Search

US-12616772-B2 - Two-dimensional material for medical wound area treatment

US12616772B2US 12616772 B2US12616772 B2US 12616772B2US-12616772-B2

Abstract

A two-dimensional material for the medical wound area treatment is disclosed. A non-woven fabric consists of resorbable polymer filaments and collagen particles which have a particle size I>80 μm and are disposed on and/or in the non-woven fabric.

Inventors

  • Heinrich Planck
  • Erhard Mueller
  • Svenja Reimer
  • Christian Planck

Assignees

  • POLYMEDICS INNOVATIONS GMBH

Dates

Publication Date
20260505
Application Date
20230601
Priority Date
20201203

Claims (19)

  1. 1 . A method for producing a two-dimensional material for medical wound area treatment, comprising the steps of: providing a non-woven fabric made of resorbable polymer filaments; providing collagen particles having a particle size I>80 μm; scattering the collagen particles onto the non-woven fabric, the collagen particles which are then arranged on and/or in the non-woven fabric; and subsequently calendering the non-woven fabric with the collagen particles.
  2. 2 . The method for producing the two-dimensional material according to claim 1 , wherein the collagen particles have an average particle size in the range between 80 μm and 500 μm.
  3. 3 . The method for producing the two-dimensional material according to claim 1 , wherein the collagen particles have an average particle size in the range between 100 μm and 250 μm.
  4. 4 . The method for producing the two-dimensional material according to claim 1 , wherein the collagen particles have an average particle size in the range between 100 μm and 150 μm.
  5. 5 . The method for producing the two-dimensional material according to claim 1 , wherein the two-dimensional material comprises between 0.4 and 80 weight % collagen particles.
  6. 6 . The method for producing the two-dimensional material according to claim 1 , wherein the two-dimensional material comprises between 0.5 and 25 weight % collagen particles.
  7. 7 . The method for producing the two-dimensional material according to claim 1 , wherein the collagen particles are arranged on the surface side of the non-woven fabric.
  8. 8 . The method for producing the two-dimensional material according to claim 1 , wherein the collagen particles are produced from native, bovine, Type I and/or Type III collagen.
  9. 9 . The method for producing the two-dimensional material according to claim 1 , wherein the polymer filaments comprise: a polymer selected from the group consisting of the monomers lactide, trimethylene carbonate, glycolide, ¿-caprolactone and/or 1,4-eioxan-2-one, or polyhydroxybutyrate (PHB); or a mixture of these polymers.
  10. 10 . The method for producing the two-dimensional material according to claim 9 , wherein the polymer comprises copolymers and terpolymers.
  11. 11 . The method for producing the two-dimensional material according to claim 9 , wherein the polymer filaments comprise a terpolymer of 65 to 87 weight % lactide, 5 to 20 weight % trimethylene carbonate and 5 to 20 weight % ε-caprolactone.
  12. 12 . The method for producing the two-dimensional material according to claim 11 , wherein the monomers lactide, trimethylene carbonate and ε-caprolactone are present in the terpolymer in the range of 87/8/5 to 70/20/10 weight %.
  13. 13 . The method for producing the two-dimensional material according to claim 1 , wherein the two-dimensional material has a nominal thickness of 50 μm to 3000 μm.
  14. 14 . The method for producing the two-dimensional material according to claim 1 , wherein the two-dimensional material has a nominal thickness of 80 μm to 500 μm.
  15. 15 . The method for producing the two-dimensional material according to claim 1 , wherein the two-dimensional material has a nominal thickness of 1000 μm to 2500 μm.
  16. 16 . The method according to claim 1 , wherein calendering the non-woven fabric with the collagen particles is done with a heat input.
  17. 17 . The method according to claim 1 , wherein the method to produce the two-dimensional material does not include a wet coating.
  18. 18 . A method for producing a dry two-dimensional material for medical wound area treatment, comprising the steps of: providing a non-woven fabric made of resorbable polymer filaments; providing collagen particles having a particle size I>80 μm; suspending the collagen particles in an aqueous solution forming a collagen suspension; subsequently applying the collagen suspension to the non-woven fabric; and subsequently drying the non-woven fabric with the collagen suspension.
