WO2011004212A1

WO2011004212A1 - Catheter

Info

Publication number: WO2011004212A1
Application number: PCT/IB2009/006706
Authority: WO
Inventors: Arpad DR.DANI; Peter PROF.DR.SZENDRO
Original assignee: Dani Arpad Dr; Szendro Peter Dr
Priority date: 2009-07-09
Filing date: 2009-07-17
Publication date: 2011-01-13

Abstract

The catheter is a flexible and elastic pipe-like part (1, 11) whose inner canal is in the bladder of the patient and is in connection with the body through one or more openings, and during the use of the catheter it is at the end of the patient's bladder. With the fixing harmonica-like distal part (1a) and with the harmonica-like proximal part that prevents the catheter from slipping into the bladder where the diameter of both the distal part (1a) and the proximal part (1c) is bigger at the end of the bladder, but its diameter stretched out horizontally is smaller than the diameter of the urethra. The size of the distal and proximal parts (1a, 1c) connecting harmonica-like intermediate part (1b) reduces to an approximate size, and it makes possible to introduce the catheter through the bladder, while the distal part (1a) goes into the inside of the bladder, and the parts (1a, 1b, 1c) get back their original size without the horizontal pressure, and the intermediate part (1b) agrees with all-time change in size and form because of its flexibility. In the distal part (1a) with a closing devise that is made of flexible membrane valve (13) opening with manual deformation at the external end of the harmonica-like proximal part (1a).

Description

Catheter

The subject of the invention is a catheter that is a long, flexible and elastic with a pipe-like element in the body with a medium leading canal that connects the canal with the ventricle of the patient. At least with one opening, on the body or with the body itself, or with the body, with at least one fixing device that prevents the catheter from the unwilling moving, in a given case with an interlock, where the body has a distal part that goes into the ventricle of the patient and a part that is in the body of the patient.

In the previous known solutions try only that a solution is found for leading away the different medium that is in different ventricles like fluids first of all, but solely, for example under normal circumstances the continuously urine. This solution has been found in the catheters. Whether it can be used once or several times, it stays in, or it has to be introduced more times every day, it was insignificant from the view of the solution of the question, because the main goal has been reached to prevent life-threatening situation.

As a result of the known solutions, a more or less thick, inconvenient plastic pipe hangs out of the urethra from which urine flows out continuously which is regulated with a plug or with urine collecting bag by lengthening the pipe. This solution is very inconvenient for the patient, but it only concerns the patient.

The above mentioned solution has 2 problems: one is the length of the catheter, and the other one is the continuous flow.

1. The length of the catheter:

The conducive length of the catheter is actually a ca. 4-6 cm part that the most common obstacle, the prostate bridges. From the aspect of the other solutions, we dispense with the solution of the stricture of the urethra where a longer catheter might be needed depending on the place of the stricture. The solution suggested by us can be used as well. Depending on the fact that the urological catheters go out or "hang out" through the urethra opening or they stay in the urethra after introducing them, so they cannot be seen, catheters with whole or partial length exist.

The catheter with whole length is usually a pipe-like element that can be led into the bladder through the urethra or sometimes through the abdominal. One end stays in the urethra and the other end goes out through the external opening of the urethra. Catheters are nowadays made of flexible materials such as latex, polyurethane or silicon. On the internal end there is usually a flexible, blow able balloon introduced through a separate canal. It can be emptied a similar way. The blown up balloon prevents the catheter from slipping out of the urethra. The external end of the so called Foley-catheters can be with one or more lines dependency on what we use them for. These prevent the catheter to slip into the urethra and the urine can be led away or the internal balloon can be blown up or the continuous rinse of the bladder can be done through them.

The led out urine can be introduced into a collecting bag or the led out pipe can be plugged in with a plug. The patient or his/her care-taker can introduce the catheter several times a day if it is necessary, so it doesn't stay in the patient. This solution is more advantageous in certain cases. The group of the partial length catheters consists of catheters that do not reach the length of the urethra after introducing them, so they cannot be seen.

Most of them are available with balloons. There is also a balloon at the distal end to prevent the catheter from slipping out, and a second balloon that prevents the catheter from slipping into the bladder. This second balloon is externally from the prostate.

