# Patent

## Title
Pelvic floor training device

## Abstract

The training device for training human pelvic floor muscles, intended to be placed for training externally onto the human body directly or indirectly between the two ischial bones while sitting, including a seat part and a pressure sensor device for detecting the muscle force.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application is the U.S. national phase of PCT Application No. PCT/EP2012/072560 filed on Nov. 14, 2012, the disclosure of which is incorporated in its entirety by reference herein.
TECHNICAL FIELD
The invention relates to a pelvic floor training device according to the preamble of claim 1.
BACKGROUND
Pelvic floor training devices are used to train the muscles of the human pelvic floor. Well trained pelvic floor muscles are important, for example, to ensure continence in men and women.
For example, a training device for training the pelvic floor muscles is known from EP 1 747 048 A1. This training device has proven of great use but has the disadvantage that the force acting on it cannot be measured very accurately.
WO 2004/045411 discloses another pelvic floor training device. The latter training device, integrated in a chair, is very difficult to operate, is inexact in terms of pressure measurement and, moreover, can normally be used only in urology practices.
DETAILED DESCRIPTION
The object of the present invention is to form a more advantageous training device for training the human pelvic floor muscles.
This object is achieved with a training device comprising the features of claim 1. Dependent claims 2 to 14 relate to further advantageous embodiments.
The object is achieved in particular with a training device for training human pelvic floor muscles, intended to be placed for training externally onto the human body directly or indirectly between the two ischial bones while seated, comprising a seat part, and comprising a pressure sensor for detecting the muscle force, wherein the pressure sensor comprises a pressure-measuring or force-measuring device and also a hollow body extending in a longitudinal direction, wherein the hollow body comprises an upper fixed end part, a lower fixed end part and a spacer element, wherein the upper end part and the lower end part are held spaced apart from each other by the spacer element, wherein the spacer element extends in the longitudinal direction, and wherein the hollow body comprises a flexible outer sheath which connects the upper end part to the lower end part in such a way that a closed inner space forms within which the spacer element is also arranged, wherein the inner space of the hollow body contains a gel material, an elastic multi-component material or a liquid material that acts as pressure mediator, and wherein the pressure-measuring or force-measuring device extends in the longitudinal direction at least partially within the inner space in order to transmit the pressure from the outer sheath to the pressure-measuring or force-measuring device via the pressure mediator.
The training device according to the invention for training human pelvic floor muscles comprises a seat part and also a pressure sensor for detecting the muscle force. In one advantageous embodiment, the seat part has a recess into which the pressure sensor can be placed, wherein the recess and the pressure sensor are designed matching each other in such a way that the hollow body of the pressure sensor protrudes at least partially above the seat surface of the seat part. This embodiment has the advantage that the pressure sensor can be easily removed from the seat part, for example in order to clean the pressure sensor. However, it may also prove advantageous to have several seat parts with recesses of different depths for the pressure sensor. It is thereby possible that, depending on the seat part used, the height of the pressure sensor protruding above the seat surface can be varied. In a preferred embodiment, the hollow body is rod-shaped and has a hollow cylindrical portion. However, the hollow body could also have an outer contour which, on the side facing the seat part, is designed matching the recess of the seat part and, on the opposite side, has a shape adapted to the human body, for example similar to the anatomy of the human body part placed on the seat. The training device according to the invention has the advantage that the forces effected by the human pelvic floor muscle can be measured reliably and in a reproducible manner. Moreover, the training device can be easily cleaned. Moreover, the training device can be easily adapted to differently shaped human bodies by a suitable combination of seat part and/or pressure sensor.
In one possible use, the pressure sensor can rest directly on the skin of a person who is training. However, a particular advantage of the training device according to the invention is that a person who is training can also train with the training device when fully clothed, by means of the fully clothed person sitting on the seat part. There is therefore no intimate contact between the person training and the pressure sensor, which greatly facilitates the use of the training device.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows a side view of a pressure sensor;
FIG. 2 shows a longitudinal section through FIG. 1 along the section line A-A;
FIG. 3 shows a side view of a spacer element;
FIG. 4 shows a cross section through FIG. 3 along the section line B-B;
FIG. 5 shows a side view of a pressure-measuring device;
FIG. 6 shows a longitudinal section through the pressure-measuring device from FIG. 5 along the section line C-C;
FIG. 7a shows a schematic longitudinal section through a further illustrative embodiment of a housing with spacer elements;
FIG. 7b shows a schematic plan view of FIG. 7a; 
FIG. 8 shows a schematic side view of a further pressure-measuring device;
FIG. 9 shows a longitudinal section through a rod-shaped pressure sensor;
FIG. 10 shows a side view of the pressure sensor shown in FIG. 9;
FIG. 11 shows a plan view of a training device;
FIG. 12 shows a perspective view of the training device shown in FIG. 11;
FIG. 13 shows a section through FIG. 11 along the section line D-D;
FIG. 14 shows a section through FIG. 11, perpendicular to the pressure sensor;
FIG. 15 shows a schematic view of a tracking device.



