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ALPS has recently introduced an innovative and skin friendly silicone prosthetic liner for lower limb amputation. This liner provides a solution to some of the clinical problems and disadvantages of silicone in skin-contact applications due to the inherently high coefficient of static friction typical of silicone polymers.
History or prosthetic liners
Silicone liners have been used since the 1980s in the prosthetic industry because 2 component RTV silicones were commonly used in prosthetic facilities for a number of applications thanks to the ease of mixing and to the room temperature cure as well as to the great detail resolution that silicone provided when molded.
Therefore when the first triple S sockets (silicone suction sockets) were developed by Carlton Fillauer in the 1980’s he simply used, with great success, the 2-component silicones that he already had readily available on his lab bench.
Ossur, then, developed the first non-custom silicone liner using a matrix reinforcement at the distal end, making a more convenient, off-the-shelf version of the 3S liner, so to speak.
In many respects silicone seemed, at the time to be the ideal choice for prosthetic liners as it has the following desirable properties:
Easy to clean
Repels dirt
Does not stain
Does not retain bad odors
Has a high coefficient of heat transfer (cools the limb better)
Can be molded in very thin sections, resulting in very light liners
However, the high coefficient of static friction of silicone caused skin blisters in patients with sensitive skin.
Therefore approximately 25% of patients could not tolerate long term use of silicone liners.
The high coefficient of friction per-se would not be a huge problem if the modulus of elasticity of silicone were low enough to allow the skin to move when subjected to shear forces.
The modulus of silicone though is not low enough for many patients resulting in blistering of the skin.
Such blisters are prone to be a source of more serious sores especially in patients with poor vascularity.
Over the years different additives have been developed that are introduced in the silicone rubber formulation which exude from the liners and provide lubricity on the skin.
And thermoplastic gel liners have been developed having a much lower modulus of elasticity than silicones and some like the EasyGel liners that have a modified surface to eliminate sticking altogether.
ALPS skin friendly silicone liners
Prosthetic liners manufacturers tried to solve the above-mentioned issues by including additives to the silicone to reduce the coefficient of static friction; however, the exudate substance can collect dirt, exacerbating the risk of skin issues, and the prosthetic liner may become slippery.
Alps expertise in processing silicone allowed our engineers to come up with a new manufacturing method which improved the friction characteristics of the silicone prosthetic liner.
The surface of the prosthetic liner has been modified, to create micro craters that reduce the static friction without any additives, resulting in a completely skin friendly silicone.
Silicone with the modified surface layer shows a reduction of 80% of the coefficient of static friction, as shown in the graph below.
Alps Silicone Pro liner is manufactured using pure silicone. This makes our Silicone Pro suitable for a wide range of amputees, including elderly and vascular patients with a lower limb amputation.
The Silicone Pro stands alongside our liner manufactured in EasyGel, Grip Gel and the newest High Density Gel (Silicone Equivalent).
What happens when a shear force, like that generated inside a prosthetic socket during ambulation, is applied on a pure silicone surface?
Due to the high coefficient of static friction of pure silicone, the shear stress is transferred to the skin of the residual limb, leading to blisters in patients with sensitive skin and poor vascularity.
ALPS, thanks to its expertise, was able to develop an innovative,100% skin friendly silicone liner without any additives.
Prosthetic liners and sleeves provide the interface between the residual limb of the amputee and the socket, one of the many elements that make up a prosthetic leg: their aim is to provide the user with consistent and reliable comfort, control and stability.
As liners and sleeves are in direct contact with the skin of the residual limb, they act as a second skin for the amputee. It is therefore extremely important that the material they are made of is gentle and skin friendly, to avoid irritating the skin and to minimize any issues related to amputation and the need to wear a prosthetic device.
ALPS expertise in the field of chemistry and our position as a leading manufacturer of advanced gel-based medical devices have led to the development of a wide range of prosthetic liners and sleeves over the years, characterized by an innovative and unique product: our gel.
ALPS GEL MAKING THE DIFFERENCE
ALPS offers different types of gels to meet the needs of an increasingly demanding market and to satisfy the specific, individual needs of each patient, according to his or her clinical conditions and lifestyle.
Our gels provide optimal protection against both shear and other normal stresses and ensure a perfect combination of control and even pressure distribution within the socket.
ALPS Gel is a patented material exclusively manufactured by Alps.
The variety of ALPS GELs allows each individual patient to find a unique, perfect fit:
EasyGel was the first we developed. Characterized by a soft and powdery texture and enriched with antioxidants promoting skin healing benefits, EasyGel reduces skin breakdown and improves comfort, making it ideal for patients with sensitive or scarred skin (geriatric, diabetic, and dysvascular patients).
High Density Gel- silicone equivalent has a dense and firm texture. Its relatively firm consistency combines comfort with control and stability. It’s recommended for dynamic patients as well as for those who are transitioning from a silicone liner to a gel liner.
