Devices and methods for stimulating nerves

• US 9,248,285 B2
• Filed: 12/09/2013
• Issued: 02/02/2016
• Est. Priority Date: 06/09/2012
• Status: Active Grant

• Current Assignee: FemPulse, LLC
• Original Assignee: FemPulse, LLC
• Inventors: Haessler, Alexandra
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US14/101,336
• Publication Number:
  US 20140296933A1
• Time in Patent Office: 785 Days
• Field of Search: 600/9, 600/372, 607/138
• US Class Current: 1/1
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61M 2210/1017 Peritoneal cavity
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/0514 Electrodes for the urinary tract
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A device for stimulating nerves adjacent the vagina includes a nerve stimulating element coupled to a main body. The nerve stimulating element is positioned and designed to stimulate the vesical, Frankenhauser'"'"'s and/or inferior hypogastric plexuses. The device may reside in the vaginal formices. An implant is also provided which has a nerve stimulating element in contact with a uterosacral ligament. The device positioned in the vagina may be used to charge a power source for an implant, which may be a capacitor.

Claims

1. A method of stimulating nerves adjacent a vaginal canal, comprising the steps of:

positioning a device in the vagina, the device including a main body and a first nerve stimulating element coupled to the main body, the positioning step is carried out with the nerve stimulating element being positioned to stimulate an autonomic plexus without intervening somatic nerves;

stimulating nerves adjacent the vaginal canal using the first nerve stimulating element.

2. The method of claim 1, wherein:

the stimulating step is carried out by stimulating nerves with the first nerve stimulating element sufficiently to change a signal transmitted by the nerves to associated nerves.

3. The method of claim 1, wherein:

the positioning step is carried out with the device having a second nerve stimulating element; and

the stimulating step is carried out with the second nerve stimulating element stimulating a second target plexus selected from the group of nerve plexuses consisting of the vesical plexus, the inferior hypogastric plexus and the Frankenhauser'"'"'s plexuses, the second target plexus being different from the first target nerve plexus.

4. The method of claim 3, wherein:

the stimulating step is carried out with the first nerve stimulating element being actuated at a different time from the second nerve stimulating element.

5. The method of claim 1, wherein:

the positioning step is carried out with the first nerve stimulating element being positioned no more than 3 cm from the first target plexus.

6. The method of claim 5, wherein:

the positioning step is carried out with the device having a second nerve stimulating element; and

the stimulating step is carried out with the first nerve stimulating element stimulating a first portion of the target plexus and the second nerve stimulating element stimulating a second portion of the first target plexus.

7. The method of claim 1, wherein:

the positioning step is carried out with a controller separate from the main body, the controller being positioned outside the main body when the main body is positioned in the vagina.

8. The method of claim 7, wherein:

the positioning step is carried out with the controller configured to control a duration of stimulation and an intensity of stimulation.

9. The method of claim 1, wherein:

the positioning step is carried out with the device positioned in the vaginal fornices, the vaginal fornices being a space between the cervix and the vagina and bounded by a plane extending through a distal end of the cervix and perpendicular to a cervical axis, the first nerve stimulating element contacting the surface of the vaginal canal proximal to the distal end of the cervix.

10. The method of claim 1, wherein:

the positioning step is carried out with the main body having a central opening, the cervix being positioned in the central opening and the main body extending around at least 180 degrees of the cervix relative to a cervical axis.

11. The method of claim 1, further comprising the step of:

orienting the device about the cervix using the nerve stimulating elements.

12. The method of claim 11, wherein:

the orienting step is carried out with the device having a plurality of nerve stimulating elements, at least one of the nerve stimulating elements emitting energy and at least one other of the nerve stimulating elements measures the energy emitted.

13. The method of claim 11, wherein:

the stimulating step is carried out with the device having a plurality of stimulating elements, the stimulating elements being activated after the orienting step.

