CN104623742A - Bioactive absorbable medical strapping tape and forming method - Google Patents
Bioactive absorbable medical strapping tape and forming method Download PDFInfo
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- CN104623742A CN104623742A CN201510026866.4A CN201510026866A CN104623742A CN 104623742 A CN104623742 A CN 104623742A CN 201510026866 A CN201510026866 A CN 201510026866A CN 104623742 A CN104623742 A CN 104623742A
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Abstract
The invention relates to the field of bio-medical instruments, and in particular relates to a bioactive absorbable medical strapping tape and a forming method. The bioactive absorbable medical strapping tape is prepared by combining a biological absorbable high polymer material and bioactive ceramic or bioactive glass, wherein in percentages by weight, the biological absorbable high polymer material accounts for 70-95% of the total weight of the composite material and the bioactive ceramic or bioactive glass accounts for 5-30% of the total weight of the composite material; the biological absorbable high polymer material is selected from any one or more of polylactic acid, polycaprolactone, a polylactic acid-glycolic acid copolymer, polyglycolic acid, polyhydroxyalkanoate and polyhydroxybutyrate, and the molecular weight is 100,000-2,000,000. The medical strapping tape not only can achieve expected physical properties, mechanical properties, degradation rate, biocompatibility and osteogenesis effect, but also can relieve stress shielding, accelerate fracture healing and avoid second operation.
Description
Technical field
The present invention relates to biomedical devices field, in particular to one, there is bioactive absorbable medical strapping tape and forming method.
Background technology
Along with the arrival of aging society, senile joint disease has become the main diseases kind that human society is only second to cardiovascular disease, and corresponding hip, replacement knee in arthroplasty increase rapidly thereupon; Meanwhile, the patient populations of osteoporosis and harm brought thus also become a difficult problem for patient and doctor's facing.Easily there is fracture in art or postoperative when carrying out hip replacement in old people, femur upper segment binding is fixedly treatment and the major measure of preventing femur splitting in full hip art.
The binding apparatus mainly metal strapping strand that current application is maximum.In addition, what metal strapping strand was also widely used in osteoporotic fracture preventatively ties up, the treatment of other non-weight bearing bone oblique fractures.From materialogy development retrospect, the fixing material used of binding is around more, as steel wire bundle, silk thread, fracture with memory alloy embrace fixator, absorbable suture and titanium cable etc.
All there are some defects in above-mentioned binding fixture in the process of union of fracture.Suture strapping tape compressive stress is less, and fracture fixation is unstable, is also unfavorable for union of fracture.In addition, during steel wire parcel silly in bone, second operation takes out and very ties difficulty.The shortcoming of silk thread is that insufficient strength is large, therefore only for comparatively ossiculum block or auxiliary fixing, and mostly also want extenal fixation to protect.
Fracture with memory alloy embrace fixator obtains good result in fracture fixation, but the nickel in its constitution element is that modal contact metal allergy is former, and has clear and definite carcinogenesis.For in artificial total hip arthroplasty and postoperative Fracture of femur, and other strapping tapes fixedly have its significant advantage, but metal strapping strand compressive stress is excessive, easily causes stress shielding, is unfavorable for union of fracture.
In view of this, special proposition the present invention, to provide a kind of strapping tape more effectively helping knitting.
Summary of the invention
The first object of the present invention is to provide a kind of and novel has bioactive absorbable medical strapping tape, not only reach the physical property of expection, mechanical property, degradation speed, biocompatibility, bone-forming effect, and stress shielding, accelerating bone healing can be reduced, avoid second operation.
The second object of the present invention is to provide a kind of described forming method with bioactive absorbable medical strapping tape, and the product stability made is high, and internal stress is little.
In order to realize above-mentioned purpose of the present invention, spy by the following technical solutions:
There is bioactive absorbable medical strapping tape, be made up of biological absorbable macromolecular material and bioactive ceramics or bioactivity glass compound; According to weight percent meter, described biological absorbable macromolecular material accounts for the 70-95% of composite gross weight, and described bioactive ceramics or bioactivity glass account for the 5-30% of composite gross weight;
Described biological absorbable macromolecular material is selected from: one or more in polylactic acid, polycaprolactone, polylactic acid-co-glycolic acid, polyglycolic acid, polyhydroxyalkanoate, poly butyric ester, and its molecular weight is 10-200 ten thousand.
