Abstract: A system and method for anterior fixation of the spine utilizes a cylindrical implant engaged in the intradiscal space at the cephalad and caudal ends of the construct. The implants are cylindrical fusion devices (10) filled with bone material to promote bone ingrowth and fusion of the disc space. An attachment member (40) is connected to each of the fusion devices (10) and a spinal rod (50) is connected to each of the attachment members using an eyebolt assembly (53, 54, 55). In a further inventive method, a revision of the construct is achieved by removing the fusion devices. Each fusion device is engaged by an elongated guide member (62) over which a cylindrical trephine (70) is advanced. The trephine (70) is used to extract a core (84) of bone material around the fusion implant, while the guide member (62) is used to remove the bone core (84) containing the fusion implant (10). In another aspect of the invention, a removal insert (90, 90') is provided that engages an implanted fusion device (10).

Abstract: A template assembly is provided for marking locations on the disc annulus for the implantation of an interbody fusion device or the introduction of a working instrument. The template assembly includes a tubular body sized for percutaneous introduction into a patient and advancement to an affected intervertebral disc. An elongated shaft slidably extends through the tubular body and is threadedly engaged to the handle-mounted thumb wheel so that rotation of the thumb wheel relative to the tubular body retracts the shaft through the body. A guide foot with a rotatable cam near the distal end of the tubular body is operable by the shaft and may be pivoted from a first position aligned with the tubular body to a second deployed position oriented transversely to the tubular body. The guide assembly has an electrocautery projection for marking locations on the disc annulus.

Abstract: A system and method for anterior fixation of the spine utilizes a cylindrical implant engaged in the intradiscal space at the cephalad and caudal ends of the construct. The implants are cylindrical fusion devices (10) filled with bone material to promote bone ingrowth and fusion of the disc space. An attachment member (40) is connected to each of the fusion devices (10) and a spinal rod (50) is connected to each of the attachment members using an eyebolt assembly (53, 54, 55). In a further inventive method, a revision of the construct is achieved by removing the fusion devices. Each fusion device is engaged by an elongated guide member (62) over which a cylindrical trephine (70) is advanced. The trephine (70) is used to extract a core (84) of bone material around the fusion implant, while the guide member (62) is used to remove the bone core (84) containing the fusion implant (10). In another aspect of the invention, a removal insert (90, 90') is provided that engages an implanted fusion device (10).

Abstract: A template assembly is provided for marking locations on the disc annulus for the implantation of an interbody fusion device or the introduction of a working instrument. The template assembly includes a tubular body sized for percutaneous introduction into a patient and advancement to an affected intervertebral disc. An elongated shaft slidably extends through the tubular body and is threadedly engaged to the tubular body at its proximal end so that rotation of the shaft relative to the tubular body advances the shaft through the body. A guide foot is pivotably connected to the distal end of the tubular body to be pivoted from a first position aligned with the tubular body to a second deployed position oriented substantially perpendicular to the tubular body. The guide body is pivoted from the first position to the second position by advancement of the elongated shaft through the tubular body.

Abstract: An interbody fusion device includes a tapered body defining a hollow interior for receiving bone graft or bone substitute material. The body defines exterior threads which are interrupted over portions of the outer surface of the device. The fusion device defines truncated side walls so that on end view the body takes on a cylindrical form. The side walls are provided with vascularization openings, and the body wall device includes opposite bone ingrowth slots extending through the interrupted thread portion of the body. An implant driver is provided which engages the truncated side walls to complete the cylindrical form of the implant at the root diameter of the interrupted threads. The driver facilitates threaded insertion of the implant to the intra-discal space between adjacent vertebrae. The implant is tapered at a predetermined angle generally corresponding to a desired lordotic angle of the spine.

Abstract: An adjustable vertebral body replacement implant and assembly includes a thin-walled cylindrical body configured to span over most of the length between intact vertebrae when damaged or diseased vertebrae have been removed. The cylindrical body defines a hollow interior with a plurality of bone-ingrowth apertures communicating with the interior. The replacement assembly further includes endplates configured to contact the adjacent vertebra and to engage the cylindrical body therebetween. The cylindrical body and the endplates include mating threads to permit adjustment of the overall height of the implant. A means for fixing the cylindrical body to the endplates is contemplated, which in one embodiment is a set screw for locking the components in place. In another embodiment, the means for fixing includes a crimping channel and notch defined in the endplates to be crimped onto the cylindrical body.

Abstract: An adjustable vertebral body replacement implant and assembly includes a thin-walled cylindrical body configured to span over most of the length between intact vertebrae when damaged or diseased vertebrae have been removed. The cylindrical body defines a hollow interior with a plurality of bone-ingrowth apertures communicating with the interior. The replacement assembly further includes endplates configured to contact the adjacent vertebra and to engage the cylindrical body therebetween. The cylindrical body and the endplates include mating threads to permit adjustment of the overall height of the implant. A means for fixing the cylindrical body to the endplates is contemplated, which in one embodiment is a set screw for locking the components in place. In another embodiment, the means for fixing includes a crimping channel and notch defined in the endplates to be crimped onto the cylindrical body.

Abstract: An adjustable vertebral body replacement implant and assembly includes a thin-walled cylindrical body configured to span over most of the length between intact vertebrae when damaged or diseased vertebrae have been removed. The cylindrical body defines a hollow interior with a plurality of bone-ingrowth apertures communicating with the interior. The replacement assembly further includes endplates configured to contact the adjacent vertebra and to engage the cylindrical body therebetween. The cylindrical body and the endplates include mating threads to permit adjustment of the overall height of the implant. A means for fixing the cylindrical body to the endplates is contemplated, which in one embodiment is a set screw for locking the components in place. In another embodiment, the means for fixing includes a crimping channel and notch defined in the endplates to be crimped onto the cylindrical body.

