Sampling device and sampling method

Abstract

The invention discloses a sampler and a sampling method with the sampler, and the sampler comprises a conveying sheath, the middle of the conveying sheath is provided with a first channel, and the end part of the conveying sheath is provided with a guide groove; the core rod is suitable for detecting bioelectricity; the sampling assembly comprises a conveying catheter and a cutting head, the cutting head is arranged at one end of the conveying catheter, the core rod can slide along the interior of the conveying catheter, the conveying catheter is movably installed in the first channel and drives the cutting head to extend out of the end of the conveying sheath, and the guide groove drives the cutting head to achieve cutting sampling. High-precision sampling can be realized, and the safety in the sampling process is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a sampler and a sampling method. Background Art

[0002] At present, for the myocardial sampling device applied clinically, after constructing the working channel, it relies on the traditional sampling forceps to obtain the cardiac muscle tissue sample. However, the existing sampling forceps mainly operate by twisting or clamping to take out the tissue from the heart. This method has significant risks. Due to the lack of detection equipment, it may induce arrhythmia or cause serious complications such as cardiac perforation. In addition, this traditional method also faces challenges in terms of positioning accuracy and creating a safe and convenient sampling path, increasing the surgical difficulty and uncertainty. Summary of the Invention

[0003] The present invention aims to solve at least one of the technical problems existing in the prior art. For this purpose, the present invention provides a sampler that can achieve high-precision sampling and improve the safety during the sampling process.

[0004] The present invention also provides a sampling method having the above sampler.

[0005] A sampler according to an embodiment of the first aspect of the present invention includes: A delivery sheath, a first channel is provided in the middle of the delivery sheath, and a guiding groove is provided at the end of the delivery sheath; A core rod adapted to detect bioelectricity; A sampling assembly, including a delivery catheter and a cutting head. The cutting head is provided at one end of the delivery catheter. The core rod can slide along the inside of the delivery catheter. The delivery catheter is movably installed in the first channel and drives the cutting head to extend out from the end of the delivery sheath. The guiding groove drives the cutting head to perform cutting and sampling.

[0006] The sampler according to the embodiments of the present invention has at least the following beneficial effects: By providing a guiding groove at the end of the delivery sheath, it ensures that the cutting head can be accurately guided when it extends, achieving accurate cutting of the target tissue; this design greatly improves the accuracy of sampling and reduces the risk of damage to surrounding healthy tissues; the core rod can not only slide inside the delivery catheter but also has the function of detecting bioelectricity; this enables real-time monitoring of cardiac electrical activity during sampling, ensuring the safety and accuracy of the sampling position and avoiding interference or damage to the cardiac conduction system; the delivery catheter is movably installed in the first channel of the delivery sheath and can drive the cutting head to extend from the end of the delivery sheath, this design simplifies the operation steps, shortens the operation time, reduces the learning difficulty of the operator, and improves the overall operation convenience; the design of the guiding groove ensures the stability of the cutting head during extension and retraction, reducing the possibility of operation errors; the real-time bioelectricity monitoring function of the core rod further enhances the safety of the operation and reduces the risk of complications; the structure of the entire sampler is compact, and the cooperation between components is tight, ensuring the stability and reliability of the device during delivery and recovery, and improving the fluency and success rate of the operation.

[0007] According to some embodiments of the present invention, the delivery sheath and the delivery catheter are in threaded cooperation to adjust the extension length of the cutting head. The threaded cooperation design ensures a tight connection between the delivery catheter and the delivery sheath, preventing loosening or slipping during operation. This design not only allows precise adjustment of the extension length of the cutting head from the end of the delivery sheath but also ensures that the cutting head has sufficient force to overcome the resistance of the guiding groove during extension. The threaded cooperation provides a stable mechanical advantage, enabling the cutting head to extend smoothly and powerfully from the guiding groove when needed, ensuring the effectiveness of the cutting operation.

[0008] According to some embodiments of the present invention, the threaded cooperation between the delivery sheath and the delivery catheter is located on the side of the delivery sheath facing the guiding groove. This ensures the directness and controllability of the cutting head's extension action. The operator can make fine adjustments at the position closest to the cutting point, thereby improving the accuracy of sampling and reducing the risk of damage to surrounding tissues.