Based on the design defect of clinical strapping tape existence in the past, the mentality of designing of Absorbable rod strapping tape heaves in sight, but from many absorbable materials, select best material category to be very important problem.Good internal fixtion requires two aspects, one is to have enough mechanical strengths, to ensure that fracture segment is relatively stable in agglutination, two is inner fixing device healings along with fracture, lose its intensity gradually, cause retardance knitting to avoid its stress force shelter reaction, Absorbable rod strapping tape meets this 2 requirements just.
Research for many years for Medical absorbable material shows, and polylactic acid (PLA) is a kind of desirable strapping tape basic material, but its original mechanical property and biocompatibility not good enough.And hydroxyapatite (HA) is the basis of skeleton, its elastic modelling quantity is close to natural bone, there is good biological activity and biocompatibility, and increasing research display nano HA is expected to become more preferably bone tissue engineering stent material, the nanostructured of its uniqueness makes its degradability and mechanics strengthen, and material can be made to have self-bone grafting performance further as the slow-released carrier of somatomedin.
Provided by the invention a kind ofly novel have bioactive absorbable medical strapping tape, under the requirement meeting bone internal fixtion, the mechanical property required according to different parts and the difference of degradation time, choose the biological absorbable macromolecular material of different materials, different molecular weight.Biological absorbable macromolecular material and bioactive ceramics or bioactive glass material are combined, in actual use, if the catabolite of biological absorbable macromolecular material presents acidity, bioactive ceramics or bioactive glass material not only have osteoinductive, and its catabolite presents alkalescence, weakly alkaline product can play the effect of neutralization to weakly acidic product, and because of the difference of its content, the degradation speed of adjustable composite material and local acid-base value, reduce the aseptic inflammation that material causes in degradation process.Meanwhile, bioactive ceramics or bioactive glass material, as reinforcing material, can meet clinical required tying up and fixing requirement.
Further, described bioactive ceramics or bioactivity glass are: hydroxylapatite ceramic, activated alumina hand hay cutter is beautiful, any one or multiple combination in beta-tricalcium phosphate porous ceramic or titanium dioxide.
Further, described bioactive ceramics or bioactivity glass are: hydroxylapatite ceramic or beta-tricalcium phosphate porous ceramic.
This programme utilizes the biological activity feature of the excellence of hydroxylapatite ceramic or beta-tricalcium phosphate porous ceramic, namely the short period has Ca-P layer to deposit in vivo to make designed strapping tape, and along with the prolongation of Implantation Time, make to form freshman bone tissue around implanting device, promote the healing of damaged part.
Further, described bioactive ceramics or bioactivity glass are the powder that particle diameter is 0.5-100 μm;
Further, described bioactive ceramics or bioactivity glass are dusty material, and its particle diameter is the powder of 10-20 μm.
Further, according to weight percent meter, described biological absorbable macromolecular material accounts for the 80-90% of composite gross weight, and described bioactive ceramics or bioactivity glass account for the 10-20% of composite gross weight.
The present invention also provides a kind of forming method with bioactive absorbable medical strapping tape, comprises the following steps:
(1) appropriate described biological absorbable macromolecular material and bioactive ceramics or bioactivity glass is got according to described percentage by weight;
(2) the described material obtained is obtained homodisperse composite by liquid phase adsorption method or powder planet stirring method;
(3) by described composite at 50-240 DEG C after thermoplastification, adopt hot compression molding method, shearing forming method, or injection molding forming method obtain required profile, structure, size there is bioactive absorbable medical strapping tape.
Further, described hot-press molding method is specially: add in mould by the composite after thermoplastification, 50-240 DEG C, carry out hot moulding under 0.1-50MPa condition, obtained required profile, structure, size there is bioactive absorbable medical strapping tape.Wherein, range of pressure values the best is 6-30MPa.
Further, described shearing forming method is: first use the method for hot moulding that composite is processed into flat board under 50-240 DEG C, 0.1-50MPa pressure condition; Then under room temperature state punching press cut into required profile, structure, size there is bioactive absorbable medical strapping tape.Preferably, optimal pressure range is 6-30MPa.
