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EP1009333A1 - Formbare, bioaktive zusammensetzung - Google Patents

Formbare, bioaktive zusammensetzung

Info

Publication number
EP1009333A1
EP1009333A1 EP98934324A EP98934324A EP1009333A1 EP 1009333 A1 EP1009333 A1 EP 1009333A1 EP 98934324 A EP98934324 A EP 98934324A EP 98934324 A EP98934324 A EP 98934324A EP 1009333 A1 EP1009333 A1 EP 1009333A1
Authority
EP
European Patent Office
Prior art keywords
bioactive
composition
dextran
glass
polysaccharide
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP98934324A
Other languages
English (en)
French (fr)
Inventor
Larry L. Hench
Guy Latorre
Jon K. West
June Wilson
William Toreki, Iii
Christopher Batich
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Florida
USBiomaterials Corp
University of Florida Research Foundation Inc
Original Assignee
University of Florida
USBiomaterials Corp
University of Florida Research Foundation Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University of Florida, USBiomaterials Corp, University of Florida Research Foundation Inc filed Critical University of Florida
Publication of EP1009333A1 publication Critical patent/EP1009333A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C03—GLASS; MINERAL OR SLAG WOOL
    • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
    • C03C3/00—Glass compositions
    • C03C3/04—Glass compositions containing silica
    • C03C3/076—Glass compositions containing silica with 40% to 90% silica, by weight
    • C03C3/097—Glass compositions containing silica with 40% to 90% silica, by weight containing phosphorus, niobium or tantalum
    • 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
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/446—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
    • 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
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
    • C—CHEMISTRY; METALLURGY
    • C03—GLASS; MINERAL OR SLAG WOOL
    • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
    • C03C4/00—Compositions for glass with special properties
    • C03C4/0007—Compositions for glass with special properties for biologically-compatible glass
    • 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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable

