Controllable transurethral prostate tissue ablation system

Abstract

The controllable transurethral prostate tissue ablation system comprises a handle, a conveying sheath and an ablation assembly, the handle is fixedly connected with the conveying sheath, the ablation assembly can move along the conveying sheath, the far end of the conveying sheath is provided with a conical head end which can be easily inserted into the urethra, and a bent ablation needle guide cavity is formed in the conical head end. An outlet of the bent ablation needle guiding cavity is formed in the side face of the conical head end, the handle comprises a handle body, a needle switch, a movement assembly, an adjusting assembly and a visible window, the needle switch can be kneaded, and the movement assembly is driven by the needle switch to push one end of the ablation assembly out of the conveying sheath from the outlet of the ablation needle guiding cavity; the adjusting assembly controls the push-out depth of the ablation assembly, and the push-in depth of the ablation assembly can be observed through the visible window. The utility model relates to a visual system for performing irreversible electroporation on selective tissues. The system can realize tracking of the propelling depth of an ablation needle, adjustment of the depth of the ablation needle, prevention of mistaken touch of a switch and adjustment of a pulse release position.

Description

Technical Field

[0001] The utility model relates to a controllable transurethral prostate tissue ablation system in interventional surgery and application thereof, belonging to the field of interventional medical equipment. Background Art

[0002] The normal shape of prostate tissue is walnut-shaped. With age, the prostate tissue is affected by internal and external factors such as living environment, living habits, genetic factors, hormones, etc., and the prostate tissue gradually develops benign / malignant lesions. Common prostate tissue lesions are divided into two types: prostate hyperplasia and prostate cancer. The treatment methods for the two lesions are all different. The treatment of prostate hyperplasia depends on the patient's urination symptoms, and drug therapy is the first choice. When drug therapy is ineffective, transurethral resection or enucleation of the prostate is used for treatment. In the early stages of prostate cancer, radical treatment is the main treatment, including radical radiotherapy and radical brachytherapy. In the late stage, due to the spread of prostate cancer, systemic treatment is the main treatment.

[0003] Prostatic hyperplasia (BPH) is a benign degenerative disease. The lesions are mainly located in the bilateral lobes and the middle lobe. The prostate volume gradually increases during the disease. When the prostate volume expands to a certain range, the capsule wrapped around the outside of the prostate restricts the continued growth of the prostate. At this time, the tissue in the prostate capsule begins to squeeze the urethra inside the prostate, thereby restricting or even interrupting the drainage of urine from the prostate. The symptoms of BPH are mainly manifested as thinning of urine flow, frequent urination, and difficulty urinating. In severe cases, it may cause complications such as lower urinary tract infection (LUTI) and urine retention, affecting the patient's normal life.

[0004] In the male urinary system, the bladder neck is located above the prostate. The contraction and expansion of the bladder wall allow urine to flow in the lower urinary tract. Prostatic urethral stenosis can easily lead to lower urinary tract outlet obstruction. The gold standard for surgical treatment of prostatic hyperplasia is transurethral resection of the prostate (TURP). The hyperplastic prostate tissue is removed by electrosurgical resection, which has the advantages of less bleeding, less damage, and obvious effect in solving urination difficulties. However, this surgery may cause postoperative complications such as retrograde ejaculation, affecting sexual function, and electrosurgical resection syndrome. With the development of interventional surgery, a type of ablation treatment method that uses energy to induce apoptosis of lesion tissue and then eliminate lesion tissue has gradually developed. Common ablation methods for prostatic hyperplasia generally include radiofrequency ablation, water vapor ablation, and laser ablation. These ablation surgeries are based on the principle of thermal ablation. They have good treatment effects but cannot ablate a specific type of tissue cells. The ablation range is uncontrollable, which is a great test of the operator's operating skills. Thermal ablation is prone to produce high heat effects during surgical treatment, which may burn the surrounding normal tissue cells while causing the local temperature of the lesion to rise. Pulse ablation is a treatment method that uses specific electric pulses, during which irreversible electroporation is formed on tissue cells. Based on tissue specificity, the irreversible electroporation caused by electric pulses on specific tissues changes the cell permeability, causes an imbalance in the homeostasis of cells, and ultimately leads to cell apoptosis, thereby ablating the target tissue. The morphological observation of prostate cancer is different from the surrounding normal tissue, just like prostate hyperplasia, so it is expected that electric pulse ablation can be applied to prostate cancer. Based on the ablation principle of electric pulses, electric pulse treatment of prostate cancer can be achieved by adjusting the electric pulse parameters.

[0005] Prostate cancer is a malignant tumor that occurs in the prostate epithelium and is the most common malignant tumor in the male urogenital system. The lesions are mainly located in the peripheral zone of the prostate. Radical treatment of prostate cancer in the early stage can completely remove tumor cells and effectively inhibit the spread of cancerous cells throughout the body. Symptoms of early prostate cancer may include pain in the waist and abdomen, retrograde ejaculation, difficulty urinating, lymphadenopathy, etc. In severe cases, it may lead to renal failure. Currently, prostatectomy can be performed in the early stage of prostate cancer, but there are many surgical complications, and a minimally invasive transurethral surgical alternative is needed.

[0006] CN108635041A discloses a steam delivery system, comprising an elongated shaft configured to be inserted into a patient's urethra: a steam delivery needle comprising a plurality of steam delivery ports, arranged in the shaft and configured to be advanced approximately laterally from the shaft into the prostate when the shaft is in position in the patient's urethra; a steam generator connected to the steam delivery needle to allow condensed liquid to leave the steam delivery ports of the steam delivery needle through the steam delivery ports of the steam delivery needle; and an electronic controller operatively connected to the steam generator, configured to: deliver a first dose of steam from the steam generator through the steam delivery ports of the steam delivery needle into the prostate; deliver a second dose of steam from the steam generator through the steam delivery ports of the steam delivery needle into the prostate; and pump a continuous flow of steam through the steam delivery needle between the delivery of the first dose of steam and the second dose of steam to prevent condensation from forming in the steam delivery system.