Further, described injection molding forming method is: by composite by injection moulding machine, inject at 100-240 DEG C the obtained required profile of difform mould, structure, size there is bioactive absorbable medical strapping tape.
The various different profile that forming method provided by the invention obtains, structure, size there is bioactive absorbable medical strapping tape, its machine-shaping device is simple, be easy to molding, low production cost, be easy to batch production.
Compared with prior art, beneficial effect of the present invention is:
(1) there is good biocompatibility and controlled degradation.The present invention is fully in conjunction with the advantage of degradable high polymer material and surface modification, need to come the composition of choice and optimization macromolecular material, molecular size range and surface reforming layer according to rigid strapping tape for medical use, control the degradation process that it is early stage, ensure the excellent mechanical property of rigid strapping tape for medical use, phase rigid strapping tape for medical use can degraded fast and safely after degradation.
(2) stress-shielding effect can be avoided.Relative conventional medical strapping tape, degradable high polymer material has the density close with people's bone and elastic modelling quantity.The density of degradable high polymer material is 1.70g/cm
3left and right, with the Compact bone density (1.75g/cm of people's bone
3) very close; The elastic modelling quantity of degradable high polymer material is about 25GPa, close to elastic modelling quantity about the 20GPa of people's bone, stress shielding can be avoided to imitate as rigid strapping tape for medical use.
(3) can constant intensity required for fracture healing process, progressively degrade, make bone remodeling at a specified future date more excellent, avoid the fracture osteoporotic defect in local around.
(4) composite can progressively be degraded, and avoids second operation and takes out, decrease the misery that patient performs the operation again, also greatly alleviate the medical burden of patient and society.
(5) machine-shaping device simple, be easy to molding, low production cost, be easy to batch production, and the product stability made is high, and internal stress is little, in use not easy fracture and cracking.
Accompanying drawing explanation
In order to be illustrated more clearly in the embodiment of the present invention or technical scheme of the prior art, be briefly described to the accompanying drawing used required in embodiment or description of the prior art below.
Fig. 1 is an embodiment schematic diagram with bioactive absorbable medical strapping tape provided by the invention;
Picture group 2 is osteoblast a kind of absorbable medical strapping tape growing states designed by the present invention; Wherein Fig. 2 (A) the 1st day growing state, Fig. 2 (B) the 3rd day growing state, Fig. 2 (C) the 7th day growth situation map; Fig. 2 (D) the 10th day growing state; Fig. 2 (E), 2 (F) the 14th day growing state.
Detailed description of the invention
Below in conjunction with embodiment, embodiment of the present invention are described in detail, but it will be understood to those of skill in the art that the following example only for illustration of the present invention, and should not be considered as limiting the scope of the invention.Unreceipted actual conditions person in embodiment, the condition of conveniently conditioned disjunction manufacturer suggestion is carried out.Agents useful for same or the unreceipted production firm person of instrument, be and can buy by commercially available the conventional products obtained.
As shown in Figure 1, there is bioactive absorbable medical strapping tape, be made up of biological absorbable macromolecular material and bioactive ceramics or bioactivity glass compound; According to weight percent meter, described biological absorbable macromolecular material accounts for the 70-95% of composite gross weight, and described bioactive ceramics or bioactivity glass account for the 5-30% of composite gross weight;
Described biological absorbable macromolecular material is selected from: one or more in polylactic acid, polycaprolactone, polylactic acid-co-glycolic acid, polyglycolic acid, polyhydroxyalkanoate, poly butyric ester, and its molecular weight is 10-200 ten thousand.
Preferably, described bioactive ceramics or bioactivity glass are: hydroxylapatite ceramic, activated alumina hand hay cutter is beautiful, any one or multiple combination in beta-tricalcium phosphate porous ceramic or titanium dioxide.
Preferably, described bioactive ceramics or bioactivity glass are: hydroxylapatite ceramic or beta-tricalcium phosphate porous ceramic.
This programme utilizes the biological activity feature of the excellence of hydroxylapatite ceramic or beta-tricalcium phosphate porous ceramic, namely the short period has Ca-P layer to deposit in vivo to make designed strapping tape, and along with the prolongation of Implantation Time, make to form freshman bone tissue around implanting device, promote the healing of damaged part.
