Percutaneous pericardiocentesis assembly and system

Abstract

The percutaneous pericardium puncture assembly comprises a puncture tube and a puncture piece, and the puncture tube comprises a tube body and a puncture section arranged at the far end of the tube body. A puncture channel, a negative pressure suction channel and an imaging channel are formed in the tube body and communicated with a working opening in the far end of the puncture section. The imaging module is arranged in the imaging channel in a penetrating mode, and real-time visualization of in-vivo puncture operation is achieved. The near end of the negative pressure suction channel can be in butt joint with a negative pressure suction device to provide negative pressure for the working port so as to adsorb the pericardium wall layer; the puncture piece penetrates through the puncture channel and can puncture the adsorbed pericardium wall layer. According to the embodiment, the vacuum suction channel is formed, the pericardium wall layer can be captured before puncture of the puncture piece, in this way, even if only a small amount of pericardial effusion exists between the pericardium wall layer and the pericardium dirty layer, medical staff can easily complete puncture of the pericardium wall layer under the condition that the pericardium dirty layer is not damaged, and the puncture efficiency of the pericardium wall layer is improved. The operation is simple, and the safety and the success rate of percutaneous pericardium paracentesis under full indications are greatly improved.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a percutaneous pericardiocentesis component and system. Background Art

[0002] The pericardial cavity is one of the important anatomical spaces in the body. Chronic or acute pericardial effusion can seriously affect the diastolic and systolic functions of the heart. In severe cases, it can lead to cardiogenic shock or death. It is one of the serious complications of various related diseases / surgeries. Therefore, in recent years, how to safely and effectively perform pericardiocentesis has become an important issue that needs to be solved in the treatment of heart-related diseases.

[0003] At present, the number of passive punctures for various types of pericardial tamponade complications in China can reach up to 58,000 cases per year. From the perspective of clinical application, both radiofrequency ablation of epicardial ventricular tachycardia and drainage of pericardial effusion require pericardial puncture. However, traditional percutaneous pericardial puncture is highly dependent on the operator's proficiency and understanding of anatomical relationships, and has the characteristics of a long learning curve and a high incidence of puncture complications. Common pericardial puncture complications include cardiac perforation, arrhythmia, bleeding, infection, pneumothorax, coronary artery injury, etc. Moreover, unlike pericardial puncture drainage when there is a large amount of pericardial effusion, there are currently a large number of clinical cases that require pericardial puncture, usually because the amount of effusion in the puncture area is not large, or the heartbeat affects the needle insertion angle, or it is necessary to establish a pericardial cavity track under normal pericardial conditions.

[0004] Dry pericardiocentesis has been widely used since Sosa et al. first reported the successful treatment of a patient with Chagas disease and ventricular tachycardia-dependent epicardial ablation by subxiphoid pericardiocentesis in 1996. The dry pericardiocentesis method described by Sosa et al. is also named the Sosa method, but many electrophysiology centers have concerns about the use of this technology because of the risk of causing varying degrees of pericardial bleeding, peripheral organ damage, and even cardiac tamponade.

[0005] Ultrasound-guided pericardiocentesis is currently the preferred method in clinical practice. However, ultrasound-guided pericardiocentesis is easily affected by lung and diaphragm obstruction, patient position restrictions, and the operator's use of ultrasound equipment. Computed tomography (CT)-guided pericardiocentesis is an accurate, safe, and effective method that can provide high-definition three-dimensional images and accurately locate the puncture point. However, this technology has limitations such as large equipment that cannot be moved, difficulty in transferring critically ill patients, the need for cooperation from the radiology team, and a long operation time (average 65 minutes), making it difficult to carry out routine operations.

[0006] CardioVia, an Israeli company, has innovatively developed a new type of blunt-tipped concealed pericardiocentesis device (ViaOne) and evaluated its safety and effectiveness in human trials. Its patent (CN 115038384A) discloses that ViaOne consists of a handle (controller, pulse pressure indicator, and status window), a concealed puncture piece with an inner diameter of 1.1 mm, a stainless-steel spring-assisted telescopic tube (with a rotating serrated disk structure), a stainless-steel inner tube, and a 146-mm-long stainless-steel guide tube. There is a passage inside the device that allows a guide wire to be inserted into the pericardial cavity. Pericardiocentesis needs to be performed under general anesthesia and DSA fluoroscopy. The specific steps include skin incision, access establishment, device insertion, and grasping the pericardial layer. Although the preliminary trial results show good safety and effectiveness of the device, accurate positioning and grasping of the pericardium still pose challenges in some cases with complex anatomical structures or adhesions.

[0007] Therefore, how to improve the technical deficiencies in the existing technology and solve the difficult pericardiocentesis operations in the above situations has always been an urgent problem for those of ordinary skill in the art. Summary of the Invention

[0008] The purpose of this application is to provide a percutaneous pericardiocentesis assembly and system, which can pre-capture the parietal pericardium, solve the problems of high puncture risk and difficult operation caused by trace or small amounts of pericardial effusion in current clinical percutaneous pericardiocentesis, and greatly improve the safety and success rate of percutaneous pericardiocentesis for all indications.

