WO2010020971A2

WO2010020971A2 - Catheter

Info

Publication number: WO2010020971A2
Application number: PCT/IB2009/053895
Authority: WO
Inventors: Árpád DANI
Original assignee: Dani Arpad
Priority date: 2008-07-07
Filing date: 2009-09-07
Publication date: 2010-02-25
Also published as: HUP0800419A2; WO2010020971A3; HU0800419D0

Abstract

Catheter comprising a flexible and elastic, pipe-like body part (1, 11), the internal canal of which is connected to the bladder of the patient through one or several body orifices and, furthermore, with a bellow-shaped distal section (1a) located at the outlet of the patient's bladder when the catheter is in use, which fixes the catheter position, and an opposite, bellow-shaped proximal section (1c) which prevents the slipping in of the catheter; where in default case the diameter of both distal section (1a) and proximal section (1c) exceeds that of the outlet of the bladder but, stretched out horizontally, it is smaller than the diameter of the urethra and reduces to approximately the size of the below-shaped intermediate section (1b) connecting distal and proximal sections (1a, 1c), thereby allowing to introduce the catheter through the urethra until distal section (Ia) is located inside the bladder and, following the termination of the axial pulling pressure, sections (1a, 1b, 1c) revert to their original size, and thanks to its bellow shape, intermediate section (1b) flexibly adjusts to the size and shape changes ever and, furthermore, with a closing device designed in distal section (1a), made up by flexible membrane valve (13) openable by manual deformation, located at the external end of proximal section (1c).

Description

Title of Invention: CATHETER Technical Field Technical Field

[1] The invention relates to 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 section that goes into the ventricle of the patient and a section that is in the body of the patient.

Background Art Background Art

[2] 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.

[3] The above mentioned solution has two problems: one is the length of the catheter, and the other one is the continuous flow.

[4] 1. The length of the catheter: The conducive length of the catheter is actually a ca.

4-6 cm part that bridges the most common obstacle, the prostate. 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.

[5] The catheter of 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 dependently 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.

[6] 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.

[7] 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.

[8] 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 Figure: 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.

[9] 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 time, and the most important thing is that they take over the role of the sphincters, and they enable for people to urine willingly.

[10] 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'.

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

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

[13] 1. - Catheters have to ensure the controllable urine emptying.

[14] 1. - Catheters - after being positioned - have to stay at one place.

[15] Known catheters fulfill the above mentioned requirements in the following way:

[16] 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.

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

[18] 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.

[19] 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.

[20] Appropriate positioning is very important, 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.

[21] 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.

[22] 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.

[23] The 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.

[24] 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.

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

[26] US 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 bigger 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 are described in EP 0368473 A2, US 7,264,609B2 and US 2006/0119553, and a similar catheter can be found in the US 4,973,301 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.

[27] EP 0368473 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.

[28] A similar solution is described in the US 2006/0229553 Al 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.

[29] Another similar solution is described in WO 2004/045696 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.

[30] To this solution a similar solution is suggested in the GB 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 and prevents the catheter from slipping out.

[31] US 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 the 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.

[32] WO 91/100074 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. Beside 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.

[33] WO 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.

[34] US 4,710,169 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 in the 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.

[35] GB 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.

[36] US 6,004,290 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.

[37] US 2004/0049170 Al 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. Disclosure of Invention Technical Problem

[38] 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 own 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.

Technical Solution

[39] 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, distal end is formed bellows type. The characteristic of the bellows type 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 bellows type 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.

[40] 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 bellows type. The external diameter of the bellows type parts exceeds the external diameter of the neighboring one or more parts in a basic state where the bellows type distal part serves as the fixing device for the catheter to prevent it from slipping out.

[41] Preferred embodiments of the catheter according to the invention are listed in the dependent claims. Advantageous Effects

[42]

Description of Drawings

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

[44] Fig. 1 shows a perspective view of a catheter according to the invention used by men in a basic position of the catheter,

[45] Fig. 2 shows a side view of the catheter according to Fig. 1,

[46] Fig. 3 shows a section of the catheter according to Fig. 1 along line III-III of Fig. 2,

[47] Fig 4 shows a perspective view of the catheter according to Fig. 1 after being introduced,

[48] Fig. 5 shows a side view of the catheter according to Fig. 4,

[49] Fig. 6 is a sectional view along line VI-VI of Fig. 5,

[50] Fig. 7 shows a perspective view of a catheter according to the invention used by women in a basic position of the catheter, [51] Fig. 8 shows a side view of the catheter according to Fig. 7,

