IP Verse

Bi-Planar Instrument For Bone Cutting And Joint Realignment Procedure

Patent No. US11627954 (titled "Bi-Planar Instrument For Bone Cutting And Joint Realignment Procedure") was filed by Midcap Funding Iv Trust on Aug 7, 2020.

What is this patent about?

’954 is related to the field of surgical instruments, specifically those used for bone cutting and realignment procedures. The background of the invention lies in addressing bone deformities, such as hallux valgus (bunions), where the metatarsal bone is misaligned. Current surgical interventions aim to correct this misalignment, but there's a need for instruments that can facilitate efficient, accurate, and reproducible clinical results during bone realignment techniques.

The underlying idea behind ’954 is to provide a single instrument that can simultaneously space apart bones at one joint while acting as a pivot point at another, adjacent joint. This is achieved through a bi-planar instrument featuring a spacer body and a fulcrum body connected by a bridge. The spacer maintains space in the joint between the metatarsal and cuneiform, while the fulcrum, positioned between metatarsals, acts as a pivot during realignment.

The claims of ’954 focus on a method for correcting bone alignment and preparing bones for fusion using a unitary instrument. This involves inserting the instrument such that the spacer body occupies the joint space between a metatarsal and cuneiform, while the fulcrum body is simultaneously inserted between the metatarsal and an adjacent metatarsal. The method further includes preparing the ends of the metatarsal and cuneiform using a bone preparation guide aligned with the spacer body, and then realigning the metatarsal by pivoting it around the fulcrum body.

In practice, the surgeon inserts the instrument into the specified joint spaces. The bridge member connecting the spacer and fulcrum helps position the instrument correctly by contacting a corner of the metatarsal. A bone preparation guide, either pre-attached or subsequently connected to the spacer, then allows for precise cutting of the metatarsal and cuneiform ends. Finally, the metatarsal is moved, pivoting around the fulcrum, to reduce the intermetatarsal angle and correct the alignment.

This approach differs from prior solutions by providing a single instrument that combines the functions of joint spacing, pivoting, and alignment guidance. The fulcrum body prevents lateral shifting of the metatarsal base during realignment, which can be a problem with other techniques. The bi-planar design allows for controlled movement in multiple planes, addressing complex misalignments more effectively than instruments that only focus on a single plane of correction.

How does this patent fit in bigger picture?

Technical landscape at the time

In the late 2010s when ’954 was filed, bone realignment procedures were typically performed using a collection of individual surgical instruments. At a time when surgical techniques commonly relied on visual alignment and manual manipulation, achieving precise and reproducible bone positioning was non-trivial. When hardware or software constraints made computer-assisted surgical navigation systems expensive and complex, surgeons often relied on their skill and experience to achieve the desired outcome.

Novelty and Inventive Step

The examiner allowed the claims because the prior art (Santrock et al.) did not disclose that the spacer and fulcrum are parts of a unitary instrument for inserting them simultaneously in situ in such a way to allow performing the steps of the claimed method for correcting an alignment of a bone in a foot. The examiner stated that the amended claims are allowable over the discovered prior art.

Claims

This patent contains 21 claims, with claim 1 being the only independent claim. Independent claim 1 is directed to a method for correcting bone alignment in a foot and preparing bones for fusion using a unitary instrument. The dependent claims generally elaborate on and refine the specifics of the method described in the independent claim, including variations in instrument structure, adjustment methods, and additional steps in the bone fusion process.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Bone preparation guide
(Claim 1)		“The second portion of the spacer body can be connected to a bone preparation guide. The bone preparation guide may be removable from and engageable with the spacer body (e.g., by inserting the bone preparation guide on the spacer body after the spacer body is inserted into the joint space). Alternatively, the bone preparation guide can be permanently coupled to the spacer body (e.g., to define a unitary structure). In either case, the bone preparation guide may define one or more guide surfaces for guiding a bone preparation instrument to prepare the ends of adjacent bones (e.g., to prepare an end of the metatarsal and/or an end of the opposed cuneiform).”A guide aligned with the spacer body, used to direct a bone preparation instrument to prepare the ends of the metatarsal and opposed cuneiform.
Fulcrum body
(Claim 1)		“The instrument also includes a fulcrum body coupled to the spacer body. The fulcrum body may be configured (e.g., sized and/or shaped) to be positioned in an intermetatarsal space between adjacent metatarsals, such as in the intermetatarsal space between the first metatarsal and the second metatarsal. The fulcrum body may define a fulcrum, or pivot surface, about which the metatarsal can rotate to realign a position of the metatarsal relative to the opposing cuneiform and/or adjacent metatarsal.”A component of a unitary instrument coupled to the spacer body, configured to be inserted between a metatarsal and an adjacent metatarsal, and about which the metatarsal can pivot.
Intermetatarsal angle
(Claim 1)		“The fulcrum body may define a fulcrum, or pivot surface, about which the metatarsal can rotate to realign a position of the metatarsal relative to the opposing cuneiform and/or adjacent metatarsal. For example, the fulcrum body may define a pivot surface about which a proximal base of the metatarsal can pivot as an intermetatarsal angle is closed between the metatarsal and the adjacent metatarsal.”The angle between the metatarsal and the adjacent metatarsal, which is reduced by pivoting the metatarsal about the fulcrum body.
Opposed cuneiform
(Claim 1)		“For example, the spacer body can be positioned in a joint space between opposed bone ends, such as a joint space between a metatarsal and an opposed cuneiform. In some implementations, the metatarsal is a first metatarsal and the opposed cuneiform is a medial cuneiform. In either case, the spacer body may define a first portion positionable in the joint space between opposed bone ends and a second portion that extends above (e.g., dorsally) from the joint space.”A cuneiform bone that opposes the metatarsal, with the spacer body positioned in the joint space between them.
Spacer body
(Claim 1)		“The instrument can include a spacer body connected to a fulcrum body. The spacer body and fulcrum body may be positionable in adjacent joint spaces, with a connecting member between the spacer body and fulcrum body helping to control the relative position of the spacer body and fulcrum body when inserted into respective joint spaces. For example, the spacer body can be positioned in a joint space between opposed bone ends, such as a joint space between a metatarsal and an opposed cuneiform.”A component of a unitary instrument configured to be inserted into a joint space between a metatarsal and an opposed cuneiform.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-00592May 12, 2025Treace Medical Concepts, Inc. V. Zimmer Biomet Holdings, Inc.
2:24-cv-09763Oct 14, 2024TREACE MEDICAL CONCEPTS, INC. v. STRYKER CORPORATION et al

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US11627954

MIDCAP FUNDING IV TRUST
Application Number
US16987916
Filing Date
Aug 7, 2020
Status
Granted
Expiry Date
Aug 7, 2040
External Links
Slate, USPTO, Google Patents