Atrial septum puncture system

Abstract

The invention relates to an atrial septum puncture system which comprises a puncture needle body, an expansion tube and a handle part. The puncture needle body is movably arranged in the expansion tube, an exhaust gap is formed between the outer side of the needle wall of the puncture needle body and the inner side of the tube wall of the expansion tube, a first sealing structure is arranged between the puncture needle body and the expansion tube, and a through hole enabling the exhaust gap to be communicated with the needle cavity is formed in the needle wall. According to the interatrial septum puncture system, frequent exchange of a guide wire and a needle is not needed in the interatrial septum puncture operation process, operation steps are reduced, meanwhile, air can be exhausted, air can be prevented from entering the system in the use process, the probability that air enters the body of a patient can be reduced, and the operation efficiency is improved. And the risk of thrombus and thrombus formation of patients is reduced.

Description

Technical Field

[0001] This invention relates to the field of cardiovascular interventional technology, and in particular to an atrial septal puncture system. Background Technology

[0002] In the early 1950s, invasive hemodynamic assessment via right heart catheterization became a core method for clearly defining the characteristics of acquired and congenital heart disease. To obtain accurate measurements of the left ventricle, various left atrial access methods had emerged at that time (such as the suprasternal approach, posterolateral thoracic approach, transbronchial approach, and direct left ventricular puncture), but most of these methods were technically demanding and cumbersome to perform.

[0003] In 1959, Ross et al. developed a new left ventricular access technique that reached the left atrium through a puncture of the interatrial septum (especially the fossa ovalis), laying a crucial foundation for valvular intervention. Subsequently, Bronckenbrough et al. improved the technique, reducing the distal diameter of the puncture needle from 18G to 21G, further optimizing operative safety. However, with the advent of the Swan-Ganz catheter (which can directly measure most left ventricular pressure parameters) and the widespread adoption of echocardiography (which provides indirect measurement of left ventricular parameters), transseptal puncture (TSP) has gradually become marginalized in clinical practice due to its relatively complex procedure and potential risks.

[0004] Until the 1980s, the emergence of various new interventional procedures revitalized the clinical value of the TSP, including percutaneous balloon mitral valve repair (PBMV), transcatheter mitral valve repair (TMVR) using edge-to-edge technology, transcatheter mitral annulus repair systems, transcatheter mitral valve replacement for degenerative mitral bioprosthetic valve failure (some dedicated systems are still in the clinical evaluation stage), and percutaneous left atrial appendage occlusion (LAAC). Furthermore, the incidence of paravalvular mitral leak (MVL) is increasing across all age groups, and percutaneous repair, as a minimally invasive procedure with a high success rate and low complication rate, effectively avoids re-open-heart surgery. Some devices used in this procedure are precisely delivered via the TSP pathway; simultaneously, the implantation of some percutaneous left ventricular assist devices also requires the assistance of the TSP to enter the left ventricle.

[0005] The currently used atrial septal puncture system consists of a puncture needle and a dilator, and adopts a split design. Its standard operating procedure is as follows: 1) Under fluoroscopic guidance in the PA position, advance the outer sheath along the guidewire to the opening of the superior vena cava in the right atrium. At this time, the sheath indicator points to the 12 o'clock position; 2) Withdraw the guidewire, insert the atrial septal puncture needle into the outer sheath (the tip should not extend beyond the sheath opening), and rotate the sheath indicator clockwise to the 4-5 o'clock position; 3) Switch to the PA position or right anterior oblique 45° (RAO45°) fluoroscopic view, and slowly withdraw the needle-sheath complex. Usually, two distinct "jumping sensations" can be felt, indicating that the fossa ovalis region has been reached; 4) 5) Maintain a 45° fluoroscopic angle at RAO, adjust the direction of the puncture needle, and routinely ensure that the tip of the puncture needle is straight and perpendicular to the fossa ovalis for puncture preparation; 6) After confirming that the puncture point is correct, slowly advance the puncture needle. When a "breakthrough sensation" is felt (indicating that the interatrial septum has been penetrated), inject contrast agent through the puncture needle to confirm that the needle tip is located in the left atrium; 7) Fix the position of the puncture needle, push the dilator to completely cover the tip of the puncture needle; then withdraw the puncture needle, reinsert the guidewire along the lumen of the dilator to the left pulmonary vein, and then advance the dilator and outer sheath together along the guidewire to the left atrium; after fixing the outer sheath, withdraw the guidewire and dilator, and the interatrial septal puncture operation is completed.

[0006] The existing split-type system is a classic clinical configuration, but it has several clinical pain points that need improvement: First, preoperatively, the inner and outer surfaces and lumens of the dilator and puncture needle can only be flushed with heparinized saline to remove air. During the procedure, the frequent exchange of the puncture needle and guidewire leads to cumbersome operation steps and prolonged operation time, which not only increases the risk of thrombosis and air embolism, but also exposes both doctors and patients to X-ray radiation for a long time. Second, the puncture needle and the inner wall of the dilator are prone to scraping during the sliding process, producing "shavings"-like debris, which may cause insoluble plastic foreign bodies to fall out and enter the heart chamber, causing potential safety hazards. Third, the success of the puncture depends on the injection of contrast agent after the procedure, lacking a real-time feedback mechanism. Fourth, the puncture needle tip diameter is small, resulting in insufficient clarity under X-ray or ultrasound imaging, leading to reliance on the operator's sense of touch during the puncture process. Furthermore, the needle extension length of the puncture needle and dilator is difficult to control precisely, and over-insertion is prone to occur during the overall push, thereby increasing the risk of heart chamber wall abrasion or cardiac tamponade. Summary of the Invention

[0007] The purpose of this invention is to provide a transseptal puncture system to solve at least some of the technical problems existing in the prior art.

[0008] To achieve the above objectives, the present invention provides the following solution: A transseptal puncture system includes a puncture needle body, a dilator, and a handle portion with a hollow internal structure, wherein: The puncture needle body includes a needle cavity and a needle wall, the expansion tube includes a tube cavity and a tube wall, the puncture needle body is movably disposed in the tube cavity of the expansion tube, and an exhaust gap is formed between the outer side of the needle wall and the inner side of the tube wall, a first sealing structure is provided between the handle and the expansion tube, and a through hole is provided on the needle wall to allow the exhaust gap to communicate with the needle cavity.

[0009] In some embodiments, according to the atrial septal puncture system of the present invention, the first sealing structure is located at the end of the dilation tube.

[0010] In some embodiments, according to the atrial septal puncture system of the present invention, the first sealing structure includes a first needle body sealing portion that seals with the puncture needle body and a single dilation tube sealing portion connected to the dilation tube; In some embodiments, according to the atrial septal puncture system of the present invention, the sealing fit between the dilator and the single dilator sealing part is sufficient to ensure a seal between the dilator and the single dilator sealing part. For example, the dilator can be tightly abutted against the single dilator sealing part to achieve a sealing fit between the two, and no particular limitation is made here.

[0011] Preferably, the first needle body sealing portion includes a first sealing ring and / or a sealing valve; Preferably, the inner wall of the first sealing ring is in a sealing fit with the outer wall of the puncture needle body (i.e., the outer side of the needle wall of the puncture needle body); Preferably, the single expansion tube sealing part includes, but is not limited to, fixed or detachable connection structures, such as threaded connection structures, pin connection structures, adhesive, interference fit connection structures and / or snap-fit ​​connection structures.

[0012] In some embodiments, according to the atrial septal puncture system of the present invention, the single dilation tube sealing portion includes a first sealing structure body and a first sealing cap, and the first sealing cap is connected to the dilation tube; Preferably, the main body of the first sealing structure includes a sealing block; Preferably, the sealing block and the first sealing cap are connected by means of mechanical structure, pin connection or adhesive bonding, among other things. Preferably, the mechanical structure connection includes, but is not limited to, a snap-fit ​​connection or an expansion ring connection.

[0013] In some embodiments, according to the atrial septal puncture system of the present invention, the connection between the first sealing cap and the dilation tube may be by means including but not limited to a fixed connection, such as by bolt connection or adhesive bonding, and is not particularly limited herein.

[0014] In some embodiments, according to the atrial septal puncture system of the present invention, the through hole is disposed adjacent to the first sealing ring; Preferably, the cross-sectional area of ​​the through hole is greater than or equal to the cross-sectional area of ​​the exhaust slit.

[0015] Preferably, the cross-sectional area of ​​the through hole is equal to the cross-sectional area of ​​the exhaust slit.

[0016] In some embodiments, according to the transseptal puncture system of the present invention, a connecting tube is provided at the end of the handle portion away from the dilator tube. The system further includes a second sealing structure disposed between the end face of the puncture needle and the connecting tube.

