WO1995011054A1

WO1995011054A1 - A device for catheterization of the male urethra

Info

Publication number: WO1995011054A1
Application number: PCT/NO1994/000167
Authority: WO
Inventors: Knut Johnsen; Jørgen BLACH; Truls E. Bjerklund Johansen
Original assignee: Knut Johnsen; Blach Joergen; Johansen Truls E Bjerklund
Priority date: 1993-10-18
Filing date: 1994-10-18
Publication date: 1995-04-27
Also published as: EP0788389A1; NO933735D0; FI961694A; AU8005594A; FI961694A0

Abstract

A device for catheterization of the male urethra, especially in the case of traumatic rupture, comprises two substantially circular parts (1, 2) of unequal length which are connected at one of their ends with a hinge joint (8, 9). The devices's shortest part (2) is passed up through the urethra from the outside, while the longest part (1) is inserted through an opening above the pubic bone, through the bladder and into engagement with the part (2), in such a manner that the parts (1, 2) form a closed rind and can be locked in this position. The device according to the invention can be used to bring the two ends of a ruptured urethra into a position which allows atraumatic catheterization of the urethra.

Description

A Device for Catheterization of the Male Urethra

The invention concerns a device for catheterization of the male urethra, especially in the case of traumatic rupture.

Although it is generally accepted that primary surgery should be postponed in cases of traumatic rupture of the male urethra, most urologists will want to obtain a catheterization of the urethra as soon as possible. Various devices are known in the prior art to accomplish this. For example in Ambike V.S.: Railroad Dilators, British Journal of Urology, 1982, 54: 66, there are described rigid probes which can be interlocked; in Joubert J.D.: Injuries to the urethra, South African Medical Journal, 1958, 32: 919-21 , catheters are described which can be interlocked, and in Winsbury- White H .: Textbook of Genito-Urinary Surgery, Edinburgh, 1948, page 397, semi¬ circular steel guides are described. However, all these methods carry either the risk of picking up and pulling along the urethral wall, the creation of false passages or the need for open cystotomy. These factors are probably responsible for the poor final results obtained in early attempts at realignment of the urethra over a urethral cathe¬ ter, as described in Peters P.C., Sagalowsky A.I.: Genitourinary trauma, in Walsh & al.eds.: Campbell's Urology, 5th edition, London-Philadelphia, 1986, pages 1217-34.

Experience gained from radical prostatectomies shows that a proper adaption of the urethral ends is sufficient to obtain a good final result, and that a primary watertight anastomosis should not be aimed at.

The object of the invention, therefore, is to eliminate the above-mentioned disadvantages and provide a device in the form of a ring which enables the two ends of the ruptured urethra to be brought into a position which allows atraumatic catheterization of the urethra in the acute phase by means of a percutaneous technique.

This object is achieved by a device which is characterized by a device which comprises a first, substantially circular part and a second substantially circular part, the parts thus together forming a substantially circular, bipartite ring, that the first part is connected at one if its ends with a first connecting element, that the second part is connected at one of its ends with a second connecting element, that the first connecting element matches the second connecting element and releasably connected with it forms a hinge joint, and that the first and the second parts respectively are rotatable about an axis in the hinge joint, thus enabling the first part and the second part to be rotated into approximate mutual engagement with a free end of the first part and a free end of the second part respectively and to be closed into the substantially circular ring, the ring, by means of a locking device provided on the rotating joint, being arranged to be locked in this closed position.

Various advantageous embodiments of the device are characterized by the features presented in the attached independent claims.

The device according to the invention will now be described in more detail with reference to an embodiment in connection with the attached drawing, together with a discussion of the method in connection with the clinical application of the device.

Fig. 1 is a top view of the device according to the invention in a connected and closed position.

Fig. 2 illustrates the device in fig. 1 viewed from the side and in the radial plane.

Figs. 3a, 3b illustrate two connecting elements which form part of a hinge joint used for connecting the device together, shown in a top view and sectional elevation respectively.

Figs. 4a, 4b illustrate a fixing screw and a locking screw respectively, shown in a sectional elevation and a top view respectively and as used in a hinge joint in the device in fig. 1.

Fig. 5a illustrates end pieces for use in the device in fig. 1 and arranged for mutual engagement.

Fig. 5b illustrates a retaining disk which forms part of the hinge joint as used in the device in fig. 1.

Fig. 6a is a longitudinal section through the normal lower urinary tract in the male.