[52] Fig. 9 shows a section of the catheter according to Fig. 7along line IX-IX of Fig. 8,

[53] Fig 10 shows a perspective view of the catheter according to Fig. 7 after being introduced,

[54] Fig. 11 shows a side view of the catheter according to Fig. 10,

[55] Fig. 12 is a sectional view along line XII-XII of Fig. 11,

[56] Fig. 13 shows the introduced guidance string into the catheter at rest,

[57] Fig. 14 shows the introducing element at the end of the guidance string,

[58] Fig. 15 shows the introducing element led in guidance string before it enters the catheter according to the invention,

[59] Fig. 16 shows the introducing element led all the way to the distal end of the catheter,

[60] Fig. 17 shows the catheter stretched out with the introducing element,

[61] Fig. 18 shows the straightened out catheter after stretching,

[62] Fig. 19 shows the size difference between the catheter according to Fig. 18 and a catheter in its basic position, [63] Fig. 20 shows a possible embodiment of the interlock as membrane valve at the proximal end of the catheter,

[64] Fig. 21 shows manual operation of the membrane valve according to Fig. 20,

[65] Fig. 22 shows the membrane valve at rest according to Fig. 20, in a front view, and

[66] Fig. 23 shows the membrane valve according to Fig. 22 during operation, in an open position. Best Mode

[67] Now we are describing the Figures detailed, but we have to note that the catheter in the drawings according to the invention is only a sample. We illustrate its embodiment with its advantageous characteristics.

[68] The recommended catheter is a short or partial length catheter.

[69] In Fig. 1, we have shown an advantageous embodiment for men according to the invention. In the shown case, part 1 of the catheter has been formed bellows type and it is introduced into the bladder of the patient, and it has a distal section Ia and a to it connecting central section Ib, and a external, proximal section Ic that is followed by a further central section Id and then an external section Ie. As it is shown in the Figure, the diameter of sections Ia, Ic Ie at rest of the catheter exceeds the diameter of sections Ib and Id significantly, at 40-60%.

[70] In Fig. 2 it can be seen that the distal section Ia 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 embodiment is of course a sample, the end of the catheter can more taper, round or even smooth surface, although this embodiment is not necessary. On the section Ia there are more openings 2. In the shown embodiment there are five openings 2 horizontally and around the periphery there are six openings 2 that ensure that the collected urine in the bladder gets into the inside of the catheter, into the canals 3. It can be observed that the length of the sections Ib and Id in the shown embodiment is approximately twice the size of the length of the sections Ia, Ic, Ie, and the full length of the catheter at rest is about 65 mm, and its biggest diameter at rest can almost reach 10 mm.

[71] In the section of the Fig. 3, the material thickness of the sections Ib, Id of the catheter is chosen that it could ensure a relative big inner canals 3 to lead away the urine and to introduce the catheter. The material thickness of the catheter in the sections Ia, Ic, Ie is slightly smaller that in the sections Ib, Id, so that it could help perform the bellows type form of the sections Ia, Ic, Ie and function it for a professional. In the shown sample, it can be observed that sections Ia, Ic, Ie contain five- five ribs 4 and valleys 5 between the ribs 4 where the diameter of the sections Ib, Id is approximately similar to the diameter of the valleys 5. When we pull the catheter vertically, the bellows type sections Ia, Ic, Ie stretched out, and the diameter of their ribs 4 will decrease about to the length of the diameter of sections Ib, Id.

[72] In the embodiment shown, sections Ib, Id are built bellows type as well, only with the difference that the diametrical difference between the ribs 6 and valleys 7 is much smaller which results radial measure stability besides the fact that the length of sections Ib, Id could stretch out for pulling the catheter, while their diameter could significantly reduce.

[73] Although in the shown embodiment, sections Ia, Ic, Ie contain five-five ribs 4, it is obvious for a professional that the all-time number, size of the ribs, the size of the valleys 5 between the ribs 4 could defer in number and size from the shown sample. To reach the goal it is also appropriate if you form not ribs 4 cyclic, but if we form sections Ia, Ic, Ie and/ or sections Ib, Id with a thread where the rise of the thread serves as the distance between two neighboring ribs 4. Another solution is if sections Ia-Ie are formed not according to the shown bellows type embodiment, but with a laryngeal pipe, we can ensure the necessary flexibility and elasticity by choosing the proper material for the catheter.

