An ablation device and a prostate tissue ablation system

Abstract

This invention provides an ablation device and a prostate tissue ablation system. The ablation tissue includes a head electrode assembly, a needle electrode assembly, and a handle assembly. The head electrode assembly includes a head end body and an outer tube connected to each other. The head end body is disposed at the distal end of the outer tube, and a head electrode is disposed at the distal end of the head end body. A needle electrode channel is disposed within the outer tube, and the needle electrode assembly is housed within the needle electrode channel. The needle electrode assembly includes at least one needle electrode and extends from the side of the ablation device based on the operation of the handle assembly. This invention enables interventional surgery via the natural urethra under visual guidance, employing tissue-selective irreversible electroporation with steep pulsed electric fields, significantly improving surgical efficiency and safety.

Description

Technical Field

[0001] This utility model relates to the technical field of ablation devices, and more specifically, to an ablation device and a prostate tissue ablation system. Background Technology

[0002] Benign prostatic hyperplasia (BPH) is a common chronic disease in middle-aged and elderly men, primarily characterized by urinary dysfunction, and is one of the most frequently encountered diseases in urological clinical practice. BPH is a common chronic disease with main symptoms such as urinary frequency and incomplete flow, interrupted or weak urine stream, urgency, and leakage. The condition can worsen over time, leading to complications such as bladder strain, urinary tract infections, bladder or kidney damage, bladder stones, and urinary incontinence. While BPH is not fatal, it significantly reduces the patient's quality of life.

[0003] The prostate gland can be clearly divided into three regions: the peripheral zone (PZ), the central zone (CZ), and the transition zone (TZ). These regions play different roles in prostate function and disease development. The peripheral zone (PZ) accounts for approximately 70% of the prostate volume in young men, located at the posterior part of the gland and closely surrounding the distal urethra. This region is particularly crucial as it is the origin of 70-80% of prostate cancer cases. The central zone (CZ), surrounding the ejaculatory ducts, accounts for 20-25% of the total prostate volume. This region often becomes the focus of inflammatory processes, especially in inflammatory diseases such as prostatitis. The transition zone (TZ) is the primary area for the development of benign prostatic hyperplasia (BPH). In a normal prostate structure, the transition zone accounts for only 5-10% of the glandular volume, but in patients with BPH, its volume can significantly increase to as high as 80%. The transition zone comprises the two lateral lobes of the prostate and the glandular region surrounding the urethra, and is surrounded by a series of natural barriers, such as the prostatic urethra, the anterior fibromuscular matrix, and the fibrous plane between it and the peripheral zone. These barriers play an important supporting and protective role in the transition zone.

[0004] BPH results from an imbalance between the proliferation of glandular cells and normal cell apoptosis (i.e., natural cell death) within the prostate gland. This excessive proliferation, rather than normal cell death, leads to a cumulative increase in prostate tissue, resulting in a gradual enlargement of the overall size of the prostate. This increase in size is particularly pronounced in the transitional zone across the prostatic urethra during the progression of BPH, thus becoming the primary source of BPH-related symptoms. In the early stages of BPH, medication can alleviate some symptoms. For example, alpha-blockers have proven effective before glandular elements induce extreme cell growth in the prostate.

[0005] However, later stages of BPH can only be treated surgically. The gold standard for surgical treatment of BPH is transurethral resection of the prostate (TURP), which removes the enlarged prostate tissue through transurethral resection. It has advantages such as less bleeding, less damage, and significant relief of urinary difficulties. However, this surgery may lead to postoperative complications such as retrograde ejaculation, impaired sexual function, and TURP syndrome.

[0006] With the development of technology, a class of ablation therapies that induce apoptosis in lesions through energy, thereby eliminating the lesions, has gradually emerged. Common examples include radiofrequency ablation, steam ablation, microwave ablation, and cryoablation. These ablation procedures may only provide temporary relief, or cause significant pre- and post-operative discomfort and morbidity, or they may not be able to target specific types of tissue cells, resulting in uncontrollable ablation range and placing great demands on the surgeon's skill.

