Introduction:
Percutaneous tissue-to-bone fixation device
Brief Description
Gluteus tendon tears (hip abductor injury) and sports hernia (groin injury), are common in the older population and athletes, respectively; these injuries involve the tendon being stripped off of the bone. State of the art minimally invasive solutions for such tendon tears include a substrate injection but so far this procedure has demonstrated little proven clinical benefit. Another current treatment regimen is open surgery that yields a better recovery but is costly, time intensive, and has a higher risk for complications. Additionally, gluteus tendon tear leads to muscle weakness and increased risk of a fall resulting in a hip fracture. Jefferson University researchers and clinicians have created a novel device that can be used to easily and effectively reattach a tendon to a patient’s bone via a needle. The device offers an easy to implement percutaneous procedure that obviates the need for open surgery for patients with tendon injuries using component materials that are already FDA approved for surgery, indicating that an expedited 501k FDA approval pathway may be employed. A provisional patent has been filed, and Jefferson is currently seeking partners for the commercial translation of this technology.
Application and Advantages
• Offers a novel method of reattaching a torn tendon to bone that obviates the need for open surgery.
• Facilitates minimally invasive procedure to fix gluteus tendon tears, groin injuries, and other tendon and fascial tears around the body.
• Device uses currently FDA-approved products and existing reimbursement codes for an expected expedited regulatory pathway and reimbursement structure
Detailed Description
Hip and groin injuries are extremely common. In athletes, a “sports hernia” (actually caused by a tear of the adductor tendons from the pubic bone) can keep a player sidelined or force retirement. At Jefferson a search of the Radiology reports database shows 6,906 such injuries over the past six years (peak age 25). In the older population, hip abductor tendon injury is a cause of debilitation and falls. The abductor muscles are needed for balance during walking; loss of function of these muscles related to abductor tendon tear is a major cause of falls and hip fracture. A search of our database shows 12,150 such injuries over the past six years, with a peak age of 60. In the US, there are approximately 250,000 hip fractures that occur each year, with the majority of people suffering such injuries being over 65.1 Moreover, in the year following a hip fracture, there is nearly 20% mortality rate.1 These adductor and abductor tendon injuries have a commonality: the tendon usually ‘lifts off’ the bone, thereby potentially enabling percutaneous repair.
State of the art minimally invasive solutions for such tendon tears include a substrate injection, but so far, this procedure has demonstrated little proven clinical benefit because this method does not re-attach the separated tendon to the bone. Another current treatment is open surgery that yields a better recovery but is costly with a longer recovery and a higher risk of complications.
Jefferson University researchers and clinicians have developed a novel method of more effectively reattaching the tendon to the bone using a counter-clockwise employed bio-absorbable screw coated in a vascular stimulator. The method utilizes an image-guided needle that secures the position of the tendon or ligament by engaging a spring that then implants the screw into the bone. The novel Jefferson application is best applied to fascial planes where the tendon is parallel to the bone; injury to these tendons usually results in the tendon initially being ‘lifted off’ the bone. Though the method is meant for the pelvis and hip, there are potential applications for a host of tears including rotator cuff tears (shoulder), biceps partial tears (elbow), tears around the knee, and tears around the ankle joint.
The device employs a counter-clockwise wound spring coated with a vascular stimulator attached to a bio-absorbable screw with clockwise threads. The implant is attached to a placement rod passed through a sheath that is inserted percutaneously using imaging guidance. The screw tip is positioned on the surface of the bone at the site of tendon separation. The sheath is then pulled back, exposing the spring. As the placement rod is turned counter-clockwise, the spring uncoils within the substance of the tendon (or fascia). The rod is then turned clockwise to advance the screw into the bone; the coil disengages from the screw shank via a mechanism outlined in the patent application, but the screw is held in place by the head. The screw/coil combination re-attaches the separated tendon (or fascia) to the bone. The rod and sheath are then removed.
The Jefferson method is a percutaneous procedure that obviates the need for open surgery. The materials already exist and are FDA approved for surgery, thus indicating an expedited FDA approval strategy pathway. A provisional patent has been filed on the method of treatment of repairing tendon/fascia using imaging guidance. Jefferson is currently seeking partners for the commercial translation of this technology.
Supporting publications:
Marks R, et al. Hip fracture epidemiological trends, outcomes, and risk factors, 1970–2009. Int J Gen Med. 2010; 3: 1–17
Relevant patent filings:
Morrison, W et al: Percutaneous tendon/fascia repair via needle using imaging guidance, Filed Provisional.
PCT/US2018/041346 Dual Function Anchor System