Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
  • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
  • A61M27/008—Implant devices for drainage of body fluids from one part of the body to another pre-shaped, for use in the urethral or ureteral tract
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents

Definitions

• the field of the invention is that of endo-ureteral probes, used for the maintenance of urinary flow in the ureter.
• the ureter U is a channel connecting a kidney R to the bladder V, and in which the urine flows freely in the absence of obstacles.
• the ureter may be obstructed under certain conditions, for example in the presence of kidney stones C, pyelo-ureteral junction syndromes, in the case of extrinsic compression by malignant or benign retroperitoneal fibrosis, in case of ureteral or pyelic tumor, or in case of ureteral ischemic or radiation narrowing.
• a first end 12 opens into the kidney, and a second end 14 opens into the bladder, both ends being bent to maintain the position of the probe. Because both ends are curved J-shaped, such a probe is commonly called "JJ probe".
• the JJ probes are generally polyurethane, silicone or metal and have an average diameter of 6 or 7 French, or 2 or 2.3 mm. They are asked for a duration of 6 to 12 months.
• the probe 1 comprises throughout its length a plurality of through orifices 16, for the communication of fluid, in this case urine, between the inner channel of the probe and the environment in which it is placed.
• fluid in this case urine
• the urine can again flow freely between the kidney and the bladder through the probe 1 and the orifices 16. It can flow only via the internal channel of the probe or between the walls of the probe and the ureter depending on the nature and position of the obstacle in the ureter.
• the JJ probes have already rendered great service, but they nevertheless have certain disadvantages.
• the urine can not only flow freely from the kidney to the bladder, but also in the opposite direction from the bladder to the kidney, because the catheter opens an anatomical system that normally prevents urine to flow back from the bladder to the kidney.
• this probe because of its diameter may rub in the bladder or against the ureter, and give irritation, edema, pelvic heaviness, or urge urge urges in men and women.
• the probe is poorly supported by approximately 80% of patients.
• each wire has a diameter greater than 0.5 French, that is to say greater than 0.16 mm, and preferably between 2 and 4 French, that is to say between 0.66 and 1.3 mm, so that to obtain, with the two bent wires, a section large enough to allow a good drainage of the urine.
• the tail is described as generally rigid to keep shape in memory. It is indeed considered imperative to maintain a sufficiently large wire thickness to allow the drainage of urine, to avoid the risk of not draining the urine and lead to obstructive pyelonephritis, or even septic shock iatrogenic.
• the invention aims to overcome the problems mentioned above.
• the purpose of the invention is to propose an endo-ureteral probe allowing the drainage of urine from the kidney to the bladder, without causing irritation to the patient or reflux.
• the subject of the invention is an endo-ureteral catheter, comprising a renal end portion and a bladder end portion, the renal end portion being tubular and curved,
• said probe being characterized in that the bladder end portion comprises at least one wire, and in that the probe further comprises a tubular intermediate portion extending between the renal end portion and the bladder end portion, said portion having a decreasing outer diameter towards the bladder end portion and the minimum outer diameter of the tubular intermediate portion, at the connection with the bladder end portion, is equal to the diameter of the yarn (s) of the bladder end portion; bladder end, said intermediate portion having a length of between 0.5 cm and 12 cm.
• the probe according to the invention may further comprise at least one of the following characteristics:
• the son or son are of circular section, each wire having a diameter less than 0.15 mm.
• the bladder end portion comprises a single wire.
• the intermediate portion has a length of 3 cm.
• the diameter of the intermediate portion decreases evenly over the entire length of said portion.
• the intermediate portion is tapered.
• the bevelled intermediate portion comprises a tubular portion and a solid portion terminating said portion, the bladder end portion comprising a wire passing through the wall of the solid portion and the wall of the tubular portion or the renal end portion.
• the intermediate portion comprises a tubular portion and a full portion extended by the bladder end portion, the wire of the bladder end portion being integral with a wall of the intermediate portion.
• the bladder end portion has a length greater than or equal to 2 cm, preferably between 5 and 30 cm.
• the renal end portion and the intermediate portion each comprise a plurality of through perforations.
• the probe further comprises a tubular ureteral portion disposed between the renal end portion and the intermediate portion, said ureteral portion having an outer diameter equal to that of the renal end portion and being devoid of perforations.
• the tubular ureteral portion has a length of between 10 and 25 cm.