[0007] Steep pulse ablation is a treatment that uses specific electrical pulses to create irreversible electroporation in tissue cells. Based on the differences in the ablation threshold of different tissues, selective irreversible electroporation in specific tissues alters cell permeability, disrupts intracellular homeostasis, and ultimately leads to apoptosis, thereby ablating the target tissue.

[0008] Among these procedures, electroresection (ERG) uses high-frequency current generated by electrical energy to heat and cut the enlarged prostate tissue using instruments such as high-frequency electrosurgical units or electrosurgical loops. During the procedure, the surgeon must have a high degree of precision in operating the instruments. Furthermore, due to potential deviations during cutting, other normal tissue may be removed simultaneously, leading to complications such as urinary incontinence and retrograde ejaculation. Radiofrequency ablation, being a form of thermal damage energy, lacks tissue selectivity. Therefore, the surgeon must also have high precision in operating the instruments. The lack of tissue selectivity and thermal effects can damage other tissue cells, leading to complications such as necrosis, sloughing, and bladder contracture. Pulsed electric field ablation is a novel ablation method that utilizes pulsed electric fields as energy.

[0009] Pulsed electric field ablation involves designing an appropriate pulsed electric field and using multiple short-duration, high-voltage electrical pulses to release ablation energy. This makes the ablation process non-thermal (without Joule heating), effectively inducing electroporation of cells and cell fragmentation and death in proliferating tissue. Damage to tissues with high pulsed electric field thresholds is reversible, allowing for targeted damage to proliferating tissue and avoiding complications caused by damage to surrounding tissues. Compared to traditional electroresection and radiofrequency energy, pulsed electric field ablation is non-thermal, thus allowing selective damage to proliferating tissue while preserving normal cells around nerves.

[0010] Existing technologies for benign prostatic hyperplasia surgery suffer from problems such as long operation time, cumbersome operation, high operation difficulty, and many complications due to the large size of instruments and the defective arrangement of electrodes between the ablation needles inside and outside the body. Utility Model Content

[0011] In view of this, the present invention aims to provide an ablation device and a prostate tissue ablation system to solve the above-mentioned technical problems in the prior art.

[0012] One aspect of this utility model provides an ablation device, including a head electrode assembly, a needle electrode assembly, and a handle assembly. The head electrode assembly includes a head end body and an outer tube connected to each other. The head end body is disposed at the distal end of the outer tube. A head electrode is disposed at the distal end of the head end body. A needle electrode channel is disposed inside the outer tube. The needle electrode assembly is housed within the needle electrode channel. The needle electrode assembly includes at least one needle electrode. The needle electrode assembly extends from the side of the ablation device based on the operation of the handle assembly.

[0013] In some embodiments, the end face of the head body is an arc surface, the head electrode is nested above the end face of the head body and fits tightly with the head body, and a head electrode channel is also provided inside the head body, through which the wire of the head electrode passes and is connected to the handle assembly.

[0014] In some embodiments, a flexible insulating tube is provided within the needle electrode channel. A first portion of the insulating tube is disposed inside the needle electrode channel, and a second portion of the insulating tube extends into the head end body and bends within the head end body. The outlet of the insulating tube is disposed on the side of the head end body.

[0015] In some embodiments, a recess is provided on the side of the head body, the first inner surface of the recess is arc-shaped, the second inner surface of the recess forms a predetermined angle with the needle electrode channel, an opening is provided on the second inner surface, and the second part of the insulating tube is bent along the arc shape of the first inner surface.

[0016] In some embodiments, an endoscope channel is further provided inside the outer tube. The endoscope channel is arranged parallel to the needle electrode channel. One end of the endoscope channel is connected to an external endoscope, and the other end of the endoscope channel is connected to the opening.

[0017] In some embodiments, a needle electrode insulating layer is provided on the outer side of the needle electrode, a support tube is provided on the outer side of the proximal portion of the needle electrode, the proximal end of the support tube is connected to the tail end, a support tube insulating layer is provided on the outer side of the support tube, and a colored insulating layer is also provided on the outer side of the needle electrode insulating layer and the support tube insulating layer.

