A multi-purpose electrode for positioning guidance and puncture

Abstract

The application provides a multipurpose electrode for positioning, guiding and puncturing, comprising a mapping electrode head, a bending sheath, a magnetic positioning sensor, a mapping tube electrode, a mapping tube, a handle and a guide wire; wherein the mapping tube is a multi-cavity tube, comprising a signal line cavity, a magnetic sensor cable cavity and a bending sheath cavity for the bending sheath; the guide wire is arranged in the bending sheath, the mapping electrode head is arranged at one end of the mapping tube, the handle is connected to the other end of the mapping tube, two mapping tube electrodes are arranged on the mapping tube, and the magnetic positioning sensor is arranged between the two mapping tube electrodes; the application integrates many functions such as electromagnetic positioning, endocardial potential mapping, electrical excitation sequence mapping, excitation time slot mapping, accurate positioning of the catheter head end region, point radio frequency ablation and guide wire delivery. One catheter can be used in many different surgical procedures and scenes.

Description

Technical Field

[0001] This invention relates to the field of myocardial ablation technology, and in particular to a multipurpose electrode for positioning guidance and puncture. Background Technology

[0002] Atrial septal puncture is one of the most commonly used techniques in interventional cardiology. In recent years, with the development of three-dimensional electroanatomy, clinical understanding of atrial septal puncture has improved. Anatomically, the discovery of the fossa ovalis potential demonstrates how electrical methods can reconstruct anatomy, helping to transform "atrial septal identification and puncture" into "fossa ovalis identification and puncture." Instrumentally, newly developed radiofrequency needles and guidewires facilitate the puncture process. Methodologically, compared to X-ray methods, three-dimensional electroanatomical mapping provides a three-dimensional perspective, allowing for precise localization of the fossa ovalis through potential mapping, thus improving the success rate; the latter does not require an electroanatomical mapping system or pre-mapping, making the operation simpler. Compared to ultrasound methods, three-dimensional electroanatomical mapping can map the central location of the fossa ovalis with precision and real-time tracking of the needle tip; the latter provides clear anatomical layers but only displays a two-dimensional interface, and is more expensive due to the need for additional ultrasound equipment. While X-ray-guided atrial septal puncture is safe and effective in most cases, and ultrasound-assisted localization can improve safety, the recently developed three-dimensional electroanatomical mapping technique is a more suitable radiation-free method for atrial septal puncture.

[0003] Currently, the transseptal puncture sheaths used in clinical practice are made of PEEK and PEBAX materials. The operator still needs to use mechanical force to perform transseptal puncture. This method relies on the operator's feel, and during the puncture process, because the sheath cannot be accurately positioned and supported, slippage or improper force can still lead to puncture errors. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention discloses a multi-purpose electrode for positioning guidance and puncture. The technical solution of this invention is implemented as follows:

[0005] A multipurpose electrode for positioning guidance and puncture includes a mapping electrode head, a bending sheath, a magnetic positioning sensor, a mapping tube electrode, a mapping tube, a handle, and a guidewire;

[0006] The measuring tube is a multi-cavity tube, including a signal line cavity, a magnetic sensor cable cavity, and a bending sheath cavity for the bending sheath to pass through;

[0007] The guide wire is disposed inside the bending sheath, the calibration electrode head is disposed at one end of the calibration tube, the handle is connected to the other end of the calibration tube, two calibration tube electrodes are disposed on the calibration tube, and the magnetic positioning sensor is disposed between the two calibration tube electrodes.

[0008] The bending sheath includes a sheath head end, and an ablation electrode ring is provided at the sheath head end.

[0009] Preferably, the calibration electrode head includes a calibration electrode, an electrode arm, and a guide cap; one end of the electrode arm is connected to the calibration tube, and the other end is connected to the guide cap, and the calibration electrode is disposed on the electrode arm.

[0010] Preferably, the number of electrode arms is 4-6.

[0011] Preferably, the number of the calibration electrodes on each electrode arm is 4-8, and the spacing between the calibration electrodes on each electrode arm is 1.5mm-2.5mm.

