In-vitro device for evaluating heat effect in laser lithotripsy process and evaluation method

Abstract

The invention relates to an in-vitro device and an evaluation method for evaluating a heat effect in a laser lithotripsy process, and the in-vitro device comprises a urinary tract simulation assembly which at least comprises a ureter simulation tube and is used for simulating a ureter on which calculi grow; the lithotripsy assembly is used for performing laser lithotripsy on the calculus from one end of the ureter simulation tube and is mounted on the urinary tract simulation assembly; the body temperature simulation assembly is used for simulating the human body temperature environment, and the urinary tract simulation assembly is installed in the body temperature simulation assembly; and the monitoring assembly is used for monitoring the heat effect in the stone crushing process. The device can effectively simulate and reflect the real heat effect of laser treatment in the clinical operation process, and provides more accurate guidance for the treatment process.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an in vitro device and evaluation method for assessing the thermal effects during laser lithotripsy. Background Technology

[0002] Urinary tract stones often cause severe pain and discomfort for patients. Currently, one of the common treatment methods is laser lithotripsy, which uses a laser to directly target the surface of the stone, breaking it down into smaller particles for excretion.

[0003] However, during laser lithotripsy, especially when breaking down stones in the sensitive ureter, the local temperature can rise due to the laser's effect and varying parameters. This can cause irreversible damage to the ureteral tissue, ultimately leading to ureteral stricture. Ureteral stricture can cause recurrent urinary tract infections, worsening kidney function, and other serious burdens on patients. Therefore, testing the local temperature generated during lithotripsy under different laser parameters is essential. Summary of the Invention

[0004] To address the aforementioned issues, an extracorporeal device and evaluation method for assessing the thermal effects during laser lithotripsy are provided. This method aims to help reflect the true thermal effects of laser treatment during clinical surgery and provide more accurate guidance for the treatment process.

[0005] The specific technical solution is as follows:

[0006] A first aspect of the present invention is to provide an extracorporeal device for evaluating thermal effects during laser lithotripsy, comprising:

[0007] A urinary tract simulation component, including at least a ureteral simulation tube, for simulating a ureter with stones growing in it;

[0008] The lithotripsy assembly is used to perform laser lithotripsy on stones from one end of the ureteral simulation tube and is installed on the urinary tract simulation assembly.

[0009] A body temperature simulation component is used to simulate the human body temperature environment; a urinary tract simulation component is installed within the body temperature simulation component; and

[0010] Monitoring components are used to monitor the thermal effects during the crushing process.

[0011] Furthermore, the body temperature simulation component includes a test tank and a heating rod. The test tank contains a heating medium, and the heating rod is installed inside the test tank.

[0012] Furthermore, the body temperature simulation component also includes a circulation pump, the inlet and outlet of which are connected to the test tank via pipes.

[0013] Furthermore, the ureteral simulation tube is made of transparent material, and a stent for supporting the stones is installed inside the ureteral simulation tube.

[0014] Furthermore, the urinary tract simulation component also includes a renal pelvis simulation tube, used to simulate the renal pelvis, which is installed on the ureteral simulation tube.

[0015] Furthermore, the crushed stone component includes:

[0016] An infusion tubing, installed on and connected to a ureteral simulator tubing; and

[0017] The lithotripsy fiber can be inserted from one end of the irrigation tube and into the ureteral simulation tube.

[0018] Furthermore, the monitoring components include at least a temperature sensor, in which a temperature-sensing element is slidably sealed onto a ureteral simulation tube.

[0019] Furthermore, the temperature sensor is slidably sealed to the simulated ureteral wall via a sealing rubber ring.

[0020] A second aspect of the present invention is to provide a method for evaluating the thermal effects during laser lithotripsy, comprising the following steps:

[0021] The excised stone was implanted into a ureteral simulation tube and assembled to form an external device;

[0022] A heating medium is placed inside the test tank to stabilize the temperature of the medium at human body temperature.

[0023] The device was placed in the test tank and left to stand for a period of time to measure the baseline temperature inside the simulated ureteral tube. Then, infusion was performed into the infusion tube and the temperature inside the simulated ureteral tube was monitored. Laser lithotripsy was then started and the temperature inside the simulated ureteral tube was continuously monitored. After laser excitation was stopped, infusion and monitoring were continued for a period of time to observe the decrease in the temperature of the liquid inside the simulated ureteral tube.

[0024] Temperature sensors collect the highest temperatures recorded during laser lithotripsy as an indicator of the thermal effects of the laser.

[0025] The beneficial effects of the above scheme are:

[0026] The device described above can effectively simulate and reflect the real thermal effect of laser treatment during clinical surgery, providing more accurate guidance for the selection of parameters during treatment. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the external device provided in an embodiment of the present invention;

[0028] Figure 2This is a partial structural schematic diagram of the external device provided in an embodiment of the present invention.

