WO2008010001A1

WO2008010001A1 - Equipment to void body liquid

Info

Publication number: WO2008010001A1
Application number: PCT/HU2007/000062
Authority: WO
Inventors: Arpad Dani
Original assignee: Arpad Dani
Priority date: 2006-07-19
Filing date: 2007-07-09
Publication date: 2008-01-24
Also published as: HU0600601D0; HUP0600601A2

Abstract

The invention is a device for the draining of body fluid, especially a urinary catheter, which is like a tube, and includes an internal section (10), with at least one lateral hole (11) for the body fluid, a central section (12) developed with a continuous wall, as well as an external section (14) equipped with an outlet hole (17). The invention is of the characteristic by that the internal section (10), central section (12) and external section (14) have a pigtail shape.

Description

Equipment to void body liquid

The invention refers to an equipment to void body liquid, especially to a bladder catheter, which is like a tube and contains inner section to the body liquid with a sidegap, a middle section with a continuous wall, and an outer section with an exitgap.

The bladder catheters, applied now in urology, like the so called Foley catheters have the following characteristics.

- they are settled at full length of the urethra, one end in the bladder, other end out of the urethra-slot

- to locate them an inflatable balloon near to the inner ends is needed, which prevent the catheter to slip out or the outer end of the catheter must be mechanicly fastened, like some of the so called Rusch types.

- The thickening of the outer end prevents the catheter to slip in

- There is no difference among the female and male catheters, although the anatomical difference would need it

During onetime insert, but in case of the long time retained catheters, the so called contant catheters many side effects can appear. For example the mechanic injuries, the local and ascending infections and the secondary urethra stricture. The further disadvantages of the well-known catheters are the uncomfortable, sometimes painful wearing and the impossible sexual life.

In case of other ventricle, for example removing abdominal liquid or liquid from the thoraric cavity, the located drains,suitable for more usages, are not really used and the already used were usually put in only by minor operations.

According to the state of technique many catheter are known to void body liquid. Such equipments are reviewed for example in US 4 931 037, US 5 704 353, US

5 916 195, US 6 004 290, US 6 119 967, US 2005/0059929 Al, US 2005/0080399 Al, US 2005/0165383 Al and EP 0 733 379 Bl patent documents.

The catheters, reviewed in the US 4 931 037 and EP 0 733 379 Bl patent documents, have spiralend- or ,,pigtail" end- (on the specialization called) stabilization. In the US

6 199 697, US 2005/0059929 A' and US 2005/0080399 Al patent documents such short catheters are reviewed, that do not protrude from the body of the patient.

The disadvantage of the well-known solutions, that different length catheters are needed, depended on the given application, or rather the measure of the organ of the patient, thus catheter-supply is needed so that the catheters can be applied in case of different conditions. None of the well-known solutions has so physical form, that make possible after application surroundings conditions dinamic length and cross-section adaptation. The further disadvantage of the well-known solutions, that because of the relative thickness of the catheters the danger of decubitus is high and it is difficult to put them in. Another problem, that the known solutions do not make the regulated void of the body liquid possible, and the application like a bladder catheter hinders the sexual life. By the creation of the invention we aimed, that we create a equipment to void the body liquid, which is free from the disadvantages of the solutions, depending on the state of technique. Our further aim was to create a equipment, which does not make necessary different length catheters to be held in stock, but can be used for any application by dinamic measure-adaptation. Our intention was to achieve the easy insert, to lessen the danger of decubitus and the simple production.

That's why the invention is a equipment to void body liquid, especially bladder catheter, which is like a tube and contains inner part to the body liquid with a sideslot, a middle part with a continuous wall, and an outer part with an exitslot. According to the invention the inner section and the middle section is figured to a pigtail.

The equipment, which can be applied like a catheter or a drain, has always the needed length, because it is taken shape to adjust dinamicly in ventricle.

The location of the equipment is provided by the double pigtail structure.

The inner pigtail is settled int he bladder or another ventricle and it hinders the catheter (drain) to slip out.

