Percutaneous pericardiopuncture assembly and system

Abstract

A percutaneous pericardial puncture assembly and system, the percutaneous pericardiopuncture assembly comprises a puncture tube and a puncture piece, the puncture tube comprises a tube body and a puncture section arranged at the distal end of the tube body. A puncture channel, a negative pressure suction channel and an imaging channel are arranged in the tube body, and are communicated with the working port at the distal end of the puncture section. The imaging module is arranged in the imaging channel to realize real-time visualization of the in-vivo puncture operation; the proximal end of the negative pressure suction channel can be connected to a negative pressure suction device to provide negative pressure for the working port and then adsorb the pericardial wall layer; the puncture piece is arranged in the puncture channel and can puncture the adsorbed pericardial wall layer. By arranging the negative pressure suction channel, the pericardial wall layer can be captured before the puncture piece punctures, so that even if only a small amount of pericardial effusion exists between the pericardial wall layer and the pericardial visceral layer, the medical staff can also complete the puncture of the pericardial wall layer without damaging the pericardial visceral layer, the operation is simple, and the safety and success rate of percutaneous pericardial puncture under full indications are greatly improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a percutaneous pericardial puncture component and system. Background Technology

[0002] The pericardial cavity is one of the most important anatomical spaces in the body. Chronic or acute pericardial effusion can severely affect the heart's diastolic and systolic functions, and in severe cases, can lead to cardiogenic shock or death, constituting a serious complication of various related diseases and surgeries. Therefore, in recent years, how to safely and effectively perform pericardiocentesis has become a crucial issue that urgently needs to be addressed in the treatment of heart-related diseases.

[0003] Currently, the number of passive puncture procedures for various complications of cardiac tamponade in China can reach up to 58,000 cases per year. From a clinical application perspective, pericardiocentesis is necessary for both radiofrequency ablation of epicardial ventricular tachycardia and drainage of pericardial effusion. However, traditional percutaneous pericardiocentesis is highly dependent on the operator's skill and understanding of anatomical relationships, characterized by a long learning curve and a high incidence of puncture complications. Common pericardiocentesis complications include cardiac perforation, arrhythmia, bleeding, infection, pneumothorax, and coronary artery injury. Moreover, unlike pericardiocentesis drainage performed when there is a large amount of pericardial effusion, many cases requiring pericardiocentesis in clinical practice are usually due to a small amount of effusion in the puncture area, the heartbeat affecting the needle insertion angle, or the need to establish a pericardial cavity track under normal pericardial conditions.

[0004] Since Sosa et al. first reported in 1996 the successful treatment of a Chagas disease patient with ventricular tachycardia dependence via subxiphoid pericardiocentesis for epicardial ablation, dry pericardiocentesis has been widely used. The dry pericardiocentesis method described by Sosa et al. is also known as the Sosa method. However, due to the risks of pericardial hemorrhage of varying degrees, damage to surrounding organs, and even cardiac tamponade, many electrophysiology centers have reservations about performing this technique.

[0005] Ultrasound-guided pericardiocentesis is currently the preferred clinical method. However, ultrasound-guided pericardiocentesis is easily affected by obstruction from the lungs and diaphragm, patient positioning limitations, and the operator's skill in using the ultrasound equipment. Computed tomography (CT)-guided pericardiocentesis is an accurate, safe, and effective method that can provide high-resolution three-dimensional images and accurately locate the puncture point. However, this technique has limitations such as the inability to move large equipment, difficulties in transporting critically ill patients, the need for a radiology team, and a long operation time (average 65 minutes), making it difficult to perform routinely.

[0006] The Israeli company CardioVia has innovatively developed a novel 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 1.1mm inner diameter concealed puncture device, a stainless steel spring-assisted telescopic tube (with a rotating serrated disc structure), a stainless steel inner tube, and a 146mm long stainless steel guide tube. The device contains a pathway allowing a guidewire to be inserted into the pericardial cavity. Pericardiocentesis is performed under general anesthesia and DSA fluoroscopy, and the specific steps include skin incision, pathway establishment, device insertion, and pericardial retrieval. Although preliminary trial results indicate that the device has good safety and effectiveness, accurate positioning and retrieval of the pericardium still present challenges in cases with complex anatomy or adhesions.