In some cases these catheters contain an interlock that is placed at the distal end of the catheter. It can be felt from outside, so it can be put under pressure. The lock can be with a valve, ball- valve or any kind. The size of the structure can be a problem, because the internal diameter of the urethra is ca. 5-6 cm in this area.

Besides the psychical effects their other advantage is that they can be worn easier, and socially they give more freedom to the patient. With some catheters it is a problem that the length of the urethra is different by every person. It changes as the body moves, and it also depends on the congestion of the penis. The length of the prostatic urethra is also different, and it depends on the size of the prostate.

The other problem is the continuous flow, because the catheter makes the patient incontinent. It doesn't refer to those catheters used nowadays that can be emptied several times. They have other disadvantages. At this point another big group of patients comes into the picture: people who live with incontinence. Since after a while women are significantly affected, we can say when we include men as well that the number of people who lose urine unwillingly exceeds the number of people who are not able to urinate. A solution for losing urine is also a permanent catheter.

The sought and required solution means such permanent catheters whose size is only the necessary, they are unnoticeable by other people, they are able to stay in for a longer period of lime, and the most important thing is that they take over the role of the sphincters, and they enable for people to urine willingly.

A catheter where the interlock is the most significant part can be produced today. This interlock can be mechanical, electromagnetic or only magnetic, but other solutions are suitable as well. With this thing we can control our "flowing necessities".

The catheters for diverting the urine have to agree with the following requirements:

-Catheters have to bridge the tight part (in that case if emptying the urine is a problem).

-Catheters have to ensure the controllable urine emptying.

-Catheters - after being positioned - have to stay at one place.

Catheters do not agree with the above mentioned requirement in the following way:

The strictures can be bridged in two different ways: there is a classical solution when we introduce a pipe through the stricture, and the other known method is that running canals around a thick central part lead away the urine.

The willing control of urinating can happen in two ways as well:

a) According to the first one - the biological method - the function of the sphincter has to be ensured if it is functional. It is done so that the diameter of the catheter is tightened at the part of the sphincter which, therefore, is able to close. b) According to the other one - the artificial one - the catheter is provided with an interlock which functions in different methods. This can be mechanical, hydraulic, electromagnetic or magnetic, etc.

The appropriate positioning is a very important part, especially in case of catheters with partial length. By catheters with full length, the further movement is not attended after introducing, although it causes several side effects. By catheters with partial length, the positioning is very important, especially that it stays in. In most cases it is solved with a balloon that fixes the catheter at the both ends - usually prostate - of the stricture. Of these, the inner balloon which is in the bladder is less problematic, its size is variable, and in most cases it is unimportant how tight its connection with the bladder collar. The external balloon is more problematic which is placed at the level of the stricture or its immediate closeness. The size of the balloon is important here, because it can move under relative tight limits, and its position with only a few millimeter differences can cause urinating.

Every single catheter - we mean not only urological catheters but also catheters that lead away fluid from other parts of the body - has to be positioned; it has to stay at one place after introducing.

At most catheters, one or more blow able balloons or other know positioning-fixing elements serve to keep the catheter at one place.

But such a method can also be the so-called flexible basket or a form that can be opened as an umbrella which has been used several times.

TΛC basic problem is the following: a part in the body has to be bridged. At urological catheters this part is the prostate by men, and the urethra by women. When we want to lead fluid out of the body from different places, this part to be bridged could be chest, the abdominal or other part of the body in rare cases. From the specification it is clear and understandable that the length of these parts to be bridges is different.

Speaking of the urological catheters, the fact that the size of the prostate is different for every person and that its size changes with ageing has not been considered. But its size changed at different positions of the body as well. In most cases this change can be 3-6 cm. For the same person this change can be 0,5-1 cm dependently on the position of the body.

A fixed sized catheter is not suitable to follow these changes which can cause severe side effects.

The US patent, number 5,518,498 describes such a partial length catheter which is introduced into the bladder of the patient through one sleeve which is actually described in the introduction. At the distal end of the catheter entering the bladder, and its opposite proximal end, there is a basket-like part made of the own material of the body. The peripheral size of this basket-like part is bigger than the diameter of the long pipe-like part of the catheter at rest or in moving of the catheter. The basket at the distal end of the catheter in the bladder of the patient prevents the catheter from slipping out by leaning on the wall of the bladder. The basket at the proximal end of the catheter prevents the catheter from slipping into the bladder of the patient.

