WO2024144430A1

WO2024144430A1 - Nephrovesical shunt procedure kit

Info

Publication number: WO2024144430A1
Application number: PCT/RU2023/050286
Authority: WO
Inventors: Степан Иванович НОВИКОВ; Дмитрий Владимирович ТРОФИМЦОВ; Роман Алексеевич КАЗАНКИН; Татьяна Дмитриевна СИТНИКОВА
Priority date: 2022-12-27
Filing date: 2023-12-08
Publication date: 2024-07-04

Abstract

The invention relates to medical equipment for treating patients suffering from ureteral obstructions. A nephrovesical shunt procedure kit comprises a connector, a nephrostomy catheter for implantation in the pelvis, a cystostomy catheter for implantation in the bladder, a port for administering drugs, taking samples or flushing, a silicone tube for connecting the connector to the port, and couplings for securing the proximal ends of the catheters and the tube on branches of the connector. The connector is designed to allow for fluidic coupling between the port and the catheters. Disposed in a longitudinal opening in the nephrostomy catheter is a wire which passes through transverse openings on a coiled distal end of said catheter. A proximal end of the nephrostomy catheter has two branches. The ends of the wire are passed through a membrane on a cap installed on one of said branches and are secured by a seal. The proximal end of the nephrostomy catheter is trimmable. The invention provides for a safe shunt procedure by minimizing complications in that it reduces the risk of inflammation, allows easy adjustment of the position of the nephrostomy catheter inside the pelvis and better secures the nephrostomy and cystostomy catheters in the patient's body.

Description

NEPHROVESICULAR BYPASS KIT

The technical field to which the invention relates.

The invention relates to medical equipment intended for the treatment of patients, including small animals, suffering from ureteral obstruction. More specifically, this invention relates to procedures for implanting a nephrovesicular shunt device into the abdomen of a patient.

State of the art.

Known devices for intra-abdominal urine diversion (shunting) are currently the optimal solution to problems that arise when using external nephrostomy catheters such as infection, irregular patient care, urine leakage or displacement.

A device for nephrovesicular shunting is known from the prior art (patent No. US 8808261 B2, MIC A61B17/11, A61B5/20, A61B6/508, published on August 19, 2014), which contains a nephrostomy catheter, a cystostomy catheter, the proximal ends of which are hydraulically connected using a connector that has an internal reservoir compartment and a drug administration/sampling site covered by a self-sealing silicone septum. The connector is configured to subcutaneously position the insertion site in close proximity to the patient's skin after implantation of the ureteral bypass device into the patient and provide access to the insertion site through the skin to enable diagnostic and therapeutic procedures.

A disadvantage of the known device is the likelihood of postoperative complications due to the penetration of infections through the drug administration/sampling port.

The closest in technical essence is a device for ureteral shunting (patent application No. US 2021402136 Al, IPC A61M25/00; A61M39/02, published 12/30/2021), which contains a nephrostomy catheter, a cystostomy catheter, the proximal ends of which are hydraulically connected using a connector. In this case, the device additionally contains a drug administration/sampling port, closed with a self-sealing silicone septum, hydraulically connected to the connector via a silicone tube. Silicone tubing defines a non-dynamic volume between the adapter and the sampling/flushing port through which urine does not flow. Thus, the non-dynamic volume serves as a reservoir for protection against infection.

A disadvantage of the known device is the likelihood of postoperative complications due to uncontrolled bending of the distal end of the nephrostomy catheter. Also, the design of the known device does not allow, after installing the nephrostomy catheter, to remove the thread to tighten the folded distal end, which leads to the risk of salt encrustation of the nephrostomy catheter, leading to obstruction of the system and disruption of urine drainage from the kidney and, as a consequence, to inflammation of the renal pelvis.

Disclosure of the invention When creating the invention, the problem of eliminating postoperative complications and thereby significantly improving the patient’s quality of life was solved.