[0018] In some embodiments, the handle assembly includes a housing and an electrical connector. A trigger is disposed on the housing. A limiting structure, a fixing block, a power signal line, and an elastic block are disposed inside the housing. The fixing block is connected to the trigger. The power signal line is connected to the electrical connector. The limiting structure is connected to a knob. The needle electrode assembly passes through the needle electrode channel and through the elastic block and is fixed to the fixing block. The tail end of the needle electrode assembly is connected to the electrical connector through the power signal line. The electrical connector is connected to an external power supply device.

[0019] In some embodiments, the knob is restricted from rotation by the limiting structure, and the knob is provided with a safety boundary adjustment position and multiple extension length adjustment positions.

[0020] In some embodiments, the handle assembly is assembled with the head electrode assembly via a quick-release structure, and is also fixedly connected to an external sheath device.

[0021] Another aspect of this utility model provides a prostate tissue ablation system, including an ablation device, an outer sheath device, an endoscope, and a power supply device, wherein the ablation device is any of the ablation devices described above.

[0022] This invention enables interventional surgery that can be performed via the natural cavity of the urethra under visual guidance, employing an organized and selective irreversible electroporation steep pulse electric field, which greatly improves surgical efficiency and safety.

[0023] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0024] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with or without letter suffixes may indicate different instances of similar parts. The drawings generally illustrate various embodiments by way of example rather than limitation and, together with the description and claims, serve to illustrate the disclosed embodiments. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method. The accompanying drawings, which are provided to further understand the present invention and form part of this application, illustrate exemplary embodiments of the present invention and, together with their description, serve to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0025] Figure 1 This is a schematic diagram of the ablation device in an embodiment of this utility model;

[0026] Figure 2 This is a cross-sectional view of the ablation device in an embodiment of this utility model;

[0027] Figure 3 This is a schematic diagram of the head electrode assembly in the ablation device in this embodiment of the present invention;

[0028] Figure 4 This is a schematic diagram of the arrangement of the head electrode and needle electrode in the ablation device in this embodiment of the present invention;

[0029] Figure 5 This is one of the structural schematic diagrams of the needle electrode assembly in the ablation device of this utility model embodiment;

[0030] Figure 6 This is the second schematic diagram of the needle electrode assembly in the ablation device of this utility model embodiment;

[0031] Figure 7 This is the third schematic diagram of the needle electrode assembly in the ablation device of this utility model embodiment;

[0032] Figure 8 This is a schematic diagram of the handle assembly in the ablation device in this embodiment of the present invention;

[0033] Figure 9 This is a schematic diagram of the electrical connector connection of the handle assembly in the ablation device in this embodiment of the present invention;

[0034] Figure 10 This is a schematic diagram of the trigger of the handle assembly in the ablation device in this embodiment of the present invention;

[0035] Figure 11 This is a schematic diagram showing the connection between the handle assembly and the needle electrode assembly in the ablation device of this utility model embodiment;

[0036] Figure 12 This is one of the working schematic diagrams of the ablation device in the embodiments of this utility model;

[0037] Figure 13 This is the second schematic diagram of the operation of the ablation device in this embodiment of the present invention.

[0038] Figure label:

[0039] 1-Head electrode assembly; 11-Head electrode; 12-Head end body; 13-Insulating tube; 14-Needle electrode channel; 15-Endoscope channel; 17-Outer tube; 18-Recess; 18a-First inner surface; 18b-Second inner surface; 19-Opening; 2-Needle electrode assembly; 21-Needle electrode; 22-Needle electrode insulating layer; 23-Colored insulating layer; 24-Support tube; 25-Tail end; 26-Support tube insulating layer; 3-Handle assembly; 31-Trigger; 32-Limiting structure; 33-Outer shell; 34-Fixing block; 35-Knob; 36-Quick-release structure; 37-Lock; 38-Power signal line; 39-Electrical connector; 310-Elastic block; 311-Transparent block; 41-Prostate epithelial tissue; 42-Prostate hyperplasia site. Detailed Implementation

[0040] The specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings, but these are not intended to limit the scope of the present invention.

[0041] It should be understood that various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be considered as limiting, but merely as an example of embodiments. Other modifications within the scope and spirit of this invention will be apparent to those skilled in the art.