During introducing, the catheter is introduced into the ventricle of the patient through the sleeve with a flexible, but horizontally stiff rod; the rod at the distal end of the catheter pushes it forward. Since the other, proximal end is held, it stretches out in its length - which is in functional state as well -, the basket at both ends that ensure the biggsr peripheral size tighten, so that they do not cause any serious resistance by being pushed to the wall of the sleeve. The catheter can be removed, pull out of the ventricle of the patient by the line fixed to the proximal end.

The disadvantage of this solution is that a sleeve is needed for introducing because of the baskets that have been produced in attendance of the necessary force, and the central part in the body of the patient between the two ends of the catheter is fixed, has a permanent length, so every patient needs to be measured in advance, and after the given measurements the appropriate catheter needs to be chosen. Further disadvantage is that in case of catheters staying for longer periods of time, concretums can dissolve or form a deposit around the basket from the urine because the basket-like form. This can cause some problems by removing the catheter.

Similar solutions describe EP0368473A2 and US 7,264,609B2 and US 2006/0119553 patent documents, and a similar catheter can be found in the US 4,973,301 patent description with the disadvantageous characteristic that the given catheter does not pay attention to the changes of the size when the patient is in motion. So a catheter that is suitable at rest might be too big in different positions of the body after introducing. It can move and irritate the bladder and/or the urethra of the patient.

The EP0368473 patent describes a catheter where the own material of the pipe-like element gets bigger horizontally at the distal end; the catheter swells at rest/ in motion. It can be reached that the catheter is not just a simple, smooth pipe, but two concentrically pipe that can slide on each other. The internal pipe ensures the eventual leading canal, and during introducing, an additional force is produced horizontally with an appropriate device that the external skin-like pipe slides on the internal pipe and it pushes out the distal end of the catheter. It ensures the catheter not to slip out of the bladder of the patient. The length of the catheter does not agree either with the body sizes of the patient or with the actual body positions.

A similar solution is described in the US patent 2006/0229553A1 where the long pipe-like element of the catheter is slashed horizontally at the distal end of the catheter with fixed length. In consequences of the slashes, the catheter at rest of the body widens basket-like around the periphery, which keeps the catheter in the bladder of the patient.

Another similar solution is described the WO patent 2004/045696 documentation where more horizontally slashes can be found at the distal end of the catheter, it is forced by separated band with slashes that the catheter widens to the size extending the size of the introduction and the catheter is fixed in the bladder of the patient.

To this solution a similar solution is suggested by the GB patent 1536019 where the external skin-like pipe is provided with several, slightly spiral slashes at the distal end, and the band between the slashes open at the horizontal pressure of the external pipe. It enlarges the distal end of the catheter in the bladder of the patient arid prevents the catheter from slipping out.

The US patent 5,322,501 describes a catheter with full length that is recommended for preventing the urethra stricture after operation, and where flexible, splayed lines are at the distal end of the catheter - precisely in the patient's ventricle, bladder that the catheter slips out its place. The disadvantage of this solution is that it ensures mainly the free cross-section of tint exit of the bladder, it does not deal with the transfusion of the other parts of the urethra, so there is no connected pipe-like element, which would ensure along the prostate and the sphincter in the urethra that those do not close the urethra in a wrong way. Since the catheter is connected to the pipe part through thin strings, the eventual injury of the strings or the move or slip upwards of the pipe part horizontally can cause that the catheter falls into the bladder and cannot provide its original function.

The WO patent 91/100074 documentation describes, first of all a catheter for prevention of incontinent. At the distal end of this long pipe-like part there is a mushroom-like collar that closes willingly the opening of the bladder by the introduced catheter, and the collected urine can flow out solely through the canal of the catheter. At the external proximal end of the catheter a similar to the previous mentioned, but bigger collar runs around that prescribes the introducing position of the catheter and ensures it not to slip into the inner part of the bladder.

Besiαe the collar at the two end part, there is a third one that has a smaller collar around without any fixing function. It only stimulates the stricture.

According to general experiences, the document describes the length of the catheter 5-7 cm, but the accurate sizes can be given only previous measurements. It means a problem by production of the catheter, because different sizes must be produced. Another disadvantage is that collar around at the distal end does not slick into the peripheral size of the catheter, so it only depends on the flexibility of the material of the collar that when the catheter is being removed, whether the patient feels pain or the distal end of the catheter hurts the end of the bladder or the urethra.

