CN102772271B - Self-retaining tissue patch - Google Patents
Self-retaining tissue patch Download PDFInfo
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- CN102772271B CN102772271B CN201210238399.8A CN201210238399A CN102772271B CN 102772271 B CN102772271 B CN 102772271B CN 201210238399 A CN201210238399 A CN 201210238399A CN 102772271 B CN102772271 B CN 102772271B
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Abstract
The present invention relates to a kind of self-retaining tissue patch, it degradation material hook side layer comprising polypropylene material wire side layer and be fixed on described polypropylene material wire side layer lower surface.Self-retaining tissue patch of the present invention is a kind of real no-station pole canopy tissue patch, and the polypropylene wire side on upper strata is for repairing defect or weak area, and the function that degradable hook side has location and prevents sticking patch from sliding.When operation technique, self-retaining tissue patch can fully launch, and avoids sewing up fixing, and saves operating time, alleviates the slight illness of patient.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments, in particular, the present invention relates to a kind of self-retaining tissue patch of repair of inguinal hernia clinically.
Background technology
Hernia refers to that internal organs have left original position, enters another position by the weak spot of human body or defect, hole.The position that hernia the most often occurs is abdominal part.In abdomen internal organs by the congenital or posteriority defect of stomach wall or weak area outstanding to body surface, being partially formed a lump, be called abdominal external hernia.In abdomen internal organs or nethike embrane through the normal or abnormal duct of intraperitoneal, crack leaves original position and namely forms internal abdominal hernia, can not be inspection finding, such as hernia of foramen of Winslow, diaphragmatocele etc.Abdominal external hernia is common far beyond internal abdominal hernia.Abdominal external hernia is one of modal disease of abdominal surgery, often with the name of the outstanding region of anatomy, wherein the highest with inguinal hernia incidence rate, accounts for more than 90%.Abdominal external hernia is a kind of multiple diseases, all may occur, and elderly men is the group of people at high risk of this disease child to old all age brackets.The cause of disease of abdominal external hernia increases relevant with stomach wall weakness and intra-abdominal pressure.Stomach wall weakness is generally geneogenous, also may be caused by acquired disposition, as old, amyotrophy etc.The common situations that intra-abdominal pressure increases has chronic cough, constipation, dysuria and child cry etc.Though abdominal external hernia is not fatal disease, it can bring very large misery to patient, has a strong impact on quality of life, and can have multiple complications, can threat to life time serious.
At present, abdominal external hernia treatment goldstandard is row " tension-free hernioplasty ".Namely in operating mode, the patching material with given shape or structure is implanted stomach wall, by stimulating the body fibrosed tissue that hypertrophy is a large amount of on patching material fast, repairing and strengthening the tissue of defect, finally reaching the object of radical cure abdominal external hernia.
Net implanted by polypropylene is current application tension-free hernia material the most widely.It is a kind of can the netted fabric of polypropylene monofilament of Permanent implantation human body, adopt warp knitting braiding also to process through series of formed.The advantage of propene polymer patch: stimulate proliferation of fibrous tissue effect obvious; Ability is infected; There is higher tensile strength; Price is relatively cheap.In in the past 60 years, polypropylene mesh produces tremendous influence to surgical field, because there being it, life is extended countless patients, many surgery knotty problems solve because of its application, it has been proved to be the most popular implant of current surgery, and however, polypropylene net also exists some problems in the application: the surface ratio of mesh sheet is more coarse, when repairing for stomach wall full-thickness defects, with internal organs adhesion; When carrying out large abdominal defect repairing, the cicatricial contraction in later stage can cause mesh sheet distortion, and its irregular surface may stimulate and damaging surrounding tissue, causes infection and skin tunnel.
The material of current sticking patch requires more lightweight, and under the prerequisite keeping enough tension stress intensity, lighter sticking patch has more comfortable patient's sensation and better compliance; The mesh requirements of polypropylene mesh is enough large to reduce the chance that infects and to provide better compliance, and these 2 mainly make foreign body sensation less, and supervisor feels more comfortable.The research of absorbable material is important developing direction, every material putting into human body, so long as not requiring permanent support thing, should be that absorbable material is made.Absorbable hernia patching material mainly contains polyglycolic acid (polyglycolic acid (Dexon)), polylactic-co-glycolic acid (polyglactin (Vicryl)) two kinds of Absorbable rod mesh sheet at Clinical practice, and its complete soak time is 3 months.But it is found that in actual applications, because Dexon and Vicryl can not stimulate enough proliferations of fibrous tissue, after absorption, often again form abdominal hernia at repairing position.Therefore, this bi-material is repaired still immature for abdominal-wall defect.
