IP Library Granted Patent US 12,427,030
Granted Patent B2
US 12,427,030 · App. 17/816,600 · Granted Sep 30, 2025

Total ankle replacement trial and preparation systems, guides, instruments and related methods

Inventors: Joseph Dogué (Aurora, CO); Daniel J. Lee (Denver, CO); Mark Ray Dalton (Austin, TX)
Assignee: Paragon 28, Inc.
A61F2/4202A61B17/15A61B17/1682A61B17/1775A61F2/4606A61F2/4684A61B2017/00707A61B2017/565A61B2090/0811A61F2002/30492A61F2002/30594A61F2002/4205A61F2002/4207
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Quick Facts
Patent No.
US 12,427,030
App. No.
17/816,600
Granted
Sep 30, 2025
Kind
B2
Abstract

Instruments, guides, systems and related methods for total ankle prostheses are disclosed. The instruments, guides, systems and related methods facilitate preparation of a tibia and/or talus of a patient for implantation of a total ankle prosthesis therein. The instruments, guides, systems and related methods also facilitate selection of a particular size of a tibial component, a talus component and/or a tibial insert of the total ankle prosthesis that suits the patient. The instruments, guides, systems and related methods include a tibial trial component, a talar trial component and tibial insert trial component that replicate one or more aspects of the tibial component, the talus component and the tibial insert, respectively, of the total ankle prosthesis. The talar trial component includes an articulation surface that articulates with the tibial insert trial component, and slots that facilitate chamfered resection of the patient's talus for the implantation of the talus component thereon.

Claims (59)

1. A total ankle replacement (TAR) trial and bone preparation guide system, comprising:

a first component configured as a tibial trial and as a tibia bone preparation device comprising:

a base portion comprising a first side with a first tibial engagement surface configured to engage a resected distal tibia and at least one bone aperture formation guide through hole extending from the first tibial engagement surface to a second tibial insert engagement side; and

an arm portion extending proximally from an anterior portion of the base portion configured to engage an anterior side of the resected distal tibia; and

a second component configured as a talar trial and as a talus bone preparation device comprising:

a first talar engagement surface on a distal side of the second component configured to engage a portion of a resected talus;

a posterior trial articulation surface on a proximal side of the second component that is anteriorly-posteriorly arcuately convex;

an anterior window extending through the second component between the proximal side and the distal side thereof;

a posterior cut slot extending through the second component between the proximal side and the distal side thereof that is angled posteriorly as in extends from the proximal side to the distal side; and

a plurality of pin apertures extending through the second component between the proximal side and the distal side.

2. The system according to claim 1 , further comprising a tibial trial insert comprising a distal side with a first talar trial engagement surface that is configured to engage the posterior trial articulation surface of the second component, and a proximal side configured to removably couple with the second tibial insert engagement side of the first component.

3. The system according to claim 2 , wherein the second tibial insert engagement side of the first component comprises a coupling slot, and wherein the tibial trial insert comprises a coupling projection configured to removably mate within the coupling slot.

4. The system according to claim 3 , wherein the coupling slot and the coupling projection extend and are elongated anteriorly-posteriorly.

5. The system according to claim 2 , wherein the first talar trial engagement surface is arcuately concave in an anterior-posterior direction.

6. The system according to claim 1 , wherein the system is configured to trial, and prepare the resected distal tibia and the resected talus for implantation therein and therebetween, a TAR prosthesis comprising a tibial component comprising a second tibial engagement surface and at least one bone engagement projection, a tibial insert configured to removably couple with the tibial component and comprising a second tibial articulation surface, and a talar component comprising a second talar engagement surface and a talar articulation surface that articulates with the second tibial articulation surface.

7. The system according to claim 6 , wherein the configuration of the first talar trial engagement surface corresponds to at least a portion of the second tibial articulation surface, wherein at least a portion of the first tibial engagement surface corresponds in size and shape to at least a portion of the second tibial engagement surface, and wherein the posterior trial articulation surface corresponds in size and shape to at least a portion of the talar articulation surface of the talar component.

