Bone positioning guide

Patent No. US11116558 (titled "Bone positioning guide") on Aug 19, 2020. The application was issued on Sep 14, 2021.

What is this patent about?

’558 is related to the field of orthopedic surgery and bone realignment, specifically focusing on instruments and techniques for correcting anatomical misalignments in the foot. The background context involves the complexity of manually realigning bones, such as the first metatarsal during a bunion correction or Lapidus procedure, where maintaining precise positioning across multiple planes while fixating the joint is traditionally difficult and prone to inconsistent results.

The underlying idea behind ’558 is to provide a mechanical advantage for multi-planar bone realignment through a specialized guide that applies controlled compression between two different bones. By anchoring one side of the device to a stable anatomical reference—such as the second or third metatarsal—and the other to the misaligned bone, the tool allows a surgeon to precisely reduce the intermetatarsal angle. The inventive insight lies in using a movable shaft and bone engagement member to not only translate the bone but also facilitate rotation, ensuring the deformity is corrected in the transverse, sagittal, and frontal planes simultaneously.

The claims of ’558 focus on a method for correcting a bunion deformity using a bone positioning guide that utilizes a fixation wire to secure the device to the bone being moved. Specifically, the independent claim describes a process where a bone engagement member is placed against the medial side of the first metatarsal, and a wire is driven through a cannulation in that member directly into the bone. This creates a stable mechanical link that allows the mechanism to move the first metatarsal in at least the transverse plane to close the intermetatarsal angle when the engagement member and the tip are urged toward one another.

In practice, the invention works by creating a temporary bridge across the metatarsals. The surgeon positions the tip of the main body against the lateral side of a stable metatarsal and the engagement member against the first metatarsal. By actuating a knob or handle, the threaded shaft advances, pushing the first metatarsal toward the stable reference. Because the engagement member is rotatably coupled to the shaft and pinned to the bone via the K-wire, the device can hold the bone in a corrected, supinated position, allowing the surgeon to perform bone preparation and permanent fixation without the bone slipping back into its deformed state.

This approach differs from prior solutions by moving away from purely manual manipulation or simple two-dimensional clamping. The integration of a cannulated engagement member ensures that the force applied by the guide is directly coupled to the bone's orientation, preventing the tool from sliding along the bone surface during compression. Furthermore, by providing a stable, hands-free hold of the realigned anatomy, the system allows for more accurate bone cuts and better compression across the fusion site, addressing the three-dimensional nature of the deformity rather than just the visible lateral deviation.

How does this patent fit in bigger picture?

Technical Landscape

In the mid-2010s when ’558 was filed, orthopedic surgical procedures for bone realignment were typically implemented using manual manipulation and handheld instrumentation to achieve anatomical correction. At a time when surgeons commonly relied on freehand positioning and temporary manual fixation rather than integrated mechanical alignment systems, the process of maintaining multi-planar stability during the transition from correction to permanent fixation was often inconsistent. Hardware constraints in small-bone surgery, such as those involving the metatarsals, made the simultaneous control of bone rotation and translation non-trivial, as existing clamps and distractors were often designed for simple compression or distraction rather than complex spatial realignment.

Prosecution Position

The disclosed invention represents a meaningful technical advancement through the integration of a specialized bone positioning guide that enables precise, controlled realignment of bones across multiple planes. By utilizing a main body with a wrap-around architecture that defines a specific bone realignment space between a movable bone engagement member and a fixed tip, the system shifts from manual manipulation to a mechanical screw-driven interface. This structural solution allows for the application of force that can correct bone position in the frontal, transverse, and sagittal planes simultaneously. The technical effect achieved is the ability to maintain a stable, corrected anatomical position under mechanical tension, which overcomes the constraint of manual instability and allows for more accurate fixation of bones or joints during complex reconstructive procedures.

Claims

This patent contains 30 claims, with claim 1 serving as the sole independent claim. The independent claim focuses on a surgical method for correcting a bunion deformity using a bone positioning guide that employs a cannulated engagement member and a movable tip to reduce the intermetatarsal angle between the first and second metatarsals. The dependent claims further define the procedure by specifying bone preparation techniques such as fenestration and joint cutting, detailing various provisional and permanent fixation methods, describing specific mechanical components and radiolucent materials of the positioning guide, and outlining precise anatomical placements and multi-planar movements during the corrective process.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Bone engagement member
(Claim 1)
The shaft can carry a bone engagement member on a distal end of the shaft configured to engage with a bone. In one example, the bone engagement member is rotatably coupled to the shaft and has a surface configured to engage a bone. The clinician may translate the shaft relative to the main body until the bone engagement member contacts a medial side of a first metatarsal.A component of the positioning guide, often carried on a shaft, featuring a surface and a cannulation designed to contact a bone and allow a fixation wire to pass through it.
Bone positioning guide
(Claim 1)
Embodiments of the invention include a bone positioning guide and method of positioning bones in a medical procedure. In an exemplary application, embodiments of the bone positioning guide can be useful during a surgical procedure, such as a bone alignment, osteotomy, fusion procedure, and/or other procedures where one or more bones are to be prepared. The bone positioning guide may hold the first metatarsal in the realigned position while a clinician fixates the position.A surgical instrument comprising a main body, a bone engagement member, and a tip, designed to hold and manipulate the position of bones (such as metatarsals) during alignment, osteotomy, or fusion procedures.
Cannulation
(Claim 1)
The bone engagement member comprises a cannulation. A fixation wire extends through the cannulation of the bone engagement member and into the first metatarsal. This allows the clinician to use pins, screws, plates, wire and/or other desired fixation instruments to secure the bone while the guide holds it in position.A hollow channel or passage through the bone engagement member configured to receive and guide a fixation wire into the bone.
Fixation wire
(Claim 1)
The clinician may use pins, screws, plates, wire and/or other desired fixation instruments to secure the first metatarsal to a medial cuneiform in the realigned position. A fixation wire extends through the cannulation of the bone engagement member and into the first metatarsal. The guide holds the first metatarsal in the realigned position while these instruments are used.A surgical pin or wire (such as a K-wire) inserted through the guide and into the bone to stabilize the bone's position or facilitate fixation.
Intermetatarsal angle
(Claim 1)
A procedure utilizing an embodiment of the bone positioning guide can be performed to correct an alignment between a metatarsal (e.g., a first metatarsal) and a second metatarsal. As the bone engagement member is advanced toward the tip, the position of the first metatarsal may be realigned and corrected with respect to the second metatarsal. This causes the first metatarsal to move in at least a transverse plane.The angular relationship between the first metatarsal and the second metatarsal, which is reduced or 'closed' to correct a bunion deformity.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
2:24-cv-09763Oct 14, 2024TREACE MEDICAL CONCEPTS, INC. v. STRYKER CORPORATION et al

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US11116558

Application Number
US16997864A
Filing Date
Aug 19, 2020
Publication Date
Sep 14, 2021
External Links
Slate, USPTO , Google Patents