An electrode guide wire usable for mapping and treatment

Abstract

The application belongs to the field of medical devices, and particularly relates to an electrode guide wire for mapping and treatment, which comprises a tube body, a patient end electrode, a guide wire, a first wire and a second wire. The patient end electrode is arranged on the side wall of the distal end of the tube body. The guide wire is arranged in the tube body, one end of the guide wire is connected with the patient end electrode, and the other end of the guide wire extends from the proximal end of the tube body. The first wire and the second wire are both spiral and arranged in the tube body. The first wire is arranged on the side of the patient end electrode facing the proximal end. One end of the second wire is connected with the first wire, and the other end of the second wire is arranged at the distal end of the tube body. The first wire is plastic. The second wire and the first wire are made of the same material or different materials. The electrode guide wire provided by the application can collect the distal end electrical signals of the coronary sinus and the coronary vein, has high adaptability, and can increase the collection position when used with a mapping electrode catheter.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to an electrode guidewire that can be used for mapping and treatment. Background Technology

[0002] In recent years, with the widespread clinical application of radiofrequency ablation and cardiac resynchronization therapy, the coronary sinus system (CVS) has received considerable attention. However, the CVS exhibits significant anatomical variations, complex adjacent structures, and a tortuous course with numerous branches. Based on its opening location, vessel diameter, and the location of ventricular blood return, it can be divided into: coronary sinus (CS), great cardiac vein (GCV), central cardiac vein (MCV), small cardiac vein (SIV), anterior interventricular vein (AIV), posterior left ventricular vein, and lateral left ventricular vein. The coronary veins originate from the coronary sinus, which is the opening for catheter entry. The great cardiac vein, which connects to the coronary sinus, is the longest and largest in diameter, and is the routine site for placing coronary sinus electrodes and for mapping ablation catheters. Its distal end connects to the anterior interventricular vein. The anterior interventricular vein runs within the anterior interventricular groove. Due to its steep angle with the great cardiac vein, mapping and ablation catheters often struggle to reach it, posing challenges for mapping and ablation of premature ventricular contractions (PVCs). Recent studies have shown that the proportion of idiopathic ventricular arrhythmias (IVA) originating from the epicardium of the coronary veins is 9% to 15%, with varying ablation success rates of approximately 50% to 70%. The main reason for this is that there are currently no effective means to map and ablate the veins distal to the coronary sinus.

[0003] Electrophysiological mapping of the coronary sinus and coronary veins plays a crucial role. Many electrophysiological examinations require the placement of coronary sinus electrodes, such as those for ablation of left epicardial accessory pathways, epicardial premature ventricular contractions, and complex atrial fibrillation, which require intracoronary artery ablation. Left ventricular electrodes for cardiac resynchronization therapy (CRT) are also placed within the coronary vein. Improving the stability of coronary sinus electrode placement and effectively collecting electrical signals from distal coronary veins, reaching deeper into the coronary sinus veins that conventional mapping catheters cannot penetrate, has always been an important research topic in this field. Summary of the Invention

[0004] The present invention provides an electrode guidewire that can be used for mapping and treatment, which can effectively solve the problems in the prior art.

[0005] The present invention provides an electrode guidewire that can be used for mapping and treatment, comprising a tube body, a patient-end electrode, a lead wire, a first winding wire, and a second winding wire;

[0006] The patient electrode is located on the side wall at the distal end of the tube; the lead wire is located inside the tube, with one end of the lead wire connected to the patient electrode and the other end of the lead wire extending from the proximal end of the tube.

[0007] Both the first and second windings are spiral-shaped and located inside the tube. The first winding is located on the side of the patient-end electrode facing the proximal end. One end of the second winding is connected to the first winding, and the other end of the second winding is located at the distal end of the tube. The first winding is malleable. The second winding and the first winding are made of the same material or different materials.

[0008] As a further optimization of the present invention, the electrode guidewire is a bipolar guidewire, wherein the patient end electrode includes a patient end first electrode and a patient end second electrode, and the wire includes a first wire and a second wire.