[0007] Therefore, how to improve the technical defects in the existing technology and solve the difficult pericardiocentesis operation in the above situation has always been a problem that ordinary people skilled in the art need to solve. Summary of the Invention

[0008] The purpose of this application is to provide a percutaneous pericardiocentesis component and system that can pre-capture the pericardial parietal layer, solving the problems of high puncture risk and difficult operation caused by small or minimal pericardial effusion in current clinical percutaneous pericardiocentesis, and greatly improving the safety and success rate of percutaneous pericardiocentesis under all indications.

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

[0010] A percutaneous pericardiocentesis assembly includes:

[0011] Puncture tubes and puncture devices;

[0012] The puncture tube includes a tube body and a puncture section located at the distal end of the tube body. The tube body has a puncture channel and a negative pressure suction channel. 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 connects the puncture channel and the negative pressure suction channel.

[0013] The proximal end of the negative pressure suction channel is adapted to connect to the negative pressure suction device, providing negative pressure to the working port to adsorb the pericardial wall layer; the puncture channel is used for the insertion of the puncture device, and the distal end of the puncture device is adapted to puncture the adsorbed pericardial wall layer.

[0014] In some embodiments, the negative pressure suction channel, the tube body, and the working port are all coaxially arranged, and the diameter of the working port is consistent with the inner diameter 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, which is suitable for the installation of the imaging module.

[0018] The inner diameter of the puncture section gradually increases from the distal end to the proximal end, which is suitable for guiding the distal end of the imaging module to shift towards the working port so that the imaging module can acquire image information at the working port and its surroundings; and the inner wall of the puncture section is suitable for guiding the distal end of the puncture piece to move to the working port.

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

[0020] A puncture-guided stent is suitable for insertion into a negative pressure suction channel.

[0021] The puncture-guided stent includes a rod and a blunt tip located at the distal end of the rod. The blunt tip has a conical structure, with the distal end being the pointed end and the proximal end being the large end. The outer diameter of the large end is matched with the diameter of the working port, which is suitable for the blunt tip to pass through the puncture port.

[0022] In some embodiments, the blunt tip is made of a transparent material, and the distal end of the blunt tip has an accommodating space.

[0023] The rod has a slit that connects to the accommodating space, which is suitable for the imaging module to enter the accommodating space through the slit.

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

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

[0026] In some embodiments, a ring-shaped card holder is provided near the first connecting channel;

[0027] The proximal end of the rod is provided with a locking component, which includes a connecting part and a hook. The connecting part is located at the proximal end of the rod, and the hook is located at the distal end of the connecting part. A locking space is formed between the hook and the connecting part. The annular locking platform is adapted to be locked in the locking space to connect the tube body and the puncture guide bracket.

[0028] In some embodiments, a limiting member is provided at the proximal end of the puncture member. When the puncture member is inserted into 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 segment is flat or inclined, and at least the distal wall of the puncture segment is blunt; and / or, the puncture element has an internal hollow structure suitable for guide wire insertion.

[0030] This 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 advantages of this application are as follows:

[0032] 1. In this application, by setting 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 pericardial wall layer, so that a certain gap is formed between it and the visceral pericardial layer. Combined with the puncture function, the puncture piece can puncture the pericardial wall layer under negative pressure suction without damaging the visceral pericardial layer. This solves the problems of high puncture risk and difficult operation caused by small or small amounts of pericardial effusion in current clinical percutaneous pericardiocentesis, and greatly improves the safety and success rate of percutaneous pericardiocentesis under all indications.

