Patent Application
20220331592
Embodiments of the present invention relate generally to methods and devices for treating pelvic pain and external genital pain in women, and more particularly to methods and devices that use electrical stimulation to cause neuromodulation of the nerves that transmit the sensation of pain from anatomical structures in the pelvis and the external genitalia to the central nervous system in women.
Many women suffer from pelvic pain. Types of pelvic pain include, without limitation, dysmenorrhea, dyspareunia, chronic pelvic pain, pain originating in the urinary tract, myofascial pain originating in the muscles and supporting tissues of the pelvis, pain related to childbirth, post-surgical pain and idiopathic pain. In addition, some women experience pain in the area of their external genitalia.
Pelvic pain in women typically originates in their reproductive organs, bladder, pelvic floor or the peritoneal lining of the pelvis. The sensation of pelvic pain is transmitted to the central nervous system through sympathetic, parasympathetic, and afferent sensory nerve fibers that traverse nerves and nerve plexuses in the abdomen and the pelvis, and the thoracic, lumbar, and sacral nerves. The sensation of pain originating in the external genitalia is transmitted to the central nervous system via afferent sensory fibers that traverse the pudendal nerves and the S2, S3 and S4 sacral nerve roots.
The sensation of pelvic pain from the intraperitoneal reproductive organs (e.g., uterus, ovaries and fallopian tubes) reaches the central nervous system by way of the hypogastric nerves, superior hypogastric plexus, lower aortic plexus, ovarian plexus, lumbar splanchnic nerves, lower thoracic and lumbar nerves, uterovaginal plexuses and the inferior hypogastric plexuses. The sensation of pelvic pain from the pelvic floor and the subperitoneal reproductive organs (e.g., the cervix and upper vagina) reaches the central nervous system by way of the uterovaginal plexuses, inferior hypogastric plexuses, pelvic splanchnic nerves and the S2, S3 and S4 nerves. The sensation of pelvic pain from the lower vagina and the external genitalia reaches the central nervous system by way of the pudendal nerves and the S2, S3 and S4 nerves.
For the purposes of this disclosure, the nerves that innervate the intraperitoneal reproductive organs and traverse the hypogastric nerves, superior hypogastric plexus, lower aortic plexus, ovarian plexus, lumbar splanchnic nerves, lower thoracic and lumbar nerves shall hereinafter be referred to collectively as the “pelvic nerves.” The nerves that innervate the intraperitoneal reproductive organs and the subperitoneal reproductive organs and traverse the uterovaginal plexuses, inferior hypogastric plexuses, pelvic splanchnic nerves and the S2, S3 and S4 nerves shall hereinafter be referred to collectively as the “paracervical nerves.” The nerves that innervate the lower vagina and the external genitalia and traverse the pudendal nerves and the S2, S3 and S4 nerves shall hereinafter be referred to collectively as the “sacral nerves.”
It should be noted that uterosacral plexuses and the inferior hypogastric plexuses are located in the areas where the uterosacral ligaments and the cardinal ligaments attach to each side of the cervix. These areas are located just above (superior to and internal to) the areas where the vaginal epithelium joins the cervix in the posterior and lateral fornices on each side of the midline. A significant concentration of sympathetic, parasympathetic and afferent sensory nerves and nerve fibers related to the “paracervical nerves” (as defined above) are present in these areas.
Electrical neuromodulation devices (sometimes referred to as electrical stimulation devices) have been developed to deliver electrical stimulation to specific collections of neurons in the brain, the spine, and a sacral nerve root. These devices usually use an electrical pulse generator to deliver pulsed electrical current to electrodes that are placed in close proximity to these specific collections of neurons in the brain, spinal cord or sacral nerve root to neuromodulate the nearby neurons or nerves.
To date, however, no electrical neuromodulating device has been developed that is capable of delivering targeted electrical stimulation to the pelvic nerves, the paracervical nerves and the sacral nerves. Moreover, prior to the present invention, no electrical neuromodulation device has been developed that delivers electrical current to an electrode that is placed inside a woman's upper vagina. Furthermore, prior to the present invention, no electrical neuromodulating device provides an electrode that is in contact with the paracervical vaginal epithelium in the posterior and lateral vaginal fornices to deliver targeted electrical stimulation to cause neuromodulation of the pelvic nerves, the paracervical nerves and the sacral nerves.
The ability of existing electrical stimulation devices to reduce or relieve pelvic pain and external genital pain is extremely limited because the pelvic nerves, paracervical nerves and sacral nerves all reside deep within the pelvis. Consequently, there is considerable need for an intravaginal device that places a paracervical electrode or electrodes in a woman's vagina without surgery, and which can deliver targeted electrical stimulation to the pelvic nerves, the paracervical nerves and the sacral nerves.
Embodiments of the present invention address the aforementioned need by providing an intravaginal electrical neurostimulation device for treating pelvic pain and external genital pain in female patients (the “IVENS device”) capable of delivering targeted electrical stimulation to the pelvic nerves, the paracervical nerves and the sacral nerves. More specifically, IVENS devices constructed according to embodiments of the present invention deliver targeted electrical stimulation to neuromodulate the pelvic nerves, the paracervical nerves and the sacral nerves using an electrode that is in direct contact with the paracervical vaginal epithelium in the posterior and lateral vaginal fornices. Beneficially, IVENS devices constructed and used in accordance with embodiments of the present invention can be used without the aid of a medical practitioner and can be dynamically controlled and adjusted by the patient to provide personalized electrical stimulation patterns when the patient is experiencing pain or when she anticipates the onset of pelvic pain due to, for example, menstruation or sexual intercourse.