[0009] The first electrode and the second electrode at the patient end are spaced apart on the side wall at the distal end of the tube; the first wire and the second wire are both located inside the tube, with one end of the first wire and the second wire respectively connected to the first electrode and the second electrode at the patient end, and the other end of the first wire and the second wire extending from the proximal end of the tube; the first winding wire is located between the first electrode and the second electrode at the patient end.

[0010] As a further optimization of the present invention, the first winding wire is made of stainless steel; the second winding wire is made of tungsten wire.

[0011] As a further optimization of the present invention, it also includes a nickel-titanium alloy core wire; the core wire is disposed inside the tube; a first winding wire and a second winding wire are wound on the core wire.

[0012] As a further optimization of the present invention, the patient-end electrode is ring-shaped and made of stainless steel or platinum-iridium alloy.

[0013] As a further optimization of the present invention, a TPU material wrapping layer is provided at the distal end of the tube from the first electrode at the patient end to the end.

[0014] As a further optimization of the present invention, a socket end electrode is also provided on the side wall near the proximal end of the tube; the other end of the wire is connected to the socket end electrode.

[0015] As a further optimization of the present invention, it also includes a mapping electrode conduit; the mapping electrode conduit includes a body, an electrode ring, and an electrode wire;

[0016] The body includes a hollow inner layer and an outer layer sleeved outside the inner layer; an electrode ring is sleeved on the outer sidewall of the far end of the body; an electrode wire is located between the inner and outer layers of the body, the electrode wire corresponds to the electrode ring, one end of the electrode wire is connected to the electrode ring, and the other end of the electrode wire extends from the proximal end of the body.

[0017] The tube extends into the main body and the patient's electrode protrudes from the distal end of the main body.

[0018] As a further optimization of the present invention, a wire guide plug is also included, which includes a housing, a compression spring, a pressure block, a hose, and a conductor.

[0019] The housing has a cavity and a pressing part; a compression spring is located in the cavity; a pressure block is pressed on the compression spring and also corresponds to the pressing part; a flexible tube passes through the pressure block; conductors pass through the flexible tube from the side of the pressure block; a conductive wire extends from one end of the housing into the cavity and connects to the conductor; the proximal end of the electrode wire is inserted into the flexible tube from the other end of the housing, and the socket end electrode contacts the conductor located in the flexible tube.

[0020] The hose bends from a straight state under the action of the compression spring; pressing the pressure block will restore the hose to a straight state.

[0021] An electrode guidewire for mapping and treatment according to claim 1, characterized in that the diameter of the bipolar guidewire is 0.014-0.035 inches.

[0022] The present invention provides an electrode guidewire that can be used for mapping and treatment, which can collect electrical signals from the coronary sinus and distal coronary veins. It is highly adaptable and can be used in conjunction with mapping electrode catheters to increase the number of acquisition sites.

[0023] Instruction manual illustrations

[0024] Figure 1 This is a schematic diagram of the structure of Embodiment 1;

[0025] Figure 2 This is a schematic diagram of the wire plug structure in Embodiment 1;

[0026] The components include: tube body 1, patient end first electrode 2, patient end second electrode 3, first lead wire 4, second lead wire 5, first winding wire 6, second winding wire 7, socket end first electrode 8, socket end second electrode 9, core wire 10, pressure block 11, flexible tube 12, and conductor 13. Detailed Implementation

[0027] Example 1

[0028] like Figure 1 As shown, the present invention provides an electrode guidewire that can be used for mapping and treatment. The electrode guidewire is a bipolar guidewire, including a tube body 1, a first electrode 2 at the patient end, a second electrode 3 at the patient end, a first lead wire 4, a second lead wire 5, a first winding wire 6, and a second winding wire 7.

