WO2021133298A1

WO2021133298A1 - Ultra mini flexible percutaneous nephrolithotomy device

Info

Publication number: WO2021133298A1
Application number: PCT/TR2020/050968
Authority: WO
Inventors: Murat KAYABEKİR; İbrahim KARABULUT; Berkan REŞORLU
Original assignee: Atatürk Üni̇versi̇tesi̇ Bi̇li̇msel Araştirma Projeleri̇ Bi̇ri̇mi̇
Priority date: 2019-12-26
Filing date: 2020-10-21
Publication date: 2021-07-01

Abstract

The invention relates to a device (1) so as to be used in the treatment of renal calculus smaller than 20 mm, comprising at least one control arm so as to enable the operator who performs the renal calculus lithotripsy operation to manage said operation (1.1), at least one laser probe so as to apply lithotripsy for renal calculus (1.6), at least one flexible telescope (1.5) so as to monitor the region instantly where lithotripsy is performed, at least one first operation channel (1.3) in which flexible telescope (1.5) is located, at least one second operation channel (1.4) in which laser probe (1.6) is located and at least one lock system (1.7) that fixes said flexible telescope (1.5) and laser probe (1.6).

Description

ULTRA MINI FLEXIBLE PERCUTANEOUS NEPHROLITHOTOMY DEVICE

TECHNICAL FIELD

The invention relates to an ultra mini flexible percutaneous nephrolithotomy (UMFPNL) device so as to be used in the surgical treatment of renal calculus smaller than 20 mm.

The invention is particularly related to an ultra-mini flexible percutaneous nephrolithotomy (UMFPNL) device comprising at least one laser probe, at least one flexible telescope and at least one locking system so as to fix the telescope with said laser probe to reach and intervene renal calculus smaller than 20 mm.

STATE OF THE ART

Today, approximately 10 percent of the world’s population is affected directly by the kidney diseases. At the same time, it is known that kidney diseases are at the top places among common death causes. Various methods are used in the technical field so as to treat renal calculus. General surgical approach to renal calculus according to the European Association of Urology (EAU) guideline on urinary system stone disease is as follows; open surgery, ureterorenoscopy, Extracorporeal shock wave lithotripsy (ESWL) and percutaneous nephrolithotomy (PNL).

Said percutaneous nephrolithotomy (PNL) is a method which is first defined by Fernstrom and Johansson in 1976 and is used in the treatment of renal calculus. Said method which is more preferred compared to open surgery has advantages such as high treatment success, quick recovery, short period of hospital stay and better cosmetic results. The most dreadful complication is bleeding in the percutaneous nephrolithotomy (PNL). Tract dilatation method, tract diameter, number and monitoring method used are among the important factors that have affect on bleeding. It is known when the number and diameter of the tract is reduced also it reduces morbidity and complications. Accordingly, studies are initiated so as to perform percutaneous nephrolithotomy (PNL) by means of using a smaller diameter nephroscope in said technical field.

Ultra mini percutaneous nephrolithotomy (UMFPNL) is a percutaneous nephrolithotomy (PNL) intervention carried out by minimizing the size of the system. Ultra mini percutaneous nephrolithotomy (UMFPNL) consists of an 11 -13 f sized sheath and a specifically designed 7.5 f rigid nephroscope within said sheath. This system enables a reduction in the surface area of approximately one eighth percent compared to the 28 - 30 f axle used in the original PNL known in the technical field. This difference assists in reducing tissue trauma and bleeding. However, it is insufficient to intervene by reaching the small sized stones due to said rigid structure.

The Chinese national utility model application document numbered CN204169897 U is found in the patent and literature research made in the direction of the state of the art. In said utility model application document, a system comprising a stone vacuum apparatus, a stone vacuum channel, a light source and a drainage path is described.

As a result, many problems and disadvantages are encountered in said technical field as mentioned above; the current applications are insufficient in solving these problems and disadvantages. This situation makes it necessary to make an improvement and innovation in the state of the art.