[74] In Figs 4 to 6 we have demonstrated the catheter in the Figures 1 to 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 sections Ia, Ic, Ie reduces significantly to the same or similar diameter of the sections Ib, Id. Just for information, in case of the shown sample we can reach by choosing the proper material for the catheter that the diameter of sections Ia, Ic, Ie can be similar to the diameter of sections Ib, Id at rest, while the diameter of sections Ib, Id gets smaller, reduces at about 10%. The length of the catheter grows three times of its size. [75] In Fig. 7, according to the invention, we have demonstrated the possible embodiment of the catheter perspectives for women. In this embodiment, the catheter has distal sectionla, central sectionlb and proximal section Id to which join sleeves 8 connect, and bent emptying pipe 9 connect to the join sleeves 8. In the join sleeves 8 interlock 10 are built according to the Figure.

[76] In Fig. 8, the side view of the catheter in the Fig. 7 can be seen with the known openings 2, ribs 4, 6 and valleys 5, 7. 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 Figures 1 to 3.

[77] In the section of Fig. 9 it can be seen that the emptying pipes 9 are bent in the shown sample which makes the treatment of the catheter easier. The embodiment of the emptying pipes 9 can be different, and the emptying of the urine can happen in a different way as well.

[78] In Figs 10 to 12 we have demonstrated the catheter in the Figures 7 to 9 in the introduced position, so when the diameter of the sections Ia-Ic reduces approximately to the diameter of the section Ib. In such a state, the catheter stretches out twice the size of the length at rest.

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

[80] In Fig. 13 we demonstrate the first step of the use of the catheter according to the invention. In the Figure, it can be seen that there is a guidance string 11 introduced into the catheter which goes through the canals 3 of the catheter, all the way to the distal section Ia of the catheter. Although the end of the guidance string 11 can be seen at the distal end of the catheter in the Figure, it is only for illustration of the procedure. According to the invention, the guidance string 11 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 sections Ia, Ic, Ie of the catheter at rest is significantly bigger than the diameter of the sections Ib, Id.

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

[82] In order to stretch out the catheter and to reduce its diameter organically, we put pressure with the introducing elements 12 to the distal end of the catheter, so that the proximal end of the catheter does not move. It is illustrated in the Figure 17 so that we hold the proximal end of the catheter. In the praxis, holding string 14 is used for this purpose that can be seen in the Figure 13 and that is fixed to the Ie proximal end of the catheter.

[83] In Fig. 18 it can be seen that the catheter straightens on pressure, and in Fig. 19 it can be seen that the catheter stretched out with the introducing elements 12 is indeed longer that it is at rest. In the Figure, the reduction of the diameter of sections Ib, Id is hard to see, but the reduction of the diameter of sections Ia, Ic, Ie can be recognized.

[84] In Fig. 20 one part of the proximal section Ie of the catheter according to the invention can be seen that shows a sample for a solution of the interlock according to the invention. There is an interlock with membrane valves 13 at the end of the proximal section Ie of the catheter. The membrane valves 13 - for a person skilled in the art known way - have two at rest riding in a way of medium dense, so it contains a membrane plates 13a, 13b that stops the medium transit that are located perpendicular to the medium flowing. When we deform the membrane valves 13 according to Fig. 21, the fixed membrane plates 13a, 13b 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 membrane valves 13. In the Figures 22 and 23 we illustrate the rest position of the membrane valves 13 and the opening position because of the effect of the deformation in the front view of the membrane valves 13. The disadvantage of the used mechanical interlock is in its simplicity.

[85] In case of the catheter according to the invention, the three bellows type 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. Mode for Invention

[86] 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. Industrial Applicability

[87] 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. [88] 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. Sequence List Text

[89]

Claims

[Claim 1] 1. Catheter, comprising

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

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

- at least one opening (2) for connecting said medium- transmission canal (3) to a patient's ventricle; and

- at least one fixing means formed on the body (1, 11) or by the body itself (1, 11), or associated with the body (1, 11), ensuring the prevention of any unintentional movement of the introduced catheter,

- whereas the body (1, 11) comprises a first distal section (Ia) which extends into the ventricle of the patient; a second section (Ib) located in the patient's body in introduced position; and occasionally a further external section (Ie), characterised in that

- the distal section (Ia) and the proximal section (Ic), respectively, is bellow-shaped in at least part of its length,

- the external diameter of the bellow-shaped parts (Ia, Ic) exceeds the external diameter of the neighbouring one or several sections (Ib, Id) in the basic and in the introduced position of the catheter,

- where means for preventing the catheter from slipping out are formed by the bellow-shaped distal section (Ia), and means for preventing the catheter from slipping in are formed by the bellow- shaped proximal section (Ic).

