Magnetic positioning atrial septum puncture needle

Abstract

The utility model provides a magnetic positioning atrial septum puncture needle. The magnetic positioning atrial septum puncture needle comprises a needle head, a first magnetic sensor, a first wire and a tube body, the needle head is arranged at the far end of the tube body in a plugging manner; the needle head is arranged at the far end of the tube body in a plugging manner; the first magnetic sensor is connected with the needle head and is positioned in the needle head and the tube body; the first magnetic sensor is connected with the first wire, and the first wire extends towards the near end; the tube body is provided with side holes formed in the tube wall, and an inner cavity of the tube body and the side holes are used for liquid circulation. By means of the configuration, on one hand, the first magnetic sensor is connected with the needle head, the position of the needle head can be accurately fed back in the magnetic positioning process, on the other hand, the inner cavity and the side hole of the tube body are used for liquid circulation, and therefore the magnetic positioning atrial septum puncture needle still has the functions of sucking and pouring liquid. This allows, after magnetic positioning, the position of the needle also to be confirmed by injecting contrast fluid and by means of X-rays.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a magnetically positioned interventricular septal puncture needle. Background Technology

[0002] A transseptal puncture needle is a puncture device used to create a pathway in the heart. It is widely used in cardiac surgeries such as left atrial appendage occlusion, cryoballoon ablation of the left atrium, and radiofrequency ablation. It creates a slit to provide a pathway from the right heart to the left heart.

[0003] During atrial septal puncture, X-rays or ultrasound are often needed to locate the needle within the heart chambers. The introduction of X-rays increases the radiation exposure time for both the operator and the patient, potentially causing varying degrees of harm. Ultrasound-assisted procedures can avoid or reduce X-ray exposure; however, ultrasound catheters are relatively expensive, making them unaffordable for many patients and limiting their availability.

[0004] Regarding the positioning of the atrial septal puncture needle, several positioning techniques exist, such as electro-positioning. The basic principle is to use the distal metal portion of the atrial septal puncture needle exposed in the blood as an electrode, combined with three-dimensional electro-positioning technology, to display the needle tip in a three-dimensional system. However, this technology also has limitations. Due to the limitations of the electro-positioning principle, its positioning accuracy is relatively lower. Furthermore, because electro-positioning requires electrode contact with blood, it cannot be displayed before the electrode contacts the blood. These limitations have, to some extent, hindered the widespread adoption of electro-positioning-based atrial septal puncture. Summary of the Invention

[0005] The purpose of this invention is to provide a magnetically positioned transseptal puncture needle to solve the problems existing in the positioning of existing transseptal puncture needles.

[0006] To solve the above-mentioned technical problems, this utility model provides a magnetic positioning interventricular septum puncture needle, which includes: a needle tip, a first magnetic sensor, a first wire, and a tube body;

[0007] The needle plug is located at the distal end of the tube; the first magnetic sensor is connected to the needle and is located inside the needle and the tube; the first magnetic sensor is connected to the first wire, which extends proximally.

[0008] The tube has a side hole formed in the tube wall, and the inner cavity of the tube and the side hole are used for liquid flow.

[0009] Optionally, the needle has a receiving cavity, the distal portion of the first magnetic sensor is received and fixed in the receiving cavity, and the proximal portion of the first magnetic sensor extends out of the receiving cavity; the side hole corresponds to the proximal portion of the first magnetic sensor along the axial direction of the tube body, and there are gaps between the tube wall of the tube body and the first wire and between the tube wall of the tube body and the first magnetic sensor for fluid flow, and the gaps communicate with the side hole.

[0010] Optionally, the needle is electrically connected to the tube body, and the needle is configured to transmit electrical signals through the tube body; the tube body includes a thin segment at a distal end and a thick segment at a proximal end, the thin segment being connected to the thick segment.

[0011] Optionally, the first magnetic sensor and the first wire have an insulating layer; and / or, the inner wall of the tube and the inner wall of the accommodating cavity have an insulating layer.

[0012] Optionally, the needle includes a head and a circumferentially concave stepped portion, the distal end of the tube is sleeved on the stepped portion and is connected to the stepped portion in a matching shape; the outer circumferential contour of the tube is flush with the outer circumferential contour of the head.

[0013] Optionally, the magnetically positioned interventricular septal puncture needle further includes a handle and a handle connection portion, wherein the proximal end of the tube body is inserted into and connected to the handle connection portion; the handle is circumferentially arranged outside the handle connection portion.

