Pacemaker electrode lead

Abstract

The utility model relates to the technical field of medical instruments, in particular to a pacemaker electrode wire, which comprises a wire conduit, the wire conduit comprises a head part and a tail part which are connected with each other, the head part is provided with an electrode assembly, and the electrode assembly comprises a first electrode and a second electrode which are electrically connected with each other. The first electrode and the second electrode are arranged in a spaced mode in the direction from the head to the tail, and a fixing piece located between the first electrode and the second electrode is arranged on the outer side of the wire conduit. The head of the wire conduit can be sent to the right ventricular apex of the heart of a patient through vein puncture, and the fixing piece is in contact with and fixed to the surface of the endocardium, so that the first electrode is firmly fixed to the right ventricular apex, the electrode wire is kept stable in the heart of the patient, and the electrode wire is prevented from shifting or falling off; and the normal cardiac function of the patient is ensured.

Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of medical apparatus and instruments, especially a pacemaker electrode lead. BACKGROUND

[0002] A cardiac pacemaker is an electronic therapeutic instrument implanted in the human body, which sends out electric pulses provided by a battery through a pulse generator, conducts through a lead electrode, stimulates the myocardium contacted by the electrode, and makes the heart contract and contract, that is, simulates the impulse formation and conduction of the normal heart, so as to achieve the purpose of treating heart dysfunction caused by some arrhythmia.

[0003] In clinical practice, the electrode lead is generally sent into the distal end or right ventricular apex of the patient's heart through femoral vein, subclavian vein or internal jugular vein puncture, the electrode head is inserted into the right ventricular apex of the patient's heart under the guidance of X-ray perspective or electrocardiogram and embedded in the trabeculae carneae to contact the endocardium, after the electrode head is in place, the cardiac pacemaker can send out pulse current through the electrode lead to stimulate myocardial cell excitation and contraction, thereby maintaining the normal rhythm and function of the heart.

[0004] At present, the fixing methods of the cardiac pacemaker electrode in clinical practice include simple suture fixation and venous indwelling needle film fixation, and both of the two fixing methods have a high probability of electrode dislocation, that is, the electrode is easy to shift or fall off, the electrode dislocation will affect the heart function of the patient, increase the risk of cardiac arrest of the patient, and the patient needs to return to the intervention room to adjust the electrode position, which increases the risk of radiation of the patient and medical staff under X-ray, and additionally increases the pain and medical expenses of the patient.

[0005] The utility model is proposed in view of the deficiencies of the prior art. CONTENT OF THE UTILITY MODEL

[0006] The utility model provides a pacemaker electrode lead in view of the above-mentioned fixing method of the cardiac pacemaker electrode, which has a high probability of electrode dislocation, and the electrode is easy to shift or fall off, and the utility model provides a pacemaker electrode lead.

[0007] The utility model solves the technical problems by adopting the technical scheme of:

[0008] The pacemaker electrode lead comprises a lead pipe, the lead pipe comprises a head portion and a tail portion connected with each other, the head portion is provided with an electrode assembly, the electrode assembly comprises a first electrode and a second electrode connected with each other in electricity, the first electrode and the second electrode are arranged at intervals along the direction from the head portion to the tail portion, and the outer side of the lead pipe is provided with a fixing piece located between the first electrode and the second electrode.

[0009] The pacing electrode lead as claimed in any of the preceding claims, wherein the first electrode is arranged at an end of the head portion, the fixation member extends from the first electrode towards the second electrode, and the fixation member has a first preset angle with the lead tube.

[0010] The pacing electrode lead as claimed in any of the preceding claims, wherein a plurality of fixation members are arranged along a circumferential direction of the lead tube.

[0011] The pacing electrode lead as claimed in any of the preceding claims, wherein a plurality of fixation members are arranged in a layered structure between the first electrode and the second electrode, the layered structure comprises at least a first fixation member layer and a second fixation member layer, the first fixation member layer and the second fixation member layer are arranged along a circumferential direction of the lead tube, and the first fixation member layer and the second fixation member layer each comprise at least two fixation members.

[0012] The pacing electrode lead as claimed in any of the preceding claims, wherein the first preset angle between the fixation members in the first fixation member layer and the lead tube is greater than or equal to the first preset angle between the fixation members in the second fixation member layer and the lead tube, and the length of the fixation members in the first fixation member layer is less than or equal to the length of the fixation members in the second fixation member layer.

[0013] The pacing electrode lead as claimed in any of the preceding claims, wherein the lead tube is provided with a first guide wire channel for a guide wire to pass through, the first guide wire channel extends through the head portion and the tail portion, and the first guide wire channel is in communication with the outside.

[0014] The pacing electrode lead as claimed in any of the preceding claims, wherein the lead tube further comprises an outer tube layer, an inner tube layer, and a conductive layer arranged between the outer tube layer and the inner tube layer, the inner tube layer surrounds the first guide wire channel, the first electrode and the second electrode are arranged between the outer tube layer and the inner tube layer and are electrically connected to the conductive layer, the first electrode and the second electrode are exposed outside the outer tube layer, and the outer tube layer is arranged as an insulating layer.

[0015] The pacing electrode lead as claimed in any of the preceding claims, wherein the outer tube layer of at least the head portion of the lead tube is provided with a polyurethane coating layer, or the outer tube layer of at least the head portion of the lead tube is arranged as a polyurethane layer.

[0016] The pacing electrode lead as claimed in any of the preceding claims, wherein the tail portion is provided with a connecting seat at an end away from the head portion, the connecting seat is provided with a second guide wire channel in communication with the first guide wire channel, and the connecting seat is connected to a pacemaker through a connecting lead assembly at an end away from the tail portion.

