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-10010609-B2
Publication Date
2018-07-03
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 comprising: selecting at least one reinforcing element to be combined with an injectable matrix material to 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 wherein the injectable matrix material interfaces with the at least one reinforcing element; and transforming the injectable matrix material from a flowable state to a nonflowable state to establish a static structure that supports the adjacent bone.
Core Innovation
A composite implant is provided comprising an injectable matrix material that is flowable and settable, and at least one reinforcing element integrated with the injectable matrix material. The injectable matrix material comprises a resin, and the at least one reinforcing element adds sufficient strength such that when the composite implant is disposed in a cavity in a bone, the composite implant supports the bone as an internal splint.
The invention uses injectable resin systems and reinforcing elements together so that a flowable-and-settable matrix is formed into a tough, non-brittle internal splint. Reinforcing elements take forms such as flexible reinforcing sheets, concentric reinforcing tubes, flexible reinforcing rods, and particulates, optionally configured with containment bag/permeation barrier materials.
The composite implant further enables tailoring of resin and reinforcement to meet performance relationships, including compressive modulus ratio and flexural modulus ratio between cured resin and reinforcing element. The document also describes resin chemistry and interfacial adhesion features, including acrylic resin formulations, polyurethane with terminal isocyanate functionality, polyurethane containing residual isocyanate groups, and surface coatings such as sizer/primer and amino-functional materials to support adhesion and molecular weight increase.
Claims Coverage
The independent claims identified are clm-00001, clm-00009, clm-00014, clm-00019, clm-00024, clm-00029, clm-00039, clm-00045, clm-00049, and clm-00053. Across these independent claims, the inventive features include an injectable flowable-and-settable resin matrix integrated with reinforcing elements to support a bone cavity, with multiple independent claims further specifying resin chemistries, adhesion and secondary catalyst coatings, modulus and strength relationships, reinforcement architecture, and storage and curing behavior for polyurethane with residual isocyanate groups.
Injectable flowable-and-settable acrylic matrix with integrated reinforcing element for bone support
The injectable matrix material is flowable and settable, comprises an acrylic resin, and is combined with at least one reinforcing element integrated with the injectable matrix material so that when disposed in a cavity in a bone, the composite implant supports the bone.
Terminal isocyanate polyurethane injectable matrix with integrated reinforcing element and specified viscosity behavior
The injectable matrix material is flowable and settable and comprises a polyurethane having terminal isocyanate functionality, integrated with at least one reinforcing element so that when disposed in a cavity in a bone, the composite implant supports the bone, with specified viscosity at application temperature and at 20-25 degrees C.
Terminal isocyanate resin applied to coated reinforcing element with adhesion and secondary catalyst capability
The injectable matrix material is flowable and settable and comprises a resin having terminal isocyanate functionality, combined with at least one reinforcing element so that when disposed in a cavity in a bone, the composite implant supports the bone, where the reinforcing element is surface coated with a size or prime that provides additional adhesion and can optionally act as a secondary catalyst for further molecular weight increase of the resin and adhesion to the reinforcing element.
Modulus ratio-based reinforcement strength relationship
The injectable matrix material is flowable and settable and comprises a resin integrated with at least one reinforcing element so that when disposed in a cavity in a bone, the composite implant supports the bone, where the compressive modulus ratio between the cured resin and the reinforcing element and the flexural modulus ratio between the cured resin and the reinforcing element are each defined.
Continuous resin application with defined viscosity and reinforcing element fiber volume fraction
The injectable matrix material is flowable and settable and comprises a resin integrated with at least one reinforcing element so that when disposed in a cavity in a bone, the composite implant supports the bone, where the resin is applied to the at least one reinforcing element in a continuous process with defined resin viscosity at application temperature and fiber content of the at least one reinforcing element.
Very high modulus fiber retained by low modulus thermoplastic pre-melted retaining structure
The injectable matrix material is flowable and settable and comprises a resin integrated with at least one reinforcing element so that when disposed in a cavity in a bone, the composite implant supports the bone, where the reinforcing element comprises a very high modulus fiber and a low modulus thermoplastic fiber, wherein the thermoplastic fiber is pre-melted so as to provide a retaining structure for the very high modulus fiber.
Polyurethane terminal isocyanate injectable matrix with specified application viscosity window
The injectable matrix material is flowable and settable and comprises a polyurethane with terminal isocyanate functionality, integrated with at least one reinforcing element so that when disposed in a cavity in a bone, the composite implant supports the bone, with specified viscosity at the temperature when applied to the reinforcing element and at 20-25 degrees C.
Surface coating as a secondary catalyst for resin molecular weight increase and adhesion facilitation
The injectable matrix material is flowable and settable and comprises a resin integrated with at least one reinforcing element so that when disposed in a cavity in a bone, the composite implant supports the bone, where the reinforcing element is surface coated so as to provide additional adhesion between the resin and the reinforcing element, and the surface coating acts as a secondary catalyst for further molecular weight increase of the resin and can facilitate adhesion to the reinforcing element.
Amino functional surface coating for additional adhesion between resin and reinforcing element
The injectable matrix material is flowable and settable and comprises a resin integrated with at least one reinforcing element so that when disposed in a cavity in a bone, the composite implant supports the bone, where the reinforcing element is surface coated with an amino functional material selected from amino silanes, lysine, polyamines, amino acids, and polyamino acids.
Polyurethane with residual isocyanate groups allowing dry storage and further in-body curing
The injectable matrix material is flowable and settable and comprises a polyurethane resin integrated with at least one reinforcing element so that when disposed in a cavity in a bone, the composite implant supports the bone, where the composite implant contains residual isocyanate groups such that it can be stored in a dry inert atmosphere without further crosslinking reactions and then further cure in the body where moisture is present.
Across the independent claims, the core claim structure is an injectable flowable-and-settable resin matrix integrated with at least one reinforcing element to support bone when disposed in a bone cavity, with independent claim scope further defined by resin chemistry, defined viscosity and application conditions, modulus ratio relationships, reinforcement architecture and retention mechanisms, and surface coatings including sizer/primer and amino-functional materials that enhance adhesion and, in some claims, act as a secondary catalyst for further molecular weight increase.
Stated Advantages
Supports the bone when disposed in a cavity in a bone.
Provides additional adhesion between the resin and the reinforcing element.
Surface coatings can act as a secondary catalyst for further molecular weight increase of the resin and can facilitate adhesion.
Residual isocyanate groups allow storage in a dry inert atmosphere without further crosslinking reactions and then further cure in the body where moisture is present.
Documented Applications
Bone fracture treatment/augmentation by disposing the composite implant in a cavity in a bone as an internal splint.
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