In the drawings, identical parts are in principle provided with identical reference signs.
SUMMARY
FIG. 1 shows a pressure sensor 1 in a side view, and FIG. 2 shows same in a longitudinal section along the section line A-A. The pressure sensor 1 comprises a hollow body 3 extending in a longitudinal direction L, wherein the hollow body 3 comprises an upper fixed end part 3c, a lower fixed end part 3d and a spacer element 3e, wherein the upper end part 3c and the lower end part 3d are held spaced apart from each other by the spacer element 3e, wherein the spacer element 3e extends in the longitudinal direction L. The hollow body 3 comprises a flexible outer sheath 3a which connects the upper end part 3c to the lower end part 3d in such a way that a closed inner space 3b forms, in particular an inner space closed so as to be fluid-tight, within which the spacer element 3e is also arranged. The outer sheath 3a is designed in such a way that it can be placed directly or indirectly onto the human body. The upper end part 3c and lower end part 3d are of particular importance for precise measurement, since the upper end part 3c and lower end part 3d are fixed or rigid and prevent an excursion or an enlargement of the inner space 3b in the longitudinal direction L. The device 1 additionally comprises a pressure-measuring or force-measuring device 7 which extends in the longitudinal direction L within the inner space 3b. The inner space 3b of the hollow body 3 contains or is filled with a gel material 4a, an elastic multi-component material 4a or a liquid material 4a which acts as pressure mediator in order to transmit the pressure from the outer sheath 3a to the pressure-measuring or force-measuring device 7 via the pressure mediator. A closed inner space 3b is understood as an inner space 3b which is closed off from the outside in such a way that the pressure mediator, i.e. the gel material 4a, the elastic multi-component material 4a or the liquid material 4a, located in the inner space 3b cannot escape outward from the device 1. At least when a fluid is used as pressure mediator, the inner space 3b is thus closed off in a fluid-tight manner. In FIG. 2, the lower end part 3d has an aperture 3p which is designed as an internal thread, into which the pressure-measuring device 7 is screwed. The pressure-measuring device 7 is connected to the aperture 3p and/or designed in such a way that it is not possible for the pressure mediator to escape via the aperture 3p. The hollow body 3 thus encloses a closed inner space 3b, and any passages in the upper end part 3c and/or lower end part 3d, for example for electric cables or, as shown in FIG. 2, for securing the pressure-measuring device 7, are sealed off in order to form a closed inner space from which the pressure mediator cannot escape.
The spacer element 3e, which is shown in a side view in FIG. 3 and is shown in detail in FIG. 4 in a section along the section line B-B, is designed as a half tube with wall openings 3f, for example circular wall openings 3f, and comprises fastening portions 3o at the top and bottom, which fastening portions 3o, as is shown in FIG. 2, are firmly connected to the upper end part 3c and lower end part 3d, respectively, in order to hold the two end parts 3c, 3d at a defined distance from each other. The wall openings 3f or wall apertures can be designed in a great many shapes in order to ensure that, starting from the flexible outer sheath 3a, a pressure-conveying connection to the pressure-measuring or force-measuring device 7 can be made with the aid of the material located in the inner space 3b, e.g. a gel material 4a. 
As is shown in FIG. 2, the pressure-measuring and force-measuring device 7 is inserted from underneath into the inner space of the spacer element 3e through the lower end part 3d, wherein the pressure-measuring or force-measuring device 7 is screwed onto the lower end part 3d and is thereby held secure. The pressure-measuring or force-measuring device 7 is shown in detail in FIGS. 5 and 6, where FIG. 5 shows a side view and FIG. 6 shows a section along the section line C-C. As can be seen from FIG. 6, the pressure-measuring or force-measuring device 7 comprises a flexible hollow body 7a extending in the direction of extent M and having an inner space 7b, wherein the flexible hollow