Abstract:
Methods and devices to diagnose and treat fecal incontinence in females and males are provided. A multiple sensor-enabled catheter for positioning in a patient&#39;s rectum allows for the visualization and manipulation or positioning of an anatomical reference point(s) in the patient&#39;s body. A multiple sensor-enabled catheter for rectal insertion in a patient allows for the visualization and implementation of efficient and effective exercises to strengthen pelvic floor muscles.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part application of U.S. patent application No. 14/359,890, entitled “Treatment of Urinary Incontinence,” filed May 21, 2014, which claims priority to international patent application PCT/US2012/066613, filed Nov. 27, 2012, and U.S. provisional patent application Ser. No. 61/563,889, filed Nov. 28, 2011, the entireties of which are incorporated herein by reference for all purposes. 
     
    
     BACKGROUND 
       [0002]    The present embodiments relate to the devices, diagnosis, and treatment of fecal incontinence in females and males. The diagnosis and treatment may involve the use of a multiple sensor-enabled catheter capable of providing real-time data regarding the patient&#39;s anatomy and physiology, such as muscular function of the pelvic floor and rectal sphincter, as well as the position and movement of the catheter within the patient. 
         [0003]    Fecal incontinence refers to the involuntary loss of gas or liquid stool (called minor incontinence) or the involuntary loss of solid stool (called major incontinence). An estimated 6.5 million Americans suffer with fecal incontinence, but the number of patients suffering from this condition is likely under-reported due to the embarrassment associated with the malady. The percentage of affected females is higher than males because of trauma to the pelvic floor musculature experienced during parturition. More specifically, female fecal incontinence can be caused by sphincter damage at the time of childbirth, injury to the muscles of the pelvic floor, or the innervation of these tissues. These injuries increase in direct proportion to the number of deliveries, the weight of the baby, and the number of operative deliveries. Cesarean section decreases the incidence of fecal incontinence in females, but carries the risks and complications of surgery. Other reasons for fecal incontinence in both females and males include constipation, chronic diarrhea, old age, depression, urinary incontinence, systemic diseases such as Irritable Bowel Syndrome (IBS), and problems involving the nervous system such as stroke, spinal cord injury, multiple sclerosis, and Parkinson&#39;s disease. 
         [0004]    Current medical diagnostic tests for fecal incontinence include direct examination, anorectal manometry, sensory testing, anal endosonography, defecography, ultrasound, magnetic resonance imaging (MRI), pudenal nerve terminal latency (PNTML), and stool tests. Current treatments for fecal incontinence may involve changes in diet, pelvic floor muscle training (PFMT), medical therapy, and surgical correction. 
         [0005]    PFMT (or Kegel) exercises includes a series of exercises designed to rehabilitate the musculature of the pelvic floor. For example, PFMT can help strengthen and tone the muscles under the uterus, bladder, and bowel (large intestine), and thus aid those who have problems with bowel control or rectal sphincter function. A current problem with PFMT, however, is that the individual is often unable to visualize or attain the proper muscle position and control to carry out an efficient and effective exercise regimen required to rehabilitate the pelvic floor muscles. 
       SUMMARY 
       [0006]    The embodiments described herein relate to the diagnosis and treatment of fecal incontinence in females and males. In one embodiment, diagnosis and treatment involves the use of a probe device capable of providing real-time data regarding a patient&#39;s anatomy and physiology; such as muscular function of the rectal sphincter or pelvic floor, as well as the position or movement of the device within the patient. In one embodiment, the device may be a pressure sensor-enabled catheter. 
         [0007]    In one embodiment, the multiple sensor-enabled catheter may include 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. 
         [0008]    The present embodiments also provide for methods for the diagnosis or treatment of fecal incontinence in females and males, comprising positioning a multiple sensor-enabled catheter in a patient&#39;s rectum and determining the anatomical state of the patient, which treatment is capable of relieving or ameliorating incontinence. The anatomical state may be the sphincteric or supportive functions of the pelvic floor, such as muscle tone and strength. The method of diagnosis or treatment may also include manipulating the patient to relieve the fecal incontinence. The manipulation may be performed by the health care provider or the patient. The manipulation may include achieving a particular anatomical position of the patient&#39;s internal organs to achieve a particular muscular function of the pelvic floor. 
         [0009]    The present embodiments contemplate the real-time position and movement tracking as described in U.S. Pat. No. 8,805,472. In this regard, the real-time position and movement tracking may include sensing the position of a fixed reference point(s) within the subject&#39;s body, by providing a catheter enabled with a sensor and capable of providing positional or movement data that can be perceived by a device, person, health care provider, or patient. The fixed reference point within the patient&#39;s body may be the pubic bone, the coccyx, the bladder, the urethra, the uterus, the prostate, or the rectum. The method may be performed in real-time, for example, during an operation. In another embodiment, the method may be performed at multiple time intervals. The multiple time intervals may occur, for example, pre- and post-event, wherein the event may be parturition, injury, or surgery. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  depicts a view of an example probe device comprising a multiple sensor-enabled catheter. 