The middle pigtail is settled on the level of stricture. In case of urological catheters it is mostly the prostate section of the urethra, in case of another ventricle it is the part between the body surface and the ventricle, for example abdomen and chest cavity. This section firstly provides it to stay in place, and due to its structure it adapts flexibly to the long of the stricture.

Advantageously the outer section is formed to a pigtail, that makes the triple pigtail structure.

The outer pigtail is settled directly after the stricture, and expediently only the lock section of the equipment separates from the second pigtail. The function of the outer section is to hinder the catheter (drain) to slip in.

According to one form the outer section is shorter, than the middle section. The urological catheters in most cases are used for smoothing over urethra-strictures. A typical example is the prostate enlarging: the prostate and the part of the urethra (running in it) , the so called pars prostatica make only small part of the complete length of the urethra (about 20cm). This length in zero-setting 2,5-4cm, but in case of prostate enlarging it is rarely bigger than 5-7 cm.

From the length of the currently used catheters, the part outside of the bridging is unnecessary, and it only damages the urethra with the purpose to make the outer end of the catheter accessible, and its size hinders it to slip in. The export shape makes it possible to adjust the length of the urological catheters to the useful part of the bridging. The spiral diameter of the middle section's pigtail is smaller according to an advanced export shape, than the spiral diameter of the inner section's pigtail. This way the equipment adjusts easier to the natural or artificial duct which serves the lead of the body liquid.

The inner section's wall and the outer section's wall are advantageously endowed with sidegaps. The sequence of gaps of the expediently complete section-lengths facilitate the entrance and the secession of the body liquid.

One of the especially advanced export shape contains a closingdevice which makes the regular excretion of the body liquid possible.

The closingdevice is favourably located at the meeting point of the middle-section and the outer-section in order to ease the placing positioning, and the equipment in the territory of the closingdevice is formed with a bigger cross-section,in order to hinder its slip-in into the body. The closingdevice advantageously contains a closingunit which is prostrained with a spring, as well as a string fixed to the closingunit and led outside the body, while opening the closingdevice by pulling.

In the following we introduce the invention's exemplary advantageous export shapes

(with drawings), where figure # 1 is an equipment in the prepared placing phase/position figure # 2 is the sketchy sectional drawing of the 1. figure's closingdevice, figure # 3 is figure # 1 in the position without propstring, and figure # 4 is a sketchy picture of the equipment placed in the bladder.

The invention serves the supervised removal of liquid which issues in human, animal organisms' natural or pathological chambers.

The invention is specifically used for the lead of urine, as urological catheter, but it can be used for other purposes as a so called "drain", for example the removal of liquid collected in the abdomen, thoracic/chest cavity or other parts of the body.

The equipment on figure #1 and #3 contains three sections according to the invention, or to be precise ten inner sections, twelve middle sections and fourteen outer sections. According to the invention, at least the inner and middle ten, twelve sections are formed with pigtails. In the descriptions and demandpoints, we use the "pigtail" expression (applied on field) in the widest meaning as possible, and it involves all those shaping, which possesses at least with one spiral or wavelike shaped segment.

The inner ten sections are formed with 11 sidegaps expediently along its whole length, where the liquid can go across and enter the equipment. Of course the invention can not only be formed according to the figures, but all those solutions can come into question, which applies a sidegap to the bodyliquid.The inner ten sections may contain elastic optic or other measurerstring placed in its wall.

The inner ten sections are in possession of advantageously rounded, closed ends for the devoid of injury and easy placing.

Due to its elastic past, it hooks after the removal of the preminilary wire or propstring, simultaniously also thanks to its elasticity it irritates the chamber's wall only a little or rather accommodates itself to the inner circumstances. For example this way during the extension of the bladder, the degree of the curve can change due to the quantity increase of urine, or in the case of an abdominal drain, the elastic inner pigtail eludes the intestines which contingently may drift towards it. The invention's twelve sections are provided with constant wall, which means that there are no gaps or breakthrough on the sidewalls. These twelve sections serve the lead of the body liquid from the ventricle, or the bridging of the stricture.