The technical result is to ensure safe nephrovesicular shunting by minimizing the likelihood of complications by reducing the risk of inflammation, ease of adjustment of the position of the nephrostomy catheter inside the renal pelvis and improved fixation of nephrostomy and cystostomy catheters in the patient's body.

The specified technical result is achieved in that the kit for nephrovesicular shunting contains a connector, a nephrostomy catheter for installation in the renal pelvis, a cystostomy catheter for installation in the bladder, a port for administering drugs, taking samples or washing, a silicone tube for connecting the connector to the port, connecting couplings . A thread is placed in the longitudinal hole of the nephrostomy catheter, passing through transverse holes made at its folded distal end. Moreover, according to the invention, the proximal end of the nephrostomy catheter is made with two branches, and the ends of the thread are passed through a membrane on a cover installed on one of the branches and secured with a seal.

In addition, according to the invention, the membrane on the lid and the seal are made of silicone, and tips for Luer Lock fastening are installed on the outlets.

In addition, according to the invention, the outer surface of the nephrostomy catheter is coated with a hydrophilic layer.

In addition, according to the invention, a cuff is installed at the distal end of the nephrostomy and cystostomy catheters, fixed to the catheter tube using a silicone ring.

In addition, according to the invention, the connector can be made with three branches for connecting the proximal ends of the silicone tube, nephrostomy and cystostomy catheters. Also, the connector may additionally contain a second nephrostomy catheter for installation in the pelvis of the patient’s second kidney, wherein the connector is made with four bends for connecting the proximal ends of the silicone tube, nephrostomy and cystostomy catheters.

In addition, according to the invention, the connector branches are equipped with colored fittings.

In addition, according to the invention, the kit additionally contains devices for installing nephrostomy and cystostomy catheters into the patient’s body, including a conductor with a guide at the end, a mandrel with a needle, as well as a plastic cannula with a stylet or a Seldinger needle.

The basis of the present invention was the solution to problems associated with the occurrence of ureteral obstruction caused by the migration of nephrolites from the renal collecting system into the lumen of the ureter, accompanied by inflammation, and the occurrence of acute renal failure due to impaired outflow of urine from the kidney.

Reduced complications are achieved through the safe insertion of a nephrostomy catheter into the renal pelvis. Rolled distal end nephrostomy catheter fixes its position in the renal pelvis. Changing the bend of the distal end using a thread determines the optimal position in the renal pelvis and eliminates the risk of occlusion due to kinking and mobility of the nephrostomy catheter, which also reduces the risk of complications.

Unlike known analogues, the proximal end of the nephrostomy catheter included in the kit is made with two outlets on which tips for Luer Lock fastening are installed. The presence of two Luer Lock tips at the proximal end allows for simultaneous staining of the renal pelvis at the time of installation of the nephrostomy catheter to control the correct location of the distal end of the nephrostomy catheter through one Luer Lock. The second Luer Lock serves to remove the fixing polypropylene thread, by tightening which it is possible to achieve optimal bending of the distal end of the nephrostomy catheter and thereby the correct positioning of the nephrostomy catheter inside the renal pelvis.

The presence of two outlets at the proximal end of the nephrostomy catheter allows you to safely remove the polypropylene thread after installing the distal end, which significantly reduces the risk of encrustation.

The presence of two Luer Lock tips at the proximal end of the nephrostomy catheter can significantly simplify its placement in the renal pelvis by fixing the mandrel to the nephrostomy catheter, which also contributes to the safe performance of the bypass procedure.

In addition, a reduction in salt encrustation of the nephrostomy catheter was achieved due to an additional coating of its outer surface with a hydrophilic layer.

The kit uses a plastic port for administering medications/taking samples of reduced size, which allows to reduce the amount of surgical trauma (smaller incision for installation) and reduce pain (fewer points of fixation). At the same time, the risks of incorrect assembly of the device during ureteral bypass surgery are reduced due to the use of painted connector fittings in the set.

The kit for nephrovesicular shunting proposed for protection may include alternative devices for inserting catheters into the patient’s body, which in some cases provides an advantage during the operation, reduces the operation time and simplifies its implementation.

