Process for preparing a body having an osseointegrative topography formed on its surface

Patent metadata

Field	Value
Publication number	US-10864062-B2
Application number	US-201715730253-A
Country	US
Kind code	B2
Filing date	Oct 11, 2017
Priority date	Oct 13, 2016
Publication date	Dec 15, 2020
Grant date	Dec 15, 2020

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.

First claim

The invention claimed is:

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.

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

3. 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.

4. The process according to claim 1 , wherein in step b) Al 2 O 3 particles having an average particle size in a range from 0.1 mm to 0.6 mm are used as sandblasting material.

5. 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 (S a ) 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 (S r ) in three dimensions in a range of from 1.0 μm to 20.0 μm;
iii) a skewness of the profile (S sk ) 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%.

6. 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-%.

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

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

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

10. 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.

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

12. 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).

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

14. The process according to claim 1 , wherein in step b) Al 2 O 3 particles having an average particle size in a range of from 0.15 mm to 0.5 mm are used as sandblasting material.

15. The process according to claim 1 , wherein in step b) Al 2 O 3 particles having an average particle size in a range of from 0.2 mm to 0.4 mm are used as sandblasting material.

16. 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 (S a ) 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 (S r ) in three dimensions in a range of from 3.0 μm to 18.0 μm; and
iii) a skewness of the profile (S sk ) in three dimensions in a range of from −0.4 to 0.6.

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

Assignees

• Straumann Holding Ag

Inventors

• Habersetzer Philippe
• Berner Simon
• Appert Christoph

Classifications

• C23F1/26 Primary

  for etching refractory metals · CPC title

• A61L27/06

  Titanium or titanium alloys · CPC title

• A61L2400/18

  Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment · CPC title

• A61C8/0012 Primary

  characterised by the material or composition, e.g. ceramics, surface layer, metal alloy (use of specific materials A61K6/00) · CPC title

• A61C8/005

  Connecting devices for joining an upper structure with an implant member, e.g. spacers · CPC title