HUP0600601A2 - Device for emptying body fluid - Google Patents

Description

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Device for draining bodily fluids

The invention relates to a device for draining body fluid (drain), in particular to a bladder catheter, which is tubular and comprises an inner section with at least one side opening for body fluid, a central section formed with a continuous wall, and an outer section with an outlet opening.

Bladder catheters currently used in urology, such as the so-called Foley catheters, have the following characteristics.

- They are located along the entire length of the urethra, with one end in the bladder and the other end outside the urethral opening.

- Their positioning requires an inflatable balloon located near their inner end, which prevents the catheter from slipping out, or the outer end of the catheter must be mechanically fixed, as in some so-called Rüsch types.

- The catheter is prevented from slipping in by thickening the outer end.

- There is no difference between male and female catheters, although anatomical differences would require it.

Even with a single insertion, but with catheters that are kept in place for a longer period of time, the so-called permanent catheters, a number of side effects may occur. These include mechanical injuries, local and ascending infections, and secondary urethral strictures. Another disadvantage of known catheters is the uncomfortable, sometimes painful wearing and the inability to have sex.

In other body cavities, such as the removal of fluid from the abdomen or chest cavity, indwelling, reusable drains are not really used, and those used so far can mostly only be inserted through minor surgeries.

-2 In the prior art, a number of catheter devices for draining body fluids are known. Such devices are described, 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 A1, US 2005/0080399 A1, US 2005/0165383 A1 and EP 0 733 379 B1.

The catheter devices described in US 4,931,037 and EP 0 733 379 B1 have a helical end, or what is known in the art as a pigtail end, attachment. US 6,119,697, US 2005/0059929 A1 and US 2005/0080399 A1 describe short catheters that do not extend outside the patient's body.

The disadvantage of the known solutions is that catheter devices of different lengths are required depending on the application and the size of the patient's individual organs, i.e. a catheter set is required in order to be able to use the catheter devices under different conditions. None of the known solutions has a physical design that would allow dynamic length and cross-section adaptation according to the conditions of the application environment. Another disadvantage of the known solutions is that due to the relative thickness of the catheters, there is a high risk of decubitus and their insertion is difficult. Another problem is that the known solutions do not allow for the controlled emptying of body fluids, and their use as a bladder catheter hinders sexual life.

When creating the invention, we set ourselves the goal of creating a device for draining body fluids that is free from the disadvantages of the prior art solutions. Our further goal was to create a device that does not require keeping a stock of catheter devices of different lengths, but can be used for any application with dynamic size adaptation. Our further goals were to achieve easy insertion, reduce the risk of decubitus and be simple to produce.

-3 Accordingly, the invention is a device for draining body fluid, in particular a bladder catheter, which is tubular and comprises an inner section with at least one side opening for body fluid, a central section formed with a continuous wall, and an outer section with an exit opening. According to the invention, the inner section and the central section are formed in a pigtail shape.

The device according to the invention, which can also be used as a catheter or drain, always has the required length due to its dynamically adaptable design in the body cavity or body passage.

The positioning of the device is ensured by the double pigtail structure.

- The internal pigtail is placed in the bladder or other body cavity and prevents the catheter (drain) from slipping out.

- The middle pigtail is located at the level of the stenosis. In the case of urological catheters, this is most often the prostatic part of the urethra, in the case of other body cavities, the part between the body surface and the body cavity, for example the abdominal wall or chest wall. This section ensures that it remains in place, and on the other hand, due to its structure, it flexibly adapts to the length of the stenosis.

Preferably, the outer section is also formed in a pigtail shape, in which case a triple pigtail structure results.

- The outer pigtail is located immediately after the stenosis and is preferably separated from the second pigtail by the locking part of the device. The function of the outer section is to prevent the catheter (drain) from slipping in.

