CN120514468A - Ablation device and prostate tissue ablation system - Google Patents

Abstract

The present disclosure 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 that are connected to each other, the head end body is disposed at a distal end of the outer tube, a head electrode is disposed at a distal end of the head end body, a needle electrode channel is disposed in the outer tube, the needle electrode assembly is received in the needle electrode channel, the needle electrode assembly includes at least one needle electrode, and the needle electrode assembly extends from a side of the ablation device based on an operation of the handle assembly. The embodiment of the disclosure can realize the access through the natural orifice urethra and the operation under the visual condition, and adopts the interventional operation of the irreversible electroporation steep pulse electric field with tissue selectivity, thereby greatly improving the operation efficiency and the operation safety and effectiveness.

Description

Ablation device and prostate tissue ablation system

Technical Field

The present disclosure relates to the technical field of ablation devices, and in particular, to an ablation device and a prostate tissue ablation system.

Background

Benign Prostatic Hyperplasia (BPH) is a chronic disease which is a common urination disorder of middle-aged and elderly men and is one of the most common diseases in clinical diagnosis and treatment of urinary surgery. BPH generally occurs after age 40 with increasing incidence year by year, with more than half of men over age 50 suffering from benign prostatic hyperplasia and up to 90% of men over age 80. BPH is a common chronic condition with major symptoms such as frequent and unsmooth urination, interruption or weak urine flow and sense of urgency and leakage. Conditions may be exacerbated over time, such as bladder tightening, urinary tract infections, bladder or kidney injuries, bladder stones and urinary incontinence. BPH does not die but can significantly reduce the quality of life of the patient.

The glandular structure of the prostate can be clearly divided into three regions, peripheral Zone (PeripheralZone, PZ), central Zone (CZ) and Transition Zone (TZ). These regions play different roles in prostate function and disease occurrence. Wherein the Peripheral Zone (PZ) occupies about 70% of the prostate volume in young men, is located posterior to the gland and immediately surrounds the distal urethra. This area is particularly critical because it is the origin of 70-80% of cases of prostate cancer. The Central Zone (CZ) then surrounds the ejaculatory duct, accounting for 20-25% of the total volume of the prostate. This region often becomes the focus of the inflammatory process, particularly in inflammatory diseases such as prostatitis. The Transition Zone (TZ) is the main development area of BPH. In normal prostate architecture, the transition zone is only 5-10% of the gland element volume, but in BPH patients its volume can be significantly increased up to 80%. The transition zone includes two lateral prostatic lobes and a gland region surrounding the urethra and is surrounded by a series of natural barriers such as the prostatic urethra, the anterior fibromuscular stroma, and the fiber plane between the peripheral zone. These barriers provide important support and protection for the transition zone.

BPH is the result of a imbalance between prostatic cell proliferation and normal apoptosis (i.e., natural death) in the prostate. This overactivity of cell proliferation, rather than normal cell death, leads to an increased accumulation of prostate tissue, thus gradually expanding the overall size of the prostate. This increase in size is particularly pronounced in the transition zone across the prostatic urethra during the progression of BPH, which thus becomes the primary source of symptoms associated with BPH. In the early cases of BPH, drug treatment may alleviate some symptoms. For example, alpha-blockers, such drugs can prove effective before the glandular element causes extreme cell growth in the prostate.

However, the more advanced stages of BPH can only be treated by surgery. The gold standard for BPH surgery treatment is transurethral prostatectomy (TURP), and the operation enucleates the proliferated prostate tissue by electrotomy, has the advantages of less bleeding, less damage, obvious effect of solving the difficult urination and the like, but the operation may cause postoperative complications such as retrograde ejaculation, sexual function influence, electrotomy syndrome and the like.

Along with the development of technology, a type of ablation treatment means for eliminating focal tissues by inducing focal tissues to apoptosis through energy is gradually developed. Common are radio frequency ablation, steam ablation, microwave thermal ablation, cryoablation, etc. Such ablative procedures either provide only temporary relief, or cause significant preoperative and postoperative discomfort and morbidity, or fail to ablate a particular class of tissue cells, with an uncontrollable range of ablation, quite challenging the operative skill of the operative practitioner.

