Alpha DESIGN® Liners
Alpha® Advanced Formulas
Why are you making the change to Advanced Formulas?
- The Tapered style is for very conical or bony limbs or for Symes amputees. The gel thickness on the sides of the liner increases toward the distal end.
- The Contoured style is for active amputees, or amputees who have a sharp, non-rounded distal tibia. They need extra padding at the front of the socket to protect the tibia.
- The Uniform style is for amputees with very evenly-shaped residual limbs. The gel is uniformly thick throughout the liner.
- The Progressive gel style is available only for the Alpha Select Liner. It features thicker gel at the distal end and in the tibial crest area, and thinner gel behind the knee and at the proximal edge.
At the end of the day, wash the liner with water and a body soap that does not irritate the skin. Allow the liner to dry on the drying stand overnight. Once a week, disinfect the liner by wiping the gel with ethyl or isopropyl alcohol and allowing the liner to dry overnight.
- Examine Alpha® Liners daily. Report any signs of unusual wear to your prosthetist.
- Apply Volume Management Pads, made of 3mm-thick Alpha® Gel, on the limb in the area where volume has been lost – for example, at the back of the leg for a BK amputee.
- Avoid the use of socks, which increase the volume symmetrically (not just in the places where volume has been lost).
- Although our Alpha® liners have proven to be very skin-friendly for most amputees, we do occasionally hear reports of skin irritations. Possible causes:
- Not cleaning the liner daily. Neglecting to clean the liners daily may cause a rash to occur on the residual limb due to a buildup of bacteria from the skin.
- Not rinsing all the soap off the liner. Soap residue may cause an irritation to develop.
- Not drying the liners correctly. Drying the liner gel side out (instead of gel side in) can damage the liner and can allow dirt to stick to the gel, which can lead to skin irritation.
- Not disinfecting the Alpha Liner with alcohol every week. If a rash appears after two or three months of using an Alpha Liner, this is the likely cause. Note: using an anti-bacterial soap instead of alcohol is not an effective means of disinfection
- Use of a harsh or irritating soap, lotion, or cream. Use the same soap on the liner that is used in the bath or shower. Do not use talcum powder, or any creams or lotions that contain animal fats or oils (lanolin, vitamin E oil, etc.) or hydrocarbon oils (petroleum jelly, silicone oil, etc.).
- Pulling the liner onto the limb instead of rolling it on. Some amputees will grab the top edge of the liner and try to pull it as high on the leg as possible, like putting on a boot. This can lead to irritation along the top edge of the liner. Be sure to roll the liner onto the limb without pulling.
- Gouges, holes or other damage on the gel surface. Cleaning the gel by scrubbing it instead of wiping it gently can cause damage.
- Liner is loose. If a liner is too big, or if the limb has shrunk, air can get trapped between the skin and the liner. This can result in excessive sweating that can lead to a rash. Also, a liner that is too loose allows the limb to rub back and forth on the liner. Try applying Volume Management Pads to the area that has shrunk.
- An allergic reaction. Though we’ve never had a documented case of an allergic reaction to the Alpha gel, it’s possible. To rule this out, put a clean piece of Alpha gel somewhere else on the body for a few days to see if the skin reacts the same way.
- Fungal and/or bacterial infection. This will require treatment from a dermatologist.
- Trim the drying stand to a shorter length to make it easier to fit in a suitcase.
- When packing a liner in a suitcase, put some socks or a t-shirt in a plastic bag and roll the liner over it.
- To dry a Locking Liner without having to pack a drying stand: take a shoe string (or other similar string), tie a slip knot on both ends, slip one knot over a coat hanger, slip the other end around the pin on the end of the liner, and hang the liner to dry.
- Avoid leaving Alpha Liners in hot places (like the trunk of a car), because the heat can deform the liner.
- Pack some Volume Management Pads to help deal with daily volume fluctuations.
It depends on the residual limb. Prefabricated Alpha® Liners are great for amputees who have more regularly-shaped limbs. Amputees whose residual limbs are scarred, bony, short, or uneven in shape may be candidates for a custom Alpha DESIGN Liner.
It’s a liner in which the gel pattern has been created specifically to address an individual amputee’s needs – for example, thicker gel in certain areas to accommodate sensitive areas or invaginations.
