Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
1999-03-15
2001-09-18
Brown, Michael A. (Department: 3733)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C607S138000, C128SDIG008
Reexamination Certificate
active
06289894
ABSTRACT:
The invention relates to a device for treating incontinence, which device includes a frame part and a, at least partially tubular, sensor part fastened at an angle in relation to the frame part, having sensors on its sides for measuring the function of the pelvic floor muscles.
Incontinence means reduction of the ability to restrain urine. The main reason to the problem is the weakening of the pelvic floor muscles and the reduction of their ability to be activated. This may be influenced by a lot of different reasons, for example overweight, psychological reasons and as one reason, the reduction of the restraining ability caused by the delivery of children. It is essential when treating incontinence to restore the muscle strength and the muscle control of the patients pelvic floor muscles. This may be realized through practice or electrical stimulation of the muscles.
These days different kinds of devices exist with which it is possible to exercise the pelvic floor muscles and/or measure their activity. The device is placed in the vagina and when the muscles are contracted the condition of the muscles is elucidated with the help of the data transmitted by the sensors. By repeating the contracting exercises the muscle strength is grown to a level where the problem to hold the urine disappears. With the training made possible with the devices it may be possible to avoid surgery.
Several problems are connected with the known devices. The devices are generally intended for use only in research and laboratory conditions and are not possible to use at home. The devices are often staff-shaped and their use is troublesome. In addition, some devices have a thickening at the end of the staffs which is an inconvenience to the measurements in standing and squatting position. When using some devices it is not possible to get them completely clean in spite of the sterilization or exchange of the sensor part, but secretions from the body may transfer from the sensor part to the frame part and stay in cavities in the device. Another problem is the conveniency to handle and the safety to use the device. A disadvantage is also that the device is not easy to adjust to the user.
Devices also exist where a pressure sensor is placed inside a flexible tube which is placed into the vagina. This kind of measurement with pressure is not accurate enough, since it is possible to create pressure in the vagina by squeezing the feet or the muscles in the abdomen or the seat. A disadvantage when using pressure sensors is that it is not possible to discover a situation where the muscles on one side are functioning worse than the muscles on the other side.
The object of the invention is to bring forward a device for treating incontinence with which disadvantages connected to present devices are removed. The object of the invention is especially to bring forward a device which is easy to use both at home and in laboratory conditions and which is safe, reliable and hygienic. Further, the object of the invention is to bring forward a device which is adjustable for different users or which the user may adjust to different values in different phases of the treatment.
The object of the invention is achieved with a device characterized by that described in the claims.
According to the invention the sensor part is detachably attached to the frame part, the sensors are placed on the sides of the sensor-part-tube, on both sides of the center of the side, and the sensors are electrodes which are arranged to measure the muscle activity of the pelvic floor muscles with the help of the electrical signal produced by them. A sensor part according to the invention is a so called disposable part which is exchanged after each patient so that the device is hygienic and safe. When using the device at home it is possible, when the same patient is using the device, to continuously use the sensor part several times in a row. In this case it shall be carefully cleaned after use. The frame part is only exchanged if it is broken. An electronic case is placed inside the frame part, inside which adjustment and functioning organs are placed.
The measurement taking place with the apparatus is preferably based on electromyographic measurement (EMG). The muscle activation of the pelvic floor expressed with a rms-EMG-signal is from a few micro volts to about 50-80 &mgr;V. The electrode plate pairs functioning as sensors register the sum-potential of the contracting muscle and thus the signal accurately describes the activation capacity of the pelvic floor muscles on both sides. The measurement results are collected separately from each side.
A device with a frame part according to the invention is accurately placed in its position in the vagina by placing it in such a position that the frame part extends forward. In this case the sensors are in the desired way at the muscles to be examined or exercised. An additional advantage is that the frame part is spacious enough and can be equipped with the necessary measurement and control electronics and possibly with a displaying device. Still, the device is so small that it can be placed under the trousers.
In the advantageous embodiment of the invention the sensor part is an integrated moulded part. The sensors are situated on the side surface of the tubular part during the moulding, forming a part of the construction. When the sensor part is moulded as an integrated part no secretions from the body may enter the sensor part and therethrough continue to the frame part. Thus the device is sufficiently hygienic all the time.
In the second embodiment of the invention a cover belongs to the lower part of the sensor part. The lower surface of the cover is placed on the upper surface of the frame part. The cover protects the frame part so that the frame part does not come into contact with the secretions from the body. The cover is placed at an angle compared with the other part of the sensor part.
The contact connections between the sensors and the frame part are advantageously placed at the frame part. In this way the risk of contamination is small.
In an advantageous additional embodiment of the invention the tube of the sensor part is converging essentially over its whole length 1°-5° against the tip. The tube does not press against the user too much and does not cause pain when using the device. The device may be used in a lying-down, a standing and a squatting position.
In an advantageous embodiment of the invention the sensors are placed on the sides of the tube on both sides of the center of the side symmetrically and at about an 50°-70° angle compared with each other seen from the center of the tube. When the device is accurately placed in its position with the help of the invention, reliable knowledge is acquired of the muscles on both sides separately.
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Brown Michael A.
Pillsbury & Winthrop LLP
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