Steep pulse ablation is a treatment by specific electrical pulses during which irreversible electroporation is formed on tissue cells. Based on the difference of electric field ablation thresholds of different tissues, irreversible electroporation selectively generated on specific tissues changes the cell permeability, and imbalance of intracellular homeostasis finally leads to apoptosis, so that target tissues are ablated.

The electrotomy generates high-frequency current through electric energy, so that a high-frequency electrotome or an electrotome ring and other instruments for cutting tissues through electric energy heat and cut a prostatic hyperplasia tissue region, and in the operation process of an operator on a patient, the operator is required to have high operation accuracy on the instrument, and meanwhile, other normal tissues can be cut off at the same time due to deviation in cutting, so that a series of complications such as urinary incontinence, retrograde ejaculation and the like are caused. The radio frequency ablation is heat injury energy, and is a novel ablation mode using a pulse electric field as energy because the energy has no tissue selectivity, the operation accuracy of the device is required to be high in the operation process of the operator on a patient, and other tissue cells can be damaged due to the fact that the tissue selectivity and the heat effect are not available, so that various complications such as necrosis and abscission, bladder contracture and the like are caused.

The pulsed electric field ablation is to design a proper pulsed electric field, and release ablation energy by adopting a plurality of electric pulses with short time and high voltage, so that the ablation process is nonthermal ablation (without joule heat generation), and cells are effectively induced to generate electroporation, and cells of the proliferation tissue are disintegrated and dead. The damage to the tissues with higher threshold values of the pulse electric field is reversible, so that the tissue with hyperplasia can be directionally damaged, and complications caused by the damage of other surrounding tissues can be avoided. Compared with traditional electrotomy and radio frequency energy, pulsed electric field ablation is nonthermal ablation, so that the pulsed electric field can selectively damage the proliferated tissue while retaining normal cells around the nerve.

In the prior art, the benign prostatic hyperplasia surgery has the problems of long surgery time, complex operation, great operation difficulty, multiple complications and the like caused by large instrument volume and defects of internal and external arrangement forms of electrodes in an ablation needle.

Disclosure of Invention

In view of the foregoing, the present disclosure is directed to an ablation device and a prostate tissue ablation system, which solve the above-mentioned technical problems in the prior art.

An aspect of the present disclosure provides an ablation device including a head electrode assembly, a needle electrode assembly, and a handle assembly, the head electrode assembly including a head end body and an outer tube that are connected to each other, the head end body being disposed at a distal end of the outer tube, the distal end of the head end body being provided with a head electrode, a needle electrode channel being disposed within the outer tube, the needle electrode assembly being received within the needle electrode channel, the needle electrode assembly including at least one needle electrode, the needle electrode assembly extending from a side of the ablation device based on operation of the handle assembly.

In some embodiments, the end face of the head end main body is an arc face, the head electrode is nested above the end face of the head end main body and is tightly matched with the head end main body, a head electrode channel is further arranged in the head end main body, and a wire of the head electrode passes through the head electrode channel and is connected to the handle assembly.

In some embodiments, a flexible insulating tube is disposed within the needle electrode channel, a first portion of the insulating tube is disposed inside the needle electrode channel, a second portion of the insulating tube extends into and curves within the head end body, and an outlet of the insulating tube is disposed to a side of the head end body.

In some embodiments, a recess is provided on a side of the head end body, a first inner surface of the recess is curved, a second inner surface of the recess is at a predetermined angle to the needle electrode channel, an opening is provided on the second inner surface, and a second portion of the insulating tube is curved along the curve of the first inner surface.

In some embodiments, an endoscope channel is further disposed in the outer tube, the endoscope channel is disposed in parallel with the needle electrode channel, one end of the endoscope channel is connected with an external endoscope, and the other end of the endoscope channel is connected with the opening.

