CN102772829A - Partially absorbed herniorrhaphy patch - Google Patents
Partially absorbed herniorrhaphy patch Download PDFInfo
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- CN102772829A CN102772829A CN2012102384153A CN201210238415A CN102772829A CN 102772829 A CN102772829 A CN 102772829A CN 2012102384153 A CN2012102384153 A CN 2012102384153A CN 201210238415 A CN201210238415 A CN 201210238415A CN 102772829 A CN102772829 A CN 102772829A
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Abstract
The invention relates to a partially absorbed herniorrhaphy patch, which comprises a meshed bottom patch and a plurality of petals, wherein the meshed bottom patch is made of an absorbable material; the petals are located on the meshed bottom patch; and the absorbable material is a blend of poly(3-polyhydroxybutyrate and poly-4-polyhydroxybutyrate) and polylactic acid. According to the partially absorbed herniorrhaphy patch, through compound knitting, implantation quantity of foreign matter is reduced. The partially absorbed herniorrhaphy patch is good in tissue compliance and can be used for effectively repairing defected parts.
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 hernia patch of repairing abdominal-wall defect clinically.
Background technology
Utilize open surgery or laparoscopic surgery to use the tension-free hernia of hernia patching material reinforcement stomach wall more and more general, even become the therapeutic scheme of standard in many countries.The consumption of hernia patching material is very huge, has promoted the rapid progress of hernia patching material in recent years.Just the someone attempts filling in inguinal canal with stopper through skin of scrotum and makes it bind the treatment inguinal hernia before Bassini in 1884 begins to propose to strengthen the inguinal canal rear wall.To repair inguinal canal is after modern age, the anatomical kposthesis began of representative, and people further explore various artificial materials and carry out hernia and repair.Material of a great variety, from gold, silver, silk fabrics, tantalum yarn, rustless steel to various synthetic materials and artificial fabric.At the end of the fifties, the technology of utilizing high-molecular organic material to carry out the hernia repairing begins to be applied to clinical.Through the artificial material repair deficiency, allow operation not destroying normal anatomical structures and not causing under the high-tension situation and carry out, so post-operative complication is few; Relapse rate is low; It is short that the patient recovers the required time of normal activity, and this type of operation is simple and easy to do, can under local anaesthesia, accomplish.
Polypropylene material is widely used because good clinical effectiveness is arranged, and polypropylene net is formed by polypropylene ultimate fibre or multiply fibrage, is the monolayer RF, is first-selected at present abdominal-wall defect patching material.The advantage of polypropylene sticking patch: stimulate the proliferation of fibrous tissue effect obvious; Ability is infected; Higher tensile strength is arranged; Price is relatively cheap.In in the past 60 years, polypropylene mesh produces tremendous influence to surgical field, and life is able to prolong countless patients because it has been arranged; Many surgery knotty problems solve because of its application; It has been proved to be the most popular implant of current surgery, and however, also there are some problems in polypropylene net in application: the surface ratio of net sheet is more coarse; When being used for stomach wall holostrome defect repairing, with the internal organs adhesion; When carrying out big abdominal defect repairing, the cicatrix contraction in later stage can cause the distortion of net sheet, and its irregular surface possibly stimulate and damage surrounding tissue, causes and infects and the formation of skin sinus tract.
The material of sticking patch requires more lightweight at present, and under the prerequisite of the enough tension stress intensity of maintenance, light more sticking patch has more comfortable patient's sensation and better compliance; The mesh of polypropylene mesh require enough greatly with the chance that reduces to infect with better compliance is provided, these 2 mainly is to make foreign body sensation littler, the person in charge feels more comfortable.The research of absorbable material is important developing direction, and every intravital material of people of putting into so long as not requiring the permanent support thing, should be that absorbable material is processed.Absorbable hernia patching material mainly contain polyglycolic acid (polyglycolic acid (Dexon)), polylactic-co-glycolic acid (polyglactin (Vicryl)) but two kinds of absorption mesh sheets in clinical use, its complete soak time is 3 months.But in practical application, it is found that, evoke enough proliferations of fibrous tissue, often form abdominal hernia once more after the absorption at the repairing position because Dexon and Vicryl can not sting.Therefore, it is still immature that these two kinds of materials are used for the abdominal-wall defect repairing.
