Abstract:
A device and method for treating nocturia that transmits a vibratory signal into the lumbar region of a subject. The vibratory signal couples into the subject from a flexible medium, such as a visco-elastic foam, so that the vibratory signal has a dominant frequency. The flexible medium can be a bed mattress, a chair, a recliner, as well as a seat in a vehicle. A vibratory signal source is used to generate the vibratory signal, and can be an oscillating motor. The motor can mount on a membrane stretched across a surface of the flexible medium, or can be supported and held in contact with the flexible medium while on a stand.

Description:
BACKGROUND 
       [0001]    1. Field of Invention 
         [0002]    The invention relates generally to the field of treating nocturia. More specifically, the present invention relates to a method and apparatus for propagating a mechanical vibratory signal to the sacral nerve of a subject. Yet more specifically, the present invention relates to a method and apparatus for transmitting a mechanical signal to the sacral nerve of a recumbent subject for a protracted period of time. 
         [0003]    2. Description of Prior Art 
         [0004]    Most people can sleep for six to eight hours without the sensing a need to urinate. People afflicted with nocturia though experience many episodes of an urgency to urinate throughout the night; whether or not an actual need to relieve their bladder actually exists. The frequent sleep disruptions of these individuals deprive them of needed rest to adequately function during normal waking hours. The cause of nocturia is typically of neurogenic origin rather than other conditions that can produce urinary frequency; such as an infection or an enlarged prostrate. 
         [0005]    The sacral nerve, which runs from the lower spinal cord to the bladder, influences muscles that control the bladder. One treatment for nocturia involves applying electrical stimulation to the sacral nerve of a subject using a sacral nerve stimulator. Similar to a pacemaker, sacral nerve stimulators typically are self contained devices implanted subdural within the subject. An electrical signal lead from the sacral nerve stimulator connects to the sacral nerve of the subject. A power source, typically a battery, in the sacral nerve stimulator provides an electrical signal that is transmitted through the lead and to the sacral nerve. The electrical signal is usually delivered to the nerve in the form of a pulse, and interrupts signals from the bladder to a subject&#39;s brain that convey a need to urinate. Other devices direct an electrical signal to one or more muscles for relaxing overactive muscles and contracting weaker ones. Experiments have been conducted both transcutaneously, and with treatment heads inserted into the rectums or vagina of the subject. In these experiments, the electrical frequencies used have been in the 10-75 Hertz region. The aforementioned devices though are invasive and require maintenance. 
       SUMMARY OF INVENTION 
       [0006]    Disclosed herein is a method and device for noninvasively treating nocturia. In an example embodiment the method includes providing a flexible medium that has a treatment surface and transmitting a vibratory signal into the medium that makes its way to the treatment surface and when the treatment surface contacts a lumbar region of a subject, the vibratory signal is transmitted to a sacral nerve in the subject to mute a bladder control signal in the sacral nerve. The treatment surface oscillates at a dominant single frequency within a designated location on the surface, placing the designated location against the subject transmits the vibratory signal into the subject. In an example embodiment, the flexible medium is a bed mattress having a visco-elastic foam, where the visco-elastic foam couples the vibratory signals into the subject. In an example embodiment, the single dominant frequency ranges from about 10 Hertz to about 50 Hertz. The single dominant frequency can range from about 13 Hertz to about 15 Hertz. The method may further include providing a source for the vibratory signal that includes an oscillating motor, where the vibratory signal is produced by operating the oscillating motor. The example method can further include positioning the vibration source on a side of the medium opposite the treatment surface and substantially across from the designated location. In yet another example embodiment, an adjustable frame can be provided for holding the oscillating motor in close contact with the medium. In an example embodiment, the vibratory signal when produced by the oscillating motor has more than one dominant frequency. 