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

[0034] 3. This application also includes a puncture guide bracket that can be inserted into the suction channel. Its blunt tip can be used for tissue penetration into the chest wall muscle layer after local anesthesia, solving the problem of unsatisfactory penetration results due to the large diameter of the puncture tube caused by integrating puncture, negative pressure suction, and visualization functions. Furthermore, the blunt tip minimizes tissue damage and bleeding, and its transparent material does not interfere with image acquisition by the imaging module. Attached Figure Description

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

[0036] Figure 1 This is a schematic diagram of the percutaneous pericardiocentesis system provided in one embodiment of this application;

[0037] Figure 2 This is a schematic diagram of the percutaneous pericardiocentesis assembly provided in one embodiment of this application;

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

[0039] Figure 4This is a schematic diagram of the imaging module provided in one embodiment of the present application, which is inserted through a puncture tube;

[0040] Figure 5 This is a cross-section of the tube provided in one embodiment of this application;

[0041] Figure 6 This is a cross-section of the tube provided in another embodiment of this application;

[0042] Figure 7 This is a schematic diagram of the puncture-guided stent provided in one embodiment of this application;

[0043] Figure 8 This is a schematic diagram of the puncture insertion stent provided in one embodiment of the present application, which is inserted through a puncture tube;

[0044] Figure 9 This is a structural view of the puncture member, limiting member, and guide wire provided in one embodiment of this application.

[0045] Figure label:

[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 connecting channel; 132. Second connecting channel; 133. Third connecting channel; 134. Sealing valve; 135. Annular clamping station;

[0047] 200. Puncture pieces;

[0048] 300. Limiting components;

[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 insertion stent; 610. Rod; 620. Blunt tip; 621. Accommodating space; 630. Engaging component; 631. Connecting part; 632. Hook; 633. Accommodating space;

[0052] 700, guidewire;

[0053] 800. Pericardial parietal layer. Detailed Implementation

[0054] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application can also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of this application with unnecessary detail.

[0055] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the specific implementation methods of this application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of this application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0056] To keep the drawings concise, each drawing only schematically shows the parts relevant to this application, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some drawings, only one of the components with the same structure or function is schematically shown, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0057] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0058] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0059] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) used to explain the structure and movement of the various components of this application are relative rather than absolute. These descriptions are appropriate when these components are in the positions shown in the drawings. If the description of the positions of these components changes, these directional indications also change accordingly.

[0060] Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance. Also, in the description of this application, "proximal" refers to the end along the length of the percutaneous pericardial puncture assembly that is closer to the operator, and "distal" refers to the end along the length of the percutaneous pericardial puncture assembly that is farther from the operator.

[0061] Currently, most cases requiring percutaneous pericardiocentesis in clinical practice involve small amounts of fluid in the puncture site, or the heartbeat affects the needle insertion angle, or the pericardial cavity needs to be established under normal pericardial conditions. However, during pericardiocentesis, the puncture site is the parietal pericardium, and in the aforementioned cases, there is a high risk of puncturing the visceral pericardium as well.

[0062] To address the significant clinical challenges of percutaneous pericardiocentesis, such as the high risk of puncture due to small or minimal pericardial effusions and the difficulty of accessing epicardial devices in the presence of a normal pericardium, this application provides a percutaneous pericardiocentesis component.

[0063] In one specific embodiment, see Figure 1 and Figure 2 The percutaneous pericardiocentesis assembly includes a puncture tube 100 and a puncture element 200. The puncture tube 100 further includes a tube body 110 and a puncture section 120 located at the distal end of the tube body 110. The tube body 110 has a puncture channel 111 and a negative pressure suction channel 112 inside. The distal end of the puncture section 120 has a working port 121, which connects the puncture channel 111 and the negative pressure suction channel 112. The proximal end of the negative pressure suction channel 112 is adapted to engage with a negative pressure suction device 400 to provide negative pressure to the working port 121, thereby adsorbing the pericardial wall layer 800. The puncture channel 111 is used for the puncture element 200 to pass through, and the distal end of the puncture element 200 is adapted to puncture the adsorbed pericardial wall layer 800.