[0007] CN217566284U discloses a prostate PFA ablation catheter, including an outer catheter, the inner catheter of which is sleeved, and the inner catheter is provided with a plurality of memory ablation needle groups, the memory ablation needle groups are composed of a plurality of memory ablation electrode needles uniformly arranged on the inner catheter in a circumference; the memory ablation electrode needles are made of memory alloy, and the cross-section of the memory ablation electrode needles is a hemispherical, polygonal or elliptical flat structure; the surface of the memory ablation electrode needles has no insulating coating, and the width of the memory ablation electrode needles is 0.1-5mm; the outer catheter, the inner catheter and the memory ablation electrode needles are all made of biocompatible materials; when the memory ablation needle group of the inner catheter extends out of the outer catheter, the memory ablation electrode needles are perpendicular to the inner catheter. The PFA ablation catheter of the utility model causes little damage during surgery, does not damage important tissues such as blood vessels, nerves, sphincters, etc., can retain sexual function and urinary control function, and the operation is simple and fast.

[0008] In the prior art, transurethral prostate steam ablation (steam ablation system) is performed by applying high-temperature steam to the gap between diseased tissues. The steam flows between the intercellular gaps to ablate the cell tissues swept by the steam. This ablation method may result in insufficient energy acquisition of some cells swept by the steam due to the narrow gap between diseased cells or heat transfer loss, incomplete heat conduction between the steam and the cell tissues, and the target tissue cannot be completely ablated. In addition, the ablation method based on the principle of thermal ablation is very demanding on the operator's skills. Inaccurate operation may cause damage to adjacent normal tissues.

[0009] The transurethral PFA prostate ablation catheter (a PFA ablation catheter for the prostate) cannot be used for ablation under direct vision, which affects the accuracy of the ablation surgery. The catheter position cannot be adjusted, and the puncture depth of the ablation needle cannot be accurately controlled. The ablation needle puncture has no effective mechanical driving device and endoscope channel, and cannot be operated under direct vision. In addition, ablation needles at multiple sites can easily lead to difficulties in surgical positioning, affecting the timeliness and accuracy of the surgery.

[0010] Therefore, surgeons expect a prostate ablation system that can be operated under direct vision and accurately positioned during surgery, making treatments such as transurethral minimally invasive prostate surgery safer and easier. Utility Model Content

[0011] In view of the problems existing in the prior art, the purpose of the present invention is to provide a controllable transurethral prostate tissue ablation system to address the shortcomings of existing prostate ablation devices or systems, such as the inability to operate under direct vision, inaccurate positioning during surgery, incomplete ablation treatment and other complications. The system can realize non-invasive transurethral operation during interventional surgery and can achieve precise positioning under direct vision.

[0012] In order to achieve the above purpose, the technical solution adopted by the utility model is:

[0013] A controllable transurethral prostate tissue ablation system includes a handle, a delivery sheath and an ablation component. The handle is fixedly connected to the delivery sheath, and the ablation component can move along the delivery sheath. The distal end of the delivery sheath has a conical head end that is easy to insert into the urethra, and a curved ablation needle guide cavity is provided in the conical head end. The outlet of the curved ablation needle guide cavity is provided on the side of the conical head end. The handle includes a handle body and a needle switch, a motion component, an adjustment component, and a visual window arranged on the handle body. The needle switch can be pinched, and the motion component pushes one end of the ablation component out of the delivery sheath from the outlet of the ablation needle guide cavity through the drive of the needle switch. The motion component also automatically withdraws the ablation component into the delivery sheath after ablation is completed through elastic resetting. The adjustment component controls the pushable depth of the ablation component by limiting the motion range of the motion component, and the advancement depth of the ablation component can be observed through the visual window.

[0014] As a further improvement of the above technical solution:

[0015] The motion component includes sheet metal, a slider, a guide groove and an elastomer. The needle switch and the sheet metal are fixedly connected together. The middle part of the whole formed by the sheet metal and the needle switch is hinged on the handle body, so that the sheet metal and the needle switch as a whole can rotate in a plane around the hinge point. An elastomer is provided at the hinge, one end of the elastomer is connected to the handle body, and the other end is connected to the sheet metal or the needle switch. One end of the sheet metal is connected to the needle switch, and the other end drives the slider to move along the guide groove. The slider is connected to the ablation component.

[0016] The adjusting assembly includes a positioning bead, a limiting cam, a spring and an adjusting knob. The adjusting knob and the limiting cam are fixedly connected. The adjusting knob and the limiting cam are rotatably mounted on the handle body as a whole. A plurality of grooves are arranged on one end face of the limiting cam. The depth of the grooves is less than the diameter of the positioning bead. The end face contacts the handle body. A mounting groove is arranged on the handle body. A positioning bead and a compressed spring are arranged in the mounting groove. As the limiting cam rotates, the grooves on the limiting cam can be rotated to be aligned and connected with the mounting grooves on the handle body respectively. When a groove on the limiting cam is connected with the mounting groove on the handle body, the positioning bead is pressed into the groove on the limiting cam by the spring. The positioning bead is partially located in the groove and partially located in the mounting groove. The sheet metal rotates until the middle part of the sheet metal contacts the circumferential side of the limiting cam. The distances from each point on the circumferential side of the limiting cam to the rotation axis of the limiting cam are different.

[0017] The position of the slider can be observed through the visual window to determine the advancement depth of the ablation component.

[0018] The ablation system also includes an endoscope that is inserted into the urethra together with the ablation component, and the ablation component is directly observed through the endoscope.

[0019] The delivery sheath is a slender tubular structure, which is connected to the handle body. At least two through holes are provided in the delivery sheath. The length direction of the through holes is consistent with the length direction of the delivery sheath. The through holes include at least an ablation component guide channel and an endoscope guide channel, which are used for the movement and guidance of the ablation component and the endoscope respectively.

[0020] The ablation assembly includes an ablation needle, an energy delivery ring, an ablation needle insulation layer and an electric wire. All parts of the ablation needle except the needle tip are covered with the ablation needle insulation layer. The energy delivery ring is arranged on the outer surface of the ablation needle insulation layer. The ablation needle and the energy delivery ring are independently connected to the electric wire respectively. The electric wire passes through the handle and is connected to an external energy generator.

[0021] The ablation system also includes a fluid flushing component, which includes an endoscope sheath. The endoscope sheath is a slender tubular structure. The inner diameter of the endoscope sheath is larger than the outer diameter of the delivery sheath. The endoscope sheath is coaxially sleeved on the outside of the delivery sheath. The endoscope sheath and the delivery sheath are pushed into the natural cavity of the human body together. The annular channel between the endoscope sheath and the delivery sheath is a fluid flushing channel, and the external flushing fluid can enter the natural cavity through the fluid flushing channel.