Definitions

  • the present invention generally relates to bioactive compositions. More particularly, the present invention relates to bioactive compositions with a polysaccharide carrier.
  • Bioactive glasses and glass ceramics are examples of these synthetic materials
  • the particulate form of bioactive glasses has been used m the repair of pe ⁇ odontal defects m humans for several years
  • the mate ⁇ al is usually mixed with ste ⁇ le salme. or the patient's own blood, which forms a coherent mass and remains workable for several
  • graft mate ⁇ als may be in the form of a paste or putty, which
  • U S Patent No 5,263,985 (“the '985 patent”) desc ⁇ bes an implantable mate ⁇ al for promoting bone growth which has a microporous structure exhibiting an average pore
  • the porous biomaterial is capable of retaining
  • macromolecules having a molecular weight of at least 15,000 and up to 500,000.
  • Hydroxyapatite is not class A bioactive. This
  • dextran with or without water or saline solution. Saline was added to ste ⁇ hzed dextran
  • polylactic dimethacyrate have been used as carriers for bioactive implant materials.
  • the present invention relates to moldable bioactive compositions including (a) bioactive particles of bioactive glass, glass-ceramics, calcium phosphates, calcium apatites, or mixtures thereof; and (b) a biodegradable polysaccharide carrier including a polysaccharide with an average molecular weight of about 200,000 - 5,000,000.
  • the present invention is directed to moldable bioactive and biocompatible
  • compositions with at least bioactive particles and a biodegradable polysaccharide carrier for example, dextran, dextran sulfate, diethylammoethyl dextran, or dextran phosphate or mixtures thereof.
  • a biodegradable polysaccharide carrier for example, dextran, dextran sulfate, diethylammoethyl dextran, or dextran phosphate or mixtures thereof.
  • a biodegradable polysaccharide carrier for example, dextran, dextran sulfate, diethylammoethyl dextran, or dextran phosphate or mixtures thereof.
  • plastic is used herein, it is intended to describe compositions that have sufficient viscosity such that they are not readily injectable into a patient with a standard needle with an opening smaller in diameter than 17 guage.
  • Moldable compositions in accordance with the invention may also take the form of a paste.
  • Applicants have discovered that the use of polysaccharides with bioactive particles provides a surprisingly good implant material.
  • the polysaccharide component is absorbed over time and the particulate glass remains at the selected anatomic structures and bonds uniformly throughout the particulate surfaces thereof with the tissue (bone) at the anatomic structures to provide anatomic integ ⁇ ty and to enhance osseous ingrowth
  • Polysaccha ⁇ des such as dextrans are particularly well adapted for such use because the rate at which these mate ⁇ als are resorbed is complementary to the formation of HCA.
  • a biodegradable polysaccha ⁇ de earner is any polysaccha ⁇ de capable of resorbmg over time when implanted into a patient such as, for example, dextran, dextran sulfate, diethylammoethyl dextran, or dextran phosphate or mixtures thereof
  • Biodegradable polysaccha ⁇ de earners in accordance with the present invention preferably include a liquid diluent such as deionized water in amounts in a weight of polysaccha ⁇ de to volume
  • viscous solution means any moldable or semi solid composition, including highly viscous compositions sometimes referred to as "pastes or putties.”
  • animal means mammal including a human.
  • patient means a human patient.
  • pharmaceutically acceptable as used herein is consistent with the art and means compatible with the other ingredients of a pharmaceutical composition and not deleterious to the recipient thereof.
  • syringe means any surgical instrument such as a cement gun, which is standard in the industry, with an opening whose diameter is larger than that of a 17 gauge syringe.
  • anatomic structure refers to any site or locus composed of hard tissue (bone) and/or soft tissue withm the body of an animal.
  • anatomic integrity refers to the desired size, shape or configuration of a particular anatomic structure after bonding therewith of the particulate glass phase of the composition of the present invention.
  • Anatomic structures treatable according to the method of the present invention include, but are not limited to maxilla, mandible, temporomandibular joint, chin, zygomatic arch, nose, ear, tooth root canal, tooth pulp caps, dental restoration; and osseous defects in the appendicular and axial skeleton, including long bones, vertebral spaces and around articulating joints.
  • One embodiment of the present invention is a pharmaceutically acceptable moldable, semi-solid or solid composition capable of being placed by hand or via a surgical syringe into a defect site, comprising a homogenous mixture of bioactive and biocompatible glass particulate composition having particle size from about 1000 ⁇ m to about 10 ⁇ m. in a viscous solution of dextrans or of dextran derivatives having an average molecular weight of about 200,000 to about 5,000,000 daltons and optionally, one or more material enhancing agents, including preservatives, colorants, and flow enhancing, thickening or suspension agents.
  • This invention is particularly useful in the repair, replacement, reconfiguration, reconstruction or augmentation of selected tissue (bone) anatomic structures.
  • the ratio of particulate glass to the viscous solution in the suspension is such that the composition has the ability to be moldable and remains in place after placement.
  • bioactive and biocompatible material are known in the art of medicine as useful in the restoration of bone and soft tissue.
  • This art is discussed extensively in Introduction to Bioceramics, Ed., L.L. Hench and J. Wilson, especially chapter 1, World Scientific, London (1993).
  • bioactive and biocompatible glasses having the following weight percent compositions give satisfactory results when utilized as the particulate glass component of the invention.
  • the bioactive particulate glass used in the present invention may be prepared according to the methods of the art such as taught in U.S. Patent No's.4,159,358; 4,234,972; 4,103,002; 4,189,325; 94,171,544; 4,775,646; 4,857,046, and 5,074,916.
  • the raw materials e.g., SiO , CaO, Na 2 O and P 2 O 5
  • plastic materials e.g., SiO , CaO, Na 2 O and P 2 O 5
  • bioactive particles that may be used in accordance with the present invention
  • bioactive particles are well known to those of ordinary skill in the art.
