NL1032961C2 - Balloon catheter for ureter, includes flexible check valve for covering pressure medium inlet opening in tube wall in order to keep balloon inflated - Google Patents

Abstract

The catheter (4) comprises an elongate tube containing at least one pressure medium supply conduit (14); a balloon placed over the tube and inflatable via an opening (11) in the tube wall; a check valve (13) comprising at least partly flexible material which is placed over the opening so that the balloon is inflated once there is sufficient pressure to do so, and so that the balloon is kept in a predetermined shape in the absence of this overpressure; and a second conduit which combines with a second opening in the tube wall to allow the balloon to be deflated, the distal end of this conduit being sealed. Independent claims are also included for the following: (1) method for sealing a pressure medium supply conduit used to inflate a balloon placed over a catheter for placing in the ureter and/or pyelo-ureter tract, by providing a suitable catheter containing at least one axial conduit; placing the balloon over at least part of the catheter, the conduit being in communication with the balloon via at least one opening in the catheter wall; providing a flexible seal around the catheter inside the balloon at the conduit opening so that if the pressure inside the balloon is higher than the pressure inside the conduit the seal presses against the opening, sealing it to prevent liquid and/or gas flowing out of the balloon and into the conduit, and so that if the pressure inside the conduit is higher than the pressure in the balloon the pressure difference stretches the seal to allow liquid and/or gas to flow into the balloon from the conduit; (2) first system for treating a ureter and/or pyelo-ureter tract, comprising a stretching device for a constriction; a guide for directing the stretching device through the urethra, bladder and ureter, the device being removed after the guide has passed the pyelo-ureter tract; and a device comprising the above catheter for holding open the stretched constriction; and (3) second system for treating a ureter and/or pyelo-ureter tract, comprising a stretching device for a constriction; a device comprising the above catheter for holding open the stretched constriction; and a guide for directing the stretching device from the pyelum, through the ureter and into the bladder.

Description

SYSTEM OF DEVICES FOR TREATING THE URETER AND OR THE PYELOURETER TRANSITION AND RECOVER VALVE FOR SUCH DEVICE

The present invention relates to a system of devices for treating the ureter and / or the pyelo-ureter transition and a non-return valve for such a device.

Impediments of the ureter, which are generally caused by a narrowing thereof (in medical terms: "stenosis"), can lead to serious medical problems such as pain, inflammation of the ureteral wall and obstructing urine drainage.

A narrowing on the pyelo-ureteral junction or more distal in the ureter is remedied by an endoscopic method in which a nephrostomy catheter is inserted into the surgically expanded pyelum, whereby nephrostomy is understood to mean: a deviation for urinary discharge through a catheter that is introduced via the back into the pyelum, or the renal pelvis, which cannot be done in the X-ray department and, as a rule, under general anesthesia. Despite local anesthesia, this procedure can be very painful. After this a pyeloscopy is performed, whereby pyeloscopy is understood to mean: treating the pyelum with a scope that can be inserted in two ways: 1) in retrograde pyelotomy via the ureteral bladder and ureter to the pyelum, the scoop being in the form of a has fiber optic scoop. This procedure is often impossible with a narrowing in the ureter.

2) in the case of antegrade pyelotomy through a tube (10-15 mm in diameter) that is inserted through the back into the pyelum, after the aforementioned nephrostomy has first been carried out.

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Retrograde and antegrade pyelotomy are performed in the operating room under general anesthesia.

With antegrade pyelotomy, a guide wire is first manipulated from the pyelum through the constrictions to the bladder, through which a dilatation balloon is slid.

This dilatation balloon is inflated to a pressure of 10-17 atm., In order to stretch the ureteral wall at the level of the stenosis.

The dilatation balloon is then removed.

While the guide wire remains in place, one or more surgical incisions on site will further narrow the narrowing in the longitudinal direction.

An endopyelotomy tent is then placed over the wire 15 into the bladder. This is a catheter that lies with one curl in the pyelum and with the other end with a curl in the bladder, so that it does not protrude into the wall of the bladder. The function of this stent is to keep the restriction open to prevent a recurrence.