The Select Fabric and the Hybrid Gel are available for use in an Alpha DESIGN Liner. However, the accordion umbrella is not currently an option. Please contact our DESIGN team at 800-848-4930 to discuss the most suitable alternative for your patient.
The suggested code for an initial DESIGN Liner is L-5681 or L-5683. The suggested code for a duplicate liner is L-5679 for a cushion liner, and L-5673 for a locking liner.
No, but if want to facilitate knee flexion, you can design the liner so that the gel is thinner at the patella. Selecting the “Pre-Stretch Liner” option when ordering can also be helpful.
No. The gel layer of the DESIGN Liner is the part that is custom-designed. The size of the fabric covering, and therefore the size of the liner, is not a custom option. DESIGN Liners are available in the same sizes as the prefabricated liners, plus 2 additional sizes. Each size is designed to fit a wide range of limb circumferences, so there’s a good chance that we’ll have a size that works for your patient. Give our DESIGN team a call at 800-848-4930 to discuss the options.
For amputees whose limb circumferences are at the upper end of a size range for a liner, the liner may initially be slightly difficult to don. To make the liner easier to don, we can “pre-stretch” the liner over a model of your patient’s limb at no charge before shipping it to you.
We dispose of the cast after we digitize it, but we do keep the electronic shape on file forever.
Send a cast (or non-Tracer shape file) and a completed order form. If you choose to send a cast, use standard casting techniques.
- Alpha Original – Comfortable and dependable, the gel conforms to the shape of the residual limb and protects against abrasions and shear forces.
- Alpha Spirit – Fabric is more flexible than Original and MAX, and adheres to Velcro®. Perfect for users with limited hand dexterity.
- Alpha MAX – Fabric is three times more durable than Original and Spirit. Perfect for heavy-duty users.
- Alpha Select - This fabric allows for easy bending and flexing of the knee. It also provides circumferential stretch for easy donnting, yet maintains liner elongation within specified limits. Select fabric is a one-way stretch fabric that controls pistoning without a distal matrix.
From the day the cast or file is received, it takes 3 days to make cushion DESIGN Liners and 4 days to make locking DESIGN Liners. If a custom liner is requested to be made with Hybrid Gel the turnaround time is 7 days.
Our tireless development team at WillowWood are constantly exploring how new technologies in materials and manufacturing processes can be utilized to improve our existing products. Our Advanced Formulas are a direct result of this. New innovations have allowed us to provide a more durable gel, while maintaining the same unparalleled comfort your patients have come to expect from the Alpha Liner.
Which products are affected?
Any product that contains Alpha Classic Gel or Alpha Hybrid Gel, including:
- All Alpha Classic Gel Liners
- All Alpha Hybrid Gel Liners (with Kevlar® Additive)
- Alpha DESIGN® Liners
- All Alpha Classic Suspension Sleeves
- All Alpha Hybrid Suspension Sleeves
- Alpha Gel Cups & Volume Management Pads
Why are Advanced Formulas better?
Alpha gel is developed, first and foremost, to be the most comfortable and skin-friendly liner available. In general, most factors that define “comfort” and “durability” directly oppose one another. However, advancement in material science has allowed us to create formulas that improve durability without any compromise to comfort. For example, the Advanced Formulas are less likely to migrate away from high pressure areas, such as bony prominences, during extended wear. The result: Some patients will notice that their liners are lasting longer than ever before.
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Does this mean that Classic Gel and Hybrid Gel are being discontinued?
No. The Advanced Formula is simply an enhancement to both Classic Gel and Hybrid Gel products. Once we begin shipping the Advanced Formulas, they will become the standard; the older formulas will no longer be produced. In the future, our gels will continue to be known as Alpha Classic Gel and Alpha Hybrid Gel.
Will the Advanced Formulas change the durometer or softness of your liners?
No. The durometer, or softness, remains the same. Just as before, Classic Gel remains the softest available solution, while Hybrid Gel is still slightly more firm.
Do the Advanced Formulas mean that Classic Gel is now as durable as Hybrid Gel?
