CN1371664A - Multi-layer structured artificial ligament with external covered biological film - Google Patents
Multi-layer structured artificial ligament with external covered biological film Download PDFInfo
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- CN1371664A CN1371664A CN 01105502 CN01105502A CN1371664A CN 1371664 A CN1371664 A CN 1371664A CN 01105502 CN01105502 CN 01105502 CN 01105502 A CN01105502 A CN 01105502A CN 1371664 A CN1371664 A CN 1371664A
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Abstract
The biological membrane covered multi-layer artififical ligament includes at least one layer of woven structure made of cord-like polyester material, at least one layer of cross structure formed from cross-connected polyester fibres with different length and angle, at least one layer of felt-like structure made of porous polyester material and at least one layer of biological membrane. The described ligament is a tubular structure, and possesses high tensile strength and viscoelasticity, and is favourable for tissue growht and can reduce tissue rejection.
Description
The present invention relates to the outer biomembranous multiple structure artificial ligament that covers.
Adopting ideal biomaterial reparation is the important topic of medical science and technical field of biological material because of the ligament due to the wound and tendon are damaged.At present, the research direction of external a few class artificial ligaments mainly concentrates on aspects such as polyester material and carbon fiber.In addition, domestic have people's Crinis Carbonisatus material on probation to manufacture experimently artificial ligament.
Though polyester material has better biocompatibility and good intensity, still has small number of patients that it rejection occurred, and it still has certain gap with the human body ligament aspect biomechanics.Carbon fiber is then more crisp, and easy fracture, carbon dust can deposit to intraarticular or be absorbed into lymph node and cause untoward reaction such as aseptic inflammation.
In view of above-mentioned problems of the prior art, the objective of the invention is to utilize the material behavior of polyester material, by improving braiding and combined method, provide by having that polyester material constitutes than high-tensile and viscoelastic power, be beneficial to tissue and grow into, and can reduce tissue rejection reaction cover biomembranous multiple structure artificial ligament outward.
Covering biomembranous multiple structure artificial ligament outside of the present invention is tubular structure, comprise at least 1 layer of strand polyester material braiding structure from inside to outside, the chi structure that the polyester fiber of at least 1 layer of different length that connects by crossing one another and different angles is formed, at least 1 layer of polyester material felt shape structure, and at least 1 layer of biomembrane with many micropores.
Below, be specifically described covering biomembranous multiple structure artificial ligament outside of the present invention.
Strand polyester material braiding structure is because of having higher intensity to vertical tensile stress, thus mainly bear vertical tensile stress, but autologous tissue is difficult for growing into.The used polyester material of the present invention is dacron fibre (hereinafter referred to as terylene), polybutylene terephthalate (PBT) fiber etc.
The chi structure that the different length that connects by crossing one another and the polyester fiber of different angles are formed, make ligament when being subjected to different tensile stress, have the part fiber to elongate, there is the part fibre length to keep constant relatively again, keeping tension force, and has ability tensile stress.In addition, the microcellular structure that forms of fiber interconnection helps tissue and grows into.
Have micropore in the polyester material felt shape structure of many micropores and help tissue and grow into, itself also possesses certain tensile strength.
Biomembrane helps reducing the tissue rejection reaction, and better biocompatibility and tissue growth inducibility are provided.After this ligament was accepted by human body, biomembrane is degraded and absorbed voluntarily.
Aspect connected mode in this design, and the chi structure that forms of the polyester fiber interconnection of different length, different angles and felt shape structure with many micropores, make ligament have advantages of higher tensile strength, enough deal with the stress that is subjected in the daily life, meet the characteristics of human body self ligament more.And, because this ligament has viscoelastic power, so, allow ligament after elongating certain-length, still can return to normal length.In addition, multiple structure makes load disperse to have fatigue resistance preferably by artificial ligament.
In addition, the double-deck microcellular structure that the chi structure of this ligament and felt shape structure form had both helped tissue and had grown into, and had considered mechanical characteristic simultaneously again.
Above-mentioned multiple structure combines covers biomembranous multiple structure artificial ligament by improving braiding and combined method outward, has formed the kernel of novel artificial ligament, covers the biomembrane that reduces immunological rejection and has constituted the novel artificial ligament outward simultaneously.
Fig. 1 is the outer cross-sectional structure sketch map that covers the preferred example of biomembranous multiple structure artificial ligament of the present invention.
Below, describe covering biomembranous 4 layers of structure artificial ligament as preferred example of the present invention outer.
