 100
  • FIG. IB shows the technical front 100B of the mesh 100.
  • FIGS. 2A and B an example mesh 200 is produced on a double needle bed warp knitting machine according to aspects of the present invention.
  • FIG. 2A shows the technical front 200A of the mesh 200
  • FIG. 2B shows the technical back 200B of the mesh 200.
  • FIG. 3 illustrates an example mesh 300 produced with single filament silk yarn according to aspects of the present invention.
  • FIG. 4 shows an example mesh 400 produced on a single needle bed warp knitting machine according to aspects of the present invention.
  • FIG. 5A illustrates an example mesh 500A produced on a double needle bed warp knitting machine.
  • the mesh 500A has a parallelepiped pore with a section demonstrating a plush design according to aspects of the present invention.
  • FIG. 5B illustrates an example mesh 500B produced on a double needle bed warp knitting machine.
  • the example mesh 500B has a hexagonal pore according to aspects of the present invention.
  • FIGS. 6A and B illustrate example narrow mesh fabrics 600A and 600B according to aspects of the present invention.
  • the mesh fabrics 600A and 600B have varying stitch densities incorporating a plush variation.
  • an example mesh 700 incorporates loop pile according to aspects of the present invention.
  • FIG. 8 illustrates an example narrow mesh fabric 800 with pore design achieved through variation in the yarn feed rate according to aspects of the present invention.
  • FIG. 9A illustrates an example collapsed mesh fabric 900A with hexagonal-shaped pores according to aspects of the present invention.
  • FIG. 9B illustrates an example opened mesh fabric 900B with hexagonal shaped pores according to aspects of the present invention.
  • an example of a stable, non-collapsible mesh fabric 1000 includes hexagonal-shaped pores according to aspects of the present invention.
  • FIG. 11A illustrate an example three-dimensional mesh 1100 with the same technical front and technical back according to aspects of the present invention.
  • FIG. 11B illustrates the 2.55 mm thickness of the three-dimensional mesh 1100.
  • FIG. 12 illustrates another example three-dimensional mesh 1200 with a thickness of 3.28 mm according to aspects of the present invention.
  • FIGS. 13A-C illustrate an example non-porous mesh 1300 according to aspects of the present invention.
  • FIG. 13A shows the technical front 1300A of the non-porous mesh 1300.
  • FIG. 13B shows the technical back 1300B of the non-porous mesh 1300.
  • FIG. 13C shows that non-porous mesh 1300 has a thickness of 5.87 mm.
  • FIG. 14A illustrates an example three-dimensional mesh 1400 with the same technical front and technical back according to aspects of the present invention.
  • FIG. 14B shows that the three-dimensional mesh 1400 has a thickness of approximately 5.36 mm.
  • FIGS. 15A and B illustrate another example three-dimensional mesh fabric 1500 according to aspects of the present invention.
  • FIG. 15A shows the technical front 1500A of the fabric 1500
  • FIG. 15B illustrates the technical back 1500B of the fabric 1500.
  • FIGS. 16-20 illustrate respective example meshes 1600, 1700, 1800, 1900, and 2000 that are produced on a double needle bed weft knitting machine.
  • the meshes 1600, 1700, 1800, 1900, and 2000 demonstrate shaping of a mesh for a breast support application according to aspects of the present invention.
  • a test method was developed to check the cutability of the surgical mesh formed according to aspects of the present invention.
  • the surgical mesh evaluated according to the number of were needed to cut the mesh with surgical scissors.
  • the mesh was found to cut excellently because it took one scissor stroke to cut through it.
  • the mesh was also cut diagonally and in circular patterns to determine how easily the mesh unraveled and how much it unraveled once cut.
  • the mesh did not unravel more than one mode after being cut in both directions.
  • a suture was passed through the closest pore from the cut edge, and pulled. This manipulation did not unravel the mesh.
  • the surgical mesh is easy to cut and does not unravel after manipulation.
  • Embodiments may be processed with a surface treatment, which increases material hydrophilicity, biocompatibility, physical, and mechanical properties such as handling for ease of cutting and graft pull-through, as well as anti-microbial and anti-fungal coatings.
  • surface treatments include, but are not limited to: • plasma modification
  • protein such as but not limited to fibronectin, denatured collagen or gelatin, collagen gels and hydrophobin by covalent link or other chemical or physical method
  • peptides contain one silk-binding sequence and one biologically active sequence- biodegradable cellulose
  • a method to evaluate the ease of delivery through a cannula was done to make sure the surgical mesh could be used laparoscopically.
  • Various lengths were rolled up and pushed through two different standard sized cannulas using surgical graspers. The mesh was then evaluated to determine if there was any damage done to the mesh.
  • the mesh that was put through the cannulas was found to have slight distortion to the corner that was held by the grasper.
  • the 16 cm and 18 cm lengths of mesh that were rolled up and pushed through the 8 mm cannula had minimal fraying and one distorted pore, respectively. It was also found that no damage was done to the cannula or septum in any of the tests. It was found that appropriately sized surgical mesh will successfully pass through a laparoscopic cannula without damage, enabling its effective use during laparoscopic procedures.
  • a surgical mesh device has been found to bio-resorb by 50% in approximately 100 days.
  • Sprague-Dawley rats were used to compare the bio-resorption of embodiments according to the present invention to MersileneTM mesh (Ethicon, Somerville, N.J.).
  • the MersileneTM was found to have less in growth in the defect region than along the abdominal wall.
  • Physical properties include thickness, density and pore sizes.
  • the thickness was measured utilizing a JlOO Kafer Dial Thickness Gauge.
  • a Mitutoyo Digimatic Caliper was used to find the length and width of the samples; used to calculate the density.
  • the density was found by multiplying the length, width and thickness of the mesh then dividing the resulting value by the mass.
  • the pore size was found by photographing the mesh with an Olympus SZX7 Dissection Microscope under 0.8x magnification. The measurements were taken using ImagePro 5.1 software and the 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.
  • a method was developed to compare the suture pull out strength of the surgical mesh device according to aspects of the present invention to other surgical mesh on the market.
  • Tested mesh was sutured with three 3.5 mm diameter suture anchors (Arthrex, Naples, Fla.) and secured to 15 pcf solid rigid polyurethane foam. Each device was positioned with the center of the 20 mm width over the center anchor with a 3 mm suture bite distance employed during suturing of the mesh to the 3 anchors.
  • the saw bone was mounted in the lower pneumatic fabric clamp and offset to provide loading along the axis of the device when the device was centered under the load cell.
  • the surgical mesh device By utilizing the pattern for the double needle bed mesh and modifying the yarn size, yarn feed rate and/or needle bed width, the surgical mesh device according to aspects of the present invention would meet the physical and mechanical properties necessary for a soft or hard tissue repair depending on the application. Such properties include pore size, thickness, ultimate tensile strength, stiffness, burst strength and suture pull out.
