+

WO2021221685A1 - Système de confinement de greffe osseuse - Google Patents

Système de confinement de greffe osseuse Download PDF

Info

Publication number
WO2021221685A1
WO2021221685A1 PCT/US2020/031143 US2020031143W WO2021221685A1 WO 2021221685 A1 WO2021221685 A1 WO 2021221685A1 US 2020031143 W US2020031143 W US 2020031143W WO 2021221685 A1 WO2021221685 A1 WO 2021221685A1
Authority
WO
WIPO (PCT)
Prior art keywords
casing
bioresorbable
implantable device
open
ended
Prior art date
Application number
PCT/US2020/031143
Other languages
English (en)
Inventor
Sahil Jalota
Russell Cook
Original Assignee
SECADA MEDICAL LLC dba VENTRIS MEDICAL, LLC
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
Application filed by SECADA MEDICAL LLC dba VENTRIS MEDICAL, LLC filed Critical SECADA MEDICAL LLC dba VENTRIS MEDICAL, LLC
Priority to PCT/US2020/031143 priority Critical patent/WO2021221685A1/fr
Priority to AU2020445491A priority patent/AU2020445491A1/en
Publication of WO2021221685A1 publication Critical patent/WO2021221685A1/fr

Links

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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
    • 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
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/12—Phosphorus-containing materials, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/28—Bones
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • 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
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • 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
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30957—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. moulds
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
    • A61F2310/00371—Collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the present disclosure generally relates to fillable collagen containers for use in bone grafting.
  • Osteoconductivity is the ability to serve as a scaffold for new bone growth while osteo inductivity refers to the ability of graft material to induce de novo bone growth with biomimetic substances, such as bone morphogenetic proteins.
  • Calcium phosphates may include hydroxyapatite (HA) or beta- tricalcium phosphate (PTCP) or biphasic calcium phosphate (a combination of HA and bT €R).
  • Artificial or synthetic bone, as well as demineralized bone is most commonly, and advantageously, used in particulate form as powders or granules.
  • the particulate nature radically increases the available surface area once implanted, improving osteo inductivity.
  • the preferred particulate nature of graft materials poses a problem when trying to form larger prostheses for implantation, such as in spinal fusion procedures.
  • the use of putties attempts to address handling issues with particulate DBM but often require a significant (about 60% in some cases) amount of carrier which dilutes the amount of DBM and therefore reduces its effectiveness.
  • mesh pouches such as Ballast from SeaSpine Holdings Corporation (Carlsbad, CA) and Magnifuse from Medtronic pic (Ireland) have been designed to provide containment and shape to particulate bone grafting material without relying on putties with large amounts of carrier. Such pouches also allowing access for bodily fluids and osteogenic cells to the grafting material therein. Such designs attempt to retain the surface area advantages of particulate grafting materials while allowing for containment and shaping for specific prostheses and procedures. However, the materials and specifics used in the existing designs have their own shortcomings and leave room for improvement.
  • the present invention provides bioresorbable casings having both micropores and macropores suitable for containing a variety of bone-grafting materials while allowing osteogenic cells and bodily fluids to pass through.
  • the casing may be constructed of collagen providing advantages over existing mesh pouches constructed from absorbable polymers such as polyglycolide (PGA) or poly (lactic-co-glycolic)acid (PLGA) in that the degraded material does not require clearance from the body.
  • the casings may be filled with bone-grafting particles such as bioceramics, demineralized bone matrix (DBM), or combinations thereof in any form including fibers, granules, paste, powder, chips, strips, and sponge.
  • the DBM can be obtained from cortical or cancellous bone.
  • the bioceramics particles may include HA, tricalcium phosphate, monetite, brushite, or mono calcium phosphate monohydrate (MCPM).
  • Additional fill materials may include bioglass, collagen-ceramic mixtures, cell based products, autografts, and growth factor containing products.
  • micropores and macropores differentiate the present casing from existing products. Those pores may be randomly distributed or may be localized in specific patterns based on intended use and orientation of the implanted casing. Pores may be generated through molding or may be generated after molding through mechanical or thermal techniques such as laser perforation.
