Abstract:
An improved apparatus is disclosed for use in diagnosing and treating pelvic floor musculature disorders. The device includes a handle ( 18 ) and head ( 10 ) mounted on opposite ends of a shaft ( 12 ), with a barrier ( 14 ) mounted on the shaft ( 12 ) between the handle ( 18 ) and head ( 10 ), and an indicator ( 16 ) mounted on the shaft ( 12 ) between the barrier ( 14 ) and handle ( 18 ). The other apparatus consists of the head ( 10 ) which is detachable from the shaft ( 12 ) and attached to a pin ( 20 ). The apparatus provide magnetic resistance to pelvic floor musculature contraction to ( 1 ) measure and track the progress of pelvic floor musculature strength, and ( 2 ) exercise pelvic floor musculature to improve strength at a private, patient-determined frequency.

Description:
FIELD OF THE INVENTION 
     This invention relates generally to pelvic floor exercises, and more specifically to devices and methods that can quantify pelvic floor diagnostic findings and monitor and improve pelvic floor strength. 
     BACKGROUND OF THE INVENTION 
     Disorders of pelvic support are a significant health care concern, resulting in the loss of billions of dollars annually. Associated with the rigors of childbirth, trauma, and the aging process, these disorders not only result in financial loss, but have a profound emotional component often altering one&#39;s self image as well. The resultant loss in function and selfesteem associated with such disorders is often extremely debilitating, leading to prolapse, discomfort, and both urinary and sexual dysfunction. 
     To combat these disorders, a variety of therapeutic approaches have been entertained. Both non-surgical and surgical techniques have been utilized with varying degrees of success. While surgical management certainly has its role, it is not without risk and expense. Medical management likewise must be carefully individualized, requiring thorough surveillance by the prescribing physician. 
     With this in mind, non-operative therapies to enhance the support of pelvic tissues are highly desirable. Traditionally, supportive devices such as the pessary or specialized pelvic floor exercises, commonly referred to as Kegel exercises, have been the mainstay of therapy. While pessaries provide artificial support to pelvic floor musculature, Kegel exercises help strengthen such tissues. Patients are trained to utilize isometric contractions of the pubococcygeus and levator ani muscles to strengthen the pelvic floor musculature and thus improve function. Utilization of such exercises requires training and motivation, and variations of such methodology have been successfully utilized and proven with respect to the ability to overcome stress incontinence. 
     Several investigators have confirmed the benefits of such non-operative therapies, both subjectively and objectively. Two studies by Henalla, et al, published in the British Journal of Obstetric and Gynecology in 1988 and 1989, demonstrated improvement in two-thirds of patients utilizing such closely monitored therapy. The later study showed such exercises to be even more beneficial than both electrical stimulation of the pelvic floor and estrogen supplementation. Studies such as that of Tchou, et al, published in the 1988 Journal of Physical Therapy confirmed such outcomes utilizing urodynamic evaluations, both prior to and after pelvic floor exercise therapy. In a variation of this theme, Peattie, et al, published in the British Journal of Obstetric and Gynecology in 1988, utilized weighted vaginal cones to provide resistance with which pelvic muscle contraction could be taught, musculature strengthened, and function restored. 
     Critical to the success of such therapy is an understanding of how best to perform these exercises correctly, considering that when proper technique is not utilized, the potential for a worsening of function also exists. In one study by Bump, et al, published in the American Journal of Obstetric and Gynecology in 1991, less than half of those given either verbal or written instructions were able to illicit an ideal Kegel effort as demonstrated by an increase in the force of urethral closure. 
     With these principles and concepts in mind, it is clear that non-operative means are proven to be successful in improving the function of the pelvic floor. Such techniques may be learned and, as such, the ability to perform them properly is critical to achieving the outcome desired. It is these aforementioned concepts which have spawned desire to improve upon the non-operative techniques that have traditionally been utilized to improve pelvic floor function and further alleviate the need for both medical and surgical therapies. 
     The prior art demonstrates electronic and pneumatic pelvic floor exercise devices, e.g., Sawchuck U.S. Pat. No. 5,733,230 and Sample U.S. Pat. No. 5,674,238, spring-biased exercise devices, e.g., Wallick U.S. Pat. No. 5,865,715, heated and vibrating mechanism exercise devices, e.g., Benderev U.S. Pat. No. 5,782,745, and exercise devices utilized external to the body, e.g., Harris U.S. Pat. No. 5,531,226. However, the prior art poses the threat of further injury to the patient attributed to malfunction of the electronic, thermal, vibrating or pneumatic. Additionally, the complexity of the prior art diminishes reliability, in that numerous moving parts introduce a higher likelihood for malfunction. Finally, the prior art requires multiple apparatus for the performing both the diagnosis and treatment of pelvic floor injuries. 
