WO1997044088A1

WO1997044088A1 - Ureteral catheter

Info

Publication number: WO1997044088A1
Application number: PCT/DE1997/000979
Authority: WO
Inventors: Uwe Friedrich; Ralph Erich Vetter; Manuela Muhr; Sándor LOVASZ
Original assignee: WILLY RüSCH AG
Priority date: 1996-05-21
Filing date: 1997-05-15
Publication date: 1997-11-27

Abstract

The invention relates to a ureteral catheter (10) which has an elongate shaft and a lumen (15) for ureteral peristalsis. The renal-pelvis end (11) of the ureteral catheter (10) is closed and a plurality of through openings (17) provide access to the lumen (15). The bladder end (12) of the ureteral catheter (10) is open. At least one electrode (19, 20) connected to a current source is provided at the renal-pelvic end (11) of the catheter (10) and can deliver at least electrical pulses to adjacent tissue. In another embodiment, the ureteral catheter may extend from the kidney out into an extra-corporeal area, and the through openings are only provided at the renal-pelvis end of the ureteral catheter. In said embodiment, the renal pelvis can be filled via the ureteral catheter with a fluid from outside, and it is easier to wash out fragments of stone in the ureter.

Description

U r e t e r k a t h e t e r

The invention is based on a ureteral catheter

an elongated shaft and a lumen for drainage, the closed end of the kidney pelvis merging into a rollable shaft section with a plurality of passage openings which are connected to the lumen and

- An open end or an open end on the bladder side.

Such a ureteral catheter has become known from EP-A-208841. Known ureteral catheters have two roll-in shaft ends that fix the catheter in position and prevent uncontrollable migration into the kidney pelvis or into the bladder. The bladder-side end of such ureteral catheters can alternatively be provided with a valve mechanism, which likewise prevents uncontrolled migration of the ureteral catheter and, above all, vesico-ureteral reflux. The ureteral catheters bridge the ureter and ensure a safe flow of urine from the renal pelvis into the bladder. However, in the case of pyeloureteral peristaltic disorders which disrupt the natural flow of urine, the known ureteral catheters cannot solve the problem requiring treatment alone.

Pyeloureteric drainage disorders occur in newborns and children in approximately 0.8 to 1% of births. Chronic recurrent urinary retention can lead to kidney damage (hydronephrosis), ureter enlargement (megaureters), severe infections and other long-term problems requiring treatment. A medicinal influencing of the clinical picture is practically impossible due to the systemic side effect of the active pharmaceuticals. This often leaves only the operative consequence. For this purpose, the ureter is separated from the bladder and connected directly to the outer skin (cranial or terminal ureterostomy).

It is therefore an object of the present invention to provide a ureteral catheter which can be inserted into the renal pelvis and which supports and promotes the flow of urine from the renal pelvis to the bladder in the case of the pyeloureteral outflow disorders described or which potentiates the urinary tract. terperistalsis, for example in connection with the forced expulsion of stone fragments after shock wave lithotrypsia, can be used.

This object is achieved according to the invention in that at the end of the ureteral catheter on the kidney side, at least one electrode which can be coupled or is connected to a current source is designed such that it can at least emit electrical pulses to an adjacent tissue, or that the open end A body-free end is that the passage openings are limited to the end of the kidney pelvis and that at the end of the catheter at the kidney pelvis at least one electrode which can be coupled or is connected to a current source is designed such that it can at least emit electrical pulses to an adjacent tissue .

The ureteral catheter according to the invention thus has the essential advantage that it can stimulate the pacemaker centers (pacemaker centers) located in the upper urinary tract in such a way that the ureter is stimulated to rhythmic contractions which are necessary for regulated urinary transport from the kidney pelvis to the bladder. If several electrodes are provided, the different pacemaker centers (middle cup group, cone of the kidney pelvis, upper, middle or lower ureter) can be stimulated with different frequencies and / or current strengths. Although fundamentally different pacemaker areas can be stimulated with the ureter catheter according to the invention, the middle calyx group is preferably stimulated. With the ureter catheter according to the invention, the peristalsis of the ureter is restarted by topical irritation by means of electrical current pulses in the area of one of these pacemaker centers. If the ureteral catheter according to the invention is used, this leads to a general improvement in the urodynamics of the decompensated upper urinary tract, so that primarily an operative intervention can be avoided or, however, in previously operated children, e.g. B. in cutan ureterostomy in megaureters or in operations of a decompensated ureteral stenosis with hydronephrosis and spontaneous pacemaker loss and renal parenchymal damage to the urinary flow is further improved.

