Puncture expansion assembly and puncture system

Abstract

The invention relates to a puncture expansion assembly and a puncture system, and belongs to the technical field of medical instruments. The dilator, the puncture needle and the control handle are combined into the puncture dilation assembly, the control handle can control the far end of the puncture needle to stretch out or retract from the far end of the dilator, the puncture needle does not need to be repeatedly withdrawn in the puncture operation process, operation is convenient, and safety is high; a pushing part is arranged on the outer wall of a moving part, a fluid channel communicated with an inner cavity of a puncture needle is arranged in the moving part, the fluid channel extends to the pushing part and is communicated with a three-way valve A, the three-way valve A is communicated with a fluid source, and fluid (such as a contrast agent) provided by the fluid source enters the fluid channel of the moving part through the three-way valve A and then enters the fluid channel of the moving part. A catheter does not need to be additionally connected into the body in the puncture positioning process, operation is more convenient and simpler, and potential safety hazards can be reduced easily.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a puncture expansion assembly and a puncture system. Background Art

[0002] With the development of electrophysiological intervention and structural heart disease surgery, atrial septal puncture technology has become a key path for left atrial interventional treatment and has been widely used in surgeries such as radiofrequency ablation of atrial fibrillation, left atrial appendage occlusion, mitral valve intervention, congenital heart disease correction, and percutaneous left ventricular assist device implantation. In current clinical operations, a mechanical puncture system consisting of a guide sheath, dilator, and puncture needle is commonly used. During the operation, the surgeon must first assemble the guide sheath and dilator and then transport them along the guidewire to the predetermined position in the right atrium. After withdrawing the guidewire, the puncture needle is inserted into the inner cavity of the dilator and the distal needle tip of the puncture needle is manipulated to penetrate the atrial septum to complete the puncture.

[0003] However, existing dilators have the following significant drawbacks in clinical applications: Since the dilator itself does not have an integrated contrast agent infusion channel, when confirming the puncture site during surgery, the puncture needle must be repeatedly withdrawn and a dedicated angiography catheter must be replaced for left atrial angiography, which leads to the following problems: ① Increased surgical steps and operation time, especially in cases with complex anatomical structures, where multiple instrument changes are required; ② Repeated insertion and removal of instruments may cause complications such as thrombosis in the sheath and endothelial damage; ③ After the puncture needle is withdrawn, the position of the dilator is prone to shifting, resulting in a deviation between the angiography positioning and the actual puncture position, affecting the puncture accuracy. In addition, for special cases such as atrial septal thickening, heart transposition, or previous history of cardiac surgery, traditional dilators cannot synchronize imaging and puncture operations in real time, which significantly increases the difficulty of the operation and the incidence of complications.

[0004] Therefore, there is an urgent need to develop a new puncture and expansion component with contrast agent input function to solve the technical problems that existing devices need to rely on external catheters during puncture positioning, which are cumbersome to operate and have safety risks. Summary of the Invention

[0005] The purpose of this application is to overcome the shortcomings of the prior art and provide a puncture expansion component and a puncture system.

[0006] To achieve the above objectives, the technical solutions adopted in this application are:

[0007] In the first aspect, the present application provides a puncture expansion assembly, including an expander, a puncture needle and a control handle, wherein the expander is a hollow tubular structure, and the puncture needle is coaxially sleeved in the expander; the control handle includes a first handle shell and a moving part, the moving part is fixedly connected to the proximal end of the puncture needle, and the moving part is used to drive the puncture needle to move along its axial direction, the outer wall of the moving part is provided with a pushing part, and the interior of the moving part is provided with a fluid channel connected to the inner cavity of the puncture needle, the proximal end of the fluid channel extends to the pushing part and is connected to the three-way valve A, and the three-way valve A is connected to a fluid source.

[0008] Preferably, the control handle also includes an expander fixing part, the distal end of which is fixedly connected to the proximal end of the expander and is sleeved on the outside of the puncture needle; the first handle shell is hollow and sleeved on the outside of the moving part, and the first handle shell is provided with an empty slot, and one end of the pushing part passes through the empty slot and is exposed to the outside of the first handle shell, and the outer wall of the pushing part slides with the inner wall of the empty slot.

[0009] Preferably, the control handle also includes a limiter, which is located between the moving part and the expander fixing part. The limiter is a hollow structure and is sleeved on the outside of the puncture needle; the outer wall of the moving part is provided with a limit step, and the proximal port of the limiter cooperates with the limit step to form an axial limit structure.

[0010] More preferably, a spring member is provided between the moving member and the limiting member; when the spring member is in a natural state, the distal end of the puncture needle is located inside the expander.

[0011] More preferably, the first handle housing is provided with a limit knob, and the limit knob can limit or release the limit of the moving part;

[0012] The limit knob includes a screw cap and a limit part, the screw cap is located outside the first handle shell, the limit part is connected to the screw cap, the first handle shell is provided with a limit hole, the outer wall of the limit part is threadedly connected to the inner wall of the limit hole, and the screw cap can drive the limit part to move so that the limit part and the moving part are switched between limit cooperation and release of limit; when the limit part and the moving part are in a limit cooperation state, the lower end of the limit part is located inside the first handle shell and abuts against the moving part, so that the moving part cannot drive the puncture needle to extend out of the expander; when the limit part and the moving part are in a release state, the lower end of the limit part is located in the limit hole, and the moving part can drive the puncture needle to extend out of the expander.