     In order for pelvic floor disorders to be properly and efficiently diagnosed, it is highly desirable to provide a non-operative method for both physician and patient diagnosis, as well as a hygienic and reliable diagnostic tool that is easy to use in private, as an alternative to traditional procedures which can be inaccurate, cumbersome and embarrassing. In order for pelvic floor disorders to be properly and efficiently treated, it is highly desirable to provide a method and device allowing patients to perform exercise treatment in private, with selfgoverned frequency, in a simple and hygienic manner, and in any environment. 
     The disadvantage of the prior art are overcome by the present invention, and an improved pelvic floor exercise device and methods for pelvic floor musculature dysfunction diagnosis and treatment is hereafter disclosed. 
     SUMMARY OF THE INVENTION 
     The present invention provides a device for diagnosing and treating pelvic floor dysfunction which, in a preferred embodiment, combines both the traditional approach of Kegel exercises and an innovation utilizing attractive magnets. This technique allows for several advantages over the existing technology, in that magnets may be calibrated so as to allow the patient to more properly learn the techniques associated with successful treatment. Further, the patient may follow personal progress, objectively demonstrating improvements in the strength of one&#39;s pelvic floor musculature. This invention offers advantages over the prior art in that performing exercise with the device is not postural based, since the magnets may be calibrated so that exercises may be performed in a reproducible and progressive manner regardless of body habitus and positioning. This invention also offers patient safety and the anti-microbial benefits of magnet associated therapies, benefits not offered by prior art. 
     The magnetic attraction between a magnetic head and barrier may provide a biasing feature against which the contracting pelvic floor musculature may react. The head and barrier may be so magnetized as to provide a constant and reproducible attractive force between the head and the barrier, a force which may be calibrated via magnet and material selection. The head may be secured by thread engagement to a metal shaft. The shaft may have a measuring indication along a portion of a length of the shaft, may pass through the approximate center of the barrier. The head may have a generally semi-spherical shaped upper end and a generally conical lower end. The barrier may have a generally hourglass shaped barrier as to provide proper placement of the device in relation to the patient&#39;s body. The lower end of the shaft may be secured by thread engagement to a handle to prevent the separation of the barrier from the shaft. The contraction of the pelvic floor musculature may move the head away from the stationary barrier, such that the shaft may slide upwards through the barrier. As the shaft slides through the barrier, an indicator opposite the barrier from the head may slide down the shaft, indicating the degree to which the head has traveled from its initial position when the pelvic floor musculature was at rest. This indication feature is a primary objective of this invention. The feature allows the physician and patient to measure the strength of the pelvic floor musculature. 
     The magnetic head maybe detachable from the device shaft in such a manner that it may be reattached to a pin. The pin may provide an attach point for a lanyard to the magnetic head. Once the head is detached from the device and reattached to the lanyard, the patient may repeat the above pelvic floor musculature contraction procedure using only the head and lanyard, as opposed to the entire device. In this manner, the patient may continue to exercise the pelvic floor musculature in a private, self-paced manner, thereby increasing the strength of the pelvic floor musculature. 
     It is an object of this invention to provide a pelvic floor exercising device comprising a shaft, a measuring indication along a portion of a length of the shaft, a head secured to an upper end of the shaft, a barrier moveably mounted on the shaft between the handle and the head, and an indicator moveably mounted on the shaft between a lower end of the shaft and the barrier that is moveably responsive to separation of the head from the barrier. It is a related object to provide such a device that provides hygienic, safe, reproducible and private diagnosis and rehabilitation. 
     It is a feature of the present invention that the device may provide a combination of magnetically attractive head and barrier components on a mutual shaft having a measuring indication. The barrier may have a substantially hourglass shaped configuration. It is a further feature that the barrier and the indicator may slide along a portion of the length of the shaft. It is a further feature that the head may be detached from the shaft and thereafter attached to a pin and lanyard. 
     It is an advantage of the present invention that the pelvic floor exercise device is relatively simple in design and construction, and is highly reliable. It is an additional advantage that magnets offer an advantage over the aforementioned utilization of weighted vaginal cones in strengthening the pelvic musculature, in that performing such exercise is no longer postural based. Regardless of both body habitus and positioning, magnets may be calibrated so that exercises may be performed in a reproducible and progressive manner. In this way, outcomes and process can be prospectively followed by the physician and patient alike. 
     It is a further advantage of the present invention that magnet associated therapies have an anti-microbial benefit shown in other venues, and that such therapy may provide improvements not only in function, but in the vaginal milieu as well. This advantageous feature is particularly of interest in the perimenopausal and postmenopausal population in which both of these disorders are more prominent. 
