WO2016131938A1

WO2016131938A1 - Urethral probe assembly and method for customised assembly

Info

Publication number: WO2016131938A1
Application number: PCT/EP2016/053500
Authority: WO
Inventors: François-Noël DESFEMMES; Benoît VOGT
Original assignee: Desfemmes François-Noël; Vogt Benoît
Priority date: 2015-02-19
Filing date: 2016-02-19
Publication date: 2016-08-25
Also published as: FR3032885A1; FR3032886B1; FR3032886A1

Abstract

The invention relates to a urethral probe assembly (1) comprising: a probe body (10) comprising a vesical part (14) having a free end, said part being formed by a tubular wall (11) surrounding an inner channel (12) opening up at the free end, and having a constant diameter over the entire length of said part, a so-called renal end part (13), and an intermediate part (15) connecting the vesical part (14) to the renal part (13), and a holding tip (20) comprising an inner channel (22) opening up on two opposite sides of the tip, the inner channel being designed so as to receive, over at least part of the length thereof, a portion of the vesical part of the probe body, wherein the vesical part (14) extends from a distance from the renal end part (13), of more than or equal to 15 cms, and extends up to a distance from the renal end part (13) of more than at least 26 cms.

Description

URETERAL PROBE ASSEMBLY AND METHOD FOR ASSEMBLING THE SAME

MEASURED

FIELD OF THE INVENTION

The invention relates generally to endo-ureteral probes.

The invention is applicable in particular for the drainage of urine in case of compression of the ureter.

STATE OF THE ART

FIGS. 1 a and 1 b show diagrammatically a kidney R connected to a bladder V of an individual by a ureter U. The ureter is used to convey urine from the kidney to the bladder. It opens into the bladder at a meatus M.

Many pathologies can prevent the normal flow of urine into the ureter, for example kidney stones C, pyelo-ureteral junction syndromes, cases of extrinsic compression by malignant or benign retroperitoneal fibrosis, in case of ureteral or pyelic tumor, or in the case of ischemic or radicular ureteric narrowing.

The various pathologies preventing the drainage of urine are all indications for placing in the ureter, a so-called endo-ureteral probe.

With reference to FIG. 1a, we already know from the Applicant an endo-ureteral probe described in the patent application WO 2014/096264.

This probe has a renal portion 200 tubular and curved to be retained in the kidney, then a transition portion 220 tapered to become a wire

210, at the level of the ureter or bladder.

This probe has already rendered great services, to restore the drainage of urine from the kidney to the bladder, especially in case of obstruction of the ureter by stones. Indeed, the presence of a wire in the ureter induces, surprisingly, a dilation of the ureter which not only allows the flow of urine but can also allow the evacuation of stones.

However, this probe is not indicated in certain cases of extrinsic compression of the ureter, especially in the bladder meatus, for example by a cancerous tumor, or in cases of fibrous narrowing of the meatus or inflammation after dilatation. ureteral or removal of pelvic stones ... Indeed, under the effect of compression, the ureter can not expand. The wire of the probe being very fine, it does not prevent the compression of the ureter, until its total obstruction.

In this type of case, an indicated probe model is a conventional probe, commonly referred to as a "JJ probe", described with reference to Figure 1b.

This probe is tubular throughout its length. It has at its ends two curved loops 12, 14 J-shaped, which allow its maintenance in the kidney on the one hand and in the bladder on the other hand, and a medial portion 10 connecting these two loops, extending to inside the ureter.

However, this probe has disadvantages, in particular in that it is poorly supported by patients. In particular, the bladder loop of the probe can rub into the bladder and give irritation, edema, bleeding, pelvic heaviness, or urge urge urges in men and women.

This is particularly the case when the length of the probe is not adapted to the patient, and the bladder loop is in contact with the wall of the bladder opposite the meatus.

PRESENTATION OF THE INVENTION

The invention aims to overcome the problems mentioned above. In particular, the object of the invention is to propose a ureteral catheter allowing drainage of the ureter, including in the case of compression of the ureter in the vicinity of the meatus, and which is better supported by the patients. In this regard, the subject of the invention is a set of ureteral catheter comprising:

a probe body, comprising a so-called bladder part comprising a free end, said part being formed by a tubular wall surrounding an internal channel opening at the free end, the internal channel being of constant diameter along the entire length of said portion, a renal end portion, and an intermediate portion connecting the bladder portion to the renal portion, and

a retaining tip, having an internal channel opening on two opposite sides of the tip, the inner channel being shaped to receive, on at least part of its length, a portion of the bladder portion of the probe body,

wherein the bladder portion extends from a distance of the renal end portion greater than or equal to 15 cm, and extends to a distance of at least 26 cm from the renal end portion greater than .

Advantageously, but optionally, the probe assembly according to the invention may further comprise at least one of the following characteristics: the internal channel of the retaining tip has, over its entire length, a diameter of a greater value or equal to a minimum value among:

o that of the diameter of the internal channel of the bladder part of the probe body, and

o 0.9 mm.

the retaining tip has a wall extending around the internal channel, and the wall has, in at least one direction transverse to the direction of the internal channel, a dimension greater than the diameter of a section of the wall of the bladder portion; from the body.

the inner channel of the retaining tip is straight and the retaining tip has one of the following group:

a ball shape centered on the internal channel,

a coaxial cylinder shape with the internal channel,

o a flared shape along the axis of the internal channel.

the retaining tip comprises two half-shells, and a connecting device half-shells.

