An atrial septostomy needle sheath system

Abstract

The application provides an atrial septum puncture needle sheath system, and relates to the technical field of medical devices, to solve the problem that the existing technology lacks feedback to the operator when puncturing through the foramen ovale. The atrial septum puncture needle sheath system comprises an expander outer tube, a handle shell, an inner needle assembly, and a pushing mechanism and a pull rod installed in the handle shell. The expander outer tube is connected to the front end of the handle shell. The rear end of the inner needle assembly is arranged in the handle shell, and the front end of the inner needle assembly extends into the expander outer tube. The rear end of the inner needle assembly is movably connected to the front end of the pull rod through a first elastic member. When the front end of the inner needle assembly pierces the puncture site, the first elastic member pushes the inner needle assembly to move relative to the pull rod towards the front end of the pull rod and triggers a feedback mechanism. The atrial septum puncture needle sheath system can trigger the feedback mechanism when the puncture site is pierced, so that the operator can perceive that the inner needle assembly has pierced the puncture site, and further advancement is avoided, thereby improving the safety of operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a transseptal puncture needle sheath system. Background Technology

[0002] Atrial septal puncture has become one of the most commonly used techniques in interventional cardiology, used for the treatment of left ventricular arrhythmias, left atrial appendage closure, percutaneous left ventricular assist device placement, and various mitral valve surgeries. The atrial septal puncture needle is responsible for penetrating the atrial septum during this procedure. Early atrial septal puncture techniques were developed by Ross. The key steps involve inserting the puncture sheath and dilator along the guidewire into the superior vena cava. The needle is then advanced to a point 1 cm distal to the dilator opening. Simultaneously, the puncture sheath is slowly withdrawn from the superior vena cava towards the right atrium while rotating clockwise towards the left and lower back (appearing to the 4-5 o'clock position from bottom to top). As the sheath continues to withdraw slowly, its distal end moves to the right, crossing the carina of the aortic root and overlapping with the spine. The sheath is then withdrawn further, allowing its distal end to slide into the fossa ovalis. Under X-ray observation, three skipping signs can be observed during the sheath withdrawal process. Finally, the needle is pushed forward to puncture the left atrium. The needle is slowly advanced from the tip of the component into the septum, and the operator can feel the breakthrough sensation as it passes through the septum and enters the left atrium. In recent years, with the rapid development of catheter ablation therapy for atrial fibrillation, the technical requirements for atrial septal puncture have become increasingly higher. Operators are required not only to be able to puncture through the atrial septum, but also to puncture at the optimal site to improve safety and effectiveness.

[0003] A standard atrial septal puncture device includes a puncture needle, guidewire, dilator, and puncture sheath. Currently, integrated atrial septal puncture devices have emerged, such as the one described in patent application CN115919431A, which combines a dilator and puncture needle into a single device and controls their movement via a handle. Compared to the standard atrial septal puncture assembly, this integrated design reduces the need for exchanging the puncture needle and dilator. Furthermore, the handle's transmission mechanism can be configured to limit the needle's penetration beyond the dilator, reducing the risk of damage to the atrial wall caused by excessive needle penetration. In this type of puncture device, the needle is typically pushed directly along the handle's axial direction by a drive assembly, with the drive assembly's progress and the needle's progress being in a 1:1 ratio. Regardless of whether it's a traditional puncture method or this integrated puncture method, the actual distance the puncture needle extends beyond the dilator during the procedure is generally 3-6 millimeters. Although mechanical limiting designs prevent the risk of excessive force leading to over-protrusion, the short distance movement still makes precise control difficult when pushed directly by hand on the handle, increasing the learning curve for operators to use such instruments correctly. Integrated puncture devices have also seen rotary pushing methods. For example, patent CN115670610A describes a rotating, turntable-like device on the handle that controls the extension and retraction of the needle tip. Another related patent, CN115349927A, describes an integrated device for performing atrial septal puncture in conjunction with an interventional robotic arm. This device controls the movement of the puncture needle within the dilator by rotating a screw in the handle around its axis. This rotary needle insertion design allows for more precise operation. Because the degree of rotation by the finger is limited each time—for example, a half-turn (180 degrees) only advances the needle by 1 millimeter—the risk of excessive force leading to over-protrusion is effectively avoided.

