IP Library Granted Patent US 12,465,408
Granted Patent B2
US 12,465,408 · App. 18/062,867 · Granted Nov 11, 2025

Spinal rod connecting components with active sensing capabilities

Inventors: Newton H. Metcalf (Memphis, TN); Arjun Siby-Kurian (Memphis, TN); Mark C. Dace (Collierville, TN); Steven C. Alley (Germantown, TN)
Assignee: WARSAW ORTHOPEDIC, INC.
A61B17/7032A61B5/0031A61B5/4566A61B5/4851A61B5/686A61B2562/0261A61F2/44A61F2002/4666
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Quick Facts
Patent No.
US 12,465,408
App. No.
18/062,867
Granted
Nov 11, 2025
Kind
B2
Abstract

A digital pedicle screw assembly may be installed inside of the body of a patient and be configured to sense various attributes of the assembly and the patient. Embodiments may include a receiver having a U-shaped cavity for supporting a longitudinal rod and set screw therein. The receiver may include a lower cavity configured to couple to a pedicle screw and a side portion integrally connected to the receiver and including a housing defining a sealed cavity for supporting a microelectronics assembly and a battery therein. Embodiments may include at least one antenna attached to an outside of the housing and being in electrical communication with the microelectronics assembly, and at least one strain gauge configured to detect a localized force experienced by the receiver and being in electrical communication with the microelectronics assembly.

Claims (28)

1 . A load sensing spinal implant, comprising:

a receiver comprising a U-shaped cavity for supporting a longitudinal rod and set screw therein, the receiver including a lower cavity configured to couple to a pedicle screw;

a side portion integrally connected to the receiver and including a housing defining a sealed cavity for supporting a microelectronics assembly and a battery therein;

at least one antenna attached to an outside of the housing and being in electrical communication with the microelectronics assembly; and

at least one strain gauge configured to detect a localized force experienced by the receiver and being in electrical communication with the microelectronics assembly;

wherein the at least one antenna is configured to transmit information received from the at least one strain gauge to an external device,

wherein the receiver is connected to the side portion by an isolation beam, and

wherein the isolation beam further comprises an internal cylindrical cavity that extends through the isolation beam and into the cavity defined by the housing, the at least one strain gauge being disposed inside of the cylindrical cavity.

2 . The load sensing spinal implant of claim 1 , wherein the at least one antenna is configured to utilize a Medical Implant Communication System (MICS) technology.

3 . The load sensing spinal implant of claim 1 , wherein the at least one antenna is configured to utilize a Bluetooth low energy (BLE) technology.

4 . The load sensing spinal implant of claim 1 , wherein an overmold is configured to surround the at least one antenna thereby forming a hermetic seal over the at least one antenna.

5 . The load sensing spinal implant of claim 1 , wherein the sealed cavity is hermetically sealed.

6 . The load sensing spinal implant of claim 1 , wherein at least one pass through connection extends through a sidewall of the housing thereby placing the at least one antenna in electrical communication with the microelectronics assembly.

7 . The load sensing spinal implant of claim 1 , wherein the housing further comprises a cover configured to seal an opening of the cavity for placing the microelectronics assembly therein.

8 . The load sensing spinal implant of claim 7 , wherein the cover is welded to the housing.

9 . The load sensing spinal implant of claim 1 , further comprising at least one of: a temperature sensor, an accelerometer sensor, a gyroscope sensor, and an impedance sensor.

10 . The load sensing spinal implant of claim 1 , further comprising the microelectronics assembly, wherein the microelectronics assembly further comprises a memory storage configured to periodically store information received from the at least one strain gauge.

11 . The load sensing spinal implant of claim 1 , further comprising the microelectronics assembly, wherein the microelectronics assembly further comprises a wake-up sensor configured to power up the microelectronics assembly and cause the at least one antenna to initiate a transmission of information to the external device.

12 . The load sensing spinal implant of claim 1 , wherein a size and shape of the at least one strain gauge corresponds to a diameter of the cylindrical cavity.