- The connecting device comprises a hinge connecting the half-shells pivotally on an edge, and the tip further comprises a means for retaining the half-shells on an opposite edge.

- The retaining means of the half-shells is of magnetic or snap type.

- The probe body has graduations on at least the bladder part.

- The bladder portion of the probe body comprises a plurality of cutting lines for the separation of a portion of the bladder part of the rest of the body. the retaining tip is slidably mounted on the bladder portion of the probe body.

the tubular wall of the bladder portion of the probe body has, on its outer surface, a plurality of notches arranged along said portion, and the retaining tip comprises a wall extending around the internal channel, said wall; having at least one protruding lug adapted to fit in the notches of the tubular wall of the probe body,

the retaining tip further comprises at least one recovery wire, preferably fixed to the tip by its two ends to form a loop. the wall of the probe body comprises, over at least a part of its length, a plurality of through orifices. The retaining tip may further include an anti-reflux valve adapted to obstruct an end section of the inner channel of the retaining tip.

The anti-reflux valve is advantageously a flexible membrane.

the renal end portion of the main body comprises a plurality of loops of increasing diameter towards the renal end, and extending transversely to the main direction of the main body.

The invention also relates to a method of assembling a ureteral probe assembly according to the preceding description, the probe body further comprising a renal portion and an intermediate portion extending between the renal part and the bladder part. , characterized in that it comprises the steps of:

a) from a target ureter length value, attaching the retaining tip to the bladder portion of the probe body at a distance from the renal portion corresponding to the target length of the ureter, and

b) removing a portion of the bladder portion of the probe body extending at a distance from the renal portion greater than the target length. Advantageously, but optionally, step b) is implemented after step a), and includes removing the entire length of the bladder portion emerging from the retaining tip. The proposed probe assembly makes it possible to adjust the length of the probe according to the patient who receives it, by cutting the bladder part of the probe to a given length and fixing the retaining tip at the end thus cut.

In this way, it eliminates the risk of contact between the probe and the wall of the bladder located opposite the meatus.

In addition, the retaining tip maintains the probe in the bladder by replacing the bladder "J" loop of the traditional "JJ" probe.

Finally, the width of the internal channel of the retaining tip allows, once the probe in place, that it is not obstructed by compression exerted on the ureter or bladder. The drainage of urine into the bladder is thus ensured.

DESCRIPTION OF THE FIGURES

Other features, objects and advantages of the invention will emerge from the description which follows, which is purely illustrative and nonlimiting, and which should be read with reference to the appended drawings in which:

Figures 1a and 1b, already described, illustrate probes of the prior art.

FIG. 2 diagrammatically represents an example of a set of ureteral probe,

FIGS. 3a and 3b show schematically the implantation of an example of a ureteral probe assembled from a probe assembly,

FIGS. 4a to 4h show schematically different examples of external forms of a retaining tip,

FIGS. 5a to 5f show various examples of attachment of a retaining tip on a probe body,

FIGS. 6a and 6b show various examples of probe bodies,

Figures 7a and 7b show the implementation of the main steps of a method of assembly of a ureteral probe assembly according to the invention.

- Figures 8a to 8c show the implementation of the main steps of an assembly method according to another embodiment.

- Figure 9 schematically shows the main steps of an assembly method according to the invention.

FIGS. 10a to 10d illustrate an example of a probe comprising an anti-reflux valve. Figures 11a and 11b illustrate two exemplary shapes of a renal end portion.

DETAILED DESCRIPTION OF AT LEAST ONE EMBODIMENT OF THE INVENTION

Set of ureteral catheter

With reference to FIG. 2, a set 1 of endo-ureteral (or ureteral) probe according to one embodiment of the invention is schematically represented.

The assembly comprises a main body 10 of probe, and a retaining tip 20.

The main body 10 comprises a tubular wall January 1 surrounding an internal channel 12 in which a fluid can flow.

The tubular wall 11 may be bent at a first end to form a renal end 13 in the shape of a semicircle or "J" loop analogous to a conventional probe end "JJ" in order to keep the probe in position in a Other embodiments of the renal end portion 13 are described in more detail below.

Other endings of the main body can be retained to perform this same function.

The main body 10 also includes a bladder end portion

14, this portion being connected to the renal end portion by an intermediate portion

15, and having a free end forming the bladder end of the probe body. The internal channel 12 opens at the free end of the bladder part.

The tubular wall 1 1 of the probe body 10 advantageously comprises a plurality of orifices 1 10 over at least a part of its length, for example at least on the renal end portion 13 to allow the passage of fluid between the outside. of the probe and the internal channel.

Advantageously, the probe body 10 has orifices 1 10 along its entire length.

However, in some cases part of the length of the probe, in particular the intermediate portion 15 and / or the bladder portion 14, may be without holes 1 10, in the case where the probe body 10 is intended to be implanted in a ureter near or around which there is a tumor.

The absence of orifices makes it possible at the same time to strengthen the probe body to prevent its obstruction by the tumor compressing the ureter and to prevent the tumor from entering the probe through openings.

