WO2012075004A1 - Membrane de régénération dentaire renforcée - Google Patents

Membrane de régénération dentaire renforcée Download PDF

Info

Publication number
WO2012075004A1
WO2012075004A1 PCT/US2011/062393 US2011062393W WO2012075004A1 WO 2012075004 A1 WO2012075004 A1 WO 2012075004A1 US 2011062393 W US2011062393 W US 2011062393W WO 2012075004 A1 WO2012075004 A1 WO 2012075004A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical barrier
reinforcement members
flexible membrane
degradable
barrier
Prior art date
Application number
PCT/US2011/062393
Other languages
English (en)
Inventor
Thomas F. Mcgillicuddy
Original Assignee
Mcgillicuddy Thomas F
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 Mcgillicuddy Thomas F filed Critical Mcgillicuddy Thomas F
Publication of WO2012075004A1 publication Critical patent/WO2012075004A1/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
    • A61F2/2803—Bones for mandibular reconstruction
    • 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
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0003—Not used, see subgroups
    • A61C8/0004—Consolidating natural teeth
    • A61C8/0006—Periodontal tissue or bone regeneration
    • 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
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30462—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements retained or tied with a rope, string, thread, wire or cable

Definitions

  • the present invention relates to medical barriers including a flexible membrane and removably insertable reinforcement members held in place therein by pockets and or apertures.
  • barrier membranes do not need structural support as the bone graft material and the boney walls of the boney defect provide sufficient structural integrity.
  • barrier membranes that drape well are desirable such that the barrier membrane adapts to the bone to more effectively prevent in-growth of gingival cells.
  • barrier membranes that both drape well and have structural support are needed.
  • barrier materials with space-making ability are also required in some instances. Such barrier membranes which provide these advantages and structural features are not currently available.
  • Barrier membranes made of polytetrafluoroethylene (PTFE) provide structural support and have space-making ability but drape poorly.
  • barrier membranes made of PTFE with permanently embedded titanium struts allow the barrier membranes to adapt to limited boney defects, such barrier membranes still have limited draping ability. Poor draping may result in gingival cells penetrating a bone graft site onto which the barrier membrane is placed.
  • barrier membranes made of PTFE often become exposed to the oral environment and thus require premature removal by a second surgical procedure.
  • barrier membranes made of materials which drape well and are resorbable are also effective at preventing ingrowth of gingival cells to a bone graft site and advantageously avoid the need for a second surgical procedure to remove them.
  • resorbable barrier membranes remain covered by gingiva during the healing process.
  • resorbable membranes include, the fact that many of them lack sufficient structural support and space-making ability as sometimes required at the site of a boney defect.
  • the present invention solves the above-mentioned problems as well as other problems associated with customization of barrier membranes to specific boney defects.
  • Barrier membranes of the present invention permit an array of possible support configurations which can be selected by the practitioner to support the customized shaping and fitting of the membrane at the boney defect site.
  • medical barriers including a flexible membrane and removably insertable reinforcement members which are held in place in the flexible membrane by pockets and or apertures. Additionally, there is provided medical barriers including a flexible membrane including pockets and/or apertures for releasably holding reinforcement members as well as a kit to form such medical barriers.
  • the medical barriers of the present invention can be customized to a particular shape by selectively configuring reinforcement members in the flexible membrane as desired. Cutting of the membrane to properly drape the defect can be accomplished without having to also cut the structural support members along with the membrane material. Once the size and shape of the membrane is determined, the structural support members can be inserted in the membrane pockets and/or apertures built into the membrane structure. Various sizes of support members may be used, as desired to span the membrane at locations determined to best provide the shaped support necessary for proper bone growth and healing.
