DS CoBlast Surface Modification Technology 170809

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EnBIO Tel: +353 21 488 2655 [email protected] www.enbiomaterials.com Page 1 Rev 1.0 Enabling New Surfaces on Reactive Metals Overview The CoBlast™ process is a new, non-complex, room temperature and non-wet-chemistry means of depositing dopant materials on the surface of any reactive metal (titanium and its alloys—including nitinol, cobalt chrome, aluminium, and some stainless steels) i.e., those metals typically utilized in implants. CoBlast is based on the mechanical process of microblasting (a form of grit blasting). While conventional grit blasting focuses on surface roughening and material removal, CoBlast is a blast-based technique for material deposition. The resultant surface modification gives rise to a textured mor- phology and chemical alteration as a result of the entrapped dopant mate- rial. As the deposited material is entrapped in the surface—in the metal oxide layer—and does not constitute a laminate layer or coating, the new surface cannot delaminate or chip off as is the case with conventional coat- ings. The CoBlast process is in fact a novel variation of grit blasting, which is a well practiced process in the medical device industry—and the CoBlast processing equipment is essentially a modified version of standard grit blasting equipment. The benign (chemical-free, room-temperature) conditions of the CoBlast process mean that the applied bioceramic materials (dopants) are funda- mentally unaltered post-deposition. Many therapeutic and biologic agents (antibiotics, growth factors, anti-proliferatives, etc.) can be added to these bioceramics—and hence to implant surfaces—without any loss of potency, pointing to unlimited flexibility and potential. For the first time it is possi- ble for new functionalities to be added to the surface of any metallic implant in a manner devoid of complica- tions. EnBIO believes that this capability will lead to the development of new ideas and product concepts not previously considered. The straightforward nature of the CoBlast process means that it can easily be added to any production process and at a favorable cost relative to conventional deposition techniques in the medical device sector. Abrasive blasting is already well regulated in medical device manufacturing and this, coupled with the fact that all the materials—dopants and substrates—are also well established, gives precedence for regulatory approval and hence sector acceptance. It also means that there is already appropriate equipment and expertise available within the industry. (Figure 1 shows an example of lathe configuration processing equipment.) CoBlast Technology CoBlast is a novel variant of the standard grit blasting proc- ess, whereby two blast jets are used on a coincident point on the surface (see Figure 2). One jet blasts an abrasive grit which abrades and churns up the metal surface, baring the reactive metal beneath the oxide layer, while the second jet introduces the dopant material to this newly exposed sur- face. While the metal oxide layer is reforming, the dopant material is integrated into the new surface via a combination of tribochemical bonding and interlocking (see Figure 3). The consequent biointerface is in effect an amalgam of the metal oxide and the deposited material rather than a coating in the traditional sense. Indeed, due to its unique conforma- tion—a disjointed non-continuous deposition of bioceramic material in and on the metal oxide—the newly formed “modified” surface is not prone to delamination through chip- ping or peeling, as is the case with a coating. Figure 1: Lathe configuration processing equipment Figure 2: Schematic of the CoBlast™ process Dop a n t G r i t

Transcript of DS CoBlast Surface Modification Technology 170809

Page 1: DS CoBlast Surface Modification Technology 170809

EnBIO � Tel: +353 21 488 2655

[email protected] � www.enbiomaterials.com Page 1 Rev 1.0

Enabling New Surfaces on Reactive Metals

Overview

The CoBlast™ process is a new, non-complex, room temperature and non-wet-chemistry means of depositing

dopant materials on the surface of any reactive metal (titanium and its alloys—including nitinol, cobalt chrome,

aluminium, and some stainless steels) i.e., those metals typically utilized in implants.

CoBlast is based on the mechanical process of microblasting (a form of grit

blasting). While conventional grit blasting focuses on surface roughening

and material removal, CoBlast is a blast-based technique for material

deposition. The resultant surface modification gives rise to a textured mor-

phology and chemical alteration as a result of the entrapped dopant mate-

rial. As the deposited material is entrapped in the surface—in the metal

oxide layer—and does not constitute a laminate layer or coating, the new

surface cannot delaminate or chip off as is the case with conventional coat-

ings. The CoBlast process is in fact a novel variation of grit blasting, which

is a well practiced process in the medical device industry—and the CoBlast

processing equipment is essentially a modified version of standard grit

blasting equipment.

The benign (chemical-free, room-temperature) conditions of the CoBlast

process mean that the applied bioceramic materials (dopants) are funda-

mentally unaltered post-deposition. Many therapeutic and biologic agents

(antibiotics, growth factors, anti-proliferatives, etc.) can be added to these bioceramics—and hence to implant

surfaces—without any loss of potency, pointing to unlimited flexibility and potential. For the first time it is possi-

ble for new functionalities to be added to the surface of any metallic implant in a manner devoid of complica-

tions. EnBIO believes that this capability will lead to the development of new ideas and product concepts not

previously considered.

The straightforward nature of the CoBlast process means that it can easily be added to any production process

and at a favorable cost relative to conventional deposition techniques in the medical device sector. Abrasive

blasting is already well regulated in medical device manufacturing and this, coupled with the fact that all the

materials—dopants and substrates—are also well established, gives precedence for regulatory approval and

hence sector acceptance. It also means that there is already appropriate equipment and expertise available

within the industry. (Figure 1 shows an example of lathe configuration processing equipment.)

CoBlast Technology

CoBlast is a novel variant of the standard grit blasting proc-

ess, whereby two blast jets are used on a coincident point

on the surface (see Figure 2). One jet blasts an abrasive grit

which abrades and churns up the metal surface, baring the

reactive metal beneath the oxide layer, while the second jet

introduces the dopant material to this newly exposed sur-

face. While the metal oxide layer is reforming, the dopant

material is integrated into the new surface via a combination

of tribochemical bonding and interlocking (see Figure 3).