14. A method of stimulating nerves adjacent a vaginal canal, comprising the steps of:

positioning a device in the vagina, the device including a main body and a first nerve stimulating element coupled to the main body;

stimulating nerves adjacent the vaginal canal using the first nerve stimulating element;

assessing a current orientation of the device;

the positioning step being carried out with the first nerve stimulating element of the device positioned in the vaginal fornices, the device also having a control system and a plurality of nerve stimulating elements, the positioning step being carried out to position the device in a starting orientation;

the assessing step being carried out to determine the current orientation of the device; and

reassigning the plurality of nerve stimulating elements using the control system based on a change in orientation between the starting orientation and the current orientation determined in the assessing step.

15. The method of claim 14, wherein:

the assessing step is carried out with the control system automatically carrying out the assessing step.

16. The method of claim 14, further comprising the step of:

sensing a parameter related to the starting orientation of the device;

storing the parameter related to the starting orientation; and

the assessing step includes the steps of sensing the parameter in the current orientation and comparing the parameters from the starting orientation and the current orientation.

17. The method of claim 16, wherein:

the sensing step is carried out with the parameter related to the starting orientation being an electrophysiological parameter.

18. The method of claim 17, wherein:

the sensing step is carried out with the parameter being electrical activity sensed by the device.

19. The method of claim 17, wherein:

the sensing step is carried out with the first nerve stimulating element being used to sense the parameter.

20. The method of claim 14, further comprising the step of:

providing an object, the device having a sensor configured to sense the object; and

sensing the object using the sensor to sense the object.

21. The method of claim 20, further comprising the step of:

placing the object at a predetermined location relative to the user'"'"'s body during the assessing step;

the assessing step is carried out by sensing the object with the sensor when the object is in the predetermined position to assess the current orientation of the device.

22. The method of claim 20, wherein:

the providing step is carried out with the object forming a magnetic field and the sensor being a magnetic sensor.

23. The method of claim 20, further comprising the step of:

placing a controller at a predetermined position relative to the user;

the providing step is carried out with the controller including the object; and

the assessing step being initiated by using the controller to instruct the device to assess the current orientation of the device in the vagina.

24. The method of claim 14, wherein:

the positioning step is carried out with the device including a gravity sensor;

the assessing step being initiated using the controller while the user is in a predetermined body position, the controller sending a signal to the control system of the device to carry out the assessing step when the user is in the predetermined body position;

the assessing step also being carried out with the gravity sensor transmitting data to the control system relating to the current orientation of the device.

25. The method of claim 14, further comprising the step of:

providing a first implant having a first body, a first implant nerve stimulating element coupled to the body, and a first implant control system coupled to the first body, the first implant being implanted in the user.

26. The method of claim 25, wherein:

the assessing step being carried out with the device including a sensor that senses a parameter relating to the first implant.

27. The method of claim 25, wherein:

the assessing step is carried out with the device sensing electrical activity of the first implant.

28. The method of claim 26, wherein:

the assessing step is carried out with the control system sensing a starting parameter of the first implant when the device is in the starting orientation, the control system saving the starting parameter and comparing the starting parameter with a current parameter sensed by the sensor when the device is in the current orientation.

29. The method of claim 25, further comprising the step of securing the first implant adjacent to a uterosacral ligament so that the first implant nerve stimulating element is in contact with the uterosacral ligament.

30. The method of claim 14, further comprising the steps of:

providing the device with a controller external to the user'"'"'s body;

placing the controller at a predetermined body position of the user;

the assessing step is carried out with the device having a sensor positioned in the vagina configured to sense the controller during the placing step to determine the current orientation of the device in the vagina.

31. A method of stimulating nerves adjacent a vaginal canal, comprising the steps of:

positioning a device in the vagina, the device including a main body and a first nerve stimulating element coupled to the main body, the positioning step is carried out with a controller separate from the main body, the controller being positioned outside the main body when the main body is positioned in the vagina; and

stimulating nerves adjacent the vaginal canal using the first nerve stimulating element;

the positioning step being carried out with the controller being a personal electronic device.