Atrial septum puncture device

Abstract

The utility model discloses an atrial septum puncture device, which relates to the technology of medical instruments and comprises a puncture needle component, a puncture needle body, a puncture needle core shaft, a puncture needle core shaft, a puncture needle core shaft and a puncture needle core shaft, the transmission handle is detachably arranged on the basis of the puncture needle assembly, covers part of the puncture needle body led out and is provided with a transmission structure used for being connected with a surgical robot, and the transmission handle can be connected into the surgical robot on the basis of the transmission structure; driving force for axial movement and circumferential rotation is provided for the puncture needle handle through the surgical robot, so that rotation and axial movement of the puncture needle are controlled. The puncture needle can be controlled based on the robot, when the puncture needle needs to be manually operated, manual control can be achieved by detaching the transmission handle, and product application and popularization are facilitated.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to an atrial septum puncture device. Background Art

[0002] The heart includes a right ventricle, a right atrium, a left ventricle, and a left atrium. The right atrium communicates with the superior vena cava and the inferior vena cava. The tricuspid valve separates the right atrium and the right ventricle, and the mitral valve separates the left atrium and the left ventricle. The right atrium is separated from the left atrium by the interatrial septum. During surgery, the left atrium is the most difficult to access. The most common method used to access the left atrium is to puncture the interatrial septum. Under normal circumstances, a percutaneous catheter cannot reach the left atrium directly in a forward direction. Although it is possible to enter the left atrium retrogradely through two turns of the aortic valve and the mitral valve, catheter operation is very complex. Puncturing the atrial septum allows the catheter to pass through the atrial septum from the right atrium directly to the left atrium. In the early years, atrial septum puncture was mainly used for left heart catheterization in patients with mitral or aortic valve stenosis. In the past 20 years, with the development of interventional treatment for cardiovascular diseases, especially percutaneous mitral valvuloplasty and radiofrequency ablation, especially the booming development of atrial fibrillation radiofrequency ablation, this technology of atrial septum puncture has begun to be increasingly valued by electrophysiologists and has become one of the technologies that electrophysiologists must master.

[0003] All atrial septum puncture surgeries are performed by the operator manually holding surgical instruments such as a puncture needle, a sheath, and a guide wire. During the surgery, it is not convenient to determine the puncture point, puncture direction, and puncture force, and the puncture needle cannot be accurately and stably controlled. During the process of manually holding the puncture needle, due to the fatigue of the operator and the unstable factors of personnel operation, it is easy to affect the safety of the surgery, especially cardiac perforation during the surgery. The surgical difficulty and workload are relatively large, and the doctor training cycle is long and the learning curve is long.

[0004] Chinese Patent 202210784193.9 proposes a puncture catheter, a puncture system, and an atrial septum puncture method. The puncture catheter includes: a dilator, a puncture needle, a handle, a first control component, and a second control component. The first control component and the second control component are both arranged on the handle. The first control component is used to control the axial movement of the puncture needle to extend and retract into the dilator. The second control component is used to control the synchronous rotation of the dilator and the puncture needle. It uses the same handle for mechanical transmission to control the dilator and the puncture needle, simplifies the entire surgery, improves the efficiency of the puncture surgery, and can accurately control the puncture needle to puncture the atrial septum, making the entire puncture process more stable and safe. Moreover, it is not necessary to operate the surgery beside the operating table, avoiding the impact of radiation on the health of the operator during the surgery.

[0005] Although the above method can effectively solve a series of problems caused by the instability of manual puncture by doctors and radiation, its usage method is single. Both the puncture needle and the dilator are driven by mechanical transmission through a control component, and it can only be adapted to a surgical robot for surgery and cannot be switched to a manual mode, resulting in its limited application and affecting the promotion of the product. Summary of the Invention

[0006] An embodiment of the present application provides an atrial septum puncture device, which can control the overall rotation and axial advancement of a detachable transmission handle and a puncture handle through a robot transmission structure, so as to control the robot puncture needle. When manual operation of the puncture needle is required, the transmission handle can be removed and then manually controlled, which is convenient for the popularization and application of the product.

