External stimulation therapy for dorsal genital nerve stimulation

• US 10,322,282 B2
• Filed: 06/05/2015
• Issued: 06/18/2019
• Est. Priority Date: 06/06/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wei, Xuan K., Bonde, Eric H., LaLonde, John R., Dinsmoor, David A.
• Primary Examiner(s): Philips, Bradley H
• Application Number:
  US14/731,664
• Publication Number:
  US 20150352357A1
• Time in Patent Office: 1,474 Days
• CPC Class Codes: A61F 13/42 with wetness indicator or alarm
• CPC Class Codes: A61F 13/84 Accessories, not otherwise provided for, for absorbent pads
• CPC Class Codes: A61F 2013/424 having an electronic device
• CPC Class Codes: A61F 2013/8479 including electric or magnetic devices
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

A system including a stimulation generator configured to delivery external stimulation to control or alleviate urinary or fecal incontinence. The system may also include sense electrodes configured to sense the presence of wetness. The system may provide closed loop therapy based on the presence of wetness.

Claims

1. An external stimulating device comprising:

a stimulation generator configured to generate stimulation for stimulation of a first dorsal genital nerve and a second dorsal genital nerve of a patient;

at least two stimulation electrodes positioned to deliver the stimulation to the first dorsal genital nerve and the second dorsal genital nerve;

a moisture absorbing pad configured to at least partially encapsulate the stimulation generator; and

a lead with two branches, each branch carrying at least one of the stimulation electrodes, wherein the branches are configured to be positioned between the patient and the moisture absorbing pad and in contact with skin of the patient.

2. The device of claim 1, further comprising at least two sensing electrodes and sensing circuitry configured to sense urine leakage via the sensing electrodes.

3. The device of claim 2, wherein the sensing electrode is configured to sense wetness.

4. The device of claim 3, wherein the stimulation generator is configured to deliver stimulation in response to the sensing circuitry sensing a wetness volume above a pre-determined volume.

5. The device of claim 2, wherein at least one of the sensing electrodes is within approximately 10 centimeters of at least one of the stimulation electrodes.

6. The device of claim 2, wherein at least one of the sensing electrodes is within approximately 12 centimeters of at least one of the stimulation electrodes.

7. The device of claim 1, wherein the moisture absorbing pad is disposable.

8. The device of claim 1, wherein the moisture absorbing pad comprises an adhesive configured to adhere to an undergarment.

9. The device of claim 1, wherein the lead is a spring loaded member configured to bias the stimulation electrodes against skin of the patient.

10. The device of claim 3, wherein at least a portion of the moisture absorbing pad is configured to be positioned between the patient and the sensing electrodes.

11. The device of claim 1, wherein the stimulation electrodes are spaced apart from one another to straddle a midline of a clitoris of a patient.

12. The device of claim 1, further comprising a flex circuit substrate, the stimulation generator located on the flex circuit substrate.

13. The device of claim 1, wherein the at least two stimulation electrodes are positioned to deliver the stimulation to the first dorsal genital nerve and the second dorsal genital nerve of a female patient.