Prostate steam ablation system

Abstract

The utility model discloses a prostate steam ablation system. The system includes an introducer sheath for transurethral access into the body of a patient, a handle coupled to the introducer sheath, a vapor generator disposed in the handle and configured to generate condensable vapor, the steam conveying needle is communicated with the steam generator and is arranged in the guide tube sheath in a sliding manner; the micro servo electric cylinder is attached to the steam conveying needle and is used for driving the steam conveying needle; and guide tube sheath scales are engraved on the outer wall of the guide tube sheath along the length direction of the guide tube sheath. According to the prostate steam ablation system, the guide tube sheath scales are additionally arranged on the outer wall of the guide tube sheath, so that the surgical operation of a doctor can be greatly facilitated, reference is provided for the spacing distance of puncture needles, the defect that the doctor performs operation completely depending on experience is overcome, and the application prospect is good.

Description

Technical Field

[0001] The utility model relates to the technical field of minimally invasive treatment of prostate, in particular to a prostate steam ablation system, and in particular to a system for treating benign prostatic hyperplasia by using steam transmitted to the prostate. Background Art

[0002] With the continuous improvement of living and medical conditions, people's pursuit of quality of life is also constantly increasing. At this stage, the aging of the population is constantly intensifying, and geriatric diseases are becoming increasingly prominent. Among them, benign prostatic hyperplasia is one of the common diseases in elderly men, which seriously affects the quality of life of the elderly.

[0003] Benign prostatic hyperplasia is usually diagnosed when patients complain of troublesome urination difficulties and seek medical treatment. The main symptoms of benign prostatic hyperplasia are frequent urination and urgency, as well as a significant decrease in flow rate during urination. Benign prostatic hyperplasia may also cause urine to be retained in the bladder, which in turn may cause lower urinary tract infection. In many cases, the lower urinary tract infection may then rise in the kidneys and cause chronic pyelonephritis, which may eventually lead to renal insufficiency. Benign prostatic hyperplasia may also cause sexual dysfunction associated with sleep disorders or psychological anxiety caused by severe urination difficulties. Therefore, as the male population ages, benign prostatic hyperplasia may significantly change the quality of life.

[0004] In early cases of BPH, medications can relieve some symptoms. For example, alpha-blockers treat BPH by relaxing the smooth muscle tissue found in the prostate and bladder neck, which also allows urine to flow out of the bladder more easily. This type of medication can prove effective before glandular elements cause extreme cell growth in the prostate.

[0005] However, the late stage of benign prostatic hyperplasia can only be treated by surgery or minimally invasive thermal elimination device intervention. Developed a variety of methods utilizing electrosurgery or mechanical tissue aspiration (extraction) and thermal elimination or cryo-elimination of intracapsular prostate tissue. In many cases, this type of intervention only provides short-term relief, and these treatments usually result in significant discomfort and morbidity before and after surgery.

[0006] The current hot steam treatment equipment uses pulse energy to heat sterile distilled water to 103°C, which is then injected into the proliferating prostate tissue through a disposable prostate hot steam treatment device. The hot steam releases heat energy through intercellular convection diffusion, raising the temperature of the tissue in the treatment area by about 70°C in 9 seconds, causing cell membrane degeneration and cell death. Necrotic tissue is absorbed by the body, reducing the volume of the prostate tissue next to the urethra and alleviating lower urinary tract infection. In addition, heat energy can cause blood vessels in the treatment area to collapse, ensuring that there is basically no bleeding during the operation.

[0007] The existing steam thermal ablation devices Rezum on the market (i.e., the steam elimination system disclosed in CN 113855214 A and the system for prostate treatment disclosed in CN105816237A) have the following defects: 1) It needs to be used with a cystoscope with a 4mm / 30° / 30cm lens. The cystoscope needs to be equipped with a light source and an image display device, and there are many cables connecting external devices; 2) Before steam delivery and release, the front needle needs to be punctured deeply into the prostate tissue. The current steam thermal ablation device Rezum uses a magnetic device to provide the movement power of the needle, and it is impossible to effectively determine whether the needle has punctured into the correct position; 3) During the prostate ablation operation, in order to maintain a clear surgical observation field of view, the urethra needs to be flushed with sterile saline from time to time. The current steam thermal ablation device Rezum, due to structural limitations, the endoscope and sterile saline flushing share one channel, which cannot meet the surgical requirements well. To solve the above problems, the applicant has developed a prostate steam ablation system (Chinese patent application number 202410153910.7), but it still has the following defects: 1) When performing prostate ablation surgery, doctors need to perform puncture and ablation with 3 to 6 needles in the three main areas of prostate hyperplasia depending on the size of the hyperplasia. The interval between each needle needs to be controlled at about 10 mm, and current products (including rezum products) are not equipped with scales. The 10 mm interval depends entirely on the doctor's experience, which requires a high level of experience from the doctor; 2) The handle needs to be rotated 180° during the operation. If the rotation angle is insufficient or exceeds 180°, it is very likely to puncture the patient's non-diseased area, causing irreparable losses.

