CN102202701A - Block-polymer membranes for attenuation of scar tissue - Google Patents

Block-polymer membranes for attenuation of scar tissue Download PDF

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Publication number
CN102202701A
CN102202701A CN2009801281438A CN200980128143A CN102202701A CN 102202701 A CN102202701 A CN 102202701A CN 2009801281438 A CN2009801281438 A CN 2009801281438A CN 200980128143 A CN200980128143 A CN 200980128143A CN 102202701 A CN102202701 A CN 102202701A
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absorbable
base material
mocromembrane
polymer base
scar tissue
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约尔格·特斯马尔
托马斯·赖因特耶斯
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MAST Biosurgery AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

Precut, user-shapeable, resorbable polymer micro-membranes are disclosed. The micro-membranes are constructed of resorbable polymers, which are engineered to attenuate adhesions and to be absorbed into the body relatively slowly over time. The membranes can formed to have very thin thicknesses, for example, thicknesses between about 0.010 mm and about 0.300 mm, while maintaining adequate strength. The membranes can be extruded from polylactide polymers having a relatively high viscosity property, can be stored in sterile packages, and can be preshaped with relatively high reproducibility during implantation procedures.

Description

In order to reduce the block polymer film of scar tissue
The application's request U.S. Provisional Application number 61/059,795, June 8 2008 applying date, denomination of invention is the priority of " in order to reduce the block polymer film of scar tissue ", it is a U. S. application number 12/199,760, August 27 2008 applying date, denomination of invention for during treating in order to reduce scar tissue can this application of absorption group barrier mocromembrane the partial continuous application case, and with U. S. application case number 10/385,399, March 10 2003 applying date, denomination of invention is can be correlated with by absorption group barrier mocromembrane in order to the minimizing scar tissue during treating, the patent No. that obtains is 6,673,362 now, each or whole above-mentioned application case contents are all integrated with this paper clearly as reference.
The application also with U. S. application number 10/631,980, July 31 2003 applying date (Att.Docket MA9604P), U. S. application number 11/203,660, August 12 2005 applying date (Att.Docket MB9828P), U. S. application number 10/019,797, July 26 2002 applying date (Att.Docket MB9962P), U.S. Provisional Application number 60/966,782, August 27 2007 applying date (Att.Docket MB8039PR) and U.S. Provisional Application number 60/966,861, August 29 2007 applying date, patents such as (Att.Docket MB8039PR2) was relevant.The all identical and content each or whole above-mentioned application case of the applicant of above-mentioned application is all integrated with the application as a reference clearly.
Technical field
The present invention is relevant to medical implant substantially, but particularly is relevant to absorbing film and its using method, and uses its method as medical implant.
Background technology
The subject matter clinically of surgical repair and inflammatory diseases is: at be stained with glutinous (adhesion) of operation or the generation of treatment incipient stage after being ill.Being stained with glutinous is a kind of caused undesired state of organizing chain formation of formation that relates to fibrous scar.These chain may, for example damage physical function, produce infertilely, block intestinal and gastral other partly (intestinal obstruction) and generation general malaise, for example pelvic pain.These states are entail dangers to life in some cases.Although be stained with glutinous may being caused by other course of treatment or situation, for example existence of pelvic inflammation, clone's formula disease, peritonitis, mechanical injury, radiotherapy and foreign substance, being stained with glutinous modal a kind of form is that surgical operation is caused.
It is glutinous to prevent to be stained with to have carried out various trials at present, particularly postoperative be stained with glutinous.For instance, utilize the improvement of peritoneal lavage, heparin solution, forerunner's thrombin, surgical technic, the for example use of microscope or peritoneoscope surgical technic, Pulvis Talci intercept the use of (film, gel or other solution) by the use of the removing of surgical gloves, less suture and the adherent physical property that is intended to minimize serosa surface, are all attempted.Unfortunately, these methods it seems that the success that obtains is limited.In addition, various forms of barrier material, for example film is organized adherent stickiness peritoneal fluid with being designed to restriction, and the success that is obtained is limited too.These barrier material comprise cellulose obstruct, polytetrafluoroethyl-ne olefinic substance and dextran solution.
The patent of the U.S. Patent number 5,795,584 that people such as Tokahura propose discloses anti-being stained with and sticked or scar tissue reduction thin film, and the patent of the U.S. Patent number 6,136,33 that people such as Cohn propose also discloses similar structure.Propose in the patent people such as Tokahura, biologically absorbable polymer and suitable carbonate combined polymerization form anti-glutinous obstruct the, for example thin film be stained with of imporosity monolayer then.Propose in the patent people such as Cohn, use in case be stained with the glutinous polyalcohol hydrogel that does not have chemical crosslinking by using the Polyurethane chemistry to form.These patents all relate to complicated chemical formula and/or produce in order to be stained with the reaction of the glutinous ad hoc structure that intercepts as operation.Therefore, still continue at present to need a kind of film of improvement can prevent to be stained with glutinous.
Summary of the invention
The invention provides a kind of Improvement type Resorbable micro-membrane, it can be used under the various surgery situation, for example suppress, postpone or prevent tissue be stained with glutinous with reduce cicatrix, for example when organization healing; Then, it can be absorbed behind the process reasonable time or dissolve.This Improvement type Resorbable micro-membrane can be made into has extremely thin thickness, and for example its thickness and keeps enough intensity simultaneously between about 0.010 millimeter and 0.300 millimeter.
The invention provides a kind of Improvement type Resorbable micro-membrane, it can be easily and forms and be positioned on the anatomical structure that comprises hard or soft tissue definitely or around this anatomical structure or be positioned near this anatomical structure.This Improvement type Resorbable micro-membrane can be used under the various surgery situation, for example postpones or prevents that tissue is stained with glutinous and reduces cicatrix.In addition, copolymer of the present invention can help to provide better simply chemical reaction and/or chemical formula, and/or can help to provide one or more enhanced or the mechanical strength of controllability is more arranged and/or with respect to other material, for example parent, polyester have degraded acceleration or that have more controllability.
According to one embodiment of present invention, can provide a kind of Resorbable micro-membrane, it comprises the diblock copolymer of evenly forming substantially.This diblock copolymer can comprise first block, and it comprises, consists essentially of or comprise one or more polylactic acid (ploylactide) and/or poly-glycolic acid (polylactic acid (poly lactic acid for example; Abbreviation PLA), polyglycolic acid (being called for short PGA) or polylactic acid-glycolic acid (being called for short PLGA)); And second block, it comprises, consists essentially of or comprise one or more Polyethylene Glycol (for example PEG).First block, be called polylactic acid/polyglycolic acid block (PLA/PGA block), can comprise hydrophobicity and biodegradable polylactic acid/polyglycolic acid block (PLA/PGA block), and second block, be called Polyethylene Glycol block (PEGblock), can comprise hydrophilic Polyethylene Glycol block (PEG block).