[0017] In some embodiments, according to the transseptal puncture system of the present invention, the connecting tube is fixedly connected to the puncture needle body, thereby enabling the connecting tube and the puncture needle body to move synchronously; or The connecting tube is movably connected to the puncture needle body, thereby enabling relative movement between the connecting tube and the puncture needle body.

[0018] In some embodiments, according to the interventricular septal puncture system of the present invention, the second sealing structure includes a second sealing cap connected to the connecting tube and a second needle body sealing part that seals with the puncture needle body; Preferably, the second needle body sealing portion includes a second sealing ring; Preferably, the inner wall of the second sealing ring is in sealing fit with the outer wall of the puncture needle body (i.e., the outer side of the needle wall of the puncture needle body); Preferably, the connection between the connecting pipe and the second sealing cap is not limited to threaded connection, snap-fit ​​connection, expansion ring connection, pin connection or adhesive bonding, and no particular limitation is made here.

[0019] In some embodiments, according to the atrial septal puncture system of the present invention, the first sealing structure and the second sealing structure are integrated to form an integral sealing structure, which includes an integral sealing body and a movable groove formed on the connecting tube, the expansion tube is located in the movable groove and slides in cooperation with the connecting tube, the integral sealing body is sealed in cooperation with the expansion tube, and the end face of the puncture needle is connected to the connecting tube. Preferably, the movable groove is connected to the interior of the connecting pipe; Preferably, the integrated sealing body includes a third sealing ring, and the third sealing ring is located within the moving groove; Preferably, the inner wall of the third sealing ring is in a sealing fit with the outer wall of the puncture needle body (i.e., the outer side of the needle wall of the puncture needle body); Preferably, the integrated sealing structure is provided with an exhaust groove that communicates with the exhaust gap; Preferably, the exhaust groove is formed inside the connecting pipe.

[0020] In some embodiments, according to the transseptal puncture system of the present invention, the connection between the end face of the puncture needle and the connecting tube may be by means including but not limited to a fixed connection, such as by bolt connection or adhesive bonding, and is not particularly limited herein.

[0021] In some embodiments, the transseptal puncture system according to the present invention includes, but is not limited to, a structure at the tip of the puncture needle body that narrows from both sides toward the middle; Preferably, the tip of the puncture needle body is provided with both the interior and exterior of a chamfered structure, a rounded corner structure, or other irregular transition structures.

[0022] In some embodiments, the septal puncture system according to the present invention further includes a contrast ring and / or a magnetic sensor.

[0023] In some embodiments, according to the interventricular septal puncture system of the present invention, the raw material of the dilation tube includes, but is not limited to, radiopaque materials such as tungsten powder, bismuth salt, barium salt and / or tantalum powder.

[0024] In some embodiments, the septal puncture system according to the present invention further includes a wire disposed electrically connected to the puncture needle body, such that the needle tip acts as an electroposition electrode for positioning when the needle tip of the puncture needle body exits the dilation tube.

[0025] In some embodiments, the septal puncture system according to the present invention further includes a guidewire with wires connected to its tip and end, thereby allowing the tip of the guidewire to be used as a positioning electrode for positioning.

[0026] In some embodiments, according to the atrial septal puncture system of the present invention, the end face of the puncture needle body and the needle tip of the puncture needle body are respectively the two ends of the puncture needle body.

[0027] In a second aspect, the present invention provides another transseptal puncture system, comprising a puncture needle body, a dilator, and a handle, wherein: The puncture needle body includes a needle cavity and a needle wall, the expansion tube includes a lumen and a tube wall, the puncture needle body is movably disposed in the lumen of the expansion tube, and an exhaust gap is formed between the outer side of the needle wall and the inner side of the tube wall, and a second sealing structure is provided between the end face of the puncture needle body and the handle portion.

[0028] In some embodiments, the room septum puncture system of the second aspect of the present invention further includes a first sealing structure between the puncture needle body and the dilation tube, and further includes a through hole that allows the venting gap to communicate with the needle cavity.

[0029] Beneficial effects Different specific embodiments of the transseptal puncture system according to the present invention have the following technical effects: In some embodiments, the puncture system of the present invention eliminates the need for frequent exchange of guidewire and puncture needle during atrial septal puncture, significantly reducing surgical steps and time. It also prevents prolonged exposure of doctors and patients to X-ray radiation, ensuring their health and safety. Furthermore, it reduces the probability of air entering the patient's body, decreasing the risk of thrombosis and air embolism, thus guaranteeing the patient's health and safety.

[0030] In some embodiments, the present invention, through the double-sealing structure and the through-hole, can simultaneously expel air from the venting gap between the puncture needle body and the dilator tube, as well as air from inside the puncture needle body. It can also prevent external air from entering the bismuth salt and barium salt gap between the puncture needle body and the dilator tube, the interior of the puncture needle body, and the limiting sliding connection between the handle and the puncture needle body. This further reduces the probability of air entering the patient's body, further reduces the risk of thrombosis and air embolism, and ensures the patient's health and safety. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a schematic diagram of the overall structure of the exemplary puncture system in the first and second embodiments of the present invention; Figure 2 This is a schematic diagram of an exemplary first sealing structure in the first and second embodiments of the present invention, which includes a first sealing cap and a sealing block, which are connected by threads; Figure 3This is a schematic diagram of an exemplary first sealing structure in the first and second embodiments of the present invention, which includes a first sealing cap and a sealing block, which are connected by a first snap-fit ​​method; Figure 4 This is a schematic diagram of an exemplary first sealing structure in the first and second embodiments of the present invention, which includes a first sealing cap and a sealing block, which are connected by a second snap-fit ​​method; Figure 5 This is a schematic diagram of an exemplary first sealing structure in the first and second embodiments of the present invention, which includes a first sealing cap and a sealing block, which are connected by a first expansion ring; Figure 6 This is a schematic diagram of an exemplary second sealing structure in the first and second embodiments of the present invention, which includes a second sealing cap and a second sealing structure body, which are connected by threads; Figure 7 This is a schematic diagram of an exemplary second sealing structure in the first and second embodiments of the present invention, which includes a second sealing cap and a second sealing structure body, which are connected by a first snap fastener; Figure 8 This is a schematic diagram of an exemplary second sealing structure in the first and second embodiments of the present invention, which includes a second sealing cap and a second sealing structure body, which are connected by a second snap fastener; Figure 9 This is a schematic diagram of an exemplary second sealing structure in the first and second embodiments of the present invention, which includes a second sealing cap and a second sealing structure body, which are connected by a second expansion ring; Figure 10 This is a schematic diagram of an exemplary second sealing structure in the first and second embodiments of the present invention, which includes a second sealing cap and a second sealing structure body, the two being connected by a pin; Figure 11 This is a schematic diagram of the overall structure of an exemplary first or second expansion ring in the first and second embodiments of the present invention; Figure 12 This is a schematic diagram of the structure of the needle tip of the puncture needle body, as exemplary in the first and second embodiments of the present invention. Figure 13 for Figure 12 A sectional view; Figure 14 This is a schematic diagram of a partial structure as exemplified in the third embodiment of the present invention.

[0033] Explanation of reference numerals in the attached figures: 1. Puncture needle body; 2. Dilatation tube; 3. Handle; 4. Push button; 5. Connecting tube; 6. Through hole; 7. First sealing cap; 8. First sealing ring; 9. First snap; 10. Second snap; 11. First expansion ring; 12. Second sealing cap; 13. Second sealing ring; 14. Third snap; 15. Fourth snap; 16. Second expansion ring; 17. Pin; 18. Sealing block; 19. Venting gap; 20. Third sealing ring; 21. Venting groove; 22. Moving groove. Detailed Implementation

[0034] The features and exemplary embodiments of various aspects of the present invention will now be described in detail. To make the objectives, technical solutions, and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only configured to explain the present invention and to exemplify the principles of the present invention, and are not configured to limit the present invention. In addition, the structural components in the drawings are not necessarily drawn to scale. For example, the dimensions of some structural components or regions in the drawings may be enlarged for other structural components or regions to aid in the understanding of the embodiments of the present invention.

[0035] The directional terms used in the following description refer to the directions shown in the figures and are not intended to limit the specific structure of the embodiments of the present invention. In the description of the present invention, it should be noted that, unless otherwise stated, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in the present invention according to the specific circumstances.

[0036] Furthermore, the terms "comprising," "including," "having," or any other variations thereof are intended to cover non-exclusive inclusion, such that a structure or component that includes a list of elements includes not only those elements but also other structural elements that are not expressly listed or inherent to the structure or component. Without further limitations, an element defined by the phrase "comprising..." does not exclude the presence of other identical elements in the article or apparatus that includes the element.