[0012] Preferably, the electrode arm is made of platinum-iridium alloy, with an outer diameter of 1.4mm-1.7mm and a length of 0.5mm-2mm.

[0013] Preferably, the guide cap is a hollow annular structure with a developing ring on the outside and a magnet inside.

[0014] Preferably, it further includes two intermediate tubes; wherein, one intermediate tube is connected to the end of the bending sheath and the guide cap, and the other intermediate tube is disposed at the other end of the bending sheath; the intermediate tubes are provided with 3mm-4mm elongated holes on both sides.

[0015] Preferably, the handle includes a calibration tube bending knob, a sheath bending knob, an ablation locking mechanism, a connector, and an infusion interface;

[0016] The injection port is connected to the bending sheath cavity of the calibration tube; the connector is located at one end of the handle and connected to the bending sheath.

[0017] This invention integrates multiple functions, including electromagnetic positioning, endocardial potential mapping, electrostimulation sequence mapping, activation time slot mapping, precise catheter tip region positioning, point-like radiofrequency ablation, and guidewire delivery. A single catheter can be used in various procedures and scenarios. In interventional cardiology, it can be used as a radiofrequency ablation device, an electrophysiological mapping device, and a guidewire delivery device for small cavities. This achieves the "all-in-one" design goal. For example, it can be used for atrial septal puncture in structural heart disease, especially procedures requiring precise puncture site measurements, such as transseptal mitral valve intervention or transseptal left ventricular assist device implantation. Alternatively, it can be used in electrophysiological procedures requiring high-density mapping of the mapping site and real-time endocardial potential mapping; or during surgery, it can be used to deliver guidewires when locating small orifices within the heart chambers, such as narrow pulmonary veins or the left atrial appendage. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only one embodiment of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Identical parts are indicated by the same reference numerals. It should be noted that the terms "front," "rear," "left," "right," "up," and "down" used in the following description refer to directions in the accompanying drawings, while the terms "bottom surface," "top surface," "inner," and "outer" refer to directions toward or away from the geometric center of a specific part, respectively.

[0020] Figure 1 A schematic diagram of a multipurpose electrode embodiment for positioning guidance and puncture;

[0021] Figure 2 A partial structural schematic diagram of an embodiment of a multipurpose electrode for positioning guidance and puncture;

[0022] Figure 3 Another partial structural schematic diagram of an embodiment of a multipurpose electrode for positioning guidance and puncture;

[0023] Figure 4 This is a schematic cross-sectional view of an embodiment of a bendable sheath.

[0024] Figure 5 A schematic diagram of the unfolded configuration of a multipurpose electrode embodiment for positioning guidance and puncture in the heart;

[0025] Figure 6 A schematic diagram of another embodiment of a multipurpose electrode for positioning guidance and puncture (handle not shown).

[0026] In the above figures, the figure numbers indicate the following:

[0027] 1. Calibration electrode head;

[0028] 1-1, Calibration electrode; 1-2, Electrode arm; 1-3, Guide cap;

[0029] 2. Adjust the bending of the sheath;

[0030] 2-1, Ablation of electrode rings;

[0031] 3. Magnetic positioning sensor;

[0032] 4. Test tube electrodes;

[0033] 5. Test tube;

[0034] 5-1, Signal line cavity; 5-2, Magnetic sensor cable cavity; 5-3, Bend adjustment sheath cavity;

[0035] 6. Handle;

[0036] 6-1, Marking tube bending adjustment knob; 6-2, Bending adjustment sheath knob; 6-3, Ablation locking mechanism; 6-4, Connector; 6-5, Infusion interface;

[0037] 7. Intermediate pipe;

[0038] 8. Guide wire. Detailed Implementation

[0039] The technical solutions of the present invention will now be clearly and completely described with reference to the embodiments and accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0040] In a specific embodiment 1, such as Figures 1-5 As shown, a multipurpose electrode for positioning guidance and puncture includes a mapping electrode head 1, a bending sheath 2, a magnetic positioning sensor 3, a mapping tube electrode 4, a mapping tube 5, a handle 6, and a guide wire 8.