[0013] More preferably, a first sealing member is provided between the distal end of the limiting member and the expander fixing member, and the first sealing member is provided with a through hole adapted to the puncture needle.

[0014] Preferably, the inner cavity of the puncture needle forms a first fluid channel, the outer wall of the puncture needle and the inner wall of the expander form a second fluid channel, the outer wall of the puncture needle is provided with a connecting hole, the first fluid channel and the second fluid channel are connected through the connecting hole, and the puncture needle moves axially under the drive of the control handle, driving the connecting hole and the distal port of the first fluid channel to synchronously displace.

[0015] Preferably, the expander assembly further comprises a guide wire connector, which is a hollow structure and is connected to and communicated with the proximal end of the moving part;

[0016] The guidewire connector is sealed with the proximal end of the moving part through a second sealing member, and the second sealing member is provided with a through hole adapted to the puncture guidewire.

[0017] Preferably, the puncture needle includes a needle tip, a flexible connecting needle tube and a needle tube body which are sequentially connected from the distal end to the proximal end.

[0018] Further preferably, a plurality of grooves are distributed on the outer wall of the flexible connecting needle tube, and the grooves are symmetrically or spirally arranged.

[0019] Further preferably, a plurality of grooves are distributed on the outer wall of the flexible connecting needle tube, and the center lines of the grooves are axially aligned with the highest point of the bevel at the distal end of the needle tip.

[0020] Preferably, the inner wall of the expander is provided with a first step, the outer wall of the puncture needle is provided with a second step, the first step is located between the second step and the needle tip of the puncture needle, and the first step and the second step cooperate to form an axial limiting structure.

[0021] In a second aspect, the present application provides an atrial septal puncture system, comprising: the puncture expansion assembly provided in the first aspect of the present application, a radiofrequency puncture guidewire that can be passed through the inner cavity of the puncture needle, and a sheath assembly that is sleeved on the outside of the expander.

[0022] Preferably, the radiofrequency puncture guidewire includes a monitoring electrode for detecting potential information at the location of the fossa ovalis.

[0023] Preferably, the sheath assembly includes a sheath handle and a three-way valve B, the sheath handle includes a three-way valve interface B and an observation window, the observation window is made of optically transparent material, the observation window is used to observe the internal structure and / or internal fluid conditions of the sheath handle, and the three-way valve interface is connected to the three-way valve B.

[0024] Compared with the prior art, the present invention has the following advantages:

[0025] The present application combines a dilator, a puncture needle, and a control handle into a puncture and dilation assembly, wherein the control handle includes a moving part, which is fixedly connected to the proximal end of the puncture needle and is used to drive the puncture needle to move along its axial direction. The control handle can be used to control the distal end of the puncture needle to extend or retract from the distal end of the dilator, making it easier for the user to manipulate the puncture needle. During the puncture operation, there is no need to repeatedly withdraw the puncture needle, thereby avoiding complications such as thrombosis in the sheath and vascular endothelial damage caused by repeated insertion and withdrawal of the instrument. The operation is convenient and safe.

[0026] The present application provides a pushing portion on the outer wall of the moving part, and a fluid channel connected to the inner cavity of the puncture needle is provided inside the moving part. The proximal end of the fluid channel extends to the pushing portion and is connected to the three-way valve A. The three-way valve A is connected to the fluid source. The fluid provided by the fluid source (such as contrast agent, cold saline, etc.) enters the fluid channel of the moving part through the three-way valve A and is ejected through the expander and / or the puncture needle. There is no need to connect an additional catheter to the body during the puncture positioning process, which makes the operation more convenient and simple, and helps to reduce safety hazards. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 A front view of the puncture and expansion assembly provided for this application;

[0028] Figure 2 A perspective view of the control handle provided for this application;

[0029] Figure 3 A partial cross-sectional view of the puncture and expansion assembly provided in this application;

[0030] Figure 4 Another partial cross-sectional view of the puncture and expansion assembly provided by the present application;

[0031] Figure 5 for Figure 4 Enlarged view of part A;

[0032] Figure 6 for Figure 5 Enlarged view of part B;

[0033] Figure 7 A schematic diagram of the structure of the puncture needle provided in this application;

[0034] Figure 8a and Figure 8b A schematic diagram of the partial structure of the puncture needle provided in this application;

[0035] Figure 9 A partial stereoscopic view of the puncture needle provided in this application;

[0036] Figure 10 A partial front view of the puncture needle provided in this application;

[0037] Figure 11 A partial left side view of the puncture needle provided in this application;

[0038] Figure 12 A partial cross-sectional view of a puncture needle expansion assembly provided in some other embodiments of the present application;

[0039] Figure 13 A perspective view of a control handle provided in some other embodiments of the present application;

[0040] Figure 14 A perspective view of the sheath assembly provided for this application;

[0041] Figure 15 A front view of the sheath assembly provided for this application;

[0042] Figure 16 A cross-sectional view of the sheath assembly provided in this application.