[0029] In the attached diagram: 1. Ureteral simulation tube; 2. Test tank; 3. Heating rod; 4. Irrigation tube; 5. Lithotripsy fiber optic cable; 6. Temperature sensor; 7. Renal pelvis simulation tube; 8. Iron stand. Detailed Implementation

[0030] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other.

[0032] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, but this is not intended to limit the scope of the invention.

[0033] like Figure 1 , Figure 2 As shown, the extracorporeal device provided in the embodiments of the present invention includes a urinary tract simulation component, a lithotripsy component, a body temperature simulation component, and a monitoring component; the urinary tract simulation component includes at least a ureteral simulation tube 1 simulating the growth of stones; the lithotripsy component is used to perform laser lithotripsy on the stones from one end of the ureteral simulation tube 1 and is installed on the urinary tract simulation component; the body temperature simulation component is used to simulate the human body temperature environment, and the urinary tract simulation component is installed in the body temperature simulation component; the monitoring component is used to monitor the thermal effects during the lithotripsy process.

[0034] This invention uses a transparent material, such as polymethyl methacrylate (PMMA), to form a 7mm inner diameter circular tube as the ureteral simulation tube 1. This material is used to facilitate observation of local conditions during the testing process and to allow for accurate adjustment of the monitoring and lithotripsy components under direct vision. With the above structure, a plastic or metal mesh structure can be cut according to the inner diameter of the ureteral simulation tube 1. This mesh structure is then inserted into the ureteral simulation tube 1 as a support for the lithotripsy. During the test, the stone can be inserted into the ureteral simulation tube 1 and placed on the mesh structure before subsequent testing.

[0035] As a specific example, such as Figure 1As shown, the aforementioned body temperature simulation component includes a test tank 2 and a heating rod 3. The test tank 2 contains a heating medium (such as water), and the heating rod 3 is installed inside the test tank 2 to heat the medium and stabilize its temperature at 36.5℃, thus simulating the human body temperature environment. During subsequent lithotripsy experiments in the test tank 2, a ureteral simulation tube 1 can be installed inside the test tank 2 using an iron frame 8 to reflect the actual thermal effect of laser treatment during clinical surgery. Based on this technical solution, to further improve the accuracy of temperature control within the test tank 2, the aforementioned body temperature simulation component may also include a circulation pump (not shown in the figure). The inlet and outlet of the circulation pump are connected to the test tank 2 via pipes. With this structure, the circulation pump can be activated to accelerate the flow of the medium within the test tank 2, and the heating rod 3 can then be used to achieve precise temperature control within the test tank 2, thereby more accurately simulating the core temperature of the human body during clinical surgery.

[0036] As a specific example, such as Figure 1 , Figure 2 As shown, the above-mentioned lithotripsy assembly includes an irrigation tube 4 and a lithotripsy fiber optic cable 5. The irrigation tube 4 (which can be simulated by a syringe with a diameter of 2 mm) is installed on the ureteral simulation tube 1 through a rubber stopper and is connected to the ureteral simulation tube 1. One end of the lithotripsy fiber optic cable 5 can be inserted through the irrigation tube 4 and extended into the ureteral simulation tube 1 to guide laser lithotripsy. During the experiment, irrigation fluid at a temperature of about 25-26℃ can be injected into the irrigation tube 4 first, and then the irrigation fluid can be dripped onto the stone in the ureteral simulation tube 1 through the needle-like channel on the irrigation tube 4. At the same time, the lithotripsy fiber optic cable 5 is used to perform laser lithotripsy to simulate the process of the fiber optic cable and the irrigation fluid entering the ureter in the same direction during ureteroscopic lithotripsy. During the lithotripsy process, the thermal effect during the lithotripsy process is monitored by a monitoring component, so as to truly reflect the thermal effect of laser treatment during clinical surgery and provide more accurate guidance for the selection of parameters during the treatment process. To avoid the perfusion fluid of different temperatures communicating with the medium in the test tank 2 and affecting the actual thermal effect during the test, the present invention further utilizes a rubber stopper to install a renal pelvis simulation tube 7 (which can be simulated by a centrifuge tube with a volume of 7 mL) on the ureter simulation tube 1, thereby forming a closed structure at the bottom of the ureter simulation tube 1.

[0037] As a specific example, such as Figure 1 As shown, the above-mentioned monitoring components include at least a temperature sensor 6 (such as a K thermocouple). The temperature sensing element in the temperature sensor 6 is slidably sealed on the ureteral simulation tube 1. Specifically, a small hole can be drilled in the ureteral simulation tube 1, and a sealing ring can be installed in the small hole. The temperature sensing element in the temperature sensor 6 can then be inserted into the sealing ring. During the test, the research standards in this field can be referred to, and the temperature sensing element can be adjusted to be located 2 mm away from the end of the fiber optic cable 5 in the ureteral simulation tube 1, in accordance with the actual position of the fiber optic cable 5.