In general, embodiments of the present invention typically comprise a set of intravaginal components and a set of extravaginal components. The intravaginal components include a frame, a paracervical electrode (or electrodes), and a paracervical electrode connecting wire (or wires) that exit the vagina through the vaginal orifice. The paracervical electrode comprises one or more wires embedded in the covering of the proximal portion of the frame that are capable of carrying or conducting electrical current. A “full-length” paracervical electrode is an electrode that extends entirely across the proximal portion of the frame. A “partial-length” paracervical electrode is a shorter electrode, embedded in the covering of the lateral and distal portions of the proximal portion of the frame. Paracervical electrode connecting wires are insulated wires that electrically connect a paracervical electrode to the IVENS Stimulator (described below). If the device is configured to use multiple paracervical electrodes, then that device will typically require multiple paracervical electrode connecting wires.
When the frame is properly positioned in the vagina, a full-length paracervical electrode will be in contact with the vaginal epithelium in the posterior and lateral vaginal fornices. If the frame is embedded with two partial-length paracervical electrodes with an electrode on each side of the frame, each of the partial-length paracervical electrodes will be in contact with the vaginal epithelium only in the lateral vaginal fornices on each side of the cervix.
The extravaginal components of the present invention include an IVENS Stimulator, and, in some embodiments, a cutaneous electrode (or electrodes), a cutaneous electrode connecting wire (or wires) and the portion of the paracervical electrode connecting wire or wires that extend through the vaginal orifice to remain on the outside of the vagina. The cutaneous electrode is an electrode that can conduct an electrical current that is attached to the patient's skin. The cutaneous electrode connecting wire is an insulated wire that electrically connect a cutaneous electrode to the IVENS Stimulator. If the device is configured to use multiple cutaneous electrodes, then that device will suitably require multiple cutaneous electrode connecting wires.
For the sake of brevity and ease of comprehension, full length paracervical electrodes, partial-length paracervical electrodes and cutaneous electrodes may hereinafter be referred to collectively as “electrodes,” unless the context dictates otherwise. Also, for the sake of brevity and ease of comprehension, the paracervical electrode connecting wires and cutaneous electrode connecting wires may be referred to collectively as “connecting wires,” unless the context dictates otherwise.
The IVENS Stimulator (IS) comprises an electrical stimulation generator (“ESG”) and at least one IVENS Stimulator Channel (“ISC”). Each ISC is configured with a pair of electrical connections to receive and electrically connect to a pair of connecting wires which are each connected to an electrode.
The ESG is configured to periodically generate and output electrical stimulation pulses to an ISC, which transmits the pulses to the pair of connecting wires attached to the ISC, and the electrodes attached to each connecting wire. The ESG, the electrical contacts in an ISC, the connecting wires attached to the electrical contacts in the ISC, and the electrodes attached to the connecting wires are the components of an Electrical Stimulation Circuit (“ESC”). When the IS is turned on and energized, electrical stimulation pulses from the ESG, create an electric potential between the electrodes in the ESC to create an electrical field between and around the electrodes in the ESC. The electrical field passes through and neuromodulates the pelvic nerves, paracervical nerves, and sacral nerves present within the electrical field to eliminate or reduce pelvic pain and external genital pain.
In some embodiments, the IS may be equipped with multiple ISCs. With multiple ISCs, embodiments of the present invention may be configured to produce multiple combinations of overlapping electrical fields produced by multiple electrical stimulation circuits that are designed to neuromodulate the pelvic nerves, the paracervical nerves, and the sacral nerves simultaneously, consecutively or in an alternating pattern of electrical fields. The overlapping electrical fields may (or may not) be tuned to have different characteristics, depending on the desired overall effect of applying the overlapping electrical fields to the pelvic nerves, the paracervical nerves and the sacral nerves.
The IS typically comprises a case with a digital display screen. The case, which is preferably constructed from a rigid or hard plastic material, has a hollow that defines an internal cavity for housing most of the electronic components of the IS. The case is preferably designed to be carried in one of the patient's pockets, or clipped or fastened to the woman's clothing in the area of her lower anterior abdominal wall (e.g., around her waist, on her hips, or in any of the areas where her pockets, if any, would normally be located). This positioning will allow the paracervical electrode connecting wire (or wires) and the cutaneous electrode connecting wire (or wires), if any, to be easily connected to the IS while the IS is carried in a pocket or attached to a convenient location on the woman's clothing. In other embodiments, the IS may come with, and/or be attached to a waist or shoulder strap.
Suitably, in addition to the electronic stimulation generator (ESG), the electronic components housed inside the case of the IS also include a printed circuit board, which is affixed to an interior wall of the case. Attached to the printed circuit board is an electronic circuit comprising a battery, a microprocessor, a memory, a local control program in the memory, a radio frequency transceiver and the aforementioned ESG. The local control program stored in the memory comprises one or more programming modules having programming instructions that, when executed by the microprocessor, will cause the microprocessor to perform certain functions herein described, including sending electronic signals to the ESG, and thereby controlling the output of the ESG. The ESG then converts the DC current from the battery into the appropriate electrical stimulation patterns (“ESP's”) to be delivered to one or more ISCs to create one or more electrical stimulation circuits to neuromodulate the pelvic nerves, the paracervical nerves and the sacral nerves.