     It is a further advantage that an alternative to medical and/or surgical therapies with respect to the dilemma of pelvic floor dysfunction is provided by the apparatus, which may significantly improve upon an already existing non-surgical modality, and which has been proven and desired. 
     These and further objects, features and advantages of the present invention will become apparent from the following detailed description, wherein references are made to the figures in the accompanying drawings. 
     The foregoing and the following disclosure and description of the pelvic floor exercise device and methods are illustrative and explanatory thereof. This invention is not intended to be limited to the illustrated and discussed embodiments, as one skilled in the art will appreciate that various changes in the size, shape and materials, as well as in the details of the construction or combination of features of the pelvic floor exercise device may be made without departing from the spirit of the invention. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a simplified side view of a preferred embodiment of the invention, illustrating a handle and detachable head connected by a shaft, with a barrier and indicator located adjacent one another on the shaft. 
     FIG. 2 is a simplified top view of the barrier shown in FIG. 1, illustrating the hourglass shape of the barrier. 
     FIG. 3 is a simplified side view of another embodiment of the invention, illustrating a detachable head assembled to a pin having an attached lanyard. 
     FIG. 4 is a simplified side view of another embodiment of the invention, illustrating a handle and detachable head connected by a shaft, a barrier and indicator located adjacent one another on the shaft, and biasing members between head and the barrier and between the barrier and the handle. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Reference is made to the attached drawings only for the purpose of demonstrating preferred embodiments and not for the purpose of limiting the same. FIG. 1 illustrates generally a pelvic floor exercise device in the configuration used primarily for diagnosis. The device is held by the handle  18  and placed into the injured tissue, such that the barrier  14  rests against the exterior surface of the treatment area with the long axis of the barrier  14  parallel to the patient&#39;s front-to-back direction. FIG. 3 illustrates generally a second configuration used primarily for exercise treatment. In this configuration, the shaft  12  is removed from the head  10  and replaced with the pin  20 , to which a lanyard  22  is secured. FIG. 4 illustrates generally another embodiment of the invention, in which biasing members  28  and  30  each oppose the separation of the head from the barrier. 
     In the FIG. 1 embodiment, a handle  18  is secured to a lower end of a shaft  12 . The handle  18  may be spatulated in a manner similar to a reflex hammer. A head  10  is secured to an upper end of the shaft  12 . In a preferred embodiment, the head has a generally semi-spherical shaped upper end and a generally conical shaped or half-egg shaped lower end. A preferred embodiment depicts a barrier  14  as moveably mounted on the shaft  12  between the head  10  and the handle  18 . An indicator  16  is mounted on the shaft  12  between the barrier  14  and the handle  18 , and is moveably responsive to the separation of the head  10  from the barrier  14 . In a preferred embodiment, the head  10  and barrier  14  are composed of and/or house a magnetic material, providing a magnetically attractive force to one another, opposing the separation of the head from the barrier. The magnetic material may have any desired configuration, and in the head  10  has a generally ball-shaped configuration, while in the barrier  14  comprises a pair of elongate strips. The magnetic material  11  and the strips  15  are shown in dashed lines in FIG.  1 . Each of the magnetic materials may thus be embedded in a suitable plastic material. In a preferred embodiment, the barrier  14  has a generally hourglass shaped configuration to conform to the exterior genitalia of the user, and is relatively flat. The head and a portion of the shaft are thus inserted into the vagina to the extent permitted by the attraction of the barrier, with the relatively flat upper surface of the barrier resting against an exterior surface of the user surrounding her vagina. In a preferred embodiment, the shaft  12  has measuring indications  13  along a portion of a length of the shaft. In the FIG. 3 embodiment, a head  10  similarly has a generally semi-spherical shaped upper end and a generally conical shaped lower end is secured to a lanyard  22 . 
     In the FIG. 4 embodiment, a handle  18  is secured to a lower end of a shaft  12 . A head  10  is secured to an upper end of the shaft  12 . The head has a generally semi-spherical shaped upper end and a generally conical shaped lower end. The FIG. 4 embodiment depicts a barrier  14  as moveably mounted on the shaft  12  between the head  10  and the handle  18 . An indicator  16  is mounted on the shaft  12  between the barrier  14  and the handle  18 , and is moveably responsive to the separation of the head  10  from the barrier  14 . In the FIG. 4 embodiment, biasing members  28  and  30  are moveably mounted on the shaft  12  between the head  10  and the barrier  14  and between the barrier  14  and the handle  18 . The barrier  14  has a generally hourglass shaped configuration. In a preferred embodiment, the shaft  12  has a measuring indication along a portion of a length of the shaft. 