body 7a has, on the right, an upper end portion 7c, which is connected firmly and preferably in a fluid-tight manner to an upper closure piece 7d. The opening of the upper closure piece 7d is closed with a screw 7e. The flexible hollow body 7a has, on the left, a lower end portion 7f, which is connected firmly and preferably in a fluid-tight manner to a lower closure piece 7g. A force transducer 2 is arranged in the lower closure piece 7g, wherein the lower closure piece 7g has a fluid-conveying channel 7i, which connects the inner space 7b to the force transducer 2. The inner space 2b and the fluid-conveying channel 2i are filled with a second liquid material 7h. The force transducer 2 has a surface which extends perpendicularly with respect to the direction of extent M and on which the second liquid material 7h bears, such that the force transducer 2 is coupled to the inner space 7b in a manner perpendicular to the direction of extent M in order to measure the pressure of the second liquid material 7h. The force transducer 2 is connected by a cable 8 to the electronics unit 5 shown in FIG. 2. The wall of the flexible, tubular hollow body 7a transmits a pressure force, acting externally along the portion 7k, to the liquid 7h located in the inner space 7b, wherein the force transducer 2 measures the pressure or the force applied by the liquid 7h to the force transducer 2. The hollow body 7a can transmit the force from the outside inward only along the portion 7k, since the hollow body 7a bears, along the upper end portion 7c, on the upper closure piece 7d and, along the lower end portion 7f, against the lower closure piece 7g. The screw 7e serves inter alia to completely fill the inner space 7b with the liquid 7h and thereafter to close the inner space 7b in a fluid-tight manner again. In an advantageous embodiment, the portion 7k of the flexible hollow body 7a has a Shore hardness in the range of between 10 and 20, in particular as a result of the second liquid material 7h. An oil, for example, is used as the liquid material 7h. 
In a preferred embodiment, the force-measuring device 7, as shown in FIG. 2, extends along the entire length L of the inner space 3b and moreover also along the lower end part 3d, wherein the portion 7k extends only within the inner space 3b. In a further embodiment, the force-measuring device 7 could also be designed in such a way that it does not extend along the entire length L of the inner space 3b but instead, for example, only by half the length L, or for example by three quarters of the length L. In the most preferred configuration, the force-measuring device 7, as shown in FIG. 2, extends along the center or along the axis L. The force-measuring device 7 is, as shown, preferably centered with respect to the longitudinal axis, such that the forces applied to the flexible outer sheath 3a are transmitted uniformly to the pressure-measuring or force-measuring device 7. However, the pressure-measuring or force-measuring device 7 could also be arranged extending eccentrically in the inner space 7b. 
In a particularly advantageous embodiment, the flexible outer sheath 3a, as shown in FIGS. 1 and 2, is designed in the shape of a hollow cylinder. The flexible outer sheath 3a is preferably made of silicone, vulcanized rubber or unvulcanized rubber. The gel material 4a acting as pressure mediator, the elastic multi-component material 4a or the liquid material 4a transmits the pressure from the outer sheath 3a to the pressure-measuring or force-measuring device 7. When being introduced into the inner space 3b, the pressure mediator is advantageously introduced with a predetermined pressure, such that the pressure mediator in a rest state, that is to say without any force acting on the outer sheath 3a, has a predetermined pressure. The predetermined filling pressure of the pressure mediator influences the hardness or the pliability of the flexible outer sheath 3a. In a particularly advantageous embodiment, the flexible outer sheath 3a is chosen to be of such a material and/or the predetermined pressure of the pressure mediator is chosen in such a way that the flexible outer sheath 3a has a Shore hardness in the range of between 20 and 90. The following, among other things, can be achieved in this way: Firstly, the flexible outer sheath 3a