[0004] However, existing rotary integrated puncture devices still have two shortcomings: First, while the rotary needle insertion system allows for precise operation and is well-suited for use with robotic arms, it lacks the tactile feedback (sense of breakthrough) provided to the operator when puncturing and penetrating the foramen ovale. Second, if the puncture needle extends too far out of the dilator, there is a risk of puncturing the distal atrial wall. Ideally, atrial septal puncture should not only limit the extension of the puncture needle but also allow it to automatically retract into the dilator after breakthrough, enabling the operator to directly push the dilator into the left atrium. Summary of the Invention

[0005] The purpose of this invention is to provide a transseptal puncture needle sheath system to solve the problem of lacking tactile feedback for the operator when puncturing and penetrating the foramen ovale in the prior art. The transseptal puncture needle sheath system of this invention can trigger a feedback mechanism when puncturing the site to be punctured, so that the operator can feel that the inner needle component has punctured the site to be punctured, avoiding further advancement and improving the safety of the operation.

[0006] The present invention provides a transseptal puncture needle sheath system, including an outer tube of a dilator, a handle housing, an inner needle assembly, and a pushing mechanism and a pull rod installed in the handle housing. The outer tube of the dilator is connected to the front end of the handle housing, the rear end of the inner needle assembly is disposed in the handle housing and its front end extends into the outer tube of the dilator, and the rear end of the inner needle assembly is movably connected to the front end of the pull rod through a first elastic element.

[0007] The pushing mechanism can drive the inner needle assembly and the pull rod to move simultaneously toward the front end of the handle housing and extend the front end of the inner needle assembly out of the expander outer tube; when the front end of the inner needle assembly abuts against the part to be pierced, the inner needle assembly moves toward its rear end relative to the pull rod and compresses the first elastic member; when the front end of the inner needle assembly pierces the part to be pierced, the first elastic member pushes the inner needle assembly to move toward its front end relative to the pull rod and triggers the feedback mechanism.

[0008] As a preferred embodiment of the present invention, it further includes a linkage mechanism, which is installed at the front end of the pull rod. The linkage mechanism enables the push mechanism and the pull rod to be in a locked or unlocked state. When the linkage mechanism and the pull rod are in a locked state, the push mechanism can drive the pull rod to move. When the push mechanism and the pull rod are in an unlocked state, the pull rod can move relative to the push mechanism.

[0009] In a preferred embodiment of the present invention, the inner needle assembly includes an inner needle and a push rod. The push rod is fixedly connected to the outside of the inner needle. The front end of the inner needle extends into the outer tube of the expander. The push rod is installed in the handle housing. A mounting groove is provided at the front end of the pull rod. The rear end of the push rod extends into the mounting groove. The first elastic element is installed in the mounting groove, with one end abutting against the push rod and the other end abutting against the pull rod. The rear end of the pull rod extends to the outside of the handle housing.

[0010] As a preferred embodiment of the present invention, a sliding groove is provided inside the mounting groove of the pull rod, and a sliding block is provided on the side wall of the push rod. The sliding block is slidably disposed in the sliding groove along the axial direction of the pull rod. The linkage mechanism is installed on one side of the sliding groove. The movement of the sliding block in the sliding groove can drive the linkage mechanism to put the push mechanism and the pull rod into a locked or unlocked state.

[0011] In a preferred embodiment of the present invention, the linkage mechanism includes a first link, a second link, and a connecting block. The first link and the second link are respectively disposed on the front and rear sides of the connecting block. The middle sections of the first link and the second link are rotatably connected to the pull rod via a pivot. The first end of the first link is rotatably connected to the connecting block, and its second end extends toward the front end of the pull rod. The first end of the second link is rotatably connected to the connecting block, and its second end extends toward the rear end of the pull rod.

[0012] As a preferred embodiment of the present invention, the pushing mechanism includes a pushing component and a connecting sleeve. The pushing component is connected to the connecting sleeve and can drive the connecting sleeve to move back and forth. The connecting sleeve is sleeved on the outside of the front end of the pull rod. An elastic limiting block is provided inside the connecting sleeve. The connecting block and the elastic limiting block can be in a locked state or an unlocked state.

[0013] As a preferred embodiment of the present invention, when the sliding block moves to the front end of the sliding groove, it can drive the second end of the first connecting rod to lift up and move the connecting block to the inside of the push rod, so that the connecting block and the elastic limiting block are in an unlocked state.

[0014] As a preferred embodiment of the present invention, it further includes a fixing ring, which is sleeved on the outside of the push rod and fixedly connected to the handle housing. When the push rod and the linkage mechanism move toward the fixing ring, the fixing ring can press the second end of the second linkage toward the inside of the push rod and drive the connecting block to move toward the outside of the push rod, so that the connecting block and the elastic limiting block are in a locked state.

[0015] As a preferred embodiment of the present invention, it further includes a second elastic member, which is installed on the outside of the pull rod. One end of the second elastic member is connected to the tail end of the handle housing and the other end is connected to the pull rod. When the pushing mechanism and the pull rod are in an unlocked state, the second elastic member can pull the pull rod toward the tail end of the handle housing.