[0064] In this embodiment, by setting a puncture channel 111 and a negative pressure suction channel 112 on the puncture tube 100, it integrates the puncture function and the negative pressure suction function. The negative pressure suction function can be used to capture the pericardial wall layer 800, so that a certain gap is formed between the pericardial wall layer 800 and the visceral pericardium layer; combined with the puncture function, the puncture piece 200 can puncture the pericardial wall layer 800 under negative pressure suction without damaging the visceral pericardium layer. This solves the problems of high puncture risk and difficult operation caused by micro- or small amounts of pericardial effusion and puncture under normal pericardial conditions in current clinical percutaneous pericardiocentesis, and greatly improves the safety and success rate of percutaneous pericardiocentesis under all indications. Moreover, if pericardial effusion is present during the puncture, the negative pressure suction channel 112 connected to the external negative pressure suction device 400 can also play a role in rapid drainage, thereby relieving the condition and improving symptoms. The structure is reasonably designed and has a high utilization rate.

[0065] Preferably, the axial length of the puncture segment 120 is controlled within 4 cm to provide space for adsorption and capture of the pericardial wall layer 800. When part of the pericardial wall layer 800 is drawn into the puncture segment 120, a negative pressure adsorption state can be maintained for the puncture member 200 to puncture the pericardial wall layer 800.

[0066] See Figure 3 To improve the negative pressure suction function of the puncture tube 100 and enable it to better capture the pericardial wall layer 800 for pericardial puncture, the negative pressure suction channel 112 and the working port 121 should be coaxially arranged, and the diameter of the working port 121 should be consistent with the inner diameter of the negative pressure suction channel 112. This is more conducive to the negative pressure suction device 400 quickly drawing a vacuum around the working port 121, thereby enabling the working port 121 to quickly adsorb and capture the pericardial wall layer 800, with better capture effect and less detachment.

[0067] Furthermore, the distal end face of the puncture segment 120, serving as the contact surface of the pericardial wall layer, is preferably planar or inclined. This improves the negative pressure sealing between the distal end of the puncture segment 120 and the pericardial wall layer 800, further enhancing the capture ability of the puncture segment 120 for the pericardial wall layer 800. Simultaneously, at least the inner and outer walls of the distal end of the puncture segment 120 are smooth surfaces after blunt treatment. Because the pericardial wall layer 800 will be in close contact with the distal end face of the puncture segment 120 during the adsorption capture process, and because some of the pericardial wall layer 800 may be drawn into the interior of the puncture segment 120, the inner and outer walls of the distal end of the puncture segment 120 will inevitably come into contact with the pericardial wall layer 800. By making the inner and outer walls of at least the distal end of the puncture segment 120 smooth surfaces after blunt treatment, the physical damage caused by the contact between the pericardial wall layer 800 and the puncture segment 120 can be effectively reduced.

[0068] Furthermore, the outer diameter of the puncture segment 120 gradually increases from the distal end to the proximal end, and its outer contour is generally frustum-shaped. The outer wall surface of the puncture segment 120 is a smooth wall surface after blunt treatment, which can reduce the physical damage to biological tissues when the puncture tube 100 moves in the human body.

[0069] In contrast, the inner diameter of the puncture section 120 gradually increases from the distal end to the proximal end. At this time, the puncture section 120 has a single-lumen variable diameter tube structure, and the inner wall surface of the puncture section 120 forms a guide structure to guide the distal end of the puncture piece 200 that passes through the puncture channel 111 to move towards the working port 121. This is beneficial for the puncture piece 200 to puncture the cell wall layer that has been adsorbed and captured. The structure is reasonable and practical.

[0070] In a preferred embodiment, see Figure 2 and Figure 4The percutaneous pericardiocentesis 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 puncture operation in vivo, solving the problem of lack of direct image guidance in the current clinical pericardiocentesis, and reducing the difficulty of the operation.

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

[0072] In this embodiment, the camera 510 can be fixed at the far end of the imaging channel 113 or at a position near the proximal end of the puncture section 120. No further limitations are imposed, and both are within the scope of protection of this application. When the camera 510 is fixed at a position near the proximal end of the puncture section 120, the inner wall surface of the puncture section 120 can also guide the camera 510 to shift towards the working port 121, which is more conducive to the imaging module 500 acquiring image information at and around the working port 121.

