The elbow is one of the most heavily used joints, used in a variety of everyday activities. Injuries to the elbow can occur from overuse, incorrect repetitive mechanical motion, trauma associated with athletic participation, work, or accidents. These often require surgical repairs or reconstruction. An ulnar collateral ligament reconstruction (UCLR), also known as Tommy John surgery, is one such surgery that repairs a torn ulnar collateral ligament, located in the elbow. The ulnar collateral ligament (UCL), located on the inside of the elbow, connects the humerus bone in the upper arm to the ulna bone in the forearm. A UCL injury typically results from repetitive stress or trauma to the elbow. The UCL can develop small or large tears or can stretch and lengthen to the point where it no longer supports the elbow during throwing activities. During a UCLR, a tendon is taken from elsewhere in the patient's body, such as the wrist, forearm, or hamstring, and used to replace the weak, torn ligament. The surgeon then drills tunnels into the ulna and humerus and threads the tendon through the tunnels and securing them to the bone.
Post-surgical rehabilitation typically takes 12 to 18 months, sometimes longer, before the elbow returns to pre-injury form. The new “system” is very weak immediately after the surgery, and the rebuilding process must be gradual as the body needs adequate time to convert the inserted tendon, which attaches muscle to bone, into a ligament, which connects bone to bone. During recovery, the arm is fitted in a postoperative, range-of-motion orthosis used to protect the repair, restrict movement, and prevent valgus and varus stress.
Current postoperative elbow orthoses are limiting because they are cumbersome, difficult to adjust, only allow for static changes in positioning without the option for gradual range-of-motion extension, and do not provide the rehabilitative opportunity for forced hyperextension, making it difficult for the user to regain full extension of the elbow. Because the arm is often incapable of reaching full-end range-of-motion after surgery the disclosed orthosis offers an alternative solution by using the orthosis to passively force the arm into full extension for a more complete healing process.
A postoperative elbow orthosis is needed that provides therapeutic circumferential compression to the arm, allows for both sequential and dynamic extension, and provides gradual range-of-motion extension, allowing up to 10° of forced hyperextension.
In a preferred embodiment, a postoperative, range-of-motion elbow orthosis which provides rehabilitative support for patients in the form of dynamic range-of-motion extension for the treatment of ligamentous injuries and stable fractures of the elbow and distal humerus is disclosed.
The orthosis consists of an asymmetric, s-shaped upper frame that lies medially beneath the axilla and laterally at the humeral head of the shoulder as well as a lower frame that lies near the distal portion of the radius and ulna. Together the upper and lower frame is designed to follow the contour of the arm, allowing the frame to extend up to the axilla and the shoulder, ultimately creating a longer lever to minimize the force required to achieve maximum extension. Constructed with lightweight materials, such as thermoplastic polyurethane, nylon, plastic, aluminum, or carbon fiber, the frame is comfortable and compact, eliminating unnecessary weight for the user. The frame is secured to the user through a series of proximal and distal straps and clasps, helping to prevent frame migration by providing a secure and customized fit to the user.
A circumferential compression sleeve, made of an elastic material such as spandex, lined with a gripping element such as silicone, prevents migration. The circumferential compression sleeve extends from the wrist to the shoulder, provides cushioning for comfort during movement, reduces swelling of the affected area, absorbs moisture produced by the skin, and provides ventilation while allowing the wrist and hand to move freely. The circumferential compression sleeve is applied independently and worn beneath the frame.
A cable-tensioning system, consisting of a dial, tensioning cable, cable-tunneling system, and cable guides, are used to create a customized tensioning system which allows for sequential, dynamic, and gradual forced extension to the elbow, progressively adjusting the orthosis' position of extension, allowing up to 10° of hyperextension.
The dial, consisting of a dial head, spool, one-way cable-tensioning system, and a release mechanism, located on the distal portion of the frame near the forearm, is easily accessed by the opposite hand of the user. Turning the dial clockwise creates tension and results in extension.
The cable-tensioning system causes the elbow guard, made of a rigid material such as thermoplastic polyurethane, aluminum, carbon fiber, or various other forms of plastic, the elbow into extension. The elbow pad, located on the interior portion of the elbow guard and consisting of foam or gel, mimics the shape of the elbow guard and conforms to the elbow. Together these serve as the fulcrum for the cable-tensioning system and provide added protection to the elbow.
A medial and lateral range of motion hinge, located between the upper portion of the frame and the lower portion of the frame, allows the orthosis to be locked into specific degrees of flexion or extension, and 10° of hyperextension.
The completed orthosis will be available in a variety of sizes, as well as a custom-fitted option.
Indications for this elbow orthosis include treatment of: ligamentous injury distal bicep tendon repair, tricep tendon repair, collateral ligament reconstruction, ulnar collateral ligament repair, lateral ulnar collateral ligament repair, radial collateral ligament repair, stable fractures of the elbow or upper arm, distal humerus fracture, proximal radius fracture, radial head fracture, ulna fracture, chronic elbow injury, elbow hyperextension, range-of-motion control post-injury, tennis elbow release, among others.
The present invention relates to an elbow orthosis 10, as shown in
The orthosis 10 includes an asymmetric, s-shaped upper frame 12 that lies medially beneath the axilla 14 and laterally at the humeral head of the shoulder 21, as seen in
A circumferential compression sleeve 28, as seen in
The circumferential sleeve 28 is applied independently and worn beneath the frame 11. In one embodiment, the compression sleeve 28 incorporates a closure system utilized to create a customized fit for the wearer 20. In another embodiment, the compression sleeve 28 provides post-rehabilitative compression and can be worn independently from the frame 11 during performance.
A cable-tensioning system 30, consisting of a dial 46, tensioning cable 32, cable-tunneling system 34 etched into the frame 11, cable guides 36, and a u-joint 56 adhered to the elbow guard 58, as shown in
The tensioning cable 33 rests and moves along the frame 11 through cord guides 36 and a cable tunneling system 34. In one embodiment, the cable tunneling system 34 is integrated externally into the frame 11, as shown in
The dial 46, consisting of a dial head 48, spool 50, one-way cable-tensioning system 52, and a release mechanism 54, as shown in
The elbow pad 60 located on the interior portion of the elbow guard 58, shown in
A medial 62 and lateral 63 range-of-motion hinge, as shown in
The completed orthosis 10 will be available in a variety of sizes, as well as a custom-fitted option.
Indications for this elbow orthosis 10 include treatment of: ligamentous injury distal bicep tendon repair, tricep tendon repair, collateral ligament reconstruction, ulnar collateral ligament repair, lateral ulnar collateral ligament repair, radial collateral ligament repair, stable fractures of the elbow or upper arm, distal humerus fracture, proximal radius fracture, radial head fracture, ulna fracture, chronic elbow injury, elbow hyperextension, range-of-motion control post-injury, tennis elbow release, among others.
Number | Date | Country | |
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62632243 | Feb 2018 | US |