Device to Diagnose TCS

Occult Tethered Cord Syndrome (TCS) is a serious medical condition often detected before birth. If the spinal cord is not free it can result in several other urological problems and can result in a life-long disability.

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Leah Langlais
Mgr, Venture Development , Tech Launch Arizona

The Problem

Occult Tethered Cord Syndrome (TCS)is a medical condition where the spinal cord, which is normally free to move within the spinal canal, becomes abnormally attached or “tethered” to the surrounding tissue. This tethering can restrict the movement of the spinal cord, causing it to stretch abnormally as the body grows.
This condition is called “occult” because it’s not always obvious or easily detected, especially in its early stages. It can lead to various symptoms such as pain, weakness, numbness, or problems with bladder or bowel control.
This conditions can happen for various reasons, including birth defects, spinal injuries, or scar tissue forming after surgery. Treatment typically involves surgery to release the tethering and relieve the pressure on the spinal cord, which can help alleviate symptoms and prevent further damage.

The Solution

Testing the integrity of the sacral nerves has been established by measuring rectal tone (the pressure response of the inner and outer sphincters). Currently rectal tone is measured subjectively, using a finger during a rectal exam. Researchers have developed an instrumented ano-rectal tonometer which can report rectal tone and any dynamic changes. Dynamic pressure pulses (reflexory response) can be induced through stimulation of the external sphincter by the instrument itself. The device is small and approximately the size of a suppository which is much more acceptable to patients and doctors.

The Opportunity

TCS has an incidence rate of 0.25 per 1,000 births affecting 1000 children in US every year.  
Spinal cord surgeries, including those for conditions like tethered cord syndrome, spinal cord injuries, and other spinal abnormalities, constitute a significant portion of the overall neurosurgery market. The global neurosurgery market size was estimated to be over $3B annually with projections for steady growth.
While Occult Tethered Cord Syndrome may not be as prevalent as some other spinal conditions, the need for surgical intervention can still be significant for affected individuals, particularly considering the potential complications and disabilities associated with untreated or improperly managed cases.

Status

An adult version of the tonometer has been developed by an NSF training grant (NEU 1446048). The initial prototype was tested and calibrated using a pneumatic cuff. It successfully displayed actual pressure. The design includes a disposable piece (tip) and a permanent piece (electronic interface). Low volume costs were established. An enhanced 2nd generation device, capable of recording dynamic tone, was created in 2019. The device uses a USB interface to a computer, recording the rectal tone in real-time. The device is also capable of detecting bulbocavernous reflex. The technology has been presented to three neurosurgeons.

Meet the Team

Eniko Enikov PhD

Eniko Enikov PhD

Co-Founder
Center for Biomedical Informatics & Biostatistics
Steven Wood MS, MBA

Steven Wood MS, MBA

Mentor
Tech Launch Arizona

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Leah Langlais

Mgr, Venture Development
Tech Launch Arizona