WO2007132026A1 - Bone-regenerating substance composed of semi-hydrated calcium sulphate and calcium phosphate - Google Patents

Bone-regenerating substance composed of semi-hydrated calcium sulphate and calcium phosphate Download PDF

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Publication number
WO2007132026A1
WO2007132026A1 PCT/ES2006/000240 ES2006000240W WO2007132026A1 WO 2007132026 A1 WO2007132026 A1 WO 2007132026A1 ES 2006000240 W ES2006000240 W ES 2006000240W WO 2007132026 A1 WO2007132026 A1 WO 2007132026A1
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WO
WIPO (PCT)
Prior art keywords
bone
calcium phosphate
semi
calcium
substance composed
Prior art date
Application number
PCT/ES2006/000240
Other languages
Spanish (es)
French (fr)
Inventor
Christobal Martin-Nieto Camacho
Francisco Javier Poblete Martin
Original Assignee
Martin-Nieto Camacho Christoba
Poblete Martin Francisco Javie
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 Martin-Nieto Camacho Christoba, Poblete Martin Francisco Javie filed Critical Martin-Nieto Camacho Christoba
Priority to PCT/ES2006/000240 priority Critical patent/WO2007132026A1/en
Publication of WO2007132026A1 publication Critical patent/WO2007132026A1/en

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Classifications

    • 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
    • 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
    • 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
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite

Definitions

  • the present invention relates to a substance, composed of calcium sulfate hemihydrate and calcium phosphate.
  • the substance, to which the present invention refers, acts as a bone regenerator, both for its application in stomatology, traumatology and in any other medical specialty that requires bone regeneration, traumatology for its development.
  • the bone regeneration process involves the following stages: 1.- Activation of osteogenic precursor cells. 2.- Active bone absorption, resorption. 3.- Rest period and 4.- New bone formation.
  • osteoblasts bone-producing cells
  • the osteoclastic absorption lagoons are repopulated by a contingent of osteoblasts that make osteoid (young bone), which calcifies, the bone being restored.
  • For osteogenesis to exist it is necessary that the tissue from which the bone is formed is very vascularized, so that vessels can grow inside blood.
  • the products that are used for bone regeneration can be classified into two large groups: Organic or inorganic or synthetic.
  • the oldest of the synthetic products used is calcium phosphate, since the body transforms that product into bone tissue.
  • the proportion of reabsorption varies and depends on the chemical structure of the material, its porosity and size of the par- title It is osteoconductive.
  • B) Calcium sulfate It is soluble in water, a condition lacking calcium phosphate and is, like this one, osteoconductive and, in addition, of great osteoinductive capacity.
  • Dr. Dreesman used calcium sulfate as a filler for cavitary defects due to its osteoconductive quality. Resorbable in bone in a shorter time than calcium phosphate (2-3 months).
  • the substance in question here composed of calcium sulfate hemihydrate and calcium phosphate, using potassium sulfate as a catalyst, combines the advantages of calcium sulfate hemihydrate and calcium phosphate, that is: it is a porous material, and by therefore of great vascular capacity, of easy reabsorption, containing the phosphate anion and calcium cation necessary for bone neoformation. It is antiseptic and easy to use, not presenting rejection by being inorganic with increased osteoconductivity.
  • potassium sulfate in catalytic amounts, to 4%, to accelerate the setting process.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Bone-regenerating substance composed of semi-hydrated calcium sulphate and calcium phosphate, for application in stomatology and traumatology and in any other medical speciality that requires bone regeneration in order to proceed. It is an inorganic compound that, combining the advantages of semi-hydrated calcium sulphate and calcium phosphate, forms a material that is ideal as a bone regenerator, an osteoinductive, or an osteoconductive, and it is reabsorbable, antiseptic, non-toxic and easily handled, in addition to being very economical.

