Prostate tumor steam ablation system and use method thereof

Abstract

The invention discloses a prostate tumor steam ablation system and a using method thereof.The prostate tumor steam ablation system comprises operation equipment and a control host, and the operation equipment comprises an outer sleeve, a handle, a steam generator, a steam delivery needle, an angle sensor for obtaining the rotation angle of the steam delivery needle and delivery needle driving equipment; the end, away from the steam delivery needle, of the steam generator is connected with a sterile water inlet pipe. The end, away from the handle, of the outer sleeve is provided with a camera and integrated with a magnetic positioning sensor. The control host comprises a data processing control unit; the data processing control unit is used for processing prostate examination data of a patient before an operation to obtain a three-dimensional model of the prostate, determining a prostate tumor processing scheme according to user setting, and processing related data collected by the camera, the magnetic positioning sensor and the angle sensor to obtain a three-dimensional model of the outer sleeve and the steam delivery needle in the prostate. The steam ablation equipment is applied to the field of prostate tumor treatment for the first time, the treatment recovery time is short, and the male sexual function is reserved.

Description

Technical Field

[0001] The present invention relates to the technical field of minimally invasive prostate treatment, and relates to a prostate tumor steam ablation system and a method of using the same, and in particular to a system that uses steam delivered to the peripheral area of ​​the prostate to kill prostate tumors and a method of using the same. Background Art

[0002] As living and medical conditions continue to improve, people's pursuit of quality of life is also constantly improving.

[0003] In male urogenital anatomy, the prostate gland is located below the bladder and bladder neck. The bladder wall can expand and contract to cause urine to flow through the urethra. The portion of the urethra surrounded by the prostate gland is called the prostatic urethra. The prostate also surrounds the ejaculatory ducts, which have an open terminal end in the prostatic urethra. During sexual arousal, the vas deferens transports sperm from the testicles to the prostate, which provides fluid that combines with the sperm to form semen during ejaculation. The vas deferens and the seminal vesicles connect on each side of the prostate to form a single tube called the ejaculatory duct. Thus, each ejaculatory duct transports seminal vesicle secretions and sperm into the prostatic urethra.

[0004] The prostate glandular structure can be divided into three zones: the peripheral zone, the transition zone, and the central zone. The peripheral zone (PZ) encompasses approximately 70% of the prostate volume in young men. This subcapsular portion of the prostate gland, located posteriorly, surrounds the distal urethra, and 70-80% of cancers originate in the peripheral zone tissue. The central zone (CZ) surrounds the ejaculatory ducts and encompasses approximately 20-25% of the prostate volume. The central zone is often the site of inflammatory processes. The transition zone (TZ) is where prostatic hyperplasia develops and comprises approximately 5-10% of the glandular volume in a normal prostate, but can comprise up to 80% in cases of benign prostatic hyperplasia (BPH). The transition zone encompasses the two lateral prostate lobes and the periurethral glandular area. A natural barrier surrounds the transition zone: the prostatic urethra, the anterior fibromuscular stroma, and a fibrous plane between the transition zone and the peripheral zone. The anterior fibromuscular stroma or fibromuscular zone is primarily composed of fibromuscular tissue.

[0005] Current treatment options for prostate cancer include radical surgery (robot-assisted surgery accounts for approximately 20%) and radiotherapy (primarily three-dimensional conformal radiotherapy) for early-stage treatment. In advanced stages, androgen deprivation therapy (ADT) is the primary treatment, with newer drugs (abiraterone and enzalutamide) gradually being introduced, albeit at a higher cost. Some hospitals also offer specialized treatments, such as minimally invasive procedures like high-intensity focused ultrasound (HIFU) and cryoablation.

[0006] Due to the structural characteristics of prostate tissue, early radical surgery was lengthy (several hours long), required the reconstruction of urethral tissue, and inevitably destroyed male sexual function. At the same time, the incidence of postoperative sequelae such as urinary incontinence was extremely high.

[0007] Therefore, it is of great practical significance to develop a system that can use ultra-minimally invasive steam ablation technology to treat prostate tumors. Summary of the Invention

[0008] Due to the above-mentioned defects in the existing technology, the present invention provides a system that can use ultra-minimally invasive steam ablation technology to treat prostate tumors, which solves the defects of existing prostate tumor treatment methods such as great damage to patients, long operation time and poor treatment effect.