U.S. Metabolix was a raw material with reproducible starch, fiber in 1992; Adopt plurality of enzymes such as the gene engineering technique PHA that the biosynthesis PHA is required, PHB to be implemented among the E.Coli; Reproducible carbon source is converted into gathers the hydroxyl macromolecular compound in bacterial body; Extract the PHA of different component with wet method, success develop the 4th 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 of being processed by P34HB has obtained 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, and is the same with other all macromolecules, and (Poly Lactic Acid, performance PLA) has very big influence to polylactic acid for molecular weight size, distribution, crystallinity.Because there is optical isomer in polylactic acid, also be key factor to the mechanical property influence.Another characteristic of polylactic acid-based material is to process with multiple mode, as extrude, spinning, biaxial stretch-formed, molecular orientation not only can significantly increase mechanical strength in the course of processing, makes degradation time slack-off simultaneously.Though polylactic acid has advantages such as good biocompatibility, biodegradability, it has limited its practical application having following defective in nature: 1) a large amount of ester bonds is arranged in the polylactic acid, be lyophobic dust, reduced its biocompatibility; 2) degradation cycle is difficult to control; Simultaneously, in practical application, also have some special functional requirements.This all impels people that the modification of poly-lactic acid material is launched deep research.
Have in the prior art and utilize the research of polylactic acid the P34HB blending and modifying; In poly 3-hydroxy butyrate 4 hydroxybutyric acid ester performance study one literary composition of delivering in " plastics science and technology " the 39th the 5th phase of volume; The P34HB that will hang down 4-HB content is disclosed; With low-molecular-weight PLA (M=990-18000) and high-molecular weight PLA (M=20000-39000) blending and modifying, and point out in 100 parts of P34HB to add 10 parts PLA, the compatibility of two kinds of materials is very good; The rigidity of compound back material increases substantially, and processing characteristics is improved; But this material is still more crisp, can not be processed to form the large aperture structure, and pliability and comfortableness are also relatively poor in addition, can not use as absorbable hernia patching material.In gathering in (3-hydroxybutyric acid and 4 hydroxybutyric acid ester) copolymer and polylactic acid blend system performance study one literary composition of delivering " Chinese plastics " the 22nd the 3rd phase of volume; Disclose and to have gathered (3-hydroxybutyric acid-co-4 butyric ester) and PLA blending and modifying; The content that wherein gathers 4HB in (3-hydroxybutyric acid-co-4 butyric ester) is 10.0mol%, and mean molecule quantity is 50-60 ten thousand; The molecular weight of polylactic acid is 80,000; The content of PLA is 5-60% in the blend; The intermingling material for preparing can improve the crystallinity of pure PHB copolymer, improves glass transition temperature and heat stability, is convenient to cooling forming; Can substitute nondegradable common plastics goods uses; But it can not be processed to form the large aperture structure, and plasticity, pliability and comfortableness are also relatively poor in addition, can not use as absorbable hernia patching material.
Summary of the invention
In order to solve the above-mentioned technical problem that exists in the prior art; The object of the present invention is to provide a kind of hernia patch that partially absorbs that comprises novel absorbable material; Through composite braided, reduce foreign body implantation amount, reduce foreign body implantation amount; Have the favorable tissue compliance, and can the Efficient software patching defect.
Realize the foregoing invention purpose in order to solve the problems of the technologies described above, the present invention adopts following technical scheme:
A kind of hernia patch that partially absorbs; It comprises the netted egative film of being processed by absorbable material and is positioned at a plurality of petals on the said netted egative film; It is characterized in that described absorbable material for gathering the blend of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer (P34HB) and polylactic acid (PLA), the number-average molecular weight of wherein said polylactic acid is 9-15 * 10
4, the content of polylactic acid is 75-90wt% in blend; Said gathering, the number-average molecular weight of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer was 25-40 * 10
4, the content in blend is 10-25wt%, the molar content of wherein in copolymer, gathering the 4 hydroxybutyric acid ester is 40%.