[0007] An embodiment of the present application provides an atrial septum puncture device, including:

[0008] A puncture needle assembly 2, with a puncture needle body 23 led out at one end and a Luer mandrel 3 connected at the other end. The Luer mandrel 3 includes a mandrel 32. The puncture needle body 23 is used to guide the mandrel 32, and a hemostatic valve 24 is provided at one end of the puncture needle handle 21 of the puncture needle assembly 2 connected to the mandrel 32.

[0009] A transmission handle 1, detachably arranged based on the puncture needle assembly 2 and covering a part of the led-out puncture needle body 23. It is provided with a transmission structure for connecting with a surgical robot. The transmission handle can be connected to the surgical robot based on the transmission structure, so as to provide a driving force for axial movement and circumferential rotation for the puncture needle handle through the surgical robot to control the rotation and axial movement of the puncture needle.

[0010] Optionally, the puncture needle assembly 2 includes a puncture needle handle 21 and a puncture needle body 23;

[0011] For the puncture needle handle 21, the transmission handle 1 is detachably sleeved on the puncture needle handle 21. The puncture needle handle 21 is coaxially arranged with the puncture needle body 23. A bent indicating structure is provided on the puncture needle handle 21, and the direction of the bent indicating structure is consistent with the bending direction of the needle tip of the puncture needle body 23;

[0012] For the puncture needle body 23, its far needle tip is coaxially and inlaid and fixed in the puncture needle handle, and the near needle tip is arc-shaped.

[0013] Optionally, a needle cavity is provided in the puncture needle body 23. The needle cavity runs through the entire puncture needle to the puncture needle tip, and the needle cavity is used for injecting contrast agent or withdrawing blood.

[0014] Optionally, the Luer mandrel 3 includes:

[0015] The mandrel Luer cap 31 is provided at the tail end of the Luer mandrel 3, and the mandrel Luer cap 31 is fixedly connected to the mandrel 32;

[0016] The mandrel 32 passes through the transmission handle 1 and passes out of the puncture needle body 23.

[0017] Optionally, the mandrel Luer cap 31 is provided with a convex block 33 inside, and the mandrel 32 is embedded and fixed on the convex block 33;

[0018] A cavity adapted to the convex block 33 is provided at the tail of the puncture needle handle 21. After the mandrel Luer cap 31 is connected to the puncture needle handle 21, the convex block 33 enters the cavity.

[0019] Optionally, a bent section is provided at a portion of the puncture needle body 23 near the needle tip, and the bending angle of the bent section is 19° - 38°.

[0020] Optionally, the transmission handle 1 includes:

[0021] A handle adaptation structure 11, the structure of which is adapted to the puncture needle handle 21;

[0022] A rotating gear 12 for driving the overall rotation of the transmission handle 1 and the puncture needle handle 21;

[0023] A propulsion buckle 13 is axially provided to limit the relative axial position between the puncture needle assembly 2 and the surgical robot actuator.

[0024] The atrial septum puncture device of the embodiment of the present application can control the overall rotation and axial propulsion of the detachable transmission handle and the puncture handle through the robot transmission structure, so as to realize the control of the robot puncture needle. When manual operation of the puncture needle is required, the transmission handle can be removed for manual control, which is convenient for the popularization and application of the product.

