A pacing electrode lead assembly automatically fixed in the left ventricle

By designing a pacing electrode wire assembly that is automatically fixed in the left ventricle, the umbrella-shaped head end and shape memory alloy support device, combined with the delivery steel cable and sheath track, the problem that the head end of the pacing electrode wire cannot be fixed in the left ventricle cavity is solved, and the firm fixation and efficient implantation of the pacing electrode wire is achieved.

CN110393854BActive Publication Date: 2025-04-22霍勇
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Patent Information

Application Number
CN201910658111.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2019-07-20
Publication Date
2025-04-22
Estimated Expiration
2039-07-20

AI Technical Summary

Technical Problem

The prior art cannot fix the head end of the pacing electrode wire in the left ventricular cavity, resulting in great limitations in the pacing electrode wire and difficulty in effectively fixing.

Method used

A pacing electrode wire assembly is designed that is automatically fixed in the left ventricle, using an umbrella-shaped head end and a shape memory alloy support device, combining the conveying steel cable and sheath track to achieve automatic and firm fixation of the head end of the pacing electrode wire.

Benefits of technology

Through the automatic expansion of the umbrella-shaped head end and the restraining effect of the shape memory alloy, the head end of the pacing electrode lead can have a large area, all-round, no dead corners, close and firm contact with the apical part of the left ventricle, significantly reducing the risk of dislocation, improving the success rate of implantation and the quality of life of the patient.

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Abstract

The present invention discloses a pacing electrode lead assembly that is automatically fixed in the left ventricle. The pacing electrode lead comprises a lead body, a head end, and a plug for connecting to a pulse generator. The lead body is arranged between the plug and the head end. The plug and the rear end of the lead body are integrally constructed. The front end of the lead body is detachably connected to the head end. When the head end reaches the left ventricular cavity, the head end opens to form an umbrella structure. The present invention solves the problem that the head end of the pacing electrode lead cannot be fixed in the left ventricular cavity.
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Description

Technical Field

[0001] The invention relates to the field of interventional treatment instruments in clinical cardiovascular medicine, and in particular to a pacing electrode lead assembly which is automatically fixed in the left ventricle. Background Art

[0002] Cardiac resynchronization therapy has become an important treatment for patients with heart failure. During the treatment, the pacing electrode wire connected to the pulse generator needs to be implanted into the right atrium, left and right ventricles respectively, so that the heart can contract synchronously, thereby treating heart failure. Implanting the left ventricular pacing electrode wire through the vein along the coronary sinus is the key to chemotherapy.

[0003] The pacing electrode lead in the prior art has not undergone any major changes compared to the traditional one, and adopts a single integral structure of a connector, a lead body, a ring electrode and a fixing device, and the fixing device is opened after reaching the target vein.

[0004] For example, the utility model patent with Chinese patent publication number CN206239897U discloses an active fixed left ventricular pacing electrode lead, which includes a connector, a lead body, a ring electrode and a fixing device; the lead body includes an outer lead layer and an inner lead layer, the outer lead layer connects the ring electrode to the positive pole of the connector, the inner lead layer connects the fixing device to the negative pole of the connector, and the fixing device is formed by a metal surround. The beneficial effects of the utility model are: the active fixed left ventricular pacing electrode lead can solve the problem of easy dislocation of the electrode during surgery, and effectively improves the success rate of the surgery; at the same time, the active fixed left ventricular pacing electrode lead has good pacing and sensing effects, effectively improves the quality of life of patients, is safe and effective, and is convenient and easy to use.

[0005] There are at least the following problems in the above prior art:

[0006] In actual operation, the fixing device included in the tip of the pacing electrode lead is formed by a metal wire. After being implanted into the target vein, the connector is twisted to open the fixing device. The existing technology cannot fix the tip of the pacing electrode lead in the left ventricular cavity, resulting in great limitations of the pacing electrode lead.

[0007] With regard to the problem that the tip of the pacing electrode lead cannot be fixed in the left ventricular cavity in the prior art, no effective solution has been proposed yet. Summary of the invention

[0008] The object of the present invention is to provide a pacing electrode lead assembly which is automatically fixed in the left ventricle.

[0009] The pacing electrode lead assembly includes a lead body, a head end and a plug for connecting to a pulse generator. The lead body is arranged between the plug and the head end. The plug and the rear end of the lead body are integrally constructed. The front end of the lead body is detachably connected to the head end. When the head end reaches the left ventricular cavity, the head end opens to form an umbrella structure.

[0010] Furthermore, the head end includes a supporting device and a first connecting piece, the front end of the wire body is provided with a second connecting piece adapted to the front end of the first connecting piece, and the top of the supporting device is provided with a through hole for accommodating the front end of the first connecting piece to pass through. When the front end of the first connecting piece passes through the through hole and is connected to the second connecting piece, the top of the supporting device is fixed on the first connecting piece.

[0011] Furthermore, the supporting device includes an umbrella cover and a keel, the umbrella cover and the keel are integrally constructed, and the through hole is arranged at the top of the keel.