  • the casing may comprise nanopores.
  • Casings may be provided closed and pre-filled with grafting material, ready for implantation.
  • the casing may be provided with an opening.
  • the open casing may be pre-filled with some amount of grafting material or may be empty ready for filling by a technician or medical professional in advance of implantation or as part of the implantation process.
  • Open casings may remain open or may be closed through the use of sutures, adhesives, heat, chemical treatment, pressure, folded or other means before implantation. Sutures may also be made of collagen.
  • sutures may also be made of collagen.
  • Casings may be molded or otherwise formed in a tube shape of desired size or may be formed from one or more strips of a material such as collagen. For example, a strip of collagen mesh may be folded over itself and the folded sides sutured or otherwise joined together to form a pouch.
  • Casings described herein allow them to be prepared in almost any shape and size for a variety of applications.
  • Casings can be sized and shaped to repair patient- specific injuries or defects as modeled from radiographic or other patient imaging.
  • Casing can be provided in standard shapes and sizes for procedures such as spinal fusion (e.g., placement in the posterolateral gutter) across two or more vertebrae.
  • Kits may include one or more of a holder for receiving and positioning a casing for fill, a fill material, a rigid or semi-rigid fill tube to insert into the casing to facilitate filling, and a plunger to aid in loading the casing with fill.
  • Means for closing the casing after filling such as a suture material may also be included.
  • the casing may be collagen or other materials as described herein.
  • a fill tube can be sized to fit snugly into an opening in the casing to provide a stable path for fill material to be inserted.
  • the fill tube may be in two or more portions which may be assembled by inserting one into another.
  • the end of the fill tube that is not inserted into the casing may have a larger cross- sectional profile than the inserted end providing a funnel shape to facilitate filling.
  • the funnel portion may be separable from the inserted portion of the fill tube.
  • the holder may comprise a body sized and shaped similarly to the casing such that the casing can be placed in and positioned by the body.
  • the holder may fully enclose the casing apart from an opening that is aligned with the casing’s open end when the casing is positioned in the body.
  • the holder may comprise two or more pieces including, for example, a lid so that the casing can be placed in the body before the lid is joined to enclose the casing within the holder. The lid can then be removed to facilitate removal of the casing after filling.
  • the fill tube may be shaped and sized to fit snugly within the inlet of the holder.
  • the fill material may comprise any known bone-grafting particles including DBM from cancellous or cortical bone and bioceramic materials.
  • fill material may include calcium phosphate materials including biphasic calcium phosphate materials with an osteo inductivity-boo sting needle-like or nanorod-like surface morphology using hydrothermal and/or chemical processes including exposure to peroxides (e.g., hydrogen peroxide).
  • Other bioceramic fill materials may include monetite, brushite, or MCPM.
  • Additional fill materials may include bioglass, collagen-ceramic mixtures, cell based products, autografts, and growth factor containing products.
  • an implantable bone graft device comprising a bioresorbable casing comprising both micropores and macropores.
  • the bioresorbable casing may comprise collagen.
  • the collagen casing can contain demineralized bone matrix (DBM) in one or more formats selected from the group consisting of fibers, granules, paste, powder, chips, strips, and sponge.
  • DBM demineralized bone matrix
  • the DBM may be processed from one or more of the group consisting of cortical and cancellous bone.
  • the collagen casing can contain bioceramics in one or more formats selected from the group consisting of fibers, granules, paste, powder, chips, strips, and sponge with or without DBM.
  • the bioceramics particles may include HA, tricalcium phosphate, monetite, brushite, or mono-calcium phosphate monohydrate (MCPM).
  • Additional fill materials may include bioglass, collagen-ceramic mixtures, cell based products, autografts, and growth factor containing products.
  • the implantable device may include nanopores.
  • the micropores, the macropores, and/or the nanopores may be patterned or random and may be generated through molding or through various mechanical or thermal techniques.
  • the bioresorbable casing can be closed or may comprise an opening for filling the casing.
  • the bioresorbable casing can be formed by one or more strips of collagen joined together with sutures.