The characteristics of the electrical stimulation produced by the ESG may be varied by, for example, varying the flow of current, varying the voltage, varying the frequency of the pulses, by using tonic stimulation or burst stimulation, or by altering the pulse width, frequency and amplitude of the electrical stimulation being produced. The operations of the microprocessor within the device may be controlled or adjusted by pressing buttons, or by flipping or sliding switches, on the external surface of the case of the IS. These physical (or iconic) buttons and/or switches, may be configured, for example, to permit the user to activate, deactivate or tune the ESG inside the IS.
In some embodiments of the present invention, the ESG inside the IS may be more dynamically (or more precisely) controlled by instructions and commands generated on an IVENS external controller (the “IEC”). The IEC may comprise, for example, a smart phone, tablet, tablet computer, a personal wearable device (such as a smart watch) or personal computer. In this embodiment, a control application executing on the IEC communicates with an IVENS device control application (the “IDCA”) executing in the primary memory of the IS. The communication is typically implemented between a first radio frequency transceiver located in the IEC communicating wirelessly with a second radiofrequency transceiver located in the IS using a standard wireless communication protocol, such as Bluetooth. More specifically, the first radio frequency transceiver inside the IEC may be configured to establish a wireless communication channel with the second radio frequency transceiver on the printed circuit board inside the IS.
The IEC also comprises a microprocessor, a memory, and another control application (referred to hereinafter as the “IVENS app”) that is stored in the memory of the IEC. The IVENS App comprises program instructions that, when executed by the microprocessor on the IEC, will cause the microprocessor on the IEC to communicate with the IDCA of the IS via the wireless data communications channel established between the radio frequency transceiver on the IS and the radio frequency transceiver on the IEC.
A user interface module in the IVENS app running on the IEC is configured to receive operating instructions from the user, and thereby permits a user to activate, adjust and tune the electrical stimulation being delivered by electrical stimulation generator in the IS to the electrodes in an electrical stimulation circuit. Thus, the user can manipulate controls on a display screen of the IEC (such as digital representations of buttons, icons and sliders) in the user interface on the IEC to select, personalize, optimize, adjust, activate and/or deactivate the electrical stimulation provided to the pelvic nerves, the paracervical nerves and the sacral nerves by the IVENS device. In addition, the radio frequency transceiver and the microprocessor inside the IEC can receive over the wireless communication channel IVENS device status information and other data generated by the microprocessor connected to the circuit board inside the IS case, and/or data stored in the memory on the circuit board inside the IS case. The status information and other data may be displayed on the display screen associated with the IEC via the user interface. Preferably, the user interface module in the IVENS app running on the IEC also includes program instructions configured to permit the IEC or the user to use email, text messaging or another data or information transmitting process to send the status information and other data retrieved from the memory of the IS to other devices, organizations or people, such as, for example, the user's personal physician or other health care provider.
Preferably, the IVENS app stored in the memory of the IEC also includes program instructions that permit the IEC to periodically query a remote computer system or server for (1) the availability of program updates associated with the control application running on the IEC, and/or (2) the availability of operating system updates, local program updates or firmware updates associated with the local control program stored in the memory of the IS. If such an update is available, the IVENS app may be configured to automatically download and install the update on the IEC, on the IS, and/or both. By downloading such updates as they become available, the IVENS app running on the IEC, as well as the operating system, application program and firmware running on the IS, will automatically remain substantially up-to-date with the latest bug fixes and/or improvements. In some embodiments, the user interface module of the IVENS app may be configured to prompt the user for permission or confirmation before downloading and/or installing new, updated or upgraded programs, operating systems or firmware.
Anatomical Terminology
Turning now to the figures,
An anatomical plane (or anatomical section) refers to a view of anatomical structures in reference to a certain plane. For example, the median plane (or midline section) is the vertical plane that passes through the body longitudinally, front to back, dividing it into right and left halves. A sagittal plane is any vertical planes passing through the body that is parallel to the median plane. Sagittal planes divide the body into right and left parts. Therefore, the midline plane is a sagittal plane, but a sagittal plane need not be the midline plane. The coronal planes, also called the frontal planes, are vertical planes passing through the body, from one side to the opposite side, dividing the body into anterior (front) and posterior (back) portions. These vertical planes are at right angles)(90° to the median and sagittal planes.
Transverse planes are horizontal planes passing through the body, dividing it into superior (upper) and inferior (lower) parts. Transverse planes are at right angles)(90° to the median, sagittal and coronal planes. A superior view (sometimes called a “top view” or “bird's-eye” view) is a view that shows how an object would appear if when looking down on the object from a location above the object when the object is properly oriented within the body. An inferior view (sometimes called a “bottom view”) is a view that shows how an object would appear if looking up at the object from a location below the object when the object is properly orientated within the body.
Pelvic Anatomy
The pelvis is the lower part of the abdomen that is below the rim of the pelvic bones.
Pelvic Neuroanatomy
Pelvic pain in women typically originate in their reproductive organs, bladder, pelvic floor or the peritoneal lining of the pelvis. The sensation of this pain is transmitted to the central nervous system through sympathetic, parasympathetic, and afferent sensory nerve fibers that traverse nerves and nerve plexuses in the abdomen and the pelvis, and the thoracic, lumbar, and sacral nerve roots.
