IP Library › Granted Patent US 12,245,850
Granted Patent B2
US 12,245,850 · App. 18/524,436 · Granted Mar 11, 2025

System and method of utilizing ECG signal for static catheter tip confirmation

Inventors: Anthony D. DeCheek (Salt Lake City, UT); Anthony K. Misener (Bountiful, UT)
Assignee: Bard Access Systems, Inc.
A61B5/061A61B5/349A61B5/6852A61M25/0068A61M25/0158A61M25/09A61M2025/0166A61M2205/0233A61M2205/581A61M2205/582A61M2205/583A61M2210/125A61M2230/04
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Quick Facts
Patent No.
US 12,245,850
App. No.
18/524,436
Granted
Mar 11, 2025
Kind
B2
Abstract

Systems and methods for confirming the tip location of a catheter. The system can include an ivECG acquisition module for receiving ECG data from an implanted endovascular device and a notification module. The system can calculate PxI and distance parameters to determine the location of the tip of the implanted endovascular device relative to a predetermined location such as the cavoatrial junction. The system can use chaos theory and the concept of self-organized criticality (SOC) to determine parameters where P-waves are absent or atypical. The notification module can include one or more of an audio signal, a video signal, and a tactile signal. Also disclosed are systems and methods of establishing an electrical pathway within a previously positioned catheter, including saline columns and electrically conductive guidewires.

Claims (14)

1. A system for confirming a tip location of a catheter previously placed within a patient, the system comprising:

an ivECG acquisition module;

a multiscale complexity analysis module;

a notification module, including one or more features selected from an audio feature, a video feature, and a tactile feature; and

an adaptor configured to couple to the catheter previously placed within the patient, the adaptor configured to establish an electrical pathway with the ivECG acquisition module via a saline column or an electrically conductive device,

wherein the multiscale complexity analysis module uses ivECG signals, provided by the ivECG acquisition module and the electrical pathway, to provide a PxI (proximity index), the notification module indicating a location of a distal tip of the catheter relative to a predetermined target location.

2. The system of claim 1 , wherein the electrical pathway includes an embedded electrode extending from a proximal hub to the distal tip of the catheter.

3. The system of claim 1 , wherein the electrically conductive device is configured to be disposed within a lumen of the catheter, extending from a proximal hub to the distal tip thereof.

4. The system of claim 3 , wherein the electrically conductive device includes one of a stylet, a guidewire, and a trocar.

5. The system of claim 1 , wherein the electrical pathway includes the saline column extending from a proximal hub to the distal tip of the catheter.

6. The system of claim 1 , wherein the catheter is selected from the group consisting of a central venous catheter (CVC), a peripherally inserted central catheter (PICC), a hemodialysis catheter, a tunneled catheter, and a guiding catheter.

7. The system of claim 1 , wherein the notification module includes the audio feature and the video feature.

8. The system of claim 1 , wherein the notification module includes the tactile feature.

9. The system of claim 1 , wherein the system further comprises one or more external electrodes to provide an external ECG.

