Resorptive intramedullary implant between two bones or two bone fragments

Patent No. US8414583 (titled "Resorptive intramedullary implant between two bones or two bone fragments") on Sep 2, 2009. The application was issued on Apr 9, 2013.

What is this patent about?

’583 is related to the field of orthopedic implants, specifically intramedullary devices used for arthrodesis or osteosynthesis in small bones, such as those in the hand or foot. The invention addresses the challenge of providing stable fixation between two bone fragments using a resorbable material that eventually dissolves in the body. Traditional metal implants often require permanent placement or secondary removal, but resorbable polymers like PLA or PGA present unique mechanical challenges in maintaining primary stability and resisting shear forces during the healing process.

The underlying idea behind ’583 is the use of a hybrid anchoring geometry that combines two distinct mechanical fixation methods into a single-piece body to maximize stability in soft or healing bone. By utilizing a threaded cylindrical end on one side and a split flat bar with elastic legs on the other, the implant leverages both rotational threading and compressive expansion. This dual-action design ensures that one bone segment is rigidly engaged via a screw mechanism while the other is secured through the outward tension of deformable arms, providing a robust bridge that resists both pull-out and rotation.

The claims of ’583 focus on a one-piece elongated body featuring a threaded cylindrical anchor at the first end and a flat-cross-section anchor at the second end. The flat anchor is specifically characterized by a plurality of outwardly projecting teeth arranged in opposing pairs along its longitudinal axis to grip the internal bone structure. Furthermore, the independent claims specify a central transition zone or step that acts as a physical abutment, defining a perpendicular plane that prevents the threaded end from being over-inserted into the first bone fragment.

In practice, the implant is installed by first drilling and tapping a hole in the proximal bone to receive the threaded cylindrical section. The surgeon screws the implant in until the central abutment step sits flush against the bone face, ensuring precise depth control. The second bone fragment is then pressed onto the flat distal end. The opening in the flat section allows the two anchor arms to compress during insertion and then elastically expand, driving the teeth into the cancellous bone to create a secure, high-friction fit.

This design differentiates itself from prior art by optimizing the geometry for resorbable polymers, which lack the sheer stiffness of stainless steel or titanium. While previous implants used uniform shapes at both ends, the ’583 hybrid approach accounts for the morphology of the implantation site by allowing the two anchor zones to be angularly offset by up to 30 degrees. This bend, typically set at 10 degrees for foot arthrodesis, aligns the implant with the natural anatomical curvature of the joint while the central transition zone absorbs the shear and flexion forces that would otherwise cause a resorbable device to fail.

How does this patent fit in bigger picture?

Technical Landscape

In the late 2000s when ’583 was filed, intramedullary fixation for small bone arthrodesis was typically implemented using metallic staples, wires, or screws that relied on rigid mechanical fixation or shape-memory effects. At a time when systems commonly relied on non-resorbable materials to maintain structural integrity throughout the healing process, the use of bioresorbable polymers was constrained by the inherent mechanical limitations of these materials, such as lower shear strength and reduced rigidity compared to titanium or stainless steel. Consequently, achieving both primary stability and long-term compression using degradable materials was non-trivial, as standard hardware geometries often failed to account for the specific elastic and load-bearing profiles required to prevent implant failure before bone consolidation was complete.

Prosecution Position

The disclosed invention represents a technical advancement through an asymmetrical architectural shift that optimizes fixation for bioresorbable materials. By integrating a tapered, threaded cylindrical anchor at one end with a flat, bifurcated elastic anchor at the opposite end, the implant overcomes the structural constraints of lactic acid polymers. This hybrid geometry enables a dual-mode fixation strategy: the threaded section provides high-torque mechanical engagement in one bone segment, while the opening in the flat section allows for elastic expansion and adaptation to the medullary canal of the second bone segment. This configuration achieves a technical effect of enhanced rotational stability and resistance to shear and flexion forces at the arthrodesis site, ensuring the implant maintains its structural role during the specific six-month window required for biological resorption and bone fusion.

Claims

This patent contains a total of 18 claims, with claims 1, 12, and 16 serving as the independent claims. These independent claims focus on the structural design of a one-piece intramedullary implant featuring a cylindrical threaded anchor at one end and a flat, toothed, or split-bar anchor at the opposite end, often incorporating a perpendicular step to act as an insertion abutment. The dependent claims serve to further specify material compositions such as resorptive substances, geometric variations including angular offsets and tapered profiles, and mechanical features like elastic deformation capabilities or specific arm configurations for the anchor zones.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Flat cross-section
(Claim 1, Claim 16)
According to the invention, one of the zones has a cylindrical shape, whereas the other zone is flat. To solve the given problem of enabling a deformation by elasticity, thus causing an expansion adapted to the geometry of the site and to the properties of the material, the flat cross-section zone has, substantially in its median portion, an opening adapted to enable elastic deformation of the zone. The opening defines at least two anchor arms.A non-cylindrical, planar geometry for an anchor zone that is wider than it is thick, designed to provide stability and resist rotation within a bone fragment.
Outwardly projecting teeth
(Claim 1, Claim 16)
The anchor zones are shaped and made of a material selected to enable insertion into the bone parts, then to ensure an anchor in the bone parts by preventing any rotational movement by resisting traction and by maintaining a compression force. The anchor zones are either coaxial or angularly offset by between about 1° and 30° and, advantageously, by 10°. [The teeth form] a portion of the flat cross-section thereof.Sharp protrusions extending from the edges of the flat anchor zone, arranged in opposing pairs and spaced longitudinally to grip the internal bone structure.
Split flat metal bar
(Claim 12)
This document describes an implant in the form of two anchor zones connected by a central zone and whose general shape is substantially inscribed in a very elongated rectangle of X-shape, so as to form in the anchor zones two legs adapted to move apart by elastic or shape-memory effect. The opening defines at least two anchor arms.A planar anchoring component divided into multiple flexible segments or legs capable of elastic expansion.
Spreadable and elastically deformable legs
(Claim 12)
To solve the given problem of enabling a deformation by elasticity, thus causing an expansion adapted to the geometry of the site and to the properties of the material, the flat cross-section zone has, substantially in its median portion, an opening adapted to enable elastic deformation of the zone. The opening defines at least two anchor arms.Flexible structural members at one end of the implant that can bend or expand outward to engage the medullary canal of a bone.
Step having a flat face
(Claim 12, Claim 16)
To solve the given problem of resisting the shear and flexion forces susceptible of occurring in the area of the bone site, between the two anchor zones, the body has a central zone of transition adapted to resist the shear and flexion forces occurring in the area of the bone site and adapted to serve as an abutment. [The] step having a flat face defining a plane perpendicular to the longitudinal axis and forming an abutment between the opposing ends, the abutment adapted to prevent overinsertion.A physical transition or shoulder between the cylindrical and flat zones that acts as a mechanical stop to limit insertion depth.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-00637May 22, 2025Stryker European Operations Holdings Llc V. Treace Medical Concepts, Inc.

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US8414583

Application Number
US12918105A
Filing Date
Sep 2, 2009
Publication Date
Apr 9, 2013
External Links
Slate, USPTO , Google Patents