Static Tourniquet Pressure Device, Pneumatic Compression Device, Subfacial Endoscopic Perforator Surgery and Miniature Diaphragm Pumps, Custom Injection Molding
ACI Medical, Inc. is a biomedical engineering firm engaged in the research, development, manufacture and sale of therapeutic products and technologies for individuals with varying degrees of life-impairing vascular conditions. With 18 years experience in bringing innovative healthcare products to market, ACI is committed to developing, producing and distributing the highest-quality products for patients, consumers and healthcare partners.
ACI holds exclusive rights to several U.S. patents that are the foundation of its hallmark device, the ArtAssist®.
The need for noninvasive medical devices that increase, monitor, or measure arterial blood flow is vital to the treatment of several patient populations, including people with diabetes and individuals suffering from what is commonly called ``hardening of the arteries.``
Diabetes is the most frequent cause of non-traumatic lower limb amputation, with more than 92,000 amputations performed each year. In America alone, there are 13 million diabetics, or 5.2% percent of the population. Diabetic foot ulcers, suffered by more than two million diabetics annually, are often the first symptom of reduced blood flow that can lead to amputation.
ArtAssist also relieves symptoms of Peripheral Arterial Disease (PAD), called ``hardening of the arteries`` which affects more than 4 million Americans each year.
Treating arterial disease with the ArtAssist device results in substantial cost savings to the healthcare system when compared to amputation. Although currently not covered by Medicare/Medicaid, ACI is in the process of obtaining an individual Medicare/Medicaid code for this product, which will increase the market further.
ACI`s established products include:
- ArtAssist® - an in-home therapeutic device designed to increase arterial blood flow to lower limbs.
- VenAssist® - a pneumatic compression device for preventing blood clots from forming in the veins of at risk hospitalized patients. Blood clots can travel to the lungs and are a major cause of postoperative death.
- VenaPulse® - a noninvasive device that generates static, tourniquet pressure to limbs of patients undergoing vascular testing. It is used for vein mapping and quantification of venous flow to identify suitable distal vessel for bypass, among other uses.
- APG® - a noninvasive diagnostic tool that quantifies the physiological components of chronic venous disease. APG helps identify and follow-up patients that are good candidates for deep venous reconstruction. A modified version of the APG system has been used on the Mir Space Station to quantify the effects of prolonged microgravity on peripheral vascular tone in arms and legs.
The company also manufactures and markets:
- Miniature diaphragm pumps for use in a wide variety of applications, including medical equipment, industrial gas sampling applications and toys.
- Custom injection molding used with CAD/CAM capabilities and a wide range of molding equipment.
ArtAssist®...the Arterial Assist Device™
Applies a unique form of pneumatic compression to the foot, ankle and calf to increase arterial blood flow to the lower limbs. ArtAssist® is helping many patients who suffer from poor circulation and who are not good surgical candidates
Who Benefits From the ArtAssist ®
Diabetic Foot/Arterial Ulcers
The diabetic foot ulcer is one of the most common and devastating complications of diabetes mellitus. Each year, more than 92,000 amputations are performed on people with diabetes in the United States alone. When a patient develops an ulcer on the foot due to poor circulation, even the best dressings and expensive drug therapies may not help without sufficient blood to the wound. If adequate blood flow is not reestablished, amputation may result.
ArtAssist® dramatically increases blood flow by three times. It is helping to heal wounds and prevent amputations.
About 1 million Americans are diagnosed annually for leg pain caused by poor circulation, called intermittent claudication. If an artery is partially obstructed due to plaque build up (artherosclerosis), activities such as walking or climbing stairs can trigger pains or aches. This is a sign that leg muscles may not be getting enough oxygen and nutrients. As a result of inadequate blood flow, walking distance may be severely impaired.
ArtAssist® increases walking distance by three times and increases blood pressure at the ankle.
ArtAssist® applies compression to the foot, ankle and calf using comfortable cuffs to increase arterial blood flow. This compression regimen simulates the beneficial effects of brisk walking, without pain or tissue trauma.
First, ArtAssist® compresses the foot and ankle. A second later the calf is compressed and the foot, ankle and calf veins are almost completely emptied. In return, the arterial blood is more easily pushed down to the toes and blood-deprived tissues.