The spiral-diameter of the middle 12 sections pigtail's shape is advantageously smaller, than the shape of the spiral-diameter in the inner 10 sections.

The middle twelve sections, due to its flexible past, accomodate to the diameter and length of the stricture. In most cases the forming of one sort of equipment is applicable, there is no need for production in other sizes. Its additional advance is that during the modification of bodyposition it not only changes its length and enframing place, but also changes its position relative to its stricture, so lowering the danger of decubitus.

According to the invention - advantageously also pigtail formed - outer 14 sections contain 17 exitgaps, where the bodyliquid can be led across. Expediently the outer 14 sections are provided with 15 sidegaps, where the urine exits, or other liquid in case of a drain. The outer 14 sections are expediently shorter than the middle 12 sections.

Due to the flexible past of the pigtail shaped outer 14 sections, after the removal of the leadingwire or the propstring it hooks, so helping the positioning of the equipment. Similarly to the middle pigtail, it is capable for non-stop adaptation, respectively lowers the danger of decubitus due to its mobility. This section's pigtail shape means additional safety against sideeffects in cases where the equipment slips into the body in extreme measure. According to the invention however the outer 14 sections may not only be pigtail shaped but it can be provided by other arbitrary for example straight shapes.

The equipment on figure # 1 is stiffened by 18 propstrings, which secures the appropiate shape of the equipment for insert.

The described equipment is provided expediently with 16 closingdevices which makes the regular excretion of the bodyliquid possible. The sketch of the structure of the closingdevice can be seen on figure # 2. The 16 closingdevice advantageously is located at the meeting point of the middle 12 sections and the outer 14 sections and the in the territory of the 16 closingdevices the equipment is formed with a larger cross-section in order to hinder it to slip in to the ventricle.

The part wider than the other parts of the equipment helps the positioning, because it indicates the start of the narrowed part during inserting. Concering its shape it is advantageously assymmetrical arbor shaped, where the inner end is wider than the outer, and it connects with appropiate transition to the outer and middle 14,12 sections.

The 16 closingdevices may exemplary contain 32 closingunits prostrained with 30 springs, and 20 leading strings that are fixed to 32 closingunits and are outlet of the body. It opens the 16 closingdevices by pulling.22 "ears" are fastened to the end of the 20 exit strings which facilitate the opening of the 16 closingdevices. The 22 ears hinder the string to slip in, on the other hand it helps to identify the otherwise thin string during use. The 16 closingdevices can be of course formed as electromagnetic or other type of lock.

From the 16 closingdevices the 20 exit strings lead outside of the opening of the urinary canal or across other bodysurface gap. On one hand the 20 exit strings secure the opening of the lock by a slight pull, on the other hand the equipment can be taken away by the increase of pulling force.

This exit string can contain a so called optic or electronic wiring, whichby we can gain information about the characteristics (e.g. pH,ion content, temp, etc.) of inner liquid collected in the abdomen or other ventricle. In this case of course the measure string must be so long that it enters the ventricle determined by the pigtail. Equipments appropiate to the required measurements can be connected to its outer end.

With regard to the fact that the 20 exit strings are thin, the sideffects observed on the conventional catheters can be eliminated. The 20 exit strings are made of thin, large and tensile strength strings. It is barley sensible due to its size, it does not irritate and does not cause ascending infection.

On the 3. figure the equipment is described without the 18 propstring. It can be seen on the figure, that without the strained position the equipment takes up the so called triple pigtail's position.

On the 4. figure the equipment is seen in position for the void of 40 bladder. It is seen on the figure that the pigtail shaped inner 10 sections are located in the 40 bladder, the also pigtail shaped middle 12 sections bridge the extension of the 42 prostates, the exemplary also pigtail shaped outer 14 sections are located on the 44 ureters' initial segment.

Similiarly to the already known ureter-catheters, the equipment described previously can be placed in with the help of the 18 propstrings or -wires. After the removal of the propstring the triple pigtail hooks and takes position. Dependency from the modification of the bodyposition, the catheter's (drain) position automatically corrigates.