2. Catheter according to Claim 1, characterised in that the intermediate section (Ib) between the distal section (Ia) and the proximal section (Ic) and/or the intermediate section (Id) between the proximal section (Ic) and the external section (Id) is bellow- shaped along at least part of its length.

3. Catheter according to Claim 1 or 2, characterised in that the bellow design is formed by juxtaposed ribs (4, 6) with grooves (5, 7) between them on the sections (Ia-Ie) concerned.

4. Catheter according to Claim 1 or 2, characterised in that the bellow structure is provided for by the threaded design of all or some sections (Ia-Ie).

5. Catheter according to any of Claims 1 to 4, characterised in that in introduced position, the diameter of the below-shaped distal, proximal and external, if any, sections (Ia, Ic, Ie) of the catheter corresponds to around 1,5 times the diameter of the one or several intermediate sections (Ib, Id).

6. Catheter, which comprising

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

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

- closing means for closing the medium-transmission canal in an openable way,

- where means for preventing the catheter from slipping out are formed by the bellow-shaped distal section (Ia), and means for preventing the catheter from slipping in are formed by the bellow- shaped proximal section (Ic), and

- where the closing means are formed by a membrane valve (13) openable by manual deformation, at the external end of bellow-shaped proximal section (Ic) or of external section (Ie), if any.

7. Catheter according to Claim 6, characterised in that the intermediate section (Ib) between the distal section (Ia) and the proximal section (Ic) and/or the intermediate section (Id) between the proximal section (Ic) and the external section (Id) has a bellow-like shape along at least part of its length.

8. Catheter according to Claims 6 or 7, characterised in that the bellow design is formed by juxtaposed ribs (4, 6) with grooves (5, 7) between them on the sections (Ia-Ie).

9. Catheter according to Claims 6 or 7, characterised in that the bellow structure is provided for by the threaded design of all or some sections (Ia-Ie).

10. Catheter according to any of Claims 6 to 9, characterised in that in introduced position, the diameter of the bellow- shaped distal, proximal and external, if any, sections (Ia, Ic, Ie) of the catheter corresponds to around 1,5 times the diameter of the one or several intermediate sections (Ib, Id).

11. Catheter according to any of Claims 6 to 10, characterised in that the membrane valve (13) is constituted by membrane plates (13a, 13b) which are partly overlapping and therefore provide for sealed closure.

12. Catheter comprising a flexible and elastic, pipe-like body part (1, 11), the internal canal of which is connected to the bladder of the patient through one or several body orifices and, furthermore, with a bellow-shaped distal section (Ia) located at the outlet of the patient's bladder when the catheter is in use, which fixes the catheter position, and an opposite, bellow-shaped proximal section (Ic) which prevents the slipping in of the catheter; where in default case the diameter of both distal section (Ia) and proximal section (Ic) exceeds that of the outlet of the bladder but, stretched out horizontally, it is smaller than the diameter of the urethra and reduces to approximately the size of the below-shaped intermediate section (Ib) connecting distal and proximal sections (Ia, Ic), thereby allowing to introduce the catheter through the urethra until distal section (Ia) is located inside the bladder and, following the termination of the axial pulling pressure, sections (Ia, Ib, Ic) revert to their original size, and thanks to its bellow shape, intermediate section (Ib) flexibly adjusts to the size and shape changes ever.

13. Catheter comprising a flexible and elastic, pipe-like body part (1, 11), the internal canal of which is connected to the bladder of the patient through one or several body orifices and, furthermore, with a bellow-shaped distal section (Ia) located at the outlet of the patient's bladder when the catheter is in use, which fixes the catheter position, and an opposite, bellow-shaped proximal section (Ic) which prevents the slipping in of the catheter; where in default case the diameter of both distal section (Ia) and proximal section (Ic) exceeds that of the outlet of the bladder but, stretched out horizontally, it is smaller than the diameter of the urethra and reduces to approximately the size of the below-shaped intermediate section (Ib) connecting distal and proximal sections (Ia, Ic), thereby allowing to introduce the catheter through the urethra until distal section (Ia) is located inside the bladder and, following the termination of the axial pulling pressure, sections (Ia, Ib, Ic) revert to their original size, and thanks to its bellow shape, intermediate section (Ib) flexibly adjusts to the size and shape changes ever and, furthermore, with a closing device designed in distal section (Ia), made up by flexible membrane valve (13) openable by manual deformation, located at the external end of proximal section (Ic).

14. Catheter according to any of Claims 1 to 13, characterised in that it is formed as a catheter of partial length.