Atrial septum puncture system

Abstract

The utility model provides an atrial septum puncture system. The atrial septum puncture system comprises a puncture needle, a three-dimensional system and a developing part, the puncture needle comprises a needle tube and a needle tip, and the needle tip is connected to the far end of the needle tube. The needle point is configured to be an electrode and electrically connected with the three-dimensional system, the needle point puncture needle sends an obtained electric signal to the three-dimensional system, and the three-dimensional system displays the position of the needle point according to the electric signal sent by the needle point; the developing part is arranged at the needle tip and is used for displaying the position of the needle tip under the irradiation of developing equipment. Therefore, when the atrial septum puncture system provided by the utility model is used for positioning the needle point of the puncture needle, two positioning modes can be selected.

Description

Technical Field

[0001] This utility model relates to the field of medical technology, and in particular to an atrial septal puncture needle and atrial septal puncture system. Background Art

[0002] Cardiovascular diseases pose a serious threat to human health, characterized by high morbidity, disability, and mortality rates. Interventional therapy is a relatively effective treatment for cardiovascular diseases. During interventional procedures, a guide sheath is typically used to support the intracardiac catheter and establish access. For interventional treatment of diseases such as atrial fibrillation and atrial flutter, since the procedure needs to be performed in the left ventricular system, an atrial septal puncture is usually required to establish a pathway from the right atrium to the left atrium. In an atrial septal puncture, a puncture needle, along with a dilator and a guide sheath, is used to puncture at the fossa ovalis. After the puncture is completed, the catheter is advanced into the left atrium through the guide sheath.

[0003] At present, the mainstream atrial septal puncture technique at home and abroad is still the atrial septal puncture technique under X-ray fluoroscopy guidance. This technique was developed more than half a century ago and is a two-dimensional planar perspective technique. For some patients whose cardiac anatomy is easy to puncture and for operators with experience in mechanical puncture, there are limitations in the choice of technique; (1) The puncture component must be located under the assistance of X-ray or ultrasound, and only the position information in two-dimensional space can be obtained. The learning difficulty is high and it is difficult to accurately select the puncture point; (2) The use of X-ray poses health risks to both the operator and the patient, while the use of ultrasound catheter requires additional surgical consumables and operators, which greatly increases the cost of the operation. Utility Model Content

[0004] The purpose of this invention is to provide a transseptal puncture system to solve one or more problems existing in the prior art.

[0005] To address the aforementioned problems, this utility model provides a transseptal puncture system, comprising: a puncture needle, a three-dimensional system, and a contrast agent; the puncture needle includes a needle tube and a needle tip, the needle tip being connected to the distal end of the needle tube;

[0006] The needle tip is configured as an electrode and electrically connected to the three-dimensional system. The needle tip sends the acquired electrical signals to the three-dimensional system, and the three-dimensional system displays the position of the needle tip based on the electrical signals sent by the needle tip.

[0007] The developing element is disposed at the needle tip, and the developing element is used to display the position of the needle tip under the illumination of the developing equipment.

[0008] Optionally, in the said interseptal puncture system, the imaging element is disposed within the needle tip, and the needle tip has contour features that match the inner contour of the needle tip.

[0009] Optionally, in the room-septal puncture system, the needle tip has a first inclined surface, the imaging element has a second inclined surface, and the first inclined surface and the second inclined surface coincide on the same plane.

[0010] Optionally, in the atrial septal puncture system, the imaging element is connected to the proximal end of the needle tip, and the outer contour dimension of the imaging element matches the distal inner diameter of the needle tube. The imaging element is inserted into the needle tube from the distal end to connect the needle tip to the distal end of the needle tube.

[0011] Optionally, in the aforementioned inter-septal puncture system, the needle tube has an axially oriented liquid channel inside, and the distal end of the needle tube has a through hole penetrating the sidewall, the through hole communicating with the liquid channel.

[0012] Optionally, in the said interseptal puncture system, the needle tube has at least two through holes, and the at least two through holes are evenly distributed along the circumference of the needle tube.