In the case of abdominal or chest cavity application, expediently the equipment that is thinner than the catheter is applicable. For these inserts,there is need for flexible trocars in appropiate length and width, also provided with leadingwire. We take away the trocar's leadingwire after reaching the abdomen or chest cavity, whereupon the drain may be inserted. All these can be done by local anaesthetization, applied punctio.

In the case of urological catheters the equipment can be produced with solid length because the double or triple pigtail combination secures appropiate length adaptation, in most cases.

The equipment's width is chosen by the following.

The inner pigtail is the thinnest part, for the easy insert, with 10-12 Ch diameter

(Charriere = 1/3 mm). Its length is advantageously 8-10 cm. The middle pigtail has similar width, 10 -12 Ch diameter suits here as well.This part is expediently somewhat shorter, 5-7 cm. The closingdevice's territory is wider, than the catheter's other parts, its diameter is 16-18 Ch. Its length is advantageously 1 - 1,5 cm,dependently from the closingdevice. The outer 14 sections' width is advantageously 14 Ch, its length 2-3 cm. In the case of drains the diameter might be smaller, and the size of trocar used for insert suits it. In case of drains 1,5 -2 cm width is satisfactory.

The invention's important advantage is that it is provided with the appropiate length in the case of urological catheters. This way a larger part of the urethra devoids the constant sideffects caused by the catheter, for example mechanical irritation,injuries, infections, secondary narrowings. The inner pigtail does not irritate the bladder-wall, (the ventricle's wall in case of drain), not even when the chamber is absolutely empty.

The double or triple pigtail construction makes the complex dinamic adaptation possible. On one hand it positions the equipment (catheter,drain) into the narrow territory.On the other hand this positioning is in change according to the modification of bodyposition, the incidental infenction's decrease or the to the change of the bladder's size (the different ventricles in case of drains).

With the application of the equipment the danger of decubitus reduces significantly. The equipment's width (10-14 Ch) is smaller than that of the conventional catheters' (16-20 Ch), on the other hand the double or triple pigtail structure reduces the pressure on every part of the catheter.

The insert of the equipment is extremely easy, because it is relatively thin, its inner end is rounded, its material is elastic, and the closingdevice-part indicates the place of narrowing. The closingdevice is simple, and the liquid's removal is easily carried into effect.

The equipment does not block sexual life in case of constant insert. The equipment can be applied for women as special catheter with a little modification: the outer section's length and width must be cut back, respectively the leading string may be shorter. This way the female catheter can be applied in case of incontinence.

Claims

Patent Claims

1. Device for the draining of body fluid, especially a urinary- catheter, which is tube-like, and includes an internal section with at least one lateral hole for the body fluid, a central section developed with continuous wall, as well as an external section equipped with an outlet hole, of the characteristic that the internal section (10), central section (12) and external section (14) have been formed to the shape of a pigtail .

2. Device according to claim No. 1, of the characteristic by that the external section (14) is shorter than the central section (12.)

3. Device according to claims No. 1 or 2, of the characteristic by that the spiral diameter of the pigtail shape of the central section (12) is smaller than the spiral diameter of the pigtail shape of the internal section (10).

4. Device according to any of claims No. 1-3, of the characteristic by that the wall of internal section (10) and the wall of the external section (14) is equipped with lateral holes (11,15).

5. Device according to any of claims No. 1-4, of the characteristic that it contains a locking mechanism (16) which enables the controlled removal of body fluid.

6. Device according to claim No. 5, of the characteristic by that the locking mechanism (16) is arranged at the junction of the central section (12) and the external section (14).

7. Device according to claim No. 6, of the characteristic by that there is a larger cross section developed in the region of the locking mechanism (16) suitable for preventing slipping into the body.

8. Device according to any of claims No. 5-7, of the characteristic by that the locking mechanism (16) includes an end piece (32) pre-stressed by a spring (30), as well as an outlet string (20), fixed to the end piece (32) and leading outside the body, which, upon tightening, will bring the locking mechanism (16) into an open position.