In one particularly advantageous embodiment, the outer section is shorter than the middle section. Urological catheters are used in most cases to bridge urethral strictures. A typical example of this is prostate enlargement: the prostate and the urethral part running within it (the so-called pars prostatica) make up only a small part of the total length of the urethra, which is approximately 20 cm. This length is normally 2.5 - 4.0 cm, but even in the case of prostate enlargement it is rarely greater than 5-7 cm. Of the length of the catheters currently used, the part outside the bridging section is unnecessary and only damages the urethra, with the sole purpose of making the outer end of the catheter accessible and preventing it from slipping in. The embodiment allows the length of urological catheters to be adjusted to the useful part that bridges the obstruction (stenosis).

The spiral diameter of the pigtail shape of the middle section is, in a preferred embodiment, smaller than the spiral diameter of the pigtail shape of the inner section. In this way, the device better conforms to the natural or artificial passageway for the passage of body fluid.

The wall of the inner section and the wall of the outer section are preferably provided with side openings. The series of openings, preferably running along the entire length of the sections, greatly facilitates the entry and exit of body fluid.

One particularly preferred embodiment comprises a closure device for allowing controlled discharge of body fluid. The closure device is preferably arranged at the junction of the middle section and the outer section to facilitate insertion and positioning, and the device is designed with a larger cross-section in the region of the closure device to prevent slipping into the body. The closure device preferably comprises a spring-biased closure element and an exit thread attached to the closure element and led out to the outside of the body, when pulled, the closure device is brought into the open state.

In the following, preferred embodiments of the invention are described by way of example with reference to the drawings, where the

Figure 1 shows a device according to the invention in a position prepared for insertion, Figure 2 is a schematic sectional drawing of the closure mechanism of the device according to Figure 1, Figure 3 shows the device according to Figure 1 in a position without a stiffening thread, and

Figure 4 is a schematic representation of a device according to the invention placed in a urinary bladder.

• ·· ·* 9 · ·« • · · · « · ·

-5Α invention serves for the controlled removal (drainage) of any fluid present or produced in natural or pathological cavities of the human or animal body. The invention is specifically intended for the drainage of urine, as a urological catheter, but is also suitable for other purposes as a so-called drain, for example for the removal of fluid accumulation in the abdominal cavity, chest cavity or other body cavities.

The device shown in Figures 1 and 3 according to the invention comprises three sections, namely an inner section 10, a middle section 12 and an outer section 14. According to the invention, at least the inner and middle sections 10, 12 are formed in a pigtail shape. In the description and claims, the term pigtail is used in the broadest sense in the art and includes any design that has at least one segment shaped like a spiral or a wave.

The inner section 10 is preferably provided with side openings 11 along its entire length, through which the body fluid to be drained can enter the interior of the device. The invention can of course be designed not only as shown, but any solution is possible that has at least one side opening for the body fluid. The inner section 10 may optionally include a flexible optical or other measuring fiber built into its wall.

The inner section 10 preferably has a rounded, closed end for easy and damage-free insertion. Due to its flexibility, it bends after removal of the guide wire or stiffening thread, but also due to its flexibility, it irritates the cavity wall less and adapts to internal conditions. For example, when the bladder expands, the degree of curvature may change with the increase in the amount of urine, or in the case of an abdominal drain, the flexible inner pigtail will move away from intestines that may drift nearby.

The central section 12 according to the invention is formed with a continuous wall, which means that there are no openings or breakthroughs in its side walls. This section 12 serves to drain body fluid from the body cavity or to prevent a narrowing.

The spiral diameter of the pigtail shape of the middle section 12 is preferably smaller than the spiral diameter of the pigtail shape of the inner section 10.

The flexibility of the middle 12 sections allows it to adapt to the diameter and length of the stenosis. Thus, in most cases, a single design device can be used, and it is not necessary to manufacture different sizes. Another advantage is that when the body position changes, it not only changes its length and the size of the enclosed space, but also its position relative to the stenosis, thus reducing the risk of decubitus.