[0009] The technical solution provided by the present invention is as follows:

[0010] A percutaneous pericardiocentesis assembly includes:

[0011] A puncture tube and a puncture piece;

[0012] The puncture tube includes a tube body and a puncture section provided at the distal end of the tube body. A puncture channel and a negative pressure suction channel are opened inside the tube body. The outer diameter of the puncture section gradually increases from the distal end to the proximal end, and a working port is opened at the distal end of the puncture section. The working port communicates the puncture channel and the negative pressure suction channel;

[0013] The proximal end of the negative pressure suction channel is adapted to be docked with a negative pressure suction device to provide negative pressure for the working port to adsorb the parietal pericardium; the puncture channel is used for the puncture piece to pass through, and the distal end of the puncture piece is adapted to puncture the adsorbed parietal pericardium.

[0014] In some embodiments, the negative pressure suction channel, the tube body, and the working port are coaxially arranged, and the caliber size of the working port is consistent with the inner diameter size of the negative pressure suction channel.

[0015] In some embodiments, the percutaneous pericardiocentesis assembly further includes:

[0016] Imaging module;

[0017] An imaging channel is provided inside the tube body and is adapted to allow the imaging module to pass through;

[0018] Wherein, the inner diameter of the puncture section gradually increases from the distal end to the proximal end, and is adapted to guide the distal end of the imaging module to deflect towards the working port, so as to allow the imaging module to acquire image information at and around the working port; and, the inner wall of the puncture section is adapted to guide the distal end of the puncture member to move to the working port.

[0019] In some embodiments, the percutaneous pericardiocentesis assembly further includes:

[0020] A puncture introduction stent adapted to be passed through the negative pressure suction channel;

[0021] The puncture introduction stent includes a rod member and a blunt head end provided at the distal end of the rod member. The blunt head end has a conical structure, and the distal end of the blunt head end is a tip, the proximal end of the blunt head end is a large end, and the outer diameter of the large end is adapted to the caliber of the working port, and is adapted to allow the blunt head end to penetrate through the puncture port.

[0022] In some embodiments, the blunt head end is made of a transparent material, and a receiving space is provided at the distal end of the blunt head end;

[0023] The rod member has a slit communicating with the receiving space, and is adapted to allow the imaging module to enter the receiving space from the slit.

[0024] In some embodiments, a connecting pipe section is provided at the proximal end of the tube body;

[0025] The connecting pipe section is provided with a first connection channel, a second connection channel and a third connection channel. The first connection channel communicates with the negative pressure suction channel, the second connection channel communicates with the puncture channel, and the third connection channel communicates with the imaging channel; and, sealing valves are provided at the proximal ends of the second connection channel and the third connection channel.

[0026] In some embodiments, an annular clamping platform is provided at the proximal end of the first connection channel;

[0027] A clamping member is provided at the proximal end of the rod member. The clamping member includes a connecting portion and a hook. The connecting portion is provided at the proximal end of the rod member, the hook is provided at the distal end of the connecting portion, and a clamping space is formed between the hook and the connecting portion. The annular clamping platform is adapted to be clamped in the clamping space to connect the tube body and the puncture introduction stent.

[0028] In some embodiments, a limiting member is clamped at the proximal end of the puncture member. When the puncture member passes through the puncture channel, the limiting member is located outside the puncture tube and is used to limit the puncture depth of the puncture member.

[0029] In some embodiments, the distal end face of the puncture section is planar or inclined, and at least the wall surface of the distal end of the puncture section is blunt; and / or, the puncture member has a hollow internal structure and is adapted to allow a guide wire to pass therethrough.

[0030] The present application also provides a percutaneous pericardiocentesis system, comprising: a negative pressure suction device and the percutaneous pericardiocentesis assembly provided in any of the above embodiments.

[0031] The technical effects of the present application are as follows:

[0032] 1. In the present application, by providing a puncture channel and a negative pressure suction channel on the puncture tube, the puncture function and the negative pressure suction function are integrated. The negative pressure suction function can be used to capture the parietal pericardium, forming a certain interval between it and the visceral pericardium. Then, in combination with the puncture function, the puncture member can puncture the parietal pericardium under the negative pressure suction state without damaging the visceral pericardium, solving the problems of high puncture risk and difficult operation caused by trace or small amounts of pericardial effusion in the current clinical percutaneous pericardiocentesis, and greatly improving the safety and success rate of percutaneous pericardiocentesis under all indications.

[0033] 2. In the present application, an imaging channel is also provided on the puncture tube, which can integrate the visualization function and realize the real-time visualization of the in-vivo puncture operation, solving the problem of the lack of direct vision image guidance in the current clinical pericardiocentesis and being more conducive to the operation of medical staff.

