Changing Seasons

“The hardest thing about learning something new, is unlearning the way you know it now.”

Some Things Never Change The key to patient comfort is a balanced and controlled socket environment that never allows a single force or combination of forces to reach a level of distress and damage tissue. Dr. Sanders and Dr. Burgess identify five forces inside the socket that can be managed but not eliminated. - Journal of Rehabilitation Research and Development Vol. 29 No. 4, 1992, Pages 1-8 ImpactRotationalSheerRepetitiveResultant

Optimal System Physiological component (Limb) Liner Interface medium Mode of suspension Socket design Features: Un-restricted vascular flow Volume management Enhanced Linkage Comfort

Limb

Stump Length Shape Residual Tissue Scarring Invaginations Maturity Above Knee Below Knee Limb Considerations

Limb Shapes

Liner

Liner Material Considerations Experimental Details - Force vs. Displacement Slope Hysterisis Residual Displacement Permanent Displacement

Material Performance Material Types - Comparative overlay, 1 Hz Thermoplastic Elastomer Silicone Urethane Human Muscle

Socket

Basic “TEC” System Total Surface Weight Bearing Socket (TSB) Sheath (air wick) Urethane Liner Suspension (sealing) Sleeve One Way Expulsion Valve Creates sealed suction suspension AK or BK

MUST be total surface weight bearing No more than 3-ply fit No built-in relief's or voids No single wall sockets in a supracondylar or suprapatella/supracondylar configuration Socket

Specific-Weight Bearing Socket Tight Anterior-Posterior round peg in the triangle hole constrict systems Heavy emphasis on Patella Tendon creates high/low pressures increases shear force Relief in socket design creates harbor for fluid retention decreases surface to distribute pressures

Total Surface Weight Bearing Socket Anatomical Shape round peg in the round hole reduces forces implied by shape Natural Anterior-Posterior shape does not constrict systems Socket shape is determined by patient no relief to harbor fluids uses total limb surface to distribute pressures

TEC Liners Custom TEC Fabricated from a cast, query, or measurements Symes, BK, AK, KD, up to hemi-pelvectomy Tapered or Uniform Thickness All TEC liners are made of Urethane All liners can be ordered covered or uncovered, locking or non-locking

TEC Liners

TEC Prefabricated Liners TEC Profile (6Y510, 6Y511) Flexion built into liner Sizing based on over 25,000 custom mold database 17 different sizes Urethane thickness tapers proximal above MPT for ease of flexion Transtibial only Optional Wearforce cover TEC Liners

Liners (Interfaces) TEC Prefabricated Liners TEC AKuire (6Y540) Transfemoral 7 Sizes Flexible Uncovered

Harmony Liner Recommendations Urethane Interface Material Only material that will flow under vacuum Custom Profile or Sirona Tapered AKuire or Simplicity Uncovered Sleeve will seal on top of liner not on skin Tapered Thin proximal is more comfortable under vacuum

Post Operative Management ProTECtor

Utilises liner technology with early post operative fitting Total surface bearing socket Easily removed for wound inspection Easily adjusted to control volume fluctuation Used in conjunction with stump shrinker or bandaging 4 hole pattern allows for secure attachment of modular componentry

ProTECtor Sizes MPT CIRCDISTAL CIRC Small29-34cm27-32cm Medium34-39cm32-37cm Large38-43cm36-41cm X-Large cm40-45cm

ProTECtor Patient Fitting

Suspension PTB Sleeve Supracondylar Valve-Suction Harmony

Dr. Sanders identifies that suspension modes can increase forces by acceleration. The best suspension mode is the one with little or no displacement in swing phase. -Journal of Rehabilitation and Development Vol. 29, No. 4, 1992, Pages 1-8 Suspension

Above Knee Harmony

Success comes from understanding the complete system. It is a process of learning and understanding

Harmony® A unique volume-management system that marries two technologies to offer the benefits of improved linkage, increased proprioception, shock absorption and rotation.

How does it work? The Vertical shock movement activates a pump that pulls air out of the socket and creates an elevated vacuum connection between the Urethane Liner and Socket. Harmony

Evolution of Harmony Technology Electric UnitBackpack Unit

Best Suspension Volume Management Improved Proprioception Improved Blood Flow Shock Absorber Evolution of Harmony Technology Rotation

What’s New… Torsional Dampening & Rotation Streamlined (smaller) Simplified Increased Reliability Lighter Weight

Torsional Dampening & Rotation We’ve re-engineered the new Harmony P2 to include torsional damping and rotation. This allows wearers to move more naturally – whether they are walking, running errands or golfing.