         [0007]    Also disclosed herein is a device for treating nocturia that includes a vibratory signal source and a flexible medium in contact with the vibratory signal source. The flexible medium can have a treatment surface with a designated location. In this embodiment of the device, when the designated location is put into contact with a lumbar region of a subject while the vibratory signal source produces a vibratory signal; the signal is transmitted into the flexible medium, the subject, and to a sacral nerve in the subject and mutes other signals in the sacral nerve. In an example embodiment, the flexible medium includes a visco-elastic foam. Optionally, the flexible medium can be a portion of a bed mattress. In an example embodiment, the designated location oscillates from about 10 Hz to about 50 Hz, and optionally can oscillate at about 13 Hz. In an example embodiment, the vibration source is selectively positioned on a side of the flexible medium opposite the treatment surface and directly from the lumbar region of the subject. In an example embodiment, the vibratory signal has a dominant single frequency when transmitted into the subject. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0008]    Some of the features and benefits of the present invention having been stated, others will become apparent as the description proceeds when taken in conjunction with the accompanying drawings, in which: 
           [0009]      FIGS. 1A and 1B  are respective a side perspective view and an end sectional view of an example embodiment a device for treating nocturia. 
           [0010]      FIG. 2  is a side view of a vibration source. 
           [0011]      FIG. 3  is a side partial sectional view of an alternate embodiment of the device of  FIG. 1 . 
           [0012]      FIG. 4  is a side view of an alternate embodiment of the device of  FIG. 1 . 
           [0013]      FIGS. 5A and 5B  respectively illustrate sensor locations on a test device and levels of attenuation at distances away from a reference. 
           [0014]      FIGS. 6A and 6B  illustrate sensor locations on a test device with a subject and showing attenuation levels from a reference point on the test device. 
           [0015]      FIGS. 7A and 7B  contain power density plots for the respective vertical and horizontal axes of a vibration source. 
           [0016]      FIGS. 8A through 8E  show power density plots for the horizontal axis of a vibration device being loaded with the mattress. 
           [0017]      FIGS. 9A through 9E  show power density plots of a vibration source in the vertical axes while being loaded with the mattress. 
           [0018]      FIGS. 10A and 10B  show power density plots for respective horizontal and vertical axes of a shaker loaded with a mattress and a test subject. 
           [0019]      FIGS. 11A and 11B  are power density plots of horizontal and vertical axes of a shaker loaded with a mattress and a test subject. 
           [0020]      FIGS. 12A through 12E  are frequency response function plots of the vertical axes of a shaker loaded with a mattress. 
           [0021]      FIGS. 13A through 13E  are coherence plots, respectively, for the data plots of  FIGS. 12A through 12E . 
           [0022]      FIGS. 14A through 14E  are frequency response function plots for the Y axis of a treatment surface and taken at locations along the treatment surface. 
           [0023]      FIGS. 15A through 15E  are coherence plots, respectively, for the data plotted in  FIGS. 4A ,  14 A through  14 E. 
           [0024]      FIGS. 16A and 16B  are frequency response function plots taken on a treatment surface having a subject. 
           [0025]      FIGS. 17A and 17B  are coherence plots of the data plotted in  FIGS. 16A and 16B . 
       
    
    
       [0026]    While the invention will be described in connection with the preferred embodiments, it will be understood that it is not intended to limit the invention to that embodiment. On the contrary, it is intended to cover all alternatives, modifications, and equivalents, as may be included within the spirit and scope of the invention as defined by the appended claims. 
       DETAILED DESCRIPTION OF INVENTION 
       [0027]    The present invention will now be described more fully hereinafter with reference to the accompanying drawings in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the illustrated embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout. 
         [0028]    It is to be understood that the invention is not limited to the exact details of construction, operation, exact materials, or embodiments shown and described, as modifications and equivalents will be apparent to one skilled in the art. In the drawings and specification, there have been disclosed illustrative embodiments of the invention and, although specific terms are employed, they are used in a generic and descriptive sense only and not for the purpose of limitation. 
         [0029]    Referring now to  FIG. 1A , an example embodiment of a treatment system  10  is shown in a side perspective view. In the illustration of  FIG. 1 , the treatment system  10  includes a generally rectangular medium  12  coupled with a vibration source  14  shown in dashed outline. In the embodiment of  FIG. 1 , the vibration source  14  is coupled to a lower surface of the medium  12  and generates vibratory signals that couple into the medium  12  and propagate up to the upper surface of the medium  12 . In an alternate embodiment, the vibration source  14  could be in (partially or wholly) the medium  12 . In an example embodiment the medium  12  is a mattress and can reside on a bed frame  15 , that can be a simple trolley. The bottom of the mattress can be suspended in the frame by slats or a wooden board (not shown). 