[0016] In a preferred embodiment of the present invention, the pushing component includes a knob and a screw. The knob is rotatably mounted on the handle housing. The knob and the screw are coaxially connected by a thread. The rear end of the screw is connected to the connecting sleeve through a bearing. Rotating the knob can drive the screw and the connecting sleeve to move back and forth along the axial direction of the handle housing.

[0017] Compared with the prior art, the present invention has the following positive effects:

[0018] The room-wide puncture needle sheath system provided by this invention includes an expander outer tube, a handle housing, an inner needle assembly, and a pushing mechanism and a pull rod installed in the handle housing. The expander outer tube is connected to the front end of the handle housing. The rear end of the inner needle assembly is disposed in the handle housing, and its front end extends into the expander outer tube. The rear end of the inner needle assembly and the front end of the pull rod are movably connected through a first elastic member. The pushing mechanism can drive the inner needle assembly and the pull rod to move simultaneously toward the front end of the handle housing and cause the front end of the inner needle assembly to extend out of the expander outer tube. When the front end of the inner needle assembly abuts against the puncture site, the inner needle assembly moves toward its rear end relative to the pull rod and compresses the first elastic member. When the front end of the inner needle assembly punctures the puncture site, the first elastic member pushes the inner needle assembly to move toward its front end relative to the pull rod and triggers the feedback mechanism. In use, the transseptal puncture needle sheath system of the present invention moves the inner needle assembly and the pull rod simultaneously toward the front end of the handle housing via a pushing mechanism, causing the front end of the inner needle assembly to extend out of the dilator outer tube. When the front end of the inner needle assembly abuts against the site to be punctured, the inner needle assembly moves toward its rear end relative to the pull rod and compresses the first elastic element. When the front end of the inner needle assembly punctures the site to be punctured, the resistance at the front end of the inner needle assembly disappears, and the first elastic element pushes the inner needle assembly toward its front end relative to the pull rod and triggers a feedback mechanism. The feedback mechanism provides the operator with vibration or sound feedback, allowing the operator to perceive that the inner needle assembly has punctured the site to be punctured, avoiding further advancement and improving the safety of the operation. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art 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.

[0020] Figure 1 This is a schematic diagram of the interatrial septal puncture needle sheath system of the present invention;

[0021] Figure 2 This is a schematic diagram of the internal structure of the handle housing in this invention;

[0022] Figure 3 This is an exploded view of the interior of the handle housing in this invention;

[0023] Figure 4 This is a schematic diagram of the internal structure of the intercompartment puncture needle sheath system in the initial state of the present invention;

[0024] Figure 5 for Figure 4 A magnified view of part A in the image;

[0025] Figure 6This is a diagram showing the state of the linkage mechanism when the tip of the inner needle in this invention abuts against the area to be punctured.

[0026] Figure 7 This is a diagram showing the state of the linkage mechanism when the tip of the inner needle pierces the area to be pierced in this invention.

[0027] Figure 8 This is a diagram showing the state of the linkage mechanism when the second elastic element in this invention pulls the pull rod and the inner pin assembly backward.

[0028] Figure 9 This is a diagram showing the state of the linkage mechanism when the connecting sleeve of the pushing mechanism in this invention moves backward.

[0029] In the diagram: 1. Handle housing; 2. Expander outer tube; 3. Inner needle assembly; 31. Inner needle; 32. Push rod; 321. Sliding block; 322. First collision surface; 4. Pushing mechanism; 41. Knob; 42. Screw; 43. Connecting sleeve; 431. Elastic limiting block; 44. Bearing; 5. First elastic element; 6. Pull rod; 61. Mounting groove; 62. Sliding groove; 621. Second collision surface; 63. Limiting ring; 64. Mounting hole; 65. Limiting plate; 66. Sliding groove; 7. Second elastic element; 8. Linkage mechanism; 81. Connecting block; 82. First connecting rod; 83. Second connecting rod; 9. Fixing ring. Detailed Implementation

[0030] In the description of this invention, it should be noted that, unless otherwise stated, "a plurality of" means two or more; the terms "upper," "lower," "front," "rear," "left," "right," "top," "bottom," "inner," "outer," "front end," "rear end," "head," "tail," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the invention and simplifying it, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0031] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" 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. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0032] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

[0033] Example 1:

[0034] This embodiment provides a transseptal puncture needle sheath system, such as Figures 1-9 As shown, the device includes an expander outer tube 2, a handle housing 1, an inner needle assembly 3, and a push mechanism 4 and a pull rod 6 installed in the handle housing 1. The expander outer tube 2 is connected to the front end of the handle housing 1. The rear end of the inner needle assembly 3 is disposed within the handle housing 1, and its front end extends into the expander outer tube 2. The rear end of the inner needle assembly 3 and the front end of the pull rod 6 are movably connected via a first elastic member 5. The first elastic member 5 can provide a thrust for the relative movement of the inner needle assembly 3 and the pull rod 6. The inner needle assembly 3, the push mechanism 4, and the pull rod 6 are coaxially disposed within the handle housing 1. The push mechanism 4 is detachably connected to the pull rod 6. The inner needle assembly 3 is movably disposed through the interior of the push mechanism 4.