Brief description of drawings

The invention is illustrated by graphic materials of a specific example of its implementation, where in: FIG. 1 set for nephrovesicular shunting; fig. 2 - diagram of a bypass device with one nephrostomy catheter; fig. 3 - diagram of a bypass device with two nephrostomy catheters.

Implementation of the invention.

The kit for nephrovesicular shunting contains a connector 1 (Fig. 1), a nephrostomy catheter 2 for installation in the patient’s renal pelvis, a cystostomy catheter 3 for installation in the bladder, a port 4 for administering drugs, taking samples or flushing, a silicone tube 5 intended for connecting connector 1 to port 4, as well as connecting couplings 6, made, for example, of silicone and intended for securing the proximal ends of the nephrostomy catheter 2, cystostomy catheter 3 and silicone tube 5 on the branches of the connector 1.

The connector 1 is configured to hydraulically connect port 4, nephrostomy 2 and cystostomy 3 catheters. The components of the kit thus connected constitute a device for nephrovesicular shunting (Fig. 2 or 3), which is installed in the abdominal cavity of the patient. In this case, for convenience, for example, the administration of drugs, port 4 and the distal end of the silicone tube 5 are located subcutaneously so that the entrance 7 of port 4, closed by a silicone septum, is in close proximity to the patient’s skin.

To install the proximal ends of the nephrostomy catheter 2, the cystostomy catheter 3 and the silicone tube 5, the connector 1 is made with bends, the number of which varies depending on the need to bypass one or two kidneys.

Thus, connector 1 can be made with three bends for connecting the proximal ends of the silicone tube 5, intended for connection to port 4, nephrostomy catheter 2 and cystostomy catheter 3 (Fig 2). However, if it is necessary to perform nephrovesicular shunting of two kidneys, a connector 1 is used, which is made with four bends to connect the proximal ends of the silicone tube 5, two nephrostomy catheters 2 for the patient’s two kidneys and a cystostomy catheter 3 (Fig. 3).

In order to ensure convenience and safety when carrying out the procedure for installing nephrostomy 2 and cystostomy 3 catheters and port 4, the connector bends 1 are equipped with colored fittings: the golden fitting 8.1 is installed on the bend for connecting to the cystostomy catheter 3, the silver fitting 8.2 is on the bend for connecting to port 4 through a silicone tube 5, and a blue fitting 8.3 is on the outlet for connecting to one or two nephrostomy catheters 2 (Figs. 2 and 3).

Nephrostomy catheter 2 is made of elastomeric material, for example, polyurethane, the outer surface of the nephrostomy catheter is covered with a hydrophilic layer to protect against organic formations (encrusted with salts, biofilms, etc.), thereby significantly reducing the risk of infections. Cystostomy catheter 3 is made of silicone.

The distal end of the nephrostomy catheter 2 is made folded, with the ability to fix the position of the nephrostomy catheter 2 in the renal pelvis. At the distal end of the nephrostomy catheter 2 there are transverse holes 9 for the outflow of fluid from the renal pelvis.

To secure it to the patient's organs and prevent urine leakage during healing, a cuff 10 is installed at the distal end of each catheter 2 or 3, fixed to the catheter tube using a silicone ring. The cuff 10 can be made of PTFE or fluoroplastic-4. The proximal end of the nephrostomy catheter is made with two branches with installed Luer Lock tips intended for fastening, for example, devices used for installing a nephrostomy catheter 2.

The diameters of catheters 2 and 3 are selected optimally in order to ensure the best drainage. The lengths of catheters 2 and 3 can be shortened to suit specific patient sizes.