[0009] In order to achieve the above object, the present invention provides the following technical solutions:

[0010] A prostate tumor steam ablation system, comprising an operating device and a control host;

[0011] The operation device includes an outer sleeve for entering the patient's body through the urethra, a handle connected to the outer sleeve, a steam generator arranged in the handle and configured to generate condensable steam (used to apply voltage and current to generate high temperature, and the high temperature pyrogen heats sterile water to generate water vapor), a steam delivery needle connected to the steam generator and slidably arranged in the outer sleeve, and a steam delivery needle attached to the steam delivery needle (used to deliver steam to the lesion site, reciprocate back and forth in the delivery needle tube, advance from the starting point in the protective head to the patient's lesion site, retreat and return to the starting position of the protective head, and deliver steam to the patient). The front end of the needle is processed with 3 rows of 4 steam outlet holes, totaling 12 (which can be set as needed). The steam holes are laser-marked, and the marks can be transmitted to the display screen via a camera, making it easy for the doctor to observe whether the steam needle has reached the lesion site. The delivery needle driving device is used to drive the steam delivery needle (used to generate a power source for the steam delivery needle to move forward and backward). The steam generator is connected to the sterile water inlet pipe away from the steam delivery needle end. The outer sleeve is equipped with a camera away from the handle end and is integrated with a magnetic positioning sensor. The operating device is equipped with an angle sensor for obtaining the rotation angle of the steam delivery needle.

[0012] The control host includes a data processing control unit and a display unit;

[0013] The data processing and control unit is used to process the patient's preoperative prostate examination data to obtain a three-dimensional model of the prostate, and determine a prostate tumor treatment plan based on user settings. The data processing and control unit processes relevant data collected by the camera, magnetic positioning sensor, and angle sensor on the operating device to obtain a three-dimensional model of the outer cannula and steam delivery needle in the prostate. The prostate tumor treatment plan includes the number of needle insertions, the location of each needle insertion, and the amount of steam input for each needle insertion. The data processing and control unit is signal-connected to the steam transmitter;

[0014] The display unit is connected to the data processing control unit and is used to display a prostate tumor treatment plan and a three-dimensional model of the outer cannula and the steam delivery needle in the prostate.

[0015] The prostate tumor steam ablation system of the present invention is the first to use steam ablation equipment in the field of prostate tumor treatment. The prostate tumor specifications are determined based on prostate examination data, and the control host determines the steam ablation plan based on the prostate tumor specifications. Once the steam ablation operating device is inserted into the patient's body, the control host guides the doctor to operate according to the steam ablation plan. The doctor is guided by screen images to insert the catheter into the patient's urethra at a specified location. The steam delivery needle is then immediately released, accurately piercing the center of the tumor tissue area. A certain amount of condensable steam energy is then applied to the prostate tumor tissue, causing tumor cell death and achieving the purpose of killing the tumor (over a set time, the tissue temperature in the treatment area is raised by approximately 70°C, causing tumor cell membrane degeneration and tumor cell death. At the same time, the thermal energy can cause blood vessels in the treatment area to collapse, ensuring that there is virtually no bleeding during the operation). Compared with existing surgical options, the system of the present invention has a short treatment time (less than 20 minutes), is doctor-friendly, and has a highly efficient process. It preserves male sexual function, shortens postoperative recovery time, and rarely causes serious sequelae.

[0016] As the preferred technical solution:

[0017] A prostate tumor steam ablation system as described above, wherein the outer sleeve is equipped with a camera module wire sub-tube (for camera module cable routing assembly), an irrigation sub-tube (for delivering normal saline), a delivery needle sub-tube (for limiting the reciprocating motion path of the steam delivery needle), and a liquid outlet sub-tube (for delivering the irrigation normal saline to the patient's body); the outer sleeve is equipped with a module base at the end away from the handle; the module base is equipped with a camera and an LED light (providing a light source for illuminating the patient's body to facilitate camera imaging); the irrigation sub-tube and the liquid outlet sub-tube are connected to the module base, and the outlet of the irrigation sub-tube is located above the camera and the LED light; the camera and the LED light are arranged at an angle and aligned with the steam delivery needle tip; the steam delivery needle is slidably installed in the delivery needle sub-tube, and the steam delivery needle tip is located on the side of the camera away from the handle; the camera module cable of the camera passes through the camera module wire sub-tube and enters the handle;

[0018] A protective head is fixedly mounted on the outer sleeve away from the handle end. A hollow portion is formed in the middle of the protective head, which is connected to the module base and the delivery needle tube. Side drainage ports connected to the hollow portion are provided on both sides of the protective head. A top opening is formed on the top of the protective head for the steam delivery needle to penetrate and is connected to the hollow portion.

[0019] The delivery needle driving device is an electromagnetic coil. The sensor module is installed on the module base, which can effectively solve the problem of difficult camera and LED light assembly process, and provides a new camera module assembly process idea; the protective head is installed on the outer sleeve, and the protective head is used as the travel path of the steam delivery needle. The steam delivery needle is turned 90 degrees to facilitate the steam delivery needle to puncture the urethra wall; the module base and the protective head are plugged together, which is convenient for installation, not only facilitating the installation of the sensor, but also greatly facilitating assembly, reducing product processing difficulty and equipment cost; the structure is optimized, and the layout position of the flushing sub-tube, camera and LED light is optimized, so that the camera can be flushed at the same time, which can overcome the problem of easy dirtiness of the camera and facilitate the operation of the operator; the protective head is reasonably designed, which greatly improves the drainage efficiency and can improve the operating efficiency of the operator.