Wherein, the number-average molecular weight of described polylactic acid is 9-12 * 10
4, the content of polylactic acid is 75-85wt% in blend, said gathering the number-average molecular weight of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer be 25-35 * 10
4, the content in blend is 15-25wt%.
Wherein, the number-average molecular weight of described polylactic acid is 10 * 10
4, the content of polylactic acid is 80wt% in blend, said gathering the number-average molecular weight of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer be 30 * 10
4, the content in blend is 20wt%.
Wherein, described petal be polypropylene not absorbable material or above-mentioned gathering (3-butyric ester with gather the 4 hydroxybutyric acid ester) copolymer and the blend of polylactic acid.
Wherein, described a plurality of petals are arranged around the center of described netted egative film, and the far-end of said petal is free, and near-end is fixed in the central area of said netted egative film.
Wherein, the number of described petal is 2-8, is preferably 3,4 or 8.
Wherein, said a plurality of petals are separate each other, and are individually fixed in the central area of described netted egative film through near-end separately.
Wherein, said a plurality of petals are an integral body, link together through their proximal end region.
Wherein, describedly be fixed as bonding, welding or sew up.
Compared with prior art, the present invention has the following advantages: it is 9-15 * 10 to number-average molecular weight that the present invention gathers (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer through utilization
4Polylactic acid carry out blending and modifying and successfully developed and be used for the novel absorbable material that hernia is repaired.
When the number-average molecular weight of polylactic acid is lower than 9 * 10
4The time, during as the hernia patching material, the intensity of polylactic acid is often not enough, and is higher than 15 * 10 when the number-average molecular weight of polylactic acid
4The time, the ester bond quantity in the polylactic acid is big, and biocompatibility reduces, and is not suitable for as the hernia patching material; But research finds simultaneously that also number-average molecular weight is 9-15 * 10
4The polylactic acid degradation cycle be difficult to control, evoke enough proliferations of fibrous tissue nor can sting.Inventor of the present invention for this reason is devoted to polylactic acid is carried out modification, and the inventor finds when utilizing number-average molecular weight to be 25-40 * 10
4Plasticity P34HB when carrying out blending and modifying; When the content of P34HB in 10-25wt%, can dissolve each other fully that it is good to obtain pliability, the intermingling material that non-deformability is stronger; And the research modification intermingling material also finding when the content that gathers the 4 hydroxybutyric acid ester in the copolymer is 40%, to obtain good mechanical properties not only; Zoopery shows, and is can also the control degradation cycle relatively stable through above-mentioned P34HB blending and modifying, continues 3-6 month from beginning degraded usually to being absorbed fully; And good biocompatibility, the stomach wall after the repairing has compliance preferably.
Description of drawings
Hernia patch structural representation shown in Fig. 1: the embodiment 1.
Hernia patch structural representation shown in Fig. 2: the embodiment 2.
The specific embodiment
Utilization gathers (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer (P34HB) polylactic acid (PLA) is carried out blending and modifying; P34HB is mixed with PLA; Adopt twin-screw mixer machine blend basis pelletize; Hot-forming under 160 ℃, with CMT4000 system controlled by computer electronics universal testing machine material sample is carried out mechanical analysis then, measure hot strength (test strength), elongation at break (elongation at break) and the elastic modelling quantity (modulus of elasticity) of material.Determine behind the dumb-bell shape batten with the thickness and the width of miking batten, initial gauge length 25mm clips the dumb-bell shape batten, and displacement begins the load-deformation curve with the speed record material of 5mm/min draw speed after returning zero.Experimental result shows: in blend, when the content of P34HB was 10-25wt%, hot strength was 20-35MPa, and elongation at break is greater than 130%; With differential scanning calorimetry DSC the blending and modifying measurement is carried out thermoanalytical the time; We find when the content of P34HB is 10-25wt%, to have only a Tg; Thereby be illustrated under the selected number-average molecular weight condition; P34HB and PLA are compatible fully, and when utilizing P34HB to the PLA modification, can also improve the plasticity and the comfortableness of material.The research modification intermingling material also finding when the content that gathers the 4 hydroxybutyric acid ester in the copolymer is 40%, to obtain good mechanical properties not only in addition; Zoopery shows; Can also the control degradation cycle relatively stable through above-mentioned PHB blending and modifying; Usually continue 3-6 month from beginning degraded to being absorbed fully, and good biocompatibility, the stomach wall after the repairing has compliance preferably.