As shown in Figure 1, of the present inventionly outer cover biomembranous 4 layers of structure artificial ligament and comprise strand polyester material braiding structure as innermost layer, the chi structure of forming as the polyester fiber of the 2nd layer different length that connects by crossing one another and different angles, as the 3rd layer polyester material felt shape structure with many micropores, and as outermost biomembrane with reduction immunological rejection and induced tissue energy for growth.
Above-mentioned braiding structure, chi structure, felt shape structure and biomembranous specifying as previously mentioned.
Below, the outer polyester material felt shape structure of covering in the biomembranous multiple structure artificial ligament with many micropores of above-mentioned multiple structure is used to repair because of the ligament due to the wound and the test example of tendon injury describes.
1. Implantation Test:
1) experiment grouping: with the terylene felt, the polyester material felt shape structure that promptly has many micropores is cut into 1.0 * 0.5cm
2Behind the small pieces of size, with the gamma-rays sterilization, 20 of selection standard SD cleaning level male white rats, behind amobarbital sodium 30mg/kg intraperitoneal injection of anesthesia, lose hair or feathers with depilatory cream at field of operation, behind partly sterilised's drape, respectively 4 terylene felts are implanted the limb muscle tissue, sew up the incision.Under standard environment, raise, put to death in the 1st, 2,4,8,12 weeks respectively, 4 weekly, take out the terylene felt and carry out histological observation.
2) observational technique:
(1) histological observation: the specimen of taking out is liquid-solid fixed with neutral formalin, adopt the two embedded blocks of collodion paraffin, section, light microscopic is observed down after row HE, Masson ' s and the netted dyeing.
(2) electron microscopic observation: tissue specimen is cut into 1mm
3Size, fixing behind the osmic acid with fixing before 4% glutaraldehyde solution, dewater step by step, soak into, epoxy resin 816 embeddings, ultrathin section, plumbous uranium double staining is observed under the H500 of Hitachi transmission electron microscope.
(3) ECT observes: after every group of 2 rat are anaesthetized with amobarbital sodium by stages by grouping, inject technetium from its tail intravenous
99The M-methoxy isobutyl isonitrile (
99MTC-M1B1) 0.5 milliliter, observe the myocardial revascularization situation in the terylene felt of implanting.
2. fibroblast strain and artificial material In vitro culture
To cultivate component is terylene felt group, silica gel group and matched group.Adopt human fibroblasts strain HFL-1, with cell culture to the stable phase of growing, trypsinization, Hanks liquid cleans cell 3 times, with the cell transferred species to 6 well culture plates that contain the PRMI1640 culture fluid, simultaneously, respectively terylene felt and silica gel sheet are inserted culture hole, matched group only adds cell, in 37 ℃, in the 5%CO2 incubator, cultivate, every the growth of 24 hours observation of cell and with the situation of material adhesion, inverted phase contrast microscope is observed down.
3. biological mechanics determining
The terylene felt is cut into 1.0 * 10cm
2, 1.2 * 10cm
2, 2.0 * 4.0cm
2Vertically become 1.0 * 4.0cm after the doubling
2Size.
Adopt the silica gel tube of diameter 0.3cm to make 10cm length.
Above-mentioned two kinds of materials are carried out mechanical test under the strength tester of Tianjin, DCS-500 island, detect its mechanical strength respectively.
The result of above-mentioned test is:
1. histopathology is observed
1) 1 week after the implantation, as seen there is fibrous tissue to hold around the terylene felt in the implanting tissue, Masson ' s and netted dyeing demonstration are mainly collagen fiber and reticular fiber, more lymphocyte appears around the felt, eosinophil leucocyte and multinucleated giant cell, the fibroblast active growth forms a small amount of granulation tissue, various cells are grown to its central authorities around the terylene felt, but felt central authorities major part is " blind area ".
2) 2 weeks after the implantation, the reaction of the perienchyma of implantation terylene felt is similar to the 1st week, felt perivascular granulation tissue and various cell extend to its central authorities, the blind area obviously dwindled than the 1st week, can see blood capillary in the blind area and grow into, muscular tissue can be observed histiocyte and wraps up to the impaired muscle of periphery and engulf and repair.
3) 4 weeks after the implantation, felt central authorities blind area disappears in the muscular tissue, is filled by the fiber granulation tissue, and muscle cell and terylene felt fiber are chimeric closely, and form the collagen fiber band.
4) 8 weeks after the implantation, inflammatory cell further reduces in the granulation tissue, and the collagen fiber showed increased is arranged fine and close.