  • the pore size could be modified dependent to the feed rate to create a more open fabric and the thickness could range from 0.40 mm up to as wide as 19.0 mm. With modifications to the pore size and thickness the UTS, stiffness, burst strength and suture pull out would all be modified as well, most likely tailoring the modifications of the pore size and/or thickness to meet certain mechanical needs.
  • This mesh created on the flat knitting machine would be made in such a way to increase or decrease pore size and/or thickness by changing the yarn size and/or changing the loop length found within the knitting settings.
  • the loop placements in combination with the node lock design allow changes to the shape and/or to the mechanical properties of the mesh.
  • a biocompatible yarn with elasticity, such as highly twisted silk, could be used for shaping.
  • FIGS. 21A-D The implantation of a mesh and subsequent testing according to aspects of the present invention is illustrated in FIGS. 21A-D.
  • FIG. 21A illustrates a full-thickness rat abdominal defect created using a custom designed 1-cm stainless steel punch. The defect appears oval in shape due to body wall tension applied.
  • FIG. 2 IB illustrates a 4 cm x 4 cm implant centered on top of the open defect, and held in place with single interrupted polypropylene sutures (arrow) through the implant and muscle.
  • FIG. 21C illustrates an explanted specimen 94 days post implantation.
  • FIG. 2 ID illustrates ball burst testing performed with a 1-cm diameter ball pushed through the defect site reinforced with the mesh.
  • a knitted mesh may be used for a filler material.
  • the knitted mesh may be cut into 1 mm x 1 mm sections to separate one or more nodes, e.g., 3 nodes.
  • the sections may be added to fat tissue or a hydro-gel to form a solution that can be injected into a defective area.
  • the filler material may provide a desired texture, but will not unravel.
  • the knitted silk mesh or scaffold is used in breast reconstruction procedures.
  • the present invention relates to method(s) of using the knitted silk scaffold in single-stage or two-stage breast reconstruction.
  • the method comprises suturing the knitted, silk scaffold to a chest wall creating a pocket for placement of a tissue expander or a breast implant.
  • FIGS. 28 A and 28B illustrate placement of a silk scaffold in accordance with the methods of the present invention.
  • FIG. 29 illustrates a pocket or sling formed by the scaffold at the pectoralis muscle suitable to hold a tissue expander or breast implant.
  • the silk scaffold is of the node- lock construction such that the knitted mesh or scaffold includes at least two yarns laid in a knit direction and engaging each other to define a plurality of nodes, the at least two yarns including a first yarn and a second yarn extending between two nodes, the second yarn having a higher tension at the two nodes than the first yarn, the second yarn substantially preventing the first yarn from moving at the two nodes and substantially preventing the knitted mesh from unraveling at the nodes.
  • the knitted, silk scaffold has other properties as discussed herein that are particularly desirable in breast reconstruction surgical procedures.
  • the fabric described herein can be designed for use as an implantable prosthesis in surgical procedures performed to alter the size, shape, position or appearance of a breast mound in a patient.
  • the fabric described herein is used as an implantable prosthetic device for supporting surrounding tissue and at the same time serving as a scaffold for the in vivo generation of such supportive tissue within the breast of the patient.
  • the fabric described herein is useful for implantation in procedures such as mastopexy, breast augmentation, and breast reconstruction post-mastectomy.
  • the fabric further provides a site for new breast tissue in-growth in vivo.
  • the fabric also serves as a scaffold for tissue generation within the breast at the site of implantation.
  • the new tissue generated to replace the fabric can serve as an integral component of the breast repair/augmentation, and/or an aid in recovery from the incisions made during the surgery (e.g., breast reconstruction, breast augmentation, mastopexy).
  • the fabric is designed so that it can at least partially replace breast connective tissue in the patient (e.g., tissue that was lost due to surgical removal or otherwise damaged).
  • the fabric can take the form of one or more components designed to resemble and replicate native tissue components within the breast, described herein.
  • the fabric can be designed to replicate one specific tissue structure, or can resemble a plurality of tissue structures (e.g., that are normally found closely associated or interconnected within the breast).
  • the fabric is designed to replace or replicate connective tissue that spans the breast area and connects the fascia and/or skin (e.g., connective retinaculum, fascia mammae, fibrous lamella).
  • the fabric is a two-dimensional web or mesh.
  • the web or mesh can be designed to have one or more biomechanical properties of the fascia of the breast (e.g., superficial fascia, muscular fascia).
  • the fabric in the form of a web or mesh may additionally comprise one or more components which resemble native tissue components within the breast (e.g., ligament or ligament- like structures).
  • a web or mesh with thicker ligament- like structures interspersed through the body of the mesh.
  • Such thicker structures can run along the length of the web, through the center of the web, they can be dispersed in a variety of patterns, e.g., run in straight and/or branching lines radially from the center. They may have circular/elliptical form (e.g., different sized circles arranged to have the same center).
  • the structures are arranged in a pattern throughout the web that resembles the connective tissue of the breast.
  • Such structures can be designed and generated as integral components of the web or mesh, or can be generated separately and added post production of the web or mesh by attachment.
  • Such structural components of the breast are known in the art.
  • the fabric is comprised of intertwined yarns (e.g., intertwined by weaving, knitting, or stitch bonding).
  • the yarns are made from sericin-extracted fibroin fibers described herein.
  • the fibroin fibers can be organized into the yarns by one, two, three or four level hierarchical organization, as described herein. For example, parallel or intertwined fibers are grouped together to form the yarn in single-level hierarchical organization. A second level of hierarchical organization is added when a plurality of groups are intertwined together to form one or more bundles present within the yarns.
  • a third level of hierarchical organization is added when a plurality of bundles are intertwined together to form one or more strands present within the yarns.
  • a fourth level of hierarchical organization is added when a plurality of strands are intertwined together to form one or more cords, present within the yarns. Intertwining consists of non-randomly aligning with one another via parallel, helical organization. Such organization can occur at any hierarchical level, to produce a fabric with the desired properties (biomechanical, porosity, etc.). The ordinary skilled artisan will recognize various combinations of these levels of hierarchical organization can be used to produce a fabric with different overall structures (e.g., twisted, braided, knitted, stitch bonded). In addition, fabrics with any combination of these structures can be generated.
  • the fabric is designed and implanted to support the breast structure and/or a prosthesis placed within the breast.
  • the structure of the fabric extends in at least one dimension (a first dimension) and has at least one surface (a first surface) adapted to engage the resulting breast (comprising natural breast tissue and/or a prosthetic breast implant).
  • the fabric can be designed to have a variety of different overall shapes (e.g., to conform with the breast tissue when implanted).
  • a fabric that is a web or mesh may be flat, or it may have a concavity.
  • the fabric can have a predefined shape that is adapted to conform to at least a portion of a region of natural breast tissue or of a breast implant, within the patient.
  • the fabric has a crescent shape, or an elliptical shape.
