A multi-electrode ablation device for endocrine regulation through the digestive tract

Abstract

The present application relates to the technical field of gastrointestinal ablation, in particular to a multi-electrode ablation device for adjusting endocrine through digestive tract, comprising an elongated catheter body longitudinally extending along a longitudinal axis between a proximal end and a distal end, and a plurality of expandable electrode assemblies are arranged circumferentially on the distal end of the catheter body to adapt to the endodermis of different diameters, so that the electrodes can be well attached to the target position and the ablation effect is ensured.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of gastrointestinal ablation, in particular to a multi-electrode ablation device for adjusting endocrine through digestive tract. BACKGROUND

[0002] The clinical market of medical metabolic endocrine and cardiovascular disease treatment is a treatment scheme for a simple obesity or obesity with cardiovascular risk factors group, which introduces a treatment device into the intestinal target through a gastrointestinal endoscope to perform ablation (the energy selected can be radiofrequency, microwave, electric field ablation, and cryoablation, etc.), so as to destroy and reshape the overgrown intestinal mucosa of the obese patient, reduce the absorption area of the small intestinal mucosa, slow down the peristalsis function of the intestinal tract, block / reduce the absorption of sugar, fat, etc. through the intestinal tract, and achieve the treatment scheme of reducing body weight, improving obesity, reducing blood lipids, blood glucose and other cardiovascular risk factors.

[0003] Endoscopic duodenum-jejunum bypass sleeve implantation is to place a 60cm biological tubular sleeve through a gastroscope in the duodenum and upper jejunum to isolate chyme and duodenal / near segment intestinal mucosa, accelerate the speed of food through the near segment of the small intestine, interfere with the hormone signals related to insulin resistance, and affect the digestion and absorption of food, so as to achieve the purpose of treating obesity and obesity-related complications. The biological tubular sleeve is generally left in the human body for 6-12 months, and then the device needs to be removed through a gastroscope. According to the 2024 China Obesity Digestive Endoscopy Treatment Expert Consensus, the duodenum-jejunum bypass sleeve implantation treatment scheme may cause intestinal ulcers and upper gastrointestinal bleeding due to long-term friction between the device and the intestinal mucosa. At the same time, the device needs to be left in the body for a long period of 6-12 months, which may also be accompanied by related risks such as intraluminal foreign body sensation and other adverse reactions and instrument failure risks.

[0004] According to the search, the patent with the publication number CN106691585B discloses a radiofrequency ablation electrode device, which further comprises a sliding sleeve ring arranged on the intermediate electrode guide wire. The sliding sleeve ring can slide in the axial direction of the intermediate electrode guide wire when the sleeve tube or the intermediate electrode guide wire is pushed and pulled, so as to change the position and shape of the electrode guide wire, adapt to different lumen environments, facilitate entering the lesion site, and adjust the radiofrequency ablation area according to the size of the tumor and the lumen environment, thereby improving the operation effect. It can be seen that the head end of the known pulse ablation electrode catheter mainly adopts a whole flexible electrode arm, which is mostly in the form of single circular arc, basket, flower or cage. However, these forms of electrode catheters generally have the following disadvantages: the net basket can only perform two actions of stretching and completely unfolding under the action of the push rod, and cannot be adjusted according to the inner diameter of the lumen wall when performing segmented ablation, resulting in that the electrode cannot completely adhere to the lumen wall; the electrode arm cannot be well adhered to the target position, and is easily deformed in the body, so multiple ablations are required to achieve good results, thereby prolonging the operation time. SUMMARY

[0005] In order to solve the problem that the electrode arm in the form of the existing net basket cannot be adjusted according to the inner diameter of the cavity, resulting in that the electrode arm cannot be completely attached to the cavity wall when performing segmented ablation, the present application provides a multi-electrode ablation device for adjusting endocrine through the digestive tract, the extension length of the electrode arm is controlled through the winding of the alloy cable, so as to adapt to the inner diameter of the cavity with different inner diameters, so that the electrode can be well attached to the target position, and the ablation effect is guaranteed.

