EP2809367A1 - Implant matriciel constitué d'un mélange de polymères - Google Patents

Implant matriciel constitué d'un mélange de polymères

Info

Publication number
EP2809367A1
EP2809367A1 EP13702577.1A EP13702577A EP2809367A1 EP 2809367 A1 EP2809367 A1 EP 2809367A1 EP 13702577 A EP13702577 A EP 13702577A EP 2809367 A1 EP2809367 A1 EP 2809367A1
Authority
EP
European Patent Office
Prior art keywords
mixture
matrix
polymers
porous
implant matrix
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP13702577.1A
Other languages
German (de)
English (en)
Inventor
Martin GÖRNE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bioenergy Capital AG
Original Assignee
Bioenergy Capital AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bioenergy Capital AG filed Critical Bioenergy Capital AG
Priority to EP13702577.1A priority Critical patent/EP2809367A1/fr
Publication of EP2809367A1 publication Critical patent/EP2809367A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/26—Mixtures of macromolecular compounds
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body

Definitions

  • the present application relates to porous matrices for surgical purposes.
  • Cell implants based on porous matrices of biocompatible polymers are known from WO 2004/108810 AI.
  • the pores are cross-linked and serve as a template for the location of cells in vivo (eg, therapeutically) or in vitro (eg, diagnostically).
  • in transplantation such bioresorbable matrix ⁇ for temporary localization of the transplant and as a placeholder for gradually forming fabric can be used.
  • the known templates are not yet fully satisfactory in some applications, in particular with regard to the clinical results.
  • the invention therefore sets itself the goal of achieving an improvement in the clinical performance of the template.
  • the invention proposes a porous template of a mixture of different rapidly degradable polymers, wherein nominal absorption times of two of the mixture components, each of which accounts for at least 10% of the mixture differ by a factor of at least 5.
  • nominal absorption times of two of the mixture components each of which accounts for at least 10% of the mixture differ by a factor of at least 5.
  • the invention proposes methods for the production of porous bioresorbable matrices, wherein a mixture of at least two polymers which can be absorbed at different rates and a water-soluble pore former and a solvent for one of the polymers, followed by evaporation of the solvent and watering for pore formation.
  • the mixture is compacted after evaporation of the solvent. Both methods result in highly porous polymer matrix discs whose clinical performance is outstanding.
  • the degradation times of the polymers differ by a factor of 5 or more.
  • matrices are provided for defect coverage, such as hernia dehiscence. It is envisaged that a first portion of the polymer mixture used is degraded faster and erodes another part of the polymer mixture more slowly (ratio of degradation times at least 5) and the structural cohesion longer time, z. B. 2.5-3 years (or at least 2 and / or less than 5 years) guaranteed. By gradually dissolving the faster degradable portion of the matrix within 3-4 months, or at least 2 and / or less than 7 months, the physiological milieu is influenced in a manner conducive to therapeutic success.
  • Such polymers are useful based on ct-hydroxy carboxylic acids such as lactic acid and / or glycolic acid, eg. PLA or PLGA.
  • the polymers used here are z. Available from the company Evonik and bear the designations L210s, L210, L09s, L207s, L206s (slower degradable PLGA polymers) and RG502, RG502H, RG505 (faster degradable PLGA polymers).
  • the matrices according to the invention are produced mechanically sufficiently stable that they z.
  • the matrices can thereby be connected to body tissue. Their porosity ensures that the matrices are infiltrated with connective tissue cells.
  • the matrix has a pore-poor or free side which provides the actual cover and a pore-rich which is favorable for infiltration.
  • the smoother, low-pore side can be arranged facing the interior of the body in order not to provide a point of attack when pressure is exerted by the body organs on the defect site.
  • the matrix is previously infiltrated, for example, with hepatocytes and / or with Langerhans' islet cells.
  • biochemical function cells attach to the inner walls of the pores of the foamy matrix (attachment rates over 80% or, suitably coated, over 95%) and can be transplanted with the matrix into mesothelial pockets, ideally the cell donor itself In this case, no rejection reaction takes place, but only a comparatively mild, for the therapeutic process favorable foreign body stimulus is exercised.
  • the matrix becomes vascularized and the implanted cells no longer rely on diffusive supply.
  • the matrices are arranged so that the pore-poor (or -free) side is on the inside and the pore-rich side on the outside to keep the loss rate low due to the migration of the cells.
  • a solution of one of the polymers used in chloroform approved for medical purposes is poured into a mold and the solvent is evaporated off at 45 ° -65 °.
  • a polymer mixture of defined particle size distribution is mixed with a saline granules also defined particle size distribution, mixed with a solution of one of the polymers in chloroform and then added to the polymer layer already prepared.
  • the solvent evaporates at a slightly elevated temperature (45-65 ° C) from; then he can if desired, be compacted by applying pressure. Subsequently, the compact is watered to provide the desired porosity by removing the salt. In this case, an initially produced polymer layer remains pore-free.
  • the thickness of the low-pore layer can be adjusted by the amount and concentration of the initial solution.
  • the filling height is about 5-50 mm, typically 20-25 mm.
  • the evaporation of the chloroform then takes about 1.5 h and results in a layer thickness of about 0.5-2 mm.
  • the resulting membrane has a thickness of only about 10-20 ⁇ ⁇ has.
  • the saline particles of the pore-forming mixture are slightly coarser (median at 400-420 ⁇ ) than the polymer particles (median of the slower degradable polymer between 210 ⁇ and 230 ⁇ , that of the faster degradable polymer between 150 ⁇ ⁇ and 170 ⁇ ).
  • the distribution widths (5% / 95%) are similar, namely about ⁇ 85-95 ⁇ for salt or polymer in total.
  • the distribution form can be bi- or trimodal.
  • the composition of the layer mixture is about 96% salt, 1-1.5% solid polymer and another about 3-5% dissolved polymer, wherein the volume fractions of solids and liquid are about the same. Overall, the proportion of the rapidly degradable polymer is only about 5-20% of the polymer.
  • the total thickness of the pore-forming layer is 4-5 mm.
  • the salt can be chosen somewhat finer (median about 350-370 ⁇ ). In this case, the total thickness of the pore-forming layer is 5-6 mm.
  • the water lasts about 24 h and is followed by drying at 45-50 ° C.
  • a matrix as described above may serve to fix cells exposed to agents in a bioreactor.
  • defined cell types can be examined in this way to see if they are applicable Medication or not, and the therapy can be planned depending on the results obtained in this way.
  • drug development can be simplified ver ⁇ because toxicity is detected early.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Botany (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Dispersion Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Implant matriciel poreux constitué principalement d'un mélange de polymères à durée de dégradation différente, les durées de résorption nominales de deux des constituants du mélange, représentant chacun au moins 10 % du mélange, se différenciant à raison d'un facteur d'au moins 5. Ledit implant matriciel poreux est produit à partir d'un mélange des au moins deux polymères à durée de dégradation différente, des particules des deux polymères étant mélangées avec des particules d'une matière solide hydrosoluble et avec un solvant pour l'un des polymères, et étant compactées si nécessaire après évaporation du solvant, la matière solide étant alors éliminée par lavage à l'eau.
EP13702577.1A 2012-02-01 2013-02-01 Implant matriciel constitué d'un mélange de polymères Withdrawn EP2809367A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP13702577.1A EP2809367A1 (fr) 2012-02-01 2013-02-01 Implant matriciel constitué d'un mélange de polymères