[0009] According to some embodiments of the present invention, the cutting head includes multiple cutting blades, and the multiple cutting blades are arranged circumferentially along the delivery catheter. The groove wall of the guiding groove drives the multiple cutting blades to close inward to achieve cutting and sampling. The multiple cutting blades are evenly arranged circumferentially along the delivery catheter, ensuring multi-point and uniform cutting of the target tissue during the cutting process. When the groove wall of the guiding groove drives the multiple cutting blades to close inward, the multiple cutting blades act together to form a concentrated and powerful cutting force.

[0010] According to some embodiments of the present invention, the cross-section of the guiding groove is circular. When the groove wall of the guiding groove approaches the end of the delivery sheath, the groove wall of the guiding groove gradually thickens. The thickened groove wall design enables the guiding groove to more precisely control the closing action of the cutter head, ensuring that each cutter head can accurately reach the predetermined position and complete the cutting task. This design reduces under-sampling or excessive damage caused by position deviation, improving the accuracy and quality of sampling.

[0011] According to some embodiments of the present invention, after multiple cutter heads are closed, an activity channel for the core rod is formed between the multiple cutter heads. When multiple cutter heads are closed, the formed activity channel provides a smooth movement path for the core rod, ensuring that the core rod can slide freely during the sampling process without affecting its function of detecting bioelectrical signals, and improving the flexibility and efficiency of the operation.

[0012] According to some embodiments of the present invention, the wall thickness of the delivery catheter is greater than the wall thickness of the delivery sheath. The thicker wall of the delivery catheter can provide better support during the sampling process, reducing the risk of operation failure caused by catheter bending or breakage. Especially in the case where precise control of the cutting head movement is required, this design can ensure the safety and reliability of the operation, reducing the risk of surgical complications.

[0013] According to some embodiments of the present invention, the core rod is provided with a marking portion and a detection portion. The detection portion is adapted to acquire bioelectrical information. The detection portion is arranged at the end of the core rod, and the marking portion and the detection portion are located on the same side of the core rod. The marking portion can be visualized under X-ray, providing an intuitive visual reference for the operator to ensure precise control of the insertion depth of the core rod, helping to avoid the detection head being inserted too deep, reducing unnecessary damage to the heart tissue, and improving the safety and accuracy of the operation.

[0014] According to some embodiments of the present invention, a flushing port is arranged at one end of the delivery sheath away from the guiding groove. Before introducing the sampler into the body, the entire sampler is flushed with heparinized saline through this flushing port. This step ensures the cleanliness of the inside and surface of the sampler, reduces the risk of thrombus formation, and prevents possible contaminants from entering the blood vessel.

[0015] According to the sampling method of the second aspect embodiments of the present invention, using a sampler as in the first aspect embodiments, the method includes the following steps: a. Establish a working channel, clean the delivery sheath, and then introduce the sampler through the axillary blood vessel to make it reach near the heart target tissue, and ensure that the sampler abuts against the heart surface; b. Confirm the sampling position, insert the core rod into the predetermined sampling position, monitor and transmit the electrical signal at the current position using the core rod, and determine whether the selected position is in the cardiac conduction system by analyzing the transmitted signal. If the detection result shows that the current position may affect the cardiac conduction path, adjust the sampling position until a suitable position that does not affect the cardiac conduction system is found. After finally determining the sampling point, temporarily fix the core rod here; c. Sampling: Rotate the delivery catheter to bring the cutter head close to the cardiac tissue through the guiding port. When the cutter head passes through the guiding groove, the gap between the cutter heads narrows to achieve cutting and sampling of the cardiac tissue; d. Sample recovery: After sampling, first withdraw the core rod, then retract the delivery catheter from the guiding port, then retrieve the delivery catheter, and safely withdraw the entire sampler from the blood vessel while ensuring the recovery of the obtained tissue.

[0016] According to the sampling method of the embodiment of the present invention, it has at least the following beneficial effects: By real-time monitoring and transmitting electrical signals through the core rod, the safety and accuracy of the sampling position are ensured, and interference or damage to the cardiac conduction system is avoided; The real-time electrical signal monitoring combined with precise position adjustment greatly reduces the risks caused by improper position or misoperation, and reduces the occurrence probability of complications such as arrhythmia and cardiac perforation.