Fig. 6b illustrates a supradiaphragmatic rupture of the urethra, and figs. 6c-6j illustrates the various steps in the antegrade stenting and catheterization of the ruptured urethra by means of the device according to the invention. As illustrated in fig. 1 , in the closed position the device according to the invention forms a circular ring 1 ,2, consisting of a first part 1 and a second part 2. The parts 1 ,2 are rigidly connected at their respective first ends with connecting elements 8,9 which form a hinge joint. The parts 1 ,2 can be attached to the elements 8,9 by means of, for example, a screw connection or also welded thereto. The part 1 is approximately double the length of the part 2, both 1 and 2 having the same diameter, apart from the fact that the section of the part 1 which is located closest to the connecting element 8 is preferably made thicker in order to obtain better rigidity and greater mechanical strength.

The free end 7 of the part 1 engages with a corresponding free end 6 of the part 2 when the device according to the invention is closed into a ring. The free end of the part 1 is formed as a point 7 which is illustrated in more detail in fig. 5a and the free end of the part 2 is formed from a point 6 which is illustrated in more detail in fig. 5b. The end pieces or the points 6,7 can be attached to the respective parts 1 ,2 by means of, for example, screw connections or welding. At the end of the point 7 which engages with the point 6 a not shown radial recess is hollowed out which matches the corresponding end of the point 6 which in fig. 5b is preferably shown as conical in shape. This design of the points 6,7 provides a relatively secure attachment of the parts 1 ,2 when the device is closed to form a ring.

Fig. 3a shows the connecting element 8 in a top view and a side view, while fig. 3b shows the connecting element 9 in a top view and a side view. The parts 1 ,2 are attached to the connecting elements 8,9 respectively by means of, e.g., screw connections which are not shown in detail or preferably by means of welding. When assembling the device the matching connecting elements 8,9 are placed above each other in the position illustrated in fig. 1 and connected, for example, by means of a fixing screw 3 which is shown in fig. 4a. In assembling the device a retaining disk 5, which is illustrated in a top view and sectional elevation respectively in fig. 5, is employed between the connecting elements 8,9 in order to ensure a frictionless joining of the connecting elements 8,9 to a hinge joint which permits the parts 1 ,2 to be rotated from each other to a maximum deflection, which, for example, is limited by abutment between a projecting part 8a on the element 8 and a corresponding projecting part 9a on the element 9. Similarly, the parts 1 ,2 above the hinge joint 3,8,9 can be rotated about the axis which is formed by the fixing screw 3 until the device's free ends 6,7 come into engagement over the points 6,7, thus forming a closed ring. This is preferably locked by means of a locking screw 4 which is illustrated in more detail in fig. 4b. The locking screw 4 is passed through a not shown boring in the projecting part 8a on the element 8 and abuts against the projecting part 9a on the element 9, as is best illustrated in fig. 1. The device thereby forms a closed ring which is kept in position by means of the fixing screw 4. The closed ring, when viewed from the side and in the ring plane, appears as shown in fig. 2.

When the device according to the invention is closed into a ring, the fixing screw 4 ensures that there is a clearance of approximately 2 mm between the points 6,7. This is important in the application of the device for catheterization of the urethra, since such a clearance reduces the risk of detaching the wall of the urethra. The device is dismantled by loosening the locking screw 4 and removing the fixing screw. The hinge joint could also have been attached in a different way to that shown here, since, for example, the connecting elements 8,9 can be installed together by means of a catch member or a spring-loaded clamping member. In the latter case the spring-loaded clamping member causes the rotational movement which brings the parts 1 ,2 together with the free ends 6,7 in engagement during the formation of the ring 1 ,2. In this position the clamping member can be locked mechanically and in such a manner that the desired clearance of approximately 2 mm still exists between the ends 6,7. By employing a clamping member of this kind the device according to the invention can be closed using only one hand.

The free end 7 of the first part 1 can be connected with a catheter when the first part 1 is separated from the second part 2 or the device is in an open position.

There now follows a description of how the device according to the invention is used in order to achieve an atraumatic catheterization of the urethra with reference to fig. 6 which illustrates the catheterization process.