[0012] Furthermore, the material of the umbrella surface is shape memory alloy.

[0013] Furthermore, a thread is provided at the front end of the first connecting member, and a first thread groove adapted to the front end of the first connecting member is provided at the second connecting member.

[0014] Furthermore, the diameter of the wire body is 3.2 mm.

[0015] Furthermore, a second thread groove is provided at the rear end of the first connecting member.

[0016] Furthermore, the wire body is provided with electrodes.

[0017] In order to achieve the above-mentioned purpose, according to another aspect of the present invention, there is provided a pacing electrode lead assembly that is automatically fixed in the left ventricle, the pacing electrode lead assembly comprising a sheath, a delivery cable and an automatically fixed head-end left ventricular pacing electrode lead, the front end of the delivery cable is provided with a connector that is adapted to the second thread groove, the connector is detachably connected to the second thread groove, and the automatically fixed head-end left ventricular pacing electrode lead and the delivery cable are both arranged inside the sheath.

[0018] Furthermore, the front end of the sheath tube is conical.

[0019] Compared with the prior art, the present invention has the following advantages:

[0020] 1. By implanting the umbrella-shaped tip of the pacing electrode lead into the left ventricular cavity, the area covered by the tip of the electrode lead encompasses the entire ellipsoid tip region endocardium from the middle of the left ventricle to the apex. The outer diameter of the umbrella-shaped tip of the pacing electrode lead matches the inner diameter of the ellipsoid tip at the apex of the left ventricle, and the two can be in close and firm contact over a large area, in all directions, without dead angles.

[0021] 2. Through the strong support of the umbrella-shaped metal skeleton and the restraining effect of the shape memory alloy mesh, the pacing electrode lead tip can be accurately matched with the left ventricular apex in a large area, multiple targets, and all directions. It can be automatically and firmly fixed immediately after implantation, and there is almost no risk of dislocation.

[0022] 3. By setting the pacing electrode lead in the sheath track, during the implantation operation, the pacing electrode lead does not contact with any part other than the implantation target, thereby reducing stimulation and damage to the heart structure.

[0023] 4. The tip of the pacing electrode lead is controlled by the delivery cable, so that the control force on the tip of the pacing electrode lead is strong during the implantation operation.

[0024] 5. By manipulating an additional delivery cable to deliver the tip of the pacing electrode lead to the left ventricular cavity, the lead body of the pacing electrode lead is no longer the stress subject, so a large-diameter, high-strength lead body is not required. The smaller the diameter of the pacing electrode lead, the more effectively it can reduce the risk of thrombosis caused by the pacing electrode lead as a coagulation core in the long-term effect after implantation. It also reduces the space-occupying effect of the pacing electrode lead in the implanted blood vessel and its impact on blood flow. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a structural schematic diagram of a pacing electrode lead assembly automatically fixed in the left ventricle of the present invention;

[0026] Figure 2 It is a structural schematic diagram of the conveying steel cable of the present invention;

[0027] Figure 3 It is a schematic structural diagram of the pacing electrode lead assembly automatically fixed in the left ventricle of the present invention.

[0028] As shown in the figure:

[0029] 1-wire body, 2-head end, 21-support device, 211-keel, 212-canopy, 213-center ring, 22-first connecting piece, 3-plug, 4-sheath, 5-transmission cable, 6-second connecting piece, 7-electrode, 9-connector. DETAILED DESCRIPTION

[0030] In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0031] Embodiment 1

[0032] like Figure 1As shown, the pacing electrode lead assembly includes a lead body 1, a head end 2 and a plug 3 for connecting to a pulse generator (not shown in the figure), the lead body 1 is arranged between the plug 3 and the head end 2, the plug 3 and the rear end of the lead body 1 are integrally constructed, the front end of the lead body 1 is detachably connected to the head end 2, when the head end 2 reaches the left ventricular cavity, the head end 2 opens to form an umbrella structure, the head end 2 includes a supporting device 21 and a first connecting member 22, the front end of the lead body 1 is provided with a second connecting member 6 adapted to the front end of the first connecting member 22, and the top of the supporting device 21 is provided with a front end of the first connecting member 22. Through the through hole (not shown in the figure), when the front end of the first connecting member 22 passes through the through hole and is connected to the second connecting member 6, the top of the supporting device 21 is fixed on the first connecting member 22, the head end 2 is composed of an umbrella cover 212 and a keel 211, the umbrella cover 212 surrounds the keel 211, and the keel 211 is fixed on the first connecting member 22, the front end of the first connecting member 22 is provided with a thread, the second connecting member 6 is provided with a first thread groove (not shown in the figure) adapted to the front end of the first connecting member 22, the rear end of the first connecting member 22 is provided with a second thread groove (not shown in the figure), and the wire body 1 is provided with an electrode 7.

[0033] Furthermore, the material of the umbrella surface 212 is a shape memory alloy, which makes the umbrella surface 212 less prone to damage and increases the service life of the umbrella surface 212.

