System and method for soft tissue gripping
Inventors
Shah, Sameer B. • Le, Johnathan L. • Moskowitz, Daniel • Ramirez, Fabian • Tran, Aileen • Delson, Nathan
Assignees
Office of General Counsel of VA • University of California San Diego UCSD • Government of the United States of America
Publication Number
US-10231736-B2
Publication Date
2019-03-19
Expiration Date
2036-06-13
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Abstract
Systems and methods disclosed stimulate nerve growth by applying a tensile (axial pulling) load on a proximal stump of the nerve. This load may be imposed once, at the time of repair. This implementation may be advantageously employed to remove tension away from the repair site, for any number of soft tissues, e.g., nerves, ligaments, tendons, and so on. Alternately, for a larger gap, by progressively elongating a nerve through tensile stimulation, the nerve may regenerate and be fully functional, particularly if elongated at a proper rate. After sufficient regrowth, nerve ends may be reattached, resulting in more complete functional recovery. Two implementations, which have been embodied in prototype devices, also include particularly useful features, one of which uses a screw and clamp with slotted insert design, and the other of which enables the use of sutures or straps to secure the tissue to the clamp.
Core Innovation
The invention provides systems and methods to stimulate nerve growth by applying a tensile (axial pulling) load on a proximal stump of a nerve. This load can be applied once at the time of repair or progressively through elongating the nerve to regenerate and restore function, particularly when elongated at a proper rate. After sufficient regrowth, nerve ends may be reattached, leading to more complete functional recovery.
These systems and methods include specially designed clamping mechanisms to grip soft tissues such as nerves, ligaments, tendons, and muscles without causing damage. Two device implementations include a screw and clamp design with a slotted insert and another that uses sutures or straps to secure the tissue to the clamp.
The problem addressed is the lack of effective strategies to repair large gaps in peripheral nerves resulting from injury, which can cause loss of mobility, motor function, and sensation. Existing technologies like nerve grafts or balloon expansion have limitations such as non-linear bowing of nerves or patient immobility. The invention overcomes these by providing a modular, implantable device that grips soft tissue securely without damage and allows nerve lengthening under axial tension with minimized risk of slippage or damage.
Claims Coverage
The patent claims cover three independent claims including an implantable device to grip nerves, a kit for elongating tissue, and a method for elongating tissue or bringing disparate tissues together. The main inventive features involve specialized tissue gripping devices with micro-barbs, a modular elongation kit, and a method for sequential tissue elongation.
Implantable tissue gripping device with micro-barbs
An implantable device having a housing with a tissue engagement portion that includes a tissue engagement surface having tissue piercing micro-barbs operable to hold nerve tissue against movement by engaging only the epineurium to prevent damage to inner nerve. The device connection portion includes a throughhole to receive a tube and backbone and allows distribution of radial compressive load along the nerve while fitting for implantation within a host.
Kit for elongating tissue with interconnected devices
A kit comprising at least two tissue gripping devices as described, connected via a backbone that allows sliding engagement, and means such as a guidewire, set screw, or tie-off hitch to maintain a maximum distance between devices, configured to fit and be implanted within a host.
Method for elongating or bringing tissue together
A method involving attaching a first device to a proximal portion of tissue and a second device to a distal portion, affixing a backbone between them to maintain distance, then successively altering the position of one or both devices on the backbone to reduce the distance, enabling tissue elongation or approximation.
The claims comprehensively cover the design and functional features of an implantable tissue gripping device with micro-barbs, a modular kit for tissue elongation using multiple devices and a backbone, and a method for controlled elongation or bringing tissue ends together, all configured to protect tissue and promote regeneration.
Stated Advantages
Securely grips tissue while causing little or no electrical or mechanical damage.
Allows nerves to be lengthened under axial tension without over compressing or damaging the nerve.
Can be implanted in patients and manually pulled at intervals to stimulate nerve growth effectively.
Documented Applications
Neurosurgical or orthopedic applications for soft tissue repair following acute traumatic injury or chronic degenerative injury.
Lengthening of peripheral nerves with large gaps to promote regrowth and functional recovery.
Strain relief in nerve repair to prevent suture failure under physiological movement.
Gripping and securing various soft tissues including nerves, ligaments, tendons, and muscles without damage.
Use in patient populations including military, veterans, athletes, elderly, and those with traumatic or degenerative nerve injuries.
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