[0006] The present application provides a multi-electrode ablation device for adjusting endocrine through the digestive tract, comprising an elongated catheter body extending longitudinally along a longitudinal axis between a proximal end and a distal end, a plurality of electrode assemblies are circumferentially arranged at the distal end of the catheter body, ablation notches are formed in the outer wall of the catheter body corresponding to the electrode assemblies, and a drive assembly is arranged inside the catheter body for extending the electrode assemblies out of the ablation notches and cutting along the outer wall of the catheter body or retracting the electrode assemblies to block the ablation notches. The electrode assemblies are cut out of the ablation notches and attached to the cavity wall by the drive assembly, and then the electrodes are powered on to ablate the cavity wall tissue, which can adapt to the ablation operation of different cavity inner diameters.

[0007] Further, the electrode assembly comprises an alloy cable and an electrode arm, one end of the alloy cable is fixedly connected with the drive assembly, the other end of the alloy cable is connected with the electrode arm, the electrode arm is fitted with the ablation notch, and a plurality of ablation electrodes are arranged on the electrode arm. After use, the electrode arm can be retracted into the ablation notch, without affecting the placement of the device.

[0008] Further, two alloy cables are connected with each electrode arm, and the two alloy cables are arranged at both ends of the electrode arm, and the alloy cables connected with the electrode arm are wound on the drive assembly. The two alloy cables can smoothly extend the electrode arm and provide a certain supporting force, so that the electrodes on the electrode arm are attached to the cavity wall.

[0009] Further, the alloy cable is made of shape memory alloy. The shape memory alloy has both elasticity and rigidity.

[0010] Further, the drive assembly comprises a center rod and a drive head for driving the center rod to rotate, the center rod is arranged in the catheter body, the alloy cable is wound on the distal end of the center rod, and the drive head is arranged at the proximal end of the center rod. The center rod is driven by the drive head to wind or unwind the alloy cable.

[0011] Further, the drive head comprises a fixed sleeve and a movable sleeve, the fixed sleeve is arranged at the proximal end of the center rod, and the movable sleeve is slidably assembled outside the fixed sleeve through a pin. The fixed sleeve and the movable sleeve are slidably connected through the pin shaft.

[0012] Further, the movable sleeve is symmetrically provided with two pins, and the fixed sleeve is provided with two inclined grooves along the length direction of the fixed sleeve, which are in sliding fit with the pins, so that the movable sleeve drives the central rod to rotate during the sliding of the movable sleeve along the fixed sleeve.

[0013] Further, the distal end of the catheter body is provided with a guide head, the central rod is connected with the guide head through a screw, and the guide head is provided with a through hole in the center for the screw to pass through.

[0014] Further, the electrode arms and the ablation slots are correspondingly provided with three groups, and the ablation electrodes on the three groups of electrode arms are arranged in a spiral manner in the longitudinal direction.

[0015] Further, the electrode arm has an ablation surface and a connecting surface, the ablation electrode is arranged on the ablation surface, and the connecting surface is provided with a temperature sensor.

[0016] The beneficial effects of the present application are:

[0017] (1) The present application provides a multi-electrode ablation device for adjusting endocrine through the digestive tract, which can replace the traditional basket or spring structure that can only be completely expanded and retracted by simultaneously providing elastic and rigid alloy cables for electrode arm winding and unwinding operation, can release a corresponding amount of cable according to the inner diameter of the cavity wall, so that the electrode arm can be completely fitted with the cavity wall, and can lock the alloy cable through the driving head to ensure the stability of ablation.

[0018] (2) The present application provides a multi-electrode ablation device for adjusting endocrine through the digestive tract, when the electrode assembly is retracted into the ablation slot, the outer surface of the electrode arm is flush with the outer surface of the catheter body, that is, the electrode arm has an arc that is completely fitted with the cavity wall, and the three groups of electrode arms can stably place the device in the cavity to improve the ablation effect.

[0019] (3) The present application provides a multi-electrode ablation device for adjusting endocrine through the digestive tract, which can be operated by converting the linear motion of the movable sleeve and the fixed sleeve into the rotary motion of the central rod, and can conveniently wind and unwind the alloy cable without occupying the radial space of the catheter body. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the technical solutions in the specific embodiments of the present application or the prior art, the accompanying drawings needed to be used in the specific embodiments or prior art description will be briefly introduced as follows. Obviously, the accompanying drawings in the following description are some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative effort based on these drawings.

