Progress 07/01/17 to 02/28/18
Outputs
Target Audience:The target audience is the patient, prescribing doctor and the payer. During this project period we have not reached out to the patient directly. The doctor we are currently reaching is Dr. Robert McBane at the Mayo Gonda Wound Care Center who we have interacted with throughout PHI. AVT eventually want to reach all prescribing physicians through validation. The payers will eventually be Medicare and insurance companies. We have reached out to reimbursement specialist Brian Mullinax who is advising us going forward how to best reach these payers. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?AVT hired contracted intern Purdue students. They were surprised what could be done with hand tools and their own hands and what could be fabricated. They adapted well and were able to use their creativity and help us use ours. We learned much about using CAD modeling and 3D printing from them. We learned from each other. How have the results been disseminated to communities of interest?We interacted with the Mayo wound care clinitians as described in accomplishments and it gave us a greater idea of the industry's needs and how to better meet them. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
Impact: USDA SBIR Phase I (PHI) funding - Rural and Community Development transformed AVT's original patented pneumatic compression device (PCD) into a Smart PCD for critical wound healing to reduce amputation rates costing $25B/YR in US in patients with arterial insufficiency (often diabetic) and other circulatory ailments for in-clinic and at-home use. The AVT Smart PCD is especially needed for rural, Indian reservation, VA and low income patients, and to assure compliance and fair reimbursement compared to current PCDs. AVT plans to reduce wound healing times, costs, and amputation rates and to provide close, safe remote access not currently available. Technical Objective #1: Detailed Results: The AVT Original PCD is use in a pilot study at Mayo Clinic Rochester. The pilot study data appears promising. Patients undergo a 30 minute session of PCD therapy. Skin perfusion is measured before and after treatment. Dermal arterial perfusion measured by laser Doppler blood flow and transcutaneous oxygen tension (tcpO2) nearly doubles compared to pre-therapy values in patients with severe PAD. These values are statistically significant when using a paired Student T-test. Dr. McBane (pilot PI) made special note of increase in mean Doppler blood flow in the big toe. Interpretation of Results: The data generated from the Mayo Clinic physician-sponsored pilot continues to validate the efficacy of the AVT technology. AVT's PHI Medical Director, the Mayo Clinic physician and Physician Assistant overseeing the pilot resolved that the settings and technology for arterial insufficiencies should remain unchanged in the AVT Smart PCD. As the settings (pressures and timings) mirror industry standards for both in-clinic and at-home PCDs, so should the settings for additional circulation insufficiency conditions. Technical Objective #2: Detailed Results: AVT consulted several times with our manufacturer GMI and our design engineer Mike Hoffa, who provided engineering and development input. Two Purdue interns and a Computer Scientist consultant helped perform the work needed. Our first goal for Technical Objective #2 was to reduce the PCD size from 3 cubic feet to 2 cubic feet, which we accomplished. AVT's original prototype is 34 lbs. Our PHI prototype is 31 lbs, less than the original but more than the 25 lbs estimated. Maintaining efficacy, while reducing size and noise were the most important factors, not weight, especially with spinner wheels and an extendable handle for easy transport in an attractive case. Dr. McBane and GMI approved this trade-off. Noise reduction was a major goal of Technical Objective #2. We also achieved this goal. The noise level of the AVT Smart PCD is between 64 decibels (db) and 68 db at its lowest part of cycle and can go up to 71 db at 3 feet. This noise level is similar to conversation. The AVT Original PCD prototype in use at Mayo Clinic is a minimum noise level of 72 db and a maximum of 76 db, or about twice as loud. The FDA is concerned with both electromagnetic force (EMF) emissions that might hurt the patient (ex: with a pacemaker) and EMF from other devices that might affect the AVT PCD. Thus, not only emissions but susceptibility had to be considered. To limit EMF emissions AVT added a steel band around the blower, directing magnetism back to North or South poles of its motor and Faraday cages to shield radio frequency (RF) signals for both emissions and susceptibility around circuitry. AVT created most of the prototype with a 3D printer or fabricated it by hand, including the AVT proprietary valve. AVT started with the case, using a modified polycarbonate suitcase with wheels and handle to meet design specifications, and modified the blower and designed baffling and ducting to meet the noise level goals. The blower mounts balanced weight and strength, minimizing noise. The team removed the blower cooling fan and added an auto resetting thermal fuse (140 degrees Fahrenheit) placed inside the motor near its coils. AVT created air handling parts to duct air around the motor. Ducts were successfully made with supporting foam and polycarbonate material using 3D-printed couplings that all snap nicely together to form the device. Interpretation of Results: AVT achieved Technical Objective #2 with slightly more prototype weight than anticipated, but less than the original, and our contract manufacturer (GMI) will further refine and improve these goals in PHII. The resulting AVT Smart PCD is portable, light weight, and functional at conversation level, retaining the same technology as the AVT Original PCD in use at the Mayo Clinic pilot. The AVT Smart PCD underwent operational review by both GMI and the Mayo Clinic clinicians who administer the pilot, and they verify it to be ready for manufacture and use. The Mayo Clinic clinicians were thrilled with the redesign, portability and noise level. The AVT Smart PCD, is an improved prototype, maximizing the patented technology benefit for wound healing and ease of use for individuals to more effectively heal wounds in a clinical or home setting. Technical Objective #3: Detailed Results: AVT used a 7-inch touch screen to work with the AVT Smart PCD's internal computer and hardware. AVT built in a hardware-based safety failsafe combined with software safety checks, limiting set compression time per cycle, and maximum set pressures per condition. A hidden Secure Digital (SD) card like used in a camera provides an operating system (OS) to determine function for use, and a second accessible SD card collects usage times. AVT programmed one clinical OS providing completely adjustable settings with defaults for arterial, venous, and lymphatic insufficiency PCD therapy and programmed three OSs for in-home use providing defaults for arterial, lymphatic, or venous conditions. Depending on the prescription the user receives, only the hidden OS SD card is changed. The at-home unit only displays the time remaining and a touch anywhere on the screen will pause/start the AVT Smart PCD which stops when completed. AVT's regulatory consultant agency Pearl Pathways determined we will need 2 predicate devices for FDA 510(k) Clearance, ACI Medical's PCD model ArtAssist and NormaTec PCD models T&B, whose defined pressures for each circulation insufficiency are the pressures AVT chose for each default. AVT's PHI Medical Director, the Mayo Clinic physician overseeing the pilot, and Mayo Clinic Physician Assistant administering the pilot, also reviewed the Smart AVT PCD and approved all of the proposed settings for all of the intended uses of the Smart AVT PCD based on the proposed predicates and the physician-sponsored pilot. Pearl Pathways reviewed the AVT device and recommended AVT use product code JOW, predicting that the AVT PCD will be a Class II medical device that does not require clinical studies to receive FDA 510(k) Clearance. Interpretation of Results: AVT was able to achieve Technical Objective #3, and transform their technology from the Original AVT PCD to the Smart AVT PCD with settings for the three circulatory insufficiency conditions that people often suffer from (arterial, lymphatic, venous), with the ability to program the device in a future iteration for deep vein thrombosis prevention (DVT). Currently, this requires 3-4 separate devices, not just one. This is an attractive time, storage, and cost savings to future customers based on doctor evaluations. This new device includes technology that captures usage data that can be shared with a provider and/or caregiver, important for patient compliance/adherence for healing, and potentially important for reimbursement in the future. These features are especially attractive in remote rural areas. No other PCD on the market today offers these options. Conclusion: The AVT USDA Phase I SBIR project proved technical feasibility, coming in at budget and on time, achieving every Technical Objective as described above.
Publications
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