[0035] The pushing mechanism 4 can simultaneously move the inner needle assembly 3 and the pull rod 6 towards the front end of the handle housing 1, causing the front end of the inner needle assembly 3 to extend out of the dilator outer tube 2. When the front end of the inner needle assembly 3 abuts against the puncture site, the inner needle assembly 3 moves towards its rear end relative to the pull rod 6 and compresses the first elastic element 5. At this time, the pushing force of the first elastic element 5 on the inner needle assembly 3 is less than the resistance of the puncture site on the inner needle assembly 3, so it is necessary to continue pushing the inner needle assembly 3 forward through the pushing mechanism 4. When the front end of the inner needle assembly 3 punctures the puncture site, the first elastic element 5 pushes the inner needle assembly 3 towards its front end relative to the pull rod 6 and triggers the feedback mechanism. The first elastic element 5 can be a spring. The feedback mechanism can be the vibration or sound generated by the first elastic element when the inner needle assembly 3 punctures the puncture site, to provide feedback to the operator, allowing the operator to perceive the puncture and avoid further advancement, thereby improving the safety of the operation.

[0036] In this embodiment, the interventricular septal puncture needle sheath system, when in use, drives the inner needle assembly 3 and the pull rod 6 to move simultaneously toward the front end of the handle housing 1 via the pushing mechanism 4, causing the front end of the inner needle assembly 3 to extend out of the dilator outer tube 2. When the front end of the inner needle assembly 3 abuts against the site to be punctured, the inner needle assembly 3 moves toward its rear end relative to the pull rod 6 and compresses the first elastic member 5. When the front end of the inner needle assembly 3 punctures the site to be punctured, the resistance at the front end of the inner needle assembly 3 disappears, and the first elastic member 5 pushes the inner needle assembly 3 to move toward its front end relative to the pull rod 6 and triggers the feedback mechanism. The feedback mechanism provides the operator with vibration or sound feedback, allowing the operator to perceive that the inner needle assembly 3 has punctured the site to be punctured, avoiding further advancement and improving the safety of the operation.

[0037] In a preferred embodiment, the interventricular septal puncture needle sheath system of this embodiment further includes a linkage mechanism 8, which is installed at the front end of the pull rod 6. The linkage mechanism 8 enables the push mechanism 4 and the pull rod 6 to be in a locked or unlocked state. When the linkage mechanism 8 and the pull rod 6 are in the locked state, the push mechanism 4 can drive the pull rod 6 to move. When the push mechanism 4 and the pull rod 6 are in the unlocked state, the pull rod 6 can move relative to the push mechanism 4.

[0038] When the linkage mechanism 8 and the pull rod 6 are locked, the push mechanism 4 can drive the inner needle assembly 3 and the pull rod 6 to move simultaneously toward the front end of the handle housing 1, causing the front end of the inner needle assembly 3 to extend out of the expander outer tube 2. When the push mechanism 4 and the pull rod 6 are unlocked, the pull rod 6 can drive the inner needle assembly 3 to move simultaneously toward the rear end of the handle housing 1 relative to the push mechanism 4, so as to pull the inner needle assembly 3 back in time and retract it into the expander outer tube 2.

[0039] As a preferred implementation method, such as Figure 2 As shown, the inner needle assembly 3 includes an inner needle 31 and a push rod 32. The push rod 32 is fixedly connected to the outside of the inner needle 31. The front end of the inner needle 31 extends into the outer tube 2 of the expander, and the push rod 32 is installed in the handle housing 1. The front end of the push rod 32 is connected to the handle housing 1, and the rear end of the push rod 32 passes through the push mechanism 4. A mounting groove 61 is provided at the front end of the pull rod 6, and the mounting groove 61 extends along the axial direction of the pull rod. The rear end of the push rod 32 extends into the mounting groove 61, and the first elastic member 5 is installed in the mounting groove 61, with one end abutting against the push rod 32 and the other end abutting against the pull rod 6. The rear end of the pull rod 6 extends to the outside of the handle housing 1. The mounting groove 61 securely positions the first elastic member between the pull rod 6 and the push rod 32, and also provides guidance for the movement of the push rod 32 relative to the pull rod 6.