[0008] Therefore, it is of great practical significance to develop a prostate steam ablation system that can facilitate surgical operations and reduce the risks of surgical errors. Utility Model Content

[0009] Since the prior art has the above-mentioned defects, the utility model provides a prostate steam ablation system that can facilitate surgical operations and reduce the risks caused by surgical misoperation, thereby solving the defects of the existing prostate steam ablation system that has high requirements for operators and a certain risk of misoperation.

[0010] In order to achieve the above purpose, the utility model provides the following technical solutions:

[0011] A prostate steam ablation system comprises an introducer sheath for entering a patient's body through the urethra, a handle coupled to the introducer sheath, 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 within the introducer sheath, and a micro servo electric cylinder attached to the steam delivery needle and used to drive the steam delivery needle;

[0012] The outer wall of the guide sheath is engraved with guide sheath scales along the length direction of the guide sheath.

[0013] The utility model adds guide tube sheath scales on the outer wall of the guide tube sheath. The existence of the guide tube sheath scales can greatly facilitate the doctor's surgical operation and provide a reference for the spacing distance of the puncture needle, thereby avoiding the disadvantage that the doctor relies entirely on experience to operate, and has good application prospects.

[0014] As the preferred technical solution:

[0015] A prostate steam ablation system as described above, the prostate steam ablation system further comprising an angle sensor for monitoring the angle of the handle and arranged in the handle;

[0016] The guide tube sheath is provided with a front camera aimed at the front end of the guide tube sheath, a rear camera aimed at the needle tip of the steam delivery needle, and an ultrasonic probe module at the end of the guide tube sheath away from the handle.

[0017] The presence of the angle sensor can further provide a reference for the doctor's operation, reducing the possibility of the steam delivery needle piercing the patient's non-diseased part due to the doctor's inaccurate rotation angle to fire the steam delivery needle, causing irreparable damage; two front and rear cameras are set on the guide sheath (the front camera of the guide sheath and the rear camera of the guide sheath). The rear camera of the guide sheath aimed at the needle tip of the steam delivery needle can observe the firing and withdrawal of the delivery needle and the treatment site, which is convenient for the operator to perform surgical operations; the added ultrasound probe module can not only assist in the positioning of the puncture needle, but also determine the surgical effect through the ultrasound probe during the operation; a micro-servo electric cylinder is used to drive the steam delivery needle, which has high stroke accuracy (the delivery stroke accuracy reaches ±0.03mm) compared to the magnetic drive parts in the prior art.

[0018] A prostate steam ablation system as described above, wherein the steam generator is a coil pulse heater, which heats sterile distilled water into sterile distilled water vapor by converting electrical energy into thermal energy, has a small volume and high heating efficiency;

[0019] The handle is made of biodegradable material by injection molding, is environmentally friendly, and is provided with a firing button for controlling the steam generator and the micro servo electric cylinder.

[0020] In the prostate steam ablation system as described above, the guide sheath is further provided with a guide sheath video / ultrasound signal cable channel, the guide sheath video / ultrasound signal cable channel is provided with a video / ultrasound signal cable for connecting the guide sheath rear camera, the guide sheath front camera and the ultrasound probe module, the video / ultrasound signal cable is connected to the angle sensor after passing through the handle, and then passes through the bottom of the handle to connect with the main control device signal;

[0021] The signal on the main control device is connected with a control cable, and the control cable is inserted into the handle from the bottom of the handle and connected with the steam generator and the micro servo electric cylinder signal respectively. A safety assurance program is running on the main control device, which will determine whether to lock the steam delivery needle (whether the micro servo electric cylinder can be fired) according to the angle information collected by the angle sensor obtained through the video / ultrasound signal cable. For example, 75 to 110 degrees is a dangerous firing angle (that is, when the handle is turned to this angle, the steam delivery needle is likely to pierce the rectum and cause serious harm to the patient). If the main control device receives the angle signal of the angle sensor, it will automatically lock the firing action of the puncture needle and display a warning signal on its display to remind the doctor that the handle angle is wrong. This can greatly reduce the possibility of the doctor firing the steam delivery needle due to inaccurate rotation angle, and the steam delivery needle piercing the patient's non-diseased part, causing irreparable losses. The above safety assurance program is a conventional setting program in this field, and technicians in this field can flexibly set it according to their needs.