If the open end is a body-free end, a spontaneous emptying and relief of the renal pelvis via the catheter into the body-free area can take place. In addition, a retrograde filling of the hollow kidney system with a liquid from the outside is possible. An optimal bolus can be achieved via the retrograde artificial filling of the pyelon. The peristaltic activity of the ureter can be stimulated and the transport activity of the ureter can be promoted by the electrode in the area of the pacemaker centers. Kidney stones, which are present in large numbers as stone fragments in the ureter, for example after a shock wave lithotrypsia (extra-corporeal shock wave lithotripsy [ESWL]), may block, at least partially, these and / or possibly a kidney basin. Causing overpressure can be improved with a liquid supplied from outside and, above all, can be flushed out safely and completely into the bladder in a shorter time.

Alternatively, the body-free end is led directly outwards via a percutaneous nephrotomy. When forced stone fragments are driven out, this has the advantage that the ureter itself is not loaded with a catheter system. The In this case, electrical stimulation takes place via the electrode on the side of the kidney. Liquids of higher viscosity than urine applied in antigrad support the forced expulsion of stone fragments via the ureters.

Colic infections and inflammation of the kidneys that cannot be excluded can be prevented. This flushing can also be carried out with liquids of higher viscosity. The effectiveness of the electrostimulation can be ascertained via the amount of liquid supplied and removed, and known radiographic or electromyographic methods can be dispensed with.

In a preferred embodiment of the invention, two electrodes are provided at the end of the catheter on the kidney side.

This has the advantage that the ureteral catheter according to the invention can be operated not only unipolar but also bipolar. The bipolar mode of operation is more effective, safer and less stressful for the patient. After each kidney cup has its own dynamic with a corresponding frequency and flow rate, it can be advantageous to also operate further electrodes on the ureteral catheter according to the invention.

In a further embodiment of the invention, the electrode or the electrodes are made of an electrically conductive material, preferably platinum, and are helically attached to the outer circumference of the ureteral catheter, or the electrode or the electrodes are in the form of axially extending metallic tube pieces Integrated outer surface of the ureteral catheter. This has the advantage that the electrode or electrodes are not only compatible with the tissue, but they can also be permanently fixed in position on the shaft of the ureteral catheter. With an increase or decrease in the number of coils, the performance of a particular electrode can also be influenced.

If the electrode or the electrodes are designed as tube pieces, they can be incorporated into the catheter shaft and the lines run in the catheter shaft up to the free end of the catheter in the body-free area. There, the line or lines can again lead into one or more stirring pieces attached to the outer surface of the catheter, which are to be provided as connection contacts for a current source to be connected.

In a further development of the invention, the electrode or the electrodes are worked into the outer surface of the catheter without a step.

This has the advantage that the ureteral catheter according to the invention can be advanced as gently as possible on the inner walls of the hollow organs when inserted through the urethra into the ureter. For additional protection of adjacent tissue and a safer operation of the electrodes, these can additionally be covered with an electrically conductive protective film.

In a further embodiment of the ureteral catheter according to the invention, the electrode or electrodes are formed from an electrically conductive plastic which is incorporated as a shaft section in the ureteral catheter. This has the advantage that the electrodes can be incorporated into the shaft of the ureteral catheter in a material-locking manner. The entire shaft surface can be given a uniform surface quality, and the flexibility of the ureteral catheter does not differ significantly from the other shaft regions in the area of the electrodes.

In a further embodiment of the invention, the electrodes or the electrodes are connected to lines which run in the catheter wall and exit at the end of the catheter on the bladder side.

This has the advantage that the electrodes can be coupled to any current source. With the ureter catheter in place, the lines are led out of the body via the bladder and the urethra.