  • a circular, semi-circular, oval, cup shape, or half-moon shape may also be used.
  • An elongated strip can also be used.
  • the fabric is sufficiently large to completely or partially cover the lower and/or lateral sections of the breast prosthesis or breast tissue.
  • the fabric is formed in a sling shape (e.g., to provide support for a breast or breast implant, within the patient.
  • the fabric is formed in an elongated shape (e.g., to provide support in an inframammary region of the breast, within the patient).
  • the fabric is formed in a cup shape (e.g., to provide medial or lateral support for the breast within the patient).
  • the fabric may additionally comprise a portion that is adapted to be fastened to the tissue of the patient. This will facilitate implantation.
  • the structure of the portion so adapted will depend upon the means of attachment and/or the place of attachment to the patient.
  • the attachment is to tissue surrounding the chest cavity of the patient.
  • the attachment is soft tissue surrounding the breast tissue or surrounding the prosthetic breast implant.
  • the attachment is to a boney structure adjacent to the breast tissue, or adjacent the prosthetic breast implant.
  • the fabric may additionally include one or more agents that promote in-growth of cells to thereby generate new breast tissue.
  • agents include, without limitation, cell attachment factors, growth factors, attachment promoting materials, drugs, chemoattractants described herein.
  • the inframammary fold is the natural boundary of the breast from below where the breast and the chest meet.
  • the inframammary fold is located at the fifth- sixth rib. The lowest portion extends to the sixth intercostal space. This fold has a constant position.
  • the inframammary region contains a number of thick collagen fibers, stretched between superficial fascia and deep fascia.
  • the superficial fascia is made up of both collagen and elastic fibers.
  • the superficial fascia of the female breast subcutaneous fascial system is exceptionally thick.
  • the superficial fascia connects to the deep fascia (muscular fascia) through thickened retinaculum along the sternum.
  • a connective band known as the anterior breast capsule (fascia mammae) detaches from the superficial fascia. This fascia, and the fascia of the subclavian area support the mammary gland by means of their retinaculum fibrosa (Cooper's ligaments).
  • the inframammary retinaculum originate from the superficial fascia, and consists of merging dense connective retinaculum.
  • the superficial fascia is separated from the muscular fascia through a thin, deep, subcutaneous layer where the connective retinacula are almost horizontal. They are joined by elastic septa which include adipose lobules. In thin women there are only a few of these and they are small, and fixed to the deeper muscular fascia. There is fusion of the superficial fascia with the deeper fascia, along the sternum.
  • Medially the superficial fascia merges into the anterior membrane of the sternum and is composed of fibers coming from the tendinous apparatus of the sternocleidomastoid and pectoralis major muscles.
  • a transverse fibrous lamella comes off the fascia almost at the 6.sup.th rib, and extends the full length of the inframammary crease.
  • This structure has a different texture and a denser consistency from the superficial fascia.
  • Between the superficial and deep fascia there is a layer consisting of fibroareolar tissue and occasionally fibrofatty tissue.
  • the tissue is more fibrous at the sixth rib-sixth intercostal space.
  • the superficial fascia connects with the deeper muscular fascia by means of thicker retinaculum at the deep inframammary subcutaneous layer.
  • the superficial fascia here is adherent to the deep plane (muscular fascia) and more resistant to traction. The adherence is histologically made up of multiple, short, fibrous connections which do not pass through the fibromuscular plane.
  • Mammary ligaments form a circumferential ligament about the breast to form a circumferential fusion between the superficial fascia and the deep fascia.
  • This connective ligament which completely surrounds the breast to form a circular boundary to the cleft between the superficial fascia and deep fascia is often referred to as the circumferential mammary ligament.
  • the circumferential mammary ligament forms a natural boundary connecting two tissue layers that a surgeon dissecting between the layers may use to define and limit the extent of the dissection. These defined layers also offer a region for tissue growth, as disclosed in U.S. Patent Application Publication 2008/0300681.
  • Fabrics designed to serve as tissue supports and/or scaffolds for breast reconstruction may be used in a wide range of procedures involving breast augmentation or mastopexy, including, for example, in breast lift procedures, breast augmentation procedures, in post- mastectomy reconstruction.
  • One aspect of the invention relates to the use of the fabric described herein in a method for supporting a breast structure within a patient.
  • the method involves positioning the fabric (e.g., configured as a scaffold for support and new tissue in-growth) within the patient in a supporting position relative to the breast structure.
  • the breast structure may comprise native breast tissue (e.g., a mammary gland), or a breast prosthesis (e.g., a breast implant), or a combination thereof.
  • this involves implanting the fabric structure at an anatomical location between the skin covering the breast tissue and the breast tissue and/or breast implant to be supported within the patient.
  • the specific position (e.g., depth) between the skin and the supported tissue will vary with the actual procedure, and can be determined by the skilled practitioner.
  • positioning the fabric comprises covering the lower and lateral sections of the breast area.
  • the fabric is inserted in a medial side of the breast to support medial positioning of the breast and/or implant, and reduce medial displacement of the breast and/or implant.
  • the fabric is inserted in a lateral side of the breast to support lateral positioning of the breast and/or implant, and reduce lateral displacement of the breast and/or implant.
  • the fabric comprises one or more biomechanical properties of a tissue that would be present naturally in the breast at such a supportive position. Such tissues are described herein.
  • Implanting the fabric typically involves inserting the fabric structure and fixing the matrix in the desired position. Such methods typically involve fixation of the matrix in the desired position (e.g., across the lower and lateral sections of the breast to support the lower pole of a breast prosthesis/breast tissue, or on the lateral or medial side of the breast to inhibit lateral or medial displacement). Fixation or attachment may be achieved using any suitable method known in the art, for example, by placement of sutures or staples, or with use of a tacking device. Appropriate methods for attachment of the fabric described herein, during the implantation procedure, is to be determined by the skilled practitioner.
  • the fabric described herein can be attached to bone (e.g., one or more ribs), muscle, or soft tissue.
  • the fabric is attached to one or more soft tissues within the breast region, described herein.
  • Various methods of attachment are known in the art, and include, without limitation, suturing, stapling, gluing, and laying in place.
  • Various attachment methods are described in U.S. Pat. No. 5,584,884.
  • attachment or fastening of the fabric is to tissue surrounding the chest cavity of the patient. In one embodiment, attachment or fastening is to soft tissue surrounding the breast tissue and/or the prosthetic implant within the patient.
  • the fabric can alternatively be attached or fastened to a boney structure adjacent to the breast tissue and/or the prosthetic implant within the patient.
  • the fabric structure may be beneficial or necessary for the skilled practitioner to form the fabric structure into a predefined shape that is adapted to conform to a region, or at least a portion, of the natural breast tissue and/or the prosthetic implant within the patient.
  • useful shapes include, without limitation, circular shapes, oval shapes, crescent shapes, cup shapes, and elongated strips.