Abstract: A system and method for anterior fixation of the spine utilizes a cylindrical implant engaged in the intradiscal space at the cephalad and caudal ends of the construct. The implants are cylindrical fusion devices (10) filled with bone material to promote bone ingrowth and fusion of the disc space. An attachment member (40) is connected to each of the fusion devices (10) and bone screws (30) having similar attachment members (33) are engaged in the vertebral bodies of the intermediate vertebrae. A spinal rod (50) is connected to each of the attachment members using an eyebolt assembly (53, 54, 55). In a further inventive method, a revision of the construct is achieved by removing the fusion devices. Each fusion device is engaged by an elongated guide member (62) over which a cylindrical trephine (70) is advanced. The trephine (70) has an inner diameter larger than the diameter of the fusion implant and includes cutting teeth (72) for extracting a core (84) of bone material around the fusion implant.

Abstract: An interbody fusion device in one embodiment includes a tapered body defining a hollow interior for receiving bone graft or bone substitute material, The body defines exterior threads which are interrupted over portions of the outer surface of the device. The fusion device defines truncated side walls so that on end view the body takes on a cylindrical form. The side walls are provided with vascularization openings, and the body wall device includes opposite bone ingrowth slots extending through the interrupted thread portion of the body. In another embodiment, the tapered body is solid and formed of a porous biocompatible material having sufficient structural integrity to maintain the intradiscal space and normal curvature. The material is preferably a porous tantalum having fully interconnected pores to facilitate complete bone tissue ingrowth into the implant.

Abstract: A template assembly is provided for marking locations on the disc annulus for the implantation of an interbody fusion device or the introduction of a working instrument. The template assembly includes a tubular body sized for percutaneous introduction into a patient and advancement to an affected intervertebral disc. An elongated shaft slidably extends through the tubular body and is threadedly engaged to the tubular body at its proximal end so that rotation of the shaft relative to the tubular body advances the shaft through the body. A guide foot is pivotably connected to the distal end of the tubular body to be pivoted from a first position aligned with the tubular body to a second deployed position oriented substantially perpendicular to the tubular body. The guide body is pivoted from the first position to the second position by advancement of the elongated shaft through the tubular body.

Abstract: A disk arthroplasty device (310) is provided for replacement of a spinal disk. The device is implantable into a resected disk space and is formed with ball (346) and socket (326) members and shaped to provide lateral bending and backward extension of up to about 5.degree. and forward flexion of up to about 15.degree.. Four embodiments (10), (110), (210) and (310) permit up to about 5.degree. axial rotation and a fifth embodiment (410) permits unrestricted axial rotation. Metal insert cups (70) and (170) are provided for attaching to the device surfaces and are convexly shaped along one axis to conform to the natural contours of the top and bottom vertebra surfaces. The metal insert cups (70) and (170) provide tensile support to the structure and provide for the attachment of additional structures for retaining the device in position after implantation into a disk space.

Abstract: A disk arthroplasty device (310) is provided for replacement of a spinal disk. The device is implantable into a resected disk space and is formed with ball (346) and socket (326) members and shaped to provide lateral bending and backward extension of up to about 5.degree. and forward flexion of up to about 15.degree.. Four embodiments (10), (110), (210) and (310) permit up to about 5.degree. axial rotation and a fifth embodiment (410) permits unrestricted axial rotation. Metal insert cups (70) and (170) are provided for attaching to the device surfaces and are convexly shaped along one axis to conform to the natural contours of the top and bottom vertebra surfaces. The metal insert cups (70) and (170) provide tensile support to the structure and provide for the attachment of additional structures for retaining the device in position after implantation into a disk space.

Abstract: According to the invention, there is provided an implantable prosthetic device inflatable by a self-contained resealable valve in combination with an external locator for determining the position of the valve. The prosthesis includes a flexible outer envelope defining a closed lumen and having a valve attached to an area of the envelope with indicia on the valve responsive to the external locator for determining the position of the valve. A plurality of spaced sensors are each fixedly arrayed on the locator so that when the sensors are in a certain non-juxtaposed relationship with the indicia the sensors orientate with one another, signifying a true location of the valve. A multi-compartmental design having a tethered valve for selective inflation of an inner lumen is also disclosed. The tissue-contacting surface of the outer envelope is micro-textured to minimize tissue capsule contracture.

Abstract: A system and method for anterior fixation of the spine utilizes a cylindrical implant engaged in the intradiscal space at the cephalad and caudal ends of the construct. The implants are cylindrical fusion devices (10) filled with bone material to promote bone ingrowth and fusion of the disc space. An attachment member (40) is connected to each of the fusion devices (10) and a spinal rod (50) is connected to each of the attachment members using an eyebolt assembly (53, 54, 55). In a further inventive method, a revision of the construct is achieved by removing the fusion devices. Each fusion device is engaged by an elongated guide member (62) over which a cylindrical trephine (70) is advanced. The trephine (70) is used to extract a core (84) of bone material around the fusion implant, while the guide member (62) is used to remove the bone core (84) containing the fusion implant (10). In another aspect of the invention, a removal insert (90, 90') is provided that engages an implanted fusion device (10).