[0017] The additional aspects and advantages of the present invention will be partially given in the following description, partially become apparent from the following description, or be understood through the practice of the present invention. Description of the Drawings

[0018] The following further describes the present invention in conjunction with the drawings and embodiments, where: Figure 1 It is a schematic diagram of the delivery sheath according to the embodiment of the present invention; Figure 2 It is a schematic diagram of the delivery catheter according to the embodiment of the present invention; Figure 3 It is a schematic diagram of the core rod according to the embodiment of the present invention.

[0019] Reference numerals: delivery sheath 100; internal thread 110; guiding groove 120; groove wall 130; first channel 140; delivery catheter 150; external thread 160; cutter head 170; core rod 180; marking portion 190; detection portion 200; flushing port 210. Detailed Embodiments

[0020] The following details the embodiments of the present invention. The examples of the embodiments are shown in the drawings, where the same or similar reference numerals represent the same or similar elements or elements with the same or similar functions throughout. The embodiments described below by referring to the drawings are exemplary and are only used to explain the present invention and should not be construed as a limitation of the present invention.

[0021] In the description of the present invention, it should be understood that with respect to the orientation description, such as the orientation or positional relationship indicated by up, down, front, back, left, right, etc., it is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present invention.

[0022] In the description of the present invention, the meaning of "several" is one or more, the meaning of "multiple" is two or more, and understandings such as "greater than", "less than", "exceeding", etc. do not include the recited number, and understandings such as "above", "below", "within", etc. include the recited number. If there is a description of "first" and "second", it is only for the purpose of distinguishing technical features, and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features or implicitly indicating the sequence relationship of the indicated technical features.

[0023] In the description of the present invention, unless otherwise clearly defined, terms such as "set", "installed", "connected", etc. should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the above terms in the present invention in combination with the specific content of the technical solution. In the description of the present invention, the description with reference to terms such as "one embodiment", "some embodiments", "schematic embodiments", "examples", "specific examples", or "some examples", etc. means that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic descriptions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. In the description of this specification, the description with reference to terms such as "one embodiment", "some embodiments", "schematic embodiments", "examples", "specific examples", or "some examples", etc. means that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic descriptions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments or examples.

[0024] Referring to Figures 1 to 3 , a sampler, comprising: A delivery sheath 100, a first channel 140 is provided in the middle of the delivery sheath 100, and a guiding groove 120 is provided at the end of the delivery sheath 100; A core rod 180, adapted to detect bioelectricity; Sampling assembly, including a delivery catheter 150 and a cutting head. The cutting head is disposed at one end of the delivery catheter 150. A core rod 180 is slidable along the interior of the delivery catheter 150. The delivery catheter 150 is movably mounted within the first channel 140 and drives the cutting head to extend from the end of the delivery sheath 100. The guiding groove 120 drives the cutting head to perform cutting and sampling.

[0025] By providing the guiding groove 120 at the end of the delivery sheath 100, it is ensured that the cutting head can be accurately guided when extending, achieving accurate cutting of the target tissue; this design greatly improves the accuracy of sampling and reduces the risk of damage to surrounding healthy tissues; the core rod 180 can not only slide within the delivery catheter 150, but also has the function of detecting bioelectricity; this enables real-time monitoring of cardiac electrical activity during sampling, ensuring the safety and accuracy of the sampling position and avoiding interference or damage to the cardiac conduction system; the delivery catheter 150 is movably mounted within the first channel 140 of the delivery sheath 100 and can drive the cutting head to extend from the end of the delivery sheath 100. This design simplifies the operation steps, shortens the operation time, reduces the learning difficulty of the operator, and improves the overall convenience of operation; the design of the guiding groove 120 ensures the stability of the cutting head during extension and retraction, reducing the possibility of operation errors; the real-time bioelectricity monitoring function of the core rod 180 further enhances the safety of the operation and reduces the risk of complications; the structure of the entire sampler is compact, and the cooperation between components is tight, ensuring the stability and reliability of the device during delivery and retrieval, and improving the smoothness and success rate of operation.