ArtAssist® triples blood flow at the tissue level.2
A second mechanism of action which accounts for the large blood flow increase involves the endotheliums, which are cells that comprise the lining of all blood vessels. Endothelial cells release important biochemical factors, such as nitric oxide and Tissue Foctor Pathway Inhibitor that help circulate the blood. These substances are released in amounts corresponding to the rate of blood flow moving along the cells that line the vessels.
ArtAssist® therapy takes place in the comfort of your own home. It is portable and easy to use. The cuffs are made of soft, durable material designed to last for months of therapy. Recommended use for ArtAssist® is 3 hours daily. Positive results with ulcers should be seen well within the first month of therapy.
ArtAssist® is typically rented from month to month, but may also be purchased. The average rental period is 3-5 months.
VenAssist®...The Next Generation Compression Device
This Device applies external pneumatic compression (EPC) for the prevention of deep vein thrombosis (DVT). Comfortable cuffs are applied to the lower limbs of patients at risk for DVT. The cuffs contain two air bladders, one positioned at the foot/ankle region and the other at the calf. The bladders in the cuffs are inflated periodically to stimulate significant increases in the venous blood flow velocities including those at the popliteal and femoral levels. VenAssist® pressure is applied rapidly in a manner similar to foot-only compression devices yet much faster than devices that compress the calf or thigh regions.
The two sets of bladders (foot/ankle and calf) within the cuff are inflated with a rise time of approximately 300 milliseconds (0.3 seconds). The foot/ankle bladder is inflated first, followed by the calf bladder, one second later. Both bladders have their pressures maintained for 8 seconds. The foot/ankle bladder is deflated first, which is again followed by calf bladder deflation, one second later. Inflation pressures are preset at the factory and can range from 20 to 100 mmHg. However, 80 mmHg is thought to be optimal. The bladders are deflated to approximately 6 mmHg for 60 seconds to allow for venous refilling in the supine patient. The 6mmHg deflation pressure allows for venous filling. It also helps the bladders to fill rapidly with less air. A smaller, quieter pump is therefore possible.
The calf bladder is inflated through a fitting that is on the distal portion of the bladder. The bladder fills with air from the distal to proximal calf. That, coupled with the initial inflation of the foot/ankle bladder, creates what is called ``progressive compression,`` which returns the venous blood quickly and efficiently toward the heart.
The foot/ankle bladder compresses veins in that region rapidly in order to empty them into the calf veins. The so-called ``foot-pump`` is therefore being activated by VenAssist® to prime the calf pump. The compression by the calf bladder rapidly empties the calf veins which constitute a relatively large volume of blood and are the most common site of DVT. The rapid nature of compression, combined with the large blood volumes of the foot, ankle and calf, creates a dramatically large increase in common femoral vein velocity.
Rapid compression is also associated with higher blood shear rates, which have been shown to stimulate endothelial release of fibrinolytic biochemical factors. VenAssist® also rapidly releases its cuff pressures with the intention of further shear rate stimulation of the endothelial cells. Pressure fall times are approximately 300 milliseconds (0.3 seconds).
Rise time and fall time are defined under the strict engineering definition of ``time taken for a waveform to rise from 10% to 90% (or fall from 90% to 10%) of its full change in amplitude.
Accomplishing these fast rise- and fall-times was a significant engineering design task. The internal pump was designed specifically for this application to be housed within a pressure reservoir. The reservoir and pump operate as a tuned system for maximum performance and minimal noise. The pressure regulator, switching valves and other pneumatic components are custom devices that have large flow capacities. The tubing and connectors are of large bore (compared with all other EPC devices) to accommodate larger airflows.
VenaPulse® Model VP-25 generates static, tourniquet pressure to limbs of patients undergoing vascular testing. The tourniquet pressure is reached very rapidly and the tourniquet cuff is deflated very rapidly with approximately 300 millisecond rise and fall times. Inflation and deflation are controlled with a foot switch or with a manual switch. The pressure is regulated between 0 and 240mmHg. There are safety alarms to ensure safe operation.
