TREATMENT OF PELVIC ORGAN PROLAPSE

Abstract

The present invention relates to the diagnosis and treatment of pelvic floor prolapse. The diagnosis and treatment may involve the use of a multiple sensor-enabled device for vaginal insertion capable of providing real-time data regarding the pa -tient’s physiology, the position and movement of the urethra, and the muscular strength of the patient’s vagina and pelvic floor. The methods and devices of the invention may also be useful to addressing other medical issues, including urinary incontinence, sexual health, and fecal incontinence, as well as facilitate patient home wellness activities.

Claims

1. An intravaginal device comprising a plurality of sensors mounted on a flexible printed circuit board (PCB) attached to or incorporated within the device, wherein the device is configured to: a) provide real-time data selected from position, movement, pressure, and flow of the vagina and/or urethra; and b) transmit the real-time data wirelessly to a graphical user interface; wherein the position data relates to at least one of the position of the vagina and the position of an anatomical organ of interest relative to an anatomical or external reference point.

2. The intravaginal device of claim 1, wherein the sensors are accelerometers.

3. The intravaginal device of claim 1, wherein the sensors are positioned along a length of the device.

4. The intravaginal device of claim 1, wherein the real-time data is position or movement data.

5. The intravaginal device of claim 1, wherein the device comprises a pressure sensor.

6. The intravaginal device of claim 5, wherein the data is pressure data.

7. The intravaginal device of claim 1, wherein at least one of the plurality of the sensors comprises at least one of a gyroscope, an inductive noncontact position sensor, a string potentiometer, a linear variable differential transformer, a potentiometer, a capacitive transducer, an Eddy-current sensor, a Hall effect sensor, an optical proximity sensor, a piezo-electric transducer, and a photodiode array.

8. The intravaginal device of claim 1, wherein the position and movement data comprises at least one of: magnetic, electromagnetic, microelectromechanical, radio frequency, ultrasound, and video data.

9. The intravaginal device of claim 1, wherein at least one of the plurality of sensors comprises at least one of a force collector, a piezo-resistive sensor, a capacitive sensor, an electromagnetic sensor, a piezo-electric sensor, an optical sensor, a potentiometric sensor, a resonant sensor, a thermal sensor, an ionization sensor; an ultrasonic sensor, a density sensor, a resistive sensor, a surface acoustic wave sensor, a capacitive sensor, an infrared sensor, an optical imaging sensor, a dispersive signal technology sensor, and an acoustic pulse recognition sensor.

10. The intravaginal device of claim 1, wherein the device is inflatable.

11. The intravaginal device of claim 10, wherein the device comprises a plurality of inflatable compartments.

12. The intravaginal device of claim 1, wherein at least one of the plurality of sensors has multiple measurement and reporting capabilities.

13. A method for treating a female subject with a pelvic floor disorder comprising the steps of: (a) inserting into the subject’s vagina the device of claim 1; (b) displaying on a graphical user interface a visual representation of the subject’s vagina corresponding to a position of the device that is generated by the sensors prior to performance of a pelvic floor exercise, and recording the position that is prior to the performance; (c) displaying on the graphical user interface a visual representation of the subject’s vagina corresponding to a position of the device that is generated by the sensors during the performance of the pelvic floor exercise by the subject, and recording the position that is during the performance; (d) repeating steps (b) and (c) one or more times; and (e) generating pelvic floor position information based on the recorded positions of the subject’s vagina during steps (b) and (c) and using the pelvic floor position information to guide the subject via the visual representation during at least one step (c) so as to activate pelvic floor muscles that strengthen the pelvic floor or to limit activation of pelvic floor muscles that harm the pelvic floor, thereby treating the pelvic floor disorder.

14. The method of claim 13, wherein steps (b) and (c) occur in real-time.

15. The method of claim 13, wherein the device transmits the positions of the subject’s vagina during steps (b) and (c) wirelessly to the graphical user interface.

16. The method of claim 13, wherein the graphical user interface is a display screen of a computer or smart phone.

17. The method of claim 13, wherein steps (b) and (c) are repeated five or six times daily and/or wherein steps (b) and (c) are performed every four to six weeks.

18. The method of claim 13, wherein the method strengthens the pelvic floor muscles of the subject.

19. The method of claim 13, wherein the pelvic floor exercise comprises a Kegel maneuver or a Valsalva maneuver.

20. The method of claim 13, wherein the pelvic floor disorder is pelvic floor weakness or pelvic organ prolapse (POP).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 depicts a lateral view of an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0019] When used in the claims, the terms “a” and “an” and “the” and similar references in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Also when used in the claims, the terms “comprising,” “having,” “including,” and “containing” are to be construed as open- ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. To the extent used, the recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. Variations of the embodiments may become apparent to those of ordinary skill in the art upon reading the description. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