[0042] The accompanying drawings, which are included in and form part of this specification, illustrate embodiments of the present invention and, together with the general description of the present invention given above and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

[0043] These and other features of the present invention will become apparent from the following description of preferred forms of embodiments given as non-limiting examples, with reference to the accompanying drawings.

[0044] It should also be understood that although the present invention has been described with reference to some specific examples, those skilled in the art can certainly implement many other equivalent forms of the present invention, which have the features described in the claims and are therefore all within the scope of protection defined herein.

[0045] The above and other aspects, features and advantages of the present invention will become more apparent when taken in conjunction with the accompanying drawings and in view of the following detailed description.

[0046] Specific embodiments of the present invention will now be described with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely examples of the present invention, which may be implemented in various ways. Well-known and / or repeated functions and structures are not described in detail to avoid unnecessary or redundant details that could obscure the present invention. Therefore, the specific structural and functional details disclosed herein are not intended to be limiting, but merely to serve as the basis and representative basis for the claims to teach those skilled in the art to use the present invention in a variety of substantially any suitable detailed structures.

[0047] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this utility model are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the utility model described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0048] This specification may use the phrases “in one embodiment,” “in another embodiment,” “in yet another embodiment,” or “in other embodiments,” all of which may refer to one or more of the same or different embodiments according to the present invention.

[0049] The first embodiment of this utility model provides an ablation device used in a prostate tissue ablation system, which performs ablation via the natural cavity of the urethra. The prostate tissue ablation system includes an ablation device, an external sheath device, an endoscope, and a power supply device.

[0050] like Figures 1-13 As shown, the ablation device includes a head electrode assembly 1, a needle electrode assembly 2, and a handle assembly 3. The head electrode assembly 1 is relatively fixed in position relative to the handle assembly 3, and it can move with the movement of the ablation device. The needle electrode assembly 2 extends out of the ablation device based on the operation of the handle assembly 3. In this way, the head electrode assembly 1 and the needle electrode assembly 2 can emit energy at two different positions to cooperate in performing ablation operations at a predetermined location. Specifically, the head electrode assembly 1 and the needle electrode assembly 2 can emit steep pulse energy to selectively perform irreversible electroporation on the lesion tissue.

[0051] Specifically, the head electrode assembly 1 and the needle electrode assembly 2 can be inserted together through a natural cavity or urethra. The head electrode assembly 1 can be positioned at a predetermined location within the natural cavity to emit energy by the movement of the ablation device. The needle electrode assembly 2 can continue to move and extend from the ablation device under the operation of the handle assembly 3 to puncture the natural cavity, and finally move to the lesion area to emit energy. The handle assembly 3 can control the advancement or retraction of the needle electrode assembly 2 relative to the ablation device.

[0052] Furthermore, the head electrode assembly 1 includes a head end body 12 and an outer tube 17 connected to each other. The head end body 12 is located at the distal end of the outer tube 17, and a head electrode 11 is disposed at the distal end of the head end body 12. The head electrode 11 is made of materials such as copper or gold. Specifically, the portion of the head electrode 11 used for emitting energy has a size of (1-2 mm) * (3-4 mm).

[0053] In the head electrode assembly 1 described here, the end face of the head end body 12 is a smooth arc surface, and the head electrode 11 is nested above the end face of the head end body 12, fitting tightly with the head end body 12. To ensure operational safety, the edges of the head electrode 11 are rounded to facilitate matching with the end face of the head end body 12.

[0054] In order to achieve the ablation effect of the head electrode 11, a head electrode channel is also provided in the head end body 12. The wire suitable for the head electrode 11 passes through the head electrode channel and is connected to the handle assembly 3. The head electrode 11 is welded to one end of the wire, and the other end of the wire runs along the head electrode channel in the head end body 12 and the outer tube 17 until it reaches the handle assembly 3.

[0055] Furthermore, a needle electrode channel 14 is provided inside the outer tube 17. The needle electrode channel 14 is, for example, an internal cavity of a stainless steel tube, which is used to accommodate the needle electrode assembly 2. The needle electrode assembly 2 can be housed in the needle electrode channel 14 of the head electrode assembly 1. It can move together with the head electrode assembly 1 and extend from the side of the head electrode assembly 1 when energy needs to be emitted for ablation.