[0043] In the figure, 1-dilator, 11-inner layer, 12-middle layer, 13-outer layer, 14-first step, 2-puncture needle, 21-needle tube body, 22-needle tip, 23-flexible connecting needle tube, 231-groove, 24-second step, 3-control handle, 31-dilator fixing part, 32-first handle shell, 321-empty groove, 322-limiting hole, 323-gear mark, 33-moving part, 331-limiting step, 332-first channel, 333-second channel, 334-installation groove, 335-third channel, 336-pushing part, 34-limiting part, 341 -through groove, 35-sliding structure, 351-slider, 352-slide groove, 36-spring member, 37-first sealing member, 38-second sealing member, 39-limiting knob, 391-screw cap, 392-limiting part, 4-guide wire connector, 51-first fluid channel, 52-second fluid channel, 6-sheath assembly, 61-delivery sheath, 62-sheath handle, 621-bending knob, 622-second handle housing, 623-connector part, 6231-three-way valve interface, 624-hemostasis valve, 625-transmission mechanism, 6251-first transmission member, 6252-second transmission member. DETAILED DESCRIPTION

[0044] To make the purposes, advantages, and features of this application more clear, the present application is further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale. They are only used to conveniently and clearly assist in explaining the purpose of the embodiments of this application. In addition, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may need to show different focuses and sometimes use different scales.

[0045] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0046] It will be understood that spatial relational terms such as "under," "beneath," "below," "under," "above," "above," etc., may be used herein to describe the relationship of an element or feature shown in the figures to other elements or features. It will be understood that in addition to the orientations shown in the figures, spatial relational terms also include different orientations of the device in use and operation. For example, if the device in the drawings is turned over, the element or feature described as "under" or "beneath" or "beneath" the other elements will be oriented as "above" the other elements or features. Thus, the exemplary terms "under" and "under" may include both upper and lower orientations. In addition, the device may also include alternative orientations (e.g., rotated 90° or other orientations), and the spatial descriptors used herein are interpreted accordingly.

[0047] It should be noted that when an element is considered to be "connected" to another element, it can be directly connected to the other element or connected to the other element through an intermediate element. In the following embodiments, "connection" should be understood as "electrical connection", "communication connection", etc., if the connected circuits, modules, units, etc. can transmit electrical signals or data to each other.

[0048] It should be noted that when an element is considered to be “communicating with” another element, it may be directly communicating with the other element or communicating with the other element through an intermediate element (such as a conduit).

[0049] It should be noted that the singular forms "a", "an" and "the" may include plural forms as well, unless the context clearly indicates otherwise.

[0050] When it is necessary to clarify, “plurality” can be one or not less than two.

[0051] It should also be understood that the terms "include / comprise" or "have" and the like specify the presence of stated features, wholes, steps, operations, components, parts or combinations thereof, but do not exclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts or combinations thereof.

[0052] It should also be understood that, unless otherwise specified or indicated, the terms "first", "second", "third", etc. in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, and are not used to indicate the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0053] In the description of this application, it should be noted that the term "distal end" generally refers to the end of the medical device that first enters the patient's body during normal operation, while the "proximal end" generally refers to the end of the medical device that is close to the operator during normal operation.

[0054] See also Figure 1-7 The present application provides a puncture and expansion assembly, which includes an expander 1, a puncture needle 2 and a control handle 3. The expander 1 is a hollow tubular structure that passes through from its proximal end to its distal end, and the puncture needle 2 is coaxially sleeved in the expander 1; the control handle 3 includes a first handle shell 32 and a moving part 33, the moving part 33 is fixedly connected to the proximal end of the puncture needle 2, and the moving part 33 is used to drive the puncture needle 2 to move along its axial direction. The outer wall of the moving part 33 is provided with a pushing part 336, and the interior of the moving part 33 is provided with a fluid channel connected to the inner cavity of the puncture needle 2. The proximal end of the fluid channel extends to the moving part 33 and is connected to the three-way valve A, and the three-way valve A is connected to the fluid source.

[0055] The fluid source is used to provide fluid (such as contrast agent, cold saline, etc.). When in use, the fluid provided by the fluid source enters the fluid channel of the moving part 33 through the three-way valve A and is ejected through the expander 1 and / or the puncture needle 2. There is no need to connect an additional catheter to the body during the puncture positioning process, which makes the operation more convenient and reduces safety hazards.

[0056] See Figure 1-3 In some embodiments, the control handle 3 includes an expander fixing member 31, a first handle housing 32, and a moving member 33;

[0057] The expander fixing member 31 is hollow, and the distal end of the expander fixing member 31 is fixedly connected to the proximal end of the expander 1 , and the proximal end of the expander fixing member 31 is fixedly connected to the distal end of the first handle housing 32 ;

[0058] The first handle housing 32 is hollow and is sleeved on the moving part 33. The inner wall of the first handle housing 32 and the outer wall of the moving part 33 are slidably matched or have a gap.

[0059] The moving member 33 is fixedly connected to the puncture needle 2 . The moving member 33 is used to drive the puncture needle 2 to move along its axial direction and to make the distal end of the puncture needle 2 extend from or retract from the distal end of the dilator 1 .

[0060] When the doctor operates the instrument, he can control the axial movement of the puncture needle 2 by holding the first handle shell 32 and moving it axially, which facilitates the operation and improves the operation efficiency.

[0061] Furthermore, the first handle housing 32 is sleeved on the expander fixing member 31 and is fixedly connected to the expander fixing member 31 via threads.

[0062] Furthermore, the inner wall of the expander fixing member 31 is fixedly connected to the outer wall of the expander 1 by threads or adhesively connected.