  • the fabric described herein is used as a surgical tool in breast augmentation.
  • Breast augmentation refers to increasing the size of a breast, such as is generally achieved by the insertion of prosthetic implants.
  • the fabric of the instant invention can be used to promote wound healing and soft tissue reconstruction by providing strength and covering at the site of a surgical incision (e.g., at the site of breast implant insertion. It can provide immediate strength to an incision site or site of soft tissue reconstruction/augmentation, and also provide a substrate for new tissue ingrowth.
  • the fabric comprises interconnecting cells or a fibrous network with enough strength to provide closure and protection of incision sites.
  • the fabric described herein is used in placement or repositioning of a breast prosthesis.
  • the fabric for example, can be used to support the lower pole position of breast implants or can be used as a partial or complete covering of the breast implant. Covering of the implants within the fabric provides a beneficial interface with host tissue and reduces the potential for malpositioning or capsular contracture. Covering of the implant also reduces or prevents tissue adhesions to the implant.
  • the fabric can be absorbed and replaced by the infiltrating tissue. As such, the fabric can provide temporary scaffolding and well-defined structure until it is no longer needed.
  • the fabric of the instant invention can be used to reposition a breast implant in follow-up corrective surgery, or can be used prophylactically at the time of initial implant placement to prevent displacement.
  • the fabric can be configured and implanted to position the breast implant in the desired position within the patient (e.g., in completely sub-muscular, partial sub-muscular, or sub-glandular placement).
  • Implants are typically positioned within the chest in one of three positions: (1) implant over the pectoralis major muscle and under the breast tissue (subglandular); (2) implant partially under the muscle (partial submuscular); and (3) implant completely under the muscle (submuscular).
  • the subglandular placement puts the implant directly behind the breast tissue and mammary gland and in front of the pectoralis major muscle. This placement requires the least complicated surgery and yields the quickest recovery.
  • the downsides of this placement are increased chances for capsular contracture, greater visibility and vulnerability for the implant. This is because only the skin and breast tissue separate the implant from the outside world. Depending on the amount of available breast tissue, the implant may be seen "rippling" through the skin.
  • Partial submuscular placement involves placing the implant under the pectoralis major muscle. Because of the structure of this muscle, the implant is only partially covered. This alternative reduces the risk of capsular contracture and visible implant rippling, but recovery time from this positioning is typically longer and more painful because the surgeon has to manipulate the muscle during surgery. Also, because of increased swelling, the implant may take longer to drop into a natural position after surgery. Completely submuscular placement puts the implant firmly behind the chest muscle wall. The implant is placed behind the pectoralis major muscle and behind all of the supporting fascia (connective tissue) and non- pectoral muscle groups. This placement has even longer recovery time, potential loss of inferior pole fullness, and involves a more traumatic surgical procedure.
  • the surgery is carried out through an incision placed to minimize long-term scarring.
  • the incision is made in one of three areas: (1) peri-areolar incision; (2) inframammary fold incision; and (3) transaxillary incision.
  • the peri-areolar incision enables the surgeon to place the implant in the subglandular, partial submuscular or completely submuscular position, with the implant being inserted, or removed, through the incision.
  • the inframammary fold incision provides for all three placement types and both insertion and removal of the implant through the incision.
  • the incision is made in the crease under the breast, allowing for discreet scarring. Once the incision is made, the implant is inserted and worked vertically into place.
  • Implant malposition may be the result of several factors, including poor surgical technique, i.e. the implant pocket is too big or too low; implant weight; or lack of soft tissue support.
  • cancer treatments such as chemotherapy, weaken the soft tissue and surgery, in general, interrupts the natural anatomic plains of the soft tissue.
  • the fabric described herein is implanted within a patient for initial positioning of a breast implant within the patient.
  • the fabric may be configured to form a receiving area for receiving the breast implant.
  • the fabric may further comprise one or more regions for tissue affixation. One of the regions may be adapted to attach the fabric to soft tissue surrounding the breast implant or a boney structure within the patient, such as the periosteum of the chest cavity, with a first suture or by conventional or endoscopic tacking.
  • the surgeon can use the initial incision made to insert the fabric, provided the initial incision was peri-areolar or in the inframammary fold, to access and position the implant with the fabric.
  • the fabric e.g., rolled up
  • the fabric may comprise a suture or tack at the distal end which can be removed enabling the end to unroll once in the desired position for implanting.
  • the fabric of the present invention can be configured to be implanted within the patient in varying orientations, depending on the specific situation to be remedied or prevented. For example, when used to correct medial displacement (symmastia) or lateral displacement of an implant, the fabric is positioned in a substantially vertical position on the medial or lateral side, respectively, of the implant. When the fabric is used to correct inferior displacement of an implant (otherwise known in the art as bottoming out), the fabric is placed in a substantially horizontal position, supporting the implant from below. Proper positioning of the fabric during the initial implant placement procedure is dependent on the tissue structure surrounding the implant and the desired placement of the implant within the patient.
  • Fixation of the fabric is achieved, for example, by placement of permanent sutures at key locations via the tissue affixation regions, or with use of a tacking device, either conventional or endoscopic, depending on the placement of the incision.
  • An inframammary fold incision may require suturing of the fabric in place whereas a peri-areolar incision will enable the use of an endoscopic tacking device.
  • the fabric When the fabric is orientated in vertical position to fix or prevent medial displacement of the implant, the fabric can be secured at tissue affixation regions to one or more of the following structures and soft tissue: 1) the backwall to the periosteum of the chest wall, 2) the upper intersection of the first and second portions to the sternal border of the chest wall, 3) at the lower intersection of the first and second portions to periosteum of the chest wall, and 4) on the frontwall to the posterior aspect of the pectoralis fascia.
  • FIGS. 31 A, 3 IB, 31C and 3 ID are photographs of a representative breast augmentation (revision) surgical procedure in accordance with the present invention.
  • FIG. 31A is a photograph showing a patients' breast cut open, the breast implant having been removed, and SeriScaffold 100 being positioned in the breast.
  • FIG. 3 IB is a photograph of the FIG. 31A breast showing SeriScaffold 100 further positioned within the breast.
  • FIG. 31C is a photograph of the FIG. 3 IB breast showing SeriScaffold 100 at its final position in place ready to support a new augmentation breast implant that will be placed at location E.
  • FIG. 3 ID is a photograph of the FIG. 31C breast (both breasts now shown) after the wound has been sutured closed (over the breast implant supported by SeriScaffold 100), and showing a very positive breast augmentation result.
  • Mastopexy or breast lift, is a procedure designed to improve the appearance of sagging or ptotic breasts. Mastopexy presents one of the greatest challenges to the breast surgeon. Numerous techniques provide improvement in the shape of the breast, but aesthetic improvements comes at the cost of scars. In addition, the use of implants in mastopexy presents specific risks and complications.
