WO2018107121A2 - Bouchon de greffe osseuse comprenant une enveloppe de collagène intégrée et procédés associés - Google Patents

Bouchon de greffe osseuse comprenant une enveloppe de collagène intégrée et procédés associés Download PDF

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Publication number
WO2018107121A2
WO2018107121A2 PCT/US2017/065465 US2017065465W WO2018107121A2 WO 2018107121 A2 WO2018107121 A2 WO 2018107121A2 US 2017065465 W US2017065465 W US 2017065465W WO 2018107121 A2 WO2018107121 A2 WO 2018107121A2
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WO
WIPO (PCT)
Prior art keywords
collagen
bone graft
core
shell
bone
Prior art date
Application number
PCT/US2017/065465
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English (en)
Other versions
WO2018107121A3 (fr
Inventor
Chan Qian WANG
Original Assignee
Wang Chan Qian
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 Wang Chan Qian filed Critical Wang Chan Qian
Priority to CN201780085736.5A priority Critical patent/CN110430838B/zh
Publication of WO2018107121A2 publication Critical patent/WO2018107121A2/fr
Publication of WO2018107121A3 publication Critical patent/WO2018107121A3/fr

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Classifications

    • 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
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C5/00—Filling or capping teeth
    • A61C5/20—Repairing attrition damage, e.g. facets
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
    • A61F2310/00982—Coating made of collagen