feels comfortable on the applied body part, which is achieved by the fact that the flexible outer sheath 3a or the pressure mediator has certain elastic properties. These elastic properties, which are felt comfortable by the body part, have the advantage that no pressure sores occur on the body part bearing directly or indirectly on the device. A hard outer sheath 3a could cause pressure sores on an applied body part, of which a possible consequence could be that the training of the pelvic floor muscle is not carried out at all, or is carried out only incompletely, because of the unpleasant feeling and/or on account of pain. The avoidance of such pressure sores is therefore of crucial importance for the training of the pelvic floor muscle. Secondly, it is particularly advantageous if the diameter of the flexible outer sheath 3a is only slightly changed, even under quite considerable forces, the reason being that, for the body part resting on the outer sheath 3a, it becomes more difficult to exert great force on the outer sheath 3a the smaller the diameter of the flexible outer sheath 3a. In a particularly advantageous embodiment, the device according to the invention thus has the advantage that the aforementioned properties of the outer sheath 3a can be adjusted or predetermined via the filling pressure of the pressure mediator.
FIG. 2 also shows a pressure sensor 1 having a housing 6 with a mounting surface 6b, wherein the lower fixed portion 3d forms part of the housing 6. The lower fixed portion 3d is arranged in such a way that the hollow body 3 extends substantially perpendicularly with respect to the mounting surface 6b. The housing 6 also preferably accommodates an electronics unit 5, which is connected to the force transducer 2 by the cable 8. The pressure sensor 1 can, for example, be mounted on a wall via the mounting surface 6b. A seat part 21, which could be pushed under the pressure sensor 1, is not shown in FIG. 2. FIG. 9 shows a further embodiment of a pressure sensor 1 which, while being otherwise identical to that shown in FIGS. 2 to 6, differs from the embodiment in FIG. 2 in terms of being completely rod-shaped. FIG. 9 does not show the full length of the housing.
FIG. 7a shows a schematic and only partial view of a section through a housing 6 with bore 6c and recess 6d, while FIG. 7b shows a plan view of the housing 6. In the example shown, the spacer element 3e is composed of four pins which extend in the direction of extension L and connect the upper end part 3c to the lower end part 3d. The spacer element 3e can be produced in many possible ways in order to provide this spacing.
FIG. 8 shows a schematic view of a spacer element 3e and a pressure-measuring or force-measuring device 7, in which a plurality of force transducers 2 are arranged, spaced apart in the longitudinal direction L, on the spacer element 3e. Each force transducer 2 is connected to the electronics unit for signal transmission, such that the pressure exerted in the inner space 3b by the pressure mediator can be measured.
FIG. 10 shows a side view of the pressure sensor 1 shown in FIG. 9, the full length of the housing 6 being shown in FIG. 10. FIG. 11 shows an illustrative embodiment of a training device 20 comprising a seat part 21 in which the pressure sensor 1 is arranged. FIG. 12 shows a perspective view of the training device 20 shown in FIG. 11. The seat part 21 has two seat surfaces 21a, between which a depression 21c is formed in order to receive the pressure sensor 1. FIG. 13 shows a section along the section line D-D according to FIG. 11. The depression 21c is made deep in the seat part 21 and is adapted with respect to the geometric design of the pressure sensor 1 in such a way that the hollow body 3 and in particular the elastic outer sheath 3a protrude at least partially above the seat surface 21a of the seat part 21.
The training device 20 is particularly advantageously designed in such a way that the seat part 21 and the pressure sensor 1 are designed as separate units that can be joined together and separated again. In a particularly advantageous embodiment, the pressure sensor 1 is placed loosely in the seat part 21.
