FR2557460A1 - URETRAL DRAIN AND EQUIPMENT FOR BRIDGING OBSTRUCTIONS IN THE URETRE COMPRISING SUCH A DRAIN - Google Patents

Abstract

THE INVENTION RELATES TO A DRAIN-CATHETER CONSTITUTED ESSENTIALLY BY AN ELONGATED FLEXIBLE TUBULAR ELEMENT WITH AN EXTERIOR SURFACE SENSITIVELY UNITED THROUGHOUT ITS LENGTH, AND PROXIMAL 11 AND DISTAL 12 OPEN ENDS. THIS DRAIN IS CHARACTERIZED IN THAT THE SAID PROXIMAL END 11 OF THE TUBULAR ELEMENT IS SHAPED SO AS TO HAVE THE SHAPE OF A HOOK 13, 14, AND IN THAT THE OPENING 11A DEFINED AT THIS PROXIMAL END 11 HAS A DIAMETER MORE SMALL THAN THAT OF THE OPENING 12A DEFINED AT THE SAID DISTAL END 12 OF THE SAID ELEMENT. APPLICATION IN THE FIELD OF URETRAL CATHETERIZATION AND DRAINAGE.

Description

D RTRAL

  The present invention relates to urethral drains. It relates more particularly to an improved drain which can be used for bridging obstructions and which is easier to replace than

drains known until now.

  Urethral drains-catheters for permanent placement are used for bridging urethral obstructions or urethrovaginal fistulas and for maintaining urinary drainage. In the past, drains consisting of straight sections of open ended tubes have been used for this purpose and have

  satisfactory drainage for prolonged periods of time. Toute-

  However, the use of these open ended tubes is not entirely

  given satisfaction. For example, in some cases, the tube is

  it moved unexpectedly and in other cases was expelled.

  Various attempts have been made to create drains that do not pose the problems encountered when using open tubes of the kind mentioned above. In this way, drains have been designed which are closed at one of their ends to facilitate the introduction and passage through the channel of a body and which are provided with a flange at the other end to prevent, as far as possible, any inadvertent movement of the drain forward (or towards the

  above). According to another solution, the body of the drain is provided with barbs.

  very sophisticated arrangements arranged in such a way as to prevent

  pestifying backwards (or downwards) and expelling the drain. However, such barbs cause an increase in the diameter of the drain, which makes its introduction more difficult and, under certain conditions, they

  can cause a "migration" of the drain outside the bladder.

  U.S. Patent Nos. 4,212,304 issued July 15, 1979 and No. 4,307,723 published December 29, 1981 disclose urethral drains provided at each end with hooks which are

2 2557460

  surprisingly effective in preventing inadvertent movements and expulsion. The drains covered by these patents are used

  on a large scale because they are easy to introduce as endosco-

  only during "open" surgery.

  All drains available on the market have some common disadvantages. When they are flexible enough and flexible so as not to cause discomfort to the patient, it is difficult to pass them in front of obstructions in the urethra, and when

  remove them, they are difficult to replace or put back.

  The present invention aims to create a perfused urethral drain

  which is flexible and flexible enough to ensure patient comfort, and can be used to bridge obstructions

present in the urethra.

  Moreover, the subject of the invention is a method for bridging an obstruction using the drain, as well as equipment for the implementation of

of this process.

  The invention also relates to a method for replacing the drain according to the invention, as well as equipment for the implementation

of this process.

  The urethral drain-catheter-according to the present invention has an elongate flexible tubular member having a substantially solid surface along its entire length, as well as open proximal and distal ends. The proximal end of the tubular element has the shape of a hook and an opening smaller than that of the end.

distal.

  The drain is preferably formed in a flexible, flexible and X-ray-opaque manner, and may be provided with visible indicator means through a cystoscope and indicative of the direction in which the proximal end hook is extends when the

drain has been put in place.

  To put the drain in place, a guidewire is generally introduced through the distal opening and into the passageway concerned. The

  guide wire used for this purpose has a front end presenting

  dimensions larger than those of the opening of the

  proximal mite. The guidewire is introduced until its front end reaches the proximal opening. Since the guidewire is relatively stiff, the hook recovers during this phase of operation. Then, put a push-pull on the end

3 2557460

  free of the guide wire behind the drain, to facilitate the passage

of the drain through a cystoscope.