[0026] The delivery sheath 100 is threadedly engaged with the delivery catheter 150 to adjust the protruding length of the cutting head. The design of the threaded engagement ensures a tight connection between the delivery catheter 150 and the delivery sheath 100, preventing loosening or slippage during operation. This design not only allows for precise adjustment of the length of the cutting head protruding from the end of the delivery sheath 100, but also ensures that the cutting head 170 has sufficient force to overcome the resistance of the guiding groove 120 during protrusion. The threaded engagement provides a stable mechanical advantage, enabling the cutting head to smoothly and powerfully protrude from the guiding groove 120 when needed, ensuring the effectiveness of the cutting operation. It can be understood that an internal thread 110 is provided at the end of the delivery sheath 100, and an external thread 160 is provided at the corresponding position of the delivery catheter 150. Through the precise cooperation of the internal thread 110 and the external thread 160, not only is it ensured that the cutting head smoothly and powerfully protrudes from the guiding groove 120, but also a stable mechanical advantage is provided, enabling the cutting head 170 to overcome the resistance during protrusion and ensuring the reliability of the operation. After the cutting head 170 protrudes from the guiding groove 120, the groove walls 130 of the gradually narrowing guiding groove 120 exert uniform pressure on the plurality of cutting heads 170, causing them to converge towards the middle. This design ensures that the cutting heads 170 can precisely close during cutting, forming a concentrated and powerful cutting force, thereby achieving efficient and safe cutting and sampling.

[0027] The threaded engagement between the delivery sheath 100 and the delivery catheter 150 is located on the side of the delivery sheath 100 facing the guiding groove 120. This ensures the directness and controllability of the cutting head's protruding action. The operator can make fine adjustments at the position closest to the cutting point, thereby improving the accuracy of sampling and reducing the risk of damage to surrounding tissues.

[0028] The cutting head includes a plurality of cutter heads 170, which are arranged circumferentially along the conveying catheter 150. The groove wall 130 of the guiding groove 120 drives the plurality of cutter heads 170 to close inward to achieve cutting and sampling. The plurality of cutter heads 170 are evenly arranged circumferentially along the conveying catheter 150, ensuring that the target tissue can be cut at multiple points and evenly during the cutting process. When the groove wall 130 of the guiding groove 120 drives the plurality of cutter heads 170 to close inward, the plurality of cutter heads 170 cooperate to form a concentrated and powerful cutting force. It can be understood that the shape of the cutter head 170 is designed as a triangle, its root is firmly fixed at the end of the conveying catheter 150, and is arranged along the extending direction of the conveying catheter 150. When the plurality of triangular cutter heads 170 close, they will form a conical-like structure, and cutting and sampling are carried out by the precise closing of the sides of the cutter heads 170. Specifically, the number of cutter heads 170 can be adjusted according to actual needs, and can be 2, 3, 4, 5 or 6. In some preferred embodiments, a design with three cutter heads is selected. This configuration not only provides good mechanical balance, but also ensures the stability and efficiency of the cutting action. In summary, by designing the cutter head 170 as a triangle and making it form a conical-like structure when closing, combined with different configurations of the number of cutter heads 170, especially the preferred scheme of three cutter heads 170, the present invention achieves high precision and reliability in cutting and sampling.

[0029] The cross-section of the guiding groove 120 is circular. When the groove wall 130 of the guiding groove 120 approaches the end of the conveying sheath 100, the groove wall 130 of the guiding groove 120 gradually thickens. The thickened groove wall 130 design enables the guiding groove 120 to more precisely control the closing action of the cutter head 170, ensuring that each cutter head 170 can accurately reach the predetermined position and complete the cutting task. This design reduces under-sampling or excessive damage caused by position deviation, and improves the accuracy and quality of sampling. It can be understood that an avoidance portion can be provided at the tip of the end of the cutter head 170. After the plurality of cutter heads 170 are closed, these avoidance portions will form a notch at the tip, thereby providing an exit channel for the core rod 180. Specifically, this design ensures that after the cutting and sampling are completed, the core rod 180 can smoothly exit from the formed notch without being blocked by the cutter head 170. The existence of the avoidance portion not only improves the smoothness and safety of the operation, but also ensures that the continuous monitoring function of the core rod 180 during the sampling process is not affected. In summary, by providing an avoidance portion at the tip of the end of the cutter head 170, an exit channel for the core rod 180 is formed when the plurality of cutter heads 170 are closed, and the present invention further optimizes the operation process of the sampler, improving the overall safety and reliability. The circular cross-section design enhances the structural stability of the guiding groove 120, making it not easily deformed or damaged when subjected to external forces. This not only extends the service life of the device, but also ensures the consistency and reliability of each operation.

