Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants

Inventors

D'Agostino, Jeffrey A.Carter, Andrew J.Watterson, ArthurLane, Joseph P.

Assignees

206 Ortho Inc

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Publication Number

US-10028776-B2

Patent

Publication Date

2018-07-24

Expiration Date


Abstract

A composite implant comprising an injectable matrix material which is flowable and settable, and at least one reinforcing element for integration with the injectable matrix material, the at least one reinforcing element adding sufficient strength to the injectable matrix material such that when the composite implant is disposed in a cavity in a bone, the composite implant supports the bone.A method for treating a bone, the method comprising: selecting at least one reinforcing element to be combined with an injectable matrix material so as to together form a composite implant capable of supporting the bone;positioning the at least one reinforcing element in a cavity in the bone;flowing the injectable matrix material into the cavity in the bone so that the injectable matrix material interfaces with the at least one reinforcing element; andtransforming the injectable matrix material from a flowable state to a non-flowable state so as to establish a static structure for the composite implant, such that the composite implant supports the adjacent bone.

Core Innovation

The invention relates to a biodegradable composite implant formed in situ for treating a bone fracture, fortifying bone, and/or augmenting bone. The approach selects at least one reinforcing element and combines it with an injectable matrix material and a containment bag to create a biodegradable composite implant capable of supporting adjacent bone.

The entire containment bag is positioned in a cavity in the bone and the reinforcing element is positioned in the containment bag. The injectable matrix material is flowed into the containment bag so that it interfaces with the reinforcing element and the containment bag to form the biodegradable composite implant.

The injectable matrix material is configured to transform after delivery from a flowable state to a non-flowable state so as to establish a static structure. The composite implant includes reinforcing elements such as flexible reinforcing sheets, concentric reinforcing tubes, rolled sheets, reinforcing rods, and/or particulates delivered sequentially, and the resulting structure is described as tunable by tailoring implant dimensions and properties, including stiffness/strength gradients and reinforcing volume ranges.

Claims Coverage

The document provides one independent claim that covers a method for treating a bone fracture, fortifying bone, and/or augmenting bone. The claim is organized around three core inventive features, with dependent claims refining reinforcing volume constraints and containment/degradation features.

Biodegradable composite implant formed by flowable injectable matrix and containment bag

Selecting at least one reinforcing element to be combined with an injectable matrix material and with a containment bag so as to together form a biodegradable composite implant capable of supporting the bone, wherein the injectable matrix material is configured to thereafter transform from a flowable state to a non-flowable state so as to establish a static structure for the biodegradable composite implant.

Placement of containment bag and reinforcing element in a bone cavity

Positioning the entire containment bag in a cavity in the bone, and positioning the at least one reinforcing element in the containment bag.

In-bag interface formation by flowing injectable matrix into the containment bag

Flowing the injectable matrix material into the containment bag so that the injectable matrix material interfaces with the at least one reinforcing element and with the containment bag so as to form the biodegradable composite implant.

Overall claim coverage focuses on forming a biodegradable composite implant in situ by positioning a containment bag in a bone cavity, placing reinforcing elements in the bag, flowing a flowable injectable matrix to interface with both reinforcing elements and the bag, and using post-delivery transformation of the injectable matrix to establish a static structure supporting adjacent bone.

Stated Advantages

Supports adjacent bone by establishing a static load-supporting structure after the injectable matrix transforms to a non-flowable state.

Documented Applications

Treating a bone fracture.

Fortifying bone.

Augmenting bone.

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