The consequent biointerface is in effect an amalgam of the

metal oxide and the deposited material rather than a coating

in the traditional sense. Indeed, due to its unique conforma-

tion—a disjointed non-continuous deposition of bioceramic

material in and on the metal oxide—the newly formed

“modified” surface is not prone to delamination through chip-

ping or peeling, as is the case with a coating.

Figure 1: Lathe configuration processing equipment

Figure 2: Schematic of the CoBlast™ process

Dopant

Grit

Page 2: DS CoBlast Surface Modification Technology 170809

EnBIO � Tel: +353 21 488 2655

[email protected] � www.enbiomaterials.com Page 2 Rev 1.0

Enabling New Surfaces on Reactive Metals

Process Characteristics

■ Simple and low-cost process

■ Dry (no wet chemical processing required)

■ Room temperature

■ Vacuum free

■ Exact delineation between treated/non-treated surface areas is possible, potentially eliminating masking

steps in some manufacturing environments

■ Roughening is inherently incorporated in the process (single step)

■ Equipment is already established and regulated in the medical device arena (i.e., most standard grit blast-

ing systems can be modified to implement CoBlast)

■ Compatible with the active metals (Ti, CoCr, NiTi, and stainless steels)

■ Compatible with a large range of bioceramic dopants

■ Represents an evolution in blasting (or microblasting), a process commonly used in the medical device in-

dustry and well established with regulatory bodies

Figure 3: TEM image showing a CoBlasted surface (Hydroxyapatite on Titanium)

Page 3: DS CoBlast Surface Modification Technology 170809

EnBIO � Tel: +353 21 488 2655

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Enabling New Surfaces on Reactive Metals

Surface Characteristics

Figures 4 and 5 show cross-sectional profile views of a sur-

face modified using CoBlast. It can be seen that the dopant

(in this case Hydroxyapatite – HA) merges into the metal sub-

strate (titanium in this case) ending with a situation where the

typical oxide layer is replaced with the dopant infused oxide.

The dopant layer can be controlled and optimized by varying

the CoBlast process and material parameters.

■ The dopant is not degraded or damaged by the CoBlast

process (low-temperature process).

■ The deposited dopants / materials are an integral part of

the oxide layer.

■ Dopant becomes an inherent part of surface, which

eliminates delamination.

■ The new oxide or dopant layer is ~10µm thick.

■ Surface roughness RA ~ 1 to 2µm (see Figure 6).

■ Active agents (multiple) can be incorporated into the

surface in single step process.

The process has been fully characterized and has been

shown to be repeatable and reproducible.

Verified Substrates and Dopants

The CoBlast process has been tested and validated in various permeations of the following substrates and dopants:

Substrates: Titanium, Cobalt Chrome, Nitinol, Steel, Copper, Stainless Steels

Dopants: Hydroxyapatite, Substituted Apatites (Fl, Mg, Ag, Zn, Sr, Carbonate), Bioglass, Substituted Bioglass

(Sr, Ag), Teflon, Carbon Pyrolytic, Tungsten Disulphide, Molybdenum Disulphide, Graphite, Boron

Carbide, Silicon Carbide, Tungsten Carbide, Artificial Diamond, Zirconia

Figures 4 and 5: Cross-sectional profile views of a surface modified using CoBlast

Figure 6: Surface roughness of a CoBlasted surface

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Enabling New Surfaces on Reactive Metals

Long-Term Stability

Adhesion testing (to ASTM F1147) and shear testing (to ASTM F1044) of the CoBlasted surface versus results

in the literature for plasma sprayed HA surfaces show the CoBlasted surface to be superior in both. This is an

excellent indicator for the long-term stability of implants with a CoBlasted surface.

Licensing and Customized Solutions

EnBIO will license the CoBlast process, supply the processing equipment (via partners) and supply the custom

materials required to enable OEMs apply a surface of choice to their products, i.e., EnBIO’s application team will

work to customize and optimize the CoBlast process to obtain a customer-specific bespoke surface, if required.

About EnBIO

EnBIO offers a variety of novel surfaces for the reactive metals (titanium, CoCr, NiTi, and stainless steel) based

on our patent pending CoBlast™ surface modification technology, with a particular focus on treatments for hard

tissue implants. EnBIO is working to exploit this approach with the recent launch of its OsteoZip™ surface and

with ongoing development of our anti-colonization surface (OsteoZap™) and drug elution surfaces. We offer a

fully integrated single supplier solution for your surface modification requirements. This includes support and

consultancy to develop your surface functionality, supply of equipment, and the supply of media. At EnBIO,

innovation is a cultural cornerstone expressed not only in our technology breakthroughs, but in the way we are

organized and in our approach to fulfilling our mission as world leaders of surface modification technologies for

metallic medical implants.

For more information, please visit our website: www.enbiomaterials.com

Figure 7: CoBlasted (measured) vs plasma sprayed HA surfaces (literature search)

Notes:

■ Ti coupons coated with HA using CoBlast.

■ Coupons underwent ASTM F1147 tensile and ASTM F1044 shear tests.

■ The charts compare results of EnBIO tests to published results for HA coatings applied using a plasma coating process.

■ Shear and Tensile results for CoBlast are significantly better than the published results.

Note: EnBIO reserves the right to change all product specification and functionality without notification.

Information on this datasheet is believed to be accurate, however, no responsibility is assumed for any inaccuracies or omissions.