[0021] Figure 1 is a schematic diagram of a retracted state of the electrode arm;

[0022] Figure 2 is a schematic diagram of an extended state of the electrode arm;

[0023] Figure 3 is a schematic diagram of a first angle internal structure of the catheter body;

[0024] Figure 4 is a schematic diagram of a second angle internal structure of the catheter body;

[0025] Figure 5 is a schematic diagram of cooperation of the alloy cable and the center rod;

[0026] Figure 6 is a schematic diagram of the ablation device placed in the intestinal tract;

[0027] Figure 7 is a schematic diagram of a retracted state of the basket-shaped ablation device;

[0028] Figure 8 is a schematic diagram of an extended state of the basket-shaped ablation device;

[0029] Figure 9 is a schematic diagram of cooperation of the basket-shaped ablation device and the guide wire;

[0030] Figure 10 is a schematic diagram of cooperation of the basket-shaped ablation device and the gastroscope to reach the area to be ablated;

[0031] Figure 11 is a schematic diagram of cooperation of the basket-shaped ablation device and the gastroscope to perform the ablation operation;

[0032] Figure 12 is a schematic diagram of the balloon-shaped ablation device;

[0033] Figure 13 is a schematic diagram of cooperation of the balloon-shaped ablation device and the guide wire;

[0034] Fig. 1. catheter body, 11. ablation slot, 12. guide head, 2. electrode assembly, 21. alloy cable, 22. electrode arm, 221. ablation surface, 222. connecting surface, 23. electrode, 24. temperature sensor, 3. drive assembly, 31. center rod, 32. fixed sleeve, 33. movable sleeve, 34. pin, 35. inclined slot, 4. screw, 5. balloon, 6. guide wire, 7. intestinal tract, 8. gastroscope. DETAILED DESCRIPTION

[0035] The technical solutions of the present application will be described clearly and completely below in combination with the drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments.

[0036] In order to adapt to the ablation operation of different inner diameter cavities, a multi-electrode ablation device for adjusting endocrine through the digestive tract is designed, as shown in Figure 1 、 2 and 6, which comprises an elongated catheter body 1 extending longitudinally along a longitudinal axis between a proximal end and a distal end, a plurality of electrode assemblies 2 are arranged circumferentially at the distal end of the catheter body 1, and ablation slots 11 are formed in the outer wall of the catheter body 1 corresponding to the electrode assemblies 2. The catheter body 1 is internally provided with a drive assembly 3 for extending the electrode assemblies 2 out of the ablation slots 11 and cutting along the outer wall of the catheter body 1 or retracting the electrode assemblies 2 to block the ablation slots 11.

[0037] The electrode assemblies 2 can be retracted and extended relative to the catheter body 1. When not ablated, the electrode assemblies 2 are retracted into the catheter body 1, so as to be placed through the cavity structure such as gastroscope or through the guide wire 6. When reaching the ablation site, the electrode assemblies 2 are extended under the action of the drive assembly 3, and the extension degree can also be controlled by the drive assembly 3. In this way, when performing segmented ablation, different inner diameters of the cavity wall can be adapted for use, so that the electrodes 23 can be in full contact with the cavity wall tissue. The material of the electrodes 23 is a metal material with low resistivity, such as gold, platinum, stainless steel, etc. The external control host is directly connected with the multi-electrode ablation device. When the electrodes are in full contact with the tissue, the control host starts the electrodes 23 to release energy for tissue ablation, and the energy is preferably pulse electric field ablation (PFA). The mechanism of radiofrequency ablation technology is mainly thermal effect. When radiofrequency current flows through the tissue in the ablation area, the water molecules in the tissue move at high speed due to the rapid change of electromagnetic field, generating heat, causing cell dehydration and necrosis, thereby achieving the purpose of tissue ablation. The control host starts and stops the electrodes 23 to ablate the target area tissue, which is a mature existing technology, which is described in detail in the patent with publication number CN106691585B, which will not be described here.

[0038] Example one, as shown in Figure 5As shown, the core of the technical solution is that the electrode assembly 2 comprises an alloy cable 21 and an electrode arm 22, one end of the alloy cable 21 is fixedly connected with the driving assembly 3, the other end of the alloy cable 21 is connected with the electrode arm 22, the electrode arm 22 is fitted with the ablation slot 11, and a plurality of electrodes 23 are arranged on the electrode arm 22.