[0022] A prostate steam ablation system as described above, wherein the guide tube sheath is further provided with a saline inlet channel and a saline outlet channel in the guide tube sheath, one end of the saline inlet channel in the guide tube sheath is connected to a liquid inlet located at an end of the guide tube sheath away from the handle and the liquid inlet is aligned with a rear camera of the guide tube sheath, and the other end is connected to a saline inlet tube, the saline outlet channel in the guide tube sheath is connected to a liquid discharge port located at an end of the guide tube sheath away from the handle, and the other end is connected to a saline outlet tube;

[0023] The front camera of the guide sheath is installed at the end of the guide sheath away from the handle end.

[0024] Compared with the existing technology in which the endoscope and the flushing channel share the same channel, the dedicated inlet and outlet channels for physiological saline in the guide sheath are convenient for flushing and clearing the field of vision during surgery, and the existence of the dedicated channel can avoid contamination; integrating the steam delivery needle, the saline inlet channel in the guide sheath, and the saline outlet channel in the guide sheath can reduce the diameter of the guide sheath (to 6 mm), thereby reducing the surgical burden on patients.

[0025] In the above-mentioned prostate steam ablation system, the saline inlet channel and the saline outlet channel in the guide sheath are respectively connected to the saline inlet pipe and the saline outlet pipe through a water divider. The quick connection of the pipeline can be achieved through the Luer connector.

[0026] A prostate steam ablation system as described above, wherein the saline inlet tube and the saline outlet tube extend out from the bottom of the handle;

[0027] The free end of the physiological saline inlet tube is installed with a physiological saline inlet tube Luer connector, and the free end of the physiological saline outlet tube is installed with a physiological saline outlet tube Luer connector.

[0028] In the prostate steam ablation system as described above, the steam generator is connected to a sterile distilled water inlet tube away from the steam delivery needle end, and the sterile distilled water inlet tube passes through the bottom of the handle.

[0029] In the prostate steam ablation system as described above, the guide sheath is fixed to the handle via a knob and the guide sheath can rotate around the handle.

[0030] In the prostate steam ablation system as described above, the micro servo electric cylinder has an embedded force sensor, which can feed back the puncture force to the micro servo electric cylinder. The micro servo electric cylinder controls the steam delivery needle according to the puncture force, which can avoid to the greatest extent the serious harm to the patient caused by the steam delivery needle piercing the cyst wall during the operation. Compared with the current reliance on the surgeon's experience to judge the puncture depth of the steam delivery needle, it has good reliability and adds a layer of safety guarantee for the patient's surgical safety.

[0031] The above technical solution is only a feasible technical solution of the present utility model, and the protection scope of the present utility model is not limited thereto. Those skilled in the art can reasonably adjust the specific design according to actual needs.

[0032] The above utility model has the following advantages or beneficial effects:

[0033] (1) The prostate steam ablation system of the present invention has a guide sheath scale on the outer wall of the guide sheath. The guide sheath scale can greatly facilitate the doctor's surgical operation and provide a reference for the spacing distance of the puncture needle, thereby avoiding the disadvantage that the doctor relies entirely on experience to operate.

[0034] (2) The angle sensor in the prostate steam ablation system of the utility model can further provide a reference for the doctor's operation, thereby reducing the possibility of the steam delivery needle piercing the patient's non-diseased part due to the doctor's inaccurate rotation angle to fire the steam delivery needle, causing irreparable losses, and has good application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The present invention and its features, appearance and advantages will become more apparent by reading the detailed description of the non-limiting embodiments with reference to the following drawings. The same reference numerals indicate the same parts in all the drawings. The drawings are not drawn to scale, and the emphasis is on illustrating the subject matter of the present invention.