DESCRIPTION OF THE INVENTION

The present invention is related to an ultra mini flexible percutaneous nephrolithotomy (UMFPNL) device so as to be used in the treatment of renal calculus smaller than 20 mm which fulfills the abovementioned requirements, eliminates all disadvantages and brings some additional advantages.

The main aim of the invention is to provide a device which can be easily controlled due to its flexibility, therefore allows reaching the nearest region of stones smaller than 20 mm even in the most difficult kidney regions and makes intervention possible. In the inventive device structure, there are control arms which can be controlled with fingers. Therefore, it is possible to allow the end section of the device to give an angle between 90 and 120 degrees in the desired direction, to allow performing flexion and deflection. In this sense, it eliminates the problems of access caused by the rigid devices available in the applications of the state of the art.

Another aim of the invention is to provide a device which allows for realizing the operation without requiring second personnel. The inventive device comprises at least one lock system to be used in fixing the laser probe and high-resolution telescope in its structure different from the applications of the state of the art. For this reason, a second person is not required so as to hold the laser probe and high resolution telescope during the intervention.

It is aimed to provide a radiolucent device that can be monitored under fluoroscopy with the invention. Another aim of the invention is to provide a device which eliminates the processes of placing intraoperative nephrostomy tube and double J catheter to the patients as in the applications of the state of the art, shortens the average operation duration and eliminates the requirement of a second inlet tract.

Said device which is developed within the scope of the invention is used at the millimetric level, can pass through 9-11 f ureteral access sheath (it is the tunnel formed by the surgeon between the kidney and the skin) and forms an opening (dead-space) which provides discharge of the water in the tunnel. Water and transurethral resection are drained and thus the sharpness of the cameras providing images through the device is not distorted by means of the millimetric channels that pass through said opening (dead-space).

Another aim of the invention is to provide high stone-free ratio and low complication ratio for small volume renal calculus.

In order to fulfil all abovementioned aims and to provide solutions to the problems in the state of the art, the invention is a device to be used in the treatment of renal calculus smaller than 20 mm; it comprises the following;

• at least one control arm so to enable the operator who performs the renal calculus lithotripsy operation to manage said operation,

• at least one laser probe so as to apply lithotripsy for renal calculus,

• at least one flexible telescope so as to monitor the region instantly where lithotripsy is performed,

• at least one first operation channel in which flexible telescope is located,

• at least one second operation channel in which laser probe is located,

• at least one lock system which fixes said flexible telescope and laser probe.

The structural and characteristic features of the present invention will be understood clearly by the following detailed description. Therefore the evaluation shall be made by taking this detailed description and the figures into consideration.

FIGURES CLARIFYING THE INVENTION

In Figure 1 , a general view of the inventive ultra mini flexible percutaneous nephrolithotomy (UMFPNL) device is given. REFERENCE NUMBERS

1 Device

1 .1 Control arm

1 .2 End section

1 .3 First operation channel

1 .4 Second operation channel

1 .5 Telescope

1 .6 Laser probe

1 .7 Lock system

1 .8 Liquid discharge connection

1 .9 Water channel connection

DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the preferred embodiments of the invention is described only for clarifying the subject matter in a manner such that no limiting effect is created.

The invention relates to an ultra mini flexible percutaneous nephrolithotomy (UMFPNL) device (1) so as to be used in the treatment of renal calculus smaller than 20 mm. In Figure 1 , a general view of the inventive device (1) is given.

The inventive device (1) comprises, at least one control arm (1.1) that is preferably controlled with a finger, so as to enable the operator who will perform this operation to manage said device (1 ). The end of the device (1 ) that intervenes to the renal calculus is named as the end section (1 .2). It is provided to allow said end section (1 .2) to have an angle between 90 and 120 degrees in the desired direction by means of said control arm (1.1). Therefore, it is possible for the inventive device (1 ) to perform flexion and deflection.

