In-situ curing biodegradable anchor with reinforcement

Inventors

Khowaylo, Alex • McCarthy, Michael P. • Tran, Minh-Tuan Richard • Ferreira, Rui J.

Assignees

Acuitive Technologies Inc

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Publication Number

US-11684467-B2

Patent

Publication Date

2023-06-27

Expiration Date


Abstract

The present invention provides an anchor system for musculoskeletal applications, e.g., for anchoring tendons or ligaments to bone or anchoring two or more bone sections. The anchor system comprises a substantially solid pre-manufactured distal portion (i.e., anchor component) and a settable, biodegradable composite. The biodegradable composite is flowable at the time of delivery and is introduced into the fixation site before or after the anchor component. Both the anchor component and the biodegradable composite may be manufactured from citrate-based polymers.

Core Innovation

The disclosure describes an intracorporeal anchor system and method for anchoring a device relative to bone. A bone cavity is created and a flowable non-thermoplastic composite is introduced into the bone cavity. An anchor component is then pressed into the bone cavity such that the anchor component forces the composite into interstices of the bone and the composite sets in situ.

The composite is described as a citrate-based, biodegradable, flowable settable material that is non-thermoplastic and configured to harden after introduction and compression into bone. The disclosed citrate-based polymer options include poly(1,8-octanediol-citrate) (POC), methacrylated POC (mPOC), a crosslinked urethane-doped polyester (CUPE), biodegradable photoluminescent polymer (BPLP), dual-crosslinkable poly(alkylene maleate citrate) (PAMC), and a clickable POC-based elastomer (POC-Click).

Crosslinking and hardening in situ are described using citrate-based chemistry and polymer network formation under initiation stimuli, including polycondensation and free-radical polymerization pathways, and ionic crosslinking via double-bond monomers reacting with citric acid carboxyl/hydroxyl groups. The anchor component is described as a substantially solid distal anchor component that can include alignment features and protrusions such as barbs, knurls, or threads, with optional cannulation and cross holes to interact with the composite and/or device elements.

Claims Coverage

The independent claim clm-00001 covers a method of intracorporeally anchoring a device relative to bone using a flowable non-thermoplastic citrate-based composite that is forced by a pressed anchor component into bone interstices and sets in situ. The claim is characterized by three inventive parts: creating the bone cavity, introducing the specified citrate-based composite, and pressing the anchor component so that in situ setting occurs.

Bone cavity creating

Creating a bone cavity as part of an intracorporeal anchoring method relative to bone.

Flowable non-thermoplastic citrate-based composite introduction

Introducing a flowable non-thermoplastic composite into the bone cavity, the non-thermoplastic composite comprising a citrate-based polymer selected from poly(1,8-octanediol-citrate) (POC), methacrylated POC (mPOC), a crosslinked urethane-doped polyester (CUPE), biodegradable photoluminescent polymer (BPLP), dual-crosslinkable poly(alkylene maleate citrate) (PAMC) and a clickable POC-based elastomer (POC-Click).

Pressing anchor component to force composite into interstices for in situ setting

Pressing an anchor component into the bone cavity, wherein the anchor component comprises a citrate-based polymer selected from poly(1,8-octanediol-citrate) (POC), methacrylated POC (mPOC), a crosslinked urethane-doped polyester (CUPE), biodegradable photoluminescent polymer (BPLP), dual-crosslinkable poly(alkylene maleate citrate) (PAMC) and a clickable POC-based elastomer (POC-Click), and wherein the anchor component forces the non-thermoplastic composite into interstices of the bone wherein the non-thermoplastic composite sets in situ.

Across the provided independent claim, the core coverage is the intracorporeal method combining a bone cavity, a flowable non-thermoplastic citrate-based composite selected from specified citrate-based polymer families, and pressing a citrate-based anchor component so the composite is forced into bone interstices and sets in situ.

Stated Advantages

Documented Applications

Tendon/ligament anchoring.

Multi-bone fixation.

Sternotomy closure.

Plate fixation as pop rivet.

Compression buttons.

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