System and method for removing calcified double-j catheters

Abstract

The invention relates to a system and a method for removing a calcified double-J catheter, which provides a simpler and safer solution in procedures for removing calcified double-J catheters. The system comprises: an elongate tubular body sized to allow a double-J catheter to slide therein, comprising a receiving end and a coupling end; and a device that generates impact energy, designed to couple to the coupling end of the elongate tubular body and transmit impact energy associated with small sequential strikes through the elongate tubular body, wherein the elongate tubular body comprises a side opening in an area adjacent to the coupling end to enable, during use, the exit of a double-J catheter that enters through the receiving end.

Description

[0001] SYSTEM AND METHOD FOR THE REMOVAL OF A CALCIFIED DOUBLE J CATHETER

[0002] The present invention relates to medical devices used in urology services. Specifically, the present invention consists of a system for the removal of calcified double-J catheters between the renal and bladder cavities or for the removal of a retained double-J catheter.

[0003] BACKGROUND

[0004] A double-J stent is a urinary diversion catheter, consisting of a small, flexible, multi-perforated tube inserted into the ureter to connect the kidney to the bladder and facilitate urine flow. One of the major complications associated with double-J ureteral stents is calcification, as lithogenic mineral salts tend to adhere to or become embedded in the catheter, either in its bladder portion, its renal portion, both, or even its entire surface.

[0005] The removal of a calcified ureteral catheter is highly complex and is currently performed using various techniques, the most common being:

[0006] - Extracorporeal shock wave lithotripsy (ESWL), performed using shock waves, involves dislodging the calcified catheter and then removing it if complete catheter release is achieved. - Percutaneous nephrolithotomy (PCNL), used in cases of proximal loop calcification, either due to large stone masses or the impossibility of retrograde access. - Endoscopic ureteroscopy and nephrolithotomy (EUR) requires inserting an optical instrument parallel to the calcified double-J stent along the entire length of the ureter, along with the need to repeatedly free the catheter from adhered stone fragments. This makes the procedure extremely slow and tedious, often preventing complete stone release in a single procedure.

[0007] - Cystolithectomy which corresponds to the direct fragmentation of the stones attached to the distal loop of the double J catheter that is in an intravesical position (portion of the double J catheter that is the easiest to release).

[0008] 1

[0009] REPLACEMENT SHEET (RULE 26) However, each of these techniques is highly complex, with inconsistent results and often requiring more than one procedure to release the retained catheter. Consequently, prior art demonstrates a need for simpler and safer systems that provide greater efficacy and safety in procedures for removing calcified double-J stents.

[0010] BRIEF DESCRIPTION OF THE INVENTION

[0011] To address the deficiencies mentioned above, a system for the extraction of retained double J catheters is presented, comprising:

[0012] an elongated tubular body sized to allow the sliding of a double J catheter inside, comprising a receiving end and a coupling end; and

[0013] an impact energy generating device configured to couple to the elongated tubular body at its coupling end and transmit impact energy associated with small sequential blows through said elongated tubular body;

[0014] wherein the elongated tubular body comprises a lateral opening in an area adjacent to the coupling end, to, in use, allow the exit of a double J catheter that enters through the receiving end.

[0015] Thus, the double-J catheter extraction system comprises an elongated tubular body, shaped like a cannula, providing a lithotripter system that allows for the treatment of calcification of the proximal loop and the mid-portion of the double-J catheter inserted between the renal and bladder cavities, or the presence of a retained catheter. The system operates by using an impact energy generator that produces small, sequential impacts at the receiving end of the elongated tubular body. This can be achieved through ultrasonic vibrations on an object or through ballistic pneumatic systems, such as the EMS Lithoclast® system, or other similar systems widely known in the prior art.In this configuration, the double-J catheter extraction system is designed to receive a retained double-J catheter at the receiving end of the elongated tubular body and allow its removal using the impact energy supplied by the impact energy generator. The double-J catheter is then slid into the elongated tubular body until it exits through the lateral slot, in an area adjacent to the coupling end.

[0016] The double-J catheter extraction system described here offers several advantages over current technologies. First, the system significantly reduces the time required to remove a calcified catheter, thereby saving on the use of expensive medical devices such as semi-rigid ureteroscopes (and their associated wear and tear) and disposable flexible ureteroscopes, and decreasing the number of laser medical device uses. Consequently, the system reduces the number of operating rooms required for successful removal of a calcified catheter, increasing operating room availability and freeing up operating rooms for other patients.

[0017] BRIEF DESCRIPTION OF THE FIGURES

[0018] Figures 1a and 1b show schematic representations of the main components of the system, according to a preferred configuration of the present invention.

[0019] Figure 2 is an image showing a side opening in an area adjacent to the coupling end of the elongated tubular body, according to a preferred configuration of the present invention.