[0037] Spatial relation terms such as "below," "under," "under," "low," "above," "on," and "high" are used for descriptive convenience to explain the positioning of one element relative to a second element, indicating that these terms are intended to cover different orientations of the device, in addition to those different from those shown in the figure. Furthermore, phrases such as "one element on / below another element" can indicate that two elements are in direct contact, or that there are other elements between the two elements. In addition, terms such as "first" and "second" are also used to describe individual elements, areas, parts, etc., without specifically indicating order or sequence, and should not be considered restrictive. Similar terms are used throughout the description to represent similar elements.

[0038] It will be apparent to those skilled in the art that the present invention can be practiced without requiring some of these specific details. The following description of embodiments is merely intended to provide a better understanding of the invention by illustrating examples of the invention.

[0039] Example 1 like Figures 1-10 As shown, the present invention provides a transseptal puncture system.

[0040] In the following embodiments, there may be descriptions such as "this system". Those skilled in the art should understand that "this system" refers to an atrial septal puncture system provided by the present invention.

[0041] like Figure 1 As shown, this system includes at least a puncture needle body 1, a dilation tube 2, and a handle part 3 with a hollow internal structure; wherein: The puncture needle body 1 includes a needle cavity and a needle wall, and the dilation tube 2 includes a tube cavity and a tube wall. The puncture needle body 1 is movably connected inside the tube cavity of the dilation tube 2, and an air vent 19 is formed between the outer side of the needle wall and the inner side of the tube wall. A first sealing structure is provided between the handle part 3 and the dilation tube 2, and a through hole 6 is provided on the needle wall to connect the air vent 19 with the needle cavity.

[0042] It should be understood that, since both the puncture needle body 1 and the dilator tube 2 are hollow cylindrical structures, that is, the needle cavity is the cavity inside the puncture needle body 1 and the tube cavity is the cavity inside the dilator tube 2.

[0043] like Figure 1 As shown, one end of the expansion tube 2 (i.e. Figure 1 The left end of the expansion tube 2 and one end of the handle 3 (i.e. Figure 1 The needle body 1 is connected to the right end of the handle portion 3. The needle body 1 is located inside the dilator tube 2. There is a gap between the outer side of the needle wall of the needle body 1 and the inner side of the dilator tube wall of the dilator tube 2. The end of the needle body 1 near the handle portion 3 is connected to it and is limited to sliding fit.

[0044] In this embodiment, a connecting tube 5 is provided on the end of the handle part 3 away from the expansion tube 2.

[0045] In this embodiment, as Figure 6 As shown, the puncture needle body 1 can be coaxially arranged with the handle part 3, and the puncture needle body 1 can be located at the center of the handle part 3.

[0046] In this embodiment, as Figure 6 As shown, the end of the connecting tube 5 closest to the puncture needle body 1 (i.e. Figure 6 The right end of the connecting tube 5 can be provided with a sliding groove for the puncture needle body 1 that is adapted to the puncture needle body 1 along the axial direction of the connecting tube 5, and the sliding groove for the puncture needle body can communicate with the interior of the connecting tube 5. The end of the puncture needle body 1 closest to the connecting tube 5 (i.e., Figure 6 The left end of the puncture needle body 1 can slide within the sliding groove of the puncture needle body, thereby achieving a limiting sliding fit between the puncture needle body 1 and the connecting tube 5.

[0047] In one embodiment of the present invention, the system further includes a first sealing structure and a second sealing structure. The first sealing structure includes a first needle body sealing portion that tightly abuts against the puncture needle body 1 and a single expansion tube sealing portion that tightly abuts against the expansion tube.

[0048] Preferably, the first needle body sealing portion includes a first sealing ring 8.

[0049] Preferably, the single expansion tube sealing part is a fixed connection or a detachable connection structure, such as a threaded connection structure, a pin connection structure, an adhesive connection structure, an interference fit connection structure, and / or a snap-fit ​​connection structure.

[0050] The first sealing structure is used to seal the dilation tube 2 and the puncture needle body 1, and the second sealing structure is used to seal the puncture needle body 1 and the handle part 3. The first sealing structure is used to make a sealed movable connection between the puncture needle body 1 and the dilation tube 2, and the second sealing structure is used to seal and isolate the handle part 3 and the puncture needle body 1. This can prevent air from entering the gap between the puncture needle body 1 and the dilation tube 2 during the puncture process, and can also prevent air from entering the interior of the limiting sliding connection between the handle part 3 and the puncture needle body 1 during the puncture process.

[0051] In one embodiment of the present invention, such as Figures 2-5 As shown, the puncture needle body 1 has a through hole 6, which corresponds to the first sealing structure. The through hole 6 allows air to be expelled from the gap between the puncture needle body 1 and the dilator tube 2 before the puncture procedure.

[0052] It should be understood that, since the puncture needle 1 is located inside the dilation tube 2, meaning the two can be considered as a single unit, frequent exchanges between the guidewire (not shown in the figure, and the guidewire is a component known in the art) and the puncture needle 1 are unnecessary when using this system for atrial septal puncture. The guidewire can be directly inserted after the puncture is completed, and no contrast agent needs to be injected, greatly reducing the number of surgical steps and the duration of the procedure. This also prevents doctors and patients from being exposed to X-ray radiation for extended periods, ensuring their health and safety. Furthermore, because frequent exchanges between the guidewire and the puncture needle 1 are unnecessary during atrial septal puncture using this system, the probability of air entering the patient's body is reduced, decreasing the risk of thrombosis and air embolism, thus ensuring the patient's health and safety.

[0053] In this embodiment, the first sealing structure includes a first sealing structure body and a first sealing cap 7, and the first sealing cap 7 is in close contact with the expansion tube 2; Preferably, the first sealing structure body and the first sealing cap 7 are connected by a mechanical structure, a pin connection, or an adhesive bond. Preferably, the mechanical structure connection includes a snap-fit ​​connection or an expansion ring connection.

[0054] Specifically, such as Figures 2-5 As shown, the first sealing structure includes at least one of a sealing block 18 (i.e., the main body of the first sealing structure), a first sealing ring 8, and a first sealing cap 7, wherein: The sealing block 18 is fitted onto the puncture needle body 1 and slides in contact with the outer wall of the puncture needle body 1. The first sealing cap 7 is located at the connection between the dilation tube 2 and the sealing block 18, which serves as the sealing body (i.e., the first sealing structure described above is located at the connection between the dilation tube 2 and the puncture needle body 1). The first sealing cap 7 is fitted onto the end of the dilation tube 2 near the handle portion 3 and is connected to the outer wall of the dilation tube 2. The end of the first sealing cap 7 away from the dilation tube 2 is connected to the inner wall of the sealing body, meaning that the dilation tube 2 can be connected to the puncture needle body 1 through the first sealing cap 7.

[0055] In this embodiment, the through hole 6 is disposed adjacent to the first sealing ring 8 in the first sealing structure.

[0056] Preferably, the cross-sectional area of ​​the through hole 6 is greater than or equal to the cross-sectional area of ​​the exhaust gap 19.

[0057] In this embodiment, the first sealing cap 7 and the outer wall of the expansion tube 2, and the first sealing cap 7 and the inner wall of the sealing body can be connected by bolts or adhesives as known in the art, without any particular limitation.

[0058] In this embodiment, as Figures 2-5As shown, the through hole 6 is correspondingly provided with the first sealing ring 8 (that is, the through hole 6 is correspondingly provided with the first sealing structure). Specifically, the through hole 6 is located at the end of the first sealing ring 8 furthest from the sealing block 18 (i.e., located at the end of the first sealing ring 8 furthest from the sealing block 18). Figure 1 (at the right end of the middle) and adjacent to and closely fitted with the first sealing ring 8.

[0059] In one embodiment of the present invention, the sealing block 18 is detachably connected to the first sealing cap 7, the first sealing ring 8 is located between the sealing block 18 and the first sealing cap 7, and the first sealing ring 8 is sleeved on the puncture needle body 1 and slides in cooperation with the outer wall of the puncture needle body 1, thereby achieving the sealing isolation between the inside of the gap between the puncture needle body 1 and the expansion tube 2 and the outside through the sealing performance of the first sealing ring 8.

[0060] In some embodiments of the present invention, the detachable connection method between the sealing block 18 and the first sealing cap 7 is not particularly limited. For example, it can be configured as follows: like Figures 2-4 As shown, the first sealing cap 7 can be detachably connected to the sealing block 18 by threads, snaps, or pins (not shown in the figure).

[0061] Specifically, such as Figure 2 As shown, the outer wall of the first sealing cap 7 is provided with a first external thread, and the connection between the sealing block 18 and the outer wall of the first sealing cap 7 is provided with a first internal thread that corresponds to and matches the first external thread. That is, the first sealing cap 7 can be detachably connected to the sealing block 18 (threaded connection) through the first external thread and the first internal thread.