[0029] The tube body 1 is hollow. To enhance the rigidity of the tube body 1, a core wire 10 is provided inside the tube body 1. The core wire 10 is made of nickel-titanium alloy material with good plastic deformation recovery properties. The diameter of the tube body is 0.014, 0.018 or 0.035 inches.

[0030] The first electrode 2 and the second electrode 3 at the patient end are disposed alternately on the side wall of the distal end of the tube body 1. The first electrode 2 and the second electrode 3 at the patient end are arranged in a thin-walled annular structure on the distal end of the tube body 1. In this embodiment, the first electrode 2 and the second electrode 3 at the patient end are made of 304 stainless steel; in other embodiments, they may also be made of platinum-iridium alloy.

[0031] The first lead wire 4 and the second lead wire 5 are both located inside the tube body 1. One end of the first lead wire 4 and the second lead wire 5 are respectively connected to the first electrode 2 and the second electrode 3 at the patient end, and the other end of the first lead wire 4 and the second lead wire 5 extend from the proximal end of the tube body 1.

[0032] This embodiment also includes a socket-end first electrode 8 and a socket-end second electrode 9 at the proximal end of the catheter, corresponding to the patient-end first electrode 2 and the patient-end second electrode 3. The socket-end first electrode 8 and the socket-end second electrode 9 also employ a thin-walled annular structure and are fitted onto the proximal end of the catheter body 1. The other ends of the first lead 4 and the second lead 5 are connected to the socket-end first electrode 8 and the socket-end second electrode 9, respectively. An external socket is then connected via the socket-end first electrode 8 and the socket-end second electrode 9.

[0033] In the above structure, the ends of the first wire 4 and the second wire 5 are respectively connected to the inner walls of the first electrode 2 at the patient end, the second electrode 3 at the patient end, the first electrode 8 at the socket end, and the second electrode 9 at the socket end. All the connectors can be hidden. When an external device is needed, the lead wire can be directly pulled out from the proximal end of the tube body 1, that is, the first electrode 8 at the socket end and the second electrode 9 at the socket end of the tube body 1, and connected to the device, or the lead wires on the device can be connected to the first electrode 8 at the socket end and the second electrode 9 at the socket end.

[0034] The electrocardiogram (ECG) signals acquired by the patient-side first electrode 2 and patient-side second electrode 3 are transmitted through the socket-side first electrode 8 and socket-side second electrode 9. In this embodiment, the first lead 4 and second lead 5 are made of copper wire; in other embodiments, the first lead 4 and second lead 5 may also be made of other materials.

[0035] The first winding wire 6 and the second winding wire 7 are both located inside the tube body 1 and spirally wound around the core wire 10. The first winding wire 6 is located between the first electrode 2 and the second electrode 3 at the patient end. One end of the second winding wire 7 is connected to the end of the first winding wire 6, and the other end of the second winding wire 7 is wound to the distal end of the tube body 1. In this embodiment, the area formed by the first winding wire 6 is a malleable area. The first winding wire 6 is made of 304 stainless steel, and the initial state of the malleable area is a straight line. During use, the operator can bend this area into the desired shape as needed. The second winding wire 7 is made of tungsten wire, and the spiral radius of the second winding wire 7 gradually decreases from the end connected to the first winding wire 6 to the end towards the distal end of the tube body 1. That is, the second winding wire 7 forms a gradually thinner shape from the direction towards the proximal end of the tube body 1 to the direction towards the distal end of the tube body 1.

[0036] Because the heart structures of different patient groups are different, the location of the coronary sinus ostium is not fixed. Their shapes and positions are different. In order to make the bipolar guidewire used in this embodiment more accessible during the operation, the bending shape can be adjusted according to the characteristics of the heart structure of different groups, so that the bipolar guidewire can enter the coronary sinus ostium better, reducing the difficulty of operation for doctors during the operation.

[0037] In another embodiment, the second winding wire 7 and the first winding wire 6 are made of the same material, that is, the second winding wire 7 and the first winding wire 6 are made of a single winding wire, or the first winding wire 6 is also used as the second winding wire 7. This embodiment can avoid the connection problem between winding wires of different materials.