         [0030]    Referring now to  FIG. 1B , the treatment system  10  of  FIG. 1A  is provided in a side sectional view that shows the vibration source  14  in contact with a side of the medium  12 . In this embodiment, the medium  12  includes a mattress  11 , that can be wholly or partly made from the foam materials described below. The mattress  11  is shown disposed on a support  13 , that in an example embodiment is a box spring and includes springs (not shown) for resiliently supporting the mattress  11 . Also provided in  FIG. 1B  is that the vibration source  14  is offset and not centered with the centerline of the length of the medium  12 , which is represented as line M L  ( FIG. 1A ) As will be described in further detail below, the vibration source  14  can be selectively positioned at locations along the length of the medium  12  or directing a vibration signal to a subject for treatment. Referring back to  FIG. 1A , the vibration source  14  is illustrated at the center of the width of the medium  12 , designated by line M W . The selective positioning of the vibration source  14  provides placement of the vibration source  14  at any point along the width or length of the medium  12 , and is not restricted to the locations depicted in the figures. Selective positioning of the vibrator along the length of the bed is possible and can be achieved by drilling holes in the frame  15  supporting the medium  12 , or by appropriate spacing of slats (not shown) supporting the medium  12  (if supported by slats instead of a solid sheet of wood). In an example embodiment, the vibration source  14  is positioned at a location which is about two-thirds the length of M L . 
         [0031]    Referring now to  FIG. 2 , an example embodiment of the vibration source  14  is shown having motor  18  coupled on an upper end to a detachable plate  19 , where the plate  19  can be as large as one square foot. The motor  18  reciprocatingly motivates the plate  19  and the vibration source  14  is disposed proximate the medium  12  so that the reciprocating motion of the plate  19  causes contact with the medium  12 . The contact can occur on a lower or bottom surface of the medium  12 . The contact between the plates  19  and medium  12  imparts a vibratory signal in the medium  12  that is transmitted through the medium  12 . The vibration source  14  can be chosen from devices used for industrial or domestic use: such as an electric motor (mechanical), pneumatic, or electromagnetic. A controller  17  may be included for controlling the force and vibration frequency of the vibration source  14 . The reciprocating motion of the plate  19 , illustrated by the double headed arrows, can be directed away from/towards the motor  18 , lateral to the motor  18 , circular, helical, or combinations thereof. 
         [0032]      FIG. 3  illustrates an alternate embodiment of a treatment system  10 A shown in a side partial sectional and exploded view. In the example embodiment of  FIG. 3 , the vibration source  14 A is illustrated separate from the medium  12  for clarity. However, when the embodiment of  FIG. 3  is in operation, the upper end of the vibration source  14 A would be mounted onto the bottom of the medium  12 . In the example embodiment of  FIG. 3 , the vibration source  14 A is mounted to the medium  12  by coupling to a planar membrane  16  attached to the bottom of the medium  12 , or the bottom of the springs ( 13 ) if the springs and flexible material ( 11 ) are a single unit. In an example embodiment, the membrane  16  is a sheet of wood or slats for supporting the medium  12 . Optionally, an opening may be formed through the wood sheet for inclusion of the vibration system  14 A. The vibrating force generated by the vibration source  14 A of  FIG. 3  is transmitted to the medium  12  via a support  20  that couples the vibration source  14 A to the membrane  16 . The support  20  can have rod-like lugs  22  that mount to a frame on the motor  18  and on an upper end bolt to the plate  19  shown disposed on a side of the membrane  16  opposite from the motor  18 . In an alternate example embodiment the membrane  16  may be made of any woven material such as a sheet-like cloth, as well as a screen woven from metal members. In this configuration it is advisable to support the vibration source  14  with belting attached to the slats or sheet of wood. In an example embodiment, the motor  18  can be asymmetrically weighted so that upon rotation an oscillatory force is generated that is transmitted to the medium  12 . Other examples of vibrations sources  14  include electromagnetic vibrators, that in one embodiment include a core disposed within a magnetic field, wherein oscillating the magnetic field, such as by a change in polarity, vibrates the core. Examples of core material include metal and may specifically include ferrous metals. 
