CN1446591A - Injectable solidifying on site cement with inorganic framework and application in micro traumatic treatment - Google Patents
Injectable solidifying on site cement with inorganic framework and application in micro traumatic treatment Download PDFInfo
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- CN1446591A CN1446591A CN03115250A CN03115250A CN1446591A CN 1446591 A CN1446591 A CN 1446591A CN 03115250 A CN03115250 A CN 03115250A CN 03115250 A CN03115250 A CN 03115250A CN 1446591 A CN1446591 A CN 1446591A
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- bone cement
- phosphate bone
- calcium phosphate
- injectable
- magnesium phosphate
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- 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
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- 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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/02—Surgical adhesives or cements; Adhesives for colostomy devices containing inorganic materials
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- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
Abstract
An inorganic bone cement able to be soldified in-situ by injection for treating disease with microwound features that after the substance with shielding action to X ray, inorganic bone cement powder and solidifying liquid are proportionally mixing, the mixture is injected into the pathologic vertebral body where it is solidified by itself. Its advantages are high biocompatibility, biosafety, flowability, and penetrability, and gradual degradation.
Description
Technical field
The invention belongs to the biomaterial for medical purpose field, relate to a class and be used for vertebral body and fix, improve bone cement and their application in the minimally-invasive treatment of bone tumor thereof of spinal stability.
Background technology
For collapse of vertebra, pain and neurological deficit that vertebral body unstable fracture or vertebral tumor cause, traditional treatment means is surgical operation+internal fixation, and vertebral tumor is also adopted radiotheraping method.General radiotherapy to two weeks of mitigation of pain after display result, and it is fixed to guarantee and strengthen the unstable spine that causes because of tumor destruction.The surgical operation therapy wound is big, and indication is narrow, and the postoperative complication incidence rate is up to 24%, and most above vertebra tumor patients of two joints of crossing over can not get treatment.Having the scholar to propose to adopt the percutaneous vertebral body plastic operation to reset in recent years and strengthening vertebral body is Therapeutic Method effectively, and that the percutaneous injection bone cement is filled is simple, economical, easy row.The reinforcement that the PMMA bone cement is used for vertebral body be fixed to 1999 cases reported reach examples up to a hundred, obtained tangible curative effect, still do not have severe complication and take place.But, because monomer whose easily causes cell-cytotoxic reaction in vivo, fibrous tissue growth is arranged between osseous tissue interface, form thick conjunctive tissue film, simultaneously with blood pressure drops or rising, heart rate is accelerated, and the patient still exists potential complication.
Self-curable calcium phosphate bone cement (CPC) is a kind of novel hard tissue repairing material, by solid-liquid two phase compositions, can reconcile into pastel, and is moulding arbitrarily according to defect.Its good biocompatibility, under the environment of human body and temperature conditions, solidify voluntarily, progressively be organized and absorb and generation bone regeneration effect, can stimulation of bone growth, its composition finally is converted into hydroxyapatite (hydroxyapatite HAP), it is too fast to have overcome tricalcium phosphate pottery absorption degraded, the shortcoming that the HAP pottery can't absorb, clinical application effect aspect the filling treatment of the filling reparation of defect of human body bone and root canal is satisfactory, can be widely used in orthopaedics, field such as the plastic surgery and the department of stomatology (Liu C Set al., J.Endodontics, 1997,23 (4): 490～3).
(Magnesium Phosphate Bone Cement MPC) have with the similar character of calcium phosphate bone cement, and its rate of set is faster, early strength is higher, and volume microdilatancy during curing can combine more closely with implant site for the magnesium phosphate bone cement.This class material safety is nontoxic, can not cause the significant change of metaboilic level after implanting, and does not occur tangible inflammatory cell at the interface and assembles and fibrous membrane, does not cause foreign body reaction, has degradability, and hydrated product is the biological Ore of ammonium magnesium phosphate and so on.For the research of MPC, mainly concentrate on the construction material aspect both at home and abroad, be generally used for robbing repair roads, public utility such as airfield runway, harbour, as the research of biomaterial, fragmentary report is only arranged, both at home and abroad as tooth cement (Hirano, et al., JP04352706,1992.).