[0062] Specifically, the first sealing cap 7 can be detachably connected to the sealing block 18 via a snap fastener in at least two ways (i.e., including but not limited to two).

[0063] For example, such as Figure 3 As shown, the cross-section of the first sealing cap 7 can be a T-shaped structure. The end of the sealing block 18 near the expansion tube 2 is provided with a first buckle 9, and the end of the first sealing cap 7 away from the expansion tube 2 is provided with a first slot. The first buckle 9 and the first slot are adapted to each other and are correspondingly set, that is, the first sealing cap 7 can be detachably connected to the sealing block 18 through the first buckle 9 and the first slot (buckle connection).

[0064] For example, such as Figure 4 As shown, the cross-section of the first sealing cap 7 can also be an arc-shaped structure. The end of the sealing block 18 away from the expansion tube 2 is provided with a second slot, and the end of the first sealing cap 7 near the expansion tube 2 is provided with a second buckle 10. The second buckle 10 is adapted to and correspondingly set with the second slot, that is, the first sealing cap 7 can be detachably connected to the sealing block 18 through the second buckle 10 and the second slot (buckle connection).

[0065] Specifically, the first sealing cap 7 has a first pin mounting groove at the end away from the puncture needle body 1. A pin (not shown in the figure) is installed in the first pin mounting groove, and the pin abuts against the outer wall of the sealing block 18, thereby making the first sealing cap 7 detachably connected to the sealing block 18 through the pin and the first pin mounting groove (pin connection).

[0066] In this embodiment, taking the first sealing cap 7 as an example of being detachably connected to the sealing block 18 via threads, when the first sealing cap 7 is installed on the sealing block 18, the first sealing cap 7 will squeeze the first sealing ring 8, thereby making the outer wall of the first sealing ring 8 tightly adhere to the outer wall of the puncture needle body 1 (but without affecting the relative sliding between the outer wall of the puncture needle body 1 and the outer wall of the first sealing ring 8), thus achieving the sealing and isolation of the gap between the puncture needle body 1 and the expansion tube 2 from the outside world.

[0067] Furthermore, taking the first sealing cap 7 as an example of being detachably connected to the sealing block 18 via threads, the compression force of the first sealing ring 8 can be adjusted by adjusting the degree of screwing in the first sealing cap 7, thereby adapting to various different working conditions.

[0068] In one embodiment of the present invention, such as Figure 5 As shown, a first expansion ring 11 is installed at the connection between the first sealing cap 7 and the sealing block 18, and the first expansion ring 11 is located on one side of the first sealing ring 8 (i.e., the first expansion ring 11 does not contact the first sealing ring 8). That is, the first sealing cap 7 can also be detachably connected to the sealing block 18 through the first expansion ring 11.

[0069] Specifically, in this embodiment, such as Figures 6-10 As shown, the second sealing structure includes at least a second sealing cap 12 and a second sealing ring 13, wherein: The second sealing cap 12 is sleeved on the puncture needle body 1 and slides in cooperation with the outer wall of the puncture needle body 1. The second sealing cap 12 is located at the connection between the puncture needle body 1 and the main body of the second sealing structure and is detachably connected to the main body of the second sealing structure.

[0070] In one embodiment of the present invention, the second sealing ring 13 is located between the second sealing cap 12 and the main body, and the second sealing ring 13 is sleeved on the puncture needle body 1 and slides in cooperation with the outer wall of the puncture needle body 1, thereby achieving the sealing isolation between the inside and the outside of the limiting sliding connection between the main body and the puncture needle body 1 through the sealing performance of the second sealing ring 13.

[0071] In some embodiments of the present invention, the detachable connection method between the second sealing cap 12 and the sealing body is not particularly limited. For example, it can be configured as follows: like Figure 6 , Figure 7 , Figure 8 and Figure 10 As shown, the second sealing cap 12 can be detachably connected to the sealing body by threads, snaps, or pins.

[0072] Specifically, such as Figure 6 As shown, the outer wall of the second sealing cap 12 is provided with a second external thread, and the connection between the sealing body and the outer wall of the second sealing cap 12 is provided with a second internal thread that corresponds to and matches the second external thread. That is, the second sealing cap 12 can be detachably connected to the sealing body (threaded connection) through the second external thread and the second internal thread.

[0073] Specifically, the second sealing cap 12 can be detachably connected to the sealing body via a snap fastener in at least two ways (i.e., including but not limited to two).

[0074] For example, such as Figure 7 As shown, the cross-section of the second sealing cap 12 can be a T-shaped structure, and a third buckle 14 is provided on the outer wall of the second sealing cap 12. A third slot is provided at the connection between the sealing body and the outer wall of the second sealing cap 12, and the third buckle 14 and the third slot are adapted to each other and are correspondingly provided, that is, the second sealing cap 12 can be detachably connected to the sealing body (buckle connection) through the aforementioned third buckle 14 and third slot.

[0075] For example, such as Figure 8 As shown, the cross-section of the second sealing cap 12 can be an arc-shaped structure. The end of the second sealing cap 12 near the puncture needle body 1 is provided with a fourth buckle 15. The outer wall of the sealing body is provided with a fourth slot, and the fourth buckle 15 is adapted to and correspondingly set with the fourth slot. That is, the second sealing cap 12 can be detachably connected to the sealing body (buckle connection) through the above-mentioned fourth buckle 15 and fourth slot.

[0076] Specifically, such as Figure 10 As shown, the second sealing cap 12 has a second pin mounting groove at the end away from the puncture needle body 1. The pin 17 can be installed in the second pin mounting groove, and the pin 17 abuts against the outer wall of the sealing body, thereby making the second sealing cap 12 detachably connected to the sealing body through the pin 17 and the second pin mounting groove (pin connection).

[0077] It should be understood that the pin 17 described here (i.e., the pin 17 located in the second pin mounting slot) is not the same pin as the pin located in the first pin mounting slot mentioned above.

[0078] In this embodiment, taking the second sealing cap 12 as an example of being detachably connected to the connecting pipe 5 via threads, when the second sealing cap 12 is installed on the connecting pipe 5, the second sealing cap 12 will squeeze the second sealing ring 13, thereby enabling the outer wall of the second sealing ring 13 to be tightly attached to the outer wall of the puncture needle body 1 (but without affecting the relative sliding between the outer wall of the puncture needle body 1 and the outer wall of the second sealing ring 13), thus achieving the sealing isolation between the inside and the outside of the sliding connection between the connecting pipe 5 and the puncture needle body 1.

[0079] Furthermore, taking the second sealing cap 12 as an example of being detachably connected to the connecting pipe 5 via threads, the compression force of the second sealing ring 13 can be adjusted by adjusting the degree of screwing in the second sealing cap 12, thereby adapting to various different working conditions.

[0080] In one embodiment of the present invention, such as Figure 9 As shown, a second expansion ring 16 is installed at the connection between the second sealing cap 12 and the connecting pipe 5, and the second expansion ring 16 is located on one side of the second sealing ring 13 (i.e., the second expansion ring 16 does not contact the second sealing ring 13). That is, the second sealing cap 12 can also be detachably connected to the connecting pipe 5 through the second expansion ring 16.

[0081] Furthermore, in order to completely expel the air from the gap between the puncture needle body 1 and the dilator tube 2, the cross-sectional area of ​​the through hole 6 is greater than or equal to the cross-sectional area of ​​the gap between the puncture needle body 1 and the dilator tube 2.

[0082] Preferably, the cross-sectional area of ​​the through hole 6 is equal to the cross-sectional area of ​​the gap between the puncture needle body 1 and the expansion tube 2.

[0083] In this embodiment, the number of through holes 6 can also be multiple, that is, the sum of the cross-sectional areas of multiple through holes 6 is greater than or equal to the cross-sectional area of ​​the gap between the puncture needle body 1 and the expansion tube 2.

[0084] In this embodiment, the cross-sectional shape of the through hole 6 is not particularly limited; for example, it can be... Figures 2-5 The circular structure shown.

[0085] During the puncture procedure, it is necessary to simultaneously expel air from the gap between the puncture needle body 1 and the dilator tube 2, as well as from the air inside the puncture needle body 1, to reduce the probability of air entering the patient's body, thereby reducing the risk of thrombosis and air embolism and ensuring the patient's health and safety. Therefore, before the puncture procedure, a liquid (such as heparin, as known in the art) can be introduced into the puncture needle body 1. After entering the puncture needle body 1, the heparin will simultaneously enter the gap between the puncture needle body 1 and the dilator tube 2 through the through-hole 6, and exit from the needle tip of the puncture needle body 1 at the location of the gap between the dilator tube 2. This allows for the simultaneous expulsion of air from both the gap between the puncture needle body 1 and the dilator tube 2, and from the air inside the puncture needle body 1. Meanwhile, since the cross-sectional area of ​​the through hole 6 is preferably equal to the cross-sectional area of ​​the gap between the puncture needle body 1 and the dilator tube 2, the ratio of the heparin flow rate in the puncture needle body 1 to the heparin flow rate in the gap between the puncture needle body 1 and the dilator tube 2 will always remain in a 1:1 ratio. This ensures that the air in the gap between the puncture needle body 1 and the dilator tube 2 and the air inside the puncture needle body 1 are emptied simultaneously and synchronously, and there will be no situation where the air in either the gap between the puncture needle body 1 and the dilator tube 2 or the inside of the puncture needle body 1 is not completely emptied.