  • the sutures may comprise a bioabsorbable material such as polyglycolic acid, polylactic acid, poly(lactic-co-glycolic acid).
  • sutures may comprise collagen or any known resorbable or non-resorbable polymer.
  • the bioresorbable casing may be formed from a single strip of folded collagen.
  • the bioresorbable casing may be molded in a single piece.
  • the casing may be sized and configured for placement in an anatomical structure of a spine such as in a posterolateral gutter for spinal fusion.
  • a bone grafting method may comprise implanting at a target site an implantable device comprising a bioresorbable casing comprising both micropores and macropores and filled with a fill material comprising one or more of the group consisting of demineralized bone matrix (DBM) and bioceramics.
  • a fill material comprising one or more of the group consisting of demineralized bone matrix (DBM) and bioceramics.
  • Prior to implanting methods of the invention may include providing an implantable device comprising an open-ended bioresorbable casing comprising both micropores and macropores, filling the open-ended bioresorbable casing with one or more of the group consisting of demineralized bone matrix (DBM) and bioceramics, and closing the open end of the filled bioresorbable casing.
  • the closing step can include suturing the open end of the filled bioresorbable casing at the time of surgery.
  • an implantable device kit comprising a holder.
  • the holder may include a body configured for receiving an open-ended bioresorbable casing and sized to accommodate the open-ended bioresorbable casing when filled and an inlet aligned with the body and sized to allow the open-ended bioresorbable casing to pass through the inlet and into the body.
  • Kits may include a fill tube having a distal end having a cross-sectional profile sized to fit within the open-ended bioresorbable casing and the inlet.
  • the fill tube can include a proximal end having a larger cross-sectional profile than the distal end.
  • the fill tube may have two or more detachably coupled segments.
  • kits may include a plunger sized to fit within the fill tube and operable to force a fill material through the fill tube and into the open-ended bioresorbable casing.
  • the open-ended bioresorbable casing and the fill material may be included in kits of the invention.
  • methods of the invention may include making an implantable device by providing a kit as described above with a holder comprising a body configured for receiving an open-ended bioresorbable casing and sized to accommodate the open-ended bioresorbable casing when filled and an inlet aligned with the body and sized to allow the open-ended bioresorbable casing to pass through the inlet and into the body; a fill tube having a distal end having a cross-sectional profile sized to fit within the open-ended bioresorbable casing and the inlet; and a plunger sized to fit within the fill tube.
  • Methods may include coupling an open- ended bioresorbable casing to the fill tube; inserting the open-ended bioresorbable casing through the inlet and into the body of the holder such the fill tube and open-ended bioresorbable casing become held by the holder; and inserting, via the plunger, a fill material through the fill tube and into the open-ended bioresorbable casing to produce a filled open-ended bioresorbable casing.
  • methods may include removing the filled open-opened ended bioresorbable casing from the holder and uncoupling the fill tube from the filled open-opened ended bioresorbable casing.
  • Methods can comprise closing the filled open-ended bioresorbable casing.
  • the body may enclose the bioresorbable casing on all sides apart from the inlet.
  • the holder may further comprise a removable lid that upon removal, providing access to the body for insertion and removal of the open-ended bioresorbable casing.
  • the fill tube can include a distal end having a cross-sectional profile sized to fit within the open-ended bioresorbable casing and the inlet.
  • the fill tube can comprise a proximal end having a larger cross-sectional profile than the distal end.
  • the fill tube may include two or more detachably coupled segments.
  • the inlet of the holder and the distal end of the fill tube may be sized such that the distal end of the fill tube can be inserted into the inlet.
  • the inlet of the holder and the distal end of the fill tube can be sized such that an outer surface of the fill tube forms a seal with an inner surface of the inlet.
  • FIG. 1 shows an open-ended bioresorbable casing according to certain embodiments.
  • FIG. 2 shows an exemplary closed bioresorbable casing.
  • FIG. 3 shows an exemplary open-ended bioresorbable casing with a fill tube inserted therein.
  • FIG. 4 shows an exemplary two-piece fill tube
  • FIG. 5 shows an exemplary assembled fill tube
  • FIG. 6 shows an exemplary plunger.
  • FIG. 7 shows an exemplary open-ended bioresorbable casing with a fill tube and plunger inserted therein.
  • FIG. 8 shows an exemplary holder.