The WO patent 99/45997 describes a similar catheter where the disadvantage is that the long pipe-like part of the catheter has a fixed length with which it is tried to compensate that the collar-like part along the catheter at the proximal end of the catheter can be slid horizontally, so it can be suited to the body sizes. At this catheter, the collar around between the two side collar-like parts can be found that stimulates the stricture. Due to the mentioned, independent from each other and relative moveable cotenants, catheters cannot be produced so simple and propitiously as the economical procedures and the rationalism dictate.

The US patent 4,710,169 document describes a catheter where an umbrella-like expanding umbrella forms of the own material of the catheter at rest of the catheter at the distal end. This is iv: tlie bladder and prevents the catheter from slipping out. The body of the catheter is provided with a presumable part, and there is a part at the proximal end that is suitable to empty the collected urine manually. The deficiency of the solution that the stiff leading part needs to be led in the inner part of the catheter in order to be able to remove it and it needs to hit its distal end, so that the umbrella could be closed by pushing it into the inner part of the bladder of the distal end, and the catheter could be removed properly out of patient. Besides this, the document does not describe or refer to parts that could prevent the catheter to get into the bladder deeper as it is necessary.

The GB patent 2403656 document describes a catheter where there is a further line on/ in one of the sides of the long pipe-like part of the catheter. In the line a thin string made of flexible material is put in that is flexible and spins as a pig tail when it is pushed to the distal end of the catheter at the introduced catheter, so that the catheter stays in the bladder. Removing the catheter with fixed length, we only need to pull the span strings out of the lines - not only one but more lines and strings can be formed - this vanishes the diametrical difference that has ensured for the catheter to stay at one place, and the catheter can be removed easily. The disadvantage of the solution is the complex structure, because the catheter has to be flexible, bendable to ensure the leading and build-in of the strings, or to remove the strings after a longer period of time as well.

The US patent 6,004,290 document describes a catheter with three characteristic elements: the first one is that a positioning balloon at both ends of the prostate urethra, the second one is that it does not exceed the opening of the urethra, it means that it is invisible, hidden. The third one is that the part between the two balloons has a flexible structure, so it can change its size according to the size of the prostate. In one form of the catheter, a mechanical lock is built in that can be opened manually. The problem is to determine the length of the catheter, because catheters with appropriate size can be used. We have stated that the length of the urethra changes with the body position: shorter when the patient lies and longer when he stands. The length of the catheter has to be chosen that it is long enough to manipulate the lock and to remove the catheter when it is necessary, and it is short enough so that it does not hang out of the urethra. This problem has been solved that the length of the urethra is measured with a measuring catheter, and out of six different catheters the proper catheter is chosen. Above all, there are still difficulties: the distance between the positioning balloons dependently on the size of the prostate that equals and changes with the length of the prostate urethra. A special part of the intervention to this: the part between the balloons has been planned flexible. The simple lock that is part of the solution can be opened so, that it has to put pressure on the part of the catheter in the urethra.

The US patent 2004/0049170Al describes the disadvantages of the common Foley-balloon catheter and tries to bridge it so that the distal end of the long pipe-like part of the catheter recommended by him is bigger compared to the diameter of the other parts of the catheter; it means that the end of the catheter is widened. Choosing the suitable material for the catheter it can be ensured that the diameter of the widened part can be reduced by putting horizontal pressure, it gets longer, and without the pressure it gets its original from back. To reach it, the catheter needs to be provided with thread-insets that go along and close an angle with the chosen length axle of the catheter, and they ensure the required size changes happen due to the pressure, and it gets its form and size back without the pressure. The production of this catheter is expensive because of the thread-insets. Its length cannot be changed, and it cannot be suited to the sizes and size changes of the patient.

Our goal with our invention is to bridge the deficiencies of the known catheters, and to produce a catheter that can be produced simply, cheap, and from one piece, and it ensures in its ϋWΛ material that it can be introduced and removed easily. The introduced catheter stays at one place, follows the sizes of the patient, the size changes of the patient in motion or in different body positions - under determined limits, and it also ensures the reliable closure of the emptied part, and can be emptied quick and simple.

