University of Pittsburgh researchers have developed a novel dynamic epidural needle to thread spinal cord stimulator (SCS) device leads into the epidural space. SCS devices have been used for decades to manage a wide variety of chronic pain. Most widely used in those with chronic back and leg pain, SCS devices require the surgical insertion of two electrode leads into the epidural space (between spinal cords and vertebrae) requiring at least two separate insertion sites, to enable patients to send controlled electrical impulses to the spinal cord to relieve pain. This novel dynamic epidural needle is designed to insert both leads using a single insertion site. Widespread use of this dynamic epidural needle could dramatically improve patient outcome after surgery.
Description
Millions of Americans live with chronic pain conditions. When all non-surgical options for pain relief fail, between 50–100,000 Americans annually will choose to undergo SCS implantation. During this surgical procedure, generally performed under local anesthetic and sedation, leads are inserted into the epidural space through an incision using a 14-Gauge (14G) needle. At least two incisions over the spine are required to implant the SCS leads which are then connected to an electric pulse generator that can be externally controlled to relieve pain. This novel needle is designed to reduce the number of incisions required to implant SCS leads and should reduce the risk of postoperative complications.
Applications
- Chronic back pain
• Chronic leg pain
• Surgical teaching tool
Advantages
At present, the insertion of SCS device leads requires at least two epidural needles (14G, external diameter 2.108 mm) to insert each lead into the epidural space. This surgical procedure requires multiple punctures of the patient’s skin. Each insertion of a needle into the epidural space increases the risk of surgical site pain, infection, and cerebrospinal fluid (CSF) leak and can extend recovery times.
This dynamic epidural needle is designed to reduce the number of incisions required for SCS device lead insertion. These needles are wide enough to enable both leads to be threaded into the epidural space with the same needle, removing the need for repeated incisions. This approach should result in fewer postoperative complications experienced by the patient.
Invention Readiness
Currently in the design phase, a prototype dynamic epidural needle has been produced. This needle has a latch and a slat that can be removed to push out the first lead prior to the placement of a second lead.
IP Status
https://patents.google.com/patent/WO2024238333A2