         [0033]    Referring now to  FIG. 4 , another alternate embodiment of a treatment system  10 B can be as shown in a side view. Here, a frame  26  is shown for supporting a motor  18 B to deliver a vibration signal  27  into the medium  12 . The frame  26  is shown having a series of upwardly extending legs and cross-members that connect the legs. An elongate fastener  28  is shown having an end coupled with a lower end of the motor  18 B, and another end mounted onto a cross-member of the frame  26  for supporting the motor  18 B in place. In the embodiment of  FIG. 4 , lock nuts  30  secure the fastener  28  onto the frame  26 . Optional vibration dampeners  32  are shown wedged between the lock nuts  30  and frame  26 , wherein the dampeners may be made of an elastomer for damping vibration or eliminating harmonics within the frame  26 . A plate  34  is shown mounted on an upper end of the motor  18 B on an upper extension  36 . The plate  34  contacts a lower surface of the medium  12 ; by operating the oscillating motor  18 B, that in turn accelerates the plate  34  in a reciprocating motion against the medium  12 , forms vibrations signals  27  through the medium  12 . The signals  27  can be transmitted to a desired location on the subject  38  by strategically situating the vibration source  14 B. 
         [0034]    In an example embodiment of  FIG. 4 , the medium  12  is a mattress having a treatment surface  37  on a side opposite where the medium  12  is contacted by the plate  34 . A subject  38  is shown recumbent on the medium  12  and strategically located so the signals  27  contact the subject  38  within a lumbar region of the subject  38 . Moreover, the vibrating signal  27  transmits into the subject  38  and propagates to the sacral nerve (not shown) of the subject  38  thereby masking or muting signals in the nerve that may travel between the bladder and brain of the subject  38 . Accordingly, the vibratory vibrating signal  27  must be of sufficient magnitude when reaching the treatment surface  37  to mute the signals from the bladder and in the sacral nerve. In examples incorporating the medium  12  of  FIG. 1B , the vibrating signal  27  also travels through the support  13 , across the interface between the support  13  and mattress  11 , and to the treatment surface  37 . By directing a vibratory signal  27 , that is transmitted transdermally to a subject so that the signal  27  travels into the sacral nerve of a subject  38 , the subject  38  can experience relief from nocturia. Optionally, the signal  27  can be continuously directed into the subject  38  while the subject  38  is in contact with the treatment system  10 . In an example embodiment, vibratory signals  27  are generated and directed to the subject  38  during a protracted period of time, where the protracted period of time exceeds an hour and having a duration substantially the same as the time the subject  38  is in a state of suspended consciousness, either completely or partially. A rest cycle for a subject  38  can be the time the consciousness of the subject  38  is suspended. Examples of suspended consciousness include meditation, sleep, sedation, anesthesia, and the like. 