13 . The load sensing spinal implant of claim 1 , wherein the at least one strain gauge is disposed within a cavity inside of the receiver at a relative height that disposes the at least one strain gauge at a height that is above a lower surface of the U-shaped cavity.

14 . The load sensing spinal implant of claim 1 , wherein the at least one strain gauge is disposed within a cavity inside of the receiver at a relative height that disposes the at least one strain gauge at a height that is below a lower surface of the U-shaped cavity.

15 . A load sensing spinal implant, comprising:

a receiver comprising a U-shaped cavity for supporting a longitudinal rod and set screw therein, the receiver including a lower cavity configured to couple to a pedicle screw;

a side portion integrally connected to the receiver by an isolation beam, the side portion including a housing defining a sealed cavity for supporting a microelectronics assembly and a battery therein;

at least one antenna attached to an outside of the housing and being in electrical communication with the microelectronics assembly, the at least one antenna being configured to utilize a Medical Implant Communication System (MICS) technology; and

at least one strain gauge disposed in a region corresponding to the isolation beam, the at least one strain gauge being configured to detect a localized force experienced by the receiver and being in electrical communication with the microelectronics assembly,

wherein the at least one antenna is configured to transmit information received from the at least one strain gauge to an external device, and

wherein the isolation beam further comprises an internal cylindrical cavity that extends through the isolation beam and into the cavity defined by the housing, the at least one strain gauge being disposed inside of the cylindrical cavity on a sidewall thereof closest to the U-shaped cavity.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 7, 2022
From: METCALF, NEWTON H.; SIBY-KURIAN, ARJUN; DACE, MARK C.; ALLEY, STEVEN C.
To: WARSAW ORTHOPEDIC, INC.
Reel/Frame 062013/0823 →
Continuity (2)
Provisional Application 63329982 · Apr 12, 2022
Related Publication 20230320760A1 · Oct 12, 2023
References Cited (119)
US 3444775A · Hills · 1969 [cited by applicant]
US 5697929A · Mellinger · 1997 [cited by applicant]
US 6004349A · Jackson · 1999 [cited by applicant]
US 6179841B1 · Jackson · 2001 [cited by applicant]
US 6280445B1 · Morrison et al. · 2001 [cited by applicant]
US 6485491B1 · Farris et al. · 2002 [cited by applicant]
US 6884244B1 · Jackson · 2005 [cited by applicant]
US 7357037B2 · Hnat et al. · 2008 [cited by applicant]
US 7993269B2 · Donofrio et al. · 2011 [cited by applicant]
US 8057519B2 · Justis et al. · 2011 [cited by applicant]
US 8372147B2 · Roche · 2013 [cited by applicant]
US 8868200B2 · Abrahamson et al. · 2014 [cited by applicant]
US 8882803B2 · Iott et al. · 2014 [cited by applicant]
US 9241738B2 · Quevedo et al. · 2016 [cited by applicant]
US 9498294B2 · Rigsby et al. · 2016 [cited by applicant]
US 9585602B1 · Navarro et al. · 2017 [cited by applicant]
US 9711840B2 · Lin · 2017 [cited by applicant]
US 10219699B2 · Wilder et al. · 2019 [cited by applicant]
US 10362982B2 · Stevenson et al. · 2019 [cited by applicant]
US 20030073996A1 · Doubler et al. · 2003 [cited by applicant]
US 20050018749A1 · Sato et al. · 2005 [cited by applicant]
US 20050187549A1 · Jackson · 2005 [cited by applicant]
US 20050228326A1 · Kalfas et al. · 2005 [cited by applicant]