  When there is an obstruction in the urethra that prevents the drain from being positioned in the normal way, the drain and guidewire are removed, and the drain is threaded onto a second wire. guide having a small diameter and a terminal end which passes through the opening of the proximal end of the drain. The guide wire

  thinner is introduced into the urethra and, using a standard procedure

  of retrograde catheterization and a cystoscope

  the front end and the end of the guide wire in front of the obstruction

  struction. When the terminal end and the leading end of the thin guidewire have reached their desired position in the lower calyx or renal pelvis, the drain is advanced along the guidewire.

  and it is positioned in a suitable manner, using a drain-pump.

  The guide wire is then removed and, if necessary, the

push-drain drain.

  When it is desired, for any reason, to replace the drain, locate its distal open end and introduce the thin guide wire through the drain so as to straighten the hook. The drain is then completely removed, leaving the thin guide wire in place, and then a second additional drain (or replacement drain) is passed through the thin guidewire through the length of the thin guidewire. the desired position, using a push-drain. When the replacement or replacement drain is positioned correctly,

  the push-pull and the guide wire are removed.

  The invention will be described below in more detail, in particular with reference to the appended figures, by way of illustration,

but not limitation.

  FIG. 1 represents, in elevation, a preferred embodiment of the drain, the drain pump and the guide wires according to the present invention; - Figure 2 shows the drain shown in Figure 1, seen from behind; - Figure 3 shows, in elevation, a guide wire with enlarged proximal end; - Figure 4 shows, on a larger scale and partially in section, the proximal end of the drain shown in Figure 1; - Figure 5 shows-, in section and on a larger scale, a part

4 2557460

  the body of the drain shown in Figure 1; - Figure 6 shows, in elevation, the large guide wire placed in the drain, the hooks being straightened;

  FIG. 7 shows, in section and on a larger scale, the end

  proximal mite of the drain and the guide wire of Figure 6; Figure 8 is an elevational view similar to that of Figure 6, but shows the thin guide wire placed in the drain;

  FIG. 9 shows, in section and on a larger scale, the extremes

  proximal mites and the thin guidewire of the

figure 8.

  In the preferred embodiment shown in FIG.

  drain 10 is formed of an elongate tubular member having an end

  proximal mite 11 and a distal end 12. The portions adjacent to each of the ends 11 and 12 form hooks 13 and 14 at low

  curvature which respectively extend in two opposite directions.

  The two hooks 13, 14 of the drain, with a small curvature and oriented in opposite directions, prevent unwanted displacements or "migrations" of the drain forwards and backwards (or upwards and downwards), when it has been put in place. Hooks 13 and 14 can be incorporated with a suitable material which reduces its flexibility

  and thereby, in a more efficient manner,

  inadvertent effects of the drain. The hooks 13 and 14 extend in opposite directions, so that when the drain 20 serves as an indwelling urethral drain, the proximal end 11 can hook into the

  calyx or renal pelvis, while the distal end

  Tale 12 extends into the bladder along a curved path. This arrangement also prevents the drain from directly striking the mucosa of the

  bladder, which reduces the risk of discomfort and inflammation.

  The drain 10 has a relatively rectilinear central portion 15

  which extends between the proximal hook 13 and the distal hook 14.

  The drain 10 is formed of a suitable flexible material, such as

  nylon, which is sufficiently flexible and rigid enough to correspond to

  to the conditions of use envisaged, and which contains, preferably

  The drain can be dimensioned in French size of 7 and 8.5 and with lengths of 16, 24, 26, 28 and 30 cm. The nominal length indicated is that of the

2557460

  part 15 and does not take into account the hooked or curved ends 13 and 14. With this system, the user can evaluate radioscopically the urethral length and choose the appropriate drain for each particular case. As is apparent from FIGS. 1, 2, 4 and 5, the drain 10 comprises radial drainage passages 16 which connect the channel (or bore) 17

  drain 10 on the outside and allow indoor / outdoor drainage.

  The drainage passages 16 are arranged on both sides of the

  rectilinear part 15 and spaced about 5 cm. As shown in particular

  5, the passages placed respectively on the two sides

  are preferably aligned with each other.