Preferably, described bioactive ceramics or bioactivity glass are the powder that particle diameter is 0.5-100 μm;
Preferably, described bioactive ceramics or bioactivity glass are dusty material, and its particle diameter is the powder of 10-20 μm.
Preferably, according to weight percent meter, described biological absorbable macromolecular material accounts for the 80-90% of composite gross weight, and described bioactive ceramics or bioactivity glass account for the 10-20% of composite gross weight.
Based on the design defect of clinical strapping tape existence in the past, the mentality of designing of Absorbable rod strapping tape heaves in sight, but from many absorbable materials, select best material category to be very important problem.Good internal fixtion requires two aspects, one is to have enough mechanical strengths, to ensure that fracture segment is relatively stable in agglutination, two is inner fixing device healings along with fracture, lose its intensity gradually, cause retardance knitting to avoid its stress force shelter reaction, Absorbable rod strapping tape meets this 2 requirements just.
Research for many years for Medical absorbable material shows, and polylactic acid (PLA) is a kind of desirable strapping tape basic material, but its original mechanical property and biocompatibility not good enough.And hydroxyapatite (HA) is the basis of skeleton, its elastic modelling quantity is close to natural bone, there is good biological activity and biocompatibility, and increasing research display nano HA is expected to become more preferably bone tissue engineering stent material, the nanostructured of its uniqueness makes its degradability and mechanics strengthen, and material can be made to have self-bone grafting performance further as the slow-released carrier of somatomedin.
Provided by the invention a kind ofly novel have bioactive absorbable medical strapping tape, under the requirement meeting bone internal fixtion, the mechanical property required according to different parts and the difference of degradation time, choose the biological absorbable macromolecular material of different materials, different molecular weight.Biological absorbable macromolecular material and bioactive ceramics or bioactive glass material are combined, in actual use, if the catabolite of biological absorbable macromolecular material presents acidity, bioactive ceramics or bioactive glass material not only have osteoinductive, and its catabolite presents alkalescence, weakly alkaline product can play the effect of neutralization to weakly acidic product, and because of the difference of its content, the degradation speed of adjustable composite material and local acid-base value, reduce the aseptic inflammation that material causes in degradation process.Meanwhile, bioactive ceramics or bioactive glass material, as reinforcing material, can meet clinical required tying up and fixing requirement.
The present invention also provides a kind of forming method with bioactive absorbable medical strapping tape, comprises the following steps:
(1) appropriate described biological absorbable macromolecular material and bioactive ceramics or bioactivity glass is got according to described percentage by weight;
(2) the described material obtained is obtained homodisperse composite by liquid phase adsorption method or powder planet stirring method;
(3) described composite after thermoplastification, adopt hot compression molding method, shearing forming method, or injection molding forming method is obtained the described blade plate of required profile and structure at 50-240 DEG C.
Preferably, described hot-press molding method specifically comprises: add in mould by the composite after thermoplastification, 50-240 DEG C, carry out hot moulding under 0.1-50MPa condition, the adsorbable bone internal fixtion implanting device with biological activity, shaping of obtained required profile and structure.Wherein, range of pressure values the best is 6-30MPa.
Preferably, described shearing forming method comprises: first use the method for hot moulding that composite is processed into flat board under 50-240 DEG C, 0.1-50MPa pressure condition; Then under room temperature state, punching press cuts into the adsorbable bone internal fixtion implanting device with biological activity shaping of various shape.Preferably, optimal pressure range is 6-30MPa.
Preferably, described injection molding forming method comprises: by composite by injection moulding machine, injects the obtained adsorbable bone internal fixtion implanting device with biological activity shaping of various difform mould at 100-240 DEG C.
Not only technique is simple for forming method provided by the invention, cost is low, and the product stability made is high, and internal stress is little, in use not easy fracture and cracking.
Picture group 2 is osteoblast a kind of absorbable medical strapping tape growing states designed by the present invention; Wherein Fig. 2 (A) the 1st day growing state, Fig. 2 (B) the 3rd day growing state, Fig. 2 (C) the 7th day growth situation map; Fig. 2 (D) the 10th day growing state; Fig. 2 (E), 2 (F) the 14th day growing state.