We have realized that we could reach the above mentioned goals with such a catheter that is formed as a simple long pipe-like part and its one, dibtal end is formed harmonica-like. The characteristic of the harmonica-like form is that its diameter significantly reduces at horizontal pressure, as pulling, and when this pressure seduces its material is suitable to get back its harmonica-like form, including its original diameter.

When we form the catheter at several part or its full length, so the catheter makes the necessary changes in length by itself automatically. This change is reversible, so when it's necessary the growth of diameter reduces again. We have solved the aimed goal with a catheter whose long, flexible, elastic pipe-like body, its part leading canal connects the canal with the ventricle of the patient. It has at least one fixing device that prevents the introduced catheter from moving unwillingly. It has a distal part into the patient's ventricle and a part in the introduced state in the patient's body where at least a part of their length is harmonica-like. The external diameter of the harmonica-like parts exceeds the external diameter of the neighboring one or more parts in a basic state where the harmonica-like distal part serves as the fixing device for the catheter to prevent it from slipping out.

According to the invention we summarized some especially advantageous performance under sub demand points.

We describe the invention with the attached drawing on which we show some exemplars of the catheter according to the invention. In the drawing

1. picture catheter according to the invention used by men

perspective view in a basic position of the catheter,

2. picture according to the 1. picture - side view of the catheter,

3. picture the 2. picture IH-III line section,

4. picture it shows the catheter according to the 1. picture after being introduced, perspective

5. picture side view of the picture 4,

6. picture VI-VI line section of 5. picture,

In the picture 7. a catheter used by women, perspective view in a basic position

8. picture side view of the catheter according to the picture 7

9. picture IX-IX line section of the picture 8,

10. picture the catheter in the introduced position according to the picture 7, perspective

11. picture side view of the catheter according to the picture 10

12. picture XII-XII line section of the picture 11

13. picture the introduced leading string into the catheter at rest

14. picture the introducing part at the end of the leading line

15. picture in the catheter according to the invention led in leading line before it enters the catheter

16. picture the introducing part led all the way to the distal end of the catheter

17. picture the catheter stretched out with the introducing part

18. picture the straightened out catheter after stretching

19. picture the size difference between the catheter according to the picture 18 and a catheter in iV; basic position

20. picture a possible performance of the interlock as membrane valve at the proximal end of the catheter

21. picture manual function of the membrane valve according to the picture 20

22. picture the membrane valve at rest according to the picture 20, front view

23. picture during function of the membrane valve according to the picture 22, in an open position

Now we are describing the pictures detailed, but we have to note that the catheter in the drawings according to the invention is only a sample. We illustrate its performance with its advantageous characteristics. The recommended catheter is a short or partial length catheter.

In the 1. picture, we have shown an advantageous performance for men according to the invention. In the shown case, 1 part of the catheter has been formed harmonica-like and it is introduced into the bladder of the patient, and it has a distal Ia part and a to it connecting central Ib part, and a external, proximal Ic part that is followed by a further central Id part and then an external Ie part.

As it is shown in the picture, the diameter of Ia, Ic Ie parts at rest of the catheter exceeds the diameter of Ib and Id parts significantly at 40-60%.

In the 2. picture, it can be seen that the distal Ia part of the catheter, the inner part of the catheter is fully closed, it is tapered that makes the introduction of the catheter easier.

The shown performance is of course a sample, the end of the catheter can more taper, round or even smooth surface, although this performance is not necessary.

On the Ia part there are more 2 openings. In the shown performance there are five 2 openings horizontally and around the periphery there are six 2 openings that ensure that the collected urine in the bladder gets into the inside of the catheter, into the 3 canals. It can be observed that the length of the Ib and Id parts in the shown performance is approximately twice the size of the length of the Ia, Ic, Ie parts, and the full length of the catheter at rest is about 65mm, and its biggest diameter at rest can almost reach 10 mm.

In the section of the 3rd picture, the material thickness of the Ib, Id parts of the catheter is chosen that it could ensure a relative big inner 3 canals to lead away the urine and to introduce the catheter. The material thickness of the catheter in the Ia, Ic, Ie parts is slightly smaller that in the Ib, Id parts, so that it could help perform the harmonica-like form of the Ia, Ic, Ie parts and function it for a professional.