Intravaginal Electrical Neurostimulation Device for Treating Pelvic Pain and External Genital Pain
The Intravaginal Components of the IVENS Device
The Frame
The frame 104 is a semi-elliptical structural element that is designed to be inserted and remain comfortably in a woman's vagina 146 when the IVENS device 100 is in use. Its core may be made of a semirigid, yet flexible material, such as a coiled spring made of metal or plastic or a rod made of metal, plastic or fiberglass or a combination of several of these materials. In addition, the material, or materials, used in the frame 104 may have different configurations and properties in different areas of the frame 104 to achieve the semi-rigidity or flexibility desired for that area of the frame 104. Notably, those skilled in the art will recognize and appreciate that a variety of alternative construction materials may be suitably substituted for the aforementioned materials without departing from the scope of the present invention.
In one embodiment of the IVENS device 100, the frame 104 has a posteriorly directed curvilinear shape when its lateral portions are compressed toward each other. The compressive forces are introduced, for example, when the woman squeezes the lateral portions of the frame 104 toward each other with the thumb and fingers of one hand prior to its insertion into the vagina 146. The frame 104 is constructed so that it has a propensity to return to its original shape when the compressive forces are reduced. The compressive forces are reduced after the device is inserted through the vaginal orifice and comes to rest completely within the vagina 146. Suitably, the proximal and distal ends of the frame 104 are typically the most flexible portions of the frame 104, allowing significant compression of the frame 104 along its longitudinal axis. Compression of the frame 104 along its longitudinal axis and the resulting posterior curvature of the frame 104 make insertion of the device into the vagina 146 easier to accomplish. Once the frame 104 is completely inserted into the vagina 146 and released, the frame 104 returns to its original configuration where the distal end of the frame 104 rests upon the anterior vaginal wall 141 behind the synthesis pubis 142 and the proximal portion of the frame 104 rests upon the vaginal epithelium in the posterior vaginal fornix 150. In this configuration inside the vagina 146, the paracervical electrode 110 embedded in the surface of the covering of the proximal portion of the frame 104 will come into contact with the vaginal epithelium in the lateral and posterior vaginal fornices. The lateral portions of the frame 104 are configured to gently press against the lateral walls of the vagina 146, keeping the frame 104 in the proper position within the vagina 146. The core elements of the frame 104 may be covered with a smooth, flexible medical grade covering, such as silicone rubber.
In another embodiment of the present invention, a “transitional” portion 124 may be placed in both of the lateral portions of the frame 104 at a point approximately seventy-five percent of the distance from the distal end to the proximal end of the frame 104. See
Embodiments of the present invention may be manufactured in a variety of different sizes, and have a variety of longitudinal lengths for the frame 104 (for example from 6.5 to 8.5 centimeters, in increments of 5 millimeters) in order to accommodate the various vaginal depths of the women who may use the device. The lateral flexibility of the frame 104 increases the device's ability to address and accommodate differences in vaginal caliber among different women. The increased flexibility of the transitional portion 124 of the frame 104 and its propensity to return to its original configuration, when pressure placed upon it is released helps maintain the proper positioning of the paracervical electrodes 110 in the lateral vaginal fornices.
In an embodiment of the device intended for the treatment of postsurgical pain following a hysterectomy, the shape of the proximal portion of the frame 104 will be modified so it can rest in the upper the vagina 146 when the uterine cervix is absent.
The Paracervical Electrodes
A paracervical electrode 110 comprises one or more wires, capable of carrying or conducting electrical current, which are embedded in the covering of the proximal portion of the frame 104. In one embodiment, the surface area of a paracervical electrode 110 may be increased by attaching a thin “wafer” of electrode material (that might be round, square or rectangular in cross section, for example) to the paracervical electrode (or electrodes) 110 embedded in the covering of the proximal portion of the frame 104. The wire(s) and wafers comprising the paracervical electrode 110 are either not insulated, or minimally insulated, so the electrical stimulation generated by the electrical stimulation generator and transmitted to the paracervical electrodes 110 is delivered to the paracervical vaginally epithelium, and hence, the pelvic nerves, paracervical nerves and sacral nerves.
For the purposes of this disclosure, three embodiments of the IVENS device 100 are presented.
In the first embodiment of the present invention, the paracervical electrode 110 is a full length paracervical electrode 110. The full length paracervical electrode 110 extends from the junction of the transitional portion 124 of the frame 104 and the proximal portion of frame 104 on one side of the frame 104 to the same position on the other side of the frame 104. When the frame 104 is properly positioned in the vagina 146, the full length paracervical electrode 110 will be in contact with the vaginal epithelium of both lateral vaginal fornices and the posterior vaginal fornix.
In the second embodiment of the present invention, two partial length paracervical electrodes 110 are embedded in the covering of the distal and lateral portion of the proximal portion of the frame 104 with one partial-length paracervical electrode 110 present on each side of the frame 104. When the frame 104 is properly positioned in the vagina 146, the two partial-length paracervical electrodes 110 will be in contact with the vaginally epithelium in the lateral vaginal fornices on each side of the cervix 148.
In the third embodiment of the present invention four partial-length paracervical electrodes 110 are embedded in the covering of the distal and lateral portion of the proximal portion of the frame 104 with a pair of partial-length paracervical electrodes 110 present on each side of the frame 104. When the frame 104 is properly positioned in the vagina 146, the two pairs of partial-length paracervical electrodes 110 will be in contact with the vaginal epithelium in the lateral vaginal fornices, with one pair of paracervical electrodes 110 on each side of the uterine cervix 148.
Those skilled in the art should recognize that other embodiments can be created using multiple paracervical electrodes 110 embedded in the distal portion of the frame 104 and multiple cutaneous electrodes 111 applied to the lower back, or other areas of the lower abdomen or pelvis which can be paired together to create a wide variety of electrical stimulation circuits.