[0038] In this embodiment, a TPU material wrapping layer is also provided at the distal end of the tube 1 from the first electrode 2 at the patient end to the tip. This material not only has a soft touch, but also effectively prevents moisture penetration.

[0039] Furthermore, this embodiment also includes a mapping electrode conduit. The mapping electrode conduit includes a body, an electrode ring, and an electrode wire.

[0040] The main body is hollow, consisting of a hollow inner layer and an outer layer that is fitted over the inner layer.

[0041] A number of electrode rings are spaced apart on the outer sidewall of the far end of the main body. The electrode rings are all made of platinum-iridium alloy. In other embodiments, only one electrode ring may be used. The electrode rings may also be made of other materials such as 304 stainless steel.

[0042] The electrode wires are located between the inner and outer layers of the body. In this embodiment, the number of electrode wires is relative to the number of electrode rings. One end of each electrode wire is connected to an electrode ring, and the other end of the electrode wire extends from the proximal end of the conduit and is connected to an electrode plug.

[0043] This embodiment uses a hollow structure body, which facilitates the insertion of the bipolar guidewire. Because an inner layer is provided to isolate the bipolar guidewire, the medical tool will not affect the wire during insertion or removal.

[0044] This embodiment is used for cardiac mapping, particularly for measuring electrophysiological signals from perfusion veins and distal coronary veins. The bipolar guidewire can penetrate deep into the distal coronary sinus to measure the potentials of the left atrium or right ventricle. Therefore, the combined use of the mapping electrode catheter and bipolar guidewire can expand the measurement potentials and acquire more comprehensive data. Differential bends in the curved sections of the mapping electrode catheter and bipolar guidewire can also be used to acquire more points. Simultaneously, it can be used for electrical discharge.

[0045] like Figure 2 As shown, this embodiment also provides a wire guide plug, which includes a housing, a compression spring, a pressure block 11, a hose 12, and a conductor 13.

[0046] The housing has a cavity and a pressing part. A compression spring is located inside the cavity, with one end fixed to the bottom of the cavity and the other end facing the pressing part. A pressure block 11 is pressed onto the other end of the compression spring, with its top end located at the pressing part. Pressing the pressing part causes the pressure block 11 to press the compression spring.

[0047] The flexible tube 12 passes through the pressure block 11. There are two conductors 13, which pass through the flexible tube 12 from both sides of the pressure block 11. Both conductors 13 are connected to conductive wires, and the conductive wires extend from one end of the housing and connect to the equipment. The proximal end of the bipolar guide wire is inserted into the flexible tube 12 from the other end of the housing, and the first electrode 8 and the second electrode 9 at the socket end are in contact with the two conductors 13 located inside the flexible tube 12, respectively.

[0048] Under the action of the compression spring, the hose 12 bends from a straight state; pressing the pressure block 11, the hose 12 can return to a straight state.

[0049] In use, after the bipolar guidewire is inserted into the flexible tube 12, the flexible tube 12 bends upward into a bridge shape under the action of the compression spring, making it impossible to pull out the bipolar guidewire. If you want to pull out the bipolar guidewire, simply press the pressing part to make the pressure block 112 sink against the spring force, allowing the flexible tube 12 to return to a straight state, and then the bipolar guidewire can be easily pulled out.

[0050] Example 2

[0051] This embodiment is basically the same as embodiment 1, except that the electrode guidewire in this embodiment is a single electrode guidewire. Therefore, compared with embodiment 1, there is no second electrode 3 and second lead wire 5 at the patient end.

[0052] The first electrode 2 at the patient end of the single-electrode guidewire is located on the side wall at the distal end of the tube body 1; the first wire 4 is located inside the tube body 1, with one end of the first wire 4 connected to the first electrode 2 at the patient end and the other end of the first wire 4 extending from the proximal end of the tube body 1; the first winding wire 6 is located on the side of the first electrode 2 at the patient end facing the proximal end.