[0025] The above description is only an overview of the technical solution of the present application. In order to be able to understand the technical means of the present application more clearly, it can be implemented according to the content of the specification. And in order to make the above and other purposes, features and advantages of the present application more obvious and understandable, the following specific embodiments of the present application are specifically given. Brief Description of the Drawings

[0026] By reading the detailed description of the preferred embodiments below, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present application. And throughout the drawings, the same reference numerals are used to represent the same components. In the drawings:

[0027] Figure 1 It is a schematic diagram of the overall structure of the atrial septum puncture device of the embodiment of the present application;

[0028] Figure 2 Schematic diagram of the exploded structure of the atrial septum puncture device according to an embodiment of the present application;

[0029] Figure 3 Schematic diagram of the structure of the puncture needle assembly according to an embodiment of the present application;

[0030] Figure 4 Perspective schematic diagram of the handle end and Luer cap of the puncture needle assembly according to an embodiment of the present application;

[0031] Figure 5 Schematic diagram of the structure of the near needle tip part of the puncture needle assembly according to an embodiment of the present application;

[0032] Figure 6 Schematic diagram of the structure of the drive handle according to an embodiment of the present application. Detailed implementation manners

[0033] Hereinafter, exemplary embodiments of the present disclosure will be described in more detail with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be completely conveyed to those skilled in the art.

[0034] During the atrial septum puncture surgery, the key step is to accurately deliver the tip of the puncture needle to the target puncture position of the atrial septum of the heart cavity. The existing atrial septum puncture methods used clinically have the following disadvantages:

[0035] The existing atrial septum puncture requires manual operation by the operator, and it is impossible to accurately control the insertion amount of the puncture needle. If the insertion is too shallow, the puncture effect cannot be achieved. If the insertion is too deep, it may cause cardiac perforation. During the process of manually holding the puncture needle, due to the fatigue of the operator and the unstable factors of personnel operation, it is easy to affect the surgical safety.

[0036] The existing puncture needles adapted to surgical robots are all integrated designs of surgical robots. During the surgery, the doctor cannot manually operate the puncture needle for the surgery, and the application is relatively limited. During the surgery, if you want to switch back to manual operation, you can only operate with a new puncture needle, which increases the surgical cost.

[0037] After the traditional puncture needle completes the puncture, it is necessary to inject a contrast agent through the puncture needle for verification. Therefore, the puncture needle has a hollow structure, and due to the need to inject the contrast agent, the tip size cannot be made particularly fine. When encountering some patients with a relatively thick atrial septum tissue, a relatively large force is required to pierce the fossa ovalis of the atrial septum, which poses a certain danger and requires a high level of operation for the operator.

[0038] The existing transseptal puncture surgery requires the operator to perform the operation beside the operating table, and the long-term surgery under the fluoroscope is not beneficial to the health of the operator.

[0039] In the existing transseptal puncture surgery, it is difficult to accurately judge whether the tip of the puncture needle reaches the puncture point of the fossa ovalis. When the tip of the puncture catheter passes through the fossa ovalis, a jump will occur, which can only be perceived by the operator's hand feeling. The operation difficulty is high and the learning curve is long.

[0040] This application proposes a robotic puncture needle kit, which can be manually punctured or precisely control the puncture needle to puncture the target puncture position through the robotic arm to solve or partially solve the above problems. Specifically, the embodiments of this application propose a transseptal puncture device, as Figure 1 、 Figure 2 shown, including:

[0041] The puncture needle assembly 2 has a puncture needle body 23 led out at one end and a Luer mandrel 3 connected at the other end. The Luer mandrel 3 includes a mandrel 32. The puncture needle body 23 is used to guide the mandrel 32. A hemostatic valve 24 is provided on one end of the puncture needle handle 21 of the puncture needle assembly 2 connected to the mandrel 32.

[0042] The transmission handle 1 is detachably arranged based on the puncture needle assembly 2 and covers a part of the led-out puncture needle body 23. It is provided with a transmission structure for connecting with the surgical robot. The transmission handle can be connected to the surgical robot based on the transmission structure to provide the driving force of axial movement and circumferential rotation for the puncture needle handle through the surgical robot, so as to control the rotation and axial movement of the puncture needle. In some specific examples, the surgical robot can provide the driving force of axial movement and circumferential rotation for the puncture needle handle through the transmission handle, control the overall rotation and axial movement of the puncture needle, with a rotation accuracy of 1 degree and a front-back axial propulsion accuracy of 1 mm. With millimeter-level precision control, when puncturing and advancing at the appropriate position of the fossa ovalis, the occurrence of complications can be reduced, and at the same time, the operation requirements for the operator are also reduced.