According to another characteristic of the invention, a kind of Resorbable micro-membrane can be provided, it comprises, consists essentially of or comprise the triblock copolymer of evenly forming substantially, this triblock copolymer comprises first block, and it comprises, consists essentially of or comprise a polylactic acid and/or a poly-glycolic acid (for example polylactic acid (PLA), polyglycolic acid (PGA) or polylactic acid-glycolic acid (PLGA)); Second block, it comprises, consists essentially of or comprise one or more Polyethylene Glycol (for example PEG); And the 3rd block, it comprises, consists essentially of or comprise a polylactic acid and/or a poly-glycolic acid (for example polylactic acid (PLA), polyglycolic acid (PGA) or polylactic acid-glycolic acid (PLGA)).Each of first block and the 3rd block all is called polylactic acid/polyglycolic acid block (PLA/PGA block), preferably comprise one or more hydrophobicitys and biodegradable polylactic acid/polyglycolic acid block (PLA/PGA block), and second block, be called Polyethylene Glycol block (PEG block), preferably comprise one or more hydrophilic Polyethylene Glycol blocks (PEG block).
When identical with the 3rd block or the total one or more common feature of first block, both all are referred to as " A " block, and second block then is referred to as " B " block.
First polylactic acid/polyglycolic acid block (first PLA/PGA block) and the second Polyethylene Glycol block (second PEG block) are together, can form polylactic acid/polyglycolic acid-Polyethylene Glycol (for example A-B) copolymer (PLA/PGA-PEG copolymer), it is all flocked together and form polylactic acid/polyglycolic acid-polyethylene glycol-lactic acid/polyglycolic acid (for example A-B-A) copolymer (PLA/PGA-PEG-PLA/PGA copolymer) and add the 3rd polylactic acid/polyglycolic acid block (third PLA/PGA block).Can form these polylactic acid/polyglycolic acid-Polyethylene Glycol (PLA/PGA-PEG) (or polylactic acid/polyglycolic acid-polyethylene glycol-lactic acid/polyglycolic acid (PLA/PGA-PEG-PLA/PGA)) co-polymer membrane by for example extrusion molding in the state that is the higher viscosity property of tool at the beginning.This initial high viscosity characteristic produces by reducing this film, situation such as for example destroys or tear, and can help certain formation of this Obstruct membrane in the process of extrusion molding.After handling and sterilizing, the viscosity or the viscosity property that comprise the copolymer of this film can reduce usually.Can use other viscosity property (as higher viscosity property) according to another feature of the present invention, for example, for example increase the intensity of polylactic acid/polyglycolic acid-Polyethylene Glycol (PLA/PGA-PEG) (or polylactic acid/polyglycolic acid-polyethylene glycol-lactic acid/polyglycolic acid (PLA/PGA-PEG-PLA/PGA)) copolymer in the process of extrusion molding in order in manufacturing process.In the embodiment of some improvement, initial viscosity property can be higher viscosity property.The manufacturing process of extrusion molding can provide the thin film with the orientation of bias voltage molecule.
According to further feature, film has first smooth surface and second smooth surface, and this film is an imporosity, and measure between this first smooth surface and second smooth surface and this film thickness greatly about 0.01 millimeter to 0.300 millimeter.Therefore this film can have various section thicknesses.For example this film can comprise at least one thicker part, and it is formed at least one fragment at an edge of this film.In other embodiments, this film may have homogeneous thickness.
Though, will be for the fluency of grammer with functional description tracing device and method, what must be well understood that is, unless have datedly in addition, claim can not be interpreted as the restriction of any aspect by the structure that device and step are limited; But under the equalization opinion of the administration of justice, the gamut of the connotation that it will be provided with claim and the definition of equipollent are consistent.
Any feature described here or combination of features all are contained in the category of the present invention, as long as the feature that is contained in any combination is not conflicted mutually, it will be shown in the knowledge category of background technology, description and the technical field of the invention tool those of ordinary skill.In addition, any feature described herein and combination of features may be by especially by getting rid of among any embodiment of the present invention.In order to summarize the present invention, some aspect of the present invention, advantage and novel features can be described.Certainly, be understandable that, do not need the purpose that the present invention is all, advantage and novel features all specific implementation in accordance with any particular embodiment of the present invention.In following detailed description and claim thereafter, any additional advantage of the present invention and purpose can be presented.
Description of drawings
First figure to the, six figure illustrate the constituent and the characteristic of embodiments of the invention.
The specific embodiment
The preferred embodiments of the present invention will be described in detail with as reference, and each embodiment is showed in the appended diagram.As much as possible, the diagram with description in the use identical or similar label represent identical or similar assembly.It should be noted that these diagrams all are to draw and do not draw with accurate yardstick with the form of simplifying.About content disclosed herein, only for convenience with purpose clearly, user tropism's term in relevant drawings, for example top, bottom, left and right, upper and lower, on, top, below, under, the back side and front.The term of these directivity should not be interpreted as the restriction to protection scope of the present invention by any way.
Though the disclosed content of the application is meant that some is showed in the embodiment of this paper, it must be appreciated, provide these embodiment with as example, but not as restriction.When exemplary embodiment was discussed, this disclosed purpose can be understood as all improvement, replacement scheme and the equipollent that follow-up detailed description contains embodiment, and it all falls in defined spirit of the present invention of the claim that is proposed and the category.
Obstruct membrane of the present invention can be made of various biodegradable material, for example absorbable polymer.According to one embodiment of present invention, the non-limiting polymer that can be used for forming Obstruct membrane of the present invention can comprise two block (agglomerate) copolymers.As described in the present application, this diblock copolymer can comprise first block, and it comprises, consists essentially of or comprise polylactic acid and/or a poly-glycolic acid (polylactic acid (poly lactic acid for example; Abbreviation PLA), polyglycolic acid (polyg lycolic acid; Be called for short PGA) or polylactic acid-glycolic acid (Poly (Lactic-co-glycolicacid); Be called for short PLGA)); And second block, it comprises, consists essentially of or comprise Polyethylene Glycol (for example PEG).This first block, be called polylactic acid/polyglycolic acid block (PLA/PGAblock), can comprise one or more hydrophobicitys and biodegradable polylactic acid/polyglycolic acid block (PLA/PGA block), and this second block, be called Polyethylene Glycol block (PEG block), can comprise hydrophilic Polyethylene Glycol block (PEG block).The first polylactic acid/polyglycolic acid block can be described as " A " block, and the second Polyethylene Glycol block can be described as " B " block.The first polylactic acid/polyglycolic acid block and the second Polyethylene Glycol block can form polylactic acid/polyglycolic acid-Polyethylene Glycol (PLA/PGA-PEG) (for example A-B or AB) diblock copolymer together.