[0022] The handle also includes a zero-position locking member, which prevents one end of the ablation component from extending out of the delivery sheath by blocking the action of the needle switch.

[0023] An endoscope observation window is also provided on the conical head end, through which the endoscope observes the ablation component being pushed out of one end of the delivery sheath.

[0024] the term

[0025] Interventional surgery: a minimally invasive treatment performed using modern high-tech means; under the guidance of medical imaging equipment, special catheters, guide wires and other precision instruments are introduced into the human body to diagnose and treat pathologies in the body.

[0026] Transurethral resection of the prostate (TURP): refers to a minimally invasive surgery inserted through the urethra. This procedure is performed with the assistance of an endoscope. The diseased tissue is removed by an electric knife to create a non-open incision for treatment. It is the gold standard for surgery when drug treatment is ineffective. It is suitable for various surgical forms such as prostate hyperplasia, prostate cancer, lower urinary tract symptoms, lower urinary tract obstruction, and prostate stones.

[0027] Transurethral prostate steam ablation surgery: refers to the introduction of high-temperature steam into the prostate lesion site through the urethra, using high-temperature steam to induce apoptosis of lesion cells, and is often used for prostate hyperplasia.

[0028] Prostate ablation device: refers to a device that supplies specific energy (including but not limited to high-temperature steam, radio frequency, microwave, pulse, freezing and other energy forms) to the site of prostate lesions, destroys the morphology of prostate lesion tissue cells, and induces apoptosis of lesion tissue.

[0029] Nanoknife pulse ablation: refers to a form of ablation that produces irreversible electroporation on the cell membrane of diseased cells by releasing nanoscale electric pulses.

[0030] Compared with the prior art, the beneficial effects of the utility model are:

[0031] (1) Provides a visualization system for irreversible electroporation of selective tissues through urethral insertion. The pulsed electric field used is tissue-selective, greatly improving efficiency and surgical safety;

[0032] (2) The system can track the advancement depth of the ablation needle, adjust the depth of the ablation needle, prevent accidental touch of the switch, and adjust the pulse release position, providing a new research direction for the ablation of prostate cancer and prostate hyperplasia. Specifically, multiple ring electrodes are arranged on the ablation needle, and pulse ablation can be accurately selected between two electrodes according to clinical needs. A zero-position locking device is set, and one end of the ablation component can be pushed out only after the tube body reaches the prostate area and the gear depth setting is selected; a visual window is set to assist in judging the position of the ablation needle, further improving the safety of the ablation system. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 This is a schematic diagram of the structure of the ablation system of the utility model when the needle switch is not pinched;

[0034] Figure 2 This is a schematic diagram of the structure of the ablation system after the needle switch of the utility model is pinched;

[0035] Figure 3 for Figure 2 AA cross-sectional diagram of ;

[0036] Figure 4 for Fig.12 A schematic diagram of the structure after removing the shell of the handle main body;

[0037] Figure 5 It is a schematic diagram of the structure of the utility model after removing the endoscope sheath and the endoscope sheath fixer;

[0038] Figure 6 This is a schematic diagram of the structure of the conical head end of the utility model;

[0039] Figure 7 This is a schematic diagram of the structure of the ablation component of the utility model;

[0040] Figure 8 This is a schematic diagram of the distribution of the ablation area and the insulation area of ​​the utility model;

[0041] Fig. 9 This is a schematic diagram of the utility model for ablating diseased tissue through an ablation field;

[0042] Fig.10 This is a schematic diagram of the structure of the adjustment component of the utility model;

[0043] Fig.11 This is a schematic diagram of the structure of the visual window of the utility model;

[0044] Fig.12 This is a schematic diagram of the appearance and structure of the ablation system of the present utility model. DETAILED DESCRIPTION

[0045] The brain protector and its application provided by the present invention are further described in detail and completely in conjunction with the embodiments below. The embodiments described below are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

[0046] The utility model provides a controllable transurethral prostate tissue ablation system, which is used by medical departments for performing irreversible electroporation of benign and malignant prostate lesions with electric pulses, thereby ablating the lesion tissue. The ablation system comprises a handle, a delivery sheath 200 and an ablation assembly 300 arranged in sequence, wherein the handle is fixedly connected to the delivery sheath 200, and the ablation assembly 300 is arranged in the cavity of the delivery sheath 200 and can move along the delivery sheath 200, and the handle can control the movement of the ablation assembly 300 in the delivery sheath 200, and can also control the ablation operation of the ablation assembly 300 after reaching the lesion position.

[0047] The handle includes a handle body 110, a motion component, an adjustment component, and a needle switch 140, and the motion component, the adjustment component, and the needle switch 140 are all arranged on the handle body 110. The shell of the handle body 110 is made of PC or ABS material, and the structure and shape conform to the ergonomic design. The handle appearance is designed to be able to be operated by a single person. The motion component and the adjustment component are located in the handle body 110. The motion component is used to push the ablation component 300 out of the delivery sheath 200 and can be inserted into the prostate lesion tissue. It can also control the puncture depth of the ablation component 300 so that the ablation component 300 punctures the urethra to reach the prostate lesion tissue, and can also automatically withdraw the ablation component 300 into the delivery sheath 200 after the ablation is completed. The adjustment component can be provided with an adjustment knob, and the adjustment knob controls the push-out depth of the ablation component 300, which is used to further accurately control the puncture depth of the ablation component 300. The needle switch 140 can control the movement of the motion component, and the motion component is driven by pinching the needle switch 140, and the motion component drives the ablation component 300.

[0048] The handle body 110 is mainly composed of multiple shells connected by buckles or screws, which play the role of supporting and installing various functional components. When the ablation component 300 fails to retract, the ablation component 300 can be manually removed by removing the shell.

[0049] The delivery sheath 200 is a slender tubular structure, which is connected to the handle body 110. The delivery sheath 200 is provided with at least two through holes, and the length direction of the through holes is consistent with the length direction of the delivery sheath 200. Preferably, the delivery sheath 200 is provided with two through holes, and the apertures of the two through holes are different, which are the ablation component guide channel 210 and the endoscope guide channel 220, respectively, for the movement and guidance of the ablation component 300 and the endoscope 700, as shown in FIG. Figure 3 The delivery sheath 200 can be made of metal materials such as stainless steel, nickel-titanium alloy, etc. or high-strength medical polymer materials such as PEEK, ABS, PC, etc., which effectively ensures the delivery sheath's good straightness. In this embodiment, ABS is selected, and the tube body can have any shape suitable for insertion into a natural biological cavity.