Streamlined The slimmer profile of the Harmony P2 makes it easier to finish the prosthesis, achieving the look your patients desire. Harmony P2 compared to the earlier PRS unit

Simplified The new Harmony P2 design features a totally new vertical shock-absorbing system with elastomer rod technology. This allows the practitioner to make infinite adjustments and eliminates the need to add air.

Reliability An improved, double-filtration system, shorter tubing and fewer in-line connections makes the Harmony more reliable than ever before.

Lightweight By integrating the pyramid into the Harmony P2, we’ve made it lighter (40% less weight). The integrated pyramid also adds convenience as fewer parts need to be inventoried.

Indications for Use The Harmony P2 is ideal for moderate to higher activity lower extremity amputees who experience one or more of the following issues: volume fluctuation pressure on the residual limb skin irritation difficult to fit limbs and balance issues.

Life in Harmony

Anterior 30 degrees flexion 0 degrees Posterior 30 degrees flexion 0 degrees Shape Difference

Vacuum Casting Vacuum captures true limb shape Consistency and reproducibility Cast over liner being fit Hands Off Portable

Custom Liner

Vacuum Casting

~ 80 Degrees5 to 10 Degrees Vacuum Casting

Vacuum Casting Review 3 part cast to capture anatomical differences between flexion and extension First anterior shell ≈ 80 degrees flexion midline to midline Second anterior shell degrees include fib head Circumferential cast over anterior shell degrees Vacuum captures true limb shape Consistency and reproducibility Cast over liner being fit Hands Off

Modification Why Reduce? Create the drive/flow of the liner in TSB socket Global Circumferential 4% reduction ¼”(5mm) distal reduction mandatory No relief's or voids Can create TEC Relief using TEC Spot Utilize scribing tool if needed to verify reduction

Trim Lines Trim lines will affect knee flexion Trim lines can affect life of sealing sleeve Lower trim lines possible when using Harmony 1.5” (38 mm) 1.5” (38 mm) MPT 2.5” (65 mm) 2.5” (65 mm) +¼” (6 mm) -¼-¼

Fitting Uniform drive/flow of Urethane Utilize Spots, ½ socks, full socks to check fit Go to extreme to verify good fit If making too many adjustments to get good fit, start over with a new cast and re-modify Save test socket to verify limb change in future visits

The System

New Harmony Sleeve Replaces the TEC Prolink Improved Durable Cover Standard and Tapered

Suspension Sleeves Lower socket trim lines when using Harmony Eliminates excessive stretching when flexed How to make them Last Longer

Suspension Sleeves Use the new Gaiter to protect the sleeve from the socket trim lines How to make them Last Longer

Suspension Sleeves Fabricate hard slip cover over socket and sleeve How to make them Last Longer

Harmony Technology Process to Stability Complete patient evaluation Clear understanding of patient Limb maturity and health Activity level Prior socket system Mental capacity 1 st follow-up 1 week to 10 days Continue test sockets until limb stabilizes to Harmony. May take more than one test socket.

Permanent Volume Loss Normal muscle atrophy Pressure atrophy New socket every few years Daily Volume Fluctuation 6-12% daily volume loss Socket fit and comfort problems Utilize Socks and other volume management tools Realities of Volume

Volume and Pressure Relationship

Volume Management - Vacuum Testing Subjects using a regular suction socket lost 10% or more Subjects under vacuum lost 1% or less of stump volume Subjects under vacuum felt more “connected to the prosthesis” Knee flexion was not inhibited Note: Some subjects gained volume W.J. Board, G.M. Street, C. Caspers, A comparison of trans- tibial amputee suction and vacuum socket conditions, Prosthetics and Orthotics International, 2001, 25,

LIMB SLEEVE SHEATH LINER SOCKET SEAL Area Under Vacuum

Testing the System Use Gauge to Test the Entire System Testing Only the Pump Disconnect at Pump

Installed properly as a complete system, the following are some incredible results achieved.

71 Year Old Male Below Knee Amputee Open ulcer for several months Spending most of time on crutches Healing in Harmony

“He is tolerating prolonged walking very well” Healing in Harmony

11 Weeks in VASS - Completely Healed Healing in Harmony

1 Year Later - Still in Harmony Healing in Harmony

Sore healing under the scab Draining stopped just after a few days in Harmony May 6, 2002 Completely Healed February 7, 2002 Ulcer for 2 months Healing in Harmony

AK Healing in Harmony