[0040] As a preferred implementation method, such as Figure 2 and Figure 5 As shown, a sliding groove 62 is provided inside the mounting groove 61 of the pull rod 6. The sliding groove 62 can be provided around the inner side of the pull rod 6 or along both sides of the pull rod 6. A sliding block 321 is provided on the side wall of the push rod 32. It can be provided around the outer wall of the push rod 32 or along both sides of the push rod 32. The sliding block 321 is slidably disposed in the sliding groove 62 along the axial direction of the pull rod 6. The sliding groove 62 provides guiding space for the sliding block 321 to slide in the axial direction of the pull rod 6. The linkage mechanism 8 is installed on one side of the sliding groove 62. The movement of the sliding block 321 in the sliding groove 62 can drive the linkage mechanism 8 to lock or unlock the push mechanism 4 and the pull rod 6. Specifically, as shown... Figure 3As shown, a mounting hole 64 is provided on the side wall of the pull rod 6, which communicates with the sliding groove 62. The linkage mechanism 8 is installed in the mounting hole 64. The sliding groove 62 provides guidance and limit for the sliding block 321, making the connection between the push rod 32 and the pull rod 6 more stable, and limiting the distance that the push rod 32 moves relative to the pull rod 6.

[0041] Preferably, such as Figure 6 As shown, the sliding block 321 has a first collision surface 322 on its front sidewall, and the sliding groove 62 has a second collision surface 621 on its front sidewall. Corresponding metal pieces are provided on the first collision surface 322 and the second collision surface 621. When the first elastic member 5 pushes the push rod 32 forward, the sliding block 321 moves forward in the sliding groove 62 until the first collision surface 322 collides with the second collision surface 621. The two corresponding metal pieces collide, producing a sound, which is then fed back to the surgeon to remind them that the tip of the inner needle assembly 3 has pierced the area to be pierced.

[0042] As a preferred implementation method, such as Figure 2 and Figure 5 As shown, the linkage mechanism 8 includes a first link 82, a second link 83, and a connecting block 81. The first link 82 and the second link 83 are respectively disposed on the front and rear sides of the connecting block 81. The middle sections of the first link 82 and the second link 83 are rotatably connected to the pull rod 6 via pivots. The first end of the first link 82 is rotatably connected to the connecting block 81, and its second end extends toward the front end of the pull rod 6. The first end of the second link 83 is rotatably connected to the connecting block 81, and its second end extends toward the rear end of the pull rod 6.

[0043] Specifically, such as Figure 3 As shown, the first connecting rod 82 and the second connecting rod 83 are rotatably mounted in the mounting hole 64 via a pivot. A groove 66 is provided in the middle of the mounting hole 64, and the groove 66 has a bottom surface. The connecting block 81 is movably disposed in the groove and can move radially along the tie rod 6. The width of the groove 66 is greater than the width of the mounting hole 64, preventing the connecting block 81 from moving back and forth along the mounting hole. The bottom end of the connecting block 81 is connected to the bottom surface of the groove 66 via a third elastic element. The connecting block 81 protrudes from the outer wall of the tie rod 6 or retracts into the tie rod 6. When the connecting block 81 protrudes from the outer wall of the tie rod 6, the third elastic element keeps the connecting block 81 protruding from the outer wall of the tie rod 6. A limiting plate 65 is also provided in the mounting hole 64 on the rear side of the groove 66. The limiting plate 65 is located close to the inner wall of the mounting groove 61. The second end of the second connecting rod 83 extends to the outside of the limiting plate 65 to prevent the second end of the second connecting rod 83 from rotating into the mounting groove 61.

[0044] like Figure 5As shown, when the second end of the first link 82 is raised, it can drive the connecting block 81 to move downward, and when the second end of the second link 83 is pressed down, it can drive the connecting block 81 to move upward.

[0045] Preferably, such as Figure 5 As shown, the width of the first end of both the first link 82 and the second link 83 is smaller than the width of their respective second ends, so that when the sliding block 321 slides in the sliding groove 62, it touches the second end of the first link 82 upwards, causing it to rotate and drive the connecting block 81 to move downwards. The length of the second end of the second link 83 is greater than the length of the second end of the first link 82.

[0046] In a preferred embodiment, the pushing mechanism 4 includes a pushing component and a connecting sleeve 43. The pushing component is connected to the connecting sleeve 43 and can drive the connecting sleeve 43 to move back and forth. The connecting sleeve 43 has a cylindrical structure with openings at both ends. The connecting sleeve 43 is fitted onto the outer side of the front end of the pull rod 6. An elastic limiting block 431 is provided inside the connecting sleeve 43. The connecting block 81 and the elastic limiting block 431 can be in a locked state or an unlocked state.

