IP Library Granted Patent US 12,514,614
Granted Patent B2
US 12,514,614 · App. 19/013,803 · Granted Jan 6, 2026

Metatarsophalangeal joint implants and methods thereof

Inventors: Mary Tribble (Somerville, MA); James Craig Fryman (Middleton, MA); Michael E. Hawkins (Columbia City, IN); Brad Vale (Santa Clara, CA); Daniel C. Taylor (Littleton, MA); Jessica Indyk (Mansfield, MA); Julia Beekman (Brighton, MA); Carl Vause (Concord, MA); Mary Elizabeth Schmidt (Pomfret Center, CT)
Assignee: HYALEX ORTHOPAEDICS, INC.
A61B17/562A61F2/4225A61F2/4241A61F2002/30224A61F2002/4233A61F2002/4251
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,514,614
App. No.
19/013,803
Granted
Jan 6, 2026
Kind
B2
Abstract

Systems, methods, and devices described herein relate an implant adapted to be placed in a bone in the metatarsophalangeal joint or a metacarpophalangeal joint. In some embodiments, the implant includes a head portion extending from a first surface to a second surface and having a plurality of layers located between the first surface and the second surface. In some embodiments, the first surface is lubricious. In some embodiments, the implant comprises a post portion extending from the second surface of the head portion to a bone facing surface.

Claims (47)

1 . A method for disposing an implant at least partially into a metatarsal bone in a metatarsophalangeal joint, the method comprising the steps of:

disposing a recess through an articular surface of a metatarsal head of the metatarsal bone such that the metatarsal head maintains articulation with a sesamoid bone;

inserting an alignment pin into the recess; and

inserting the implant into the metatarsal bone at an angle between 15-30 degrees with respect to a longitudinal axis of the metatarsal bone;

wherein the implant comprises a head portion and a post portion extending from the head portion, the implant further comprises a cavity at least partially disposed into a distal end of the post portion, and the cavity extends along a longitudinal axis of the post portion.

2 . The method of claim 1 , wherein the implant further comprises a foot portion extending from the head portion towards a distal end of the foot portion, thereby creating an articulating surface with a phalangeal bone.

3 . The method of claim 1 , wherein the recess is formed by contacting a distal end of a drill bit with the articular surface of the metatarsal head of the metatarsal bone, and wherein the method further comprises the steps of:

forming a first cavity of the recess with a first drill bit portion having a first drill bit diameter about equal to a diameter of the post portion of the implant; and

forming a second cavity of the recess with a second drill bit portion having a second drill bit diameter about equal to a diameter of the head portion of the implant, wherein a distal end of the first drill bit portion extends distally from a distal end of the second drill bit portion, and wherein the first drill bit diameter is smaller than the second drill bit diameter.

4 . The method of claim 3 , wherein the drill bit comprises a depth guide configured to contact a drill guide when the drill bit reaches a final depth of the recess.

5 . The method of claim 1 , further wherein the implant comprises a post extension having a first end configured to be at least partially disposed in the metatarsal bone and a second end configured to couple with the cavity of the post portion.

6 . The method of claim 2 , wherein a first surface of the head portion extends along a length of the foot portion.

7 . The method of claim 1 , wherein a first surface of the head portion is convex having a substantially spherical curvature.

8 . The method of claim 1 , wherein a first surface of the head portion comprises a first curvature and a second curvature.

9 . The method of claim 8 , wherein the first curvature has a more acute angle than the second curvature.

10 . The method of claim 1 , further comprising visually evaluating a pin guide against the articular surface, such that the pin guide has a diameter that is equal to a diameter of the recess, wherein the pin guide makes three points of contact against the articular surface.

11 . The method of claim 1 , wherein the alignment pin is inserted into the recess to a depth of 30-50 mm.

12 . A method for disposing an implant at least partially into a metatarsal bone in a metatarsophalangeal joint, the method comprising the steps of:

disposing a recess through an articular surface of a metatarsal head of the metatarsal bone such that the metatarsal head maintains articulation with a sesamoid bone; and

inserting the implant into the metatarsal bone at an angle between 15-30 degrees with respect to a longitudinal axis of the metatarsal bone; and

inserting a trial implant into the recess to visually inspect a relative location of the articular surface and the trial implant;

wherein the trial implant comprises a defined etched band disposed along a circumference of the trial implant.

13 . The method of claim 12 , wherein the articular surface is located proximally to a distal border of the defined etched band and distally to a proximal border of the defined etched band when the trial implant is inserted into the recess.

14 . The method of claim 12 , wherein the articular surface is aligned with a proximal edge of the defined etched band when the trial implant is inserted into the recess.

