Implants for tissue fixation and fusion

Inventors

Kuntz, KylePatel, Shyam

Assignees

Cutting Edge Spine LLC

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Publication Number

US-11771482-B2

Patent

Publication Date

2023-10-03

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 document describes a fixation implant for tissue fixation and fusion having a shank with a proximal end and a distal end, and a solid-walled through cannula formed through the implant. At least a portion of the shank includes an open network body selected from a helix, an organized arrangement of trusses, and combinations thereof, with the open network body formed from a metal, a biocompatible polymer, or a combination thereof. The implant further includes a head integral with the shank at the proximal end, a tip integral with the shank at the distal end, and tool recess engagement with a driving instrument for the head.

The implant places at least one thread formed of solid metal along an external surface of the shank and over the open network body so that the thread is integral with and disposed on the outer surface of the open network body. The open network body is exposed in gaps between the at least one thread, thereby providing circumferential exposure of the open structure. The threaded ingrowth portion and exposed open network body are used to enable bony integration while resisting rotational motion, migration, and pull-out.

In additional embodiments, the open network body is porous and comprises a helix, an organized arrangement of trusses, or combinations thereof, and the porous ingrowth portion is exposed in gaps between at least one metal thread. The shank includes configurations with a solid portion in addition to the open network portion, while maintaining a solid-walled through cannula through the implant. Head and tip structures can be non-porous and formed from solid materials, and the open network can be configured as a dual helical arrangement with different pitch.

Claims Coverage

The document includes three independent claims. Across them, the inventive coverage consistently focuses on a fixation implant with an exposed open network ingrowth portion and at least one solid metal external thread that leaves gaps exposing the open network body, in combination with solid head/tip structure, tool recess engagement, and a solid-walled through cannula.

Exposed open network ingrowth with external metal thread gaps

A fixation implant in which at least a portion of the shank includes an open network body selected from a helix, an organized arrangement of trusses, and combinations thereof, formed from a metal, a biocompatible polymer, or a combination thereof, wherein at least one thread formed of solid metal extends along an external surface of the shank and over the open network body such that the thread is integral with and disposed on an outer surface of the open network body, and the open network body is exposed in gaps between the at least one thread.

Tool recess head integral with shank and solid tip

A fixation implant having a head integral with the shank at a proximal end, the head formed from a solid material and comprising a tool recess configured for engagement with a driving instrument, and a tip integral with the shank at a distal end, the tip formed from a solid material.

Solid-walled through cannula through shank with exposed open network

A fixation implant comprising a shank having a length from a proximal end to a distal end with a solid-walled through cannula formed therethrough, where the open network body is included in at least a portion of the shank and is exposed in gaps between solid metal external threads.

Across independent claims, the patent consistently claims an implant architecture that couples a solid-walled through cannula and solid head and tip with an exposed open network ingrowth portion, where solid external threads are integral with the open network portion yet leave gaps exposing the open network body.

Stated Advantages

Improved resistance to rotational motion.

Improved resistance to migration.

Improved resistance to pull-out.

Circumferential tissue infiltration and bony integration enabled by exposure of the open network body in gaps between threads.

Documented Applications

Fixation implant for bone/joint fusion including sacroiliac joint fusion.

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