In some embodiments, a needle electrode insulating layer is disposed on the outer side of the needle electrode, a support tube is disposed on the outer side of the proximal end portion of the needle electrode, the proximal end of the support tube is connected to the tail end portion, a support tube insulating layer is disposed on the outer side of the support tube, and a colored insulating layer is further disposed on the outer sides of the needle electrode insulating layer and the support tube insulating layer.

In some embodiments, the handle assembly comprises a housing and an electrical connector, a trigger is arranged on the housing, a limit structure, a fixed block, a power signal wire and an elastic block are arranged in the housing, the fixed block is connected with the trigger, the power signal wire is connected with the electrical connector, the limit structure is connected with the knob, the needle electrode assembly passes through the needle electrode channel and penetrates through the elastic block and is fixed with the fixed block, the tail end of the needle electrode assembly passes through the power signal wire and is connected with the electrical connector, and the electrical connector is connected with an external energy supply device.

In some embodiments, the knob is limited in rotation by the limit structure, the knob setting a safety margin adjustment gear and a plurality of extension adjustment gears.

In some embodiments, the handle assembly is assembled with the head electrode assembly by a quick-fit structure while being fixedly connected with an external sheath device.

Another aspect of the present disclosure provides a prostate tissue ablation system comprising an ablation device, a sheath device, an endoscope, and an energy supply device, the ablation device being any one of the ablation devices described above.

The embodiment of the disclosure can realize the access through the natural orifice urethra and the operation under the visual condition, and adopts the interventional operation of the irreversible electroporation steep pulse electric field with tissue selectivity, thereby greatly improving the operation efficiency and the operation safety and effectiveness.

The foregoing objects, features and advantages of the disclosure will be more readily apparent from the following detailed description of the preferred embodiments taken in conjunction with the accompanying drawings.

Drawings

In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. The same reference numerals with letter suffixes or different letter suffixes may represent different instances of similar components. The accompanying drawings illustrate various embodiments by way of example in general and not by way of limitation, and together with the description and claims serve to explain the disclosed embodiments. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive of the present apparatus or method. The accompanying drawings, which are included to provide a further understanding of the disclosure, illustrate and explain the present disclosure, and together with the description serve to explain the present disclosure. In the drawings:

FIG. 1 is a schematic illustration of the structure of an ablation device in an embodiment of the disclosure;

FIG. 2 is a cross-sectional view of an ablation device in an embodiment of the disclosure;

FIG. 3 is a schematic structural view of a head electrode assembly in an ablation device in an embodiment of the disclosure;

FIG. 4 is a schematic illustration of the placement of a head electrode and a needle electrode in an ablation device in an embodiment of the disclosure;

FIG. 5 is a schematic illustration of one of the structures of a needle electrode assembly in an ablation device in an embodiment of the disclosure;

FIG. 6 is a schematic illustration of a needle electrode assembly in an ablation device in accordance with an embodiment of the disclosure;

FIG. 7 is a schematic illustration of a needle electrode assembly in an ablation device in accordance with an embodiment of the disclosure;

FIG. 8 is a schematic structural view of a handle assembly in an ablation device in an embodiment of the disclosure;

FIG. 9 is a schematic illustration of the connection of electrical connectors of a handle assembly in an ablation device in an embodiment of the disclosure;

FIG. 10 is a schematic view of a trigger of a handle assembly in an ablation device in an embodiment of the disclosure;

FIG. 11 is a schematic illustration of the connection of a handle assembly to a needle electrode assembly in an ablation device in accordance with an embodiment of the disclosure;

FIG. 12 is a schematic illustration of the operation of an ablation device in an embodiment of the disclosure;

fig. 13 is a second schematic illustration of the operation of an ablation device in an embodiment of the disclosure.

Reference numerals:

1-head electrode assembly, 11-head electrode, 12-head end main body, 13-insulating tube, 14-needle electrode channel, 15-endoscope channel, 17-outer tube, 18-recess, 18 a-first inner surface, 18 b-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-limit structure, 33-housing, 34-fixed block, 35-knob, 36-quick-fit structure, 37-latch, 38-power signal wire, 39-electrical connector, 310-elastic block, 311-transparent block, 41-prostatic epithelial tissue, 42-prostatic hyperplasia site.