US 20050267477A1 · Jackson · 2005 [cited by applicant]
US 20060052782A1 · Morgan et al. · 2006 [cited by applicant]
US 20070017295A1 · Ohta et al. · 2007 [cited by applicant]
US 20070073300A1 · Attawia et al. · 2007 [cited by applicant]
US 20070100218A1 · Sweitzer et al. · 2007 [cited by applicant]
US 20080133009A1 · Caylor · 2008 [cited by applicant]
US 20080281212A1 · Nunez et al. · 2008 [cited by applicant]
US 20090143696A1 · Najafi et al. · 2009 [cited by applicant]
US 20090171178A1 · He et al. · 2009 [cited by applicant]
US 20090198273A1 · Zhang et al. · 2009 [cited by applicant]
US 20090228074A1 · Edgell · 2009 [cited by examiner]
US 20090234391A1 · Butler et al. · 2009 [cited by applicant]
US 20090298650A1 · Kutliroff · 2009 [cited by applicant]
US 20100152621A1 · Janna et al. · 2010 [cited by applicant]
US 20100201118A1 · Anton et al. · 2010 [cited by applicant]
US 20100217331A1 · Spagnoli et al. · 2010 [cited by applicant]
US 20100298886A1 · Kraus et al. · 2010 [cited by applicant]
US 20110106179A1 · Prevost et al. · 2011 [cited by applicant]
US 20110213221A1 · Roche · 2011 [cited by applicant]
US 20110319755A1 · Stein et al. · 2011 [cited by applicant]
US 20120059389A1 · Larson · 2012 [cited by examiner]
US 20120143029A1 · Silverstein et al. · 2012 [cited by applicant]
US 20120221057A1 · Zhang et al. · 2012 [cited by applicant]
US 20130072982A1 · Simonson · 2013 [cited by applicant]
US 20130076157A1 · Stein · 2013 [cited by applicant]
US 20130079669A1 · Stein et al. · 2013 [cited by applicant]
US 20130079680A1 · Stein et al. · 2013 [cited by applicant]
US 20130096396A1 · Riedel · 2013 [cited by applicant]
US 20130253334A1 · Al-Ali et al. · 2013 [cited by applicant]
US 20140214097A1 · Jackson et al. · 2014 [cited by applicant]
US 20150080901A1 · Stein · 2015 [cited by applicant]
US 20150164401A1 · Toth et al. · 2015 [cited by applicant]
US 20150201974A1 · DeRidder et al. · 2015 [cited by applicant]
US 20150257687A1 · Pushpala · 2015 [cited by examiner]
US 20160128573A1 · Wilder · 2016 [cited by examiner]
US 20160235480A1 · Scholl et al. · 2016 [cited by applicant]
US 20160331415A1 · Serhan et al. · 2016 [cited by applicant]
US 20170007420A1 · Stevenson et al. · 2017 [cited by applicant]
US 20170079555A1 · Munro et al. · 2017 [cited by applicant]
US 20170138387A1 · Saigo et al. · 2017 [cited by applicant]
US 20170196499A1 · Hunter · 2017 [cited by applicant]
US 20170196508A1 · Hunter · 2017 [cited by applicant]
US 20170231559A1 · Cuevas et al. · 2017 [cited by applicant]
US 20180195547A1 · Demeocq · 2018 [cited by applicant]
US 20180310964A1 · Stevenson · 2018 [cited by examiner]
US 20190038214A1 · Mikhail et al. · 2019 [cited by applicant]
US 20190344070A1 · Molnar · 2019 [cited by examiner]
US 20190346313A1 · Cox · 2019 [cited by applicant]
US 20200022733A1 · Benson · 2020 [cited by examiner]
US 20200022735A1 · Fields · 2020 [cited by examiner]
US 20200022739A1 · Benson et al. · 2020 [cited by applicant]
US 20200022740A1 · Benson · 2020 [cited by examiner]
US 20200022772A1 · Benson · 2020 [cited by examiner]
US 20200069247A1 · Hunter · 2020 [cited by applicant]
US 20200085366A1 · Benson et al. · 2020 [cited by applicant]
US 20200297513A1 · Zellmer et al. · 2020 [cited by applicant]
US 20200330230A1 · Macewan et al. · 2020 [cited by applicant]
US 20200405239A1 · Trabish et al. · 2020 [cited by applicant]
US 20210153909A1 · Siby-Kurian et al. · 2021 [cited by applicant]
US 20210186567A1 · Bobbitt et al. · 2021 [cited by applicant]
US 20210361377A1 · Metcalf et al. · 2021 [cited by applicant]