  • Crescent mastopexy is for patients with mild sagging, excess breast skin in the upper half of the breast, and a normal amount of skin in the lower half, a semi-circular incision is made on the upper portion of the areola. A crescent shaped piece of skin is removed, and when the skin edges are sewn back together, the nipple and areola are raised slightly (1 to 2 inches). A crescent mastopexy is best for women with only mild breast ptosis (sagging). [00211] Donut mastopexy, also called a Benelli mastopexy or circumareolar mastopexy since the incision is around the areola, a donut mastopexy removes a ring of skin from outside the areola.
  • the donut mastopexy is also useful for women with a projecting nipple/areola complex (sometimes called torpedo or missile shaped breasts), and can also be used to reduce the size of the areola at the same time.
  • Lollipop or vertical mastopexy is when an incision for a lollipop mastopexy is made around the areola and then down the center of the breast to the inframammary fold. This technique is used for mild to moderate breast ptosis. As with the circumareolar or donut lift, the size of the areola may be reduced at the same time.
  • Anchor mastopexy also referred to as a Wise pattern (or sometimes Weiss pattern) mastopexy, full breast lift, or inverted-T incision, is considered the traditional technique for breast lifting.
  • the incisions are made around the areola, down the center of the lower portion of the breast and then across the breast in the inframammary fold. Like the donut and lollipop incisions, the areola can be made smaller at the same time. The resulting scar is in the shape of an anchor.
  • the Wise pattern or anchor mastopexy used to be the standard it is now usually reserved only for those with moderate to severe breast sagging.
  • Mastopexy can be performed with or without a corresponding change in the breast size (either breast reduction or breast augmentation).
  • the fabric described herein can be used in any of these types of procedures.
  • the fabric described herein is used to promote wound healing and/or tissue support in the procedure.
  • the fabric can be also be used to augment or replace pre-existing breast tissue.
  • the fabric is used in a method to reduce breast volume.
  • the method can be performed as follows:
  • the fabric is used in a method to lift breast tissue.
  • the method can be performed as follows:
  • the fabric is used in a method of mastopexy treatment with breast augmentation.
  • the method can be performed as follows:
  • Breast reconstruction is the re-creation of a breast following mastectomy.
  • Mastectomy is the most common treatment of localized breast cancer. While breast reconstruction can be performed at the time of mastectomy, the better candidates are those who have confirmed elimination of the cancer as sometimes implant materials and reconstruction will interfere with detection of recurrence.
  • Reconstruction usually involves a two part process, where in the first series of surgeries, a tissue expander is inserted beneath the skin and the pectoralis muscle. The expander is an air or saline-filled balloon that is periodically injected over a number of months with additional saline in order to gradually stretch the skin and muscle. When the skin and muscle are sufficiently lengthened, an implant (saline or silicone) is inserted to recapitulate the native breast structure.
  • an implant saline or silicone
  • an additional section of a patient's tissue an autograft
  • an autograft must be used along the lateral side of the breast, usually the latissimus dorsi or abdominus recti.
  • Autograft tissue bears a risk of tissue morbidity and total coverage and support of the implant or the expander with the muscle tissue in the mastectomy pocket is a challenge. Without appropriate coverage, the implant can become exposed and reduce cosmetic outcome.
  • the fabric described herein can be used for to promote wound healing and/or tissue support in the procedure.
  • the fabric can also be also be used to augment or replace pre-existing breast tissue.
  • the fabric can further be used in implant placement as described herein in the breast reconstruction procedure.
  • the fabric described herein is used in complement or in place of autograft tissue in the breast reconstruction procedure (e.g., to cover and/or support the implant or the expander at the lower breast pole).
  • the fabric of the present invention is used to provide strength to breast fascia and/or soft tissue weakened by the mastectomy surgery. During mastectomy, as much of the superficial fascial system in the inframammary fold is preserved as possible. Generally, Cooper's ligaments are cut in the course of the surgery.
  • the fabric of the present invention is used to recreate the inframammary fold following mastectomy.
  • the fabric of the present invention is designed to have one or more biomechanical properties of the inframammary fold tissue that is damaged during the mastectomy process. This fabric can be implanted at the location of the damaged tissue. Such implanted fabric supports the reconstructed breast and also serves as a scaffold for the generation of new tissue at that site within the body.
  • the fabric of the present invention can be used in place of, or in combination with, the omental flap, in postmastectomy breast reconstruction.
  • One such procedure is described by Goes and Macedo (The Surgery of the Breast, Principles and Art, Lippincott Williams & Wilkins, Second Edition, Chapter 52, pages 786-793, 2006).
  • FIG. 32 illustrates a three-dimensional mesh with a pocket shape to position and secure a breast implant against a chest wall according to aspects of the present invention.
  • a silk fibroin pocket or pouch 3200 is formed in a tridimensional structure having a shape of a marsupium like pouch.
  • the structure allows the insertion and seating of a breast implant 3210 inside its pocket 3200.
  • the pocket structure allows the suturing of one of the structure faces 3220 against the chest wall therefore positioning the pocket 3200 and the relative breast implant 3210 in the desired placement.
  • the knitted mesh of the pocket structure (indicated by cross-hatching) has tailored physical and mechanical properties to hold in place the breast implant 3210 during the pocket bioresorption time while newly formed tissue will increasingly support the breast implant load.
  • the knitted mesh is in the pattern referred to as the "node-lock" design.
  • the "node-lock" design substantially prevents unraveling and preserves the stability of the mesh device, especially when the mesh device is cut.
  • Additional benefits may include prevention or correction to the following surgical complication: inferior malpositioning; lower pole reinforcement to allow for larger implants in primary augmentation; reinforce implant position during augmentation-mastopexy; lateral/medial malposition correction without extensive procedure-neopocket or suture lines, prone failure; capsulectomy due to capsular contracture.
  • FIG. 32 is made with a seam 3230; two parts are put together and sewn together.
  • FIG. 33 is a photograph of a breast implant outside of a SeriScaffold TM mesh pocket made in accordance with FIG. 32.
  • FIG. 34 is a photograph of a breast implant seated in the SeriScaffold TM mesh pocket made in accordance with FIG. 32.
  • the pocket 3500 may have two different structure faces 3520A and 3520B characterized by varying physical and mechanical properties.
  • FIG. 35 illustrates is a three-dimensional mesh with a pocket shape and breast implant according to aspects of the present invention.
  • FIG. 35 illustrates the pocket having two faces 3520A and 3520B.
  • one of the faces of the pocket is a knitted mesh having lower stretchability than the other face.
  • one of the faces of the pocket is a knitted mesh having higher stretchability than the other face.
  • the pocket 3500 is made with a seam or without a seam (such as folded) but in either case still comprised of two different fabric structure faces (indicated by cross-hatching).
  • the fabrics of the faces are knit with a double needle bed or a single needle bed, or tubular knit.
  • the structure is seamless to allow for better and more uniform bioresorption than a pocket or pouch with a seam. Additionally, irritation of the surrounding tissue is minimized by using the seamless design.