The Paracervical Electrode Connecting Wires
The full length paracervical electrode 110 and each partial-length paracervical electrode 110 embedded in the covering of the proximal portion of the frame 104 are attached to individual paracervical electrode 110 connecting wires that have color-coded electrical connections at their terminus that will attached to one of the two electrical connections in an ISC 109 port on the IS 107.
The color-coding of the terminal ends of the paracervical electrode 110 connecting wires and the cutaneous electrode connecting wires 113 (as described below) will allow the patient to use a color-coded chart to connect different combinations of electrodes to multiple ISCs 109 to create multiple electrical stimulation circuits to enable creating multiple electrical fields at the same time.
The ability of the ESG 130 to create and deliver multiple ESPs to multiple ISCs 109 simultaneously allows for the creation of a variety of similar and dissimilar electrical fields between multiple pairs of electrodes appropriately placed in the proximity of the pelvic nerves, paracervical nerves, and sacral nerves at the same time allows multiple modes of operation for multiple embodiments of the present invention. Thus, the electronic signals sent to the ESG 130 in the IS 107 by the microprocessor operating under the control of the IDCA 137 in the static memory causes the electrical stimulation generator to transmit multiple electrical stimulation patterns through multiple ISCs 109 to create multiple electrical stimulation circuits to create multiple electrical fields between multiple pairs of electrodes that are placed in specific locations within or around the pelvis to specifically target the pelvic nerves, the paracervical nerves and the sacral nerves causing electrical neuromodulation of these nerves to reduce or eliminate pelvic pain and external genital pain.
For the purpose of further describing and illustrating exemplary embodiments of the present invention, three embodiments of the IVENS device 100 will now be described in some detail.
In the first embodiment, the paracervical electrode is a full-length paracervical electrode 110A.
In the second embodiment of the present invention, two partial length paracervical electrodes 110B and 110D. In this embodiment, a first partial-length paracervical electrode 110B is embedded in the covering on the right side of the distal and lateral portions the frame 104, and a second partial-length paracervical electrode 110D is embedded in the covering on the left side of the distal and lateral portion of the frame 104. When the IVENS device 100 is properly positioned in the vagina, the first partial-length paracervical electrode 110B will be in contact with the vaginal epithelium in the right lateral vaginal fornix and the second partial-length paracervical electrode 110D will be in contact with the vaginal epithelium in the left lateral vaginal fornix.
In the third embodiment of the present invention (not shown), four partial-length paracervical electrodes are present, with two partial-length paracervical electrodes embedded in the covering of the distal and lateral portion of the proximal portion of the frame 104 on each side of the frame 104.
Persons skilled in the art will recognize and appreciate, however, that other embodiments can be created using multiple paracervical electrodes 110 embedded in the proximal portion of the frame 104 and multiple cutaneous electrodes 111 applied to the lower back, or other areas of the lower abdomen or pelvis, which can be paired together to create a wide variety of electrical stimulation circuits and a wide variety of overlapping electrical fields.
While the first and second embodiments require at least one cutaneous electrode 111, the third embodiment does not necessarily require using a cutaneous electrode 111.
The first exemplary embodiment has at least one mode of operation. The second embodiment has at least two modes of operation. And the third embodiment has at least two modes of operation. Therefore, when considered together, the three exemplary embodiments may be operated in a total of five different modes of operation. These five different modes of operation for the IVENS device 100 will now be described in more detail with reference to
The electrode types, electrode placement locations, and number of ISCs 109. used in the embodiments and the modes of operation presented hereinafter are summarized in the table below. In this table, the labels in the first column identify the embodiments and modes of operations as follows:
E1M1=Embodiment 1—Mode of Operation 1,
E2M1=Embodiment 2—Mode of Operation 1,
E2M2=Embodiment 2—Mode of Operation 2,
E3M1=Embodiment 3—Mode of Operation 1, and
E3M2=Embodiment 3—Mode of Operation 2.
As shown in Table 1, in a first mode of operation for the first embodiment of the present invention (see the rows associated with the label E1M1 in Table 1), a full length paracervical electrode 110 is positioned in the posterior and lateral vaginal fornices of the upper vagina and a single cutaneous electrode 111 is attached to the lower back in the area of the L5-S1 vertebral junction. For this embodiment, the full length paracervical electrode and the cutaneous electrode 111 are attached by connecting wires to a single ISC 109 of the electrical stimulation generator 130 in the IS 107. The ESG 130 is configured to generate an electrical field between the full length paracervical electrode and the cutaneous electrode 111 using the single ISC 109. This electric field will influence and neuromodulate the pelvic nerves, the paracervical nerves and the sacral nerves. The direct and targeted electrical neuromodulation of these nerves results in a reduction or elimination of perceived pelvic pain, as well as perceived external genital pain. This first embodiment of the present invention was discussed above in connection with the descriptions of
In the second embodiment of the present invention (see the rows associated with the labels E2M1 and E2M2 in Table 1), a first partial-length paracervical electrode on the right side of the frame 104 is positioned in the right lateral vaginal fornix, and a second partial-length paracervical electrode on the left side of the frame 104 is positioned in the left lateral vaginal fornix. In a first mode of operation for this second embodiment of the present invention, the first partial length paracervical electrode 110 (positioned in the right lateral vaginal fornix) and a first cutaneous electrode 111 (placed on the skin of the lower back in the area of the L5-S1 vertebral junction to the right of the midline) are attached to the first ISC 109 on the IS 107. In addition, a second partial length paracervical electrode 110 (positioned in the left lateral vaginal fornix) and a second cutaneous electrode 111 (placed on the skin of the lower back in the area of the L5-S1 vertebral junction to the left of the midline) are attached to a second ISC 109 on the IS 107.