[0063] Furthermore, the control handle 3 also includes a limiter 34, which is located between the moving part 33 and the expander fixing part 31. The limiter 34 is a hollow structure and is sleeved on the puncture needle 2. The inner wall of the limiter 34 slides with the outer wall of the puncture needle 2 or leaves a gap. The distal end of the moving part 33 is connected to the limiter 34 via a spring member 36. After the puncture is completed, the operator slowly releases the pushing force of the control handle end. Under the action of the rebound force of the spring member 36, the moving part 33 moves toward the proximal end of the control handle 3, driving the distal end of the puncture needle 2 to withdraw into the expander 1, further improving the safety after the puncture.

[0064] Furthermore, a limiting step 331 is provided on the outer wall of the moving member 33 , and the proximal end port of the limiting member 34 and the limiting step 331 form a limiting structure.

[0065] When the spring member 36 is in its natural state, the distal end of the puncture needle 2 is located within the dilator 1, and the axial distance D1 between the stop step 331 and the proximal end of the stop member 34 is 0.5 mm ≤ D1 ≤ 10 mm. For example, D1 can be 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, or a range consisting of any two of these values.

[0066] More preferably, 3mm≤D1≤7mm. This design can ensure that the maximum distance that the distal end of the puncture needle 2 extends out of the dilator 1 during the puncture operation is ≤D1, which can achieve an ideal puncture effect and improve the safety of the puncture operation.

[0067] Furthermore, the moving member 33 and the limiting member 34 are slidably matched via at least one sliding structure 35 .

[0068] The hollow cavity of the limiting member 34 includes a through slot 341 adapted to the moving member 33 . The distal end of the moving member 33 extends into the through slot 341 , and the spring member 36 is located in the through slot 341 .

[0069] In the present application, the sliding structure 35 may include a sliding block 351 and a sliding groove 352 .

[0070] Exemplarily, the slider 351 is disposed on the outer wall of the moving part 33 , and the sliding groove 352 is disposed on the inner wall of the through groove 341 .

[0071] Exemplarily, the sliding groove 352 is provided on the outer wall of the moving part 33 , and the sliding block 351 is provided on the inner wall of the through groove 341 .

[0072] Furthermore, the expander fixing member 31 is sleeved on the distal end of the limiting member 34 , and the outer wall of the limiting member 34 and the inner wall of the expander fixing member 31 are fixedly connected via threads.

[0073] Furthermore, the distal end of the stopper 34 is sealed against the expander fixture 31 via a first seal 37. The first seal 37 is provided with a through hole adapted to accommodate the puncture needle 2. The provision of the first seal 37 effectively prevents fluid within the expander 1 (e.g., blood flowing into the expander 1 during puncture) from overflowing into the hollow cavity of the stopper 34.

[0074] Furthermore, the first handle shell 32 is provided with an empty slot 321, and the outer wall of the moving part 33 is provided with a pushing portion 336. One end of the pushing portion 336 passes through the empty slot 321 and is exposed to the outside of the first handle shell 32. The outer wall of the pushing portion 336 slides with the inner wall of the empty slot 321 or leaves a gap.

[0075] Furthermore, the hollow cavity of the moving part 33 includes a first channel 332, a second channel 333 and a mounting groove 334 that are coaxially arranged and connected in sequence. The proximal end of the puncture needle 2 extends into the first channel 332, and the outer wall of the puncture needle 2 is fixedly connected to the inner wall of the first channel 332 by a threaded connection or adhesive connection. The hollow cavity of the moving part 33 also includes a third channel 335, one end of the third channel 335 is connected to the second channel 333, and the other end of the third channel 335 is connected to the hollow pushing part 336, thereby forming the fluid channel.

[0076] The pushing portion 336 can be arranged at an angle or perpendicular to the central axis of the first handle housing 32 .

[0077] One end of the three-way valve A is connected to a pressure sensor to monitor the internal pressure of the moving part 33 .

[0078] The inner diameter of the second channel 333 is larger than that of the first channel 332 , and the inner diameter of the second channel 333 is larger than that of the third channel 335 . The second channel 333 can be funnel-shaped, truncated cone-shaped, cylindrical, column-shaped, or a combination of several thereof.

[0079] In some embodiments, the expander assembly 2 further includes a guidewire connector 4 , which is a hollow structure and is connected to and communicates with the proximal end of the moving part 33 .

[0080] Furthermore, the outer wall of the guidewire connector 4 is fixedly connected to the inner wall of the mounting groove 334 via threads. The distal end of the guidewire connector 4 is sealed against the inner wall of the mounting groove 334 by a second seal 38. The second seal 38 is provided with a through hole adapted to accommodate the puncture guidewire. The provision of the second seal 38 can effectively prevent the fluid in the second channel 2333 from overflowing.

[0081] During use, the distal end of the radiofrequency puncture guidewire is passed through the guidewire connector 4 , the through hole of the second sealing member 38 , the hollow cavity of the moving member 33 , and the puncture needle 2 in sequence, and extends out from the distal end of the puncture needle 2 .

[0082] In some embodiments, the expander 1 is a single-layer hollow tube structure, and the material of the expander 1 is a polymer material, which may be PA and / or PEBAX.

[0083] In some embodiments, the expander 1 includes an inner layer 11 , a middle layer 12 , and an outer layer 13 , which are sequentially arranged from the inside to the outside.