In the structure of the inventive device (1), there is at least one first operation channel (1.3) and at least one second operation channel (1.4). Said first operation channel (1.3) and second operation channel (1.4) has preferably a diameter of 1.3 mm. There is at least one flexible telescope (1 .5) located in said first operation channel (1 .3). Said flexible telescope (1 .5) has an external diameter of 1 .2 mm, a length of 40 cm and an image quality of 20000 pixels. Said flexible telescope (1.5) enables monitoring the operation area instantly during the operation. There is a laser probe (1.6) preferably with a thickness of 572 nm in said second operation channel (1.4). The laser probe (1 .6) is directly responsible from lithotripsy of renal calculus.

At the same time, the first operation channel (1 .3) and the second operation channel (1 .4) are the structures that permit the passage of the irrigation fluid. There is at least one liquid discharge connection (1 .8) in the structure of the inventive device (1 ) so as to provide liquid drainage. Said liquid discharge connection (1.8) is preferably compatible with the transurethral resection set (TUR) because transurethral resection set (TUR) is used in said technical field. It is necessary to wash the telescope (1.5) with the water drainage so as to prevent image loss of small-scale bleeding during the lithotripsy process. The inventive device (1 ) comprises at least one water channel connection (1.9) in accordance with this aim.

Said device (1 ) comprises at least one lock system (1 .7) that fixes the flexible telescope (1 .5) and laser probe (1.6) so as to realize the operation by a single operator healthily. Said lock system (1.7) is preferably positioned at the middle section of the device (1).

In a preferred embodiment of the invention, said device (1 ) has an external diameter of 3 mm and a length of 300 mm. At the same time, it exhibits radiolucent characteristic and can be monitored under fluoroscopy.

Said device (1 ) which is developed within the scope of the invention is used at the millimetric level, can pass through 9-11 f ureteral access sheath (it is the tunnel formed by the surgeon between the kidney and the skin) and forms an opening (dead-space) which provides discharge of the water in the tunnel. Water and transurethral resection are drained and thus the sharpness of the cameras providing images /integrated with the telescope (1 .5)) through the device (1 ) is not distorted by means of the millimetric channels that pass through said opening (dead-space).

Claims

1. So as to be used in the treatment of renal calculus smaller than 20 mm,

• at least one control arm (1.1 ) so as to enable the operator who performs the renal calculus lithotripsy operation to manage said operation, and

• at least one laser probe (1.6) so as to apply lithotripsy for renal calculus, characterized in comprising a device (1) ;

• at least one flexible telescope (1.5) so as to monitor the region instantly where lithotripsy is performed,

• at least one first operation channel (1.3) in which flexible telescope (1.5) is located,

• at least one second operation channel (1 .4) in which laser probe (1.6) is located,

• at least one lock system (1.7) which fixes said flexible telescope (1.5) and laser probe (1.6).

2. The device (1) according to claim 1 characterized in that; said device (1) comprises at least one end section (1 .2) which is located at the end portion of the same in contact with the renal calculus and can be angled 90 to 120 degrees.

3. The device (1 ) according to claim 1 characterized by comprising; a first operation channel (1.3) with an external diameter of 1.3 mm.

4. The device (1) according to claim 1 characterized by comprising; a second operation channel (1 .4) with an external diameter of 1.3 mm.

5. The device (1) according to claim 1 characterized by comprising; a flexible telescope (1.5) with an external diameter of 1.2 mm, a length of 40 cm and an image quality of 20000 pixels.

6. The device (1 ) according to claim 1 , characterized by comprising; a laser probe (1.6) with a thickness of 572 nm.

7. The device (1) according to claim 1 , characterized by comprising; at least one liquid discharge connection (1 .8) that is compatible with the transurethral resection set so as to provide liquid drainage.

8. The device (1) according to claim 1 , characterized by comprising; at least one water channel connection (1.9).

9. The device (1 ) according to claim 1 , characterized in that; it has an external diameter of 3 mm and a length of 300 mm.