In a first mode of operation for the second embodiment (E2M1) of the present invention, the electrical stimulation generator is configured to generate a first electrical field located between the first partial-length paracervical electrode and the first cutaneous electrode 111 using the first ISC 109, and a second electrical field between the second partial-length paracervical electrode 110 and the second cutaneous electrode 111 using the second ISC 109.
In a second mode of operation for this second embodiment of the present invention (see the rows associated with the E2M2 label in Table 1 above), a first partial-length paracervical electrode 110 on the right side of the frame 104 is positioned in the right lateral vaginal fornix and a second partial-length paracervical electrode 110 on the left side of the frame 104 is positioned in the left lateral vaginal fornix and both electrodes are attached to a single ISC 109 (the first ISC) on the ESG 130 of the IS 107. The electrical pulse generator is configured to generate a single electrical field between the first partial-length paracervical electrode 110 and the second partial-length paracervical electrode 110, which provides targeted electrical neuromodulation of the paracervical nerves and, to a lesser extent, additional neuromodulation of the pelvic and sacral nerves. The direct and targeted neuromodulation of the paracervical nerves, pelvic nerves and sacral nerves in this fashion results in a reduction or elimination of perceived pelvic pain, as well as perceived pain from the perineum and external genitalia.
In a third embodiment of the present invention (identified with the labels E3M1 and E3M2 of Table 1 above), four partial-length paracervical electrodes 110 are present. Two of the four partial-length paracervical electrodes 110 are embedded in the covering of the distal and lateral portion of the proximal portion of the frame 104 on each side of the frame 104. When the frame 104 is properly positioned in the vagina, the first partial-length paracervical electrode 110 is positioned in the right anterior Lateral vaginal fornix, the second partial-length paracervical electrode 110 is positioned in the left anterior lateral vaginal fornix, the third partial-length paracervical electrode 110 is positioned in the right posterior lateral vaginal fornix, and the fourth partial-length paracervical electrode 110 is positioned in the left posterior lateral vaginal fornix.
In a first mode of operation for this third embodiment (see the rows associated with the E3M1 label in Table 1), the first partial-length paracervical electrode 110 (positioned in the right anterior lateral vaginal fornix) and the second partial-length paracervical electrode 110 (positioned in the left anterior lateral vaginal fornix) are attached to the first ISC 109 of the ESG 130 in the IS 107, and the third partial-length paracervical electrode 110 (positioned in the right posterior lateral vaginal fornix) and the fourth partial-length paracervical electrode 110 (positioned in the left posterior lateral vaginal fornix) are attached to the second ISC 109 of the ESG 130 in the IS 107. The ESG 130 is configured to generate an electrical field between the first partial-length paracervical and the second partial-length electrodes using the first ISC 109, and a second electrical field between the third partial-length paracervical and the fourth partial-length paracervical electrode 110 using the second ISC 109. In some situations, the first and second electrical fields may have identical electrical stimulation profiles. In other situations, the first and second electrical fields may have different electrical stimulation profiles. The two electrical fields may exist simultaneously, consecutively or in an alternating pattern. Each of these electrical fields are targeted to influence and neuromodulate the pelvic nerves, the paracervical nerves and the sacral nerves. The direct and targeted electrical neuromodulation of these nerves results in a reduction or elimination of perceived pelvic pain, as well as perceived external genital pain. A schematic representation of the shape of the electrical field created using the first mode of operation for the third embodiment of the present invention using the anterior partial-length paracervical electrodes 110 and the first ISC 109 is presented in
In a second mode of operation for this third embodiment of the present invention (see the rows associated with the E3M2 label of Table 1 above), the first partial-length paracervical electrode 110 (positioned in the right anterior lateral vaginal fornix) and the second partial-length paracervical electrode 110 (positioned in the right posterior lateral vaginal fornix) are attached to the first ISC 109 of the ESG 130 in the IS 107. The third partial-length paracervical electrode 110 (positioned in the left anterior lateral vaginal fornix) and the fourth partial-length paracervical electrode 110 (positioned in the left posterior lateral vaginal fornix) are attached to the second ISC 109 of the ESG 130 in the IS 107. The ESG 130 is configured to generate an electrical field between the first partial-length paracervical electrode 110 and the second partial-length paracervical electrode 110 using the first ISC 109, and a second electrical field between the third partial-length paracervical electrode 110 and the fourth partial-length paracervical electrode 110 using the second ISC 109.
In some situations, the first and second electrical fields may have identical electrical stimulation profiles. In other situations, the first and second electrical fields may have different electrical stimulation profiles. The two electrical fields may exist simultaneously, consecutively or in an alternating pattern. Each of these electrical fields are targeted to influence and neuromodulate the pelvic nerves, the paracervical nerves and the sacral nerves. Each of these electrical fields are targeted to influence and neuromodulate the pelvic nerves, the paracervical nerves and the sacral nerves. The direct and targeted electrical neuromodulation of these nerves results in a reduction or elimination of perceived pelvic pain, as well as perceived external genital pain. A schematic representation of the shape of the two electrical fields created using the second mode of operation for the third embodiment of the present invention is presented in
The Extravaginal Components of the IVENS Device
Returning now to
The IVENS Stimulator
The IVENS Stimulator (IS) 107 is an electronic device that generates electrical stimulation pulses to create an electrical field between a pair of electrodes in an electrical stimulation circuit.