[0013] Optionally, in the room-segment puncture system, the needle tip has a first puncture mode and a second puncture mode. In the first puncture mode, the needle tip is connected to an energy source device and punctures the target object by applying energy. In the second puncture mode, the needle tip performs mechanical puncture on the target object.

[0014] Optionally, in the room-septal puncture system, the surface of the needle is covered with an insulating layer.

[0015] Optionally, in the room septum puncture system, the needle tube includes a first segment and a second segment, and the needle tip, the first segment, and the second segment are connected sequentially from the distal end to the proximal end; the outer diameter of the second segment is larger than the outer diameter of the first segment.

[0016] Optionally, in the room-septal puncture system, the puncture needle further includes a handle, the handle having a socket for electrical connection with the three-dimensional system.

[0017] In summary, the atrial septum puncture system provided by this utility model includes: a puncture needle, a three-dimensional system, and a contrast agent; the puncture needle includes a needle tube and a needle tip, the needle tip being connected to the distal end of the needle tube; the needle tip is configured as an electrode and electrically connected to the three-dimensional system, the needle tip sending acquired electrical signals to the three-dimensional system, and the three-dimensional system displaying the position of the needle tip based on the electrical signals sent by the needle tip; the contrast agent is disposed on the needle tip, and the contrast agent is used to display the position of the needle tip under the irradiation of the contrast agent. Therefore, the atrial septum puncture system provided by this utility model offers two positioning methods for locating the needle tip. Under normal circumstances, three-dimensional electro-positioning contrast agent can be used. The three-dimensional electro-positioning contrast agent of the needle tip embodies the concept of green electrophysiological surgery, prioritizing the welfare of patients and doctors, reducing the harm of radiation to both. Simultaneously, the puncture needle itself also supports two-dimensional contrast agent under X-ray irradiation, which can play an auxiliary positioning role in some special application scenarios. Attached Figure Description

[0018] Those skilled in the art will understand that the accompanying drawings are provided to better understand the present invention and do not constitute any limitation on the scope of the present invention. Wherein:

[0019] Figure 1 This is a schematic diagram of the puncture needle in an embodiment of the present invention;

[0020] Figure 2 This is a schematic diagram of the distal structure of a puncture needle in an embodiment of the present invention;

[0021] Figure 3 for Figure 2 Cross-sectional view of the structure shown;

[0022] Figure 4 This is a schematic diagram of another distal structure of the puncture needle in an embodiment of the present invention;

[0023] Figure 5 for Figure 4 Cross-sectional view of the structure shown;

[0024] Figure 6 This is a schematic diagram showing the connection between the first pipe segment and the second pipe segment in an embodiment of this utility model;

[0025] Figure 7 This is a schematic diagram of the distal internal structure of the developing element when it is located inside the needle tip in an embodiment of this utility model.

[0026] Figure 8 for Figure 7 Disassembly diagram of the structure shown;

[0027] Figure 9This is a schematic diagram of the distal internal structure of the developing element when it is connected to the proximal end of the needle tip in an embodiment of this utility model;

[0028] Figure 10 for Figure 9 Disassembly diagram of the structure shown;

[0029] Figures 11-14 This is a schematic diagram showing the component relationships corresponding to each step of the puncture process in an embodiment of this utility model;

[0030] The markings in the attached diagram are explained as follows:

[0031] 1-Needle tip; 2-Insulating layer; 3-Through hole; 4-First tube section; 5-Connection between first and second tube sections; 6-Second tube section; 7-Direction indicator; 8-Luer connector; 9-Handle; 10-Socket; 11-Developing element; 12-Liquid channel;

[0032] 100-Catheter sheath; 200-Dilator; 300-Guidewire; 400-Puncture needle; 500-Standard connector for dilator; 600-Hemostatic valve; 700-Flange. Detailed Implementation

[0033] To make the objectives, advantages, and features of this utility model clearer, the present utility model will be 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, and are only used to facilitate and clarify the explanation of the objectives of the embodiments of this utility model. Furthermore, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may emphasize different aspects and sometimes use different scales.