When being used to describe petal, particularly with regard to it with regard to the position on the netted egative film time, term " far-end " refers to the end away from netted plate center, and term " near-end " refers to the end near netted plate center.The near-end of petal also can be called " base portion ".
When being used to describe the quantity of quantity, particularly petal, term " a plurality of " refers to more than 2 or 2, for example 3,4,5,6,7,8,12 etc.
Term used herein " petal " is meant the laminated structure in the patch of the present invention.Should be understood that " petal " of the present invention can have the shape of similar plants petal, for example Flos persicae is petal, but is not limited to any specific petal shape.For example, " petal " of the present invention can have the fan shape of fundamental rule, and for example 45 °, 60 °, 90 °, 120 ° are fan-shaped; Also can have shapes such as ellipse, olive shape; Even can be irregular shape, as long as it is convenient to preparation and is convenient to the doctor when operation, use.For example, the shape of petal can be suitable for each petal being clipped together and petal and hernia circumferential weld being lumped together with mosquito forceps.Those skilled in the art can easily confirm the shape and the size of petal according to concrete medical science needs.
Petal shape in the patch can be all identical, or identical at interval, or different fully each other.From being convenient to operation technique and the aspect that is easy to process, petal shape is all identical to be preferred.
Petal of the present invention can be to be shaped separately separately, thereby forms structure independent of each other; Also can be the overall structure that is for example formed through laser cutting by a fabric, the base portion through each petal connects together.
Petal can be fitted with netted egative film keep flat (when promptly not stressing, petal is attached on the netted egative film naturally, each other a fixed gap can be arranged), or is pre-formed as with netted egative film is vertical and places.Can be by cutter, ultrasound wave or laser cutting.
" symmetric radial arrangement " is meant that petal roughly is symmetric radial arrangement on netted egative film, is not necessarily strict symmetry also radially, scrambling to a certain degree can be arranged, as long as can realize its function.This is conspicuous to those skilled in the art.
Term used herein " netted egative film " is meant the bottom or the substrate of patch of the present invention, is sheet usually.From the angle of being convenient to perform the operation and implant, the circular netted egative film that perhaps is roughly circle is preferred, and when with mosquito forceps each petal being clipped together, netted egative film can form cone shape beveled structure like this, is convenient to send into hernia ring place.The circular 40-130mm that typically has a diameter from that perhaps is roughly circular netted egative film better is 80-100mm, and that best is 100mm.Certainly, other shapes that are suitable for implanting also can adopt, for example ellipse, olive shape, pyriform, even irregular shape.According to the concrete condition of damaged (for example hernia ring) to be repaired, the size of netted egative film and shape can change.Those skilled in the art can easily confirm the shape and size of netted egative film according to concrete medical science needs.
Netted egative film is generally one deck; But as required,, also can be two-layer or multilamellar more for example in order to increase the hardness of netted egative film.
