Biocompatibility layer and coated objects

Patent metadata

Field	Value
Publication number	US-8992590-B2
Application number	US-200913056719-A
Country	US
Kind code	B2
Filing date	Jul 31, 2009
Priority date	Jul 31, 2008
Publication date	Mar 31, 2015
Grant date	Mar 31, 2015

Abstract

The present invention relates to the use of a crosslinked, silicon-containing layer containing, substantially consisting of or consisting of silicon, O, C, H, optionally N which can be produced by plasma polymerization and/or crosslinking of organosilicon liquids by a plasma process and/or UV radiation of a wavelength of less than 250 nm, without using metals of an atomic number of more than 14, as a biocompatible surface, for imparting to a surface or providing a surface with a non-genotoxic effect. The invention also relates to correspondingly coated articles and to processes for the production thereof.

First claim

The invention claimed is:

1. A non-genotoxic medical technical article, comprising a surface region of the article with a crosslinked silicon layer containing silicon, O, C, and H, which is produced by plasma polymerization and/or crosslinking of organosilicon liquids by a plasma process and/or UV radiation of a wavelength of less than 250 nm, without using metals of an atomic number of more than 14, said layer having an atomic ratio of oxygen to silicon of 0.75 to 2.2 and an atomic ratio of carbon to silicon of 0.1 to 2.5, measured by XPS, the article being selected from the group consisting of:
a) a membrane, pipe or tube, oxygenator membrane, catheter, angioplasty balloon, stent, cannula, sensor and probe;
b) an implantable article selected from the group consisting of:
medical nails, clasps, threads and screws, bone attachment nails, stents or vessel prostheses, injection systems, catheters, cardiovascular implants, artificial organs, pacemakers and power sources thereof, prostheses, orthopedic implants, artificial joints, sockets and counterparts cooperating therewith, hip or knee prostheses, spine prostheses, cochlea implants, artificial heart valves, heart valve rings, intraocular lenses, artificial corneas, pumps or other devices for releasing substances in the body, and epitheses;
c) a container for receiving and/or transporting bodily fluid, tissue or the constituents thereof of a living being or of biomolecules including peptides, proteins, lipids, carbohydrates, nucleic acids or active substances prepared therewith;
d) an article for the at least partial covering of skin or a mucous membrane of a living being including wounds; and
e) an article otherwise in contact with bodily fluid, tissue or the constituents thereof of a living being or with biomolecules, including peptides, proteins, lipids, carbohydrates, nucleic acids or active substances prepared therewith during intended use;
wherein the crosslinked silicon layer has a thickness of 5 nm to 2 μm.

2. The article as claimed in claim 1 , characterized in that the article has a region of the silicon layer with
a) a water contact angle of not more than 35°, or
b) a water contact angle of at least 90°.

3. The article as claimed in claim 1 , characterized in that the silicon layer consists, apart from hydrogen, to at least 98 atom %, of the elements silicon, carbon and oxygen and preferably of from 0.1% to 2% of nitrogen, measured by XPS.

4. The article as claimed in claim 3 , characterized in that the silicon layer has 3-15 atom % of carbon, based on all the elements apart from hydrogen, determined according to XPS.

5. The article according to claim 1 , characterized in that the carbon atoms of the silicon layer have a proportion of 5 to 35% of carbon atoms with a bond to one oxygen atom (“C—O carbon”), measured by XPS.

6. The article according to claim 1 , characterized in that the carbon atoms of the silicon layer have a proportion of 5 to 20% of carbon atoms with bonds to two oxygen atoms (“COO carbon”), measured by XPS.

7. The article as claimed in claim 1 , characterized in that the silicon layer is produced by crosslinking a methylsiloxane precursor, preferably hexamethyldisiloxane, by plasma polymerization, in particular by low pressure or atmospheric pressure plasma polymerization, or by crosslinking a silicone oil without chemically reactive groups under the effect of a plasma or UV radiation of a wavelength of less than 250 nm, in particular excimer radiation.

8. The article as claimed in claim 7 , characterized in that after the precursor or silicone oil was crosslinked and the silicon layer was at least partly oxidized, preferably by plasma effect, flame treatment, oxy-fluorination, laser treatment or a treatment with excimer lamps.