In a further embodiment of the invention, the lines are provided with an insulating sheath at least outside the catheter, and the free ends of the lines are equipped with connecting means for a current source to be connected.

With such a design of the lines, the ureteral catheter according to the invention can be operated safely.

In a further embodiment, the electrode or electrodes are connected to a current source which is provided in the catheter wall or on the bladder-side free end of the catheter. This has the advantage that the lines do not have to be led out of a patient's body via the urethra. As a power source, miniatu- standardized batteries are used which have a long service life and also operate microprocessors which specify the pulse frequency or pulse duration. If these batteries are designed as accumulators, they can be inductively recharged from outside the body of a patient if necessary.

In a preferred embodiment of the ureteral catheter according to the invention, the electrode or electrodes are coupled to connections of a coil or coils which inductively supply the electrode or electrodes with current.

This has the advantage that a placed ureteral catheter from the outside, i. H. can be controlled and regulated from outside the body of a patient. The current source can be implanted under the skin or carried on the skin. The stimulation frequency, intensity, etc. can be influenced in a line-less manner via such an operating mode.

In a further embodiment of the invention, the electrode or electrodes are connected to means which supply the electrode or the electrodes with freely selectable current and voltage strengths, with a pulse duration and pulse frequency being specified.

This has the advantage that the pyeloureteral stimulation takes place in a very differentiated manner and can be tailored to the patient as best as possible.

In a further embodiment of the invention, the ureteral catheter has a length such that the ureteral catheter extends outward from the kidney via the ureter, bladder or urethra into an area outside the body extends.

This has the advantage that a ureter catheter developed in this way can be charged with a liquid from the outside for flushing the renal pelvis and the ureter. Likewise, the lines for the electrodes can be led safely through the hollow organs to the outside.

In a further embodiment of the invention, a body-free end is provided with a Luer lock connection. Via this coupling, liquid systems can be coupled to the ureteral catheter according to the invention in a liquid-tight and quickly detachable manner.

In a further embodiment of the invention, the outer surface of the ureteral catheter has a hydrophilic property, which is achieved in particular by means of a hydrophilic coating. Due to the hydrophilic coating, stone fragments can be removed more easily in the space between the ureteral catheter according to the invention and the adjacent inner surface wall of the ureter.

Furthermore, an end of the ureteral catheter on the kidney pelvis can be fixed in the kidney pelvis via a synthetic fiber. This has the advantage that a placed ureteral catheter cannot move unintentionally.

The ureter catheters according to the invention are preferably provided with an outer marking so that the endoscopic placement of these catheters is facilitated.

Further advantages result from the description of the attached drawing. Likewise, the above and according to the invention the features listed further can be used individually or in any combination with one another. The mentioned embodiments are not to be understood as an exhaustive list, but rather have an exemplary character.

The invention is shown in the drawing. It shows:

1 shows a ureter catheter according to the invention with shaft ends that can be rolled up at both ends, two electrodes being provided at the shaft end on the renal pelvis;

2 shows a ureteral catheter according to the invention with an inserted guide wire, via which the free ends can be axially aligned;

3 shows an end of an ureteral catheter according to the invention, partially in cross section, with helix-shaped electrodes;

4 shows an end of an ureteral catheter according to the invention, partly in cross section, with electrodes incorporated into the catheter shaft and made of an electrically conductive plastic material;

Fig. 5 is a view according to V-V of Fig. 1;

Fig. 6 is a view according to VI-VI of Fig. 1;

Fig. 7 is a view according to VII-VII of Fig. 1; 8 shows a cross section through a catheter shaft of a ureter catheter according to the invention with incorporated current sources in the catheter wall;

9 shows a section of a ureteral catheter according to the invention, which shows a passage opening, line lumens and a drainage lumen;

10 shows a further embodiment of a ureteral catheter according to the invention with a shaft end on the kidney side and a body-free shaft end.

The individual figures The drawing shows the subject according to the invention in a highly schematic manner and is not to be understood to scale. The individual items are in the individual figures. partially greatly enlarged so that its structure can be shown better.