[0020] In the prostate tumor steam ablation system as described above, the irrigation sub-tube is arranged above the delivery needle sub-tube, and the camera module line sub-tube and the liquid outlet sub-tube are arranged on both sides of the irrigation sub-tube and located between the irrigation sub-tube and the delivery needle tube;

[0021] The flushing sub-tube is connected to a saline inlet tube (for delivering saline to the flushing sub-tube), which passes through the rear of the handle and has a saline Luer connector at its free end for connecting to a saline cannula to provide saline for flushing.

[0022] The liquid outlet sub-tube is connected to the liquid outlet tube, and the liquid outlet tube passes through the bottom of the handle, providing a liquid outlet tube to guide the saline solution out of the patient's body to avoid damage to organs due to excessive saline solution.

[0023] In the prostate tumor steam ablation system as described above, the steam generator is connected to the steam delivery needle via a steam transmission tube, and the water vapor generated by the steam generator is delivered to the steam delivery needle;

[0024] The other end of the steam generator is connected to a sterile water inlet pipe, which passes through the bottom of the handle and has a sterile water Luer connector at its free end for connecting to a sterile water connection pipe, providing a source of sterile water for generating steam. The sterile water inlet pipe is connected to a sterile water peristaltic pump, i.e., water is supplied to the sterile water inlet pipe through the sterile water peristaltic pump. The sterile water peristaltic pump is signal-connected to the data processing control unit. The sterile water peristaltic pump is controlled by a control host, and the operating device only provides an on switch.

[0025] The physiological saline inlet pipe is connected to the physiological saline peristaltic pump, that is, water is supplied to the physiological saline inlet pipe through the physiological saline peristaltic pump, and the physiological saline peristaltic pump is directly controlled by the operating device.

[0026] In the above-mentioned prostate tumor steam ablation system, the handle includes a handle housing, and the handle housing is equipped with a manual top cover for emergency use. For example, when the retract button is pressed and the steam delivery needle cannot retract to the starting point, the manual top cover can be manually opened and the steam delivery needle can be manually pulled back to the starting point. At the same time, after the manual top cover is opened, it cannot be reassembled for use, effectively preventing the reuse of the device;

[0027] The handle housing is provided with a retraction board PCBA, a relay board and a control board PCBA;

[0028] The retraction plate PCBA is provided with a retraction switch button and is electrically connected to the delivery needle driving device. The handle housing is provided with a retraction button that matches the retraction switch button (used to trigger the steam delivery needle retraction function and retract the steam delivery needle to the starting position);

[0029] The control panel PCBA is provided with a flushing switch button, a firing switch button and a steam switch button, and the control panel PCBA is electrically connected to the physiological saline peristaltic pump, the delivery needle drive device and the steam generator. The handle housing is provided with a flushing button that matches the flushing switch button (used to trigger the physiological saline flushing function, lubricate to facilitate the insertion of the protective head, and flush the dirt on the surface of the camera to improve the clarity of the surgical field of view), a firing button that matches the firing switch button (used to trigger the steam delivery needle forward function to send the steam delivery needle from the starting point to the lesion point), and a steam button that matches the steam switch button (used to trigger heating to generate steam, used to provide a pyrogen for thermal ablation treatment);

[0030] The relay board is electrically connected to the rollback board PCBA, the control board PCBA and the data processing control unit, and the relay board is used to relay image signals and control signals;

[0031] The relay board is connected to the camera module cable and the data processing control unit respectively.

[0032] In the prostate tumor steam ablation system as described above, the flushing button is provided with a spring retractable pin A, and the spring retractable pin A is used to provide a pressing restoring force for the flushing button;

[0033] The firing button is provided with a spring retractable pin B, which is used to provide a pressing restoring force for the firing button;

[0034] The steam button is provided with a spring retractable pin C, which is used to provide a pressing restoring force for the steam button;

[0035] The data processing control unit is electrically connected to the relay board via a control cable, and the control cable is passed through the rear of the handle;

[0036] The power cable provides power to various components in the operating device (delivery needle drive device, steam generator, camera, LED light) and the power cable is passed through the bottom of the handle.

[0037] In the prostate tumor steam ablation system described above, the outer sleeve is fixed to the handle via a rotating body and the outer sleeve can rotate around the handle. By controlling the angle of the rotating body, the doctor is effectively prevented from operating the handle, thereby improving the flexibility and operability of the operation. The angle sensor is integrated into the rotating body.

[0038] The protective head is in an arc shape away from the outer tube end, which is convenient for inserting the urethra tube;

[0039] The outer tube surface is engraved with scale lines to facilitate observation of the insertion depth into the urethra;

[0040] LED lights are installed on both sides of the camera.