9. A process for the production of an article as claimed in claim 1 , comprising the steps of:
a) preparing a crosslinked, silicon layer with an atomic ratio of oxygen to silicon of 0.75 to 2.2, and an atomic ratio of carbon to silicon of 0.1 to 2.5, measured by XPS, and
b) oxidizing at least portions of the layer prepared in step a).

10. The process as claimed in claim 9 , characterized in that to delimit the area to be oxidized, a mask is used, preferably a detachable self-adhesive mask, more preferably an adhesive tape, or a printed mask and/or a substance which can be at least partially dissolved or dispersed, preferably in water and is preferably removed after step b).

11. A non-genotoxic medical technical article, comprising a surface region of the article with a crosslinked silicon layer consisting of silicon, O, C, and H, which can be produced by plasma polymerization and/or crosslinking of organosilicon liquids by a plasma process and/or UV radiation of a wavelength of less than 250 nm, without using metals of an atomic number of more than 14, having an atomic ratio of oxygen to silicon of 0.75 to 2.2 and an atomic ratio of carbon to silicon of 0.1 to 2.5, measured by XPS, the article being selected from the group consisting of:
a) a membrane, pipe or tube, in particular oxygenator membrane, catheter, angioplasty balloon, stent, cannula, sensor and probe,
b) an implantable article selected from the group consisting of:
medical nails, clasps, threads and screws, bone attachment nails, stents or vessel prostheses, injection systems, catheters, cardiovascular implants, artificial organs, pacemakers and power sources thereof, prostheses, orthopedic implants, artificial joints, artificial sockets and counterparts cooperating therewith, hip or knee prostheses, spine prostheses, cochlea implants, artificial heart valves, heart valve rings or intraocular lenses, artificial corneas, pumps or other devices for releasing substances in the body and epitheses,
c) a container for receiving and/or transporting bodily fluid, tissue or the constituents thereof of a living being or of biomolecules, preferably peptides, proteins, lipids, carbohydrates, nucleic acids or active substances prepared therewith,
d) an article for the at least partial covering of skin or mucous membrane of a living being and preferably of wounds, and
e) an article otherwise in contact with bodily fluid, tissue or the constituents thereof of a living being or with biomolecules, preferably peptides, proteins, lipids, carbohydrates, nucleic acids or active substances prepared therewith during intended use;
wherein the crosslinked silicon layer has a thickness of 5 nm to 2 μm.

12. The article of claim 11 , characterized in that the carbon atoms of the silicon layer have a proportion of 5 to 35% of carbon atoms with a bond to one oxygen atom (“C—O carbon”), measured by XPS.

13. The article of claim 11 , characterized in that the carbon atoms of the silicon layer have a proportion of 5 to 20% of carbon atoms with bonds to two oxygen atoms (“COO carbon”) measured by XPS.

14. A non-genotoxic medical technical article comprising a biocompatibility layer with crosslinked silicon containing silicon, O, C, and H, which is produced by plasma polymerization and/or crosslinking of organosilicon liquids by a plasma process and/or UV radiation of a wavelength of less than 250 nm, without using metals of an atomic number of more than 14, the biocompatibility layer having an atomic ratio of oxygen to silicon of 0.85 to 1.8, an atomic ratio of carbon to silicon of 0.8 to 2.8, an atomic ratio of carbon to oxygen of 0.5 to 2.6, and an atomic ratio of hydrogen to carbon of 1.8 to 3.1, measured by XPS;
wherein the article is selected from the group consisting of:
a) a membrane, pipe or tube, oxygenator membrane, catheter, angioplasty balloon, stent, cannula, sensor and probe;
b)

Assignees

• Ott Matthias
• Grunwald Ingo
• Salz Dirk
• Wagener Michael
• Vissing Klaus-Dieter
• Hielscher Wolfgang
• Dölle Christopher
• Fraunhofer Ges Forschung
• Bio Gate Ag

Inventors

• Ott Matthias
• Grunwald Ingo
• Salz Dirk
• Wagener Michael
• Vissing Klaus-Dieter
• Hielscher Wolfgang
• Dölle Christopher

Classifications

• B05D1/62

  Plasma-deposition of organic layers (plasma deposition in general C23C14/00, C23C16/00) · CPC title

• C23C16/56 Primary

  After-treatment · CPC title

• A61L27/34

  Macromolecular materials · CPC title

• A61L29/085

  Macromolecular materials · CPC title

• C23C16/30

  Deposition of compounds, mixtures or solid solutions, e.g. borides, carbides, nitrides · CPC title