[0034] As used in this invention, the singular forms “a,” “an,” and “the” include plural objects; the term “or” is generally used to mean “and / or”; the term “a number” is generally used to mean “at least one”; the term “at least two” is generally used to mean “two or more”; furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, features defined with "first," "second," and "third" can explicitly or implicitly include one or at least two of those features. "One end" and "the other end," as well as "proximal end" and "distal end," generally refer to two corresponding parts, not only those included in this application. "Proximal end" and "distal end" refer to the relative orientation, position, and direction of the components or actions relative to each other from the perspective of the doctor using the medical device. Although "proximal end" and "distal end" are not restrictive, "proximal end" generally refers to the end of the medical device that is closer to the doctor during normal operation, while "distal end" generally refers to the end that first enters the patient's body. Furthermore, as used in this utility model, terms such as "installed," "connected," and "attached," and "set" of one element on another element, should be interpreted broadly. They generally only indicate that there is a connection, coupling, cooperation, or transmission relationship between the two elements, and the connection, coupling, cooperation, or transmission between the two elements can be direct or indirect through an intermediate element. They should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be in any position such as inside, outside, above, below, or to one side of the other element, unless otherwise explicitly stated.

[0035] This invention provides an atrial septal puncture system, comprising a puncture needle, a three-dimensional system, and a contrast agent. The atrial septal puncture system provided in this invention has two positioning modes: one using three-dimensional electro-positioning contrast agent, and the other using a contrast agent.

[0036] Specifically, such as Figure 1 As shown, the puncture needle includes a needle tube and a needle tip 1, the needle tip 1 being connected to the distal end of the needle tube. In this embodiment, Figure 1 The first tube segment 4 and the second tube segment 6 shown together constitute the needle tube. A detailed description of the needle tube is provided below. The needle tip 1 is configured as an electrode and electrically connected to the three-dimensional system. The needle tip 1 transmits acquired electrical signals to the three-dimensional system, which displays the position of the needle tip 1 based on the transmitted signals. The needle tip 1, used as an electrode in conjunction with the three-dimensional system, provides a first positioning method for locating the needle tip 1.

[0037] In addition, such as Figure 3 As shown and Figure 5 As shown, the developing element 11 is disposed on the needle tip 1. The developing device is capable of emitting X-rays, and the developing element 11 is used to display the position of the needle tip 1 under the illumination of the developing device. The placement of the developing element 11 on the needle tip 1 provides a second positioning method for positioning the needle tip 1.

[0038] Therefore, it can be seen that the room septum puncture system provided by this utility model has two positioning methods to choose from when positioning the needle tip 1 of the puncture needle. Under normal circumstances, three-dimensional electro-positioning imaging can be used. The three-dimensional electro-positioning imaging of the needle tip 1 implements the concept of green electrophysiological surgery, takes the welfare of patients and doctors as the starting point, and reduces the harm of radiation to both. At the same time, the puncture needle itself also supports two-dimensional imaging under X-ray irradiation, which can play an auxiliary positioning role in some special application scenarios.

[0039] The needle tip 1 can be made of a conductive material such as metal, which can be used as an electrode. The electrical signal acquired by the needle tip 1 can be transmitted to the three-dimensional system through a wire. Alternatively, the needle tube can also be made of a conductive material, thus acting as a wire to transmit the electrical signal acquired by the needle tip 1 to the three-dimensional system. The material of the developing element 11 includes, but is not limited to, at least one of tantalum alloy, platinum-iridium alloy, platinum-tungsten alloy, and gold.

[0040] To achieve an electrical connection between the puncture needle and the three-dimensional system, specifically, as follows: Figure 1 As shown, the puncture needle also includes a handle 9, which is ergonomically designed for ease of use by the operator. Preferably, the handle 9 is provided with a socket 10, which can be electrically connected to the three-dimensional system via a tail wire, and the socket 10 can be electrically connected to the needle tip 1 via a wire or the needle tube made of conductive material, thereby creating an electrical connection path between the needle tip 1 and the three-dimensional system.