Embodiment 1
There is bioactive absorbable medical strapping tape: be made up of polylactic acid (PLA) and hydroxyapatite (HA) compound, the molecular weight of polylactic acid (PLA) is 10-20 ten thousand, the granularity of hydroxyapatite (HA) is 0.5 μm, according to weight percent meter, the total amount of polylactic acid (PLA) accounts for 90% of composite gross weight, and hydroxyapatite (HA) accounts for 10% of composite gross weight.
The above-mentioned forming method with bioactive absorbable medical strapping tape, comprises the following steps:
(1) appropriate described polylactic acid (PLA) and hydroxyapatite (HA) is got according to described percentage by weight;
(2) the described material obtained is obtained homodisperse composite by liquid phase adsorption method;
(3) at 80 DEG C, after thermoplastification, shearing forming method is adopted to obtain the described strapping tape of required profile and structure in described composite.
Wherein, described shearing forming method comprises: first use the method for hot moulding that composite is processed into flat board under 80-90 DEG C, 12-14MPa pressure condition; Then under room temperature state punching press cut into various shape there is bioactive absorbable medical strapping tape.
The absorbable medical strapping tape provided by the present embodiment soaks 7 days in simulated body fluid, and surface has Ca-P layer to deposit, and illustrates that this strapping tape has good biological activity.When implanting in animal body latter 1 month, around absorbable medical strapping tape, have a large amount of cambiums to surround, and around titanium alloy strapping tape, cambium is relatively less, thus also demonstrates the biological activity that this absorbable medical strapping tape has excellence.
Embodiment 2
There is bioactive absorbable medical strapping tape: by Poly(D,L-lactide-co-glycolide (PLGA), polyglycolic acid (PGA), make with beta-tricalcium phosphate porous ceramic (β-TCP) compound, Poly(D,L-lactide-co-glycolide (PLGA), the molecular weight of polyglycolic acid (PGA) is 80-150 ten thousand, the granularity of beta-tricalcium phosphate porous ceramic (β-TCP) is 10-13 μm, according to weight percent meter, Poly(D,L-lactide-co-glycolide (PLGA), the total amount of polyglycolic acid (PGA) accounts for 70% of composite gross weight, beta-tricalcium phosphate porous ceramic (β-TCP) accounts for 30% of composite gross weight.
The above-mentioned forming method with bioactive absorbable medical strapping tape, comprises the following steps:
(1) appropriate described Poly(D,L-lactide-co-glycolide (PLGA), polyglycolic acid (PGA) and beta-tricalcium phosphate porous ceramic (β-TCP) is got according to described percentage by weight;
(2) the described material obtained is obtained homodisperse composite by powder planet stirring method;
(3) at 100-120 DEG C, after thermoplastification, injection molding forming method is adopted to obtain absorbable medical strapping tape in described composite.
Wherein, described injection molding forming method comprises: by composite by injection moulding machine, injects that various difform mould is obtained has bioactive Absorbable rod strapping tape at 150-160 DEG C.
The absorbable medical strapping tape provided by the present embodiment soaks 7 days in simulated body fluid, and surface has Ca-P layer to deposit, and illustrates that this strapping tape has good biological activity.When implanting in animal body latter 1 month, around absorbable medical strapping tape, have a large amount of cambiums to surround, and around titanium alloy strapping tape, cambium is relatively less, thus also demonstrates the biological activity that this absorbable medical strapping tape has excellence.
Although illustrate and describe the present invention with specific embodiment, however it will be appreciated that can to make when not deviating from the spirit and scope of the present invention many other change and amendment.Therefore, this means to comprise all such changes and modifications belonged in the scope of the invention in the following claims.
Claims (10)
1. there is bioactive absorbable medical strapping tape, it is characterized in that, be made up of biological absorbable macromolecular material and bioactive ceramics or bioactivity glass compound; According to weight percent meter, described biological absorbable macromolecular material accounts for the 70-95% of composite gross weight, and described bioactive ceramics or bioactivity glass account for the 5-30% of composite gross weight;
Described biological absorbable macromolecular material is selected from: one or more in polylactic acid, polycaprolactone, polylactic acid-co-glycolic acid, polyglycolic acid, polyhydroxyalkanoate, poly butyric ester, and its molecular weight is 10-200 ten thousand.
