Novel heart temporary pacemaker electrode and use method thereof

By designing a new cardiac temporary pacemaker electrode that includes a flexible tube sleeve, working lumen and fixing components, the problem of complications that traditional electrodes are prone to slip and placement positions is easily generated, and the stability of the electrodes and the safety of the installation process is improved.

CN119607407APending Publication Date: 2025-03-14THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIV
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Patent Information

Application Number
CN202411836769.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-13
Publication Date
2025-03-14

AI Technical Summary

Technical Problem

The existing temporary pacemaker fixing devices usually do not have a fixing device. The electrodes that are fixed in traditional ways are easy to slip off, and the placement position of the existing temporary pacemaker fixing devices is likely to cause different complications during the installation of the temporary pacemaker.

Method used

A new cardiac temporary pacemaker electrode is provided, including a flexible tube sleeve and a working tube lumen, with a fixing assembly provided inside. The fixing assembly includes a sliding clamped connection base, an orientation block, a spiral electrode and a puncture tip, through which the electrodes can be securely fixed to the inner wall of the patient's myocardium.

Benefits of technology

Through the design of the fixation assembly, the electrodes can be securely fixed to the inner wall of the patient's myocardium, avoiding the risk of slippage, and reducing complications during installation through improved insertion paths and use of the isolation sleeve.

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Abstract

The invention discloses a novel heart temporary pacemaker electrode and a using method thereof.The novel heart temporary pacemaker electrode comprises a flexible pipe sleeve and a working pipe cavity, one end of the flexible pipe sleeve is connected with one end of the working pipe cavity, a fixing assembly is arranged in the working pipe cavity and comprises a connecting base clamped in the working pipe cavity in a sliding mode, and one end of the connecting base is connected with a directional block; a spiral electrode is arranged on the side, close to the free end of the working tube cavity, of the connecting base and wound around the outer side of the directional block, the 1.8 mm screw pitch of the spiral electrode from the free end of the working tube cavity to the inside is constant, the screw pitch of the remaining part is gradually reduced till the remaining part makes contact with the connecting base, and a puncture tip is arranged at the end, close to the free end of the working tube cavity, of the spiral electrode. The device can be fixed to the myocardial inner wall of a patient through the fixing assembly, the problem that the electrode slips when the patient is subjected to cardio-pulmonary resuscitation or is moved is completely solved, meanwhile, the temporary pacemaker installation path is changed from the precious vein or the head vein of the left hand or the right hand, and operative complications easily caused by a traditional implantation path are avoided.
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Description

Technical Field

[0001] The present invention relates to the field of cardiac pacing technology, and more specifically, to a novel temporary cardiac pacemaker electrode and a method for using the same. Background Art

[0002] Temporary cardiac pacing is an emergency and effective measure for treating severe arrhythmias, and is also an emergency means of cardiopulmonary resuscitation. It also plays an important role in safety protection for patients undergoing surgical operations. A temporary pacemaker is a temporary battery-powered cardiac pacing device, usually composed of a temporary pacemaker generator and temporary pacing electrodes.

[0003] Existing temporary cardiac pacemaker fixing devices usually do not have a fixing device and are fixed by the pacemaker electrode's own tension. The electrode fixed in this way is easy to slip off. When the patient is undergoing cardiopulmonary resuscitation or when a surgical patient is moved, if the electrode slips off, there is a great risk. In addition, the insertion position of the existing temporary cardiac pacemaker fixing device is usually any one of the three veins: femoral vein, subclavian vein and jugular vein. The above three insertion positions are prone to different complications during the installation process of the temporary pacemaker. Summary of the invention

[0004] The present invention provides a novel temporary cardiac pacemaker electrode and a method of using the same, in order to solve the problems that the temporary cardiac pacemaker fixing device in the prior art usually has no fixing device, the electrode fixed in the traditional way is easy to slip off, and the insertion position of the existing temporary cardiac pacemaker fixing device is easy to cause various complications during the temporary pacemaker installation process.