[0036] Figure 1 It is a front perspective view of the prostate steam ablation system of the utility model;

[0037] Figure 2 It is a front view of the prostate steam ablation system of the utility model;

[0038] Figure 3 It is a three-dimensional perspective view of the prostate steam ablation system of the utility model;

[0039] Figure 4 is a cross-sectional schematic diagram of the guide sheath;

[0040] Figure 5 is a schematic diagram of the end of the guide tube sheath;

[0041] Among them, 1 is a handle, 2 is a saline inlet tube, 3 is a saline outlet tube, 4 is a sterile distilled water inlet tube, 5 is a video / ultrasound signal cable, 6 is a control cable, 7 is a steam generator, 8 is a water distributor, 9 is a micro servo electric cylinder, 10 is a knob, 11 is a firing button, 12 is a guide sheath, 13 is a steam delivery needle, 14 is a saline inlet channel in the guide sheath, 15 is a saline outlet channel in the guide sheath, 16 is a video / ultrasound signal cable channel in the guide sheath, 17 is a front camera of the guide sheath, 18 is a rear camera of the guide sheath, 19 is a Luer connector for the saline inlet tube, 20 is a Luer connector for the saline outlet tube, 21 is an ultrasound probe module, 22 is a liquid inlet, 23 is a liquid outlet, 24 is a guide sheath scale, and 25 is an angle sensor. DETAILED DESCRIPTION

[0042] The structure of the present invention is further described below in conjunction with the accompanying drawings and specific embodiments, but is not intended to limit the present invention.

[0043] Example 1

[0044] A prostate steam ablation system, such as Figures 1 to 5 As shown, it includes a guide sheath 12 for entering a patient's body through the urethra, a handle 1 connected to the guide sheath 12 (the guide sheath 12 is fixed to the handle 1 by a knob 10 and the guide sheath 12 can rotate around the handle 1), a steam generator 7 (coil pulse heater) disposed in the handle 1 and configured to generate condensable steam, a steam delivery needle 13 that is connected to the steam generator 7 and slidably disposed in the guide sheath 12, a micro servo electric cylinder 9 attached to the steam delivery needle 13 and used to drive the steam delivery needle 13, and an angle sensor 25 located in the handle 1 for monitoring the angle of the handle 1;

[0045] The outer wall of the guide tube sheath 12 is engraved with a guide tube sheath scale 24 along the length direction of the guide tube sheath 12. The end of the steam generator 7 away from the steam delivery needle 13 is connected to a sterile distilled water inlet pipe 4, and the sterile distilled water inlet pipe 4 passes through the bottom of the handle 1. A control cable 6, one end of which is connected to the signal on the main control device, passes through the handle 1 from the bottom of the handle and is respectively connected to the steam generator 7 and the micro servo electric cylinder 9. The micro servo electric cylinder 9 has a force sensor embedded therein, and a firing button 11 for controlling the steam generator 7 and the micro servo electric cylinder 9 is provided on the handle 1;

[0046] The guide tube sheath 12 is also provided with a saline inlet channel 14, a saline outlet channel 15 and a video / ultrasound signal cable channel 16 in the guide tube sheath. One end of the saline inlet channel 14 in the guide tube sheath is connected to a liquid inlet 22 located at the end of the guide tube sheath away from the handle, and the other end is connected to a saline inlet tube 2. The saline outlet channel 15 in the guide tube sheath is connected to a liquid discharge port 23 located at the end of the guide tube sheath away from the handle, and the other end is connected to a saline outlet tube 3. The saline inlet tube 2 and the saline outlet tube 3 pass through the bottom of the handle 1. The free end of the saline inlet tube 2 is provided with a saline inlet. A liquid pipe Luer connector 19, a physiological saline liquid outlet tube Luer connector 20 is installed at the free end of the physiological saline liquid outlet tube 3, the saline liquid inlet channel 14 in the guide tube sheath and the saline liquid outlet channel 15 in the guide tube sheath are respectively connected to the physiological saline liquid inlet tube 2 and the physiological saline liquid outlet tube 3 through a water divider 8, and a video / ultrasound signal cable channel 16 in the guide tube sheath is provided with a video / ultrasound cable for connecting the guide tube sheath rear camera 18, the guide tube sheath front camera 17 and the ultrasound probe module 21. After the video signal cable is inserted into the handle 1, it is also connected to the angle sensor 25, and then passes through the bottom of the handle 1 to connect with the main control device signal;

[0047] A guide sheath front camera 17 is installed on the end of the guide sheath 12 away from the handle 1, and the guide sheath rear camera 18 is also installed on the guide sheath 12, which is aimed at the needle tip of the steam delivery needle 13, and the liquid inlet 22 is aligned with the guide sheath rear camera 18.