U.S. Metabolix in 1992 with reproducible starch, fiber for raw material, gene engineering technique is adopted to be implemented in E.Coli by the multiple enzyme such as PHA, P34HB needed for biosynthesis PHA, reproducible carbon source is converted into poly-hydroxyl macromolecular compound in bacterial body, extract the PHA of different component in a wet process, successfully develop forth generation PHA biological plastics-poly 3-hydroxy butyrate 4 hydroxybutyric acid ester.Tepha company has carried out special later stage applied research to this material, and in February, 2007, the operation suture thread be made up of P34HB obtains the approval of U.S. FDA.But poor heat stability, the hot strength of P34HB material are low, processability is poor, if not in addition modification can not use as hernia patch.
Polylactic acid has excellent physical and mechanical properties, the same with other all macromolecule, and molecular size range, distribution, the performance of crystallinity to polylactic acid (Poly Lactic Acid, PLA) have a significant impact.Because polylactic acid exists optical isomer, it is also the key factor to Effect on Mechanical Properties.Another characteristic of polylactic acid material can be processed with various ways, and as extruded, spinning, biaxial stretch-formed, course of processing Middle molecule orientation not only significantly can increase mechanical strength, makes degradation time slack-off simultaneously.Although polylactic acid has the advantages such as excellent biocompatibility, biodegradability, it limits its practical application there is following defect in nature: 1) having a large amount of ester bonds in polylactic acid, is lyophobic dust, reduces its biocompatibility; 2) degradation cycle is difficult to control; Meanwhile, some special Functional Requirements are also had in actual applications.This all impels the modification of people to poly-lactic acid material to launch deep research.
Summary of the invention
In order to solve the above-mentioned technical problem existed in prior art, the object of the present invention is to provide a kind of self-retaining tissue patch, by composite braided, reduce foreign body implantation amount and avoid sewing up and fix, can not only Efficient software patching defect, and significantly reduce the pain of patient.
Realize foregoing invention object to solve the problems of the technologies described above, the present invention by the following technical solutions:
A kind of self-retaining tissue patch, it degradation material hook side layer comprising wire side layer and be fixed on described wire side layer lower surface.
Wherein, described wire side layer is polypropylene material wire side layer.
Wherein, described degradation material is the blend of poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer (P34HB) and polylactic acid (PLA), and the number-average molecular weight of wherein said polylactic acid is 9-15 × 10
4, the content of polylactic acid is 75-90wt% in the blend; The number-average molecular weight of described poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer is 25-40 × 10
4, content is in the blend 10-25wt%, and wherein the molar content of poly-4 hydroxybutyric acid ester is 40% in the copolymer.
Wherein, the number-average molecular weight of described polylactic acid is 9-12 × 10
4, the content of polylactic acid is 75-85wt% in the blend, and the number-average molecular weight of described poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer is 25-35 × 10
4, content is in the blend 15-25wt%.
Wherein, the number-average molecular weight of described polylactic acid is 10 × 10
4, the content of polylactic acid is 80wt% in the blend, and the number-average molecular weight of described poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer is 30 × 10
4, content is in the blend 20wt%.
Wherein, be describedly fixed as bonding, welding or sew up.
Wherein, the shape of described polypropylene material wire side layer is circular, oval or Long Circle.
Wherein, described hook side layer comprises the barbed ditch composition of a large amount of tool, and little hook direction is consistent, length is identical.
Compared with prior art, the present invention has the following advantages:
(1) self-retaining tissue patch of the present invention is a kind of real no-station pole canopy tissue patch, and the polypropylene wire side on upper strata is for repairing defect or weak area, and the function that degradable hook side has location and prevents sticking patch from sliding.When operation technique, self-retaining hernia patch can fully launch, and avoids sewing up fixing, and saves operating time, alleviates the slight illness of patient.