The bladder end portion 14 may take several possible forms described in more detail below. The internal channel 12 is, at this part, a circular section of constant diameter channel. Preferably, the internal channel 12 is of circular section and of constant diameter over the entire length of the main body 10.

In addition, the bladder end portion 14 at least, and preferably the main body in its entirety, advantageously has a constant outer diameter, between 4 and 10 French, or between 1.3 and 3.4 mm, preferably between 5 and 8 French, or between 1.7 and 2.7 mm, and very advantageously of the order of 7 or 8 French, or 2.3 or 2.7 mm.

The diameter of the inner channel 12 depends on the outer diameter of the probe body. It is preferably between 0.9 mm and 1.55 mm.

In addition, the bladder end portion 14 comprises at least a substantially rectilinear portion, that is to say without loop. According to one embodiment, shown in Figure 2, the bladder end portion 14 may be integrally rectilinear.

As a variant not shown, the bladder end portion 14 may comprise a rectilinear portion and, adjacent thereto, a curved or semicircular curved end.

As described in more detail below, the probe assembly is assembled by mounting the retaining tip 20 on the bladder end portion 14 of the main body 10. The tip must be positioned so that once the probe in place, it is located in the bladder, near the ureteral meatus, so as to prevent the probe from rising in the ureter. Moreover, the bladder end portion 14 must be adjusted in length, depending on the length of the ureter of an individual, so that the probe, once assembled and positioned, does not irritate the wall of the bladder opposite the meatus. Therefore, the bladder portion 14 advantageously has a size large enough to cover all possible uses cases, before being adjusted in length.

As the ureter of a patient has an average length of between 20 and 26 cm, the bladder portion 14 should extend from a distance less than the minimum length of a ureter and up to a distance greater than the maximum length.

Advantageously, the portion 14 therefore extends from a distance of the renal end portion greater than or equal to 15 cm, for example equal to 20 cm, corresponding to the minimum size of the ureter of an individual, and extends to a distance from the renal end portion greater than at least 26 cm, for example between 30 and 40 cm.

In addition, once the probe assembly is assembled by mounting the retaining tip 20 on the bladder portion 14 to form a probe 1 'which will be positioned in the ureter of the patient, the tip being positioned in the bladder at ureteral meatus level, it is particularly advantageous that the tip 20 remains permanently plated ureteral meatus, including adapting to the movements of the kidney and therefore the length changes of the ureter when the patient breathes, moves or changes position.

For example, during inspiration, the kidney descends and the ureter shortens slightly, and during expiration, the kidney rises and the ureter extends slightly. In another example, a calculus present in the ureteral meatus can cause the presence of edema that makes the meatus tightened. After the removal of the calculation, the healing of the edema can cause a dilation of the meatus which allows the tip to rise slightly while being blocked laterally on the meatus by the appropriate shape of the tip 20.

To adapt to these variations in length, the renal end portion 13 of the main body 10 is advantageously shaped to allow dynamic adaptation of the total length of said body 10, and therefore of the probe 1 'once the tip 20 assembled on the main body.

To ensure this dynamic adaptation, the renal end portion is advantageously elastically deformable in the main direction of the probe body, so as to have a variable length in this direction. The elastic nature of the renal end portion gives it a shape memory that allows it to return to its original geometry after a deformation

The renal end portion is further flared towards the renal end so as to have at least one, and preferably a plurality, of the renal end portion support points on the wall of the renal pelvis or on the renal end portion. end of the ureter opening into the pelvis, when the probe 1 'is positioned in the ureter.

For example, the renal end portion 13 comprises a succession of loops of increasing diameter towards the renal end, the loops extending transversely to the main direction of the probe body, and preferably in a plane orthogonal to said direction .

With reference to FIGS. 11a and 11b, two exemplary embodiments of such a renal end portion 13 of the probe are shown. In Fig. 11a, the renal end portion 13 has a helical shape, and the loops are turns 130 of increasing radius towards the end.

In Fig. 11b, the renal end portion is S-shaped or zigzag-shaped, i.e. substantially planar, and each loop 131 has an increasing distance from the axis XX extending from the intermediate part and towards the renal end.

There is shown for each of these examples of renal end portion of the bearing points on the renal pelvis. By thus relying on the pelvis, the renal end portion 13 remains in position in case of slight shortening of the ureter and will generate a booster effect on the tip 20 positioned in the bladder and thus maintain the tip plated against the meatus of the ureter.

In the case of a lengthening or a shortening of the ureter, or a change of position of the kidney in the main direction of the probe body, the elastic nature of the part 13 makes it possible to accommodate this variation in length and still keep the tip 20 against the meatus of the ureter.

The width of the loops intended to bear against the pelvis is preferably greater than 20 mm, and preferably between 30 and 40 mm to allow this part to adapt to different sizes of pelvis.

A semi-circle or loop shape of the traditional "JJ" probe does not allow this operation because on the one hand it is not rigid enough and the loop can unfold during a lengthening of the ureter and move the probe to the bladder, which does not occur with the presence of several loops and secondly it does not exhibit elastic behavior in the main direction of the body 10. In addition, it can be difficult to deploy in a dilated pelvis and the Loop then becomes a random form that can render the calculated target length null and void. In another example, the distal end of the loop can be positioned in a lower calyx of the kidney and part of this loop become too long to be projected into the ureter, away from the mouthpiece 20 of the meatus ureter.

