Method of manufacturing an implant for use in a surgical procedure

Patent metadata

Field	Value
Publication number	US-2016220730-A1
Application number	US-201314916090-A
Country	US
Kind code	A1
Filing date	Sep 2, 2013
Priority date	Sep 2, 2013
Publication date	Aug 4, 2016
Grant date	—

Abstract

A method of manufacturing an implant for use in a surgical procedure, a corresponding implant and the use thereof during the incorporation of a substance is presented. Specifically anodized and blasted titanium implant substrates are provided with a hydroxyapatite (HA) coating for incorporating for example a therapeutic agent. In particular, an anodizing procedure by an electrolytic process in an alkaline liquid is carried out. Moreover, blasting of the anodized titanium implant substrate is carried out by the presented method. The HA coating can be in the range of 1 to 5 μm, particularly in the range of 1 to 3 μm. A local delivery of the active pharmaceutical ingredient is achieved by the implant of the present invention. Moreover, the implant allows for the removal of the implant without damaging surrounding tissue or a bone. Moreover, the HA coating is provided to the substrate such that enhanced fixation as measured by pull-out force is achieved whilst having a relatively low removal torque. The HA coating and drug incorporation may be carried out sequentially but also co-precipitation approach can be used.

First claim

1 . A method of manufacturing an implant for use in a surgical procedure, the method comprising:
providing a titanium implant substrate (S 1 ); anodizing the titanium implant substrate by an electrolytic process in an alkaline liquid (S 2 ), blasting the anodized titanium implant substrate (S 3 ), and coating the blasted and anodized substrate with hydroxyapatite (HA) leading to a HA coating (S 4 ).

2 . The method according to claim 1 ,
wherein the titanium implant substrate is formed of titanium alloy Ti6Al-4V.

3 . The method according to claim 1 ,
wherein the steps of anodizing and blasting are carried out according to AMS 2488-D resulting in a type II anodized titanium implant substrate.

4 . The method according to claim 1 ,
wherein the step of coating the substrate with HA is based on crystal growth of HA on a surface of the implant.

5 . The method according to claim 1 ,
wherein the HA coating is deposited from a solution, or from an aqueous solution containing ions.

6 . The method according to claim 5 ,
wherein the titanium implant substrate is inserted into the solution for a time period t, and wherein the time period t is selected from the group comprising between 20 h and 80 h, between 40 h and 80 h, between 60 h and 80 h, between 65 h and 75 h, between 70 h and 75 h, and 72 h.

7 . The method according to claim 5 ,
wherein the solution has a temperature between 37° C. and 85° C.

8 . The method according to claim 1 ,
wherein the HA coating has a crystalline structure, and wherein the HA coating has a thickness which is between 0.5 μm and 5 μm or between 1 μm and 3 μm.

9 . The method according to claim 1 , the method further comprising:
inserting the titanium implant substrate into a NaOH solution (S 5 ) before the step of coating the substrate with a HA coating, wherein the titanium implant substrate is kept in the NaOH solution for a time period t, and wherein the time period t is selected from the group comprising between 5 and 15 minutes, between 8 and 12 minutes, between 9 and 11 minutes, and 10 minutes.

10 . The method according to claim 1 ,
wherein a surface of the blasted substrate is not treated, particularly not with a NaOH solution, before the step of coating the substrate with a HA coating.

11 . The method according to claim 1 , the method further comprising:
incorporating a substance into the HA coating, and wherein the substance is selected from the group comprising a therapeutic agent, an osteoporotic drug, bisphosphonates, strontium, PTH, antibiotics, gentamycin, tobramycin, vancomycin, doxycycline, a chemotherapy drug, analgetics, antiphlogistics, metal ions, copper ions, silver ions, organic molecules, and any combination thereof.

12 . An implant for use in a surgical procedure, the implant comprising;
a titanium implant substrate, wherein the titanium implant substrate has an anodized and blasted surface and a HA coating on said surface, and wherein the surface is anodized by an electrolytic process in an alkaline liquid.

13 . The implant according to claim 12 ,
wherein the titanium implant substrate is formed of titanium alloy Ti6Al-4V.

14 . The implant according to claim 12 ,
wherein titanium implant substrate is anodized and blasted according to AMS 2488-D resulting in a type II anodized titanium implant substrate.

15 . The method of claim 1 wherein a type II anodized titanium implant is used during the incorporation of a medical or pharmaceutical product into a HA coating of the implant.

16 . The method according to claim 2 ,
wherein the steps of anodizing and blasting are carried out according to AMS 2488-D resulting in a type II anodized titanium implant substrate.

17 . The method as set forth in claim 6 ,
wherein the solution has a temperature between 37° and 85°.

Assignees

• Stryker European Holdings I Llc

Inventors

• Procter Philip
• Söerensen Jan Henrik
• Steckel Hartwig
• Sörensen Torben Christian
• Welch Ken

Classifications

• C23C22/83

  Chemical after-treatment · CPC title

• A61L27/06

  Titanium or titanium alloys · CPC title

• C25D11/26

  of refractory metals or alloys based thereon · CPC title

• C23C28/042

  including a refractory ceramic layer, e.g. refractory metal oxides, ZrO2, rare earth oxides · CPC title

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title