To ensure convenience and safety of the procedure for inserting a nephrostomy catheter 2 into the renal pelvis, a thread 11 is placed in the longitudinal through hole of the nephrostomy catheter 2, passing through transverse holes 9 made at the distal end of the catheter 2. In this case, the ends of the thread 11 are passed through the silicone membrane of the lid 12, installed on one of the branches of the nephrostomy catheter 2 and designed to seal the thread 11 and partially fix it. The ends of the thread 11 passed through the membrane of the cover 12 are secured with a silicone seal 13 as follows: the ends of the thread 11 are passed through the silicone seal 13 and secured to each other using a knot. Thus, the silicone seal 13 is designed to fix the tension of the thread 11 for the purpose of forced bending of the distal end of the nephrostomy catheter 2. The thread 11 is made of non-absorbable material, for example, polypropylene.

In addition to the elements that make up the device for nephrovesicular shunting, the kit contains devices for installing nephrostomy 2, cystostomy 3 catheters and port 4 into the patient’s body, which may include a conductor 17 with a guide at the end, placed in a protective plastic tube 14, a mandrel 15 with a needle 16, Seldinger needle 18 and plastic cannula 19 with stylet 20. (Fig. 1)

The devices included in the kit allow the doctor to choose the technique for introducing the kidney bypass device depending on the characteristics of the patient’s body.

The nephrovesicular shunt procedure is performed as follows.

Under the control of fluoroscopy or ultrasound examination, a puncture of the renal pelvis is performed using a Seldinger needle 18, or a plastic cannula 19 with a stylet 20 until urine appears at the tip of the needle. A bacterial culture is taken from the kidney. Next, a conductor 17 is inserted into the kidney through a Seldinger needle 18 or a plastic cannula 19, from which the stylet 20 is previously removed, and is located in the renal pelvis in a circular manner (in a circle), guided by fluoroscopy or ultrasound data. After which the Seldinger needle 18 or plastic cannula 19 is removed from the kidney along the conductor 17, without displacing the conductor 17 itself.

Next, a mandrel 15 without a needle 16 is inserted into the nephrostomy catheter 2 and fixed by turning clockwise the Luer Lock tip made at the end of the nephrostomy catheter 2 and at the end of the hollow mandrin 15. Then the nephrostomy catheter 2 with the fixed mandrel 15 is inserted through the guide 17 into the renal pelvis under fluoroscopy or ultrasound control.

When the distal end of the nephrostomy catheter 2 enters the renal pelvis, the mandrin 15 is disconnected from the Luer Lock of the nephrostomy catheter 2 and continues insertion of the nephrostomy catheter 2 into the renal pelvis along the conductor 17 until the cuff 10 stops, without displacing the mandrin 15. After which the mandrin 15 and the conductor 17 are completely removed from the nephrostomy catheter 2 under the control of fluoroscopy or ultrasound.

An alternative method for installing a nephrostomy catheter 2 into the renal pelvis involves using a 16 mandrin needle 15 instead of a 18 Seldinger needle or a 19 plastic cannula with a 20 stylet.

The mandrin 15 with a needle 16 is inserted into the nephrostomy catheter 2 and fixed to it by turning clockwise the Luer Lock tip made at the end of the nephrostomy catheter 2. The nephrostomy catheter 2 and the mandrin 15 assembled in this way with a needle 16 are inserted into the body under the control of fluoroscopy or ultrasound. patient until the distal end of the nephrostomy catheter 2 enters the renal pelvis.

Next, mandrin 15 with a fixed needle 16 is disconnected from the nephrostomy catheter 2 by turning the Luer Lock tip counterclockwise. The insertion of nephrostomy catheter 2 into the renal pelvis is continued until the cuff 10 stops, without displacing the mandrin 15. After which the mandrin 15 with needle 16 is completely removed from the nephrostomy catheter 2 under the control of fluoroscopy or ultrasound.

Thus, the devices contained in the kit provide the ability to choose the technique for inserting the nephrostomy catheter 2 into the renal pelvis, which increases the convenience and safety of the nephrovesicular shunting procedure

If necessary, the distal end of the nephrostomy catheter 2, located inside the renal pelvis, is additionally bent by pulling up the ends of the polypropylene thread 11, passed through the holes in the distal end of the nephrostomy catheter 2. The ends of the polypropylene thread 11 are pulled up at the exit from the lid with a silicone membrane 12, and then fixed by silicone seal 13. Control of the correct position of the distal end of the nephrostomy catheter is carried out by introducing a contrast agent into the free outlet with a Luer Lock tip.