[0034] 3. The present application also provides a puncture introduction stent, which can be inserted into the suction channel, and the blunt head end thereon can be used to penetrate the tissue of the chest wall muscle layer after local anesthesia, solving the problem that the puncture tube has a large tube diameter due to the integration of the puncture function, the negative pressure suction function, and the visualization function, resulting in an unsatisfactory penetration effect. Moreover, the present application uses a blunt head end, which can minimize tissue damage and bleeding to the greatest extent. At the same time, the blunt head end is made of a transparent material, which does not affect the image information acquisition of the imaging module. Description of the Drawings

[0035] The present invention will be further described in detail below in conjunction with the drawings and specific embodiments:

[0036] Figure 1 is a schematic structural diagram of the percutaneous pericardiocentesis system provided in an embodiment of the present application;

[0037] Figure 2 is a schematic structural diagram of the percutaneous pericardiocentesis assembly provided in an embodiment of the present application;

[0038] Figure 3 is a schematic structural diagram of the puncture tube provided in an embodiment of the present application;

[0039] Figure 4It is a schematic structural view of an imaging module penetrating through a puncture tube provided in an embodiment of the present application;

[0040] Figure 5 It is a cross-section of a tube body provided in an embodiment of the present application;

[0041] Figure 6 It is a cross-section of a tube body provided in another embodiment of the present application;

[0042] Figure 7 It is a schematic structural view of a puncture introduction stent provided in an embodiment of the present application;

[0043] Figure 8 It is a schematic structural view of a puncture introduction stent penetrating through a puncture tube provided in an embodiment of the present application;

[0044] Figure 9 It is a structural view of a puncture member, a limiting member, and a guide wire provided in an embodiment of the present application.

[0045] Reference numerals:

[0046] 100, puncture tube; 110, tube body; 111, puncture channel; 112, negative pressure suction channel; 113, imaging channel; 120, puncture section; 121, working port; 130, connecting tube section; 131, first connection channel; 132, second connection channel; 133, third connection channel; 134, sealing valve; 135, annular clamping platform;

[0047] 200, puncture member;

[0048] 300, limiting member;

[0049] 400, negative pressure suction device; 410, vacuum pump; 420, negative pressure drainage bottle; 430, negative pressure pipeline;

[0050] 500, imaging module; 510, camera; 520, video transmission module; 530, video receiving cable;

[0051] 600, puncture introduction stent; 610, rod member; 620, blunt head end; 621, accommodating space; 630, engaging member; 631, connecting portion; 632, hook; 633, engaging space;

[0052] 700, guide wire;

[0053] 800, parietal pericardium. Detailed implementation manners

[0054] In the following description, specific details such as specific system architectures and technologies are presented for purposes of illustration rather than limitation, so as to provide a thorough understanding of the embodiments of the present application. However, those skilled in the art should understand that the present application can also be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to avoid unnecessary details from obscuring the description of the present application.

[0055] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will describe the specific implementation manners of the present application with reference to the accompanying drawings. Obviously, the accompanying drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings, and other implementation manners can also be obtained.

[0056] To make the drawings concise, only the parts related to the present application are schematically shown in each drawing, and they do not represent the actual structure of the product. Additionally, to make the drawings concise and easy to understand, for components with the same structure or function in some drawings, only one of them is schematically illustrated, or only one of them is labeled. In this document, "one" not only means "only one", but also can mean "more than one" situation.

[0057] It should also be further understood that the term "and / or" used in the specification and appended claims of the present application refers to any combination and all possible combinations of one or more of the related listed items, and includes these combinations.

[0058] In this document, it should be noted that unless otherwise clearly specified and limited, the terms "mounted", "connected", and "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific situations.

[0059] In the embodiments shown in the drawings, the indication of directions (such as up, down, left, right, front, and back) is used to explain that the structures and movements of various components of the present application are not absolute but relative. When these components are in the positions shown in the drawings, these explanations are appropriate. If the descriptions of the positions of these components change, then the indication of these directions also changes accordingly.

[0060] In addition, in the description of the present application, terms such as "first" and "second" are only used for distinguishing descriptions and cannot be construed as indicating or implying relative importance. Also, in the description of the present application, "proximal end" refers to the end closer to the operator along the length direction of the percutaneous pericardiocentesis assembly, and "distal end" refers to the end farther from the operator along the length direction of the percutaneous pericardiocentesis assembly.

[0061] Currently, for cases that require percutaneous pericardiocentesis clinically, most of them have a small amount of fluid accumulation in the puncture area, or the heart beating affects the needle insertion angle, or a pericardial cavity track needs to be established under normal pericardial conditions. During pericardiocentesis, the parietal pericardium is punctured, and in the above case situations, there is a high risk of accidentally puncturing the visceral pericardium together.

[0062] To solve the major clinical problems in current clinical percutaneous pericardiocentesis, such as high puncture risks caused by trace or small amounts of pericardial effusion, and difficulties in accessing the epicardial instruments under normal pericardial conditions, the present application provides a percutaneous pericardiocentesis assembly.

