DE20009854U1 - Device for pressure measurements - Google Patents

Description

Device for pressure measurements

The invention relates to a device for measuring pressure between adjacent tissue layers in the human body.

Such devices for pressure measurements are already known in the field of neurosurgery, where pressures are measured between the skull bone and the dura mater using an air-filled balloon.

These are already being used successfully in examinations and operations, but due to their design and the measuring principle used, they are not universally applicable.

In the treatment of female urinary incontinence, which is operated on by colposuspension after a hernia, the lateral vaginal vault is sutured by suturing the upper edge of the superior pubic ramus, with the sutures being pulled through the top of the so-called Cooper's ligament. This suture is not pulled completely, but a loop is pulled that sews the Cooper's ligament and the lateral vaginal vault together without leading to direct contact between the two structures.

For this operation, it is very important that sufficient thread tension is achieved, as this is the only way to achieve sufficient elevation of the bladder neck with a corresponding improvement in incontinence symptoms. On the other hand, excessive thread tension can result in constriction of the bladder floor and urethra, which can manifest clinically as problems with bladder emptying or even the complete impossibility of urinating, known as urinary retention.

According to the current state of the art, the thread tension was defined according to the feeling and experience of the treating surgeon.

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Many patients operated on with colposuspension experience overcorrection, which requires intermittent bladder catheterization, sometimes even a permanent catheter. As a result, the longer hospital stay results in significantly higher hospital costs, with the patients then being discharged to primary care with appropriate aftercare, which also results in high follow-up costs. Another disadvantage of this method is that many patients undergo recurrent operations for overcorrection, which further increases the costs.

This is where the invention comes in, which has set itself the task of improving the disadvantages of the previously known state of the art and which enables sufficient reproducibility of the surgical result, a reduction in additional costs, since no follow-up and further treatment is required, which drastically reduces the costs for additional recurrence operations and which ultimately leads to greater patient satisfaction.

According to the invention, this is achieved in that the device for pressure measurements between adjacent tissue layers in the human body consists of at least one elastic film and a tube, wherein the elastic film is connected at its edge regions to form a gas- and liquid-tight element, in the lumen of which at least one tube is located, that the surface of the element is changeable, wherein this change can be detected via a medium located in the element 25 and in the tube and that the element is positioned between the front vaginal wall with the urethra lying thereon and the symphysis rear side.

With this device according to the invention, a correct thread tension can be achieved at any time, which is independent of the experience and feeling of the surgeon. The innovation brings the tissue layers of the front vaginal wall with the urethra lying on it and the symphysis back closer together, which leads to a corresponding pressure on the device according to the invention, which can be recorded and controlled by measuring elements located at the end of the tube. This gives the surgeon an objective criterion, which forms the prerequisite for the positive conclusion of such an operation.

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In a further advantageous embodiment, there is a hose in the edge area of the element, which is connected to the element in a gas- and liquid-tight manner and through which an optimal transmission and thus faster and, above all, more accurate measurements of the pressure in an element are possible.

It is also advantageous that when using two hoses which are connected to the element in a gas- and liquid-tight manner, they are spaced apart from each other so that bubble-free filling and undamped pressure transmission are possible without having to interrupt the pressure measuring line.

Another advantage is that both the element and the hose are made of a polymer material, which can therefore be made available economically, in sufficient quantities and in reproducible quality.

In a further advantageous embodiment of the device according to the invention, a transparent polymer material is used for the element and the tube, which allows optical control at any time as to whether the filled lumens and volumes are filled in such a way that there are no air bubbles in the system that could impair the transmission frequency.

Furthermore, the invention teaches that the tube connected to the element is adjusted to be X-ray contrast-capable, which in turn means that the positioning of the element can be adjusted very precisely and controlled at any time by the surgeon.

By using such an objective pressure measurement method in colposuspension operations, the recurrence rate can be significantly reduced from the current level of approximately 30 to 40% through intraoperative registration, which, in addition to reducing costs, leads to significantly higher patient satisfaction.

In the following, the invention will be described in more detail using non-limiting embodiments.

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Show it:

Figure 1: Device according to the invention

Figure 2: Use of the device according to the invention in the human body

Figure 1 shows the device 1 according to the invention for pressure measurements. In the embodiment shown here, it consists of an elastic film 2, which is sealed gas- and liquid-tight at its edge areas 21, 22, 23 and 24. In the volume 26 of the resulting element 25, the free end 31 of the hose is

3, whereby the hose 3 is also connected to the element 25 in a gas- and liquid-tight manner.

Spaced from the free end 31 of the hose 3 is the free end 41 of a hose

4 is positioned in the volume 26 of the element 25, wherein the hose 4 is connected to the element 25 in a gas- and liquid-tight manner.

At the free ends 32, 42 of the hose 3, 4, connecting elements 5, 6 are integrally attached, to which the required measuring elements 7, 8 can be connected.

Figure 2 shows the device 1 according to the invention being used in the human body. The element 25 of the device 1 according to the invention is positioned between the pubic bone 100 and the bladder 101. The bladder 101 is supported on the uterus 102, the upper urinary fornix 103 and the pubic bone 100. The surgeon exerts pressure on the element 25 by tightening the threads 104 via the bladder 101. The resulting pressure difference is transmitted via the hose 3 to the associated measuring element 7, which is positioned outside the human body within sight of the surgeon, and is registered by the surgeon. The force with which the threads 104 are tightened changes the pressure on the element 25 of the device 1 according to the invention, so that the surgeon can tie the threads 104 when a minimum or limit value, which is displayed on the measuring element 7, is reached. After removal of the device 1 according to the invention from the human body, the operation can be successfully completed.

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Claims (8)

1. Device for measuring pressure between adjacent tissue layers in the human body, consisting of at least one elastic film ( 2 ) and a tube ( 3 ), the elastic film ( 2 ) being connected at its edge regions ( 21 , 22 , 23 , 24 ) to form a gas- and liquid-tight element ( 25 ), in the volume ( 26 ) of which at least one tube ( 3 ) is located, the surface of the element ( 25 ) being changeable, this change being transferable via a medium located in the element ( 25 ) and in the tube ( 3 ), and the element ( 25 ) being between the pubic bone ( 100 ) and the bladder ( 101 ). 2. Device according to claim 1, characterized in that a hose ( 4 ) is located in at least one edge region ( 21 , 22 , 23 , 24 ). 3. Device according to one of the preceding claims, characterized in that the hose ( 4 ) is connected to the element ( 25 ) in a gas- and liquid-tight manner. 4. Device according to one of the preceding claims, characterized in that the free ends ( 31 , 41 ) of the hose ( 3 , 4 ) are spaced apart from one another in the volume ( 26 ) of the element ( 25 ). 5. Device according to one of the preceding claims, characterized in that measuring elements ( 7 , 8 ) are located at the free end ( 32 , 42 ) of the hose ( 3 , 4 ) opposite the element ( 25 ). 6. Device according to one of the preceding claims, characterized in that the element ( 25 ) and the hose ( 3 , 4 ) consist of a polymeric material. 7. Device according to one of the preceding claims, characterized in that the element ( 25 ) and the hose ( 3 , 4 ) consist of a transparent polymeric material. 8. Device according to one of the preceding claims, characterized in that the tube ( 3 , 4 ) is adjusted to be X-ray contrast capable.