Using the cuff 10, the nephrostomy catheter 2 is fixed by applying cyanoacrylate medical glue to the surface of the cuff 10 associated with the kidney body, and then pressing it until polymerization of the glue is achieved. After fixing the nephrostomy catheter 2, the tightness of the system is checked by introducing 1-10 ml of non-ionic contrast agent into the free outlet with a Luer Lock tip of the nephrostomy catheter 2.

To reduce the risk of incrustation with uric acid salts and the formation of biofilms and thereby reduce the likelihood of an inflammatory process after the intervention, the polypropylene thread 11 is removed from the nephrostomy catheter 2. While maintaining the tightness of the connection of the nephrostomy catheter 2 to the kidney, an incision is made at one of the ends of the thread 11 and the thread is removed 11 from the outlet of the nephrostomy catheter 2, closed with a cap 12 s silicone membrane, by pulling on the uncut part and the seal located on it 13.

The next step is to install a cystostomy catheter 3. To do this, isolate the bladder from the abdominal organs with a damp gauze cloth, in an anatomically correct location, avoiding twisting of the urethra. In the area of the apex of the bladder, in the avascular part, a purse-string suture made of monofilament, non-absorbable suture material, for example, 4\0 polypropylene, is applied without tightening. In the center of the purse-string suture, coagulation of the serous and muscular layer of the bladder with a diameter of 1.5 to 2.5 mm is carried out using a monopolar coagulator, avoiding perforation of the mucous layer.

A puncture is carried out into the center of the purse-string suture using a Seldinger needle 18 or a plastic cannula 19 with a stylet 20, after which a conductor 17 is inserted through a Seldinger needle 18 or a plastic cannula 19 with a previously removed stylet 20. A hollow mandrel 15 without a needle 16 is inserted into the cystostomy catheter 3. Along the conductor 17, a cystostomy catheter 3 with an inserted hollow mandrel 15 is inserted into the bladder. Then the purse string suture is tightened, after which the mandrel 15 and conductor 17 are completely removed.

An alternative method for installing a silicone cystostomy catheter 3 into the bladder cavity involves using a 16 mandrin needle 15 instead of a 18 Seldinger needle or a 19 plastic cannula with a 20 stylet.

The hollow mandrin 15 is inserted into the cystostomy catheter 3, after which a needle 16 is inserted into the mandrin 15, which is fixed on the Luer Lock tip of the mandrin 15 by turning clockwise. With a cystostomy catheter 3 and a mandrel 15 assembled in this way with a needle 16, a puncture is carried out in the center of the purse-string suture until the distal end of the cystostomy catheter 3 enters the cavity of the bladder. Next, the needle 16 for mandrin 15 is disconnected by turning the Luer Lock tip counterclockwise and removed from the hollow mandrin 15. Then the purse-string suture is pulled in, after which mandrin 15 is also removed.

Thus, the devices contained in the kit provide the ability to choose the technique for inserting the cystostomy catheter 3 into the bladder, which makes it possible to increase the convenience and safety of the nephrovesicular shunt procedure.

After insertion of the cystostomy catheter 3, its cuff 10 is fixed to the wall of the bladder with 3-4 simple knotted sutures made of non-absorbable suture material, for example, 4\0 polypropylene. The interface between the cuff 10 and the bladder wall is sealed by applying cyanoacrylate medical glue to the surface of the cuff and pressing the cuff 10 against the bladder wall until polymerization of the glue is achieved.

After installing nephrostomy catheter 2 and cystostomy catheter 3, their proximal ends are trimmed to the required length, depending on the size of the patient. Connecting couplings 6 are put on the proximal ends of catheters 2 and 3, with the help of which catheters 2 and 3 are connected to fittings 8.1 and 8.3 of connector 1 (Fig. 2 and 3). In this case, colored fittings help correctly connect catheters 2 and 3 to connector 1: the proximal end of the cystostomy catheter 3 is connected to the golden fitting 8.1 and the proximal end of the nephrostomy catheter 2 is connected to the blue fitting 8.3.