[0020] Figure 3 is a first image of the system in use, showing a double-J catheter exiting through the lateral opening of the elongated tubular body, according to a preferred configuration of the present invention. Figure 4 is a second image of the system in use, showing a double-J catheter entering through the receiving end of the elongated tubular body, according to the configuration in Figure 3.

[0021] Figure 5 is an image of different elements of the system in a disassembled state, according to the configuration of Figures 3 and 4.

[0022] DESCRIPTION OF THE INVENTION

[0023] The following describes preferred implementations of the present invention, particularly for double-J catheter extraction systems, which can be implemented in various ways and under different operating conditions. As such, the following description of preferred configurations is not intended to limit the scope of the patent.

[0024] According to the preferred configuration illustrated in Figure 1, the invention consists of a double J catheter extraction system, comprising:

[0025] an elongated tubular body (110) dimensioned to allow the sliding of a double J catheter inside it, comprising a receiving end (112) and a coupling end (111); and

[0026] an impact energy generating device (120) configured to couple to the elongated tubular body at its coupling end (111) and transmit impact energy associated with small sequential blows through said elongated tubular body;

[0027] wherein the elongated tubular body comprises a lateral opening (113) in an area adjacent to the coupling end (111), to, in use, allow the exit of a double J catheter that enters through the receiving end (112).

[0028] Preferably, the elongated tubular body (110) may have a length and diameter that vary according to specific operating requirements, or depending on the type of impact energy generating device and its technical specifications. However, in general, the elongated tubular body (110) has dimensions appropriate to allow the sliding of a double-J catheter inside it and is made of a material robust enough to transmit the impact energy generated by the impact energy generating device (120).

[0029] The size and shape of the side slot (113) may vary depending on specific operating conditions, but it is sized to allow the free exit of a double-J catheter. For example, the side slot (113) may have various geometric shapes, including circular, oval, rectangular, or other shapes, provided it allows for the free exit of the retained catheter, has a sufficiently long longitudinal extension to allow the retrogradely inserted catheter to exit through the side slot (113), and allows for a smooth curve so that it is not constricted or restricted in its movement. Preferably, the size of the side slot (113) comprises less than 40% or 50% of the circumference of the elongated tubular body (110) to prevent the side slot (113) from structurally weakening the elongated tubular body (110).

[0030] According to Figures 1 and 2, in preferred configurations of the invention, the elongated tubular body comprises a wedge element (114), which is disposed inside the elongated tubular body (110), in the area of ​​the lateral groove (113). As can be seen more clearly in Figures 3 and 4, the wedge element (114) acts in conjunction with the lateral groove (113) to allow the exit of a double J catheter that slides inside said elongated tubular body (110), where the wedge element is positioned in such a way as to act as a stop or a guide element for the double J catheter as it advances inside the elongated tubular body (110), thus forcing its exit through the lateral groove (113).

[0031] More specifically, according to Figures 3 and 4, for the dislodgement and removal of a calcified double-J stent, a distal end of the double-J stent (130) is tied to the tip of a ureteral catheter (140), which is inserted retrogradely into the elongated tubular body (110) through the receiving end (112) and brought out through a lateral slot (113). In this way, once the double-J stent is threaded into the ureteral catheter, the impact energy generator is activated to dislodge the double-J stent (130), and the elongated tubular body (110) is advanced along the entire length of the double-J stent until it is completely extracted through the lateral slot (113).The impact energy generating device (120) may incorporate various known prior art devices, allowing the system to be adapted to operate with existing solutions, such as lithotripter systems like the EMS Lithoclast® system, Inceler medikal Lithobox, ELMED Vibrolith, Swiss Lithoclast Trilogy, or others. Impact energy, as defined herein, refers to any type of energy associated with generating a cyclical movement of the elongated tubular body, which produces a series of impacts at the receiving end (112) that dislodge a double-J catheter.Preferably, the impact energy generating device (120) includes ballistic-type pneumatic systems, or systems that combine ballistic-type pneumatic technologies with ultrasonic vibrations, with a combined fragmentation and pulverization effect for use with calculations and continuous aspiration through the elongated tubular body (110).

[0032] Figure 5 shows an exploded view of a preferred implementation of the present invention, wherein the double J catheter extraction system comprises coupling means configured to allow the attachment of the elongated tubular body (110) to the impact energy generating device (120). In this particular configuration, the system comprises a polymer sealing element (121) and a cap (122), which are configured to allow the removable connection between the elongated tubular body (110) and the impact energy generating device (120), as well as to allow the correct transmission of the impacts when using a ballistic pneumatic device.

