Magnetic navigation guided tearable sheath for cardiac conduction bundle pacing

Abstract

The application relates to a magnetic navigation guiding tearable sheath for heart conduction bundle pacing, which comprises a sheath body and a joint fixedly connected to the rear end of the sheath body, the sheath body comprises a front soft section and a rear fixed section, and the front soft section can be arbitrarily bent; a plurality of pairs of half-ring magnets are arranged on the outer surface of the front soft section close to the head end, two half-ring magnets in each pair of half-ring magnets are symmetrically arranged and form a ring, and a gap is left between the two half-ring magnets; three electrodes are arranged on the head end of the front soft section and are uniformly distributed in the circumferential direction, the three electrodes can be combined in any two, and three electrode pairs for intracardiac potential recording and positioning are formed; each electrode is connected with an electrode lead wire, and the rear end of the sheath body is provided with an electrode tail wire interface, and the other ends of the three electrode lead wires are fixedly arranged in the electrode tail wire interface. The application is beneficial to intracardiac potential recording and positioning, is convenient to contact with the heart cavity, stably adheres to the endocardium, and ensures that the pacing electrode is stably rotated out.

Description

Technical Field

[0001] This invention relates to a magnetically guided tearable sheath for cardiac conduction bundle pacing, belonging to the field of cardiac pacing electrophysiology technology. Background Technology

[0002] Artificial cardiac pacing has been used clinically for over 60 years. With the rapid development of bioengineering technology, various new cardiac pacing techniques are constantly being introduced. Traditional cardiac pacing techniques involve placing pacing electrodes on the surface of the heart muscle wall and using simple electrical stimulation to restore the heartbeat. Newer cardiac pacing techniques place pacing electrodes on the cardiac conduction bundle within the heart wall, achieving artificial pacing through this bundle. This method of artificial cardiac pacing is closer to physiological pacing and can reduce the incidence of heart failure or improve cardiac function.

[0003] The main challenges of cardiac conduction bundle pacing currently include: 1. The cardiac conduction bundle cannot be directly visualized; 2. Electroanatomy is not entirely equivalent to tissue anatomy; 3. The surrounding tissues of the cardiac conduction bundle are diverse; 4. The heart is constantly beating; 5. Cardiac anatomical variations and structural changes; 6. Inconsistent operator habits, skills, and intuition. These challenges lead to problems such as low success rates, long learning curves, and lengthy surgical times in cardiac conduction bundle pacing.

[0004] Research has revealed that one of the main reasons for the aforementioned problems with cardiac conduction bundle pacing is the inadequacy of existing sheaths used for implanting pacing electrodes. While pre-shaped and adjustable sheaths can provide different levels of support, their adjustment range is limited and their precision is low. During electrode insertion, the angle and depth are difficult to control; excessive insertion carries the risk of myocardial perforation, and the insertion angle often fails to reach the intended area. In cases of cardiac enlargement or anatomical variations, potentials may not be found within conventional anatomical areas. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the existing technology and provide a magnetically guided tear-away sheath for cardiac conduction bundle pacing that is ingeniously structured, rationally designed, and easy to use.

[0006] According to the technical solution provided by the present invention: a magnetic navigation-guided tearable sheath for cardiac conduction bundle pacing includes a sheath body and a connector fixedly connected to its rear end, wherein the connector contains a one-way leak-proof valve, and the sheath body is hollow inside; characterized in that: the sheath body includes an integrally formed front flexible section and a rear fixed section, the front flexible section being arbitrarily bendable; the outer surface of the front flexible section near the tip is provided with several pairs of semi-annular magnets, two of the semi-annular magnets in each pair being symmetrically arranged and forming a ring, with a gap between the two semi-annular magnets for the passage of a cutting knife; the tip of the front flexible section is also provided with three circumferentially distributed electrodes, the three electrodes being arbitrarily combined in pairs to form three electrode pairs, the three electrode pairs being able to record three bipolar potentials in a local area of ​​the heart for intracardiac potential recording and positioning; each electrode is connected to an electrode wire, the electrode wire being embedded in the wall of the sheath body along the length direction of the sheath body, and an electrode tail wire interface is provided near the tail end of the sheath body, the other end of the three electrode wires being fixedly installed in the electrode tail wire interface.

[0007] As a further improvement of the present invention, the length of the front soft section is 6 to 8 cm and the inner diameter is greater than or equal to 1.88 mm.

[0008] As a further improvement of the present invention, the length of the rear fixing section is 35-45cm and the inner diameter is greater than or equal to 1.88mm.

[0009] As a further improvement of the present invention, a cutting guide line is provided on the outer wall of the sheath body, and a cutting guide opening corresponding to the rear end of the cutting guide line is provided at the tail end of the connector. The front end of the cutting guide line passes through the gap between the two semi-annular magnets.

[0010] As a further improvement of the present invention, a liquid inlet pipe is also connected to the side wall of the connector, the rear end of the liquid inlet pipe is the liquid inlet, and the front end of the liquid inlet pipe communicates with the interior of the connector.