Definitions

  • the present invention generally relates, to a bone graft plug with integrated collagen shell and. methods thereof. Although the invention will be illustrated, explained and exemplified, by dental bone graft, plug, it should be appreciated that the present invention can also be applied to other fields.
  • the bone graft can come in a number of forms. For example, granular bone graft may be mixed with the patient's blood. A separate membrane is used for holding the bone graft, granules in place during healing.. After the graft is placed into the. socket, the dentist, must sew the membrane to the surrounding tissue at the top of the socket to cover the bone graft material and prevent it from escaping the socket at the crestal area of the bone. The membrane may be absorbable into the bone.
  • a separate absorbable membrane can also be used to cover areas of defects in the bone so that the bone graft granules do not escape the socket.
  • the bone graft material paste is. provided in paste form so that the dentist, can pick.it up out of its container and directly place it in the socket.
  • the membrane is still needed to cover the graft, and sewing the membrane to the tissue may be necessary.
  • Current bone graft plug is a. mixture of bone graft granules or other bone graft materials within a collagen framework, other framework or no framework.
  • This, approach has the advantage of not necessarily requiring sewing a membrane to surrounding tissue, which can. reduce chair time compared to the granular bone graft, and the bone graft, putty as described above.
  • This approach also reduces the surgical invasiveness by eliminating the procedure of sewing to the tissue.
  • the membrane can also be used to cover areas of bone defect so that the bone graft granules do not escape the socket while the membrane itself will be absorbed into the bone.
  • the present invention provides an improved means of preserving the socket, particularly when defects, exist in the. bone.
  • One aspect of the present invention provides a bone graft plug for regenerating bone inside a dental socket and having a. shape configured for inserting into the dental socket.
  • the plug includes a bone graft collagen core, and a collagen shell optionally including a bone grafting material.
  • the shell is integrated with the bone, graft collagen core, and the collagen shell covers at least a part of the core's surface.
  • An example of "integrated" is that the collagen shell is chemically crosslinked to a collagen component in the bone graft collagen core.
  • Another aspect of the invention provides a process of preparing the above bone graft plug, comprising, providing a bone graft collagen core,, and integrating a collagen shell with the core, wherein the collagen shell covers at least a part of the core's surface.
  • Figure 1 schematically shows a bone graft plug designed for inserting into a dental socket in accordance with an exemplary embodiment of the present invention.
  • Figure 2 depicts a bone graft plug with a substantially cylindrical shape in accordance with an exemplary embodiment of the present invention.
  • Figure 3 illustrates a bone graft plug with different configurations of top shell and. side. shell in accordance with an exemplary embodiment of the present invention.
  • Figure 4 demonstrates a bone grafting material being injected into a bone graft collagen core in accordance with an exemplary embodiment of the present invention.
  • Figure. 5 depicts a bone graft injection device in accordance with an exemplary embodiment of the present invention.
  • Figure 6 schematically shows different microstructures of collagen material used for the plug in accordance with an exemplary embodiment of the present invention.
  • Figure 7 demonstrates different methods of preparing the bone graft plug in accordance with an exemplary embodiment of the present, invention.
  • the present invention provides methods and designs, for improvement of bone healing and soft tissue healing in general surgery, where an opening is created in bone and soft tissue covers the bone as part of the healing process.
  • a socket 102 is created within the alveolar.
  • the invention may be employed for the improvement of bone and soft, tissue healing after a dentist extracts, a tooth and surgically repairs the bone and the soft tissue contiguous with the tooth extraction region around socket 102.
  • Said socket 102 will typically be exposed to soft tissue at the point where the tooth was interfaced with the crestal ridge.
  • defects 102d occur where other regions of the interior of the socket 102 are exposed to soft tissue through defects 102d in the alveolar.
  • a bone graft plug 101 is designed for regenerating bone inside dental socket 102.
  • Bone graft plug 101 may have any shape and size suitable for inserting into the dental socket 102.
  • Bone graft plug 101 includes a bone graft collagen core 103, and a collagen shell 104 integrated with the core 103.
  • the collagen shell 104 comprises a bone grafting material, or comprises no bone grafting material at all.
  • core 103 includes a bone graft component and a collagen component.
  • the term "blank bone graft collagen core” means core 103 has not been loaded or infused or mixed with a bone grafting material yet. When collagen shell 104 is integrated with the core 103, it is typically integrated with the. collagen component in core 103.
  • the invention improves the borie and soft tissue healing process by integrating, a collagen, shell 104 such as a collagen wall 104W into a bone graft core 103 comprising commonly available bone regenerating materials and compositions.
  • the bone regenerating materials and compositions will remain within the socket 102 during the healing process, both improving the healing process, and reducing the. time taken by the dentist, in the bone grafting and soft tissue, suturing process.
  • One embodiment of the present, invention can. make the socket preservation easier for a dentist by creating a single plug product 101 from mass-production that includes both the bone graft material in core 103 and the membrane/shell 104 in a single form.
  • the dentist can remove the plug product 101 from its packaging and place the plug product 101 into the socket 102 in such a way that that a pre-Iocated membrane/shell 104W is appropriately located to cover the bone defect 102d, or at other locations as appropriate.
  • the top of the core 103 will also be covered, by an integrated membrane/shell 104T so as to reduce the need, or perhaps eliminate the need, to sew the membrane to the tissue in most cases where it is applicable.