[0020] For purposes of the present invention, the term “urethra” may be defined as the canal leading from the bladder, discharging the urine externally. See STEDMAN’s MEDICAL DICTIONARY, at page 2072 (28.sup.th ed). In females, the urethra is a canal about 4 centimeters long passing from the bladder, in close relation with the anterior wall of the vagina and having a long axis that parallels that of the vagina opening in the vestibule of the vagina posterior to the clitoris and anterior to the vaginal orifice. Id. The term “urinary bladder” refers to a musculomembranous elastic bag serving as a storage place for the urine, filled via the ureters and drained via the urethra. Id. at page 226. The term “bladder neck” is defined as the smooth muscle of the bladder neck is histologically, histochemically and pharmacologically distinct from the detrusor muscle proper and so the bladder neck should be considered as a separate functional unit. See GRAY’s ANATOMY, at page 1290 (39.sup.th ed.). The arrangement of smooth muscle in this region is quite different in males and females, and therefore each sex is described separately. In females, the bladder neck consists of morphologically distinct smooth muscle. The large diameter fasciculi characteristic of the detrusor is replaced in the region of the bladder neck by small diameter fasciculi which extend obliquely or longitudinally into the urethral wall. Id. In the normal female the bladder neck which above the pelvic floor supported predominantly by the pubovesical ligaments, the endopelvic fascia of the pelvic floor and levator ani. These support the urethra at rest; with elevated intra-abdominal pressure the levators contract increasing urethral closure pressure to maintain continence. This anatomical arrangement commonly alters after parturition and with increasing age, such that the bladder neck lies beneath the pelvic floor, particularly when the intra-abdominal pressure rises. The mechanism described above may fail to maintain continence (incontinence as a result of urethral hypermobility).

[0021] As commonly understood, the term “vagina” refers to an elastic muscular canal that extends from the cervix to the vulva. Although there is wide anatomical variation, the length ofthe unaroused vagina of a woman of child-bearing age is approximately 6 to 7.5 cm (2.5 to 3 inches) across the anterior wall (front), and 9 cm (3.5 inches) long across the posterior wall (rear). The vagina connects the superficial vulva to the cervix of the deep uterus. In a typical woman standing upright, the vaginal tube points in an upward-backward direction and forms an angle of slightly more than 45 degrees with the uterus. The vaginal opening is at the caudal end of the vulva, behind the opening of the urethra. The upper one- fourth of the vagina is separated from the rectum by the recto-uterine pouch.

[0022] In the present invention, for example, a device for vaginal insertion may be equipped with at least one sensor capable of providing real-time data of one or more types selected from the group consisting of position, movement, pressure, and flow. In this regard, a sensor may have a single measurement and reporting capability, or may have multiple measurement and reporting capabilities. The data obtained by the multiple sensor-enabled device may be reported in any number of ways known in the art, including the transmission to, and visualization on, a graphical user interface wirelessly.

[0023] The device would be inserted into the vagina until the patient feels her cervix. The distal section of the device, in an inflatable embodiment, would be filled with air, gel, liquid, or other appropriate material suitable for inflation and deflation of a compartment, to fit the patient’s vagina. In an embodiment with multiple inflatable sections, the rest of the compartments could be filled from distal to proximal (vaginal opening). In this way, a patient with POP not only would strengthen her vaginal muscles but could also use the device as a pessary that can be easily removed at home and would not have the complications currently associated with pessaries, such as pressure point problems and vaginal infections.

[0024] When the device is properly inserted and inflated, the health care provider or patient can visualize the device on a display screen. When the patient is asked to perform Kegel movements, the vaginal pressure or strength of the vaginal musculature will also be visualizable on the screen. The health care provider could then go through the exercises with the patient to ensure that she is performing the exercises optimally and has understood how to interpret the information and otherwise use the equipment properly.

[0025] The multiple sensor-enabled device would be invaluable as a study or rehabilitation tool for the health care provider as well as the patient who is considering a pregnancy. The health care provider may be able to provide the patient with an exercise regimen that could strengthen her vagina and urinary musculature at home before she had her baby, helping her prevent urinary incontinence in the future and strengthening her pelvic floor, before the possible damage may occur during pregnancy and delivery.

[0026] The multiple sensor-enabled device could aid various diagnoses that rely upon data concerning the position, strength and pressures of the vaginal space. By combining pressure sensors along the multiple sensor-enabled inflatable vaginal insert along with the positional sensors, objective measurements relating to vaginal pressure and positional location can be evaluated and correlated to aid in the diagnosis and treatment of UI or POP and the rehabilitation of the vaginal muscles and pelvic floor.

[0027] In yet another embodiment of the present invention, the multiple sensor-enabled device can provide data, which is transmitted and recorded in a manner to create and maintain historical patient information for medical and/or fitness purposes, such as a pelvic floor muscle strengthening exercise calendar.