[0084] Furthermore, the material of the inner layer 11 and the material of the outer layer 13 are the same or different polymer materials, and the polymer material may be PA and / or PEBAX.

[0085] Furthermore, the middle layer 12 is a sea wave tube structure or a braided mesh tube structure, and the middle layer 12 is made of an alloy material, which can be stainless steel or nickel-titanium alloy, so that the middle layer 12 can play a good supporting role, improve the strength of the expander 1, and thereby improve the stability of the system puncture operation.

[0086] See also Figure 4-7 In some embodiments, a first step 14 is provided on the inner wall of the dilator 1, and a second step 24 is provided on the outer wall of the puncture needle 2. The first step 14 is located between the second step 24 and the needle tip 22 of the puncture needle 2. The first step 14 and the second step 24 form a stop structure. When the spring member 36 is in its natural state, the distance between the first step 14 and the second step 24 is D2, with a range of 0.5 mm ≤ D2 ≤ 10 mm. This design ensures that the maximum distance the distal end of the puncture needle 2 extends from the dilator 1 during the puncture procedure is ≤ D2, thereby improving the safety of the puncture procedure.

[0087] More preferably, 3mm≤D2≤7mm.

[0088] Furthermore, D2=D1.

[0089] In some embodiments, the hollow cavity of the puncture needle 2 forms a first fluid channel 51, and a second fluid channel 52 is formed between the outer wall of the puncture needle 2 and the inner wall of the dilator 1. The puncture needle 2 includes a connecting tube section, which is located inside the dilator 1 and has multiple connecting holes arranged at equal intervals along its axial direction. During fluid injection, the fluid can enter the second fluid channel through the connecting holes, allowing the fluid to be ejected from the distal end of the dilator 1.

[0090] In some embodiments, the puncture needle 2 moves axially under the drive of the control handle 3, driving the connecting hole and the distal port of the first fluid channel 51 to move synchronously, so that the distal port of the first fluid channel 51 can be closer to the puncture position relative to the distal port of the second fluid channel 52, thereby achieving better imaging or cooling effects when contrast agent or cold saline is injected, improving the accuracy of puncture positioning, and reducing possible thermal damage during the puncture process.

[0091] In some embodiments, the puncture needle 2 includes a needle body 21 and a needle tip 22 sequentially connected from the distal end to the proximal end.

[0092] Furthermore, the needle tube body 21 and the needle tip 22 are connected by bonding or welding, or the needle tube body 21 and the needle tip 22 are an integrally formed structure.

[0093] Furthermore, the needle body 21 is made of metal. For example, the metal material may be stainless steel or nickel-titanium alloy.

[0094] Furthermore, the puncture needle 2 also includes a flexible connecting needle tube 23. The needle tube body 21, the flexible connecting needle tube 23, and the needle tip 22 are sequentially connected. The flexible connecting needle tube 23 can be a hypotube structure or a braided mesh structure, which allows the flexible connecting needle tube 23 to bend. The needle tube body 21, the flexible connecting needle tube 23, and the needle tip 22 are integrally formed, or the needle tube body 21 and the flexible connecting needle tube 23 are integrally formed, and the needle tip 22 and the flexible connecting needle tube 23 are connected by bonding or welding.

[0095] like Figure 8a and 8b The flexible connecting needle tube 23 shown in FIG. Figure 8a As shown, the wall of the flexible connecting needle tube 23 is provided with a plurality of symmetrically arranged grooves 231. The plurality of grooves 231 are symmetrically arranged so that the flexible connecting needle tube 23 can be bent in two specific directions. Figure 8b As shown, the wall of the flexible connecting needle tube 23 is provided with a plurality of spirally arranged grooves 231. The plurality of grooves 231 are arranged in a spiral so that the flexible connecting needle tube 23 can be bent in any direction.

[0096] like Figure 9-11As shown, the flexible connecting needle tube 23 is provided with a plurality of grooves 231 extending along its circumference. The grooves 231 are regularly arranged on the body of the flexible connecting needle tube 23. For example, the grooves 231 are arranged at equal intervals along the axial direction of the flexible connecting needle tube 23; alternatively, the grooves 231 are arranged in at least two rows, with each row of grooves arranged at equal intervals along the axial direction of the flexible connecting needle tube 23, and any two adjacent rows of grooves are staggered along the circumference of the flexible connecting needle tube 23.

[0097] Further, such as Figure 9-11 As shown, the highest point of the distal bevel of the needle tip 22 is spatially aligned with the centerline of one row of grooves 231 (with an error controlled within ±0.5°). This causes the flexible connection needle tube 23 of the groove 231 to bend and deform first during actual use due to its low structural strength. The stress generated by this deformation is transmitted to the needle tip 22. Based on the mechanical constraint characteristics of the matching direction of the groove 231 and the needle tip 22, the needle tip 22 bends toward the groove opening, with the bending angle controlled between 10° and 90°. Traditional puncture needles have a 23% probability of touching the dangerous area. However, this design, thanks to the directional guidance of the groove, achieves 100% bending in the preset direction, effectively avoiding the risk of puncture and ensuring the safety and accuracy of the operation.

[0098] The groove 231 on the flexible connecting needle tube 23 can be cut by a machining method such as laser cutting.

[0099] See also Figure 12 and Figure 13 In some embodiments, the first handle housing 32 is provided with a limit knob 39 , which can limit or release the limit of the moving part 33 .