[0041] Among them, the test tube 5 is a multi-cavity tube, including a signal line cavity 5-1, a magnetic sensor cable cavity 5-2, and a bending sheath cavity 5-3 for the bending sheath tube 2 to pass through.

[0042] The guide wire 8 is set inside the bending sheath 2, the calibration electrode head 1 is set at one end of the calibration tube 5, the handle 6 is connected to the other end of the calibration tube 5, two calibration tube electrodes 4 are set on the calibration tube 5, and the magnetic positioning sensor 3 is set between the two calibration tube electrodes 4; the head end of the bending sheath 2 is provided with an ablation electrode ring 2-1.

[0043] The calibration electrode head 1 includes a calibration electrode 1-1, an electrode arm 1-2, and a guide cap 1-3; one end of the electrode arm 1-2 is connected to the calibration tube, and the other end is connected to the guide cap 1-3, and the calibration electrode 1-1 is disposed on the electrode arm 1-2.

[0044] The number of electrode arms 1-2 is 4. The number of calibration electrodes 1-1 on each electrode arm 1-2 is 4-8, and they are evenly arranged from the head end of the electrode arm 1-2 downwards. The spacing between the calibration electrodes 1-1 on each electrode arm 1-2 is 1.5mm-2.5mm.

[0045] Electrode arms 1-2 are made of platinum-iridium alloy, with an outer diameter of 1.4mm-1.7mm and a length of 0.5mm-2mm.

[0046] In this embodiment, the guide cap 1-3 is a hollow annular structure with a developing ring on the outside and a magnet inside.

[0047] In this embodiment, the mapping electrode head 1 is used for unipolar or bipolar endocardial potential mapping of the cardiac inner wall and cardiac tissue impedance detection. Simultaneously, it can also be connected to a three-dimensional mapping system via connector 6-4 for magnetoelectric fusion positioning. The guide cap 1-3 is made of metal (such as stainless steel) and can accommodate the ablation electrode ring 2-1 at the end of the bendable sheath 2.

[0048] In this embodiment, the length of the bending sheath 2 located at the head of the calibration electrode 1-1 is 4F to 7F (this length is a commonly used unit symbol in the art).

[0049] The inside of the bendable sheath 2 is hollow with an inner diameter of 1 mm, and is used to accommodate the guidewire 8 commonly used for guidance or puncture in interventional cardiology procedures.

[0050] The adjustable bending angle of the bending sheath 2 is ±180°. The ablation electrode ring 2-1 is made of metal, such as stainless steel, to facilitate its adsorption into the groove within the guide cap 1-3. Besides being used for unipolar or bipolar endocardial potential mapping and tissue impedance detection of the cardiac wall, it can also be connected to a three-dimensional mapping system for magnetoelectric fusion localization, and can also be connected to high-frequency electrosurgical units, radiofrequency generators, and other energy-generating devices for myocardial tissue ablation.

[0051] The bending sheath 2 can move freely within the measuring tube 5. When bending is required, the bending sheath 2 is pulled back to separate the ablation electrode ring 2-1 at its head from the guide cap 1-3 before bending.

[0052] In this embodiment, the magnetic positioning sensor 3 is used to connect to the back-end three-dimensional mapping system and, combined with the electric field positioning of the ablation electrode ring 2-1 and the mapping tube electrode 4, achieves a more accurate positioning effect.

[0053] In this embodiment, the signal line lumen 5-1 is used to accommodate the signal line (enameled wire) connected to the mapping electrode 1-1; the bending sheath lumen 5-3 also serves as an infusion lumen, which is connected to the infusion interface 6-5 for infusion operations during surgery.

