Implants for tissue fixation and fusion
Inventors
Assignees
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Publication Number
US-12376895-B2
Publication Date
2025-08-05
Expiration Date
Abstract
A fixation implant includes a head, a shank and a distal tip, and one or more of the head, shank and distal tip may be cannulated. The shank includes a threaded ingrowth portion extending from the head to the tapered distal tip that includes external threads, and at least one open network body extending along the length of the ingrowth portion. The open network body selected from one or a combination of a helix, an arrangement of trusses, a scaffold of open and interconnected pores, a porous framework of random open and interconnected pores, and combinations of these.
Core Innovation
The invention relates to fixation implants and fusion implants for spinal stabilization, including a pedicle screw having a shank with a proximal end and a distal end, a tapered distal tip integral with the shank, and a partially spherical pedicle screw head monolithic with the shank at the proximal end. A three-dimensional open network body extends along at least a portion of the shank and allows communication through the three-dimensional open network body and 360 degrees around the shank when inserted in bone.
The three-dimensional open network body includes at least one of a scaffold of random open and interconnected pores, an elongate helix formed along the entire length of the shank, or an organized or random arrangement of trusses formed along the entire length of the shank. The open network body is selected to provide bony ingrowth and complete bony integration, with a scaffold of random open and interconnected pores configured to mimic trabecular bone.
The invention further includes at least one solid or non-porous thread extending along an external surface of the shank, where the at least one solid thread and the three-dimensional open network body are formed from metal and the at least one solid thread is integral with a surface of the three-dimensional open network body. The three-dimensional open network body may be exposed in gaps between the at least one thread, while particular embodiments also recite a non-porous head and tip, a tool recess for engagement with a driving instrument, and a non-porous proximal shank portion.
Claims Coverage
The provided independent claims comprise three inventive scopes that each require a fixation/fusion-type implant with a partially spherical monolithic head and an open-network shank portion enabling communication and complete bony integration, coupled with external threads that are integral with the open-network surface. Across the independent claims, there are three main inventive feature sets.
Metal pedicle screw with three-dimensional open network enabling 360-degree communication
A pedicle screw comprising a shank with a three-dimensional open network body along at least a portion of the shank that allows communication through the three-dimensional open network body and 360 degrees around the shank, wherein the three-dimensional open network body comprises at least one of a scaffold of random open and interconnected pores formed along at least a central portion of the shank, an elongate helix formed along the entire length of the shank, or an organized or random arrangement of trusses formed along the entire length of the shank.
Partially spherical monolithic head with tool recess and tapered integral tip
A partially spherical pedicle screw head monolithic with the shank at a proximal end, where at least a portion of the pedicle screw head includes the three-dimensional open network body, and a tip that is tapered relative to the shank and is integral with the shank at the shank's distal end.
Integral solid external thread and open-network surface formed from metal
At least one solid thread extending along an external surface of the shank, wherein the at least one solid thread and the three-dimensional open network body are formed from metal, and wherein the at least one solid thread is integral with a surface of the three-dimensional open network body.
Non-porous partially spherical monolithic head and non-porous tip with continuous external thread and exposed distal open-network scaffold
A pedicle screw comprising a non-porous, partially spherical pedicle screw head monolithic with the shank at its proximal end and comprising a tool recess for engagement with a driving instrument; a tip integral with the shank at its distal end, non-porous and formed from a solid material; and at least one non-porous thread formed along an external surface of the pedicle screw, wherein a first portion of the shank adjacent the distal end includes a three-dimensional open network body comprising a scaffold of open and interconnected pores mimicking a trabecular bone structure allowing communication through the three-dimensional open network body and 360 degrees around the shank, while a second portion of the shank adjacent the proximal end is non-porous, wherein the at least one thread is continuous along a thread length of the pedicle screw from the tip into and over at least a portion of the second portion of the shank, and wherein the three-dimensional open network body is exposed in gaps between the at least one thread.
Fixation implant with non-porous partially spherical head, non-porous tip, and continuous thread exposing distal open-network scaffold
A fixation implant comprising a shank having a length from a proximal end to a distal end; a non-porous, partially spherical head monolithic with the shank at its proximal end and comprising a tool recess configured for engagement with a driving instrument; a tip integral with the shank at its distal end, non-porous and formed from a solid material; and at least one non-porous thread formed along an external surface of the fixation implant, wherein a first portion of the shank adjacent the distal end includes a three-dimensional open network body comprising a scaffold of open and interconnected pores mimicking a trabecular bone structure allowing communication through the three-dimensional open network body and 360 degrees around the shank when inserted in bone, wherein a second portion of the shank adjacent the proximal end is non-porous, and wherein the three-dimensional open network body is exposed in gaps between the at least one thread.
Across the independent claims, the coverage centers on an implant with a distal shank portion incorporating a three-dimensional open network body that provides communication through the network and 360 degrees around the shank to optimize complete bony integration, combined with metal external threads that are integral with the open-network surface and, in the non-porous head/tip variants, a distal open-network scaffold exposed in gaps between continuous threads.
Stated Advantages
Enables communication through a three-dimensional open network body and 360 degrees around the shank.
Optimizes complete bony integration when inserted in bone.
Mimics trabecular bone structure using a scaffold of open and interconnected pores.
Documented Applications
Spinal stabilization using fixation implants and fusion implants, including pedicle screws for insertion in bone.
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