For patients that experience excessive gel migration over high pressure areas, both Classic and Hybrid Gel incorporating the Advanced Formulas can expect extended life. Hybrid Gel still features the Kevlar® additive and a more firm durometer, resulting in the more robust solution of the two.
Will my long-time Alpha patient notice a difference?
Not at all. The liners look, feel and fit the same way that they always have. Some patients may, however, notice extended liner life due to the enhanced properties of the Advanced Formulas.
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Does the gel still contain mineral oil? Vitamin E?
Yes, both of these hallmark Alpha Liner ingredients are still included.
Why are the various mechanical tests mentioned important?
Gel Migration/Return – This tells us how much/how fast the gel flows away from areas of high pressure. It also tells us how quickly the liner returns to its original shape when relieved of pressure.
Gel Durometer – Measures the softness or firmness of the gel.
Gel Peel Strength – Measures the bond strength between the outer fabric and inner gel.
Gel Tensile/Tear Strength – Measures the ability of the gel to withstand the forces within a socket.
Gel Elastic Modulus – Indicates how tight the liner will feel to the patient.
Are the Advanced Formulas still skin-friendly?
Absolutely. We extensively test biocompatibility in order to ensure that the gel can contact skin without producing any harmful or adverse effects. Alpha products are tested in accordance with the International Organization for Standardization (ISO): (1) ISO 10993-5, in vitro cytotoxicity, (2) ISO 10993-10, irritation, and (3) ISO 10993-10, skin sensitization.
How do I know if my new Alpha Liner has Advanced Formula?
You won’t. The liner, associated packaging and instructions have not changed. But, if you’re curious, it’s as simple as contacting us and providing one of our Customer Care representatives a serial number.
When will I begin receiving liners and sleeves with the Advanced Formulas?
Starting January 1, 2013, shipping of all applicable liners and sleeves will begin transitioning to the Advanced Formulas. Several of the most popular sizes/types of liners, as well as Alpha DESIGN Liners, will begin to reach patients in the next few weeks.
How much patient testing has been completed?
- 83 test patients (53 internal WillowWood test patients, 30 external beta test site patients).
- 3,676 days (equivalent to nearly 10 years of patient wear) of testing on internal WillowWood test patients.
- Many patients alternated daily between existing formula liners and Advanced Formula liners. This was one way to ensure that there were no noticeable differences between the two.
Does Advanced Formula change the way I select liner sizes?
No. The sizing charts have not changed. Assuming patient measurements have not changed, new liners with Advanced Formula will fit identically to their previous liner.
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Will the warranty be changing?
No. Each liner will still carry our industry-leading 12 month warranty, as well as our no-questions-asked 30 day trial period.
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Have the cleaning & care requirements changed?
No. The procedures for daily cleaning and weekly disinfection have not changed. Please refer to the Alpha instruction manual for additional information.
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What makes the Pathfinder® II different from other feet?
Unlike any other foot, the Pathfinder II features a toe spring, a foot plate, and a pneumatic heel spring all connected in a triangular configuration. This design provides shock absorption during heel strike without diminishing the energy return of the toe spring. The result is a foot that requires less energy for walking or running, yet provides excellent balance and stability.
Every amputee is different, and every amputee has different needs. Amputees must talk to their prosthetists about their pre-amputation activity level, their current activity level, and the activity level they hope to achieve. Foot weight, energy return, and response must also be discussed so that the prosthetist can select a foot that matches the amputee’s needs.
We offer live courses for both prosthetists and technicians at our Education Center. For those who are unable to attend the live courses, we also offer online courses. Click here to register for any of these courses.
Yes. When ordering the LimbLogic VS, be sure to specify that a thermoplastic socket will be used so that the correct adapter will be shipped.
Each single-unit box includes a LimbLogic VS pump, a hand-held fob, a lamination kit OR a thermoplastic fabrication kit, a patient accessory kit, the patient and prosthetist manuals, a battery charger, and an international power plug.
A drop-in adapter, a Poron Filter, four M6 x 55 screws, a ¼ x 20 Cap Screw, a Plastic Anchor, a Latex Form, and two Forming Sleeves (one large, and one small). The kit also includes a fabrication instructional video.
Yes, a one-time purchase of a Thermoplastic Tooling Kit (LLV-02100) is required.