[0014] Optionally, the handle connection portion has a first rotation limiting structure, the tube body has a second rotation limiting structure, the first rotation limiting structure and the second rotation limiting structure are matched and connected to restrict the tube body from rotating relative to the handle connection portion about its own axis; and / or; the handle has a third rotation limiting structure, the handle connection portion has a fourth rotation limiting structure, the third rotation limiting structure and the fourth rotation limiting structure are matched and connected to restrict the handle connection portion from rotating relative to the handle about its own axis.

[0015] Optionally, the handle connection portion has a wire lead-out hole, and the magnetic positioning interventricular septal puncture needle further includes a second wire, one end of which is electrically connected to the tube body; the other end of the second wire and the proximal end of the first wire pass through the wire lead-out hole and exit the handle connection portion.

[0016] Optionally, the magnetically positioned interventricular septal puncture needle further includes a sealing part, which is sleeved outside the tube body and the handle connection part to seal the tube body and the handle connection part; the sealing part is also sealed to the handle to prevent liquid from flowing into the handle along the tube body.

[0017] Optionally, the magnetically positioned interventricular septal puncture needle may further include a second magnetic sensor and a third lead wire;

[0018] The second magnetic sensor is disposed on the inner wall of the tube and is spaced apart from the first magnetic sensor in the axial direction of the tube; the second magnetic sensor is connected to the third wire, which passes through the inner cavity of the tube and extends to the proximal end;

[0019] The second magnetic sensor is ring-shaped and has a wire through-hole extending along the axial direction of the tube; there is a gap between the wire through-hole and the wire passing through it for fluid flow.

[0020] In summary, the magnetic positioning septal puncture needle provided by this utility model includes: a needle tip, a first magnetic sensor, a first wire, and a tube body; the needle tip is sealed at the distal end of the tube body; the first magnetic sensor is connected to the needle tip and is located within the needle tip and the tube body; the first magnetic sensor is connected to the first wire, which extends proximally; the tube body has a side hole opened on the tube wall, and the inner cavity of the tube body and the side hole are used for fluid flow.

[0021] This configuration allows for two key improvements: firstly, the first magnetic sensor connects to the needle, accurately reflecting its position during magnetic positioning; secondly, the inner cavity and side holes of the tube allow for fluid flow, enabling the magnetically positioned transseptal puncture needle to still perform aspiration and infusion. This also allows the needle's position to be confirmed after magnetic positioning by injecting contrast fluid and using X-rays, effectively improving the accuracy and reliability of the positioning. Attached Figure Description

[0022] 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.

[0023] Figure 1 This is an overall schematic diagram of the magnetic positioning interventricular septum puncture needle according to an embodiment of the present invention.

[0024] Figure 2 This is a schematic diagram of the distal part of the magnetic positioning interventricular septum puncture needle according to an embodiment of the present invention.

[0025] Figure 3 This is an exploded view of the magnetic positioning interventricular septum puncture needle after the tube body has been removed, according to an embodiment of this utility model.

[0026] Figure 4 This is a schematic axial cross-sectional view of the distal part of the magnetic positioning interventricular septum puncture needle according to an embodiment of the present invention.

[0027] Figure 5This is a partial side view of the distal end of the magnetic positioning interventricular septal puncture needle according to an embodiment of the present invention.

[0028] Figure 6 This is an exploded view of the tube body and handle connection part according to an embodiment of the present invention.

[0029] Figure 7 This is an axial cross-sectional view of the tube body and handle connection part after assembly and connection according to an embodiment of the present utility model.

[0030] Figure 8 This is a side view of the tube body and handle connection part after assembly and connection according to an embodiment of the present utility model.

[0031] Figure 9 This is an exploded view of the proximal portion of the magnetic positioning interventricular septal puncture needle according to an embodiment of the present invention.

[0032] Figure 10 This is a schematic diagram of the handle of an embodiment of the present utility model.

[0033] Figure 11 This is a schematic axial cross-sectional view of the distal part of a magnetic positioning interventricular septal puncture needle including a second magnetic sensor, according to an embodiment of the present invention.

[0034] Figure 12 This is a partial axial cross-sectional view of the distal end of a magnetically positioned interventricular septal puncture needle containing two second magnetic sensors, according to an embodiment of the present invention.

[0035] In the attached diagram: 10-needle tip; 11-accommodating cavity; 12-head; 13-stepped portion; 21-first magnetic sensor; 22-second magnetic sensor; 220-wire through hole; 30-connecting wire; 31-first wire; 32-second wire; 33-third wire; 34-connector; 40-tube body; 401-thin section; 402-thick section; 403-insulating outer layer; 41-side hole; 42-gap; 44-second rotation limiting structure; 50-handle; 51-through hole; 52-sealing cavity; 55-third rotation limiting structure; 60-handle connection; 61-connecting section; 610-tube body connection cavity; 62-variable diameter section; 63-Luer connector; 64-first rotation limiting structure; 65-fourth rotation limiting structure; 66-wire lead-out hole; 70-sealing portion. Detailed Implementation

[0036] 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.

