A segmental removal device for cardiac pacing electrodes via the inferior vena cava route

Abstract

This invention discloses a segmented removal device for cardiac pacing electrodes via the inferior vena cava route. It includes an operating handle and a main tube connected to one end of the operating handle, a control component axially slidable inside the main tube and extending to its distal end; a grabbing and cutting assembly installed at the distal end of the main tube, controlled by the control component and a pull rod within the main tube to clamp and cut the cardiac pacing electrode lead; and a lead-grabbing bracket fitted on the outside of the main tube, movable distally and detached from the main tube under external force. The lead-grabbing bracket is an elastic structure with a coiled state and an open state; when fitted on the outside of the main tube, it is in a coiled state, and after detachment, it automatically opens, allowing other objects to pass through. This invention solves the problem that existing pacing electrode removal tools may increase the risk of vascular tearing and myocardial perforation when pulling on cardiac pacing electrodes.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a segmental removal device for cardiac pacing electrodes via the inferior vena cava route. Background Technology

[0002] Pacemakers, as implantable electronic therapeutic devices, are used to treat certain bradycardias and some types of congestive heart failure that cannot be controlled by medication. Electrode removal is necessary when pacemaker-related pocket infection, bloodstream infection, or endocarditis occurs, or when the electrode affects the patient's physiological function due to non-infectious factors. Using specialized instruments during removal can improve the success rate and reduce surgical risks.

[0003] Existing pacemaker electrode removal tools still have limitations. In particular, when using an inferior vena cava approach electrode removal device to pull the electrode, the part of the electrode that is adhered to the myocardial tissue and the part that is adhered to the blood vessel will be subjected to force at the same time. This cannot be well coordinated with the counter-pushing force of the delivery sheath for electrode removal, and it also increases the risk of blood vessel tearing and myocardial perforation. Summary of the Invention

[0004] This invention provides a segmental removal device for cardiac pacing electrodes via the inferior vena cava, which can solve the problem that existing pacing electrode removal tools may increase the risk of vascular tearing and myocardial perforation when pulling on cardiac pacing electrodes.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a segmented removal device for cardiac pacing electrodes via the inferior vena cava, comprising an operating handle and a main tube connected to one end of the operating handle, and a control component axially slidably mounted inside the main tube and extending to the distal end of the main tube; a grabbing and shearing assembly mounted at the distal end of the main tube, which is controlled by the control component and a pull rod inside the main tube to clamp and cut the cardiac pacing electrode lead; and a lead grabbing bracket sleeved on the outside of the main tube, which can move distally and detach from the main tube under external force, wherein the lead grabbing bracket has a coiled state. The elastic structure, in its open state, is in a coiled state when the lead capture bracket is fitted outside the main tube, and automatically opens after detaching from the main tube, allowing other objects to pass through. The operating handle is equipped with multiple sliders to drive the control components and levers. By designing the main tube, capture and shearing assembly, and lead capture bracket, it is possible to first grasp, cut, and grab the cardiac pacing electrode lead, and finally pull it into the delivery sheath, which can efficiently detach it from the myocardial tissue. This solves the problem that existing pacing electrode removal tools may increase the risk of vascular tearing and myocardial perforation when pulling on the cardiac pacing electrode.

[0006] Preferably, the capture and shearing assembly includes a pair of jaws hinged to the distal end of the main tube and a shearing blade disposed inside the main tube. The proximal end of the jaws is connected to a control unit, and the shearing blade is connected to a pull rod. The jaws clamp the cardiac pacing electrode lead under the drive of the control unit, and the shearing blade moves distally under the drive of the pull rod to cut the cardiac pacing electrode lead. The control unit can control the opening and clamping of the jaws to achieve smooth clamping of the cardiac pacing electrode lead. The shearing blade can cut the cardiac pacing electrode lead while the jaws are clamping it.

[0007] Preferably, the claws are provided with transverse cutting grooves on opposite sides, and the shearing blade can be slidably inserted into the transverse cutting grooves, so that the shearing blade can also be inserted into the transverse cutting grooves to cut the cardiac pacing electrode leads while the claws are gripping them, without damaging the tissue around the cardiac pacing electrode leads.

[0008] Preferably, the claws are provided with arc-shaped grooves on their opposite sides. When the claws are clamped together, a gripping hole is formed between the two claws. The gripping hole can be used to limit the position of the cardiac pacing electrode lead. The cardiac pacing electrode lead can be gripped without always applying clamping force, which is simple to operate.