• the invention also relates to a method for treating an urological disorder by implantation of an endo-ureteral probe, the method comprising:
• the endo-ureteral probe comprising a renal end portion, a bladder end portion, and an intermediate portion extending between the renal end and the bladder end portion, the intermediate portion having an outer diameter decreasing towards the bladder end portion, and the bladder end portion comprising at least one wire extending from the intermediate portion, and
• the method of treating a urological disorder may further comprise at least one of the following features:
• implantation of the probe comprises positioning the renal end portion in a kidney of a subject and the at least one wire in the ureter such that the at least one wire causes dilation of the ureter.
• Implantation of the probe includes positioning the renal end portion in the kidney and the intermediate portion in the ureter such that the at least one wire extends from the ureter into the bladder.
• the implantation comprises positioning the intermediate portion in the kidney so that the at least one wire extends from the kidney into the ureter.
• the urological disorder comprises kidney or ureteral stones, and the dilation of the ureter comprises dilating the ureter with the at least one ureter.
• the urological disorder includes ureteral or ureteral stones, obstructive ureteropelvic junction syndrome, extrinsic tumor ureteral stenosis, malignant retroperitoneal fibrosis, benign retroperitoneal fibrosis, ischemic ureteral stenosis, post-radiation ureteral stenosis, or ureteral stenosis. or intrinsic tumor pyelic.
• the invention also relates to a method for treating an urological disorder by implantation of an endo-ureteral probe, the method comprising:
• Implantation of an endoureteral probe in the ureter of a subject the endo-ureteral probe having a wire portion sized to dilate the ureter, and
• the treatment of the urological disorder by the dilation of the ureter with the wire part of the endo-ureteral probe.
• this method of processing further comprises at least one of the following features:
• the wire portion comprises a circular section of diameter less than 0.15 mm.
• the endo-ureteral probe further comprises a tubular portion having a decreasing diameter to a first end, and wherein the wire portion extends from said end of the tubular portion, and the implantation comprises positioning the tubular portion in a kidney of a subject and the wire part in the ureter.
• the tubular portion comprises a curved portion at an opposite end of the first end, and the curved portion and the first end comprise orifices, and a ureteral portion extending between the curved portion and the first end is devoid of orifices; and the implantation comprises positioning the ureteral portion and the wire portion in the ureter.
• the urological disorder includes kidney stones or ureteral stones, and the treatment includes the removal of stones, or fragments of stones, kidney or ureter when the endo-ureteral probe remains implanted in the ureter.
• the urological disorder comprises one of renal stones, ureteral stones, or obstructive pyelo-ureteral junction syndrome
• the implantation comprises positioning the tubular portion of the endoureteral probe in a kidney of a subject and the wire part in the ureter.
• the urological disorder includes one of extrinsic tumor ureteral stenosis, malignant peritoneal fibrosis, benign retroperitoneal fibrosis, ischemic ureteric stenosis, post-radiation ureteral stenosis, or ureteric or intrinsic tumor pyelic stenosis.
• extrinsic tumor ureteral stenosis malignant peritoneal fibrosis, benign retroperitoneal fibrosis, ischemic ureteric stenosis, post-radiation ureteral stenosis, or ureteric or intrinsic tumor pyelic stenosis.
• the calculus fragments are evacuated around the son (s) and the renal end portion without any pain of renal colic. This phenomenon is explained by the fact that the dilation of the ureter promotes the evacuation of the fragments, and the son or son prevent the brutal obstruction.
• the intermediate portion of decreasing diameter between the two end portions being regularly tapered, it reduces the risk of edema may result from attachment of the probe in a portion of ureter.
• FIG. 1 already described, schematically represents the implantation of a probe of the state of the art in a ureter comprising a renal calculus.
• FIG. 2a schematically represents an endoureteral probe according to one embodiment of the invention
• Figure 2b schematically shows the implantation of a probe shown in Figure 2a in a ureter comprising a ureteral computation.
• Figures 2c and 2d show two variants of the probe of the figure
• Figure 3a schematically shows an endo-ureteral probe according to a second embodiment of the invention.
• Figure 3b schematically shows the implantation of a probe of Figure 3a into a ureter.
• FIG. 4a is a scanner made on a patient in which a probe has been implanted, illustrating the dilation of the ureter following the laying of the probe.
• Figure 4b is a photograph taken from the inside of a ureter in which a probe has been placed, and which also illustrates the dilation of the ureter.
• Figures 5a to 5c are radiographs showing the natural evacuation of calculation through the establishment of a probe.
• Figures 6a and 6b show longitudinal sectional views of an intermediate portion of a probe.
• Figures 7a to 7c schematically illustrate the movement of a probe in a ureter during breathing of an individual.
• Figure 8a schematically shows an endo-ureteral probe according to an alternative embodiment of that of Figure 2a.