Embodiment 1
Shown in accompanying drawing 1, the described hernia patch of present embodiment is made up of with petal 20 netted egative film 10.In this embodiment, the profile of netted egative film 10 is circular, is processed single layer structure by netted fabric.Fixing 8 petals 20 at the upper surface of netted egative film 10, its far-end 22 is free, can move freely, and near-end 24 is fixed in the central area of netted egative film 10.The circular circumference of central area is schematically, and does not mean that the so clear and definite boundary of physical presence, and its purpose only is to explain the approximate location of central area.The periphery 12 of the netted egative film 10 of far-end 22 distances of petal 20 has certain distance.As required, the far-end 22 of petal 20 can change with the distance of the periphery 12 of netted egative film 10, can be littler, can be bigger, and can be roughly concordant with periphery 12, even can exceed periphery 12.Also can form an integral body between the petal 20, for example by a fabric through laser cutting direct forming, link together in central area through near-end 24.The absorbing material that netted egative film uses is for gathering the blend of (3-butyric ester with gather the 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 blend; Said gathering, the number-average molecular weight of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer was 30 * 10
4, the content in blend is 20wt%, the molar content of wherein in copolymer, gathering the 4 hydroxybutyric acid ester is 40%.The material that petal 20 adopts is a not absorbable material of polypropylene.
Embodiment 2
Shown in accompanying drawing 2, the patch of present embodiment comprises that integrally formed four petals 20 and the center that 30,4 petals of integrally formed cross reinforcement 20 center on circular netted egative film 10 are symmetric radial arrangement.Said petal 20 links together in the central area of netted egative film 10 with reinforcement 30, and fixes with welding manner through being positioned at netted egative film 10 centers.Netted egative film 10, petal 20 are processed by identical mesh structural porous fabric with reinforcement 30.The far-end of reinforcement 30 only is fixed near the periphery of netted egative film 10 through stitching near the end points.Can adopt welding or suture way in the time of fixedly.This dual mode difference on effect is not very big.When adopting welding, outward appearance is comparatively smooth, and is attractive in appearance, and being easy to is doctor and patient's acceptance, but has viewpoint to think the structure and/or the mechanical property that may change netted egative film and/or reinforcement etc.Show wired head outward when adopt sewing up, may influence attractive in appearancely, but can the mechanical property of patch not exerted an influence.Those skilled in the art can judge which kind of mode of use according to concrete needs, also can adopt other fixed forms well known in the art, for example heat seal.Netted egative film, petal and reinforcement all use above-mentioned absorbing material in the present embodiment; Promptly gather the blend of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer (P34HB) and polylactic acid (PLA), the number-average molecular weight of wherein said polylactic acid is 10 * 10
4, the content of polylactic acid is 80wt% in blend; Said gathering, the number-average molecular weight of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer was 30 * 10
4, the content in blend is 20wt%, the molar content of wherein in copolymer, gathering the 4 hydroxybutyric acid ester is 40%.The material that petal 20 adopts is a not absorbable material of polypropylene.
Hernia patch of the present invention has the typical occupation mode of two kinds of suggestions: thromboembolism mode and preperitoneal space mode.Thromboembolism (Plug) mode may further comprise the steps: return and to receive hernical sac; With a plurality of petals of suitable operating theater instruments (like mosquito forceps) clamping patch, the netted egative film that makes lower floor forms the structure of similar " umbrella shape " to hand-held direction upset distortion; Whole patch is filled in the hernia ring, make patch become umbrella shape to place and make the edge almost concordant with the hernia ring; In case of necessity, with patch edge and hernia ring surrounding tissue sutured.The preperitoneal space mode may further comprise the steps: free hernical sac, isolate enough big preperitoneal space; Return and to receive hernical sac; With a plurality of petals of suitable operating theater instruments (like mosquito forceps) clamping patch, the netted egative film that makes lower floor forms the structure of similar " umbrella shape " to hand-held direction upset distortion; Whole patch is filled in the hernia ring, be positioned over isolating preperitoneal space; Make its smooth placement in preperitoneal space with finger or the suitable belt pushing of apparatus sticking patch; With the petal sutured in hernia ring surrounding tissue.
The specific embodiment described herein only is from illustrative purpose, the scope that does not limit the present invention in any way.Under situation without departing from the spirit and scope of the present invention, those of ordinary skills can make various changes and improvement to the present invention in form and details, and these all are considered to fall into the protection domain of requirement protection of the present invention.
