Title of the Invention AN APPARATUS FOR MEASURING THE CHARACTERISTICS OF PELVIC FLOOR TISSUE AND A METHOD FOR TRAINING THE TISSUE Background of the invention Field of the invention This patent application is related to an apparatus and a set of parts used for diagnosing and testing/training pelvic floor musculature (tissue). It also includes a method for monitoring training of the pelvic floor in the absence of specialists.

Description of the Prior Art During the last 50-60 years, it has been known that weakness in the pelvic floor tissue is one of the cause of urine leakage. During this time there has been an attempt to develop various measuring devices to help find the causes of the leakage, and to develop improved methods for evaluating the force in the pelvic floor in a reproducible and quantitative manner. These improvements would help spe- cialists determine which persons should be treated in a conservative manner, and which persons should be treated operatively. Without knowledge of the normal and abnormal mechanical conditions in the pelvic floor, as well as the normal physiological and patophysiological conditions, this is problematic.

The most common method for evaluating the function of the pelvic floor is manual palpation. Such a method pro- vides no reliable parameters, and the variation between different investigators is large.

Balloons have been used, and are still in use. Bal- loons are inserted into the vagina or the rectum. Since the

balloon senses pressure changes without regard to direc- tions, these results are also associated with large uncer- tainty. Additionally, one cannot know the changes of the balloon diameter during a test, nor the physical character- istics of the balloon. This has the consequence that it is not possible to calculate pelvic floor force from the pres- sure measurements.

Tubes working as electromyographic (EMG) measurement electrodes have also been used. This method is also associ- ated with a large uncertainty, since the electrical activ- ity in the pelvic floor musculature is not proportional to the force output. In addition, great measurement uncer- tainty arises when the vaginal tissue moves relative to the inserted EMG sensor, i. e., a movement-induced increase in EMG activity arises, which increase is not related electri- cal activity in the tissue.

Brief Summary of the Invention The purpose of the invention is to overcome the dis- advantages of the prior art accounted for above, and for this purpose the invention provides an apparatus to be inserted in the vagina or rectum to measure passive and active characteristics of the pelvic floor comprising a first rod; a second rod; and a means for coupling the first rod in parallel to the second rod, wherein the first rod and the second rod define an opening with a variable size, and further wherein a force corresponding to the passive and active characteris- tics of the pelvic floor is measured perpendicular to a longitudinal axis of the apparatus by determining a change in said variable size.

The invention also provides a method for training pelvic floor tissue comprising the steps of

adapting a training apparatus to an individual user, connecting the training apparatus to a programmable signal processing unit; inserting the training apparatus into either one of a vagina and a rectum; and executing a training program.

Brief Description of the Drawing FIG 1 is a side view a preferred embodiment of the measurement and training apparatus of the invention, FIG 2 is an end view of the apparatus in FIG 1, FIG 3 is a side view, partly a longitudinal cross sectional view of the apparatus in FIG 1 and 2 in a situa- tion with a flexural load, FIG 4 is a side view of an alternative embodiment of the measurement and training apparatus of the invention, FIG 5 is an end view of the apparatus in FIG 4, and FIG 6 is a side view of the apparatus in FIG 4 and 5 under a flexural load.

Detailed Description of the Invention Referring to FIGS 1 to 3 a sensor 10 which is intended to be inserted into the vagina or the rectum com- prises two stiff measurement rods 11,12 which have semi- round cross section to impart to the sensor a round cross sectional profile. The rods can be shifted mutually in par- allel so that the opening 17 there between and thus the diameter of the sensor can be changed. The material of the measurement rods 11,12, is such that it cannot be deformed. One of the measurements rods, rod 11 is split into two parts 18,19. This rod is thereafter spliced together using a strip 13 of a material with other physical characteristics than the measurement rods 11,12. The rear

part of the sensor contains three pins 14,15 which have the effect that deformation of this part cannot occur. Both measurement rods 11,12 can move freely relative to the two bracing pins 14. The centre pin 15, which also takes part in bracing or stiffening the sensor, engages by screw threads with the rods and is used to regulate the distance between the measuring rods 11 and 12, i. e. the size of the opening 17 of the measurement sensor 10.

A strain gauge 20 is mounted to strip 13, which will flex during testing when the sensor is inserted into vagina or rectum and the rods 11 and 12 are pressed together by forces F in the pelvic floor acting thereon during measure- ment and training. Said forces can be measured passively and actively for various openings by means of the signal obtained from the strain gauge 20.

The sensor should be connected to a signal processing system (not shown) by which said signal is processed.

FIGS 5 to 4 disclose a training apparatus 21 based on the same principles as the measurement apparatus of FIGS 1 to 3. This training apparatus shall also be inserted into the vagina or rectum. The measuring rods 22 are made of a material that is approximately rigid. The rods are passed onto a metal plate 23 by shoes 26. The opening 24 between the rods is adapted individually by passing rods 22 onto plates 23 of various lengths. The distance between rods 22, i. e. the size of opening 24, thus can be adjusted in order to adapt the apparatus optimally to the individual person that shall use the apparatus for training. A strain gauge 25 is attached to plate 23.

The training apparatus should be connected to a sig- nal processing unit (not shown) receiving the signal from wire gauge 25, so that the training person will receive information regarding execution of the exercises, and regarding the obtained force to be used in training, as well as the duration of each training session and when to

end each training session. This entails that qualified per- sonnel will not necessarily have to be present for stimu- lating/training the tissue. In continued training, it is possible to adapt the opening 24, dependent on achieved and measured changes in the active and passive characteristics of the pelvic floor, so that optimum training can be main- tained all the time.