[0041] In the prostate tumor steam ablation system as described above, the patient's preoperative prostate examination data includes the patient's preoperative prostate ultrasound data and MRI scan data.

[0042] The steam generator of the tumor steam ablation system of the present invention provides energy for converting liquid water into high-temperature steam. The heat released when the steam condenses is used to heat the tumor tissue to a lethal temperature. That is, the core of the relationship between prostate tumor volume and steam energy is that, based on heat balance, the heat released by steam condensation is equal to the heat required to heat the tumor tissue.

[0043] The relationship between prostate tumor volume and steam energy involved in the above-mentioned prostate tumor steam ablation system is as follows:

[0044] The energy required to ablate a certain volume of prostate tumor is Q1 = V × p × C2 × (T2-T1);

[0045] Steam energy provided by the steam generator Q2 = m × [L + C1 × (t2 - t1)];

[0046] Steam generator power P=Q2 / t;

[0047] Where V is the volume of the prostate tumor in cm 3 , m is the mass of sterile water, unit is g, t1 is the water inlet temperature of the steam generator, unit is °C, t2 is the steam outlet temperature, unit is °C, T1 is the initial temperature of the prostate tumor, unit is °C, T2 is the lethal temperature of the tumor cells, unit is °C, t is the heating time, unit is s, P is the power of the steam generator, unit is W, C1 is the specific heat capacity of water, unit is 4168 J / (kg*°C), L is the latent heat of water vaporization, unit is 2257000 J / kg, 100°C steam, C2 is the specific heat capacity of prostate cell tissue, unit is 2.9~4 J / (cm 3 *℃), p is the prostate tissue density, unit is kg / m 3 ;

[0048] Assuming that the energy P generated by the steam generator is used to release heat from steam condensation, taking into account the heat loss, the efficiency factor α is increased (α≤1); assuming that the heat released by the steam is locally lost in the tumor area, the efficiency factor β is increased (β≤1), that is;

[0049] Q2=β×Q1;

[0050] P = Q2 / (t×α);

[0051] Under the conditions of a fixed steam outlet temperature of 100°C, a sterile water inlet temperature of 25°C, an initial prostate tissue temperature of 37°C, and a tumor cell lethal temperature of 70°C, the above formula can be used to determine how long (t) it takes for a tumor of a certain volume to generate appropriate heating energy, thereby further locking the physical parameters of the steam generator such as voltage and current required to generate heating energy for precise treatment. Of course, this involves the energy loss and impact between the steam generator, steam conversion, and tumor ablation, and requires final adjustment under conditions such as a large number of experiments and in vitro tissue testing to meet the safety and effectiveness requirements of medical devices.

[0052] The present invention also provides a method for using the prostate tumor steam ablation system as described above, comprising the following steps:

[0053] (1) Inputting the patient's preoperative prostate examination data into the control host, the control host obtains the patient's preoperative prostate examination data in advance, such as ultrasound & MRI scan data;

[0054] (2) The control host outputs a three-dimensional model of the prostate and determines the prostate tumor treatment plan according to the user's settings (i.e., the user-doctor defines the treatment plan on the control host (such as the number of injections, the order of injections, the energy level of each injection, and the depth of each injection), that is, determines the position of each injection and the required steam energy required for tumor treatment, and simulates the shape and size of the prostate and identifies the treatment point on the control host display unit);

[0055] (3) The operator operates the operating device to extend the outer cannula into the patient's position. The operator determines the position based on the three-dimensional model of the outer cannula and steam delivery needle in the prostate output by the control host, and controls the operating device according to the prompts of the prostate tumor treatment plan (the outer cannula of the operating device is inserted into the patient's urethra, and combined with the camera and magnetic positioning sensor, it accurately stops at the needle insertion position; at the same time, the 3D simulation image on the host screen shows whether the actual position is consistent with the previous treatment plan. If it is consistent, the puncture needle is fired into the predetermined prostate position according to the established plan (that is, it stays precisely at the designated position, releases a certain length of steam delivery needle to the center area of ​​the tumor at a specific angle, and then releases a certain amount of steam energy to kill tumor cells while avoiding damage to normal tissues, so as to achieve the purpose of accurate identification, accurate positioning, and accurate treatment of tumors). The predetermined steam is released to kill tumor cells and achieve the treatment purpose). When the control host detects that there is a safety risk in the operator's operation, an alarm will be issued.

[0056] The above technical solution is only a feasible technical solution of the present invention. The protection scope of the present invention is not limited thereto. Those skilled in the art can reasonably adjust the specific design according to actual needs.

[0057] The above invention has the following advantages or beneficial effects:

[0058] (1) The prostate tumor steam ablation system of the present invention is the first to use steam ablation equipment in the field of prostate tumor treatment. The prostate tumor specifications are determined based on prostate examination data, and the control host determines the steam ablation plan based on the prostate tumor specifications. When the steam ablation operation device enters the patient's body, the control host guides the doctor to operate according to the steam ablation plan. The operation process is doctor-friendly, convenient and efficient.