  • Figure 1 is a cross section of a boney defect surrounded on all sides by boney walls. Specifically, a jaw bone with a tooth socket space having a bone graft therein which is covered by a membrane to prevent in-growth of gingival cells from the surrounding gum tissue.
  • Figure 2 is a side view of a boney defect lacking boney walls on all sides. Specifically, a jaw bone with a tooth socket space having a bone graft therein which is covered by a membrane having reinforcement members therein which adapts the membrane to the bone and thus prevents in-growth of gingival cells from the surrounding gum tissue.
  • Figure 3 is a perspective view of a membrane having sleeves which hold reinforcement members therein.
  • Figure 4 is a perspective view of a membrane having a series of slits therein whereby reinforcement members are held within the membrane.
  • Figure 5 is a perspective view of a membrane having a series of loops therein some of which are employed to hold reinforcement members within the membrane.
  • Figure 6 is a perspective view of a membrane having a series of slits therein some of which are employed to hold reinforcement members within the membrane. Notably, the paths of the reinforcement members cross each other.
  • Figure 7 is a top view of a membrane having a series of blind pockets facing each other designed to hold reinforcement members therein and a series of loops designed to guide the reinforcement members between blind pockets.
  • rod-like shaped with reference to reinforcement members refers to having a form or shape that resembles a rod in that it is curved and somewhat round in shape rather than jagged.
  • pocket with reference to a flexible membrane refers to a sleeve or other means for releasably housing a reinforcement member.
  • aperture refers to a tubular protrusion, a loop, a slit or other means for releasably holding a reinforcement member inserted therethrough.
  • non-degradable includes substantially non-degradable materials which are, from a practical standpoint, not degradable to any appreciable extent during their useful life, i.e., while used in the patient.
  • degradable means substantially degradable in the patient such that the material which is degradable is resorbed by the body. Desirably, membranes made from degradable materials do not require removal once placed in the body.
  • the present invention provides medical barriers including (i) a flexible membrane having a length, a width, and top and bottom surfaces; (ii) a plurality of pockets on at least one of said surfaces for releasably housing reinforcement members; and (iii) a plurality of reinforcement members selectively removably insertable within one or more pockets to permit selective positioning and repositioning of said reinforcement members with respect to said surfaces, thereby permitting multiple reinforcement arrangements.
  • the aforementioned medical barrier further includes one or more apertures on at least one of said surfaces to selectively releasably position and reposition one or more reinforcement members inserted therethrough.
  • the present invention provides medical barriers including (i) a flexible membrane having a length, a width and top and bottom surfaces; (ii) a plurality of apertures on at least one of said surfaces for releasably holding reinforcement members to be inserted therethrough; and (iii) a plurality of reinforcement members selectively removably insertable within said apertures to permit selective positioning and repositioning of said reinforcement members with respect to said surfaces, thereby permitting multiple reinforcement arrangements.
  • the aforementioned medical barrier further includes a plurality of pockets on at least one of said surfaces for releasably housing said reinforcement members.
  • the present invention provides a medical barrier including (i) a flexible membrane having a length, a width and top and bottom surfaces; and (ii) a plurality of apertures and/or pockets on at least one of said surfaces for releasably holding reinforcement members.
  • the aforementioned medical barriers of the present invention may include any of the following embodiments. Active Agent(s)
  • the aforementioned medical barriers of the present invention further include at least one active agent releasable held on or within the flexible membrane.
