# US 10,864,062 B2 · Process for preparing a body having an osseointegrative topography formed on its surface

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- Number: US 10,864,062 B2
- Document ID: US10864062B2
- Status: Granted
- Kind: B2
- Application number: 15/730,253
- Filed: 2017-10-11
- Published: 2018-04-19
- Granted: 2020-12-15
- Earliest claimed: 2016-10-13
- Assignees: Straumann Holding AG
- Applicants: Straumann Holding AG
- Inventors: Philippe Habersetzer; Simon Berner; Christoph Appert
- Web page: https://patentgrep.com/patent/US10864062B2

## CPC

- A61C 8/0012: {characterised by the material or composition, e.g. ceramics, surface layer, metal alloy (use of specific materials A61K6/00)}
- C23F 1/26: for etching refractory metals
- A61C 8/005: {Connecting devices for joining an upper structure with an implant member, e.g. spacers}
- A61L 27/06: Titanium or titanium alloys
- C04B 41/5042: {Zirconium oxides or zirconates; Hafnium oxides or hafnates}
- A61L 2400/18: Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
- C04B 41/009: {characterised by the material treated}
- C04B 41/5353: {Wet etching, e.g. with etchants dissolved in organic solvents}
- C04B 41/87: Ceramics
- C04B 2111/00836: {for medical or dental applications}
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)
- C23F: NON-MECHANICAL REMOVAL OF METALLIC MATERIAL FROM SURFACE (working metal by laser beams B23K26/00; desurfacing by applying flames B23K7/00; working of metal by electro-erosion B23H; producing decorative effects by removing surface material, e.g. by engraving, by etching, B44C1/22; electrolytic etching or polishing C25F); INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL; MULTI-STEP PROCESSES FOR SURFACE TREATMENT OF METALLIC MATERIAL INVOLVING AT LEAST ONE PROCESS PROVIDED FOR IN CLASS C23 AND AT LEAST ONE PROCESS COVERED BY SUBCLASS C21D OR C22F OR CLASS C25
- 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)
- C04B: LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE {(roofing granules E04D7/005)}; CERAMICS (devitrified glass-ceramics C03C10/00); REFRACTORIES; TREATMENT OF NATURAL STONE

## Abstract

A process for preparing a body having an osseointegrative topography formed on its surface. The process includes the steps of providing a primary body made of a titanium-zirconium alloy containing 13 to 17 wt-% of zirconium, sandblasting the primary body, and etching the sandblasted primary body with an etching solution including hydrochloric acid, sulfuric acid and water at a temperature of above 80° C. to obtain the body, said etching being performed for a duration of 350 seconds at least.

## Claims

### Claim 1

A process for preparing a body having an osseointegrative topography formed on its surface, the process comprising:
a) providing a primary body made of a titanium-zirconium alloy containing 13 to 17 wt-% of zirconium,
b) sandblasting the primary body, and
c) etching the sandblasted primary body with an etching solution comprising hydrochloric acid, sulfuric acid and water at a temperature of above 80° C. for a duration in a range of from 350 to 540 seconds to obtain the body.

### Claim 2 (depends on 1)

The process according to claim 1, wherein the etching is performed for a duration in a range of from 360 to 480 seconds.

### Claim 3 (depends on 1)

The process according to claim 1, wherein at least in a region directly adjacent to the surface, the alloy is essentially in the alpha-phase.

### Claim 4 (depends on 1)

The process according to claim 1, wherein in step b) Al2O3 particles having an average particle size in a range from 0.1 mm to 0.6 mm are used as sandblasting material.

### Claim 5 (depends on 1)

The process according to claim 1, wherein the topography is defined by at least one of the following parameters:
i) an arithmetic mean deviation of the surface (Sa) in three dimensions in a range of from 0.1 μm to 2.0 μm;
ii) a maximum peak to valley height of the profile (Sr) in three dimensions in a range of from 1.0 μm to 20.0 μm;
iii) a skewness of the profile (Ssk) in three dimensions in a range of from −0.6 to 0.6; and
iv) a developed surface area (Sdr) in a range of from 15% to 25%.

### Claim 6 (depends on 1)

The process according to claim 1, wherein an amount of zirconium contained in the alloy is in a range of from 13 to 15 wt-%.

### Claim 7 (depends on 1)

The process according to claim 1, wherein the alloy contains iron in an amount higher than 0.001 wt-%.

### Claim 8 (depends on 1)

The process according to claim 1, wherein the alloy contains an amount of iron less than 0.05 wt-%.

### Claim 9 (depends on 1)

The process according to claim 1, wherein the alloy contains less than 0.1 wt.-% hafnium.

### Claim 10 (depends on 1)

The process according to claim 1, wherein after step b) and prior to step c) the sandblasted primary body is treated with a pickling solution comprising hydrofluoric acid and nitric acid, whereby a native oxide layer formed on the titanium-zirconium alloy is at least partially removed.

### Claim 11 (depends on 1)

The process according to claim 1, wherein the temperature of the etching solution during the entire etching is higher than 80° C.

### Claim 12 (depends on 1)

The process according to claim 1, wherein the sandblasted primary body is pre-heated to a temperature above room temperature immediately prior to step c).

### Claim 13 (depends on 1)

The process according to claim 1, wherein the etching is performed for a duration in a range of from 360 seconds to 420 seconds.

### Claim 14 (depends on 1)

The process according to claim 1, wherein in step b) Al2O3 particles having an average particle size in a range of from 0.15 mm to 0.5 mm are used as sandblasting material.

### Claim 15 (depends on 1)

The process according to claim 1, wherein in step b) Al2O3 particles having an average particle size in a range of from 0.2 mm to 0.4 mm are used as sandblasting material.

### Claim 16 (depends on 1)

The process according to claim 1, wherein the topography is defined by at least one of the following parameters:
i) an arithmetic mean deviation of the surface (Sa) in three dimensions in a range of from 0.4 μm to 1.8 μm;
ii) a maximum peak to valley height of the profile (Sr) in three dimensions in a range of from 3.0 μm to 18.0 μm; and
iii) a skewness of the profile (Ssk) in three dimensions in a range of from −0.4 to 0.6.

### Claim 17 (depends on 1)

The process according to claim 1, wherein the alloy contains iron in an amount higher than 0.005 wt-%.
