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Publication Number
US-12349946-B2
Publication Date
2025-07-08
Expiration Date
Abstract
Internal bone fixation devices and methods for using the devices for repairing a weakened or fractured bone are disclosed herein. A device for use in repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of at least one reinforcing material and an inner lumen for passage of a light source; a conformable member releasably engaging the distal end of the delivery catheter, wherein the conformable member moves from a deflated state to an inflated state when the at least one reinforcing material is delivered to the conformable member; and an adapter releasably engaging the proximal end of the delivery catheter for receiving the light source and the at least one reinforcing material.
Core Innovation
The invention provides an internal bone fixation device for repairing a weakened or fractured bone using a conformable member configured for placement in a bone. The device includes a delivery catheter configured to deliver a curable material to the conformable member, such that an amount of inflation of the conformable member can be adjusted by altering an amount of the curable material in the conformable member. The conformable member includes one or more radiopaque inks on an outer surface configured to provide visibility of the conformable member using fluoroscopy during inflation and adjustment to determine positioning during placement and adjustment in the bone cavity.
After the conformable member is adjusted, an optical fiber configured to deliver light into the conformable member is used to cure the curable material after adjustment. The device further applies a water soluble glue to an outer surface of the conformable member, the water soluble glue being configured to act as a gripping member to grip the bone and increase a conformal bond between the conformable member and the bone. In some configurations, the conformable member is releasably engaging a distal end of the delivery catheter and the delivery catheter has an inner lumen engaging the conformable member to minimize thermal egress of light energy from the optical fiber to surrounding tissue.
The invention also includes an adjustable relationship between inflation and the amount of curable material delivered, including configurations where the curable material has a viscosity of 1000 cP or less. Further refinements include delivering the conformable member into a cavity of a bone and configuring a kit for repairing a weakened or fractured bone that includes the conformable member, the curable material, the delivery catheter, the optical fiber, and the water soluble glue with the radiopaque inks configured for fluoroscopic visibility to determine positioning within the cavity.
Claims Coverage
The claims cover six core inventive features: adjustable inflation by altering curable material, fluoroscopic visibility using radiopaque inks, optical-fiber curing after adjustment, water soluble glue for gripping and conformal bonding, reduced thermal egress through catheter engagement, and delivery into a bone cavity, with an additional stated viscosity limit for the curable material.
Adjustable inflation by altering curable material in the conformable member
A delivery catheter delivers a curable material to a conformable member configured for placement in a bone so that an amount of inflation of the conformable member can be adjusted by altering an amount of the curable material in the conformable member.
Fluoroscopic visibility using radiopaque inks during inflation and adjustment
One or more radiopaque inks on an outer surface of the conformable member are configured to provide visibility of the conformable member using fluoroscopy during inflation and adjustment to determine positioning during placement and adjustment.
Optical fiber curing after adjustment
An optical fiber is configured to deliver light into the conformable member to cure the curable material after adjustment.
Water soluble glue as a gripping member
A water soluble glue applied to an outer surface of the conformable member acts as a gripping member to grip the bone and increase a conformal bond between the conformable member and the bone.
Minimizing thermal egress by catheter and conformable member engagement
The conformable member is releasably engaged to a distal end of the delivery catheter and the inner lumen of the delivery catheter engages the conformable member to minimize thermal egress of light energy from the optical fiber to surrounding tissue.
Delivery into a cavity of a bone
A delivery catheter is configured to deliver the conformable member into a cavity of a bone.
Inflation adjustability with low-viscosity curable material
The curable material has a viscosity of 1000 cP or less in configurations where the amount of inflation is adjusted by altering the amount of curable material delivered.
Kit for repairing a weakened or fractured bone
A kit includes a conformable member, a curable material, a delivery catheter, an optical fiber, and a water soluble glue, with one or more radiopaque inks configured for fluoroscopy to determine positioning.
The claims collectively center on an inflatable conformable member whose inflation is adjustable by altering delivered curable material, fluoroscopic positioning support via radiopaque inks, and optical-fiber curing after adjustment, with water soluble glue providing grip and increased conformal bonding. The claims further include catheter/conformable engagement to minimize thermal egress, delivery into a bone cavity, a curable material viscosity limit, and a kit configuration for bone repair.
Stated Advantages
Provide visibility of the conformable member using fluoroscopy during inflation and adjustment to determine positioning.
Cure the curable material after adjustment of the conformable member using an optical fiber.
Grip the bone and increase a conformal bond between the conformable member and the bone.
Minimize thermal egress of light energy from the optical fiber to surrounding tissue.
Allow inflation amount to be adjusted by altering an amount of the curable material in the conformable member.
Documented Applications
Repairing a weakened or fractured bone using a kit including the conformable member, delivery catheter, curable material, optical fiber, and water soluble glue with radiopaque inks for fluoroscopic visibility.
Delivery of the conformable member into a cavity of a bone.
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