Grip Gel features a smooth and tacky texture that helps in reducing bunching in the popliteal area, and is recommended for patients with healthy skin tissue.
All ALPS Gels are characterized by a lower modulus of elasticity.
This means that ALPS Gels are more stretchable and expand and regain shape easier than silicone under compression.
The low modulus of elasticity, or ease of stretch, is a beneficial property for dysvascular patients because it conforms to the pressure point without restricting blood flow, while providing optimum compression, stability, freedom of movement and secure suspension for both above and below the knee amputees. At the same time, it provides extended durability to both liners and sleeves.
What ALPS gels offer in summary:
Comfort: different degrees of elasticity provide a high level of adaptability and customization
Extreme versatility: conforms to the shape of the residual limb
Universal use: different gels designed to fit the various specific needs of geriatric, diabetic, traumatic and active patients for any level of activity
Ease of stretch: ensures the right amount of compression without restriction of blood flow
Reduces shear forces: the adhesion and cushioning of gel absorbs friction on the skin
All these features have as their goal a single, very simple and extremely important concept: the well-being at 360° for each lower limb amputee, that can find in the variety of ALPS gels his own second skin.
In the period immediately following amputation surgery, the medical personnel will be in charge of making sure the wound heals correctly and completely, telling you exactly what you need to do.
Once past the post-operative phase, you will be fitted with a prosthesis. You will need to follow a few simple directions during your daily hygiene routine to make sure the skin of the limb remains healthy:
Use a neutral cleanser. The skin of the residual limb is particularly sensitive so it is highly recommended that you use exclusively neutral cleansing products (for example prosthetic cleanser PD595)
Rinse thoroughly after washing. Residues from cleansing products can cause the skin of the stump to become red and irritated. This is why careful rinsing when bathing is essential
Dry thoroughly. Before donning your prosthetic device, make sure the residual limb is completely dry
Check the condition of the skin daily. Your daily hygiene routine should include a careful inspection of every part of the skin of the residual limb to make sure there are no points of irritation
Apply lotion before putting on your liner. If you use a prosthetic liner, be sure to use a lotion that makes it easier to slip on and provides a protective barrier, while still allowing the skin to breathe. We recommend SL 108 Skin Lotion
Apply cream before bed. To keep the skin soft and supple, it can be useful to apply a good skin cream like Alps Antioxidant Cream before bed. Alps Antioxidant Cream keeps skin supple, soothes irritations, and stimulates skin-cell regeneration
If you have specific needs, your orthopedic therapist and/or technician will provide you with further instructions on keeping your limb healthy.
TAKING CARE OF YOUR ALPS PROSTHETIC LINERS AND SLEEVES
The steps to take to keep your Alps prosthetic sleeves or liners clean are simple, but fundamental. Keeping the liner clean is essential for avoiding problems further down the line.
Wash the inside of your prosthetic sleeve or liner with warm water and a neutral detergent (PD595). This is particularly important for prosthetic liners that maintain contact with the residual limb’s skin the whole day long. Daily cleaning of the inside surfaces of the liner with a mild detergent removes any traces of grease of dead skin cells
Rinse thoroughly. Again, this is fundamental to make sure that no detergent residue remains that could cause chafing and irritation, especially if your skin is particularly sensitive
Carefully dry the inside of the liner with a dry cloth
We recommend an additional weekly cleaning (or daily, if your skin is particularly oily) with an alcohol-soaked soft cloth. Carefully wipe the entire interior surface of the liner with the cloth and then thoroughly dry with a clean towel.
To clean the fabric exterior of the sleeve or liner, wash it by hand or in the washing machine at a low temperature with prosthetic detergent PD595.
A LITTLE CARE GOES A LONG WAY TOWARDS MAKING YOUR PROSTHETIC SLEEVE OR LINER LAST A LONG TIME
Let’s take a look at some simple things you can do to increase the lifespan of your Alps prosthetic sleeve or liner:
Always keep your liner/sleeve away from radiators or other sources of direct heat
When not in use, put the foam padding inside to help keep its shape: try not to leave it lying flat for long periods of time
Never leave your sleeve/liner partially inside-out
Separate the sleeve from the socket when not wearing the prosthesis
SWEAT AND GREASY SKIN
During the first 2-6 weeks of using a prosthetic liner, you may experience an increase in perspiration. This effect will gradually disappear.
Should your level of perspiration be particularly intense in the first weeks of wearing a prosthesis, it is advisable to give your body time to get used to wearing it gradually, limiting the number of consecutive hours you wear it and slowing increasing this time as your skin adapts.
You can also regulate your perspiration by using our specific antiperspirant lotion designed for amputees, ALPS ATP008 whether during those first weeks or any time you don the prosthesis afterward.
If it is used in combination with a lotion designed to ease donning the liner (for example our SL108), first apply the ATP008 antiperspirant lotion followed by the SL108 skin lotion.