8. The system according to claim 6 , wherein the distal side of the second component further comprises a medially-laterally extending center reference slot extending through the first talar engagement surface corresponding to the medial-lateral center of the talar component, the medially-laterally extending center reference slot being exposed at medial and lateral sides of the second component.

9. The system according to claim 1 , wherein the first tibial engagement surface is convex in a medial-lateral direction.

10. The system according to claim 1 , wherein the first side of the base portion of the first component includes at least one reference slot extending in a medial-lateral direction through at least a portion of the first tibial engagement surface.

11. The system according to claim 10 , wherein the at least one reference slot comprises at least one of:

a center reference slot positioned in the medial-lateral center of the base portion corresponding to the medial-lateral center of the tibial component;

a bone aperture formation reference slot extending through at least a portion of the at least one bone aperture formation guide through hole;

an anterior reference slot positioned in an anterior end portion of the base portion corresponding to an anterior end of the tibial component; and

a posterior reference slot positioned in a posterior end portion of the base portion corresponding to a posterior end of the tibial component.

12. The system according to claim 1 , wherein the arm portion of the first component comprises a plurality of pin through holes extending therethrough anteriorly-posteriorly.

13. The system according to claim 12 , wherein the arm portion of the first component comprises a medial wing and a lateral wing, the medial and lateral wings each comprising at least one pin through hole of the plurality of pin through holes, and wherein the at least one pin through hole of the medial and lateral wings converges in a medial-lateral direction as they extend posteriorly.

14. The system according to claim 1 , wherein the arm portion of the first component comprises a positioning mechanism that is configured to engage the anterior side of the resected distal tibia and adjust the anterior-posterior position of the base portion of the first component relative to the resected distal tibia, wherein the positioning mechanism comprises at least one adjustment screw threadably coupled with the arm portion.

15. The system according to claim 1 , wherein the first talar engagement surface is planar and is configured to engage a planar portion of the resected talus.

16. The system according to claim 1 , wherein the posterior cut slot is exposed at medial and lateral sides of the second component at the distal side of the second component.

17. The system according to claim 1 , wherein the distal side of the second component further comprises a medially-laterally extending anterior reference slot, the medially-laterally extending anterior reference slot being exposed at medial and lateral sides of the second component and corresponding to the position and orientation of an anterior-posterior directed pathway of the posterior trial articulation surface at the distal side of the second component.

18. The system according to claim 1 , further comprising at least one anterior cut guide configured to engage the proximal side of the second component and extend at least partially over the anterior window, the at least one anterior cut guide comprising a bone cutting guide through hole configured to mate with at least one cutting implement to form an anterior chamfer on the resected talus.

19. The system according to claim 18 , wherein the distal side of the second component further comprises a medially-laterally extending anterior cut reference slot, the medially-laterally extending anterior cut reference slot being exposed at medial and lateral sides of the second component and corresponding to the position and orientation of the anterior chamfer on the resected talus.

20. The system according to claim 1 , wherein the posterior cut slot is positioned anteriorly-posteriorly between at least a portion of the posterior trial articulation surface and the anterior window, and wherein the posterior cut slot is configured to accept a cutting blade therethrough to form a posterior chamfer on the resected talus.

21. The system according to claim 1 , wherein the plurality of pin apertures extending through the second component between the proximal and distal sides thereof comprise a pair of first pin apertures that converge as the extend from the proximal side to the distal side, and a pair of second pin apertures that extend parallel to each other aligned with each other as the extend from the proximal side to the distal side, and wherein at least a portion of the anterior window is positioned anteriorly-posteriorly between the pair of first pin apertures and the pair of second pin apertures.

22. The system according to claim 1 , wherein the system further comprises a chamfer checker instrument, the chamfer checker instrument comprising at least one third talar engagement surface configured to engage the resected talus, a fourth talar engagement surface extending from the at least one third talar engagement surface configured to engage an anterior chamfer of the resected talus formed via the anterior window of the second component, and a fifth talar engagement surface extending from the at least one third talar engagement surface configured to engage a posterior chamfer of the resected talus formed via the cut slot of the second component.