[0005] In order to achieve the above object, the present invention provides the following technical solutions:

[0006] A novel temporary cardiac pacemaker electrode and a method of using the same, comprising a flexible tube sleeve and a working tube cavity, wherein one end of the flexible tube sleeve is connected to one end of the working tube cavity, a fixing assembly is arranged in the working tube cavity, the fixing assembly comprises a connecting seat slidably clamped in the working tube cavity, one end of the connecting seat is connected to an directional block, a spiral electrode is arranged on the side of the connecting seat close to the free end of the working tube cavity, the spiral electrode is wound around the outside of the directional block, the spiral electrode has a constant pitch of 1.8 mm from one end of the free end of the working tube cavity to the inside, and the pitch of the remaining part gradually decreases until it contacts the connecting seat, and a puncture tip is arranged on one end of the spiral electrode close to the free end of the working tube cavity.

[0007] Preferably, a threaded sleeve is connected to the inner side of the connecting seat, a threaded ring is arranged in the working tube cavity, the inner side of the threaded ring is threadedly connected to the threaded sleeve, and one side of the threaded ring is in contact with one side of the connecting seat.

[0008] Preferably, when one side of the threaded ring contacts one side of the connecting seat, the distance between the outer end of the spiral electrode and the free end of the working lumen is 0.2 mm, and the threaded sleeve is connected to a limiting plate at one end away from the connecting seat. When one side of the limiting plate contacts one side of the threaded ring, the distance between the outer end of the spiral electrode and the free end of the working lumen is 1.8 mm.

[0009] Preferably, a rotating sleeve is clamped on the inner wall of the flexible tube sleeve, one end of the rotating sleeve is coaxially connected to the limiting plate, and a power supply component is arranged in the rotating sleeve.

[0010] Preferably, the power supply assembly includes a main pipe clamped in the rotating sleeve, a spirally arranged anode ring is arranged on the inner wall of the main pipe, a branch pipe is clamped on the inner side of the anode ring, a cathode ring is arranged in the branch pipe, and the anode ring and the cathode ring are both connected to an electrode connector at one end away from the working tube cavity.

[0011] Preferably, the threaded sleeve and the limiting plate are both hollow, and the anode ring and the cathode ring are both connected to the spiral electrode via the connecting seat.

[0012] Preferably, an isolation sleeve is provided inside the cathode ring, the inner diameter of the isolation sleeve is slightly larger than the outer diameter of the guide wire, the length of the isolation sleeve is greater than 40 mm, and the isolation sleeve is closed at one end away from the working lumen.

[0013] Preferably, a control assembly is provided at one end of the rotating sleeve near the electrode connector, and the control assembly comprises a connecting plate connected to one end of the rotating sleeve, a rotating frame is rotatably connected to the connecting plate, and an operating handle is hinged at one end of the rotating frame.

[0014] Preferably, a clamp is provided at one end of the flexible tube sleeve, a positioning shaft is provided on the operating handle, and the positioning shaft is clamped inside the clamp.

[0015] Preferably, the flexible tube sleeve and the working tube cavity are both made of transparent materials, and the flexible tube sleeve is provided with distance rings at regular intervals, and the distance rings are colored black.

[0016] A method for using a novel temporary cardiac pacemaker electrode comprises the following steps:

[0017] S1: Choose the left or right basilic vein of the patient for puncture;

[0018] S2: The guidewire is gradually inserted under ultrasound guidance, and after the guidewire is inserted, the sheath is inserted;

[0019] S3: implant the device along the guide wire and fix the device to the inner wall of the patient's myocardium through a fixing component;

[0020] S4: Pull out the guide wire and observe the fixation status of the device through ultrasound equipment. If it is qualified, fix the device outside the patient's body and connect the electrode connectors at one end of the cathode ring and the anode ring to the pacemaker generator. If it is unqualified, completely withdraw the device and return to S2 to cycle the steps until the device is set to a qualified fixation state.