Continuity (3)
Continuation 16938700 · Jul 24, 2020
Provisional Application 62879342 · Jul 26, 2019
Related Publication 20240099604A1 · Mar 28, 2024
References Cited (46)
US 7289844B2 · Misczynski et al. · 2007 [cited by applicant]
US 9463301B2 · Bukhman · 2016 [cited by applicant]
US 9999750B2 · Bukhman · 2018 [cited by applicant]
US 10722686B2 · Bukhman · 2020 [cited by applicant]
US 11918339B2 · Decheek · 2024 [cited by examiner]
US 20080234978A1 · Neumann et al. · 2008 [cited by applicant]
US 20090005675A1 · Grunwald et al. · 2009 [cited by applicant]
US 20090156926A1 · Messerly et al. · 2009 [cited by applicant]
US 20090259124A1 · Rothenberg · 2009 [cited by applicant]
US 20100036227A1 · Cox · 2010 [cited by examiner]
US 20100261977A1 · Seely · 2010 [cited by applicant]
US 20100317981A1 · Grunwald · 2010 [cited by applicant]
US 20120143029A1 · Silverstein et al. · 2012 [cited by applicant]
US 20130150740A1 · Narayan et al. · 2013 [cited by applicant]
US 20140249505A1 · Bukhman · 2014 [cited by examiner]
US 20150216446A1 · Bukhman et al. · 2015 [cited by applicant]
US 20160228019A1 · Grunwald et al. · 2016 [cited by applicant]
US 20170021131A1 · Bukhman · 2017 [cited by applicant]
US 20180296796A1 · Bukhman · 2018 [cited by applicant]
US 20210023341A1 · Decheek et al. · 2021 [cited by applicant]
CN 101939738A · 2011 [cited by applicant]
GB 2335747A · 1999 [cited by applicant]
WO 2009043144A1 · 2009 [cited by applicant]
WO 2010125116A1 · 2010 [cited by applicant]
WO 2012040487A1 · 2012 [cited by applicant]
WO 2014137841A1 · 2014 [cited by applicant]
WO 2021021663A1 · 2021 [cited by applicant]
CN 201480011618.6 filed Aug. 31, 2015 Office Action dated Jun. 27, 2017. [cited by applicant]
CN 201480011618.6 filed Aug. 31, 2015 Office Action dated Mar. 29, 2018. [cited by applicant]
EP 14760648.7 filed Aug. 31, 2015 Supplementary Search Report dated Sep. 2, 2016. [cited by applicant]
EP 20846962.7 filed Feb. 9, 2022 Extended European Search Report dated Jul. 6, 2023. [cited by applicant]
PCT/US2014/019664 filed Feb. 28, 2014 International Search Report and Written Opinion dated May 30, 2014. [cited by applicant]
PCT/US2020/043580 filed Jul. 24, 2020 International Search Report and Written Opinion dated Oct. 19, 2020. [cited by applicant]
Pittiruti, et al. “The EKG Method for Positioning the Tip of PICCs: Results from Two Preliminary Studies.” JAVA, vol. 13, No. 4, pp. 179-185, 2008. [cited by applicant]
U.S. Appl. No. 13/844,755, filed Mar. 15, 2013 Non-Final Office Action dated Feb. 25, 2015. [cited by applicant]
U.S. Appl. No. 13/844,755, filed Mar. 15, 2013 Notice of Allowance dated Aug. 28, 2015. [cited by applicant]
U.S. Appl. No. 14/772,069, filed Sep. 1, 2015 Non-Final Office Action dated Apr. 27, 2016. [cited by applicant]
U.S. Appl. No. 15/286,418, filed Oct. 5, 2016 Advisory Action dated Dec. 1, 2017. [cited by applicant]
U.S. Appl. No. 15/286,418, filed Oct. 5, 2016 Final Office Action dated Oct. 12, 2017. [cited by applicant]
U.S. Appl. No. 15/286,418, filed Oct. 5, 2016 Non-Final Office Action dated Jun. 23, 2017. [cited by applicant]
U.S. Appl. No. 15/286,418, filed Oct. 5, 2016 Notice of Allowance dated Jan. 17, 2018. [cited by applicant]
U.S. Appl. No. 16/011,409, filed Jun. 18, 2018 Final Office Actino dated Apr. 23, 2020. [cited by applicant]
U.S. Appl. No. 16/011,409, filed Jun. 18, 2018 Non-Final Office Actino dated Jan. 29, 2020. [cited by applicant]
U.S. Appl. No. 16/938,700, filed Jul. 24, 2020 Non-Final Office Action dated Jun. 22, 2023. [cited by applicant]
U.S. Appl. No. 16/938,700, filed Jul. 24, 2020 Notice of Allowance dated Oct. 17, 2023. [cited by applicant]
U.S. Appl. No. 16/938,700, filed Jul. 24, 2020 Restriction Requirement dated Mar. 2, 2023. [cited by applicant]