[0038] The evaluation method using the above-mentioned in vitro device in this invention includes the following steps:

[0039] The excised stone was implanted into a ureteral simulation tube 1 and assembled to form an external device;

[0040] A heating medium is placed into the test tank 2, and the heating medium stabilizes the medium temperature at 36.5℃;

[0041] The device was placed in the test tank 2 and left to stand for a period of time. The baseline temperature inside the ureteral simulation tube 1 was measured. Then, the accompanying intelligent peristaltic pump was used to infuse the irrigation fluid at a temperature of about 25-26℃ at a rate of 20ml / min and the temperature inside the ureteral simulation tube 1 was monitored for 20 seconds. Laser lithotripsy was then continuously started for 60 seconds and the temperature inside the ureteral simulation tube 1 was monitored. After the laser excitation was stopped, the infusion was continued and monitored for 20 seconds to observe the decrease in the temperature of the liquid inside the ureteral simulation tube 1.

[0042] Temperature sensor 6 collects the highest temperature recorded during laser lithotripsy as an indicator of the thermal effects of the laser; specifically, if the temperature inside the ureteral simulation tube 1 is >43°C, it is determined that the corresponding laser lithotripsy parameters will cause damage to the ureteral wall tissue.

[0043] Since there is no feasible way to monitor the local temperature of tissues during lithotripsy in the human body, this application uses the above-mentioned device to test in vitro according to the actual surgical procedure to understand the highest temperature that different parameters can produce, thereby evaluating whether the parameter can be used in human surgery.

[0044] The above are merely preferred embodiments of the present invention and are not intended to limit the implementation methods and protection scope of the present invention. Those skilled in the art should recognize that any equivalent substitutions and obvious changes made based on the description and illustrations of the present invention should be included within the protection scope of the present invention.

Claims

1. An extracorporeal device for evaluating thermal effects during laser lithotripsy, characterized in that, include: A urinary tract simulation component, including at least a ureteral simulation tube, for simulating a ureter with stones growing in it; A lithotripsy assembly, used for laser lithotripsy of stones from one end of the ureteral simulation tube, is installed on the urinary tract simulation assembly; A body temperature simulation component is used to simulate the human body temperature environment, and the urinary tract simulation component is installed in the body temperature simulation component; as well as Monitoring components are used to monitor the thermal effects during the crushing process.

2. The extracorporeal device for evaluating the thermal effects during laser lithotripsy according to claim 1, characterized in that, The body temperature simulation component includes a test tank and a heating rod. The test tank contains a heating medium, and the heating rod is installed inside the test tank.

3. The extracorporeal device for evaluating the thermal effects during laser lithotripsy according to claim 2, characterized in that, The body temperature simulation component also includes a circulation pump, the inlet and outlet of which are connected to the test tank via pipes.

4. The extracorporeal device for evaluating the thermal effects during laser lithotripsy according to claim 2 or 3, characterized in that, The ureteral simulation tube is made of a transparent material, and a stent for supporting the stones is installed inside the ureteral simulation tube.

5. The extracorporeal device for evaluating the thermal effects during laser lithotripsy according to claim 4, characterized in that, The urinary tract simulation component also includes a renal pelvis simulation tube for simulating the renal pelvis, which is installed on the ureter simulation tube.

6. The extracorporeal apparatus for evaluating thermal effects during laser lithotripsy according to claim 2 or 3, characterized in that, The crushing component includes: An infusion tubing, installed on and connected to the ureteral simulation tubing; and The lithotripsy fiber has one end that can be inserted from the irrigation tube and extend into the ureteral simulation tube.

7. The extracorporeal device for evaluating the thermal effects during laser lithotripsy according to claim 6, characterized in that, The monitoring component includes at least a temperature sensor, wherein the temperature sensing element of the temperature sensor is slidably sealed onto the ureteral simulation tube.

8. The extracorporeal device for evaluating the thermal effects during laser lithotripsy according to claim 7, characterized in that, The temperature sensor is slidably sealed to the simulated ureteral wall via a sealing rubber ring.

9. A method for evaluating the thermal effects during laser lithotripsy, characterized in that, The extracorporeal apparatus for evaluating the thermal effects during laser lithotripsy, as described in claims 6-8, comprises the following steps: The excised stone was implanted into a ureteral simulation tube and assembled to form an external device; A heating medium is placed inside the test tank to stabilize the temperature of the medium at human body temperature. The device was placed in the test tank and left to stand for a period of time to measure the baseline temperature inside the simulated ureteral tube. Then, infusion was performed into the infusion tube and the temperature inside the simulated ureteral tube was monitored. Laser lithotripsy was then started and the temperature inside the simulated ureteral tube was continuously monitored. After laser excitation was stopped, infusion and monitoring were continued for a period of time to observe the decrease in the temperature of the liquid inside the simulated ureteral tube. Temperature sensors collect the highest temperatures recorded during laser lithotripsy as an indicator of the thermal effects of the laser.

Images