Detailed Description

Specific embodiments of the disclosure are described in detail below with reference to the drawings, but are not limiting of the disclosure.

It should be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be taken as limiting, but merely as exemplification of the embodiments. Other modifications within the scope and spirit of this disclosure will occur to persons of ordinary skill in the art.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above and the detailed description of the embodiments given below, serve to explain the principles of the disclosure.

These and other characteristics of the present disclosure will become apparent from the following description of a preferred form of embodiment, given as a non-limiting example, with reference to the accompanying drawings.

It should also be understood that, although the present disclosure has been described with reference to some specific examples, a person skilled in the art will certainly be able to achieve many other equivalent forms of the present disclosure, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

The above and other aspects, features and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings.

Specific embodiments of the present disclosure will be described hereinafter with reference to the drawings, however, it should be understood that the disclosed embodiments are merely examples of the disclosure, which may be embodied in various ways. Well-known and/or repeated functions and constructions are not described in detail to avoid obscuring the disclosure in unnecessary or unnecessary detail. Therefore, specific structural and functional details disclosed herein are not intended to be limiting, but merely serve as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

It should be noted that the terms "first," "second," and the like in the description and claims of the present disclosure and in the foregoing figures are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate such that the embodiments of the disclosure described herein may be capable of operation in sequences other than those illustrated or described herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.

The specification may use the word "in one embodiment," "in another embodiment," "in yet another embodiment," or "in other embodiments," which may each refer to one or more of the same or different embodiments in accordance with the disclosure.

A first embodiment of the present disclosure provides an ablation device for use in a prostate tissue ablation system that achieves ablation through the natural orifice urethra. The prostate tissue ablation system herein includes an ablation device, an outer sheath device, an endoscope, and an energizing device.

As shown in fig. 1-13, the ablation device comprises a head electrode assembly 1, a needle electrode assembly 2 and a handle assembly 3, wherein the position of the head electrode assembly 1 relative to the handle assembly 3 is relatively fixed, the head electrode assembly 2 can move along 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, and thus, the head electrode assembly 1 and the needle electrode assembly 2 can realize energy emission at two different positions to cooperatively realize ablation operation at a preset position, and in particular, can emit steep pulse energy through the head electrode assembly 1 and the needle electrode assembly 2 to selectively perform irreversible electroporation operation on focal tissues.

In particular, the head electrode assembly 1 and the needle electrode assembly 2 can jointly enter through a natural cavity or urethra, wherein the head electrode assembly 1 can be placed at a preset position in the natural cavity through the movement of the ablation device to emit energy, the needle electrode assembly 2 can continue to move and extend out of the ablation device to puncture the natural cavity under the operation of the handle assembly 3, and finally move to a focus area to emit energy, and the handle assembly 3 can control the pushing or withdrawing of the needle electrode assembly 2 relative to the ablation device.

Further, the head electrode assembly 1 includes a head end body 12 and an outer tube 17 connected to each other, wherein the head end body 12 is disposed at a distal end of the outer tube 17, and the head electrode 11 is disposed at a distal end of the head end body 12. The head electrode 11 is made of copper, gold, or the like. Specifically, the area of the head electrode 11 for emitting energy has a partial size of (1-2 mm) ×3-4 mm.

The end face of the head end main body 12 in the head electrode assembly 1 is a smooth arc face, and the head electrode 11 is nested above the end face of the head end main body 12 and is tightly matched with the head end main body 12. To ensure operational safety, the edges of the head electrode 11 are rounded to match the end face of the head end body 12.

In order to achieve the ablation of the head electrode 11, a head electrode channel is further provided in the head end body 12, through which a wire adapted for the head electrode 11 passes and is connected to the handle assembly 3, wherein the head electrode 11 is welded to one end of the wire, the other end of the wire being routed along the head electrode channel in the head end body 12 and the outer tube 17 into the handle assembly 3.