[0054] The handle 6 includes a mapping tube bending knob 6-1, a sheath bending knob 6-2, an ablation locking mechanism 6-3, a connector 6-4, and an infusion interface 6-5. The mapping tube bending knob 6-1 controls the bidirectional bending of the mapping tube 5, the sheath bending knob 6-2 controls the bidirectional bending of the sheath 2 at the mapping electrode head 1, and the ablation locking mechanism 6-3 positions the bend after the sheath 2 has been bent to a certain angle. The connector 6-4 connects to the rear-end three-dimensional mapping and high-frequency electrosurgical unit or radiofrequency generator for magnetoelectric positioning and ablation. The infusion interface 6-5 is used for infusion of contrast agent or heparin during surgery.

[0055] The injection port 6-5 is connected to the bending sheath cavity 5-3 of the test tube 5; the connector 6-4 is located at one end of the handle 6 and connected to the bending sheath 2.

[0056] The unfolded state of this embodiment in the heart is as follows: Figure 5 As shown.

[0057] Example 2

[0058] In a preferred embodiment 2, such as Figure 6 As shown, a multipurpose electrode for positioning guidance and puncture includes a mapping electrode head 1, a bending sheath 2, a magnetic positioning sensor 3, a mapping tube electrode 4, a mapping tube 5, a handle 6, two intermediate tubes 7, and a guide wire 8.

[0059] This embodiment relies on the structure of Embodiment 1, but differs from Embodiment 1 in that two intermediate tubes are added.

[0060] One intermediate tube 7 connects the end of the bending sheath 2 and the guide cap 1-3, and the other intermediate tube 7 is located at the other end of the bending sheath 2; the intermediate tube 7 has long holes of 3mm-4mm on both sides.

[0061] In this embodiment, the intermediate tube 7 is a fixed structure, with 3-4 mm long holes on each of its two sides (perpendicular to the arrangement direction of the electrode arms 1-2). The long holes are used to bend the head end of the sheath tube 2 and allow it to pass through the intermediate tube 7.

[0062] It should be noted that the above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A multi-purpose electrode for positioning guidance and puncture, characterized by, The mapping electrode head, the bending sheath, the magnetic positioning sensor, the mapping tube electrode, the mapping tube, the handle and the guide wire are included. The mapping tube is a multi-lumen tube, including a signal line lumen, a magnetic sensor cable lumen and a bending sheath lumen for the bending sheath to pass through. The guide wire is arranged in the bending sheath, the mapping electrode head is arranged at one end of the mapping tube, the handle is connected to the other end of the mapping tube, two mapping tube electrodes are arranged on the mapping tube, and the magnetic positioning sensor is arranged between the two mapping tube electrodes. The bending sheath includes a sheath head end, and the sheath head end is provided with an ablation electrode ring. The mapping electrode head includes a mapping electrode, an electrode arm and a guide cap, one end of the electrode arm is connected to the mapping tube, the other end of the electrode arm is connected to the guide cap, and the mapping electrode is arranged on the electrode arm. The number of electrode arms is 4-6. The number of mapping electrodes on each electrode arm is 4-8. When the mapping electrode head is unfolded, the mapping electrode head is in a cage shape.

2. The multi-purpose electrode for positioning guidance and puncture according to claim 1, wherein, The spacing between the mapping electrodes on each electrode arm is 1.5-2.5 mm.

3. The multi-purpose electrode for positioning guidance and puncture according to claim 2, wherein, The material of the electrode arm is platinum-iridium alloy, the outer diameter is 1.4-1.7 mm, and the length is 0.5-2 mm.

4. The multi-purpose electrode for positioning guidance and puncture according to claim 3, wherein, The guide cap is a hollow ring structure, provided with a developing ring outside and a magnet inside.

5. The multi-purpose electrode for positioning guidance and puncture according to claim 4, wherein, Two intermediate tubes are further included, one of which is connected to the end of the bending sheath and the guide cap, and the other is arranged at the other end of the bending sheath, and long holes with a length of 3-4 mm are formed on both sides of the intermediate tube.

6. The multi-purpose electrode for positioning guidance and puncture according to claim 5, wherein, The handle includes a mapping tube bending knob, a sheath bending knob, an ablation locking mechanism, a connector and a perfusion interface. The perfusion interface communicates with the bending sheath lumen of the mapping tube, and the connector is arranged at one end of the handle and connected to the bending sheath.

Images