[0043] The transmission handle is detachably sleeved on the puncture needle device. During the operation, the transmission handle is removed, and the operator can perform the operation by manually operating the puncture needle device. When operating manually, the transmission handle is removed, and the operator manually controls the axial and circumferential movements of the puncture needle by axially pushing and rotating the puncture needle handle.

[0044] The transseptal puncture device of the embodiments of this application can control the overall rotation and axial propulsion of the detachable transmission handle and the puncture handle through the robot transmission structure, so as to realize the control of the robotic puncture needle. When manual operation of the puncture needle is required, the transmission handle can be removed and then manually controlled, which is convenient for the promotion and application of the product.

[0045] Independently or additionally, asFigure 3 As shown, the puncture needle assembly 2 includes a puncture needle handle 21 and a puncture needle body 23;

[0046] For the puncture needle handle 21, the drive handle 1 is detachably sleeved on the puncture needle handle 21. The puncture needle handle 21 and the puncture needle body 23 are coaxially arranged. A bent indicating structure is provided on the puncture needle handle 21, and the direction pointed by the bent indicating structure is consistent with the bending direction of the needle tip of the puncture needle body 23;

[0047] For the puncture needle body 23, its far needle tip is coaxially and embeddedly fixed in the puncture needle handle, and the near needle tip is arc-shaped. Through such a design, it is convenient for the operator to judge the bending direction of the puncture needle tip in the patient's body through the bent indicating structure on the handle during the operation, so as to determine the next surgical action.

[0048] After the operator completes the puncture, it is necessary to confirm through angiography whether the puncture is successful. The puncture needle needs to have the function of injecting contrast agent. Independently or additionally, a needle cavity is provided in the puncture needle body 23. The needle cavity runs through the entire puncture needle to the puncture needle tip, and the needle cavity is used for injecting contrast agent or withdrawing blood. Since the needle cavity has a certain size, the tips of traditional puncture needle bodies are not particularly sharp. When encountering some patients with a thicker atrial septum, the puncture is more laborious. To solve the above problems, in the embodiment of the present application, a thinner Luer mandrel is provided for atrial septum puncture. The Luer mandrel passes through the needle cavity of the puncture needle body and extends out of the needle tip of the puncture needle. The mandrel provides a sharper puncture needle tip for the operator, facilitating the operator's puncture.

[0049] Independently or additionally, as Figure 4 shown, the Luer mandrel 3 includes:

[0050] A mandrel Luer cap 31 is provided at the tail end of the Luer mandrel 3. The mandrel Luer cap 31 is connected and fixed to the mandrel 32. In some examples, the mandrel Luer cap 31 is Luer-connected and fixed to the mandrel 32. The mandrel Luer cap 31 is detachably threadedly connected to the puncture handle 21. The mandrel Luer cap 31 is provided with an internal thread adapted to the external thread of the puncture handle 21. A hemostatic valve 24 is also provided at the connection between the puncture handle 21 and the mandrel Luer cap 31.

[0051] The mandrel 32 passes through the drive handle 1 and passes out of the puncture needle body 23.

[0052] Independently or additionally, as Figure 4 shown, the mandrel Luer cap 31 has a convex block 33 provided therein. The mandrel 32 is embedded and fixed on the convex block 33 to improve the connection stability between the mandrel 32 and the mandrel Luer cap 31.