Indications for Use:
- Distal augmentations
- Proximal augmentations
- Vein mapping
- Locating suitable distal vessel for bypass
- Quantification of venous flow
- Reflux measurements of specific venous valves
Contraindications - Do Not Use This Device On Patients With:
- Acute deep vein thrombosis
- Hot, swollen and tender leg
APG® is a noninvasive diagnostic tool that quantifies the physiological components of chronic venous disease. Those components are: chronic obstruction, valvular reflux, calf muscle pump function and venous hypertension. APG® is the only system that measures true blood volume changes in milliliters and blood flow in milliliters per second.
APG® senses pressure changes in a large cuff that extends from knee to ankle, which is calibrated in milliliters using a calibration syringe.
The test protocol for APG® has three phases. First, the patient is supine and outflow testing identifies obstruction and the degree of superficial collateralization. Next, the patient is asked to stand and the filling rate of the veins by reflux through incompetent valves is measured. The patient is then asked to do a toe-up exercise and the calf muscle pump function is measured as an ejection fraction. Finally, the patient does 10 toe-ups quickly and a noninvasive measure of ambulatory venous pressure is completed.
The presence of chronic obstruction usually indicates a post-thrombotic limb. If the saphenous system is measured to be the limbs primary outflow collateral by APG®, its removal may become problematic for the patient. Reflux in the deep and superficial veins are separately quantified to allow the physician to understand how the two systems contribute to the patient`s symptoms. Poor calf muscle pump function may be due to obstruction, varicose veins calf perforator reflux or the patient`s inability to perform exercise from arthritis, stroke, etc. APG® is now used in studies to identify patients for the new subfacial endoscopic perforator surgery (SEPS). Both reflux and poor calf pump function are related to clinical manifestations of the disease.
APG® helps identify and follow-up patients that are good candidates for deep venous reconstruction. Also, as testing can be performed over compression garments, the effectiveness of elastic or non-elastic compression devices can be assessed and tailored to the individual patient. Other uses for APG® include its use in selecting the best arm for dialysis access graft or AV fistula. Arterial inflow can be measured to identify patients that are the best candidates for drug therapy (such as synthetic prostacyclin) and for follow-up to vascular interventions.
A modified version of the APG® system has been used on the Mir Space Station to quantify the effects of prolonged microgravity on peripheral vascular tone in arms and legs.
Miniature diaphragm pumps
Block ACI Medical is an FDA registered company that produces high quality miniature diaphragm pumps for use in a variety of medical and non-medical applications. Our pumps have air, vacuum and liquid capabilities. We specialize in pumps with low voltage (6, 12, 19 and 24 DC), flows up to 10 LPM, and pressures up to 35 PSI and vacuum up to 26 inches of Hg. Our diaphragm pumps are available in a wide range of materials. ACI has patents on different aspects of pump designs that make them suitable for many diaphragm pump applications. The combination of our expert engineers, who are available to assist with product development, and our design laboratory and machine shop, can rapidly produce virtually any type of diaphragm pump prototype. Some of the qualities are:
- Low Noise & Vibration
- Custom Pump Designs Available
- Variety of Custom Mountings
- Made in USA, Fast Delivery
- Expert Engineering Assistance
- Self-Lubricating, Maintenance Free
- Pump Sub-Assemblies Available:
- Electrical, Pneumatic, Molded Parts
Custom Injection Molding
ACI combines a modern CAD/CAM tool room with a wide range of injection molding equipment, assembly capabilities and part printing. Parts are molded for medical, industrial and consumer products. ACI offers many advantages for plastic injection molding. Here are some capabilities ACI offers
- Our complete tool room includes CNC, EDM and conventional machinery.
- In addition to standard steel tooling, we are experts at low cost ALUMINUM TOOLING. More than 100,000 parts can be produced before tool modifications will be required (usually at ejectors or slides).
- Small parts can be tooled as inserts to either MUD frames or our proprietary frames resulting in even lower cost tooling
- Tooling can be generated in days, if necessary, by combining aluminum tooling with our insert capabilities.
- Our mold makers have many years of experience in medical product design and we are happy to suggest design changes that will reduce tooling cost to improve part function.
- We maintain a wide variety of FDA resins in stock to quickly try new ideas.
- Molding capacities range from 28 to 308 tons and up to 25 ounce shots - very small parts to instrument enclosures.
- Secondary operations include machining, assembly, ultrasonic inserts and part printing