[0050] The delivery sheath 200 has a tapered head 230 at the distal end and is connected to the handle body 110 at the proximal end. Figure 5As shown. The material of the conical head end 230 is ABS. The shape and structure of the conical head end 230 is designed to be easily inserted into the urethra, reducing insertion damage, and making the delivery sheath 200 itself easy to push. The endoscope 700 and the ablation component 300 are synchronously pushed into the natural cavity through the delivery sheath 200. A cavity is provided in the conical head end 230. Preferably, the cavity in the conical head end 230 includes an ablation needle guide cavity and an endoscope observation window. One end of the ablation needle guide cavity is connected to the ablation component guide channel 210, and the other end is an ablation needle outlet connected to the outside. The ablation needle guide cavity is a curved channel, and the ablation needle outlet is provided on the side of the conical head end 230, so that the ablation component 300 extends substantially perpendicular to the length direction of the delivery sheath 200, punctures into the prostate lesion tissue or retracts into the delivery sheath 200 cavity. In order to obtain a visual image of the distal end of the delivery sheath 200 and realize a visual operation of directly viewing the prostatic urethra, a large observation window is designed on the side of the ablation needle outlet of the tapered head 230 as the main window for endoscope observation. There is a window on each side of the main window to increase the field of view on both sides. The endoscope 700 can be extended from the delivery sheath 200 to observe the surgical operation in real time from the tapered head 230. Figure 5 and 6 The endoscope observation window can also be flexibly arranged in other ways according to needs.

[0051] In order to further assist the therapeutic effect, the delivery sheath 200 may also be coated with drugs or other chemicals or compounds to be pushed into the prostatic urethra together with the delivery sheath 200, such as anesthetics, hydrophilic agents, anti-inflammatory agents, lubricants, etc.

[0052] The ablation assembly 300 includes an ablation needle 310, an energy delivery ring 320, an ablation needle insulation layer 330, and a wire 340. Figure 7 As shown, Figure 7 is a schematic diagram of an electrode body according to an embodiment of the present application, Figure 7 The embodiment in the embodiment is described in the form of a needle-shaped electrode body. The ablation needle 310 is made of any conductive material suitable for the field of electrophysiology. The ablation needle 310 is coated with an ablation needle insulating layer 330 except for the needle tip, that is, the needle tip of the ablation needle 310 is exposed. The needle tip of the ablation needle 310 is pointed and sharp, with a small force-bearing area, which can achieve minimally invasive surgical operations and greatly reduce the discomfort of surgical patients. In other words, the distal end of the ablation needle 310 is designed to be any shape suitable for puncture, and the ablation needle 310 punctures the prostatic urethra through the terminal needle and reaches the prostate lesion tissue. The ablation needle 310 has good elastic properties, and the ablation needle 310 can be restored to a straight shape after passing through the curved section of the ablation needle guide cavity in the tapered head end 230. The ablation needle insulating layer 330 requires a material with good biocompatibility and good insulation effect, such as nylon and fluorinated polymers.

[0053] The energy delivery ring 320 is arranged on the outer surface of the ablation needle insulation layer 330, that is, the energy delivery ring 320 is not wrapped by the insulation layer, and one or more energy delivery rings 320 are provided. When multiple energy delivery rings 320 are provided, multiple energy delivery rings 320 are arranged at intervals along the length direction of the ablation needle 310. The energy delivery ring 320 is made of any conductive material suitable for the field of electrophysiology, and is suitable for receiving energy and diffusing the energy to a specific area.

[0054] The needle tip of the ablation needle 310 and the energy delivery ring 320 are both arranged at the distal end of the ablation component 300. The ablation needle 310 and the energy delivery ring 320 are respectively and independently connected to the wire 340, so that the surface of the electrode body of the ablation component 300 is divided into an ablation area 350 and an insulating area 360. Among them, the area not wrapped by the insulating layer forms the ablation area 350, that is, the energy delivery ring 320 forms the ablation area 350, and the needle tip of the ablation needle 310 is not wrapped by the insulating material on the outside, and also serves as one of the ablation areas 350 to play an ablation role. The area wrapped by the insulating layer forms the insulating area 360. The ablation component 300 transmits energy to the surrounding diseased tissue with a certain parameter through the ablation area 350, and transmits a specific energy form to the prostate diseased tissue. An ablation field 370 is formed between the two ablation areas 350 to ablate the diseased tissue. Specifically, the ablation field 370 causes irreversible electroporation to the diseased tissue to achieve cell apoptosis, such as Figure 8 and 9 As shown. The energy delivery ring 320 directly contacts the lesion site, and the needle tip of each energy delivery ring 320 or ablation needle 310 can be read by the same energy generator 600 to read the working status and be individually controlled to form a positive or negative pole to form an ablation field to transmit energy to the lesion tissue. During the treatment of some or all lesion sites of the prostate, partial or complete necrosis of the prostate lesion site can be achieved. In some specific embodiments, an ablation field 370 can be composed of the needle tip of an ablation needle 310 and an energy delivery ring 320.

[0055] The wire 340 is wrapped with a coaxial insulating layer. The wire 340 without the insulating layer is connected to the ablation needle 310 and the energy delivery ring 320 by welding or the like. The wire 340 is wrapped in the ablation needle insulating layer 330. The distal ends of each wire 340 are independently connected to the ablation needle 310 and the energy delivery ring 320, and the proximal ends of each wire 340 are integrated into the energy transmission line 410 by an insulating tube bundle. The ablation needle 310, the energy delivery ring 320 and the ablation needle insulating layer 330 are located in the ablation component guide channel 210. One end of each wire 340 extends into the ablation component guide channel 210, and the other end passes through the handle body 110 and is connected to the energy generator 600. Specifically, one end of each wire 340 extending out of the ablation needle insulation layer 330 is integrated into an energy transmission line 410 by an insulating tube bundle. The energy transmission line 410 extends from the bottom of the handle body 110, and the end of the energy transmission line 410 has a plug, which can be self-lockingly connected to the socket of the energy generator 600, so as to obtain energy, such as Fig.12 shown.