[0041] Better, such as Figures 2-4 As shown, the surface of the syringe is covered with an insulating layer 2, which provides insulation protection for the instrument. The ultra-smooth nature of the insulating layer 2 also ensures smooth, unobstructed delivery of the product within the compatible instrument. The insulating layer 2 can be made of polymer materials such as PTFE (polytetrafluoroethylene) or Pebax (polyamide).

[0042] In this embodiment, the needle tip 1 and the needle tube can be connected in various ways. In one possible implementation, please refer to... Figure 7 and Figure 8The needle tip 1 is integrally formed with the needle tube. For example, a tubular body is stretched and its head is squeezed to close its distal end to form the needle tip 1. The imaging element 11 can be pre-placed in the inner cavity of the head of the tubular body after it is stretched, and then squeezed to form the needle tip 1. Preferably, the needle tip 1 has an inner cavity, and the imaging element 11 is disposed in the inner cavity of the needle tip 1 and has a contour feature that matches the contour of the inner cavity of the needle tip 1. This contour feature can be, for example, an edge or a corner. By imaging this contour feature, the fixed position of the needle tip 1 can be characterized, improving the accuracy of positioning. It is understood that since the needle tip 1 has a variable diameter design from the proximal end to the distal end, it has an inclined surface, which is defined in this embodiment as having a first inclined surface. Based on this, it is further preferred that the imaging element 11 has a second inclined surface. The first inclined surface and the second inclined surface coincide on the same plane. Through this design, the position of the distal end of the needle tip 1 can be obtained more intuitively, and its puncture state can be known. The needle tip 1 can also be directly connected to the distal end of the needle tube, for example, by bonding, welding or other methods. When this connection method is used, the developing element 11 can also be disposed inside the needle tip 1.

[0043] In another possible implementation, please refer to Figure 9 and Figure 10 The developing element 11 is connected to the proximal end of the needle tip 1, and the outer contour size of the developing element 11 matches the inner diameter of the distal end of the needle tube. The developing element 11 is inserted into the needle tube from the distal end to connect the needle tip 1 to the distal end of the needle tube. Thus, on the one hand, the connection between the needle tube and the needle tip 1 can be realized through the developing element 11, and on the other hand, the position of the proximal end of the needle tip 1 can also be displayed through the developing element 11.

[0044] The septal puncture system provided in this embodiment can not only display the position of the needle tip 1, but also display the tissue outline by delivering contrast agent. For details, please refer to... Figures 6-10 The syringe has a liquid channel 12 inside, and a through hole 3 penetrating the side wall at the distal end. The through hole 3 communicates with the liquid channel 12 for delivering liquid, including contrast agent, but can also be used for injecting saline or aspirating blood. Preferably, the syringe has at least two through holes 3, which are evenly distributed along the circumference of the syringe. This allows liquid to be injected or blood to be aspirated from different angles, improving work efficiency and ensuring effectiveness.

[0045] Furthermore, preferably, the needle tip 1 has a first puncture mode and a second puncture mode. In the first puncture mode, the needle tip 1 is connected to an energy source device and completes puncture by applying energy to the target object. In the second puncture mode, the needle tip 1 performs mechanical puncture on the target object.

[0046] For components that rely solely on mechanical force for atrial septal puncture, it may be difficult to penetrate the fossa oval due to factors such as fibrosis or thickening of the fossa oval. Furthermore, during the puncture, continuous pressure needs to be applied to the fossa oval, and the needle may penetrate too deeply due to inertia after breaking through, potentially damaging the posterior wall of the left atrium. For components that rely solely on radiofrequency discharge for atrial septal puncture, their blunt tip structure makes mechanical puncture impossible. This presents limitations in the choice of surgical procedures for patients with easily puncturable cardiac anatomy and for surgeons experienced in mechanical puncture. However, the atrial septal puncture system provided in this embodiment allows the needle tip 1 to perform mechanical atrial septal puncture without radiofrequency energy, and it can also be used as a discharge electrode to perform radiofrequency atrial septal puncture when mechanical puncture is ineffective. For example, it can perform purely physical atrial septal puncture when facing normal atrial septal tissue, and it can also assist in stoma formation using an energy source when facing specific diseased tissue.