[0011] As a further improvement of the present invention, the number of semi-annular magnets is 2 to 4 pairs.

[0012] As a further improvement of the present invention, several pairs of semi-annular magnets are evenly distributed at equal intervals on the outer surface of the front flexible section.

[0013] As a further improvement of the present invention, the material of the front soft section is a biocompatible polymer material, and the material of the electrode is a biocompatible inert metal material.

[0014] As a further improvement of the present invention, the surface of the electrode is preferably configured as a smooth and rounded arc.

[0015] Compared with the prior art, the present invention has the following advantages:

[0016] 1) The present invention has an ingenious structure and reasonable design. By setting several pairs of semi-circular magnets on the front flexible section, the front flexible section can be bent arbitrarily in the external magnetic field environment [magnetic navigation system], and the direction and angle can be adjusted to facilitate the search for the conduction system potential and facilitate contact with the heart chamber, stably adhering to the endocardium, and ensuring the stable rotation of the pacing electrode. The front flexible section has three electrodes at its head end. The three electrodes can be combined in any two pairs to form three electrode pairs. The three electrode pairs can record three bipolar potentials in the heart, which are used for intracardiac potential recording and positioning.

[0017] 2) The present invention allows contrast agent to be injected through the inlet of the inlet tube, facilitating angiography to visualize the endocardium.

[0018] 3) The present invention is equipped with a cutting guide line. The front end of the cutting guide line passes through the gap between the two semi-annular magnets. In this way, a conventional cutting knife can accurately cut the sheath body without being blocked by the semi-annular magnets, making it convenient to remove the sheath. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the present invention.

[0020] Figure 2 for Figure 1 Enlarged cross-sectional view of plane AA in the diagram.

[0021] Figure 3 for Figure 1 Enlarged schematic diagram of part B in the diagram.

[0022] Figure 4 for Figure 1 Enlarged schematic diagram of part C in the diagram.

[0023] Explanation of reference numerals in the attached drawings: 1-Sheath body, 1a-front flexible section, 1b-rear fixed section, 2-connector, 3-semi-annular magnet, 4-gap, 5-electrode, 6-electrode wire, 7-electrode tail wire interface, 8-inlet tube, 8a-inlet, 9-cutting guide wire, 10-cutting guide port. Detailed Implementation

[0024] The present invention will be further described below with reference to specific accompanying drawings and embodiments.

[0025] like Figures 1-4As shown, an embodiment discloses a magnetically guided tearable sheath for cardiac conduction bundle pacing, comprising a sheath body 1 and a connector 2 fixedly connected to its rear end. The connector 2 contains a one-way leak-proof valve. The sheath body 1 is hollow inside and includes an integrally formed front flexible section 1a and a rear fixed section 1b. The front flexible section 1a can be bent arbitrarily. Several pairs of semi-annular magnets 3 are provided on the outer surface of the front flexible section 1a near the head end. Two semi-annular magnets 3 in each pair of semi-annular magnets 3 are symmetrically arranged to form a ring, and a gap 4 is left between the two semi-annular magnets 3 for the passage of a cutting knife. The head end of the front flexible section 1a is also provided with three circumferentially distributed electrodes 5. Each electrode 5 is connected to an electrode wire 6. The electrode wire 6 is embedded in the wall of the sheath body 1 along the length direction of the sheath body 1. An electrode tail wire interface 7 is provided near the tail end of the sheath body 1, and the other end of the three electrode wires 6 is fixedly installed in the electrode tail wire interface 7.

[0026] In practical use, the sheath is first implanted in the conventional manner. Since the soft segment 1a at the front of the sheath has several pairs of semi-circular magnets 3, the soft segment 1a can be bent arbitrarily in the external magnetic field environment [magnetic navigation system]. By adjusting its direction and angle through magnetic navigation, it is easier to find the potential of the cardiac conduction system and facilitate contact with the heart chamber, stably adhering to the endocardium, and ensuring that the pacing electrode is stably rotated out. The improved accuracy can also effectively avoid myocardial perforation, reduce operation time, reduce surgical risks, and improve the success rate of the operation. The three electrodes 5 can be combined in any two pairs to form three electrode pairs. The three electrode pairs can record three bipolar potentials in the local area of ​​the heart for intracardiac potential recording and localization.

[0027] like Figure 1 As shown in this embodiment, an inlet pipe 8 is also connected to the side wall of the connector 2. The rear end of the inlet pipe 8 is an inlet port 8a, and the front end of the inlet pipe 8 communicates with the interior of the connector 2. With this configuration, contrast agent can be injected through the inlet port 8a, which facilitates the visualization of the endocardium during angiography and makes the operation convenient.

[0028] like Figure 1 As shown, in this embodiment, two pairs of semi-annular magnets 3 are provided on the outer surface of the front flexible segment 1a. In actual production, 2 to 4 pairs of semi-annular magnets 3 can be provided, and the pairs of semi-annular magnets 3 are evenly distributed at equal intervals on the outer surface of the front flexible segment 1a. This arrangement ensures that the front flexible segment 1a has sufficient flexibility under magnetic navigation.