[0047] like Figure 5 As shown, when the connecting block 81 is engaged in front of the elastic limiting block 431, the connecting block 81 and the elastic limiting block 431 are locked together. The forward movement of the connecting sleeve 43 can drive the pull rod 6 forward, and the push rod 32, under the pushing force of the first elastic element 5, also moves forward, thereby allowing the front end of the inner needle 31 to extend out of the expander outer tube 2. Figure 7 As shown, when the connecting block 81 moves downward to the lower side of the elastic limiting block 431, the connecting block 81 and the elastic limiting block 431 are in an unlocked state, allowing the pull rod 6 to be pulled backward relative to the connecting sleeve 43.

[0048] Specifically, the front sidewall of the elastic limiting block 431 is planar and the rear sidewall is arc-shaped; the front sidewall of the connecting block 81 is arc-shaped and the rear sidewall is planar. When the connecting block 81 is engaged with the front side of the elastic limiting block 431, the front sidewall of the elastic limiting block 431 engages with the rear sidewall of the connecting block 81, locking the connecting block 81 to the elastic limiting block 431. When the rear sidewall of the elastic limiting block 431 is in contact with the front sidewall of the connecting block 81, because the elastic limiting block 431 has a certain elastic deformation capability and the connecting block 81 can move up and down, the elastic limiting block 431 cannot lock with the connecting block 81.

[0049] In a preferred embodiment, when the sliding block 321 moves to the front end of the sliding groove 62, it can drive the second end of the first connecting rod 82 to lift up and move the connecting block 81 to the inside of the push rod 32, so that the connecting block 81 and the elastic limiting block 431 are in an unlocked state.

[0050] When the front end of the inner needle assembly 3 pierces the area to be pierced, the first elastic element pushes the push rod 32 forward, causing the sliding block 321 to move to the front end of the sliding groove 62, pushing the second end of the first connecting rod 82 to lift up, thereby causing the connecting block 81 to move inward to the inside of the push rod 32, so that the connecting block 81 and the elastic limiting block 431 are unlocked.

[0051] In a preferred embodiment, the interventricular septal puncture needle sheath system of this embodiment further includes a retaining ring 9. The retaining ring 9 is sleeved on the outside of the push rod 32 and fixedly connected to the handle housing 1. The retaining ring 9 has a cylindrical structure with openings at both ends. In the initial state, the retaining ring 9 is located on the rear side of the connecting sleeve 43, and the front end of the retaining ring 9 can extend into the rear end of the connecting sleeve 43.

[0052] When push rod 32 and linkage mechanism 8 move toward fixed ring 9, fixed ring 9 can press the second end of second linkage 83 toward the inside of push rod 32 and drive connecting block 81 toward the outside of push rod 32, so that connecting block 81 and elastic limiting block 431 are locked. The second end of second linkage 83 extends to the rear side of sliding groove 62 so that it can be pressed down by fixed ring 9. The second end of second linkage 83 is limited by limiting plate 65 and will not fall into sliding groove 62, so it is not affected by sliding block 321. Preferably, as Figure 5 As shown, the front end face of the retaining ring 9 is arc-shaped to facilitate the second end of the second connecting rod 83 sliding into the inner side of the retaining ring 9.

[0053] In this embodiment, by setting a fixing ring 9, the fixing ring 9 can press the second end of the second connecting rod 83 toward the inside of the push rod 32 and drive the connecting block 81 to move toward the outside of the push rod 32, thereby enabling the connecting block 81 and the elastic limiting block 431 to be locked.

[0054] In a preferred embodiment, the interventricular septal puncture needle sheath system of this embodiment further includes a second elastic element 7. The second elastic element 7 is installed on the outside of the pull rod 6, with one end connected to the tail end of the handle housing 1 and the other end connected to the pull rod 6. When the pushing mechanism 4 and the pull rod 6 are in the unlocked state, the second elastic element 7 can pull the pull rod 6 toward the tail end of the handle housing 1. Specifically, a limiting ring 63 is provided at the tail end of the pull rod 6, and the limiting ring 63 is located on the inner side of the handle housing 1. The second elastic element 7 is located between the limiting ring 63 and the mounting groove 61.

[0055] When the connecting block 81 and the elastic limiting block 431 are in the unlocked state, the connecting block 81 is not limited by the elastic limiting block 431, and the pull rod 6 and the inner needle assembly can be pulled towards the tail end of the handle housing 1 under the pulling force of the second elastic element 7, so that the inner needle can retract into the outer tube 2 of the expander in time.