[0033] The invention also includes a method for removing a calcified double J catheter, comprising the following steps:

[0034] • having a double J catheter extraction system that includes an elongated tubular body (110) with a receiving end (112) and a coupling end (111), and an impact energy generating device (120);

[0035] • release and / or dislodge a distal end of a calcified double J catheter; • externalize the distal end of the double J catheter, and tie the distal end of the double J catheter to the tip of a ureteral catheter, which is inserted retrogradely into the elongated tubular body (110) through the receiving end (112) and externalized through a lateral slot (113); • once the double J catheter is threaded, activate the impact energy generating device (120), and advance the elongated tubular body (110) over the calcified double J catheter, causing the dislodgement of the calcifications from the catheter by means of impact energy, and thus allowing access to the proximal intrarenal end;

[0036] • completely remove the double J catheter, already de-embedded, through the side slot (113) of the elongated tubular body (110).

[0037] Preferably, the step of freeing and / or dislodging the distal end of a calcified double-J stent can be performed using either a holmium or thulium laser fiber or a pneumatic / ballistic rod. Furthermore, preferably, the step of exteriorizing the distal end of the double-J stent can be performed either directly through the urethra or via a cystostomy.

[0038] Finally, it should be noted that various features of the invention, such as dimensions, materials, and specific aspects of the preferred configurations described above, may vary or be modified according to specific operational requirements. Consequently, the description of the specific configurations described above is not intended to be limiting, and such variations and / or modifications are within the spirit and scope of the invention.

Claims

LIST OF CLAIMS 1. A double J catheter extraction system, CHARACTERIZED in that it comprises: an elongated tubular body (110) dimensioned to allow the sliding of a double J catheter inside it, comprising a receiving end (112) and a coupling end (111); and an impact energy generating device (120) configured to couple to the elongated tubular body at its coupling end (111) and transmit impact energy associated with small sequential blows through said elongated tubular body; wherein the elongated tubular body comprises a lateral opening (113) in an area adjacent to the coupling end (111), to, in use, allow the exit of a double J catheter that enters through the receiving end (112).

2. A double J catheter extraction system according to claim 1, CHARACTERIZED in that the elongated tubular body (110) is configured with an extension and diameter appropriate to allow the sliding of a double J catheter inside it and is made of a material robust enough to transmit the impact energy generated by the impact energy generating device (120).

3. A double J catheter extraction system according to claim 1, CHARACTERIZED in that the side slot (113) includes different geometric shapes and has a longitudinal extension such that it allows the catheter being inserted retrogradely to come out through the side slot (113) and allows a smooth curve, so that it is not squeezed or restricted in its movement.

4. A double J catheter extraction system according to claim 1, CHARACTERIZED in that the size of the side slot (113) covers less than 40% or 50% of the circumference of the elongated tubular body (110).

5. A double J catheter extraction system according to claim 1, CHARACTERIZED in that the elongated tubular body comprises a wedge element (114), which is disposed inside the elongated tubular body (110), in the area of ​​the lateral groove (113), which acts as a stop or guide element to allow the exit of a double J catheter that slides through the inside of said elongated tubular body (110), 6. A double J catheter extraction system according to claim 1, CHARACTERIZED in that the impact energy generating device (120) includes the use of ballistic-type pneumatic systems and / or systems that combine ballistic-type pneumatic technologies with ultrasonic vibrations, among others.

7. A double J catheter extraction system according to claim 1, CHARACTERIZED in that it comprises coupling means configured to allow the removable coupling of the elongated tubular body (110) to the impact energy generating device (120) and to allow the correct transmission of the transmitted sequential shocks.

8. A method for the removal of a calcified double J catheter, CHARACTERIZED in that it comprises the steps of: • having a double J catheter extraction system that includes an elongated tubular body (110) with a receiving end (112) and a coupling end (111), and an impact energy generating device (120); • release and / or dislodge a distal end of a calcified double J catheter; • externalize the distal end of the double J catheter, and tie the distal end of the double J catheter to the tip of a ureteral catheter (140), which is inserted retrogradely into the elongated tubular body (110) through the receiving end (112) and externalized through a lateral slot (113); • Once the double J catheter is threaded, activate the impact energy generating device (120), and advance the elongated tubular body (110) over the calcified double J catheter, using impact energy to dislodge the calcifications from the catheter, thus allowing access to the proximal intrarenal end; and • completely remove the double J catheter, already de-embedded, through the side slot (113) of the elongated tubular body (110).

9. A method for the extraction of a calcified double J catheter according to claim 8, CHARACTERIZED in that the step of releasing and / or dislodging a distal end of a calcified double J catheter can be performed either with a holmium laser fiber or thulium fiber or by using a pneumatic / ballistic rod.

10. A method for removing a calcified double J catheter according to claim 8, CHARACTERIZED in that the step of externalizing the distal end of the double J catheter can be performed either directly through the urethra or through a cystostomy.

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