[0037] As used herein, the singular forms “a,” “an,” “one,” and “the” include plural objects; the term “or” is generally used to include the meaning of “and / or”; the term “a number” is generally used to include the meaning of “at least one”; and the term “at least two” is generally used to include the meaning of “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 indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature; “one end” and “the other end,” and “proximal end” and “distal end” generally refer to two corresponding parts, which include not only the endpoints. The terms “proximal end” and “distal end” are defined herein in relation to a magnetically positioned transseptal puncture needle having an end (needle tip) for insertion into the human body and a control end extending outside the body. The term "proximal" refers to the position closer to the manipulatory end of the magnetically positioned transseptal puncture needle protruding from the body, and the term "distal" refers to the position closer to the end of the magnetically positioned transseptal puncture needle inserted into the body and therefore further away from the manipulatory end of the magnetically positioned transseptal puncture needle. Optionally, in manual or hand-operated applications, the terms "proximal" and "distal" are defined herein relative to the operator, such as a surgeon or clinician. The term "proximal" refers to the position closer to the operator, and the term "distal" refers to the position closer to the patient's affected area and therefore further away from the operator. Furthermore, as used in this invention, "installed," "connected," "attached," and "set" of one element on another element should be interpreted broadly, generally indicating only a connection, coupling, cooperation, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element, and should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located inside, outside, above, below, or to one side of the other element, unless otherwise explicitly stated. For those skilled in the art, the specific meanings of the above terms in this utility model can be understood according to the specific circumstances. Furthermore, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as shown in the figures, with upward or up direction pointing towards the top of the corresponding figure, and downward or down direction pointing towards the bottom of the corresponding figure.

[0038] The purpose of this invention is to provide a magnetically positioned transseptal puncture needle to solve the problems existing in the positioning of existing transseptal puncture needles.

[0039] Studies have found that to improve the accuracy of magnetic localization, the magnetic sensor needs to be placed as close as possible to the distal end of the puncture needle to reflect the needle's position. However, this placement presents challenges. First, it requires ensuring a reliable connection between the magnetic sensor and the needle tip. Second, as mentioned in the background section, the accuracy and reliability of magnetic localization are relatively lower than those assisted by X-ray or ultrasound. Often, after magnetic localization, contrast fluid is injected, and X-rays are used to confirm the needle's position. However, placing the magnetic sensor at the distal end of the puncture needle near the needle tip can obstruct the injection of contrast fluid, preventing it from being injected at the corresponding location of the magnetic sensor, thus reducing the accuracy of X-ray-assisted confirmation.

[0040] To solve the above problems, please refer to Figures 1 to 5 This utility model provides a magnetically positioned interventricular septum puncture needle, comprising: a needle tip 10, a first magnetic sensor 21, a first lead wire 31, and a tube body 40; the needle tip 10 is disposed at the distal end of the tube body 40. Figure 4 and Figure 5 (left end of the tube); the first magnetic sensor 21 is connected to the needle 10 and is located inside the needle 10 and the tube body 40; the first magnetic sensor 21 is connected to the first wire 31, which extends proximally; the tube body 40 has a side hole 41 opened on the tube wall, and the inner cavity of the tube body 40 and the side hole 41 are used for liquid flow.

[0041] This configuration allows the first magnetic sensor 21 to be connected to the needle 10, accurately reflecting the position of the needle 10 during magnetic positioning. Furthermore, the inner cavity of the tube 40 and the side hole 41 allow for fluid flow, thus enabling the magnetically positioned transseptal puncture needle to still perform aspiration and infusion of fluid. This allows the position of the needle 10 to be confirmed after magnetic positioning by injecting contrast fluid and using X-rays, effectively improving the accuracy and reliability of positioning.

[0042] Preferably, the needle 10 has a receiving cavity 11, the distal portion of the first magnetic sensor 21 is received and fixed in the receiving cavity 11, and the proximal portion of the first magnetic sensor 21 extends out of the receiving cavity 11; the side hole 41 corresponds to the proximal portion of the first magnetic sensor 21 along the axial direction of the tube body 40; there is a gap 42 between the tube wall of the tube body 40 and the first wire 31 and between the tube wall of the tube body 40 and the first magnetic sensor 21 for fluid flow, and the gap 42 communicates with the side hole 41.