[0059] (2) Compared with existing surgical solutions, the prostate tumor steam ablation system of the present invention has a shorter treatment time (less than 20 minutes), preserves male sexual function, shortens postoperative recovery time, rarely causes serious sequelae, and has good application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] The present invention and its features, configurations, and advantages will become more apparent upon reading the detailed description of non-limiting embodiments with reference to the following drawings. Like reference numerals indicate like parts throughout the drawings. The drawings are not drawn to scale, emphasis instead being placed on illustrating the subject matter of the present invention.

[0061] Figure 1 It is a schematic diagram of the three-dimensional structure of the operating equipment;

[0062] Figure 2 A three-dimensional perspective view of the operating equipment;

[0063] Figure 3 It is a schematic diagram of the three-dimensional structure of the operating device under different viewing angles;

[0064] Figure 4 is an enlarged cross-sectional view of the steam delivery needle;

[0065] Figure 5 This is an enlarged view of the steam delivery needle;

[0066] Figure 6 Schematic diagram of the hardware connection of the prostate tumor steam ablation system of the present invention;

[0067] Figure 7 Schematic diagram of each software module in the data processing control unit;

[0068] Figure 8 This is a schematic diagram of the power supply system connection of the prostate tumor steam ablation system of the present invention;

[0069] Among them, 1 is the steam delivery needle, 2 is the protective head, 3 is the outer sleeve, 4 is the rotating body, 5 is the back button, 6 is the flush button, 7 is the firing button, 8 is the steam button, 9 is the manual top cover, 10 is the handle shell, 11 is the normal saline Luer connector, 12 is the normal saline inlet tube, 13 is the sterile water inlet tube, 14 is the sterile water Luer connector, 15 is the outlet tube, 16 is the control cable, 17 is the power cable, 18 is the control line aviation plug, 19 is the power line aviation plug, 20 is the module base, 21 is the angle Sensor, 22 is the retraction board PCBA, 23 is the delivery needle drive device, 24 is the spring telescopic pin A, 25 is the spring telescopic pin B, 26 is the spring telescopic pin C, 27 is the relay board, 28 is the steam generator, 29 is the camera, 30 is the LED light, 31 is the camera module cable, 32 is the camera module line sub-tube, 33 is the flushing sub-tube, 34 is the delivery needle sub-tube, 35 is the liquid outlet sub-tube, 36 is the steam transmission tube, 37 is the control board PCBA, 38 is the drainage port on the side of the protective head, and 39 is the opening on the top of the protective head. DETAILED DESCRIPTION

[0070] The structure of the present invention is further described below with reference to the accompanying drawings and specific embodiments, but is not intended to limit the present invention.

[0071] Example 1

[0072] A prostate tumor steam ablation system, comprising an operating device and a control host;

[0073] Operating equipment such as Figures 1 to 5 As shown, the invention comprises an overtube 3 for entering a patient's body through the urethra, a handle coupled to the overtube 3, a heating tube 28 disposed in the handle and configured to generate condensable steam, a steam delivery needle 1 communicating with the heating tube 28 and slidably disposed within the overtube 3, and a delivery needle driving device 23 (electromagnetic coil) attached to the steam delivery needle 1 and used to drive the steam delivery needle 1;

[0074] The outer sleeve 3 is fixed to the handle by a rotating body 4 and the outer sleeve 3 can rotate around the handle. The rotating body 4 has an angle sensor 21 built in. The surface of the outer sleeve 3 is engraved with scale lines. The outer sleeve 3 is integrated with a magnetic positioning sensor. The outer sleeve 3 has a camera module line sub-tube 32, a flushing sub-tube 33, a delivery needle sub-tube 34 and a liquid outlet sub-tube 35 built in. The flushing sub-tube 33 is arranged above the delivery needle tube 34. The camera module line sub-tube 32 and the liquid outlet sub-tube 35 are arranged on both sides of the flushing sub-tube 33 and are located between the flushing sub-tube 33 and the delivery needle tube 34. The outer sleeve 3 is provided with a module base 20 away from the handle end. A camera 29 and an LED light 30 are installed on the module base 20. The flushing sub-tube 33 and the liquid outlet sub-tube 35 are connected to the module base 20 and the outlet of the flushing sub-tube 33 is located above the camera 29 and the LED light 30. LED lights 30 are installed on both sides of the camera 29. The camera 29 and the LED light 30 are arranged tilted and aimed at the steam The delivery needle 1 needle head, the steam delivery needle 1 is slidably installed in the delivery needle tube 34 and the steam delivery needle 1 needle head is located on the side of the camera 29 away from the handle, the camera module cable 31 of the camera 29 passes through the camera module cable tube 32 into the handle, the flushing sub-tube 33 is connected to the physiological saline inlet tube 12, the physiological saline inlet tube 12 passes through the rear of the handle, and its free end is equipped with a physiological saline Luer connector 11, the physiological saline inlet tube 12 is connected to the physiological saline peristaltic pump, the liquid outlet sub-tube 35 is connected to the liquid outlet tube 15, the liquid outlet tube 15 passes through the bottom of the handle, the steam generator 28 is connected to the steam delivery needle 1 through the steam transmission tube 36, the other end of the steam generator 28 is connected to the sterile water inlet tube 13, the sterile water inlet tube 13 passes through the bottom of the handle, and its free end is equipped with a sterile water Luer connector 14, the sterile water inlet tube 13 is connected to the sterile water peristaltic pump, and the sterile water peristaltic pump is connected to the control host (data processing control unit) signal.