[0056] In a preferred embodiment, the actuating assembly includes a knob 41 and a screw 42. The knob 41 is rotatably mounted on the handle housing 1. The knob 41 and the screw 42 are coaxially connected by threads. The rear end of the screw 42 is connected to the connecting sleeve 43 via a bearing 44. Rotation of the knob 41 can drive the screw 42 and the connecting sleeve 43 to move back and forth along the axial direction of the handle housing 1. In the initial state, the connecting block 81 and the elastic limiting block 431 are locked, thereby driving the pull rod 6 and the push rod 32 to move forward simultaneously, so as to push the inner needle forward and extend it out of the dilator outer tube 2 for piercing operation.

[0057] In this embodiment, a knob 41 is set up, and the distance of the inner needle forward is adjusted by controlling the rotation angle of the knob 41. Compared with the traditional method of pushing by the handle, it effectively avoids the danger of the traditional puncture or simple push rod design, which may cause the puncture needle to puncture the inner wall of the atrium by pushing it too quickly during the operation of the doctor. The control is more precise and can achieve good fine control, thus improving safety.

[0058] In this embodiment, when using the interventricular septal puncture needle sheath system, the tip of the dilator outer tube 2 rests against the site to be punctured.

[0059] In the initial state, such as Figure 5 As shown, the front end of the fixing ring 9 extends into the tail end of the connecting sleeve 43, and the second end of the second connecting rod 83 is pressed against the inner side of the fixing ring 9. The connecting block 81 is forced to move outward of the pull rod and protrudes from the outer wall of the pull rod. At this time, the connecting block 81 and the elastic limiting block 431 are locked. When the knob 41 is rotated, the knob 41 drives the connecting sleeve 43 to move forward through the screw 42. Under the limiting action of the linkage mechanism 8, the pull rod 6 moves forward, and the push rod 32 also moves forward under the pushing force of the first elastic element 5.

[0060] When the tip of the inner needle 31 abuts against the area to be pierced, due to the resistance of the area to be pierced, the push rod 32 moves rearward and compresses the first elastic element 5, such as... Figure 6 As shown, the slider 321 moves to the rear side of the sliding groove 62. The knob 41 continues to push the pull rod 6 and the push rod 32 forward.

[0061] When the tip of the inner needle 31 pierces the puncture site, the resistance at the tip of the inner needle 31 disappears, and the first elastic element 5 pushes the inner needle assembly 3 to move towards its front end relative to the pull rod 6. The sliding block 321 moves to the front side of the sliding groove 62, triggering the feedback mechanism, so that the surgeon feels that the puncture has been completed. The sliding block 321 touches the second end of the first connecting rod 82, causing it to rotate and drive the connecting block 81 to move downward, thereby unlocking the connection block 81 from the elastic limiting block 431. Figure 7 As shown.

[0062] Under the pulling force of the second elastic element 7, the pull rod 6 drives the inner needle assembly 3 to move a certain distance towards the rear end of the handle housing, causing the front end of the inner needle to retract into the dilator outer tube 2. This distance can be 1-2 mm, realizing the function of automatic retraction of the inner needle after puncture, further ensuring that the inner needle will not damage the atrial wall and improving safety. Figure 8 As shown, at this time, the second end of the second connecting rod 83 slides to the inner side of the fixing ring 9, causing the connecting block 81 to be forced to move outward of the pull rod 6 and protrude from the outer wall of the pull rod 6.

[0063] Rotating knob 41 in the reverse direction causes connecting sleeve 43 to move backward. When the rear side of elastic limiting block 431 contacts the front side of connecting block 81, ... Figure 9 As shown, due to its arc-shaped structure and the elastic action of the elastic limiting block 431, the elastic limiting block 431 can move backward past the connecting block 81, allowing the connecting sleeve 43 to return to its initial position, as shown. Figure 5 As shown.

