Pulse ablation device

Abstract

The pulse ablation device comprises a catheter, an ablation needle and a bag body, a first channel and a second channel are arranged in the catheter, and the ablation needle is arranged in the first channel in a penetrating mode and can stretch out of a needle outlet of the first channel to conduct pulse ablation. The balloon body is connected to the outer surface of the catheter and communicated with the second channel, the second channel is used for filling or discharging a filling medium to enable the balloon body to expand or contract, and the balloon body is used for abutting against biological tissue to position the catheter after being filled and expanded. According to the pulse ablation device, the catheter is positioned through the bag body, operation time can be effectively shortened, and pain of a patient is relieved.

Description

Technical Field

[0001] The utility model relates to the field of medical devices, and in particular to a pulse ablation device. Background Art

[0002] Benign prostatic hyperplasia is one of the common diseases in elderly men, which seriously affects the health status and quality of life of patients. Although prostatectomy is still regarded as the standard surgical procedure for the treatment of benign prostatic hyperplasia, with the continuous improvement of medical level, minimally invasive treatment methods for benign prostatic hyperplasia have made continuous breakthroughs. Minimally invasive treatment has better perioperative outcomes while maintaining the same efficacy. However, existing minimally invasive treatments often require the use of cystoscopy, which is not only troublesome but also increases the pain of patients. Utility Model Content

[0003] The embodiment of the utility model provides a pulse ablation device, which can effectively shorten the operation time and alleviate the pain of the patient.

[0004] An embodiment of the utility model provides a pulse ablation device, including a catheter, an ablation needle and a capsule, wherein a first channel and a second channel are provided in the catheter, the ablation needle is inserted into the first channel and can be extended from the needle outlet of the first channel to perform pulse ablation, the capsule is connected to the outer surface of the catheter and communicates with the second channel, the second channel is used to fill or discharge a filling medium to expand or contract the capsule, wherein the filled and expanded capsule is used to abut against biological tissue to position the catheter.

[0005] The pulse ablation device of the utility model positions the catheter by clamping biological tissue (such as the bladder neck) through the expansion of the capsule without the need for a cystoscope, thereby effectively shortening the operation time and alleviating the pain of the patient.

[0006] In a feasible solution, the needle exit port is adjacent to the first end of the catheter for entering biological tissue and is disposed on the circumferential side wall of the catheter; the capsule is located between the first end of the catheter and the needle exit port. Designing the needle exit port on the circumferential side wall of the catheter and adjacent to the first end of the catheter for entering biological tissue facilitates smooth entry of the ablation needle into the target tissue.

[0007] In a feasible solution, the pulse ablation device further includes a guide tube, the guide tube includes a straight section located in the first channel and a bent section located in the needle outlet of the first channel, the straight section and the bent section transition in an arc shape; the ablation needle is inserted into the guide tube. The guide tube can provide guidance for the ablation needle, so that the ablation needle can smoothly pass through the side wall of the catheter and form a certain angle with the side wall of the catheter, so that the ablation needle can smoothly enter the target tissue.

[0008] In a feasible solution, the pulse ablation device further includes an inner liner tube, which is received in the first channel and connected to the straight section of the guide tube, and the ablation needle is inserted through the inner liner tube. The inner liner tube can provide a smooth passage for the ablation needle to advance and retreat in the first channel. In addition, the inner liner tube also has a certain pressure resistance performance, which can provide further safety protection for the catheter.

[0009] In a feasible solution, the catheter is further provided with a third channel for discharging liquid in biological tissue, and the liquid inlet of the third channel is located between the first end of the catheter for entering biological tissue and the capsule. The third channel can be used to timely discharge excess urine produced by the patient during the operation to avoid affecting the ablation operation.

[0010] In a feasible solution, a first branch pipe, a second branch pipe and a third branch pipe are provided at a second end of the conduit axially opposite to the first end, the first channel is connected to the first branch pipe, the second channel is connected to the second branch pipe, and the third channel is connected to the third branch pipe. Each channel is connected to an external pipeline through a corresponding branch pipe, which is easy to assemble.

[0011] In a feasible solution, the pulse ablation device further includes a handle assembly, the handle assembly includes a fixed portion and a push-pull portion slidably connected to the fixed portion, the fixed portion is connected to the needle entrance of the first channel, and the push-pull portion is connected to the ablation needle. The ablation needle can be advanced and retreated by pushing and pulling the push-pull portion relative to the fixed portion, which is easy to operate.