[0056] The needle electrode assembly 2 here includes at least one needle electrode 21, wherein the single needle diameter of the needle electrode 21 is <0.5mm, the length of the part used to transmit energy is 4-8mm, and the material of the needle electrode 21 is a shape memory alloy, such as nickel-titanium.

[0057] Specifically, a flexible insulating tube 13 is provided inside the needle electrode channel 14. The outer diameter of the insulating tube 13 is smaller than the inner diameter of the needle electrode channel 14. A first part of the insulating tube 13 is located inside the needle electrode channel 14, and a second part of the insulating tube 13 extends into the head end body 12 and bends inside the head end body 12. The outlet of the insulating tube 13 is located on the side of the head end body 12.

[0058] Furthermore, the head end body 12 has a semi-hollow structure. Specifically, a recess 18 is provided on the side of the head end body 12. The first inner surface 18a of the recess 18 is arc-shaped, and the second inner surface 18b of the recess 18 forms a predetermined angle with the needle electrode channel 14. Preferably, the second inner surface 18b can be perpendicular to the direction of the needle electrode channel 14. Here, an opening 19 is provided on the second inner surface 18b of the recess 18.

[0059] Specifically, the needle electrode channel 14 is disposed outside the first part of the insulating tube 13, and the second part of the insulating tube 13 is bent inside the head end body 12. Preferably, the second part of the insulating tube 13 is curved along the arc of the first inner surface 18a of the recess 18, so that the outlet of the insulating tube 13 can be disposed on the side of the head end body 12, thereby facilitating the needle electrode assembly 2 to extend from the outlet of the insulating tube 13 located on the side of the head end body 12.

[0060] In addition, an endoscope channel 15 is provided inside the outer tube 17. The endoscope channel 15 is arranged parallel to the needle electrode channel 14. One end of the endoscope channel 15 is connected to an external endoscope, and the other end of the endoscope channel 15 is connected to the opening 19 on the second inner surface 18b of the recess 18. In this way, the endoscope can extend out from the opening 19 through the endoscope channel 15 and extend the ablation device through the recess 18, thereby facilitating the operation of the endoscope during the ablation process.

[0061] Furthermore, a needle electrode insulating layer 22 is provided on the outer side of the needle electrode 21, and a support tube 24 is provided on the outer side of the proximal portion of the needle electrode 21. The proximal end of the support tube 24 is connected to the tail end 25, and a support tube insulating layer 26 is provided on the outer side of the support tube 24. Furthermore, a colored insulating layer 23 is also provided on the outer side of the needle electrode insulating layer 22 and the support tube insulating layer 26.

[0062] In this embodiment, the needle electrode 21 in the needle electrode assembly 2 is covered with at least two insulating layers on its outer side. The needle electrode insulating layer 22 is attached to the outer surface of the needle electrode 21, and the colored insulating layer 23 covers the outer side of the needle electrode insulating layer 22. Similarly, the support tube 24 is covered with at least two insulating layers on its outer side. The support tube insulating layer 26 is attached to the outer surface of the support tube 24, and the colored insulating layer 23 covers the outer side of the support tube insulating layer 26.

[0063] Furthermore, considering that the needle electrode assembly 2 can extend out of the ablation device and pierce the lesion, the needle electrode 21 is provided with an insertion depth mark so as to observe the depth of insertion into the tissue, thereby improving the accuracy of surgical ablation and achieving precise positioning under the visual condition of endoscopy. For example, the needle electrode 21 is provided with a depth indicator mark of 1-5mm segments with alternating shallow and deep depths.

[0064] This embodiment achieves both ablation and measurement functions through the head electrode assembly 1 and the needle electrode assembly 2. In this embodiment, the head electrode 11 and the needle electrode 21 are configured with opposite polarities (e.g., one positive and one negative). When used for pulse ablation, the dual electrodes within the needle electrode assembly 1 and the needle electrode assembly 2 are simultaneously inserted into the natural cavity of the urethra. A circuit is formed between the head electrode 11 and the needle electrode 21 near the lesion area, thereby concentrating energy in the lesion area. The head electrode 11 and the needle electrode 21 each emit energy, resulting in an output voltage of 500-5000V between the two electrodes, preferably 1000-2600V. This high voltage between the two electrodes enables pulse ablation.