[0086] It should be understood that, in the default state (i.e., before the puncture procedure), the through-hole 6 is located at the end of the first sealing ring 8 furthest from the sealing block 18 (i.e., the end closest to the needle tip of the puncture needle body 1) and adjacent to and tightly fitted with the first sealing ring 8. Therefore, when heparin enters the gap between the puncture needle body 1 and the dilator 2, the end of the dilator 2 closest to the first sealing ring 8 can be used as the starting point to expel air, thus completely emptying the air from the gap between the puncture needle body 1 and the dilator 2. Simultaneously, the first sealing structure (i.e., the first sealing ring 8) not only prevents external air from entering the gap between the puncture needle body 1 and the dilator 2, but also prevents heparin from leaking from the gap between the puncture needle body 1 and the dilator 2 to the outside.

[0087] In one embodiment of the present invention, such as Figure 1 As shown, a push button 4 is slidably mounted on the handle 3 along the length of the expansion tube 2. The push button 4 can be located, for example, between the first sealing structure and the second sealing structure, and connected to the outer wall of the puncture needle body 1. With the push button 4, the puncture needle body 1 can be pushed more conveniently (i.e., the puncture needle body 1 can be moved relatively within the expansion tube 2 more conveniently).

[0088] In this embodiment, the connection method between the push button 4 and the outer wall of the puncture needle body 1 is not particularly limited. For example, it can be connected by bolts as known in the art.

[0089] In one embodiment of the present invention, a spring (not shown in the figure) is fitted onto the puncture needle body 1. The spring is located between the first sealing structure and the second sealing structure. One end of the spring is connected to the end of the push button 4 near the first sealing structure, and the other end of the spring is connected to the inner wall of the handle portion 3. By setting the spring, it can provide reverse resistance to the push button 4 when it is pushed, thereby enabling more precise control over the pushing distance and pushing speed of the puncture needle body 1.

[0090] In one embodiment of the present invention, such as Figure 12 and Figure 13 As shown, the tip of the puncture needle body 1 has a structure that narrows from both sides towards the middle (i.e., Figure 12 The area indicated by the symbol R), and the tip of the puncture needle 1 has a chamfered structure both inside and outside. Through the aforementioned narrowing of both sides of the needle tip towards the center and the chamfered structure, the tip of the puncture needle 1 can be prevented from scratching the inner wall of the dilation tube 2 when it moves relative to the dilation tube 2, thus avoiding the "shaving" phenomenon. This prevents insoluble plastic foreign objects from falling into the patient's heart chambers, ensuring the patient's health and safety.

[0091] In this embodiment, as Figure 13 As shown, the angles at positions α and β at the tip of the puncture needle body 1 can both be greater than 120° and less than 180°, and the transition section at this part can be a straight line or a protective line, without any special limitation.

[0092] In this embodiment, the first sealing ring 8 and the second sealing ring 13 can both be made of soft polymer materials known in the art, such as natural rubber, etc., and are not particularly limited here.

[0093] In this embodiment, both the first expansion ring 11 and the second expansion ring 16 are existing technologies known in the art, and are achieved through... Figure 11 This allows one to understand the specific structure of both the first rising circle 11 and the second rising circle 16, which will not be elaborated upon here.

[0094] In this embodiment, in order to ensure the visibility of the venting and sealing, both the first sealing structure and the second sealing structure can be made of transparent polymer materials known in the art, such as PC or ABS, etc., which are not particularly limited here.

[0095] In this embodiment, a magnetic sensor (not shown in the figure) known in the art can be installed inside the head end of the expansion tube 2 (i.e., the end of the expansion tube 2 away from the handle part 3), thereby enabling precise positioning in the three-dimensional mapping system. Alternatively, a wire (not shown in the figure) known in the art can be added to the puncture needle body 1, so that the tip of the puncture needle body 1 can act as an electro-positioning electrode for precise positioning when it extends out of the head end of the expansion tube 2.

[0096] In this embodiment, in order to further improve the subsequent developing effect, a developing ring (not shown in the figure) known in the art can be fused to the inside of the head end of the expansion tube 2.

[0097] Example 2 like Figures 1-13 As shown in this embodiment, the present invention provides an interatrial septal puncture system.

[0098] like Figure 1 As shown, this system includes at least a puncture needle body 1, a dilation tube 2, and a handle part 3 with a hollow internal structure; wherein: like Figure 1 As shown, one end of the expansion tube 2 (i.e. Figure 1 The left end of the expansion tube 2 and one end of the handle 3 (i.e. Figure 1 The puncture needle body 1 is connected to the right end of the handle portion 3. The puncture needle body 1 is located both inside the dilation tube 2 and the handle portion 3; that is, a portion of the puncture needle body 1 is located inside the dilation tube 2, while another portion is located inside the handle portion 3, with the end of the puncture needle body 1 furthest from the dilation tube 2 (i.e., the end furthest from the dilation tube 2)... Figure 1 The left end of the puncture needle body 1 can communicate with the outside of the handle portion 3 to allow the required fluid to be introduced into the puncture needle body 1 during interventricular septal puncture. For example, Figure 1 As shown, the tip of the puncture needle body 1 is located at the end of the dilator tube 2 furthest from the handle portion 3 (i.e., Figure 1 (Right end of expansion tube 2).

[0099] In this embodiment, as Figure 1 As shown, the end of the handle 3 furthest from the expansion tube 2 (i.e., the other end of the expansion tube 2, that is...) Figure 1 A connecting tube 5 is installed at the left end of the handle portion 3, and the connecting tube 5 can communicate with the interior of the handle portion 3. The end of the puncture needle body 1 furthest from the dilation tube 2 (i.e., Figure 1 The left end of the puncture needle body 1 can be connected to the connecting tube 5 and can be limited and slidably engaged with the connecting tube 5, that is, the end of the puncture needle body 1 away from the dilation tube 2 can be connected to the outside of the handle part 3 through the connecting tube 5.

[0100] In this embodiment, the connecting tube 5 can be partially located inside the handle portion 3, that is, the connecting tube 5 can completely penetrate the handle portion 3. Figure 1 At the left end of the tube, the outer wall of the connecting tube 5 can be connected to the handle part 3.

[0101] In this embodiment, as Figure 1 As shown, the connecting tube 5 can be coaxially arranged with the handle part 3, and the connecting tube 5 can be located at the center of the handle part 3.

[0102] In this embodiment, as Figure 6 As shown, the puncture needle body 1 can be coaxially arranged with the connecting tube 5, and the puncture needle body 1 can be located at the center of the connecting tube 5.

[0103] In this embodiment, as Figure 6 As shown, the end of the connecting tube 5 closest to the puncture needle body 1 (i.e. Figure 6 At the right end of the connecting tube 5, a sliding groove for the puncture needle body 1, which is adapted to the outer contour shape of the puncture needle body 1, can be formed along the axial direction of the connecting tube 5 at the center position of the connecting tube 5. The sliding groove for the puncture needle body 1 is also connected to the interior of the connecting tube 5. The end of the puncture needle body 1 closest to the connecting tube 5 (i.e., the end of the connecting tube 5) Figure 6 The left end of the puncture needle body 1 can slide within the sliding groove of the puncture needle body (i.e., the outer wall of the puncture needle body 1 contacts the inner wall of the sliding groove of the puncture needle body and can simultaneously slide with the inner wall of the sliding groove of the puncture needle body), thereby achieving the limiting sliding fit between the puncture needle body 1 and the connecting tube 5.

[0104] In this embodiment, the connecting tube 5 and the handle part 3 can be connected by bolts or adhesives as known in the art, and no particular limitation is made here.

[0105] In this embodiment, the end of the connecting tube 5 furthest from the handle portion 3 (i.e. Figure 1 The left end of the connecting tube 5 can be used to introduce the required fluid into the puncture needle body 1 during interatrial septal puncture.