• Figure 8b schematically shows the implantation of a probe of Figure 8a into a ureter compressed by an extrinsic tumor.
• Figures 9a and 9b schematically represent steps of a therapeutic treatment implemented with the probe.
• This probe 2 comprises a first renal end portion 200.
• This part is tubular, that is to say it comprises a cylindrical wall 201 defining an internal channel 202 in which a fluid can flow.
• a plurality of through orifices 203 are furthermore arranged in the cylindrical wall 201, allowing the fluid to enter the internal channel 202 or exit through the wall 201.
• the renal end portion 200 is curved J-shaped, i.e., has a semicircular or loop-shaped (i.e., ring-shaped) end allowing, once the probe is implanted, the maintenance of this part 200 in a kidney R.
• this part may have one or more segments interconnected by rounded elbows to avoid abrupt or cutting section.
• the renal end portion 200 is configured to enter the kidney once the probe is in place, and extend from the kidney R to the ureter U of the patient.
• it has a length, when curved, between 6 and 20 cm, preferably between 8 and 10 cm, preferably equal to 9 cm.
• This variation in length depends on the location of the obstacle at the level of the ureter because indeed the renal end portion 200 "advantageously bypasses" the obstacle, that is to say ends at a level of the ureter no longer including any obstacle.
• this renal end portion is limited to the loop of the "J", that is to say to a single tubular ring, of the order of 22 mm in diameter.
• the loop when the loop is bent, which corresponds to a length, maintaining this straight part, of the order of 7 cm, or more generally a diameter of between 10 and 25 mm, the minimum diameter used to prevent the loop from entering the ureter in the curled state, and the maximum serving diameter being limited so as not to cause pain or discomfort.
• the portion 200 has a constant external diameter D 2 oi of between 2 and 3.4 mm (ie from 6 to 10 French), preferably between 2 and 2.4 mm ( from 6 to 7 French), and very advantageously of the order of 2.4 mm (7 French).
• this portion 200 preferably has a constant outer diameter of between 1 and 3 mm, and preferably of the order of 2 mm (6 French), or even 1 .6 mm (or 4, 8 French) so that this part, shorter, is also more flexible to allow to unfold it during its withdrawal.
• the probe 2 furthermore has a second bladder end portion 210 intended to penetrate into the bladder V and to extend from the ureter U to in the bladder V.
• This portion comprises at least one yarn, and preferably may comprise a single yarn, which may be free or folded to form a loop, as illustrated in FIG. 2c, or two yarns, illustrated in FIG. preferably full, that is to say of circular section and devoid of internal channel. The absence of an internal canal eliminates the risk of reflux from urine to the kidney.
• each wire has a constant diameter D 2 of less than 0.15 mm, that is to say 0.45 French, preferably between 0.05 and 0.15 mm, even more advantageously understood. between 0.1 and 0.15 mm, that is to say from 0.3 to 0.45 French, and preferably equal to 0.1 mm or 0.3 French. In any case, the diameter of the wire or the accumulated section of the wires must not exceed 0.3 mm.
• the two-wire separation also avoids the rigidity of a single thicker yarn.
• the inventors have discovered that, surprisingly, the use of a single wire of small diameter makes it possible, unlike the prejudices prevalent in the field, to drain the urine from the ureter to the bladder.
• the proposed probe and in particular the wire of small diameter, causes dilation of the ureter, within a period of two weeks to ten days after the installation of the probe.
• FIG. 4a is a scanner made in a patient in which one probe has been placed in the right ureter, the other ureter being devoid of a probe.
• Probe S1 has been called a probe according to the embodiment of FIGS. 2a and 2b
• Probe S2 is a probe according to the embodiment of FIGS. 3a and 3b, in which the renal part is shorter and the intermediate portion 220 is also in the kidney.
• a method of treating kidney stones is proposed.
• a first step is to implant a probe in the ureter and kidney.
• the probe used is preferably in accordance with the embodiment of Figures 3a and 3b, because it is not necessary to drain the urine from the inside. the probe to get around an obstacle.
• the ureter After the insertion of the probe, the ureter is dilated over its entire length, and furthermore, the son or wires of the probe are sufficiently thin so as not to encumber the ureter and allow the insertion of a ureteroscope associated with a tool.
• ad hoc for example a laser fiber, for locally processing a calculation. It is therefore not necessary, unlike interventions previously implemented after the installation of a probe JJ, to remove the probe JJ to process the calculation, then to put a probe in place. This results in a reduction of the manipulations and the cost of the intervention.