[0030] After multiple cutter heads 170 are closed, an activity channel for the core rod 180 is formed between the multiple cutter heads 170. When the multiple cutter heads 170 are closed, the formed activity channel provides a smooth movement path for the core rod 180, which ensures that the core rod 180 can slide freely during the sampling process, does not affect its function of detecting bioelectric signals, and improves the flexibility and efficiency of the operation.

[0031] The wall thickness of the delivery catheter 150 is greater than that of the delivery sheath 100. The thicker wall of the delivery catheter 150 can provide better support during the sampling process, reduce the risk of operation failure caused by catheter bending or breaking. Especially in the case where precise control of the cutting head movement is required, this design can ensure the safety and reliability of the operation and reduce the risk of surgical complications.

[0032] The core rod 180 is provided with a marking portion 190 and a detection portion 200. The detection portion 200 is adapted to acquire bioelectric information. The detection portion 200 is arranged at the end of the core rod 180, and the marking portion 190 and the detection portion 200 are located on the same side of the core rod 180. The marking portion 190 can be visualized under X-ray, providing an intuitive visual reference for the operator, ensuring that the insertion depth of the core rod 180 is precisely controlled, helping to avoid the detection head being inserted too deep, reducing unnecessary damage to heart tissue, and improving the safety and accuracy of the operation. It can be understood that the lengths of both the marking portion 190 and the detection portion 200 are five millimeters. The core rod 180 further includes a wire portion with a length of 50 centimeters. This wire portion is connected in series with the marking portion 190 and the detection portion 200 respectively and is made of a conductive material to ensure that bioelectric signals can be accurately acquired. Specifically: The marking portion 190 has a length of five millimeters and is designed to be visualized under X-ray to provide an intuitive depth indication and avoid the detection head being inserted too deep. The detection portion 200 also has a length of five millimeters and is arranged at the end of the core rod 180 to monitor and transmit the bioelectric signals at the current position in real time. The wire portion has a length of 50 centimeters and is made of a conductive material to ensure that the bioelectric signals acquired from the detection portion 200 can be stably and losslessly transmitted to an external monitoring device. The wire portion is connected in series with the marking portion 190 and the detection portion 200 to form a complete signal transmission path. To ensure that the core rod 180 can smoothly pass through the channel of the delivery catheter 150 and will not be cut by the cutting head, the core rod 180 is designed to have a very small diameter. This small design not only ensures the smooth movement of the core rod 180 inside the delivery catheter 150 but also avoids its being damaged or interfered with during the cutting process.

[0033] One end of the delivery sheath 100 away from the guiding groove 120 is provided with a flushing port 210. Before introducing the sampler into the body, the entire sampler is flushed with heparinized saline through the flushing port 210. This step ensures the cleanliness of the inside and surface of the sampler, reduces the risk of thrombosis, and prevents possible contaminants from entering the blood vessels. After the flushing is completed, the sampler is introduced through the axillary blood vessels and smoothly reaches near the heart target tissue. By flushing with heparinized saline, the risk of thrombosis can be effectively reduced, ensuring the safety of the surgical procedure. The flushing step can remove possible contaminants on the surface and inside of the sampler, avoid bringing impurities into the blood vessels, and improve the sterility of the operation. The cleaned sampler is more smoothly introduced into the blood vessels, reducing the operation difficulties caused by dirt on the surface of the instrument. Flushing with heparinized saline not only helps to keep the sampler clean, but also provides additional anticoagulant protection for the patient, reducing the risk of postoperative complications.