Description

SUSTANCIA REGENERADORA DE HUESO, BONE REGENERATING SUBSTANCE,
COMPUESTA DE SULFATO CALCICO HEMIHIDRATADO Y FOSFATO CALCICO. OBJETO DE LA INVENCIÓN.COMPOUND OF HEMIHYDRATED CALCIUM SULPHATE AND CALCIUM PHOSPHATE. OBJECT OF THE INVENTION
La presente invención se refiere a una sustancia, compuesta de sulfato calcico hemihidratado y fosfato calcico.The present invention relates to a substance, composed of calcium sulfate hemihydrate and calcium phosphate.
La sustancia, a que se refiere la presente invención, actúa como regeneradora del hueso, tanto para su aplicación en estomatología, traumatología como en cualquier otra especialidad médica que requiera para su desarrollo la regeneración ósea, traumatología. ANTECEDENTES DE LA INVENCIÓN.The substance, to which the present invention refers, acts as a bone regenerator, both for its application in stomatology, traumatology and in any other medical specialty that requires bone regeneration, traumatology for its development. BACKGROUND OF THE INVENTION
El proceso de regeneración del hueso implica las siguientes etapas: 1.- Activación de las células osteogénicas precursoras. 2.- Absorción activa del hueso, reabsorción. 3.- Período de descanso y 4.- Formación de hueso nuevo.The bone regeneration process involves the following stages: 1.- Activation of osteogenic precursor cells. 2.- Active bone absorption, resorption. 3.- Rest period and 4.- New bone formation.
La formación de hueso por los osteoblastos, células productoras de la substancia ósea, se da en la zona que ha sido reabsorbida por los osteoclastos. Las lagunas de absorción osteoclástica (lagunas de howship) se repueblan por un contingente de osteoblastos que fabrican osteoide (hueso joven), el cual calcifica, quedando restaurado el hueso. Para que exista la osteogénesis es necesario que el tejido a partir del cual se forme el hueso esté muy vascularizado, para que así puedan crecer en su interior vasos sanguíneos.Bone formation by osteoblasts, bone-producing cells, occurs in the area that has been reabsorbed by osteoclasts. The osteoclastic absorption lagoons (howship lagoons) are repopulated by a contingent of osteoblasts that make osteoid (young bone), which calcifies, the bone being restored. For osteogenesis to exist it is necessary that the tissue from which the bone is formed is very vascularized, so that vessels can grow inside blood.
En la actualidad, los productos que se utilizan para la regeneración de hueso se pueden clasificar en dos grandes grupos: Orgánicos o inorgánicos o sintéticos.At present, the products that are used for bone regeneration can be classified into two large groups: Organic or inorganic or synthetic.
Dentro de los orgánicos se utilizan:Within the organic ones are used:
A) Injertos procedentes del propio paciente. No producen rechazo, pero implica una actuación quirúrgica en la zona de elección del injerto. Por ejemplo: tibia, fémur, costilla, etc.A) Grafts from the patient himself. They do not produce rejection, but it implies a surgical action in the area of graft choice. For example: tibia, femur, rib, etc.
B) Injertos procedentes de otra persona. Cabe la posibilidad cierta de rechazo, sin descartar el contagio de infecciones. C) Injertos procedentes de animales, principalmente de ganado bovino y equino. Muy utilizados en implantes dentales que, además de producir rechazo, ofrecen la desventaja de que pueden contener priones, lo que exige una exhaustiva esterilización para eliminar esas sustancias, lo que encarece en gran medida el producto y así puedan ser utilizados. No puede descartarse que una deficiente esterilización del material en presencia pueda producir en el paciente efectos indeseables. Dentro de los inorgánicos o sintéticos se utilizan:B) Grafts from another person. There is a certain possibility of rejection, without ruling out the spread of infections. C) Grafts from animals, mainly cattle and horses. Very used in dental implants that, in addition to producing rejection, offer the disadvantage that they can contain prions, which requires an exhaustive sterilization to eliminate these substances, which greatly increases the cost of the product and thus can be used. It cannot be ruled out that poor sterilization of the material in the presence may produce undesirable effects on the patient. Within the inorganic or synthetic are used:
A) El más antiguo de los productos sintéticos utilizados es el fosfato calcico, ya que el organismo transforma ese producto en tejido óseo. La proporción de la reabsorción varía y depende de la estructura química del material, su porosidad y tamaño de la par- tícula. Es osteoconductivo.A) The oldest of the synthetic products used is calcium phosphate, since the body transforms that product into bone tissue. The proportion of reabsorption varies and depends on the chemical structure of the material, its porosity and size of the par- title It is osteoconductive.
B) El sulfato calcico. Es soluble en agua, condición de la que carece el fosfato calcico y es, al igual que éste, osteoconductor y, además, de gran capacidad osteoinductiva. En 1982, el Dr. Dreesman utilizó el sulfato de calcio como relleno de defectos cavitarios por su cualidad osteoconductora. Reabsorbible en hueso en un tiempo más corto que el fosfato calcico (2-3 meses). B) Calcium sulfate. It is soluble in water, a condition lacking calcium phosphate and is, like this one, osteoconductive and, in addition, of great osteoinductive capacity. In 1982, Dr. Dreesman used calcium sulfate as a filler for cavitary defects due to its osteoconductive quality. Resorbable in bone in a shorter time than calcium phosphate (2-3 months).
