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Publication Number
US-10314714-B2
Publication Date
2019-06-11
Expiration Date
Abstract
A multi-chamber balloon for a nuclear implant has an elastomeric membrane defining inner and outer chambers integral with a valve body. The valve body includes a core portion and sealing membrane for sealing the inner and outer chambers. An assembly for manufacturing the multi-chamber balloon includes a balloon mandrel which may be dip coated in a silicone dispersion to create an elastomeric membrane for the inner and outer chambers integral with the valve body. The elastomeric membrane formed on the mandrel is partially inverted to form a coaxial elastomeric structure with the smaller inner chamber disposed within the larger outer chamber. The valve is incorporated into the inner and outer chambers to form a unitary structure.
Core Innovation
The document describes a percutaneously deliverable spinal/nuclear prosthesis that includes a multi-chamber coaxial elastomeric implant. The implant has an inner inflatable enclosure forming an inner balloon and an outer inflatable enclosure forming an outer balloon, with the outer enclosure encapsulating the inner enclosure to create a coaxial, multi-chamber arrangement.
A one-way valve assembly is disposed between the inner and outer enclosures to enable independent inflation and to prevent backflow. The valve section includes a conduit having a sidewall with at least one opening extending through the sidewall, and the implant includes distal plug inner and distal plug outer sections at the distal ends of the inner and outer membrane sections.
The outer balloon is reinforced and sealed using a distal plug and an annular reinforcement band that provides anti-overstretch reinforcement. Manufacturing is described using a prosthesis blank with outer and inner membrane sections and a valve section between them, followed by partial inversion so the outer membrane encloses the inner membrane.
Claims Coverage
The independent claim framework contains three inventive features centered on forming a prosthesis blank and partially inverting it to form a multi-chamber implant.
Forming outer and inner membrane sections with a valve section
forming a prosthesis blank comprising an outer membrane section with a proximal end and a distal end, an inner membrane section with a proximal end and a distal end, and a valve section disposed between the proximal end of the outer membrane section and the proximal end of the inner membrane section, wherein the valve section comprises a conduit having a sidewall with at least one opening extending through the sidewall
Adding distal plug inner and distal plug outer sections
a distal plug inner section at the distal end of the inner membrane section, and a distal plug outer section at the distal end of the outer membrane section
Partially inverting to form an outer balloon surrounding an inner balloon
partially inverting the prosthesis blank so that the outer membrane section encloses the inner membrane section so that the outer membrane section forms an outer balloon surrounding an inner balloon formed by the inner membrane section
The independent claim concept combines the outer and inner membrane sections, the valve section with a conduit sidewall opening, distal plug inner and outer sections, and partial inversion to form an outer balloon surrounding an inner balloon.
Stated Advantages
compliant modulus closer to native disc tissue
load stress redirection inward
potential reinforcement for torn annulus fibrosus via reinforcement band and tissue in-growth
Documented Applications
Percutaneous implantation of the spinal/nuclear prosthesis after discectomy with independent inflation of an inner nuclear chamber and an outer annular chamber.
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