[0100] Furthermore, the limiting knob 39 includes a screw cap 391 and a limiting portion 392. The screw cap 391 is located outside the first handle housing 32, and the limiting portion 392 is connected to the screw cap 391.

[0101] The first handle shell 32 is provided with a limiting hole 322, and the outer wall of the limiting portion 392 is threadedly connected to the inner wall of the limiting hole 322; the screw cap 391 can drive the limiting portion 392 to move so that the limiting portion 392 and the moving part 33 are switched between limiting engagement and releasing the limit; when the limiting portion 392 and the moving part 33 are in the limiting engagement state, the spring member 36 is in a natural state, and the lower end of the limiting portion 392 is located in the first handle shell 32 and abuts against the moving part 33 (such as Figure 12 As shown), the moving part 33 cannot drive the puncture needle 2 to extend out of the dilator 1; when the limiting portion 392 and the moving part 33 are in the released limit state, the lower end of the limiting portion 392 is located in the limiting hole 322, and the moving part 33 can drive the puncture needle 2 to extend out of the dilator 1.

[0102] Optionally, the limiting hole 322 can be located between the distal end face of the moving part 33 and the distal end of the through groove 341. The limiting part 34 is provided with a through hole corresponding to the limiting hole 322 and adapted to the limiting portion 392. When the limiting portion 392 and the moving part 33 are in a limiting matching state, the lower end of the limiting portion 392 is located in the through groove 341 and abuts against the distal end face of the moving part 33, so that the moving part 33 cannot drive the puncture needle 2 to extend out of the expander 1.

[0103] Furthermore, the first handle housing 32 is provided with a gear position mark 323 , and the gear position mark 323 may include an ON gear position and an OFF gear position.

[0104] When puncture is not required, the spring member 36 is in a natural state, the limit knob 39 is rotated to the point where its screw cap 391 points to or covers the OFF position, and the lower end of the limit portion 392 abuts against the distal end surface of the moving member 33. At this time, the limit knob 39 limits the moving member 33, thereby ensuring that the distal end of the puncture needle 2 is located inside the dilator 1 when puncture is not required; when puncture is required, the limit knob 39 is rotated to the point where its screw cap 391 points to or covers the ON position. At this time, the lower end of the limit knob 39 is in contact with the distal end surface of the moving member 33. Located in the through hole of the first handle shell 32 or the through hole of the limit member 34, the limit knob 39 releases the limit on the moving member 33, and the moving member 33 can drive the puncture needle 2 to extend out of the dilator 1 and puncture the target part of the patient. After the puncture is completed, under the action of the rebound force of the spring member 36, the moving member 33 is reset, and the limit knob 39 can be rotated again until its screw cap 391 points to or covers the OFF position, which can prevent unnecessary harm to the doctor or patient caused by misoperation and improve the safety of the instrument.

[0105] Optionally, the limiting hole 322 can be located between the limiting step 331 and the proximal end face of the limiting member 34. When the limiting hole 322 is located between the limiting step 331 and the proximal end face of the limiting member 34, when the limiting portion 392 and the moving member 33 are in a limiting mating state, the lower end of the limiting portion 392 is located on the inner wall of the first handle shell 32 and abuts against the limiting step 331 of the moving member 33.

[0106] Optionally, the limit knob can also be replaced by a latch. When the spring member 36 is in a natural state, the latch is inserted into the limit hole 322, and the lower end of the latch abuts against the moving member 33.

[0107] It is understood that, unless otherwise specified, this application imposes no particular restrictions on the shape and size of the components of the puncture and dilation assembly, and may be designed based on actual needs. For example, the length of the slot 321 may be designed to be greater than D1. During use, the user grasps the first handle housing 32 and applies a thrust to the pusher 336 or the proximal end of the guidewire connector 4, causing the movable member 33 to move relative to the first handle housing 32, thereby driving the puncture needle 2 and simultaneously moving the pusher 336 within the slot 321.

[0108] The present application also provides a puncture system, comprising: the above-mentioned puncture and dilation assembly, a radiofrequency puncture guidewire that can be inserted into the inner cavity of the puncture needle 2, and a sheath assembly 6 that is sleeved on the outside of the dilator 1.

[0109] In some embodiments, the sheath assembly 6 is an adjustable bend sheath assembly or a fixed bend sheath assembly.

[0110] The puncture process using the system provided by this application includes the following steps:

[0111] First, send the radiofrequency puncture guidewire along the blood vessel until its electrode puncture head enters the inferior vena cava. Then, send the puncture dilator assembly into the blood vessel along the guidewire through the sheath assembly 6. Adjust the bend according to the standard puncture process and pull it down until the distal end of the dilator 1 hits the expected puncture tissue in the atrial septum. Then, extend the radiofrequency puncture guidewire from the distal end of the dilator 1. After confirming that the electrode puncture head is in contact with the atrial septum tissue, power on and push the radiofrequency puncture guidewire forward. After the puncture is completed, push the dilator 2 and the adjustable bend sheath along the radiofrequency puncture guidewire. Retain some instruments according to the needs of subsequent surgery and withdraw the remaining instruments.

[0112] During the above operation, if the radiofrequency puncture guidewire cannot complete the atrial septal puncture, the puncture guidewire 3 is withdrawn and the puncture needle 2 is pushed forward for mechanical puncture. After the puncture, contrast agent is injected to observe and judge whether the puncture is successful through imaging.

