Intravaginal electrical stimulation device for treating female pelvic pain
An intravaginal electrical stimulation device for treating pelvic pain in a female patient includes, in one embodiment, a set of intravaginal components comprising a frame, at least one pair of paracervical electrodes, an intravaginal capsule, a socket in the proximal end of the intravaginal capsule, an electrode plug that plugs into the socket, and connecting wires that electrically couple the electrode plug to the paracervical electrodes. The intravaginal components are designed to inserted into the patient's vagina so that one or more electrodes are in direct contact with the vaginal epithelium in the lateral vaginal fornices. In some embodiments, a cutaneous electrode may be included to be attached to the skin of the female patient. A microprocessor and an electrical stimulation generator are operable to cause low-voltage electrical current to flow through the intravaginal electrodes, the cutaneous electrode, or both, to create one or more electrical fields that neuromodulate the intrapelvic nerves of the patient. An external controller, which communicates with the intravaginal components over a wireless data communications channel, sends instructions to and receives status updates from the microprocessor inside the intravaginal capsule. In some embodiments, the electrical stimulation generator is located inside an external electrical stimulator generator (EESG) worn outside the body, instead of being located in an intravaginally worn intravaginal capsule, and the EESG is electrically coupled to the intravaginal components via one or more connecting wires that pass through the orifice of the female patient's vagina.
1 . A device for treating pelvic pain in a female patient, comprising:
a set of intravaginal components including a frame having a distal portion and a proximal portion, the frame being configured so that when the set of intravaginal components are inserted into the vagina of the female patient, the proximal portion of the frame will be in contact with the paracervical vaginal epithelium of the posterior and the lateral vaginal fornices of the female patient;
a paracervical electrode attached to the proximal portion of the frame;
a cutaneous electrode configured to be attached the skin of the female patient;
an intravaginal capsule comprising a distal end, a proximal end, a microprocessor, a memory and an electrical stimulation generator communicatively connected to the microprocessor;
a socket in the proximal portion of the intravaginal capsule;
an electrode plug that plugs into the socket in the intravaginal capsule to establish an electrical connection with the electrical stimulation generator;
a first connecting wire that electrically couples the electrode plug to the paracervical electrode;
a second connecting wire that electrically couples the electrode plug to the cutaneous electrode; and
a local control program in the memory comprising program instructions that, when executed by the microprocessor, will cause the microprocessor to generate and send control signals to the electrical stimulation generator, the control signals being configured to cause the electrical stimulation generator to apply a voltage to the first connecting wire;
wherein,
the voltage applied to the first connecting wire causes a low voltage electrical current to flow through the socket, the electrode plug, the first connecting wire, the paracervical electrode, the cutaneous electrode and the second connecting wire, and the low-voltage electrical current creates an electrical field between the paracervical electrode and the cutaneous electrode,
the electric field passes through the paracervical vaginal epithelium of the posterior and the lateral vaginal fornices of the female patient to cause neuromodulation of intrapelvic nerves in the female patient.
2 . The device of claim 1 , wherein the intrapelvic nerves neuromodulated by the electrical field include the pelvic nerves in the pelvis of the female patient.
3 . The device of claim 1 , wherein the intrapelvic nerves neuromodulated by the electrical field include the paracervical nerves in the pelvis of the female patient.
4 . The device of claim 1 , wherein the intrapelvic nerves neuromodulated by the electrical field include the sacral nerves of the female patient.
5 . The device of claim 4 , wherein the sacral nerves neuromodulated by the electrical field include nerves that innervate the lower vagina and external genitalia of the female patient.
6 . The device of claim 1 , further comprising:
a sling attached to the frame; and
a pouch molded into the sling;
wherein the pouch is configured to receive and hold the distal end of the intravaginal capsule.
7 . The device of claim 1 , further comprising:
a first radio frequency transceiver located inside the intravaginal capsule; and
program instructions in the local control program that, when executed by the microprocessor, will cause the microprocessor to cause the first radio frequency transceiver to establish a data communications channel with an external controller and to receive, via the data communications channel, a remote-control instruction to control operation of the electrical stimulation generator in the intravaginal capsule.
8 . The device of claim 7 , further comprising the external controller.
9 . The device of claim 8 , wherein the external controller comprises a second radio frequency transceiver configured to transmit the remote-control instruction from the external controller to the first radio frequency transceiver located inside the intravaginal capsule.
10 . The device of claim 7 , wherein:
the external controller further comprises a second microprocessor and a memory storage area;
the memory storage area stores a remote-control application and an electrical stimulation pattern; and
the remote control application comprises program instructions that, when executed by the second microprocessor on the external controller, will cause the second microprocessor to send a control signal to the microprocessor inside the intravaginal capsule, the control signal being configured to cause the microprocessor in the intravaginal capsule to cause the electrical stimulation generator inside the intravaginal capsule to apply the voltage to the first connecting wire in a manner that causes the low voltage electrical current and the electrical field to vary according to the electrical stimulation pattern stored in the memory storage area of the external controller.
11 . The device of claim 10 , wherein the remote control program on the external controller further comprises a user interface module, stored in the memory storage area on the external controller, the user interface module having program instructions that, when executed by the second microprocessor on the external controller, will cause the second microprocessor to receive an operating instruction from the female patient.