Medical device for improving skin fixation of indwelling catheters and other transcutaneous implants with a reduced risk of infection

• US 6,050,979 A
• Filed: 07/06/1998
• Issued: 04/18/2000
• Est. Priority Date: 07/03/1997
• Status: Expired due to Fees

• Current Assignee: NMI Natural and Medical Sciences Institute at the University TÜBINGEN
• Original Assignee: Huels Aktiengesellschaft
• Inventors: Schindler, Fritz, Haemmerle, Hugo
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US09/110,126
• Time in Patent Office: 652 Days
• Field of Search: 604/174, 604/175, 604/264, 604/265, 623/1, 623/11
• US Class Current: 604/265
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: C08L 25/04 Homopolymers or copolymers of styrene
• CPC Class Codes: C08L 33/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08L 33/06 of esters containing only carbon, hydrogen and oxygen, which oxygen atoms are present only as part of the carboxyl radical
• CPC Class Codes: C08L 33/10 Homopolymers or copolymers of methacrylic acid esters
• CPC Class Codes: C08L 35/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a carboxyl radical, and containing at least one other carboxyl radical in the molecule, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

A transcutaneous medical device which has on its surface a fibrous material with free collagen fibers which are present in a natural structure. The transcutaneous medical device is prepared by applying to the surface of such a device a fibrous material with free collagen fibers present in a natural structure.

Claims

1. A transcutaneous medical device which has on its surface a fibrous material having free collagen fibers which are present in a natural structure.

2. A transcutaneous medical device as claimed in claim 1, prepared by:

(a) preparing said fibrous material by;

(a1) preparing a collagen felt from collagen fibers which are present in a natural structure;

(a2) infiltrating the collagen felt with a polymerizable monomer mixture;

(a3) conducting a free-radical polymerization of the monomers in the presence of polymerization inhibitors which act out from the surface of the infiltrated felt;

(a4) detaching of the incompletely polymerized surface layer of the resulting polymer to expose the collagen fibers by treatment with a solvent; and

(b) subsequently applying the fibrous material produced to the surface of a transcutaneous medical device.

3. The transcutaneous medical device as claimed in claim 2, wherein the polymerizable monomer mixture comprises free-radically polymerizable monomers.

4. The transcutaneous medical device as claimed in claim 3, wherein the polymerizable monomer mixture comprises acrylates.

5. The transcutaneous medical device as claimed in claim 3, wherein the polymerizable monomer mixture comprises methacrylates.

6. The transcutaneous medical device as claimed in claim 5, wherein the polymerizable monomer mixture comprises at least one compound selected from the group consisting of:

methyl methacrylate, ethyl methacrylate, n-butyl methacrylate, isobutyl methacrylate, 2-ethylhexyl methacrylate, cyclohexyl methacrylate, isobornyl methacrylate, tetrahydrofurfuryl methacrylate, benzyl methacrylate, morpholinoethyl methacrylate, diethylene glycol dimethacrylate, triethylene glycol dimethacrylate, diurethane dimethacrylate, isopropylidenebis(2(3 )-hydroxy-3(2 )-(4-phenoxy)propyl methacrylate) and methacrylic acid.

7. The transcutaneous medical device as claimed in claim 5, wherein the polymerizable monomer mixture comprises at least one compound selected from the group consisting of:

styrene, α

-methylstyrene, styrenesulfonic acid, vinyl compounds and maleic anhydride.

8. A transcutaneous medical device as claimed in claim 1, prepared by:

preparing a collagen felt from collagen fibers which are present in a natural structure;

infiltrating the felt with a polymerizable monomer mixture;

applying the infiltrated felt to the surface of the transcutaneous medical device;

conducting a free-radical polymerization of the monomers in the presence of polymerization inhibitors which act out from the surface of the infiltrated felt; and

detaching the incompletely polymerized surface layer of the resulting polymer to expose the collagen fibers by treatment with a solvent.

9. The transcutaneous medical device as claimed in claim 8, wherein the polymerizable monomer mixture comprises free-radically polymerizable monomers.

10. The transcutaneous medical device as claimed in claim 9, wherein the polymerizable monomer mixture comprises acrylates.

11. The transcutaneous medical device as claimed in claim 9, wherein the polymerizable monomer mixture comprises methacrylates.

