WO2011004212A1 - Cathéter - Google Patents

Cathéter Download PDF

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Publication number
WO2011004212A1
WO2011004212A1 PCT/IB2009/006706 IB2009006706W WO2011004212A1 WO 2011004212 A1 WO2011004212 A1 WO 2011004212A1 IB 2009006706 W IB2009006706 W IB 2009006706W WO 2011004212 A1 WO2011004212 A1 WO 2011004212A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
harmonica
parts
bladder
distal
Prior art date
Application number
PCT/IB2009/006706
Other languages
English (en)
Inventor
Arpad DR.DANI
Peter PROF.DR.SZENDRO
Original Assignee
Dani Arpad Dr
Szendro Peter Dr
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dani Arpad Dr, Szendro Peter Dr filed Critical Dani Arpad Dr
Priority to PCT/IB2009/006706 priority Critical patent/WO2011004212A1/fr
Publication of WO2011004212A1 publication Critical patent/WO2011004212A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features

Definitions

  • 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.
  • the above mentioned solution has 2 problems: one is the length of the catheter, and the other one is the continuous flow.
  • the conducive length of the catheter is actually a ca. 4-6 cm part that the most common obstacle, the prostate bridges.
  • the solution suggested by us can be used as well.
  • 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.
  • 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.
  • 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.
  • 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:
  • 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 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.
  • 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.
  • one or more blow able balloons or other know positioning-fixing elements serve to keep the catheter at one place.
  • 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.
  • T ⁇ C 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the distance between the positioning balloons dependently on the size of the prostate that equals and changes with the length of the prostate urethra.
  • 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.
  • 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 ⁇ W ⁇ 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.
  • 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.
  • 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.
  • the diameter of Ia, Ic Ie parts at rest of the catheter exceeds the diameter of Ib and Id parts significantly at 40-60%.
  • the end of the catheter can more taper, round or even smooth surface, although this performance is not necessary.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the proximal Ie part of the catheter shows a sample for a solution of the interlock according to the invention.
  • 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.
  • 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.
  • 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 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 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.

Abstract

L'invention porte sur un cathéter qui est une partie (1,11) de type tuyau flexible et élastique dont le canal interne est dans la vessie du patient et est relié avec le corps par une ou plusieurs ouvertures, et pendant l'utilisation du cathéter, il se trouve à l'extrémité de la vessie du patient. Le cathéter a une partie distale de fixation de type harmonica (1a) et une partie proximale de type harmonica qui empêche le cathéter de glisser dans la vessie où le diamètre à la fois de la partie distale (1a) et de la partie proximale (1c) est plus grand au niveau de l'extrémité de la vessie, mais ce diamètre étiré horizontalement est inférieur au diamètre de l'urètre. La dimension des parties distale et proximale (1a, 1c) reliant une partie intermédiaire de type harmonica (1b) est réduit à une dimension approximative, et cela rend possible d'introduire le cathéter à travers la vessie, tandis que la partie distale (1a) vient dans l'intérieur de la vessie, et les parties (1a, 1b, 1c) reprennent leur dimension initiale sans la pression horizontale, et la partie intermédiaire (1b)s'accorde avec le changement tout le temps de dimension et de forme en raison de sa flexibilité. La partie distale (1a) comporte un dispositif de fermeture qui est constitué d'une soupape à membrane flexible (13) s'ouvrant avec une déformation manuelle au niveau de l'extrémité externe de la partie proximale de type harmonica (1a).
PCT/IB2009/006706 2009-07-09 2009-07-17 Cathéter WO2011004212A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2009/006706 WO2011004212A1 (fr) 2009-07-09 2009-07-17 Cathéter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RUNONE 2001-10-15
PCT/IB2009/006706 WO2011004212A1 (fr) 2009-07-09 2009-07-17 Cathéter

Publications (1)

Publication Number Publication Date
WO2011004212A1 true WO2011004212A1 (fr) 2011-01-13

Family

ID=43428836

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/006706 WO2011004212A1 (fr) 2009-07-09 2009-07-17 Cathéter

Country Status (1)

Country Link
WO (1) WO2011004212A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4973301A (en) * 1989-07-11 1990-11-27 Israel Nissenkorn Catheter and method of using same
US5518498A (en) * 1992-10-09 1996-05-21 Angiomed Ag Stent set
RU2113245C1 (ru) * 1993-01-18 1998-06-20 Магомед-Салах Алхазурович Газимиев Устройство для длительного пассажа мочи
US20050101941A1 (en) * 2003-11-06 2005-05-12 Hakky Said I. Indwelling urinary catheter

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4973301A (en) * 1989-07-11 1990-11-27 Israel Nissenkorn Catheter and method of using same
US5518498A (en) * 1992-10-09 1996-05-21 Angiomed Ag Stent set
RU2113245C1 (ru) * 1993-01-18 1998-06-20 Магомед-Салах Алхазурович Газимиев Устройство для длительного пассажа мочи
US20050101941A1 (en) * 2003-11-06 2005-05-12 Hakky Said I. Indwelling urinary catheter

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