The outer section 14 according to the invention - preferably also in the shape of a pigtail - contains 17 exit openings through which the body fluid can be drained to a suitable place. Preferably, the outer section 14 is also provided with 15 side openings; urine, or in the case of a drain, other fluid, is drained through these. The outer section 14 is preferably shorter than the middle section 12.

The pigtail-shaped outer section 14 is flexible and bends after the guide wire or stiffening wire is removed, thus helping to position the device. Similarly to the central pigtail, it is capable of continuous dimensional adaptation and, thanks to its mobility, reduces the risk of decubitus. The pigtail shape of this section also provides additional safety against side effects in the event that the device slides excessively into the body. According to the invention, however, the outer section 14 may not only be pigtail-shaped, but may also have any other shape known per se, for example a straight shape.

The device shown in Figure 1 is reinforced with 18 stiffening fibers which provide the device with a shape suitable for insertion.

The illustrated device is preferably provided with a closure device 16 for the controlled discharge of body fluid. A schematic diagram of the construction of the closure device is shown in Figure 2. The closure device 16 preferably includes a central section 12 and an outer section 16.

-714 is arranged at the junction of the sections and in the region of the closure mechanism 16 the device is designed with a larger cross-section suitable for preventing slipping into the body cavity. The part that is thicker than the rest of the device also helps positioning, as it indicates the beginning of the narrowed part during insertion. In terms of its shape, it is preferably asymmetrically spindle-shaped, the inner end of which is thicker than the outer end, and is connected to the outer and middle sections 14, 12 with a suitable transition.

The closure device 16 may, for example, comprise a closure element 32 pre-tensioned by a spring 30, and an exit thread 20 attached to the closure element 32 and led out to the outside of the body, which, when pulled, brings the closure device 16 into the open state. A tab 22 is suitably attached to the end of the exit thread 20, which facilitates the opening of the closure device 16. The tab 22 also prevents the thread from slipping back, and on the other hand, helps to identify the otherwise thin thread during use. The closure device 16 may of course also be designed as an electromagnetic or other type of lock.

The exit thread 20 leads from the closure device 16 to the outside through the urethral opening or other body surface opening. The exit thread 20, on the one hand, ensures the opening of the lock by gentle pulling, and on the other hand, the device can be removed by further increasing the pulling force.

This outlet fiber may optionally contain a so-called optical or electrical wire, which can be used to obtain information about the characteristics of the internal fluid collection in the bladder or other cavity in a known manner (e.g. pH value, ion composition, temperature, etc.). In this case, of course, the measuring fiber must be long enough to reach the cavity defined by the internal pigtail. Instruments suitable for the desired measurements can be connected to its outer end.

Given that the 20 exit threads are very thin, the side effects seen with traditional catheters are eliminated. The 20 exit threads are thin, • 4.

-8 It is made of high tensile strength fiber. Due to its size, it is barely noticeable, does not irritate and does not cause ascending infection.

In Figure 3, the device according to the invention is shown, by way of example, without the reinforcing thread 18. The figure shows that in the unstiffened position, the device according to the invention assumes the so-called triple pigtail position.

Figure 4 shows an exemplary device according to the invention 40 in a position arranged for emptying the bladder. The figure shows that the pigtail-shaped inner section 10 falls inside the bladder 40, the pigtail-shaped middle section 12 bridges the prostate extension 42, and the pigtail-shaped outer section 14 falls on the initial segment of the urethra 44, as an example.

Similar to the known ureteral catheters, the device described above can be inserted using the 18 guide wire. After the guide wire is removed, the triple pigtail is bent and positioned. Depending on the change in body position, the position of the catheter (drain) is subsequently automatically corrected.

In the case of abdominal or thoracic cavity application, it is advisable to use a drain device that is thinner than the catheter. For their insertion, a somewhat flexible trocar of appropriate length and thickness, also equipped with a guide wire, is also required. Upon reaching the abdominal or thoracic cavity, the guide wire of the trocar is removed, after which the drain can be inserted. This can also be done with local anesthesia and puncture.

