TWO-DIMENSIONAL MATERIAL FOR MEDICAL WOUND AREA TREATMENT

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.

Claims

1. A two-dimensional material for medical wound area treatment, comprising: a non-woven fabric made of resorbable polymer filaments; and collagen particles having a particle size I >80 μm, which are arranged on and/or in the non-woven fabric.

2. 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. 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. 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. The two-dimensional material according to claim 1, wherein the two-dimensional material comprises between 0.4 and 80 weight % collagen particles.

6. The two-dimensional material according to claim 1, wherein the two-dimensional material comprises between 0.5 and 25 weight % collagen particles.

7. The two-dimensional material according to claim 1, wherein the collagen particles are arranged on the surface side of the non-woven fabric.

8. 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. The two-dimensional material according to claim 1, wherein the polymer filaments comprise: a polymer based on the monomers lactide, trimetalcarbonate, glycolide, ε-caprolactone and/or 1,4-eioxan-2-one, or polyhydroxybutyrate (PHB); or a mixture of these polymers.

10. The two-dimensional material according to claim 9, wherein the polymer comprises copolymers and terpolymers.

11. 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 % trimethyl carbonate and 5 to 20 weight % ε-caprolactone.

12. 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. The two-dimensional material according to claim 1, wherein the two-dimensional material has a nominal thickness of 50 μm to 3000 μm.

14. The two-dimensional material according to claim 1, wherein the two-dimensional material has a nominal thickness of 80 μm to 500 μm.

15. The two-dimensional material according to claim 1, wherein the two-dimensional material has a nominal thickness of 1000 μm to 2500 μm.

16. A method for producing the two-dimensional material according to claim 1, in which the collagen particles are scattered onto the non-woven fabric, and the non-woven fabric provided with the collagen particles is subsequently calendered.

17. A method for producing the two-dimensional material according to claim 1, in which the collagen particles are suspended in an aqueous solution, and the collagen suspension thus obtained is subsequently applied to the non-woven fabric, wherein the non-woven fabric provided with the collagen particles is finally dried.

18. The method according to claim 17, in which a sugar for stabilizing the collagen particles is added to the solution, or an n-hexane solution is used.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In the drawings:

[0022] FIG. 1 shows a schematic side view of a two-dimensional material according to the invention for medical wound area treatment, comprising a non-woven fabric made of resorbable polymer filaments and comprising collagen particles having a particle size I >80 μm;

[0023] FIG. 2 shows a microscopically enlarged detail view of a two-dimensional material comprising a non-woven fabric and comprising collagen particles, at 250 times magnification;

[0024] FIG. 3 shows a microscopic, enlarged detail of the two-dimensional material according to FIG. 2, at 500 times magnification; and

[0025] FIG. 4 shows a microscopic, enlarged detail of a two-dimensional material in which the non-woven fabric was calendered after scattering-on of the collagen particles.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] FIG. 1 is a schematic sectional view of a two-dimensional material 10 for medical wound area treatment. The two-dimensional material 10 comprises a non-woven fabric 12 made of resorbable polymer filaments 14. The non-woven fabric 12 has a nominal thickness d which can be from 50 to 3000 μm, preferably from 80 to 500 μm or from 1000 to 2500 μm, depending on the mechanical application requirements placed on the two-dimensional material 10. The non-woven fabric 12 can be produced depending on the desired diameter (not denoted in the drawing) of the polymer filaments 14, by means of what is known as the meltblown method or else by means of electrospinning or centrifugal spinning or other known non-woven formation methods for manufacturing micro- or nanofibers.

[0027] The resorbable polymer filaments 14 consist of a resorbable polymer of at least 2 monomers, in particular, a co- or terpolymer based on the monomers lactide, trimethylene carbonate, ε-caprolactone and/or 1,4-dioxan-2-one, polyhydroxybutyrate (PHB) or mixtures of these polymers. The polymer filaments 14 are therefore biocompatible and degradable and completely resorbable in vivo, hydrolytically or by body's own enzymes.