[0073] In actual production, see Figure 3 , Figure 5 and Figure 6 The negative pressure suction channel 112 is preferably located at the center of the tube body 110, meaning that the negative pressure suction channel 112, the tube body 110, and the working port 121 are all coaxially arranged. The puncture channel 111 and the imaging channel 113 are located around 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 radially along the tube body 110. Furthermore, the distal openings of the puncture channel 111, the negative pressure suction channel 112, and the imaging channel 113 may or may not be located on the same plane. If they are not located on the same plane, the distal opening 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 sequentially from distal to proximal. The imaging channel 113 can be a quadrangular prism or a cylindrical channel; these are not elaborated upon here, but are all within the scope of protection of this application.

[0074] Specifically, see Figure 1 , Figure 3 and Figure 4The proximal end of the tube body 110 is provided with a connecting tube section 130, which has a first connecting channel 131, a second connecting channel 132, and a third connecting channel 133, forming a multi-lumen tube with a special shape and three lumens. The distal end of the first connecting channel 131 is connected to the negative pressure suction channel 112, and the proximal end of the first connecting channel 131 can be used to connect an external negative pressure suction device 400, thereby achieving docking between the negative pressure suction channel 112 and the negative pressure suction device 400. The distal end of the second connecting channel 132 is connected to the puncture channel 111, and the puncture member 200 is inserted into the puncture channel 111 through the proximal opening of the second connecting channel 132. Conversely, the distal end of the third connecting channel 133 is connected to the imaging channel 113, and the imaging module 500 is inserted into the imaging channel 113 through the proximal opening of the third connecting channel 133.

[0075] In this embodiment, the outer diameter of the puncture member 200 is slightly smaller than the inner diameter of the puncture channel 111 and the second connecting channel 132, so that the puncture member 200 can be smoothly inserted into the puncture channel 111. Furthermore, a sealing valve 134 is provided at the proximal end of the second connecting channel 132, which forms damping with the puncture member 200. This ensures the flexibility of the puncture operation and prevents unnecessary positional movement of the puncture member 200 after it is in place, thus enhancing safety. Conversely, the outer diameter of the imaging module 500 is slightly smaller than the inner diameter of the imaging channel 113 and the third connecting channel 133, so that the imaging module 500 can be smoothly inserted into the imaging channel 113. Furthermore, a sealing valve 134 is provided at the proximal end of the third connecting channel 133, which forms damping with the imaging module 500, ensuring that unnecessary positional movement of the imaging module 500 after it is in place, which is beneficial for the stable acquisition of image information.

[0076] In one example embodiment, the proximal opening of the first connecting channel 131 is opened at the proximal end of the connecting pipe segment 130, while the proximal openings of the second connecting channel 132 and the third connecting channel 133 are respectively opened on opposite sides or one side of the connecting pipe segment 130 in the radial direction. This is not limited and all are within the protection scope of this application.

[0077] To minimize the radial dimension of the tube body 110, the inner diameter of the puncture channel 111 should not exceed 2.0 mm, while the inner diameter of the imaging channel 113 should be controlled within the range of 1-2 mm. However, since the tube body 110 integrates puncture, negative pressure suction, and visualization functions, its radial dimension makes it difficult to achieve the ideal penetration effect.

[0078] Therefore, see Figure 7 and Figure 8In a preferred embodiment, the percutaneous pericardiocentesis assembly further includes a puncture guide stent 600, which includes a rod 610 and a blunt tip 620 located at the distal end of the rod 610. The blunt tip 620 has a conical structure, specifically, the distal end of the blunt tip 620 is a pointed tip, and the proximal end of the blunt tip 620 is a large end. The puncture guide stent 600 is inserted into the negative pressure suction channel 112 through the proximal opening of the first connecting channel 131, and after insertion, the blunt tip 620 of the puncture guide stent 600 can exit from the puncture port, providing blunt dissection breakthrough of the chest wall muscle layer, thereby solving the problem that the diameter of the tube 110 of the puncture tube 100 is large and the penetration effect is not ideal due to the integration of puncture function, negative pressure suction function, and visualization function.