Before calcium phosphate bone cement and magnesium phosphate bone cement solidified, the flowability of slurry and permeability were better than PMMA, can be penetrated into better in the tissue, are full of the hole, chamber.Its setting time is controlled, and the flow regime steady change of slurry in the solidification process can guarantee operating time of doctor, it is low to have viscosity, the advantage of good fluidity, and the flow resistance of slurry is little in the injection process, thereby operability is stronger, is convenient to material is injected in the vertebral body.Also can control rate of heat release in the solidification process for the magnesium phosphate bone cement, to satisfy different clinical instructions for uses by regulating magnesian activity.The combination of " moulding arbitrarily, curing voluntarily, bio-compatible, progressively degraded " characteristic, make these two kinds of inorganic-bone cements overcome the defective of PMMA biocompatibility and biological safety difference, and can reach the effect of fixed-point injection, in-situ solidifying, be expected to hinder in the treatment and obtain extensive use in the Wicresoft of vertebral body molding and bone tumor.
For benign bone tumor, bone in children tumor particularly, conventional Therapeutic Method is that incision, elimination or bone are transplanted.The minimally-invasive treatment method of Cai Yonging is to bone tumor place injection hormone in recent years, though can fix, kills bone tumor, does not have bone to transplant step.To the inorganic-bone cement that the injection of bone tumor position is slowly degraded, can reach and fill the purpose of repairing, and diseased region is had the reinforcement fixation, slowly the material of degraded plays the support effect in addition, the formation of bootable new bone, this is that the PMMA bone cement is incomparable.By the slow degraded in vivo of control inorganic-bone cement, can form occupy-place at the green bone tumor locus, be helpful to the relapse rate that reduces tumor.If further adopt medicine control tumor recurrence, can make the compound antitumor drug of CPC or MPC reach the long-time slow release of high local concentrations, improve curative effect and reduce toxic and side effects.
1987, Galibert etc. at first report percutaneous injection bone cement treatment vertebral body hemangioma obtained the effect that attracts people's attention (Galibert P., Neurochirurgie, 1987,33:166-68).Because the strong exothermicity of PMMA solidification process, the surrounding tissue of can burning is so PMMA can not use the compression fracture of vertabral body that causes because of osteoporosis or wound.Inject calcium phosphate and magnesium phosphate bone cement by means of the percutaneous vertebral body plastic operation and realize the purpose of repairing and treating by non-infringement or Wicresoft's mode of hindering, broken through the limitation of traditional treatment means, overcome the deficiency of using PMMA, reduce doctor's operation technique difficulty, improve success rate of operation, reduce medical tangle; For the patient, operation wound is little, complication is few, and nursing is convenient, effectively the alleviating pain symptom, suppress pathological changes, improve the quality of living, prolong life span, improve the treatment level of vertebral body pathological changes, have great clinical use value and wide application prospect, have bright development prospect as a kind of minimally-invasive treatment means.
But present widely used calcium phosphate bone cement and magnesium phosphate bone cement have bigger blindness when fixed-point injection, and injection position can't accurately be located, and has influenced therapeutic effect.
Summary of the invention
The technical issues that need to address of the present invention are to disclose a kind of Injectable in-situ to solidify inorganic-bone cement and the application in minimally-invasive treatment thereof, Injectable in-situ of the present invention solidifies inorganic-bone cement and can be injected in the vertebral body exactly by means of the percutaneous vertebral body plastic operation, alleviate the pain that the vertebral body pathological changes causes and prevent subsiding of vertebral body, realize in-situ solidifying, play and strengthen fixed effect, overcome accurately location defect of current material biological safety difference and injection position, with the application of further expansion material.
Design of the present invention is such:
The material that will have a shielding action to X ray mixes with conventional in-situ solidifying inorganic-bone cement pressed powder, and be in harmonious proportion according to a certain percentage evenly with consolidation liquid, after becoming heavy-gravity pastel, be circulated in the pressure injector, assisting down of fluoroscopic guidance equipment, percutaneous puncture pathological changes vertebral body is injected pastel in the vertebral body, solidifies voluntarily in the human body environment.
It is a kind of compositions that Injectable in-situ of the present invention solidifies inorganic-bone cement, is made of with the additive that X ray is shielded effective dose calcium phosphate bone cement or magnesium phosphate bone cement.