[0009] Preferably, the capture and shearing assembly includes a pair of clamps hinged to the distal end of the main tube. The clamps are curved, with their proximal ends connected to the control components. When the clamps are in a fully open to fully closed state, the hole formed by the curved structure will decrease in size until it is closed. The clamps are provided with blades on their opposite inner sides. By controlling the clamping force of the clamps, the cardiac pacing electrode leads can be captured and cut without the need for additional cutting blades or damage to other tissues.

[0010] Preferably, the wire capture bracket includes a main rod and a coiled bracket disposed on one side of the main rod. The coiled bracket has a mesh design and has perforated holes at both ends that allow other objects to pass through. One end of the main rod is connected to a push rod. The wire capture bracket is made of elastic material and extends to the end of the delivery sheath via the push rod. It is manually controlled. When it encounters an obstacle, the wire capture bracket can change from an overlapping closed state to an open state, allowing the obstacle to pass through.

[0011] Preferably, the geometric structure of the mesh on the coiled support is an open-loop or closed-loop design, and its circumferential structure is a coiled open structure that can be converted into an open state when it encounters an obstacle.

[0012] Preferably, the edges of the hollow holes at both ends of the coiled bracket are inclined strips. The function of the inclined strip at the far end of the coiled bracket is to make it easier for the coiled bracket to change from an overlapping closed state to an open state when it encounters an obstacle while pushing forward. The function of the inclined strip at the near end of the coiled bracket is to make it easier for the bracket to enter the delivery sheath when it retracts.

[0013] Compared with the prior art, the beneficial effects of the present invention are:

[0014] With its ingenious and rational structure, it can utilize existing delivery sheaths for delivery. Through the design of the main tube, the grabbing and cutting component, and the lead grabbing bracket, it can first grab, cut, and retrieve the cardiac pacing electrode lead, and then deliver it along the electrode into the delivery sheath. The delivery sheath can hold the electrode against the site of adhesion between the electrode and myocardial tissue or blood vessels, and the electrode can be removed by using reverse thrust, reducing myocardial or vascular damage, improving the success rate, and solving the problem that existing pacing electrode removal tools may increase the risk of vascular tearing and myocardial perforation when pulling on cardiac pacing electrodes. Attached Figure Description

[0015] Figure 1 This is a three-dimensional structural diagram of the present invention;

[0016] Figure 2 This is a three-dimensional structural diagram of the capture and shearing component of the present invention;

[0017] Figure 3 This is a schematic diagram of the wire capture bracket of the present invention in the open state;

[0018] Figure 4 This is a schematic diagram of the lead capture bracket of the present invention reverting to a curled state to capture the cardiac pacing electrode lead;

[0019] Figure 5 This is a structural diagram of the first embodiment of the capture and shearing component of the present invention;

[0020] Figure 6 This is a structural diagram of a second embodiment of the capture and shearing component of the present invention;

[0021] Figure 7 This is a schematic diagram of the wire capture bracket of the present invention.

[0022] Figure label:

[0023] 1. Main component; 2. Capture and shearing assembly; 21. Shearing blade; 22. Claw; 23. Cross-cutting slot; 24. Clamp; 25. Arc-shaped groove; 26. Blade; 3. Wire capture bracket; 31. Main rod; 32. Push rod; 33. Coiling bracket; 34. Inclined side strip; 35. Hole; 4. Control component; 5. Pull rod; 6. Operating handle; 7. Slider; A. Cardiac pacing electrode lead. Detailed Implementation

[0024] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

[0025] This invention addresses the problem that existing pacing electrode removal tools may increase the risk of vascular tearing and myocardial perforation when pulling on cardiac pacing electrodes. Figure 1-7 As shown, the following technical solution is provided: a segmented removal device for cardiac pacing electrodes via the inferior vena cava, comprising an operating handle 6 and a main tube 1 connected to one end of the operating handle 6, and a control component 4, which is axially slidably installed inside the main tube 1 and extends to the distal end of the main tube 1; a grabbing and cutting assembly 2, installed at the distal end of the main tube 1, which is controlled by the control component 4 and a pull rod 5 inside the main tube 1 to clamp and cut the cardiac pacing electrode lead A; and a lead grabbing bracket 3, sleeved on the outside of the main tube 1, which can move distally and detach from the main tube 1 under the action of external force, wherein the lead grabbing bracket 3 has a coiled state and an open state. The elastic structure in the open state is in a curled state when the lead capture bracket 3 is sleeved on the outside of the main tube 1, and automatically turns into an open state after being detached from the main tube 1, allowing other objects to pass through; the operating handle 6 is equipped with multiple sliders 7 for driving the control component 4 and the pull rod 5 to move. By designing the main tube 1, the capture and cutting component 2 and the lead capture bracket 3, it is possible to first grasp, cut and grab the cardiac pacing electrode lead A, and finally pull it into the delivery sheath, which can efficiently detach it from the myocardial tissue. This solves the problem that existing pacing electrode removal tools may increase the risk of vascular tearing and myocardial perforation when pulling the cardiac pacing electrode.