  • FIG. 9 shows an open-ended bioresorbable casing in a body of an exemplary holder.
  • FIG. 10 shows an open-ended bioresorbable casing enclosed in an exemplary holder.
  • FIG. 11 shows an exemplary kit of the invention.
  • FIG. 12 shows an exemplary collagen strip.
  • Systems and methods of the invention relate to bioresorbable casings for providing containment and shape to bone graft particles.
  • Such casings can be preferentially made of collagen or other bio-compatible and/or natural materials. They may be formed of a mesh comprising micro, macro, and/or nanopores. The pores should be sized based on the graft material contained therein to prevent the material from escaping and while allowing osteogenic cells and other biological fluids and materials to pass through, providing access to the graft material.
  • Casings may be provided pre-filled, closed, and ready for use or may be provided open to be filled by a user before use. The open casing may be provided as part of a kit along with fill material and means for filling and closing the casing. Methods of preparing and using casings of the invention are also described herein.
  • FIGS. 1 and 2 show exemplary bioresorbable casings 101 of the invention.
  • the casing 101 may be made of synthetic materials such as polyesters, polyamides, or polyolefins.
  • Preferred synthetic materials include biodegradable polymers such as polyglycolide (PGA) and poly(lactic-co-glycolic acid) (PLGA).
  • PGA polyglycolide
  • PLGA poly(lactic-co-glycolic acid)
  • the casing is made of a natural material such as collagen.
  • Casings preferably have both micropores and macropores.
  • Macropores generally refer to pores between lOOpm to lOOOpm.
  • Micropores generally refer to pores less than about lpm to lOOpm and, in certain embodiments, between about lpm and aboutlOpm.
  • the casing material may comprise nanopores, generally referring to pores lpm or smaller.
  • any of the above pores may be distributed randomly or patterned across the casing’s surface.
  • the pores may be distributed in a pattern based on the application of the final implant.
  • the macropores may be concentrated based on the anatomical location of the casing 101 once implanted to provide better access to osteogenic cells, fluids, or other biological material.
  • Micro and macropores may be randomly distributed or patterned based on other considerations.
  • FIG. 11 shows an exemplary collagen strip for use in preparing a casing having an exemplary pattern of pores across the surface of the material.
  • Pores may be formed via molding of the casing material wherein the size and distribution of the pores are dictated by the surface features of the mold.
  • Casing materials may comprise solid sheets in which pores are created via known mechanical, chemical, or thermal processes.
  • laser processing is used to form the desired size and pattern of pores in the casing material.
  • pores may be punched into the casing.
  • Casings 101 may be formed into the final desired size and shape through any known technique including injection or other molding techniques. Casings 101 are preferably prepared with a cavity therein to receive and contain the graft material. In initial preparation, an opening 105 should left by which the graft material can be inserted into the casing 101.
  • the open end 105 may be closed after filling either at a remote manufacturing site or by a user such as a surgeon or other medical professional before implantation using sutures 203 (FIG. 2).
  • Sutures may be any biocompatible material including the natural and synthetic materials used to form the casing 101.
  • the sutures 203 comprise PGA or PLGA or collagen.
  • Sutures may also include non-resorbable materials such as polypropylene and polyethylene. Other sealing methods are contemplated including adhesives, heat, and pressure, depending upon the nature of the casing material and intended use.
  • the casing 101 may be prepared from one or more sheets of the porous casing material.
  • a tube-shaped casing 101 may be prepared from two sheets of collagen or other material by laying the sheets together and suturing or otherwise sealing the sides 103 and bottom 107 to form a casing 101 with an opening 105 through which to add graft material.
  • a single sheet of porous material may be folded along an edge to form the bottom 107 of the casing 101 and then sutured or otherwise joined along the sides 103 to create the open-ended casing 101.
  • Casings 101 can be prepared and used in any size and shape depending on the intended application. Casing are contemplated for use in medical procedures such as orthopedic surgery and maxillofacial procedures.
  • casings of the invention may be sized and shaped for use in spinal fusion procedures.
  • casings and implants made therefrom may be configured for placement in a posterolateral gutter for spinal fusion. They may be offered in various sizes depending on the number and position of the vertebrae to be fused and based on the age and/or size of the patient.
