Bone positioning and preparing guide systems and methods

Patent No. US11911085 (titled "Bone positioning and preparing guide systems and methods") on Mar 13, 2023. The application was issued on Feb 27, 2024.

What is this patent about?

’085 is related to the field of orthopedic surgery, specifically instruments and techniques for correcting anatomical misalignments in the foot. It addresses the complexities of bunion correction, such as the Lapidus procedure, where a first metatarsal must be repositioned relative to the second metatarsal and the medial cuneiform to restore proper skeletal geometry and facilitate joint fusion.

The underlying idea behind ’085 is that a bunion is a multi-planar deformity that requires simultaneous correction in the transverse, sagittal, and frontal planes. Rather than addressing these dimensions through separate manual manipulations, the invention utilizes a mechanical guide that applies a controlled force to move the bone into an anatomically aligned position, specifically correcting frontal plane rotation (supination/pronation) alongside the reduction of the intermetatarsal angle.

The claims of ’085 focus on a method for correcting a bunion by utilizing a bone positioning guide to move a first metatarsal in both a transverse plane and a frontal plane relative to a medial cuneiform. The claimed process involves using this mechanical guidance to close the intermetatarsal angle and subsequently preparing the facing ends of the first metatarsal and medial cuneiform for fusion while the corrected orientation is maintained.

In practice, the system employs a C-shaped main body with a bone engagement member and a tip that are urged toward one another via an actuator. By anchoring the tip against a stable lateral metatarsal and the engagement member against the first metatarsal, the device creates a multi-planar shift that rotates the bone about its long axis. This mechanical advantage ensures that the sesamoid bones are restored to their proper position under the metatarsal head, a critical factor in preventing bunion recurrence.

This approach differs from prior surgical techniques that often relied on freehand bone cuts or simple lateral shifting, which frequently failed to address the rotational component of the deformity. By integrating a bone preparation guide that aligns with the corrected position, the invention allows for precise, parallel bone cuts after the deformity has been reduced. This sequence ensures maximum surface contact for fusion and provides a more predictable, stable clinical outcome compared to traditional methods.

How does this patent fit in bigger picture?

Technical Landscape

In the mid-2010s when ’085 was filed, orthopedic corrective procedures were typically implemented using manual manipulation and freehand osteotomies at a time when surgical workflows commonly relied on sequential, independent adjustments of bone position rather than integrated multi-planar correction. During this era, achieving simultaneous translation and rotation of bone segments was non-trivial due to hardware constraints that often required surgeons to choose between rigid fixation and the flexibility needed to address complex deformities across multiple anatomical planes.

Prosecution Position

The disclosed invention achieves a technical advancement in orthopedic surgery through an architectural shift that enables simultaneous multi-planar bone alignment and preparation. By integrating a force-application mechanism that moves a bone from a misaligned to an aligned position across multiple planes with a guided preparation system, the technology overcomes the constraint of positional loss during the transition from alignment to fixation. This structural approach allows for the preparation of bone ends while the anatomical relationship is maintained in a corrected state, ensuring higher precision in fusion procedures and reducing the mechanical variability associated with traditional sequential positioning and cutting techniques.

Claims

This patent contains 30 claims, with claims 1, 21, and 29 serving as the independent claims. The independent claims focus on methods for correcting bunion deformities by utilizing a bone positioning guide to manipulate the first metatarsal in both transverse and frontal planes relative to the second metatarsal and medial cuneiform, followed by the preparation of bone ends for joint realignment. The dependent claims further specify the procedural steps and tools used, including the use of fixation devices like screws or plates, the application of bone preparation guides with cutting slots, the specific timing of bone cutting relative to positioning, and the mechanical operation of the positioning guide via components such as rack and pinion systems or cannulated engagement members.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Bone positioning guide
(Claim 1, Claim 21, Claim 29)
Embodiments of the invention include a bone positioning device and a bone preparation guide, and methods of using such guides. The bone is anatomically aligned in more than one plane such that the bone both translates and rotates in response to a moving force. The method includes moving a first metatarsal from an anatomically misaligned position to an anatomically aligned position by applying a force to the first metatarsal.A mechanical instrument used to manipulate the position of a bone, specifically configured to move a first metatarsal in both the transverse and frontal planes relative to adjacent bones.
Frontal plane
(Claim 1, Claim 21, Claim 29)
In some embodiments, the bone is anatomically aligned in more than one plane such that the bone both translates and rotates in response to a moving force. The method includes moving the first metatarsal to correct an alignment in more than one plane, including moving the first metatarsal relative to a medial cuneiform in a frontal plane.The anatomical plane of motion involving rotation of the bone, specifically the rotational correction of the first metatarsal relative to the medial cuneiform.
Intermetatarsal angle
(Claim 1, Claim 21, Claim 29)
The method includes using a bone positioning guide to move a first metatarsal in a transverse plane to close an intermetatarsal angle between the first metatarsal and a second metatarsal adjacent to the first metatarsal to correct a bunion deformity.The angular measurement in the transverse plane between the longitudinal axes of the first metatarsal and the second metatarsal.
Joint seeker
(Claim 29)
One embodiment includes inserting a joint seeker into a tarsal-metatarsal joint separating a first metatarsal from a medial cuneiform. The method further involves removing the joint seeker from the tarsal-metatarsal joint before or during the positioning and preparation steps.A surgical instrument inserted into the tarsal-metatarsal joint space to identify or maintain the joint location prior to positioning and preparation.
Tarsal-metatarsal joint
(Claim 29)
The method includes preparing an end of the first metatarsal and preparing an opposing end of a medial cuneiform for fusion. Fixating a moved position of the first metatarsal is achieved by inserting at least one fixation device across the tarsal-metatarsal joint.The articulation point between the medial cuneiform (a tarsal bone) and the first metatarsal bone where fusion or preparation occurs.

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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US11911085

Application Number
US18183013A
Filing Date
Mar 13, 2023
Publication Date
Feb 27, 2024
External Links
Slate, USPTO , Google Patents