15 . The method of claim 12 , wherein the implant comprises a head portion and a post portion extending from the head portion, wherein the implant further comprises a foot portion extending from the head portion towards a distal end of the foot portion, thereby creating an articulating surface with a phalangeal bone.

16 . The method of claim 15 , wherein a first surface of the head portion extends along a length of the foot portion.

17 . The method of claim 12 , wherein the recess is formed by contacting a distal end of a drill bit with the articular surface of the metatarsal head of the metatarsal bone, and wherein the method further comprises the steps of:

forming a first cavity of the recess with a first drill bit portion having a first drill bit diameter about equal to a diameter of the post portion of the implant; and

forming a second cavity of the recess with a second drill bit portion having a second drill bit diameter about equal to a diameter of the head portion of the implant, wherein a distal end of the first drill bit portion extends distally from a distal end of the second drill bit portion, and wherein the first drill bit diameter is smaller than the second drill bit diameter.

18 . The method of claim 17 , wherein the drill bit comprises a depth guide configured to contact a drill guide when the drill bit reaches a final depth of the recess.

19 . The method of claim 12 , further wherein the implant comprises a post extension having a first end configured to be at least partially disposed in the metatarsal bone and a second end configured to couple with the cavity of the post portion.

20 . The method of claim 12 , wherein the implant comprises a head portion and a post portion extending from the head portion, wherein a first surface of the head portion is convex having a substantially spherical curvature.

21 . The method of claim 12 , wherein the implant comprises a head portion and a post portion extending from the head portion, wherein a first surface of the head portion comprises a first curvature and a second curvature.

22 . The method of claim 21 , wherein the first curvature has a more acute angle than the second curvature.

23 . A method for disposing an implant at least partially into a metatarsal bone in a metatarsophalangeal joint, the method comprising the steps of:

disposing a recess through an articular surface of a metatarsal head of the metatarsal bone such that the metatarsal head maintains articulation with a sesamoid bone; and

inserting the implant into the metatarsal bone at an angle between 15-30 degrees with respect to a longitudinal axis of the metatarsal bone;

wherein the metatarsal head comprises at least 2 mm of bone surrounding the recess;

wherein the recess is formed by contacting a distal end of a drill bit with the articular surface of the metatarsal head of the metatarsal bone, and wherein the method further comprises the steps of:

forming a first cavity of the recess with a first drill bit portion having a first drill bit diameter about equal to a diameter of the post portion of the implant; and

forming a second cavity of the recess with a second drill bit portion having a second drill bit diameter about equal to a diameter of the head portion of the implant, wherein a distal end of the first drill bit portion extends distally from a distal end of the second drill bit portion, and wherein the first drill bit diameter is smaller than the second drill bit diameter.

24 . The method of claim 23 , wherein the drill bit comprises a depth guide configured to contact a drill guide when the drill bit reaches a final depth of the recess.

25 . A method for disposing an implant at least partially into a metatarsal bone in a metatarsophalangeal joint, the method comprising the steps of:

disposing a recess through an articular surface of a metatarsal head of the metatarsal bone such that the metatarsal head maintains articulation with a sesamoid bone; and

inserting the implant into the metatarsal bone at an angle between 15-30 degrees with respect to a longitudinal axis of the metatarsal bone;

wherein the metatarsal head comprises at least 2 mm of bone surrounding the recess;

further wherein the implant comprises a post extension having a first end configured to be at least partially disposed in the metatarsal bone and a second end configured to couple with a cavity within the post portion.