[0106] In one embodiment of the present invention, the system further includes a first sealing structure. The first sealing structure is located at the connection point between the expansion tube 2 and the handle portion 3, such as... Figures 2-5 As shown, an exhaust slit 19 is provided between the outer wall of the puncture needle body 1 and the inner wall of the dilation tube 2. The first sealing structure can be used to seal and isolate the interior of the exhaust slit 19 between the outer wall of the puncture needle body 1 and the inner wall of the dilation tube 2 from the outside of the system, thereby preventing air from outside the system from entering the gap between the puncture needle body 1 and the dilation tube 2 during the interventricular septal puncture.

[0107] In one embodiment of the present invention, such as Figures 2-5 As shown, the puncture needle body 1 has a through hole 6, through which the interior of the puncture needle body 1 can communicate with the interior of the venting gap 19, and the through hole 6 is correspondingly set with the first sealing structure. By setting the through hole 6, the air in the gap between the puncture needle body 1 and the dilator tube 2 can be discharged before performing the puncture of the interventricular septum.

[0108] It should be understood that, since the puncture needle 1 is located inside the dilation tube 2, meaning the two can be considered as a single unit, frequent exchanges between the guidewire (not shown in the figure, and the guidewire is a component known in the art) and the puncture needle 1 are unnecessary when using this system for atrial septal puncture. The guidewire can be directly inserted after the puncture is completed, and no contrast agent needs to be injected, greatly reducing the number of surgical steps and the duration of the procedure. This also prevents doctors and patients from being exposed to X-ray radiation for extended periods, ensuring their health and safety. Furthermore, because frequent exchanges between the guidewire and the puncture needle 1 are unnecessary during atrial septal puncture using this system, the probability of air entering the patient's body is reduced, decreasing the risk of thrombosis and air embolism, thus ensuring the patient's health and safety.

[0109] In some embodiments of the present invention, the specific structure of the first sealing structure is not particularly limited. For example, it may include, but is not limited to, the following structures: Specifically, in this embodiment, such as Figures 2-5 As shown, the first sealing structure includes at least a sealing block 18, a first sealing ring 8, and a first sealing cap 7, wherein: The sealing block 18 is fitted onto the puncture needle body 1 and can slide against the outer wall of the puncture needle body 1. The first sealing cap 7 in the first sealing structure is located at the connection between the dilation tube 2 and the handle part 3 (i.e., the first sealing structure is located at the connection between the dilation tube 2 and the handle part 3), and the first sealing cap 7 is fitted onto the dilation tube 2 (i.e., the first sealing cap 7 is fitted onto the end of the dilation tube 2 near the handle part 3) and is connected to the outer wall of the dilation tube 2. The end of the first sealing cap 7 away from the dilation tube 2 is connected to the inner wall of the handle part 3, that is, the dilation tube 2 can be connected to the handle part 3 through the first sealing cap 7.

[0110] In this embodiment, the first sealing cap 7 and the outer wall of the expansion tube 2, and the first sealing cap 7 and the inner wall of the handle portion 3 can be connected by bolts or adhesives as known in the art, without any particular limitation.

[0111] In this embodiment, as Figures 2-5 As shown, the through hole 6 is correspondingly disposed with respect to the first sealing ring 8 in the first sealing structure (i.e., the through hole 6 is correspondingly disposed with respect to the first sealing structure). Specifically, the through hole 6 is located on the side of the first sealing ring 8 away from the sealing block 18 (i.e., located on the side of the first sealing ring 8 away from the sealing block 18). Figure 1 (on the right side of the middle) and adjacent to and closely fitted with the first sealing ring 8.

[0112] In one embodiment of the present invention, the sealing block 18 can be detachably connected to the first sealing cap 7, the first sealing ring 8 is located between the sealing block 18 and the first sealing cap 7, and the first sealing ring 8 is sleeved on the puncture needle body 1 and can slide in cooperation with the outer side wall of the puncture needle body 1. In this way, the sealing performance of the first sealing ring 8 can achieve the sealing isolation between the interior of the exhaust gap 19 between the outer side wall of the puncture needle body 1 and the inner side wall of the expansion tube 2 and the outside of the system.

[0113] In some embodiments of the present invention, the detachable connection method between the sealing block 18 and the first sealing cap 7 is not particularly limited. For example, it can be configured as follows: like Figures 2-4 As shown, the first sealing cap 7 can be detachably connected to the sealing block 18 by threads, snaps, or pins (not shown in the figure).

[0114] Specifically, such as Figure 2 As shown, the outer wall of the first sealing cap 7 is provided with a first external thread, and the connection between the sealing block 18 and the outer wall of the first sealing cap 7 is provided with a first internal thread that corresponds to and matches the first external thread. That is, the first sealing cap 7 can be detachably connected to the sealing block 18 (threaded connection) through the first external thread and the first internal thread.

[0115] Specifically, the first sealing cap 7 can be detachably connected to the sealing block 18 via a snap fastener in at least two ways (i.e., including but not limited to two).

[0116] For example, such as Figure 3 As shown, the cross-section of the first sealing cap 7 can be a T-shaped structure. The end of the sealing block 18 near the expansion tube 2 is provided with a first buckle 9, and the end of the first sealing cap 7 away from the expansion tube 2 is provided with a first slot. The first buckle 9 and the first slot are adapted to each other and are correspondingly set, that is, the first sealing cap 7 can be detachably connected to the sealing block 18 through the first buckle 9 and the first slot (buckle connection).

[0117] For example, such as Figure 4 As shown, the cross-section of the first sealing cap 7 can also be an arc-shaped structure. The end of the sealing block 18 away from the expansion tube 2 is provided with a second slot, and the end of the first sealing cap 7 near the expansion tube 2 is provided with a second buckle 10. The second buckle 10 is adapted to and correspondingly set with the second slot, that is, the first sealing cap 7 can be detachably connected to the sealing block 18 through the second buckle 10 and the second slot (buckle connection).

[0118] Specifically, the first sealing cap 7 has a first pin mounting groove at the end away from the puncture needle body 1. A pin (not shown in the figure) is installed in the first pin mounting groove, and the pin abuts against the outer wall of the sealing block 18, thereby making the first sealing cap 7 detachably connected to the sealing block 18 through the pin and the first pin mounting groove (pin connection).

[0119] In this embodiment, taking the first sealing cap 7 as an example of being detachably connected to the sealing block 18 via threads, when the first sealing cap 7 is installed on the sealing block 18, the first sealing cap 7 will squeeze the first sealing ring 8, thereby pressing the outer wall of the first sealing ring 8 tightly against the outer wall of the puncture needle body 1 (but without affecting the relative sliding between the outer wall of the puncture needle body 1 and the outer wall of the first sealing ring 8), thus achieving the sealing and isolation of the interior of the exhaust gap 19 between the outer wall of the puncture needle body 1 and the inner wall of the expansion tube 2 from the outside of the system.

[0120] Furthermore, taking the first sealing cap 7 as an example of being detachably connected to the sealing block 18 via threads, the compression force of the first sealing ring 8 can be adjusted by adjusting the degree of screwing in the first sealing cap 7, thereby adapting to various different working conditions.

[0121] In one embodiment of the present invention, such as Figure 5 As shown, a first expansion ring 11 is installed at the connection between the first sealing cap 7 and the sealing block 18, and the first expansion ring 11 is located on one side of the first sealing ring 8 (i.e., the first expansion ring 11 does not contact the first sealing ring 8). That is, the first sealing cap 7 can also be detachably connected to the sealing block 18 through the first expansion ring 11.

[0122] In some embodiments of the present invention, the system further includes a second sealing structure located at the connection between the puncture needle body 1 and the connecting tube 5. The second sealing structure can be used to seal and isolate the connection between the connecting tube 5 and the puncture needle body 1 (i.e., the limiting sliding connection between the connecting tube 5 and the puncture needle body 1) from the outside of the system, thereby preventing air from outside the system from entering the interior of the limiting sliding connection between the connecting tube 5 and the puncture needle body 1 during the interventricular septal puncture (i.e., preventing air from outside the system from entering the interior of the connecting tube 5 through the sliding groove of the puncture needle body).

[0123] In some embodiments of the present invention, the specific structure of the second sealing structure is not particularly limited. For example, it may include, but is not limited to, the following structures: Specifically, in this embodiment, such as Figures 6-10 As shown, the second sealing structure includes at least a second sealing cap 12 and a second sealing ring 13, wherein: The second sealing cap 12 is sleeved on the puncture needle body 1 and can slide in cooperation with the outer side wall of the puncture needle body 1. The second sealing cap 12 in the second sealing structure is located at the connection between the puncture needle body 1 and the connecting tube 5 (that is, the above-mentioned second sealing structure is located at the connection between the puncture needle body 1 and the connecting tube 5) and can be detachably connected to the connecting tube 5.