[0012] In a feasible solution, the fixing portion includes a connecting section for connecting to the needle entrance of the first channel, the connecting section includes a plurality of positioning clamps arranged at intervals along the axial direction, each positioning clamp gradually tapers toward the end of the connecting section, and the maximum outer diameter of the positioning clamp is greater than the diameter of the first channel. In this way, the handle assembly can be locked and fixed to the first channel of the catheter.

[0013] In a feasible solution, the push-pull part is provided with a plurality of grooves arranged at intervals along the axial direction, which are used to limit the push-pull part. After the push-pull part moves the ablation needle to the target position, an external clamping mechanism can be used to clamp the corresponding groove on the push-pull part, thereby limiting the push-pull part and preventing the ablation needle from shifting.

[0014] In a feasible solution, the fixing part includes a first finger ring, the push-pull part includes a second finger ring, and the first finger ring and the second finger ring can be operated with one hand. The number of the first finger ring can be one or more. During the operation, the index finger and / or the middle finger can be inserted into the first finger ring, the thumb can be inserted into the second finger ring, and then the ablation needle can be pushed with the thumb, which is convenient for one-handed operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0016] Figure 1 This is a schematic diagram of the overall structure of a pulse ablation device according to an embodiment of the utility model;

[0017] Figure 2 for Figure 1 An exploded view of the pulse ablation device shown;

[0018] Figure 3 for Figure 1 A partial cross-sectional view of the pulse ablation device shown;

[0019] Figure 4 for Figure 2 A schematic diagram of an ablation component of the pulse ablation device shown;

[0020] Figure 5 for Figure 2 An exploded view of the handle assembly of the pulse ablation device is shown. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solution and advantages of the embodiment of the utility model clearer, the technical solution in the embodiment of the utility model will be clearly and completely described below in conjunction with the drawings in the embodiment of the utility model. Obviously, the described embodiment is a part of the embodiment of the utility model, not all of the embodiments. Based on the embodiment of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0022] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0023] In the present utility model, unless otherwise clearly stipulated and limited, the terms such as "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly limited. For ordinary technicians in this field, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances. The technical solution of the present utility model is described in detail with specific embodiments below. The following specific embodiments can be combined with each other, and the same or similar concepts or processes may not be repeated in some embodiments.

[0024] refer to Figures 1 to 3 The pulse ablation device of one embodiment of the utility model comprises a catheter 100, an ablation component 200, a capsule 300 and a handle component 400. The catheter 100 is provided with a first channel 110 and a second channel 120. The ablation component 200 comprises an ablation needle 210, which is passed through the first channel 110 and can be extended from the first channel 110 for pulse ablation. The capsule 300 is connected to the outer surface of the catheter 100 and communicated with the second channel 120, and is preferably made of a silicone material with good biocompatibility. The second channel 120 is used to fill or discharge a filling medium to expand or contract the capsule 300. The filling medium can be gas or liquid, and this embodiment will be described by taking gas as an example. The handle component 400 is connected to the ablation needle 210 and is used to manipulate the ablation needle 210 to move forward or backward.

[0025] When in use, the catheter 100 can be first delivered into the body (e.g., delivered into the bladder through the urethra) with the balloon 300 contracted, and then the balloon 300 is filled with a filling medium to expand it, and then the catheter 100 is withdrawn for a distance until the expanded balloon 300 and the physiological structure of the human body (e.g., the bladder neck) are limited due to the size difference, thereby positioning the catheter 100. After that, the ablation needle 210 can be manipulated by the handle assembly 400 to extend from the first channel 110 and penetrate the target tissue for pulse ablation.

[0026] The pulse ablation device of this embodiment positions the catheter 100 by expanding the capsule 300 to clamp the biological tissue (such as the bladder neck) without the need for a cystoscope, which effectively shortens the operation time and relieves the patient's pain. In addition, compared with transurethral microwave therapy (TUMT), since pulsed non-thermal energy ablation is used, the risk of postoperative complications is low, which can further relieve the patient's pain; and pulsed ablation is mainly affected by pulse voltage, pulse width, action time, and electrode size, and these influencing factors are more controllable; furthermore, pulsed ablation does not require a water cooling circulation system, so its manufacturing cost is much lower than microwave ablation.

[0027] Preferably, the catheter 100 is further provided with a third channel 130 for timely draining excess urine produced by the patient during the operation to avoid affecting the ablation operation.

[0028] Specifically, in this embodiment, the catheter 100 includes an axially opposite first end 101, a second end 102, and a main body section 103 extending axially between the first end 101 and the second end 102, and the catheter 100 is suitable for at least partially inserting its main body section 103 into a biological body via its first end 101.