[0028] Another use for a multiple sensor-enabled device would be to correct fecal incontinence, which is often another sequela of pregnancy and childbirth. For example, if a rectocele or enterocele is diagnosed, a multiple sensor-enabled device could be inserted into the rectum. With this information the health care provider would be able to properly diagnose the etiology of the fecal incontinence whether that is due to muscle weakness of the pelvic floor, a rectal sphincter deficiency, or a combination of the two. The health care provider could target the surgical repair, in real-time if preferred, to correct the fecal incontinence.

[0029] The multiple sensor-enabled device may incorporate at least one sensor capable of measuring and/or reporting data of various types including position, movement, pressure and flow. A multiple sensor-enabled device with more than one individual sensor may be arrayed as depicted in FIG. 1. However, a multiple sensor-enabled device may incorporate a single sensor capable of multiple measurement and reporting capabilities.

[0030] The position and movement data may be of the sort measured and/or reported by any number of sensor devices, including an accelerometer, gyroscope, inductive non-contact position sensor, string potentiometer, linear variable differential transformer, potentiometer, capacitive transducer, Eddy-current sensor, Hall effect sensor, optical proximity sensor, piezo-electric transducer and photodiode array. The position and movement data may also include magnetic, electromagnetic, microelectromechanical, radio frequency, ultrasound and video.

[0031] The pressure and flow data may be of the sort measured and/or reported by any number of sensor devices, including force collector types, such as piezo-resistive, capacitive, electromagnetic, piezo-electric, optical, potentiometric, or other types, such as resonant, thermal, ionization, ultrasonic, and density (mass and index of refraction). In addition, sensor technology that recognizes movement and touch may be incorporated, which includes the types such as resistive, surface acoustic wave, capacitive (surface capacitance, projected capacitance, mutual capacitance, and self-capacitance), infrared, optical imaging, dispersive signal technology, and acoustic pulse recognition.

[0032] FIG. 1 depicts a multiple sensor-enable device for vaginal insertion with inflatable compartments. The number and precise placement of an individual sensor may vary depending on the type of positional, movement, pressure or flow measurement and/or reporting system employed. An individual sensor may have a single function or be multifunction (such as positional tracking combined with pressure and flow sensing). The multiple sensor-enabled device may also embody a video observation and/or recording device as well as an illumination source to facilitate such video capture. The precise placement of the sensor(s) and video capture component(s) need not be pre-defined, and may be configured according to the requirements of the desired application.

SPECIFIC EXAMPLES

[0033] As described earlier, the devices of the present invention may embody at least one sensor capable of measuring and reporting at least one data type, including position, movement, pressure, and flow. These include, but are not limited to, magnetic, electromagnetic, microelectromechanical, radio frequency, ultrasound and video. One example of a multiple sensor-enabled device contains various microelectromechanical (MEMS) sensors: a 3-axis accelerometer, a roll/pitch gyroscope and a yaw rate gyroscope, and a pressure and flow transducer. The sensors may be mounted on a small flexible printed circuit board (PCB) and then attached to, or incorporated within, the device. The 3-axis accelerometer tracks translation of the device in three directions. The gyroscopes are utilized to account for gravitational rotation, allowing real-time movement to be tracked.

[0034] A PCB is prepared with MEMS sensors mounted thereon. Soft leads can trail the MEMS sensors to supporting components, including, for example, a data acquisition card which may be used for transforming analog signals to digital signals. The PCB is set within the wall of the device. The location of the device may be determined by the output signals of the MEMS sensors.

[0035] In an embodiment where the multiple sensor-enabled device contains inflatable compartments, the device may be inserted in the length of the vagina at which point the compartment nearest the cervix is inflated to obtain a stationary and/or comfortable fit within the vagina. Any additional inflatable compartments may be inflated together or in sequence from distal to proximal to the vaginal opening.

[0036] The patient may be asked to perform a Kegel movement, while the health care provider and/or the patient observes the display output to confirm that the patient is performing the exercise optimally. The pressure and muscular strength of the vagina as measured by the multiple sensor-enable device would be displayed to reflect the effectiveness of the therapy. The position of the urethra and bladder neck may also be displayed in real time on a graphical user interface and/or recorded.

[0037] Following the examination using the multiple sensor-enabled device, the health care provider may conclude that rehabilitation is an efficacious option for the patient. In this regard, the measurements provided by the multiple sensor-enabled device may be recorded to facilitate appropriate patient instructions on performing Kegel exercises in an optimal manner using the visual (on-screen) information provided by the device in real-time. Once engaging the proper musculature has been successfully communicated to the patient during the medical office visit, the patient may be sent home with the instructions to perform Kegel exercises five to six times daily, for example. Four to six weeks later the patient may return for another examination using the multiple sensor-enabled device to evaluate rehabilitative treatment effectiveness, which may allow the health care provider to advise the patient about the prospects for restoring complete continence with a continued rehabilitation regime and/or a surgical procedure.

[0038] Detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various forms. It will be appreciated that many modifications and other variations that will be appreciated by those skilled in the art are within the intended scope of this invention as claimed below without departing from the teachings, spirit and intended scope of the invention.