In addition, if following a lengthening of the ureter, the probe is moved to the bladder, it can not resume its position in the pelvis later and the tip can move away from the ureter. This can then cause urine to reflux around the catheter to the kidney and irritation of the adjacent bladder.

Therefore, it is therefore preferable to use the elastic renal end portion 13 described above for best results in terms of tolerance and prevention of reflux.

The retaining tip 20 is intended to be mounted on the main body 10 of the probe, at the level of the bladder end portion 14. In this respect, it comprises a through internal channel 22, opening on either side of the retaining tip.

The inner channel 22 forms both a housing in which at least a portion of the bladder portion 14 is inserted, and, where appropriate, a fluid flow channel portion. This is the case for example when the free end of the bladder portion 14 opens into the inner channel 22 of the tip 20, for example as in Figure 4a or 4e.

The internal channel 22 is advantageously of circular section and has, in any cross section, a diameter greater than or equal to the smallest value between:

the diameter of the internal channel 12 of the main body at the level of the bladder part, and

- 0.9 mm.

This diameter thus determined is sufficient to ensure the flow of urine into the bladder, even with compression of the ureter or bladder, near the meatus. Indeed, the diameter of the inner channel of a probe being determined to ensure drainage of urine, the fact that the internal channel diameter is equal or greater also ensures this effect. In addition, 0.9 mm is the minimum diameter of the inner channel of a probe, so the inner channel 22 of the tip is preferably larger.

Advantageously, but optionally, the internal channel 22 is substantially rectilinear, to facilitate the flow of urine. Alternatively it can be slightly curved. For example, an angle formed by the normals to the sections of the internal channel 22 through which it opens the nozzle is in this regard less than 90 °, and preferably less than 50 °.

The tip 20 has a length, measured between the two sections of the inner channel 22 through which it opens, between 2 and 10 mm, preferably between 5 and 8 mm. This corresponds, once the tip in place on the bladder portion 14 of the probe body, to the length of the portion occupied by the tip 20.

According to one embodiment, shown for example in Figure 4b, the diameter of the inner channel 22 of the nozzle is constant. It is then advantageously substantially equal to the outer diameter of the probe, in order to receive the probe.

According to an alternative embodiment, shown for example in Figure 4a, the inner channel 22 comprises a portion 220 of diameter equal to the outer diameter of the main body, and a portion 221 of diameter equal to the diameter of the inner channel 12 of the main body. This portion 221 forms an internal recess which serves as a stop for the body 10 when it is inserted into the nozzle 20. This is less preferred because it is more difficult to manufacture.

According to yet another embodiment, shown for example in Figure 4e, the inner channel 22 has a cross section of increasing diameter along its entire length, preferably from a minimum diameter equal to the outer diameter of the probe body.

In this case, the tip 20 must be positioned on the main body 10 so that the diameter of the cross section is increasing towards the bladder, that is to say that the minimum diameter section is closer to the part. intermediate 15 of the main body 10 as the maximum diameter section. The main body 10 and the retaining tip 20 are preferably made of a polymeric material, preferably polyurethane or silicone. A portion of the main body 10, for example a portion of the intermediate portion 15 or the bladder portion 14, may be reinforced by adding iron-like metal type, or by a portion of metal turns extending around the wall 1 1. The tip 20 may also be reinforced, for example by adding iron-like metal type, to be more rigid than the main body and oppose compression of the urine flow channel. In order to be able to recover the probe once put in place, the tip 20 advantageously comprises one or two wires 26. A wire may be connected to the tip 20 by its two ends to form a more solid loop, presenting a decreased risk of break. External shape of the retaining tip

With reference to FIGS. 4a to 4h, the endpiece 20 also comprises a wall 21 extending around the internal channel 22 and delimiting said channel. The wall 21 is shaped to prevent the rise of the tip 20 - once mounted on the main body 10 - in the ureter via the meatus M.

Consequently, the wall 21 comprises at least one transverse section, that is to say extending transversely to the axis of the internal channel 22, of greater principal dimension than the diameter of the meatus M, so as not to be able to switch to through. The wall 21 has in particular a major dimension greater than the outer diameter of the tubular wall 1 1 of the main body.

Advantageously, the wall 21 has at least one section whose main dimension is greater than 14 French, or 4.7 mm, for example between 14 and 60 French, or between 4.7 and 20 mm, the diameter of a typical ureteral meatus being of the order of 2 mm.

The wall 21 may have a substantially constant cross section over the entire length of the internal channel 22.

Alternatively, the cross section is variable.

In Figures 4a to 4h, various non-limiting embodiments have been shown. However in all cases the sharp edges are replaced by roundings or chamfers to avoid any risk of irritation of the wall of the bladder. In Figure 4a, forming a preferred embodiment, the tip 20 has a ball shape. The maximum diameter of the ball is advantageously between 4.7 and 9 mm, for example equal to 7 mm. The ball is preferably coaxial with the internal channel 22.

This embodiment is preferred because it has no roughness likely to irritate the wall of the bladder, and is better supported by the patient.