  19. 19 . The method for producing the two-dimensional material according to claim 18 , in which a sugar for stabilizing the collagen particles is added to the solution, or an n-hexane solution is used.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This continuation application claims priority to PCT/EP2021/084219 filed on Dec. 3, 2021 which has published as WO 2022/117844 A1 and also the German application number 10 2020 215 320.5 filed on Dec. 3, 2020, the entire contents of which are fully incorporated herein with these references. FIELD OF THE INVENTION The present invention relates to a two-dimensional material for medical wound area treatment. BACKGROUND OF THE INVENTION In medical practice, resorbable two-dimensional materials have become established, which are used, for example, as a skin substitute material in burn wounds or also for the treatment of what is known as degloving, i.e., of avulsion wounds of the skin. Such a two-dimensional material is known, for example, from EP 1 181 941 A2 and is marketed by PolyMedics Innovations GmbH, Germany, under the name Supratel Suprathel® In open wound area treatment, the known resorbable two-dimensional material offers pain-relieving and anti-infectious effects and permits a largely undisturbed formation of granulation tissue with at the same time good mechanical properties. However, the two-dimensional material has only a slow adsorption and absorption capacity of the fluids on wound surfaces that are bloody or wetted with exudate, as a result of which the hemostatic effect of the two-dimensional material is limited. SUMMARY OF THE INVENTION It is therefore the object of the invention to specify a two-dimensional material for medical wound area treatment which has improved hemostatic properties. The object relating to the two-dimensional material is achieved by a two-dimensional material having the features specified in claim 1. Preferred developments of the invention are specified in the dependent claims and in the description. According to the invention, the two-dimensional material comprises a non-woven fabric made of resorbable polymer filaments, in or on which collagen particles having a particle size of more than 80 μm are arranged. Due to the swelling capacity of fibrillar collagen, i.e., collagen that is intact in its secondary or tertiary structure, the binding of water to the covering membrane can be accelerated and the water binding capacity of the covering membrane per unit area can be increased. In this case, structurally intact collagen is understood in the present application to mean such collagen of which the α and β bands are detectable in SDS-PAGE test. Due to the fact that the collagen particles are anchored in or on the, in turn water-absorbing, highly porous non-woven fabric made of resorbable polymer filaments, excess blood plasma and/or wound exudate can be removed more quickly and more effectively from the wound area in the case of wound area application. In addition, the highly porous non-woven fabric not least makes it possible to provide particularly rapid bioavailability of the collagen particles of the two-dimensional material. In the case of wound contact of fibrillar collagen, it is known that the binding of the von Willebrand factor (VWF) to the fibrillar collagen and to the corresponding receptor of the thrombocyte membrane of thrombocytes and the adhesion of thrombocytes is promoted. The emptying of thrombocyte granules (degranulation) can be enhanced, and thus the plasmatic blood clotting (secondary hemostasis) can be triggered or amplified. This is advantageous for accelerated and effective hem ostasis, and is not the case when nanoscale collagen particles are used of which the α- and β bands are no longer detectable in SDS-PAGE test. Overall, the hemostatic properties of the two-dimensional material can be further improved thereby, and a vascularization of the wound area and thus the wound healing overall can be accelerated. In the case of a correspondingly flexibly deformable design of the two-dimensional material, this can easily be adapted in a simple manner to wound areas of the skin that are regularly difficult to cover, for example in the region of joints. The collagen particles preferably have a particle size in the range from 80 μm to 500 μm, more preferably in the range from 100 μm to 250 μm, very particularly preferably in the range from 100 μm to 150 μm. It has surprisingly been found in practice that the hemostatic effect of the collagen in situ decreases beyond an average particle size of approximately 500 μm, and the anchoring of the collagen on the non-woven fabric is no longer sufficiently stable relative to the mechanical forces acting during the handling and application of the two-dimensional material. This can result in undesired detachment of the collagen particles from the non-woven fabric. In the case of the particle size between 100 μm to 150 μm, a particularly reliable hemostasis can be achieved. According to a particularly preferred development of the invention, the two-dimensional material comprises 0.4 to 80 wt. %, preferably 0.5 to 25 wt. %, collagen particles. It should be noted that the improve