[0043] The needle 10 is located at the distal end of the entire magnetically positioned interventricular septum puncture needle, and is used to perform the puncture. The distal end of the needle 10 ( Figure 4The left end of the needle 10 can be hemispherical, ellipsoidal, or other smooth curved shapes; it can also be a sharp shape to combine radiofrequency puncture and physical puncture. The proximal end of the needle 10 ( Figure 4 The right end of the needle tip 10 can be cylindrical. The accommodating cavity 11 is preferably a blind cavity located near the proximal end of the needle tip 10, its inner contour shape matching the outer contour shape of the first magnetic sensor 21 to facilitate installation and connection of the first magnetic sensor 21. In one embodiment, the accommodating cavity 11 is a cylindrical cavity, and the first magnetic sensor 21 is a cylindrical structure. The inner diameter of the accommodating cavity 11 is slightly larger than the outer diameter of the first magnetic sensor 21. After being inserted into the accommodating cavity 11, the first magnetic sensor 21 can be fixed by adhesive bonding; alternatively, it can be fixed by interference fit or other methods. In another embodiment, the first magnetic sensor 21 can also be fixed in the accommodating cavity 11 by mechanical fitting. This configuration reliably connects and fixes the first magnetic sensor 21 to the needle tip 10, while ensuring that the first magnetic sensor 21 is as close as possible to the distal end of the entire magnetic positioning interventricular septum puncture needle, which is beneficial for ensuring the accuracy of magnetic positioning.

[0044] In this application, a magnetic field generator (not shown) can be placed near the patient's heart under the operating table. A first magnetic sensor 21 is connected to a proximal magnetic field positioning device (not shown) via a first wire 31. The magnetic field generator is also connected to the magnetic field positioning device. Thus, the first magnetic sensor 21 can sense the magnetic field of the magnetic field generator to obtain a sensing signal, which is then transmitted to the magnetic field positioning device via the first wire 31. The magnetic field positioning device can then calculate the current position information of the first magnetic sensor 21. Those skilled in the art can understand the principles and specific structures of magnetic sensors, magnetic field generators, and magnetic field positioning devices for magnetic positioning by referring to existing technologies; this invention will not elaborate further.

[0045] Optionally, the needle 10 is electrically connected to the tube body 40, and the needle 10 is configured to transmit electrical signals through the tube body 40. In one embodiment, the tube body 40 includes a conductive layer or conductive wires. The conductive layer may be formed in or attached to the wall of the tube body 40. The tube body 40 needs to have a certain degree of flexibility to bend along the blood vessel. The conductive layer may be formed, for example, by braiding conductive wires or by electroplating or vapor deposition onto a flexible substrate. The conductive wires may be embedded in or attached to the wall of the tube body 40. The electrical connection between the needle 10 and the tube body 40 may be achieved by welding or mechanical abutment connection; this embodiment is not limited to this.

[0046] In some embodiments, the needle 10 can be electrically connected to an energy generator (not shown) located at the proximal end via the tube 40, thereby achieving puncture based on the radio frequency energy, PFA energy, etc. emitted by the energy generator, combined with the physical movement of the needle 10. The needle 10 is preferably made of metal, such as stainless steel, platinum-iridium alloy, gold, gold alloy, etc.

[0047] Because the tube body 40 has a gap 42 between its wall and the first wire 31 and the first magnetic sensor 21 for fluid flow, and this gap 42 communicates with the side hole 41 of the tube body 40, the magnetically positioned transseptal puncture needle can aspirate and infuse fluid. This allows the needle tip 10 of the magnetically positioned transseptal puncture needle to be positioned after magnetic positioning by injecting contrast fluid and using X-rays, effectively improving the accuracy and reliability of positioning.

[0048] In one embodiment, the inner diameter of the tube 40 is larger than the outer diameter of the first magnetic sensor 21 and also larger than the outer diameter of the first wire 31. This allows the tube wall of the tube 40 to form a gap 42 with the first magnetic sensor 21 and the first wire 31, enabling fluid flow. In a preferred example, the outer diameter of the first magnetic sensor 21 is ≤0.5mm, and the difference between the inner diameter of the tube 40 and the outer diameter of the first magnetic sensor 21 is ≥0.05mm.

[0049] Please refer to Figure 4 A side hole 41 is formed on the wall of the tube body 40 and corresponds to the proximal portion of the first magnetic sensor 21 along the axial direction of the tube body 40. In other words, the side hole 41 is directly opposite the first magnetic sensor 21. Typically, when contrast fluid is injected and an X-ray is taken, the contrast fluid is quickly washed away by the blood shortly after being injected through the side hole 41. Therefore, arranging the side hole 41 axially corresponding to the first magnetic sensor 21 allows the contrast fluid injected through the side hole 41 to be distributed near the first magnetic sensor 21, thus clearly reflecting the surrounding environment of the first magnetic sensor 21 on the X-ray. Since the first magnetic sensor 21 is very close to the needle 10, it is possible to clearly determine whether the needle 10 has successfully completed the puncture. If the side hole 41 does not correspond to the first magnetic sensor 21, then the contrast fluid injected through the side hole 41 is relatively offset from the first magnetic sensor 21 and the needle 10, resulting in an inability to clearly reflect the surrounding environment of the needle 10.