[0065] Furthermore, when performing ablation operations using the ablation device, especially when the needle electrode 21 extends a certain distance from the side of the head body 12, in order to adapt to different voltage requirements and safety considerations of pulse ablation, there is a distance L between the head electrode 11 and the needle electrode 21. Preferably, the distance L is 5-25mm.

[0066] Furthermore, in this embodiment, the head electrode assembly 1 and the needle electrode assembly 2 cooperate with each other to achieve the measurement function. Specifically, after the head electrode 11 in the head electrode assembly 1 and the needle electrode assembly 2 are connected to an external power supply device, the ablation device is inserted into the vicinity of the benign prostatic hyperplasia through the urethra, and the needle electrode assembly 2 passes through the prostatic epithelial tissue 41 to reach the prostatic hyperplasia site 42 to achieve measurement.

[0067] Specifically, the steep pulse energy generated by the power supply device flows through the needle electrode assembly 2 and through the prostate tissue. With the aid of the physiological saline circulating in the urethra, the steep pulse energy flows back to the power supply device after passing through the head electrode 11, thus forming a working circuit. Here, the needle electrode 21 and the head electrode 11 respectively form a steep pulse energy field. The steep pulse electric field selectively causes irreversible electroporation of tissue cells, ablating the proliferating tissue. A schematic diagram of the specific working principle circuit is shown below. Figure 13 .

[0068] Here, the different impedance signals fed back by the head electrode 11 and the needle electrode 21 can be used to determine the position of the head electrode 11 and the needle electrode 21 and the state of tissue change after energy release in order to achieve measurement. The state here can be, for example, when the ablation device enters the natural cavity and the needle electrode 21 pierces the natural cavity and enters the tissue, when the needle electrode 21 is completely entered into the tissue, and after the release of pulse energy, etc.

[0069] The ablation method of this utility model involves inserting the electrode structure into the body through the natural cavity of the urethra. In particular, ablation is performed by inserting a needle electrode to the lesion site, which can reduce surgical wounds and bleeding. Specifically, the dual electrodes in the needle electrode assembly and the head electrode assembly are simultaneously placed into the natural cavity of the urethra. An energy circuit is formed between the two electrodes near the lesion area, concentrating energy on the lesion tissue. This not only results in a good ablation effect but also reduces the current flow through other tissues and nerves, thus reducing stimulation to the patient.

[0070] Furthermore, the handle assembly 3 in this embodiment enables the movement of the needle electrode assembly 2. Specifically, the handle assembly 3 includes a housing 33 and an electrical connector 39. A trigger 31 is provided on the housing 33. A limiting structure 32, a fixing block 34, a power signal line 38, and an elastic block 310 are provided inside the housing 33. The fixing block 34 is connected to the trigger 31, the power signal line 38 is connected to the electrical connector 39, and the limiting structure 32 is connected to the knob 35. In addition, a latch 37 is provided inside the housing 33, and a transparent block 311 is provided on the housing 33.

[0071] In this embodiment, the needle electrode assembly 2 passes through the needle electrode channel 14 in the head electrode assembly 1 and through the elastic block 310 in the handle assembly 3, and is bonded and fixed to the fixing block 34 in the handle assembly 3. The tail end 25 of the needle electrode assembly 2 is connected to the electrical connector 39 through the power signal line 38, and is connected to an external power supply device through the electrical connector 39.

[0072] Furthermore, when the trigger 31 in the handle assembly 3 is activated, it drives the fixing block 34 to move, causing the needle electrode 21 to be pushed outward by a corresponding length, for example, at least 0-15mm. In addition, the transparent block 311 of the housing 33 can realize a visible scale, allowing the position of the fixing block 34 to be observed to determine the length of the needle electrode 21 pushed out.