This catheter has a maximum diameter of 4.7 mm and, due to the diameter of the pyelo-ureter junction, cannot be introduced into the ureter from the bladder. After a period of approximately six weeks it can be withdrawn from the ureter from the bladder. During this period, the ureter has had time to heal and stretch around the catheter.

Urine drainage is possible through a channel in the catheter during these six weeks.

International patent application WO 97/16218 describes a system of devices for treating the ureter 30 and / or the pyelo-ureter transition. The following is a description of this system to which the present invention provides an improvement.

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The stretching means, which are preferably formed by a first balloon, can be introduced from the bladder via the guide means.

The system comprises holding-open means in order to keep open the narrowed stretch, the holding-open means being formed by a second balloon.

In order to drain urine, the system holding means comprise at least one urine drain.

The diameter of the first stretched balloon is larger than the diameter of the stretched lower end of the second balloon (at the level of the restriction) to prevent the second balloon from being too tightly located at the restriction.

The diameter of the first balloon is preferably smaller than the widest part of the second balloon that is close to the pyelum, to prevent the latter from sinking into the ureter under the constriction.

In order to be able to inflate the balloon from the holding means and to keep it in an inflated state, a coupling 20 is provided which closes again after the inflation of the balloon and which can be opened again at a later time in order to deflate the balloon. The coupling comprises several parts that are difficult to manufacture due to their complex construction and small dimensions.

The disadvantage of the coupling described above is that it is a relatively complex coupling, which results in high manufacturing costs and makes the coupling susceptible to malfunctioning.

An object of the invention is to provide a device with which a balloon catheter can be inflated in a simple manner and can be kept in the inflated state. The device is preferably easy to produce with low manufacturing costs and the device offers little chance of malfunctioning.

In a first embodiment of the present invention, a catheter comprises a tubular elongate member that is provided with at least one channel for supplying pressure means; a balloon arranged over the tubular member which can be filled via an opening in the wall of the tubular member; and a non-return valve of at least partially flexible material disposed over the opening to inflate the balloon at sufficient overpressure and to keep it in a predetermined shape in the absence of that overpressure. In the resting state there is no exchange of liquid or gas between the interior of the balloon and the channel. To fill the balloon, a pressure means is introduced into the channel, creating an overpressure in the channel. This excess pressure causes the non-return valve to open, whereby the pressure medium can flow into the balloon, with which it fills. After the balloon is completely filled, pressure supply is stopped and the excess pressure is removed. The non-return valve will close the opening again in the absence of overpressure in the channel. This prevents the balloon from deflating again.

In a more advantageous embodiment the non-return valve is at least partially made of elastic material.

A further embodiment provides a catheter comprising at least a second channel. Yet a further embodiment comprises at least a third channel. The additional channels perform functions such as the discharge of pressure means 30 to allow the balloon to deflate and the discharge of urine.

In a further embodiment, the balloon can be drained via a second opening in the wall of the tubular member and via the second channel. This second opening is preferably located as far as possible towards the end of the catheter that should enter the pyelum. In this way it is prevented that during the removal of the catheter the wall 5 of the balloon closes the opening, while still pressure medium is present in the balloon, as a result of which removal is made more difficult. In yet a further embodiment, the second channel is closed at the distal end. This prevents the balloon from deflating. In order to deflate the balloon in order to be able to remove it again from the ureter, the distal end that is closed is opened, for example by cutting the distal end, so that the second channel is exposed and the pressure medium is exposed from the balloon can flow away through the second opening and the second channel.

In a further embodiment, the non-return valve comprises a body which is close-fitting around the tubular member and which substantially has a tubular shape.

In a specific embodiment, the non-return valve 20 is formed at least partially from silicone rubber.

The outside diameter of the tubular body can of course not be much larger than the inside diameter of the patient's ureter. The inner diameter of the non-return valve cannot be much larger than the outer diameter of the tubular member and is preferably substantially the same size or slightly smaller, so that it closes tightly around the catheter. In a preferred embodiment, the non-return valve has an inner diameter in the order of magnitude of at most 5 mm and preferably between 0.5 and 2 mm.