[0063] In a specific embodiment, referring to Figure 1 and Figure 2 , the percutaneous pericardiocentesis assembly includes a puncture tube 100 and a puncture member 200. The puncture tube 100 further includes a tube body 110 and a puncture section 120 provided at the distal end of the tube body 110. A puncture channel 111 and a negative pressure suction channel 112 are formed inside the tube body 110. A working port 121 is formed at the distal end of the puncture section 120, and the working port 121 communicates with the puncture channel 111 and the negative pressure suction channel 112. Among them, the proximal end of the negative pressure suction channel 112 is adapted to be connected to a negative pressure suction device 400 to provide negative pressure for the working port 121 to adsorb the parietal pericardium 800; the puncture channel 111 is used for the puncture member 200 to pass through, and the distal end of the puncture member 200 is adapted to puncture the adsorbed parietal pericardium 800.

[0064] In this embodiment, by providing a puncture channel 111 and a negative pressure suction channel 112 on the puncture tube 100, the puncture function and the negative pressure suction function are integrated. The negative pressure suction function can be used to capture the parietal pericardium 800, forming a certain interval between the parietal pericardium 800 and the visceral pericardium; combined with the puncture function, the puncture member 200 can puncture the parietal pericardium 800 under the negative pressure suction state without damaging the visceral pericardium, solving the problems of high puncture risks and difficult operations in current clinical percutaneous pericardiocentesis due to trace or small amounts of pericardial effusion and puncture under normal pericardial conditions, greatly improving the safety and success rate of percutaneous pericardiocentesis for all indications. Moreover, during the puncture process, if there is pericardial effusion, the negative pressure suction channel 112 externally connected to the negative pressure suction device 400 can also play a role in rapid drainage, thus alleviating the condition and improving symptoms. The structural arrangement is reasonable and the utilization rate is high.

[0065] Preferably, the axial length of the puncture section 120 is controlled within 4 cm to provide space for adsorbing and capturing the parietal pericardium 800. When a part of the parietal pericardium 800 is sucked into the interior of the puncture section 120, a negative pressure adsorption state can be maintained for the puncturing member 200 to puncture the parietal pericardium 800.

[0066] See Figure 3 , to improve the negative pressure suction function of the puncture tube 100 and enable it to better capture the parietal pericardium 800 to achieve pericardiocentesis, the negative pressure suction channel 112 and the working port 121 should be coaxially arranged, and the caliber size of the working port 121 is consistent with the inner diameter size of the negative pressure suction channel 112, which is more conducive to the negative pressure suction device 400 to quickly evacuate the periphery of the working port 121, so as to realize the quick adsorption and capture of the parietal pericardium 800 by the working port 121, and the capture effect is better and it is not easy to loosen.

[0067] In addition, the distal end face of the puncture section 120 serves as the contact surface with the parietal pericardium, and is preferably a flat surface or an inclined surface, which is conducive to improving the negative pressure tightness of the contact between the distal end of the puncture section 120 and the parietal pericardium 800, and further improving the capture ability of the puncture section 120 for the parietal pericardium 800. At the same time, at least the inner and outer wall surfaces of the distal end of the puncture section 120 are smooth wall surfaces after blunt treatment. Because during the adsorption and capture process, the parietal pericardium 800 will be in close contact with the distal end face of the puncture section 120, and in addition, there is also a part of the parietal pericardium 800 that will be sucked into the interior of the puncture section 120, the inner and outer wall surfaces of the distal end of the puncture section 120 will inevitably come into contact with the parietal pericardium 800. By making at least the inner and outer wall surfaces of the distal end of the puncture section 120 be smooth wall surfaces after blunt treatment, the physical damage caused by the contact between the parietal pericardium 800 and the puncture section 120 can be effectively reduced.

[0068] Furthermore, the outer diameter size of the puncture section 120 gradually increases from the distal end to the proximal end, and its external contour is generally in a frustum shape, and the outer wall surface of the puncture section 120 is a smooth wall surface after blunt treatment, which can reduce the physical damage caused by the contact between biological tissues and the puncture section 120 when the puncture tube 100 moves in the human body.

[0069] Relatively, the inner diameter size of the puncture section 120 gradually increases from the distal end to the proximal end. At this time, the puncture section 120 as a whole has a single-chamber variable-diameter tube structure, and the inner wall surface of the puncture section 120 will form a guiding structure to guide the distal end of the puncturing member 200 passing through the puncture channel 111 to move towards the direction close to the working port 121, which is beneficial to the puncturing member 200 to puncture the cell wall layer that has been adsorbed and captured, and the structural setting is reasonable and practical.

[0070] In a preferred embodiment, see Figure 2 and Figure 4The percutaneous pericardial puncture assembly also includes an imaging module 500. At this time, an imaging channel 113 is opened inside the tube body 110 of the puncture tube 100 for the imaging module 500 to pass through, so that the imaging module 500 can collect image information of the working port 121 and its vicinity in real time, thereby realizing real-time visualization of the in vivo puncture operation, solving the problem of lack of direct image guidance in current clinical pericardiocentesis, and reducing the difficulty of surgical operation.

