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US4606337A Expired / Lapsed US ⏱️ 0.0 years remaining

Resorptive sheet material for closing and healing wounds and method of making the same

Assignee: Serapharm GmbH and Co KG
•
Filing: 1983-04-19
•
Granted: 1986-08-19
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Expires: 2003-04-19
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Abstract

Abstract A resorptive sheet material for closing and healing wounds substantially consists of a glycoprotein matrix containing substances which cause and, respectively, are conducive to the coagulation of blood including fibrinogen and thrombin. The sheet material is dry and of multi-layered structure, wherein at least one layer is free from thrombin and contains in the glycoprotein matrix thereof the fibrinogen in a substantially homogeneously distributed form, and at least one further layer is free from fibrinogen and contains in the glycoprotein matrix thereof the thrombin in a substantially homogeneously distributed form. The glycoproteins coming into consideration, above all, are non-linked fibrin, fibrin fission products, collagen, globulin, myoglobulin, casein and/or albumin. Preferably, at least one of the layers, especially one or both outer layer(s), contains fibroblast cells present in dry state and/or agents conducive to the growth of the fibroblasts and their spreading-in, especially chondroitin sulphate. For the production, fibrinogen is added to a thrombin-free, predominantly aqueous solution and/or suspension of the glycoprotein and said solution and/or suspension is processed to form a sheet-material layer, and onto the full surface of this layer at least one further layer is applied which, in its turn, has been obtained from a further, fibrinogen-free and thrombin-containing solution and/or suspension of the same or of another glycoprotein. In particular, a solution and/or suspension of one composition is applied onto an inert surface, where it is subjected to deep-freezing, and onto the resultant ice-layer surface, when still in the deep-frozen state, a solution and/or suspension of different composition is applied and subjected to deep-freezing, and, finally, all layers are jointly subjected to lyophilization.

Inventors

  • 👤 Eberhard Zimmermann
  • 👤 Michael Stroetmann

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 20:08
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/50; A61L27/60; Y; Y10; Y10S; Y10S602/00; Y10S602/90