     In the preferred embodiments, the head  10  is approximately 3 centimeters in height and 2.5 centimeters in diameter. In the preferred embodiments, the barrier  14  is approximately 3 centimeters wide and 7 centimeters long. In the preferred embodiments, the handle  18  is 7.5 centimeters in height, and the handle  18  attached to the shaft  12  is approximately 14 centimeters in height. The preferred embodiments depict the shaft  12  as having a substantially cylindrical cross-section, but the shaft  12  cross-sectional shape may take the form of other geometric shapes. The preferred embodiment depict the barrier  14  and indicator  16  as each having an internal aperture with a generally circular cross-section, such that the barrier  14  and indicator  16  may slide along the length of the shaft  12 , but other embodiments may have cross-sectional shapes of other geometric forms. 
     In a preferred embodiments, the handle  18  is attached to the shaft  12  by threaded engagement, although other embodiments may utilize other methods for attaching the handle  18  to the shaft  12 , such as welding, adhesive, or by fabricating the handle  18  and shaft  12  as a single component. In the preferred embodiments, the head  10  is also attached to the shaft  12  by thread engagement, although other embodiments may utilize other forms of attachment. In the preferred embodiments, the head  10  may be removeably attachable and re-attachable to the shaft  12 , such that a pin  20  may be attached to the head  10  in the same manner that the shaft  12  is attached to the head  10 . In the FIG. 3 embodiment, the pin  20  is mounted to the head  10  by the same means utilized to mount the shaft  12  to the head  10 , although other forms of attachment are possible. A lanyard  22  composed of nylon twine is secured to the head  10 , although other embodiments may depict the lanyard  22  secured to the pin  20 . Other embodiments may depict the lanyard  22  as composed of other materials. 
     The preferred embodiments depict the head  10  and the handle  18  secured to the shaft  12  by thread engagement, but other forms of engagement are possible. A preferred embodiment depicts springs as biasing members  28  and  30  between the head  10  and the barrier  14  and between the barrier  14  and the handle  18 , but other embodiments may include fewer or additional springs. When in use, the coil spring  30  is thus in tension, while the coil spring  28  is in compression. Only one coil spring may be necessary to achieve the desired results. Preferred embodiments depict a handle  18  secured to the shaft  12 , although other embodiment may replace the handle  18  with a stop to prevent separation of the barrier  14  from the shaft  12 , or may completely eliminate the handle  18 , so as to allow the separation of the barrier  14  from the shaft  12 . In the preferred embodiments the shaft  12  is composed of metal, but other materials may be used in other embodiments. In the preferred embodiments the head  10  and the barrier  14  are composed of hard plastic, but other materials may be used in other embodiments. 
     A process for diagnosing pelvic floor injury of injured musculature comprising providing a shaft  12 , a portion of a length of the shaft  12  having a measuring indication, mounting a removeably attachable and re-attachable head  10  on an upper end of the shaft  12 , mounting a moveable barrier  14  on the shaft  12  between a lower end of the shaft  12  and the head  10 , and mounting a moveable indicator  16  on the shaft  12  between a lower end of the shaft  12  and the barrier  14 . The indicator  16  is moveably responsive to separation of the head  10  from the barrier  14 . In the FIG. 1 embodiment, magnetic materials  11  and  15  may act as biasing members to oppose separation of the head from the barrier. In the FIG. 4 embodiment, biasing members  28  and  30  are provided each for opposing separation of the head  10  from the barrier  14 . The head  10  is placed into the injured musculature and thereafter the injured musculature is contracted, such that the pelvic floor musculature exerts an upward force against the head  10 . Other embodiments may further comprise detaching the head  10  from the shaft  12  and re-attaching the head  10  to a lanyard  22 , thereafter proceeding with the pelvic floor musculature contraction described above. Other embodiments may further comprise examining the displacement of the indicator  16  along the shaft  12  after the contraction of the pelvic floor musculature. Other embodiments may further comprise providing a handle  18  secured to the lower end of the shaft  12 . 
     The magnetic biasing members as disclosed herein are preferred. The coil spring biasing members, while functionally satisfactory, present additional contamination concerns. The spring biasing member could be provided within rather than being external of the shaft  12 . 
     Other biasing members may be used, such as pneumatic or hydraulic cylinders. Other embodiments are considered for this invention which may construct any or all of the various components out of a variety of materials, including resinous compounds, other non-metallic compounds, metallic compounds, special alloys, or any combination thereof. 
     While preferred embodiments of the present invention have been illustrated in detail, it is apparent that modifications and adaptations of the preferred embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and adaptations are within the spirit and scope of the present invention as set forth in the following claims.