• the treatment differs depending on the size of the calculation to be evacuated. For small stones, less than about 10 mm in size, these stones can be removed naturally from the ureter to the bladder by the flow of urine into the ureter, and then out of the bladder through urination.
• a second step is to fragment the calculation.
• This step is preferably carried out a certain time after the placement of the probe, so that the ureter is sufficiently dilated. Thus it is preferable to wait ten days after the laying of the probe, and preferably of the order of fifteen days to three weeks to fragment the calculation.
• This fragmentation can be performed according to known methods by extracorporeal lithotripsy, or by ureteroscopy (shock waves or laser) or by percutaneous nephroscopy (shock waves or laser).
• the stones or fragments then slide from the kidney to the ureter, then from the ureter into the bladder and finally out of the bladder without pain.
• Figures 5a to 5c are radiographs of a patient at different stages of removal of kidney stone fragments.
• a probe 2 according to the embodiment of FIGS. 3a and 3b a was positioned in the ureter 15 days previously, and the computation was fractionated into fragments F.
• the wire is very flexible and does not cause any irritation, patients are relieved and see their comfort of life improve.
• Table 2 summarizes urinary symptoms experienced by patients in whom a poorly tolerated JJ probe has been replaced by an S1 Probe ( Figures 2a and 2b).
• the tolerance of the wire 210 with respect to the tolerance of the bladder part of the JJ probe was evaluated by questionnaire.
• Each question had five possible answers, to which scores of 1 to 5 were assigned, 1 being the score assigned to the response corresponding to zero discomfort and 5 to the greatest discomfort.
• score 1 is assigned to the answer “Never”, 2 to the answer “Rarely”, 3 to “Sometimes”, 4 to “Most of the time”, and 5 to “All the time”.
• Table 2 shows average scores experienced by patients
• the bladder end portion 210 has a length greater than or equal to 2 cm, preferably between 5 and 30 cm, preferably between 20 cm and 28 cm.
• the wire used therefore measures twice the bladder end portion, ie at least 4 cm, and preferably between 10 and 60 cm.
• the part of the wire penetrating inside the bladder V after placement of the probe 2 is left free in the bladder and can be cut if necessary.
• the part below the sphincter does not have a clinical translation. In particular, there is no incontinence.
• the transition between the renal end portion 200 and the bladder end portion 210 must be progressive to prevent abrupt change in probe diameter from catching in elbows. Ureter U.
• the probe further comprises an intermediate portion 220 extending between the renal end portion 200 and the bladder end portion 210.
• this intermediate portion is intended to be positioned in the U ureter when the probe 2 is in place.
• the intermediate portion is intended to be positioned in the kidney R when the probe 2 is in place, so that there is only one or two son in the ureter.
• This intermediate portion 220 is tubular, that is to say it comprises a wall 221 of annular section and further comprises an internal channel 222 in which a guide can slide for the introduction of the probe, and in which a fluid can flow once the probe is in place.
• the channel 222 is in the extension of the channel 202 of the renal end portion so as to allow fluid communication between the two.
• the intermediate portion 220 has a variable external diameter D220 decreasing towards the bladder end portion 210 so that the minimum external diameter of the intermediate portion 220 at the connection with the wire is substantially equal to the diameter D 2 of the wire of the bladder end portion 210.
• substantially it is meant that the minimum diameter of the intermediate portion 220 must not exceed twice the diameter of the wire, or the accumulated section of the son s' there are several, and in any case must be strictly less than 1 mm, and preferably less than 0.5 mm, the connection between the intermediate portion and the son or son is then smoothed to the maximum (for example bevelled) for avoid any saw-tooth asperities that can cause pain. This ensures a smooth and smooth transition between the two extreme diameters of the probe and to give more flexibility to the probe so that it can adapt to the curvature of the ureter. This reduces the pain associated with the presence of the probe and facilitates its removal.
• a probe of the type JJ has a clean cut without intermediate portion 220 ensuring a transition between the two. If the probe is at a distance from a sinuosity of the ureter, the movements of this probe do not cause pain.
• the maximum outer diameter of the intermediate portion 220 is equal to that of the renal end portion.
• the intermediate portion has a diameter decreasing regularly from a diameter of about 2.4 mm to a diameter of about 0.15 mm.
• the tubular part of the probe that is to say the part of the probe which comprises an internal channel, terminates at the end of the intermediate portion 220.
• the internal channel 222 of the portion 220 opens into the ureter through an orifice (not shown) formed in the wall 221, near the junction with the wire 210 of the bladder end portion.