  • Methods of the invention can include obtaining a casing and optionally filling with a graft material if it is not prefilled.
  • Filling may comprise the use of kit components as described below including one or more of a holder, a casing, a fill material, a plunger, and a fill tube.
  • a user may then close the casing if it was not prefilled using the methods described above.
  • Methods can include then implanting the filled casing to repair a bone defect, treat a traumatic injury, perform a spinal fusion, or any other osteogenic treatment calling for a graft prosthesis.
  • Fill material such as those described below, including DBM and/or bioceramics may be obtained in dry form and can be wetted prior to filling.
  • the bioceramics particles may include, for example, HA, tricalcium phosphate, monetite, brushite, or mono-calcium phosphate monohydrate (MCPM). Additional fill materials may include bioglass, collagen-ceramic mixtures, cell based products, autografts, and growth factor containing products.
  • kits may include one or more of a casing, a fill material, a holder, a fill tube, and a plunger to facilitate filling of the casing by a user. Additional materials such as syringes and fluids for wetting and preparing fill material and/or the casing may also be included.
  • FIG. 11 An exemplary kit is shown in FIG. 11.
  • the kit includes a holder 801, a casing 101, and a fill tube 301, all shown assembled ready for filling.
  • a plunger 601 is included as well as fill material 1101 shown in a dish for wetting and preparation as well as a syringe 1103 of fluid for wetting and preparing the fill material 1101.
  • a fill tube 301 is depicted in FIGS. 3-5.
  • the fill tube 301 should have at least one end sized to fit within the opening 105 of the casing 101.
  • the tube 301 comprises a lumen through which fill material may be passed into the casing 101 through the opening 105.
  • the casing material may generally offer little material support such that maintaining the opening 105 during filling is difficult.
  • the fill tube 301 can be rigid enough to then maintain the opening 105 for filling.
  • the outer surface of the fill tube 301 is preferably sized to fit snugly within the opening 105 and the inner lumen of the fill tube 301 is preferably sized to allow the passage of fill material therethrough and into the casing 101.
  • the outer surface and lumen of the fill tube 301 may be enlarged at the end not inserted into the opening 105 to ease loading of material.
  • the fill tube 301 may include a funnel 303 at one end providing a large opening for material to be added followed by a gradual reduction in cross-sectional profile to fit within the casing 101.
  • the fill tube 301 may comprise multiple parts to ease in packaging or to provide different funnel 303 options.
  • the fill tube 301 may be made up of two components including a casing insertion portion 307 and a funnel portion 305 which can be assembled prior to filling. Funnel portions 305 of different sizes may be selected based on the fill material.
  • kits may include a plunger 601 for aiding in casing filling as shown in FIG. 6.
  • the plunger 601 is sized to fit within the lumen of the fill tube as sized at the end inserted into the casing 101.
  • the plunger 601 may have a single size and shape or may have a smaller handle portion 603 and a larger plunging portion 605 to provide a large cross-sectional area for forcing fill material into the casing 101.
  • the plunger 601 preferably has a cross-sectional profile sized just smaller than the lumen of the fill tube 301 and the opening 105 in the casing 101 so that fill material cannot readily pass between the inside of the fill tube 301 lumen and the edges of the plunger 601. Filling action using the plunger 601 to force fill material through a fill tube 301 into the opening 105 of a casing 101 is shown in FIG. 7.
  • the plunger may include features such as serrations or openings in the plunging portion 605 to physically process the fill material during insertion including separating granules and avoiding clumping.
  • Kits may include a holder 801 for supporting and positioning a casing 101 for fill.
  • An exemplary holder 801 is shown in FIG. 8.
  • the holder 801 can comprise a body 803 sized to accept the casing 101 and align the opening 105 of the casing 101 with an inlet 805 in the body 803 of the holder 801.
  • the casing material has little rigidity and, therefore filling the casing 101 can be difficult, even with the use of the fill tube 301.
  • the holder 801 can work alone or in conjunction with the fill tube 301 to support the outside of the casing 101 during fill.
  • the holder 801 like the fill tube 301, and the plunger 601 may be made out of any known material including, for example, metal, glass, plastic, and composite materials.
