31
ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING Julius Bonini P.E., Senior Metallurgical Engineer Kaitlyn Calaluca, Metallurgical Engineer Lucideon M+P, Schenectady, NY

ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

  • Upload
    others

  • View
    6

  • Download
    0

Embed Size (px)

Citation preview

Page 1: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS

CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Julius Bonini P.E., Senior Metallurgical EngineerKaitlyn Calaluca, Metallurgical Engineer

Lucideon M+P, Schenectady, NY

Page 2: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

ALM - Challenges Associated with Cleaning and Processing

1. ALM process as applied to porous coated devices

2. General cleaning issues associated with ALM specific to porous coated devices

3. Unfused Particle Shedding

2

Page 3: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Tailored Porous Surface Structure

Additive Layer Manufacturing

3

Page 4: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

− ALM - Otherwise know as 3D printing

− Titanium Components− Electron Beam Melting (EBM) or− Direct Metal Laser Sintering (DMLS)

− Several metallurgical issues need to be resolved for medical implant applications− Complex microstructural issues (won’t be addressed here)− Cleaning and processing issues

Additive Layer Manufacturing

4

Page 5: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Porous Surface Structures of Common Medical Implants

5

Page 6: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Accurate measurements can be made and parameters established per ASTM 1854

Sintered Wire and BeadHave Definable Porous Structures

6

Page 7: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

ALM Structures Found to be Highly Variable

7

Page 8: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Cross-Sections Show Deep Porous Structures

8

Page 9: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Surface Porous Structures

9

Page 10: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Advantages of ALM Technologies

− Cost?

− Create any porous structure you want− Depth− Tapered porosity through section− Pore Size− Pore Density

− Complete flexibility for improved osseointegration

Components Manufactured via ALM Technology

10

Page 11: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Most Common Application of ALM Acetabular Cups

11

Page 12: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

− How do you keep components clean during processing?

− How do you eliminate residues and prevent entrapment?

− How do you remove all processing fluids from final product?

Cleanliness Issues Related to Components Manufactured via ALM Technology

First You Need to Understand the Life of a Typical Component

12

Page 13: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

The Life of an Acetabular CupConventional Porous CoatWire, Bead, Plasma Spray

ALM Porous CoatEBM, DMLS

Bar/Forging

Extensive Machining &Processing

Extensive Cleaning & Degreasing

Porous Coated

Final CleaningAnd Packaging

Coated Shell(porous)

Extensive Machining &Processing

Extensive Cleaning & Degreasing

Final CleaningAnd Packaging

Passivation

Page 14: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

“Dirty” Parts

14

As-Received(Clean)

After Processing(Dirty)

Page 15: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

− In-house processing operations will contaminate parts− includes applied cleaning procedures

− Think of ALM structures as sponges− Rough surfaces pick up surface debris− Substructures act as a sponge and absorb fluids and

humidity from air

− Removal of all these residues, liquids and debris is a challenge

Very Complex Issue

15

Page 16: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

To remove these contaminates, you clean: Wash, Blast, Ultrasonics?

Debris Pick-up and Removal

16

Page 17: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Effective Cleaning of Complex Porous Structures is a Challenge

− Liquid exposures can be problematic

− Ultrasonic cleaning, rinsing, passivation

− Cleaning solutions, caustics, acids

− Problem becomes effective removal of cleaning liquids

17

Page 18: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Open Cell Structures Pose Less of a Challenge

Fluids In – Fluids Out

18

Page 19: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

• Open Cells

• Closed Cells

• Semi-Closed Cells?

Closed and Complex Cell StructuresAre a Real Challenge

19

Page 20: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Processing Effects

− Thermal Effects

− Open (interconnected) cells stay open during all stages of processing− General problem that has to be dealt with− Any liquid exposure has to be effectively rinsed and dried

− Closed cells remain closed during all stages of processing− Shouldn’t be a problem

− Semi-closed – open when heated due to thermal expansion, then close upon cooling− Can be a very big issue

20

Page 21: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Processing Effects – Open Cells

21

− Typical Liquid Exposures

− Cutting fluids and coolants

− Solvents and cleaners used to remove above− May include ultrasonic with heat

− Rinse agents and water used to remove above

− Passivation

− All can be effectively removed with proper practice

Page 22: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Processing Effects – Semi-Closed Cells

− Semi-closed cells open at elevated temperature ( > 40 o C)

− Liquid infuses into now open cells at temperature

− Liquid remains trapped as cells close again upon cooling

− Liquid can be effectively rinsed from all open areas but not from now closed cells

− Subsequent thermal exposure can re-release liquid

− Particular concern during passivation step

22

Page 23: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Passivation Effects – Semi-Closed Cells

− Semi-closed cells – open when heated then close upon cooling

− Nitric Acid Exposure

− Slowly oozes out over time

Fully Porous Augment

23

Page 24: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Potential Solutions

− Effective dissolution and removal of all liquid agents

− Use of volatile alcohols

− Combined with ultrasonics + temperature to open those semi-open cells

− Followed by effective oven drying

24

Page 25: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Unfused Powder ParticlesLong Term Problem for all ALM Materials

• Nature of the material – it all starts with fine Ti powder

• Unfused particles are cleaned off of manufactured parts by blast methods using the same media

• Levels of effectiveness – surfaces look good

• Below the surface may be a problem – remember the complex porosity issue

25

Page 26: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

26

Unfused Particles

Page 27: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Particles Collected fromCleaned Sample Surface

27

Page 28: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

28

With Additional Surface BlastingAs Normally Processed

Page 29: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Unfused Particles

29

NoAdditionalBlasting

WithAdditionalBlasting

Page 30: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Conclusions

• A variety of particle cleanliness issues need to be addressed for evolving ALM components

• Stick your head in the sand?

• Test, evaluation and material standardizations specific to ALM material are needed

30

Page 31: ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS … · ADDITIVE LAYER MANUFACTURING AS APPLIED TO POROUS SURFACES ON MEDICAL IMPLANTS CHALLENGES ASSOCIATED WITH CLEANING AND PROCESSING

Thank you

Contact Details

T (518) 382‐0082E [email protected] www.lucideon.com

31