[0021] Preferably, the S3 step specifically includes:

[0022] S3.1: Insert the working lumen into the sheath tube, and slide the isolation sleeve along the guide wire until the tip of the working lumen moves to the end of the guide wire, keep the working lumen and the flexible sleeve stable, and measure the voltage value;

[0023] S3.2: Manually rotate the operating handle to disengage the positioning shaft from the clamp until the rotating frame and the connecting plate move to the same vertical line, and keep the working lumen and the flexible tube sleeve in a straight line as much as possible, and then rotate the operating handle;

[0024] S3.3: Turn the operating handle several times until a noticeable torque is felt from the rotating sleeve and the spiral electrode can be observed to penetrate the inner wall of the patient's myocardium through ultrasound equipment;

[0025] S3.4: Test the voltage value again to see if it meets the requirements.

[0026] Preferably, the observation of the fixing state of the device in S4 includes the shape of the working lumen. If the working lumen is in the shape of a smooth arc, it indicates that the tension in the device is too large and needs to be re-inserted; if the working lumen is in the shape of multiple irregular arcs connected, it indicates that the tension in the device is qualified.

[0027] The principle and beneficial effects of this technical solution:

[0028] (1) The fixing assembly provided in the present invention can fix the device to the inner wall of the patient's myocardium, completely solving the problem of electrode slippage during cardiopulmonary resuscitation or when surgical patients are moved. After the working lumen is placed in a suitable position, the operating handle is rotated, and the rotating sleeve connected to the operating handle will rotate synchronously, causing the limit plate coaxially connected to the other end of the rotating sleeve to rotate. Since the limit plate is arranged on the outside of the threaded sleeve, the threaded sleeve will also rotate synchronously during the rotation of the limit plate, causing the threaded sleeve to move along the threaded ring provided in the working lumen until one side of the limit plate contacts one side of the threaded ring. At this time, the spiral electrode connected to one end of the threaded sleeve through the connecting seat and the directional block will be completely screwed out and fixed to the inner wall of the patient's myocardium.

[0029] (2) The path for installing the temporary cardiac pacemaker is changed to the basilic vein or cephalic vein of the left or right hand. The insertion will extend the insertion path. The isolation sleeve provided in the present invention allows the device to be inserted into the patient's body along a longer path. On the one hand, it avoids the problem of improper insertion due to a short sheath, and on the other hand, it also avoids the surgical complications that are likely to be caused by the traditional insertion path. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a schematic diagram of the overall structure of the present invention;

[0031] Figure 2 for Figure 1 Schematic diagram of the enlarged structure of the A area in the middle;

[0032] Figure 3 It is a schematic diagram of the structure of some parts of the present invention after being cut away;

[0033] Figure 4 for Figure 3 Schematic diagram of the enlarged structure of the middle B area;

[0034] The figure marks in the drawings of the specification include: 1. branch pipe; 2. electrode connector; 3. main pipe; 4. flexible pipe sleeve; 5. working pipe cavity; 6. rotating frame; 7. connecting plate; 8. operating handle; 9. positioning shaft; 10. clamp; 11. rotating sleeve; 12. directional block; 13. connecting seat; 14. threaded sleeve; 15. limiting plate; 16. threaded ring; 17. spiral electrode. DETAILED DESCRIPTION

[0035] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments:

[0036] Example:

[0037] like Figures 1 to 4 As shown, the present invention provides a novel temporary cardiac pacemaker electrode and a method of using the same, comprising a flexible tube sleeve 4 and a working tube cavity 5, wherein one end of the flexible tube sleeve 4 is connected to one end of the working tube cavity 5, a fixing assembly is arranged in the working tube cavity 5, the fixing assembly comprises a connecting seat 13 which is slidably clamped in the working tube cavity 5, one end of the connecting seat 13 is connected to an directional block 12, a spiral electrode 17 is arranged on one side of the connecting seat 13 close to the free end of the working tube cavity 5, the spiral electrode 17 is wound around the outside of the directional block 12, the spiral electrode 17 has a constant pitch of 1.8 mm from one end of the free end of the working tube cavity 5 to the inside, and the pitch of the remaining part gradually decreases until it contacts the connecting seat 13, and a puncture tip is arranged on one end of the spiral electrode 17 close to the free end of the working tube cavity 5.