[0064] The above are merely preferred embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications and improvements made by those skilled in the art without departing from the inventive concept of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A transseptal puncture needle sheath system, characterized in that, The device includes an expander outer tube (2), a handle housing (1), an inner needle assembly (3), and a push mechanism (4) and a pull rod (6) installed in the handle housing (1). The expander outer tube (2) is connected to the front end of the handle housing (1). The rear end of the inner needle assembly (3) is disposed in the handle housing (1) and its front end extends into the expander outer tube (2). The rear end of the inner needle assembly (3) is movably connected to the front end of the pull rod (6) through a first elastic element (5). The pushing mechanism (4) can drive the inner needle assembly (3) and the pull rod (6) to move simultaneously toward the front end of the handle housing (1) and cause the front end of the inner needle assembly (3) to extend out of the expander outer tube (2); when the front end of the inner needle assembly (3) abuts against the part to be pierced, the inner needle assembly (3) moves toward its rear end relative to the pull rod (6) and compresses the first elastic member (5); when the front end of the inner needle assembly (3) pierces the part to be pierced, the first elastic member (5) pushes the inner needle assembly (3) to move toward its front end relative to the pull rod (6) and triggers the feedback mechanism; It also includes a linkage mechanism (8) and a fixing ring (9). The linkage mechanism (8) includes a first link (82), a second link (83) and a connecting block (81). The first link (82) and the second link (83) are respectively disposed on the front and rear sides of the connecting block (81). The middle sections of the first link (82) and the second link (83) are respectively rotatably connected to the pull rod (6) through a rotating shaft. The first end of the first link (82) is rotatably connected to the connecting block (81) and its second end extends toward the front end of the pull rod (6). The first end of the second link (83) is rotatably connected to the connecting block (81) and its second end extends toward the rear end of the pull rod (6). The pushing mechanism (4) includes a pushing component and a connecting sleeve (43). The pushing component is connected to the connecting sleeve (43) and can drive the connecting sleeve (43) to move back and forth. The connecting sleeve (43) is sleeved on the outside of the front end of the pull rod (6). An elastic limiting block (431) is provided inside the connecting sleeve (43). The connecting block (81) and the elastic limiting block (431) can be in a locked state or an unlocked state. The fixing ring (9) is fitted around the outside of the push rod (32) of the inner needle assembly (3) and is fixedly connected to the handle housing (1). When the push rod (32) and the linkage mechanism (8) move toward the fixing ring (9), the fixing ring (9) can press the second end of the second linkage (83) toward the inside of the push rod (32) and drive the connecting block (81) to move toward the outside of the push rod (32), so that the connecting block (81) and the elastic limiting block (431) are locked.

2. The interventricular septum puncture needle sheath system according to claim 1, characterized in that, The linkage mechanism (8) is installed at the front end of the pull rod (6). The linkage mechanism (8) enables the push mechanism (4) and the pull rod (6) to be in a locked or unlocked state. When the linkage mechanism (8) and the pull rod (6) are in a locked state, the push mechanism (4) can drive the pull rod (6) to move. When the push mechanism (4) and the pull rod (6) are in an unlocked state, the pull rod (6) can move relative to the push mechanism (4).

3. The interatrial septal puncture needle sheath system according to claim 2, characterized in that, The inner needle assembly (3) includes an inner needle (31) and a push rod (32). The push rod (32) is fixedly connected to the outside of the inner needle (31). The front end of the inner needle (31) extends into the outer tube (2) of the expander. The push rod (32) is installed in the handle housing (1). An installation groove (61) is provided at the front end of the pull rod (6). The rear end of the push rod (32) extends into the installation groove (61). The first elastic element (5) is installed in the installation groove (61) and one end of it abuts against the push rod (32) and the other end abuts against the pull rod (6). The rear end of the pull rod (6) extends to the outside of the handle housing (1).

4. The interventricular septum puncture needle sheath system according to claim 3, characterized in that, A sliding groove (62) is provided inside the mounting groove (61) of the pull rod (6), and a sliding block (321) is provided on the side wall of the push rod (32). The sliding block (321) is slidably disposed in the sliding groove (62) along the axial direction of the pull rod (6). The linkage mechanism (8) is installed on one side of the sliding groove (62). The movement of the sliding block (321) in the sliding groove (62) can drive the linkage mechanism (8) to make the push mechanism (4) and the pull rod (6) be in a locked or unlocked state.

5. The interatrial septal puncture needle sheath system according to claim 4, characterized in that, When the sliding block (321) moves to the front end of the sliding groove (62), it can lift the second end of the first connecting rod (82) and move the connecting block (81) to the inside of the push rod (32), so that the connecting block (81) and the elastic limiting block (431) are in an unlocked state.

6. The interatrial septal puncture needle sheath system according to claim 1, characterized in that, It also includes a second elastic element (7), which is installed on the outside of the pull rod (6). One end of the second elastic element (7) is connected to the tail end of the handle housing (1) and the other end is connected to the pull rod (6). When the push mechanism (4) and the pull rod (6) are in an unlocked state, the second elastic element (7) can pull the pull rod (6) toward the tail end of the handle housing (1).

7. The interventricular septum puncture needle sheath system according to claim 1, characterized in that, The pushing assembly includes a knob (41) and a screw (42). The knob (41) is rotatably mounted on the handle housing (1). The knob (41) and the screw (42) are coaxially connected by a thread. The rear end of the screw (42) is connected to the connecting sleeve (43) through a bearing (44). Rotating the knob (41) can drive the screw (42) and the connecting sleeve (43) to move back and forth along the axial direction of the handle housing (1).

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