The depression 21c of the seat part 21 is advantageously designed in such a way that the hollow body 3 can be placed in it in such a way that the hollow body 3 protrudes partially above the seat surface 21a of the seat part 21. In an advantageous embodiment, the depression 21c is designed matching the outer contour of the hollow body 3, such that, as is shown in FIG. 13, the hollow body 3 lies flat in the depression 21c, and in particular the elastic outer sheath 3a bears on the depression 21c along at least part of the length. Advantageously, the depression 21c extends in a manner corresponding to the outer contour of the elastic outer sheath 3a, such that the entire or substantially the entire part of the outer sheath 3a lying in the depression 21c preferably rests flat on the depression 21c. This embodiment has the advantage that the position of the part of the outer sheath 3a located in the depression 21c is precisely defined, such that the pressure forces acting on the remaining part of the outer sheath 3a can be reproduced particularly precisely and/or can be measured with minimal disturbances. As is shown in FIGS. 11 to 14, the depression 21c is preferably designed with an at least partial form fit in relation to the pressure sensor 1, which affords the advantage that the pressure sensor 1 is arranged in a defined position in the seat part 21. This is particularly advantageous if the pressure sensor 1 is designed as a part separate from the seat part 21 and the pressure sensor 1 or the seat part 21 can be exchanged. In another possible embodiment, however, the pressure sensor 1 can also be connected firmly to the seat part 21.
FIG. 14 shows a section through the training device 20 shown in FIG. 11, perpendicular to the pressure sensor 1. The pressure sensor 1 is placed into the depression 21c such that the pressure sensor 1 protrudes partially above the seat surface 21a. In one possible embodiment, a plurality of seat parts 21 are provided which have depressions 21c of different depths, such that, by an appropriate choice of one of the seat parts 21 in which the pressure sensor 1 is placed, it is possible to determine to what extent the pressure sensor 1 protrudes above the seat surface 21a, or, for example, in the case of an oblique seat surface 21a, how the pressure sensor 1 extends with respect to the seat surface 21a. In an advantageous embodiment, as shown for example in FIG. 14, the flexible outer sheath 3a can have an anatomically adapted outer shape. However, as is shown in FIG. 14, the anatomical adaptation can also be designed as a separate add-on part 19 and can be made, for example, from a flexible silicone. The outer sheath of the hollow body 3 has a cylindrical shape in FIG. 14. The add-on part 19 is placed on the hollow body 3 and can be exchanged. In one possible embodiment, the add-on part 19 could also be fixedly connected to the hollow body 3.
FIG. 15 shows a schematic view of the pelvic floor training device 20 in connection with a tracking device that comprises a calculator 24 and a screen 22. The pressure sensor 1 is connected to a computer 24 by a connection cable 24b. The computer 24 is connected to the screen by a connection cable 24b. A person who is training sits on the seat part 21, looks at the screen 22 and sees there a setpoint value profile 23 and also the currently measured actual value 23a as a function of time.
The pelvic floor training device is advantageously operated in such a way that a setpoint value 23 for the muscle tension of the pelvic floor muscle is predefined, that an actual value 23a is measured with the pressure sensor 1, and that the actual value 23a and/or the difference between actual value 23a and setpoint value 23 is output. As is shown in FIG. 15, a setpoint value profile 23 as a function of time is advantageously predefined and shown on a display device 22. The actual value 23a is measured by the pressure sensor and is shown as a function of time on the display device 22, such that the deviation between actual value and setpoint value is presented visually. By suitable contraction of the pelvic floor muscles, the person who is training can thus follow the setpoint value and can thereby train the pelvic floor muscles in a specific and controllable way. With the tracking device shown in FIG. 15, a large number of training programs or of different setpoint value profiles can be predefined. Moreover, progress made in training can be displayed.