  • FIG. 36 illustrates a breast implant outside of the pocket with low stretch face on top according to aspects of the present invention.
  • FIG. 37 illustrates a breast implant outside of the pocket with high stretch face on top according to aspects of the present invention.
  • FIG. 38 illustrates a breast implant seated in the pocket according to aspects of the present invention.
  • FIG. 39 illustrates a three-dimensional mesh with a pocket shape and dashed lines referencing a transition 3900 between the pocket 3910 and non-pocket 3920 construction according to aspects of the present invention.
  • FIG. 40 illustrates a three-dimensional mesh with breast implant referencing the transition between the pocket 4000 and non-pocket 4010 construction according to aspects of the present invention.
  • FIG. 40 indicates that the non-pocket area 4010 is cuttable for shaping.
  • the structure is formed with a process that defines the cutting area by knitting a non-pocket 4010 construction only within the cutting area for shaping.
  • a warp knit jacquard machine is the equipment of preference for manufacturing the herein described pouch.
  • FIG. 41 illustrates a template for cutting a mesh shape according to aspects of the present invention.
  • the first part of the structure is formed by imposing a template having one or more tabs 4120 as shown in FIG. 41, with dimension proportional to the size of a breast implant 4200 to adopt such as shown in FIG. 42, over the three-dimensional mesh panel 4300 illustrated in FIG. 43.
  • the panel 4400 is trimmed to its desired shape, preferably with suture tabs 4410 as shown in FIG. 44.
  • the suture tabs 4410 are incorporated in the shape of the trimmed panel.
  • the second part of the structure is formed by imposing a template having opening tabs 4500 as shown in FIG. 45, with dimension proportional to the size of breast implant to be accommodated, over the mesh panel as shown in FIG. 43.
  • the slots 4610 in the panel are formed as shown in FIG. 46.
  • FIG. 47 illustrates a second part of the structure sutured to the chest wall according to aspects of the present invention. As illustrated in FIG. 47, the second part of the structure is sutured to the patient chest at the surgeon desired position.
  • FIG. 48 illustrates a breast implant insertion in the pocket formed by the two structures. The lips of the first part of the structure are inserted in the slots of the second structure and sutured to it; and the breast implant is inserted in the pocket formed as illustrated in FIG. 48.
  • FIG. 49 illustrates forming two symmetrical pockets.
  • FIG. 50 is a photograph illustrating an outlined template on a SeriScaffold TM mesh panel according to aspects of the present invention.
  • FIG. 51 is a photograph illustrating a SeriScaffold TM mesh cut to shape according to aspects of the present invention.
  • FIG. 52 is a photograph illustrating a two part SeriScaffold TM mesh structure sutured together according to aspects of the present invention.
  • FIG. 53 is a photograph illustrating a two part SeriScaffold TM mesh structure with breast implant inserted according to aspects of the present invention.
  • FIG. 54A illustrates another mesh template 5400 in accordance with aspects of the present invention.
  • the template 5400 comprises a first panel 5410A and a second panel 5410B.
  • the first panel 5410A has a predominantly round shape and the second panel 5410B has a predominately semi-circular shape.
  • the panel is constructed of a single knitted mesh. Preferably, the knitted mesh is in a node-lock pattern. Examples of suture locations 5420 are shown for purposes of illustration.
  • the first panel 5410A is sutured to a chest wall and second panel 5410B is folded over at the fold line 5430 to form a pocket or pouch suitable for insertion of a breast implant.
  • FIG. 54B illustrates another embodiment of the mesh template 5400.
  • the first panel 5410A is comprised of a different knitted mesh having different mesh properties and/or knit construction than 5410B although both may still be of the node-lock design.
  • the panels of 5410A and 5410B are preferably of varying stretch. More preferably, panel 5410B has greater stretch than panel 541 OA.
  • FIG. 55 illustrates another mesh template 5500 in accordance with aspects of the present invention.
  • the mesh template 5500 comprises a first panel 5510 and a second panel 5520.
  • the second panel 5520 is in a rectangular shape.
  • the first panel 5510 is in a rectangular shape.
  • the second panel 5520 is larger in size than the first panel 5510.
  • a fold line 5540 is also shown for illustrative purposes but may or may not visible on an actual mesh template.
  • the first and second panels can be of the a mesh having the same properties and knit pattern, the first and second panels are optionally constructed of meshes having different properties and/or knit constructions as indicated in FIG. 55 by the difference in cross-hatching. Suitable dimensions and proportions are illustrated in FIG. 55.
  • FIG. 56A is a photograph of a pattern layout for a silk-based scaffold design in accordance with the present invention.
  • item 130 is a mesh or scaffold.
  • This variation of the scaffold in accordance with the present invention is preferably created on a raschel knitting machine such as Comez DNB/EL- 800-8B set up in 10 gg needle spacing by the use of four movements as shown in pattern layout in FIG. 56B and 56C and FIGS.
  • 56D and 56E two movements in the wale direction, the vertical direction within the fabric, and two movements in the course direction, the horizontal direction of the fabric.
  • the movements in the wale direction occur on separate needle beds with alternate yarns; loops that occur on every course are staggered within repeat.
  • the yarn follows a repeat pattern of 3/1-1/1-1/3-3/3 for one of the wale direction movements as shown in FIGS. 57A - 57D and 1/1-1/3-3/3-3/1 for the other wale direction movement as shown in FIGS. 60A - 60D.
  • the interlacing of the loops within the fabric allows for one yarn to be under more tension than the other under stress, locking it around the less tensioned yarn; keeping the fabric from unraveling when cut.
  • One of the other two movements in the course direction as shown in FIGS. 58A-D occurs in every few courses creating the porous design of the scaffold. These yarns follow a repeat pattern of 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 for the course direction movement.
  • the other movements in the course direction as shown in FIGS. 59A-D occur in every few courses creating the openings in the scaffold.
  • These yarns follow a repeat pattern of 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 for the course direction movement.
  • the pattern simulation layout of this pattern is rendered with ComezDraw 3 software in FIG. 61 considering a yarn design made with 2 ends of Td 20/22 raw silk twisted together in the S direction to form a ply with 6 tpi and further combining three of the resulting ply with 3 tpi.
  • the same yarn design is used for the movements occurring in the wale and course directions.
  • the stitch density or pick count for the scaffold design in FIG. 61 is 39 picks per centimeter considering the total picks count for the technical front face and the technical back face of the fabric, or 19.5 picks per cm considering only one face of the fabric.
  • the operating parameters are not limited to those described in FIGS. 56B-E, but just the optimum values for the specific yarn design used for the pattern simulation layout of FIG. 61.
  • FIG. 61 demonstrates a process improvement for the manufacturing process of the scaffold with the pattern layout in FIG. 56B-E.