  • Dextrans are polysaccharides of D-glucose and are commercially produced by
  • Dextrans Leuconostoc mesenteroides and L-dextranicum bacteria. Dextrans have been widely used
  • plasma substitutes and blood extenders are considered fully biocompatible and are
  • Dextrans are available in a wide range of average molecular
  • Dextrans and dextran derivatives useful in the present invention have molecular
  • composition of the present invention optionally contain additives used in the
  • additives include, but are not limited to, preservatives, colorants, and flow and suspension enhancing agents.
  • compositions of the present invention may be conveniently prepared in one form by dissolving a polysaccharide such as dextran powder in a diluent (preferably sterile and de-ionized) to form a solution of desired viscosity which is suitable for use.
  • a polysaccharide such as dextran powder
  • a diluent preferably sterile and de-ionized
  • the ratio of dextran to water will vary according to the molecular weight of the dextran but will be in the range of, for example, about one to four parts dextran to one part water by weight.
  • the resultant viscous aqueous dextran then may be mixed with bioactive glass particles in. for example, the ratio of about one part dextran to about one to three parts bioactive glass (by weight) to form a viscous solution or putty which is moldable.
  • the compositions may be prepared by mixing the polysaccharide and bioactive glass powders directly. The mixed powders would then be mixed with an
  • compositions may be prepared by premixing the polysaccharide, bioactive glass and fluid medium to produce a viscous solution, shaping this mixture to a predetermined shape and drying this resultant shape via freeze-drying or other suitable
  • This solid preform may then be supplied to the medical practitioner, at which time the preform is rehydrated, shaped as desired, and implanted. Because the viscosity and, hence moldability, is a function of the ratio of glass to polysaccharide, this ratio will vary according to application and the preference of the medical practitioner.
  • the prepared viscous composition may be marketed in several viscosities. Further, the practitioner can reduce the viscosity of the prepared solution at the time of insertion by the use of additional fluid. This fluid may include, but is not limited to, sterile water, more dextran. or more preferably, the patient's blood to add autologous osteogenic factors
  • the fluid compositions of the present invention may be placed directly into the defect site by hand, or may be injected using a standard or modified medical syringe or other hardware into the site requiring repair or augmentation.
  • the amount of material used is determined by the professional judgment of the medical practitioner treating the patient.
  • the polysaccharide will begin to degrade and be removed from the site via normal cellular, fluid transport, and enzymatic action. Degradation and removal of will be essentially complete within about two days to three weeks after implantation, with lower molecular weight polysaccharides being removed at a higher rate than higher molecular weight polysaccharides.
  • the bioactive glass component Upon removal of the polysaccharide component, the bioactive glass component will remain in the graft site.
  • the bioactive glass particles bond to the hard and soft tissues at the site and create a long-lasting augmentation of the tissue. In a hard tissue site, the particles of glass will react and bond to existing bone and induce the formation of new bone, which will infiltrate the site.
  • a moldable solution is prepared as in Example 1 except that benzyl alcohol is added as a preservative at the rate of 0.05% % by weight prior to storing under sterile conditions. Handling properties were similar to those noted in Example 1.
  • a moldable solution is prepared as in Example 1 except that the composition of the bioactive glass is Bioglass 52s4.6. Handling properties were identical to those noted
  • dextran as a moldable vehicle was accomplished by mixing a series of different molecular weight dextrans (150,000, 464,000 and 2,000,000 daltons, Sigma Scientific, St. Louis, Mo.) and de-ionized water to achieve a desired viscosity. These solutions then were mixed with a desired amount of Bioglass (trademark) 45s5 particles to form a putty. The mixtures were molded by hand and placed in a simulated defect site of 6.0 mm diameter, created in a bovine femur. The mixtures were evaluated with respect to moldability, cohesiveness, and ease of placement at the site.
  • Samples #5 and #6 produced mixtures that were easily molded and placed into the test site by hand. The mixtures were cohesive and tacky, tending to stick to the defect walls. These samples were prepared using dextrans of molecular weights of 464,000 dalton (Sample #5) and 2,000,000 dalton (Sample #6) in different concentrations and a bioactive glass content of 67% by volume. Increasing the glass content to 75% as for Samples #4 and #7 produced drier materials. These compositions became moldable on the addition of more fluid, in this case a few drops of deionized water being added. Use of the 150,000 dalton dextran (Samples #1 and #2) or lower concentrations of the 464,000 dalton dextran (Sample #3) produced mixtures having a viscosity suitable for injection through a syringe.
  • Samples #3 and #5 were identical to samples #2 and #4, respectively, with the exception of the addition of the dextran solution.
  • This dextran solution (3.0 grams 464,000 daltons dextran to 5.0 grams water) was mixed with 710 ⁇ m-90 ⁇ m 45s5 bioactive glass particulate in a volume ratio of one part dextran to three parts bioactive glass.
  • Sample #4 in Example 4 were mixed with small quantities of the blood from the surgical site at the time of implantation for easier handling.
  • Six-mm diameter defects were created bilaterally in the distal femurs of the rabbits and manually filled with the graft materials. Eight animals were used for each test material and were left to heal for periods of 1, 2, 3, 6, and 12 weeks.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Composite Materials (AREA)
  • Inorganic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Dermatology (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Geochemistry & Mineralogy (AREA)
  • Ceramic Engineering (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
EP98934324A 1997-07-10 1998-07-10 Formbare, bioaktive zusammensetzung Withdrawn EP1009333A1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US5216997P 1997-07-10 1997-07-10
US52169P 1997-07-10
PCT/US1998/014158 WO1999002107A1 (en) 1997-07-10 1998-07-10 Moldable bioactive compositions