[0028] The two-dimensional material further comprises collagen particles 16 having a particle size I of more than 80 μm. The collagen particles 16 are arranged held on or in the non-woven fabric 12 and serve for improved hemostasis or faster absorption of blood and wound fluid. The collagen particles 16 all consist of comminuted native collagen, for example Type I and/or Type III collagen, and can in particular be of bovine, murine or porcine origin. The collagen particles 14 can have a particle size I of between 80 μm and 500 μm, preferably between 100 μm and 500 μm, particularly preferably between 100 μm and 250 μm.

[0029] Due to the high porosity inherent to the non-woven fabric, a particularly large and rapid bioavailability of the collagen is ensured, so that its functional advantages can be exhausted at an early stage and comprehensively in wound area treatment. These include, in particular, the known hemostatic properties of fibrillar collagen, its swelling capacity in the case of a pronounced absorption capacity of blood and wound exudate, and the favorable effects thereof with respect to rapid vascularization of the wound area and wound healing. The fibrillar collagen particles 16 of the two-dimensional material thus rapidly extract water from a bleeding wound and thus accelerate the hem ostasis. The combination of the collagen particles 16 and the synthetic resorbable polymer non-woven fabric 12 (e.g., polylactide-caprolactone-trimethylene carbonate) combines the positive properties of both materials. The resorbable polymer filaments 14 of the two-dimensional material 10 have direct contact with the wound (e.g., burn wounds) and can improve wound healing by enzymatic release of lactic acid, and develop pain-relieving and anti-infectious action. In practice, it has been found in this case that even low mass fractions of the collagen particles 14 favor the aforementioned effects. In this respect, the two-dimensional material 10 can comprise between 0.4 and 80 wt. % collagen particles 14, preferably between 0.5 and 25 wt. %, very particularly preferably between 0.4 and 2 wt. % collagen particles 14.

[0030] The collagen-containing non-woven fabric 12 is more hydrophilic compared to a structurally identical resorbable non-woven fabric 12 without collagen particles 16, and therefore has less tendency to stick to itself. As a result, the two-dimensional material 10 is easier to handle in clinical practice.

[0031] The non-woven fabric 12 can be doped with the collagen particles 16 in different ways. For example, the non-woven fabric may be doped: by sprinkling with collagen particles 16 and calendering under pressure and heat; or by spraying, painting or rolling on a solution with finely dispersed collagen particles 16 and subsequent drying; or by dipping the non-woven fabric 12 into a collagen suspension and subsequent drying.

[0032] When manufacturing the two-dimensional material 10, preferably dried native collagen of bovine, porcine or also murine origin is comminuted to collagen particles 14 having a particle size greater than 80 μm, preferably greater than 100 μm.

[0033] In a further step, a non-woven fabric made of polymer filaments is produced by means of the meltblow method, electrospinning or centrifugal spinning of a statistical terpolymer of D, l-lactide-trimethylene carbonate-caprolactone.

Example 1—Dry-Coating of the Non-Woven Fabric

[0034] According to a first embodiment, the collagen particles are scattered onto the non-woven fabric 12 and then pressed with the non-woven fabric 12 at 40° C., 10 bar, for 40 sec. A two-dimensional material 10 in which the non-woven fabric 12 comprises, on its surface collagen particles 16 having a grain or particle size I of >80 μm, is obtained, as shown in FIGS. 2 and 3.

Example 2—Wet-Coating of the Non-Woven Fabric

[0035] According to a further embodiment, an aqueous suspension of collagen particles 16 having a particle size >80 μm is provided. Care must be taken here that the size and functionality of the collagen particles 16 are preserved. When the collagen particles 16 are suspended, an extremely gentle, in particular, time-limited stirring is advisable, in order not to further comminute or destroy the collagen particles 16 directly or by shearing. For this purpose, for example a dispersing device of the Ultra Turrax® series from IKA®-Werke GmbH & CO. KG, Germany can be used.

[0036] Subsequently, the non-woven fabric 12 is immersed in the aqueous collagen suspension, or the aqueous collagen suspension is sprayed, rolled or painted onto the non-woven fabric 12.

[0037] Finally, the non-woven fabric 12 doped with the collagen particles 16 is dried, preferably in a vacuum and at room temperature. In this way, a two-dimensional material 10, shown in FIG. 4, is obtained, consisting of a resorbable non-woven fabric 12 comprising collagen particles of >80 μm.