US 20220160428A1 · Murray et al. · 2022 [cited by applicant]
US 20220273391A1 · Metcalf, Jr. et al. · 2022 [cited by applicant]
US 20220378370A1 · Pasha · 2022 [cited by examiner]
CN 103140168A · 2013 [cited by applicant]
CN 110582229A · 2019 [cited by applicant]
JP 2015532841A · 2015 [cited by applicant]
KR 101851690B1 · 2018 [cited by applicant]
WO 2013109762A1 · 2013 [cited by applicant]
WO 15200720A2 · 2015 [cited by applicant]
WO 2017006068A1 · 2017 [cited by applicant]
WO 2017007821A1 · 2017 [cited by applicant]
WO 2017165717A1 · 2017 [cited by applicant]
WO 2017180653A1 · 2017 [cited by applicant]
WO 2020018862A1 · 2020 [cited by applicant]
International Search Report and Written Opinion in Application No. PCT/IB2023/053707 dated Jul. 24, 2023. [cited by applicant]
Chinese Office Action in Application No. 201980047442.2 dated Jun. 27, 2023. [cited by applicant]
International Search Report, PCT/US2019/042511, Oct. 31, 2019. [cited by applicant]
International Search Report, PCT/US2019/042516, Oct. 31, 2019. [cited by applicant]
International Search Report and Written Opinion in Application No. PCT/US2019/050717 mailed Jan. 3, 2020. [cited by applicant]
International Search Report and Written Opinion in Application No. PCT/US2020/041487 mailed Nov. 2, 2020. [cited by applicant]
Rodriguez-Martin, et al. “A wearable inertial measurement unit for long-term monitoring in the dependency care area.” Sensors 13.10 (2013): 14079-14104. (Year: 2016). [cited by applicant]
Conway, Justin, Christy C. Tomkins, and Andrew J. Haig. “Walking assessment in people with lumbar spinal stenosis: capacity, performance, and self-report measures.” The Spine Journal 11.9 (2011): 816-823. (Year: 2011). [cited by applicant]
Trost, et al. “Conducting accelerometer-based activity assessments in field-based research.” Medicine & Science in Sports & Exercise 37.11 (2005): S531-S543. (Year: 2005). [cited by applicant]
Liu, Ye, et al. “From action to activity: sensor-based activity recognition.” Neurocomputing 181 (2016): 108-115. (Year: 2016). [cited by applicant]
Ahmadi, Amin, et al. “Automatic activity classification and movement assessment during a sports training session using wearable inertial sensors.” 2014 11th International Conference on Wearable and Implantable Body Sens… [cited by applicant]
European Search Report in Application No. 21168012.9 dated Sep. 20, 2021. [cited by applicant]
European Search Report in Application No. 19838132.9 dated Apr. 4, 2022. [cited by applicant]
European Search Report in Application No. 19837036.3 dated Apr. 4, 2022. [cited by applicant]
European Search Report in Application No. 19838911.6 dated Apr. 4, 2022. [cited by applicant]
International Search Report and Written Opinion in Application No. PCT/IB2023/053705 dated Jul. 7, 2023. [cited by applicant]
European Search Report in Application No. 20837889 dated Apr. 25, 2023. [cited by applicant]
Karipott Salil Sidharthan et al: “An Embedded Wireless Temperature Sensor for Orthopedic Implants”, IEEE Sensors Journal, IEEE, USA, vol. 18, No. 3, Feb. 1, 2018 (Feb. 1, 2018), pp. 1265-1272, XP011675608, ISSN: 1530-43… [cited by applicant]
International Search Report and Written Opinion in Application No. PCT/IB2023/053713 dated Jul. 28, 2023. [cited by applicant]
Chinese Office Action in Application No. 202110429353.3 dated Feb. 17, 2025. [cited by applicant]
International Search Report in Application No. PCT/IB2024/054039 date of completion is Jun. 27, 2024 (13 pages). [cited by applicant]