[0039] The alloy cable 21 is made of a shape memory material, such as Nitinol, and has elasticity and rigidity, can support the electrode arm 22 on the cavity wall when extending out of the ablation slot 11, and can be well wound on the center rod 31 after retracting into the catheter body 1 from the ablation slot 11. The structure of the alloy cable 21 can maximize the flushing of the perfusion fluid to the cavity wall, and the electrode arm 22 preferably has no sharp corners or edges, but has round corners and edges (not shown in the figure) so as not to cause mechanical damage to the inner wall of the cavity.

[0040] In order to better fit the electrode arm 22 with the cavity wall, two alloy cables 21 are connected to each electrode arm 22, and the two alloy cables 21 are arranged at both ends of the electrode arm 22, and the alloy cables 21 connected with the electrode arm 22 are arranged on the driving assembly 3. The electrode arm 22 is controlled by the alloy cables 21 connected at both ends thereof, and the stability of extension or retraction is better.

[0041] In order to better place the catheter body 1 into the target cavity, a guide head 12 is arranged at the distal end of the catheter body 1, the center rod 31 is connected with the guide head 12 through a screw 4, the distal end of the center rod 31 is provided with an internal threaded hole matched with the screw 4, and a through hole is arranged in the center of the guide head 12 and can be penetrated by the screw 4. The guide head 12 is in the shape of a circular truncated cone, the diameter of the bottom surface of the guide head 12 is slightly larger than the outer diameter of the catheter body 1, and a small amount of pipe wall tissue can be carried during the placement of the catheter body 1, that is, the pipe wall tissue is prevented from being clamped in the gap between the electrode arm 22 and the ablation slot 11 during the placement process, and the multi-electrode ablation device is conveniently and smoothly sent to the target position. The relative position of the center rod 31 and the guide head 12 is limited by the screw 4, and since the screw 4 directly penetrates the through hole of the guide head 12, the screw 4 limits the center rod while not hindering the rotation of the center rod 31 under the action of the driving head.

[0042] In order to ensure that the ablation device is stably erected at the target position, the electrode arms 22 and the ablation slots 11 are correspondingly provided with three groups, the three groups of electrode arms 22 are evenly distributed along the longitudinal axis of the catheter body 1, have good stability, and the electrodes 23 on the three groups of electrode arms 22 are staggered in a spiral manner in the longitudinal direction, that is, the electrodes 23 are arranged at different positions of the three groups of electrode arms 22, so that the ablation area generated by the electrodes 23 spans one or more open arc segments around the longitudinal axis, so as to make the ablation area wider. In order to ensure the stability of the winding of the three groups of alloy cables 21, that is, to ensure the stable cutting of the electrode arms 22, the three groups of alloy cables 21 are arranged to avoid each other, that is, the alloy cables 21 connected at both ends of the connecting surface 222 of the electrode arm 22 have different spacings, so that the three groups of alloy cables 21 can be directly wound on the center rod 31.

[0043] The electrode arm 22 has an ablation surface 221 and a connecting surface 222, the ablation electrodes 23 are arranged on the ablation surface 221, and the connecting surface 222 is provided with a temperature sensor 24. When the electrode arm 22 is retracted into the catheter body 1, the ablation surface 221 of the electrode arm 22 is flush with the outer surface of the catheter body 1, that is, the ablation surface 221 is arc-shaped, the arc-shaped electrode arm 22 can better adhere to the cavity wall, the arc-shaped electrode arm 22 has better adhesion to the ablation slot 11, and the device can avoid that the pipe wall tissue is clamped in the gap during placement. The plurality of temperature sensors 24 are thermally coupled with the plurality of electrodes 23 to measure the temperature of the electrodes 23.