         [0035]    The medium  12  can include a material made from an open-cell visco-elastic foam, which in an example embodiment, is referred to as a memory foam. Optionally, the foam may be an open-cell urethane-ether foam, a closed-cell foam, such as a closed-cell ethylene-ether/dylene-polystyrene foam. Example embodiments of the visco-elastic foam have densities that range from about 4.5 to about 5.5 pounds per cubic foot and may have an indentation load deflection that ranges from about 12 pounds to about 15 pounds. The indentation load deflection is a measure of the load bearing capacity; this value is obtained by measuring the force required to compress a 4 inch thick foam sample to about 75% of the initial height of the foam. A 50 square inch circular indentor is generally used to compress the sample, where the sample is typically at least 24 square inches. In embodiments when the medium  12  includes a memory foam, the supple characteristic of the foam results in an interface between the foam and subject that substantially follows the outer surface of the subject. Moreover, because the foam compresses under a relatively small load, when the subject presses against or lies on the medium  12 , the interface not only follows the contour of the side of the subject pressed against the treatment surface  37 , but extends to surfaces lateral to the primary contact side. The substantial contact between the subject  38  and medium  12  and that the interface extends to lateral sides of the subject  38  increases signal coupling between the subject  38  and the medium  12  thereby increasing the transmission of the vibration signals  27  from the medium  12  to the subject  38  over that of traditional beds or seats that do not result in the close fitting interface described herein. Alternatively, the medium  12  can include a one or more of the embodiments of the foam described above 
       Example 
       [0036]    In a non-limiting example of use, a test medium was subjected to a vibratory signal generated by a VIBCO Model SPRT-60 vibrator and transmitted on a lower surface of a TEMPUR-PEDIC® “Cloud” memory foam mattress. Test data was collected from accelerometers measuring acceleration in the oscillating motor and on locations on the upper or treating surface of the medium. Data was also collected with a 160 pound subject supinely positioning on the treating surface of the medium.  FIG. 5A  illustrates example locations of a reference point R and accelerometer locations A 1-5 . The reference point R, which is on the lower surface of the medium, is shown roughly at the midline M W  of the width of the medium  12 A, but offset from the midline M L  taken along the length of the medium  12 A. Accelerometer A 1  is shown set about 12 inches from the reference and at about the same point along the line M W . Accelerometer A 2  is offset about 12 inches from the reference in a direction offset from the line M W  and accelerometer A 1 . Accelerometer A 3  is set about 12 inches from the reference and along the line M W , accelerometer A 4  is about 6 inches from the reference and along the line M W . A 5 , also set along line M W , is about 30 inches from the reference and on a side of accelerometer A 3  opposite from the reference. 
         [0037]    Referring now to  FIG. 5B , intensity regions  42 ,  43 ,  44  are provided that represent vertical vibrational intensity with respect to vibrational intensity at the upper surface of the plate  19  ( FIG. 3 ). In the intensity region  42 , which extends from the reference R up to location of accelerometer A 4 , the relative intensity of vibration was measured to be about 0.77 of vibrational intensity at or the bottom of the springs ( 13 ) if the springs and flexible material ( 11 ) are a single unit. In the intensity region  43 , which resembles an annular shape, the relative intensity of vibration was measured to be about 0.54 of vibrational intensity at the plate  19  ( FIG. 3 ) surface. Intensity region  44 , which was measured by accelerometer A 5 , was found to be at a relative intensity of 0.34 of vibrational intensity at the plate  19  ( FIG. 3 ) surface. 
         [0038]      FIGS. 6A and 6B  present similar results from that of  FIGS. 5A and 5B , more specifically, the test medium  12 A in  FIG. 6A  is shown with a subject set on the treatment surface  37  and accelerometers A 1A -A 4A  set adjacent the trunk portion of the subject  38 . By operating the vibration source  14  ( FIGS. 1-4 ), acceleration measurements were taken with the accelerometers A 1A -A 4A  to define the intensity regions  43 A,  44 A shown overlaid on the medium  12 A of  FIG. 6B . Intensity region  43 A, which is a circular region that having a diameter at the reference and circumference that intersects locations of accelerometers A 1A  and A 2A  was shown to have a relative intensity of about 0.07 from that of the vibrator vertical intensity. Intensity region  44 A extends from the outer periphery of intensity region  43 A into a circle that passes through both accelerometers A 3A  and A 4A . The relative intensity with an intensity region  44 A was measured to be about 0.02 of that taken from the vibrator vertical intensity. 
         [0039]    The vibrating source was operated while accelerometers positioned on a working surface of the source measured output from the source. Power density plots  45 A,  45 B are shown in  FIGS. 7A and 7B , respectively, that represent the measured the power density in the horizontal and vertical axes of the vibration source. A number of harmonic peaks are shown in the plots  45 A,  45 B that range from frequencies at 11.58 Hz up to about 46.25 Hz. As such, the vibration source produces a vibrating signal with multiple transmission frequencies. 