[0124] In one embodiment of the present invention, the second sealing ring 13 is located between the second sealing cap 12 and the connecting tube 5, and the second sealing ring 13 is sleeved on the puncture needle body 1 and can slide and cooperate with the outer side wall of the puncture needle body 1. In this way, the sealing performance of the second sealing ring 13 achieves the sealing isolation between the inside of the limiting sliding connection between the connecting tube 5 and the puncture needle body 1 and the outside of the system.

[0125] In some embodiments of the present invention, the detachable connection method between the second sealing cap 12 and the connecting pipe 5 is not particularly limited. For example, it can be configured as follows: like Figure 6 , Figure 7 , Figure 8 and Figure 10 As shown, the second sealing cap 12 can be detachably connected to the connecting pipe 5 by means of threads, snaps, or pins.

[0126] Specifically, such as Figure 6 As shown, the outer wall of the second sealing cap 12 is provided with a second external thread, and the connection between the connecting pipe 5 and the outer wall of the second sealing cap 12 is provided with a second internal thread that corresponds to and matches the second external thread. That is, the second sealing cap 12 can be detachably connected to the connecting pipe 5 (threaded connection) through the second external thread and the second internal thread.

[0127] Specifically, the second sealing cap 12 can be detachably connected to the connecting pipe 5 via a snap fastener in at least two ways (i.e., including but not limited to two).

[0128] For example, such as Figure 7 As shown, the cross-section of the second sealing cap 12 can be a T-shaped structure, and a third buckle 14 is provided on the outer wall of the second sealing cap 12. A third slot is provided at the connection between the connecting pipe 5 and the outer wall of the second sealing cap 12, and the third buckle 14 and the third slot are adapted to each other and are correspondingly provided. That is, the second sealing cap 12 can be detachably connected to the connecting pipe 5 (buckle connection) through the aforementioned third buckle 14 and third slot.

[0129] For example, such as Figure 8As shown, the cross-section of the second sealing cap 12 can be an arc-shaped structure. The end of the second sealing cap 12 near the puncture needle body 1 is provided with a fourth buckle 15. The outer wall of the connecting tube 5 is provided with a fourth slot, and the fourth buckle 15 and the fourth slot are adapted to each other and are correspondingly set. That is, the second sealing cap 12 can be detachably connected to the connecting tube 5 through the above-mentioned fourth buckle 15 and fourth slot (buckle connection).

[0130] Specifically, such as Figure 10 As shown, the second sealing cap 12 has a second pin mounting groove at the end away from the puncture needle body 1. The pin 17 can be installed in the second pin mounting groove, and the pin 17 abuts against the outer wall of the connecting tube 5, thereby making the second sealing cap 12 detachably connected to the connecting tube 5 through the pin 17 and the second pin mounting groove (pin connection).

[0131] It should be understood that the pin 17 described here (i.e., the pin 17 located in the second pin mounting slot) is not the same pin as the pin located in the first pin mounting slot mentioned above.

[0132] In this embodiment, taking the second sealing cap 12 as an example of being detachably connected to the connecting pipe 5 via threads, when the second sealing cap 12 is installed on the connecting pipe 5, the second sealing cap 12 will squeeze the second sealing ring 13, thereby making the outer wall of the second sealing ring 13 tightly adhere to the outer wall of the puncture needle body 1 (but without affecting the relative sliding between the outer wall of the puncture needle body 1 and the outer wall of the second sealing ring 13), thus achieving the sealing isolation between the interior of the sliding connection between the connecting pipe 5 and the puncture needle body 1 and the outside of the system.

[0133] Furthermore, taking the second sealing cap 12 as an example of being detachably connected to the connecting pipe 5 via threads, the compression force of the second sealing ring 13 can be adjusted by adjusting the degree of screwing in the second sealing cap 12, thereby adapting to various different working conditions.

[0134] In one embodiment of the present invention, such as Figure 9 As shown, a second expansion ring 16 is installed at the connection between the second sealing cap 12 and the connecting pipe 5, and the second expansion ring 16 is located on one side of the second sealing ring 13 (i.e., the second expansion ring 16 does not contact the second sealing ring 13). That is, the second sealing cap 12 can also be detachably connected to the connecting pipe 5 through the second expansion ring 16.

[0135] Furthermore, in order to completely expel the air from the gap between the puncture needle body 1 and the dilator tube 2, the cross-sectional area of ​​the through hole 6 is greater than or equal to the cross-sectional area of ​​the venting gap 19 between the puncture needle body 1 and the dilator tube 2.

[0136] Preferably, the cross-sectional area of ​​the through hole 6 can be equal to the cross-sectional area of ​​the venting gap 19 between the puncture needle body 1 and the expansion tube 2.

[0137] In this embodiment, the number of through holes 6 can also be multiple, that is, the sum of the cross-sectional areas of multiple through holes 6 is greater than or equal to the cross-sectional area of ​​the venting gap 19 between the puncture needle body 1 and the expansion tube 2.

[0138] In this embodiment, the cross-sectional shape of the through hole 6 is not particularly limited; for example, it can be... Figures 2-5 The circular structure shown.

[0139] During atrial septal puncture, it is necessary to simultaneously expel air from the vent gap 19 between the puncture needle body 1 and the dilator tube 2, as well as air from inside the puncture needle body 1, to reduce the probability of air entering the patient's body, thereby reducing the risk of thrombosis and air embolism and ensuring the patient's health and safety. Therefore, before performing atrial septal puncture, the required fluid (such as heparin as known in the art) can be introduced into the end of the connecting tube 5 furthest from the puncture needle body 1 (i.e., Figure 1 (From the left end of the connecting tube 5), after heparin enters the interior of the puncture needle body 1, it simultaneously enters the venting gap 19 between the puncture needle body 1 and the dilator tube 2 through the through hole 6, and exits from the venting gap 19 at the tip of the puncture needle body 1. This allows both the air in the venting gap 19 and the air inside the puncture needle body 1 to be simultaneously vented from the tip of the puncture needle body 1. Furthermore, since the cross-sectional area of ​​the through hole 6 is preferably equal to the cross-sectional area of ​​the venting gap 19, the ratio of the heparin flow rate inside the puncture needle body 1 to the heparin flow rate in the venting gap 19 remains at 1:1. This ensures that the air in the venting gap 19 and the air inside the puncture needle body 1 are vented simultaneously and synchronously, preventing any gap 19 or the interior of the puncture needle body 1 from being incompletely vented.

[0140] It should be understood that, in the default state (i.e., before the puncture procedure), the through-hole 6 is located on the side of the first sealing ring 8 away from the sealing block 18 (i.e., the side closer to the needle tip of the puncture needle body 1) and adjacent to and tightly fitted with the first sealing ring 8. Therefore, when heparin enters the venting gap 19 between the puncture needle body 1 and the dilator tube 2, the end of the dilator tube 2 closest to the first sealing ring 8 can be used as the starting point to expel air. This means that the air in the venting gap 19 between the puncture needle body 1 and the dilator tube 2 can be completely emptied, and no air will remain in the venting gap 19. At the same time, the first sealing structure (i.e., the first sealing ring 8) not only prevents external air from entering the venting gap 19 between the puncture needle body 1 and the dilator tube 2, but also prevents heparin in the venting gap 19 between the puncture needle body 1 and the dilator tube 2 from leaking to the outside.

[0141] In one embodiment of the present invention, such as Figure 1 As shown, a push button 4 is slidably mounted on the handle part 3 along the length direction of the expansion tube 2. The push button 4 is located between the first sealing structure and the second sealing structure and is connected to the outer wall of the puncture needle body 1. With the push button 4, the puncture needle body 1 can be pushed more conveniently (that is, the puncture needle body 1 can be moved relatively within the expansion tube 2 more conveniently).

[0142] In this embodiment, the connection method between the push button 4 and the outer wall of the puncture needle body 1 is not particularly limited. For example, it can be connected by bolts as known in the art.

[0143] In one embodiment of the present invention, a spring (not shown in the figure) is fitted onto the puncture needle body 1. The spring is located between the first sealing structure and the second sealing structure. One end of the spring is connected to the end of the push button 4 near the first sealing structure, and the other end of the spring is connected to the inner wall of the handle portion 3. By setting the spring, it can provide reverse resistance to the push button 4 when it is pushed, thereby enabling more precise control over the pushing distance and pushing speed of the puncture needle body 1.

[0144] In one embodiment of the present invention, such as Figure 12 and Figure 13 As shown, the tip of the puncture needle body 1 has a structure that narrows from both sides towards the middle (i.e., Figure 12 The area indicated by the symbol R), and the tip of the puncture needle 1 has a chamfered structure both inside and outside. Through the aforementioned narrowing of both sides of the needle tip towards the center and the chamfered structure, the tip of the puncture needle 1 can be prevented from scratching the inner wall of the dilation tube 2 when it moves relative to the dilation tube 2, thus avoiding the "shaving" phenomenon. This prevents insoluble plastic foreign objects from falling into the patient's heart chambers, ensuring the patient's health and safety.