The weight ratio of preferred calcium phosphate bone cement or magnesium phosphate bone cement and additive is:
10～40∶1
Said additive is for X ray being had the material of shielding action, as tantalum powder, tungsten powder, barium powder or their mixture etc.
Said calcium phosphate bone cement is by the blended according to a certain percentage mixture of several synthos, can be by (US5525148, US5545254) disclosed method preparation can be a kind of in calcium phosphate (α type or the β type) tetracalcium phosphate or both mixture; OCP, dalcium biphosphate, hydroxyapatite, fluor-apatite, a kind of in the calcium pyrophosphate or their mixture.
Said magnesium phosphate bone cement is to be mixed according to a certain percentage by suitable active magnesium oxide, phosphate and retarder, can prepare by (WO02/66090A1) disclosed method.Phosphate can be a kind of in Ammonium biphosphate, ammonium orthophosphate, pyrophosphate and the Quadrafos or their mixture.Retarder can be a kind of in sodium chloride, fluosilicate, borate, borate and the polyphosphate sodium or their mixture
Said magnesian activity can be used the kinetic analysis quantitatively characterizing, and recording its active variable color time of reflection is 3～20min.
Said kinetic analysis is to react the magnesium hydroxide that obtains and the difference of citric acid speed of action according to magnesium oxide in water, by means of the variable color time quantitatively characterizing of indicator in the solution.Concrete grammar is as follows: placing a certain amount of distilled water of beaker adding of water bath with thermostatic control, several 1% phenolphthalein indicator, citric acid solution, even with magnetic stirrer.Take by weighing a certain amount of magnesia powder and add in this mixed solution, immediately with manual time-keeping, the record magnesium oxide adds back to phenolphthalein and reddens the required time.
Calcium phosphate bone cement of being addressed or magnesium phosphate bone cement can be used as the carrier of medicine, and be compound with medicine, thereby realize the local long-time slow release of medicine, improves the local valid density of medicine, suppresses the growth diffusion and the bone destruction of tumor cell.
The medical material that calcium phosphate bone cement of the present invention or magnesium phosphate bone cement can be used for preparing treatment or alleviate the vertebral body pathological changes.
The calcium phosphate bone cement addressed or magnesium phosphate bone cement and consolidation liquid are in harmonious proportion evenly according to a certain percentage, after becoming heavy-gravity pastel, be circulated in the pressure injector, assisting down of fluoroscopic guidance equipment, percutaneous puncture pathological changes vertebral body, the position of pastel injection vertebral body pathological changes, in the human body environment, solidify voluntarily.Because the heat effect the when stable support of firming body, bloodstream blocking, occupy-place effect and bone cement solidify makes the stability of vertebral body improve pain relief.If solidify in the short period of time after requiring material to inject, strengthen the intensity of vertebral body, the symptom that effectively eases the pain, suggestion adopts the magnesium phosphate bone cement as filler; And requiring material little heat release in vertebral body, the operating time long time of doctor's filling injection then adopts calcium phosphate bone cement.
The consolidation liquid of being addressed is normal saline or other saline solution, and is even in the ratio and the cement mixing of solid-to-liquid ratio 2: 1～5: 1 (weight), and said other saline solution comprise aqueous phosphatic.
The big I of injected dose is implemented decisions such as the patient's of this treatment the state of an illness, age as required, is generally 2～15ml.
Calcium phosphate bone cement of the present invention or magnesium phosphate bone cement are suitable for preparing the medical material of alleviating the pain symptom that the vertebral body pathological changes causes especially;
Calcium phosphate bone cement of the present invention or magnesium phosphate bone cement are suitable for preparing the medical material of reinforcing before treatment vertebral body unstable fracture and the art especially, improve the stability of spinal column.
Calcium phosphate bone cement of the present invention or magnesium phosphate bone cement are suitable for preparing the injection for the treatment of bone tumor especially and fill the treatment medical material.
Compared with prior art, the present invention has following advantage:
Calcium phosphate bone cement and magnesium phosphate bone cement have the characteristic of " moulding arbitrarily, curing voluntarily, bio-compatible, progressively degraded ", can reach the effect of fixed-point injection, in-situ solidifying.The flow regime steady change of slurry has good flowability in the solidification process, and viscosity is low, and permeability is strong, so more convenient operation.Its biocompatibility and biological safety are better than PMMA far away, and complication is few, and within the specific limits, can change properties of materials according to the difference of clinical instructions for use, with better service in the patient.