You should get 6-8 applications from the resin in the kit. Additional resin is available by the gallon (LLV-02102).
The newest version of the LimbLogic VS pump (the 1600 series) is waterproof for FRESH WATER only to a depth of 3 meters (10 feet) for up to 12 hours at a time. The hand-held fob is NOT waterproof and should not get wet.
We improved the process for sealing each pump, and we test each unit to guarantee waterproofing.
Yes, if the LimbLogic VS unit is new and in an unopened box. Call us to get an RMA for the old unit and to place an order for the new unit.
LimbLogic VS has been water resistant since the product was launched. If a patient was in a wet environment, the LimbLogic VS was usually not at risk.
Two years. Damage from misuse is not covered.
Yes, there is a 30 day trial period.
190 gm (0.4 lbs).
The pump’s battery life depends on the quality of the seal and the amputee's activity level. Our tests show that the system can normally last between 1 day and 1 week on a patient. We recommend charging the unit daily. The fob has a user-replaceable CR2 camera battery that should last 6 months with normal usage.
Yes. An airtight socket is critical to proper operation of the overall system. We recommend specific fabrication methods to achieve airtight sockets. These methods are included in the kit instructions, are available on our website, and are taught in our training classes.
Yes. An airtight sealing sleeve in normally required, but there may be other methods for achieving a good vacuum seal.
Keep debris away from the filter in the socket, and flush the system monthly with water or isopropyl alcohol per the user instructions.
The vacuum is adjustable from 0 to 20 in-Hg (508 mm-Hg) with most BK patients using a 10 to 16 in-Hg upper set point. The default control range is a span of 6 in-Hg.
Our tests show that the best compatibility with vacuum is provided by Alpha Select Liners and pre-fabricated or custom Alpha MAX Liners. When using Alpha Select Liners, we typically use the Progressive gel pattern. You can use the Uniform gel pattern if you like, but the top edge tends to be bulky when it’s folded down onto the Alpha Flex Sleeve.
The LimbLogic VS System displays vacuum settings in inches of mercury. To convert from inches of mercury to millimeters of mercury, multiply by 25.4.
A negative air pressure is created between the outside of a fabric-coated liner and an airtight socket when the vacuum pump pulls the air from the between the liner gel and socket wall. The negative air pressure pulls the liner towards the wall of the socket. The liner gel creates a similar airtight seal to the limb, so when the liner is pulled towards the socket, the limb is held firmly in place.
Both methods use a difference in atmospheric pressure to attach the socket to the residual limb. But because suction suspension uses a passive expulsion valve to allow air to leave the socket, a negative pressure differential is only created when the limb begins to move. The active pump used in vacuum suspension doesn't depend upon the limb position.
L-5781 for the vacuum pump, and L-7368 for the lithium ion battery charger.
The M6 flathead screws provided should be tightened to 9 ft-lbs or 12 N-m of torque.
- The System Maximum is 20 in-Hg, which is the highest vacuum setting that is possible with the pump hardware.
- The User Maximum is set by the prosthetist as the maximum vacuum level that should be applied to the limb. The User Maximum cannot be set higher than the System Maximum.
- The Upper Set Point is the highest vacuum level that will be automatically maintained by the pump. It can be adjusted by the amputee, but cannot be set higher than the User Maximum.
Our pediatric product line includes feet, durable Alpha® Liners, and tough components...even a growth kit for accommodating growth spurts.
The pediatric SACH Foot is a basic foot that is intended for children who are not mature walkers (when they walk, the heel may not come into contact with the ground at all). The pediatric Impulse Foot is intended for children whose gait has matured to the point where they can benefit from more advanced foot function.
A suspension sleeve should be worn with any kind of suction or vacuum socket to prevent air from entering the socket after it has been expelled. WillowWood offers the Alpha Flex Seal for use with the vacuum sockets, and the Alpha Suction Seal or Alpha Spirit Suction Seal for use with suction sockets (or with locking sockets if a little additional security is desired).