As shown in
The electronic components of the IS 107 are a battery 141 and a printed circuit board which is affixed to the interior wall of the case. The components of the IS 107 installed on the “printed circuit board include a static memory 139, a microprocessor 132, A volatile memory 134, a display 133, an input device 135 (such as a touch-screen on the display 133), and an electrical stimulation generator 130. Electrical contacts 154 attached to the electrical stimulation generator 130 extend to openings in the case where connecting wires from the paired electrodes in an electrical stimulation circuit attach to a contact 155 on the IS 107.
The static memory 139 on the printed circuit board stores the programming instructions that comprise the IVENS device control application (or “IDCA”) 137. As shown in
Responding to user inputs from the user interface (display) on the IS 107, the IDCA 137 sends instructions to the microprocessor 132 that, when executed by the microprocessor, will cause the microprocessor 132 to perform certain functions herein described, including sending electronic instructions to the ESG 130, thereby controlling specific characteristics of the ESP generated by the ESG 130.
The characteristics of the ESPs produced by the ESG 130 may be varied by using, for example, constant current versus constant voltage, low frequency versus high frequency stimulation, tonic stimulation or burst stimulation and by altering the pulse width, frequency and amplitude of the electrical stimulation being produced. To this end, a portion of the static memory 139 in the IS 107 may be used by the IDCA 137 as a dedicated storage area 163 for storing certain IS 107 settings and operational parameters, such as on-off triggers, and pulse duration, waveform, frequency, voltage, intensity, amplitude, amperage and other parameters that define the ESPs. Preferably, a variety of different ESP's may be created, saved, recalled and activated by the patient by manipulating controls in the user interface related to the IDCA 137 or the IEC 103. Some of the features implemented in the user interface 136 of the IDCA 137 are discussed in more detail below.
When executed by the microprocessor 132, the programming instructions from the IDCA 137 will cause the microprocessor 132 to carry out the steps of one or more predefined algorithms. These algorithms are typically executed in response to operating instructions and parameters input by the user via the user interface. For example, the algorithms are typically arranged to allow the user to select and adjust the ESPs output by the electrical stimulation generator 130in accordance with either pre-installed ESPs, or ESPs created by the user via the user interface 151. Preferably, the static memory 139 also stores historical data regarding the operations and performance of the IVENS device 100, which is periodically uploaded to the IDCA 137. Preferably, but not necessarily, the IDCA 137 includes program instructions that, when executed by the microprocessor 132, will cause the microprocessor 132 to use the radio frequency transceiver 138 in the IS 107 to wirelessly transmit historical data to other computing devices and make this data available to the patient's practitioner and others to improve the use of the device by the patient and others. The static memory 139 of the IS 107 may also store programming instructions that, when executed by the microprocessor 132, will cause the microprocessor 132 to run a self-diagnostic test prior to sending electrical stimulation signals to the paracervical electrodes 110, and automatically generate a message for the user and then turn off the device should a fault be detected during the self-diagnostic test.
When the set of intravaginal components 102 of the IVENS device 100 is properly positioned in the vagina 146 with the paracervical electrode 110 in the posterior and lateral vaginal fornices and the cutaneous electrode 111 is properly positioned on the lower back in the area of the L5 — S5 vertebral junction, and both electrodes are connected to the IS 107 with their connecting wires, and the IS 107 is activated, an electrical field 162 is created between the paracervical electrode 110 and the cutaneous electrode 111 which causes electrical neuromodulation of the pelvic, paracervical, and sacral nerves, resulting in a decrease in or elimination of pelvic pain and external genitalia pain.
The Cutaneous Electrode
The cutaneous electrode 111 is an uninsulated wire or collection of uninsulated wires sandwiched between a medical grade adhesive pad that can conduct an electrical current that is attached to the patient's skin and a protective covering over the wire(s) that has insulating properties to prevent electrical wires from coming into contact with objects outside of the cutaneous electrode 111.
The Cutaneous Electrode Connecting Wire
The cutaneous electrode connection wire 113 has an electrical connection at its terminus that attaches to one of the two electrical connections in an ISC 109. These electrical connections are preferably color-coded to assist the user or her physician in connecting the cutaneous electrode wires 113 to the cutaneous electrode 111 and the IS 107.
The IVENS External Controller
Also as shown in
Typically, the IEC 103 includes a microprocessor 192, a volatile memory storage area 196 for temporary storage of compiled and executable program instructions suitable for execution on the microprocessor 192, a display screen 194, an input device 198, such as a keyboard or touchscreen, a static memory 199 for storing the IVENS device control application (IDCA) 137, a battery (not shown) and the radio frequency transceiver 190. The executable program instructions (the “IVENS app”) 160 running on the IEC 103 preferably permits the user to perform all of the functions available to her through the user interface 151 on the IS 107. In addition, the IVENS app 160 typically includes program instructions that, when executed by the microprocessor 192 on the IEC 103, and allows the user to provide clinically relevant information related to her user experience with device and send device status information to an external computer system or server, which might be operated and managed, for example, by the device's manufacturer or a doctor's office.