  • 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 to provide guidance for the correct length that the scaffold needs to measure and to provide guidance for the tools necessary for separating two individual scaffolds.
  • the pattern in FIGS. 56B-E requires repeating from pattern line 1 to pattern line 16 for 112 times followed by a repeat of 2 times from pattern line 17 to pattern line 20.
  • a knitted silk scaffold having a node-lock design is used in a breast reconstruction procedure.
  • the scaffold is draped and made into a sling or pocket for insertion of a breast implant. Observations of the surgeon can include that the scaffold used is easier to use than existing FLEX HD product. It is possible to see through the scaffold which is desirable. It is noted that the scaffold drapes well when in place and can be implanted as a desirable and useful breast support sling.
  • Example 1 Characteristics of a Silk-Derived Medical Device
  • SBS silk- derived bioresorbable scaffold
  • desired properties characteristics of the medical device (i.e. the SBS) include: long-term bioresorbability; utility as a surgical scaffold; easy to use and suture with no unraveling upon trimming; no side specificity; no swelling/shrinking with hydration, and; inter-sample consistency. Additionally, the pore size of fabric or material which constitutes this desired medical device should facilitate transport of fluid and cells to allow native repair of the tissue defect.
  • SeriScaffoldTM is an example of an embodiment of the stated SBS that has been developed for providing soft tissue support and which has all the characteristics set forth in this paragraph.
  • the SBS pore area was 1.3 ⁇ 0.1 mm 2 .
  • Opposing faces of the SBS were identical to each other, and all dimensions were consistent across multiple manufacturing lots. Additionally, the SBS was cut with a single stroke of standard surgical scissors, leaving no observed fraying or unraveling beyond the immediate pore area or yarn.
  • the SBS was determined to be drapable and conformable to an underlying solid shape, and following brief submersion in a saline bath, could be rolled along its length allowing for successful passage through a 7/8 mm laparoscopic cannula.
  • the SBS had ease-of-use characteristics as a surgical scaffold for eg soft tissue support including being porous with low density, easily cut, drapable and conformable, and amenable to laparoscopic insertion.
  • the SBS dimensions were precisely tailored, consistent between lots, and did not change considerably with hydration.
  • the area of SBS pores is conducive to supporting tissue ingrowth.
  • SeriScaffoldTM surgical scaffold (warp knitted, multi-filament, bioengineered, silk mesh or fabric with a "node lock" knit pattern or structure) is obtained from Allergan Medical (Santa Barbara, Calif, and Medford, Mass.). SeriScaffoldTM surgical scaffold is used as a transitory scaffold for soft tissue support and repair in two-stage breast reconstruction to reinforce deficiencies where weakness or voids existed that required the addition of material to obtain the desired surgical outcome. SeriScaffoldTM surgical scaffold is supplied sterile in a single-use 10 cm x 25 cm size, with one device utilized per breast. The surgical scaffold is placed during each subject's stage I breast reconstruction with a tissue expander placement procedure.
  • Stage I ⁇ Tissue Expander and SeriScaffoldTM Surgical Scaffold Placement is as follows.
  • SeriScaffoldTM surgical scaffold is prepared and used in accordance with the supplied package insert and standard-of-care for breast reconstruction procedures.
  • mastectomy either immediate or delayed
  • the surgical site is readied for subpectoral tissue expander insertion in accordance with standard surgical methods.
  • the serial/lot numbers of the Allergan Natrelle ® Style 133V tissue expander and SeriScaffoldTM surgical scaffold are recorded.
  • the tissue expander is rinsed in antibiotic solution (according to standard of care) and inserted into the subpectoral pocket.
  • the SeriScaffoldTM surgical scaffold is cut to size (prior to, during, and/or after suturing) to repair the void between the pectoral muscle and the chest wall (i.e., inframammary fold region).
  • the SeriScaffoldTM surgical scaffold is rinsed with antibiotic solution and sutured in place, with a minimum suture bite of 3 mm or one full row of material. If any cutting is performed in situ, rinsing of the implant site is performed. Intra-operative photography is taken of the scaffold placement prior to closure.
  • the tissue expander is filled as appropriate, drains placed according to usual standard of care and number and location of drain(s) noted. Standard rinsing of the surgical site and closure is performed. Prophylactic antibiotic use and duration is documented.
  • the surgical drain(s) is removed when deemed appropriate. Tissue expansion is performed in accordance with standard-of-care as appropriate for each subject. The number of fills, volume, and timing of tissue expander fills is recorded at all expansion visits.
  • Stage II ⁇ Tissue Expander to Breast Implant Exchange The procedure followed in Stage II ⁇ Tissue Expander to Breast Implant Exchange is as follows. In a second surgical procedure, the tissue expander is removed and replaced with a breast implant. This procedure is performed as appropriate for each subject, and therefore the duration of elapsed time after the SeriScaffoldTM surgical scaffold placement varied between subjects. A standard surgical approach is used to remove the tissue expander. Implant placement is subpectoralis muscle and the pocket is prepared in accordance with standard-of-care. The breast implant is rinsed in antibiotic solution and positioned within the pocket. Standard closure is performed. [00249] SeriScaffoldTM surgical scaffold integration is assessed through: (1) scaffold-capsule adherence to tissue expander surface and (2) vascularization of the area. Assessments are recorded during the stage II surgery.
  • Scaffold-capsule adherence to the tissue expander surface and tissue expander adherence to the pectoral muscle are each determined during removal of the tissue expander device in accordance with the following scale: 0, no adherence; 1, minimal adherence ( ⁇ 50% surface area); 2, moderate adherence (50-79% surface area); and 3, complete adherence (80-100% surface area). Capsule vascularization surrounding the biopsy site from the SeriScaffoldTM surgical scaffold is visually assessed.
  • FIGS. 30A and 30B are photographs illustrating a tissue expander to implant exchange performed in the two-stage breast reconstruction surgical procedure in accordance with the present invention.
  • the implant exchange was performed after eleven weeks.
  • the scaffold was integrated and non-palpable.
  • the capsule was flexible and vascularized.
  • the scaffold accommodated expansion to create an ideal breast shape. The result is that the patient has breasts properly positioned and proportioned which look and feel like normal breasts.
  • FIG. 30A is a photograph of a patients breast area tissue cut open, the tissue expander removed, and ready to receive the final breast implant, with the supporting SeriScaffold shown already in place.
  • the SeriScaffold fabric is shown in FIG. 30A in place on the inner surface of the skin flap held open by the two tongs.
  • FIG. 30B is a photograph of the FIG. 30A patient after the breast implant supported by SeriScaffold has been implanted and the wound of each breast so reconstructed sutured closed, and showing a very positive final surgical
  • the SeriScaffoldTM device is an FDA-510(k) approved, silk-derived, bioresorbable scaffold (SBS) developed to provide soft tissue support.