[0034] It can be understood that a hemostatic valve can also be provided on one side of the flushing port 210. The hemostatic valve can be closed after the flushing is completed to prevent blood from flowing back into the sampler. In addition, after the sampler is withdrawn, the hemostatic valve can be quickly closed to reduce the bleeding risk. The combined design of the flushing port 210 and the hemostatic valve simplifies the operation process. The doctor does not need to use other additional devices or tools to achieve the flushing and hemostasis functions, shortening the preparation time and the surgical time, and improving the overall efficiency. In the first aspect of the embodiment, the delivery sheath 100 is made of polyethylene material, having good biocompatibility and flexibility. This material is not only skin-friendly and has little irritation to tissues, but also has excellent mechanical properties, ensuring the stability and durability of the device during the operation process. A first channel 140 is provided in the middle of the delivery sheath 100 for accommodating and guiding the delivery catheter 150 and the cutting head thereon. The end of the delivery sheath 100 is provided with a guiding groove 120, the cross-section of which is circular to provide uniform guiding force. The groove wall 130 of the guiding groove 120 gradually thickens when approaching the end of the delivery sheath 100, enhancing the structural strength of this area and ensuring that the cutting head can smoothly and powerfully extend out.

[0035] The core rod 180 is designed to have a very small diameter to ensure that it can smoothly pass through the channel of the delivery catheter 150 and will not be cut by the cutting head. This design not only ensures the smooth movement of the core rod 180 inside the delivery catheter 150, but also avoids being damaged or interfered during the cutting process. The marking part 190 has a length of five millimeters and is used for imaging under X-ray to provide an intuitive depth indication and avoid the detection head being inserted too deep. The detection part 200 also has a length of five millimeters and is arranged at the end of the core rod 180 for real-time monitoring and transmitting the bioelectric signal of the current position. The core rod 180 also includes a wire part with a length of 50 centimeters, which is made of conductive material to ensure that the bioelectric signal can be accurately obtained. The wire part is connected in series with the marking part 190 and the detection part 200 respectively to form a complete signal transmission path.

[0036] The delivery catheter 150 is also made of polyethylene material, with good flexibility and stability. An external thread 160 is provided at the end of the delivery catheter 150, which cooperates with the internal thread 110 at the end of the delivery sheath 100 to ensure that the cutting head has sufficient power to extend from the guiding groove 120. This threaded fit provides a stable mechanical advantage, enabling the cutting head to extend smoothly and powerfully when needed. The cutting head is composed of a plurality of cutting blades 170 arranged circumferentially along the delivery catheter 150. Each cutting blade 170 is triangular in shape, with its root firmly fixed at the end of the delivery catheter 150 and arranged along the extending direction of the delivery catheter 150. The cutting blades 170 are made of high-strength alloy material to ensure sharpness in a complex surgical environment and achieve efficient and precise cutting and sampling. An avoidance portion is provided at the tip end of the cutting blade 170. When the plurality of cutting blades 170 are closed, a notch is formed at the tip, providing an exit channel for the core rod 180. This design ensures that after the cutting and sampling are completed, the core rod 180 can smoothly exit from the formed notch without being blocked by the cutting blades 170.

[0037] Through the marking portion 190 and the detection portion 200 of the core rod 180, precise position control and real-time bioelectric signal monitoring are achieved, avoiding interference or damage to the cardiac conduction system. The design of the multi-cutting blades 170 for uniform cutting and the tapered guiding groove 120 reduces the risk of pulling and damaging the surrounding healthy tissues. The delivery sheath 100 and the delivery catheter 150 are made of polyethylene material. The combination of the threaded fit and the design of the small-diameter core rod 180 ensures the compactness of the overall structure and the reliability of the operation. By providing an avoidance portion at the end of the cutting blade 170, it is ensured that the core rod 180 can exit safely, improving the safety and reliability of sample recovery.

[0038] Refer to Figures 1 to 3 In the embodiment of the present invention, both the delivery sheath 100 and the delivery catheter 150 are made of polyethylene material. Polyethylene material has good biocompatibility and flexibility. It is not only skin-friendly and causes little irritation to tissues, but also has excellent mechanical properties, ensuring the stability and durability of the device during operation. The cutting head is made of alloy material. The selection of alloy material provides higher hardness and wear resistance, ensuring that the cutting head can remain sharp in a complex surgical environment and achieve efficient and precise cutting and sampling. In addition, the alloy material also has good corrosion resistance, extending the service life of the cutting head and ensuring its reliability in multiple uses.

