Implants for tissue fixation and fusion
Inventors
Assignees
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Publication Number
US-12239350-B2
Publication Date
2025-03-04
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 invention relates to a fixation implant for tissue fixation and fusion, including a head integral with a shank at a proximal end and a tapered solid tip integral with the shank at a distal end. The shank includes external threads with three solid thread regions having different pitches, where the head is unthreaded and the threads are separated by unthreaded portions of the shank.
A key feature is that the shank comprises a three-dimensional open network body comprising a scaffold of random open and interconnected pores that mimics trabecular bone structure. This scaffold allows communication through the three-dimensional open network body and 360 degrees around the shank to optimize complete bony integration when inserted in bone.
The disclosed configurations include variants with and without cannulation and different internal structures, including options where the shank includes an open network body with open and interconnected pores, and the implant may include additional features such as optional fenestrations and an open core. The document further describes materials for the implant, including metal and biocompatible polymer options such as titanium and PEK, PEEK, and PAEK, and optionally hydroxyapatite.
Claims Coverage
The independent claim covers a fixation implant with an open, trabecular bone-mimicking three-dimensional scaffold of random open and interconnected pores enabling 360° communication for complete bony integration, combined with a specific three-region solid thread arrangement and a tapered solid tip integrated with the shank and an unthreaded head. Dependent claims further refine configuration constraints (e.g., cannulated/non-cannulated), materials and formation of the open network, optional fenestrations, and head/shank diameter relationships.
Three-dimensional random open and interconnected pore scaffold enabling 360° communication
The shank comprises a three-dimensional open network body comprising a scaffold of random open and interconnected pores mimicking trabecular bone structure that allows communication through the three-dimensional open network body and 360 degrees around the shank to optimize complete bony integration when inserted in bone.
Tapered solid tip integral with the shank
A solid tip that is tapered relative to the shank and is integral with the shank at the shank's distal end.
Three solid thread regions with a greater middle pitch
The implant includes a first solid thread with a first pitch extending along an external surface of the tip, a second solid thread with a second pitch extending along a first portion of an external surface of the shank, and a third solid thread with a third pitch extending along a second portion of the external surface of the shank, wherein the second pitch is greater than each of the first pitch and the third pitch, and the second portion is disposed between the first portion and the head.
Unthreaded head and unthreaded shank portions separating thread regions
The first solid thread is separated from the second solid thread by a first unthreaded portion of the shank, the second solid thread is separated from the third solid thread by a second unthreaded portion of the shank, and the head is unthreaded.
Overall, the claim coverage centers on combining a three-dimensional random open and interconnected pore scaffold that enables 360° communication for complete bony integration with a tapered solid tip and a structured three-region solid thread geometry, including a greater middle pitch and separation by unthreaded shank portions with an unthreaded head.
Stated Advantages
Improved resistance to rotation and rotational migration.
Improved resistance to pull-out failure.
Increased bone engagement surface and stress distribution versus conventional fenestrated screws.
Documented Applications
Tissue fixation and fusion using the fixation implant when inserted in bone (including an example context of the sacroiliac joint described in the partial content).
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