Assignments (2)
SECURITY INTEREST Recorded Dec 12, 2025
From: HYALEX ORTHOPAEDICS, INC.
To: CUSTOMERS BANK
Reel/Frame 073204/0901 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 14, 2025
From: TRIBBLE, MARY; FRYMAN, JAMES CRAIG; HAWKINS, MICHAEL E.; VALE, BRAD; TAYLOR, DANIEL C.; INDYK, JESSICA; BEEKMAN, JULIA; VAUSE, CARL; SCHMIDT, MARY ELIZABETH
To: HYALEX ORTHOPAEDICS, INC.
Reel/Frame 069856/0628 →
Continuity (2)
Provisional Application 63618471 · Jan 8, 2024
Related Publication 20250221739A1 · Jul 10, 2025
References Cited (137)
US 4156296A · Johnson · 1979 [cited by examiner]
US 4642122A · Steffee · 1987 [cited by examiner]
US 5037440A · Koenig · 1991 [cited by examiner]
US 5326366A · Pascarella · 1994 [cited by examiner]
US 5458648A · Berman · 1995 [cited by examiner]
US 5624463A · Stone · 1997 [cited by examiner]
US 5919196A · Bobic · 1999 [cited by examiner]
US 6626950B2 · Brown · 2003 [cited by examiner]
US 6926739B1 · O'Connor · 2005 [cited by examiner]
US 7204854B2 · Guederian · 2007 [cited by examiner]
US 7264634B2 · Schmieding · 2007 [cited by examiner]
US 7591820B2 · Schmieding · 2009 [cited by examiner]
US 7758643B2 · Stone · 2010 [cited by examiner]
US 7909880B1 · Grant · 2011 [cited by examiner]
US 7959681B2 · Lavi · 2011 [cited by examiner]
US 8303664B1 · Burstein · 2012 [cited by examiner]
US 8591592B2 · Dreyfuss · 2013 [cited by examiner]
US 8652211B1 · Jerry, Jr. · 2014 [cited by examiner]
US 8882845B2 · Wirth · 2014 [cited by examiner]
US 9095641B2 · Albertorio · 2015 [cited by examiner]
US 9554916B2 · Miller · 2017 [cited by examiner]
US 10624748B2 · Ek · 2020 [cited by examiner]
US 10653527B1 · Serafin, Jr. · 2020 [cited by examiner]
US 11058545B2 · Carioscia · 2021 [cited by examiner]
US 11478358B2 · Miniaci · 2022 [cited by examiner]
US 11607319B2 · Ek · 2023 [cited by examiner]
US 11660202B2 · Denham · 2023 [cited by examiner]
US 11759327B2 · Bailey · 2023 [cited by examiner]
US 20020022889A1 · Chibrac · 2002 [cited by examiner]
US 20030220700A1 · Hammer · 2003 [cited by examiner]
US 20040193175A1 · Maroney · 2004 [cited by examiner]
US 20040230315A1 · Ek · 2004 [cited by examiner]
US 20050065612A1 · Winslow · 2005 [cited by examiner]
US 20050165487A1 · Muhanna · 2005 [cited by examiner]
US 20050222687A1 · Vunjak-Novakovic · 2005 [cited by examiner]
US 20050251268A1 · Truncale · 2005 [cited by examiner]
US 20060052725A1 · Santilli · 2006 [cited by examiner]
US 20060229726A1 · Ek · 2006 [cited by examiner]
US 20060235541A1 · Hodorek · 2006 [cited by examiner]
US 20070005143A1 · Ek · 2007 [cited by examiner]
US 20070093896A1 · Malinin · 2007 [cited by examiner]
US 20070179608A1 · Ek · 2007 [cited by examiner]
US 20080051912A1 · Hollawell · 2008 [cited by examiner]
US 20080195215A1 · Morton · 2008 [cited by examiner]
US 20080243262A1 · Lee · 2008 [cited by examiner]
US 20100185294A1 · Ek · 2010 [cited by examiner]
US 20100241236A1 · Katrana · 2010 [cited by examiner]
US 20100249942A1 · Goswami · 2010 [cited by examiner]
US 20100256758A1 · Gordon · 2010 [cited by examiner]
US 20100262254A1 · Lawrence · 2010 [cited by examiner]
US 20100268238A1 · Sikora · 2010 [cited by examiner]
US 20110009964A1 · Schwartz · 2011 [cited by examiner]
US 20110035012A1 · Linares · 2011 [cited by examiner]
US 20110054609A1 · Cook · 2011 [cited by examiner]
US 20110054611A1 · Wu · 2011 [cited by examiner]
US 20110093085A1 · Morton · 2011 [cited by examiner]
US 20110125277A1 · Nygren · 2011 [cited by examiner]
US 20110153023A1 · Deffenbaugh · 2011 [cited by examiner]
US 20110184528A1 · Beckendorf · 2011 [cited by examiner]
US 20120323338A1 · Vanasse · 2012 [cited by examiner]
US 20130090740A1 · Linares · 2013 [cited by examiner]
US 20130110252A1 · Bake · 2013 [cited by examiner]
US 20130304226A1 · Ritz et al. · 2013 [cited by applicant]
US 20140257299A1 · Berelsman · 2014 [cited by examiner]
US 20140277552A1 · Burstein · 2014 [cited by examiner]
US 20150250594A1 · Ek · 2015 [cited by examiner]