[0047] The socket 10 of the puncture needle can also be connected to the energy source device via a tail wire to achieve an electrical connection between the needle tip 1 and the energy source device. The socket for connecting to the energy source device and the socket for connecting to the three-dimensional system can be the same socket, which can be selectively connected to the energy source device or the three-dimensional system as needed. Alternatively, the handle 9 can be provided with different sockets for connecting the energy source device and the three-dimensional system, respectively.

[0048] Optional, please see details. Figure 6 and combined Figure 1 The needle tube includes a first segment 4 and a second segment 6, with the needle tip 1, the first segment 4, and the second segment 6 connected sequentially from distal to proximal. The outer diameter of the second segment 6 is larger than that of the first segment 4. The larger outer diameter of the second segment 6 provides stronger support, while the smaller outer diameter of the first segment 4 facilitates easier entry of the distal end of the puncture needle into the heart chamber. The first segment 4 and the second segment 6 can be assembled together by interference fit, threaded fit, welding, etc., and the connection 5 between the first and second segments is smoothly transitioned. This connection can be secured by the corresponding dilator to prevent excessive extension and puncture of the heart wall.

[0049] In addition, continue as Figure 1As shown, the puncture needle may also include a direction indicator 7 and a Luer connector 8. The direction indicator 7 is located near the distal end of the handle 9 and is used for the bending direction of the puncture needle. The Luer connector 8 is connected to the proximal end of the handle 9 and is used in conjunction with other Luer structure instruments to aspirate or inject liquid.

[0050] The following describes the puncture process of the interseptal puncture system provided in this embodiment of the present invention in conjunction with the dilator and catheter sheath.

[0051] (1) Flush the dilator and catheter sheath with sterile heparinized saline. See Figure 11 Insert the dilator 200 completely into the catheter sheath 100;

[0052] (2) See Figure 12 Push the catheter sheath 100 and dilator 200 into the superior vena cava: enter from the femoral vein (preferably the right femoral vein), push the catheter sheath 100 and dilator 200 along the guidewire 300 until the tip of the catheter sheath 100 is in the superior vena cava;

[0053] (3) See Figure 13 Retract the guidewire 300, thoroughly aspirate the dilator 200 and flush with clean heparinized saline to ensure that no air enters the blood. After pulling the dilator 200 out to a distance sufficient to accommodate the bent section of the puncture needle, separate the sheath and the dilator 200.

[0054] (4) See Figure 14 Insert the puncture needle 400 into the dilator 200, allowing the puncture needle 400 to rotate freely during insertion; push the curved section of the puncture needle 400 beyond the hemostatic valve 600 of the catheter sheath 100, and reconnect the catheter sheath 100 and the dilator 200 by keeping the position of the dilator 200 unchanged, retracting the catheter sheath 100 along the dilator 200 while keeping the tip of the catheter sheath 100 in the superior vena cava, and pushing the puncture needle 400 until the pointer flange 700 reaches the predetermined distance from the standard connector 500 of the dilator, confirming that the needle tip 1 has not protruded from the dilator 200;

[0055] (5) Insertion into the fossa ovalis: Observe and determine the anatomical position. After confirming that the tip 1 of the puncture needle 400 is inside the dilator 200, slowly drag the entire assembly (including the catheter sheath 100, dilator 200 and puncture needle 400) to prevent any movement between the components. When dragging this assembly, keep the original direction of the pointer flange 700. During the dragging process, observe whether the tip of the dilator 200 suddenly moves to the middle or to the right. If so, it means that it has been placed in the fossa ovalis.

[0056] (6) Puncture the fossa ovalis with puncture needle 400: After confirming that the entire assembly has reached the correct position, push puncture needle 400. You will feel a breakthrough after entering the left atrium. At this time, connect the syringe to the needle hub and inject the contrast agent. Confirm that the needle tip 1 is in the left atrium from the fluorescent screen.

[0057] In step (4), confirming that the needle tip 1 has not extended out of the dilator 200 and in step (5), confirming that the needle tip 1 of the puncture needle 400 is located in the dilator 200 can both utilize either of the above two positioning modes. In step (6), when performing puncture, either of the above two puncture modes can also be selected as needed.