[0075] The outer sleeve 3 is fixed with a protective head 2 at the end away from the handle. The middle of the protective head 2 is provided with a hollow portion, which is connected to the module base and the delivery needle tube. The protective head 2 is provided with a protective head side drainage port 38 connected to the hollow portion on both sides. The top of the protective head 2 is provided with a protective head top opening 39 for the steam delivery needle 1 to penetrate and connected to the hollow portion. The protective head 2 is an arc-shaped structure away from the outer sleeve 3.

[0076] The handle includes a handle housing 10, and a manual top cover 9 is mounted on the handle housing 10;

[0077] The handle housing 10 is provided with a retraction board PCBA 22, a relay board 27 and a control board PCBA 37;

[0078] A retraction switch button is provided on the retraction board PCBA 22 and is electrically connected to the delivery needle drive device 23. A retraction button 5 matching the retraction switch button is provided on the handle housing 10.

[0079] The control board PCBA 37 is provided with a flush switch button, a firing switch button, and a steam switch button, and is electrically connected to the physiological saline peristaltic pump, the delivery needle drive device 23, and the steam generator 28. The handle housing is provided with a flush button 6 that matches the flush switch button, a firing button 7 that matches the firing switch button, and a steam button 8 that matches the steam switch button. The flush button 6 is provided with a spring retractable pin A 24 that provides a pressing return force for the flush button 6. The firing button 7 is provided with a spring retractable pin B 25 that provides a pressing return force for the firing button 7. The steam button 8 is provided with a spring retractable pin C 26 that provides a pressing return force for the steam button 8.

[0080] The relay board 27 is electrically connected to the retractor board PCBA 22 and the control board PCBA 37. The relay board 27 is also connected to the camera module cable 31. The control cable 16 is electrically connected to the relay board 27. The control cable 16 exits from the rear of the handle. Its free end is equipped with a control line aviation plug 18, which is used for signal connection to the control host (data processing control unit).

[0081] The power cable 17 provides power to the various components in the prostate steam ablation system. The power cable 17 extends from the bottom of the handle, and its free end is equipped with a power cable aviation plug 19 and is connected to the power source through the power cable aviation plug 19;

[0082] The control host includes a data processing control unit and a display unit;

[0083] The data processing control unit is used to process the patient's preoperative prostate examination data (including the patient's preoperative prostate ultrasound data and MRI scan data), obtain a three-dimensional model of the prostate, and determine a prostate tumor treatment plan based on user settings. The data processing control unit processes relevant data collected by the camera, magnetic positioning sensor, and angle sensor on the operating device to obtain a three-dimensional model of the outer cannula and steam delivery needle in the prostate. The prostate tumor treatment plan includes the number of needle insertions, the location of each needle insertion, and the amount of steam input for each needle insertion. The data processing control unit is signal-connected to the steam transmitter.

[0084] The display unit is connected to the data processing control unit, and is used to display the prostate tumor treatment plan and the three-dimensional model of the outer cannula and the steam delivery needle in the prostate.

[0085] The hardware connection diagram of the prostate tumor steam ablation system is as follows: Figure 6 As shown, the software modules involved in the data processing control unit are as follows Figure 7 shown.

[0086] The power supply system of the prostate tumor steam ablation system is connected as follows: Figure 8 As shown, the data processing control unit of the control host is powered by a 12V DC power supply, and the delivery needle drive device, the sterile water peristaltic pump and the physiological saline peristaltic pump are powered by a 24V DC power supply.