[0071] Specifically, the imaging module 500 includes a camera 510, a video transmission module 520, and a video receiving cable 530, wherein the camera 510 uses a high-resolution miniature cold light source CMOS camera 510, is actively connected to the video transmission module 520, and is electrically connected to an external imaging device, such as a personal PC terminal, through a video receiving line. The personal PC terminal drives the imaging module 500, and receives and displays the collected image information, thereby realizing visual monitoring of the working port 121 of the puncture segment 120 and its surrounding area.

[0072] In this embodiment, the camera 510 can be fixed at the distal end of the imaging channel 113, or at a position close to the proximal end of the puncture section 120. No further restrictions are made here, and all are within the scope of protection of this application. When the camera 510 is fixed at a position close to the proximal end of the puncture section 120, the inner wall surface of the puncture section 120 can also guide the camera 510 to deviate toward the working port 121, which is more conducive to the imaging module 500 obtaining image information at the working port 121 and its surroundings.

[0073] In actual production, see Figure 3 , Figure 5 and Figure 6 , the negative pressure suction channel 112 is preferably arranged at the center of the tube body 110, that is, the negative pressure suction channel 112, the tube body 110 and the working port 121 are all coaxially arranged, and the puncture channel 111 and the imaging channel 113 are arranged on the circumference of the negative pressure suction channel 112. For example, the puncture channel 111, the negative pressure suction channel 112 and the imaging channel 113 are arranged in sequence along the radial direction of the tube body 110. In addition, the distal openings of the puncture channel 111, the negative pressure suction channel 112 and the imaging channel 113 may be located in the same plane or not. If they are not located in the same plane, the distal openings of the puncture channel 111, the distal opening of the imaging channel 113 and the distal opening of the negative pressure suction channel 112 are arranged from the distal end to the proximal end. Among them, the imaging channel 113 can be a quadrangular prism-shaped channel or a cylindrical channel, which will not be repeated here, and are all within the protection scope of this application.

[0074] Specifically, see Figure 1 , Figure 3 and Figure 4, a connecting pipe section 130 is provided at the proximal end of the pipe body 110. The connecting pipe section 130 is provided with a first connecting channel 131, a second connecting channel 132 and a third connecting channel 133, forming a multi-chamber pipe with a special shape with a three-chamber channel. Among them, the distal end of the first connecting channel 131 communicates with the negative pressure suction channel 112, and the proximal end of the first connecting channel 131 can be used to externally connect a negative pressure suction device 400, so as to realize the docking between the negative pressure suction channel 112 and the negative pressure suction device 400; the distal end of the second connecting channel 132 communicates with the puncture channel 111, and the puncture member 200 penetrates from the proximal opening of the second connecting channel 132 into the puncture channel 111; correspondingly, the distal end of the third connecting channel 133 communicates with the imaging channel 113, and the imaging module 500 penetrates from the proximal opening of the third connecting channel 133 into the imaging channel 113.

[0075] In this embodiment, the passing outer diameter of the puncture member 200 is slightly smaller than the inner diameters of the puncture channel 111 and the second connecting channel 132, so that the puncture member 200 can smoothly penetrate into the puncture channel 111, and a sealing valve 134 is provided at the proximal end of the second connecting channel 132, which can form a damping with the puncture member 200, which can not only ensure the mobility of the puncture operation, but also avoid unnecessary position movement after the puncture member 200 is in place, and the safety is higher. Correspondingly, the passing outer diameter of the imaging module 500 is slightly smaller than the inner diameters of the imaging channel 113 and the third connecting channel 133, so that the imaging module 500 can smoothly penetrate into the imaging channel 113, and a sealing valve 134 is provided at the proximal end of the third connecting channel 133, which can form a damping with the imaging module 500, ensuring that there will be no unnecessary position movement after the imaging module 500 is in place, which is beneficial to the stable acquisition of image information.

[0076] In an exemplary embodiment, the proximal opening of the first connecting channel 131 is opened at the proximal end of the connecting pipe section 130, and the proximal openings of the second connecting channel 132 and the third connecting channel 133 are respectively opened on the opposite sides or one side of the connecting pipe section 130 in the radial direction. There is no limitation here, and they are all within the protection scope of this application.

[0077] In order to minimize the radial dimension of the pipe body 110 as much as possible, the inner diameter dimension of the puncture channel 111 should not exceed 2.0 mm, and the inner diameter dimension of the imaging channel 113 is controlled within the range of 1-2 mm. However, since the pipe body 110 integrates the puncture function, the negative pressure suction function and the visualization function, its radial dimension is difficult to achieve an ideal penetration effect.