[0058] In summary, the atrial septum puncture system provided by this utility model includes: a puncture needle, a three-dimensional system, and a contrast agent; the puncture needle includes a needle tube and a needle tip, the needle tip being connected to the distal end of the needle tube; the needle tip is configured as an electrode and electrically connected to the three-dimensional system, the puncture needle sending the acquired electrical signal to the three-dimensional system, and the three-dimensional system displaying the position of the needle tip based on the electrical signal sent by the puncture needle; the contrast agent is disposed on the needle tip, and the contrast agent is used to display the position of the needle tip under the irradiation of the contrast agent. Therefore, the atrial septum puncture system provided by this utility model offers two positioning methods for locating the needle tip. Under normal circumstances, three-dimensional electro-positioning contrast agent can be used. The three-dimensional electro-positioning contrast agent of the needle tip embodies the concept of green electrophysiological surgery, prioritizing the welfare of patients and doctors, reducing the harm of radiation to both. Simultaneously, the puncture needle itself also supports two-dimensional contrast agent under X-ray irradiation, which can play an auxiliary positioning role in some special application scenarios.

[0059] Furthermore, it should be understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the present invention's technical solutions using the disclosed technical content, or equivalent embodiments can be modified accordingly, without departing from the scope of the present invention's technical solutions. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention, without departing from the content of the present invention's technical solutions, shall still fall within the protection scope of the present invention's technical solutions.

Claims

1. A transseptal puncture system, characterized in that: include: Puncture needles, 3D systems and developing parts; The puncture needle comprises a needle tube and a needle tip, and the needle tip is connected to the distal end of the needle tube; The needle tip is configured as an electrode and is electrically connected to the three-dimensional system. The needle tip sends the acquired electrical signal to the three-dimensional system, and the three-dimensional system displays the position of the needle tip according to the electrical signal sent by the needle tip. The developing member is arranged on the needle tip, and is used for displaying the position of the needle tip under the illumination of a developing device.

2. The atrial septal puncture system according to claim 1, characterized in that: The developing member is arranged in the needle tip, and the needle tip has a contour feature matching the inner cavity contour of the needle tip.

3. The atrial septal puncture system according to claim 2, characterized in that: The needle tip has a first inclined surface, the developing member has a second inclined surface, and the first inclined surface and the second inclined surface overlap on the same plane.

4. The atrial septal puncture system according to claim 1, characterized in that: The developing member is connected to the proximal end of the needle tip, and the outer contour size of the developing member matches the inner diameter of the distal end of the needle tube. The developing member is inserted into the needle tube from the distal end of the needle tube to connect the needle tip to the distal end of the needle tube.

5. The atrial septal puncture system according to claim 1, characterized in that: The needle tube has a liquid passage opened in the axial direction inside, and the distal end of the needle tube has a through hole penetrating the side wall, and the through hole is communicated with the liquid passage.

6. The atrial septal puncture system according to claim 5, characterized in that: The needle tube has at least two through holes, and the at least two through holes are evenly distributed along the circumference of the needle tube.

7. The atrial septal puncture system according to claim 1, characterized in that: The needle tip has a first puncture mode and a second puncture mode. In the first puncture mode, the needle tip is connected to an energy source device to complete puncture by applying energy to the target object. In the second puncture mode, the needle tip mechanically punctures the target object.

8. The atrial septal puncture system according to claim 1, characterized in that: The surface of the needle tube is covered with an insulating layer.

9. The atrial septal puncture system according to claim 1, characterized in that: The needle tube includes a first tube segment and a second tube segment. The needle tip, the first tube segment and the second tube segment are connected in sequence from the distal end to the proximal end. The outer diameter of the second tube segment is greater than the outer diameter of the first tube segment.

10. The atrial septal puncture system according to claim 1, characterized in that: The puncture needle also includes a handle, and the handle is provided with a socket, and the socket is commonly used for electrical connection with the three-dimensional system.

Images