DESCRIPCIÓN DE LA INVENCIÓN La sustancia de la que aquí se trata, compuesta de sulfato calcico hemihidratado y fosfato calcico, utilizando sulfato potásico como catalizador, conjuga las ventajas del sulfato calcico hemihidratado y el fosfato calcico, es decir: resulta un material poroso, y por lo tanto de gran capacidad vascular, de fácil reabsorción, conteniendo el anión fosfato y catión calcico necesarios para la neoformación ósea. Es antiséptico y de fácil manejo, no presentando rechazo al ser inorgánico con osteoconductividad aumentada.DESCRIPTION OF THE INVENTION The substance in question here, composed of calcium sulfate hemihydrate and calcium phosphate, using potassium sulfate as a catalyst, combines the advantages of calcium sulfate hemihydrate and calcium phosphate, that is: it is a porous material, and by therefore of great vascular capacity, of easy reabsorption, containing the phosphate anion and calcium cation necessary for bone neoformation. It is antiseptic and easy to use, not presenting rejection by being inorganic with increased osteoconductivity.
Al mezclar sulfato calcico hemihidratado, que es un material soluble, con fosfato calcico se aumenta la dureza del material y proporciona a los osteoblastos el material necesario para la neoformación de tejido óseo, anión sulfato y catión calcio.Mixing calcium sulfate hemihydrate, which is a soluble material, with calcium phosphate increases the hardness of the material and provides the osteoblasts with the necessary material for bone tissue neoformation, sulfate anion and calcium cation.
A este compuesto se le añade, en el momento de su utilización, sulfato potásico en cantidades catalíticas, al 4%, para acelerar el proceso de fraguado.To this compound is added, at the time of use, potassium sulfate in catalytic amounts, to 4%, to accelerate the setting process.
Esta cristalización acelerada del sulfato y fosfato calcico hace que no se forme una estructura cristalina perfecta, sino que se crean numerosas oquedades en el material. Estos poros forman una serie de cavidades unidas unas con otras, como una esponja, que permite la entrada de capilares sanguíneos en el interior de su estructura, y por tanto la regeneración ósea. Además, como el sulfato calcico hemihidratado es soluble se crean mayores oquedades en el interior del material al estar en contacto con el torrente sanguíneo. La sustancia, de que se trata esta invención, que se comercializará en cápsulas, al disolverla en el catalizador, presenta una consistencia pastosa de color blanquecino que va endureciendo progresivamente en unos 4 minutos. Transcurrido ese tiempo el material se puede moldear con los dedos y lo podemos colocar, comprimiéndolo con una gasa. De ese modo se obtienen dos efectos: que se adapte perfectamente al defecto óseo y que elimine la sangre de la zona.This accelerated crystallization of sulfate and calcium phosphate means that a perfect crystalline structure is not formed, but that numerous holes in the material are created. These pores form a series of cavities attached to each other, such as a sponge, which allows the entry of blood capillaries inside its structure, and therefore bone regeneration. In addition, as the calcium sulfate hemihydrate is soluble, greater cavities are created inside the material when in contact with the bloodstream. The substance, which is the subject of this invention, which will be marketed in capsules, when dissolved in the catalyst, has a whitish paste consistency that gradually hardens in about 4 minutes. After that time the material can be molded with the fingers and we can place it, compressing it with gauze. In this way two effects are obtained: that it adapts perfectly to the bone defect and that it eliminates blood from the area.
Dejándolo sin tocar se procedería a la sutura de la incisión quirúrgica. Si el material quedase expuesto por falta de cierre de la herida, no ofrece ningún inconveniente, puesto que este producto actúa como barrera y además tiene propiedades bactericidas, por lo que es imposible su contaminación por acción de las bacterias de la zona, al contrario de lo que ocurre con las membranas de origen orgánico. Este nuevo material no necesita membranas. Por otra parte, el sulfato y fosfato calcico tienen un precio muy económico, constituyendo un material ideal como regenerador óseo, ya que al ser reabsorbible, inorgánico, antiséptico, no tóxico y de fácil manejo, hacen de él un material extraordinario para la regeneración ósea. Leaving it untouched would proceed to suturing the surgical incision. If the material is exposed due to lack of closure of the wound, it does not offer any inconvenience, since this product acts as a barrier and also has bactericidal properties, so it is impossible to contaminate it due to the bacteria in the area, unlike what happens with the membranes of organic origin. This new material does not need membranes. On the other hand, calcium sulphate and phosphate have a very economical price, constituting an ideal material as a bone regenerator, since being reabsorbable, inorganic, antiseptic, non-toxic and easy to use, they make it an extraordinary material for bone regeneration .