[0113] During the radiofrequency puncture process, cold saline can also be injected. The cold saline is sprayed from the distal end of the dilator 1 to cool the electrode puncture head nearby, reducing the risk of scab formation during the puncture process and improving the safety and success rate of the puncture.

[0114] In some embodiments, the distal end of the puncture needle 2 can extend relative to the distal end of the dilator 1. Before the radiofrequency puncture wire discharges and punctures, the puncture expansion assembly provided in this application releases a contrast agent to the puncture site, allowing for further confirmation of the specific location of the electrode puncture tip through imaging observation and precise positioning of the radiofrequency puncture wire. During the radiofrequency puncture wire discharge and puncture, the puncture expansion assembly provided in this application releases cold saline to the puncture site, thereby lowering the temperature at the puncture site and reducing eschar. To further enhance safety, the distal tip of the puncture needle 2 is designed to be blunt.

[0115] In some embodiments, the radiofrequency puncture guidewire is connected to a device for collecting ECG signals, such as a monitoring electrode. The monitoring electrode and the radiofrequency puncture electrode can be the same electrode or different electrodes. Furthermore, the radiofrequency puncture guidewire can collect potential information at the contact position. Because the potential information (EGM) at the oval fossa position is different from that of other tissues in the atrial septum, the oval fossa position can be accurately located. The potential difference between the oval fossa position and other locations in the atrial septum tissue is 0.5-1.5mV.

[0116] See also Figure 14-16 In some embodiments, the sheath assembly 6 includes a delivery sheath 61 and a sheath handle 62 . The delivery sheath 61 is a hollow tubular structure, and its proximal end is fixed to the distal end of the sheath handle 62 .

[0117] The sheath handle 62 includes a bending adjustment knob 621, which is operably connected to an internal transmission mechanism 625 of the sheath handle 62. The transmission mechanism 625 is fixedly connected to the proximal end of the bending adjustment wire, and the distal end of the bending adjustment wire is fixedly connected to the distal end of the delivery sheath 61. By rotating the bending adjustment knob 621, the transmission mechanism 625 is actuated and the bending adjustment wire fixed to the distal end of the delivery sheath 61 moves, thereby operating the distal end of the delivery sheath 61 to bend.

[0118] The sheath handle 62 also includes a second handle shell 622, a joint part 623 and a three-way valve B (not shown in the figure). The joint part 623 is a hollow structure, which is connected to the hollow cavity of the second handle 622. The joint part 623 is provided with a three-way valve interface 6231, which is connected to the three-way valve B.

[0119] The proximal end of the connector 623 is connected to a hemostatic valve 624 and is used for suction, injection, pressure monitoring and other operations during surgery.

[0120] The distal end of the connector portion 623 is connected to the delivery sheath 61 (for example, the connector portion 623 is connected to the delivery sheath 61 through a catheter), and the three-way valve B can be used to connect a pressure sensor to monitor the internal pressure of the sheath assembly; the three-way valve B can also be used to connect a fluid source, and the fluid source connected to the three-way valve B can be a cleaning liquid. The cleaning liquid can be input into the delivery sheath 61 through the three-way valve B and the connector portion 623 to clean the delivery sheath 61.

[0121] In some embodiments, the second handle housing 622 and / or the connector portion 623 is provided with an observation window, and the material of the observation window is an optically transparent polymer material. Under surgical conditions, the optically transparent observation window allows the operator to clearly observe the internal structure of the sheath handle 62 and the fluid flowing therethrough through visual inspection (for example, it is convenient to observe whether there are bubbles entering the sheath handle 62 during surgery), thereby enhancing the safety of the doctor during operation.

[0122] In some embodiments, the entire sheath handle 62 is made of an optically transparent polymer material.

[0123] In some embodiments, the optically transparent polymer material can be selected from at least one of polycarbonate (PC), polymethyl methacrylate (PMMA), cycloolefin copolymer / cycloolefin polymer (COC / COP), and polystyrene (PS / GPPS-general-purpose polystyrene). The optically transparent polymer material has high light transmittance (e.g., not less than 85%), good biocompatibility, and tolerance to commonly used sterilization methods for medical devices.

[0124] Optionally, the transmission mechanism 625 may include a first transmission member 6251 and a second transmission member 6252, both of which are hollow structures. The distal end of the first transmission member 6251 is fixedly connected to the bending adjustment knob 621, and the proximal end of the first transmission member 6251 is rotatably connected to the second handle shell 622. The second transmission member 6252 is located inside the second handle shell 622, and the distal end of the second transmission member 6252 is inserted into the proximal end of the first transmission member 6251 and is threadedly connected to the first transmission member 6251. The proximal end of the second transmission member 6252 slides with the inner wall of the second handle shell 622, and the second transmission member 6252 is fixedly connected to the proximal end of the bending adjustment wire. When in use, hold the second handle shell 622 and turn the bending adjustment knob 621. The first transmission member 6251 rotates under the drive of the bending adjustment knob 621. Under the action of the threaded connection, the second transmission member 6252 reciprocates along its axial direction in the second handle shell 622, thereby pulling the bending adjustment wire to adjust the degree of bending of the distal end of the delivery sheath 61, which is easy to operate.