[0050] Optionally, the first magnetic sensor 21 and the first lead wire 31 have an insulating layer; and / or, the inner wall of the tube body 40 and the inner wall of the accommodating cavity 11 have an insulating layer. The insulating layer is typically made of a polymer material, such as PET, PTFE, or Pebax. It is understood that the first magnetic sensor 21 and the first lead wire 31 form one electrical path for transmitting magnetic signals. The needle 10 and the tube body 40 form another electrical path for transmitting puncture energy (such as radio frequency energy, PFA energy, etc.), and the two electrical paths should be mutually insulated. The insulating layer provides insulation protection between the two electrical paths and also prevents the first magnetic sensor 21 and the first lead wire 31 from directly contacting the human body, thus avoiding interference from the magnetic positioning signal.

[0051] Preferably, the needle 10 includes a head 12 and a circumferentially concave stepped portion 13. The distal end of the tube body 40 is fitted onto the stepped portion 13 and is connected to it in a shape matching manner. The outer circumferential contour of the tube body 40 is flush with the outer circumferential contour of the head 12. Please refer to... Figure 3 In one embodiment, the outer contour of the stepped portion 13 is cylindrical, with its outer diameter slightly smaller than that of the head 12. The stepped portion 13 is coaxially connected to the head 12, thus forming a radial inward concavity relative to the head 12. Further details can be found in the following description. Figure 4 The inner diameter of the tube body 40 is adapted to the outer diameter of the stepped portion 13, so that the stepped portion 13 can be inserted into the tube body 40 and form a sealed connection. Optionally, the stepped portion 13 and the tube body 40 can be mechanically fitted, such as with an interference fit, or fixed by adhesive or welding, so that the needle 10 reliably seals the tube body 40. Furthermore, in some embodiments, the wall thickness of the tube body 40 can be configured to match the radial inward depth of the stepped portion 13, so that after the tube body 40 is fitted onto the stepped portion 13, the outer peripheral contour of the tube body 40 is flush with the outer peripheral contour of the head 12, making the outer contour after the connection smooth without unevenness, which helps to reduce puncture resistance.

[0052] Please refer to Figure 2 Preferably, the tube body 40 includes a thin segment 401 at the distal end and a thick segment 402 at the proximal end, with the thin segment 401 connected to the thick segment 402. As the needle 10 punctures the target tissue and advances distally, the distal portion of the tube body 40 follows into the target tissue. Therefore, the distal portion of the tube body 40 should not be configured too thick to facilitate penetration of the target tissue during puncture. Thus, the tube body 40 includes a thin segment 401 at the distal end. However, a thinner segment 401 results in weaker strength, and if the entire axial length of the tube body 40 were configured as a thin segment 401, undesirable events such as bending could easily occur during intervention and advancement. Therefore, the tube body 40 includes a thick segment 402 at the proximal end to provide additional support during advancement, enhancing the advancement performance of the entire magnetically positioned interventricular septal puncture needle, and allowing the advancement force at the proximal end to be better transmitted to the distal end. The distal, thin segment 401 can penetrate the target tissue without affecting puncture resistance, while the proximal, thicker segment 402 balances strength, support, and pushing performance. The length of the thin segment 401 can be set according to the required puncture depth.

[0053] In an alternative example, the thicker segment 402 has a relatively thicker outer insulating layer 403 (e.g., Figure 12 As shown), the insulating outer layer 403 can be, for example, a tubular component made of a polymer material. The thinner segment 401 can have a relatively thin insulating outer layer, such as an insulating coating, thereby creating a distinction in the diameter of the tube.

[0054] Please refer to Figures 6 to 10 Optionally, the magnetically positioned transseptal puncture needle further includes a handle 50 and a handle connecting portion 60. The proximal end of the tube body 40 is inserted into and connected to the handle connecting portion 60; the handle 50 is circumferentially arranged outside the handle connecting portion 60. This configuration facilitates the assembly of the magnetically positioned transseptal puncture needle at its proximal end and the operation of its external portion.