[0078] Therefore, refer to Figure 7 and Figure 8, in a preferred embodiment, the percutaneous pericardiocentesis assembly further includes a puncture introduction stent 600. The puncture introduction stent 600 includes a rod member 610 and a blunt tip 620 provided at the distal end of the rod member 610. The blunt tip 620 has a conical structure. Specifically, the distal end of the blunt tip 620 is a tip, and the proximal end of the blunt tip 620 is a large end. The puncture introduction stent 600 is inserted through the proximal opening of the first connection channel 131 into the negative pressure suction channel 112. After being inserted, the blunt tip 620 of the puncture introduction stent 600 can penetrate out of the puncture port, providing blunt separation and breakthrough of the chest wall muscle layer, thereby solving the problem that the diameter of the tube body 110 of the puncture tube 100 is relatively large due to the integrated puncture function, negative pressure suction function, and visualization function, resulting in an unsatisfactory penetration effect.

[0079] In this embodiment, the negative pressure suction channel 112 has both the functions of negative pressure suction and the function of being compatible with the introduction of the puncture introduction stent 600. The structural setting is reasonable, effective, and has a high utilization rate. Relatively, the connecting pipe section 130 has the functions of connecting the imaging module 500, connecting the negative pressure suction device 400, introducing the puncture introduction stent 600, and introducing the puncture member 200. And the connecting pipe section 130 can also be used as the holding part for medical staff during pericardiocentesis, with strong practicability. In actual production, the external contour shape of the connecting pipe section 130 can be specially set with reference to the principles of human hand ergonomics to improve the comfort of medical staff during the operation.

[0080] Preferably, the outer diameter dimension of the large end of the blunt tip 620 is adapted to the caliber dimension of the working port 121, and is only slightly smaller than the caliber dimension of the working port 121 and the inner diameter dimension of the negative pressure suction channel 112. When the puncture introduction stent 600 is inserted into the negative pressure suction channel 112, it can form a blunt penetration catheter with a tip similar to a pen tip together with the puncture tube 100, for penetrating the tissue of the chest wall muscle layer after local anesthesia, minimizing tissue damage and bleeding to the greatest extent.

[0081] Specifically, the blunt tip 620 is made of a transparent material, such as a high-transparency high-strength hard material, which can achieve tissue penetration without affecting the image information acquisition of the imaging module 500. If the camera 510 in the imaging module 500 is fixed at a position close to the proximal end of the puncture section 120, a receiving space 621 can be provided at the distal end of the blunt tip 620 for placing the camera 510. At this time, the rod member 610 has a gap communicating with the receiving space 621, through which the imaging module 500 can enter and exit the inside of the receiving space 621.

[0082] Further, refer to Figure 3 、 Figure 7 and Figure 8, to ensure the penetration effect of the puncture-introducing stent 600 and enable the puncture-introducing stent 600 and the puncture tube 100 to move synchronously and stably during the penetration process, the proximal end of the puncture-introducing stent 600 should be locked with the proximal end of the connecting pipe section 130, thereby restricting the movement of the puncture-introducing stent 600 relative to the puncture tube 100 during the penetration process.

[0083] Specifically, a circular clamping platform 135 is provided at the proximal end of the first connection channel 131, and a clamping member 630 that can be clamped with the circular clamping platform 135 is provided at the proximal end of the rod member 610. The clamping member 630 includes a connecting portion 631 and a hook 632. The connecting portion 631 is provided at the proximal end of the rod member 610, the hook 632 is provided at the distal end of the connecting portion 631, and a clamping space 633 is formed between the hook 632 and the connecting portion 631. The circular clamping platform 135 is adapted to be clamped in the clamping space 633 to connect the pipe body 110 and the puncture-introducing stent 600.

[0084] Of course, in actual production, the puncture-introducing stent 600 and the first connection channel 131 can also be fixed by screw-thread matching to restrict the movement of the puncture-introducing stent 600 relative to the puncture tube 100 during the penetration process. For example, an internal thread is provided on the inner wall surface of the proximal end of the first channel, an external thread is provided on the outer wall surface of the proximal end of the rod member 610, and a handle for medical staff to rotate the rod member 610 is provided at the proximal end of the rod member 610. The medical staff can grasp the handle and rotate the rod member 610 to achieve the fixation and separation of the puncture-introducing stent 600 and the puncture tube 100.

[0085] Specifically, referring to Figure 2 and Figure 9 , a limiting member 300 is further clamped at the proximal end of the puncture member 200. When the puncture member 200 penetrates through the puncture channel 111, the limiting member 300 is located outside the puncture tube 100 and is used to limit the puncture depth of the puncture member 200. The limiting member 300 can be an injection-molded part in the form of a butterfly clip and is conventionally loaded at a position close to the proximal end of the puncture member 200.

[0086] In this embodiment, the clamping position of the limiting member 300 on the puncture member 200 should ensure that the maximum puncture depth of the puncture member 200 does not exceed the working opening 121 of the puncture section 120 to prevent the occurrence of pericardiocentesis complications such as myocardial perforation. Of course, if necessary for clinical operations, the puncture depth of the puncture member 200 can also be appropriately adjusted by adjusting the clamping position of the limiting member 300 on the puncture member 200.