5) 12 weeks after the implantation, non-blind area exists, and inflammatory cell and hugely have a liking for cell and obviously reduce replaces the fibrous tissue of collagenzation in various degree.
Can think that from above-mentioned result of the test the rejection of intramuscular terylene felt is very little, granulation tissue growth is very fast, and the blind area disappears early, and felt is chimeric very fast with muscular tissue on every side, the collagen band early occurs.
2. transmission electron microscope observing:
1) 2 weeks after the implantation, the flesh that as seen is dispersed in unit fibrous fracture, mitochondrion degeneration swelling, reticulum dilatation, the nuclei dyeing chromaticness is deepened, the visible light and dark banded structure of muscle fiber.
2) in 4 weeks after the implantation, nucleus is complete, light and dark banded structure marshalling in the flesh unit fiber.
3) in 8 weeks after the implantation, the fibroblast collagen fiber are intensive, and the cell of parcel terylene felt silk has degeneration.
4) 12 weeks after the implantation have small artery to form in the felt of implantation, the smooth muscle fiber and the endothelial tissue of visible arterial wall have red blood cell structure in the official jargon.
Can think from above-mentioned result of the test, early stage histiocyte edema, mitochondrion and endoplasmic reticulum swelling are obvious.Along with the felt prolongation of implantation time, each organelle swelling is disappeared, and fibroblast is constantly ripe, and nuclear hyperchromatism becomes fibrocyte and generates collagen fiber.Angiogenesis is arranged in the felt.
3.ECT observe
1～2 week of postoperative, implant and to organize video picture clear around the felt, this and the early stage local inflammation cellular infiltration of damage, granulation tissue hyperplasia is active, and blood is relevant for enriching.Along with the prolongation of implanting the felt time, the video picture of felt adjacent tissue weakened more to some extent, and the inflammatory granulation tissue gradually reduces hypertrophy, is replaced by collagen fiber at last.
4. cell in vitro is cultivated and is observed:
Terylene felt group is beginning simultaneously at the bottom of culture plate and the growth of terylene felt fiber surface immediately behind the cell inoculation, 24 hour cells are covered with material surface, present the vigorous state of normal growth, and cell is big, the form rule, and refractivity is good, and is similar to matched group.And behind the silica gel group cell inoculation, begin immediately to the culture plate bottom growth, be covered with in 24 hours at the bottom of the culture plate and material surface does not have the cell growth.Have only small amounts of cells to be dispersed in after 72 hours respectively at material surface, and undergrowth, form is irregular, and cell contains a large amount of granules.
5. biological mechanics determining:
Table 1
| Index/type | ??1×10(CM) | ??1.2×10(CM) | ???2×(CM) | Silica gel tube |
| Intensity (N) | ????110.1 | ????147.4 | ????24.4 | ??105 |
| Percentage elongation (%) | ????81.9 | ????82.1 | ????89.1 | ??459.5 |
Illustrate that the terylene felt has certain intensity, and be better than silica gel tube.
Shrink because of wound or muscle are strong and to cause tendon to rupture fully, often need to pass through operative repair.Adopt ideal biomaterial reparation damaged, avoided the additional injury of drawing materials because of autologous material because of the caused ligament of wound and tendon.The invention provides by having that polyester material constitutes, be beneficial to tissue and grow into, and multiple structure outer that can reduce tissue rejection reaction covers biomembranous multiple structure artificial ligament than high-tensile and viscoelastic power.Aspect connected mode in this design, and the chi structure that forms of the polyester fiber interconnection of different length, different angles and felt shape structure with many micropores, make ligament have advantages of higher tensile strength, enough deal with the stress that is subjected in the daily life, meet the characteristics of human body self ligament more.And, because this ligament has viscoelastic power, so, allow ligament after elongating certain-length, still can return to normal length.In addition, multiple structure makes load disperse to have fatigue resistance preferably by artificial ligament.
Claims (3)
1. cover biomembranous multiple structure artificial ligament outward, it is characterized in that, described ligament is a tubular structure, comprise at least 1 layer of strand polyester material braiding structure from inside to outside, the chi structure that the polyester fiber of at least 1 layer of different length that connects by crossing one another and different angles is formed, at least 1 layer of polyester material felt shape structure, and at least 1 layer of biomembrane with many micropores.
2. cover biomembranous multiple structure artificial ligament outside as claimed in claim 1, wherein, strand polyester material braiding structure is formed by at least one fiber that is selected from dacron fibre, poly fiber etc.