  • the holder 801 can be operable to fully enclose the casing 101 only providing access to the opening 105 of the casing 101 through an inlet 805 in the holder 801. Accordingly, the holder can assist in maintaining sterility of the casing 101 and minimizing the potential for damage through repeated handling of the casing 101 directly.
  • a casing 101 inserted into the body 803 of a holder 801 is depicted in FIG. 9.
  • the body 803 and the casing 101 are similarly sized and shaped to aid in positioning of the casing opening 105 and the holder inlet 805.
  • the holder inlet 805 may also be sized and shaped along with the fill tube 301 such that the fill tube can be passed through the inlet 805 into the casing 101 within the body 803.
  • the components can be sized such that the outer surface of the fill tube 301 contacts the inner edges of the inlet 805 and may even form a seal, protecting the outside of the casing 101 such that the lumen of the fill tube 301 provides the only access and point of exposure to the casing 101.
  • the holder may comprise multiple components including a lid 1003 as shown in FIG. 10. At least a portion of the body 803 may be formed in a base 1005 of the holder 801 such that the casing 101 can be positioned therein.
  • the fill tube 301 may be inserted into the opening 105 of the casing 101 before or after the casing 101 is placed in the body 803.
  • the lid 1003 or other component of the holder 801 may then be coupled to the base 1005 to form the complete, enclosed body 803 and inlet 805 of the holder 801 with the casing inside. Once filled, the lid 1003 may be removed and the filled casing 101 can be taken from the body 803, closed, and implanted.
  • casing disclosed herein may be pre-filled with a bone-grafting material.
  • the material is provided in particulate form to provide increased surface area for infiltration by host cells and osteogenesis.
  • Materials may include bone material which may be obtained from the patient before or during the implantation procedure.
  • DBM may be used to fill the casing. DBM is bone that has had the inorganic mineral removed, leaving behind the organic matrix. Removal of the bone mineral exposes more biologically active bone morphogenetic proteins which aid in bone and cartilage formation.
  • DBM is more biologically active than standard bone grafts but the mechanical properties of the bone are lost. Accordingly, casings of the invention are particularly useful in containing DBM and providing the mechanical support and shape desired for particular bone graft prostheses.
  • graft materials may be provided in the form of fibers, granules, paste, powder, chips, strips, sponge, or any other available particle type and any combination of these particle types.
  • fill material may comprise metals, like titanium or tantalum, polymers like polylactides, hydrogel-based materials, or bioceramics.
  • Bioceramics may include biphasic calcium phosphate which may be processed to produce osteoinductive surface morphologies as described below. Additional osteoinductive fill materials as well as prosthesis applications are described in U.S. Pat. Nos. 9,364,583; 4,430,760; and 9,801,978, incorporated by reference herein.
  • Fill material may include bioglass, collagen-ceramic mixtures, as well as cell based products and growth factor containing products. See V. Krishnan and T. Lakshmi, 2013, Bioglass: A novel biocompatible innovation, J Adv Pharm Technol Res. 4(2): 78-83.
  • Example of materials and agents which may be added to a fill material in a casing of the invention include, for example, osteogenic or chondrogenic proteins or peptides; DBM powder; collagen, insoluble collagen derivatives, etc., and soluble solids and/or liquids dissolved therein; anti- AIDS substances; anti-cancer substances; antimicrobials and/or antibiotics such as erythromycin, bacitracin, neomycin, penicillin, polymycin B, tetracyclines, biomycin, Chloromycetin, and streptomycins, cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin, etc.; immunosuppressants; anti- viral substances such as substances effective against hepatitis; enzyme inhibitors; hormones; neurotoxins; opioids; hypnotics; anti- histamines; lubricants; tranquilizers; anti-convulsants; muscle relaxants and anti-Parkinson substances; anti- spasmod
  • Fill materials may include biphasic calcium phosphate with modified surface morphologies prepared using hydrothermal and/or chemical treatment such as those described, for example, in U.S. Pat. App. 16/828,583.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne des procédés pour des boîtiers biorésorbables et biodégradables ayant à la fois des micropores et des macropores pour fournir une forme, une structure et un confinement à différents matériaux de greffe osseuse. L'invention concerne également des kits et des procédés d'utilisation.
PCT/US2020/031143 2020-05-01 2020-05-01 Système de confinement de greffe osseuse WO2021221685A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/US2020/031143 WO2021221685A1 (fr) 2020-05-01 2020-05-01 Système de confinement de greffe osseuse
AU2020445491A AU2020445491A1 (en) 2020-05-01 2020-05-01 Bone graft containment system

