System and method for providing iontophoresis at tympanic membrane

• US 10,130,808 B2
• Filed: 03/14/2013
• Issued: 11/20/2018
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Inventors: Kermani, Mahyar Z., Andreas, Bernard H., Girotra, Rohit, Saleki, Mansour A., Bhat, Nikhil D.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US13/804,491
• Publication Number:
  US 20140276352A1
• Time in Patent Office: 2,077 Days
• CPC Class Codes: A61F 11/00 Methods or devices for treatment of the ears or hearing sense implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

Various systems and methods provide iontophoretic delivery of anesthesia at a patient'"'"'s tympanic membrane. Some implementations provide channel switching enabling a single current sink to pull current through two electrodes in an alternating fashion based on clock pulses. The iontophoretic delivery of anesthesia may be driven by an AC modulated current. Some implementations provide for continuous flow of fresh iontophoresis fluid to the ear canal during iontophoresis. The fluid flows from a source reservoir into the cavity between the tympanic membrane and a plug, and then drains out of the cavity to a reservoir. An iontophoresis system may also detect capacitance between an anode electrode and an auxiliary electrode in a patient'"'"'s ear canal, watching for reduced capacitance to indicate presence of a bubble in the iontophoresis fluid.

Claims

1. An iontophoresis apparatus, comprising:

(a) a first earplug configured for insertion in a first ear of a patient, wherein the first earplug includes;

(i) a first electrode; and

(ii) a first fluid port operable to deliver fluid to the first ear;

(b) a second earplug configured for insertion in a second ear of the patient, wherein the second earplug includes;

(i) a second electrode; and

(ii) a second fluid port configured to deliver fluid to the second ear;

(c) a single ground pad configured to engage exposed skin of the patient and provide an electrical ground return path for the first electrode and the second electrode;

(d) a driving circuit comprising;

(i) a first channel configured to receive a first pulsed signal and activate to provide a path for drawing a first current through the first electrode;

(ii) a second channel configured to receive a second pulsed signal and activate to provide a path for drawing a second current through the second electrode; and

(iii) a current sink connected to the first and second channels, the current sink configured to alternate between drawing the first current through the first electrode via the first channel and the second current through the second electrode via the second channel; and

(e) a single control unit configured to couple with the first electrode, the second electrode, and the ground pad, the control unit including a first discharge circuit, a second discharge circuit, a first transistor, and a second transistor, the first discharge circuit being configured to couple to the first electrode downstream from a first transistor, and the second discharge circuit being configured to couple to the second electrode downstream from a second transistor,

wherein the control unit is configured to;

provide the first pulsed signal to the first channel and the second pulsed signal to the second channel at alternating clocked intervals;

alternate between discretely activating the first channel with the first pulsed signal for iontophoretic delivery of the fluid to tissue in the first ear and discretely activating the second channel with the second pulsed signal for iontophoretic delivery of the fluid to tissue in the second ear such that current is drawn through only one of the first electrode and the second electrode at a particular instant and the single ground pad operates as the electrical ground return path.

2. The iontophoresis apparatus of claim 1, wherein the control unit is further configured to provide alternating communication based on the alternating clocked intervals between:

(i) the first electrode and the current sink; and

(ii) the second electrode and the current sink.

3. The iontophoresis apparatus of claim 1, wherein the current sink includes an op-amp.

4. The iontophoresis apparatus of claim 3, wherein the current sink further includes a third transistor.

5. The iontophoresis apparatus of claim 4, wherein:

the op-amp is configured to have an inverting input, a non-inverting input, and an output; and

the third transistor is configured to couple to the output and provide the inverting input of the op-amp.

6. The iontophoresis apparatus of claim 5, wherein the third transistor is further configured to couple to the first and second channels.

7. The iontophoresis apparatus of claim 1, wherein:

the first transistor is configured to couple with the first electrode and receive the first pulsed signal and activate the first channel; and

the second transistor is configured to couple with the second electrode and receive the second pulsed signal and activate the second channel.

8. The iontophoresis apparatus of claim 7, wherein the first pulsed signal and the second pulsed signal are 180 degrees out of phase with each other.

9. The iontophoresis apparatus of claim 7, wherein:

the first discharge circuit is configured to receive a first input signal and discharge built-up charge across tissue in the first ear from the first electrode; and

the second discharge circuit is configured to receive a second input signal and discharge built-up charge across tissue in the second ear from the second electrode.