[0053] When used in conjunction with a mapping electrode catheter, only the first electrode 2 at the patient end of the monopolar guidewire protrudes from the distal end of the main body.

[0054] In addition, in this embodiment, only the socket end first electrode 8 is provided on the side wall near the tube body 1, and the other end of the first wire 4 is connected to the socket end first electrode 8.

[0055] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. An electrode guidewire that can be used for mapping and treatment, characterized in that, Includes the tube body, patient-end electrode, lead wire, first winding wire, and second winding wire; The patient electrode is located on the side wall at the distal end of the tube; the lead wire is located inside the tube, with one end of the lead wire connected to the patient electrode and the other end of the lead wire extending from the proximal end of the tube. Both the first and second windings are spiral-shaped and located inside the tube. The first winding is located on the side of the patient-end electrode facing the proximal end. One end of the second winding is connected to the first winding, and the other end of the second winding is located at the distal end of the tube. The first winding is flexible and can be shaped. The first winding is made of stainless steel. The second winding is made of tungsten wire, and the spiral radius of the second winding decreases from the end connected to the first winding to the end facing the distal end of the tube. It also includes a nickel-titanium alloy core wire; the core wire is located inside the tube; the first winding wire and the second winding wire are wound on the core wire; A socket electrode is also provided on the side wall near the proximal end of the tube; the other end of the wire is connected to the socket electrode. It also includes a wire connector, which comprises a housing, a compression spring, a pressure block, a hose, and a conductor; The housing has a cavity and a pressing part; a compression spring is located in the cavity; a pressure block is pressed on the compression spring and also corresponds to the pressing part; a flexible tube passes through the pressure block; conductors pass through the flexible tube from the side of the pressure block; a conductive wire extends from one end of the housing into the cavity and connects to the conductor; the proximal end of the electrode wire is inserted into the flexible tube from the other end of the housing, and the socket end electrode contacts the conductor located in the flexible tube. The hose bends from a straight state under the action of the compression spring; pressing the pressure block will restore the hose to a straight state.

2. The electrode guidewire for mapping and treatment according to claim 1, characterized in that, The electrode guidewire is a bipolar guidewire, wherein the patient end electrode includes a first patient end electrode and a second patient end electrode, and the lead wire includes a first lead wire and a second lead wire; The first electrode and the second electrode at the patient end are spaced apart on the side wall at the distal end of the tube; the first wire and the second wire are both located inside the tube, with one end of the first wire and the second wire respectively connected to the first electrode and the second electrode at the patient end, and the other end of the first wire and the second wire extending from the proximal end of the tube; the first winding wire is located between the first electrode and the second electrode at the patient end.

3. The electrode guidewire for mapping and treatment according to claim 1, characterized in that, The first winding is made of stainless steel; the second winding is made of tungsten wire.

4. The electrode guidewire for mapping and treatment according to claim 1, characterized in that, The patient-end electrode is ring-shaped and made of stainless steel or platinum-iridium alloy.

5. An electrode guidewire for mapping and treatment according to claim 1, characterized in that, The distal end of the tube, from the first electrode at the patient end to the tip, is covered with a TPU material wrapping layer.

6. The electrode guidewire for mapping and treatment according to claim 1, characterized in that, It also includes a mapping electrode conduit; the mapping electrode conduit includes a body, an electrode ring, and electrode leads; The body includes a hollow inner layer and an outer layer sleeved outside the inner layer; an electrode ring is sleeved on the outer sidewall of the far end of the body; an electrode wire is located between the inner and outer layers of the body, the electrode wire corresponds to the electrode ring, one end of the electrode wire is connected to the electrode ring, and the other end of the electrode wire extends from the proximal end of the body. The tube extends into the main body and the patient's electrode protrudes from the distal end of the main body.

7. An electrode guidewire for mapping and treatment according to claim 1, characterized in that, The diameter of the bipolar guidewire is 0.014-0.035 inches.

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