[0073] Furthermore, the knob 35 is restricted from rotation by the limiting structure 32. Specifically, the knob 35 is provided with a safety boundary adjustment position, which can limit the length of the needle electrode assembly 2 extending out of the ablation device, in order to prevent the needle electrode assembly 2 from puncturing other tissues due to misoperation, avoid the risk of puncturing the outer membrane, and further improve the safety of the system.

[0074] In addition to the safety boundary adjustment setting, the knob 35 in the handle assembly 3 includes three adjustment settings for the extension length. In one specific embodiment, the extension length of the needle electrode 21 is ≤15mm by setting the safety boundary adjustment setting, and the extension lengths of the needle electrode 21 are 0mm, 10mm, and 15mm by setting the three settings. This embodiment of the invention enables minimally invasive interventional surgery through the natural orifice urethra, allowing for controllable ablation operations with adjustable ablation depth, selected ablation site, and selected safety boundary.

[0075] Furthermore, the handle assembly 3 is assembled with the head electrode assembly 1 via a quick-release structure 36, and simultaneously fixedly connected to an external sheath device. This external sheath device contains at least one channel and at least two through holes, the length of which aligns with the extension direction of the head electrode assembly 1 within the ablation device. Specifically, one of the through holes serves as a fluid outlet, and one or more as fluid inlets, thereby enabling fluid circulation. The external endoscope is secured via the latch 37 in the handle assembly 3. Once secured, the ablation device, the external sheath device, and the endoscope are inserted together into the urethra, the natural cavity, for operation.

[0076] In the ablation device of this utility model embodiment, the outer shell 33 of the handle assembly 3 is ergonomically designed, making it easy to hold, and the trigger 31 and the limiting structure 32 are easy to operate and use, thereby meeting the operation requirements of the narrow space of the urethra.

[0077] In this embodiment, the head electrode assembly, in conjunction with the needle electrode assembly, allows for less tissue flow in the current loop under normal operating conditions, concentrating energy near the lesion and minimizing stimulation to the human body. This improves the speed and stability of the ablation process. Furthermore, the head electrode assembly, in conjunction with the needle electrode assembly, can also provide measurement functions, offering a reference for the surgeon's evaluation.

[0078] This invention enables interventional surgery that can be performed via the natural cavity of the urethra under visual guidance, employing an organized and selective irreversible electroporation steep pulse electric field, which greatly improves surgical efficiency and safety.

[0079] The main difference between the second embodiment of this utility model and the first embodiment described above lies in the structure of the head electrode assembly 1, as shown in the attached figure. Figure 13 As shown, the remaining related descriptions are consistent with those in the first embodiment described above. In this embodiment, the needle electrode assembly 2 includes a plurality of needle electrodes 21. Energy flows from the power supply device 5 to the plurality of needle electrodes 21 to act on the prostatic hyperplasia site 42. The saline solution in the tissue and urethra then flows back to the device from the head electrode assembly 1. The steep pulse energy field generated by the needle electrodes 21 and the head electrode 11 selectively causes irreversible electroporation of tissue cells, ablating the hyperplastic tissue. This allows the dual-needle or multi-needle device to cover a larger ablation area during operation, reducing surgical procedures for larger lesions.

[0080] Furthermore, multiple needle electrode channels are provided inside the head end body 12. Since the distance between electrodes is too close, there will be charge concentration and electric sparks. Therefore, the distance D between adjacent needle electrodes 21 is ≥ 3.5 mm.

[0081] This invention enables interventional surgery that can be performed via the natural cavity of the urethra under visual guidance, employing an organized and selective irreversible electroporation steep pulse electric field, which greatly improves surgical efficiency and safety.

[0082] The third embodiment of this utility model provides a prostate tissue ablation system. The aforementioned ablation device is used in the prostate tissue ablation system, which performs ablation via the natural cavity of the urethra. This prostate tissue ablation system includes an ablation device, an outer sheath device, an endoscope, and a power supply device. The ablation device, the outer sheath device, and the endoscope can be quickly and securely connected to form a whole. This embodiment provides stable fluid circulation and a stable surgical environment; it also facilitates adjustment of the length of insertion into the natural cavity of the urethra, thereby enabling ablation operations at different locations.