The User Interface
Among other things, the user interface may be programmed to provide a variety of useful functions, including but not limited to:
[1] Switching the IVENS device 100 on and off (
[2] Displaying the current operating status and battery charge level for the IVENS device (
[3] Warning the patient when the battery charge level is low (
[4] Permitting the patient to choose an electrical stimulation profile (ESP) from a number of “favorited” profiles, which may be (i) pre-loaded into the app during her initial consultation with her IVENS practitioner based upon the patient's medical history and the prior treatment experiences of a multiplicity of other users, (ii) loaded into the app following consultations with her IVENS practitioner based her experiences using the device, or (iii) self-created and saved by the patient (
[5] Permitting the patient to create, select, edit and save a variety of different operating properties, such as frequency, intensity, duration, intensity, rise time, decay time and stimulation width of an electrical stimulation session. (
[6] Permitting the patient to track the starting times and ending times of certain physical events in her body, such as the beginning and end of a menstrual period, the beginning and end of menstrual cramps or backaches, the beginning and end of hot flashes or chills, etc., as well as potential side effects or complications that may be associated with the use of the device. (
[7] Permitting the patient to track the starting times and ending times of certain physical activities, such as the beginning and end of a physical workout, the beginning and end of intercourse, etc. (
[8] Permit the patient to automatically send physical event data and physical activity data to her practitioner. (
[9] Permitting the patient to set up and transmit to the local control program on the circuit board of the IVENS device a predefined schedule for the IVENS device to automatically start and stop a series of electrical stimulation sessions (not shown in the figures).
[10] Whenever an electrical stimulation session is about to begin, providing an audible or visual alert on the patient's control or smart phone so that the patient is not surprised by unexpected vaginal stimulation, if any, and will have sufficient time to cancel the session or deactivate the device if the timing of the session is inappropriate for whatever activity in which the patient is currently engaged (not shown in the figures).
[11] At the beginning, during and after an electrical stimulation session, providing an audible or visual alert on the patient's control or smart device, along with a prompt to the patient to use a slider or button on the user interface to rate on a scale her current level of pelvic pain and/or discomfort, so that this information can also be tracked, stored and subsequently uploaded to another computer system for detailed analysis and evaluation (not shown in the figures).
[12] Permitting the patient to update the IVENS app by checking for available updates on remote computer system and, if any such updates are available, automatically downloading and installing those updates on the IEC (
Protocols for Using the IVENS Device
It is anticipated that IVENS devices will be available to obtain from medical practitioners who are familiar with the causes and treatments of pelvic pain, female pelvic anatomy and female pelvic neuroanatomy. These practitioners are preferably specifically trained on the custom fitting of the devices, the use of electrical stimulation for the treatment of pelvic pain and the proper programming of settings for individual patients using the IVENS device. Medical practitioners with the above-mentioned knowledge and training will hereinafter be referred to as “IVENS Practitioners.”
Evaluation of candidates for the IVENS device
Appropriate candidates for using the IVENS device include, but is not limited to, women with a documented history of endometriosis, dysmenorrhea, dyspareunia or chronic pelvic pain that is not associated with the presence of abdominal or pelvic malignancy. In addition, postsurgical patients, intrapartum patients, and postpartum patients may benefit from using certain embodiments of the device. Prior to providing a woman with a device, she should have a complete gynecological examination including a pelvic examination and appropriate screening for cervical dysplasia or cancer and vaginal or pelvic infections. In addition, she should not have any contraindications to the use of electrical stimulation such as the presence of a pacemaker.
Initial fitting of the device by an IVENS Practitioner
Because every woman's pelvic anatomy is unique and the goal of treatment with the IVENS device is to comfortably apply electrical stimulation to the paracervical nerves beneath the paracervical vaginal epithelium in the areas of the lateral vaginal fornices, it is important that users of the device be properly fitted for its proper use.
Proper fitting of the device requires the selection of a frame 104 that is the appropriately sized for the patient with adjustment made to the shape of the frame 104 if indicated.
Initial programming of the Device
It is anticipated that individual patients will have benefit from a variety of different embodiments and modes of operation of the device to provide a variety of Electrical Stimulation Profiles (ESPs) for the electrical stimulation that is delivered by the device for different circumstances. Circumstances such as activity, time of day, the presence or absence of stress and the level of pelvic pain being experienced by the patient make one ESP preferable over another from time to time. The settings established in each ESP may include adjustments to a variety of parameters, such as electrical intensity, stimulation frequency, electrical stimulation waveform, duration of treatment and others.
The initial ESPs made available to the patient may be established in consultation with her IVENS practitioner based upon the patient's medical history and the aggregated experiences of numerous patients using the device. During the initial visit with an IVENS practitioner, the patient will be asked to complete a questionnaire detailing the degree, timing, and intensity of her pelvic pain or external genital pain. This will create a baseline for establishing initial care and to evaluate the efficacy of using the IVENS device to treat the patient's pelvic pain or external genital pain. During her initial consultation with an IVENS practitioner, the patient will receive an introduction to the use of the IVENS device, the IEC, the IVENS app, the initially available ESPs, the sensations and feelings that should be avoided during the use of the device and method of recording events through the IVENS app. During the initial consultation or a subsequent one, the patient will receive instruction regarding the creation of “personalized” user defined ESPs created and made available to her through the IVENS app.
While the present invention has been disclosed with reference to certain embodiments, numerous modifications, alterations and changes to the disclosed embodiments are possible without departing from the scope of the present invention, as defined in the appended claims. Accordingly, it is intended that the present invention not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.
| Number | Date | Country | |
|---|---|---|---|
| 63177222 | Apr 2021 | US |