2. according to claim 1 have bioactive absorbable medical strapping tape, and it is characterized in that, described bioactive ceramics or bioactivity glass are:
Hydroxylapatite ceramic, activated alumina hand hay cutter is beautiful, any one or multiple combination in beta-tricalcium phosphate porous ceramic or titanium dioxide.
3. according to claim 2 have bioactive absorbable medical strapping tape, it is characterized in that,
Described bioactive ceramics or bioactivity glass are: hydroxylapatite ceramic or beta-tricalcium phosphate porous ceramic.
4. according to any one of claim 1-3, there is bioactive absorbable medical strapping tape, it is characterized in that,
Described bioactive ceramics or bioactivity glass are the powder that particle diameter is 0.5-100 μm.
5. according to claim 4 have bioactive absorbable medical strapping tape, it is characterized in that,
Described bioactive ceramics or bioactivity glass are the powder that particle diameter is 10-20 μm.
6. according to claim 1 have bioactive absorbable medical strapping tape, it is characterized in that,
According to weight percent meter, described biological absorbable macromolecular material accounts for the 80-90% of composite gross weight, and described bioactive ceramics or bioactivity glass account for the 10-20% of composite gross weight.
7. prepare the forming method with bioactive absorbable medical strapping tape described in any one of claim 1-6, it is characterized in that, comprise the following steps:
(1) appropriate described biological absorbable macromolecular material and bioactive ceramics or bioactivity glass is got according to described percentage by weight;
(2) the described material obtained is obtained homodisperse composite by liquid phase adsorption method or powder planet stirring method;
(3) by described composite at 50-240 DEG C after thermoplastification, adopt hot compression molding method, shearing forming method, or injection molding forming method obtain required profile, structure, size there is bioactive absorbable medical strapping tape.
8. the forming method with bioactive absorbable medical strapping tape according to claim 7, it is characterized in that, described hot-press molding method is specially: add in mould by the composite after thermoplastification, 50-240 DEG C, carry out hot moulding under 0.1-50MPa condition, obtained required profile, structure, size there is bioactive absorbable medical strapping tape.
9. biological activity according to claim 7, plastic, the forming method of adsorbable bone inner fixing device, it is characterized in that, described shearing forming method is: first use the method for hot moulding that composite is processed into flat board under 50-240 DEG C, 0.1-50MPa pressure condition; Then under room temperature state punching press cut into required profile, structure, size there is bioactive absorbable medical strapping tape.
10. biological activity according to claim 7, plastic, the forming method of adsorbable bone inner fixing device, is characterized in that, described injection molding forming method is:
By composite by injection moulding machine, inject at 100-240 DEG C the obtained required profile of difform mould, structure, size there is bioactive absorbable medical strapping tape.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021253479A1 (en) * | 2019-07-05 | 2021-12-23 | 周星 | Endoscopic system for tying cervix opening |
| CN116218171A (en) * | 2023-02-01 | 2023-06-06 | 成都美益博雅材料科技有限公司 | Polylactic acid composite material and preparation method and application thereof |
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| CN1820793A (en) * | 2006-01-10 | 2006-08-23 | 中国人民解放军第二军医大学 | Biological absorptive bundling belt and its shape memory lock buckle |
| CN102085397A (en) * | 2011-01-19 | 2011-06-08 | 浙江普洛家园生物医学材料有限公司 | Absorbable implant material in bone and preparation method thereof |
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- 2015-01-20 CN CN201510026866.4A patent/CN104623742A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1820793A (en) * | 2006-01-10 | 2006-08-23 | 中国人民解放军第二军医大学 | Biological absorptive bundling belt and its shape memory lock buckle |
| CN102085397A (en) * | 2011-01-19 | 2011-06-08 | 浙江普洛家园生物医学材料有限公司 | Absorbable implant material in bone and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2021253479A1 (en) * | 2019-07-05 | 2021-12-23 | 周星 | Endoscopic system for tying cervix opening |
| CN116218171A (en) * | 2023-02-01 | 2023-06-06 | 成都美益博雅材料科技有限公司 | Polylactic acid composite material and preparation method and application thereof |
| CN116218171B (en) * | 2023-02-01 | 2024-02-27 | 成都美益博雅材料科技有限公司 | Polylactic acid composite material and preparation method and application thereof |
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