The specific embodiment
Further illustrate content of the present invention below in conjunction with example, but these examples do not limit protection scope of the present invention.
Embodiment 1
Take by weighing calcium phosphate bone cement powder 3g, mix well with the normal saline consolidation liquid that concentration is, behind the 5min heavy-gravity liquid mixture is sucked in the 2.5ml syringe, slowly pressurization is injected and is hindered in the vertebra.This group patient 10 examples are compression fracture of vertabral body, and operating time is for hindering back 5 days.Follow up a case by regular visits to after 3-6 month and find that the material filling is satisfied, blood calcium, serium inorganic phosphorus are not seen rising, and the anterior margin of vertebral body height recovers more than 80%, does not see in half a year that hindering the vertebra height loses.
Embodiment 2
Take by weighing calcium phosphate bone cement powder 3g, mix well with the normal saline consolidation liquid, behind the 5min heavy-gravity liquid mixture is sucked in the 2.5ml syringe, slowly pressurization is injected and is hindered in the vertebra.This group patient 12 examples, male 7 examples, women 5 examples in age 20-51 year, average 36.5 years old, are compression fracture of vertabral body.Postoperative 3 all patients can be at out-of-bed activity under the waistline protection, the heavy burden activity fully of 10-12 week, and the loosening and broken nail of no inside-fixture, the excellent phenomenon of breaking, no chronic low back pain is hindered vertebra height and spinal column physiologic radian and is not had and lose.
Embodiment 3
Take by weighing the calcium-phosphate cement powder 3g that contains cyclophosphamide, mix well, during about 5min heavy-gravity mixture is sucked in the 2.5ml syringe, be injected to the place that subsides (having passed through the open reduction internal fixation) of fracture of thoracic vertebrae by puncture needle with the normal saline consolidation liquid.The patient is totally 10 examples, male 7 examples, and women 3 examples in age 26-51 year (average 34.1 years old), were followed up a case by regular visits to Falling Injury 6 examples, traffic accident wound 4 examples time 3-8 month.X line and CT sheet show: calcium phosphate bone cement can be reinforced effectively and stablize and hinder vertebra, impassivity sx or new nervous symptoms occurs, and no internal fixation failure does not have correction degree and collapse of vertebra and increases the weight of.
Embodiment 4
Take by weighing the 5g calcium phosphate powder, mix well, inject right tibia lower end non ossifying fibroma patient's lesion behind the 5min with the normal saline consolidation liquid.Postoperative 3 months, calcium phosphate bone cement and bone adhesion; In the time of 31 months, fill the position and further dwindle, the surrounding bone tissue forms, and material is progressively degraded, and has area of new bone to form.
Embodiment 5
Take by weighing magnesium phosphate bone cement powder 3g, mix well with the normal saline consolidation liquid, behind the 1min heavy-gravity liquid mixture is penetrated the angiomatous lesion of vertebral body by puncture needle from pedicle of vertebral arch, totally 37 routine patients, on average followed up a case by regular visits to 13 months, patient more than 90% is pain relieving immediately in 6-72 hour, need not re-use analgesics, has obtained the effect of good pain relieving and reinforcing vertebral body.
Embodiment 6
Take by weighing calcium-phosphate cement powder 3g, mix well, during about 5min heavy-gravity mixture is sucked in the 2.5ml syringe, slowly be injected to the angiomatous lesion of vertebral body, under perspective, observe filling agent simultaneously with venous return or filling situation with the normal saline consolidation liquid.This group patient 4 examples, male 1 example, women 3 examples at 39～65 years old age (average 51.2 years old), all have the low-back pain symptom, course of disease 1-17 (average 5.3 years).4 example operations are all succeeded, and patient's postoperative pain obviously alleviates or disappears.12 hours out-of-bed activities of case 1,2,4 postoperatives are also left hospital; The aggravation of aching of about 6 hours waists of case 3 postoperatives, pain obviously alleviated and out-of-bed activity in 12 hours, and the 3rd day pain of postoperative disappears substantially and leaves hospital.
