IP Library Granted Patent US 12,257,157
Granted Patent B2
US 12,257,157 · App. 17/036,485 · Granted Mar 25, 2025

Talus formation and implantation method

Inventors: Gregory J. Kowalczyk (Little Silver, MD); Selene G. Parekh (Cary, NC); Luciano Bernardino Bertolotti (Buenos Aires, AR)
Assignee: Paragon Advanced Technologies, Inc.
A61F2/4202A61F2/30942B29C64/386B33Y10/00B33Y50/00B33Y80/00G16H30/40G16H50/30G16H50/50A61F2002/30116A61F2002/30322A61F2002/30578A61F2002/30878A61F2002/30909A61F2002/30952A61F2002/30985A61F2002/4207B29L2031/7532
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Quick Facts
Patent No.
US 12,257,157
App. No.
17/036,485
Granted
Mar 25, 2025
Kind
B2
Abstract

A process for printing a talus implant comprising the steps of scanning a joint for a damaged talus, and scanning a contralateral joint for a healthy talus. Next, the process includes obtaining dimensions for a talus based upon an initial scan and then obtaining dimensions for a talus based upon the scan of the contralateral joint. Next the process includes inverting the dimensions of the talus in the contralateral joint and then comparing the dimensions of the calculated talus with a pre-set of dimensions in a database. Next the process includes exporting a set of dimensions to a printer to print a talus implant.

Claims (35)

1. A system for scanning a talus joint comprising:

at least one computer comprising at least one microprocessor;

at least one database comprising a plurality of pre-set dimensions for a plurality of different bone implants; and

at least one scanner in communication with said at least one computer, wherein said at least one scanner is configured to scan a first joint of a patient and a second joint of a patient, the first joint being a contralateral joint of the second joint;

wherein said at least one microprocessor of said computer is configured to:

provide a mirror image of a first bone of the first scanned joint, and create a first approximated set of dimensions for said first bone from said mirror image;

create a second approximated set of dimensions of a second bone of the second scanned joint and compare said second approximated set of dimensions to said plurality of pre-set dimensions and determine a first bone implant of said plurality of different bone implants based on said second approximated set of dimensions to obtain a third approximated set of dimensions for said first bone implant; and

modify either of the first approximated set of dimensions or the third approximated set of dimensions based on any arthritis identified in the scanned second joint or in adjacent joints that articulate with one or more portions of the scanned second joint to obtain a calculated set of talus dimensions for printing;

the calculated set of talus dimensions comprising:

if arthritis is identified in a subtalar joint of the adjacent joints, but not in a navicular joint or in a tibiotalar joint of the adjacent joints, the first approximated set of dimensions or the third approximated set of dimensions having a lattice structure to promote fusion with a calcaneus bone of the subtalar joint;

if arthritis is identified in the navicular joint of the adjacent joints, but not in the subtalar joint or the tibiotalar joint of the adjacent joints, the first approximated set of dimensions or the third approximated set of dimensions having a lattice structure to promote fusion with a navicular bone of the navicular joint; or

if arthritis is identified in at least the subtalar joint, the navicular joint and the tibiotalar joint of the adjacent joints, the first approximated set of dimensions or the third approximated set of dimensions configured to engage with a total ankle replacement system and lacking any lattice structure.

2. The system as in claim 1 , wherein said at least one microprocessor includes a preset tolerance for matching an existing set of dimensions with at least one pre-set dimension of said plurality of pre-set dimensions of different bone implants in said database.

3. The system as in claim 2 , wherein said pre-set tolerance comprises a tolerance of a 1% differential in at least one pre-set dimension of said plurality of pre-set dimensions.

4. The system as in claim 2 , wherein said pre-set tolerance comprises a tolerance of 5% differential in at least one pre-set dimension of said plurality of pre-set dimensions.

5. A system for scanning a talus joint comprising:

at least one computer comprising at least one microprocessor configured to perform a method, the method comprising:

scanning a first joint of a patient comprising a damaged talus;

scanning a second joint of the patient comprising a contralateral joint with a second talus;

obtaining a first set of talus dimensions for from the scanned damaged talus;

determining if the second talus is a healthy talus; and

if the second talus is a healthy talus, obtaining a second set of talus dimensions for the scanned second talus and inverting the second set of talus dimensions to obtain an inverted set of talus dimensions for a talus implant;

if the second talus is not a healthy talus, comparing the first set of talus dimensions with at least one pre-set of talus dimensions in a database to determine a first pre-set of talus dimensions for the talus implant based on the first set of talus dimensions;

determining whether to modify the first set of talus dimensions or the inverted set of talus dimensions based on any arthritis identified in the adjacent joints that articulate with the damaged talus, the adjacent joints comprising a subtalar joint, a navicular joint and a tibiotalar joint, comprising:

determining whether there is any arthritis present in the subtalar joint but not in the navicular joint or the tibiotalar joint;

determining whether there is any arthritis present in the navicular joint but not in the subtalar joint or the tibiotalar joint; and

determining whether there is any arthritis present in all of the subtalar joint, the navicular joint and the tibiotalar joint; and

based on the determining whether to modify the first set of talus dimensions or the inverted set of talus dimensions, modifying either of the first pre-set of talus dimensions or the inverted set of talus dimensions to:

include a lattice structure configured to encourage interstitial bone growth on a surface of the talus implant; or

be compatible with a total ankle replacement system and void of any lattice structure; and

based on the modifying, obtaining; and a calculated set of talus dimension

exporting the calculated set of talus dimensions to a printer to print the talus implant.

6. The system of claim 5 , wherein said at least one microprocessor includes a preset tolerance for matching an existing set of dimensions with at least one pre-set dimension of said plurality of pre-set dimensions of different bone implants in said database.

7. The system of claim 6 , wherein said pre-set tolerance comprises a tolerance of a 1% differential in at least one pre-set dimensions of said plurality of pre-set dimensions.

8. The system of claim 6 , wherein said pre-set tolerance comprises a tolerance of 5% differential in at least one pre-set dimensions of said plurality of pre-set dimensions.

Assignments (8)
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. 56970/0320 Recorded Nov 10, 2023
From: MIDCAP FUNDING IV TRUST, AS AGENT
To: PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065549/0940 →
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST AT REEL/FRAME NO. 56950/0847 Recorded Nov 10, 2023
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065549/0963 →
SECURITY INTEREST Recorded Nov 2, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: ARES CAPITAL CORPORATION
Reel/Frame 065448/0214 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT (REVOLVING LOAN) Recorded Jul 19, 2021
From: PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 056970/0320 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT (TERM LOAN) Recorded Jul 19, 2021
From: PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 056950/0847 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 4, 2021
From: ADDITIVE ORTHOPAEDICS, LLC
To: PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 056445/0516 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 9, 2021
From: KOWALCZYK, GREGORY J.; PAREKH, SELENE G.; BERTOLOTTI, LUCIANO BERNARDINO
To: ADDITIVE ORTHOPAEDICS, LLC
Reel/Frame 055880/0058 →
Continuity (2)
Provisional Application 62908438 · Sep 30, 2019
Related Publication 20210093458A1 · Apr 1, 2021
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