[0038] like Figure 4 As shown, a threaded sleeve 14 is connected to the inner side of the connecting seat 13 , a threaded ring 16 is arranged in the working lumen 5 , the inner side of the threaded ring 16 is threadedly connected to the threaded sleeve 14 , and one side of the threaded ring 16 contacts one side of the connecting seat 13 .

[0039] like Figure 1 and Figure 4As shown, when one side of the threaded ring 16 contacts one side of the connecting seat 13, the distance between the outer end of the spiral electrode 17 and the free end of the working lumen 5 is 0.2 mm, and the end of the threaded sleeve 14 away from the connecting seat 13 is connected to the limiting plate 15. When one side of the limiting plate 15 contacts one side of the threaded ring 16, the distance between the outer end of the spiral electrode 17 and the free end of the working lumen 5 is 1.8 mm.

[0040] like Figure 1 , Figure 3 and Figure 4 As shown, a rotating sleeve 11 is clamped on the inner wall of the flexible pipe sleeve 4 , one end of the rotating sleeve 11 is coaxially connected to the limiting plate 15 , and a power supply component is arranged in the rotating sleeve 11 .

[0041] like Figure 1 and Figure 3 As shown, the power supply assembly includes a main pipe 3 clamped in a rotating sleeve 11, a spirally arranged anode ring is arranged on the inner wall of the main pipe 3, a branch pipe 1 is clamped on the inner side of the anode ring, a cathode ring is arranged in the branch pipe 1, and an electrode connector 2 is connected to the end of the anode ring and the cathode ring away from the working lumen 5.

[0042] like Figure 4 As shown, the threaded sleeve 14 and the limiting plate 15 are both hollow, and the anode ring and the cathode ring are both connected to the spiral electrode 17 through the connecting seat 13.

[0043] like Figure 1 As shown, an isolation sleeve is arranged inside the cathode ring, the inner diameter of the isolation sleeve is slightly larger than the outer diameter of the guide wire, the length of the isolation sleeve is greater than 40 mm, and one end of the isolation sleeve away from the working lumen 5 is closed.

[0044] like Figures 1 to 3 As shown, a control assembly is provided at one end of the rotating sleeve 11 near the electrode joint 2, and the control assembly includes a connecting plate 7 connected to one end of the rotating sleeve 11, a rotating frame 6 is rotatably connected to the connecting plate 7, and an operating handle 8 is hinged at one end of the rotating frame 6.

[0045] like Figure 1 and Figure 2 As shown, a clamp 10 is provided at one end of the flexible tube sleeve 4 , and a positioning shaft 9 is provided on the operating handle 8 , and the positioning shaft 9 is clamped inside the clamp 10 .

[0046] like Figure 1 As shown, the flexible tube sleeve 4 and the working tube cavity 5 are both made of transparent materials, and the flexible tube sleeve 4 is provided with distance rings at regular intervals, and the distance rings are colored black.

[0047] A method for using a novel temporary cardiac pacemaker electrode comprises the following steps:

[0048] S1: Choose the left or right basilic vein of the patient for puncture;

[0049] S2: The guidewire is gradually inserted under ultrasound guidance, and after the guidewire is inserted, the sheath is inserted;

[0050] S3: implant the device along the guide wire and fix the device to the inner wall of the patient's myocardium through a fixing component;

[0051] S4: Pull out the guide wire and observe the fixing status of the device through ultrasound equipment. If it is qualified, fix the device outside the patient's body and connect the electrode connector 2 at one end of the cathode ring and the anode ring to the pacemaker generator; if it is unqualified, completely withdraw the device and return to S2 to cycle the steps until the device is set to a qualified fixing state.