Fig. 6a is a longitudinal section through the normal lower urinary tract in the male, while fig. 6b illustrates a supradiaphragmatic rupture or lesion of the urethra. The shortest part of two parts forming the device according to the invention is placed in the urethra as a blocking instrument and is pushed forward and up through the urethra until it reaches the closest part of the rupture at the distal end of the urethra, as shown in fig. 6c. The longest part of the ring is passed into the bladder as shown in fig. 6d through a suprapubic puncture and positioned with its tip at the outlet of the bladder. The positions of the free ends 6,7 of the parts 1 ,2 are controlled by digital rectal palpation and ultrasonography with either a rectal or abdominal probe. The hinge joint which connects the parts 1 ,2 is located as illustrated in fig. 6e outside the patient's body. The device is now closed to form a ring as illustrated in fig. 6e, the free ends 6,7 engaging with each other at the site of the rupture or lesion. The device is locked in this position by means of a suitable locking device, for example the screw 4 on the hinge joint 3,8,9, the points 6,7 having a relative clearance of approximately 2 mm as mentioned above when they are in engagement. The entire ring is now rotated so that the free end of the part 1 comes into view at the external urethral orifice, as illustrated in fig. 6f. The part 2 is removed as illustrated in fig. 6g and replaced by a catheter 10, as illustrated in fig. 6h. This is attached to the tip 7 and pulled through the urethra until the tip 7 is seen in the suprapubic opening, as illustrated in fig. 6i. A balloon catheter is used, and the balloon is now inflated, the catheter being slightly withdrawn from its position at the end of the urethra, i.e. the urethra's external orifice. The ends of the ruptured urethra are thereby once again located in their correct position, as illustrated in fig. 6j. In the same figure there is also illustrated a drain 11 which is inserted through the suprapubic opening into the bladder.

The device according to the invention has been successfully tested in cadavers. It is expected that the device will prove to be suitable for the treatment of other urethral lesions such as strictures and via falsas where retrograde stenting of the urethra is impossible and an antegrade stenting is desirable.

Claims

PATENT CLAIMS

1. A device for catheterization of the male urethra, especially in the case of traumatic rupture, characterized in that the device comprises a first, substantially circular part (1 ) and a second, substantially circular part (2), the parts (1 ,2) thus together forming a substantially circular, bipartite ring, that the first part (1) is connected at one of its ends with a first connecting element (8), that the second part (2) is connected at one of its ends with a second connecting element (9), that the first connecting element (8) matches the second connecting element (9) and forms a hinge joint (8,9) loosely connected with it, and that the first part (1) and the second part (2) respectively are rotatable about an axis in the hinge joint (8,9), thus enabling the first part (1 ) and the second part (2) to be rotated to approximate mutual engagement with a free end (7) on the first part (1) and a free end (6) on the second part (2) respectively and closed to form the substantially circular ring (1 ,2), the ring (1 ,2) being arranged to be locked in this closed position by means of a locking device provided on the rotating joint.

2. A device according to claim 1 , characterized in that the first part (1) is approximately double the length of the second part (2).

3. A device according to claim 1 , characterized in that the locking device is a locking screw (4) provided in a receiving boring on a projecting section (8a) of the first connecting element (8), the locking screw (4) being arranged to be screwed through the boring until the tip of the former abuts against a projecting section (9a) on the second connecting element (9).

4. A device according to claim 1 or 3, characterized in that the free end (7) on the first part (1) has an axial groove which in the locked position of the ring (1 ,2) matches a corresponding tip on the free end (6) of the second part (2).

5. A device according to claim 4, characterized in that when the end (7) is matched with the end (6) in the locked position of the ring (1 ,2), there is a clearance of approximately 2 mm between the said ends (6,7).

6. A device according to claim 5, characterized in that the said clearance is created by means of cooperation between the hinge joint's connecting elements (8,9) when the locking screw (4) is screwed into abutment against the projecting part (9a) on the connecting element (9) and locks the ring (1 ,2) in the closed position.

7. A device according to claim 1 or 3, characterized in that the connecting elements (8,9) are mutually rotatably connected with a fixing screw (3) which constitutes the axis in the hinge joint (3,8,9).

8. A device according to claim 1 , characterized in that the hinge joint (8,9) comprises a spring-loaded clamping device, the clamping device causing the rotational movement which leads to the approximate mutual abutment between the free ends (6,7) during the formation of the substantially circular ring (1 ,2), while at the same time the clamping member can be locked mechanically in this position of the ring, where there is a clearance of approximately 2 mm between the ends (6,7).

9. A device according to one of the preceding claims, characterized in that the free end (7) on the first part (1) is arranged to be connected to a catheter when the first part (1) is separated from the second part (2) or the ring (1 ,2) is in an open position.

10. A device according to claim 1 , characterized in that, over a section which extends some distance from the connecting element (8), the first part has a larger diameter than the rest of the first part (1 ) which has the same diameter as the second part (2).