23. The system according to claim 1 , wherein the system further comprises a talar chamfer trial comprising:

a fifth talar engagement surface on a distal side of the talar chamfer trial configured to engage the resected talus;

a second posterior trial articulation surface on a proximal side of the talar chamfer trial that comprises an anteriorly-posteriorly and medially-laterally arcuately convex portion;

at least one bone aperture formation guide through hole; and

a plurality of pin through holes extending between the proximal and distal sides thereof.

24. The system according to claim 1 , wherein the second component is a one-piece component.

25. A method of using a system, comprising:

trialing a total ankle replacement (TAR) prosthesis in an ankle joint that includes a tibial component, a tibial insert with a tibial articulation surface, and a talar component with a talar articulation surface via a total ankle replacement (TAR) guide system, the TAR guide system comprising:

a first component configured as a tibial trial and as a tibia bone preparation device comprising:

a base portion comprising a first side with a first tibial engagement surface configured to engage a resected distal tibia of the ankle joint and at least one bone aperture formation guide through hole extending from the first tibial engagement surface to a second tibial insert engagement side; and

an arm portion extending proximally from an anterior portion of the base portion configured to engage an anterior side of the resected distal tibia; and

a second component configured as a talar trial and as a talus bone preparation device comprising:

a first talar engagement surface on a distal side of the second component configured to engage a portion of a resected talus of the ankle joint;

a posterior trial articulation surface on a proximal side of the second component that is arcuately convex in an anterior-posterior direction;

an anterior window extending through the second component between the proximal side and the distal side thereof;

a posterior cut slot extending through the second component between the proximal side and the distal side thereof that is angled posteriorly as it extends from the proximal side to the distal side; and

a plurality of pin apertures extending through the second component between the proximal side and the distal side; and

preparing the resected distal tibia of the ankle joint for the implantation of at least one projection of an engagement side of the tibial component therein, comprising:

coupling the arm portion of the first component to the anterior side of the resected distal tibia with the first tibial engagement surface of the first component engaged with the resected distal tibia; and

passing at least one projection of a bone aperture formation instrument though the at least one bone aperture formation guide through hole of the base portion of the first component and into the resected distal tibia to form at least one aperture in the resected distal tibia that is configured to accept the at least one projection of the tibial component therein; and

preparing the resected talus of the ankle joint for coupling with an engagement side of the talar component, comprising:

coupling the second component to the resected talus such that the first talar engagement surface of the second component engages a surface portion of the resected talus;

passing a bone cutting instrument through the anterior window of the second component to form an anterior chamfer surface on the resected talus; and

passing a bone cutting blade through the posterior cut slot of the second component to form a posterior chamfer surface on the resected talus.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Apr 22, 2025
From: ARES CAPITAL CORPORATION
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 070908/0038 →
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST AT REEL/FRAME NO. 62354/0016 Recorded Nov 11, 2023
From: MIDCAP FUNDING IV TRUST, AS AGENT
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065548/0364 →
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST AT REEL/FRAME NO. 62354/0006 Recorded Nov 10, 2023
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065548/0313 →
SECURITY INTEREST Recorded Nov 2, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: ARES CAPITAL CORPORATION
Reel/Frame 065448/0214 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 27, 2023
From: DOGUÉ, JOSEPH; LEE, DANIEL J.; DALTON, MARK RAY
To: PARAGON 28, INC.
Reel/Frame 064407/0514 →
SECURITY AGREEMENT SUPPLEMENT (REVOLVING)) Recorded Jan 11, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 062354/0016 →
SECURITY AGREEMENT SUPPLEMENT (TERM) Recorded Jan 11, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 062354/0006 →
Continuity (5)
Continuation 17345135 · Jun 11, 2021
Continuation PCTUS2019066404 · Dec 13, 2019
Provisional Application 62898854 · Sep 11, 2019
Provisional Application 62779092 · Dec 13, 2018
Related Publication 20220362031A1 · Nov 17, 2022
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