Alternatively, in Figures 4b and 4c, the wall 21 of the nozzle is flared along the inner channel, that is to say it has a circular cross section of substantially increasing diameter along the entire length of the channel 22. In longitudinal section, that is to say a section extending in a plane parallel to the axis of the internal channel, the wall 21 may have a point of inflection.

In FIG. 4b, the tip can be positioned on the main body 10 so that the minimum diameter cross-section of the wall 21 is closer to the intermediate portion 15 than the maximum diameter section - in which case the diameter of the the section is increasing from the intermediate portion 15 of the body 10 towards the bladder end.

Conversely, in FIG. 4f, the section of the tip 20 of maximum diameter can be on the side of the intermediate portion 15, and the diameter is increasing from the bladder end towards the intermediate portion 15.

In a variant, in FIG. 4d, the wall 21 of the nozzle has a cylindrical shape, preferably coaxial with the channel 22.

Alternatively, in Figures 4e and 4f, the wall of the nozzle has a frustoconical shape, preferably coaxial with the channel 22, and with rounded edges.

As for the embodiment of FIGS. 4b and 4c, the end piece can be positioned on the main body in one direction or the other (if the geometry of the internal channel 22 allows it), so that the diameter of a cross section of the tip is increasing from the intermediate portion 15 to the bladder end, or decreasing.

Alternatively, in FIGS. 4g and 4h, the wall 21 of the nozzle has a substantially tubular shape except for a section comprising one or more fins 210 extending radially around the internal channel 22. Preferably, the section carrying the fins is an end section. In addition, as in FIG. 4g, this section is advantageously the section of the tip 20 located most at the bladder end (therefore the farthest from the renal portion 13) of the main body 10 when the assembly is assembled. .

The vanes are preferably distributed at a constant angular interval over the entire circumference of the wall. In Figure 4g, the wall 21 has two opposite fins, and in Figure 4h, it has four fins disposed at 90 ° from each other.

The fins are preferably flexible. This is obtained for example by reducing the thickness of the constituent material of the tip at the fins relative to the thickness of the wall 21 of the nozzle around the inner channel.

Other forms could be envisaged as soon as the largest dimension of a cross section of the wall 21 exceeds the diameter of a ureteral meatus.

The different characteristics relating to:

The external shape of the tip 20,

The geometry of the internal channel 22 of the tip 20,

Positioning the end of the main body 10 with respect to the internal channel 22 of the endpiece 20,

are all combinable with each other. To show it, different combinations have been represented in FIGS. 4a to 4h and 5a to 5f.

Anti-reflux valve

FIGS. 10a to 10d show an advantageous variant embodiment of a probe 1.

The probe 1 advantageously comprises, at its bladder end, an anti-reflux valve 30, the function of which is to prevent a reflux of urine from the bladder to the kidney, especially during urination, this reflux being a source of pain and discomfort for patients.

The anti-reflux valve 30 is advantageously a flexible membrane, preferably elastic.

The flexible nature allows the valve to open and close only by deformation, without mechanical assembly in rotation of the valve relative to the end of the probe. In addition, the elastic nature allows the valve to be returned automatically to a closed position.

Thus the valve is advantageously made of latex or silicone.

The valve further has a shape adapted to obstruct at least one end section of the inner channel 12 of the main probe body 10, and preferably an end section of the inner channel 22 of the mouthpiece 20.

Thus the valve may for example have a disc shape whose diameter is greater than or equal to the diameter of the internal channel 12 of the main body 10 of the probe, and preferably greater than or equal to the diameter of the internal channel 22 of the nozzle 20, without however, to exceed the maximum dimension of a cross section of the tip (for example, the maximum diameter) to not protrude from the tip and cause possible irritation when the probe is in place.

If the internal channel 22 of the nozzle has a diameter equal to the outer diameter of the main body 10 at the bladder end portion 14, the valve may have a diameter equal to these diameters, for example between 1.3 and 3.4 mm, for example between 1.7 and 2.7 mm, and very advantageously on the order of 2.3 to 2.7 mm.

This disk extends transversely to the main direction of the internal channel 12 or 22 so as to close this channel at its end.

According to a particularly preferred embodiment, the anti-reflux valve 30 is carried by the nozzle 20. This allows a simplification of assembly because the tip 20 has in all cases an outer diameter greater than or equal to the outer diameter of the main body probe, so that it can be mounted on this main body. As a result, the area available for fixing the anti-reflux valve 30 is larger. Given the small sizes of commonly used probes, the tip has a double advantage of preventing the rise of the probe in the ureter and allow the mounting of a non-reflux valve, which would not otherwise be possible on a small diameter probe.

It is therefore particularly advantageous that, during assembly of the tip on the main probe body, the end 14 of the main body opens into the internal channel 22 of the tip or is flush with the end of the tip 20, not to emerge with respect to the tip. In addition, the valve advantageously has a shape adapted to obstruct the internal channel 22 of the nozzle 20, for example a disc shape whose diameter is greater than or equal to the diameter of the internal channel 22.

Thus, as can be seen in FIGS. 10a to 10c, in which the end 14 of the main body is shown flush with the end of the internal channel 22 of the nozzle 20, the valve 30 can close and cover completely the section through which the inner channel 22 and the inner channel 12 open, allowing a hermetic closure of these channels, in the closed position.