  • the collagen shell/membrane 104 of different size is integrated with the. surface, of the bone graft, collagen core 103 in a variety of locations, so that the dentist can choose the form of the plug product 101 that is optimum given the location of the thin bone or alveolar crest.
  • the collagen shell 104 may cover at least a part of the core 103 's surface, such as 10%-90% percent of the core's total external surface.
  • the density of the collagen shell 104 is at least 5% (e.g. 10%, 20%, 35%, 50%, 100%, or 200%) higher than the density of the bone graft collagen core 103.
  • the tensile strength of the collagen shell 104 is at least 5% (e.g. 10%, 20%, 35%, 50%, 100%, or 200%) higher than the tensile strength of the bone graft collagen core 103.
  • the entire bone: graft plug 101 may have any shape and size suitable for inserting into the dental socket 102, For example, it may have a. substantially cylindrical shape as shown in. Figure 2, with a. total height.H in the range of from 5 mm to 30 mm such as 8 mm to 15 mm, and a diameter D in the range of from 2 mm to 10 mm.
  • the bone grafting core includes a flat top surface configured for placing near the socket's mouth 102m, and a core body 103 extending from the flat top surface.
  • the core body 103 is configured for inserting into the dental socket 102.
  • Collagen shell 104 may include a top shell 104T, a side shell or wall shell 104W, or any combination thereof.
  • the top shell 104T covers at least a part of the (preferably the entire) flat top surface, and the side shell 104W covers at least a part of side surface of the core, body 103.
  • the top shell 1.04T may have a thickness TT in the range of from.0.5 mm to 3 mm.
  • the side shell 104W may have a thickness TW in the range of from 0.5 mm to 3 mm, or 5-20% of diameter D.
  • the side shell 104W may have a height Hw in the range of from 1 mm to 25 mm. Hw may be equal to (H - TT), or less than (H - TT) such as 20% - 50% of (H - TT).
  • the side shell 104W may surround or wrap the core .103 with a span angle ⁇ in the range of 30° to 360°.
  • the collagen shell 104 covers the entire flat top surface and a portion of the core body 103's side surface, such as 1-50%, 5-50%, and 10-50% of the body's side surface. In other embodiments, the collagen shell 104 does not cover any part of the flat top surface, but covers at least a part of the body 103 's side surface or wall surface.
  • panel (a) shows a plug 101, wherein top. shell 104T covers 100% of core 103's flat top surface, but there is no side shell 104W to cover any part of the body 103's side surface or wall surface.
  • Panel (b) shows, a plug 101,,. wherein top shell. 1.04T covers. 100% of core 103's flat top surface, and there is a side shell 104W to cover a part of the body 103's side surface or wall surface.
  • Panel (c) shows a plug 101, wherein side shell 104W covers a part of the body 103 's side surface or wall surface, but there is no top shell 104T
  • Panel (d) shows a plug 101, wherein side shell 104W covers the body 103's entire side surface or wall surface, but there is no top shell 104T.
  • Any suitable bone graft materials may be employed, in the. present invention.
  • the bone graft collagen core may comprise a bone graft material selected from xenograft, autograft, allograft, and artificial graft, such as calcium phosphate,, hydroxyapatite, ground collagen, ground bones, blood, or any combination thereof, in a semi-liquefied form, a putty form, or a granular form.
  • ground collagen matrix can be mixed outside the. patient with patient, blood to create the regenerative growth material in a semi-liquefied form.
  • the bone graft collagen core 103 may be made of any known bone graft materials or a mix of different materials, either in a putty form, a granular form, or other form, with or without a collagen matrix structure supporting the bone graft material,
  • the bone graft collagen core 103 can consist of any mix of collagen and bone graft materials.
  • the core may include two components in any suitable weight ratio such as 1 :1.
  • the first component may be calcium-phosphate based ceramic, such as Medtronic Mastergraft with 85% ceramic; or B-TCP (Hydroxyapatite and bioactive glass) such as Medtronic Mastergraft with 15% ceramic.
  • the second component may be ground up collagen.
  • Collagen shell/sheet 104 may be located on core's surface in. any suitable locations, in any suitable form, at any suitable, thickness (e.g. 2 mm thick).
  • a bone grafting material may be pre-loaded, or infused into a blank bone graft collagen core 103 in a manufacture facility, or in mass production, A dentist can apply the mass produced bone graft plugs, with, identical mechanical structure and chemical/biochemical composition to two or more patients with different symptoms.
  • the bone grafting material may be injected into a blank bone graft collagen core 103 by a dentist on site.
  • an embodiment involves injecting the bone graft material through the collagen shell 104 after the collagen shell 104 has been placed in the patient's socket 102.
  • the collagen shell 104 may completely cover the entire, surface of the core. 103.
  • the collagen shell 104 should cover the entire surface of the core 103 except, its bottom surface.
  • a bone grafting material may be injected into the bone graft collagen core 103 by a dentist using a needle 201. As shown in Figure 5, the collagen shell 104 may completely cover the. entire surface of the core 103. Or, at least, the collagen shell 104 should cover the entire surface of the core 103 except its bottom surface.
  • a bone grafting material 401 may be injected into the bone graft collagen core 103 by a dentist using a bone graft injection device 300.
  • Injection device 300 includes a curved pipe 301 , and multiple needles 201 extend from pipe 301 pointing toward a plug 101. Under pressure, a bone grafting material 401 is pumped into pipe 301, and injected into plug 101 through multiple needles.201.
  • the collagen material used for the plug 101 is preferably a porous material with voids for receiving bone grafting material 401, as shown in Figure 6.
  • the void may occupy 20-80% of the volume of plug 101 or core 103, and is filled with air before bone grafting material 401 is. pumped or injected or infused, into the voids.
  • The. voids may take any known mierostructures such, as bubbles, layers, random,, or irregular shapes, as shown in Figure 6.