10. The iontophoresis apparatus of claim 1, wherein the first discharge circuit includes a fourth transistor configured to receive the first input signal and switch on, and wherein the second discharge circuit includes a fifth transistor configured to receive the second input signal and switch on.

11. The iontophoresis apparatus of claim 10, wherein the first discharge transistor is configured to provide a first discharge path for the built-up charge across tissue in the first ear when the first discharge transistor is switched on,

wherein the second discharge transistor is configured to provide a second discharge path for the built-up charge across tissue in the second ear when the second discharge transistor is switched on.

12. The iontophoresis apparatus of claim 11, wherein the first and second input signals are 180 degrees out of phase with each other.

13. The iontophoresis apparatus of claim 11, wherein the control unit is configured to:

provide the first current through the first electrode while the second discharge transistor receives the second input signal; and

provide the second current through the second electrode while the first discharge transistor receives the first input signal.

14. The iontophoresis apparatus of claim 13, wherein the control unit is further configured to:

stop the first current through the first electrode when the first discharge transistor receives the first input signal; and

stop the second current through the second electrode when the second discharge transistor receives the second input signal.

15. The iontophoresis apparatus of claim 1, wherein current drawn through the first and second electrodes is a modulated AC current.

16. The iontophoresis apparatus of claim 8, wherein the first pulsed signal and the second pulsed signal have a common frequency that is configured to provide substantially simultaneous activation of the first electrode and the second electrode.

17. The iontophoresis apparatus of claim 12, wherein the first input signal is the second pulsed signal and the second input signal is the first pulsed signal.

18. The iontophoresis apparatus of claim 1, wherein the control unit is further configured to regulate iontophoretic delivery to the first and second ears by monitoring current drawn through the first and second electrodes.

19. The iontophoresis apparatus of claim 1, wherein the first discharge circuit is configured to discharge a charge remaining in the first electrode after the first current is drawn through the first electrode and the second discharge circuit is configured to discharge a charge remaining in the second electrode after the second current is drawn through the second electrode.

20. An iontophoresis apparatus, comprising:

(a) a first earplug configured for insertion in a first ear of a patient, wherein the first earplug includes;

(i) a first electrode; and

(ii) a first fluid port operable to deliver fluid to the first ear;

(b) a second earplug configured for insertion in second ear of the patient, wherein the second earplug includes;

(i) a second electrode; and

(ii) a second fluid port configured to deliver fluid to the second ear;

(c) a single ground pad configured to engage exposed skin of the patient and provide an electrical ground return path for the first electrode and the second electrode;

(d) a driving circuit comprising;

(i) a first channel configured to receive a first pulsed signal and activate to provide a path for drawing a first current through the first electrode;

(ii) a second channel configured to receive a second pulsed signal and activate to provide a path for drawing a second current through the second electrode; and

(iii) a current sink connected to the first and second channels, the current sink configured to alternate between drawing the first current through the first electrode via the first channel and the second current through the second electrode via the second channel; and

(e) a single control unit configured to couple with the first electrode, the second electrode, and the ground pad, the control unit including;

(i) a first transistor configured to couple with the first electrode, the first transistor configured to receive the first pulsed signal and activate the first channel;

(ii) a second transistor configured to couple with the second electrode, the second transistor configured to receive the second pulsed signal and activate the second channel,

(iii) a first discharge circuit configured to couple with the first electrode, the first discharge circuit being configured to receive a first input signal and discharge built-up charge across tissue in the first ear from the first electrode; and

(iv) a second discharge circuit configured to couple with the second electrode, the second discharge circuit being configured to receive a second input signal and discharge built-up charge across tissue in the second ear from the second electrode, the first discharge circuit including a first discharge transistor configured to receive the first input signal and switch on, the second discharge circuit including a second discharge transistor configured to receive the second input signal and switch on, the control unit being configured to;

provide the first pulsed signal to the first channel and the second pulsed signal to the second channel at alternating clocked intervals;

alternate between discretely activating the first channel with the first pulsed signal for iontophoretic delivery of the fluid to tissue in the first ear and discretely activating the second channel with the second pulsed signal for iontophoretic delivery of the fluid to tissue in the second ear such that current is drawn through only one of the first electrode and the second electrode at a particular instant and the single ground pad operates as the electrical ground return path.