Use of platinum cured silicone for increased comfort, control and moisture management in prosthetics Ana Gallego ProfGradIMMM.

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Eileen West
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1 Use of platinum cured silicone for increased comfort, control and moisture management in prosthetics Ana Gallego ProfGradIMMM. Senior Materials Engineer. New Product Development

2 Section Summary About Blatchford Amputee issues Anatomy of a liner Results

4 Company structure

5 Section Summary About Blatchford Amputee issues Anatomy of a liner Results

6 Ongoing challenges: comfort Strong connection Conducive to good residuum health Good socket fit

Socket problems connection Suspension techniques are susceptible to levels of pistoning and bell-clapper effect This is the relative movement

7 Socket problems connection Suspension techniques are susceptible to levels of pistoning and bell-clapper effect This is the relative movement of the residuum within the socket This movement needs to be minimised to give better control and proprioception of the prosthetic *Not to scale

8 Socket problems volume loss Residuums are known to fluctuate in volume, affecting the socket fit quality Many amputees try to compensate with extra socks A desirable characteristic of a suspension method is to reduce or adapt to volume changes Consistency of fit is very important *Not to scale

Socket problems interface stress If the stresses on the residuum are too high, the user won t wear their prosthesis High stresses can lead to tissue

9 Socket problems interface stress If the stresses on the residuum are too high, the user won t wear their prosthesis High stresses can lead to tissue damage and skin irritation Scar tissue, not used to loading Warning! Fig_3necroticstump.jpg

10 Energy demand and body surface area Trans-tibial amputees expend 20-40% more effort to walk Surface area reduced by 10-15% reduces cooling capacity

11 Issue: SWEAT

12 Prosthetic sockets The amputee s residuum is held in a socket Amputees will commonly wear prosthetic liners to cushion the interface Liner acts as an Interface between the skin and hard socket Disperses peak pressures Absorbs shear forces created in the socket Provide secure suspension Pressure Shear

13 Liner problems

14 Insulating materials Thermal conductivity of liner materials: Sockets: Carbon Fibre and Thermoplastics: and W/m.K Silicone/PU/TPE liners: W/m.K. Closed cell foam (i.e. Pelite): W/m.K The thermal conductivity of prosthetic sockets and liners. Klute GK, Rowe GI, Mamishev AV, Ledoux WR. Prosthet Orthot Int Sep;31(3):292-9.

15 Section Summary About Blatchford Amputee issues Anatomy of a liner Results

Silcare Breathe Liner - Anatomy Silicone moulding - Platinum cure system - Shore 00 Reinforcing fabric cover - 2 zone stretch Anti-friction coating - Reduced shear forces between

16 Silcare Breathe Liner - Anatomy Silicone moulding - Platinum cure system - Shore 00 Reinforcing fabric cover - 2 zone stretch Anti-friction coating - Reduced shear forces between stump and the silicone Silicone adhesive - Platinum cure Distal cap - Platinum cure system - Shore A Umbrella - Nylon 6,6 - Mechanical attachment Vacuum functional valve - LSR - Shore A

17 Silcare Breathe Anatomy - Inner surface (ISO 8295) Silicone moulding - Platinum cure system - Shore 00

Silcare Breathe Anatomy Fabric cover Integrated matrix with no longitudinal stretch at the distal end resists pistoning of the prosthesis Proximally bi-directional stretch

18 Silcare Breathe Anatomy Fabric cover Integrated matrix with no longitudinal stretch at the distal end resists pistoning of the prosthesis Proximally bi-directional stretch allows comfortable knee flexion Continuous knitting technology allows easier donning due to the smooth transition Bi-directional stretch zone Uni-directional distal matrix

19 Silcare Breathe Anatomy Fabric/Silicone interface Fabric - Polyamide + Elastane Silicone adhesive - Platinum cure Silicone moulding - Platinum cure

20 Silcare Breathe Anatomy Umbrella Umbrella - Nylon 66

21 Umbrella Flex - Easier donning/doffing - Eliminates trapped air - Conforms better to stump / reduces shear stresses: - Better pressure distribution

22 Silcare Breathe Anatomy Distal cap Distal cap - Platinum cure - Shore A

23 Silcare Breathe Anatomy Sweat Management Perforations

24 Silcare Breathe Anatomy Moisture management

25 Silcare Breathe Anatomy Moisture management

26 Silcare Breathe Anatomy Functional valve Stance Swing Functional valve

28 Sweat management

29 Results Perforated liner Non-perforated liner Perspiration escapes through the holes Perspiration remains (and pools) inside the liner. Reduces proprioception and forces the user to stop activity to empty and dry stump.

30 Section Summary About Blatchford Amputee issues Anatomy of a liner Results

31 Percentage of respondents Percentage of respondants Patient feedback sweating Patient s self-perception similar to the observations of their prosthetists Does heat or sweating in your prosthetic leg ever stop you wearing it? Fitting 1 month 3-4 months Do you currently have any issues with sweat in your prosthetic leg? Exercising only Yes but much reduced Yes Fitting 1 month 3-4 months Prosthesis disuse due to sweating was eliminated completely after 3-4 months

32 Percentage of respondents Prosthetist feedback vacuum Does vacuum hold? Consistently over 76% How effective is the seal at maintaining sufficient vacuum? Average rating across all responses Does the new liner with the seal hold vacuum? Fitting 1 month 3-4 months

33 Ana Gallego Materials Engineer, New Product Development t: +44(0) m: +44(0) e: w: blatchford.co.uk Blatchford Group Unit D Antura, Bond Close, Basingstoke, RG24 8PZ United Kingdom Thank you Thank you

Product Update New Liners

Product Update New Liners medi 4Seal TFS & TFC Liners Inspired by the soles of a gecko s feet, 4Seal silicone liners from medi provide a natural hold for the user, through flexible seals and medi compression