[0044] As shown in Figure 3 and 4 In order to realize the winding and unwinding of the alloy cable 21 without occupying the radial space of the catheter body 1, the driving assembly 3 includes a center rod 31 and a driving head for driving the center rod 31 to rotate, the center rod 31 is arranged in the catheter body 1, the alloy cable 21 is arranged around the distal end of the center rod 31, and the driving head is arranged at the proximal end of the center rod 31. One end of the alloy cable 21 is fixed on the center rod 31 by welding, a hole position for the end of the alloy cable 21 to extend into the welding is formed in the outer wall of the center rod 31, the other end of the alloy cable 21 is wound, and the center rod 31 is driven to rotate by the driving head, so as to wind and unwind the alloy cable 21.

[0045] The driving head can be selected according to actual needs, and can drive the central rod 31 to rotate. Preferably, the driving head comprises a fixed sleeve 32 and a movable sleeve 33. The fixed sleeve 32 is arranged at the proximal end of the central rod 31, and the movable sleeve 33 is slidably assembled outside the fixed sleeve 32 through a pin 34. Two pins 34 are symmetrically arranged on the movable sleeve 33, and the fixed sleeve 32 is provided with two inclined grooves 35 along the length direction of the fixed sleeve 32, which are in sliding fit with the pins 34. When the movable sleeve 33 slides along the longitudinal axis of the fixed sleeve 32, the pins 34 slide along the inclined grooves 35. Since the inclined grooves 35 are arranged around the length direction of the fixed sleeve 32, when the pins 34 slide against the inclined grooves 35, the fixed sleeve 32 will rotate, that is, the central rod 31 will rotate, and the winding and unwinding of the alloy cable 21 will be completed. In order to ensure the stability of the longitudinal axial sliding of the movable sleeve 33, two parallel sliding grooves can be arranged in the inner wall of the catheter main body 1, and then the ends of the two pins 34 are extended so that the two pins 34 are respectively arranged in the two sliding grooves, so as to ensure the stability of the pulling of the movable sleeve 33.

[0046] In the second embodiment, as shown in Figures 7-9 , the ablation device is in the shape of a basket. When not ablated, the ablation device is linear, which is convenient for passing through a gastroscope or an intestinal tract. The electrode 23 is an independent strip-shaped electrode. Under the control of the telescopic device, the strip-shaped electrode can be expanded from a linear state to a spherical state, so as to better adhere to the intestinal tissue and ablate. The electrode material needs to be soft and have sufficient elasticity. Preferably, the material is a medical-grade stainless steel material or a high-elasticity plastic material plated with metal on the surface. The guide wire 6 can pass through the ablation device. In actual application, the ablation device reaches the specified ablation site under the guidance of the guide wire 6. As shown in Figure 10 and 11 , the ablation device reaches the specified ablation area through a gastroscope (the ablation device can also reach the specified site without passing through the inside of the gastroscope). The guide wire 6 is extended out of the ablation device and to a more distal end, and then the ablation device is expanded, so that the electrode 23 contacts the tissue and performs an ablation program. After the ablation is completed, the ablation device is retracted by a certain distance, and the ablation program is continuously performed. The independent strip-shaped electrodes are uniformly distributed along the catheter axis in the circumferential direction. The number of strip-shaped electrodes is preferably 3-12. The strip-shaped electrodes or all the strip-shaped electrodes and the peripheral reference electrodes can release pulsed electric field energy; the strip-shaped electrodes and the peripheral reference electrodes can also release radio frequency energy.

[0047] In the third embodiment, as shown in Figure 12 and 13As shown, the ablation device is a balloon 5, which is similar to the basket mechanism, the ablation device is linear when not ablated, facilitating through the gastroscope or intestinal tract, the electrode 23 is an independent balloon electrode, the flexible electrode is attached to the surface of the balloon 5, under the control of the control host, the control host injects liquid or gas into the balloon 5 to make the balloon 5 expand and maintain a certain pressure, the balloon electrode can be expanded from a linear state to a spherical state, so as to better adhere to the intestinal tissue and ablate. The advancement of the balloon ablation device still relies on the guidance of the guide wire 6. The ablation procedure is basically the same as that of the basket ablation device, the ablation device reaches the designated ablation area through the gastroscope (the ablation device can also reach the designated position without passing through the gastroscope), the guide wire 6 is extended out of the ablation device and further distal, then the balloon 5 is expanded, the electrode 23 is in contact with the tissue, the ablation procedure is performed, after the ablation is completed, the ablation device is retracted, the ablation procedure is continued. The balloon 5 can be filled with cryogenic gas to perform tissue cryoablation, cryoablation uses high-pressure argon or nitrogen to cool the tissue to minus 40~160℃, after freezing, helium or nitrogen is used to make the target tissue rapidly rise from minus to plus 20~40℃, this temperature gradient change can make the target tissue protein denature, cells lyse, tissue ischemic necrosis, and achieve the purpose of ablation damage to the target tissue.