In the shown sample, it can be observed that Ia, Ic, Ie parts contain five-five 4 rips and 5 valleys between the 4 rips where the diameter of the Ib, Id parts is approximately similar to the diameter of the 5 valleys. When we pull the catheter vertically, the harmonica-like Ia, Ic, Ie parts stretched out, and the diameter of their 4 rips will decrease about to the length of the diameter of Ib, Id parts.

In the shown performance, Ib, Id parts are built harmonica-like as well, only with the difference that the diametrical difference between the 6 rips and 7 valleys is much smaller which results radial measure stability besides the fact that the length of Ib, Id parts could stretch out for pulling the catheter, while their diameter could significantly reduce.

Although in the shown performance, Ia, Ic, Ie parts contain five-five 4 rips, it is obvious for a professional that the all-time number, size of the ribs, the size of the 5 valleys between the 4 ribs could defer in number and size from the shown sample. To reach the goal it is also appropriate if you form not 4 ribs cyclic, but if we form Ia, Ic, Ie parts and/ or Ib, Id parts with a thread where the rise of the thread serves as the distance between two neighboring 4 ribs.

Another solution is if Ia-Ie parts are formed not according to the shown haπnonica-like performance, but with a laryngeal pipe, we can ensure the necessary flexibility and elasticity by choosing the proper material for the catheter. In the pictures 4-6 we have demonstrated the catheter in the pictures 1-3, but not in a basic position, but in the introduced position. When we put pressure on the catheter horizontally, and the catheter stretches out and the diameter of Ia, Ic, Ie parts reduces significantly to the same or similar diameter of the Ib₅ Id parts. Just for information, in case of the shown sample we can reach by choosing the proper material for the catheter that the diameter of Ia, Ic, Ie parts can be similar to the diameter of Ib, Id parts at rest, while the diameter of Ib, Id parts gets smaller, reduces at about 10%. The length of the catheter grows three times of its size.

In the 7. picture, according to the invention, we have demonstrated the possible performance of the catheter perspectives for women. In this performance, the catheter has Ia distal part, Ib central part and Id proximal part to which 8 join sleeves connect, and 9 bent emptying pipe connect to the 8 join sleeves.

In the 8 join sleeves, 10 interlock are built according to the picture.

In the picture 8, the side view of the catheter in the picture 7 can be seen with the known 2 openings, 4,6 rips and 5,7 valleys. The shown catheter at rest is about 4 cm long, and the diameter of the parts is the same as the sizes of the described catheter in the pictures 1-3.

In the section of the picture 9 it can be seen that the 9 emptying pipes are bent in the shown sample which makes the treatment of the catheter easier. The performance of the 9 emptying pipes can be different, and the emptying of the urine can happen in a different way as well. In the pictures 10-12 we have demonstrated the catheter in the pictures 7-9 in the introduced position, so when the diameter of the Ia-Ic parts reduces approximately to the diameter of the Ib part. In such a state, the catheter stretches out twice the size of the length at rest.

The 8 join sleeves, 9 emptying pipes, and 10 interlock can be formed for demand, because they are outside of the patient's body. The use of the catheter does not influence its function.

In the picture 13 we demonstrate the first step of the use of the catheter according to the invention. In the picture, it can be seen that there are 11 leading lines introduced into the catheter which goes through the 3 canals of the catheter, all the way to the distal Ia part of the catheter. Although the end of the 11 leading lines can be seen at the distal end of the catheter in the picture, it is only for illustration of the procedure. According to the invention, the 11 leading lines cannot be seen of course during use of the catheter at the closed distal end of the catheter. It can be observed that the diameter of the Ia, Ic, Ie parts of the catheter at rest is significantly bigger than the diameter of the Ib, Id parts.

After introducing the 11 leading lines, we introduce 12 flexible, pipe-like, horizontally stiff introducing parts into the inside of the catheter, as it is seen in the picture 14. We stitch the 12 introducing parts onto the 11 leading lines which leads the 12 introducing parts through the 3 canals of the catheter, all the way to the distal end of the catheter - that which an intermediate station can be seen in the picture 15; the end and result of the procedure can be seen in the picture 16.