[0079] In this embodiment, the negative pressure suction channel 112 serves both as a negative pressure suction function and a compatible insertion stent 600, exhibiting a reasonable, effective, and highly efficient structure. Conversely, the connecting tube 130 serves multiple functions, connecting the imaging module 500, the negative pressure suction device 400, the insertion stent 600, and the insertion puncture device 200. Furthermore, the connecting tube 130 can also be used as a handhold for medical personnel during pericardiocentesis, demonstrating its practicality. In actual production, the external contour shape of the connecting tube 130 can be specially designed based on human hand ergonomics to improve the comfort of medical personnel during procedures.

[0080] Preferably, the outer diameter of the large end of the blunt tip 620 is adapted to the diameter of the working port 121, and is only slightly smaller than the diameter of the working port 121 and the inner diameter of the negative pressure suction channel 112. This allows the puncture guide stent 600 to form a blunt penetrating catheter with a pen tip similar to the puncture tube 100 when inserted into the negative pressure suction channel 112, so as to be used for tissue penetration of the chest wall muscle layer after local anesthesia, thereby minimizing tissue damage and bleeding.

[0081] Specifically, the blunt tip 620 is made of a transparent material, such as a high-strength, hard material with high transparency, which allows for tissue penetration without affecting the image acquisition of the imaging module 500. If the camera 510 in the imaging module 500 is fixed near 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. In this case, the rod 610 has a gap communicating with the receiving space 621, allowing the imaging module 500 to enter and exit the receiving space 621 through this gap.

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

[0083] Specifically, the first connecting channel 131 is provided with an annular locking platform 135 at its proximal end, and the rod 610 is provided with a locking member 630 at its proximal end that can engage with the annular locking platform 135. The locking member 630 includes a connecting part 631 and a hook 632. The connecting part 631 is located at the proximal end of the rod 610, and the hook 632 is located at the distal end of the connecting part 631. A locking space 633 is formed between the hook 632 and the connecting part 631. The annular locking platform 135 is adapted to be locked in the locking space 633 to connect the tube 110 and the puncture guide bracket 600.

[0084] Of course, in actual production, the puncture guide stent 600 and the first connecting channel 131 can also be fixed by threaded engagement to limit the movement of the puncture guide stent 600 relative to the puncture tube 100 during penetration. For example, the inner wall surface of the proximal end of the first channel is provided with internal threads, the outer wall surface of the proximal end of the rod 610 is provided with external threads, and the proximal end of the rod 610 is provided with a handle for medical personnel to rotate the rod 610. Medical personnel can fix and separate the puncture guide stent 600 from the puncture tube 100 by grasping the handle and rotating the rod 610.

[0085] Specifically, see Figure 2 and Figure 9 The proximal end of the puncture member 200 is also provided with a limiting member 300. When the puncture member 200 is inserted into 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 a butterfly-clamp type injection molded part, which is conventionally installed near 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 port 121 of the puncture segment 120, so as to prevent complications such as myocardial perforation during pericardiocentesis. Of course, if clinical operation requires it, 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 device 200 is preferably an extra-long, custom-made stainless steel hollow puncture device 200, whose hollow internal structure is suitable for the insertion of the guide wire 700.

[0088] The percutaneous pericardiocentesis assembly provided in this application consists of a puncture tube 100 that can integrate an imaging module 500, a puncture guide 600, a negative pressure suction device 400, and a puncture component 200. The imaging module 500 provides real-time visualization of the in vivo puncture procedure; the transparent blunt tip 620 of the puncture guide stent 600 can provide blunt dissection of the chest wall muscle layer without affecting visualization; the puncture tube 100 connected to the negative pressure suction device 400 can non-invasively capture the pericardial wall layer 800 with negative pressure and aspirate the local pericardial wall layer 800 into the puncture section 120; the puncture element 200 can puncture the aspirated and raised pericardial wall layer 800 and insert the guide wire 700 to establish a track, thereby completing a pericardial puncture procedure that is close to direct vision. This solves major clinical problems such as the lack of direct image guidance, high risk of puncturing small or minimal pericardial effusions, difficulty in accessing epicardial devices in normal pericardial conditions, and lack of safety assurance in current procedures, greatly improving the safety and success rate of pericardial puncture under all indications.

