Soft Tissue Drainage

Twin Star has been developing porous catheters for soft tissue drainage therapy and has demonstrated a reduction of tissue swelling and improved tissue viability in pre–clinical studies.


Extremity Compartment Syndrome

Extremity Compartment Syndrome (ECS) occurs when muscle tissues take on excess fluid in the confined spaces known as fascial compartments, creating pressure that reduces blood flow. Increased pressures can cause irreversible damage, over time. Swelling and inflammation following traumatic injuries, such as fractures, burns, or crush injuries are the most common cause of ECS, but it can also occur after vascular injury, reperfusion following ischemia, extravasation of fluid, external compression, or even rigorous muscle use.

Early diagnosis and treatment of ECS is critical to retaining function and preventing long–term negative outcomes, including fracture non–union, vascular and strength compromise, limb amputation, organ toxicity, and death. However, accurate, timely diagnosis has proven difficult with present tools1, and the only available treatment is an invasive surgical procedure, fasciotomy, which has significant morbidity including infection, nerve damage, chronic venous insufficiency, skin grafting, and scarring2. Despite the morbidity associated with fasciotomy,it is the current standard of care, and is recommended early and liberally on at–risk patients.

Twin Star Medical has sought to improve the management of this difficult condition with its novel catheter and monitoring technology. Continuous monitoring has been shown to increase diagnostic accuracy while reducing the time to diagnosis of ECS3. The therapeutic effect of the Twin Star porous catheter technology is being investigated. The hypothesis is that by removing a small amount of interstitial fluid – through ultrafiltration – tissue pressures can be reduced, and tissue viability retained, without the need for fasciotomy. Published, controlled animal model studies suggest that tissue ultrafiltration reduces pressure and improves cellular viability4. Human pilot studies have been performed5.

The Twin Star ECS System has been cleared by the FDA for the immediate or continuous measurement of intracompartmental pressures, and/or the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The ECS System has been exclusively licensed to Twin Star ECS, Inc. (twinstarecs.com). Product use for pressure reduction and/or therapeutic effect is investigational and has not been reviewed by the FDA.

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Ulmer T. The clinical diagnosis of compartment syndrome of the lower leg: are clinical findings predictive of the disorder? J Orthop Trauma. 2002;16:572–577.
James P. Stannard, Andrew H. Schmidt, Philip J. Kregor. Surgical Treatment of Orthopaedic Trauma 2007: 43-57
McQueen MM, Christie J, Court-Brown CM. Acute compartment syndrome in tibial diaphyseal fractures. J Bone Joint Surg Br. 1996;78:95–98.
Odland RM, et al. Use of Ultrafiltration for Treatment of Compartment Syndrome; A Pilot Study Using Porcine Hindlimbs. J Orthop Trauma. 2005: 19: 267-275
Odland RM, Schmidt AH. Compartment Syndrome Ultrafiltration Catheters: Report of a Clinical Pilot Study of a Novel Method for Managing Patients at Risk of Compartment Syndrome. J Orthop Trauma. 2011: 25: 358-365






Twin Star Pressure Monitor Console


Twin Star Monitoring Catheter


Close–up of Hollow Fiber Micro–Catheter

Brain Injury

Brain swelling due to severe head trauma or strokes results in about 30% mortality and 30% severe disability in approximately 200,000 patients in the U.S. each year.

US annual medical costs exceed $35 billion for the care of stroke and traumatic brain injury (TBI) patients.

Traumatic brain injury is also a growing cause of long–term disability in head injuries sustained in war zones. This is becoming an issue of growing concern in modern warfare, where blast injuries are becoming common. Traumatic brain injury has been identified as the “signature injury” among those wounded in the current military engagements in Afghanistan and Iraq.

In both traumatic brain injury and stroke, brain swelling can occur and fluids accumulate within the brain space. When an injury occurs inside the skull, there is no place for swollen tissues to expand, and no tissues to absorb to drain excess fluid. This leads to an increase in the pressure, called intracranial pressure (ICP).

High ICP can cause delicate brain tissue to be crushed, or cut off vital blood flow to areas of the brain, compounding brain tissue damage.

Intracranial pressure is monitored through a catheter inserted through the skull and connected to a monitor that registers ICP.

Treatment for high ICP, may be a ventriculostomy, a procedure that drains cerebrospinal fluid (CSF) from the ventricles to bring the pressure down, or in severe cases trepanation, which removes a section of skull to provide room for swelling and drainage.

The physical and physiological factors of ICP are similar to compartment syndrome in the peripheral anatomy.

Twin Star’s system has been designed to reduce cerebral edema based on vaporization and removal of free water from the cerebro–spinal fluid (CSF) within the ventricles of the brain, using the Company’s microporous catheter technology.

Caution: Investigational device. Limited by U.S. federal law to investigational use.
Patents issued and pending.
 
   
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