[0029] Since the catheter 100 of this embodiment needs to be inserted through the urethra, the main body section 103 of the catheter 100 is preferably made of a biocompatible material, and the material should not be too hard to avoid damage to the urethra. In addition, the material of the main body section 103 of the catheter 100 should also have a certain pressure resistance performance, and should not be broken down under the high voltage (possibly several thousand volts) that can achieve the ablation effect, so as to avoid danger. Optionally, the material of the main body section 103 of the catheter 100 is selected from medical silicone, medical block polyether amide resin (PEBAX), etc.

[0030] Preferably, the first end 101 has an arc-shaped outer surface, for example, a hemispherical shape, so that the catheter 100 can be smoothly inserted into the urethra without scratching the urethra. Also preferably, the first end 101 is made of a material with good hydrophilicity (such as silica gel) so that its surface is lubricated after contact with water and can be smoothly inserted into the urethra.

[0031] Preferably, the second end 102 adopts a multi-branch design so that other components (such as the handle assembly 400) can be connected / communicated with each channel 110 / 120 / 130 in the catheter 100. In this embodiment, the second end 102 of the catheter 100 includes a first branch 140, a second branch 150, and a third branch 160 connected to the main body section 103, the first channel 110 is connected to the first branch 140, the second channel 120 is connected to the second branch 150, and the third channel 130 is connected to the third branch 160.

[0032] In this embodiment, the first channel 110 includes a first section 111 extending along the axial direction of the main section 103 of the catheter 100, and the first channel 110 has a needle entry port 112 and a needle exit port 113 at both ends. The needle entry port 112 and the needle exit port 113 are connected at both ends of the first section 111. The needle entry port 112 is formed in the first branch tube 140 and is inclined relative to the first section 111. The first section 111 and the needle exit port 113 are both formed in the circumferential side wall of the main section 103, and the needle exit port 113 is inclined relative to the first section 111. Preferably, the needle exit port 113 is adjacent to the first end 101 of the catheter 100, which is conducive to the ablation needle 210 passing through the needle exit port 113 and entering the target tissue smoothly. The capsule 300 is preferably located between the first end 101 of the catheter 100 and the needle exit port 113 to avoid affecting the exit of the ablation needle 210.

[0033] The second channel 120 includes a second section 121 extending along the axial direction of the main section 103 of the catheter 100, and an air inlet 122 and an air outlet 123 respectively connected to both ends of the second section 121. The air inlet 122 is formed in the second branch pipe 150 and is inclined relative to the second section 121. The second section 121 and the air outlet 123 are both formed in the circumferential side wall of the main section 103, and the air outlet 123 is inclined relative to the second section 121. The air outlet 123 is connected to the sac 300. Preferably, a two-way valve 151 is provided on the second branch pipe 150 to ensure that the sac 300 is filled and not collapsed after the sac 300 is expanded by the filling gas.

[0034] The third channel 130 includes a third section 131 extending axially along the main section 103 of the catheter 100, and a liquid inlet 132 and a liquid outlet 133 respectively connected to both ends of the third section 131. The third section 131 extends along the central axis of the main section 103, wherein the first section 111 and the second section 121 are respectively located on the circumference of the third section 131. The liquid inlet 132 is preferably located between the first end 101 of the catheter 100 and the gas outlet 123, and therefore also located between the first end 101 of the catheter 100 and the capsule 300, so as to prevent the capsule 300 from affecting the smooth discharge of urine, which is conducive to the capsule 300 being able to discharge urine while being positioned. It is also preferred that the liquid inlet 132 penetrates the main section 103 in the radial direction, so that urine can enter the third channel 130 from both sides of the main section 103, which is conducive to urination. The liquid outlet 133 is formed in the third branch pipe 150 and is axially connected to the third section 131 .

[0035] It is understandable that the first channel 110, the second channel 120 and the third channel 130 are shown as examples only. In other embodiments, each channel may adopt other structures / arrangements. For example, the second channel 120 may be designed to extend along the central axis of the main body section 103, and the third channel 130 may be designed to extend within the circumferential side wall of the main body section 103.

[0036] Also refer to Figure 3 and Figure 4 , corresponding to the structure of the first channel 110, in this embodiment, the ablation needle 210 includes a first straight section 211, and a tail section 212 and a puncture section 213 respectively connected to the two ends of the straight section 211. The tail section 212 and the puncture section 213 are also arranged obliquely relative to the first straight section 211. The first straight section 211 is suitable for being received in the first section 111. The tail section 212 is suitable for being received in the needle entry port 112 for connecting the pulse system. The puncture section 213 is suitable for being received in the needle exit port 113. The puncture section 213 is needle-tip-shaped, and is preferably made of a harder material with excellent conductive properties to ensure that it can accurately penetrate into the prostate tissue for ablation. Optionally, the material of the puncture section 213 is selected from stainless steel, silver, etc.