[0026] Specifically, in this embodiment, the main tube 1 needs to be inserted into the delivery sheath (not shown in the diagram) and delivered by the delivery sheath to the location of the cardiac pacing electrode lead. The delivery sheath can be an inferior vena cava delivery sheath, which is a conventional interventional medical device. It is inserted into the inferior vena cava through a puncture technique (such as lower extremity venous puncture) to provide a blood vessel access for other interventional devices (such as stents, filters, catheters, etc.) and avoid damage to the blood vessels from repeated punctures. Therefore, the delivery sheath is existing technology, and its specific structure will not be described in detail.

[0027] The main tube 1 is hollow inside, allowing the control component 4 and the pull rod 5 to pass through. The operating handle 6 can adopt a conventional handle shape, but its surface can be equipped with multiple sliders 7. The sliders 7 can move along the grooves on the surface of the operating handle 6. Different sliders 7 can be connected to the control component 4 and the pull rod 5 respectively, thereby achieving precise control of the control component 4 and the pull rod 5 separately. At the same time, the operating handle 6 can be operated with one hand, so that the entire main tube 1 and the grasping and shearing assembly 2 rotate synchronously after grasping the cardiac pacing electrode lead A, which is conducive to the detachment of the cardiac pacing electrode lead A from the myocardium and other tissues.

[0028] In this embodiment, the capture and shearing assembly 2 can have many different structures, and the number of control components 4 and pull rods 5 can also be adjusted according to the specific structure of the capture and shearing assembly 2.

[0029] As a first specific embodiment of the capture and shearing component 2, such as Figure 5 As shown, the grasping and shearing assembly 2 includes a pair of jaws 22 hinged to the distal end of the main tube 1 and a shearing blade 21 disposed inside the main tube 1. The proximal end of the jaws 22 is connected to the control component 4, and the shearing blade 21 is connected to the pull rod 5. Under the drive of the control component 4, the jaws 22 clamp the cardiac pacing electrode lead A. Under the drive of the pull rod 5, the shearing blade 21 moves distally to cut the cardiac pacing electrode lead A. The control component 4 can control the opening and closing of the jaws 22 to smoothly clamp the cardiac pacing electrode lead A. The shearing blade 21 can be used to clamp the cardiac pacing electrode lead A by the jaws 22. Simultaneously, the cardiac pacing electrode lead A is cut. A pair of claws 22 are hinged to the main tube 1 to form a rotating structure similar to a clamp. The proximal end of the claws 22 is also hinged to the control component 4. When the control component 4 is pulled back, the proximal ends of the claws 22 will move closer together, thereby causing the distal ends of the claws 22 to move closer together as well, thus clamping the cardiac pacing electrode lead A. After clamping, the pull rod 5 is pushed forward to cut the cardiac pacing electrode lead A. After cutting, the claws 22 still clamp the cardiac pacing electrode lead A, creating conditions for the subsequent lead capture bracket 3 to capture the cut cardiac pacing electrode lead A.

[0030] In the above embodiment, the opposing sides of the jaws 22 are provided with transverse cutting grooves 23. The shearing blade 21 can be slidably inserted into the transverse cutting grooves 23, so that even when the jaws 22 are gripping the cardiac pacing electrode lead A, the shearing blade 21 can also be inserted into the transverse cutting grooves 23 to cut the cardiac pacing electrode lead A without damaging the tissue around the cardiac pacing electrode lead A. At the same time, the opposing sides of the jaws 22 are provided with arc-shaped grooves 25. When the jaws 22 are clamped together, a gripping hole is formed between the two jaws 22. The gripping hole can limit the cardiac pacing electrode lead A, and the gripping of the cardiac pacing electrode lead A can be achieved without constantly applying clamping force, making the operation simple.

