Device and Method for the Non-Invasive Treatment for Compartment Syndrome (MGH 2693)
INVENTOR(S) Anderson, R. Rox; Vosburgh, Kirby; Parrish, John A.
SUMMARY Background: Compartment syndrome is a result of trauma that may occur in any soft tissue. Following trauma, the fascia, which contains the muscles, is unable to expand. If a compartment swells and the pressure within increases, the muscles, blood vessels, and nerves contained within will be compressed, causing excruciating pain and/or permanent structural damage. Unfortunately, irreversible damage occurs so rapidly that treatment must be administered within 4 – 8 hours. Compartment syndrome may affect as many as 200,000 US patients annually, however, this number is significantly increased during armed conflicts. At the 2004 Advanced Technology Applications for Combat Casualty Care (ATACCC) Conference, the US military stressed the problems of detecting and treating compartment syndrome as key unmet needs in trauma care. The current treatment for compartment syndrome is fasciotomy, which involves surgically opening the skin, superficial fascia, fat, and overlying muscle to gain access to the deep fascia. Once access is gained, the deep fascia is cut to create an opening wide enough to relieve the pressure within the compartment and restore blood flow. While effective, this is a destructive procedure. To improve the existing detection and treatment of compartment syndrome, researchers at Massachusetts General Hospital have invented a noninvasive fasciotomy device that will expedite the detection of compartment syndrome and minimize tissue damage during treatment without sacrificing efficacy. Technology: The novel non-invasive fasciotomy device allows for rapid, safe, and effective detection and treatment of compartment syndrome. The device may operate by one of two methods: 1. The device contains an acoustic wave source effective to deliver a focused acoustic wave to a target site within a patient’s body a. b. The device focuses an acoustic wave through a patient’s skin to fenestrate in a desired pattern at least one location in the patient’s fascia Integrated with the wave source is an imaging source (e.g., ultrasound) which can be used: prior to the application of the acoustic wave in order to determine the location of the target site; during the application of the acoustic wave in order to effect the desired fenestration pattern; and after the desired fenestration pattern has been effected to ensure reperfusion of the fascia
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Similarly, the device induces cavitation within a target region via an acoustic treatment source, focuses the acoustic treatment source, and adjusts the frequency of the acoustic treatment source such that the target region is appropriately penetrated a. b. Integrated with the wave source is an imaging source (e.g., ultrasound) The acoustic treatment source may be moved such that cuts or patterns of fenestration are formed on the target region
This device is designed to be portable (e.g., a hand-held wand) and may be used in an unsterile environment. A device has not currently been constructed, however, the inventors offer extensive design specifications and appropriate validation studies. Applications: An integrated system in which treatment transducer and imaging ultrasound allow for (1) detection of compartment syndrome, (2) aiming, guidance, and delivery of non-invasive fasciotomy, (3) confirmation of compartment perfusion after fasciotomy, in a rapid, effective, and safe manner Portable, hand-held device can be used for military medical needs, as well as in other trauma care settings
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Advantages: Allows for rapid and non-invasive treatment of compartment syndrome No sterile environment or surgical skills required for operation Can be used in conjunction with existing imaging systems (esp. ultrasound) Hand-held and portable Minimal post-treatment complications
PATENT STATUS Patent pending
RELEVANT PUBLICATIONS Ellsmere J et al. A new visualization technique for laparoscopic ultrasonography. Surgery. 2004 Jul;136(1):84-92.
Contact:
John Flynn Business Development Manager Partners Healthcare Research Ventures and Licensing 1249 Boylston Street, Suite 201 Boston, MA 02215 Office: 617-525-6046 jpflynn@partners.org