## Claims

1. A pelvic floor training device for training human pelvic floor muscles, intended to be placed for training externally onto the human body directly or indirectly between the two ischial bones while seated, comprising:
a seat part; and
a pressure sensor for detecting a muscle force;
wherein the pressure sensor comprises:
a pressure-measuring or force-measuring device; and
a hollow body extending in a longitudinal direction, wherein the hollow body comprises a flexible outer sheath, an upper fixed end part, a lower fixed end part and a spacer element, wherein the upper end part and the lower end part are held spaced apart from each other by the spacer element extending in the longitudinal direction, whereby the flexible outer sheath of the hollow body connects the upper end part to the lower end part in such a way that an inner space is formed within which the spacer element is arranged, the inner space contains a gel material, an elastic multi-component material or a liquid material that acts as pressure mediator, wherein the pressure-measuring or force-measuring device extends in the longitudinal direction at least partially within the inner space in order to transmit the pressure from the flexible outer sheath to the pressure-measuring or force-measuring device via the pressure mediator;

wherein the seat part and the pressure sensor are designed as separate units that can be joined together and separated again,
wherein the seat part and the pressure sensor are designed matching each other in such a way that the hollow body protrudes at least partially above a seat surface of the seat part; and
wherein the seat part has a depression into which the hollow body can be placed.

2. The pelvic floor training device as claimed in claim 1, wherein the pressure-measuring or force-measuring device extends along a center of the hollow body.

3. The pelvic floor training device as claimed in claim 2, wherein the spacer element extends along a center axis of the hollow body.

4. The pelvic floor training device as claimed in claim 3, wherein the flexible outer sheath has a Shore hardness in the range of between 20 and 90.

5. The pelvic floor training device as claimed in claim 1, wherein the depression is designed matching an outer contour of the hollow body, so that the hollow body lies flat in the depression.

6. The pelvic floor training device as claimed in claim 5, wherein the seat surface extends obliquely.

7. The pelvic floor training device as claimed in claim 1, wherein the pressure measuring or force-measuring device extends at least along an entire length of the inner space.

8. The pelvic floor training device as claimed in claim 1, wherein the spacer element is designed as a hollow tube with wall openings, and wherein the pressure-measuring or force-measuring device is arranged extending inside the spacer element.

9. The pelvic floor training device as claimed in claim 1, wherein the flexible outer sheath is designed in a shape of a hollow cylinder.

10. The pelvic floor training device as claimed in claim 1, wherein the flexible outer sheath has an anatomically adapted outer shape.

11. The pelvic floor training device as claimed in claim 1, wherein an exchangeable add-on part is provided which is designed in such a way that it can be attached to the hollow body in a manner extending in the longitudinal direction of the latter.

12. The pelvic floor training device as claimed in claim 1, wherein a hardness or a pliability of the flexible outer sheath can be determined via the pressure of the pressure mediator.

13. The pelvic floor training device as claimed in claim 1, wherein the pressure-measuring or force-measuring device comprises:
a force transducer; and
a flexible hollow body which extends rectilinearly in the direction of extent and has an inner space, the inner space is closed and contains a second liquid material, wherein the force transducer is coupled to the inner space in a manner perpendicular to the direction of extent in order to measure the pressure of the second liquid material.

14. The pelvic floor training device as claimed in claim 1, wherein the pressure-measuring or force-measuring device comprises a plurality of force transducers which are arranged, spaced apart from each other in the longitudinal direction, on the spacer element.