[0055] In an alternative example, the handle connection 60 comprises, from distal to proximal, a connecting section 61, a reducing section 62, and a Luer connector 63 connected in sequence. The connecting section 61 has an axially oriented tube connection cavity 610, the inner contour of which is adapted to the outer contour of the proximal portion of the tube 40, into which the proximal end of the tube 40 can be inserted and connected. The Luer connector 63 is used for detachable connection to an infusion or aspiration device.

[0056] Please refer to Figure 6 and Figure 7 Optionally, the handle connection 60 has a first rotation limiting structure 64, and the tube body 40 has a second rotation limiting structure 44. The first rotation limiting structure 64 and the second rotation limiting structure 44 are matched and connected to restrict the tube body 40 from rotating relative to the handle connection 60 around its own axis. In an alternative example, the first rotation limiting structure 64 is a positioning tooth protruding inwardly into the tube body connection cavity 610, and the second rotation limiting structure 44 is a positioning groove formed axially on the side wall of the tube body 40, with the shape of the positioning tooth matching the positioning groove. When the tube body 40 is inserted into the handle connection 60, the positioning tooth engages in the positioning groove, thereby forming a mechanical rotation limiting fit. Furthermore, after the tube body 40 is inserted into the handle connection 60, it can be further sealed and fixed with glue, which improves the mechanical strength and reliability of the connection and forms a seal to prevent liquid leakage from the inner cavity of the tube body 40.

[0057] Please refer to Figure 6 , Figure 9 and Figure 10Optionally, the handle 50 has a third rotation-limiting structure 55, and the handle connecting portion 60 has a fourth rotation-limiting structure 65. The third rotation-limiting structure 55 and the fourth rotation-limiting structure 65 are matched and connected to restrict the handle connecting portion 60 from rotating relative to the handle 50 about its own axis. In an alternative example, the third rotation-limiting structure 55 is a strip-shaped groove formed inside the handle 50, and the fourth rotation-limiting structure 65 is a strip-shaped protrusion protruding from the connecting section 61, the shape of which matches the strip-shaped groove. When the handle 50 and the handle connecting portion 60 are assembled and connected, the strip-shaped protrusion engages with the strip-shaped groove, thereby forming a mechanical rotation-limiting fit. It is understood that the number and distribution of the strip-shaped protrusions can be the same as the number and distribution of the strip-shaped grooves, and the number of strip-shaped protrusions can also be less than the number of strip-shaped grooves. Those skilled in the art can configure it according to actual conditions.

[0058] Please refer to Figures 6 to 9 The handle connection portion 60 has a wire lead-out hole 66. The magnetically positioned transseptal puncture needle also includes a second wire 32. One end of the second wire 32 is electrically connected to the tube body 40. The other end of the second wire 32 and the proximal end of the first wire 31 pass through the wire lead-out hole 66 and exit the handle connection portion 60. Based on the foregoing description, it can be understood that the magnetically positioned transseptal puncture needle has two electrical pathways, which need to extend out at the proximal end and be electrically connected to the corresponding device. To facilitate electrical connection, a wire lead-out hole 66 is provided on the side wall of the connection section 61, and the second wire 32 is led out from the proximal end of the tube body 40. The second wire 32 and the first wire 31 extending from the distal end pass through the wire lead-out hole 66 together. In a preferred example, the first wire 31 and the second wire 32 can pass through the tube body 40 and then through the wire lead-out hole 66 using the positioning groove of the second rotation limiting structure 44. Optionally, the wire lead-out hole 66 can be configured to be inclined to the axis of the handle connection portion 60 to facilitate the lead-out of the first wire 31 and the second wire 32.

[0059] In some embodiments, the energy generating device and the magnetic field positioning device are integrated. Optionally, after the first wire 31 and the second wire 32 are led out from the wire lead-out hole 66, they are preferably integrated into the connecting wire 30. Further, as... Figure 1 As shown, after the connecting wire 30 passes through the through hole 51, it can be connected to the connector 34 to facilitate insertion with the corresponding device.

[0060] Furthermore, the handle 50 has a through hole 51 through which a connecting wire 30 passes to connect with a corresponding device. In a preferred embodiment, the handle 50 is a two-part structure that can be assembled together. In this example of a two-part handle 50, the through hole 51 is preferably formed by assembling the two parts together to facilitate assembly with the connecting wire 30.

[0061] Please refer to Figure 9 and Figure 10 Optionally, the magnetically positioned interventricular septal puncture needle further includes a sealing part 70, which is sleeved outside the tube body 40 and the handle connection part 60 to seal the tube body 40 and the handle connection part 60; the sealing part 70 is also sealed to the handle 50 to prevent liquid from flowing into the handle 50 along the tube body 40.