What works best for one amputee might not be what works best for another, but here are some of the pros and cons of each method:
- Locking Pin Suspension
Locking pin suspension, in which a pin on the bottom of liner fits into a lock in the bottom of the socket, gives many amputees the feeling of a secure suspension. It is also generally the easiest of these three methods to don and off. The main disadvantage is “pistoning”, which is when the liner and limb stretch out within the socket while the leg is swinging forward due to daily volume fluctuation. Also, the pin must be centered exactly within the lock, which can be hard for amputees who have poor eyesight.
- Suction Suspension
Suction suspension holds the limb secure because air in the socket is forced out through a valve at the bottom of the socket, creating a vacuum effect. Pistoning is not an issue, because the weight of the prosthesis is not focused on one small point at the bottom of the socket. Also, there’s no need to line up a pin with a lock. However, a suspension sleeve is required to prevent air from entering the socket, which adds a little bit of weight and bulk.
- Vacuum Suspension
Vacuum suspension, like suction suspension, uses a difference in atmospheric pressure to attach the socket to the residual limb. But because suction suspension uses a passive expulsion valve to allow air to leave the socket, a negative pressure differential is only created when the limb begins to move. The active pump used in vacuum suspension doesn't depend upon the limb position. A disadvantage is that this type of suspension requires more maintenance (battery charging, system flushing, etc.) than the others.
No. Because the selection and fitting of WillowWood products require the technical and clinical knowledge possessed by certified prosthetists, we do not sell any of our products directly to amputees. If you are interested in one of our products, talk to your prosthetist to see if it might be suitable for you.
Yes. A gain or loss of more than 10 pounds can result in discomfort, change in gait, skin breakdowns, and stress on other parts of the body, and should be reported to the prosthetist so that appropriate adjustments can be made.
While we do not recommend support groups, we can suggest the following sources for information:
- Ask your prosthetist or look for information in their office’s waiting area
- Ask other amputees for recommendations
- Search online for the closest group
- Contact the Amputee Coalition at 888-267-5669 or go to http://www.amputee-coalition.org/npn_group_list.html for a list of amputee support groups that are registered with the National Limb Loss Information Center.
The Amputee Coalition holds summer camps for young amputees ages 10 through 17. Find out more at http://www.amputee-coalition.org/youth_camp.html.
While we do not recommend specific prosthetists, we can suggest the following sources for information:
- Other amputees: Suggestions from amputees who have amputations similar to yours can be especially helpful.
- Amputee Support Groups: Support groups can be helpful resources for just about every situation an amputee faces. For a listing of Amputee Coalition member support groups in the US, visit http://www.amputee-coalition.org/npn_group_list.html
- Your physician and/or hospital staff: Hospital staff members, including surgeons, physical therapists, nurses, and staff social/family workers may all be sources for suggestions.
- Amputee Coalition: Call the Amputee Coalition at 888-267-5669 for a wealth of information to amputees on choosing a prosthetist.
- The American Board for Certification in Orthotics and Prosthetics, Inc. (ABC) and the Board for Orthotist/Prosthetist Certification (BOC): The ABC and BOC are the two national boards that certify prosthetists and orthotists. Both organizations offer search features on their websites for locating prosthetists by city, state, zip code, or name. Contact ABC at www.abcop.org or 703-836-7114. Contact BOC at www.bocusa.org/how-choose-practitioner or call 877-776-2200.
- Educate yourself: Take time to carefully review what your insurance covers, what requirements must be met, and if there is a lifetime maximum for any procedures or equipment.
- Choose the plan best suited for you: Do your research of what options your employer or private insurance agent offers and select the plan that best suits your needs.
- Take charge: Check with your employer’s human resource or benefits manager to see how your needs can be expressed when negotiating for new or renewal of the company’s insurance plan(s).
- Don’t give up easily: When a medical claim has been declined, insurance companies do provide an appeals process.
- For more information, contact the Amputee Coalition at 1-888-267-5669 or visit their website at www.amputee-coalition.org.
This is a very personal decision. Some amputees want to blend in, while others don’t mind if anyone sees their prostheses. There are many options available, ranging from fairly simple to highly customized. Talk to other amputees or to your prosthetist for more insight on this matter.
WillowWood offers the OMEGA® Tracer® System, which allows clinicians to capture the shape of a limb electronically for the creation of a socket, a custom liner, or an orthosis.