Claims (10)
1. one kind partially absorbs hernia patch; It comprises the netted egative film of being processed by absorbable material and is positioned at a plurality of petals on the said netted egative film; It is characterized in that described absorbable material for gathering the blend of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer and polylactic acid, the number-average molecular weight of wherein said polylactic acid is 9-15 * 10
4, the content of polylactic acid is 75-90wt% in blend; Said gathering, the number-average molecular weight of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer was 25-40 * 10
4, the content in blend is 10-25wt%, the molar content of wherein in copolymer, gathering the 4 hydroxybutyric acid ester is 40%.
2. the described hernia patch of claim 1, the number-average molecular weight that it is characterized in that described polylactic acid is 9-12 * 10
4, the content of polylactic acid is 75-85wt% in blend, said gathering the number-average molecular weight of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer be 25-35 * 10
4, the content in blend is 15-25wt%.
3. the described hernia patch of claim 1, the number-average molecular weight that it is characterized in that described polylactic acid is 10 * 10
4, the content of polylactic acid is 80wt% in blend, said gathering the number-average molecular weight of (3-butyric ester with gather 4 hydroxybutyric acid ester) copolymer be 30 * 10
4, the content in blend is 20wt%.
4. each described hernia patch of claim 1-3, it is characterized in that described petal be polypropylene not absorbable material or above-mentioned gathering (3-butyric ester with gather the 4 hydroxybutyric acid ester) copolymer and the blend of polylactic acid.
5. each described hernia patch of claim 1-3 is characterized in that described a plurality of petal arranges around the center of described netted egative film, and the far-end of said petal is free, and near-end is fixed in the central area of said netted egative film.
6. each described hernia patch of claim 1-3, the number that it is characterized in that described petal are 2-8.
7. the described hernia patch of claim 6, the number that it is characterized in that described petal is 3,4 or 8.
8. each described hernia patch of claim 1-3 is characterized in that said a plurality of petal is separate each other, and is individually fixed in the central area of described netted egative film through near-end separately.
9. each described hernia patch of claim 1-3 is characterized in that said a plurality of petal is an integral body, links together through their proximal end region.
10. the described hernia patch of claim 5 is characterized in that described be fixed as bonding, welding or stitching.
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| CN2012102384153A CN102772829A (en) | 2012-07-11 | 2012-07-11 | Partially absorbed herniorrhaphy patch |
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| CN2012102384153A CN102772829A (en) | 2012-07-11 | 2012-07-11 | Partially absorbed herniorrhaphy patch |
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| CN105596114A (en) * | 2016-01-25 | 2016-05-25 | 北京天助畅运医疗技术股份有限公司 | Anti-adhesion patch having internal drainage function |
| CN107530084A (en) * | 2015-03-26 | 2018-01-02 | C.R.巴德公司 | Power actuatable clamp device for implantable prosthesis |
| CN109589187A (en) * | 2019-01-18 | 2019-04-09 | 姚飞 | A kind of hernia paster |
| CN111867515A (en) * | 2018-01-31 | 2020-10-30 | 弹性钛合金植入物有限责任公司 | Self-fixating mesh implant based on titanium wire and bioabsorbable polymer |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107530084A (en) * | 2015-03-26 | 2018-01-02 | C.R.巴德公司 | Power actuatable clamp device for implantable prosthesis |
| US10874497B2 (en) | 2015-03-26 | 2020-12-29 | C.R. Bard, Inc. | Force actuated gripping device for an implantable prosthesis |
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| CN111867515A (en) * | 2018-01-31 | 2020-10-30 | 弹性钛合金植入物有限责任公司 | Self-fixating mesh implant based on titanium wire and bioabsorbable polymer |
| CN111867515B (en) * | 2018-01-31 | 2024-01-30 | 钛合金纺织品公司 | Self-anchoring mesh implant based on titanium wire and bioabsorbable polymer |
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| CN109589187B (en) * | 2019-01-18 | 2021-01-05 | 姚飞 | Hernia patch |
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Application publication date: 20121114 |