1 shows at 10 a ureteral catheter according to the invention, which has an end 11 on the kidney and a bladder end 12. Both the kidney-side end 11 and the bladder-side end 12 are designed as roll-in shaft ends which, in the placed state, fix the ureteral catheter both in the kidney pelvis and in the bladder.

The ureteral catheter 10 is made of a flexible, yet dimensionally stable plastic material that is compatible with the tissue. A tip 13 of the kidney-side end 11 is closed. One end 14 of the end 12 on the bladder side is open and opens into a lumen 15 which extends the entire catheter shaft 16 of the ureteral catheter 10 to the closed tip. ze 13 passes through. The tip 13 itself is rounded. The catheter shaft 16 is penetrated by numerous through openings 17 which are connected to the lumen 15. The passage openings 17 are shown in the exemplary embodiment along the entire catheter shaft 16, but they can also be formed only in sections on the ureter catheter 10. The passage openings 17 can be formed on one side but also on both sides of the ureter catheter 10. Markings 18 are further provided on the catheter shaft 16, which facilitate placement of the ureter catheter 10. An X-ray-tight strip can also be incorporated into the catheter shaft 16, so that the placement of the ureter catheter 10 can be checked on the one hand and on the other hand to recognize the direction in which the free shaft ends curl.

At the kidney-side end 11, two electrodes 19, 20 are attached to the outer circumference of the catheter shaft 16. The electrodes 19, 20 have an electrical connection which leads into the catheter wall and connects there to lines 21, 22. The lines 21, 22, starting from the electrodes 19, 20, are led through the entire longitudinal extent of the ureteral catheter 10 and exit at the bladder-side end 12 of the ureteral catheter 10. The lines 21, 22 can be guided in a wedge shape in the catheter wall over the entire longitudinal extent of the ureteral catheter 10. Corresponding connection means for a current source must be provided at the free ends of the lines 21, 22.

The electrodes 19, 20 are wound helically on the outer circumference of the catheter shaft 16. The electrodes 19, 20 can be made from any electrically conductive material that is tissue compatible. The electrodes 19, 20 are preferably at a distance of 1 cm to 1.5 cm from one another, so that an adequately delimited electric field for triggering contraction is built up in the area of the electrodes 19, 20 (bipolar operation). In addition to the electrodes 19, 20, sensors can also be provided on the ureteral catheter 10 which recognize the body's own electrical signals for activating the peristalsis. By means of the electrodes 19, 20, the body's own signals can be amplified and / or synchronized if necessary. The electrodes 19, 20 can also perform the function of the sensors in a double function.

If one or more electrodes are operated unipolarly on the ureteral catheter, these electrodes work together with further electrodes attached to the patient's skin.

Fig. 2 shows a ureteral catheter 10, which does not necessarily have to correspond in all of the objective features to the ureteral catheter from Fig. 1, with a guide wire 25 which can be inserted into the lumen 15 of the ureteral catheter 10 shown in dashed lines, and which is in itself the kidney-side and bladder-side rolled ends 11, 12 can stretch straight. If the guide wire 25 is removed from the ureteral catheter 10, rolled-up ends 11, 12 on the renal pelvis and bladder side are formed again. The ends of the ureter catheter 10 are shaped by a plastic material that has a memory effect.

The electrodes 19, 20 and the passage openings are also shown in FIG. 2. The markings 18 are applied between the passage openings 17. The lines 21, 22 connect the electrodes 19, 20 to a current source. 3 shows the end 11 of a ureteral catheter according to the invention with an inserted guide wire 25. The guide wire 25 is inserted into the lumen 15 up to the tip 13. With the guide wire 25, the rolled-up end 11 on the kidney side is stretched and aligned in a straight line. The electrodes 19, 20 are made of a bendable metallic material, in the exemplary embodiment platinum wire, which can change the direction shown without damaging the electrical connection. In the front area, the end 11 of the kidney is shown in cross section, and it can be seen that the passage opening 17 opens up free access to the lumen 15. The lines 21, 22 are guided in the catheter wall.