[0083] The ablation device is fixed to the outer sheath device and the endoscope, which increases the ablation range, improves ablation efficiency, reduces energy consumption, and reduces damage to peripheral nerves and blood vessels. At the same time, the pulsed ablation needle provides ablation measurement function, which further improves the safety and effectiveness of the operation with tissue selectivity that is superior to traditional energy.

[0084] This invention enables interventional surgery that can be performed via the natural cavity of the urethra under visual guidance, employing an organized and selective irreversible electroporation steep pulse electric field, which greatly improves surgical efficiency and safety.

[0085] Furthermore, the features of the embodiments shown in the accompanying drawings or the various embodiments mentioned in this specification should not be construed as independent embodiments. Rather, each feature described in one example of an embodiment can be combined with one or more other desired features from other embodiments to produce other embodiments not described in words or with reference to the accompanying drawings.

[0086] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application, and should all be included within the protection scope of this application.

Claims

1. An ablation device, characterized by, The device includes a head electrode assembly, a needle electrode assembly, and a handle assembly. The head electrode assembly includes a head end body and an outer tube connected to each other. The head end body is disposed at the distal end of the outer tube. A head electrode is disposed at the distal end of the head end body. A needle electrode channel is disposed inside the outer tube. The needle electrode assembly is housed within the needle electrode channel. The needle electrode assembly includes at least one needle electrode. The needle electrode assembly extends from the side of the ablation device based on the operation of the handle assembly.

2. The ablation device of claim 1, wherein, The end face of the head end body is an arc surface. The head electrode is nested above the end face of the head end body and fits tightly with the head end body. A head electrode channel is also provided inside the head end body. The wire of the head electrode passes through the head electrode channel and is connected to the handle assembly.

3. The ablation device according to claim 1, characterized in that, A flexible insulating tube is provided inside the needle electrode channel. The first part of the insulating tube is located inside the needle electrode channel, and the second part of the insulating tube extends into the head end body and bends inside the head end body. The outlet of the insulating tube is located on the side of the head end body.

4. The ablation device according to claim 3, characterized in that, A recess is provided on the side of the head end body. The first inner surface of the recess is arc-shaped. The second inner surface of the recess forms a predetermined angle with the needle electrode channel. An opening is provided on the second inner surface. The second part of the insulating tube is bent along the arc shape of the first inner surface.

5. The ablation device according to claim 4, characterized in that, An endoscope channel is also provided inside the outer tube. The endoscope channel is arranged parallel to the needle electrode channel. One end of the endoscope channel is connected to an external endoscope, and the other end of the endoscope channel is connected to the opening.

6. The ablation device according to claim 1, characterized in that, The needle electrode has an insulating layer on its outer side, and a support tube is provided on the outer side of the proximal portion of the needle electrode. The proximal end of the support tube is connected to the tail end. An insulating layer is provided on the outer side of the support tube. A colored insulating layer is also provided on the outer side of the needle electrode insulating layer and the support tube insulating layer.

7. The ablation device according to claim 6, characterized in that, The handle assembly includes a housing and an electrical connector. A trigger is mounted on the housing. A limiting structure, a fixing block, a power signal line, and an elastic block are disposed inside the housing. The fixing block is connected to the trigger. The power signal line is connected to the electrical connector. The limiting structure is connected to a knob. The needle electrode assembly passes through the needle electrode channel and through the elastic block and is fixed to the fixing block. The tail end of the needle electrode assembly is connected to the electrical connector through the power signal line. The electrical connector is connected to an external power supply device.

8. The ablation device according to claim 7, characterized in that, The knob is restricted from rotation by the limiting structure, and the knob is provided with a safety boundary adjustment position and multiple extension length adjustment positions.

9. The ablation device according to claim 1, characterized in that, The handle assembly is assembled with the head electrode assembly via a quick-release structure, and is also fixedly connected to the external sheath device.

10. A prostate tissue ablation system, characterized in that, It includes an ablation device, an outer sheath device, an endoscope, and a power supply device, wherein the ablation device is the ablation device described in any one of claims 1-9.

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