Other non-limiting block (agglomerate) copolymer that can be used for forming Obstruct membrane of the present invention comprises three blocks (agglomerate) copolymer or starlike copolymer.Disclosed as the present invention, this triblock copolymer can comprise first block, and it comprises, consists essentially of or comprise a polylactic acid and/or a poly-glycolic acid (for example polylactic acid (PLA), polyglycolic acid (PGA) or polylactic acid-glycolic acid (PLGA)); Second block, it comprises, consists essentially of or comprise Polyethylene Glycol (for example PEG); And the 3rd block, it comprises, consists essentially of or comprise polylactic acid and/or poly-glycolic acid (for example polylactic acid (PLA), polyglycolic acid (PGA) or polylactic acid-glycolic acid (PLGA)).This first block, be called polylactic acid/polyglycolic acid (PLA/PGA) block, can comprise one or more hydrophobicitys and biodegradable polylactic acid/polyglycolic acid (PLA/PGA) block, and this second block, be called Polyethylene Glycol (PEG) block, can comprise one or more hydrophilic Polyethylene Glycol (PEG) block, and the 3rd block, be called polylactic acid/polyglycolic acid (PLA/PGA) block, can comprise one or more hydrophobicitys and biodegradable polylactic acid/polyglycolic acid (PLA/PGA) block.When identical with the 3rd polylactic acid/polyglycolic acid (PLA/PGA) block or the total one or more common feature of first polylactic acid/polyglycolic acid (PLA/PGA) block, they can each all be called " A " block, and second Polyethylene Glycol (PEG) block can be called " B " block.First polylactic acid/polyglycolic acid (PLA/PGA) block, second Polyethylene Glycol (PEG) block and the 3rd polylactic acid/polyglycolic acid (PLA/PGA) block can form polylactic acid/polyglycolic acid-polyethylene glycol-lactic acid/polyglycolic acid (PLA/PGA-PEG-PLA/PGA) (for example A-B-A or ABA) triblock copolymer together.
This associativity block (agglomerate) copolymer or can be named as polyethylene glycol-lactic acid/polyglycolic acid-Polyethylene Glycol (PEG-PLA/PGA-PEG) (for example B-A-B or BAB) triblock copolymer.
In other embodiments, this associativity block copolymer can be four (for example four or more blocks) block (agglomerate) copolymers just, it comprises for example Polyethylene Glycol (PEG) block (for example B block), this Polyethylene Glycol (PEG) block forms this block (agglomerate) copolymer with three or more polylactic acid/polyglycolic acid (PLA/PGA) block (for example A block), connects three or more polylactic acid/polyglycolic acid (PLA/PGA) block (for example A block) or is arranged between three or more polylactic acid/polyglycolic acid (PLA/PGA) block (for example A block).This four positive block copolymer or can comprise for example polylactic acid/polyglycolic acid (PLA/PGA) block (for example A block), this polylactic acid/polyglycolic acid (PLA/PGA) block (for example A block) forms this four (4plus) block copolymer just with three or more Polyethylene Glycol (PEG) block (for example B block), connects three or more Polyethylene Glycol (PEG) block (for example B block) or is arranged between three or more Polyethylene Glycol (PEG) block (for example B block).
This four just (4plus) block copolymer comprise and have one or more symmetric shapes and starlike Polyethylene Glycol (PEG) block (for example B block), (for example connect three or more polylactic acid/polyglycolic acid (PLA/PGA) block (for example A block), for example the number of section can comprise four with section (for example support arm, branch or point) combination.In a preferred embodiment, the number of these sections equates with the number of polylactic acid/polyglycolic acid (PLA/PGA) block.Perhaps, four positive block copolymers comprise and have one or more symmetric shapes and starlike polylactic acid/polyglycolic acid (PLA/PGA) block (for example A block), with section (for example support arm, branch or point) in conjunction with (for example connecting) three or more Polyethylene Glycol (PEG) block (for example B block).As the embodiment of front, the number of these sections equates with the number of Polyethylene Glycol (PEG) block, in a certain embodiments, can comprise four.
This associativity block polymer can the mode by extrusion molding form when having higher viscosity property at the beginning.This initial high viscosity characteristic produces by reducing Obstruct membrane, problem such as for example destroys or tear, and helps this Obstruct membrane to be shaped as really in the process of extrusion molding.After handling and sterilizing, the viscosity of this Obstruct membrane or viscosity property can reduce usually.Can use other higher viscosity property according to another feature of the present invention, with the intensity of enhancing substance (copolymer).In the embodiment of some improvement, initial viscosity property can have higher viscosity property.The manufacturing process of extrusion molding can provide the thin film with the orientation of deflection molecule.The process of extrusion molding can help to provide effective generation of Obstruct membrane.In addition, the solvent that the Obstruct membrane that is made by this extrusion forming technology can not produce in the Obstruct membrane is caught, and can further provide, and for example the molecule bias voltage comprises predetermined molecule bias voltage.Can use single shaft or twin shaft extrusion molding to make this Obstruct membrane.
The composition of this associativity block copolymer can be extruded and form Obstruct membrane of the present invention.In certain embodiments, polylactic acid/polyglycolic acid-Polyethylene Glycol (PLA/PGA-PEG) block copolymer can be taked the form of following one or more polymer: 1. poly-L type lactic acid-Polyethylene Glycol; 2. poly-L type lactic acid-DL type lactic acid-Polyethylene Glycol; 3. poly-L type lactic acid-ethanol-Polyethylene Glycol; Polylactic acid/polyglycolic acid-polyethylene glycol-lactic acid/polyglycolic acid (PLA/PGA-PEG-PLA/PGA) block copolymer can be taked following form: 4. poly-L type lactic acid-Polyethylene Glycol-L type lactic acid; 5. poly-L type lactic acid-Polyethylene Glycol-L type lactic acid-DL type lactic acid; 6. poly-L type lactic acid-Polyethylene Glycol-L type lactic acid-ethanol; 7. poly-L type lactic acid-DL type lactic acid-Polyethylene Glycol-L type lactic acid-DL type lactic acid; 8. poly-L type lactic acid-DL type lactic acid-Polyethylene Glycol-L type lactic acid-ethanol; 9. poly-L type lactic acid-ethanol-Polyethylene Glycol-L type lactic acid-ethanol; By above-mentioned polymer or copolymer in conjunction with and/or change (optionally combining) and the starlike block copolymer and/or the four positive block copolymers of other form of forming can be made or obtain with arbitrary or a plurality of other polymer open at this paper or that mention.For instance, these polymer or copolymer can be unrestrictedly made or are obtained by German Boehringer Ingelheim company, in order to be squeezed into Obstruct membrane of the present invention.
Demonstration chemical constitution used herein is with synthetic as follows with naming rule, wherein:
Graph A
Figure BPA00001300011800091
R during diblock copolymer 1=CH 3
R during triblock copolymer 1=A
Chart B shows once more by the effect of catalyst, Polyethylene Glycol (PEG) unit and polylactic acid-glycolic acid (PLGA) polymerization is gone in the block copolymer.Polyethylene Glycol (PEG) has low general toxicity, and is used in various medical treatment and medicament in recent years.
