IP Library Granted Patent US 12685565
Granted Patent B2
US 12685565 · App. 18/160,789 · Granted Jul 21, 2026

Surgical instruments, guides, and methods of use

Inventors: Michael Schmidt (Greenwood Village, CO); Richard David Hunt (Arvada, CO); Albert Dacosta (Lone Tree, CO)
Assignee: Paragon 28, Inc.
A61B17/66A61B17/1775
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Quick Facts
Patent No.
US 12685565
App. No.
18/160,789
Granted
Jul 21, 2026
Kind
B2
Abstract

The present disclosure relates to an alignment system. The alignment system includes a clamp portion including a curved member configured to contact a medial portion of a first metatarsal of a patient, and a retention element configured to releasably couple with a second metatarsal of the patient. The alignment system also includes an alignment portion releasably coupled with the clamp portion and including an alignment bar and an extension coupled with the alignment bar and configured to releasably couple with a guide arm. The retention element includes a shaft and a pair of protrusions extending from a distal-most point of the shaft, with the pair of protrusions extend substantially parallel to one another. Also disclosed is a method of coupling the alignment system to the anatomy of a patient, specifically to two bones in the foot of the patient.

Claims (44)

1 . An alignment system, comprising:

a clamp portion, comprising:

a curved member configured to contact a medial portion of a first metatarsal of a patient;

a retention element configured to releasably couple with a second metatarsal of the patient, wherein the retention element is arranged substantially opposite the clamp portion from the curved member and wherein the retention element comprises:

a shaft; and

a pair of projections extending from the shaft and terminating at a distal portion of the retention element; and

a coupling member, comprising:

a shaft portion comprising a threading disposed on at least a portion of an outer surface thereof; and

a knob disposed opposite the coupling member from a distal-most portion of the shaft portion, and wherein actuation of the knob of the coupling member is configured to translate the curved member along a length of the shaft portion of the coupling member;

an alignment portion releasably coupled with the clamp portion, comprising:

an alignment bar; and

an extension coupled with the alignment bar and configured to releasably couple with a guide arm.

2 . The alignment system of claim 1 , wherein the curved member comprises a coupling portion configured to threadably and translatably couple with the shaft portion of the coupling member.

3 . The alignment system of claim 1 , wherein the clamp portion further comprises:

a connecting member comprising:

a first opening configured to receive at least a portion of the shaft portion of the coupling member therein; and

a second opening configured to receive at least a portion of the shaft of the retention element therein.

4 . The alignment system of claim 3 , wherein the first opening comprises a first longitudinal axis and the second opening comprises a second longitudinal axis, wherein the first and second longitudinal axes are positioned in planes substantially orthogonal to one another.

5 . The alignment system of claim 1 , wherein translation of the curved member along the length of the shaft portion of the coupling member is configured to increase or decrease a distance between the retention element and the curved member.

6 . The alignment system of claim 1 , wherein the alignment bar comprises a first opening configured to receive at least a portion of the shaft of the retention element therethrough.

7 . The alignment system of claim 6 , wherein the alignment bar further comprises:

an elongated opening and a slider disposed within and translatable along a length of the elongated opening, wherein the slider comprises a bore extending therethrough.

8 . The alignment system of claim 1 , further comprising:

a guide portion comprising a shaft protruding from a lateral portion thereof and configured to be received at least partially therethrough a bore of a slider of the alignment bar.

9 . A retention element, comprising:

a shaft; and

a pair of projections extending from a distal-most point of the shaft, wherein the pair of projections extend substantially parallel to one another, wherein each of the projections further comprise:

a lobe disposed on an inner portion thereof and extending into a space between each of the projections and wherein each lobe of the pair of projections is spaced apart from the other lobe.

10 . The retention element of claim 9 , further comprising:

a threading disposed on at least a portion of the shaft.

11 . The retention element of claim 10 , wherein each lobe of the projections further comprise:

a first portion with a first straight edge parallel to an opposing parallel edge of the opposing lobe; and

a second portion with a second straight edge substantially perpendicular to the first straight edge of each lobe.

12 . The retention element of claim 11 , wherein each of the projections further comprise:

a texture disposed on an inner portion thereof and positioned between the lobe and an end of the projection.

13 . The retention element of claim 12 , wherein each of the pair of projections define a space therebetween configured to receive at least a portion of a bony anatomy of a patient.

14 . The retention element of claim 13 , wherein each of the pair of projections are configured to be flexible such that a force applied simultaneously to an outer surface of each of the projections decreases the space between the projections.

15 . The retention element of claim 12 , wherein each of the projections are integral with the shaft.

16 . A method of coupling an alignment system with the anatomy of a patient, comprising:

inserting a retention element comprising a pair of projections over a first bony anatomy of a patient such that the first bony anatomy is disposed at least partially between the projections;

releasably coupling a connecting member with the retention element such that at least a portion of a shaft of the retention element is received through a first opening of the connecting member;

releasably coupling the connecting member with a coupling member such that a shaft of the coupling member is received through a second opening of the connecting member;

releasably coupling a curved member with the shaft portion of the coupling member such that at least a portion of the shaft of the coupling member is received through a third opening of the curved member; and

actuating the coupling member to adjust the space between the curved member and the retention element such that the curved member is positioned adjacent a second bony anatomy of the patient.