# US 10,369,257 B2 · Process for the production of storable implants with an ultrahydrophilic surface

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- Number: US 10,369,257 B2
- Document ID: US10369257B2
- Status: Granted
- Kind: B2
- Application number: 15/606,004
- Filed: 2017-05-26
- Published: 2017-09-14
- Granted: 2019-08-06
- Earliest claimed: 2007-02-14
- Assignees: Nobel Biocare Services AG
- Applicants: Herbert Jennissen; Steffen Lüers; Markus Laub
- Inventors: Herbert Jennissen; Steffen Lüers; Markus Laub
- Web page: https://patentgrep.com/patent/US10369257B2

## CPC

- A61L 31/088: {Other specific inorganic materials not covered by A61L31/084 or A61L31/086}
- A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)}
- A61L 27/22: Polypeptides or derivatives thereof {, e.g. degradation products}
- A61L 27/30: Inorganic materials
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 31/022: {Metals or alloys}
- A61L 31/047: {Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- B05D 1/18: performed by dipping
- B65D 81/22: in moist conditions or immersed in liquids
- A61L 2300/102: Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
- A61L 2300/252: Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
- A61L 2300/414: Growth factors
- A61L 2300/608: having two or more layers
- A61L 2400/18: Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
- A61L 2420/08: Coatings comprising two or more layers
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- B05D: PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (conveying articles or workpieces through baths of liquid B65G, e.g. B65G49/02)
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES

## Abstract

The present invention concerns a process for the production of implants with an ultrahydrophilic surface as well as the implants produced in that way and also processes for the production of loaded, so-called bioactive implant surfaces of metallic or ceramic materials, which are used for implants such as artificial bones, joints, dental implants or also very small implants, for example what are referred to as stents, as well as implants which are further produced in accordance with the processes and which as so-called “delivery devices” allow controlled liberation, for example by way of dissociation, of the bioactive molecules from the implant materials.

## Claims

### Claim 1

A process for the production of a storable implant with an ultrahydrophilic surface, the process comprising the steps of:
providing an implant with an ultrahydrophilic surface, said ultrahydrophilic surface comprising a metal, metallic alloy, or ceramic material with dynamic contact angles from 0° to 10° upon wetting of the surface of the implant with water,
placing the implant into a salt-containing aqueous solution, which is inert in relation to the surface and which encloses the implant on all sides, and
evaporating the salt-containing aqueous solution to dryness under formation of an exsiccation layer that stabilizes and protects the surface of the implant.

### Claim 2 (depends on 1)

The process of claim 1, wherein the salt-containing aqueous solution has a total ion concentration of more than 0.5 mol/l.

### Claim 3 (depends on 1)

The process of claim 1, wherein the salt-containing aqueous solution has a total ion concentration of more than 1 mol/l.

### Claim 4 (depends on 1)

The process of claim 1, wherein the step of evaporation affords a salt layer covering at least the ultrahydrophilic surface of the implant.

### Claim 5 (depends on 4)

The process of claim 4, wherein the salt layer has a layer thickness of 1 to 500 μm.

### Claim 6 (depends on 1)

The process of claim 1, wherein the step of evaporation gives a salt layer enclosing the implant on all sides.

### Claim 7 (depends on 1)

The process of claim 1, comprising the additional step of sterilization of the implant.

### Claim 8 (depends on 7)

The process of claim 7, wherein sterilization of the implant includes sterilization with ionizing radiation.

### Claim 9 (depends on 8)

The process of claim 8, wherein the ionizing radiation is electromagnetic radiation.

### Claim 10 (depends on 1)

The process of claim 1, further comprising the step of immobilising peptides on the ultrahydrophilic surface.

### Claim 11 (depends on 10)

The process of claim 10, wherein the peptides immobilized on the ultrahydrophilic surface are present in a concentration of more than 200 ng/cm2.

### Claim 12 (depends on 10)

The process of claim 10, wherein said peptides immobilized on the ultrahydrophilic surface are selected from the group consisting of bone growth factors, transforming growth factor proteins, bone morphogenic proteins, vessel growth factors, VEGF, angiotropin, ubiquitin, and mixtures thereof.

### Claim 13 (depends on 1)

The process of claim 1, wherein the salt-containing aqueous solution comprises a combination of salts.

### Claim 14 (depends on 1)

The process of claim 1, wherein the salt-containing aqueous solution comprises a buffer solution having a pH of 7.2 to 7.6.

### Claim 15 (depends on 1)

The process of claim 1, wherein the salt-containing aqueous solution comprises a salt having a anion comprising SO4−−, HPO4−−, CH3COO−, Cl, Br, NO4−, ClO4−, CNS−, ClCH2COO−, F3CCOO−, Cl2CHCOO−, Cl3CCOO−, or Br3CCOO−.

### Claim 16 (depends on 1)

The process of claim 1, wherein the salt-containing aqueous solution comprises a salt having a cation comprising NH4+, Rb+, K+, Na+, Cs+, Li+, Mg++, Ca++, or Ba++.

### Claim 17 (depends on 1)

The process of claim 1, wherein the salt-containing aqueous solution comprises a salt having a cation comprising (CH3)4N+, (C2H5)4N+, (C3H7)4N+, or (C4H9)4N+.

### Claim 18 (depends on 1)

The process of claim 1, wherein the salt-containing aqueous solution forms a fluid layer of 0.1-0.2 μl/mm2 on a surface of the implant.

### Claim 19 (depends on 1)

The process of claim 1, wherein the salt-containing aqueous solution comprises non-volatile organic substances.

### Claim 20 (depends on 19)

The process of claim 19, wherein the non-volatile organic substances comprise a polyhydric alcohol.

### Claim 21 (depends on 1)

The process of claim 1, wherein the implant comprises steel.

### Claim 22 (depends on 1)

The process of claim 1, wherein the implant comprises a composite metallic and ceramic material.

### Claim 23 (depends on 1)

The process of claim 1, wherein the implant consists of pure titanium or metallic titanium alloys.

### Claim 24 (depends on 1)

The process of claim 1, wherein the implant is a bone implant or a dental implant.

### Claim 25 (depends on 10)

The process of claim 10, wherein said peptides comprise bone morphogenic proteins.

### Claim 26 (depends on 25)

The process of claim 25, where the bone morphogenic proteins comprise BMP-2 or BMP-7.

### Claim 27

A process for the production of a storable dental implant with an ultrahydrophilic surface, the process comprising:
providing a dental implant with an ultrahydrophilic surface with dynamic contact angles from 0° to 10° upon wetting of the surface of the implant with water,
placing the dental implant into a salt-containing aqueous solution, which is inert in relation to the surface and which encloses the dental implant on all sides, and
evaporating the salt-containing aqueous solution to dryness under formation of an exsiccation layer that stabilizes and protects the surface of the dental implant.