[0056] In this embodiment, the conductive material is gold, platinum-iridium alloy, etc.

[0057] The motion assembly is used to advance the ablation assembly 300 so that one end of the needle of the ablation assembly 300 extends out of the delivery sheath 200. The motion assembly includes a sheet metal 121, a slider 122, a guide groove 123 and an elastic body 124. Figure 2 As shown. The needle switch 140 and the sheet metal 121 are fixedly connected together, and the middle part of the whole formed by the sheet metal 121 and the needle switch 140 is hinged on the handle body 110, so that the sheet metal 121 and the needle switch 140 can rotate in a plane around the hinge point as a whole, and an elastic body 124 is provided at the hinge. One end of the elastomer 124 is connected to the handle body 110, and the other end is connected to the sheet metal 121 or the needle switch 140. The needle switch 140 is located outside the handle body 110, and the sheet metal 121 is located in a preset sheet metal cavity in the handle body 110. After installation, the elastomer 124 is in a compressed state. Under the elastic action of the elastomer 124, the upper end of the needle switch 140 is pressed against the outer shell surface of the handle body 110 to ensure that the needle switch 140 is in a stable state pressed against the handle body 110 when not subject to external force. When the needle switch 140 is pinched with one hand, the sheet metal 121 and the needle switch 140 are driven as a whole. Figure 2 The elastic body 124 is further compressed by rotating counterclockwise in the illustrated view. In this embodiment, the elastic body 124 is a torsion spring. One end of the sheet metal 121 is fixedly connected to the needle switch 140, and the other end is provided with a long strip guide through hole.

[0058] The guide groove 123 is a long strip through hole provided in the handle body 110, and the length direction of the guide groove 123 is parallel to the length direction of the ablation assembly guide channel 210. One end of the slider 122 is located in the handle body 110 and connected to the ablation assembly 300, and the other end is limited to be unable to separate from the sheet metal 121 after passing through the guide groove 123 and the guide through hole of the sheet metal 121. The slider 122 can move along the length direction of the guide groove 123. When moving, the slider 122 also moves relative to the length direction of the guide through hole of the sheet metal 121. One end of the slider 122 passing through the sheet metal 121 can be connected to a nut whose outer diameter is greater than the width of the guide through hole on the sheet metal 121 to ensure that the slider 122 does not separate from the sheet metal 121.

[0059] Based on the above structure, Figure 1 The ablation system is in the initial state, at which time one end of the ablation assembly 300 does not extend out of the delivery sheath 200. After pinching the needle switch 140, the sheet metal 121 and the needle switch 140 are driven as a whole. Figure 1 2, the elastic body 124 is further compressed, and the sheet metal 121 drives the slider 122 to move along the length direction of the guide groove 123, so that the slider 122 Figure 2 The ablation assembly 300 is pushed out toward the left in the view shown, and one end of the ablation assembly 300 extends out of the delivery sheath 200. Figure 2 As shown. After the sheet metal 121 rotates to contact the adjustment component, it cannot continue to rotate. When the needle switch 140 is released, the sheet metal 121 and the needle switch 140 are driven to Figure 2 The slider 122 is rotated clockwise to reset in the shown view, driving the slider 122 to Figure 2 Moving to the right in the illustrated view, one end of the ablation needle 310 of the ablation assembly 300 is retracted into the delivery sheath 200 .

[0060] The adjustment component is used to control the depth to which the ablation component 300 can be pushed out. The adjustment component includes a positioning bead 131, a limit cam 132, a spring 134 and an adjustment knob 133. Figure 5 and Fig.10As shown, the adjusting knob 133 and the limiting cam 132 are fixedly connected, and the adjusting knob 133 and the limiting cam 132 are integrally rotatably mounted on the handle body 110, and the rotation axis is perpendicular to the length direction of the ablation assembly guide channel 210. The adjusting knob 133 is located on the outer surface of the handle body 110 for the doctor to operate and adjust. A plurality of grooves are arranged on one end face of the limiting cam 132, and the depth of the grooves is less than the diameter of the positioning bead 131, and the end face is in contact with the handle body 110. A mounting groove is arranged on the handle body 110, and a positioning bead 131 and a compressed spring 134 are arranged in the mounting groove, and one end of the spring 134 is connected to the bottom of the mounting groove, and the other end is connected to the positioning bead 131. As the limiting cam 132 rotates, the grooves on the limiting cam 132 can be rotated to align and communicate with the mounting grooves on the handle body 110. When a groove on the limiting cam 132 is connected to the mounting groove on the handle body 110, the positioning bead 131 is pressed into the groove on the limiting cam 132 by the spring 134, and the positioning bead 131 is partially located in the groove and partially located in the mounting groove. At this time, the positioning bead 131 clamps the limiting cam 132 on the handle body 110. When the adjusting knob 133 is manually turned, the adjusting knob 133 drives the limiting cam 132, and the pressure of the limiting cam 132 on the positioning bead 131 is greater than the friction between the two, the positioning bead 131 is pushed back into the mounting groove of the handle body 110 by the limiting cam 132, and the spring 134 is further compressed. Fig.10 As shown by the dotted line in .

[0061] When the needle switch 140 is pinched, the sheet metal 121 rotates until the middle of the sheet metal 121 contacts the circumferential side surface C of the limit cam 132, as shown in FIG. Figure 1 , 2 As shown in Figure 4, the sheet metal 121 is blocked by the limiting cam 132 and cannot continue to rotate. The distances from each point on the circumferential side surface C of the limiting cam 132 to the rotation axis of the limiting cam 132 are different. Therefore, when the sheet metal 121 contacts different points on the circumferential side surface C of the limiting cam 132, the rotation range of the sheet metal 121 is different, and the moving distance of the slider 122 is also different. The length of one end of the ablation component 300 extending out of the delivery sheath 200 is also different, thereby limiting the puncture depth of the ablation component 300. In this solution, the multiple grooves on the limiting cam 132 correspond to multiple different gears, and when the positioning beads 131 are inserted into different grooves, the sheet metal 121 can rotate in different ranges. This multi-gear design meets the different surgical depths of the ablation needle 310 to avoid incomplete local ablation.

[0062] In this embodiment, the adjusting knob 133 is provided with four gears, and correspondingly, the limiting cam 132 is provided with four grooves.