[0087] Furthermore, the puncture member 200 is preferably an ultra-long customized stainless-steel hollow puncture member 200, and its internal hollow structure is suitable for the wire 700 to pass through.

[0088] The percutaneous pericardiocentesis assembly provided by the present application has its main working modules composed of an integrated imaging module 500, a puncture introduction stent 600, a negative pressure suction device 400, and a puncture tube 100 of a puncture member 200. Among them, the imaging module 500 can provide real-time visualization of in-vivo puncture operations; the transparent blunt tip 620 of the puncture introduction stent 600 can provide blunt separation and breakthrough of the chest wall muscle layer without affecting visualization; the puncture tube 100 after being connected to the negative pressure suction device 400 can non-invasively capture the parietal pericardium 800 under negative pressure and suck the local parietal pericardium 800 into the puncture section 120; the puncture member 200 can puncture the sucked and bulged parietal pericardium 800 and send a guide wire 700 into it to establish a track, thereby completing a pericardiocentesis similar to under direct vision, solving major clinical problems such as the lack of direct vision image guidance in current clinical percutaneous pericardiocentesis, high risk of puncture for trace or small amounts of pericardial effusion, difficulty in the approach of epicardial instruments in the normal pericardial state, and lack of guarantee for the safety of existing operations, and greatly improving the safety and success rate of pericardiocentesis for all indications.

[0089] See Figure 1 , the present application also provides a percutaneous pericardiocentesis system, including a negative pressure suction device 400 and the percutaneous pericardiocentesis assembly provided in any of the above embodiments. Among them, the negative pressure suction device 400 is of a general configuration and is composed of a vacuum pump 410, a negative pressure drainage bottle 420, and a negative pressure pipeline 430. One end of the negative pressure pipeline 430 is connected to a first connection channel 131 on the proximal connection pipe section 130 of the puncture tube 100, and the other end is sequentially connected to the negative pressure drainage bottle 420 and the vacuum pump 410. When preparing for pericardial capture, the vacuum pump 410 is turned on, and the puncture tube 100 can then have the function of capturing the pericardium under negative pressure; if there is pericardial effusion during the puncture process, the puncture tube 100 can have the function of draining pericardial effusion.

[0090] Specifically, the percutaneous pericardiocentesis system further includes an imaging device that can acquire and display the image information output by the imaging module 500 for medical staff to observe. Among them, the imaging device can adopt a personal PC terminal, which can drive the imaging module 500 and receive and display the collected image information, thereby realizing visual monitoring of the working port 121 of the puncture section 120 and its peripheral area.

[0091] The percutaneous pericardiocentesis assembly and system provided by the present application take the puncture tube 100 with a variable-diameter multi-channel structure as the core working component, enabling it to flexibly and compatibly assemble the imaging module 500, the puncture introduction stent 600, the negative pressure suction device 400, and the puncture member 200, and having functions such as visualization, blunt puncture, negative pressure capture of the pericardium, safe and controllable puncture, and pericardial effusion drainage, thereby realizing a pericardial negative pressure capture puncture under near direct vision, providing new instruments and new methods for overcoming the problems of high requirements, high risks, and many complications in current clinical pericardiocentesis.

[0092] Specifically, the usage method of the percutaneous pericardiocentesis system is as follows:

[0093] First, prepare the items required for percutaneous pericardiocentesis, including items related to disinfection and aseptic operation, a bedside cardiac ultrasound device, and a set of percutaneous pericardiocentesis systems (in a sterile state). Subsequently, evaluate the patient's cardiac function and the approximate position and direction of pericardiocentesis through bedside cardiac ultrasound, and mark the approximate position and direction of pericardiocentesis. Next, perform pre-puncture disinfection, draping, local infiltration anesthesia, and skin puncture. Assemble the puncture tube 100, the puncture introduction stent 600, and the imaging module 500, and externally connect a personal PC terminal through a video receiving cable for video image display, thereby forming a visualized catheter with a transparent blunt structure at the head end. Then, perform blunt puncture along the direction of the ultrasound path until the muscle layer is penetrated, that is, a light red pulsating organ (the heart) is seen on the video display of the personal PC terminal. At this time, withdraw the puncture introduction stent 600 from the first connection channel 131 of the connecting pipe section 130 and connect the negative pressure suction device 400. Send the puncture piece 200 through the second connection channel 132 of the connecting pipe section 130, and install the limiting piece 300 at a position near the proximal end of the puncture piece 200. Confirm the mobility and puncture range of the distal end of the puncture piece 200 inside the puncture section 120 through the video monitoring of the personal PC terminal. After that, start to prepare for pericardial capture. Start the vacuum pump 410, adjust its negative pressure to an appropriate level, and then control the working port 121 of the puncture tube 100 to slowly approach the pericardium under the guidance of the video monitoring of the personal PC terminal until the pericardium is captured by negative pressure. At this time, the negative pressure of the vacuum pump 410 is adjusted to the maximum, and a part of the parietal pericardium 800 is sucked into the inside of the puncture section 120 of the puncture tube 100 and bulges into a spherical shape. Use cardiac ultrasound to confirm the relationship between the puncture tube 100 and the heart to avoid accidentally aspirating other tissues. After confirmation, operate the puncture piece 200 to puncture the dome-shaped parietal pericardium 800 sucked by negative pressure. When the puncture piece 200 penetrates the parietal pericardium 800, the pericardial effusion between the parietal pericardium 800 and the visceral pericardium is aspirated. At this time, keep the position of the puncture piece 200 and send the guide wire 700 along the puncture piece 200 to establish a track. After confirming through cardiac ultrasound that the guide wire 700 is located in the pericardial cavity, the percutaneous pericardiocentesis is safely completed, overcoming the problems of high requirements, high risks, and many complications in current clinical pericardiocentesis.