[0053] A cavity adapted to the convex block 33 is provided at the tail of the puncture needle handle 21. After the core shaft Luer cap 31 is connected to the puncture needle handle 21, the convex block 33 enters the cavity. Specifically, when the Luer cap is threadedly connected to the puncture needle handle 21, the convex block 33 enters the convex block adaptation cavity inside the puncture handle to improve the connection stability between the Luer core shaft and the puncture handle. During puncture, the stability of the tip of the Luer core shaft can be improved, and the core shaft is always fixed during the puncture process. After the puncture is completed, the core shaft Luer cap 31 is unscrewed from the puncture handle 21, and then the core shaft 32 is withdrawn. Contrast agent is injected through the needle cavity from the handle end to confirm the puncture result, whether the tip of the puncture needle has passed through the atrial septum and entered the left atrium.

[0054] The tip of the traditional puncture needle is formed by welding multiple tube bodies with different diameters. The diameter of the tube body is smaller near the tip. Therefore, during the process of manually bending the curved section of the puncture needle by the operator to adjust the bending angle, the welded part is easily damaged, and there are potential hazards during the operation. Moreover, there are stepped protrusions at the connection part between the two tube bodies with different diameters in the welded connection method. During the axial movement of the puncture needle in the dilator tube, the stepped protrusions are likely to scratch the inner wall of the dilator tube, and the fine materials peeled off from the inner wall of the dilator tube entering the heart will cause serious complications such as embolism. Independently or additionally, as Figure 5 shown, a curved section is provided at the part of the puncture needle body 23 near the tip of the present application embodiment, and the bending angle of the curved section is 19° - 38°. A curved section is provided at the part of the puncture needle body of the present application near the tip, and the tip section is made by an integral variable diameter process. The whole body of the needle is overly smooth, such as Figure 5 the smooth processing section 231 in, which can avoid scratching the dilator tube body during the axial pushing of the puncture needle by the surgical robot, and at the same time facilitate the operator to adjust the bending shape, and it is not easy to bend during use.

[0055] Independently or additionally, as Figure 6 shown, the transmission handle 1 includes:

[0056] A handle adaptation structure 11, whose structure is adapted to the puncture needle handle 21. Specifically, the detachable transmission handle is sleeved on the puncture needle handle and fixed by a locking structure.

[0057] A rotating gear 12, used to drive the whole transmission handle 1 and the puncture needle handle 21 to rotate;

[0058] A pushing buckle 13, axially arranged, used to limit the relative axial position between the puncture needle assembly 2 and the surgical robot actuator. The axial overall movement of the whole actuator drives the axial advance and retreat of the puncture needle device.

[0059] In the embodiments of the present application, a transmission handle is provided, which is detachably sleeved on the puncture needle handle and can be directly adapted to the actuator of the surgical robot. The puncture needle is manipulated by the surgical robot to perform surgery, and the transmission handle can be removed for manual operation to remotely control the puncture of the atrial septum.

[0060] In the embodiments of the present application, a rotating gear and an axial propulsion bayonet are provided on the transmission handle. The rotating gear transmits the rotating power of the actuator of the surgical robot, and the axial propulsion buckle transmits the axial propulsion power of the puncture needle device.

[0061] In the embodiments of the present application, the puncture needle device includes a puncture handle. A bent indicating structure is provided on the puncture handle, through which the operator can obtain the bent orientation of the front end of the puncture needle. The puncture needle handle manually controls the axial advance and retreat and circumferential rotation of the puncture needle.

[0062] In the embodiments of the present application, a Luer mandrel is further provided on the puncture needle device. The Luer mandrel passes through the entire needle cavity of the puncture needle from the tail end of the puncture needle and extends out of the front end of the puncture needle to provide a sharper tip for the front end of the puncture needle. A mandrel Luer cap is also provided at the tail of the Luer mandrel, which is fixed to the handle of the puncture needle device through the mandrel Luer cap, so that the Luer mandrel is fixed to the handle of the puncture needle device, improving the tip stability of the Luer mandrel and making the puncture operation easier.