In one embodiment the non-return valve has a length sufficient to completely cover at least the opening in the wall of the tubular member and at most in the order of magnitude of 100 mm, but preferably the length is 5-10 mm with 7 mm is particularly preferred.

In a preferred embodiment, the balloon comprises a holding balloon.

The invention also provides a method for closing a pressure medium supply channel for inflating a balloon disposed over a catheter, comprising providing a catheter, wherein a balloon is disposed over at least a portion of the catheter and wherein catheter comprises at least one axially located channel which ends at at least one location at the height of the balloon via an opening in the wall of the catheter in the balloon; and placing a flexible closure means around the catheter at the mouth of a channel such that if the pressure in the balloon is higher than the pressure in the channel, the closure means is pressed against the mouth in order to remove it closing and preventing liquid or gases from flowing into the channel from the balloon, and such that if the pressure in the channel is higher than in the balloon, this pressure difference stretches the closing means such that liquids and / or gases from the channel into the balloon can flow.

Another embodiment of the present invention provides a system for treating the ureter and / or the pyelo-ureter junction, comprising stretching means for stretching a narrowing and guiding means for guiding the stretching means through the urethra, bladder and ureter, wherein the guide means are introduced through the uerthra, bladder and ureter up to a maximum beyond the pyelo-ureter transition into the patient, whereafter the stretching means are guided along the guide means and stretched to stretch the restriction, after which the stretching means are removed; further comprising holding-open means for holding open the expanded narrowing, the holding-open means comprising a catheter as described above.

Yet another embodiment of the present invention provides a system for treating the ureter and / or pyelo-ureter transition, comprising: - stretching means for stretching a narrowing, wherein the stretching means are brought into the narrowing and stretched in order to to narrow the constriction, after which the stretching means are removed; - holding means for keeping open the stretched restriction, wherein the holding means comprise a catheter according to one of claims 1-11; Guiding means for guiding the holding means from the pyelum through the ureter into the bladder.

In a further embodiment, the holding means further comprise at least one urine drainage channel.

In yet a further embodiment, the stretching means are formed by a second balloon.

In a further embodiment, the first balloon has a larger expandable diameter at a first end than at a second end.

In yet a further embodiment, the second balloon has a larger expandable diameter than the second end of the first expandable balloon.

In a further embodiment, the expanded diameter of the second balloon is smaller than the expanded diameter of the first end of the first balloon.

In a favorable embodiment the system further comprises: pushing means to introduce the holding means along the guide means by pushing into the patient, wherein the pushing means comprise coupling means for releasably coupling the holding means to the pushing means; and uncoupling means for uncoupling the holding means from the coupling means.

In a further embodiment the uncoupling means comprise a stylet.

In another embodiment, the system further comprises second holding-open means, which are placed next to the first holding-open means in the restriction.

In a further embodiment, the second holding-open means comprise a catheter as described above.

In another further embodiment, the second holding means comprises a JJ stent.

Further advantages and aspects of the invention are based on the claims and will become clear with reference to figures 1-14, in which a stepwise treatment of the ureter and the pyelo-ureter transition is shown, and in which the present invention is clarified, wherein: Figure 1 is a schematic representation of the pyelum and ureter as they can be treated with the aid of a system from the present invention;

Figure 2 is a schematic representation of the insertion of the stretching means of a system according to the present invention;

Figure 3 is a schematic representation of the inflated stretching means of a system according to the present invention;

Figure 4 is a schematic representation of a pyelo-ureter junction stretched with a system according to the present invention; 9

Figure 5 is a schematic representation of inserted holding means according to a system of the present invention;

Figure 6 is a schematic representation of inflated holding means inserted into the pyelo-ureter junction according to an embodiment of a system of the present invention;

Figure 7 is a schematic representation of inflated holding means 10 inserted into the pyelo-ureter junction according to an embodiment of a system of the present invention with the guide means removed;