Further, a needle electrode channel 14 is provided in the outer tube 17, the needle electrode channel 14 is a built-in cavity channel, such as a stainless steel tube, for accommodating the needle electrode assembly 2, wherein the needle electrode assembly 2 can be accommodated in the needle electrode channel 14 of the head electrode assembly 1, can move together with the head electrode assembly 1 and can protrude from the side of the head electrode assembly 1 when energy emission is required for ablation.

The needle electrode assembly 2 here comprises at least one needle electrode 21, wherein the needle electrode 21 has a single needle diameter of <0.5mm and a length of 4-8mm for transmitting energy, and the needle electrode 21 is made of a memory alloy, such as nickel titanium, etc.

Specifically, a flexible insulating tube 13 is disposed in the needle electrode channel 14, where the outer diameter of the insulating tube 13 is smaller than the inner diameter of the needle electrode channel 14, and a first portion of the insulating tube 13 is disposed inside the needle electrode channel 14, a second portion of the insulating tube 13 extends into the head end body 12 and is bent inside the head end body 12, and an outlet of the insulating tube 13 is disposed at a side surface of the head end body 12.

Further, the head end main body 12 is of a semi-hollow structure, specifically, a concave portion 18 is provided on a side surface of the head end main body 12, a first inner surface 18a of the concave portion 18 is arc-shaped, a second inner surface 18b of the concave portion 18 forms a predetermined angle with the needle electrode channel 14, preferably, the second inner surface 18b may be perpendicular to the direction of the needle electrode channel 14, and an opening 19 is provided on the second inner surface 18b of the concave portion 18.

Specifically, the needle electrode channel 14 is disposed outside of the first portion of the insulating tube 13, and the second portion of the insulating tube 13 is bent within the head end body 12, preferably, the second portion of the insulating tube 13 is bent along an arc shape 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 protrusion of the needle electrode assembly 2 from the outlet of the insulating tube 13 located on the side of the head end body 12.

In addition, an endoscope channel 15 is provided in the outer tube 17, the endoscope channel 15 is disposed in parallel with 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, so that the endoscope can be extended from the opening 19 through the endoscope channel 15 and extended out of the ablation device through the recess 18, thereby facilitating the operation of cooperating with the endoscope during the ablation.

Further, a needle electrode insulating layer 22 is provided on the outer side of the needle electrode 21, a support tube 24 is provided on the outer side of the proximal end portion of the needle electrode 21, the proximal end of the support tube 24 is connected to the tail end portion 25, and a support tube insulating layer 26 is provided on the outer side of the support tube 24. Further, the outer sides of the needle electrode insulating layer 22 and the support tube insulating layer 26 are also provided with a colored insulating layer 23.

In this embodiment, the outer side of the needle electrode 21 in the needle electrode assembly 2 is covered with at least two insulation layers, wherein the needle electrode insulation layer 22 is attached to the outer surface of the needle electrode 21, the colored insulation layer 23 is covered on the outer side of the needle electrode insulation layer 22, and similarly, the outer side of the support tube 24 is covered with at least two insulation layers, the support tube insulation layer 26 is attached to the outer surface of the support tube 24, and the colored insulation layer 23 is covered on the outer side of the support tube insulation layer 26.

Further, considering that the needle electrode assembly 2 can extend out of the ablation device and penetrate into a lesion, for this purpose, the needle electrode 21 is provided with a penetration depth mark so as to be capable of observing the penetration depth of tissue, thereby improving the ablation accuracy of surgery, and the endoscope is accurately positioned under the matched visual working condition, for example, the needle electrode 21 is provided with depth indication marks of 1-5mm each segment and with alternate depths.

The present embodiment can perform both functions of ablation and measurement by both the head electrode assembly 1 and the needle electrode assembly 2. Wherein the head electrode 11 and the needle electrode 21 are disposed with opposite polarities (e.g., positive electrode and negative electrode) in the present embodiment, when used for pulse ablation, the needle electrode assembly 2 and the double electrode in the head electrode assembly 1 are simultaneously placed in the natural orifice urethra, and a loop is formed between the head electrode 11 and the needle electrode 21 near the lesion area, thereby concentrating energy in the lesion area. Wherein the head electrode 11 and the needle electrode 21 respectively emit energy such that an output voltage between the two electrodes is 500-5000V, preferably 1000-2600V, so that pulse ablation is achieved by forming a high voltage between the two electrodes.

