Multi-Diameter Bone Pin For Installing And Aligning Bone Fixation Plate While Minimizing Bone Damage

Patent No. US11583323 (titled "Multi-Diameter Bone Pin For Installing And Aligning Bone Fixation Plate While Minimizing Bone Damage") was filed by Midcap Funding Iv Trust on Jul 12, 2019.

What is this patent about?

’323 is related to the field of bone fixation, specifically devices and techniques for surgically attaching bone plates to bones. The background involves correcting misalignments in bones, often in the foot or hand, using bone plates to maintain the corrected position. Surgical procedures may involve cutting and realigning bones, and the bone plate helps prevent them from shifting back.

The underlying idea behind ’323 is to use a specialized driving pin to create an opening in the bone for subsequent screw placement, while also allowing for precise bone plate positioning. The pin has multiple diameters: a small diameter at the tip for easy bone penetration, a larger diameter in the middle to fit snugly within the bone plate's fixation hole, and a still larger diameter at the proximal end for coupling to a driving tool.

The claims of ’323 focus on a bone plate system that includes a bone plate with a fixation hole and a specialized driving pin. The driving pin has three distinct regions: a bone penetrating region with a small diameter, a bone plate orienting region with a diameter matching the fixation hole, and a driving region with a larger diameter for tool engagement. A drill guide may extend from the top surface of the bone plate about the fixation hole. The bone plate orienting region of the driving pin has a length equal to or greater than a length of the of the drill guide.

In practice, the surgeon inserts the pin through the bone plate's hole and into the bone. The bone plate orienting region then acts as a pivot, allowing the surgeon to rotate and precisely position the bone plate before final screw fixation. The driving pin's design minimizes bone trauma compared to using a drill bit directly, especially when repositioning the plate requires creating multiple holes.

The key differentiation lies in the driving pin's ability to create a smaller initial hole than a traditional drill bit. This is important because if the bone plate needs to be repositioned, the smaller hole from the driving pin is less likely to overlap significantly with a new hole, ensuring that the final fixation screw has solid bone to grip. The multi-diameter design of the pin facilitates both bone penetration, bone plate alignment, and driver engagement.

How does this patent fit in bigger picture?

Technical landscape at the time

In the late 2010s when ’323 was filed, bone plates were typically implemented using metallic materials and fixation screws, at a time when surgical techniques commonly relied on pre-operative planning and intra-operative fluoroscopy to guide placement. At this time, hardware or software constraints made precise, minimally invasive surgical procedures non-trivial.

Novelty and Inventive Step

Claims were amended during prosecution. Arguments were presented to overcome rejections based on anticipation and obviousness. Claims 1-3, 5-14, and 23-30 were rejected. This action was made final. The prosecution record does describe claim changes and technical reasoning that led to allowance.

Claims

This patent includes 20 claims, with independent claims 1 and 16. Independent claim 1 is directed to a bone plate system comprising a bone plate and a driving pin, while independent claim 16 is directed to a driving pin for use in installing a bone plate. The dependent claims elaborate on the features and characteristics of the bone plate system and the driving pin, providing further detail and limitations.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Bone penetrating region
(Claim 1, Claim 16)
“In some examples, the driving pin has a driving pin body extending from a proximal end to a distal end. The driving pin body may define at least three regions of different cross-sectional thickness, including a bone penetrating region adjacent the distal end, a driving region adjacent the proximal end, and a bone plate orienting region between the bone penetrating region and the driving region. In general, the bone penetrating region has a smaller cross-sectional thickness than the bone plate orienting region and the bone plate orienting region has a smaller cross-sectional thickness than the driving region.”A region of the driving pin adjacent to the distal end, having a smaller cross-sectional thickness than the bone plate orienting region and the driving region. It includes a cylindrical region with a first diameter and a taper region extending distally from the cylindrical region.
Bone plate orienting region
(Claim 1, Claim 16)
“In some examples, the driving pin has a driving pin body extending from a proximal end to a distal end. The driving pin body may define at least three regions of different cross-sectional thickness, including a bone penetrating region adjacent the distal end, a driving region adjacent the proximal end, and a bone plate orienting region between the bone penetrating region and the driving region. In general, the bone penetrating region has a smaller cross-sectional thickness than the bone plate orienting region and the bone plate orienting region has a smaller cross-sectional thickness than the driving region. The bone plate orienting region may be sized to conform to the size of a fixation hole extending through a bone plate.”A region of the driving pin located between the bone penetrating region and the driving region. It has a cross-sectional thickness greater than the bone penetrating region but smaller than the driving region. Its size corresponds to the fixation hole diameter of the bone plate.
Drill guide
(Claim 1)
“The bone plate includes a body and a fixation hole. The body defines a length extending from a first end to a second end, a top surface, and a bone facing surface opposite the top surface. The fixation hole extends through a thickness of the body from the top surface to the bone facing surface and defines a fixation hole diameter; a drill guide extending from the top surface of the bone plate about the fixation hole”A component extending from the top surface of the bone plate about the fixation hole.
Driving region
(Claim 1, Claim 16)
“In some examples, the driving pin has a driving pin body extending from a proximal end to a distal end. The driving pin body may define at least three regions of different cross-sectional thickness, including a bone penetrating region adjacent the distal end, a driving region adjacent the proximal end, and a bone plate orienting region between the bone penetrating region and the driving region. In general, the bone penetrating region has a smaller cross-sectional thickness than the bone plate orienting region and the bone plate orienting region has a smaller cross-sectional thickness than the driving region.”A region of the driving pin adjacent to the proximal end, having a greater cross-sectional thickness than the bone penetrating region and the bone plate orienting region. It comprises a cylindrical region having a third diameter.
Fixation hole diameter
(Claim 1)
“The bone plate includes a body and a fixation hole. The body defines a length extending from a first end to a second end, a top surface, and a bone facing surface opposite the top surface. The fixation hole extends through a thickness of the body from the top surface to the bone facing surface and defines a fixation hole diameter.”The diameter of the fixation hole that extends through the bone plate from the top surface to the bone facing surface.

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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US11583323

MIDCAP FUNDING IV TRUST
Application Number
US16510682
Filing Date
Jul 12, 2019
Status
Granted
Expiry Date
Dec 30, 2040
External Links
Slate, USPTO, Google Patents