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2020/031143 WO2021221685A1 (fr) 2020-05-01 2020-05-01 Système de confinement de greffe osseuse

Publications (1)

Publication Number Publication Date
WO2021221685A1 true WO2021221685A1 (fr) 2021-11-04

Family

ID=78373835

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2020/031143 WO2021221685A1 (fr) 2020-05-01 2020-05-01 Système de confinement de greffe osseuse

Country Status (2)

Country Link
AU (1) AU2020445491A1 (fr)
WO (1) WO2021221685A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090148487A1 (en) * 2005-12-14 2009-06-11 Scil Technology Gmbh Moldable biomaterial for bone regeneration
US8394109B2 (en) * 2007-10-23 2013-03-12 Alphatec Spine, Inc. Systems and methods for spinal fixation
WO2013096605A1 (fr) * 2011-12-20 2013-06-27 Bionova Medical, Inc. Systèmes et procédés pour administrer un agent à une plaie sous pression négative
US20140277569A1 (en) * 2013-03-13 2014-09-18 Warsaw Orthopedic, Inc. Hybrid osteoinductive bone graft
US20160128833A1 (en) * 2010-12-23 2016-05-12 Biostructures, Llc Bone graft materials and methods
US20180318088A1 (en) * 2015-11-04 2018-11-08 Traceray Oy Bone implant
US20200093963A1 (en) * 2009-10-29 2020-03-26 Prosidyan, Inc. Dynamic bioactive bone graft material having an engineered porosity

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090148487A1 (en) * 2005-12-14 2009-06-11 Scil Technology Gmbh Moldable biomaterial for bone regeneration
US8394109B2 (en) * 2007-10-23 2013-03-12 Alphatec Spine, Inc. Systems and methods for spinal fixation
US20200093963A1 (en) * 2009-10-29 2020-03-26 Prosidyan, Inc. Dynamic bioactive bone graft material having an engineered porosity
US20160128833A1 (en) * 2010-12-23 2016-05-12 Biostructures, Llc Bone graft materials and methods
WO2013096605A1 (fr) * 2011-12-20 2013-06-27 Bionova Medical, Inc. Systèmes et procédés pour administrer un agent à une plaie sous pression négative
US20140277569A1 (en) * 2013-03-13 2014-09-18 Warsaw Orthopedic, Inc. Hybrid osteoinductive bone graft
US20180318088A1 (en) * 2015-11-04 2018-11-08 Traceray Oy Bone implant

Also Published As

Publication number Publication date
AU2020445491A1 (en) 2022-12-08

Similar Documents

Publication Publication Date Title
US11291556B2 (en) Interbody bone implant device
EP3735939B1 (fr) Implant osseux pour renfermer un matériau osseux
US8926622B2 (en) Bone delivery systems including holding and filling devices and methods
JP4635276B2 (ja) 生体組織における欠損を治療するための装置および方法
US9414939B2 (en) Delivery systems containing bioactive materials
US10532129B2 (en) Delivery systems
US9901381B2 (en) Filling systems for bone delivery devices
KR20190008813A (ko) 메쉬를 구비한 뼈 임플란트
US10492920B2 (en) Interbody bone implant device
JP2011120900A (ja) 骨インプラント及びその製造方法
US8992628B2 (en) Bone delivery system
US20220151785A1 (en) Bone graft containment system
US11083557B1 (en) Bone graft containment system
KR20180135084A (ko) 골유도성 섬유질 골편
US12121440B2 (en) Bone graft system
WO2021221685A1 (fr) Système de confinement de greffe osseuse
CN111526828A (zh) 骨材料递送系统
WO2022047068A1 (fr) Implant osseux réglable de contention de matière osseuse

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20933578

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2020445491

Country of ref document: AU

Date of ref document: 20200501

Kind code of ref document: A

122 Ep: pct application non-entry in european phase

Ref document number: 20933578

Country of ref document: EP

Kind code of ref document: A1

点击 这是indexloc提供的php浏览器服务，不要输入任何密码和下载