  • at least one active agent is a pharmaceutical or a biological agent.
  • the pharmaceutical agent is selected from the group consisting of anti-infective agents, analgesics, anti-inflammatory agents and combinations of two or more thereof.
  • the biological agent is a protein (e.g., a growth factor) or a cell.
  • flexible membranes of the present invention are non-degradable.
  • non-degradable flexible membranes may be made of non-absorbable materials.
  • flexible membranes of the present invention are degradable.
  • degradabie flexible membranes may be made of bioabsorbable materials.
  • flexible membranes of the present invention include a material selected from the group consisting of synthetic polymers (e.g., polylactic acid and polyglycolic acid), collagen, artificial dermis and combinations of two or more thereof.
  • flexible membranes of the present invention include a material selected from the group consisting of polytetrafluoroethylene, fluorinated ethylene propylene, silicone, silicone rubber, polyurethane, polyethylene, polyethylene teraphthalate, polysulfone, non-degradable polycarboxylate, non-degradable polycarbonate, non-degradable polyester, polypropylene, polyacrylic, poly(hydroxymethacrylate), polymethylmethacrylate, and polyamides such as polyesteramide, and copolymers, block copolymers and combinations of two or more thereof.
  • flexible membranes of the present invention include a material selected from the group consisting of collagen, hyaluronic acid, polylactic acid, polyglycolic acid, copolymers of polylactic acid and polyglycolic acid, polyorthoesters, degradable polycarbonate, degradable polycarboxylate, degradable polycaprolactone, polyanhydride, and copolymers, block copolymers and combinations of two or more thereof.
  • flexible membranes of the present invention include collagen.
  • flexible membranes of the present invention can be trimmed as needed (e.g., to the size and/or shape of the boney defect). Nonetheless, one or more reinforcement members of an appropriate size can be attached selectively and releasably to the trimmed flexible membrane, such that the flexible membrane can be shaped and sized as needed.
  • the flexible membrane may include perforations for tacking purposes. Such perforations may be used in conjunction with sutures, staples, pins, tacks or other stabilizing materials to anchor the barrier membrane in place in order to serve its purpose. Such anchoring materials may be pre-set on the membrane for convenience, i.e., the membrane may be "pre-tacked" for ready-use by the practitioner.
  • the anchoring materials may be separate from the membrane initially and inserted by the practitioner, desirably, but not necessarily, using pre-punched or preformed holes in the membrane. Further, in some embodiments, perforations can readily be made in the flexible membrane as needed for fixation thereof, for example, by using a punch tool or a small pilot drill.
  • barrier membranes of the present invention include permanently embedded reinforcement materials in addition to the reinforcement materials that are releasably attached as described herein.
  • reinforcement materials for example, a thin bar of titanium, stainless steel or other metal, collagen, or other resorbable and/or degradable material, or a polymeric reinforcement member, may be additionally embedded in the membrane at selective locations which do not interfere with those members which are releasably attached.
  • the relative rigidity of the reinforcement material allows one to pre- shape the membrane to cover the area of the bone graft.
  • both the flexible membrane and reinforcement member(s) include collagen.
  • barrier membranes of the present invention are adapted for use with an additional separate layer of reinforcement material which covers at least a portion of the barrier membrane.
  • Suitable reinforcement material includes, but is not limited to, a sheet of metal mesh, such as titanium mesh or a collagen layer.
  • the reinforcement material could be added on top of the barrier membrane before the peeled back gum tissue is sutured back in place to cover the barrier membrane.
  • the sheet of reinforcement material is pre-shaped to conform to the boney defect site.
  • the sheet of reinforcement material may be pre-shaped into a curved configuration (e.g., saddle-shaped) to more readily conform to the boney defect site.
  • reinforcing members of the present invention are placed, at least, on the inside (bone-facing) surface of the flexible membrane.