FIG. 4 shows a further embodiment of an end 11 of the ureter catheter 10 on the kidney side. The end 11 on the kidney side is stretched in a straight line through the guide wire 25. In the tip area, electrodes 27, 28 are incorporated into the catheter material. The electrodes 27, 28 can for example be made of a graphite plastic mass. Electrically conductive particles are, for example, mixed into the plastic material in some areas and form the electrodes. The electrodes 27, 28 are in turn connected to the lines 21, 22 which connect the electrodes 27, 28 to a power source.

4, the passage openings 17 are connected to the lumen 15, so that drainage can take place via the passage openings 17 as soon as the guide wire 25 is removed from the lumen 15.

FIG. 5 shows a cross section of the ureteral catheter 10 of FIG. 1 in the area of the tip 13. The cross section shows that the ureteral catheter 10 m in this area consists of a solid material

FIG. 6 shows a section according to VI-VI of FIG. 1. It can be seen that the ureteral catheter 10 has the lumen 15 in this area, and a catheter wall is provided with a line lumen 31 which receives a line which receives the electrode is electrically connected to a current source.

FIG. 7 shows a cross-section VII-VII of FIG. 1. This cross-section shows that the ureteral catheter 10 has the line lumen 31 and a further line lumen 32 in this area in addition to the lumen 15. The lead lumens 31, 32 connect the electrodes to a current source. In the catheter shaft wall 30, further lumens can be guided for further lines to further electrodes.

8 shows a further cross section through the catheter shaft 16 of the ureter catheter 10, which in this exemplary embodiment is equipped with energy sources 33, 34, miniaturized batteries, which are accommodated in the catheter shaft wall 30. The lumen 15 is kept completely open with respect to its free cross-sectional area. These energy sources 33, 34 do not create a constriction. If 30 energy sources 33, 34 are incorporated in the catheter shaft, no lines have to be led out of the catheter shaft 16. Further processors can also be incorporated into the catheter shaft 30, which control and regulate the intensity of stimulation by the electrodes. If the energy sources 33, 34 are accumulators, they can be charged from outside without a wire. 9 shows a short section of a shaft of the ureteral catheter 10 in the area of a passage opening 17. In this shaft section area, in addition to the lumen 15, the line lumens 31, 32 for current-carrying lines are also provided, which connect the electrodes to a current source.

10 shows a ureteral catheter 40 with an end 41 on the side of the kidney and a body-free end 42. A tip 43 of the end 41 on the side of the kidney is closed. One end 44 of the body-free end 42 is open and opens into a lumen 45 which runs through the entire catheter shaft 46 of the body-free 40 up to the closed tip 43. Passage openings 47 are provided only in the region of the end 41 on the inside of the pool. The passage openings 47 are connected to the lumen 45. Markings can be provided along the catheter shaft 46 on the catheter shaft 46 so that endoscopic placement of the ureter catheter 40 is facilitated.

An electrode 49 is formed in the region of the end 41 on the kidney pelvis on the ureter catheter 40. The electrode 49 is connected to a line 51 which runs in the catheter shaft 46 and opens into an electrical connection 52 at the body-free end 42. The line 51 can extend helically in the catheter shaft 46. Both the electrical connection 52 and the electrode 49 can be made from a metallic piece of pipe.

The axial length of the ureteral catheter 40 is designed such that it can be guided from the kidney 53 via the ureter 54 and the bladder 55 to the outside into the body-free area. The body-free end 42 is provided with a Luer lock connection 56 so that liquid Systems can be securely coupled to the ureteral catheter 40. The kidney pelvis can be filled with a liquid from the outside via the liquid systems not shown in the figure, so that stone fragments 57 located in the ureter 54 can be improved and washed out more easily.

A ureteral catheter 10 has an elongated shaft and a lumen 15 for drainage between the kidney pelvis and bladder and / or for the supply of liquids into the kidney pelvis. The end 11 of the ureteral catheter 10 on the side of the kidney is closed and a plurality of passage openings 17 ensure access to the lumen 15. The end 12 of the ureteral catheter 10 on the bladder side is open. At the kidney end 11 of the catheter 10 there is at least one electrode 19, 20 which is connected to a current source and which can emit at least electrical impulses to an adjacent tissue to activate the ureter peristalsis. In a further embodiment, the ureteral catheter can extend from the kidney to the outside into a region free of the body, and the passage openings are only provided at the end of the ureteral catheter on the kidney side. In such an embodiment, the kidney pelvis can be filled with a liquid from outside via the ureteral catheter and stone fragments located in the ureter can be washed out more easily.