The block copolymer that it produced is showed down with chart:
Chart B
RLLRLLLRLLRLLRR-O-[-CH 2-CH 2-O-] n-R
A B
Commercial polylactic acid-glycolic acid of obtaining (PLGA): Polyethylene Glycol (PEG) block copolymer comprises the product of Boehringer Ingelheim company Polyethylene Glycol (PEG) (
Figure BPA00001300011800102
PEG).
One preferable (via nonexcludability) product
Figure BPA00001300011800103
Polyethylene Glycol (PEG) sample MD type LRP d 7055 (
Figure BPA00001300011800104
PEG Sample MD Type LRP d 7055), wherein LR represents RESOMER Acronym LR (A block), P represents Polyethylene Glycol (PEG) (B block), the molar ratio of 70 representatives in the A block, first 5 percentage by weight of representing Polyethylene Glycol (PEG), and second 5 molecular weight of representing Polyethylene Glycol (PEG) is divided by 1,000.
Under the typical non-limiting example of polylactic acid/polyglycolic acid-Polyethylene Glycol (and/or polylactic acid/polyglycolic acid-polyethylene glycol-lactic acid/polyglycolic acid) copolymer: for sustained release function (controlled release functionalities (CR)), polymer contains about Polyethylene Glycol of 5% to 15% (PEG) usually.For medical device (medical devices (MD)), polymer contains usually and is less than 5% Polyethylene Glycol (PEG).For sustained release, the A block may contain, for example DL type lactic acid-ethanol (D, L-lactide-co-glycolide (RG)).For medical device, the A block may contain, for example L type lactic acid (L lactide (L)), L type lactic acid-DL type lactic acid (L-lactide-co-D, L-lactide (LR)) or L type lactic acid-ethanol (LLactide-co-glycolide (LG)).
Fig. 1-Fig. 6 illustrates some composition and the feature of embodiments of the invention.Obstruct membrane of the present invention has at least one smooth surface.Best, Obstruct membrane of the present invention has two (relative) shiny surfaces.When measure between two shiny surfaces apart from the time, Obstruct membrane of the present invention has 0.01 millimeter-0.3 millimeter thickness, and is best, has 0.01 millimeter-0.1 millimeter thickness.In a preferred embodiment, Obstruct membrane of the present invention has 0.015 millimeter-0.025 millimeter thickness.In another preferred embodiment, the maximum ga(u)ge that has of Obstruct membrane of the present invention is 0.02 millimeter.Of the present invention one preferred mocromembrane comprises one or more uniform compositions and the bias voltage molecule orientation in Obstruct membrane, forms by for example extrusion molding.
Term as used herein " imporosity " is meant the normally material of waterproof, and according to a preferred embodiment of the invention, it is not liquid permeable usually.Yet, in improvement embodiment of the present invention, micropore (it is a liquid permeable, but is not cell-penetrating) can be present in the mocromembrane of the present invention to a certain extent, and for example they can not destroy the smoothness on Resorbable micro-membrane surface significantly and cause the generation of scar tissue.For some application significantly among the embodiment of improvement, can make and use and have cell-penetrating but do not have the hole of blood vessel penetrance.
Present as present, many thickness of thin Obstruct membranes can show its profile fully, have both made not to be heated to glass transition temperature.Present as present, but the trap of Resorbable micro-membrane is nearly between 2 to 24 months.In one embodiment, Obstruct membrane of the present invention can be absorbed (for example being absorbed by mammiferous health) in a period of time, for example in mammiferous health, use in 10 to 20 week of Obstruct membrane from beginning, or in 20 to 30 week, perhaps according to other embodiment, it is up to 18 months, or up to 24 months or more a plurality of months.This Resorbable micro-membrane can be absorbed into to a certain degree in patient's body, the degree that its essential intensity no longer existed during nearly a year.The absorption fully of Resorbable micro-membrane can betide after after the use 1.5 to 2 years subsequently.At other embodiment, Resorbable micro-membrane can comprise nonabsorbable or metallics in whole or in part.
This mocromembrane is used in some surgical operations and uses; comprise the surgical repair of fracturing at the bottom of the eye socket; the surgical repair of nasal septum and perforation of ear drum mocromembrane; as the protection sheath that helps skeletonization; the surgical repair of urethral anatomy and the surgical repair of urethral stricture; in complete corrective procedure, prevent bony union) in order to skull fusion and forearm fracture; reduce soft tissue fibrosis and hyperosteogeny, in prosthesis by stages as the temporary covering of the antenatal omphalitis of breaking; periodontal regenerative art between tooth and gingival margin; tympanum is repaired; dura mater covering and neural repairing; cardiovascular is repaired; inguinal hernia is repaired; the tendon anastomosis; temporary transient joint pad; wound dressing; the cicatrix covering; and the covering that splits as abdomen.Mocromembrane of the present invention is particularly suitable for preventing that postoperative from organizing improper Colaesce, and it can cause improper cicatrix and/or influence normal physiological function.In some example, such cicatrix can influence and/or interfere with subsequent operation, rectification or other surgical operation.
The absorption rate of thicker film than using same material, these films with extremely thin structure can quicken the absorption rate of this film significantly.Yet, it is generally acknowledged that it is too fast that film absorbs the speed of human body into, can produce the decline of not expecting at partial pH-value in some cases, thereby cause/promote for example local inflammation, uncomfortable and/or external antibody response.In addition, in case produce the mocromembrane on the surface of uneven (for example break, damaged, coarse or peel off), degraded for example can cause producing tissue upheaval between tissue too early before treatment fully, it may cause tissue inflammation and/or cicatrix, be stained with glutinous formation with tissue, therefore can't realize the purpose of Obstruct membrane.At other example, different (for example more rapidly) traps may be one or more zones of patient, and/or need at one or more operating one or more time points, therefore, according to purpose of the present invention, absorption rate may be different because of time and/or space, or cause its external form difference by material or the part material that changes film.
Can provide mocromembrane of the present invention with rectangular shape, for example all be several centimeters, maybe can cut or form other special shape, structure and size, via before packing and sterilization, cutting by manufacturer on each limit.In the embodiment of improvement, various known prescriptions and copolymer are for example had lactic acid, may influence the physical property of mocromembrane.Mocromembrane of the present invention has enough flexibles, thereby can be fitted on the anatomical structure and/or around anatomical structure, can reach effect same but must heat just in hot bath for some thicker structures.In the embodiment of improvement, some aforementioned thicknesses (for example 0.25 millimeter) become harder and frangible polylactic acid with because other polymer formation and limpen polylactic acid, copolymer and/or monomer, ε-caprolactone for example can be used for forming mocromembrane.