       
    
    
     DETAILED DESCRIPTION 
       [0011]    All patents, applications, and other publications identified are expressly incorporated herein by reference for the purpose of describing and disclosing, for example, the devices methodologies described in such publications that might be used in connection with the present invention. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents are based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents. 
         [0012]    As used herein and in the claims, the singular forms include the plural reference and vice versa unless clearly indicated otherwise by context. Throughout this specification and claims, unless otherwise indicated, “comprise,” “comprises” and “comprising” are used inclusively rather than exclusively. The term “or” is inclusive unless modified, for example, by “either.” Other than in the operating examples, or where otherwise indicated, all numbers should be understood as modified in all instances by the term “about.” 
         [0013]    Unless otherwise defined, scientific and technical terms used herein shall have the meanings that are commonly understood by those of skill in the art. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention, which is defined solely by the claims. 
         [0014]    One embodiment described herein provides for methods for the diagnosis or treatment of fecal incontinence in females and males, comprising positioning in the rectum of a patient a multiple sensor-enabled catheter, visualizing the anatomical state of the patient, and manipulating the patient&#39;s body to a position capable of relieving the fecal incontinence. In an additional embodiment, the anatomical state is the relative position of one or more internal anatomical reference points selected from the pubic bone, the coccyx, the bladder, the urethra, the uterus, the prostate, or the rectum. In another embodiment, the anatomical state is the muscular function of the rectal sphincter. 
         [0015]    An additional embodiment provides for a method of rehabilitating the pelvic floor musculature, comprising positioning in the rectum of a patient a multiple sensor-enabled catheter and visualizing the anatomical state of the patient, wherein the patient manipulates the catheter as a method of exercising control of sphincter or pelvic floor muscles. 
         [0016]    In the present embodiments, for example, a catheter is enabled with at least one sensor capable of providing real-time data of at least one data type 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 catheter may be reported in any number of ways know in the art, including the transmission to, and visualization on, a graphical user interface. For purposes of the embodiments, “real-time” may include instantaneous as well as delayed observation, reporting, or recording of an event as it elapses. 
         [0017]    Advantageously, by viewing a real-time image of where one or more fixed anatomical reference points are located relative to one another during a procedure, a health care provider may manipulate the patient such that the patient is in a position capable of relieving or ameliorating fecal incontinence. In other instances, a patient may visualize her or his own anatomical state using the multiple sensor-enabled catheter, and may manipulate her or his body such that she or he is in a position capable of relieving fecal incontinence. Additionally or alternatively, the patient may visualize her or his own anatomical state using the multiple sensor-enabled catheter, and may manipulate her or his body to a position capable of controlling her or his pelvic floor muscles to relieve fecal incontinence. 
         [0018]    A multiple sensor-enabled catheter provides a valuable study or diagnostic tool for a health care provider as well as a patient, particularly when the patient is considering surgery that may result in fecal incontinence as a post-surgical complication (e.g., from colorectal or prostate surgery). For example, a health care provider may provide the patient with an in-office procedure that determines a baseline position or relative mobilization of the an anatomical reference point within the patient&#39;s body (baseline) before possible damage to her or his pelvic floor; such that if surgical repair is subsequently performed, the bladder can be repositioned to the original, pre-incontinence anatomic position. Surgery could also be performed on patients with a surgically correctable structural defect, using the multiple sensor-enabled catheter to provide positioning data. Such procedures may involve a pelvic sling or other surgical intervention. 
         [0019]    A multiple sensor-enabled catheter also provides a valuable study or diagnostic tool for a health care provider as well as a female patient pre- or post-childbirth. For example, a health care provider may provide a patient with an in-office procedure that determines a baseline position or relative mobilization of the an anatomical reference point within the patient&#39;s body (baseline) before possible damage to her pelvic floor, particularly injuries that result in pelvic organ prolapse; such that if surgical repair is subsequently performed, the bladder or prolapsed organs can be repositioned to the original, pre-incontinence anatomic position. With a female patient, another embodiment may involve a multiple sensor-enabled catheter inserted in the rectum and another multiple sensor-enabled catheter inserted in the vagina or urethra to provide additional positional or pressure data. 
         [0020]    A multiple sensor-enabled catheter may incorporate at least one sensor capable of measuring or reporting data of various types, including position, movement, pressure, or flow. A multiple sensor-enabled catheter with more than one individual sensor may be arrayed as depicted in  FIG. 1 , or it may incorporate a single sensor that has multiple measurement and reporting capabilities. 