To connect port 4 to the connector, a silicone tube 5 is used with a connecting coupling 6 on, the proximal end of which is similarly connected to the silver fitting 8.2 of connector 1.

Next, tunnelization of the rectus abdominis muscles is carried out using an atraumatic hemostatic clamp, using a blunt method. Through the formed tunnel, silicone tube 5 is brought into the subcutaneous space. The distal end of the silicone tube 5 with a pre-fitted coupling 6 is attached to fitting 21 of port 4, after which coupling 6 is lowered until it stops on the fitting of port 4, thereby fixing the connection.

Next, port 4 is fixed laterally, at a distance of 1 to 3 cm from the incision line to the muscles of the abdominal wall, with three simple interrupted sutures made of monofilament non-absorbable suture material, for example, 2\0 polypropylene. After that, the tightness of the assembled system is checked by puncturing port 4 with a Huber needle (not included) with a diameter of 19-22 G and introducing 2-20 ml of sterile, non-ionic contrast agent under fluoroscopy control. If there are no leaks, aspiration of the liquid introduced into the system is carried out, and the Huber needle is removed from inlet 7 of port 4.

Next, layer-by-layer suturing of the surgical approach is carried out according to the generally accepted technique, without involving parts of the system for draining urine from the kidney into the suture.

Thus, the proposed kit provides safe nephrovesicular shunting due to the presence at the proximal end of the nephrostomy catheter of two branches with two Luer Lock tips, the possibility of removing the polypropylene thread from the nephrostomy catheter after its placement in the renal pelvis.

Claims

Claim

1. Nephrovesicular shunt kit containing a connector, a nephrostomy catheter for installation in the renal pelvis, a cystostomy catheter for installation in the bladder, a port for drug administration, sampling or flushing, silicone tubing for attaching the connector to the port, couplings for securing the proximal ends nephrostomy catheter, cystostomy catheter and silicone tube on the connector branches, wherein the connector is configured to hydraulically connect the port, nephrostomy and cystostomy catheters to each other, and in the longitudinal hole of the nephrostomy catheter there is a thread passing through transverse holes made at its distal end, which made folded, characterized in that the proximal end of the nephrostomy catheter is made with two branches, while the ends of the thread are passed through a membrane on a cover installed on one of the branches and secured with a seal, and the proximal end of the nephrostomy catheter is made with the possibility of cutting.

2. The kit according to claim 1, characterized in that the membrane on the lid and the seal are made of silicone.

3. The kit according to claim 1, characterized in that tips for Luer Lock fastening are installed on the branches of the nephrostomy catheter.

4. The kit according to claim 1, characterized in that the outer surface of the nephrostomy catheter is coated with a hydrophilic layer.

5. The kit according to claim 1, characterized in that a cuff is installed at the distal end of the nephrostomy and cystostomy catheters, fixed to the catheter tube using a silicone ring.

6. The kit according to claim 1, characterized in that the connector is made with three bends for connecting the proximal ends of the silicone tube, nephrostomy and cystostomy catheters.

7. The kit according to claim 1, characterized in that it contains a second nephrostomy catheter for installation in the pelvis of the patient’s second kidney, wherein the connector is made with four bends for connecting the proximal ends of the silicone tube, nephrostomy and cystostomy catheters.

8. The kit according to claim 6 or 7, characterized in that the connector outlets are equipped with colored fittings.

9. The kit according to claim 1, characterized in that the proximal end of the cystostomy catheter is capable of cutting.

10. The kit according to claim 1, characterized in that it contains devices for installing nephrostomy and cystostomy catheters into the patient’s body, including a conductor made in the form of a plastic tube with a guide at the end, a mandrel with a needle, as well as a plastic cannula with a stylet or a Seldinger needle .

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SUBSTITUTE SHEET (RULE 26)