3. the outer biomembranous multiple structure artificial ligament that covers as claimed in claim 1, its feature also is, described strand polyester material braiding structure is positioned at innermost layer, the chi structure that the different length that connects by crossing one another and the polyester fiber of different angles are formed is the 2nd layer, polyester material felt shape structure with many micropores is the 3rd layer, and biomembrane is an outermost layer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011055022A CN1174716C (en) | 2001-02-28 | 2001-02-28 | Multi-layer structured artificial ligament with external covered biological film |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011055022A CN1174716C (en) | 2001-02-28 | 2001-02-28 | Multi-layer structured artificial ligament with external covered biological film |
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| Publication Number | Publication Date |
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| CN1371664A true CN1371664A (en) | 2002-10-02 |
| CN1174716C CN1174716C (en) | 2004-11-10 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB011055022A Expired - Fee Related CN1174716C (en) | 2001-02-28 | 2001-02-28 | Multi-layer structured artificial ligament with external covered biological film |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488570A (en) * | 2011-11-14 | 2012-06-13 | 东华大学 | Material for artificial ligament |
| CN104146796A (en) * | 2013-05-13 | 2014-11-19 | 苏州瑞华医院有限公司 | Method for manufacturing biological film trochlea and biological film trochlea |
| CN106256332A (en) * | 2016-08-31 | 2016-12-28 | 桐庐洲济医疗器械有限公司 | Tendon braiding device is transplanted in Healing in Anterior Cruciate Ligament Reconstruction set |
| CN107106210A (en) * | 2014-12-26 | 2017-08-29 | 奥西奥有限公司 | Continuous Fiber Reinforced Biocomposite Medical Implants |
| CN107898535A (en) * | 2017-11-17 | 2018-04-13 | 上海利格泰生物科技有限公司 | It is spaced cured artificial ligament |
| US10869954B2 (en) | 2016-03-07 | 2020-12-22 | Ossio, Ltd. | Surface treated biocomposite material, medical implants comprising same and methods of treatment thereof |
| US10869708B2 (en) | 2014-09-07 | 2020-12-22 | Ossio, Ltd. | Anisotropic biocomposite material, medical implants comprising same and methods of treatment thereof |
| US11491264B2 (en) | 2016-06-27 | 2022-11-08 | Ossio Ltd. | Fiber reinforced biocomposite medical implants with high mineral content |
-
2001
- 2001-02-28 CN CNB011055022A patent/CN1174716C/en not_active Expired - Fee Related
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488570A (en) * | 2011-11-14 | 2012-06-13 | 东华大学 | Material for artificial ligament |
| CN104146796A (en) * | 2013-05-13 | 2014-11-19 | 苏州瑞华医院有限公司 | Method for manufacturing biological film trochlea and biological film trochlea |
| US10869708B2 (en) | 2014-09-07 | 2020-12-22 | Ossio, Ltd. | Anisotropic biocomposite material, medical implants comprising same and methods of treatment thereof |
| US11678923B2 (en) | 2014-09-07 | 2023-06-20 | Ossio, Ltd. | Anisotropic biocomposite material, medical implants comprising same and methods of treatment thereof |
| CN107106210A (en) * | 2014-12-26 | 2017-08-29 | 奥西奥有限公司 | Continuous Fiber Reinforced Biocomposite Medical Implants |
| US10926004B2 (en) | 2014-12-26 | 2021-02-23 | Ossio Ltd. | Continuous-fiber reinforced biocomposite medical implants |
| CN107106210B (en) * | 2014-12-26 | 2021-05-04 | 奥西奥有限公司 | Continuous fiber reinforced biocomposite medical implants |
| US11730866B2 (en) | 2014-12-26 | 2023-08-22 | Ossio, Ltd. | Continuous-fiber reinforced biocomposite medical implants |
| US10869954B2 (en) | 2016-03-07 | 2020-12-22 | Ossio, Ltd. | Surface treated biocomposite material, medical implants comprising same and methods of treatment thereof |
| US11491264B2 (en) | 2016-06-27 | 2022-11-08 | Ossio Ltd. | Fiber reinforced biocomposite medical implants with high mineral content |
| CN106256332A (en) * | 2016-08-31 | 2016-12-28 | 桐庐洲济医疗器械有限公司 | Tendon braiding device is transplanted in Healing in Anterior Cruciate Ligament Reconstruction set |
| CN107898535A (en) * | 2017-11-17 | 2018-04-13 | 上海利格泰生物科技有限公司 | It is spaced cured artificial ligament |
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| Publication number | Publication date |
|---|---|
| CN1174716C (en) | 2004-11-10 |
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