Uterine electrical stimulation system and method

• US 9,731,120 B2
• Filed: 11/05/2013
• Issued: 08/15/2017
• Est. Priority Date: 04/07/2009
• Status: Active Grant

• Current Assignee: Dignity Health (CommonSpirit Health (Illinois))
• Original Assignee: Dignity Health (CommonSpirit Health (Illinois))
• Inventors: Carp, Harvey, Maner, William L., Garfield, Robert E.
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US14/072,716
• Publication Number:
  US 20140058473A1
• Time in Patent Office: 1,379 Days
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

Some embodiments of the invention provide a system and method for treating insufficient uterine contractions after labor and delivery. The system includes a control module and a current source controlled by the control module to produce stimulating current at a frequency greater than or equal to about 5.0 Hertz. The system also includes one or more stimulation electrodes to provide the stimulating current to the patient in order for the patient to produce tonic uterine contractions.

Claims

1. A system for treating insufficient uterine contractions in a patient after labor and delivery, the system comprising:

a control module which performs at least one of preprogrammed stimulation tasks and user-defined stimulation tasks including a combination of parameters configured to produce tonic uterine contractions, wherein pre-recorded uterine electrical traces obtained from normal contracting patients after labor and delivery are saved digitally within memory of the control module;

a current source controlled by the control module to produce biphasic, sinusoidal, tonic uterine muscle contraction stimulating current at a frequency greater than 5.0 Hertz with patterns identical to the pre-recorded uterine electrical traces;

one or more stimulation electrodes coupled to one of a uterus, a cervix, a vaginal wall, and an abdominal wall of the patient; and

wherein the control module is configured to control the current source to deliver stimulating current to the one or more electrodes during uterine atony after labor and delivery to provide the stimulating current to the patient in order for the patient to produce tonic uterine contractions that are initiated by the stimulating current and are global uterine contractions sustained for a time period after the stimulating current has been stopped.

2. The system of claim 1 and further comprising an isolation unit which prevents ground loop currents within the stimulating current produced by the current source from adversely affecting the patient.

3. The system of claim 2, wherein isolation is accomplished by the isolation unit using one of optical isolation and induction.

4. The system of claim 1 and further comprising a constant maximum current unit which regulates an amount of the stimulating current produced by the current source to be applied to the patient'"'"'s uterus;

wherein the stimulating current is regulated to a value between 0.01 milliamperes and 40 milliamperes to prevent tissue damage to the patient.

5. The system of claim 1, wherein the current source includes a biphasic converter which alternates a polarity of the stimulating current produced by current source, such that the stimulating current, as integrated over time, has a net value of zero, in order to prevent tissue damage to the patient.

6. The system of claim 1 and further comprising one or more lead wires which provide the stimulating current to the one or more electrodes.

7. The system of claim 6, wherein at least one of the one or more lead wires carry different types or strengths of the stimulating current to one of incite, induce, and augment tonic uterine contractions, as controlled by the control unit, and at least some of the one or more lead wires apply the stimulating currents to the electrodes at different times, as controlled by the control unit.

8. The system of claim 6, wherein the one or more stimulation electrodes includes between 1 and 10 stimulation electrodes, and the one or more lead wires includes between 1 and 10 lead wires.

9. The system of claim 1, wherein the one or more stimulation electrodes are coupled to one of the uterus, the cervix, the vaginal wall and the abdominal wall of the patient via one of biocompatible glue, tissue adhesive, suction, and additional self-affixing electrodes.

10. The system of claim 1, wherein the one or more stimulation electrodes include at least one of silver chloride electrodes, EEG electrodes, suction electrodes, and needle electrodes.

11. The system of claim 1, wherein the one or more stimulation electrodes include platinum-iridium metals.

12. The system of claim 1, wherein the one or more stimulation electrodes are positioned with reference to the uterus to have phasic and tonic contractile effects upon the uterus according to the electrical stimulus applied through them;

wherein at least one of the one or more stimulation electrodes acts as a local pacemaker for eliciting the tonic uterine contractions, and at least another of the one or more stimulation electrodes transmits stimulating current to the uterus for eliciting the tonic uterine contractions.

13. The system of claim 1, wherein the control module performs the preprogrammed stimulation tasks and the user-defined stimulation tasks to control the current source to output the stimulating current at a desired frequency, amplitude, pulse width, and train duration automatically for selected periods of time;

wherein the user-defined stimulation tasks can be set by a user in near-real time using at least one of dials, switches, and auxiliary inputs of the control module and the preprogrammed stimulation tasks and the user-defined stimulation tasks can be initiated by at least one of the dials, the switches, and the auxiliary inputs of the control module.

14. The system of claim 1, wherein the current source produces the stimulating current, as commanded by the control module, with current amplitude ranging from 0.01 milliamperes to 40.00 milliamperes, with voltage ranging from 0.0001 volts to 100 volts, with pulse widths ranging from 0.1 milliseconds to 1000 milliseconds, with frequencies from 5.0 Hertz to 30 Hertz, and with pulse train durations ranging from 1 second to 10,000 seconds.

15. The system of claim 1, wherein the current source provides a jolt of uterine electrical stimulation energy equivalent to between 1 Joule and 120 Joules of electrical energy in a duration between 1 milliseconds and 1000 milliseconds.

16. The system of claim 1, wherein the current source includes a plurality of stimulation outputs which are provided to the patient one of independently and in unison;

wherein at least some of the plurality of outputs include at least one of different current frequencies, different amplitudes, different pulse widths, and different train durations.

17. The system of claim 1, wherein the control module includes one of a video display, a digital display, and a light-emitting diode display to display the stimulating currents produced for a user to read and assess.

18. The system of claim 1, wherein the control module and the current source are coupled via one of a direct electrical coupling, a wired coupling, and a wireless coupling in order to perform two-way communication between the control module and the current source so that the current source can receive commands from the control module and the current source can transmit the stimulating current values which output to the patient back to the control module.

19. The system of claim 18, wherein the control module monitors the stimulating current values from the current source and automatically shuts down the current source if the stimulating current values are outside of one of prescribed, programmed, and set values.

20. The system of claim 1, wherein the current source includes at least one of dials, switches and other settings in order for current settings of the produced stimulating current to be locally adjusted manually;

and wherein the control module includes at least one of dials, switches, and auxiliary inputs in order for the current settings of the produced stimulating current to be indirectly adjusted manually.