US 20150351921A1 · Miller · 2015 [cited by examiner]
US 20160128837A1 · Juszczyk · 2016 [cited by examiner]
US 20160151076A1 · Bake · 2016 [cited by examiner]
US 20170020678A1 · Lauf · 2017 [cited by examiner]
US 20170027710A1 · Jefferis · 2017 [cited by examiner]
US 20170100251A1 · Ek · 2017 [cited by examiner]
US 20170143351A1 · Devitre · 2017 [cited by examiner]
US 20170367838A1 · Cavanagh · 2017 [cited by examiner]
US 20180153697A1 · Vitale · 2018 [cited by examiner]
US 20180154041A1 · Altschuler · 2018 [cited by examiner]
US 20180353301A1 · Goldstein · 2018 [cited by examiner]
US 20190142598A1 · Koenig · 2019 [cited by examiner]
US 20190240037A1 · Gorelick · 2019 [cited by examiner]
US 20190358042A1 · Taylor · 2019 [cited by examiner]
US 20190358048A1 · Carioscia · 2019 [cited by examiner]
US 20200107937A1 · Denham · 2020 [cited by examiner]
US 20210030550A1 · Ek · 2021 [cited by examiner]
US 20210059829A1 · Montross · 2021 [cited by examiner]
US 20210085468A1 · Ryd · 2021 [cited by examiner]
US 20210113344A1 · Bailey · 2021 [cited by examiner]
US 20210128306A1 · Taylor · 2021 [cited by examiner]
US 20210128307A1 · Taylor · 2021 [cited by examiner]
US 20210383931A1 · Spångberg · 2021 [cited by examiner]
US 20220241078A1 · Hermsen · 2022 [cited by examiner]
US 20220249239A1 · Williams · 2022 [cited by examiner]
US 20220257382A1 · Hermsen · 2022 [cited by examiner]
US 20220346965A1 · Schwartz · 2022 [cited by examiner]
US 20230190492A1 · Marks · 2023 [cited by examiner]
US 20230301794A1 · Marks · 2023 [cited by examiner]
US 20230381376A1 · Wiley · 2023 [cited by examiner]
US 20230414230A1 · Schwartz · 2023 [cited by examiner]
US 20240024113A1 · Torbati · 2024 [cited by examiner]
US 20240207052A1 · Oevering · 2024 [cited by examiner]
US 20240238094A1 · Wiley · 2024 [cited by examiner]
US 20240260852A1 · Berlet · 2024 [cited by examiner]
US 20240299175A1 · Ogilvie · 2024 [cited by examiner]
US 20240325154A1 · Ryd · 2024 [cited by examiner]
US 20240390154A1 · Julin · 2024 [cited by examiner]
US 20250025304A1 · Mai · 2025 [cited by examiner]
US 20250057658A1 · Arnold · 2025 [cited by examiner]
CA 3233740A1 · 2023 [cited by examiner]
DE 19820749A1 · 1999 [cited by examiner]
DE 102004043700A1 · 2006 [cited by examiner]
DE 102016224483A1 · 2017 [cited by examiner]
EP 3013256B1 · 2018 [cited by examiner]
FR 2727308A1 · 1996 [cited by examiner]
FR 2787013A1 · 2000 [cited by examiner]
FR 2858545A1 · 2005 [cited by examiner]
FR 2926212A1 · 2009 [cited by examiner]
FR 2940759A1 · 2010 [cited by examiner]
FR 2940760A1 · 2010 [cited by examiner]
FR 2997293A1 · 2014 [cited by examiner]
GB 2308068A · 1997 [cited by examiner]
WO WO9616613A1 · 1996 [cited by examiner]
WO WO0103613A1 · 2001 [cited by examiner]
WO WO0180772A1 · 2001 [cited by examiner]
WO WO2004026185A1 · 2004 [cited by examiner]
WO WO2006052874A2 · 2006 [cited by examiner]
WO WO2006099886A1 · 2006 [cited by examiner]
WO WO2007148220A2 · 2007 [cited by examiner]
WO WO2009073924A1 · 2009 [cited by examiner]
WO WO2014068210A1 · 2014 [cited by examiner]
WO WO2014207151A1 · 2014 [cited by examiner]
WO WO2016115172A1 · 2016 [cited by examiner]
WO WO2019022712A1 · 2019 [cited by examiner]
WO WO2021015831A1 · 2021 [cited by examiner]
WO WO2021150490A1 · 2021 [cited by examiner]
Yang et al., “A Synthetic Hydrogel Composite with the Mechanical Behavior and Durability of Cartilage”, Advanced Functional Materials, 2020, vol. 30, 2003451, 8 pages. [cited by applicant]
Zhao et al., “High-Strength Hydrogel Attachment through Nanofibrous Reinforcement”, Advanced Healthcare Materials, 2021, vol. 10, 2001119, 7 pages. [cited by applicant]
Zhao et al., “A Synthetic Hydrogel Composite with a Strength and Wear Resistance Greater than Cartilage”, Advanced Functional Materials, 2022, vol. 32, 2205662, 10 pages. [cited by applicant]
PCT/US2025/010774 International Search Report and Written Opinon mailed on Apr. 14, 2025, 14 pages. [cited by applicant]