(2) the present invention uses by gathering (3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer to number-average molecular weight is 9-15 × 10
4polylactic acid carry out intermingling material that blending and modifying obtains as hook side layer.When the number-average molecular weight of polylactic acid is lower than 9 × 10
4time, during as hook side layer, the intensity of polylactic acid is often inadequate, and when the number-average molecular weight of polylactic acid is higher than 15 × 10
4time, the ester bond quantity in polylactic acid is large, and biocompatibility reduces, and is not suitable for the hook side layer as degrading; But research also finds that number-average molecular weight is 9-15 × 10 simultaneously
4polylactic acid degradation cycle be difficult to control, nor enough proliferations of fibrous tissue can have been stimulated.The present inventor is devoted to carry out modification to polylactic acid for this reason, and inventor finds when utilizing number-average molecular weight for 25-40 × 10
4plasticity P34HB when carrying out blending and modifying, when the content of P34HB is when 10-25wt%, can dissolving each other completely, it is good to obtain pliability, the intermingling material that non-deformability is stronger, and research also finds the modification intermingling material not only good mechanical properties that the content of the poly-4 hydroxybutyric acid ester of working as in copolymer obtains when being 40%, zoopery shows, by above-mentioned P34HB blending and modifying can also the control degradation cycle relatively stable, from degraded to usually being continued 3-6 month by absorption completely, and good biocompatibility, abdomen stock hook after repairing has good compliance.
Accompanying drawing explanation
Fig. 1: the self-retaining tissue patch structural representation described in embodiment 1.
Detailed description of the invention
Poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer (P34HB) is utilized to carry out blending and modifying to polylactic acid (PLA), P34HB and PLA is mixed, adopt the blended basic pelletize of twin screw compounder, hot-forming at 160 DEG C, then with CMT4000 microcomputer controlled electronic universal tester, mechanical analysis is carried out to material sample, measure the hot strength (test strength) of material, elongation at break (elongation at break) and elastic modelling quantity (modulus ofelasticity).Use thickness and the width of miking batten after determining dumb-bell shape batten, initial gauge length 25mm, clips dumb-bell shape batten, starts with the load-deformation curve of the speed record material of 5mm/min draw speed after displacement back to zero.Experimental result shows: in the blend, and time the content of P34HB is 10-25wt%, hot strength is 20-35MPa, and elongation at break is greater than 130%; When carrying out thermoanalytical with differential scanning calorimetry DSC to blending and modifying measurement, we find to only have a Tg when the content of P34HB is 10-25wt% time, thus show under selected number-average molecular weight condition, P34HB and PLA is completely compatible, and when utilizing P34HB to PLA modification, plasticity and the comfortableness of material can also be improved.And research also finds the modification intermingling material not only good mechanical properties that the content of the poly-4 hydroxybutyric acid ester of working as in copolymer obtains when being 40%, zoopery shows, by above-mentioned P34HB blending and modifying can also the control degradation cycle relatively stable, from degraded to usually being continued 3-6 month by absorption completely, and good biocompatibility, the stomach wall after repairing has good compliance.
Embodiment 1
As shown in Figure 1, the present embodiment relates to a kind of self-retaining tissue patch, it degradation material hook side layer 2 comprising polypropylene material wire side layer 1 and be fixed on described polypropylene material wire side layer lower surface, described hook side layer comprises the barbed ditch composition of a large amount of tool, and little hook direction is consistent, length is identical; The methods such as bonding, welding or stitching such as can be adopted degradation material hook side layer 2 to be fixed on polypropylene material wire side layer lower surface; Described degradation material is the blend of poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer (P34HB) and polylactic acid (PLA), and the number-average molecular weight of wherein said polylactic acid is 10 × 10
4, the content of polylactic acid is 80wt% in the blend; The number-average molecular weight of described poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer is 30 × 10
4, content is in the blend 20wt%, and wherein the molar content of poly-4 hydroxybutyric acid ester is 40% in the copolymer.The shape of the layer of polypropylene material wire side described in accompanying drawing 1 is oval; Certainly can also be Long Circle, circle or other shape etc.