[0063] In the embodiments of the present application, the tip of the needle body of the puncture needle device adopts an integrated variable diameter process, which is convenient for the operator to adjust the bend and is not easily damaged during use. The transition section of the needle body is smoothed to avoid scratching the body of the dilator during use.

[0064] It should be noted that in the embodiments of the present application, the terms "include", "comprise" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not expressly listed, or elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "including a..." does not exclude the existence of additional identical elements in the process, method, article or device including that element.

[0065] The serial numbers of the embodiments of the present application above are only for description and do not represent the superiority or inferiority of the embodiments.

[0066] The embodiments of the present application have been described above in conjunction with the accompanying drawings. However, the present application is not limited to the above specific embodiments. The above specific embodiments are merely illustrative and not restrictive. Under the inspiration of the present application, those of ordinary skill in the art can also make many forms without departing from the purpose of the present application and the scope protected by the claims, and all of these fall within the protection scope of the present application.

Claims

1. An atrial septum puncture device, characterized in that, Comprising: A puncture needle assembly (2), one end of which leads out a puncture needle body (23), and the other end is connected to a Luer mandrel (3). The Luer mandrel (3) includes a mandrel (32). The puncture needle body (23) is used to guide the mandrel (32). A hemostatic valve (24) is provided on one end of the puncture needle handle (21) of the puncture needle assembly (2) that is connected to the mandrel (32). A drive handle (1), detachably arranged based on the puncture needle assembly (2) and covering a part of the led-out puncture needle body (23). It is provided with a drive structure for connecting to a surgical robot. The drive handle can be connected to the surgical robot based on the drive structure to provide a driving force for axial movement and circumferential rotation of the puncture needle handle through the surgical robot, so as to control the rotation and axial movement of the puncture needle.

2. The atrial septum puncture device according to claim 1, characterized in that, The puncture needle assembly (2) includes a puncture needle handle (21) and a puncture needle body (23); The puncture needle handle (21), the drive handle (1) is detachably sleeved on the puncture needle handle (21). The puncture needle handle (21) is coaxially arranged with the puncture needle body (23). A bent indicating structure is provided on the puncture needle handle (21), and the direction pointed by the bent indicating structure is consistent with the bending direction of the needle tip of the puncture needle body (23); The puncture needle body (23), its far needle tip is coaxially and inlaid and fixed in the puncture needle handle, and the near needle tip is arc-shaped.

3. The atrial septum puncture device according to claim 2, wherein A needle cavity is provided in the puncture needle body (23). The needle cavity runs through the entire puncture needle to the puncture needle tip. The needle cavity is used for injecting contrast agent or withdrawing blood.

4. The atrial septum puncture device according to claim 3, characterized in that, The Luer mandrel (3) includes: A mandrel Luer cap (31), arranged at the tail end of the Luer mandrel (3), and the mandrel Luer cap (31) is connected and fixed to the mandrel (32); The mandrel (32), passing through from the drive handle (1) and passing out from the puncture needle body (23).

5. The atrial septum puncture device according to claim 4, wherein, The mandrel Luer cap (31), in which a convex block (33) is provided, and the mandrel (32) is inlaid and fixed on the convex block (33); A cavity adapted to the convex block (33) is provided at the tail of the puncture needle handle (21). After the mandrel Luer cap (31) is connected to the puncture needle handle (21), the convex block (33) enters the cavity.

6. The atrial septum puncture device according to claim 2, wherein, A bent section is provided at a part of the puncture needle body (23) near the needle tip, and the bending angle of the bent section is 19° - 38°.

7. The atrial septum puncture device according to claim 2, wherein, The drive handle (1) includes: A handle adaptation structure (11), whose structure is adapted to the puncture needle handle (21); A rotating gear (12), used to drive the whole drive handle (1) and the puncture needle handle (21) to rotate; A pushing buckle (13), axially arranged, used to limit the relative axial position of the puncture needle assembly (2) and the surgical robot actuator.

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