  • a composition of hydrpxyapatite and calcium phosphate is mixed with crushed collagen to create the bone graft collagen core 103 that has. an integrated shell/wall of collagen sheet 104 covering all. or part of the bone graft collagen core 103, thus creating a bone graft plug 101 with an integrated collagen wall 104.
  • the collagen wall 104 may be exposed to soft tissue external to the socket 102 that is created when a tooth is removed.
  • the integrated collagen wall 104 when located between the bone graft collagen core 103 and any surgically repaired soft tissue external to the socket 102, may reduce the effects of the bone graft collagen core 103 liquefying and escaping from the. socket. 102, which would be a detriment to the healing process.
  • the bone graft collagen core 103 may be made from a composition of hydroxyapatite and calcium, phosphate, or other commonly available, bone grafting materials which, in. combination have a proven capability to regenerate bone.
  • the dentist After placing the plug 101 in the socket 102, the dentist would not need, to suture the soft tissue over the defect 102d. It would not be necessary that a collagen sheet is cut to near the shape of the. socket area that remains open on. the top of the alveolar, and the dentist would not need to place sutures holding the soft tissue together Over the crestal top.
  • the collagen shell 104 keeps the semi -liquefied (or as paste arid putty) bone graft mix in the core: 103 from leaking out as it solidifies during healing.
  • the invention eliminates the need in the prior art for the dentist to apply collagen sheets separately to cover bone defects and the alveolar at the top of the socket .
  • side shell 104W in Figure 1 is flattened, so that the bone, graft, plug 101 does not extrude through a defect 102d in the side of the crestal bone.
  • the defect 102d is repaired in a shape closer to its original shape prior to the creation of the defect 102d.
  • the invention provides a process of manufacturing the bone plug component mix, including e.g. calcium carbonate and hydroxyapatite in manners which can improve the. bone healing process.
  • One example is to create a collagen scaffold with the shape of the bone graft and insert the mix of calcium carbonate and hydroxyapatite into the pores, as previously shown in Figure 5.
  • a sheet Or multiple sheets 501 of collagen are formed, in the shape of the bone graft plug 101 or core 103.
  • Multiple tubes 601 are assembled in the shape of the bone graft plug 101 or core 103.
  • a process of manufacturing the plug 101 include (1). making molds of stainless, steel that are a negative of the bone graft plug 101, for example* the bottom of the mold is the rounded part; (2) placing a collagen wall in its. location on the side of the molds; for example, collagen sheet may be wetted so it temporarily sticks to the cylindrical wall of the mold; (3) poring the bone graft composition in the mold; and (4) putting a collagen sheet on the flat surface of the bone graft composition in the mold; and (5) thermally heating or chemically solidifying the bone graft composition within the mold, A cover may be put over the mold,
  • the density and the tensile strength of the collagen shell 104 are higher than those of the bone graft collagen core 103.
  • the step of integrating a collagen shell with the core includes chemically erosslinking the collagen shell with the collagen component, in the core* wherein the collagen shell and the collagen in the core are formed using different reaction conditions.
  • Collagen is typically isolated, from natural, sources, such as bovine hide, cartilage, or bones. Bones are usually dried, defatted, crushed, and demineralized to extract collagen, while hide and cartilage ore usually minced and digested with proteolytic enzymes (other than collagenase).
  • Collagen in its native form is typically a rigid, rod-shaped molecule approximately 300 nra long and 1,5 nm in diameter. It is composed of three collagen polypeptides which form, a tight triple helix.
  • the collagen polypeptides are characterized by a long midsection having the repeating sequence -Gly-X-Y- where X and Y are often proline or hydroxyproline, bounded at each end by the "telopeptide" regions, which constitute less than about 5% of the molecule.
  • the telopeptide regions of the collagen chains are typically responsible for the cross-linking between chains, and for the immunogenieity of the protein.
  • a collagen in solution may be precipitated to produce collagen fibers which resemble native collagen fibers.
  • The. precipitated, reconstituted fibers may additionally be cross-linked using a chemical agent (for example aldehydes such as formaldehyde and glutaraldehyde), or using heat or radiation.
  • Collagen shell 104 and collagen within core 103 may be crosslinked to each other for the purpose of "integration", but. collagen shell 104 and collagen within core 103 themselves may be internally crosslinked at different, conditions, to achieve, different density and tensile strength as desired.
  • Suitable erosslinking agents include difunctional polymers prepared by reacting a dicarboxylic anhydride (e.g., glutarie or succinic anhydride) with a diol such as polyethylene or polypropylene glycol having a molecular weight of about 400 to 10,000 daltons, preferably from about 500: to 5,000 daltons, to form a polymer derivative (e.g., succinate), which may then be activated by esterification with a convenient leaving group, e.g., N-hydroxysuccinirnide, N,N'-disuccinimidyl oxalate, N,N'-disuccininiidyl carbonate and the like.
  • a convenient leaving group e.g., N-hydroxysuccinirnide, N,N'-disuccinimidyl oxalate, N,N'-disuccininiidyl carbonate and the like.
  • Preferred dicarboxylic anhydrides used to form the crosslinking compositions include glutarie anhydride,, adipic anhydride, succinic anhydride, 1,8 -naphthalene: dicarboxylic anhydride and the like:.
  • Other suitable crosslinking agents include the more conventional materials such as aldehydes. Suitable aldehydes are formaldehyde, glutaraldehyde, acid aldehyde, glyoxalj glyoxal pyruvic, aldehyde, and aldehyde starch.
  • a process may include forming a mixture of a. calcium phosphate mineral powder and a reconstituted fibrillar atelopeptide collagen,, shaping the mixture, drying, the mixture under dry flowing air at 35-45° C to a moisture content of less than 1%, rehydrating the dried structure until a moisture content of 1-6% is achieved, and subjecting the rehydrated structure to sterilizing radiation.
  • Collagen, shell 104. and collagen within core 103 may be controlled to have different, moisture content,

