Low Insertion Force Epidural, LIFE System for Controlled Insertion

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$976,545.00
Award Year:
2010
Program:
SBIR
Phase:
Phase II
Contract:
2R44GM085844-02A1
Award Id:
89218
Agency Tracking Number:
GM085844
Solicitation Year:
n/a
Solicitation Topic Code:
NIGMS
Solicitation Number:
n/a
Small Business Information
PIEZO RESONANCE INNOVATIONS, INC. (Currently ACTUATED MEDICAL, INC.)
PIEZO RESONANCE INNOVATIONS, INC., 310 Rolling Ridge Dr, Bellefonte, PA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
791379030
Principal Investigator:
MAUREEN MULVIHILL
(814) 355-0003
MMULVIHILL@PIEZO-RES.COM
Business Contact:
MULVIHILL MAUREEN
() -
mmulvihill@piezo-res.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant: In this Phase II NIH SBIR, the Low Insertion Force Epidural (LIFE) device will be further optimized and efficacy measured on human cadavers and live porcine models. Piezo Resonance Innovations, Inc. successfully designed and demonstrated the Phase I LIFE device insertion tool in various tissue models, including trials by senior anesthesiologists. The Phase II developments will lead to a Phase III human study and commercialization in collaboration with a major medical comp any. With a global market of epidural kits near 219M, a device that will increase safety and comfort, enhance training, and raise penetration success rate by clinicians has commercial viability. The improvements derived from the LIFE device could allow le ss experienced providers, such as interventional radiologists or non-anesthesia trained pain physicians, to perform epidural procedures. Epidural anesthesia is a form of regional anesthesia involving injection of drugs directly into the epidural space. Epi dural anesthesia is used in 2.4 million births annually in the United States, in addition to a wide range of other pain-management procedures as far up the spine as the neck. The procedure can be unpleasant to the patient and difficult to perform because o f the high force levels required to penetrate the supraspinous ligament, interspinous ligament and ligamentum flavum. One of the most common complications is an accidental dural puncture. If the dura is punctured accidentally, the chance for a cerebrospina l fluid leak causing a post dural puncture headache is quite high. Headaches can be severe and last from weeks to years. Significant leakage can cause enough intracranial hypotension as to tear veins causing a subdural hematoma, and can cause traction inju ries to the cranial nerves resulting in tinnitus, hearing loss, dizziness, facial droop, or double vision. Over-insertion is even more dangerous for epidurals inserted in the neck. The LIFE device will enable the clinician a more controlled entry into the epidural space, eliminating the excessive force that results in 'over-shooting' and dural punctures. This Phase II project will advance a commercially viable LIFE System to aid penetrating the ligamentum flavum, while also minimizing dural puncture wet ta ps during epidural insertion procedures. PUBLIC HEALTH RELEVANCE: Epidural anesthesia insertion is a difficult procedure, due in large part to the force required to insert a needle through tough ligament and muscle, and into the epidural space. Whe n the needle 'pops-through' the tougher tissue into the epidural space, it is difficult to control the depth of penetration. An error in the procedure is referred to as a 'wet-tap' or dural puncture. The puncture may cause cerebrospinal fluid to leak into the epidural space, often resulting in a post dural-puncture headache and other painful complications. The development of a low force epidural insertion tool will provide clinicians with improved control to decrease pop-through and minimize dural puncture. This new technique will also enhance resident training, and with a reduction in risk, may allow less experienced providers, such as interventional radiologists or non-anesthesia trained pain physicians, to perform epidural insertion. For 2008, the global market for epidural kits is projected to be 219M.

* information listed above is at the time of submission.

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