  As indicated in FIGS. 1 and 4, the inner wall of the proximal hook 13 is provided with similar openings or passages 18,

but larger.

  FIG. 1 further shows a drainpipe 19, a relatively large diameter guidewire 20, which is normally used to place the drain 10 in position in a passage of the human body, and a guidewire 21 relatively small diameter that is used to bridge obstructions difficult to treat, and for the

  drain replacement. FIG. 3 shows a guidewire 22 comprising

  both an enlarged proximal end 22a; this guidewire can also

  be used during normal placement of a drain 10 and for

bridging obstructions.

  Both ends 11 and 12 of the drain 10 are open. As shown in particular in FIG. 4, the opening 11a of the proximal end is smaller than the opening 12a of the distal end or

  that the passage or bore 17 of the drain. When introducing the introductory

  In a normal endoscopic procedure, the relatively large guiding wire 20 is introduced into the bore 17 of the drain 10 in order to straighten both ends.

  hooks 13 and 14, as shown in Figure 6. Then, the end

  20a of the guide wire 20 is prevented from coming out of the bore 17 of the drain 20, as shown in FIG. 7, because of the opening

  proximal 11a relatively narrow.

  To facilitate the precise positioning of the drain 10, the push-rod 19 is threaded onto the free end of the guide wire 20. When the puddle 19 has reduced dimensions, it can be mounted forcibly in the distal opening 12a; this allows to partially remove and reorient the drain, if necessary, during the

6 2557460

  classic retrograde catheterization. We then use the push

  drain 19 to advance the drain 10 to the desired position. Once the drain 10 has been properly positioned, the guide wire 20 and the drainpipe 19 are moved apart by withdrawing the drainpipe 19 while holding the guidewire 20, thereby separating the drainpush 19 from the drain 10, after which the guide wire 20 is first removed,

then the push-drain 19.

  When the presence, in the urethra, of an obstruction which can not be "bridged" by the drain 10 according to the conventional method of introduction, the drain 10 and the guidewire 20 are removed, and the the drain 10 is threaded onto a guide wire 21 of smaller diameter, which

  has an elastically deformable end 23 unreinforced at its end.

  proximal mate 21a (as shown in particular in Figures 8 and 9). The non-reinforced elastic tip 23 reduces the risk of damage to the body of the

  by the guide wire 21. The tip 23 and the

  proximal mating 21a of the guidewire 21 through the proximal opening

  11a of the drain and passes them in front of, and beyond, the obstruc-

  the urethra. When it is well established that the tip 23 and the

  21a have passed the obstruction, the drain 10 is advanced along the guide wire 21 to beyond the obstruction, and pushed to put it into place, using the drain 19. The guide wire 21 is then removed and the drainpipe 19 is disengaged.

of the drain 10.

  The guidewire 22 may be used in a similar manner to position the drain 10 and point an obstruction. When it is expected that no problem will be encountered, due to an obstruction, first introduced the enlarged head 22a of the guide wire 22 in the bore 17 and the drain is passed in front of the obstruction in the same way as described above with the use of

guidance 21.

  When it is desired to replace a drain, according to the present invention,

  which has been permanently fixed, we first examine visually by cystosco-

  the X-ray opaque drain, and then a pair of

  forceps or a "computational basket" of the retractable type (not shown

  tees) to remove the drain until the distal end 12 is accessible; we must obviously be careful not to remove the drain 10

  passing it past an obstruction of the urethra. Then we introduce

  the proximal end 21a and the end 23 of the thin guidewire 21 are formed.

7 2557460

  through the distal opening 12a and into the bore 17 of the drain 10 and advanced to straighten the hooks 13 and 14 (as shown in Fig. 8). The guidewire 21 is continued to advance until the proximal end 21a and the tip 23 pass through the proximal opening 11a, as shown in FIGS. 8 and 9. Next, the drain 10 is removed without removing the guide wire 21. Another drain is threaded, with its proximal end in the head, onto the guide wire 21 and is advanced to the desired position, as described above, for example into the bladder, through the urethra and in the kidney. When the new drain has been properly

  put in place, the guide wire 21 is removed.