[0031] As a second specific embodiment of the capture and shearing component 2, such as Figure 6As shown, the capture and shearing assembly 2 includes a pair of clamps 24 hinged to the distal end of the main tube 1. The clamps 24 are curved, and their proximal ends are connected to the control component 4. When the clamps 24 are in a fully open to fully closed state, the hole formed by the curved structure will decrease in size until it is closed. The clamps 24 are provided with blades 26 on their opposite inner sides. By controlling the clamping force of the clamps 24, the cardiac pacing electrode lead A can be captured and cut without the need for a separate cutter and without damaging other tissues.

[0032] In this embodiment, as Figures 2-4 and Figure 7 As shown, the wire capture bracket 3 includes a main rod 31 and a coiled bracket 33 disposed on one side of the main rod 31. The coiled bracket 33 has a mesh design and has perforated holes 35 at both ends to allow other objects to pass through. One end of the main rod 31 is connected to a push rod 32. The wire capture bracket 3 is made of elastic material and extends to the end of the delivery sheath via the push rod 32. It is manually controlled. When encountering an obstacle, the wire capture bracket 3 can change from an overlapping closed state to an open state, allowing the obstacle to pass through. Specifically, as shown... Figure 2 As shown, the wire-catching bracket 3 is fitted onto the outside of the main pipe 1. The coiled bracket 33 has two parts, symmetrically arranged with respect to the main rod 31. Under the action of its own elasticity, the coiled bracket 33 holds the main pipe 1, which is the coiled state. When the push rod 32 pushes the wire-catching bracket 3 forward, it will open due to the obstacle when it passes the front end of the catching and shearing assembly 2. Figure 3 As shown, "opening" here means that the two parts of the coiled stent 33 separate to allow the obstacle to pass through. This allows the severed cardiac pacing electrode lead A to enter the coiled stent 33, and the two parts of the coiled stent 33 can then automatically coil under the action of elasticity. Figure 4 As shown, the cardiac pacing electrode lead A is held to capture it. After capture, the cardiac pacing electrode lead A can be pulled into the delivery sheath along with the lead capture bracket 3.

[0033] In this embodiment, the geometric structure of the mesh on the coiled stent 33 is an open-loop or closed-loop design. Its circumferential structure is a coiled open structure, which can be converted into an open state when encountering an obstacle. The mesh design allows the coiled stent 33 to undergo relatively large deformation when in the coiled and open states, which is beneficial for grasping the cardiac pacing electrode lead A. The open-loop or closed-loop structure refers to the structure of the mesh, which can be set as needed.

[0034] In this embodiment, as Figure 7The edges of the hollow holes 35 at both ends of the coiled bracket 33 are inclined strips 34. The function of the inclined strips 34 at the far end of the coiled bracket 33 is to make it easier for the coiled bracket 33 to change from an overlapping closed state to an open state when it is pushed forward and encounters an obstacle. The function of the inclined strips 34 at the near end of the coiled bracket 33 is to make it easier for the bracket to enter the delivery sheath when it is retracted.

[0035] As a specific usage step in this embodiment:

[0036] First, the main tube 1, the lead capture bracket 3, and the capture shear assembly 2 can be coaxially stacked together. With the aid of angiography, they are delivered through the inferior vena cava sheath to the location of the pacing lead in the blood vessel or heart. Figure 2 As shown, the capture and shearing assembly 2 captures and fixes the cardiac pacing electrode lead A, so that the cardiac pacing electrode lead A and the capture and shearing assembly 2 form a "T" shaped structure.

[0037] Then, the main conductor 1 and the capture and shearing assembly 2 retract or push the lead capture bracket 3 forward, allowing it to move towards the cardiac pacing electrode lead A. The coiled open structure of the lead capture bracket 3 will change to an open state, passing the junction of the "T"-shaped structure. After the lead capture bracket 3 is fully coaxial with the pacing lead on one side, it will return to its coiled structure. If necessary, a second lead capture bracket 3 can be pushed to coaxialize with the cardiac pacing electrode lead A on the other side.