[0062] The tube body 40 is connected to the handle connection portion 60 by being inserted into the tube body connection cavity 610. In some embodiments, a gap may exist between the tube body 40 and the handle connection portion 60, causing leakage of liquid from the gap when liquid is poured or drawn from one end of the Luer connector 63. One function of the sealing portion 70 is to seal the gap between the tube body 40 and the handle connection portion 60 to prevent liquid leakage.

[0063] On the other hand, during the procedure, fluid (such as blood) may flow along the tube 40 into the handle 50. At this time, the sealing connection between the sealing part 70 and the handle 50 can prevent the fluid from flowing into the handle 50 along the tube 40. In one embodiment, the distal end of the handle 50 has a sealing cavity 52 that matches the outer contour shape of the sealing part 70. When the handle 50 and the sealing part 70 are assembled, the sealing part 70 fills the sealing cavity 52, thereby forming a seal against the interior of the handle 50. The sealing part 70 can be made of a sealing material with a certain degree of deformability, such as silicone or rubber.

[0064] Please refer to Figure 11 and Figure 12 In some embodiments, the magnetically positioned interventricular septum puncture needle is not limited to including only a first magnetic sensor 21 and a first lead wire 31, but may also include a second magnetic sensor 22 and a third lead wire 33; the second magnetic sensor 22 is disposed on the inner wall of the tube body 40 and is spaced apart from the first magnetic sensor 21 in the axial direction of the tube body 40; the second magnetic sensor 22 is connected to the third lead wire 33, which passes through the inner cavity of the tube body 40 and extends proximally; the second magnetic sensor 22 is annular and has a lead wire through hole 220 extending along the axial direction of the tube body 40; there is a gap between the lead wire through hole 220 and the lead wire passing through it for fluid flow. Optionally, the outer diameter of the second magnetic sensor 22 is adapted to the inner diameter of the tube body 40, and after being inserted into a suitable position in the tube body 40, it is connected to the inner wall of the tube body 40 by mechanical fitting, adhesive bonding or welding.

[0065] The second magnetic sensor 22 is connected to the proximal magnetic field positioning device via a third wire 33. The second magnetic sensor 22 can sense the magnetic field of the magnetic field generator to obtain a sensing signal, which is then transmitted to the magnetic field positioning device via the third wire 33. The magnetic field positioning device can then calculate the current position information of the second magnetic sensor 22. Combined with the position information of the first magnetic sensor 21, the curved shape of the distal part of the magnetic positioning septal puncture needle can be determined, which further assists in the puncture.

[0066] Preferably, the magnetic field positioning device can be connected to a related three-dimensional display system, so that the three-dimensional display system can display the needle tip orientation of the magnetic positioning septal puncture needle in three dimensions based on the position information of the first magnetic sensor 21 and the second magnetic sensor 22, and can also simulate and display the curved shape of the distal part of the magnetic positioning septal puncture needle.

[0067] Optionally, the number of second magnetic sensors 22 is not limited to one; there can be two or more. Please refer to [reference needed]. Figure 12 This illustration shows an embodiment of a magnetically positioned septal puncture needle comprising two second magnetic sensors 22. Preferably, two or more second magnetic sensors 22 are arranged at intervals along the axial direction of the tube body 40. The number of third wires 33 matches the number of second magnetic sensors 22. It is known that two points define a line, and three points define a plane. Therefore, by using two or more second magnetic sensors 22 in combination with the first magnetic sensor 21, the curvature plane of the distal portion of the magnetically positioned septal puncture needle can be determined. While more second magnetic sensors 22 can theoretically provide more accurate information on the curvature and orientation of the magnetically positioned septal puncture needle, this increases cost. Therefore, the number and spacing of the second magnetic sensors 22 should be rationally considered and configured based on a balance between cost and positioning accuracy.

[0068] The wire via 220 is used for the passage of wires from the magnetic sensor located on the distal side of the second magnetic sensor 22. When there is only one second magnetic sensor 22, it can be understood that the distal side of the second magnetic sensor 22 is the first magnetic sensor 21, and in this case, the wire via 220 is used for the passage of the first wire 31. When there are two or more second magnetic sensors 22, the distal side of the second magnetic sensor 22 located on the proximal side includes not only the first magnetic sensor 21 but also other second magnetic sensors 22. Therefore, in this case, the wire via 220 is used for the passage of the first wire 31 and the third wire 33. Those skilled in the art can understand this from the above description.