The valve 30 is positioned closer to the end section of the inner channel 22 of the nozzle, that is to say on the edge of the orifice through which the inner channel 22 opens. To ensure that the valve 30 does not come off of the connector, it is advantageously attached to the edge of the hole over at least ^1/8 of the circumference of the edge, for example between ^1/8 and 1/5 ^th circumference of the edge.

The valve 30 may be integral with the nozzle 20, for example by molding the assembly formed of the nozzle and the valve, or fixed thereto, for example by welding or gluing.

In Figures 10a and 10b, the valve 30 is shown in the closed position. In case of solid bladder or in case of urination, the bladder pressure, represented by an arrow, plates the valve 30 against the orifice and completely obstructs the internal channel 22 and the channel 12. The urine reflux of the bladder towards the kidney is then impossible through the internal channel of the probe.

In Figures 10c and 10d, the valve 30 is raised by the flow of urine (represented by an arrow) from the inner channel 12 of the main body to the bladder, thereby releasing the passage from the inner channel to the bladder.

The valve thus allows the normal flow of urine to the bladder while prohibiting reflux, especially during urination.

This valve is compatible with any form of tip, any internal channel geometry, any mounting means of the tip on the main body.

Of course, the characteristics relating to the retaining tip, the valve, and the mounting of the tip on the main body are also combinable with the various embodiments of the renal end portion 13. Mounting the retaining tip

With reference to FIGS. 5a to 5f, various embodiments of means for assembling a retaining tip to the rectilinear portion of the bladder end portion 14 of a probe main body 10 will now be described.

These different embodiments are also combinable with the various external shape characteristics of the endpiece and the positioning of the end of the main body 10 with respect to the internal channel 22 of the endpiece 20.

According to a first embodiment, shown in Figures 5a and 5c, the tip 20 may be formed of two half-shells 23. Each half-shell comprises a flat surface 230 (joint plane) in which is formed a groove 231 . The half-shells are shaped to form the tip 20 when they are placed opposite each other, the grooves 231 also being opposite to form the internal channel 22.

Advantageously, the shells 23 are interconnected by a connecting device 24. This device is advantageously a fixed hinge or material coming on a respective edge of the two half-shells, so as to connect the half-shells pivotally at the level by this edge.

The end piece 20 then comprises an additional retention means 25 of the half-shells, advantageously at the edge opposite this respective edge. The retaining means 25 may be the subject of several embodiments, and preferably may be:

A magnet 250, arranged in one of the half-shells, and an insert 251 arranged opposite, selected from a material sensitive to the magnet, for example metal. This embodiment is illustrated schematically in Figure 5a.

The magnet and the insert may be incorporated into the tip material to improve the biocompatibility of the tip.

A latching device comprising a notch 252 and a hook 253 shaped to be received in the notch, by an elastic deformation of the hook. This embodiment is illustrated schematically in FIG. 5c.

This embodiment is also combinable with any geometry of the internal channel 22 of the nozzle described above. According to a second embodiment, shown in Figures 5b, and 5d to 5f, the nozzle 20 is in one piece.

For its mounting on the main body, several variants can be envisaged.

In FIG. 5d, the tip 20 can be force-fitted around the end of the bladder portion 14.

In FIG. 5b, the bladder portion 14 comprises, on its external surface, a threading 140, and the tip comprises, on the inner surface of its wall 21, a thread 21 1 shaped to cooperate with the threading 140.

The tip 20 can thus be screwed onto the bladder part of the main body

In order to ensure a rotational stop of the nozzle relative to the main body, and thus block the nozzle in position, rings 3 stop can be provided.

In Figures 5e and 5f, the tip 20 is slidably mounted on the main body. In Figure 5e, at least one notch 141, formed on the outer surface of the bladder portion 14, can receive at least one complementary lug 212, on the inner surface of the wall 21 of the nozzle.

Preferably a plurality of notches 141 are arranged on the outer surface of the bladder portion to be able to adjust the positioning of the tip 20 on the main body and thus the length of the probe once assembled.

Preferably, the notches 141 are arranged at regular intervals along the entire length of the bladder part, for example every 5 mm.

The lug 212 may be a flexible lug to be able to cross a notch 141 by deforming when subjected to a sufficiently high pressure. This makes it possible to push the tip along the body 10 so that the lug penetrates successively into a plurality of notches 141 until reaching the desired position of the tip relative to the body 10.

Preferably, the notches 141 are shaped to make it more difficult for them to pass through the lug 212 by raising the tip towards the intermediate portion 15 than downwards towards the bladder end. For this, as in Figure 5e, a notch 141 may be shaped to form in the wall 21, the side of the intermediate portion 15 of the body 10, a right-angled edge, and the opposite side, an edge forming an obtuse angle .

The lug 212 advantageously has a shape complementary to that of the notch. One can also provide the opposite, namely that the crossing of the notches by the lug 212 is easier by bringing the lug of the bladder end 14 than the renal end (and the intermediate portion).

In a variant shown in FIG. 5f, the notches 141 are circumferential, and the lug 212 of the end piece is replaced by a circumferential shoulder 213.