Figure 8 is a schematic representation of inflated holding means according to an embodiment of a system 15 of the present invention wherein a stylet is provided;

Figure 9 is a schematic representation of inflated holding means according to an embodiment of the present invention, after it has been disconnected from the coupling means;

Figure 10 is an axonometric view of a balloon catheter with a closure valve according to the present invention;

Figure 11 is a cross-sectional view of the balloon catheter 25 along the line XI of Figure 10;

Figure 12 is a cross-sectional view of the balloon catheter along the line XII in Figure 10;

Figure 13 is an axonometric view of the balloon catheter of the present invention; Figure 14 is an axonometric detail view of the distal end of the catheter of the present invention according to view XIV of Figure 13.

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In the first instance a description is given of the system of devices for treating the ureter and / or the pyelo-ureter transition. The non-return valve of one of these devices is then further discussed.

First of all, the stenosis is guided by guide means in the form of a wire element 1 (figures 1-6) via the urethra (not shown), the bladder (B) and the ureter (U) beyond the restriction (V) (fig. 1). Since an increased pressure has been created in the pyelum as a result of the constriction, the pyelum takes on a "inflated" shape. Via the wire element 1, a dilatation balloon 2 is slid over the wire element 1 as far as the restriction (V) (Fig. 2). Subsequently, this dilatation balloon 2 is inflated to a pressure of approximately 8 to 13 atmospheres, whereby the restriction 15 (V) is stretched (Fig. 3). After about one to two minutes, or possibly longer to allow stretch bleeding to be stopped, this dilatation balloon 2 is deflated and the dilatation balloon 2 is removed by withdrawing it over the wire element 1 through the ureter (U), bladder (B) and 20 urethra from the patient. The pyelo-ureter transition (0) remains stretched (fig. 4).

Subsequently, with the aid of an introducing or pushing catheter (pusher) 5, a balloon catheter 4 is advanced over the wire element 1 through the urethra, bladder (B) and ureter (U) to the pyelum (P) until marker M is visible on a X-ray monitor, located at the cranial end (E) of the restriction (V) (Fig. 5).

Once there, the balloon catheter 4 is inflated to keep the pyelo-ureter junction (0) open. Since the balloon catheter 4 has a larger elongated diameter on the side of the pyelum (P) than on the side of the ureter (U), it can withstand the cranial end (E) of the pyelum <11 ureter junction (O) hang from the pyelum wall, as a result of which the balloon catheter 4 does not sink into the ureter (U) (Fig. 6).

Since this balloon catheter 4 holds the pyelo-ureter junction (0) open without exerting a high pressure on it, preferably a pressure of 1-2 atm. and more specifically about 1 atm., healing of the pyelo-ureter transition (0) can take place optimally.

After inflation of the balloon catheter 4, the wire element 1 is removed (Fig. 7).

Subsequently, a stylet (S) is introduced into the push catheter 5, with which the end of the balloon catheter 4 is pushed out of the coupling (K) (Fig. 8), whereafter the push catheter 5 is withdrawn and removed. The end of the balloon catheter 4, which is located in the bladder (B), curls up in the bladder (B) and the balloon catheter 4 remains in its inflated state (Fig. 9) through the non-return valve 13 (see Fig. 10). ).

After approximately thirty days, the end of the balloon catheter 4 is cut off, after which the balloon catheter 4 deflates and is removed.