  • SBS silk-derived, bioresorbable scaffold
  • Example 3 Single Stage Breast Reconstruction
  • SeriScaffoldTM silk scaffold is obtained from Allergan Medical for use in breast reconstruction for tissue support and repair in direct-to-implant breast reconstruction surgery.
  • SeriScaffoldTM is used as surgical scaffold in direct-to-implant (DTI), or single- stage, breast reconstruction for soft tissue support and repair.
  • DTI direct-to-implant
  • the SeriScaffoldTM surgical scaffold is used as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that required the addition of material to obtain the desired surgical outcome.
  • SeriScaffoldTM surgical scaffold is supplied sterile in a single-use 10 cmx25 cm size, with one device utilized per breast. The device is implanted in the subject immediately post mastectomy, during the breast implant placement surgery, in a direct-to-implant breast reconstruction procedure. In this Example SeriScaffoldTM surgical scaffold in DTI breast reconstruction is used.
  • SeriScaffoldTM surgical scaffold is prepared and used in accordance with the supplied package insert and standard-of-care for breast reconstruction procedures. Following mastectomy, the surgical site is readied for subpectoral breast implant insertion in accordance with standard surgical methods. The breast implant is rinsed in antibiotic solution and inserted into the subpectoral pocket. The SeriScaffoldTM surgical scaffold is optionally cut to size (prior to, during, and/or after suturing) to repair the void between the pectoral muscle and the chest wall (i.e., inframammary fold region).
  • the SeriScaffoldTM surgical scaffold is rinsed with antibiotic solution and sutured in place to both the pectoralis muscle and chest wall, with a minimum suture bite of 3 mm or one full row of material. If any cutting was performed in situ, rinsing of the implant site is performed. Drains are placed according to usual standard of care and number and location of drain(s) noted. Rinsing of the surgical site with antibiotic solution and closure is performed. The surgical drain(s) is removed when deemed appropriate. The result is that the patient has breasts properly positioned and proportioned which look and feel like normal breasts.
  • a series of meshes was made having a knit pattern as illustrated in Figs. 56A-56E.
  • the meshes were evaluated for stretch for use in breast reconstruction.
  • the amounts and the direction of stretch were measured and sampled with varying amounts of stretch in both the fabric formation and fabric width direction.
  • Average length referred to measurements made (along the fabric formation (FF) direction: parallel with fabric wales) at three different locations, along the top, middle, and bottom portions of the scaffold. The length measurements were taken from course to course at the boundary of the scaffold sample, excluding any protruding, incised wales beyond these courses.
  • Average width referred to measurements made (along the fabric width (FW) direction: parallel with fabric courses) at three different locations, at the left, center and right locations of the scaffold width.
  • FIG. 69 illustrates placement of the three fabric formation measurements (horizontal measurements) and the placement of the three fabric width measurements (vertical measurements), noting the end points of each measurement in the magnified images of the fabric formation and fabric width edges.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une structure en tissu tridimensionnelle sous forme d'une poche destinée à être utilisée dans un protocole chirurgical de reconstruction mammaire comme une reconstruction mammaire en une étape ou en deux étapes. Le support de soie emploie un modèle de tricot qui empêche sensiblement l'effilochage et préserve la stabilité de la maille ou du dispositif de support, en particulier lorsque la maille ou le dispositif de support est découpé. Un exemple de dispositif de support emploie une maille tricotée comprenant au moins deux fils étendus dans une direction de tricot et s'entrelaçant l'un dans l'autre pour définir une pluralité de nœuds.
PCT/US2013/075053 2013-03-15 2013-12-13 Dispositif médical en soie destiné à être utilisé en augmentation mammaire et en reconstruction mammaire WO2014149096A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA2900682A CA2900682A1 (fr) 2013-03-15 2013-12-13 Dispositif medical en soie destine a etre utilise en augmentation mammaire et en reconstruction mammaire
EP13826905.5A EP2967837A1 (fr) 2013-03-15 2013-12-13 Dispositif médical en soie destiné à être utilisé en augmentation mammaire et en reconstruction mammaire
AU2013383409A AU2013383409A1 (en) 2013-03-15 2013-12-13 Silk medical device for use in breast augmentation and breast reconstruction
KR1020157025057A KR20150131039A (ko) 2013-03-15 2013-12-13 유방 확대술 및 유방 재건술에 사용하기 위한 실크 의료용 디바이스
BR112015021365A BR112015021365A2 (pt) 2013-03-15 2013-12-13 dispositivo médico de seda para uso em aumento de mama e reconstrução de mama

Applications Claiming Priority (2)

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US13/843,519 2013-03-15
US13/843,519 US20130304098A1 (en) 2008-12-15 2013-03-15 Silk medical device for use in breast augmentation and breast reconstruction

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Cited By (5)

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WO2020226558A1 (fr) * 2019-05-09 2020-11-12 Novus Scientific Ab Dispositif de support maillé tubulaire pour un implant mammaire
WO2021063851A1 (fr) * 2019-10-03 2021-04-08 Novus Scientific Ab Dispositif de support de maille pour un implant mammaire
WO2021063850A1 (fr) * 2019-10-03 2021-04-08 Novus Scientific Ab Dispositif support en filet pour un implant mammaire et procédé de fixation d'un implant mammaire dans un dispositif support en filet
SE2050274A1 (en) * 2020-03-13 2021-09-14 Novus Scientific Ab Tubular mesh support device with different circumferential areas
EP3709933A4 (fr) * 2017-11-13 2021-11-10 Surgical Innovation Associates, Inc. Poche maillée pour implant médical et son procédé d'utilisation

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US20210393388A1 (en) * 2020-06-19 2021-12-23 Davol Inc. Implantable prosthesis

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EP3709933A4 (fr) * 2017-11-13 2021-11-10 Surgical Innovation Associates, Inc. Poche maillée pour implant médical et son procédé d'utilisation
WO2020226558A1 (fr) * 2019-05-09 2020-11-12 Novus Scientific Ab Dispositif de support maillé tubulaire pour un implant mammaire
WO2021063851A1 (fr) * 2019-10-03 2021-04-08 Novus Scientific Ab Dispositif de support de maille pour un implant mammaire
WO2021063850A1 (fr) * 2019-10-03 2021-04-08 Novus Scientific Ab Dispositif support en filet pour un implant mammaire et procédé de fixation d'un implant mammaire dans un dispositif support en filet
SE2050274A1 (en) * 2020-03-13 2021-09-14 Novus Scientific Ab Tubular mesh support device with different circumferential areas
SE544808C2 (en) * 2020-03-13 2022-11-22 Novus Scientific Ab Tubular mesh support device, for an implant, with different circumferential areas

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KR20150131039A (ko) 2015-11-24
CA2900682A1 (fr) 2014-09-25
AU2013383409A1 (en) 2015-09-10
EP2967837A1 (fr) 2016-01-20
CL2015002371A1 (es) 2016-03-11
BR112015021365A2 (pt) 2017-07-18

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