Furthermore, when the ablation is performed by the ablation device, especially after the needle electrode 21 protrudes from the side of the head end main body 12 by a certain distance, a distance L is preferably provided between the head electrode 11 and the needle electrode 21, where the distance L is preferably 5-25mm, in order to accommodate different voltage requirements and safety considerations of pulse ablation.

In addition, the head electrode assembly 1 and the needle electrode assembly 2 in the present embodiment cooperate with each other to achieve a measurement function, specifically, after the head electrode 11 and the needle electrode assembly 2 in the head electrode assembly 1 are connected to an external power supply device, the ablation device is introduced into the vicinity of benign prostatic hyperplasia through the urethra, and the needle electrode assembly 2 passes through the prostatic epithelium 41 to reach the prostatic hyperplasia site 42 to achieve a measurement.

Specifically, the steep pulse energy generated by the energizing means flows through the needle electrode assembly 2 and through the prostate tissue, and by means of the physiological saline circulating in the urethra, the steep pulse energy flows back to the energizing means through the head electrode 11, thereby forming a working circuit. The needle electrode 21 and the head electrode 11 respectively form a steep pulse energy field, the steep pulse energy field selectively causes irreversible electroporation to tissue cells, and the tissue at the proliferation part is ablated, and a specific working principle loop diagram is shown in fig. 13.

The state of the positions of the head electrode 11 and the needle electrode 21 and the state of tissue change after releasing energy can be judged by different impedance signals fed back by the head electrode 11 and the needle electrode 21 so as to realize measurement, wherein the states can be a plurality of states such as when the ablation device enters a natural cavity and the needle electrode 21 punctures the natural cavity to enter the tissue, the needle electrode 21 completely enters the tissue, and the state after releasing pulse energy.

The ablation mode of the embodiment of the disclosure adopts the mode that the electrode structure enters the body through the urethra of the natural cavity, and particularly the needle electrode is penetrated to reach the focus position for ablation, so that the operation wound can be reduced and the bleeding can be reduced. Specifically, the double electrodes in the needle electrode assembly and the head electrode assembly are simultaneously placed in the natural cavity meatus urethra, an energy loop is formed between the two electrodes near the focus area, and energy is concentrated in focus tissues, so that the ablation effect is good, current flowing through other tissues, nerves and the like is reduced, and the stimulation to a patient is reduced.

Further, the handle assembly 3 in this embodiment can realize 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 disposed on the housing 33, a limit structure 32, a fixing block 34, a power signal wire 38 and an elastic block 310 are disposed in the housing 33, the fixing block 34 is connected with the trigger 31, the power signal wire 38 is connected with the electrical connector 39, and the limit structure 32 is connected with a knob 35. In addition, a lock catch 37 is further disposed in the housing 33, and a transparent block 311 is disposed on the housing 33.

In this embodiment, the needle electrode assembly 2 is adhesively fixed to the fixing block 34 in the handle assembly 3 through the needle electrode channel 14 in the head electrode assembly 1 and through the elastic block 310 in the handle assembly 3, and 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.

Further, when the trigger 31 in the handle assembly 3 works, the fixing block 34 is driven to move, so that the needle electrode 21 is pushed out by a corresponding length, for example, at least the needle electrode 21 can be pushed out to move by 0-15 mm. In addition, the transparent block 311 of the housing 33 can realize a visual scale, and the position of the fixed block 34 can be observed to judge the push-out length of the needle electrode 21.

Further, the knob 35 is limited to rotate by the limiting structure 32, specifically, the knob 35 is provided with a safety margin adjusting gear, so that the length of the needle electrode assembly 2 extending out of the ablation device can be limited, and the needle electrode assembly 2 is prevented from puncturing other tissues due to misoperation, the risk of puncturing an adventitia is avoided, and the safety of the system is further improved.