  • the reinforcing members are placed, at least, on the outside (gum tissue-facing) surface of the flexible membrane.
  • the reinforcing members may be placed, at least, between the inside (bone-facing side) and outside (gum tissue-facing) surfaces of the flexible membrane.
  • the reinforcement members may be made from one or more materials of metal, polymer, collagen or a combination thereof.
  • the reinforcement members include a material selected from the group consisting of titanium, stainless steel, nitinol, carbon fiber, polyimide, polyethylene, polypropylene, polytetrafluoroethylene, collagen and combinations of two or more thereof.
  • the reinforcement members include collagen.
  • the reinforcement members may be rod-like shaped.
  • the reinforcement members may have two substantially parallel planar surfaces, such as thin, flat and elongate stays.
  • the reinforcement members may have varying widths or diameters along their lengths to provide for degrees of stiffness and/or flexibility along the length.
  • the reinforcement members may be made from a combination of materials, such as a composite material.
  • the reinforcement members are about 1 to about 3 millimeters in width and about 10 to about 50 millimeters in length. In other embodiments, the reinforcement members are about 1 to about 3 millimeters in width and about 10 millimeters to greater than 50 millimeters in length. Desirably, the reinforcement members can be formed to the shape and length needed. For example, as desired to adapt the flexible membrane to a bone graft filled tooth socket space. In some embodiments, reinforcement members are obtained from a selection of pre-shaped reinforcement members. Additionally, reinforcement members can have perforations for tacking purposes to further stabilize the membrane.
  • perforations can be used in conjunction with sutures, staples, pins, tacks, screws or other stabilizing materials to hold the membrane in place in order to serve its purpose. Further, in some embodiments, perforations may readily be made in reinforcement members as needed for fixation thereof, for example, by using a punch tool or a small pilot drill. In one embodiment, a self drilling self tapping screw is utilized to affix the barrier membrane to the boney defect site. Naturally, one or more fixation points are utilized to affix the barrier membrane to the boney defect site for the purposes of ensuring stability of the membrane and graft.
  • kits including
  • a medical barrier including (i) a flexible membrane having a length, a width and top and bottom surfaces; and (ii) a plurality of apertures and/or pockets on at least one of said surfaces for releasably holding reinforcement members; (b) a plurality of reinforcement members; and (c) instructions for use.
  • anchoring members such as sutures, staples, pins, tacks or screws may also be included.
  • a surgeon in the field of oral surgery, a surgeon generally uses a barrier membrane 1 to cover an area where a bone graft 2 fills a tooth socket space 3 (e.g., an extracted tooth socket) in the jaw bone 10. See, Figure 1.
  • the barrier membrane is desirably shaped and reinforced to adapt to the filled tooth socket space 3 in order to prevent in-growth of gingival cells from the surrounding gum tissue 4 and provide structural support as well as space-making.
  • reinforcement members 5 are used to shape and support the membrane 1 as desired to adapt to the surface of the bone graft.
  • the membrane 1 includes a series of sleeves 6 designed to house reinforcement members 5 therein. Additionally, any of the embodiments may include pre-drilled holes 11 in the membrane and or reinforcement members as shown. See, Figure 3. [0041] In some embodiments, the membrane 1 includes a series of slits 7 in the membrane through which reinforcement members 5 are held within the membrane 1. See, Figure 4.
  • the membrane 1 includes a series of loops 8 therein designed to hold reinforcement members 5 in place in the membrane 1. As depicted in Figure 5, a plurality of the loops 8 may be employed to hold reinforcement members 5 within the membrane 1.
  • the membrane 1 includes a series of slits 7 therein designed to hold reinforcement members 5 in place in the membrane 1. As depicted in Figure 6, a plurality of the slits 7 may be employed to hold reinforcement members 5 within the membrane 1.
  • the membrane 1 includes a series of blind pockets 9 designed to hold reinforcement members 5 therein as well as a series of loops 8 designed to guide the reinforcement members 5 between the blind pockets 9. See, Figure 7.