[0063] Preferably, transparent visual windows 170 are provided on both sides of the proximal end of the handle, through which the operator can observe the advancement degree of the delivery sheath 200 in real time when necessary, that is, observe the position of the slider 122 through the visual window 170. Fig.11 As shown, the advancement depth of the ablation component 300 can be observed in real time, which is conducive to directly observing whether the ablation component 300 is accurately released in the human body. The visual window 170 is set to a highly transparent material, such as ABS, and the slider 122 moves along the directional track of the visual window. Preferably, a mark can be made on the visual window 170 to more intuitively judge the advancement depth of the ablation component 300 corresponding to the current position of the slider 122.

[0064] As a preferred implementation, Figure 1 , 2 As shown in Figure 4, the handle is also provided with a zero-position locking member 150, which is used to limit the ablation component 300 from extending out of the delivery sheath 200, so as to prevent the ablation component 300 from extending out due to an operation error during the process of pushing the delivery sheath 200 to the prostate urethra adjacent to the target tissue, thereby causing urethral damage. The zero-position locking member 150 is achieved by mechanically blocking the needle switch 140 from being pinched. When and only when the needle switch 140 is in the zero-position position, the zero-position locking member 150 can be pressed to control whether the needle switch 140 can be pinched or not. The zero-position position refers to the position of the needle switch 140 when one end of the ablation needle 310 of the ablation component 300 does not extend out of the delivery sheath 200. At this time, the zero position locking member 150 is pressed or toggled, and the zero position locking member 150 extends and blocks the limit plate 160 fixedly connected to the needle switch 140, so that the needle switch 140 cannot be pinched; when the zero position locking member 150 is pulled out or reversely toggled, the needle switch 140 is not blocked and can be pinched. The zero position locking member 150 can adopt the toggle member structure in the prior art.

[0065] In order to realize visual operation, the ablation system can also be operated together with an endoscope 700. Accordingly, an endoscope cavity 710 is provided at the proximal end of the handle. Figure 1 As shown, the endoscope cavity 710 is connected to the endoscope guide channel 220 and is coaxial with the endoscope. The endoscope 700 passes through the endoscope holder 720, the endoscope cavity 710 and the seal 530 and enters the endoscope guide channel 220, and finally extends from the distal end of the delivery sheath 200. The seal 530 is used to seal one end of the endoscope guide channel 220 to prevent other debris from entering the endoscope guide channel 220. The endoscope holder 720 is provided on the handle body 110. The endoscope holder 720 is designed with a position that matches the structure of the endoscope 700. The opening and closing of the lever is controlled to fix the endoscope 700 during the operation. Figure 3In this embodiment, the endoscope 700 is locked and fixed in the endoscope guide channel 220 by pushing the buckle of the endoscope holder 720 downward. The endoscope 700 is used to provide a view of the multiple observation windows of the tapered head 230 at the distal end of the delivery sheath 200, that is, a view of the ablation assembly 300 puncturing the prostate tissue and being withdrawn.

[0066] In order to enable the ablation system to fill the natural cavity with liquid, and enable the delivery sheath 200 to clean the natural cavity with fluid after being inserted into the prostatic urethra to ensure the clarity of the endoscope 700's field of view, the ablation system also includes a fluid flushing component, and the fluid flushing component includes an endoscope sheath 510 and an endoscope sheath holder 520. The endoscope sheath 510 is an elongated tubular structure, and the inner diameter of the endoscope sheath 510 is larger than the outer diameter of the delivery sheath 200. The endoscope sheath 510 is coaxially sleeved on the outside of the delivery sheath 200, as shown in FIG. Figure 3 As shown, the endoscope sheath 510 and the delivery sheath 200 are pushed into the natural cavity of the human body together. The annular channel between the endoscope sheath 510 and the delivery sheath 200 is a fluid flushing channel, and the external flushing fluid can enter the natural cavity through the fluid flushing channel. The endoscope sheath 510 can be inserted into the delivery sheath 200 from the distal end of the delivery sheath 200, and then fixed by the endoscope sheath fixer 520 on the handle body 110. The water inlet and outlet of the endoscope sheath 510 are arranged at one end close to the handle body 110, and the fluid flows into or out of the urethra through the handle through the water inlet and outlet. It should be noted that the endoscope sheath 510 does not block the outlet of the ablation component 300 on the conical head end 230 and the observation window of the endoscope 700.

[0067] In addition, there is another embodiment, by separately setting a fluid flushing tube 540 and a fluid controller to flush the natural cavity, the upper end of the fluid flushing tube 540 is connected to the fluid flushing channel, and the lower end extends out of the handle body 110 and is connected to the fluid controller. The fluid controller can be a three-way valve 550, such as Figure 5 The fluid flushing tube 540 is connected to an external perfusion device or suction device, and the fluid can be injected into and out of the urethra through the above device, thereby improving the direct vision clarity of the natural cavity and the accuracy of the surgical operation. The fluid can be physiological saline or the like.

[0068] Based on the above structure, the working principle of the ablation system is as follows: when the conical head 230 is placed at the prostatic urethra near the lesion tissue, the adjustment knob 133 is adjusted to a non-zero position, the needle switch 140 is pinched, and the ablation component 300 is punctured into the lesion tissue by uniformly transmitting the force through the motion component built into the handle; the needle switch 140 is released, and the ablation component 300 is automatically withdrawn into the conical head 230 through the motion component. When the ablation component 300 is extended along the distal conical head 230, its extension length is limited by the gear set by the adjustment knob 133, and under the control of the handle, it extends to a specific length, and the ablation component 300 is radially extended from the curved ablation needle guide cavity of the conical head 230 and axially bent, and finally punctured into the prostatic lesion tissue in a direction almost perpendicular to the delivery sheath 200. The ablation component 300 is pushed through multiple gears set on the ablation handle to achieve controllability of the ablation position and depth. After ablation is completed at a certain depth, the ablation needle 310 is automatically withdrawn into the delivery sheath 200 by the motion assembly.

[0069] The ablation system provided by the utility model performs the following operations for transurethral prostate ablation surgery:

[0070] Step 1: After determining that the patient has prostate hyperplasia / cancerous changes caused by the prostate lesion tissue, adjust the parameters of the energy generator 600, insert the endoscope 700 into the endoscope guide channel 220 through the endoscope cavity 710 in the ablation handle, and fix the endoscope 700 and the handle body 110 relative to each other through the endoscope fixer 720, then put the endoscope sheath 510 on the outside of the delivery sheath 200 and fix it, and finally open the zero-position locking piece 150 to prevent the needle switch 140 from being pinched.