[0037] Since the ablation needle 210 is used as an electrode during the operation, in order to maximize the safety of the operation, the portion of the ablation needle 210 other than the puncture section 213 and the tail section 212, i.e., at least the first straight section 211, is coated with an insulating layer (e.g., Pylaron) or an outer insulating tube (e.g., a polyimide (PI) tube).

[0038] In order to facilitate the ablation needle 210 to smoothly pass through the circumferential side wall of the main section 103 of the catheter 100 and form a certain angle with the side wall of the main section 103 of the catheter 100, preferably, the ablation assembly 200 also includes a guide tube 220 sleeved at the connection between the first straight section 211 of the ablation needle 210 and the puncture section 213. The inner diameter of the guide tube 220 is larger than the diameter of the ablation needle 210, which can avoid strong obstruction when the ablation needle 210 is advanced and retreated. The guide tube 220 can be made of nickel-titanium alloy, stainless steel, etc.

[0039] Specifically, the guide tube 220 includes a second straight section 221 located in the first section 111 of the first channel 110, and a bent section 222 located in the needle outlet 113 of the first channel 110, the second straight section 221 is suitable for being sleeved on the first straight section 211 of the ablation needle 210, and the bent section 222 is suitable for being sleeved on the puncture section 213 of the ablation needle 210. Preferably, the second straight section 221 and the bent section 222 have an arc transition, so that the guide ablation needle 210 can smoothly pass through the needle outlet 113 and enter the target tissue.

[0040] It is also preferred that the ablation assembly 200 further includes an inner lining tube 230. The inner surface of the inner lining tube 230 is lubricated and is accommodated in the first section 111 of the first channel 110. Specifically, the inner lining tube 230 is sleeved on the first straight section 211 of the ablation needle 210 and connected to the second straight section 221 of the guide tube 220. More specifically, the outer diameter of the inner lining tube 230 is smaller than the inner diameter of the guide tube 220 and is embedded in the guide tube 220 to ensure smooth connection between the inner lining tube 230 and the guide tube 220, and also to ensure that the ablation needle 210 can smoothly advance and retreat at the connection between the inner lining tube 230 and the guide tube 220.

[0041] The inner liner tube 230 can provide a smooth passage for the ablation needle 210 to advance and retreat in the first channel 110. In addition, the inner liner tube 230 also has a certain pressure resistance performance, which can provide further safety protection for the catheter 100. The inner liner tube 230 can be made of medical PI tube, medical polyetheretherketone (PEEK) tube, etc.

[0042] When the ablation assembly 200 is assembled, it can enter the second channel 110 from the needle entrance 112 of the first channel 110 until the puncture section 213 of the ablation needle 210 enters the needle exit 113 (but does not exceed the needle exit 113). At this time, the needle exit 113 can be blocked with a coating that is consistent with the material of the catheter 100 to ensure that the needle exit 113 is smooth and burr-free to prevent the urethra from being scratched when the catheter 100 enters the bladder. After the catheter 100 reaches the target position, the ablation needle 210 is pushed forward to pierce the coating and pass through the needle exit 113 for ablation.

[0043] Also refer to Figure 1 , Figure 2 and Figure 5 In this embodiment, the handle assembly 400 includes a fixed portion 410 and a push-pull portion 420 slidably connected to the fixed portion 410. The fixed portion 410 is connected to the first branch tube 140, and the push-pull portion 420 is connected to the ablation needle 210. The ablation needle 210 can be advanced and retreated by pushing and pulling the push-pull portion 420 relative to the fixed portion 410, which is easy to operate.

[0044] Specifically, the fixing portion 410 includes a tube portion 411 and two first finger rings 412 respectively connected to the circumference of the tube portion 411. The tube portion 411 is provided with a through hole 413 penetrating the tube portion 411, and its front end is a connecting section 414 for connecting with the first branch pipe 140. Preferably, the connecting section 414 includes a plurality of positioning brackets 415 arranged at intervals along the axial direction, and each positioning bracket 415 gradually tapers toward the front end of the connecting section 414 (the end close to the catheter 100) (from the end of the tube 411 to the end of the tube 411). Figure 5 The connecting section 414 looks like a barbed pagoda head from a perspective of the first embodiment, and the maximum outer diameter of the positioning clamping platform 415 is larger than the diameter of the needle entrance 112 of the first channel 110. Therefore, the connecting section 414 can be locked and fixed with the needle entrance 112 by interference fit using the shape and size of each positioning clamping platform 415. It can be understood that in other embodiments, the fixing portion 410 can also adopt other structures, for example, the first finger ring 412 can also be one, three or four.