[0089] See Figure 1 This application also provides a percutaneous pericardiocentesis system, including a negative pressure suction device 400 and the percutaneous pericardiocentesis components provided in any of the above embodiments. The negative pressure suction device 400 is a general-purpose configuration, consisting of a vacuum pump 410, a negative pressure drainage bottle 420, and a negative pressure tubing 430. One end of the negative pressure tubing 430 is connected to a first connecting channel 131 on the proximal connecting 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, enabling the puncture tube 100 to perform negative pressure pericardial capture; if pericardial effusion is present during the puncture, the puncture tube 100 then performs pericardial effusion drainage.

[0090] Specifically, the percutaneous pericardiocentesis system also includes an imaging device that can acquire and display image information output by the imaging module 500 for observation by medical personnel. The imaging device can be a personal PC terminal that can drive the imaging module 500 and receive and display the acquired image information, thereby enabling visual monitoring of the puncture segment 120 working port 121 and its surrounding area.

[0091] The percutaneous pericardiocentesis assembly and system provided in this application uses a puncture tube 100 with a variable diameter and multi-cavity structure as its core working component. By flexibly and compatiblely assembling an imaging module 500, a puncture guide stent 600, a negative pressure suction device 400, and a puncture piece 200, it possesses visualization, blunt puncture, negative pressure pericardial capture, safe and controllable puncture, and pericardial effusion drainage functions. This enables near-direct visualization of the pericardium under negative pressure capture puncture, providing a new instrument and method to overcome the current challenges of high requirements, high risks, and numerous complications in clinical pericardiocentesis.

[0092] Specifically, the percutaneous pericardiocentesis system is used as follows:

[0093] First, prepare all necessary items for percutaneous pericardiocentesis, including sterilization and aseptic procedures, bedside echocardiography equipment, and a percutaneous pericardiocentesis system (in sterile condition). Then, assess the patient's cardiac function and the approximate location and direction of the pericardial puncture using bedside echocardiography, and mark the approximate location and direction. Next, perform pre-puncture disinfection, draping, local infiltration anesthesia, and skin puncture. Assemble the puncture catheter 100, puncture guide stent 600, and imaging module 500, and connect them to a personal PC terminal via a video receiver cable for video image display, thus forming a visual catheter with a transparent, blunt tip. Then, perform blunt puncture along the ultrasound path until the muscle layer is broken, i.e., the pale red, beating organ (heart) is visible on the personal PC terminal's video display. At this point, withdraw the puncture guide stent 600 from the first connecting channel 131 of the connecting tube segment 130 and connect it to the negative pressure suction device 400. The puncture device 200 is inserted through the second connecting channel 132 of the connecting tube segment 130, and a limiting device 300 is installed near the proximal end of the puncture device 200. The mobility and puncture range of the distal end of the puncture device 200 within the puncture segment 120 are confirmed via video monitoring on a personal PC terminal. Next, preparation for pericardial capture begins. The vacuum pump 410 is activated and its negative pressure is adjusted to an appropriate level. Under the guidance of video monitoring on the personal PC terminal, the working port 121 of the puncture tube 100 is slowly approached towards the pericardium until the pericardium is captured by negative pressure. At this point, the negative pressure of the vacuum pump 410 is adjusted to its maximum, and part of the pericardial wall layer 800 is drawn into the puncture segment 120 of the puncture tube 100 and forms a spherical bulge. Echocardiography is used to confirm the relationship between the puncture tube 100 and the heart to prevent aspiration of other tissues. After confirmation, the puncture device 200 is used to puncture the dome-shaped pericardial wall layer 800 under negative pressure. When the puncture device 200 breaks through the pericardial wall layer 800, the pericardial effusion between the pericardial wall layer 800 and the visceral pericardium is aspirated. At this time, the position of the puncture device 200 is maintained, and the guide wire 700 is inserted along the puncture device 200 to establish a track. After the guide wire 700 is confirmed to be in the pericardial cavity by echocardiography, the percutaneous pericardiocentesis is safely completed, overcoming the current difficulties of high requirements, high risks and many complications in clinical pericardiocentesis.