Claims Analysis

Total Claims: 56
Claim 1
Independent Claim 104 words
A resorptive sheet material for closing and healing wound(s) consisting essentially of a glycoprotein matrix containing substances which cause and respectively, are conducive to the coagulation of blood, including fibrinogen and thrombin, wherein the sheet material is dry and of multi-layered structure; at least one layer is free from thrombin and contains in the glycoprotein matrix thereof, the fibrinogen in a substantially homogeneously distributed form; and at least one further layer is free from fibrinogen and contains in the glycoprotein matrix thereof, the thrombin in a substantially homogeneously distributed form and said thrombin containing layer is to be applied directly on to said wound(s).
Claim 2
Dependent Claim 104 words
A resorptive sheet material for closing and healing wound(s) consisting essentially of a glycoprotein matrix containing substances which cause and respectively, are conducive to the coagulation of blood, including fibrinogen and thrombin, wherein the sheet material is dry and of multi-layered structure; at least one layer is free from thrombin and contains in the glycoprotein matrix thereof, the fibrinogen in a substantially homogeneously distributed form; and at least one further layer is free from fibrinogen and contains in the glycoprotein matrix thereof, the thrombin in a substantially homogeneously distributed form and said thrombin containing layer is to be applied directly on to said wound(s).
Claim 3
Dependent Claim 20 words
A sheet material as claimed in claim 1 wherein at least one layer contains fibroblast cells present in dry state.
Claim 4
Dependent Claim 34 words
A sheet material as claimed in claim 2 wherein at least one layer contains in addition, an agent other than thrombin, which is specifically conducive to the growth or spreading-in, or both, of fibroblasts.
Claim 5
Dependent Claim 34 words
A sheet material as claimed in claim 1 wherein at least one layer contains in addition, an agent other than thrombin, which is specifically conducive to the growth or spreading-in, or both, of fibroblasts.
Claim 6
Dependent Claim 30 words
A sheet material as claimed in any one of claims 3 or 4 wherein the agent specifically conducive to the growth or spreading-in of fibroblasts, or both is chondroitin sulphate.
Claim 7
Dependent Claim 20 words
A sheet material as claimed in any one of claims 1, 2, or 4 wherein the sheet material is double-layered.
Claim 8
Dependent Claim 35 words
A sheet material as claimed in claim 6 wherein each layer of the double-layered sheet material has a foam or fleece structure; and each layer has a layer thickness ranging from 1 to 5 mm.
Claim 9
Dependent Claim 35 words
A sheet material as claimed in claim 3 wherein each layer of the double-layered sheet material has a foam or fleece structure; and each layer has a layer thickness ranging from 1 to 5 mm.
Claim 10
Dependent Claim 21 words
A sheet material as claimed in any one of claims 1, 2, 3, or 4 wherein the sheet material is three-layered.
Claim 11
Dependent Claim 54 words
A sheet material as claimed in claim 9 wherein the centrally disposed layer of the three-layered sheet material is free from thrombin and contains the fibrinogen in a substantially homogeneously distributed form; each outer layer is free from fibrinogen; and at least one outer layer contains the thrombin in a substantially homogeneously distributed form.
Claim 12
Dependent Claim 22 words
A sheet material as claimed in claim 2 wherein the fibroblast cells are contained in at least one of the outer layers.
Claim 13
Dependent Claim 44 words
A sheet material as claimed in any one of claims 3 or 4 wherein the fibroblast cells or the agent specifically conducive to the growth or spreading-in of fibroblasts, or both, or mixtures thereof, are contained in at least one of the outer layers.
Claim 14
Dependent Claim 22 words
A sheet material as claimed in claim 5 wherein said chondroitin sulphate is contained in at least one of the outer layers.
Claim 15
Dependent Claim 46 words
A sheet material as claimed in claim 9 wherein the glycoprotein of the centrally disposed layer differs from that of the outer layers in at least one property selected from the group of chemical identity, density, layer thickness, degree of polymerization, and stability under mechanical load.
Claim 16
Dependent Claim 46 words
A sheet material as claimed in claim 11 wherein the glycoprotein of the centrally disposed layer differs from that of the outer layers in at least one property selected from the group of chemical identity, density, layer thickness, degree of polymerization, and stability under mechanical load.
Claim 17
Dependent Claim 28 words
A sheet material as claimed in claim 9 wherein the centrally disposed layer of the three-layered sheet material is of greater layer thickness than the outer layers thereof.
Claim 18
Dependent Claim 28 words
A sheet material as claimed in claim 10 wherein the centrally disposed layer of the three-layered sheet material is of greater layer thickness than the outer layers thereof.
Claim 19
Dependent Claim 51 words