[0052] The S3 step specifically includes:

[0053] S3.1: Insert the working lumen 5 into the sheath tube, and slide the isolation sleeve along the guide wire until the tip of the working lumen 5 moves to the end of the guide wire, keep the working lumen 5 and the flexible sleeve 4 stable, and measure the voltage value;

[0054] S3.2: Manually rotate the operating handle 8 to disengage the positioning shaft 9 from the clamp 10, until the rotating frame 6 and the connecting plate 7 move to the same vertical line, and keep the working lumen 5 and the flexible tube sleeve 4 in a straight line as much as possible, and then rotate the operating handle 8;

[0055] S3.3: Rotate the operating handle 8 several times until a significant torque is felt from the rotating sleeve 11, and at the same time, the spiral electrode 17 can be observed to penetrate the inner wall of the myocardium of the patient through ultrasound equipment;

[0056] S3.4: Test the voltage value again to see if it meets the requirements.

[0057] The observation of the device fixing state in S4 includes the shape of the working lumen 5. If the working lumen 5 is in a smooth arc shape, it indicates that the tension inside the device is large and needs to be re-inserted; if the working lumen 5 is in a shape of multiple irregular arcs connected together, it indicates that the tension inside the device is qualified.

[0058] The above is only an embodiment of the present invention, and the common knowledge such as the known specific technical solutions and / or characteristics in the solution is not described in detail here. It should be pointed out that for those skilled in the art, without departing from the technical solution of the present invention, several modifications and improvements can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. A novel temporary cardiac pacemaker electrode, characterized in that: The invention comprises a flexible tube sleeve (4) and a working tube cavity (5), one end of the flexible tube sleeve (4) is connected to one end of the working tube cavity (5), a fixing component is arranged in the working tube cavity (5), the fixing component comprises a connecting seat (13) slidably clamped in the working tube cavity (5), one end of the connecting seat (13) is connected to an directional block (12), a spiral electrode (17) is arranged on the side of the connecting seat (13) close to the free end of the working tube cavity (5), the spiral electrode (17) is wound around the outside of the directional block (12), the spiral electrode (17) has a constant pitch of 1.8 mm from one end of the free end of the working tube cavity (5) to the inside, and the remaining part of the pitch gradually decreases until it contacts the connecting seat (13), and a puncture tip is arranged on one end of the spiral electrode (17) close to the free end of the working tube cavity (5).

2. A novel temporary cardiac pacemaker electrode according to claim 1, characterized in that: The inner side of the connecting seat (13) is connected to a threaded sleeve (14), and a threaded ring (16) is arranged in the working tube cavity (5). The inner side of the threaded ring (16) is threadedly connected to the threaded sleeve (14), and one side of the threaded ring (16) is in contact with one side of the connecting seat (13).

3. A novel temporary cardiac pacemaker electrode according to claim 2, characterized in that: When one side of the threaded ring (16) contacts one side of the connecting seat (13), the distance between the outer end of the spiral electrode (17) and the free end of the working lumen (5) is 0.2 mm; the end of the threaded sleeve (14) away from the connecting seat (13) is connected to a limiting plate (15); when one side of the limiting plate (15) contacts one side of the threaded ring (16), the distance between the outer end of the spiral electrode (17) and the free end of the working lumen (5) is 1.8 mm.

4. A novel temporary cardiac pacemaker electrode according to claim 3, characterized in that: A rotating sleeve (11) is clamped on the inner wall of the flexible pipe sleeve (4), one end of the rotating sleeve (11) is coaxially connected to the limiting plate (15), and a power supply component is arranged inside the rotating sleeve (11).