[0038] Next, the pacing lead is cut using the shearing function of the capture-shear assembly 2, and the main tube 1 and the capture-shear assembly 2 are retracted along the delivery sheath. The delivery sheath can be pushed forward to allow the lead capture bracket 3 to retract into the delivery sheath. Due to the limitation of the lumen size, the lead capture bracket 3 will deform, and the mesh on it will be compressed and reduced, hooking and locking the cut coaxial pacing lead together with the wall of the delivery sheath. Then, the lead capture bracket 3 and the delivery sheath are pulled back proximally to pull the cardiac pacing electrode lead A out of the body.

[0039] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indication will also change accordingly.

[0040] Furthermore, in this invention, descriptions involving terms such as "primary," "secondary," etc., are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "primary" or "secondary" may explicitly or implicitly include at least one of that feature. In the description of this invention, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0041] In this invention, unless otherwise explicitly specified and limited, the terms "connection," "fixed," etc., should be interpreted broadly. For example, "fixed" can mean a fixed connection, a detachable connection, or an integral part; it can mean a mechanical connection or an electrical connection; it can mean a direct connection or an indirect connection through an intermediate medium; it can mean the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0042] Furthermore, the technical solutions of the various embodiments of the present invention can be combined with each other, but only if they are feasible for those skilled in the art. If the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by the present invention.

Claims

1. A segmental removal device for cardiac pacing electrodes via the inferior vena cava route, characterized in that, Including an operating handle (6) and a main pipe (1) connected to one end of the operating handle (6), and also including: The control component (4) is axially slidably mounted inside the main tube (1) and extends to the distal end of the main tube (1); The capture and shearing assembly (2), installed at the distal end of the main tube (1), is controlled by the control unit (4) and the pull rod (5) inside the main tube (1) to clamp and cut the cardiac pacing electrode lead A; The wire capture bracket (3) is sleeved on the outside of the main tube (1) and can move to the far end and detach from the main tube (1) under the action of external force. The wire capture bracket (3) is an elastic structure with a curled state and an open state. When the wire capture bracket (3) is sleeved on the outside of the main tube (1), it is in a curled state. After detaching from the main tube (1), it automatically changes to an open state and allows other objects to pass through. The operating handle (6) is provided with multiple sliders (7) for driving the control unit (4) and the lever (5) to move.

2. The segmental removal device for cardiac pacing electrodes via the inferior vena cava according to claim 1, characterized in that: The capture and shearing assembly (2) includes a pair of jaws (22) hinged to the distal end of the main tube (1) and a shearing blade (21) disposed inside the main tube (1). The proximal end of the jaws (22) is connected to the control unit (4), and the shearing blade (21) is connected to the pull rod (5). The jaws (22) clamp the cardiac pacing electrode lead A under the drive of the control unit (4), and the shearing blade (21) moves distally under the drive of the pull rod (5) to cut the cardiac pacing electrode lead A.

3. The segmental removal device for cardiac pacing electrodes via the inferior vena cava according to claim 2, characterized in that: The jaw (22) has a transverse cutting groove (23) on its opposite side, and the shearing blade (21) can be slidably inserted into the transverse cutting groove (23).

4. The segmental removal device for cardiac pacing electrodes via the inferior vena cava as described in claim 3, characterized in that: The opposing sides of the claws (22) are provided with arc-shaped grooves (25), and when the claws (22) are clamped together, a gripping hole is formed between the two claws (22).

5. The segmental removal device for cardiac pacing electrodes via the inferior vena cava according to claim 1, characterized in that: The capture and shearing assembly (2) includes a pair of calipers (24) hinged to the distal end of the main tube (1). The calipers (24) are curved and their proximal ends are connected to the control unit (4). When the calipers (24) are in a fully open to fully closed state, the hole formed by the curved structure will become smaller until it is closed. The calipers (24) are provided with blades (26) on their opposite inner sides.

6. The segmental removal device for cardiac pacing electrodes via the inferior vena cava according to claim 1, characterized in that: The wire capture bracket (3) includes a main rod (31) and a coiled bracket (33) set on one side of the main rod (31). The coiled bracket (33) has a mesh design and has perforated holes (35) at both ends that allow other objects to pass through. One end of the main rod (31) is connected to a push rod (32).

7. The segmental removal device for cardiac pacing electrodes via the inferior vena cava according to claim 6, characterized in that: The geometric structure of the mesh on the coiled support (33) is either open-loop or closed-loop.

8. The segmental removal device for cardiac pacing electrodes via the inferior vena cava according to claim 6, characterized in that: The edges of the hollow holes (35) at both ends of the coiled bracket (33) are inclined strips (34).

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