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP20120000658 EP2623134A1 (fr) 2012-02-01 2012-02-01 Matrice d'implant à base d'un mélange polymère
EP13702577.1A EP2809367A1 (fr) 2012-02-01 2013-02-01 Implant matriciel constitué d'un mélange de polymères
PCT/EP2013/000328 WO2013113517A1 (fr) 2012-02-01 2013-02-01 Implant matriciel constitué d'un mélange de polymères

Publications (1)

Publication Number Publication Date
EP2809367A1 true EP2809367A1 (fr) 2014-12-10

Family

ID=47664235

Family Applications (2)

Application Number Title Priority Date Filing Date
EP20120000658 Withdrawn EP2623134A1 (fr) 2012-02-01 2012-02-01 Matrice d'implant à base d'un mélange polymère
EP13702577.1A Withdrawn EP2809367A1 (fr) 2012-02-01 2013-02-01 Implant matriciel constitué d'un mélange de polymères

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP20120000658 Withdrawn EP2623134A1 (fr) 2012-02-01 2012-02-01 Matrice d'implant à base d'un mélange polymère

Country Status (2)

Country Link
EP (2) EP2623134A1 (fr)
WO (1) WO2013113517A1 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5522895A (en) * 1993-07-23 1996-06-04 Rice University Biodegradable bone templates
JP4975432B2 (ja) 2003-06-06 2012-07-11 ヒューマンオートセル ゲーエムベーハー マトリクス、細胞インプラント並びにそれらの調製方法及び使用方法
US8529625B2 (en) * 2003-08-22 2013-09-10 Smith & Nephew, Inc. Tissue repair and replacement
DE102004059169A1 (de) * 2004-12-08 2006-06-22 Humanautocell Gmbh Verfahren zum Testen von Substanzen an Biomatrices

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2013113517A1 *

Also Published As

Publication number Publication date
EP2623134A1 (fr) 2013-08-07
WO2013113517A1 (fr) 2013-08-08

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