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, Arthur • Lane, Joseph P.
Assignees
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Publication Number
US-9320601-B2
Publication Date
2016-04-26
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.
Core Innovation
The disclosure provides a biodegradable composite implant for treating a bone fracture, and/or fortifying bone and/or augmenting bone. The implant is formed from an injectable matrix material that is delivered into a cavity in bone and thereafter transforms from a flowable state to a non-flowable state to establish a static structure that supports the adjacent bone.
The matrix material is combined with at least one reinforcing element and with a containment bag so that the composite implant has sufficient strength when implanted in a bone cavity, including the intramedullary canal. The reinforcing element is flexible and provides a mechanical reinforcement function within the biodegradable composite implant.
The composite implant architecture includes a stiffer central region and less stiff distal and proximal ends. Flexible textile-based reinforcing sheets and/or flexible filament-based reinforcing rods with sheaths and/or binders, and/or particulates, can be used as reinforcing elements to tailor stiffness and strength while reducing stress risers associated with stiffness transitions.
The containment bag uses a resorbable polymer, including polyurethane, polylactic acid, polyglycolic acid, and mixtures or copolymers thereof. The containment bag protects and constrains components, controls fluid ingress/degradation, and enhances bonding by allowing the injectable matrix material to interface with both the reinforcing element and the containment bag.
Claims Coverage
Independent claim clm-00001 describes a method for treating a bone fracture and/or fortifying and/or augmenting bone using a biodegradable composite implant. The claim includes three inventive features: flexible reinforcement combined with an injectable transformable matrix inside a resorbable containment bag, a stiffness profile with a stiffer central region and less stiff proximal/distal ends, and containment bag control of degradation via modulating fluid ingress.
Biodegradable composite implant from a transformable injectable matrix in a resorbable containment bag
At least one reinforcing element is combined with an injectable matrix material and with a containment bag to form a biodegradable composite implant. The containment bag is positioned in a cavity in the bone, the reinforcing element is positioned in the containment bag, and the injectable matrix material flows into the containment bag and transforms from a flowable state to a non-flowable state to establish a static structure that supports adjacent bone.
Flexible reinforcing element with a stiffness profile having a stiffer central region and less stiff proximal and distal ends
The composite implant has a stiffer central region and less stiff distal and proximal ends, and the at least one reinforcing element is flexible.
Resorbable polymer containment bag and degradation control by modulating fluid ingress
The containment bag comprises a resorbable polymer selected from polyurethane, polylactic acid, polyglycolic acid, and mixtures or copolymers thereof, and controls degradation of the composite implant by modulating the ingress of fluid into the containment bag.
The claim coverage centers on forming a biodegradable composite implant in-situ by flowing a matrix that transforms from flowable to non-flowable around at least one flexible reinforcing element inside a resorbable containment bag. The composite is defined by a stiffer central region with less stiff proximal and distal ends, and by containment-bag-driven degradation control through modulating fluid ingress.
Stated Advantages
Supports adjacent bone by establishing a static structure from an injectable matrix that transforms from a flowable state to a non-flowable state.
Provides sufficient strength when implanted in a bone cavity.
Controls composite implant degradation by modulating ingress of fluid into the containment bag.
Enhances bonding by allowing matrix material to interface with the reinforcing element and the containment bag.
Documented Applications
Treating a bone fracture.
Fortifying bone.
Augmenting bone.
Implantation in a bone cavity, including the intramedullary canal.
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