[0094] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer 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 merely preferred embodiments of this application. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principles of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

1. A percutaneous pericardiocentesis assembly comprising: The application relates to a percutaneous pericardial puncture assembly. The puncture tube comprises a tube body and a puncture section arranged at the distal end of the tube body, a puncture channel and a negative pressure suction channel are arranged in the tube body, the outer diameter of the puncture section gradually increases from the distal end to the proximal end, a working port is arranged at the distal end of the puncture section, the working port is communicated with the puncture channel and the negative pressure suction channel, the negative pressure suction channel, the tube body and the working port are coaxially arranged, and the diameter of the working port is consistent with the inner diameter of the negative pressure suction channel; The puncture guide support is adapted to be arranged in the negative pressure suction channel and comprises a rod and a blunt head arranged at the distal end of the rod, the blunt head is in a conical structure, the distal end of the blunt head is a pointed end, and the proximal end of the blunt head is a large end, the outer diameter of the large end is matched with the diameter of the working port, the blunt head is adapted to be arranged out of the puncture port for tissue penetration; After the puncture guide support is removed from the negative pressure suction channel, the proximal end of the negative pressure suction channel is adapted to be connected with a negative pressure suction device to provide negative pressure for the working port and to adsorb the pericardial wall; the puncture channel is used for arranging the puncture member, and the distal end of the puncture member is adapted to puncture the adsorbed pericardial wall. Further comprising:

2. The percutaneous pericardiostomy assembly according to claim 1, characterized in that An imaging module; An imaging channel is arranged in the tube body and adapted to arrange the imaging module; The inner diameter of the puncture section gradually increases from the distal end to the proximal end, the distal end of the imaging module is adapted to be offset towards the working port, the imaging module is adapted to obtain image information of the working port and the circumferential side of 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.

3. The percutaneous pericardial puncture assembly according to claim 2, wherein The blunt head is made of transparent material, and the distal end of the blunt head has a containing space; The rod has a gap connected with the containing space, and the imaging module is adapted to enter the containing space through the gap.

4. The percutaneous pericardial puncture assembly according to claim 3, wherein The proximal end of the tube body is provided with a connecting tube section; The connecting tube section is provided with a first connecting channel, a second connecting channel and a third connecting channel, the first connecting channel is communicated with the negative pressure suction channel, the second connecting channel is communicated with the puncture channel, and the third connecting channel is communicated with the imaging channel; The proximal ends of the second connecting channel and the third connecting channel are provided with sealing valves.

5. The percutaneous pericardial puncture assembly according to claim 4, wherein The proximal end of the first connecting channel is provided with an annular clamping table; The proximal end of the rod is provided with a clamping member, the clamping member comprises a connecting part and a clamping hook, the connecting part is arranged at the proximal end of the rod, the clamping hook is arranged at the distal end of the connecting part, a clamping space is formed between the clamping hook and the connecting part, and the annular clamping table is adapted to be clamped in the clamping space to connect the tube body and the puncture guide support.

6. The percutaneous pericardial puncture assembly according to any one of claims 1-5, wherein ​ The proximal end of the puncture member is clamped with a limiting member, when the puncture member is inserted into the puncture channel, the limiting member is located outside the puncture tube, and is used for limiting the puncture depth of the puncture member.

7. The percutaneous pericardiocentesis assembly according to any one of claims 1-5, wherein, The distal end face of the puncture section is a plane or an inclined plane, and the wall surface of at least the distal end of the puncture section is blunt; and / or the puncture member is an internal hollow structure, suitable for inserting a guide wire.

8. A percutaneous pericardiopuncture system, characterized by, Comprising: A negative pressure suction device and the percutaneous pericardiocentesis assembly according to any one of claims 1-7.

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