In addition to the safety margin adjustment gear, the knob 35 in the handle assembly 3 includes three extended length adjustment gears. In a specific embodiment, the gear is adjusted by setting the safety margin so that the extension length of the needle electrode 21 is less than or equal to 15mm, and the three gears are set so that the extension length of the needle electrode 21 is 0mm, 10mm, 15mm, respectively. The embodiment of the disclosure can realize the minimally invasive interventional operation of the urethra through the natural cavity and can realize the controllable ablation operation of ablation depth adjustment, ablation position selection and safety boundary selection.

In addition, the handle assembly 3 is assembled with the head electrode assembly 1 through the quick-assembly structure 36, and is fixedly connected with an external sheath device, wherein at least one channel and at least two through holes are arranged in the sheath device, and the length direction of the channel is consistent with the extending direction of the head electrode assembly 1 in the ablation device. In particular, one of the through holes is a fluid outlet and one or more is a fluid inlet, so that a fluid inlet and outlet circulation can be formed. The external endoscope is fixed by the lock catch 37 in the handle assembly 3, and the ablation device, the outer sheath device and the endoscope are integrally and jointly led into the natural cavity urethra to work after being fixed.

In the ablation device of the disclosed embodiment, the housing 33 of the handle assembly 3 is designed in an ergonomic manner, so that the handle assembly is easy to hold, and the trigger 31 and the limit structure 32 are easy to operate and use, so that the operation requirement of a narrow space of the urethra is met.

When the embodiment is adopted, the head electrode assembly is matched with the needle electrode assembly, the tissue through which the current loop flows is less under the normal working condition, so that energy is concentrated near a focus, the stimulation to a human body is less, the rapidity and the stability of an ablation process are improved, in addition, the head electrode assembly is matched with the needle electrode assembly, the measurement function can be provided at the same time, and a reference can be provided for the operation evaluation of an operator.

The embodiment of the disclosure can realize the access through the natural orifice urethra and the operation under the visual condition, and adopts the interventional operation of the irreversible electroporation steep pulse electric field with tissue selectivity, thereby greatly improving the operation efficiency and the operation safety and effectiveness.

The second embodiment of the present disclosure differs from the first embodiment described above mainly in the structure of the head electrode assembly 1, as shown in fig. 13, and the rest of the related description is identical to that in the first embodiment described above. In this embodiment, the needle electrode assembly 2 includes a plurality of the needle electrodes 21, and energy flows from the energy supply device 5 to a plurality of the needle electrodes 21 so as to act on the prostatic hyperplasia part 42, physiological saline flowing through tissues and urethra flows back from the head electrode assembly 1 to the device, the steep pulse energy fields generated by the needle electrodes 21 and the head electrodes 11 selectively cause irreversible electroporation on tissue cells, and ablation is performed on tissue at the hyperplasia part, so that the double-needle or multi-needle device has larger ablation coverage area during operation, and surgical operation can be reduced aiming at lesions with larger area.

Further, a plurality of needle electrode channels are provided in the head end main body 12, and because the distance between the electrodes is too short, there is a problem that electric spark is generated, the distance D between the adjacent needle electrodes 21 is not less than 3.5mm.

The embodiment of the disclosure can realize the access through the natural orifice urethra and the operation under the visual condition, and adopts the interventional operation of the irreversible electroporation steep pulse electric field with tissue selectivity, thereby greatly improving the operation efficiency and the operation safety and effectiveness.

A third embodiment of the present disclosure provides a prostate tissue ablation system in which the ablation device referred to above is used to ablate prostate tissue via the natural orifice urethra. The prostate tissue ablation system herein includes an ablation device, an outer sheath device, an endoscope, and an energizing device. The ablation device, the sheath device and the endoscope can be quickly and fixedly connected to form a whole. The embodiment can provide stable fluid circulation and stable operation environment, and simultaneously facilitates the length of the natural orifice urethra to be moved into, thereby realizing ablation operation at different positions.