[0125] Finally, it should be noted that the above implementation modes are only used to illustrate the technical solutions of the present application and are not intended to limit the scope of protection of the present application. Although the present application has been described in detail with reference to the preferred implementation modes, those skilled in the art should understand that the technical solutions of the present application may be modified or replaced by equivalents without departing from the essence and scope of the technical solutions of the present application.

Claims

1. A puncture and expansion assembly, characterized in that: It includes an expander, a puncture needle and a control handle. The expander is a hollow tubular structure, and the puncture needle is coaxially sleeved in the expander; the control handle includes a first handle shell and a moving part, the moving part is fixedly connected to the proximal end of the puncture needle, and the moving part is used to drive the puncture needle to move along its axial direction. The outer wall of the moving part is provided with a pushing part, and the interior of the moving part is provided with a fluid channel connected to the inner cavity of the puncture needle. The proximal end of the fluid channel extends to the pushing part and is connected to the three-way valve A, and the three-way valve A is connected to the fluid source.

2. The puncture and expansion assembly according to claim 1, wherein: The control handle also includes an expander fixing part, the distal end of which is fixedly connected to the proximal end of the expander and is sleeved on the outside of the puncture needle; the first handle shell is hollow and sleeved on the outside of the moving part, and the first handle shell is provided with an empty slot, and one end of the pushing part passes through the empty slot and is exposed to the outside of the first handle shell, and the outer wall of the pushing part slides with the inner wall of the empty slot.

3. The puncture and expansion assembly according to claim 2, wherein: The control handle also includes a limiter, which is located between the moving part and the expander fixing part. The limiter is a hollow structure and is sleeved on the outside of the puncture needle. A limit step is provided on the outer wall of the moving part, and the proximal port of the limiter cooperates with the limit step to form an axial limit structure.

4. The puncture and expansion assembly according to claim 3, wherein: A spring member is provided between the moving member and the limiting member; when the spring member is in a natural state, the distal end of the puncture needle is located inside the expander.

5. The puncture and expansion assembly according to claim 3, wherein: The first handle housing is provided with a limit knob, and the limit knob can limit or release the limit of the moving part; The limit knob includes a screw cap and a limit part, the screw cap is located outside the first handle shell, the limit part is connected to the screw cap, the first handle shell is provided with a limit hole, the outer wall of the limit part is threadedly connected to the inner wall of the limit hole, and the screw cap can drive the limit part to move so that the limit part and the moving part are switched between limit cooperation and release of limit; when the limit part and the moving part are in a limit cooperation state, the lower end of the limit part is located inside the first handle shell and abuts against the moving part, so that the moving part cannot drive the puncture needle to extend out of the expander; when the limit part and the moving part are in a release state, the lower end of the limit part is located in the limit hole, and the moving part can drive the puncture needle to extend out of the expander.

6. The puncture and expansion assembly according to claim 3, wherein: A first sealing member is provided between the distal end of the limiting member and the expander fixing member. The first sealing member is provided with a through hole adapted to the puncture needle.

7. The puncture and expansion assembly according to claim 1, wherein: The inner cavity of the puncture needle forms a first fluid channel, the outer wall of the puncture needle and the inner wall of the expander form a second fluid channel, the outer wall of the puncture needle is provided with a connecting hole, the first fluid channel and the second fluid channel are connected through the connecting hole, and the puncture needle moves axially under the drive of the control handle, driving the connecting hole and the distal port of the first fluid channel to synchronously displace.

8. The puncture and expansion assembly according to claim 1, wherein: The expander assembly further comprises a guidewire connector, which is a hollow structure and is connected to and communicates with the proximal end of the moving part; The guidewire connector is sealed with the proximal end of the moving part through a second sealing member, and the second sealing member is provided with a through hole adapted to the puncture guidewire.

9. The puncture and expansion assembly according to claim 1, wherein: The puncture needle comprises a needle tip, a flexible connecting needle tube and a needle tube body which are sequentially connected from the distal end to the proximal end.

10. The puncture and expansion assembly according to claim 9, wherein: The outer wall of the flexible connecting needle tube is distributed with a plurality of grooves, and the grooves are symmetrically or spirally arranged.

11. The puncture and expansion assembly according to claim 9, wherein: A plurality of grooves are distributed on the outer wall of the flexible connecting needle tube, and the center lines of the grooves are axially aligned with the highest point of the inclined surface at the distal end of the needle tip.

12. The puncture and expansion assembly according to claim 1, wherein: The inner wall of the expander is provided with a first step, the outer wall of the puncture needle is provided with a second step, the first step is located between the second step and the needle tip of the puncture needle, and the first step and the second step cooperate to form an axial limiting structure.

13. A transseptal puncture system, characterized in that: include: The puncture and expansion assembly according to any one of claims 1 to 12 can include a radiofrequency puncture guidewire that is inserted into the inner cavity of the puncture needle, and a sheath assembly that is sleeved on the outside of the expander.

14. The atrial septal puncture system according to claim 13, wherein: The radiofrequency puncture guidewire includes a monitoring electrode for detecting potential information at the position of the fossa ovalis.

15. The atrial septal puncture system according to claim 13, wherein: The sheath assembly includes a sheath handle and a three-way valve B. The sheath handle includes a three-way valve interface and an observation window. The observation window is made of optically transparent material. The observation window is used to observe the internal structure and / or internal fluid conditions of the sheath handle. The three-way valve interface is connected to the three-way valve B.

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