[0048] It has been verified that the prostate steam ablation system of the utility model has a guide sheath scale added to the outer wall of the guide sheath. The existence of the guide sheath scale can greatly facilitate the doctor's surgical operation and provide a reference for the spacing distance of the puncture needle, so as to avoid the disadvantage that the doctor relies entirely on experience to operate. The existence of the angle sensor can further provide a reference for the doctor's operation, reducing the possibility of the steam delivery needle piercing the patient's non-diseased part due to the doctor's inaccurate rotation angle to fire the steam delivery needle, and causing irreparable losses. The application prospect is good.

[0049] Those skilled in the art should understand that those skilled in the art can implement variations by combining the prior art and the above embodiments, which will not be described in detail here. Such variations do not affect the essential content of the present utility model, and will not be described in detail here.

[0050] The above describes the preferred embodiments of the utility model. It should be understood that the utility model is not limited to the above-mentioned specific implementation methods, 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-disclosed methods and technical contents to make many possible changes and modifications to the technical solutions of the utility model without departing from the scope of the technical solution of the utility model, or modify them into equivalent embodiments of equivalent changes, which does not affect the essential content of the utility model. Therefore, any simple modification, equivalent change and modification made to the above embodiments based on the technical essence of the utility model without departing from the content of the technical solution of the utility model still falls within the scope of protection of the technical solution of the utility model.

Claims

1. A prostate steam ablation system, characterized in that: The invention comprises an introducer sheath for entering a patient's body through the urethra, a handle connected to the introducer sheath, 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 introducer sheath, and a micro servo electric cylinder attached to the steam delivery needle and used to drive the steam delivery needle; The outer wall of the guide sheath is engraved with guide sheath scales along the length direction of the guide sheath.

2. A prostate steam ablation system according to claim 1, characterized in that: The prostate steam ablation system further includes an angle sensor for monitoring the angle of the handle and arranged in the handle; The guide tube sheath is provided with a front camera aimed at the front end of the guide tube sheath, a rear camera aimed at the needle tip of the steam delivery needle, and an ultrasonic probe module at the end of the guide tube sheath away from the handle.

3. A prostate steam ablation system according to claim 1, characterized in that: The steam generator is a coil pulse heater; The handle is made of biodegradable material by injection molding and is provided with a firing button for controlling a steam generator and a micro servo electric cylinder.

4. A prostate steam ablation system according to claim 2, characterized in that: The guide tube sheath is also provided with a guide tube sheath video / ultrasound signal cable channel, and the guide tube sheath video / ultrasound signal cable channel is provided with a video / ultrasound signal cable for connecting the guide tube sheath rear camera, the guide tube sheath front camera and the ultrasound probe module. The video / ultrasound signal cable is connected to the angle sensor after passing through the handle, and then passes through the bottom of the handle to connect with the main control device signal; The main control device is connected to a control cable, and the control cable is inserted into the handle from the bottom of the handle and connected to the steam generator and the micro servo electric cylinder signal respectively.

5. A prostate steam ablation system according to claim 2, characterized in that: The guide tube sheath is also provided with a saline inlet channel and a saline outlet channel in the guide tube sheath. One end of the saline inlet channel in the guide tube sheath is connected to a liquid inlet located at the end of the guide tube sheath away from the handle, and the liquid inlet is aligned with the rear camera of the guide tube sheath, and the other end is connected to a saline inlet tube. The saline outlet channel in the guide tube sheath is connected to a liquid discharge port located at the end of the guide tube sheath away from the handle, and the other end is connected to a saline outlet tube. The front camera of the guide sheath is installed at the end of the guide sheath away from the handle end.

6. A prostate steam ablation system according to claim 5, characterized in that: The saline inlet channel and the saline outlet channel in the guide tube sheath are respectively connected to the saline inlet pipe and the saline outlet pipe through a water divider.

7. A prostate steam ablation system according to claim 5, characterized in that: The physiological saline inlet tube and the physiological saline outlet tube extend out from the bottom of the handle; The free end of the physiological saline inlet tube is installed with a physiological saline inlet tube Luer connector, and the free end of the physiological saline outlet tube is installed with a physiological saline outlet tube Luer connector.

8. A prostate steam ablation system according to claim 1, characterized in that: The steam generator is connected with a sterile distilled water inlet pipe away from the steam delivery needle end, and the sterile distilled water inlet pipe passes through the bottom of the handle.

9. A prostate steam ablation system according to claim 1, characterized in that: The guide sheath is fixed on the handle through a knob and can rotate around the handle.

10. A prostate steam ablation system according to claim 1, characterized in that: The micro servo electric cylinder has a built-in force sensor.

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