[0145] In addition, the inside and outside of the needle tip of the puncture needle body 1 can be rounded or other irregular transition structures.

[0146] In this embodiment, as Figure 13 As shown, the angles at positions α and β at the tip of the puncture needle body 1 can both be greater than 120° and less than 180°, and the transition section at this part can be a straight line or a protective line, without any special limitation.

[0147] In this embodiment, the first sealing ring 8 and the second sealing ring 13 can both be made of soft polymer materials known in the art, such as natural rubber, etc., and are not particularly limited here.

[0148] In this embodiment, both the first expansion ring 11 and the second expansion ring 16 are existing technologies known in the art, and are achieved through... Figure 11 This allows one to understand the specific structure of both the first rising circle 11 and the second rising circle 16, which will not be elaborated upon here.

[0149] In this embodiment, in order to ensure the visibility of the venting and sealing, both the first sealing structure and the second sealing structure can be made of transparent polymer materials known in the art, such as PC or ABS, etc., which are not particularly limited here.

[0150] In this embodiment, a magnetic sensor (not shown in the figure) known in the art can be provided inside the head end of the expansion tube 2 (i.e., the end of the expansion tube 2 away from the handle part 3), thereby enabling precise positioning in a three-dimensional mapping system. Alternatively, a wire (not shown in the figure) known in the art can be added to the puncture needle body 1. This wire is configured to be electrically connected to the puncture needle body 1, so that the tip of the puncture needle body 1 can act as an electrical positioning electrode for precise positioning when it extends out of the head end of the expansion tube 2.

[0151] In this embodiment, to further improve the subsequent developing effect, a developing ring (not shown in the figure) known in the art can be fused to the inside of the head end of the expansion tube 2. Meanwhile, the raw materials used to manufacture the expansion tube 2 include, but are not limited to, developing materials such as tungsten powder, tantalum powder, bismuth salts, and / or barium salts.

[0152] Example 3 In this embodiment, the first sealing structure and the second sealing structure are integrated to form an integral sealing structure, which includes an integral sealing body, an integral needle sealing part that tightly abuts against the end face of the puncture needle, and an integral expansion tube sealing part that tightly abuts against the expansion tube, wherein: The integrated needle body sealing part is fixedly connected to the end face of the puncture needle body, and the integrated expansion tube sealing part is slidably connected to the expansion tube 2; Preferably, the integrated sealing structure is provided with an exhaust groove 21 that communicates with the exhaust gap 19.

[0153] Specifically, such as Figure 14 As shown in this embodiment, the present invention provides another interatrial septal puncture system.

[0154] like Figure 14 As shown, this system includes at least a puncture needle body 1, a dilator tube 2, a handle 3, and a connecting tube 5; wherein: The connecting tube 5 is installed on the handle part 3 and slides in cooperation with the handle part 3. The puncture needle body 1 is located inside both the connecting tube 5 and the puncture needle body 1. One end of the puncture needle body 1 located inside the connecting tube 5 is connected to the connecting tube 5 and communicates with the inside of the connecting tube 5. A venting gap 19 is provided between the outer wall of the puncture needle body 1 and the inner wall of the connecting tube 5, and between the outer wall of the puncture needle body 1 and the inner wall of the expansion tube 2. A moving groove 22 is provided on the connecting tube 5. The moving groove 22 can communicate with the venting gap 19. The end of the expansion tube 2 near the connecting tube 5 is located in the moving groove 22. A third sealing ring 20 is provided inside the moving groove 22. The third sealing ring 20 is sleeved on the expansion tube 2 and slides in cooperation with the outer side wall of the expansion tube 2. The interior of the connecting pipe 5 is provided with an exhaust groove 21, which is connected to the exhaust gap 19.

[0155] Preferably, in this embodiment, the connecting tube 5, the dilation tube 2, and the puncture needle body 1 are all coaxially arranged.

[0156] In this embodiment, there can be multiple exhaust grooves 21, which are arranged sequentially along the circumference inside the connecting pipe 5.

[0157] In this embodiment, when the system is in use, pushing the connecting tube 5 allows the puncture needle 1 to move within the expansion tube 2. The venting groove 21 allows air to be expelled from the venting gap 19, the moving groove 22 provides space for relative movement between the connecting tube 5 and the expansion tube 2, and the third sealing ring 20 seals and isolates the venting gap 19 from the outside environment of the system.

[0158] It should be understood that the above-described embodiments or examples of the present invention can be combined with each other and have corresponding technical effects.

[0159] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A transseptal puncture system, characterized in that, It includes a puncture needle body, a dilator, and a handle with a hollow internal structure, wherein: The puncture needle body includes a needle cavity and a needle wall, the expansion tube includes a tube cavity and a tube wall, the puncture needle body is movably disposed in the tube cavity of the expansion tube, and an exhaust gap is formed between the outer side of the needle wall and the inner side of the tube wall, a first sealing structure is provided between the handle and the expansion tube, and a through hole is provided on the needle wall to allow the exhaust gap to communicate with the needle cavity.

2. The atrial septal puncture system according to claim 1, characterized in that, The first sealing structure includes a first needle body sealing part that seals with the puncture needle body and a single expansion tube sealing part that connects to the expansion tube; Preferably, the first needle body sealing portion includes a first sealing ring; Preferably, the inner wall of the first sealing ring is in a sealing fit with the outer wall of the puncture needle body; Preferably, the single expansion tube sealing part includes, but is not limited to, fixed or detachable connection structures, such as threaded connection structures, pin connection structures, adhesive, interference fit connection structures and / or snap-fit ​​connection structures.

3. The atrial septal puncture system according to claim 2, characterized in that, The single expansion tube sealing part includes a first sealing structure body and a first sealing cap, and the first sealing cap is connected to the expansion tube; Preferably, the main body of the first sealing structure includes a sealing block; Preferably, the sealing block and the first sealing cap are connected by means of mechanical structure, pin connection or adhesive bonding, including but not limited to mechanical connection, pin connection or adhesive bonding; Preferably, the mechanical structure connection includes, but is not limited to, a snap-fit ​​connection or an expansion ring connection.

4. The atrial septal puncture system according to claim 2, characterized in that, The through hole is adjacent to the first sealing ring; Preferably, the cross-sectional area of ​​the through hole is greater than or equal to the cross-sectional area of ​​the exhaust slit.

5. The atrial septal puncture system according to claim 1, characterized in that, A connecting tube is provided on the end of the handle that is away from the expansion tube. The system further includes a second sealing structure disposed between the end face of the puncture needle and the connecting tube; Preferably, the connecting tube is fixedly connected to the puncture needle body, thereby enabling the connecting tube and the puncture needle body to move synchronously; or The connecting tube is movably connected to the puncture needle body, thereby enabling relative movement between the connecting tube and the puncture needle body.

6. The atrial septal puncture system according to claim 5, characterized in that, The second sealing structure includes a second sealing cap connected to the connecting tube and a second needle sealing part that seals with the puncture needle body; Preferably, the second needle body sealing portion includes a second sealing ring; Preferably, the inner wall of the second sealing ring is in a sealing fit with the outer wall of the puncture needle body; Preferably, the connecting pipe and the second sealing cap are connected by means of, but not limited to, threaded connection, snap-fit ​​connection, expansion ring connection, pin connection or adhesive bonding.

7. The atrial septal puncture system according to claim 6, characterized in that, The first sealing structure and the second sealing structure are integrated to form an integral sealing structure, which includes an integral sealing body and a movable groove formed on the connecting tube. The expansion tube is located in the movable groove and slides in cooperation with the connecting tube. The integral sealing body is sealed in cooperation with the expansion tube. The end face of the puncture needle is connected to the connecting tube. Preferably, the movable groove is connected to the interior of the connecting pipe; Preferably, the integrated sealing body includes a third sealing ring, and the third sealing ring is located within the moving groove; Preferably, the inner wall of the third sealing ring is in a sealing fit with the outer wall of the puncture needle body; Preferably, the integrated sealing structure is provided with an exhaust groove that communicates with the exhaust gap; Preferably, the exhaust groove is formed inside the connecting pipe.

8. The transseptal puncture system according to claim 1, characterized in that, The tip of the puncture needle includes, but is not limited to, a structure that narrows from both sides towards the middle.

9. The atrial septal puncture system according to claim 1, characterized in that, The raw materials of the expansion tube include, but are not limited to, developing materials such as tungsten powder, bismuth salt, barium salt and / or tantalum powder.

10. The atrial septal puncture system according to claim 8, characterized in that, The tip of the puncture needle is provided with both the interior and exterior of a chamfered structure, a rounded corner structure, or other irregular transition structures.

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