In addition, according to another object of the present invention, mocromembrane can comprise the material in order to cell control, for example in order to influence the chemotactic substance of cell migration, in order to influencing the inhibiting substances of cell migration, in order to influencing the mitotic growth factor of cell proliferation, and the somatomedin that influences cell differentiation.These materials may be arranged on the film and/or flow in the film, but also may be coated on one or more surfaces of film.In addition, these materials may be contained in the separative element on the film or in the film, and it can help the selectivity of material to discharge when film is inserted patient effectively.Can form other in order to meet the micromembrane configuration of different anatomical structures.For instance, micromembrane configuration can design and form for example pyramidal structure, to attach around essential part by the projection that is extended by the central authorities of film.Sew up perforation and around mocromembrane, form, and cell and blood vessel through hole may also can form.
In general, any data of described in the invention or reference, feature or its are in conjunction with (all or part of, structure or step) can in any file that the present invention mentions, describe or the data of reference in conjunction with any, feature and combination thereof are (all or part of, structure or step), comprise U. S. application number 11/203,660 with U.S. Provisional Application number 60/966,861 and/or U. S. application number 10/019, (whole or part such as 797 application cases such as grade, any the ordinary technical staff in the technical field of the invention in conjunction with or combination be considered as may or improvement become possible combination and combination, in structure or step, be provided at data or feature in the not conflicting combination of any of these), but not as limit.Each patent application in these patent applications all is incorporated into the application as a reference clearly.
According to one embodiment of present invention, preformed mocromembrane can be pre-formed and be sealed in the aseptic packing, in order to carry out follow-up use by the surgeon.Because the purpose of mocromembrane of the present invention can reduce sharp-pointed edge and surface, be pre-formed this film and be considered to help to make the edge slyness to reduce friction, to organize upheaval and inflammation, although the degree that helps in some example is less.In other words, the surface of mocromembrane and any sharp-pointed surface are considered to can be as time passes and because of film is exposed to the reaction of dampness in the air, and decompose very slightly, thereby form the edge of circle.This is considered to a kind of very little reaction.In addition, any before inserting initial heating cutting film in advance and can further make any sharp-pointed edge slyness to vitrification point.In addition, to these phenomenons, mocromembrane of the present invention is at least in theory may be especially responsive, and, perhaps on the degree that more attracts people's attention, tear and injure sensitivity to what come by processing, can help keeping its integrity thereby make to be pre-formed.
According to one object of the present invention, operation prosthese (for example can absorb scar tissue reduction mocromembrane system) can comprise and be stained with glutinous inhibition zone (biological example degradable zone, biology can decompose side form and/or mocromembrane), as described herein, and may comprise optionally give birth to the zone in the tissue) (for example another film, transition film, biodegradable zone and/or the biology quoted as this paper can decompose side or net sheet).
Operation prosthese (biological example degradable operation prosthese) can be built as the reparation that is used for the soft tissue defective, and for example owing to otch hernia and the caused soft tissue defective of other hernia, and because tumor is removed the soft tissue defective that operation causes.The operation prosthese also can be used to cancer operation, relates to the sarcoma of extremity and is target to preserve a limb as operation.Other application of operation prosthese of the present invention comprises that peritoneoscope is repaired or at the standard hernia repair of inguinal region, umbilical hernia is repaired, pour hernie parastomiale is repaired, femoral hernia is repaired, the repairing of waist hernia repair and other stomach wall defective, thoracic wall defective and diaphragm (diaphragmatic) hernia and diaphragm defective etc.
According to one object of the present invention, give birth in the tissue zone be stained with glutinous inhibition zone may be at (A) appearance and (B) neither identical on the function of surface.For example, giving birth to the zone in the tissue can be formed by at least one surface topography (outward appearance) and a surface composition (function) construction, one of them can help its intensity, persistence or shortage degree, and/or a large amount of fibroblast reaction in host tissue, for example with respect to being stained with a large amount of fibroblast reaction that sticks in the regional host tissue as resisting.On the other hand, being stained with glutinous inhibition zone can be formed by at least one surface topography and a surface composition construction, one of them, regional with respect to giving birth in the tissue, help anti-between absorbable biological degradable surgery implant and the host tissue to be stained with glutinous effect.
A. surface topography (outward appearance):
Give birth in the tissue zone can form have opening, non-smooth and/or distinctive surface, it comprises, for example even or non-alveolar (bubble) and/or the pore (hole) that all distributes.In embodiment further, give birth to the zone in the tissue and can form the surface of unevenness (for example break, damaged, coarse or peel off), as the surface of foregoing description, it can cause the tissue upheaval (for example potential tissue inflammation and/or cicatrix) of giving birth in host tissue and the tissue between the zone.
As time passes, be relevant to and give birth to the zone in the tissue, patient's fibrous tissue and collagen tissue can be significantly given birth to the zone, are longly given birth on the zone in tissue and be fixed in the tissue living regional in tissue with fully covering with in the tissue.In one embodiment, give birth to the zone in the tissue and comprise most macroscopic alveolars (bubble) or slit, by or pass these alveolars (bubble) or slit, host tissue can grow with obtain firm fixing.
As an example, pore (or hole) can be formed on gives birth in the tissue among the zone, by puncher perforation or other machine drilling, or by using the laser energy perforation.Non-smooth surface can be by for example forming to give birth to the zone in relative course surface (have the sand paper count be 40 or the surface of the similar sand paper of the preferably higher sand paper count) tissue abrasion, perhaps, non-smooth surface can be heated and (uses same sample to its softening temperature or fusing point and with lamina membranacea by giving birth to the zone in will organizing, the surface of similar sand paper) its impression is produced, this impression can carry out in incipient forming process or in later time.
On the other hand, being stained with glutinous inhibition zone can be made into and have surface sealing, successional, slick and/or imporosity.In one embodiment, the some of being stained with glutinous inhibition zone at least is slick, does not comprise the hole (pore) of projection, alveolar (bubble) or blood vessel penetrance, so can reduce glutinous generation of being stained with of giving birth in the tissue between zone and the host tissue.
In the embodiment of an improvement, can form the extruding of a side, in order to produce in any aforesaid tissue the surface of giving birth to the zone, can form the extruding of other side and produce the surface of being stained with glutinous inhibition zone as aforesaid.Can add additional features (for example coarse or formation slit) afterwards and, for example give birth to the surface in zone in the tissue with its surface of further definition.In the embodiment of extrusion molding, can form the delivery outlet of (for example ribbed or have rib) side, (wherein subsequent treatment can further define this surface in order to produce the interior living region surface of tissue, for example by adding cross rib (stricture of vagina)/feature) and/or alveolar (bubble)), and form the delivery outlet (for example ribbed or have rib) of other side, be stained with the glutinous biodegradable region surface that suppresses in order to generation.In one embodiment, be stained with glutinous inhibition zone and be extruded with smooth surface, and in another embodiment, behind extrusion molding, be stained with glutinous inhibition zone and further handled (for example smoothing).