In order to stretch out the catheter and to reduce its diameter organically, we put pressure with the 12 introducing parts to the distal end of the catheter, so that the proximal end of the catheter does not move. It is illustrated in the picture 17 so that we hold the proximal end of the catheter. In the praxis, 14 holding lines are used for this purpose that can be seen in the picture 13 and that is fixed to the Ie proximal end of the catheter. In the picture 18 it can be seen that the catheter straightens on pressure, and in the picture 19 it can be seen that the catheter stretched out with the 12 introducing parts is indeed longer that it is at rest. In the picture, the reduction of the diameter of Ib, Id is hard to^' see, but the reduction of the diameter of Ia, Ic, Ie parts can be seen.

In the picture 20 according to the invention, one part of the proximal Ie part of the catheter can be seen that shows a sample for a solution of the interlock according to the invention. There is an interlock with 13 membrane valves at the end of the proximal Ie part of the catheter. The 13 membrane valves - for a professional known way - have 2 at rest riding in a way of medium dense, so it contains a 13a, 13b membrane plates that stops the medium transit that are located perpendicular to the medium flowing. When we deform the 13 membrane valves according to the picture 21, the fixed 13 a, 13b membrane plates fixed to the periphery separate from each other because of the deformation and set the medium line free, and the medium, e.g. in case of the catheter the urine gets emptied through the 13 membrane valves. In the pictures 22 and 23 we illustrate the rest position of the 13 membrane valves and the opening position because of the effect of the deformation in the front view of the 13 membrane valves.

The disadvantage of the used mechanical interlock is in its simplicity.

In case of the catheter according to the invention, the three harmonica structure enables the flexible change in sizes that is capable to adapt to any local size at any given moment. So we will not need to make any measurements not only in the beginning, but also later on either.

The catheter according to the invention could be used with some changes in form, by prostate of different sizes, be women, or by any body parts.

The known catheters of better quality dealt with women and men separately. Mostly they tried to solve the problems of men (stasis of urine), and offered solutions, and only some solutions aimed the women, actually the incontinence of urine. The suggested catheter is suitable for both sexes with some changes in form.

The catheter according to the invention can be applied universally: it could e.g. a catheter for men or for women, diagnostically catheter, and it is also suitable to treat problems referring to emptying the bladder. This catheter is simple, easy to produce of materials that are used at this field such as polyethylene, polyurethane, silicon rubber of hygienically quality, etc.

It is obvious from the samples that the suggested catheter can be produced cheap and fixed reliably after introduction. It is able to follow changes in form and size that are related with the diversity of the patients' original sizes and lives.

Claims

1. Catheter

- long, flexible, elastic, with a pipe-like part (I₅ 11),

- formed in the body (1, 11), with a canal leading medium (3),

-with at least one opening (2) that connects the canal (3)with the patient's ventricle,

- on the body (I₅ 11), with the body itself (I₅ 11), associated with the body (1, 11), with a fixing device that prevents the introduced catheter from moving unwillingly,

- where the distal part (Ia) that leads in the ventricle of the body (1, 11) the patient, in introduced position the part (Ib) in the patient's body and an additional external part (Ie) -at least on one part of the length of a distal part (Ia) and a proximal part (Ic) it is formed harmonica-like,

- the external diameter of the harmonica-like parts (Ia₅ Ic) in the introduced and basic position of the catheter exceeds the external diameter of the neighboring one or more parts (Ib₅ Id),

- where the harmonica-like formed distal end (Ia) is the fixing device that prevents the catheter from slipping out, and the harmonica-like formed proximal part (Ic) is the fixing device that prevents the catheter from slipping in.

2. The catheter according to the 1^st demand point: at least on one part of the length of the intermediate part (Ib) between the distal part (Ia) and the proximal part (Ic) and/ or at least on one part of the length of the intermediate part (Id) between the proximal part (Ic) and the external part (Id) it is formed harmonica-like.

3. The catheter according to the 1^st or 2^nd demand point: the harmonica-like performance is ensured on some parts (Ia-Ie) by the ribs (4,6) next to each other and the valleys (5,7).

4. The catheter according to the 1^st or 2^nd demand point can be described whether the harmonica-like performance is ensured by all parts (Ia-Ie) or the thread performance of only some parts (Ia-Ie).