A sheet material as claimed in claim 9 wherein all layers of the three-layered sheet material have a foam or fleece structure; the centrally disposed layer has a layer thickness ranging from 3 to 8 mm; and the outer layers each have a layer thickness ranging from 1 to 3 mm.
Claim 20
Dependent Claim 49 words
A sheet material as claimed in claim 10 wherein all layers of the three-layered sheet material have a foam or fleece structure; the centrally disposed layer has a layer thickness 3 to 8 mm; and the outer layers each have a layer thickness ranging from 1 to 3 mm.
Claim 21
Dependent Claim 34 words
A sheet material as claimed in any one of claims 1, 2, 3, or 4 wherein the thrombin-containing layer contains 10 to 2,000 units of thrombin per 1 cm 3 of the glycoprotein matrix.
Claim 22
Dependent Claim 22 words
A sheet material as claimed in claim 1 wherein the thrombin-containing layer additionally contains at least one substance having a vasoactive effect.
Claim 23
Dependent Claim 29 words
A sheet material as claimed in claim 21 wherein said at least one substance having a vasoactive effect is selected from the group of adrenaline, ergotamine, and mixtures thereof.
Claim 24
Dependent Claim 33 words
A sheet material as claimed in any one of claims 1 or 2 wherein the fibroblast-containing layer contains 10 3 to 10 10 fibroblast cells per 1 cm 3 of the glycoprotein matrix.
Claim 25
Dependent Claim 29 words
A sheet material as claimed in claim 23 wherein the fibroblast-containing layer additionally contains 0.1 to 1 mg of chondroitin sulphate per 1 cm 3 of the glycoprotein matrix.
Claim 26
Dependent Claim 34 words
A sheet material as claimed in any one of claims 1, 2, 3, or 4 wherein the fibrinogen-containing layer contains 0.1 to 30 mg of fibrinogen per 1 cm 3 of the glycoprotein matrix.
Claim 27
Dependent Claim 44 words
A sheet material as claimed in any one of claims 1, 2, 3, or 4 wherein the sheet material has a length of 3 to 12 cm, a width of 1 to 12 cm and a total layer thickness of 5 to 20 mm.
Claim 28
Dependent Claim 38 words
A sheet material as claimed in any one of claims 1, 2, 3, or 4 wherein the glycoprotein is selected from the group of non-linked fibrin, a fibrin fission product, collagen, globulin, myoglobulin, casein, albumin, or mixtures thereof.
Claim 29
Dependent Claim 43 words
A sheet material as claimed in any one of claims 1, 2, 3, or 4 wherein the glycoprotein matrix is obtained by at least one of foaming or deep-freezing a substantially homogeneous, predominantly aqueous glycoprotein solution or suspension, or both, and subsequent lyophilization.
Claim 30
Dependent Claim 36 words
A sheet material as claimed in any one of claims 1, 2, 3, or 4 wherein the glycoprotein matrix forms a fleece the fibers of which are obtained by spinning a homogeneous, predominantly aqueous glycoprotein solution.
Claim 31
Dependent Claim 136 words
A resorptive sheet material for closing and healing wound(s) consisting essentially of a glycoprotein matrix containing substances which cause and respectively, are conducive to the coagulation of blood, including fibrinogen and thrombin, wherein the sheet material is dry and of multi-layered structure; at least one layer is free from thrombin and contains in the glycoprotein matrix thereof, the fibrinogen in a substantially homogeneously distributed form; and at least one further layer is free from fibrinogen and contains in the glycoprotein matrix thereof, the thrombin in a substantially homogeneously distributed form and wherein said multi-layered structure is obtained by the lyophilization of at least two different substantially homogeneous predominately aqueous solutions or suspensions, or both, containing glycoprotein each aqueous solutions or suspensions, or both, forming a layer, and said layers boned to each other by said lyophilization.
Claim 32
Dependent Claim 136 words
A resorptive sheet material for closing and healing wound(s) consisting essentially of a glycoprotein matrix containing substances which cause and respectively, are conducive to the coagulation of blood, including fibrinogen and thrombin, wherein the sheet material is dry and of multi-layered structure; at least one layer is free from thrombin and contains in the glycoprotein matrix thereof, the fibrinogen in a substantially homogeneously distributed form; and at least one further layer is free from fibrinogen and contains in the glycoprotein matrix thereof, the thrombin in a substantially homogeneously distributed form and wherein said multi-layered structure is obtained by the lyophilization of at least two different substantially homogeneous predominately aqueous solutions or suspensions, or both, containing glycoprotein each aqueous solutions or suspensions, or both, forming a layer, and said layers boned to each other by said lyophilization.
Claim 33
Dependent Claim 20 words
A sheet material as claimed in claim 30 wherein at least one layer contains fibroblast cells present in dry state.
Claim 34
Dependent Claim 34 words
A sheet material as claimed in claim 31 wherein at least one layer contains in addition, an agent other than thrombin, which is specifically conducive to the growth or spreading-in, or both, of fibroblasts.
Claim 35
Dependent Claim 25 words