During the thirty days that the balloon catheter 4 is in place, both ends thereof, which are respectively in the pyelum and the bladder, as well as perforations in the balloon shaft 6, ensure the outflow of urine. The balloon catheter 4 shown in figures 5-9 is shown in more detail in figure 10. The figure shows a balloon catheter 4 in which a pressure medium supply channel and a pressure medium discharge channel open out of the balloon 11,12. The non-return valve 13 is arranged around the mouth 11 of the pressure medium supply channel 14. In this embodiment, the non-return valve 13 consists of a silicone tube that closes tightly around the catheter. During the introduction of the balloon catheter 4-12 into the ureter (U), the balloon is still empty, so that it has a small diameter. After the balloon catheter (4) has been placed in the correct place in the pyelo-ureter junction (O), which is the case if the marking point (M) is at the level of the cranial side of the narrowing (V), via the pressure medium supply channel 14 (Fig. 11), a pressure medium is supplied which, due to the increased pressure in the pressure medium supply channel 14, causes the non-return valve 13 to stretch, so that the pressure medium can flow from the pressure medium supply channel 14 between the catheter and non-return valve 13 into the balloon, whereby the balloon is filled Fill with the pressure medium and the space in the stretched pyelo-ureter junction (O). If the supply of pressure medium is stopped and the pressure in the pressure medium supply channel 14 is reduced, an overpressure will arise in the balloon relative to the pressure medium supply channel 14, whereby, in combination with the elastic properties of non-return valve 13, the latter closely against the catheter will be pressed through which the mouth 11 of the pressure medium supply channel 14 will be closed and the pressure medium in the balloon cannot flow back into the pressure medium supply channel 14, whereby the pressure in the balloon is maintained and it retains its shape. As a result, the narrowing (V) of the pyelo-ureter junction (0) will be kept open.

The balloon catheter 4 further comprises a mouth of a pressure medium discharge channel 12 at the height of the balloon with which the pressure medium can be removed again from the balloon in order to be able to remove the balloon catheter 4 again from the body. Initially, the pressure medium discharge channel 15 (Fig. 11) is closed at the distal end in the bladder (B) so that the balloon catheter cannot deflate prematurely.

Figure 11 shows a section of the catheter (see section XI in Figure 10). The catheter has three channels: a pressure medium supply channel 14, a pressure medium discharge channel 15 and a guide wire guide / urine discharge channel 16, the latter also being used for the guide wire during insertion.

Figure 12 shows a section of the balloon catheter at the level of the non-return valve 13 (see section XII in fig.

10), in which a pressure medium supply channel 14, a pressure medium discharge channel 15 and a urine discharge channel 16 are again located. Furthermore, non-return valve 13 is shown which is arranged closely around the catheter and below which pressure medium supply channel 14 debouches (mouth 11). All this is located within the balloon of the balloon catheter 4.

The distal end of the catheter is in curled state in the bladder (B) after insertion (fig.

15). The pressure medium discharge channel 15 is closed off at this end by means of a plug 17 (Fig. 14). To remove the balloon catheter again, the balloon must first be emptied from the balloon catheter. This is done by cutting off the distal end of the balloon catheter 4, which is located in the bladder 20 and which includes the plug 17, whereby the pressure medium discharge channel 15 is exposed and the pressure medium from the balloon can deflate via pressure medium discharge mouth 12 and pressure medium discharge channel 15, after which the balloon catheter (4) can be removed from the ureter (U).

Cutting can be done outside the body of a female patient, but should be done in the bladder (B) of a male patient in the body.

The present invention is not limited to the above described preferred embodiments thereof. The rights sought are defined by the following claims within the scope of which many modifications are conceivable.

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Claims (21)

