LAMINARY MATERIAL FOR PREVENTING POST-SURGICAL ADHESIONS

Abstract

A laminary material for preventing post-surgical adhesions, a corresponding kit, and a method for preparing such a laminary material. The laminary material includes an adherence layer for adherence to a desired site and an at least essentially parallel spacing layer attached to the adherence layer at a plurality of attachment points. The adherence layer includes a first polymeric film made of a first biodegradable polymer and an adherence coating. The spacing layer includes a second polymeric film made of a second biodegradable polymer. The adherence layer and the spacing layer define a cavity between the two layers, the cavity consisting of a plurality of interconnected compartments, which are defined by the attachment points.

Claims

1. Laminary material for preventing post-surgical adhesions, comprising an adherence layer for adherence to a desired site and an at least essentially parallel spacing layer attached to the adherence layer at a plurality of attachment points, the adherence layer comprising a first polymeric film made of a first biodegradable polymer and an adherence coating, the first polymeric film having an outer surface facing away from the spacing layer and an inner surface facing towards the spacing layer, and at least part of the outer surface of the first polymeric film being coated with the adherence coating, the spacing layer comprising a second polymeric film made of a second biodegradable polymer, the second polymeric film having an outer surface facing away from the adherence layer and an inner surface facing towards the adherence layer, whereby the adherence layer and the spacing layer define a cavity between said two layers, the cavity consisting of a plurality of interconnected compartments, which are defined by the attachment points.

2. Laminary material according to claim 1, wherein the first biodegradable polymer and the second biodegradable polymer are independently from one another selected from the group consisting of polylactic acid; polyglycolic acid; poly (lactic-co-glycolic acid); polyhydroxyalkanoate, polyurethane, cellulose, ethylcellulose, and oxidized cellulose; polycaprolactone ; hyoaluronan; poly (vinyl alcohol); polyanhydrides; and mixtures thereof.

3. Laminary material according to claim 1, wherein the adherence coating is hyaluronan or hyaluronan-based.

4. Laminary material according to claim 1, wherein the adherence layer is at least essentially flat.

5. Laminary material according to claim 1, wherein the adherence layer and the spacing layer define a single cavity between them.

6. Laminary material according to claim 1, wherein each compartment of the cavity has a size of 0.1 mm.sup.2 to 20 cm.sup.2.

7. Laminary material according to claim 1, wherein the cavity contains a filler and/or one or more active agents, the filler being a liquid, a gel or a foam and, independently, the active agent(s) being selected from the group consisting of fibrinolytic agents, anticoagulants, anti-inflammatory agents, antibiotics, analgesics, anesthetics, growth factors, chemotherapeutic agents, weak acids, mono- or polysaccharides, proteins, antineoplastic agents, and mixtures thereof.

8. Laminary material according to claim 1, wherein the spacing layer and/or the adherence layer is/are perforated.

9. Laminary material according to claim 1, wherein the first polymeric film and/or the second polymeric film has/have a thickness of less than 100 m.

10. Laminary material according to claim 1, wherein the outer surface of the first polymeric film and/or the outer surface of the second polymeric film is/are provided with an active coating comprising one or more active agents, the active agent(s) being selected from the group consisting of fibrinolytic agents, anticoagulants, antiinflammatory agents, antibiotics, analgesics, anesthetics, growth factors, chemotherapeutic agents, weak acids, mono- or polysaccharides, proteins, antineoplastic agents, and mixtures thereof, and, independently, the active agent(s) being encapsulated in microspheres.

11. Laminary material according to claim 1, wherein at least one compartment of the laminary material is connected fluid-conductive with a tube having non-perforated surface portion arranged at the outer side of the compartment and a perforated surface portion arranged inside the at least one compartment.

12. Laminary material according to claim 11, wherein the at least a quarter of the volume of the at least one compartment is filled with perforated surface portion of the tube.

13. Laminary material according to claim 11, wherein the tube comprises a super absorbant polymer, optionally comprising X-ray visible particles.