         [0021]    The position or movement data may be of the sort measured or reported by any number of sensor devices, including 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, or photodiode array sensor devices. The position or movement data may also include magnetic, electromagnetic, microelectromechanical, radio frequency, ultrasound, or video data. 
         [0022]    The pressure or flow data may be of the sort measured 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, or density (mass and index of refraction) sensor devices. 
         [0023]    For example, an embodiment of a multiple sensor enabled catheter comprising a firm tip, which may be about ½ inch in length to guide the catheter through the rectum. The catheter may be a Foley catheter. The number and precise placement of an individual sensor may vary depending on the type of positional, movement, pressure or flow measurement 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 catheter may also embody a video observation 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) are not pre-defined, and may be configured according to the requirements of the desired application. 
       Examples 
       [0024]    As described herein, catheters useful in the present embodiments 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 catheter, as shown in  FIG. 1 , is a probe or catheter  100  containing multiple sensors arranged in an array  102 . The probe or catheter  100  may be constructed of a silicon or other material suitable for medical use in or on a patient&#39;s body. The probe or catheter  100  may include a distal probe or catheter tip  101 , which may be constructed of a material with sufficient hardness or rigidity to facilitate the ease of insertion of the probe or catheter  100  into a patient&#39;s rectum. The probe or catheter  100  may also contain a proximal portion with a connector/handle  104  to facilitate positioning or movement of the probe or catheter  100  by the patient or health care provider. A sensor, such as a pressure sensor  103 , may be contained in the proximal portion of the probe or catheter  100  to facilitate the assessment of rectal sphincter strength and/or control when the probe or catheter  100  is inserted into the patient&#39;s rectum. 
         [0025]    In other embodiments, the sensor(s) may be positioned in the probe or catheter  100  without a particular spatial relationship to any other sensor(s). The probe or catheter  100  may contain a microelectromechanical (MEMS) device(s), a 3-axis accelerometer, a roll/pitch gyroscope and a yaw rate gyroscope, and a pressure and flow transducer. The devices may also be mounted on a small flexible printed circuit board (PCB) and then attached to the probe or catheter. The 3-axis accelerometer may track translation of the probe or catheter in three directions. The gyroscopes are utilized to account for gravitational rotation, allowing real-time movement to be tracked. 
         [0026]    In one embodiment, a PCB may be prepared with the three MEMS devices mounted thereon. Soft leads trail the MEMS devices to supporting devices, 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 probe or catheter. The location of the probe or catheter may be determined by the output signals of the MEMS devices. 
         [0027]    The multiple sensor enabled catheter may be linked via data cable  105  to a transmitter  106 , which can provide a wireless data signal (such as Bluetooth) to a device  107  (computer, tablet, smartphone, or similar device) capable of receiving the transmission of data collected by the sensors. The connection of the data cable  105  to the catheter or probe  100  may be achieved through a mating interface with connector/handle  104 . Alternatively, the transmitter may be contained within the probe/catheter or the probe/catheter handle. The linked device  107  may process the data or provide a graphical user display, or transmit such information to another device(s) to accomplish similar tasks. In another embodiment, the probe or catheter  100  may transmit a wireless data signal directly to the device  107 . 
         [0028]    The patient may be asked to recreate maneuvers that induce fecal incontinence at the same time that the parameters for the location/pressure/flow/visualization of the anatomical reference point(s) are determined. 
         [0029]    The patient&#39;s body (and the anatomical reference point(s)) may be manipulated to the position where rectal sphincter pressure is optimized and fecal continence is improved or restored to normal. These anatomical reference point positions may be displayed in real-time on a graphical user interface or recorded. The patient&#39;s body may be manipulated by a health care provider, or by the patient as described herein. 
         [0030]    In the case of surgical intervention, if no pre-incontinence position is known, the patient&#39;s body (and the anatomical reference point(s)) may be positioned based on data collected from a cohort of patients with a similar fecal incontinence history or profile. Where pre-incontinence data is available (e.g., the positions of particular anatomical reference points are based on patient information from an earlier date), then at the time of surgery the corresponding anatomical reference points are repositioned to the location where the patient was previously fecally continent. 
         [0031]    Following examination using the multiple sensor-enabled catheter, a health care provider may conclude that rehabilitation is an efficacious option for treating a patient&#39;s fecal incontinence. In this regard, the measurements provided by the multiple sensor-enabled catheter 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 catheter in real-time. Once engaging the proper musculature has been communicated successfully to a patient during a 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 catheter to evaluate rehabilitative treatment effectiveness, which may allow a health care provider to advise the patient about the prospects for restoring complete fecal continence with a continued rehabilitation regime or a surgical procedure. 
         [0032]    Detailed embodiments are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the claimed 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.