A sheet material as claimed in claim 32 wherein the agent specifically conducive to the growth or spreading-in of fibroblasts, or both, is chondroitin sulphate.
Claim 36
Dependent Claim 19 words
A sheet material as claimed in any one of claims 30 or 3 wherein the sheet material is double-layered.
Claim 37
Dependent Claim 35 words
A sheet material as claimed in claim 34 wherein each layer of the double-layered sheet material has a foam or fleece structure; and each layer has a layer thickness ranging from 1 to 5 mm.
Claim 38
Dependent Claim 34 words
A sheet material as claimed in claim 32 wherein each layer of the sheet material has a foam or fleece structure; and each layer has a layer thickness ranging from 1 to 5 mm.
Claim 39
Dependent Claim 14 words
A sheet material as claimed in claim 30 wherein the sheet material is three-layered.
Claim 40
Dependent Claim 54 words
A sheet material as claimed in claim 37 wherein the centrally disposed layer of the three-layered sheet material is free from thrombin and contains the fibrinogen in a substantially homogeneously distributed form; each outer layer is free from fibrinogen; and at least one outer layer contains the thrombin in a substantially homogeneously distributed form.
Claim 41
Dependent Claim 22 words
A sheet material as claimed in claim 31 wherein the fibroblast cells are contained in at least one of the outer layers.
Claim 42
Dependent Claim 39 words
A sheet material as claimed in claim 32 wherein the fibroblast cells or the agent specifically conducive to the growth or spreading-in of fibroblasts, or both, or mixtures thereof, are contained in at least one of the outer layers.
Claim 43
Dependent Claim 22 words
A sheet material as claimed in claim 33 wherein said chondroitin sulphate is contained in at least one of the outer layers.
Claim 44
Dependent Claim 28 words
A sheet material as claimed in claim 37 wherein the centrally disposed layer of the three-layered sheet material is of greater layer thickness than the outer layers thereof.
Claim 45
Dependent Claim 28 words
A sheet material as claimed in claim 38 wherein the centrally disposed layer of the three-layered sheet material is of greater layer thickness than the outer layers thereof.
Claim 46
Dependent Claim 51 words
A sheet material as claimed in claim 37 wherein all layers of the three-layered sheet material have a foam or fleece structure; the centrally disposed layer has a layer thickness ranging from 3 to 8 mm; and the outer layers each have a layer thickness ranging from 1 to 3 mm.
Claim 47
Dependent Claim 51 words
A sheet material as claimed in claim 38 wherein all layers of the three-layered sheet material have a foam or fleece structure; the centrally disposed layer has a layer thickness ranging from 3 to 8 mm; and the outer layers each have a layer thickness ranging from 1 to 3 mm.
Claim 48
Dependent Claim 27 words
A sheet material as claimed in claim 30 wherein the thrombin-containing layer contains 10 to 2,000 units of thrombin per 1 cm 3 of the glycoprotein matrix.
Claim 49
Dependent Claim 22 words
A sheet material as claimed in claim 30 wherein the thrombin-containing layer additionally contains at least one substance having a vasoactive effect.
Claim 50
Dependent Claim 29 words
A sheet material as claimed in claim 47 wherein said at least one substance having a vasoactive effect is selected from the group of adrenaline, ergotamine, and mixtures thereof.
Claim 51
Dependent Claim 33 words
A sheet material as claimed in any one of claims 31 or 32 wherein the fibroblast-containing layer contains 10 3 to 10 10 fibroblast cells per 1 cm 3 of the glycoprotein matrix.
Claim 52
Dependent Claim 28 words
A sheet material as claimed in 49 wherein the fibroblast-containing layer additionally contains 0.1 to 1 mg of chondroitin sulphate per 1 cm 3 of the glycoprotein matrix.
Claim 53
Dependent Claim 27 words
A sheet material as claimed in claim 30 wherein the fibrinogen-containing layer contains 0.1 to 30 mg of fibrinogen per 1 cm 3 of the glycoprotein matrix.
Claim 54
Dependent Claim 37 words
A sheet material as claimed in claim 30 wherein the sheet material has a length of 3 to 12 cm, a width of 1 to 12 cm and a total layer thickness of 5 to 20 mm.
Claim 55
Dependent Claim 37 words
A sheet material as claimed in any one of claims 30, 31 or 32, wherein the glycoprotein is selected from the group of non-linked fibrin, a fibrin fission product, collagen, globulin, myoglobulin, casein, albumin, or mixtures thereof.
Claim 56
Dependent Claim 29 words
A sheet material as claimed in claim 30 wherein the glycoprotein matrix forms a fleece the fibers of which are obtained by spinning a homogeneous, predominantly aqueous glycoprotein solution.

References Cited (Backward Citations)

US3698392A Cited
US4225580A Cited
US4225580B1 Cited
US4265233A Cited
US4314935A Cited
US4407787A Cited
US4453939A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1989-08-18 1990-02-17 1990-08-19 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1993-08-18 1994-02-17 1994-08-19 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1997-08-18 1998-02-17 1998-08-19 $7700.00 Window Closed / Lapsed

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