B. surface composition (function):
As what present at present, give birth to the zone in the tissue and comprise first material, comprise second material different and be stained with glutinous inhibition zone with this first material.In the embodiment of improvement, give birth to the zone in the tissue and stick the inhibition zone and can comprise identical or substantially the same material with being stained with.In other embodiments, give birth to the zone in the tissue and be stained with glutinous inhibition zone and can comprise different material, for example owing at least one tissue, give birth to the zone and be stained with the different material that the adding additive causes in the glutinous inhibition zone.
According to one embodiment of present invention, be stained with glutinous inhibition zone be built as reducing as far as possible host tissue (for example internal organs of inside of human body) to the operation prosthese produce be stained with glutinous.In the embodiment of improvement, may form or form in the glutinous inhibition zone of being stained with of operation prosthese and the tissue with identical material and give birth to the zone with the material of less relatively difference, on function, being stained with glutinous inhibition zone can use together with the anti-inflammatory gel agent, for example during the operation prosthese is implanted, use and be stained with glutinous inhibition zone.According to other general embodiment, be stained with and give birth to the zone in glutinous inhibition zone and the tissue and can form or the combination of any material disclosed herein (comprises embodiment by the disclosed material of any the application, wherein this two zone is total with one deck material) or its equipollent formation, can use together with the anti-inflammatory gel agent and be stained with glutinous inhibition zone, for example during the operation prosthese is implanted, be used in and be stained with glutinous inhibition zone.
Give birth in the tissue zone can aforesaid similar substance and/or different material form, and help its intensity, persistence or shortage degree, and/or carry out direct postoperative cell transplantation, carry out via for example in host tissue, causing fibroblast reaction significantly.In one embodiment, give birth in the tissue that the zone is configured to incorporate in large quantities host tissue and/or in order to increase the structural intergrity of operation prosthese significantly.After the operation prosthese was implanted, tissue (for example subcutaneous tissue and/or outside fascia) begins to merge itself to enter gave birth to the zone in the tissue.Though it is without wanting to be limited by theory, but it is generally acknowledged, human body, in detecting tissue of the present invention, give birth in the existence in zone, tend to send fibrous tissue, this fibrous tissue growth gives birth in tissue in the zone, give birth to the zone in the tissue and/or by giving birth to the zone in the tissue, and it is interior living regional to be wound in tissue to small part.In the method, the operation prosthese can become and is attached at host's bodily tissue securely.
For different materials, according to one object of the present invention, living zone can comprise biodegradable (for example can absorb) polymer composition in the tissue, and it has one or more different qualities than giving birth to regional biodegradable (for example can absorb) the polymer composition that is comprised in the tissue more.These different characteristics may comprise biodegradation time and the speed that (1a) influenced by additive, (1b) biodegradation time or the speed that influenced by polymer architecture/composition, (2) polymer that influences intensity or structural intergrity is formed, and (3) help the ability of fibroblast reaction.
According to a method of the present invention, the operation prosthese can be in order to help to repair for example hernia repair in human abdomen zone.Can provide to have simultaneously and be arranged at the operation prosthese that being stained with on the side sticks the inhibition zone and be arranged at the implantation in the interior living zone of tissue on second side.Stomach wall comprises muscle, and this muscle is by outside fascia and inner fascia and besieged and be fixed in the zone.Internal layer is called peritoneum, can cover the inboard of inner fascia.Peritoneum is softer, a more flexible layer tissue, and it forms the bag shape shell of intestinal and other internal organs.One deck skin and one deck subcutaneous fat cover inner fascia.
Can implement the operative repair of soft tissue defective (for example hernia), by, for example conventional art or advanced laparoscopic procedures, and in order to seal nearly all soft tissue defective.According to an embodiment, otch can be by skin and fat, and afterwards, skin and fat can be stripped from, and the internal organs (not shown) of any protrusion is located in hernia inside subsequently.In certain embodiments, notch shape is formed in the peritoneum, and the prosthese of then will performing the operation inserts the hernia opening, and the prosthese of therefore performing the operation is concentrated and is arranged at the hernia opening.Give birth to the zone in the tissue and be stained with one of them of glutinous inhibition zone or same one deck that both can be attached at stomach wall, for example strongr outside fascia attaches by for example sewing up.Perhaps, be stained with glutinous inhibition zone and can be attached at another film, as inner fascia and/or peritoneum.Give birth to the zone in the tissue and can attach outside fascia with surgical method, can be attached at the interior living zone of tissue and/or optionally be attached at outside fascia and be stained with glutinous inhibition zone, by using for example hot bonding, stitching and/or the disclosed attaching method of the application and other method that equates basically.Those will appreciate that other method in order to gluing/modification/location/attaching operation prosthese of the present invention the ordinary technical staff in the technical field of the invention, can implement according to special operating content.
The size of operation prosthese determines to depend on the size of defective usually.Sew up the incidence rate of using the operation prosthese may reduce pain and postoperative hydrops (postsurgical fluid accumulation) in (tension-free closure) at no tension force.The operation prosthese that typical stitching can be used for being fixed to small part is fixed in the peritoneum structure.This stitching can be implemented this and sew up, so that so that do not have horizontal tension force to be applied on outside fascia and/or the muscle.When interrupting, skin and fat can be got back to its normal position, simultaneously, use suitable method (for example subsurface stitching), for example skin is fit to the method for use, for example subsurface stitching (subsurface sutures) by fixed to one another with another with the notching edge of fat.
In the embodiment of the present invention improvement, give birth to the zone in the tissue of operation prosthese and can be binded (or in the embodiment of improvement, can be attached, for example attach) with one of them or both that are stained with glutinous inhibition zone by heat by stitching.Hot bonding can be passed through, for example bipolar electro-cautery device, ultrasound welding or give birth to the zone and be stained with the similar closure between the glutinous inhibition zone and/or directly center on the closure of organizing and reach in tissue.This device can be used at all places, and for example at the edge and/or at intermediary point, heating operation prosthese is being higher than its vitrification point heating at least, preferably is being higher than its softening temperature heating.This material is heated, and for example together with the contiguous heating of organizing, and makes two parts combine at its interface.Heat is binded also and can be given birth to the zone in being stained with glutinous inhibition zone in the fixing organization for example being used at first.Provide more bearing function since give birth to the zone in the tissue, some typical embodiment can get rid of heat and bind as the unique method that this zone is fixed in host tissue.In other embodiments, operation prosthese heat is bonding on the technology of itself or tissue, can be fixing to strengthen in conjunction with another attaching method.For example, the operation prosthese can temporarily be attached to and use electro-cautery device to carry out in the adherent one or more points of heat, and suture, nailing or glue can be followed (or at other embodiment, alternately) adding and is fixed on the position with the prosthese of will performing the operation.
Give birth to the zone in the tissue and be stained with glutinous inhibition zone and may be arranged in multilamellar or substantial one deck, or these two zones all belong to a discrete whole cambium layer.For example give birth in the tissue zone and relative being stained with stick the inhibition zone can be arranged in two-layer in, one of them zone is arranged at the top of another zone and relative with it.