Publications (1)

Publication Number Publication Date
EP1009333A1 true EP1009333A1 (de) 2000-06-21

Family

ID=21975908

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98934324A Withdrawn EP1009333A1 (de) 1997-07-10 1998-07-10 Formbare, bioaktive zusammensetzung

Country Status (6)

Country Link
EP (1) EP1009333A1 (de)
JP (1) JP2001509419A (de)
AU (1) AU736846B2 (de)
BR (1) BR9810693A (de)
CA (1) CA2295984A1 (de)
WO (1) WO1999002107A1 (de)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9144631B2 (en) 2003-01-27 2015-09-29 Benedicte Asius Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6537574B1 (en) 1992-02-11 2003-03-25 Bioform, Inc. Soft tissue augmentation material
US7968110B2 (en) 1992-02-11 2011-06-28 Merz Aesthetics, Inc. Tissue augmentation material and method
US7060287B1 (en) 1992-02-11 2006-06-13 Bioform Inc. Tissue augmentation material and method
CN1370084A (zh) * 1999-08-13 2002-09-18 白奥佛姆公司 组织增强材料及其使用方法
US8876532B2 (en) 2002-07-31 2014-11-04 Dentsply International Inc. Bone repair putty
EP1525011B1 (de) 2002-07-31 2016-08-17 DENTSPLY International Inc. Poröse partikel und trägergel enthaltende knochenreparaturpaste
EA200501422A1 (ru) * 2003-03-04 2006-04-28 Дзе Текнолоджи Девелопмент Компани Лтд. Длительнодействующая инъецируемая композиция инсулина и способы её изготовления и применения
DE102004012411A1 (de) * 2004-03-13 2005-09-29 Dot Gmbh Kompositmaterialien auf der Basis von Polykieselsäuren und Verfahren zu deren Herstellung
EP1655042A1 (de) * 2004-11-02 2006-05-10 Vivoxid Oy Medizinische Vorrichtung
US20070184087A1 (en) 2006-02-06 2007-08-09 Bioform Medical, Inc. Polysaccharide compositions for use in tissue augmentation
EP1872806A1 (de) * 2006-06-28 2008-01-02 Vivoxid Oy Implantat, seine Anwendungen und Herstellungsmethoden
EP2032182A2 (de) * 2006-06-28 2009-03-11 Vivoxid Oy Implantat mit sauerstoffquelle
US9113879B2 (en) 2011-12-15 2015-08-25 Ethicon Endo-Surgery, Inc. Devices and methods for endoluminal plication
US9113867B2 (en) 2011-12-15 2015-08-25 Ethicon Endo-Surgery, Inc. Devices and methods for endoluminal plication
US8992547B2 (en) 2012-03-21 2015-03-31 Ethicon Endo-Surgery, Inc. Methods and devices for creating tissue plications

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5451406A (en) * 1994-07-14 1995-09-19 Advanced Uroscience, Inc. Tissue injectable composition and method of use

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9902107A1 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9144631B2 (en) 2003-01-27 2015-09-29 Benedicte Asius Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof

Also Published As

Publication number Publication date
BR9810693A (pt) 2000-08-15
AU736846B2 (en) 2001-08-02
WO1999002107A1 (en) 1999-01-21
AU8387498A (en) 1999-02-08
JP2001509419A (ja) 2001-07-24
CA2295984A1 (en) 1999-01-21

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