• the intermediate portion 220 of the probe is bevelled, so that the intermediate portion comprises a first tubular portion 224, and a second portion 225 ending the intermediate portion 220, the portion 225 being open laterally, so that the channel 222 opens into the ureter, said second portion being in fact full, that is to say non-tubular, and being extended by the bladder end portion 210.
• Embodiment is advantageous because the beveled shape has a continuity that allows the probe not to hang in the ureter.
• portion 225 because of the bevel, is very flexible, which further reduces the risk of snagging and guide the probe within the ureteral folds during breathing movements.
• the wire 210 may be integral with the wall of the intermediate portion 220. Alternatively, it may be attached thereto, for example glued or fixed on the wall, or knotted at an orifice 223.
• the wire 210 emerges from the internal channel 222 of the portion 220, that is to say it is secured to the cylindrical wall 221 at an inner surface thereof, and this so as to do not form a protrusion on the outer surface of the wall 221, as schematically illustrated in Figure 2a.
• a wire is advantageously attached to the intermediate portion 220 and folded in two, preferably in the middle, to obtain a double wire.
• This embodiment is however applicable also to the embodiment of Figures 2a and 2b.
• the wire passes through a first orifice of the wall of said portion 220 at the beveled tip 225 thereof, and crosses the wall of the probe in the vicinity of the junction between the intermediate portion 220 and the renal end portion 210, i.e., at the tubular portion 224, or at the end of the renal end portion 210.
• the wire is advantageously tied on either side of the wall of the beveled tip 225 to hold it in position.
• At least one wire 210 may be integral with the wall of the intermediate portion 220 or be attached thereto, for example glued or fixed, and emerge the inner channel 222 of the intermediate portion 220 (at the beveled tip 225). This makes it possible to preserve the continuity of the different parts of the probe and thus not to cause discomfort to the patient.
• the wall of the probe should be as smooth as possible and free of roughness (no abrupt angle variation, clean cut, surface roughness) to avoid irritation of the ureter and any discomfort of the patient.
• the junction between the intermediate portion 220 and the bladder end portion 210 is located very preferably at a distance from the meatus M of the ureter when the probe 2 is in place, that is to say from the orifice of the ureter that opens into the bladder, so that only the wire 210 crosses the meatus and enters the bladder V.
• the intermediate portion 220 has a length of between 0.5 and 12 cm, depending on the position of an obstruction of the ureter - the portion 220 then has a decreasing section evenly over its entire length, preferably of the order of 3 cm. This length ensures the smooth transition between the two end portions of the probe.
• the intermediate portion advantageously has a length of the order of 1 cm, allowing only one or two son enter the ureter and into the bladder through the meatus M.
• the urine is drained from the kidney to the bladder, through the internal channel 202 of the renal end portion and 222 of the intermediate portion 220, or along the walls of the these parts, then flowing along the wire 210.
• the probe which includes all the preceding features, further comprises a ureteral portion 240 extending between the renal end portion 200 and the intermediate portion 220.
• This ureteral portion is tubular, and therefore comprises a cylindrical wall 241 defining an internal channel 242 communicating at one end with that 202 of the renal end portion 200 and at another end with that 222 of the intermediate portion 220 to provide communication of fluid all along the probe.
• This portion 240 has an external diameter D 240 equal to that of the renal end portion 200, and a length of between 10 and 25 cm, and preferably of the order of 20 cm.
• this portion 240 is reinforced and in particular does not comprise perforating orifices, so that the fluid can only flow inside the internal channel 242.
• This part is in the ureter when the probe is in place, and allows to circulate the urine via the internal channel 242 in case of strong external compression of the ureter. This situation typically occurs in the case of tumor T adjacent to or surrounding the ureter. The absence of perforations prevents the tumor T from obstructing the internal channel 242.
• the probe 2 is preferably made of a polymeric material, preferably polyurethane or silicone.
• the wire of the bladder end portion may be made of such material or polypropylene.
• the intervention takes place under general or regional anesthesia.
• the renal end portion 200 of the probe is placed in the kidney through a endoscope and under image intensifier.
• a pusher about 50 cm is needed to push this part into the kidney.
• a ureteral probe such as the Open-End Flexi-Tip probe.
• the wire or wires of the bladder end portion are left in the bladder being careful not to push them into the ureter with the rest of the catheter.
• the probe can be removed under local anesthesia using a fiberscope and forceps by pulling on a wire.
• a wire does not break during removal of the probe, but ablation can be tricky lack of suitable grip equipment.
• it is advantageous to use a biopsy forceps such as the model Karl Storz - Endoskope, Biopsy Forceps, double action jaws, 7F (ie 2.33 mm), length 40 cm, 27175A.

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• 2012
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