In this embodiment, the internal channel 22 of the nozzle may also have a variable diameter, but preferably on a separate portion of a portion for attachment to the main body and having in this regard a thread, a lug , a shoulder, etc., as shown for illustrative purposes in Figure 5e.

According to a particular embodiment, the tip 20 is pre-mounted on the main body 10, at the bladder portion, and a flange of this portion at the bladder end section prevents separation of the tip and the body 10. The tip can then be fitted to the bladder portion 14 and fixed in position by any of the means presented above.

Adjusting the bladder part

As indicated above, the tip 20 is positioned on the bladder portion 14 of the probe body at a location such that once the probe assembled and positioned, the tip is in the bladder, in the vicinity of the ureteral meatus M.

To avoid irritation of the bladder, the length of the bladder portion 14 is adjusted so that there is the least possible material in the bladder after positioning the probe.

In this regard, a portion of the bladder portion extending beyond the position of the tip, that is to say at a distance from the renal portion greater than the length of the ureter, is advantageously cut off . The fact that the probe is made of polymer material, preferably flexible, facilitates this cutting.

To further facilitate cutting, with reference to FIG. 6b, the bladder portion 14 advantageously comprises a plurality of cutting lines 143, which are weakened sections of the bladder portion 14 by at least one primer 144 and / or perforations 145. These cutting lines allow to separate a part the main body 10 of the rest without requiring significant effort or particularly sharp tool.

The cutting lines 143 are advantageously arranged at regular intervals over the height of the bladder part, for example every 5 mm.

Cumulatively, or alternatively, with reference to FIG. 6a, the main body 10, or only the bladder portion 14, may include graduations 146, making it easier to transfer a previously measured ureter length to determine at what level to position the ureter. tip 20 and cut the excess of the bladder portion 14.

These embodiments may advantageously be combined with those of FIGS. 4a to 4h, 5a, and 5c to 5f. For Embodiments 5e and 5f, the notches may be at the same level as the cut lines - the notches also forming primers. Assembling a probe

Referring to Figures 7a and 7b, 8a to 8c and 9, a method of assembling a probe assembly 1 as described above to form a probe 1 'will now be described.

During a first step 100, a ureter length, called the target length, of a patient to be fitted with a ureteral catheter is measured. This step is carried out conventionally by inserting, in the ureter of a patient, a conventional rectilinear ureteral catheter (that is to say a straight probe, uncurved) graded. The measured distance, previously called "ureter length", is exactly the distance from the bottom of the renal pelvis (uterine junction) to the ureteral meatus. This distance is measured by visualizing the graduation at the meatus once the probe is in place.

Once the target length obtained, this length is transferred to a main body 10 of the assembly 1 during a step 200. It is measured, as in Figures 7a and 8a, from the projection, on an axis from the center of the renal end loop 13.

The section S of the bladder part at the end of the length reported corresponds to the section of the probe located at the level of the ureteral meatus. It therefore indicates the position of the end of the retaining tip 20 farthest from the bladder end. According to a first embodiment, represented in FIGS. 7a and 7b, the method first comprises a cutting step 300 of the bladder portion 14 at a section S 'between the section S thus determined and the end bladder of the main body.

The distance between the cutting section S 'and the section S delimits the portion of the bladder portion 14 on which is fixed the nozzle (portion engaged in the inner channel 22 of the nozzle).

Therefore this portion preferably has a length corresponding to the length of the tip 20, for example 5 to 10 mm. Thus the entire portion is housed in the inner channel 22 of the tip but does not emerge thereof.

Alternatively this portion may have a slightly shorter or longer length, for example being a few millimeters shorter or longer, for example up to 3 mm shorter or longer than the length of the tip.

Then the assembly method comprises a step 400 of fixing a tip 20 at the end of the bladder portion 14 thus cut, so that one end of the tip reaches the section S. If the cutting section S is distant from the section S by a length equal to the length of the tip, as in FIG. 7a, then an upper end of the tip is at the level of the section S and the opposite end is at the right of the the cut end of the main body (Figure 7b). In this way, the internal channel 12 of the main body opens to the right of the orifice through which the channel 22 emerges.

In the case where the cutting section is distant from the section S by a length a few millimeters shorter than the length of the tip, the internal channel of the bladder part emerges in that 22 of the tip (FIG. 4a for example ).

In the case where the cutting section is distant from the section S a length greater than a few millimeters to the length of the tip, the free end of the bladder portion 14 emerges slightly protruding from the tip 20.

Nevertheless, the bladder portion is preferably cut so as not to protrude from the tip 20 by more than one centimeter or even indicated above, a few millimeters, and preferably not at all protrude, to avoid any risk of irritation.

According to an alternative embodiment shown in FIGS. 8a to 8c, the tip 20 can be positioned at the section S during a step 300, then a portion of the bladder portion 14 emerging from the tip 20 can be cut during a step 400, preferably by shaving the endpiece 20 as much as possible.

The probe 1 'is then positioned in the ureter so that the renal end portion 13 is in the kidney pelvis, and the tip 20 is in the bladder, glued to the ureteral meatus.

In the case where the renal end portion 13 adapts to deformations of the ureter, the latter is deformed dynamically and keeps the tip 20 pressed against the meatus to promote the tolerance of the probe 1 'and reduce the risk of reflux and adjacent bladder irritation. In addition, the possible anti-reflux valve carried by the tip further minimizes these risks.