5. A novel temporary cardiac pacemaker electrode according to claim 4, characterized in that: The power supply assembly comprises a main pipe (3) clamped in the rotating sleeve (11), a spirally arranged anode ring is arranged on the inner wall of the main pipe (3), a branch pipe (1) is clamped on the inner side of the anode ring, a cathode ring is arranged in the branch pipe (1), and the ends of the anode ring and the cathode ring away from the working tube cavity (5) are both connected to an electrode connector (2).

6. A novel temporary cardiac pacemaker electrode according to claim 5, characterized in that: The threaded sleeve (14) and the limiting plate (15) are both hollow, and the anode ring and the cathode ring are both connected to the spiral electrode (17) via the connecting seat (13).

7. A novel temporary cardiac pacemaker electrode according to claim 6, characterized in that: An isolation sleeve is arranged inside the cathode ring, the inner diameter of the isolation sleeve is slightly larger than the outer diameter of the guide wire, the length of the isolation sleeve is greater than 40 mm, and one end of the isolation sleeve away from the working lumen (5) is closed.

8. A novel temporary cardiac pacemaker electrode according to claim 7, characterized in that: A control component is provided at one end of the rotating sleeve (11) close to the electrode connector (2), and the control component comprises a connecting plate (7) connected to one end of the rotating sleeve (11), a rotating frame (6) is rotatably connected to the connecting plate (7), and an operating handle (8) is hinged at one end of the rotating frame (6).

9. A novel temporary cardiac pacemaker electrode according to claim 8, characterized in that: A clamp (10) is provided at one end of the flexible tube sleeve (4), a positioning shaft (9) is provided on the operating handle (8), and the positioning shaft (9) is clamped inside the clamp (10).

10. A novel temporary cardiac pacemaker electrode according to claim 9, characterized in that: The flexible tube sleeve (4) and the working tube cavity (5) are both made of transparent materials. The flexible tube sleeve (4) is provided with distance rings at regular intervals, and the distance rings are colored black.

11. A method for using a novel temporary cardiac pacemaker electrode as claimed in claim 10, characterized in that: The following steps are involved: S1: Choose the left or right basilic vein of the patient for puncture; S2: The guidewire is gradually inserted under ultrasound guidance, and after the guidewire is inserted, the sheath is inserted; S3: implant the device along the guide wire and fix the device to the inner wall of the patient's myocardium through a fixing component; S4: Pull out the guide wire and observe the fixation status of the device through ultrasound equipment. If it is qualified, fix the device outside the patient's body and connect the electrode connectors (2) at one end of the cathode ring and the anode ring to the pacemaker generator; if it is unqualified, completely withdraw the device and return to S2 to cycle the steps until the device is set to a qualified fixation state.

12. The method for using a novel temporary cardiac pacemaker electrode according to claim 11, characterized in that: The S3 step specifically includes: S3.1: Insert the working lumen (5) into the sheath tube, and slide the isolation sleeve along the guide wire until the tip of the working lumen (5) moves to the end of the guide wire, keep the working lumen (5) and the flexible sleeve (4) stable, and measure the voltage value; S3.2: Manually rotate the operating handle (8) to disengage the positioning shaft (9) from the clamp (10) until the rotating frame (6) and the connecting plate (7) move to the same vertical straight line, and keep the working lumen (5) and the flexible tube sleeve (4) in a straight line as much as possible, and then rotate the operating handle (8); S3.3: Rotate the operating handle (8) several times until a noticeable torque is felt from the rotating sleeve (11), and at the same time, the spiral electrode (17) can be observed to penetrate the inner wall of the myocardium of the patient through ultrasound equipment; S3.4: Test the voltage value again to see if it meets the requirements.

13. The method for using a novel temporary cardiac pacemaker electrode according to claim 12, characterized in that: The observation of the device fixing state in S4 includes the shape of the working lumen (5). If the working lumen (5) is in the shape of a smooth arc, it indicates that the tension inside the device is too large and needs to be re-inserted; if the working lumen (5) is in the shape of multiple irregular arc connections, it indicates that the tension inside the device is acceptable.