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. • Whitehouse, Robert S. • Carter, Andrew J. • Watterson, Arthur • Lane, Joseph P. • McRury, Ian D. • Marchetti, Samantha • Seil, Nikole
Assignees
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Publication Number
US-11351261-B2
Publication Date
2022-06-07
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; and transforming 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 disclosed invention relates to a composite implant located in an opening of a bone. The implant comprises a degradable matrix material including a degradable polymer and more than one degradable reinforcing element disposed within the matrix. The reinforcing elements add sufficient strength to enable the composite implant to support and stabilize the bone when implanted, while the composite implant degrades over time.
The reinforcing elements include flexible rods that include fibers having a twist configuration formed of degradable filaments and a degradable material that binds the degradable filaments together in fixed relation to one another. The reinforcing elements are held together by a wound connecting structure, and the composite implant is formed as an elongated structure for placement in the bone opening.
The document further provides bone-locating implant articles in the form of pins or screws that include axial reinforcement elements disposed in a degradable matrix material. The pin or screw includes a wound connecting structure and one or more layers of an outer region around the wound connecting structure, where the axial reinforcement elements comprise a flexible rod with axially oriented fibers.
In these articles, the fibers include filaments formed of a degradable glass bound together by degradable material, and the matrix includes a thermoplastic polymer, with a porous surface and defined mechanical and volumetric constraints on the axial reinforcement.
Claims Coverage
The partial content includes three independent claims, each directed to a degradable bone-locating implant article that uses a degradable matrix and degradable reinforcing elements held by a wound connecting structure, with defined reinforcement geometry and, in the pin or screw claims, defined mechanical and volumetric constraints.
Degradable matrix with degradable reinforcing elements in elongated composite implant
A composite implant for locating in an opening of a bone comprising a degradable matrix material including a degradable polymer; and more than one reinforcing element disposed within the degradable matrix material, where at least one reinforcing element is degradable and adds sufficient strength so the composite implant supports and stabilizes the bone when implanted and degrades over time; where the reinforcing elements comprise a flexible rod including fibers having a twist configuration formed of degradable filaments and a degradable material which binds the degradable filaments together in fixed relation to one another; where the reinforcing elements are held together by a wound connecting structure; and where the composite implant is in the form of an elongated structure.
Axially reinforced degradable pin or screw with degradable glass filaments
An article for locating in an opening of a bone, the article being a pin or screw, and comprising a plurality of axial reinforcement elements disposed in a degradable matrix material; a wound connecting structure holding the axial reinforcement elements together; and one or more layers of an outer region around the wound connecting structure; where the screw or pin has an axial direction along its length; where the axial reinforcement elements comprise a flexible rod including fibers oriented in the axial direction extending from a first end region of the pin or screw to an opposing end region; where the fibers include filaments formed of a degradable glass bound together by degradable material; where the degradable matrix material includes a thermoplastic polymer; where the pin or screw has a porous surface; and where the axial reinforcement element has a modulus of 6 GPa to 90 GPa and is included in an amount of 10 volume percent to 75 volume percent of the pin or screw.
Axially reinforced degradable pin with braided sheath and bias reinforcement
A pin for locating in an opening of a bone comprising one or more axial reinforcement elements disposed in a degradable matrix material; a braided sheath around the one or more axial reinforcement elements; and one or more layers of an outer region around the braided sheath; where the pin has an axial direction along its length; where the axial reinforcement elements comprise a flexible rod including fibers oriented in the axial direction extending from a first end region of the pin to an opposing end region; where the fibers include filaments formed of a degradable glass bound together by degradable material; where the degradable matrix material includes a thermoplastic polymer; where the sheath includes bias reinforcement elements with fibers formed of a degradable glass; and where the axial reinforcement element has a modulus of 6 GPa to 90 GPa and is included in an amount of 10 volume percent to 75 volume percent of the pin.
Across the independent claims, the coverage centers on degradable bone-locating implants that combine a degradable polymer matrix with degradable reinforcing elements, where flexible axial or twisted fiber-rod reinforcement is held together by a wound connecting structure and, for the pin claim, additionally a braided sheath, including degradable-glass filaments and defined modulus and volume fraction constraints for the axial reinforcement.
Stated Advantages
Supports and stabilizes the bone when implanted.
Degrades over time.
Adds sufficient strength to the matrix material while remaining within a degradable implant structure.
Documented Applications
Locating a composite implant in an opening of a bone.
Locating a bone-opening implant article in the form of a pin or screw.
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