Implants for tissue fixation and fusion
Inventors
Assignees
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Publication Number
US-10993754-B2
Publication Date
2021-05-04
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 disclosed invention relates to implant devices for tissue fixation and bone fusion, including fixation implants for a sacroiliac joint. The implant includes a proximal head, a shank, and a distal tapered tip, with the head integral with the shank at the proximal end and the tip integral with the shank at the distal end.
A key structural feature is that the shank includes an at least partially non-porous region and an ingrowth portion comprising an open network body. The open network body is a scaffold of open and interconnected pores mimicking a trabecular bone structure, and it is exposed in gaps between at least one external thread formed along an external surface of the shank.
In multiple embodiments, the open network body is formed as a helical body, an organized random truss arrangement, or a scaffold/porous framework of random open and interconnected pores that mimic trabecular bone. The implant can further include an optional through cannula, and the head can be a non-porous partially spherical or cylindrical head formed from solid material.
Materials for the scaffold/open network body include metal and/or biocompatible polymers selected from PEK, PEEK, PAEK, and combinations thereof. The disclosed content also describes optional osseoinductive materials associated with the open network and/or porous structure, including titanium, hydroxyapatite, and BMP.
Claims Coverage
The partial content includes three independent claims centered on a fixation implant with a non-porous head and tip, metal external threading, and a shank portion defined by an open-network scaffold of open and interconnected pores mimicking trabecular bone. Across these claims, inventive features are organized around the open-network scaffold placement and exposure relative to threads, the integral non-porous head and tip, thread material and its integral relation to the scaffold, and optional solid-walled through cannula embodiments.
Open-network scaffold in ingrowth portion mimicking trabecular bone exposed in thread gaps
A first portion of the shank includes an open network body comprising a scaffold of open and interconnected pores mimicking a trabecular bone structure, and the open network body is exposed in gaps between the at least one thread.
Non-porous solid head with tool recess and integral shank
A non-porous and partially spherical or cylindrical head that is integral with the shank at its proximal end, formed from a solid material and comprising a tool recess configured for engagement with a driving instrument.
Non-porous solid distal tip integral with shank
A tip that is integral with the shank at its distal end, the tip being non-porous and formed from a solid material.
Metal external thread integral with scaffold surface
At least one thread formed along an external surface of the shank along the entire length of the shank, wherein the at least one thread is formed from metal and is integral with a surface of the open network body.
Open-network scaffold formed from metal or biocompatible polymer (PEK/PEEK/PAEK)
The open network body is formed from at least one of a metal or a biocompatible polymer selected from the group consisting of PEK, PEEK, PAEK, and combinations thereof.
Solid-walled through cannula through head, shank, and threaded tapered distal tip
A solid-walled through cannula formed through the head, the shank, and the threaded tapered distal tip.
Threaded cylindrical head and threaded metal shank with cannula
A non-porous threaded cylindrical head formed from metal comprising a tool recess, where at least one metal thread is formed along an external surface of the shank along an entire length of the shank.
Non-porous threaded tapered distal tip integral with shank
A non-porous threaded tapered distal tip formed from metal and integral with the shank at the distal end of the shank.
Ingrowth portion scaffold mimicking trabecular bone with scaffold-integral threads
A shank comprises an ingrowth portion comprising a scaffold of open and interconnected pores mimicking a trabecular bone structure, wherein the at least one metal threads is integral with a surface of the scaffold.
Partially non-porous shank portions with distal-to-central open network and proximal-to-central non-porous
A first portion between the distal end and a central portion includes an open network body comprising a scaffold of open and interconnected pores mimicking a trabecular bone structure, and a second portion between the proximal end and the central portion is non-porous.
Open scaffold with gaps between threads
The scaffold is open in gaps between the at least one thread.
Across the independent claims, the core claim coverage centers on a fixation implant having a non-porous solid head with a tool recess and a non-porous solid distal tip integral with a shank, combined with metal external threading spanning the shank. A scaffold/open network body of open and interconnected pores mimicking trabecular bone is defined as an ingrowth portion and is integral with the metal threads such that the open network/scaffold is exposed in gaps between the threads. Selected independent claim sets further require a solid-walled through cannula extending through specified portions of the implant.
Stated Advantages
Improved resistance to rotational and pull-out failure versus fenestrated solid screws.
360° bone ingrowth and improved bony integration due to the open network providing 360° bone ingrowth.
Documented Applications
Fixation implants for tissue fixation and bone fusion, including fixation of the sacroiliac joint.
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