Granted Patent B2

US 12,268,606 · App. 17/616,448 · Granted Apr 8, 2025

Inventors: Jason M. Maranhao (Warwick, RI); Brian R. Peterson (East Aurora, NY); Jackson G. Hobble (Buffalo, NY); Mary K. Canty (Tonawanda, NY)

Assignee: Garwood Medical Devices, LLC

A61F2/30A61N1/025A61N1/08A61N1/205A61F2002/30719A61F2002/4674A61F2310/00017A61F2310/00023A61F2310/00029

Abstract

Claims (54)

1. A method of providing cathodic voltage controlled electrical stimulation comprising:

providing a metallic object to be treated that serves as a working electrode;

applying a polarization scan to the metallic object to be treated;

using a processor, autonomously detecting a hydrogen evolution reaction threshold from the polarization scan to determine a cathodic voltage to be applied to the object to be treated wherein the processor is programmed to detect specific inflection points in the applied polarization scan in order to precisely detect the cathodic voltage; and,

applying the determined cathodic voltage to the metallic object to be treated, wherein the method further comprises:

initiating the polarization scan at an open circuit potential and scanning cathodically to a target voltage that enables the detection of the hydrogen evolution reaction by the polarization scan, followed by analyzing the polarization scan in real time; and

detecting a first change in slope in the polarization scan indicative of an oxygen reduction reaction prior to detecting the second change in slope in the polarization scan that indicates the hydrogen evolution reaction.

2. The method according to claim 1 , wherein the metallic object to be treated is an implantable medical device.

3. The method according to claim 1 , further providing an anode that represents a counter electrode and in which the metallic object represents the working electrode.

4. The method according to claim 3 , further providing a potentiostat so that an electrochemical process occurs on the working electrode that can be monitored.

5. The method according to claim 1 , further comprising:

measuring voltage at the first and second changes in slope in the polarization scan; and

comparing the measured voltages to specific voltage ranges.

6. The method according to claim 5 , further comprising:

measuring the span between the measured voltages at the first and second changes in slope; and

comparing the measured span to a specific voltage span in order to deduce the metal of the object.

7. The method according to claim 6 , and upon determination of the metal of the object, further comprising:

increasing the voltage to a specified treatment voltage upon determination of the metal of the object that is optimal for biofilm removal;

measuring the charge transfer relative to the object; and

terminating the treatment after the measured charge transfer reaches a predetermined level.

8. The method according to claim 1 , further comprising:

detecting a change in slope of the polarization scan indicative of the hydrogen evolution reaction;

determining current density based on measured current and the surface area of the object following detection of the change in slope;

comparing the determined current density to a target current density; and

applying the voltage as a treatment voltage if the determined target current density is equal to the target current density.

9. The method according to claim 8 , further comprising:

increasing the voltage if the current density is below the target current density and a measured current is over a predetermined current threshold;

decreasing the voltage if the current density is above the target current density and a measured current is under a predetermined current threshold; and

comparing the current density after increasing or decreasing the voltage to the target current density.

10. A device for controlling a cathodic stimulation voltage for treatment of a metallic object, the device comprising:

a processor configured for connection to a potentiostat;

working, counter and reference electrodes coupled to the potentiostat, wherein the working electrode is the metallic object to be treated;

wherein the processor is programmed to:

apply a polarization scan to the metallic object to be treated and generate polarization data;

using the processor, autonomously detect a hydrogen evolution reaction threshold from the generated polarization data for determining a cathodic voltage to be applied to the metallic object to be treated for removal of biofilm wherein the processor is programmed to detect various inflection points of the applied polarization scan to determine the cathodic voltage; and,

apply the determined cathodic voltage to the metallic object to be treated, wherein the processor is further programmed to:

initiate the polarization scan at an open circuit potential and scan in a negative direction to a target voltage that enables detection of the hydrogen evolution reaction from the polarization data in real time; and

detect a first change in slope in the polarization data indicative of an oxygen reduction reaction prior to detecting a second change in slope in the polarization data indicative of the hydrogen evolution reaction.

11. The device according to claim 10 , wherein the object is a surgical implant.

12. The device according to claim 10 , in which the device is separately connected to the potentiostat.

13. The device according to claim 10 , in which the device is integrated into the potentiostat.

14. The device according to claim 12 , in which the processor is further programmed to measure voltages at the first and second changes in slope in the polarization data and compare the measured voltages to predetermined voltage ranges.

15. The device according to claim 14 , in which the processor is further programmed to measure the span between the measured voltages at the first and second changes in slope and compare the measured span to a specific voltage scan or scan range, enabling the metal composition of the object to be determined.

16. The device according to claim 15 , wherein the processor is further programmed to cathodically increase the voltage to a treatment voltage following deduction of the metal composition of the object.

17. The device according to claim 16 , wherein the processor is further programmed to measure the charge transfer relative to the object following the cathodical increase to the treatment voltage, and terminate the treatment after the measured charge transfer reaches a predetermined level.

18. The device according to claim 10 , wherein the processor is further programmed to:

detect a change in slope of the polarization data indicative of the hydrogen evolution reaction;

determine current density based on measured current and the surface area of the object following detection of the change in slope;

compare the determined current density to a target current density; and

apply a suitable treatment voltage if the determined target current density is equal to the target current density.

19. The device according to claim 18 , wherein the processor is further programmed to:

cathodically increase the voltage if the current density is below the target current density and a measured current is greater than a predetermined current threshold;

decrease the voltage if the current density is above the target current density and a measured current is less than a predetermined current threshold; and

compare the current density after increasing or decreasing the voltage to the target current density.

Assignments (4)

Continuity (2)

References Cited (19)