The probe assembly and the proposed method of assembly make it possible to provide patients with ureteral probes that are tailor-made. Thanks to the geometry of the tip, it keeps the probe in place while preventing obstruction of the ureter, for example because of a tumor.

As a result, the quantity of material inside the bladder is limited at the same time as the risk of obstruction.

Adjusting the length of the bladder part helps to decrease the amount of material in the bladder. The patient is therefore less irritated and therefore less embarrassed on a daily basis.

Claims

1. Set (1) of ureteral catheter comprising:

a probe body (10) comprising a bladder part (14) comprising a free end, said part being formed by a tubular wall (1 1) surrounding an internal channel (12) opening at the free end, the channel internal catheter being of constant diameter along the entire length of said portion (14), a so-called renal end portion (13), and an intermediate portion (15) connecting the bladder portion (14) to the renal portion (13), and

a retaining tip (20) having an internal channel (22) opening on two opposite sides of the mouthpiece, the inner channel (22) being shaped to receive, over at least a portion of its length, a portion of the portion bladder (14) of the probe body (10) so that the retaining tip can be mounted on said bladder portion (14),

wherein the bladder portion (14) extends from a distance of the renal end portion (13) greater than or equal to 15 cm, and extends to a distance from the renal end portion (13) greater than at least 26 cm.

2. Assembly (1) according to claim 1, wherein the inner channel (22) of the retaining tip has, over its entire length, a diameter of a value greater than or equal to a minimum value among:

the diameter of the internal channel (12) of the bladder portion (14) of the probe body (10), and

- 0.9 mm.

3. The ureteral probe assembly (1) according to one of claims 1 or 2, wherein the retaining tip (20) has a wall (21) extending around the internal channel (22), and the wall has in at least one direction transverse to the direction of the inner channel (22), a dimension greater than the diameter of a section of the wall (1 1) of the bladder portion (14) of the body (10).

The ureteral probe assembly (1) according to claim 3, wherein the inner channel (22) of the retaining tip (20) is straight and the retaining tip has one of the following group: a ball shape centered on the internal channel,

a cylinder shape coaxial with the internal channel,

a flared shape along the axis of the internal channel.

5. Set (1) ureteral probe according to one of claims 1 to 4, wherein the retaining tip (20) comprises two half-shells (23), and a connecting device (24) half-shells .

The ureteral probe assembly (1) according to claim 5, wherein the connecting device (24) comprises a hinge connecting the half-shells pivotally to an edge, and the tip further comprises a retaining means ( 25) half-shells on an opposite edge.

7. Set (1) ureteral probe according to claim 6, wherein the retaining means (25) of the half-shells (23) is of magnetic or snap type.

8. The ureteral catheter assembly (1) according to one of the preceding claims, wherein the probe body (10) has graduations (146) on at least the bladder portion (14).

The ureteral probe assembly (1) according to one of the preceding claims, wherein the bladder portion (14) of the probe body (10) has a plurality of cut lines (143) for separating a portion of the bladder part of the rest of the body.

10. The ureteral probe assembly (1) according to one of the preceding claims, wherein the retaining tip (20) is slidably mounted on the bladder portion (14) of the probe body (10).

1 1. An assembly (1) according to claim 10, wherein the tubular wall (1 1) of the bladder portion (14) of the probe body has on its outer surface a plurality of notches (141) disposed along said portion , and the retaining tip comprises a wall (21) extending around the inner channel (22), said wall having at least one lug (212) protruding adapted to be housed in the notches of the tubular wall of the probe body.

12. Set (1) ureteral probe according to one of the preceding claims, wherein the retaining tip (20) further comprises at least one wire (26) recovery, preferably attached to the tip by its two ends to form a loop.

13. The ureteral probe assembly (1) according to one of the preceding claims, wherein the wall (1 1) of the probe body (10) comprises, over at least a part of its length, a plurality of through orifices ( 1 10).

14. The ureteral probe assembly (1) according to one of the preceding claims, wherein the retaining tip (20) comprises a check valve (30) anti-reflux adapted to obstruct an end section of the inner channel (22). of the retaining tip.

15. Set (1) of ureteral catheter according to the preceding claim, wherein the valve (30) anti-reflux is a flexible membrane.

The ureteral catheter assembly (1) according to one of the preceding claims, wherein the renal end portion (13) of the main body (10) has a plurality of loops (130, 131) of increasing diameter towards the renal end, and extending transversely to the main direction of the main body (10).

17. A method of assembling a set (1) of ureteral catheter according to one of the preceding claims, the probe body (10) further comprising a renal portion (13) and an intermediate portion (15) extending between the renal part and the bladder part (14), characterized in that it comprises the steps of:

a) from a target ureter length value, attach the retaining tip (20) to the bladder portion (14) of the probe body (10) at a distance from the renal portion (13) corresponding to the target length of the ureter, and b) removing a portion of the bladder portion (14) of the probe body extending at a distance from the renal portion greater than the target length.

18. An assembly method according to claim 17, wherein step b) is implemented after step a), and comprises removing the entire length of the bladder portion (14) emerging from the tip of restraint (20).