[0087] The relationship between prostate tumor volume and steam energy involved in the above-mentioned prostate tumor steam ablation system is as follows:

[0088] The energy required to ablate a certain volume of prostate tumor is Q1 = V × p × C2 × (T2-T1);

[0089] Steam energy provided by the steam generator Q2 = m × [L + C1 × (t2 - t1)];

[0090] Steam generator power P=Q2 / t;

[0091] Where V is the volume of the prostate tumor in cm 3 , m is the mass of sterile water, unit is g, t1 is the water inlet temperature of the steam generator, unit is °C, t2 is the steam outlet temperature, unit is °C, T1 is the initial temperature of the prostate tumor, unit is °C, T2 is the lethal temperature of the tumor cells, unit is °C, t is the heating time, unit is s, P is the power of the steam generator, unit is W, C1 is the specific heat capacity of water, unit is 4168 J / (kg*°C), L is the latent heat of water vaporization, unit is 2257000 J / kg, 100°C steam, C2 is the specific heat capacity of prostate cell tissue, unit is 2.9~4 J / (cm 3*℃), p is the prostate tissue density, unit is kg / m 3 ;

[0092] Assuming that the energy P generated by the steam generator is used to release heat from steam condensation, taking into account the heat loss, the efficiency factor α is increased (α≤1); assuming that the heat released by the steam is locally lost in the tumor area, the efficiency factor β is increased (β≤1), that is;

[0093] Q2=β×Q1;

[0094] P = Q2 / (t×α);

[0095] Under the conditions of a fixed steam outlet temperature of 100°C, a sterile water inlet temperature of 25°C, an initial prostate tissue temperature of 37°C, and a tumor cell lethal temperature of 70°C, the above formula can be used to determine how long (t) it takes for a tumor of a certain volume to generate appropriate heating energy.

[0096] The method for using the above-mentioned prostate tumor steam ablation system comprises the following steps:

[0097] (1) Inputting the patient's preoperative prostate examination data into the control host, the control host obtains the patient's preoperative prostate examination data in advance, such as ultrasound & MRI scan data;

[0098] (2) The control host outputs a three-dimensional model of the prostate and determines the prostate tumor treatment plan according to the user's settings (i.e., the user-doctor defines the treatment plan on the control host (such as the number of injections, the order of injections, the energy level of each injection, and the depth of each injection), that is, determines the position of each injection and the required steam energy required for tumor treatment, and simulates the shape and size of the prostate and identifies the treatment point on the control host display unit);

[0099] (3) The operator operates the operating device to extend the outer cannula into the patient's position. The operator determines the position based on the three-dimensional model of the outer cannula and steam delivery needle in the prostate output by the control host, and controls the operating device according to the prompts of the prostate tumor treatment plan (the outer cannula of the operating device is inserted into the patient's urethra, and combined with the camera and magnetic positioning sensor, it accurately stops at the needle insertion position; at the same time, the 3D simulation image on the host screen shows whether the actual position is consistent with the previous treatment plan. If it is consistent, the puncture needle is fired into the predetermined prostate position according to the established plan (that is, it stays precisely at the designated position, releases a certain length of steam delivery needle to the central area of ​​the tumor at a specific angle, and then releases a certain amount of steam energy to kill tumor cells while avoiding damage to normal tissues, so as to achieve the purpose of accurate identification, accurate positioning, and accurate treatment of tumors). The predetermined steam is released to kill tumor cells and achieve the treatment purpose).

[0100] Those skilled in the art should understand that they can implement variations by combining the prior art with the above embodiments, which will not be described in detail here. Such variations do not affect the essence of the present invention and will not be described in detail here.

[0101] The above describes the preferred embodiments of the present invention. It should be understood that the present invention is not limited to the above-mentioned specific embodiments, and the devices and structures that are not described in detail should be understood to be implemented in a common manner in the art; any technician familiar with the art can use the above-mentioned disclosed methods and technical contents to make many possible changes and modifications to the technical solutions of the present invention without departing from the scope of the technical solutions of the present invention, or modify them into equivalent embodiments of equivalent changes, which does not affect the essential content of the present invention. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention that do not depart from the content of the technical solutions of the present invention are still within the scope of protection of the technical solutions of the present invention.

Claims

1. A prostate tumor steam ablation system, characterized by: Including operating equipment and control host; The operation device includes an outer sleeve for entering a patient's body through the urethra, a handle connected to the outer sleeve, a steam generator disposed in the handle and configured to generate condensable steam, a steam delivery needle in communication with the steam generator and slidably disposed in the outer sleeve, and a delivery needle driving device attached to the steam delivery needle and used to drive the steam delivery needle, wherein the steam generator is connected to a sterile water inlet tube at an end remote from the steam delivery needle, a camera is installed at an end remote from the handle of the outer sleeve, and a magnetic positioning sensor is integrated into the outer sleeve, and an angle sensor is installed on the operation device for obtaining a rotation angle of the steam delivery needle; The control host includes a data processing control unit and a display unit; The data processing and control unit is used to process the patient's preoperative prostate examination data to obtain a three-dimensional model of the prostate, and determine a prostate tumor treatment plan based on user settings. The data processing and control unit processes relevant data collected by the camera, magnetic positioning sensor, and angle sensor on the operating device to obtain a three-dimensional model of the outer cannula and steam delivery needle in the prostate. The prostate tumor treatment plan includes the number of needle insertions, the location of each needle insertion, and the amount of steam input for each needle insertion. The data processing and control unit is signal-connected to the steam transmitter; The display unit is connected to the data processing control unit and is used to display a prostate tumor treatment plan and a three-dimensional model of the outer cannula and the steam delivery needle in the prostate.