In one embodiment, give birth to the zone in the tissue and be stained with glutinous inhibition zone and can be combined on the single side of operation prosthese, for example substantially on the single side of the operation prosthese in one deck, wherein, on a side of operation prosthese, these two zones are adjacent one another are.When deviation is arranged slightly, has the operation prosthese of giving birth to the zone in the tissue in its at least one side (and preferably both sides have), can use any fabrication techniques described herein, then, be stained with glutinous inhibition zone on a side of the prosthese of for example performing the operation, by smoothing, filling or alternate manner and (for example form and be coated with or fill with liquid or flowable polymer with the disclosed suitable material of the application or technology, and/or use machinery to carry out smoothing) handle the zone of giving birth to the zone in the tissue, have the glutinous inhibition zone of being stained with of being stained with glutinous inhibit feature thereby form with respect to giving birth to the zone in the tissue.
Same, a fritter be stained with glutinous inhibition zone can standardize and attach (for example heat bind, as using bipolar electro-cautery device, ultrasound welding or other similar attaching method) in one give birth to that zone and host tissue on every side implant in directly at least one tissue during.In the embodiment of improvement, attaching can be by for example pushing or gluing or sew up and to reach.In embodiment further, to the attaching of small part may before packing, make the operation prosthese during take place.This piece is stained with glutinous inhibition zone or may be partly attached (technology of using this section to enumerate) and gives birth between the zone (for example non-edge or zone line) in zone in tissue in for example being stained with the non-edge or the zone line that stick the inhibition zone, make during implanting, be attached at when giving birth to the zone tissue in when being stained with the glutinous biodegradable implant that suppresses, the surgeon can prune and be stained with glutinous inhibition zone (and/or living regional in the tissue).For example, giving birth to the zone in organizing can be around being stained with glutinous inhibition zone on a side of operation prosthese, and living zone is formed on the opposite side of operation prosthese in the tissue and only have.In such an embodiment, the operation prosthese can be changed size and shape, to cover any opening that is caused by the soft tissue defective significantly, attach to and integrate with host tissue at least one side of operation prosthese, the host tissue on the prosthese both sides of preferably performing the operation by giving birth to the zone in organizing with surgical operation.
In the embodiment of improvement, in the specific lip-deep tissue of operation prosthese, to give birth to the zone and/or be stained with glutinous inhibition zone, each can have virtually any size and shape to meet specific soft tissue defective.For example, give birth to the zone in the specific lip-deep tissue of operation prosthese and/or be stained with glutinous inhibition zone wherein any one, shape or other shape that can have ellipse, rectangle and various complexity, wherein, for each such embodiment, these two zones can have substantially the same or different ratios and/or size relative to each other.
Usually, can use various technology to make the operation prosthese, its have usually one or the tissue of two-layer definition in give birth to the zone and be stained with glutinous inhibition zone.Useful technology comprises solvent evaporation method, phase separation method, interface polymerization, extruding formation method, molding method, injection molding method, pressure sintering and the known similar techniques of general technical staff of the technical field of the invention.Give birth to the zone in the tissue and be stained with glutinous inhibition zone and can comprise two different layers or can all be formed together and become one deck.
Give birth to the zone in the tissue and be stained with glutinous inhibition zone and can partly or entirely form or combine.In conjunction with can realizing by mechanical means, for example by sewing up or by using metal clip, hemostatic clamp for example, or realize by alternate manner binds or heat is binded as chemistry.
Provide the foregoing description as example, but the present invention is not limited to these examples.Multiple variation and the improvement of embodiment disclosed by the invention so long as not what repel mutually, all can be expected to the consideration of aforementioned description to those skilled in the art's foundation.In addition, other combination, omission, replacement and modification all are conspicuous to those skilled in the art.As what reaffirm previously, the any feature or the combination of features of the application's description and reference, all be contained in the category of the present invention, as long as the feature that is contained in any such combination does not contradict, although its knowledge by context, this description and those skilled in the art is conspicuous.For example, any implant and implantation parts, inferior parts or using method, with these any details or feature, or further feature, comprising method step and technology, can combine with flow process with other structure of any this paper description or reference in whole or in part.Therefore, the present invention can not limited by the disclosed embodiments, but by define its category with reference to appending claims.

Claims (34)

1. an absorbable scar tissue is reduced the mocromembrane system, be used for putting after surgery and carry out in the body after the operation, reduce or prevent and between the perienchyma of point after the iatrotechnics and vicinity, form the scar after the operation tissue, this system has pre-implant infrastructure, this pre-implant infrastructure is to form the structure that this system is defined as this system before between point after the iatrotechnics and the contiguous perienchyma
This system comprises the basic planar film of absorbable polymer base material, it has first smooth side and second smooth side, the basic planar film of this absorbable polymer base material is included in the absorbable polymer base material of the monolayer between this first smooth side and this second smooth side, the absorbable polymer base material of this monolayer comprises: (a) at least one has the hydrophobicity block in one or more lactic acid and the glycolic acid, and (b) at least one has the hydrophilic block of one or more Polyethylene Glycol, and comprises having one or more triblock copolymers or starlike block copolymer.
2. absorbable scar tissue as claimed in claim 1 is reduced the mocromembrane system, wherein:
The absorbable polymer base material of described monolayer has roughly to be formed uniformly;
The thickness that the absorbable polymer base material of described monolayer is measured between first smooth side and this second smooth side, between about 10 microns to 300 microns:
The absorbable polymer base material right and wrong of described monolayer are porous; And
The absorbable polymer base material of described monolayer is used for keeping the ganoid obstruct between the perienchyma of point and this vicinity after this iatrotechnics, in the time of growing, alleviate effectively or eliminate this iatrotechnics after put and the perienchyma of this vicinity between the formation of scar tissue.
3. an absorbable scar tissue is reduced the mocromembrane system, be used for putting after surgery and carry out in the body after the operation, reduce or prevent and between the perienchyma of point after the iatrotechnics and vicinity, form the scar after the operation tissue, this system has pre-implant infrastructure, this pre-implant infrastructure is defined as the structure of this system before between point and the perienchyma that is close to after this system is formed at iatrotechnics
This system comprises the basic planar film of absorbable polymer base material, it has first smooth side and second smooth side, the basic planar film of this absorbable polymer base material is included in the absorbable polymer base material of the monolayer between this first smooth side and this second smooth side, the absorbable polymer base material of this monolayer comprises: (a) at least one has the hydrophobicity block of one or more lactic acid, glycolic acid or lactic acid and glycolic acid mixture, (b) at least one has the hydrophilic block of one or more Polyethylene Glycol, and comprises one or more four positive block copolymers.
4. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein:
The absorbable polymer base material of described monolayer has roughly to be formed uniformly;
The thickness that the absorbable polymer base material of described monolayer is measured between first smooth side and this second smooth side, between about 10 microns to 300 microns:
The absorbable polymer base material right and wrong of described monolayer are porous; And
The basic planar film of described absorbable polymer base material is positioned in the packing.
5. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, the absorbable polymer base material of wherein said monolayer comprises: (i) have one or the first hydrophobicity block and (ii) a plurality of second hydrophilic block with Polyethylene Glycol of individual a plurality of lactic acid, glycolic acid or lactic acid and glycolic acid mixture
6. absorbable scar tissue as claimed in claim 5 is reduced the mocromembrane system, and the absorbable polymer base material of wherein said monolayer comprises starlike block copolymer.
7. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, the absorbable polymer base material of wherein said monolayer comprises starlike block copolymer, this starlike block copolymer has: (i) the first hydrophobicity polylactic acid/polyglycolic acid block and (ii) three or more the second hydrophilic polyglycol blocks.
8. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, the absorbable polymer base material of wherein said monolayer comprises: the first hydrophobicity block that (i) has at least one Polyethylene Glycol, (ii) a plurality of second hydrophilic blocks, each this second hydrophilic block has one or more lactic acid, glycolic acid or lactic acid and glycolic acid mixture.
9. absorbable scar tissue as claimed in claim 8 is reduced the mocromembrane system, and the absorbable polymer base material of wherein said monolayer comprises starlike block copolymer.
10. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, the absorbable polymer base material of wherein said monolayer comprises starlike block copolymer, this starlike block copolymer has: (i) at least the first hydrophobicity Polyethylene Glycol block and (ii) three or more the second hydrophilic polylactic acid/polyglycolic acid blocks.
11. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, the absorbable polymer base material of wherein said monolayer comprises triblock copolymer or four positive block copolymers, and it comprises: first a hydrophobicity block with one or more lactic acid, glycolic acid or lactic acid and glycolic acid mixture; Second a hydrophilic block with at least one Polyethylene Glycol; And the 3rd hydrophobicity block with one or more lactic acid, glycolic acid or lactic acid and glycolic acid mixture and Polyethylene Glycol.
12. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, the maximum ga(u)ge of the absorbable polymer base material of wherein said monolayer is approximately 100 microns.
13. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, the maximum ga(u)ge of the absorbable polymer base material of wherein said monolayer is approximately 200 microns.
14. absorbable scar tissue reduction mocromembrane as claimed in claim 3 system, the absorbable polymer base material of wherein said monolayer is not have a liquid permeable.
15. absorbable scar tissue reduction mocromembrane as claimed in claim 3 system, the absorbable polymer base material of wherein said monolayer comprises in order to the chemotactic substance that influence cell migration, in order to the inhibitory substance that influences cell migration, in order to the mitotic growth factor that influences cell proliferation, at least a in order in the factor of the somatomedin that influences cell differentiation and promotion angiogenesis.
16. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein said absorbable scar tissue reduction mocromembrane system sealing is in aseptic packing.
17. absorbable scar tissue reduction mocromembrane as claimed in claim 3 system, the absorbable polymer base material of wherein said monolayer comprises the hole that the edge of a plurality of absorbable polymer base materials along this monolayer is provided with.
18. absorbable scar tissue reduction mocromembrane as claimed in claim 3 system, the absorbable polymer base material of wherein said monolayer does not comprise the hole that the edge of any absorbable polymer base material away from this monolayer is provided with.
19. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein said edge extends the absorbable polymer base material around this monolayer.
20. as the absorbable scar tissue reduction of volume as described in the claim 3 mocromembrane system, wherein a slit be formed at this monolayer the absorbable polymer base material around, therefore described edge extends along this slit.
21. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein:
The absorbable polymer base material of described monolayer more comprises a plurality of holes away from this edge;
Each has first diameter near this hole on every side;
Each this hole near central authorities has second diameter; And
This first diameter is greater than this second diameter.
22. absorbable scar tissue reduction mocromembrane as claimed in claim 3 system, wherein a slit be formed at this monolayer the absorbable polymer base material around, therefore described edge extends along this slit.
23. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, the absorbable polymer base material of wherein said monolayer comprises the slit that is arranged in this non-porous base material.
24. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein the absorbable polymer base material of this monolayer is cut into and has suitable size and shape, it is suitable for closely and fits in an anatomical structure anatomically, thereby reduce or prevent that scar tissue is formed at after the iatrotechnics between the point and the perienchyma that is close to, and the absorbable polymer base material of this monolayer is sealed in the aseptic packing.
25. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein the absorbable polymer base material of this monolayer is cut into and has ridge, and is also centered on this anatomical structure by folding on anatomical structure.
26. absorbable scar tissue reduction mocromembrane as claimed in claim 3 system, wherein the absorbable polymer base material of this monolayer comprises at least one and is arranged at indenture in this imporosity base material.
27. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein the absorbable polymer base material of this monolayer comprises a plurality of indentures that are arranged in this imporosity base material.
28. absorbable scar tissue reduction mocromembrane as claimed in claim 3 system, wherein the absorbable polymer base material of this monolayer is cut into and has non-rectangle and non-circular shape, and is sealed in the aseptic packing.
29. absorbable scar tissue reduction mocromembrane as claimed in claim 3 system, wherein this can absorb scar tissue reduction mocromembrane system and also comprises another film, and the maximum ga(u)ge that this another film has is less than 2000 microns and have permeability.
30. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein other film is a transition film.
31. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein other film has liquid permeable.
32. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein other film has cell-penetrating.
33. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein other film has the blood vessel penetrance.
34. absorbable scar tissue as claimed in claim 3 is reduced the mocromembrane system, wherein other film has the thickness between 500 microns and 2000 microns.
CN2009801281438A 2008-06-08 2009-06-08 Block-polymer membranes for attenuation of scar tissue Pending CN102202701A (en)

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US5979508P 2008-06-08 2008-06-08
US61/059,795 2008-06-08
PCT/IB2009/006229 WO2010001250A2 (en) 2008-06-08 2009-06-08 Block-polymer membranes for attenuation of scar tissue

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CA (1) CA2731404A1 (en)
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KR20130021438A (en) * 2010-06-09 2013-03-05 마스트 바이오서저리 아게 Adhesion-resistant surgical access, reinforcement and closure prosthetic

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US5711958A (en) * 1996-07-11 1998-01-27 Life Medical Sciences, Inc. Methods for reducing or eliminating post-surgical adhesion formation
US6211249B1 (en) * 1997-07-11 2001-04-03 Life Medical Sciences, Inc. Polyester polyether block copolymers
DK1588675T3 (en) * 2000-03-10 2008-03-25 Mast Biosurgery Ag Resorbable micro membrane to reduce scar tissue during healing
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CN113116864A (en) * 2019-12-31 2021-07-16 财团法人工业技术研究院 Multilayer film containing medicine and method for forming the same

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MX2010013521A (en) 2011-05-30
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JP2011523878A (en) 2011-08-25

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Application publication date: 20110928