12. The transcutaneous medical device as claimed in claim 11, wherein the polymerizable monomer mixture comprises at least one compound selected from the group consisting of:

methyl methacrylate, ethyl methacrylate, n-butyl methacrylate, isobutyl methacrylate, 2-ethylhexyl methacrylate, cyclohexyl methacrylate, isobornyl methacrylate, tetrahydrofurfuryl methacrylate, benzyl methacrylate, morpholinoethyl methacrylate, diethylene glycol dimethacrylate, triethylene glycol dimethacrylate, diurethane dimethacrylate, isopropylidenebis(2(3)-hydroxy-3(2)-(4-phenoxy)propyl methacrylate) and methacrylic acid.

13. The transcutaneous medical device as claimed in claim 11, wherein the polymerizable monomer mixture comprises at least one compound selected from the group consisting of:

styrene, α

-methylstyrene, styrenesulfonic acid, vinyl compounds and maleic anhydride.

14. A process of forming a fibrous collagen material on the surface of a transcutaneous medical device, which comprises:

applying to the surface of a transcutaneous medical device a fibrous material having free collagen fibers which are present in a natural structure.

15. The process as claimed in claim 14, wherein the device is produced by:

(a) preparing said fibrous material by;

(a1) preparing a collagen felt from collagen fibers which are present in a natural structure,

(a2) infiltrating of the felt with a polymerizable monomer mixture,

(a3) free-radically polymerizing the monomer mixture in the presence of polymerization inhibitors which act out from the surface of the infiltrated felt,

(a4) detaching the incompletely polymerized surface layer of the resulting polymer to expose the collagen fibers by treatment with a solvent, and subsequently

(b) applying the detached material to the surface of a transcutaneous medical device.

16. The process as claimed in claim 15, wherein the polymerizable monomer mixture comprises free-radically polymerizable monomers.

17. The process as claimed in claim 16, wherein the polymerizable monomer mixture comprises acrylates.

18. The process as claimed in claim 16, wherein the polymerizable monomer mixture comprises methacrylates.

19. The process as claimed in claim 16, wherein the polymerizable monomer mixture comprises at least one compound selected from the group consisting of:

methylmethacrylate, ethyl methacrylate, n-butyl methacrylate, isobutyl methacrylate, 2-ethylhexyl methacrylate, cyclohexyl methacrylate, isobornyl methacrylate, tetrahydrofurfuryl methacrylate, benzyl methacrylate, morpholinoethyl methacrylate, diethylene glycol dimethacrylate, triethylene glycol dimethacrylate, diurethane dimethacrylate, isopropylidenebis(2(3)-hydroxy-3(2)-(4-phenoxy)propyl methacrylate) and methacrylic acid.

20. The process as claimed in claim 16, wherein the polymerizable monomer mixture comprises at least one compound selected from the group consisting of:

styrene, α

-methylstyrene, styrenesulfonic acid, vinyl compounds and maleic anhydride.

21. The process as claimed in claim 14, wherein the fibrous material is applied to the surface of a transcutaneous medical device by:

preparing a collagen felt from collagen fibers which are present in a natural structure,

infiltrating the felt with a polymerizable monomer mixture,

applying the infiltrated felt to the surface of a transcutaneous medical device,

free-radically polymerizing said monomer mixture in the presence of polymerization inhibitors which act out from the surface of the infiltrated felt, and

detaching the incompletely polymerized surface layer of the resulting polymer to expose the collagen fibers by treatment with a solvent.

22. The process as claimed in claim 21, wherein the polymerizable monomer mixture comprises free-radically polymerizable monomers.

23. The process as claimed in claim 22, wherein the polymerizable monomer mixture comprises acrylates.

24. The process as claimed in claim 22, wherein the polymerizable monomer mixture comprises methacrylates.

25. The process as claimed in claim 22, wherein the polymerizable monomer mixture comprises at least one compound selected from the group consisting of:

methylmethacrylate, ethyl methacrylate, n-butyl methacrylate, isobutyl methacrylate, 2-ethylhexyl methacrylate, cyclohexyl methacrylate, isobornyl methacrylate, tetrahydrofurfuryl methacrylate, benzyl methacrylate, morpholinoethyl methacrylate, diethylene glycol dimethacrylate, triethylene glycol dimethacrylate, diurethane dimethacrylate, isopropylidenebis(2(3)-hydroxy-3(2)-(4-phenoxy)propyl methacrylate) and methacrylic acid.

26. The process as claimed in claim 22, wherein the polymerizable monomer mixture comprises at least one compound selected from the group consisting of:

styrene, α

-methylstyrene, styrenesulfonic acid, vinyl compounds and maleic anhydride.