[0048] The above description is only illustrative and not limiting, those skilled in the art understand that many modifications, changes or equivalents can be made without departing from the spirit and scope defined by the appended claims, but all will fall within the protection scope of the present application.

Claims

1. A multi-electrode ablation device for endocrine regulation via the digestive tract, comprising an elongated catheter body (1) extending longitudinally along a longitudinal axis between a proximal end and a distal end, characterized in that: The catheter body (1) is provided with a plurality of electrode assemblies (2) at the distal end in the circumferential direction, and the diameter of the electrode assemblies (2) is adjusted by a driving assembly (3); The catheter body (1) is provided with ablation notches (11) on the outer wall corresponding to the electrode assemblies (2), and the catheter body (1) is internally provided with a driving assembly (3) for extending the electrode assemblies (2) out of the ablation notches (11) and cutting along the outer wall of the catheter body (1) or retracting the electrode assemblies (2) to block the ablation notches (11). The electrode assembly (2) comprises an alloy cable (21) and an electrode arm (22), one end of the alloy cable (21) is fixedly connected with the driving assembly (3), the other end of the alloy cable (21) is connected with the electrode arm (22), the electrode arm (22) is matched with the ablation notch (11), and a plurality of ablation electrodes (23) are arranged on the electrode arm (22). Each electrode arm (22) is connected with two alloy cables (21), and the two alloy cables (21) are arranged at two ends of the electrode arm (22), respectively. The alloy cables (21) connected with the electrode arm (22) are arranged on the driving assembly (3).

2. A multi-electrode ablation device for endocrine regulation via the digestive tract according to claim 1, characterized in that: The alloy cable (21) is made of shape memory alloy.

3. The multi-electrode ablation device for endocrine regulation through the digestive tract according to claim 1, characterized in that: The driving assembly (3) comprises a center rod (31) and a driving head for driving the center rod (31) to rotate, the center rod (31) is arranged in the catheter body (1), the alloy cable (21) is arranged at the distal end of the center rod (31), and the driving head is arranged at the proximal end of the center rod (31).

4. A multi-electrode ablation device for endocrine regulation via the digestive tract according to claim 3, characterized in that: The driving head comprises a fixed sleeve (32) and a movable sleeve (33), the fixed sleeve (32) is arranged at the proximal end of the center rod (31), and the movable sleeve (33) is slidably arranged outside the fixed sleeve (32) through a pin (34).

5. A multi-electrode ablation device for endocrine regulation via the digestive tract according to claim 4, characterized in that: Two pins (34) are symmetrically arranged on the movable sleeve (33), and two inclined grooves (35) are formed in the fixed sleeve (32) along the length direction and are in sliding fit with the pins (34), so that the movable sleeve (33) drives the center rod (31) to rotate during sliding along the fixed sleeve (32).

6. The multi-electrode ablation device for endocrine regulation through the digestive tract according to claim 3, characterized in that: A guide head (12) is arranged at the distal end of the catheter body (1), the guide head (12) is fixedly arranged at the end of the catheter body (1), the center rod (31) is connected with the guide head (12) through a screw (4), and a through hole is formed in the center of the guide head (12) and can be penetrated by the screw (4).

7. The multi-electrode ablation device for endocrine regulation through the digestive tract according to claim 1, characterized in that: The electrode arm (22) and the ablation notch (11) are correspondingly provided with three groups, and the electrodes (23) on the three groups of electrode arms (22) are arranged in a spiral manner in the longitudinal direction.

8. The multi-electrode ablation device for endocrine regulation through the digestive tract according to claim 1, characterized in that: The electrode arm (22) has an ablation surface (221) and a connecting surface (222), the electrodes (23) are arranged on the ablation surface (221), and a temperature sensor (24) is arranged on the connecting surface (222).

Images