Abstract

La présente invention concerne des barrières médicales comprenant une membrane flexible et des éléments de renforcement pouvant être introduits de façon amovible, lesquelles barrières médicales sont maintenues en place dans la membrane flexible par des poches et/ou des ouvertures. De plus, l'invention porte sur des barrières médicales comprenant une membrane flexible comprenant des poches et/ou des ouvertures pour maintenir de façon libérable des éléments de renforcement, ainsi que sur un coffret pour former de telles barrières médicales.
PCT/US2011/062393 2010-11-29 2011-11-29 Membrane de régénération dentaire renforcée WO2012075004A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US45861710P 2010-11-29 2010-11-29
US61/458,617 2010-11-29
US201161487325P 2011-05-18 2011-05-18
US61/487,325 2011-05-18

Publications (1)

Publication Number Publication Date
WO2012075004A1 true WO2012075004A1 (fr) 2012-06-07

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Application Number Title Priority Date Filing Date
PCT/US2011/062393 WO2012075004A1 (fr) 2010-11-29 2011-11-29 Membrane de régénération dentaire renforcée

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WO (1) WO2012075004A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103349797A (zh) * 2013-07-22 2013-10-16 广西医科大学 用于增强乳牙可吸收根管桩密闭的可吸收聚乳酸薄膜
WO2016019404A1 (fr) * 2014-08-05 2016-02-11 Dietmar Sonnleitner Procédé de production d'un film multicouche
EP3299037A1 (fr) * 2016-09-27 2018-03-28 Regedent AG Système de protection et procédé pour former un système de protection, procédé de régénération d'un os et membre de renfort
CN110338944A (zh) * 2018-08-20 2019-10-18 郭建群 恒牙提取物在制备下颌填充材料中的应用及下颌填充材料
CN113429717A (zh) * 2021-07-15 2021-09-24 物生生物科技(北京)有限公司 一种抗菌耐磨牙套、制备方法及其使用方法
KR20220117950A (ko) * 2021-02-17 2022-08-25 동의대학교 산학협력단 흡수성이 향상된 치과용 멤브레인 필터 및 그 제조방법

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5499917A (en) * 1993-06-29 1996-03-19 Minnesota Mining And Manufacturing Company Dental isolation dam
US20060177796A9 (en) * 2001-04-05 2006-08-10 Heasley John M Rubber Dams With Operative Inserts Which Isolate Anatomical Structures by Effectively Resisting External Vector Forces of Displacement
US20080050693A1 (en) * 2006-08-25 2008-02-28 Ultradent Products, Inc. Non-custom dental treatment trays and mouth guards having improved anatomical features

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5499917A (en) * 1993-06-29 1996-03-19 Minnesota Mining And Manufacturing Company Dental isolation dam
US20060177796A9 (en) * 2001-04-05 2006-08-10 Heasley John M Rubber Dams With Operative Inserts Which Isolate Anatomical Structures by Effectively Resisting External Vector Forces of Displacement
US20080050693A1 (en) * 2006-08-25 2008-02-28 Ultradent Products, Inc. Non-custom dental treatment trays and mouth guards having improved anatomical features

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103349797A (zh) * 2013-07-22 2013-10-16 广西医科大学 用于增强乳牙可吸收根管桩密闭的可吸收聚乳酸薄膜
WO2016019404A1 (fr) * 2014-08-05 2016-02-11 Dietmar Sonnleitner Procédé de production d'un film multicouche
US10624747B2 (en) 2014-08-05 2020-04-21 Dietmar SONNLEITNER Method for producing a multilayer film
EP3299037A1 (fr) * 2016-09-27 2018-03-28 Regedent AG Système de protection et procédé pour former un système de protection, procédé de régénération d'un os et membre de renfort
WO2018059950A1 (fr) * 2016-09-27 2018-04-05 Regedent Ag Système de barrière et procédé de formation d'un système de barrière, procédé de régénération osseuse et élément de renforcement
CN110338944A (zh) * 2018-08-20 2019-10-18 郭建群 恒牙提取物在制备下颌填充材料中的应用及下颌填充材料
KR20220117950A (ko) * 2021-02-17 2022-08-25 동의대학교 산학협력단 흡수성이 향상된 치과용 멤브레인 필터 및 그 제조방법
KR102520633B1 (ko) 2021-02-17 2023-04-11 동의대학교 산학협력단 흡수성이 향상된 치과용 멤브레인 필터 및 그 제조방법
CN113429717A (zh) * 2021-07-15 2021-09-24 物生生物科技(北京)有限公司 一种抗菌耐磨牙套、制备方法及其使用方法
CN113429717B (zh) * 2021-07-15 2022-04-08 物生生物科技(北京)有限公司 一种抗菌耐磨牙套、制备方法及其使用方法

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