In the case of urological catheters, the device according to the invention can be manufactured with a uniform length because the double or triple pigtail combination provides adequate length adaptation in most cases.

The thickness of the device according to the invention is preferably chosen as follows. The inner pigtail is .:. ·..· ·. · 4. :

-9th thinnest part, with a diameter of 10 - 12 Ch (Charriere = 1/3 mm). Its length is preferably 8-10 cm. The middle pigtail is also of a similar thickness, a diameter of 10 - 12 Ch is also suitable here. However, this part is preferably somewhat shorter, 5 - 7 cm. The region of the locking mechanism is thicker than the rest of the catheter device, its diameter is 16-18 Ch. Its length, depending on the locking mechanism, is preferably 1 1.5 cm. The thickness of the outer section 14 is preferably 14 Ch, its length is 2-3 cm. In the case of drains, the diameter may be smaller, and the size of the trocar used for insertion may correspond to this. In the case of drains, a thickness of 1.5 - 2 mm may be sufficient.

One of the important advantages of the invention is that in the case of urological catheters it has only the necessary length. Thus, a larger part of the urethra is free from the side effects caused by a permanent catheter, such as mechanical irritation, injuries, infections, and secondary strictures. The internal pigtail does not irritate the bladder wall (in the case of a drain, the wall of the body cavity), even when the cavity is completely empty.

The double or triple pigtail construction allows for complex dynamic adaptation. On the one hand, it positions the device (catheter, drain) in the area of the stenosis. On the other hand, this positioning is constantly changing; it adapts to changing dimensions with changes in body position, possible reduction of inflammation, or changes in the size of the bladder (in the case of drains, the various body cavities).

The use of the device according to the invention significantly reduces the risk of decubitus ulcers. The thickness of the device (10-14 Ch) is on the one hand smaller than that of commonly used indwelling catheters (16-20 Ch), and on the other hand the double or triple pigtail structure reduces the constant pressure load on all parts of the catheter.

The device is extremely easy to insert because it is relatively thin, has a rounded inner end, is made of flexible material, and the closure part indicates the location of the stenosis. The • · · · · Λ · ··· *· · 1» ·

- The closure device according to the invention is simple and the discharge of the liquid can be easily carried out.

The device according to the invention does not hinder sexual life even when permanently inserted. The device can also be used as a special catheter for women with a small modification: the length and thickness of the outer section only need to be reduced, and the outlet thread can also be shorter. Thus, the female catheter can also be suitable for use in cases of incontinence.

Claims (9)

· -4· · Patent claims 1. A device for draining body fluid, in particular a bladder catheter, which is tubular and comprises an inner section with at least one side opening for body fluid, a middle section formed with a continuous wall, and an outer section with an outlet opening, characterized in that the inner section (10) and the middle section (12) are formed in a pigtail shape. 2. Device according to claim 1, characterized in that the outer section (14) is also formed in a pigtail shape. 3. A device according to claim 1 or 2, characterized in that the outer section (14) is shorter than the middle section (12). 4. A device according to any one of claims 1-3, characterized in that the spiral diameter of the pigtail shape of the middle section (12) is smaller than the spiral diameter of the pigtail shape of the inner section (10). 5. A device according to any one of claims 1-4, characterized in that the wall of the inner section (10) and the wall of the outer section (14) are provided with side openings (11, 15). 6. A device according to any one of claims 1-5, characterized in that it comprises a closure device (16) enabling controlled discharge of body fluid. 7. A device according to claim 6, characterized in that the closure mechanism (16) is arranged at the junction of the central section (12) and the outer section (14). 8. Device according to claim 7, characterized in that it is designed with a larger cross-section in the region of the closure mechanism (16) to prevent slipping into the body. 9. The device according to any one of claims 6-8, characterized in that the closure device (16) comprises a closure element (32) prestressed by a spring (30), and an exit thread (20) attached to the closure element (32) and led out of the body, by pulling which brings the closure device (16) into the open state. 2oo&- O/.öT,