[0039] According to the sampling method of the second aspect embodiment of the present invention, using a sampler as in the first aspect embodiment, it includes the following steps: a. Establish a working channel, clean the delivery sheath, and then introduce the sampler through the axillary blood vessel to make it reach near the heart target tissue, ensuring that the sampler abuts against the heart surface; b. Confirm the sampling position, insert the core rod 180 into the predetermined sampling position, use the core rod 180 to monitor and transmit the electrical signal of the current position, and judge whether the selected position is in the cardiac conduction system by analyzing the transmitted signal. If the detection result shows that the current position may affect the cardiac conduction path, adjust the sampling position until a suitable position that does not affect the cardiac conduction system is found. After finally determining the sampling point, temporarily fix the core rod 180 here; c. Sampling, rotate the delivery catheter 150 to make the cutter head 170 approach the heart tissue through the guiding port. When the cutter head 170 passes through the guiding groove 120, the gap of the cutter head 170 narrows to achieve cutting and sampling of the heart tissue; d. Sample recovery, after completing sampling, first withdraw the core rod 180, then withdraw the delivery catheter 150 from the guiding port, then retract the delivery catheter 150, and safely withdraw the entire sampler from the blood vessel, while ensuring the recovery of the obtained tissue.

[0040] Real-time monitoring and transmission of electrical signals through the core rod 180 ensure the safety and accuracy of the sampling position, avoiding interference or damage to the cardiac conduction system; the combination of real-time electrical signal monitoring and precise position adjustment greatly reduces the risks caused by improper position or misoperation, and reduces the occurrence probability of complications such as arrhythmia and cardiac perforation.

[0041] When using the sampler of the first aspect embodiment, in the first step, first, it is necessary to establish a working channel and then introduce the sampler: introduce the sampler through the axillary blood vessel to make it reach smoothly near the heart target tissue. Ensure that the sampler abuts against the heart surface for the next operation. Finally, confirm the position: use imaging equipment (such as X-ray or ultrasound) to confirm the position of the sampler to ensure that it accurately reaches the predetermined target area.

[0042] In the second step, it is necessary to confirm the sampling position and first insert the core rod 180: insert the core rod 180 into the predetermined sampling position, and use the detection part 200 at the end of the core rod 180 to monitor and transmit the electrical signal of the current position. Then analyze the signal: analyze the transmitted electrical signal through an external monitoring device to judge whether the selected position is in the cardiac conduction system. If the detection result shows that the current position may affect the cardiac conduction path, adjust the sampling position until a suitable position that does not affect the cardiac conduction system is found. Finally, fix the core rod 180: after finally determining the sampling point, temporarily fix the core rod 180 here to ensure the stable position of the core rod 180 during the sampling process.

[0043] Step 3: First, perform sampling by rotating the delivery catheter 150: Gently rotate the delivery catheter 150 so that the cutter head 170 approaches the heart tissue through the guiding port. Then, perform cutting and sampling: When the cutter head 170 passes through the guiding groove 120, the gap between the cutter heads 170 gradually narrows, and the multiple cutter heads 170 close inward under the drive of the groove wall 130 of the guiding groove 120, forming a conical-like structure. Use the precise closing of the sides of the cutter head 170 for cutting and sampling to ensure the efficiency and safety of the cutting operation. Monitor the process: During the entire cutting process, continuously monitor the bioelectrical signals to ensure the safety of the operation and promptly adjust any abnormal situations.

[0044] Step 4: Sample recovery and removal; Withdraw the core rod 180: After sampling is completed, first withdraw the core rod 180 to ensure that it no longer interferes with the cardiac electrical activity. Retract the delivery catheter 150: Then retract the delivery catheter 150 from the guiding port and retrieve the delivery catheter 150. Remove the sampler: Safely remove the entire sampler from the blood vessel while ensuring that the obtained myocardial tissue is properly recovered. Inspect the sample: Conduct a preliminary inspection of the removed tissue sample to ensure that the sample is complete and representative, providing a high-quality material basis for subsequent pathological analysis.