  The urethral drain-catheter 10 according to the present invention is preferably formed of nylon having a hardness of from about 70 Shore "A" to about 55 Shore "D", supplemented with barium sulfate as a nylon imparting agent. X-ray opacity has been observed. Drains made of this material have been found to be flexible enough not to unduly inconvenience the patient, while being rigid enough to be able to "bridge" (that is, to pass in front of the patient). or bypass) obstructions in the urethra. We can

  also use other plastics, such as rubber

  silicone rubber, which have the desired characteristics and

  resistant to encrustation under the effect of urinary salts.

  The drain 10 is preferably manufactured by extrusion of a pipe section having the desired dimensions and hardness. The proximal end 11 of the tube is then placed in a mold to reduce the dimensions of the opening 11a so that its diameter is

  less than that of the large guide wire 20 and that of the bore 17.

  The tube is then placed in a form or die to form the hooks 13 and 14. The drainage openings 16 and 18 may be provided during any stage of manufacture; for this purpose, the wall of the tube is pierced with a flattened and sharpened perforator having the desired dimensions, or with the aid of a laser, or

  still by any other suitable classical means.

  The drain-catheter 10 according to the invention can be presented in the form of a constituent element of equipment intended for normal insertion or insertion and for bridging complicated obstructions, or equipment intended for the replacement of a existing drain that was

set up permanently.

8 2557460

  Equipment for normal introduction and bridging of obstructions

  complicated urethral procedures may comprise a drain 10 having the required dimensions and either the two guide wires 20 and 21, or the

  mixed guidewire 22 (which is shown only in FIG. 3).

  Equipment for replacing a previously installed permanent drain may include a spare drain and a drain wire.

guidance 21.

  A drain pump 19 may be part of each of these two equipment.

  ments; it is also possible to manufacture a drain pump starting from a half-length section of a relatively rigid standard urethral catheter, the dimensions of which preferably correspond to the size

French 5 ("5 French").

  In the preferred embodiment described and shown in the accompanying figures, the distal and proximal end portions of the drain-catheter are both in the form of low-curvature hooks. However, it should be noted that the term "hook" is

  here, in a sense that also covers any

  functionally equivalent, which is capable of preventing inadvertent displacements, which do not result in an increase in the effective outer diameter of the drain, and which does not complicate the

introduction process.

  The invention is not limited to the embodiments described above and shown in the accompanying figures. It is likely to undergo many modifications and variations on the part of those skilled in the art, without departing so far from the spirit

  and the scope of the invention, as defined in the claims

below.

9 2557460

Claims (6)

  1.- Drain-catheter consisting essentially of an element   elongated flexible tubular having a sensitive outer surface   integrally along its entire length, and proximal (11) and distal (12) open ends, characterized in that said proximal end (11) of the tubular member is shaped to be in the form of a hook (13). , 14), and in that the opening (11a) defined at this proximal end (11) has a diameter smaller than that of   the opening (12a) defined at said distal end (12) of said member.   2. Drain according to claim 1, characterized in that the element   tubularity has a hardness of about 70 Shore "A" to about Shore "D".   3. Drain according to claim 1, characterized in that said tubular element is formed of an X-ray opaque material. 4. Drain according to claim 1, characterized in that it comprises hook-shaped portions (13, 14) arranged at its two ends.   ends and extending respectively in opposite directions.   5. Drain according to claim 1, characterized in that it comprises at least one radial drainage passage (16) allowing the indoor / outdoor drainage.   6. Equipment for bridging obstructions in the urethra by means of a urethral train, characterized in that it comprises: a) a urethral drain (10) comprising a relatively flexible elongate tubular element which has at least a drainage aperture traversing a portion of the wall of said element, the latter having a proximal end (11) and an end   distal (12), while a portion of said proximal end   male (11) is shaped to form a hook (13a) and that said proximal end (11) has an opening (11a) of smaller dimensions than that (12a) of the distal end (12), and b) a guidewire (20, 21, 22) intended to be introduced into said drain and having an end of dimensions smaller than those of said opening (11a) of the aforementioned proximal end (11), so as to allow this end of the wire 2557460   outputting the drain (10) through the aforesaid opening (11a) of the proximal end (11) of the drain (10) and bypassing an obstruction in the urethra, said guidewire (20, 21, 22) being able to act as a guide for passing said drain (10) in front of said obstruction.