The self-retaining tissue patch of the present embodiment is a kind of real no-station pole canopy tissue patch, and the polypropylene wire side on upper strata is for repairing defect or weak area, and the function that degradable hook side has location and prevents sticking patch from sliding.When operation technique, self-retaining hernia patch can fully launch, and avoids sewing up fixing, and saves operating time, alleviates the slight illness of patient.The hernia patch of the present embodiment is used for the preperitoneal space of inguinal hernia patient, the existence of little hook can ensure sticking patch by means of the pressure fixing between tissue in defect, and hook side is fitted on soft tissue has good tissue compliance.
Claims (5)
1. a self-retaining tissue patch for repair of inguinal hernia, is characterized in that the degradation material hook side layer comprising wire side layer He be fixed on described wire side layer lower surface; Described degradation material is the blend of poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer and polylactic acid, and the number-average molecular weight of described polylactic acid is 10 × 10
4, the content of polylactic acid is 80wt% in the blend, and the number-average molecular weight of described poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer is 30 × 10
4, content is in the blend 20wt%; And in described poly-(3-hydroxybutyrate ester and poly-4 hydroxybutyric acid ester) copolymer, the molar content of poly-4 hydroxybutyric acid ester is 40%; The degradation cycle of described degradation material is relatively stable, from degraded to being continued 3-6 month by absorption completely.
2. self-retaining tissue patch according to claim 1, is characterized in that described wire side layer is polypropylene material wire side layer.
3. self-retaining tissue patch according to claim 1, is characterized in that described being fixed as bonding, welding or sewing up.
4. self-retaining tissue patch according to claim 1, is characterized in that the shape of described wire side layer is for circular, oval or Long Circle.
5. self-retaining tissue patch according to claim 1, it is characterized in that described hook side layer comprises the barbed ditch composition of a large amount of tool, and little hook direction is consistent, length is identical.
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| CN201210238399.8A CN102772271B (en) | 2012-07-11 | 2012-07-11 | Self-retaining tissue patch |
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| CN201210238399.8A CN102772271B (en) | 2012-07-11 | 2012-07-11 | Self-retaining tissue patch |
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| CN102772271B true CN102772271B (en) | 2015-08-26 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105361975B (en) * | 2014-08-26 | 2017-09-12 | 上海微创医疗器械（集团）有限公司 | A kind of hernia paster and preparation method thereof |
| CN104706442B (en) * | 2015-03-16 | 2017-08-01 | 克力木·阿不都热依木 | The special sticking patch of hiatal hernia |
| CN106923930B (en) * | 2017-03-13 | 2018-07-10 | 上海瀚达医疗器械有限公司 | Patch based on novel weaving technology and shape and weaving method thereof |
| EP4309689A3 (en) * | 2018-01-31 | 2024-03-27 | Titanium Textiles AG | Self-fixing mesh endoprosthesis based on titanium thread and bioresorbable polymers |
| CN111938864A (en) * | 2020-08-20 | 2020-11-17 | 日照天一生物医疗科技有限公司 | Absorbable self-adhesive hernia repair patch and preparation method thereof |
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| CN101579540A (en) * | 2009-06-10 | 2009-11-18 | 都本立 | Antiblocking hernia patch and preparation method thereof |
| CN201389098Y (en) * | 2009-04-16 | 2010-01-27 | 北京天助畅运医疗技术有限公司 | Preperitoneal repair mesh |
| WO2012048105A1 (en) * | 2010-10-06 | 2012-04-12 | Ams Research Corporation | Implants with absorbable and non-absorbable features for the treatment of female pelvic conditions |
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| US9956067B2 (en) * | 2007-07-06 | 2018-05-01 | Claude Tihon | Partial cuff |
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| CN201389098Y (en) * | 2009-04-16 | 2010-01-27 | 北京天助畅运医疗技术有限公司 | Preperitoneal repair mesh |
| CN101579540A (en) * | 2009-06-10 | 2009-11-18 | 都本立 | Antiblocking hernia patch and preparation method thereof |
| WO2012048105A1 (en) * | 2010-10-06 | 2012-04-12 | Ams Research Corporation | Implants with absorbable and non-absorbable features for the treatment of female pelvic conditions |
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