A catheter adapted to be fitted in the ureter and / or the pyelo-ureter junction, comprising: 5. a tubular elongate member provided with at least one channel (14) for supplying pressure means; - a balloon arranged over the tubular member which can be filled through an opening (11) in the wall of the tubular member; - a non-return valve (13) of at least partially flexible material which is arranged over the opening (11) in order to inflate the balloon at a sufficient pressure and to keep it in a predetermined shape in the absence of said pressure; - a second channel in which the balloon can be led through a second opening (12) in the wall of the tubular member and via the second channel and wherein the second channel is closed at the distal end. 20 Catheter as claimed in claim 1, wherein the non-return valve is at least partially made of elastic material. The catheter of claim 1 or 2, wherein the catheter comprises at least a third channel (16). Catheter as claimed in claim 1, 2 or 3, wherein the non-return valve (13) is a round body, tightly fitting the tubular member 30, which substantially has a tubular shape. 1032961 The catheter of any one of claims 1-4, wherein the check valve (13) is formed at least partially from silicone rubber. Catheter according to one of claims 1 to 5, wherein the non-return valve (13) has an inner diameter of the order of at most 5 mm and preferably between 0.5 and 2 mm. Catheter as claimed in any of claims 1-6, wherein the non-return valve (13) has a length sufficient to completely cover at least the opening (11) in the wall of the tubular member and at most in the order of 100 mm but preferably the length is 5-10 mm with 7 15 mm being particularly preferred. The catheter of any one of claims 1-7, wherein the balloon comprises a holding balloon. A method of closing a pressure medium supply channel (14) for inflating a balloon disposed over a catheter adapted to be fitted into the ureter and / or the pyelo-ureter junction, comprising providing a catheter which is adapted to be fitted in the ureter and / or the pyelo-ureter junction, wherein a balloon is arranged over at least a portion of the catheter and wherein the catheter comprises at least one axially located channel (14) on at least 30 one location at the height of the balloon flows into the balloon via an opening (11) in the wall of the catheter; and - placing a flexible closing means (13) around the catheter at the mouth (11) of a channel (14) such that if the pressure in the balloon is higher than the pressure in the channel (14) ) the closing means (13) is pressed against the mouth (11) in order to close it and prevent liquid or gases from flowing into the channel (14) from the balloon, and such that if the pressure in the channel (14) is higher than in the balloon this pressure difference extends the closing means (13) such that liquids and / or gases can flow into the balloon from the channel (14). 10 10. System for treating the ureter and / or the pyelo-ureter transition (0), comprising: - stretching means (2) for stretching a narrowing (V) and guide means (1) for guiding the stretching means (2) ) through the urethra, bladder (B) and ureter (U), the guide means (1) being introduced into the patient through the urethra, bladder (B) and ureter (U) up to beyond the pyelo-ureter junction (10) , after which the stretching means (2) are guided along the guide means (1) and are stretched in order to stretch the restriction (V), whereafter the stretching means (2) are removed; - further comprising holding-open means (4) for holding open the expanded restriction (V), wherein the holding-open means (4) comprise a catheter according to one of claims 1-8. A system for treating the ureter and / or pyelo-ureter transition (O), comprising: 30. stretching means (2) for stretching a narrowing (V), wherein the stretching means (2) is introduced into the narrowing (V) be stretched to stretch the restriction (V), whereafter the stretching means (2) are removed; - holding means (4) for holding open the stretched restriction (V), wherein the holding means (4) comprises a catheter according to one of claims 1-8; - guide means for guiding the holding means (4) from the pyelum (P) through the ureter (U) into the bladder (B). The system of claim 10 or 11, wherein the holding means further comprises at least one urine drainage channel. A system according to claim 10, 11 or 12, 15, wherein the stretching means (2) are formed by a second balloon. 14. System as claimed in any of the claims 10-13, wherein the first balloon has a larger expandable diameter at a first end thereof than at a second end thereof. 15. System as claimed in any of the claims 10-14, wherein the second balloon has a larger expandable diameter than the second end of the first expandable balloon. 16. A system according to any of claims 10-15, wherein the expanded diameter of the second balloon is smaller than the expanded diameter of the first end of the first balloon. 17. System as claimed in any of the claims 10-16, further comprising: - pushing means (5) for pushing the holding means (4) along the guide means (1) into the patient by pushing, wherein the pushing means (5) coupling means (K ) for releasably coupling the holding means (4) to the pushing means (5); and - uncoupling means (S) for uncoupling the holding means (4) from the coupling means (K). 10 The system of claim 17, wherein the disconnecting means comprises a stylet (S). A system according to any one of claims 10-18, further comprising second open-holding means, which are placed next to the first open-holding means (4) in the restriction. 20. System as claimed in claim 19, wherein the second holding-open means comprise a catheter as claimed in any of the claims 1-11. The system of claim 19, wherein the second holding means comprises a JJ stent. 10 3 2 9 6 1.