Uterine electrical stimulation system and method

• US 10,328,254 B2
• Filed: 10/25/2016
• Issued: 06/25/2019
• Est. Priority Date: 10/27/2010
• Status: Active Grant

• Current Assignee: Dignity Health (CommonSpirit Health (Illinois))
• Original Assignee: Dignity Health (CommonSpirit Health (Illinois))
• Inventors: Garfield, Robert E., Carp, Harvey, Maner, William L.
• Primary Examiner(s): Kahelin, Michael W
• Application Number:
  US15/334,059
• Publication Number:
  US 20170036011A1
• Time in Patent Office: 973 Days
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0521 Genital electrodes
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Systems and methods for applying stimulating current to a patient for treating insufficient uterine contractions are provided. The system includes stimulation electrodes of a balloon electrode array device, a ring electrode array device, an electrode probe device, or a mesh electrode array device. Some aspects of the invention also provide a connector and cable device for coupling the stimulation electrodes to electronics for generating and providing the stimulating current to the stimulation electrodes.

Claims

1. A device configured to apply stimulating current to a patient for treating insufficient uterine contractions, the device comprising:

an applicator with a first end and an opposite second end and sized to extend through a vaginal canal;

at least one electrode positioned adjacent to the first end and configured to be arranged proximate to at least one of a cervix or a fornix of the patient; and

at least one lead wire that is electrically coupled to the at least one electrode and is routed through the applicator so that it exits the applicator adjacent to the second end to deliver electrical current through the applicator to the at least one electrode to initiate contractile activity of a uterus of the patient when the applicator is extended through the vaginal canal to engage the at least one electrode proximate to at least one of the cervix or the fornix of the patient,

wherein the at least one electrode forms an array device comprising;

a flexible ring, and

a plurality of electrodes affixed to an outer surface of the flexible ring, and

the at least one lead wire comprises a plurality of lead wires electrically coupled to the plurality of electrodes.

2. The device as recited in claim 1 wherein the applicator is constructed of one of rubber, latex, metal, and plastic.

3. The device as recited in claim 1 wherein the at least one electrode is coated with and used to administer a medication.

4. The device as recited in claim 1 wherein the applicator forms a cylindrical shape and, wherein the flexible ring is collapsible within the applicator to facilitate trans-vaginal insertion into the uterus of the patient.

5. The device as recited in claim 1 wherein at least one of the flexible ring and the plurality of electrodes is impregnated or coated with a medication.

6. The device as recited in claim 1, further comprising:

a connector and cable device configured to connect a system that produces stimulating current with the at least one electrode to apply the stimulating current to the patient for treating insufficient uterine contractions.

7. The device as recited claim 6, wherein the connector device comprises:

an electronics connector plug capable of being releasably coupled to the system and configured to receive the stimulating current from the system; and

a lead wire connector plug releasably coupled between the at least one wire lead and the at least one electrode to deliver the stimulating current to the at least one electrode.

8. The device as recited in claim 7, wherein at least one of the electronics connector plug, the lead wire connector plug, and the at least one lead wire contains electrical circuitry and one of computer software, computer hardware, logic circuits, instructions, codes, and programs stored in memory and executable by the electrical circuitry.

9. The device as recited claim 8, wherein the programs cause one of the system that produces stimulating current or the electrical circuitry to carry out steps comprising:

generating electrical stimulating current signals at a frequency between about 5.0 Hertz and about 100 Hertz; and

applying the electrical stimulating current signals to one of a cervix, a vagina, an abdominal wall, and a uterus to produce uterine tonic contractions.

10. The device as recited in claim 1, further comprising:

a control module which performs at least one of preprogrammed stimulation tasks and user-defined stimulation tasks;

a current source controlled by the control module to produce stimulating current at a frequency between about 5.0 Hertz and about 100 Hertz;

a connector configured to electrically couple the current source to the at least one lead wire to provide the stimulating current to the at least one electrode to produce tonic uterine contractions.