The ablation device, the sheath device and the endoscope are fixed, the ablation range is enlarged, the ablation efficiency is improved, the energy loss is reduced, the peripheral nerve and blood vessel injury is reduced, meanwhile, the pulse ablation needle provides an ablation measurement function, and the safety and the effectiveness of the operation are further improved in tissue selectivity superior to that of the traditional energy.

The embodiment of the disclosure can realize the access through the natural orifice urethra and the operation under the visual condition, and adopts the interventional operation of the irreversible electroporation steep pulse electric field with tissue selectivity, thereby greatly improving the operation efficiency and the operation safety and effectiveness.

Furthermore, the features of the embodiments shown in the drawings of the application or of the various embodiments mentioned in the description are not necessarily to be understood as separate embodiments from each other. Rather, each feature described in one example of one embodiment may be combined with one or more other desired features from other embodiments, resulting in other embodiments not described in text or with reference to the drawings.

The foregoing embodiments are merely illustrative of the technical solutions of the present application, and not restrictive, and although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those skilled in the art that modifications may still be made to the technical solutions described in the foregoing embodiments or equivalent substitutions of some technical features thereof, and that such modifications or substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims (10)

1. An ablation device comprising a head electrode assembly, a needle electrode assembly and a handle assembly, wherein the head electrode assembly comprises a head end body and an outer tube which are connected with each other, the head end body is arranged at the distal end of the outer tube, the head electrode is arranged at the distal end of the head end body, a needle electrode channel is arranged in the outer tube, the needle electrode assembly is accommodated in the needle electrode channel, the needle electrode assembly comprises at least one needle electrode, and the needle electrode assembly extends out of the side face 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 arcuate surface, the head electrode is nested over the end face of the head end body and is in close fit with the head end body, a head electrode channel is further provided in the head end body, and a wire of the head electrode passes through the head electrode channel and is connected to the handle assembly.

3. The ablation device of claim 1, wherein a flexible insulating tube is disposed within the needle electrode passageway, a first portion of the insulating tube being disposed inside the needle electrode passageway, a second portion of the insulating tube extending into and curving within the head end body, and an outlet of the insulating tube being disposed laterally of the head end body.

4. The ablation device of claim 3, wherein a recess is provided in a side of the head end body, a first inner surface of the recess being arcuate, a second inner surface of the recess being at a predetermined angle to the needle electrode passageway, an opening being provided in the second inner surface, and the second portion of the insulating tube being curved along the arcuate shape of the first inner surface.

5. The ablation device of claim 4, wherein an endoscope channel is further disposed within the outer tube, the endoscope channel being disposed parallel to the needle electrode channel, one end of the endoscope channel being connected to an external endoscope, the other end of the endoscope channel being connected to the opening.

6. The ablation device of claim 1, wherein a needle electrode insulation layer is disposed on an outer side of the needle electrode, a support tube is disposed on an outer side of a proximal portion of the needle electrode, a proximal end of the support tube is connected to a tail end portion, a support tube insulation layer is disposed on an outer side of the support tube, and colored insulation layers are further disposed on outer sides of the needle electrode insulation layer and the support tube insulation layer.

7. The ablation device of claim 6, wherein the handle assembly comprises a housing and an electrical connector, wherein a trigger is disposed on the housing, a limit structure, a fixed block, a power signal wire and an elastic block are disposed in the housing, the fixed block is connected with the trigger, the power signal wire is connected with the electrical connector, the limit structure is connected with the knob, the needle electrode assembly passes through the needle electrode channel and passes through the elastic block and is fixed with the fixed block, the tail end of the needle electrode assembly is connected with the electrical connector by the power signal wire, and the electrical connector is connected with an external power supply device.

8. The ablation device of claim 7, wherein the knob is limited in rotation by the limit structure, the knob providing a safety margin adjustment gear and a plurality of extension adjustment gears.

9. The ablation device of claim 1, wherein the handle assembly is assembled with the head electrode assembly by a quick-fit structure while fixedly attached to an external sheath device.

10. A prostate tissue ablation system comprising an ablation device, a sheath device, an endoscope, and an energy supply device, the ablation device being the ablation device of any one of claims 1-9.