2. A prostate tumor steam ablation system according to claim 1, characterized in that: The outer sleeve is equipped with a camera module wire sub-tube, a flushing sub-tube, a delivery needle sub-tube and a liquid outlet sub-tube. The outer sleeve is equipped with a module base at the end away from the handle. A camera and an LED light are installed on the module base. The flushing sub-tube and the liquid outlet sub-tube are connected to the module base, and the outlet of the flushing sub-tube is located above the camera and the LED light. The camera and the LED light are arranged obliquely and aligned with the needle head of the steam delivery needle. The steam delivery needle is slidably installed in the delivery needle sub-tube, and the needle head of the steam delivery needle is located on the side of the camera away from the handle. The camera module cable of the camera passes through the camera module wire sub-tube and enters the handle. A protective head is fixedly mounted on the outer sleeve away from the handle end. A hollow portion is formed in the middle of the protective head, which is connected to the module base and the delivery needle tube. Side drainage ports connected to the hollow portion are provided on both sides of the protective head. A top opening is formed on the top of the protective head for the steam delivery needle to penetrate and is connected to the hollow portion. The delivery needle drive device is an electromagnetic coil.

3. A prostate tumor steam ablation system according to claim 2, characterized in that: The flushing sub-tube is arranged above the delivery needle sub-tube, and the camera module line sub-tube and the liquid outlet sub-tube are arranged on both sides of the flushing sub-tube and located between the flushing sub-tube and the delivery needle tube; The flushing sub-tube is connected to a physiological saline inlet tube, which passes through the rear of the handle and has a physiological saline Luer connector installed at its free end; The liquid outlet sub-tube is connected to the liquid outlet pipe, and the liquid outlet pipe passes through the bottom of the handle.

4. A prostate tumor steam ablation system according to claim 3, characterized in that: The steam generator is connected to the steam delivery needle via a steam transmission tube; The other end of the steam generator is connected to a sterile water inlet pipe, which passes through the bottom of the handle and has a sterile water Luer connector at its free end. The sterile water inlet pipe is connected to a sterile water peristaltic pump, which is signal-connected to the data processing control unit. The physiological saline inlet tube is connected to the physiological saline peristaltic pump.

5. A prostate tumor steam ablation system according to claim 4, characterized in that: The handle comprises a handle shell, and a manual top cover is mounted on the handle shell; The handle housing is provided with a retraction board PCBA, a relay board and a control board PCBA; The retraction board PCBA is provided with a retraction switch button and the retraction board PCBA is electrically connected to the delivery needle driving device. The handle housing is provided with a retraction button that matches the retraction switch button. The control panel PCBA is provided with a flushing switch button, a firing switch button, and a steam switch button, and the control panel PCBA is electrically connected to the physiological saline peristaltic pump, the delivery needle drive device, and the steam generator. The handle housing is provided with a flushing button matching the flushing switch button, a firing button matching the firing switch button, and a steam button matching the steam switch button. The relay board is electrically connected to the rollback board PCBA, the control board PCBA and the data processing control unit; The relay board is connected to the camera module cable and the data processing control unit respectively.

6. A prostate tumor steam ablation system according to claim 5, characterized in that: The flush button is provided with a spring retractable pin A, which is used to provide a pressing restoring force for the flush button; The firing button is provided with a spring retractable pin B, which is used to provide a pressing restoring force for the firing button; The steam button is provided with a spring retractable pin C, which is used to provide a pressing restoring force for the steam button; The data processing control unit is electrically connected to the relay board via a control cable, and the control cable is passed through the rear of the handle; The power cable provides power to various components in the operating device and the power cable is passed through the bottom of the handle.

7. A prostate tumor steam ablation system according to claim 2, characterized in that: The outer sleeve is fixed to the handle via a rotating body and can rotate around the handle, and the angle sensor is integrated into the rotating body; The protective head is in an arc shape away from the outer sleeve end; The outer sleeve surface is engraved with scale lines; LED lights are installed on both sides of the camera.

8. The prostate tumor steam ablation system according to claim 1, characterized in that: The patient's preoperative prostate examination data includes the patient's preoperative prostate ultrasound data and MRI scan data.

9. A method for using a prostate tumor steam ablation system according to any one of claims 1 to 8, characterized in that: The following steps are involved: (1) Input the patient's preoperative prostate examination data into the control host; (2) Control the host computer to output a three-dimensional model of the prostate and a prostate tumor treatment plan; (3) The operator operates the operating device to extend the outer cannula into the patient's position. The operator determines the position based on the three-dimensional model of the outer cannula and steam delivery needle in the prostate output by the control host, and controls the operating device according to the prompts of the prostate tumor treatment plan.

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