14. Kit for preventing post-surgical adhesions, comprising a laminary material and an adherence coating, the laminary material having an adherence layer for adherence to a desired site and an at least essentially parallel spacing layer attached to the adherence layer at a plurality of attachment points, the adherence layer comprising a first polymeric film made of a first biodegradable polymer, the first polymeric film having an outer surface facing away from the spacing layer and an inner surface facing towards the spacing layer, the spacing layer comprising a second polymeric film made of a second biodegradable polymer, the second polymeric film having an outer surface facing away from the adherence layer and an inner surface facing towards the adherence layer, whereby the adherence layer and the spacing layer define a cavity between said two layers, the cavity consisting of a plurality of interconnected compartments, which are defined by the attachment points, wherein the adherence coating is supplied separately or coated to at least part of the outer surface of the first polymeric film.

15. Kit according to claim 14, further comprising a filler and/or one or more active agents, the filler being a liquid, a gel or a foam and, independently, the active agent(s) being selected from the group consisting of fibrinolytic agents, anticoagulants, anti-inflammatory agents, antibiotics, analgesics, anesthetics, growth factors, chemotherapeutic agents, weak acids, mono- or polysaccharides, proteins, antineoplastic agents, and mixtures thereof.

16. Kit according to claim 14, comprising the laminary material for preventing post-surgical adhesions, comprising an adherence layer for adherence to a desired site and an at least essentially parallel spacing layer attached to the adherence layer at a plurality of attachment points, the adherence layer comprising a first polymeric film made of a first biodegradable polymer and an adherence coating, the first polymeric film having an outer surface facing away from the spacing layer and an inner surface facing towards the spacing layer, and at least part of the outer surface of the first polymeric film being coated with the adherence coating, the spacing layer comprising a second polymeric film made of a second biodegradable polymer, the second polymeric film having an outer surface facing away from the adherence layer and an inner surface facing towards the adherence layer, whereby the adherence layer and the spacing layer define a cavity between said two layers, the cavity consisting of a plurality of interconnected compartments, which are defined by the attachment points.

17. Method for the preparation of a laminary material according to claim 1, wherein a first polymeric film is formed from a first biodegradable polymer, a second polymeric film is formed from a second biodegradable polymer, and a plurality of attachment points between the first and the second polymeric film is formed such that they define a cavity consisting of a plurality of interconnected compartments between them.

18. Method according to claim 17, wherein at least part of an outer surface of the first polymeric film is coated with an adherence coating.

19. Method according to claim 17, wherein the first and/or the second polymeric film is/are perforated.

20. Method according to claim 17, wherein the first polymeric film and/or the second polymeric film is/are prepared by extrusion.

21. Method according to claim 17, wherein a filler and/or one or more active agents is/are introduced into the cavity, the filler being a liquid, a gel or a foam and, independently, the active agent(s) being selected from the group consisting of fibrinolytic agents, anticoagulants, anti-inflammatory agents, antibiotics, analgesics, anesthetics, growth factors, chemotherapeutic agents, weak acids, mono- or polysaccharides, proteins, antineoplastic agents, and mixtures thereof.

22. Method according to claim 17, wherein the outer surface of the first polymeric film and/or the outer surface of the second polymeric film is/are provided with an active coating comprising one or more active agents, the active agent(s) being selected from the group consisting of fibrinolytic agents, anticoagulants, antiinflammatory agents, antibiotics, analgesics, anesthetics, growth factors, chemotherapeutic agents, weak acids, mono- or polysaccharides, proteins, antineoplastic agents, and mixtures thereof.

Description

[0104] FIG. 1 shows one embodiment of the present invention.

[0105] FIG. 1 shows one possible embodiment of the present invention. One compartment 5 of the laminary material 10 according to the present invention is connected fluid-conductive with a tube 15 having non-perforated surface portion 20 arranged at the outer side of the compartment and a perforated surface portion 25 arranged inside the at least one compartment.