[0094] In the above embodiments, the descriptions of each embodiment have their own focuses. For parts not described or recorded in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0095] It should be noted that the above embodiments can be freely combined as needed. The above are only the preferred embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the present application, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present application.

Claims

1. A percutaneous pericardiocentesis assembly, characterized in that, Comprising: A puncture tube and a puncture member; The puncture tube includes a tube body and a puncture section provided at the distal end of the tube body. A puncture channel and a negative pressure suction channel are provided inside the tube body. The outer diameter of the puncture section gradually increases from the distal end to the proximal end, and a working port is provided at the distal end of the puncture section. The working port communicates the puncture channel and the negative pressure suction channel; The proximal end of the negative pressure suction channel is adapted to be docked with a negative pressure suction device to provide negative pressure for the working port to adsorb the pericardial parietal layer; the puncture channel is used for the puncture member to pass through, and the distal end of the puncture member is adapted to puncture the adsorbed pericardial parietal layer.

2. The percutaneous pericardiocentesis assembly according to claim 1, wherein The negative pressure suction channel, the tube body and the working port are coaxially arranged, and the caliber size of the working port is consistent with the inner diameter size of the negative pressure suction channel.

3. The percutaneous pericardiocentesis assembly according to claim 2, wherein Further comprising: An imaging module; An imaging channel is provided inside the tube body and is adapted for the imaging module to pass through; Wherein, the inner diameter of the puncture section gradually increases from the distal end to the proximal end, and is adapted to guide the distal end of the imaging module to deflect towards the working port for the imaging module to obtain image information at and around the working port; and, the inner wall of the puncture section is adapted to guide the distal end of the puncture member to move to the working port.

4. The percutaneous pericardiocentesis assembly according to claim 3, wherein, Further comprising: A puncture introduction stent adapted to pass through the negative pressure suction channel; The puncture introduction stent includes a rod member and a blunt head end provided at the distal end of the rod member. The blunt head end has a conical structure, and the distal end of the blunt head end is a tip, and the proximal end of the blunt head end is a large end. The outer diameter size of the large end is adapted to the caliber size of the working port and is adapted for the blunt head end to pass through the puncture port.

5. The percutaneous pericardiocentesis assembly according to claim 4, wherein The blunt head end is made of a transparent material, and a receiving space is provided at the distal end of the blunt head end; The rod member has a gap communicating with the receiving space and is adapted for the imaging module to enter the receiving space from the gap.

6. The percutaneous pericardiocentesis assembly according to claim 5, wherein A connecting tube section is provided at the proximal end of the tube body; The connecting tube section is provided with a first connecting channel, a second connecting channel and a third connecting channel. The first connecting channel communicates with the negative pressure suction channel, the second connecting channel communicates with the puncture channel, and the third connecting channel communicates with the imaging channel; And, sealing valves are provided at the proximal ends of the second connecting channel and the third connecting channel.

7. The percutaneous pericardiocentesis assembly according to claim 6, wherein An annular clamping platform is provided at the proximal end of the first connecting channel; A clamping member is provided at the proximal end of the rod member. The clamping member includes a connecting portion and a hook. The connecting portion is provided at the proximal end of the rod member, and the hook is provided at the distal end of the connecting portion. A clamping space is formed between the hook and the connecting portion, and the annular clamping platform is adapted to be clamped in the clamping space to connect the tube body and the puncture introduction stent.

8. The percutaneous pericardiocentesis assembly according to any one of claims 1-7, wherein A limiting member is clamped at the proximal end of the puncturing member. When the puncturing member passes through the puncturing channel, the limiting member is located outside the puncturing tube and is used to limit the puncturing depth of the puncturing member.

9. The percutaneous pericardiocentesis assembly according to any one of claims 1-7, wherein the distal end face of the puncturing section is a plane or an inclined plane, and at least the wall surface of the distal end of the puncturing section is blunt; and / or the puncturing member has a hollow internal structure and is adapted to allow a guide wire to pass through.

10. A percutaneous pericardiocentesis system, characterized in that, comprising: a negative pressure suction device and the percutaneous pericardiocentesis assembly according to any one of claims 1-9.

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