[0071] Step 2: Slowly push the delivery sheath 200 and the endoscope sheath 510 into the prostatic urethra. During this process, the liquid in the cavity, such as saline, can enter and flow out through the water inlet and outlet of the endoscope sheath 510 to ensure a clear view in the cavity. In this step, the liquid enters the fluid flushing channel and flows out from one end of the fluid flushing channel to flush the endoscope 700.

[0072] Step 3: Under direct vision, use the endoscope 700 to confirm that the conical tip 230 reaches the urethra closest to the prostate lesion tissue, and the endoscope 700 and the ablation component 300 arranged in the delivery sheath 200 arrive in the patient's urethra at the same time.

[0073] Step 4: First, adjust the adjustment knob 133 to a suitable position to control the depth of the ablation component 300 piercing into the prostate hyperplasia lesion tissue, and close the zero-position locking piece 150 to cancel the restriction on the needle switch 140; then pinch the needle switch 140 of the ablation handle, and directly observe the ablation component 300 through the endoscope 700 to ensure that the ablation component 300 pierces into the target position of the prostate lesion tissue. During this period, observe the visual window 170 to ensure that the puncture depth of the ablation component 300 meets the expected depth.

[0074] Step 5: Start the energy generator 600 by stepping on it, and perform the electric pulse treatment for 0-10 seconds.

[0075] In this step, energy is continuously delivered to the diseased hyperplastic tissue by the energy generator 600 until the energy generator 600 indicates that the surgery at the current site is completed. The energy delivered is in the form of electric pulses, ensuring that irreversible electroporation is formed at the target location of the specific tissue.

[0076] Step 6: After the operation at the current surgical site is completed, the needle switch 140 of the ablation handle is released, and one end of the ablation needle 310 of the ablation assembly 300 is retracted into the delivery sheath 200 .

[0077] The next puncture is performed again by changing the length and direction of the delivery sheath 200 extending into the prostatic urethra, and the operation steps are the same as above, until the energy ablation covers all the prostatic lesion tissues, and then the delivery sheath 200 is slowly withdrawn.

[0078] Preferably, a single ablation system can be used to treat all areas of a single patient's prostate lesions. The length of the delivery sheath 200 extending into the urethra can be adjusted to reach different positions of the prostate urethra, and the position of the knob 133 can be adjusted to control the ablation assembly 300 to penetrate into the prostate lesion position at different depths, thereby achieving controllable ablation position of the prostate lesion tissue.

[0079] The method also includes using the pulse parameters of the ablation handle such as field strength, frequency, period, pulse width, pulse amplitude, etc. and using the ablation handle to transmit the parameters to the ablation component 300. This can be specifically set according to the instructions for use of the existing energy generator 600 and will not be repeated here.

[0080] From the above, the ablation system of the present application can be used to treat prostate diseases such as benign hyperplasia, canceration, etc. The ablation system applies the energy field directly to the lesion position, wherein the energy field can controllably ablate specific lesion cells. In one embodiment, the pulsed electric field applied by the energy field can be confined to ablate the prostate hyperplasia tissue or prostate cancer tissue adjacent to the urethra without damaging the urethra adjacent to the prostate. Under the action of electric pulses of specific parameters, the target tissue cells form irreversible electroporation, resulting in changes in the cell membrane phospholipid bilayer, thereby affecting the water balance and membrane potential of the cells, and the normal morphology of the cells cannot be maintained, resulting in cell apoptosis. The cell membranes of different tissues are affected by pulse stimulation to produce different irreversible electroporation thresholds, and the cells of the surrounding tissues will not be affected by ablation. The present application forms irreversible electroporation on the cell membrane of prostate lesion tissue by releasing pulses of specific parameters in a short period of time, and the steady-state structure in the lesion cells cannot be maintained, thereby inducing cell autophagy and causing apoptosis of lesion cells.

[0081] In summary, the advantages of this application include at least the following aspects:

[0082] (1) The ablation method is to enter the urethra through the natural cavity to reduce the surgical incision.

[0083] (2) The delivery sheath 200 is fixed on the ablation handle, and the operator does not need to assemble an additional delivery sheath 200 fixing device, and avoids the operator's uneven force and shaking left and right during the operation. By adjusting the length of the delivery sheath 200 inserted into the urethra, ablation operations at different positions can be achieved.

[0084] (3) The conical design of the conical tip 230 can help effectively advance the delivery sheath 200 and avoid damage to the natural inner cavity of the human body. The conical tip 230 is a multi-cavity design. The cavity of the conical tip 230 allows fluid to enter and exit the urethral cavity, ensuring a clear surgical field of view. The endoscope 700 is advanced synchronously with the delivery sheath 200, and the multiple windows of the conical tip 230 ensure that the operation is performed under direct vision. The curved ablation needle guide cavity in the cavity of the conical tip 230 guides the ablation component 300 from a fixed hole to puncture into the target location of the prostate, such as benign lesions or malignant lesions.

[0085] (4) The multi-lumen design of the delivery sheath 200 effectively ensures good straightness of the delivery sheath. The friction coefficient in the lumen is low, which is conducive to the advancement or withdrawal of the ablation component 300 and the endoscope.

[0086] (5) The ablation handle is ergonomically designed. The handle is lightweight and made of high-strength material. It can withstand high external forces while ensuring that the operation is easy. It is easy for surgeons to operate and improves surgical accuracy.

[0087] (6) The ablation handle has multiple operating positions to meet different surgical depths and avoid incomplete local ablation.

[0088] (7) The zero-position locking design of the ablation handle effectively prevents accidental puncture by the ablation needle and avoids improper surgical operation.

[0089] (8) The ablation component 300 adopts a dual-electrode design to ensure that the effective pulse electric field is controlled within a certain range and the damage range is uniform and controllable.

[0090] (9) The ablation handle uses a needle switch 140, and the delivery sheath 200 is pushed into the prostatic urethra with one hand. The switch is designed with a curved grip to avoid accidental touch during surgery.

