Nuclear implant apparatus and method following partial nuclectomy
Inventors
Hibri, Nadi S. • FRANCIS, W. Loren • Novotny, Mark A.
Assignees
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Publication Number
US-10524923-B2
Publication Date
2020-01-07
Expiration Date
Abstract
An expandable implant for augmenting a damaged or otherwise torn posterior annulus fibrosus. The implant is deployable into an evacuated posterior disc space following a subtotal nuclectomy. The implant includes an inflatable balloon which is fixed to the annulus fibrosus to protect against migration. When inflated with a curable polymer, the posterior wall of the implant is intimately disposed along the inner surface of the annulus fibrosus to provide a substantially fluid-tight seal of the annular tear or defect and reinforce the weakened posterior annulus. The anterior wall of the implant sequesters the nuclear remnant to guard against disc remnant herniation. The implant can restore intradiscal pressure and disc height. An integrated posterior reinforcement band creates a strong, yet flexible and resilient structure, resistant to penetration of the implant through the annular tear or defect.
Core Innovation
The invention is directed to reinforcing a posterior annulus fibrosus by using an inflatable implant delivered through percutaneous cannulas placed at annulotomies on opposite sides. The method accesses a nuclear space by spreading fibers of the annulus fibrosus, then creates a cavity by subtotal nuclectomy or partial nuclectomy, where the posterior side of the cavity is formed by the annulus fibrosus and the anterior side is formed by a nucleus remnant.
An inflatable implant or inflatable balloon is inserted into the cavity and positioned so that an anterior portion is more compliant than another portion of the inflatable implant or balloon. The implant is expanded or inflated with a curable medium so the implant substantially fills the cavity and presses against the annulus fibrosus to form a substantially fluid tight seal with the annulus fibrosus.
The implant is secured by anchoring both ends to the annulotomies or to opposite lateral sides of the annulus fibrosus. In this way, posterior annulus reinforcement is achieved using an anterior more-compliant portion combined with an inflating or expanding curable substantially fluid-tight sealing element and end anchoring at the access locations.
Claims Coverage
The document includes two independent claims. The independent claims cover an inflatable implant or inflatable balloon delivered into a surgically created cavity in a posterior annulus fibrosus, with an anterior portion more compliant and with anchoring of both ends at locations on opposite sides of the annulus fibrosus to achieve a substantially fluid tight seal.
Inflatable implant reinforcement via bilateral cannulas and annulotomies after subtotal nuclectomy
Inserting first and second cannulas through first and second annulotomies to gain access to a nuclear space, performing a subtotal nuclectomy to create a cavity with a posterior side formed by the annulus fibrosus and an anterior side formed by a nucleus remnant, inserting and positioning an inflatable implant in the cavity toward the second cannula with an anterior portion more compliant than another portion, expanding the inflatable implant with a curable medium to substantially fill the cavity and press against the annulus fibrosus to form a substantially fluid tight seal, and anchoring the first and second ends to the first and second annulotomies, respectively.
Inflatable balloon reinforcement via partial nuclectomy and anchoring to opposite lateral sides
Accessing by spreading fibers of the annulus fibrosus a nuclear space formed by the annulus fibrosus, performing a partial nuclectomy to create a cavity extending from a first lateral side to a second lateral side with a posterior side formed by an inner wall of the annulus fibrosus and an anterior side formed by a nucleus remnant, inserting an inflatable balloon with a first end and second end into the cavity with an anterior portion more compliant than another portion, inflating the inflatable balloon with a curable medium, anchoring the first end to the annulus fibrosus on the first lateral side, and anchoring the second end to the annulus fibrosus on the second lateral side.
Across both independent claims, the inventive coverage centers on creating a nuclectomy-defined cavity in the posterior annulus, placing an inflatable implant or balloon with an anterior portion more compliant, inflating or expanding with a curable medium to form a substantially fluid tight seal, and anchoring the opposite ends to annulotomy or lateral-side locations of the annulus fibrosus.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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