         [0040]    Shown in  FIGS. 8A-8E  and  9 A- 9 E are power density plots  46 A- 46 E,  48 A- 48 E that represent frequency domain oscillation of the working side of the vibration source when it is loaded with a mattress, such as in the example illustrated in  FIG. 4 . The differences between  FIGS. 8A-8E  and  9 A- 9 E are that the density plots  46   a - 46 E are taken along a horizontal axis, whereas density plots  48 A- 48 E used data measured along a vertical axis. Evident from these plots though are that the vibration source, although having a load of the mattress, continues to produce a signal with multiple dominant frequencies. These dominant frequencies are identified within each of the plots  46 A- 46 E and  48 A- 48 E. 
         [0041]    Shown in  FIGS. 10A and 10B  are power density plots  50 A,  50 B; plot  50 A in  FIG. 10A  was formed from data measured on the power signal source along the horizontal axis, whereas the power density plot SOB in  FIG. 10B  was formed using data measured along the vertical axis and on the signal source. The density plots  52 A,  52 B provided in  FIGS. 11A and 11B  were generated in the same fashion as  FIGS. 10A and 10B  but in a separate test sequence. Also evident in  FIGS. 10A ,  10 B,  11 A, and  11 B are the multiple dominant frequencies of the vibrating signal illustrated in each of these plots. As with  FIGS. 8A-8E  and  9 A- 9 E, small square-shaped points are provided for identifying dominant frequencies. 
         [0042]    Transmissibility through the test medium is provided in the frequency response function plots  54 A- 54 E of  FIGS. 12A-12E . These plots  54 A- 54 E compare the amount of vibration transferred through the medium and were obtained by comparing the values measured at the vibration source and the upper or treatment surface of the medium. Amplitude attenuation through the medium ranged from about 61% through 68%. Coherence plots  56 A- 56 E are provided in  FIGS. 13A-13E  that confirm values for dominant frequencies illustrated in the response plots and show similar reductions in amplitude from the vibration source to the treatment surface of the medium. In  FIGS. 12A-12B  and  13 A- 13 E, the measurements taken from the vibration source were along the vertical axis. 
         [0043]    Shown in  FIG. 14A  is a frequency response function plot illustrating the signal transmission through the signal source to the treatment surface of the medium, wherein accelerometers were positioned on the medium at the locations as provided in  FIG. 5A . Thus, plots  58 A- 58 E respectively represent data recorded at the signal source and at respective accelerometers A 1 -A 5 , and coherence plots  60 A- 60 E provided in  FIGS. 15A-15E  respectively, correspond to the frequency response function plots  58 A- 58 E. 
         [0044]    Additional data was recorded from the test setup of  FIG. 6A  that include the subject  38  set on the treatment surface  37 . Data recorded with accelerometer A 2A  was used to form the frequency response function plot  62 A shown in  FIG. 16A . Similarly, data recorded with accelerometer A 1A  was used to form the frequency response function plot  62 B shown in  FIG. 16B . Shown in  FIG. 62A  is a fairly \veil defined single frequency at 22.82 Hz that transmits through the medium and roughly in the lumbar region of the subject. This is confirmed with the coherence plot  64 A of  FIG. 17A  that corresponds to the plot  62 A. In  FIG. 62B , a single dominant frequency at 22.5 Hz is represented by the plot and confirmed with coherence plot  64 B provided in  FIG. 17B . 
         [0045]    In one example of operation, a vibrating source  14 ,  14 A,  14 B ( FIGS. 1-4 ) is set in close contact with a medium  12 , such as a bed mattress, and positioned on a lower side so that when a subject  38  is recumbent on a treatment side  37  of the medium  12 . Vibrational signals  27  ( FIG. 4 ) propagate through the medium  12  and to a designated location  39  on the treatment side  37  of the medium  12 . Strategically identifying the designated location  39  so that it is adjacent the lumbar region of the subject  38  can ensure transmissibility of the vibration signal into the subject with sufficient intensity to mask or mute signals from the bladder through the sacral nerve. 
         [0046]    The present invention described herein, therefore, is well adapted to carry out the objects and attain the ends and advantages mentioned, as well as others inherent therein. While a presently preferred embodiment of the invention has been given for purposes of disclosure, numerous changes exist in the details of procedures for accomplishing the desired results. These and other similar modifications will readily suggest themselves to those skilled in the art, and are intended to be encompassed within the spirit of the present invention disclosed herein and the scope of the appended claims.