Claims

REIVINDICACIONES
1.- Sustancia regeneradora de hueso, compuesta de sulfato calcico hemididratado y fosfato calcico, mezclados en diversas proporciones, para su aplicación en estomatología, traumatología y en cualquier otra especialidad médica que requiera para su desarrollo la regeneración ósea. 1.- Bone regenerating substance, composed of calcium sulphate hemididratado and calcium phosphate, mixed in various proportions, for application in stomatology, traumatology and in any other medical specialty that requires bone regeneration for its development.
PCT/ES2006/000240 2006-05-12 2006-05-12 Bone-regenerating substance composed of semi-hydrated calcium sulphate and calcium phosphate WO2007132026A1 (en)

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PCT/ES2006/000240 WO2007132026A1 (en) 2006-05-12 2006-05-12 Bone-regenerating substance composed of semi-hydrated calcium sulphate and calcium phosphate

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4619655A (en) * 1984-01-26 1986-10-28 University Of North Carolina Plaster of Paris as a bioresorbable scaffold in implants for bone repair
WO1991000252A1 (en) * 1989-06-30 1991-01-10 United States Gypsum Company Calcium sulfate hemihydrate composition having utility in the presence of blood
WO1991017722A1 (en) * 1990-05-11 1991-11-28 Lifecore Medical, Inc. Rapid setting hydroxylapatite and plaster formulation
WO2000007639A1 (en) * 1998-08-07 2000-02-17 Tissue Engineering, Inc. Bone precursor compositions
WO2000027316A1 (en) * 1998-11-06 2000-05-18 John Ricci Implantation of surgical implants with calcium sulfate
WO2002005861A1 (en) * 2000-07-17 2002-01-24 Bone Support Ab A composition for an injectable bone mineral substitute material

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4619655A (en) * 1984-01-26 1986-10-28 University Of North Carolina Plaster of Paris as a bioresorbable scaffold in implants for bone repair
WO1991000252A1 (en) * 1989-06-30 1991-01-10 United States Gypsum Company Calcium sulfate hemihydrate composition having utility in the presence of blood
WO1991017722A1 (en) * 1990-05-11 1991-11-28 Lifecore Medical, Inc. Rapid setting hydroxylapatite and plaster formulation
WO2000007639A1 (en) * 1998-08-07 2000-02-17 Tissue Engineering, Inc. Bone precursor compositions
WO2000027316A1 (en) * 1998-11-06 2000-05-18 John Ricci Implantation of surgical implants with calcium sulfate
WO2002005861A1 (en) * 2000-07-17 2002-01-24 Bone Support Ab A composition for an injectable bone mineral substitute material

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