[0091] (10) After passing through the endoscope guide channel, the endoscope can be fixed in the ablation handle by the endoscope holder. After the endoscope and the delivery sheath are pushed into the natural cavity of the human body, the operator can observe the surgical situation in real time through the endoscope.

[0092] (11) The endoscope sheath can be pushed into the natural cavity together with the delivery sheath to flush the cavity in real time to ensure a clear surgical field of view.

[0093] Finally, it is necessary to explain here that the above embodiments are only used to further illustrate the technical solution of the utility model in detail and cannot be understood as limiting the protection scope of the utility model. Any technician familiar with this profession, without departing from the scope of the technical solution of this application, using the technical content disclosed above to make slight changes, modifications, substitutions, combinations, and simplifications should all be considered as equivalent replacement methods and are included in the protection scope of the utility model.

Claims

1. A controllable transurethral prostate tissue ablation system, characterized in that: The invention comprises a handle, a delivery sheath (200) and an ablation assembly (300), wherein the handle is fixedly connected to the delivery sheath (200), the ablation assembly (300) can move along the delivery sheath (200), the distal end of the delivery sheath (200) is provided with a conical head end (230) which is easy to insert into the urethra, a curved ablation needle guide cavity is arranged in the conical head end (230), and the outlet of the curved ablation needle guide cavity is arranged on the side of the conical head end (230), the handle comprises a handle body (110) and a needle switch (140) arranged on the handle body (110), a motion assembly, and an adjustment assembly , a visual window (170), the needle switch (140) can be pinched, and the motion component drives the needle switch (140) to push one end of the ablation component (300) out of the delivery sheath (200) from the outlet of the ablation needle guide cavity. The motion component also automatically withdraws the ablation component (300) into the delivery sheath (200) after ablation is completed through elastic resetting. The adjustment component controls the pushable depth of the ablation component (300) by limiting the motion range of the motion component, and the advancement depth of the ablation component (300) can be observed through the visual window (170).

2. The ablation system according to claim 1, characterized in that: The motion component comprises a sheet metal (121), a slider (122), a guide groove (123) and an elastic body (124); the needle switch (140) and the sheet metal (121) are fixedly connected together; the middle part of the whole formed by the sheet metal (121) and the needle switch (140) is hinged on the handle body (110), so that the sheet metal (121) and the needle switch (140) as a whole can rotate in a plane around the hinge point; an elastic body (124) is provided at the hinge; one end of the elastic body (124) is connected to the handle body (110), and the other end is connected to the sheet metal (121) or the needle switch (140); one end of the sheet metal (121) is connected to the needle switch (140), and the other end drives the slider (122) to move along the guide groove (123); the slider (122) is connected to the ablation component (300).

3. The ablation system according to claim 2, characterized in that: The adjusting assembly comprises a positioning bead (131), a limiting cam (132), a spring (134) and an adjusting knob (133). The adjusting knob (133) and the limiting cam (132) are fixedly connected. The adjusting knob (133) and the limiting cam (132) are integrally rotatably mounted on a handle body (110). A plurality of grooves are arranged on one end surface of the limiting cam (132). The depth of the grooves is less than the diameter of the positioning bead (131). The end surface is in contact with the handle body (110). An installation groove is arranged on the handle body (110). The positioning bead (131) and a compressed spring (134) are arranged in the installation groove. As the limiting cam (132) is rotated, the positioning bead (131) and the compressed spring (134) are rotated. The handle body (110) is rotated to rotate until each groove on the limiting cam (132) is aligned and connected with the mounting groove on the handle body (110). When a groove on the limiting cam (132) is connected with the mounting groove on the handle body (110), the positioning bead (131) is pressed into the groove on the limiting cam (132) by the spring (134). The positioning bead (131) is partially located in the groove and partially located in the mounting groove. The sheet metal (121) is rotated until the middle of the sheet metal (121) contacts the circumferential side surface of the limiting cam (132). The distances from each point on the circumferential side surface (C) of the limiting cam (132) to the rotation axis of the limiting cam (132) are different.

4. The ablation system according to claim 2, characterized in that: The position of the slider (122) can be observed through the viewing window (170) to determine the advancement depth of the ablation assembly (300).

5. The ablation system according to any one of claims 1 to 4, characterized in that: The ablation system further comprises an endoscope (700) which is inserted into the urethra together with the ablation component (300), and the ablation component (300) is directly observed through the endoscope (700).

6. The ablation system according to claim 5, characterized in that: The delivery sheath (200) is a slender tubular structure, which is connected to the handle body (110). At least two through holes are provided in the delivery sheath (200), and the length direction of the through holes is consistent with the length direction of the delivery sheath (200). The through holes include at least an ablation component guide channel (210) and an endoscope guide channel (220), which are used for the movement and guidance of the ablation component (300) and the endoscope (700), respectively.

7. The ablation system according to any one of claims 1 to 4, characterized in that: The ablation assembly (300) includes an ablation needle (310), an energy delivery ring (320), an ablation needle insulation layer (330) and an electric wire (340). The ablation needle (310) except for the needle tip is covered with the ablation needle insulation layer (330). The energy delivery ring (320) is arranged on the outer surface of the ablation needle insulation layer (330). The ablation needle (310) and the energy delivery ring (320) are respectively and independently connected to the electric wire (340). The electric wire (340) passes through the handle and is connected to the external energy generator 600.

8. The ablation system according to any one of claims 1 to 4, characterized in that: The ablation system also includes a fluid flushing component, which includes an endoscope sheath (510). The endoscope sheath (510) is a slender tubular structure. The inner diameter of the endoscope sheath (510) is larger than the outer diameter of the delivery sheath (200). The endoscope sheath (510) is coaxially sleeved on the outside of the delivery sheath (200). The endoscope sheath (510) and the delivery sheath (200) are pushed into the natural cavity of the human body together. The annular channel between the endoscope sheath (510) and the delivery sheath (200) is a fluid flushing channel, and the external flushing fluid can enter the natural cavity through the fluid flushing channel.

9. The ablation system according to claim 1, characterized in that: The handle further comprises a zero-position locking member (150), which prevents one end of the ablation component (300) from extending out of the delivery sheath (200) by blocking the action of the needle switch (140).

10. The ablation system according to claim 6, characterized in that: An endoscope observation window is also provided on the conical head end (230), and the endoscope (700) observes the ablation component (300) being pushed out of one end of the delivery sheath (200) through the endoscope observation window.

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