Medical Device

IMPLANTABLE SPINAL RADIATION SHIELD DELIVERABLE BY OPEN OR MINIMALLY INVASIVE SURGERY

The spinal radiation shield is designed to relieve spinal cord compression caused by spinal metastatic disease, as well as allow for higher dose radiotherapy treatments such as brachytherapy and external beam radiation.

Dr. Arthur L. Jenkins, III, Neurosurgeon and Head of the Spinal Cord Injury Laboratory at Mount Sinai, along with Radiation Oncologist, Dr. Jamie Cesaretti, conceived of the implantable spinal radiation shield to create a more effective treatment for spinal metastases. Spinal metastases (bony and epidural) are the most common spine tumor, present in ~40% of all patients with cancer. Around 5% of patients with cancer, or around 60,000 people, will develop spinal metastases each year, which most commonly originate from breast, lung and prostate cancer. The current treatment options consist of surgery to resect the tumor (if possible), radiotherapy to attempt to control tumor growth or ablate it (if it’s radiosensitive) or a combination of both. Presently, radiation dose to the spinal cord is limited to no more than 50 Gy, whereas ranges of 65 to 75 Gy are needed to control or cure. One other deficiency of traditional radiation treatment to spinal pathology is the problem of primary or secondary epidural tumors in the spine recurring after initial resection and external fractionated radiotherapy.

The implantable spinal radiation shield can address all of these problems. The shield will be placed by a neurosurgeon or orthopedic spine surgeon, spanning the areas to be irradiated. It will be made of a relatively inert, radio-opaque substance (evaluating Tantalum) so that it could be left in place or removed later. Ultimately, this device could allow for the placement of brachytherapy seeds into the bone cement during vertebroplasty or kyphoplasty following a tumor resection performed during minimally invasive surgery. In addition to protecting the spine from excess radiation, the spinal shield is a physical barrier that can offer protection from decompression caused by recurring tumors.

Current Development Status

  • Working with a prototype developer
  • Then, Large Animal Study (Pig) to assess the clinical benefit in treating tumor implanted in spine and then radiating the tumor either using standard radiation or increased radiation with shield in place

Applications

  • Protects the spinal cord during radiotherapy of spinal metastases and subsequently allows for an increased radiation dose to increase odds of eliminating the tumor

Advantages

  • Allow for increased fractionated beam radiation dose to the spine
  • Protect spine from decompression following recurrence of spinal metastasis

Publications

  • Meyer SA, Singh H, Jenkins AL.  “Surgical treatment of metastatic spinal tumors.”  Mt Sinai J Med. 77, pp.124-129 (2010)

Patent Status

  • US Application 13/063,356 filed March 10, 2011
  • Status: Notice of Allowance. US Publication No. 2012-0037165

Contact

Christopher Frenz, PhD
Business Development Analyst
Mount Sinai Innovation Partners | Icahn School of Medicine at Mount Sinai
Phone: 646.605.7316