[0045] Through the sampling method of the above embodiments, the present invention excels in the following aspects: Real-time monitoring of electrical signals and precise control of the sampling position to avoid interference or damage to the cardiac conduction system. The design of the multiple cutter heads 170 for uniform cutting and the tapered guiding groove 120 reduces the risk of pulling and damaging the surrounding healthy tissues. The operation process is simple and clear, shortening the operation time, reducing the learning difficulty of the operator, and enhancing the overall convenience of the operation. Ensure the accuracy and consistency of the cutting action, improving the integrity and representativeness of the sampling. Ensure the safe recovery of the sample, reducing the risk of sample loss or contamination.

[0046] In summary, the sampling method of the present invention, through carefully designed steps, excels in high-precision positioning and safety, reducing trauma, improving operation efficiency and convenience, optimizing cutting and sampling accuracy, enhancing the safety and reliability of sample recovery, and improving the user experience, providing a more efficient, safe, and reliable solution for myocardial biopsy.

[0047] The above has described the embodiments of the present invention in detail with reference to the accompanying drawings. However, the present invention is not limited to the above embodiments, and various changes can be made without departing from the spirit of the present invention within the scope of knowledge possessed by those of ordinary skill in the relevant technical field.

Claims

1. A sampler, characterized in that, Comprising: A delivery sheath, with a first channel disposed in the middle thereof, and a guiding groove provided at the end of the delivery sheath; A core rod adapted to detect bioelectricity; A sampling assembly, including a delivery catheter and a cutting head. The cutting head is provided at one end of the delivery catheter. The core rod can slide along the inside of the delivery catheter. The delivery catheter can be movably installed in the first channel and drive the cutting head to extend from the end of the delivery sheath. The guiding groove drives the cutting head to perform cutting and sampling.

2. The sampler according to claim 1, characterized in that, The delivery sheath is in threaded cooperation with the delivery catheter to adjust the extending length of the cutting head.

3. The sampler according to claim 2, characterized in that, The threaded cooperation position between the delivery sheath and the delivery catheter is on the side of the delivery sheath facing the guiding groove.

4. The sampler according to claim 1, wherein, The cutting head includes a plurality of cutter heads, and the plurality of cutter heads are arranged circumferentially along the delivery catheter. The groove wall of the guiding groove drives the plurality of cutter heads to close inwards to perform cutting and sampling.

5. A sampler according to claim 4, characterized in that, The cross-section of the guiding groove is circular, and when the groove wall of the guiding groove approaches the end of the delivery sheath, the groove wall of the guiding groove gradually thickens.

6. A sampler according to claim 4, characterized in that After the plurality of cutter heads are closed, an activity channel for the core rod is formed between the plurality of cutter heads.

7. A sampler according to claim 1, characterized in that, The wall thickness of the delivery catheter is greater than the wall thickness of the delivery sheath.

8. A sampler according to claim 1, characterized in that, The core rod is provided with a marking portion and a detecting portion. The detecting portion is adapted to acquire bioelectricity information. The detecting portion is provided at the end of the core rod. The marking portion and the detecting portion are located on the same side of the core rod.

9. A sampler according to claim 1, wherein, A flushing port is provided at one end of the delivery sheath away from the guiding groove.

10. A sampling method, characterized in that, Using a sampler according to any one of claims 1-9, comprising the following steps: a. Establish a working channel, clean the delivery sheath, then introduce the sampler through the axillary blood vessel to make it reach near the cardiac target tissue, and ensure that the sampler abuts against the cardiac surface; b. Confirm the sampling position, insert the core rod into the predetermined sampling position, use the core rod to monitor and transmit the electrical signal at the current position, and judge whether the selected position is located in the cardiac conduction system by analyzing the transmitted signal. If the detection result shows that the current position may affect the cardiac conduction path, adjust the sampling position until a suitable position that does not affect the cardiac conduction system is found. After finally determining the sampling point, temporarily fix the core rod here; c. Sampling, rotate the delivery catheter to make the cutter head approach the cardiac tissue through the guiding port. When the cutter head passes through the guiding groove, the gap between the cutter heads narrows to perform cutting and sampling of the cardiac tissue; d. Sample recovery, after sampling is completed, first withdraw the core rod, then retract the delivery catheter from the guiding port, then retract the delivery catheter, and safely withdraw the entire sampler from the blood vessel while ensuring the recovery of the obtained tissue.

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