[0069] In summary, the magnetically positioned transseptal puncture needle provided by this invention includes: a needle tip, a first magnetic sensor, a first lead wire, and a tube body; the needle tip is sealed at the distal end of the tube body; the first magnetic sensor is connected to the needle tip and located within the needle tip and the tube body; the first magnetic sensor is connected to the first lead wire, which extends proximally; the tube body has a side hole formed in the tube wall, and the inner cavity of the tube body and the side hole are used for fluid flow. With this configuration, on the one hand, the first magnetic sensor connected to the needle tip can accurately feedback the position of the needle tip during magnetic positioning; on the other hand, the inner cavity of the tube body and the side hole are used for fluid flow, thus enabling the magnetically positioned transseptal puncture needle to still have the function of aspirating and infusing fluid. This allows the position of the needle tip of the magnetically positioned transseptal puncture needle to be confirmed by injecting contrast fluid and using X-rays after magnetic positioning, effectively improving the accuracy and reliability of positioning.

[0070] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present utility model and is not intended to limit the scope of the present utility model in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present utility model.

Claims

1. A magnetically positioned interventricular septum puncture needle, characterized in that, include: Needle, first magnetic sensor, first wire and tube; The needle plug is located at the distal end of the tube; the first magnetic sensor is connected to the needle and is located inside the needle and the tube; the first magnetic sensor is connected to the first wire, which extends proximally. The tube has a side hole formed in the tube wall, and the inner cavity of the tube and the side hole are used for liquid flow.

2. The magnetically positioned interventricular septum puncture needle according to claim 1, characterized in that, The needle has a receiving cavity, the distal portion of the first magnetic sensor is received and fixed in the receiving cavity, and the proximal portion of the first magnetic sensor extends out of the receiving cavity; the side hole corresponds to the proximal portion of the first magnetic sensor along the axial direction of the tube body, and there are gaps for fluid flow between the tube wall and the first wire and between the tube wall and the first magnetic sensor, and the gaps communicate with the side hole.

3. The magnetically positioned interventricular septum puncture needle according to claim 1, characterized in that, The needle is electrically connected to the tube body, and the needle is configured to transmit electrical signals through the tube body; the tube body includes a thin segment at a distal end and a thick segment at a proximal end, and the thin segment is connected to the thick segment.

4. The magnetically positioned interventricular septum puncture needle according to claim 1, characterized in that, The first magnetic sensor and the first wire have an insulating layer; and / or; the needle has a receiving cavity, and the inner wall of the tube and the inner wall of the receiving cavity have an insulating layer.

5. The magnetically positioned interventricular septum puncture needle according to claim 1, characterized in that, The needle includes a head and a circumferentially concave stepped portion. The distal end of the tube is fitted onto the stepped portion and is connected to it in a shape that matches the stepped portion. The outer circumferential contour of the tube is flush with the outer circumferential contour of the head.

6. The magnetically positioned interventricular septum puncture needle according to claim 1, characterized in that, The magnetically positioned interventricular septal puncture needle also includes a handle and a handle connection portion. The proximal end of the tube body is inserted into and connected to the handle connection portion. The handle is circumferentially arranged outside the handle connection portion.

7. The magnetically positioned interventricular septum puncture needle according to claim 6, characterized in that, The handle connection has a first rotation limiting structure, and the tube has a second rotation limiting structure. The first rotation limiting structure and the second rotation limiting structure are matched and connected to restrict the tube from rotating about its own axis relative to the handle connection; and / or, the handle has a third rotation limiting structure, and the handle connection has a fourth rotation limiting structure. The third rotation limiting structure and the fourth rotation limiting structure are matched and connected to restrict the handle connection from rotating about its own axis relative to the handle.

8. The magnetically positioned interventricular septum puncture needle according to claim 6, characterized in that, The handle connection portion has a wire lead-out hole, and the magnetic positioning interventricular septal puncture needle also includes a second wire, one end of which is electrically connected to the tube body; the other end of the second wire and the proximal end of the first wire pass through the wire lead-out hole and exit the handle connection portion.

9. The magnetically positioned interventricular septum puncture needle according to claim 6, characterized in that, The magnetically positioned interventricular septal puncture needle also includes a sealing part, which is sleeved outside the tube body and the handle connection part to seal the tube body and the handle connection part; the sealing part is also sealed to the handle to prevent liquid from flowing into the handle along the tube body.

10. The magnetically positioned interventricular septum puncture needle according to claim 1, characterized in that, The magnetic positioning transseptal puncture needle also includes a second magnetic sensor and a third wire; The second magnetic sensor is disposed on the inner wall of the tube and is spaced apart from the first magnetic sensor in the axial direction of the tube; the second magnetic sensor is connected to the third wire, which passes through the inner cavity of the tube and extends to the proximal end; The second magnetic sensor is ring-shaped and has a wire through-hole extending along the axial direction of the tube; there is a gap between the wire through-hole and the wire passing through it for fluid flow.

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