[0034] Furthermore, the diameter of the guide wire body 1 is 3.2 mm, which is well adapted to clinical needs.

[0035] Embodiment 2

[0036] like Figure 2 and Figure 3 As shown, the pacing electrode lead assembly includes a sheath 4, a delivery cable 5, a plug 3, a lead body 1 and a head end 2, the lead body 1 is arranged between the head end 2 and the plug 3, the head end 2 includes a supporting device 21 and a first connecting member 22, the supporting device 21 includes a center ring 213, the center ring 213 is fixed on the first connecting member 22, the front end of the lead body 1 is provided with a second connecting member 6 adapted to the front end of the first connecting member 22, the first connecting member 22 is threadedly connected to the second connecting member 6, the rear end of the first connecting member 22 is provided with a second thread groove, the front end of the delivery cable 5 is provided with a connector 9 adapted to the second thread groove, the connector 9 is threadedly connected to the second thread groove, the lead body 1, the head end 2, the plug 3 and the delivery cable 5 are all arranged inside the sheath 4.

[0037] Furthermore, the front end of the sheath tube 4 is conical.

[0038] The working principle of the pacing electrode lead assembly of the present invention is:

[0039] The first connecting piece 22 included in the head end 2 is connected and fixed to the second connecting piece 6 at the front end of the wire body 1, and the connecting head 9 on the delivery cable 5 is connected and fixed to the second thread groove at the rear end of the first connecting piece 22. The head end 2 is retracted and sent into the sheath 4 through the delivery cable 5. The sheath 4 is implanted into the left ventricular cavity. The head end 2 is pushed out from the front end port of the sheath 4 through the delivery cable 5 to expose the sheath 4. The supporting device 21 is unfolded in the left ventricular cavity to form an umbrella structure and fit against the left ventricular cavity wall. The sheath 4 is gradually pulled out of the left ventricular cavity by pressing against the delivery cable 5. The delivery cable 5 is twisted to gradually separate the connecting head 9 from the second thread groove, and the delivery cable 5 is withdrawn.

[0040] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various changes and variations. Any modifications, equivalent substitutions, improvements, etc. made within the scope of the concept of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A pacing electrode lead assembly automatically fixed in the left ventricle, characterized in that: It comprises a wire body (1), a head end (2) and a plug (3) for connecting to a pulse generator; The wire body (1) is arranged between the plug (3) and the head end (2); the plug (3) and the rear end of the wire body (1) are integrally constructed; the front end of the wire body (1) is detachably connected to the head end (2); when the head end (2) reaches the left ventricular cavity, the head end (2) opens to form an umbrella-shaped structure; The head end (2) comprises a supporting device (21) and a first connecting piece (22); the front end of the wire body (1) is provided with a second connecting piece (6) adapted to the front end of the first connecting piece (22); The top of the support device (21) is provided with a through hole for accommodating the front end of the first connecting member (22) to pass through, and when the front end of the first connecting member (22) passes through the through hole and is connected to the second connecting member (6), the top of the support device (21) is fixed on the first connecting member (22); The supporting device (21) comprises an umbrella cover (212) and a keel (211); The umbrella cover (212) and the keel (211) are integrally constructed, and the through hole is provided at the top end of the keel (211); The material of the umbrella surface (212) is shape memory alloy.

2. The pacing electrode lead assembly according to claim 1, characterized in that: The front end of the first connecting member (22) is provided with a thread, and the second connecting member (6) is provided with a first thread groove adapted to the front end of the first connecting member (22).

3. The pacing electrode lead assembly according to claim 2, characterized in that: The diameter of the wire body (1) is 3.2 mm.

4. The pacing electrode lead assembly according to claim 3, characterized in that: A second thread groove is provided at the rear end of the first connecting member (22).

5. The pacing electrode lead assembly according to claim 4, characterized in that: The wire body (1) is provided with an electrode (7).

6. A pacing electrode lead assembly automatically fixed in the left ventricle, characterized in that: It comprises a sheath tube (4), a delivery cable (5) and a pacing electrode lead assembly automatically fixed in the left ventricle as claimed in any one of claims 1 to 5; The front end of the delivery cable (5) is provided with a connector (9) adapted to the second thread groove, and the connector (9) is detachably connected to the second thread groove. The automatic fixed head end left ventricular pacing electrode wire and the delivery cable (5) are both arranged inside the sheath tube (4).

7. The pacing electrode lead assembly according to claim 6, characterized in that: The front end of the sheath tube (4) is conical.

Citation Information

Patent Citations

  • Initiatively fix left room pacing electrode wire

    CN206239897U

  • Conducting-wire-free pacemaker and conducting-wire-free pacing system

    CN109568793A

  • Intravenously implanted automatic tip fixation biventricular synchronous pacing lead

    CN109621190A

  • Pace-making electrode wire automatically fixed in left ventricle and assembly of pace-making electrode wire

    CN211097047U