[0045] The push-pull portion 420 includes a rod portion 421 and a second finger ring 422 connected to one side of the rod portion 421. The rod portion 421 is inserted into the through hole 413 of the fixing portion 410 and fixed to the tail section 212 of the ablation needle 210 by mechanical locking, bonding or Luer connector locking. Preferably, the rod portion 431 is provided with a plurality of grooves 423 arranged at intervals along the axial direction, which are used to limit the push-pull portion 420. After the push-pull portion 420 moves the ablation needle 210 to the target position, an external clamping mechanism can be used to clamp the corresponding groove 423 on the push-pull portion 420, thereby limiting the push-pull portion 420 and preventing the ablation needle 210 from shifting.

[0046] During the operation, the index finger and the middle finger of one hand can be inserted into the two first finger rings 412 respectively, and the thumb can be inserted into the second finger ring 422, and then the thumb can be used to push the push-pull part 420 to move the ablation needle 210. The one-handed operation is convenient and quick.

[0047] In the present invention, unless otherwise clearly specified and limited, a first feature being “on” or “under” a second feature may mean that the first feature and the second feature are in direct contact, or the first feature and the second feature are in indirect contact via an intermediate medium.

[0048] Moreover, the first feature being “above”, “above”, and “above” the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being “below”, “below”, and “below” the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0049] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example" or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the utility model. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.

[0050] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the utility model, rather than to limit it. Although the utility model has been described in detail with reference to the aforementioned embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not make the essence of the corresponding technical solution deviate from the scope of the technical solution of the embodiments of the utility model.

Claims

1. A pulse ablation device, characterized in that: The invention comprises a catheter, an ablation needle and a balloon. The catheter is provided with a first channel and a second channel. The ablation needle is inserted into the first channel and can extend from the needle outlet of the first channel to perform pulse ablation. The balloon is connected to the outer surface of the catheter and communicates with the second channel. The second channel is used for filling or discharging a filling medium to expand or contract the balloon. After the balloon is filled and expanded, it is used to abut against biological tissue to position the catheter.

2. The pulse ablation device according to claim 1, characterized in that: The needle outlet is adjacent to the first end of the catheter for entering biological tissue and is arranged on the circumferential side wall of the catheter; the capsule is located between the first end of the catheter and the needle outlet.

3. The pulse ablation device according to claim 1, characterized in that: The pulse ablation device also includes a guide tube, which includes a straight section located in the first channel and a bent section located in the needle outlet of the first channel, and the straight section and the bent section have an arc-shaped transition; the ablation needle is inserted into the guide tube.

4. The pulse ablation device according to claim 3, characterized in that: The pulse ablation device further comprises an inner lining tube, which is received in the first channel and connected to the straight section of the guide tube, and the ablation needle is passed through the inner lining tube.

5. The pulse ablation device according to claim 1, characterized in that: A third channel is also provided in the catheter for discharging liquid in biological tissue. The liquid inlet of the third channel is located between the first end of the catheter for entering biological tissue and the capsule.

6. The pulse ablation device according to claim 5, characterized in that: The second end of the conduit axially opposite to the first end is provided with a first branch pipe, a second branch pipe and a third branch pipe, the first channel is connected to the first branch pipe, the second channel is connected to the second branch pipe, and the third channel is connected to the third branch pipe.

7. The pulse ablation device according to any one of claims 1 to 6, characterized in that: The pulse ablation device also includes a handle assembly, which includes a fixed portion and a push-pull portion slidably connected to the fixed portion, the fixed portion is connected to the needle entrance of the first channel, and the push-pull portion is connected to the ablation needle.

8. The pulse ablation device according to claim 7, characterized in that: The fixing portion includes a connecting section for connecting to the needle entrance of the first channel, and the connecting section includes a plurality of positioning clamps arranged at intervals along the axial direction, each of the positioning clamps gradually tapers toward the end of the connecting section, and the maximum outer diameter of the positioning clamps is greater than the diameter of the first channel.

9. The pulse ablation device according to claim 7, characterized in that: The push-pull portion is provided with a plurality of grooves spaced apart along the axial direction for limiting the push-pull portion.

10. The pulse ablation device according to claim 7, characterized in that: The fixing portion includes a first finger ring, and the push-pull portion includes a second finger ring. The first finger ring and the second finger ring can be operated with one hand.

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