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • Dentistry (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Plastic & Reconstructive Surgery (AREA)
  • Developmental Biology & Embryology (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Dental Preparations (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un bouchon de greffe osseuse destiné à régénérer l'os à l'intérieur d'une alvéole dentaire et ayant une forme conçue pour être insérée dans l'alvéole dentaire. Le bouchon comprend un noyau de collagène de greffe osseuse, et une enveloppe de collagène associée au noyau, l'enveloppe de collagène recouvrant au moins une partie de la surface du noyau. La présente invention concerne également divers procédés de préparation d'un tel bouchon de greffe osseuse.
PCT/US2017/065465 2016-12-08 2017-12-08 Bouchon de greffe osseuse comprenant une enveloppe de collagène intégrée et procédés associés WO2018107121A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201780085736.5A CN110430838B (zh) 2016-12-08 2017-12-08 一种具有完整胶原蛋白外壳的骨移植塞及其制备方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662431481P 2016-12-08 2016-12-08
US62/431,481 2016-12-08

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WO2018107121A2 true WO2018107121A2 (fr) 2018-06-14
WO2018107121A3 WO2018107121A3 (fr) 2018-07-19

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Cited By (3)

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US11116613B2 (en) 2014-06-13 2021-09-14 Vp Innovato Holdings Ltd Molds for custom dental implant abutments and impression posts
US11446122B2 (en) 2017-08-21 2022-09-20 Vp Innovato Holdings Ltd. Dental abutment core and method for manufacturing a dental abutment

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CN114569787B (zh) * 2021-04-13 2022-11-18 健诺维(成都)生物科技有限公司 骨修复材料及其制备方法、应用

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US11116613B2 (en) 2014-06-13 2021-09-14 Vp Innovato Holdings Ltd Molds for custom dental implant abutments and impression posts
US11446122B2 (en) 2017-08-21 2022-09-20 Vp Innovato Holdings Ltd. Dental abutment core and method for manufacturing a dental abutment
CN112672715A (zh) * 2018-07-31 2021-04-16 补骨生物技术公司 牙科双结构膜及制造牙科双结构膜的方法
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CN110430838B (zh) 2022-03-08
CN110430838A (zh) 2019-11-08
WO2018107121A3 (fr) 2018-07-19

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