[0029] In this invention, the length of the sheath body 1 can be flexibly set. Generally, the length of the front flexible section 1a is 6-8 cm, and the length of the rear fixed section 1b is 35-45 cm. The inner diameter of both the front flexible section 1a and the rear fixed section 1b is greater than or equal to 1.88 mm. With this setting, the front flexible section 1a has sufficient length to allow for bending movements, which can basically meet all clinical needs.

[0030] like Figure 1 As shown, in this embodiment, the outer wall of the sheath body 1 is provided with a cutting guide line 9, and the tail end of the connector 2 is provided with a cutting guide opening 10 corresponding to the rear end of the cutting guide line 9. The front end of the cutting guide line 9 passes through the gap 4 between the two semi-annular magnets 3. With this configuration, the sheath body 1 can be accurately cut with a conventional cutting knife without being obstructed by the semi-annular magnets 3, making it convenient to remove the sheath.

[0031] In this invention, the material of the front flexible segment 1a is preferably a biocompatible polymer material, such as polyether-terminated amide, polyurethane, or nylon. The material of the electrode 5 is preferably a biocompatible inert metal material, such as a platinum-iridium alloy. The semi-annular magnet 3 is made of a permanent magnet material with high remanence, such as neodymium iron boron or ferrite. Both the semi-annular magnet 3 and the electrode 5 can be fixedly bonded to the front flexible segment 1a using medical adhesive, such as 4011, 4014, or 3011.

[0032] In this invention, the surface of the electrode 5 is preferably configured as a smooth, rounded arc. This configuration prevents scratches to the heart chambers, thus achieving a protective effect.

[0033] The above description is merely a preferred embodiment of the present invention, and the specific embodiments described above are not intended to limit the present invention. Various modifications and variations can be made within the scope of the technical concept of the present invention. All refinements, modifications, or equivalent substitutions made by those skilled in the art based on the above description are within the scope of protection of the present invention.

Claims

1. A magnetic navigation guided tearable sheath for cardiac conduction bundle pacing, comprising a sheath body (1) and a connector (2) fixedly connected to the rear end of the sheath body (1), a one-way leak stop valve is arranged in the connector (2), and the sheath body (1) is hollow inside; the sheath body (1) comprises a front soft section (1a) and a rear fixed section (1b) arranged integrally, and the front soft section (1a) is arbitrarily bendable; a plurality of pairs of half-ring magnets (3) are arranged on the outer surface of the front soft section (1a) near the head end, two half-ring magnets (3) in each pair of half-ring magnets (3) are symmetrically arranged and form a ring, and a gap (4) for a cutting knife to pass through is left between the two half-ring magnets (3); characterized in that: The head end of the front soft section (1a) is also provided with three electrodes (5) arranged equidistantly in the circumference, three of the electrodes (5) can be combined in any two to form three electrode pairs, which can record three bipolar potentials of the heart for intracardiac potential recording and positioning; each electrode (5) is connected with an electrode lead wire (6), the electrode lead wire (6) is embedded in the wall of the sheath body (1) along the length direction of the sheath body (1), the part of the sheath body (1) close to the tail end is provided with an electrode tail wire interface (7), the other end of the three electrode lead wires (6) is fixedly arranged in the electrode tail wire interface (7); the length of the front soft section (1a) is 6-8 cm, and the inner diameter is greater than or equal to 1.88 mm; the length of the rear fixed section (1b) is 35-45 cm, and the inner diameter is greater than or equal to 1.88 mm; ​ The sheath body (1) is provided with a cut guide line (9) on the outer wall, the tail end of the connector (2) is provided with a cut guide opening (10) corresponding to the rear end of the cut guide line (9), and the front end of the cut guide line (9) passes through the gap (4) between the two half-ring magnets (3).

2. The magnetically navigable guidable peel-away sheath for cardiac conduction bundle pacing of claim 1, wherein: The side wall of the connector (2) is also connected with a liquid inlet pipe (8), the rear end of the liquid inlet pipe (8) is a liquid inlet (8a), and the front end of the liquid inlet pipe (8) communicates with the inside of the connector (2).

3. The magnetically navigable guidable peel-away sheath for cardiac conduction bundle pacing of claim 1, wherein: The number of the half-ring magnets (3) is 2-4 pairs.

4. The magnetically navigable guidable peel-away sheath for cardiac conduction bundle pacing of claim 1, wherein: The several pairs of half-ring magnets (3) are arranged equidistantly on the outer surface of the front soft section (1a).

5. The magnetically navigable guidable peel-away sheath for cardiac conduction bundle pacing of claim 1, wherein: The material of the front soft section (1a) is a biocompatible polymer material, and the material of the electrode (5) is a biocompatible inert metal material.

6. The magnetically navigable guidable peel-away sheath for cardiac conduction bundle pacing of claim 1, wherein: The surface of the electrode (5) is arranged as a smooth and round arc.

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