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公开(公告)号：US10028839B2
公开(公告)日：2018-07-24
申请号：US15457194
申请日：2017-03-13
摘要： An inter-vertebral disc prosthesis intended for percutaneous deployment comprises an expandable annular enclosure and an expandable nuclear enclosure. The expandable annular enclosure incorporates a reinforcing annular band along its periphery and is filled with in-situ curable rubber. The expandable nuclear enclosure is filled with a gas. The nuclear prosthesis further incorporates a novel, integrally molded sealing valve assembly and is stretchable and collapsible into a minimal profile for ease of insertion into a specially designed delivery cannula, and is inflation-assisted expandable into an inter-vertebral disc in which complete percutaneous nuclectomy has been performed.
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公开(公告)号：US20160120653A1
公开(公告)日：2016-05-05
申请号：US14932242
申请日：2015-11-04
发明人： Nadi S. HIBRI , James D. LUTZ
CPC分类号： A61F2/441 , A61F2/3094 , A61F2/442 , A61F2002/30092 , A61F2002/30235 , A61F2002/30242 , A61F2002/30586 , A61F2002/444 , B29C41/14 , B29C45/14
摘要： 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.
摘要翻译： 用于核植入物的多室气囊具有限定与阀体一体的内室和外室的弹性膜。 阀体包括用于密封内室和外室的芯部分和密封膜。 用于制造多室气囊的组件包括气球心轴，其可以浸涂在硅氧烷分散体中以产生用于与阀体一体的内室和外室的弹性体膜。 形成在心轴上的弹性体膜部分地倒置以形成同轴弹性体结构，其中较小的内室设置在较大的外室内。 阀被并入内室和外室以形成一体的结构。
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公开(公告)号：US20210077266A1
公开(公告)日：2021-03-18
申请号：US17034103
申请日：2020-09-28
发明人： NADI S. HIBRI , W. LOREN FRANCIS , MARK A. NOVOTNY
摘要： A prosthesis for implantation in a de-nucleated intervertebral disc includes a fiber ring-like layer which encloses a polymeric layer to create an annular space. The annular space is inflatable with an in-situ curable liquid polymer and forms an interior cavity. The annular space may be expanded uniformly or differentially to be tailored to the needs of a particular vertebral segment and to achieve optimal disc space width and angle, thereby stabilizing the segment while preserving normal motion of the vertebral segment. The interior cavity provides a void that allows inward deformation of the implant during weight bearing activities and bending. The prosthesis can be elastically deformed through axial elongation to a reduced profile to load into a delivery cannula using pulling techniques.
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公开(公告)号：US20240099854A1
公开(公告)日：2024-03-28
申请号：US18310478
申请日：2023-05-01
发明人： Nadi S. HIBRI , James D. LUTZ
CPC分类号： A61F2/441 , A61F2/3094 , A61F2/442 , B29C41/14 , B29C45/14 , A61F2002/30092 , A61F2002/30235 , A61F2002/30242 , A61F2002/30586 , A61F2002/444
摘要： 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.
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公开(公告)号：US11744710B2
公开(公告)日：2023-09-05
申请号：US16560684
申请日：2019-09-04
CPC分类号： A61F2/441 , A61F2/442 , A61F2/4611 , A61F2002/3008 , A61F2002/30548 , A61F2002/30583 , A61F2002/30586 , A61M2025/1013 , A61M2025/1079
摘要： The present disclosure includes devices, apparatuses, kits, and methods for replacing a nucleus pulposus of an intervertebral disc with an implantable nuclear prosthesis filled with a curable silicone material in situ. Configurations of the present spinal implant devices include a flexible body defining an outer fillable enclosure that defines an outer chamber, an inner fillable enclosure that defines an inner chamber, and a proximal plug configured to be coupled to the inner fillable enclosure.
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公开(公告)号：US20230218409A1
公开(公告)日：2023-07-13
申请号：US18168475
申请日：2023-02-13
发明人： James D. Lutz , W. Loren Francis , Mark Novotny
CPC分类号： A61F2/4611 , A61F2/441 , A61F2002/4435 , A61F2002/444 , A61F2002/30069 , A61F2002/4635 , A61F2002/30593 , A61F2002/30462 , A61F2002/30586 , A61F2002/4495
摘要： A nuclear disc implant includes an inner fillable enclosure and an outer fillable enclosure. After insertion into a enucleated disc cavity, the inner enclosure is filled with a fluid and the outer fillable enclosure is filled with a curable material. The curable material is allowed to cure and the fluid is removed from the inner enclosure to leave an inner enclosure surrounded by an cured outer enclosure. A reinforcing band may be provided around the nuclear disc implant. An inflation tool to fill the nuclear disc implant is provided.
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公开(公告)号：US11633287B2
公开(公告)日：2023-04-25
申请号：US17034103
申请日：2020-09-28
发明人： Nadi S. Hibri , W. Loren Francis , Mark A. Novotny
摘要： A prosthesis for implantation in a de-nucleated intervertebral disc includes a fiber ring-like layer which encloses a polymeric layer to create an annular space. The annular space is inflatable with an in-situ curable liquid polymer and forms an interior cavity. The annular space may be expanded uniformly or differentially to be tailored to the needs of a particular vertebral segment and to achieve optimal disc space width and angle, thereby stabilizing the segment while preserving normal motion of the vertebral segment. The interior cavity provides a void that allows inward deformation of the implant during weight bearing activities and bending. The prosthesis can be elastically deformed through axial elongation to a reduced profile to load into a delivery cannula using pulling techniques.
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公开(公告)号：US11576793B2
公开(公告)日：2023-02-14
申请号：US16806580
申请日：2020-03-02
发明人： James D. Lutz , W. Loren Francis , Mark Novotny
摘要： A nuclear disc implant includes an inner fillable enclosure and an outer fillable enclosure. After insertion into a enucleated disc cavity, the inner enclosure is filled with a fluid and the outer fillable enclosure is filled with a curable material. The curable material is allowed to cure and the fluid is removed from the inner enclosure to leave an inner enclosure surrounded by an cured outer enclosure. A reinforcing band may be provided around the nuclear disc implant. An inflation tool to fill the nuclear disc implant is provided.
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公开(公告)号：US11523914B2
公开(公告)日：2022-12-13
申请号：US17034103
申请日：2020-09-28
发明人： Nadi S. Hibri , W. Loren Francis , Mark A. Novotny
摘要： A prosthesis for implantation in a de-nucleated intervertebral disc includes a fiber ring-like layer which encloses a polymeric layer to create an annular space. The annular space is inflatable with an in-situ curable liquid polymer and forms an interior cavity. The annular space may be expanded uniformly or differentially to be tailored to the needs of a particular vertebral segment and to achieve optimal disc space width and angle, thereby stabilizing the segment while preserving normal motion of the vertebral segment. The interior cavity provides a void that allows inward deformation of the implant during weight bearing activities and bending. The prosthesis can be elastically deformed through axial elongation to a reduced profile to load into a delivery cannula using pulling techniques.
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公开(公告)号：US10524923B2
公开(公告)日：2020-01-07
申请号：US15342161
申请日：2016-11-03
发明人： Nadi S. Hibri , W. Loren Francis , Mark A. Novotny
摘要： 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.
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