Claims

claims

Ureteral catheter with an elongated shaft and a lumen (15) for drainage, the closed end (11) of the kidney pelvis merging into a rollable shaft section with a plurality of passage openings (17) which are connected to the lumen (15) and one bladder-side open end (12),

characterized,

that at the kidney-basin end (11) of the catheter (10) at least one electrode (19, 20; 27, 28) that can be coupled or connected to a current source is designed such that it can at least emit electrical pulses to an adjacent tissue.

Ureteral catheter with an elongated shaft and a lumen (45), the closed end (41) of the kidney pelvis merging into a rollable shaft section with a plurality of passage openings (47) which are connected to the lumen (45) and an open end,

characterized,

that the open end is a body-free end (42), that the passage openings (47) are limited to the kidney-basin end (41) and that at the kidney-basin end (11) of the catheter (40) at least one can be coupled to a power source or connected electrode (49) is designed such that it can emit at least electrical impulses to an adjacent tissue.

Ureteral catheter according to claim 1 or 2

characterized,

that two electrodes (19, 20; 27, 28; 49) are provided at the end (11; 41) of the catheter (10; 40) on the kidney side.

Ureteral catheter according to claim 1, 2 or 3,

characterized,

that the one electrode (49) or the electrodes (19, 20) made of an electrical material, preferably platinum, are helically attached to the outer circumference of the catheter (10), or as an axially extending metallic pipe piece or pipe pieces in the outer surface of the ureteral catheter (10, 40) are incorporated.

Ureteral catheter according to one of claims 1 to 4,

characterized,

that the one electrode (49) or the electrodes (19, 20) are built into the outer surface of the ureteral catheter (10; 40) without a step.

Ureteral catheter according to claim 1, 2 or 3,

characterized,

that the one electrode (49) or the electrodes (27, 28) are formed from an electrically conductive plastic are, which is incorporated as a shaft section in the ureter catheter.

7. ureteral catheter according to one of claims 1, 3, 4, 5 or 6

characterized,

that the electrode or electrodes (19, 20; 27, 28) are connected to lines (21, 22) which run in the catheter wall (30) and exit at the end 12 of the catheter (10) on the bladder side.

8. ureteral catheter according to claim 7,

characterized,

that the lines (21, 22) have an insulating sheath at least outside the catheter (10) and are provided at their free ends with connecting means for a current source to be connected.

9. ureteral catheter according to claim 1 or one of claims 3 to 6,

characterized,

that the electrode or electrodes (19, 20; 27, 28) are connected to a current source which is provided in the catheter wall (30) or on the bladder-side free end (12) of the catheter (10).

10. ureteral catheter according to claim 1 or one of claims 3 to 6, characterized,

that the electrode or electrodes (19, 20; 27, 28) are coupled to connections of a coil or coils which inductively supply the electrode or electrodes (19, 20; 27, 28) with current.

11. Ureteral catheter according to one of claims 1 to 10,

characterized,

that the one electrode (49) or the electrodes (19, 20; 27, 28) are connected by means of which the electrode or the electrodes (19, 20; 27, 28) freely selectable current and voltage strengths, below Specify a pulse duration and pulse frequency.

12. Ureteral catheter according to one of claims 2 to 6, or claim 11,

characterized,

that the ureteral catheter (40) has a length such that the ureteral catheter (40) extends from the kidney (53) via the ureter (54), the bladder (55) and the urethra into an area outside of one Body stretches.

13. Ureteral catheter according to one of claims 2 to 6, or claim 11, 12,

characterized, that a body-free end (42) is provided with a decouplable Luer lock connector (56).

14. Ureteral catheter according to one of claims 1 to 13,

characterized in that the outer surface of the ureter catheter (10; 40) has hydrophilic properties, in particular through a coating.

15. ureteral catheter according to one of claims 1 to 14,

characterized,

that an end (41) of the ureteral catheter (40) on the side of the kidney pelvis can be fixed in the kidney pelvis via a plastic fiber.