5. The catheter according to the demand point 1-4 is described that the diameter of the harmonica-like, distal, proximal and, if there is, external parts (Ia, Ic₅ Ie) in the introduced position of the catheter is about one a half bigger than the diameter of one or more intermediate parts (Ib, Id).

6. Catheter

- long, flexible, elastic, with a pipe-like part (1, 11)₅

- formed in the body (1, 11), with a canal leading medium,

-with at least one opening that connects the canal with the patient's ventricle,

- on the body (1, 11), with the body itself (1, 11), associated with the body (1, 11), with a fixing device that prevents the introduced catheter from moving unwillingly,

- where the distal part (Ia) that leads in the ventricle of the body (I₅ 11) the patient, in introduced position the part (Ib) in the patient's body and an additional external part (Ie) -at least on one part of the length of a distal part (Ia) and a proximal part (Ic) it is formed harmonica-like,

- the external diameter of the harmonica-like parts (Ia, Ic) in the introduced and basic position of the catheter exceeds the external diameter of the neighboring one or more parts (Ib₅ Id), -where the harmonica-like formed distal end (Ia) is the fixing device that prevents the catheter from slipping out, and the harmonica-like formed proximal part (Ic) is the fixing device that prevents the catheter from slipping in.

7. The catheter according to the 6^th demand point: at least on one part of the length of the intermediate part (Ib) between the distal part (Ia) and the proximal part (Ic) and/ or at least on one part of the length of the intermediate part (Id) between the proximal part (Ic) and the external part (Id) it is formed harmonica-like.

8. The catheter according to the 6^th or 7^th demand point: the harmonica-like performance is ensured on some parts (Ia-Ie) by the ribs (4,6) next to each other and the valleys (5,7).

9. The catheter according to the 6^th or 7^th demand point can be described whether the harmonica-like performance is ensured by all parts (Ia-Ie) or the thread performance of only some parts (Ia-Ie).

10. The catheter according to the. demand point 6-9 is described that the diameter of the harmonica-like, distal, proximal and, if there is, external parts (Ia, Ic, Ie) in the introduced position of the catheter is about one a half bigger than the diameter of one or more intermediate parts (Ib, Id).

11. The catheter according to the 6^th - 10^th demand points is described that the membrane valves (13) in a basic position contain membrane plates (13a, 13b) that goes each other partially and ensure a medium dense lock.

12. The catheter is a flexible and elastic pipe-like part (1, 11) whose inner canal is in the bladder of the patient and is in connection with the body through one or more openings, and during the use of the catheter it is at the end of the patient's bladder. With the fixing luu'inbnica-like distal part (Ia) and with the harmonica-like proximal part that prevents the catheter from slipping into the bladder where the diameter of both the distal part (Ia) and the proximal part (Ic) is bigger at the end of the bladder, but its diameter stretched out horizontally is smaller than the diameter of the urethra. The size of the distal and proximal parts (Ia, Ic) connecting harmonica-like intermediate part (Ib) reduces to an approximate size, and it makes possible to introduce the catheter through the bladder, while the distal part (Ia) goes into the inside of the bladder, and the parts (Ia, Ib, Ic) get back their original size without the horizontal pressure, and the intermediate part (Ib) agrees with all-time change in size and form because of its flexibility.

13. The catheter is a flexible and elastic pipe-like part (1, 11) whose inner canal is in the bladder of the patient and is in connection with the body through one or more openings, and during the use of the catheter it is at the end of the patient's bladder. With the fixing harmonica-like distal part (Ia) and with the hannonica-like proximal part that prevents the catheter from slipping into the bladder where the diameter of both the distal part (Ia) and the proximal part (Ic) is bigger at the end of the bladder, but its diameter stretched out horizontally is smaller than the diameter of the urethra. The size of the distal and proximal parts (Ia, Ic) connecting harmonica-like intermediate part (Ib) reduces to an approximate size, and it makes possible to introduce the catheter through the bladder, while the distal part (Ia) goes into the inside of the bladder, and the parts (Ia, Ib, Ic) get back their original size wi+hout the horizontal pressure, and the intermediate part (Ib) agrees with all-time change in size and form because of its flexibility. In the distal part (Ia) with a closing devise that is made of flexible membrane valve (13) opening with manual deformation at the external end of the harmonica-like proximal part (Ia).

14. The catheter according to the 1^st- 13^th demand points is a catheter with partial length.