Claims (10)
1. an Injectable in-situ solidifies inorganic-bone cement, it is characterized in that being made of with the additive that X ray is shielded effective dose calcium phosphate bone cement or magnesium phosphate bone cement.
2. Injectable in-situ according to claim 1 solidifies inorganic-bone cement, it is characterized in that the weight ratio of calcium phosphate bone cement or magnesium phosphate bone cement and additive is:
10～40∶1
3. Injectable in-situ according to claim 1 solidifies inorganic-bone cement, it is characterized in that said additive is tantalum powder, tungsten powder, barium powder and composition thereof.
4. Injectable in-situ according to claim 2 solidifies inorganic-bone cement, it is characterized in that said additive is tantalum powder, tungsten powder, barium powder and composition thereof.
5. Injectable in-situ according to claim 1 solidifies inorganic-bone cement, and the component of said magnesium phosphate bone cement comprises magnesium oxide, phosphate and retarder, it is characterized in that, the magnesian active variable color time of being adopted is 3～20min.
6. one kind is the medicinal composition of pharmaceutical carrier with each described calcium phosphate bone cement of claim 1～5 or magnesium phosphate bone cement.
7. each described calcium phosphate bone cement of claim 1～5 or the magnesium phosphate bone cement application in the medical material of preparation treatment or alleviation vertebral body pathological changes.
8. each described calcium phosphate bone cement of claim 1～5 or the magnesium phosphate bone cement application in the medical material of the pain symptom that preparation alleviation vertebral body pathological changes causes.
9. each described calcium phosphate bone cement of claim 1～5 or magnesium phosphate bone cement are preparing the application for the treatment of in the medical material of reinforcing before vertebral body unstable fracture and the art.
10. each described calcium phosphate bone cement of claim 1～5 or magnesium phosphate bone cement are filled the application for the treatment of in the medical material in the injection of preparation treatment bone tumor.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB031152503A CN1192803C (en) | 2003-01-29 | 2003-01-29 | Injectable solidifying on site cement with inorganic framework and application in micro traumatic treatment |
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| CNB031152503A CN1192803C (en) | 2003-01-29 | 2003-01-29 | Injectable solidifying on site cement with inorganic framework and application in micro traumatic treatment |
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| CN1446591A true CN1446591A (en) | 2003-10-08 |
| CN1192803C CN1192803C (en) | 2005-03-16 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100438928C (en) * | 2005-09-02 | 2008-12-03 | 南方医院 | Injection type tissue engineering bone renovation material and construct method thereof |
| CN102908662A (en) * | 2011-07-27 | 2013-02-06 | 赫罗伊斯医疗有限责任公司 | Kit and method for producing bone cement |
| CN108392673A (en) * | 2018-02-26 | 2018-08-14 | 南昌大学 | A kind of borosilicate bio-vitric/magnesium phosphate composite bone cement and its bone holder low temperature 3D printing method |
-
2003
- 2003-01-29 CN CNB031152503A patent/CN1192803C/en not_active Expired - Fee Related
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100438928C (en) * | 2005-09-02 | 2008-12-03 | 南方医院 | Injection type tissue engineering bone renovation material and construct method thereof |
| CN102908662A (en) * | 2011-07-27 | 2013-02-06 | 赫罗伊斯医疗有限责任公司 | Kit and method for producing bone cement |
| US8865777B2 (en) | 2011-07-27 | 2014-10-21 | Heraeus Medical Gmbh | Kit and method for producing bone cement |
| CN102908662B (en) * | 2011-07-27 | 2016-01-20 | 赫罗伊斯医疗有限责任公司 | Produce test kit and the method for bone cement |
| CN108392673A (en) * | 2018-02-26 | 2018-08-14 | 南昌大学 | A kind of borosilicate bio-vitric/magnesium phosphate composite bone cement and its bone holder low temperature 3D printing method |
| CN108392673B (en) * | 2018-02-26 | 2021-07-06 | 南昌大学 | Borosilicate bioglass/magnesium phosphate composite bone cement and low-temperature 3D printing method of bone scaffold thereof |
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| Publication number | Publication date |
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| CN1192803C (en) | 2005-03-16 |
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