LimbAir™ provides a simple means to adjust socket volume and applied pressure in response to changes in limb volume or intended activity level.
• For those that experience routine daily limb volume changes, the system enables positive or negative volume compensation through manual inflation or deflation of an internal air bladder.
• Adjustments are made without removal of the prosthesis and can easily be done in a tactile manner through clothing.
• Given the ease to discretely release pressure beneath clothing, the system allows amputees to maximize time at low pressure when a tight fit is not required in order to facilitate comfort and general limb health.
• Additionally, the system is beneficial to highly active individuals that require a secure fit while engaged in dynamic activities requiring maximum coupling between the limb and prosthesis.
• For many users the system eliminates the need to carry additional socks as the range of volume compensation is equivalent to ~5-7 sock plies.
• The ultimate goal is to improve amputee comfort, health and quality of life resulting in a reduction office visits and medical expenses.
• Efficient pressure adjustment beneath clothing – The purpose-built custom pump optimizes stroke force and direction to allow simple adjustment in seconds without need to remove the prosthesis to add sock plies.
• Tactile bleed valve allows regulated pressure reduction – The high-reliability precision valve allows minor fine tuning or complete relaxation discretely by feel alone.
• Low profile and low weight – The system is constructed of machined aluminum and high durability polymers for a nearly imperceptible (170g) weight for the complete system. In many cases it provides a net weight reduction given elimination of additional sock plies.
• Robust pressure sealing with high strength bladder and precision components – It is a critical design criteria to realize a pneumatic system that can be relied upon to not leak. This is achieved through use of high quality materials, minimization of interfaces and use of precision components.
• Bladder shape optimized for wrinkle-free install in most sockets – The spade shape was evolved from extensive testing on a range of patients having a variety of limb sizes and shapes. The supplied bladder was selected as a most-likely fit for most patients. Alternate sizes and custom shapes will be available in the future.
• Bladder material facilitates longevity and consistent feel – The bladder material is highly robust to puncture and abrasion as well as rigid to in-plane stretching yet flexible to bending. By eliminating the stretch, the pressure and volume relationship is maintained for a consistent feel.
• Bladder design allows for temporary installation to locate ideal placement – As described in more detail below, the neck shape of the bladder allows it to be temporarily routed over the lip of the socket to allow test fitting for patient comfort before making any permanent modifications to the prosthesis.
• Durable construction with flexible mounting to easily adapt to any socket – The primary mounting bracket can be deformed as needed to fit most socket shapes. Mounting hardware is provided and minor modifications to implement a permanent mount can typically be done within a single standard office visit.
• Direct “tube free” mounting or alternate remote mount options – Using the direct mount method, the pump assembly interfaces directly to the bladder without need for any exposed tubing. Nevertheless, materials are included to allow a remote mount where the pump mechanism can be physically separated from the bladder.
• Suggested HCPCS Reimbursement Code – L5646