[0017] The pacing electrode lead as described above, a second preset included angle is present between the head and the tail.

[0018] Compared with the prior art, the pacing electrode lead has the advantages that:

[0019] 1. The head of the lead tube can be sent into the right ventricular apex of the patient's heart through venous puncture, the fixing member contacts and fixes the endocardial surface, thereby firmly fixing the first electrode at the right ventricular apex, so that the electrode lead remains stable in the patient's heart, preventing the electrode lead from shifting or falling off, thereby ensuring normal heart function of the patient.

[0020] 2. The lead tube can be worn outside the guide wire through the first guide wire channel and pushed along the guide wire to the right ventricular apex, so as to implant the first electrode on the endocardium, and fix the first electrode on the endocardium through the fixing member. By providing the first guide wire channel in the lead tube, the operation difficulty of electrode lead implantation is reduced, making it easier for medical staff to operate.

[0021] 3. A second preset included angle is present between the head and the tail, and the head of the lead tube is bent relative to the tail, so that the head of the lead tube is more easily inserted into the right ventricular apex of the patient's heart, thereby enabling the first electrode to be more accurately implanted in the endocardium, further enhancing the stability of the first electrode fixed on the endocardium.

[0022] The utility model will be further described in connection with the drawings and specific embodiments. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 is a schematic view of embodiment one of the pacing electrode lead of the utility model;

[0024] Figure 2 is Figure 1 is an enlarged view of part A in the schematic view of embodiment one of the pacing electrode lead of the utility model;

[0025] Figure 3 is an internal structure view of the head of the lead tube of embodiment one of the utility model;

[0026] Figure 4 is an internal structure view of the tail of the lead tube of embodiment one of the utility model;

[0027] Figure 5 is a schematic view of embodiment two of the pacing electrode lead of the utility model;

[0028] Figure 6 is an internal structure view of the head of the lead tube of embodiment two of the utility model. DETAILED DESCRIPTION

[0029] The embodiments of the present application will be described in detail below with reference to the drawings.

[0030] Embodiment one:

[0031] As Figure 1 The utility model provides a kind of pacemaker electrode lead, including lead tube 100, the lead tube 100 includes the head 101 and tail 102 being connected, the head 101 is provided with electrode assembly 200, the electrode assembly 200 includes first electrode 210 and second electrode 220 being electrically connected, the first electrode 210 and second electrode 220 are spaced apart along the direction of the head 101 to the tail 102, the outside of the lead tube 100 is equipped with fixed piece 110 between the first electrode 210 and second electrode 220.In this embodiment, the head 101 of the lead tube 100 can be sent into the right ventricular apex of patient's heart by venous blood vessel puncture, the fixed piece 110 is in contact with endocardial surface and is fixed, so that the first electrode 210 is firmly fixed at the right ventricular apex, so that electrode lead remains stable in patient's heart, prevent electrode lead displacement or drop, to further guarantee the normal function of patient's heart.

[0032] In this embodiment, the first electrode 210 is arranged at the end of the head 101, and the first electrode 210 can be directly fixed at the right ventricular apex to realize the transmission of pulse current to the patient's heart by the electrode lead, increase the effectiveness of the electrode lead implanted in the patient's heart, so as to reduce the safety risk of the patient; further, as shown in Figure 3 The fixed piece 110 extends from the first electrode 210 to the second electrode 220, and the extension direction of the fixed piece 110 and the lead tube 100 has a first preset angle 111, that is, the fixed piece 110 is outwardly inclined relative to the lead tube 100, which is beneficial to increase the contact area of the fixed piece 110 and the endocardial surface, improve the stability of the electrode lead implanted in the patient's heart, thereby reducing the risk of electrode dislocation. Preferably, the fixed piece 110 is made of insulating material, such as polyurethane or the like, to facilitate the fixation of the first electrode 210 at the right ventricular apex and prevent the displacement or drop of the electrode lead. In clinic, the first preset angle 111 can be adjusted according to the specific condition of the patient and the experience of the operating doctor.

[0033] To further improve the stability of the electrode lead implanted in the patient's heart, in some embodiments, as Figure 2 And Figure 3As shown, the fixing member 110 is provided with a plurality of fixing members 110, and each fixing member 110 is arranged along the circumference of the lead tube 100; on this basis, in order to reduce the influence of the electrode lead implantation on the patient as much as possible, the fixing member 110 is provided with two fixing members 110, and the two fixing members 110 are symmetrically arranged on the outside of the head 101 of the lead tube 100, by increasing the contact area with the endocardium and the gripping force of the head 101 of the lead tube 100, the stability of the head 101 of the lead tube 100 fixed at the patient's heart is further improved, and the electrode lead is prevented from being displaced or falling off.

[0034] In some embodiments, the fixing member 110 is made of polyurethane or the like, so as to ensure the stable fixation and long-term safety of the electrode lead in the human body.

[0035] On the other hand, as shown in Figure 3 and Figure 4 The lead tube 100 is provided with a first guide wire channel 104 for the guide wire to pass through, the first guide wire channel 104 penetrates through the head 101 and the tail 102, and the first guide wire channel 104 is communicated with the outside; the first guide wire channel 104 can pass through the commonly used guide wire in clinic, such as loach guide wire, in the clinical process of implanting the cardiac pacemaker 500, the doctor sends the guide wire into the right ventricular apex through the corresponding venipuncture, the lead tube 100 can be worn outside the guide wire through the first guide wire channel 104, and under the pushing of the human force, the lead tube 100 is sent to the right ventricular apex along the guide wire, under the X-ray guidance, the doctor can adjust the orientation of the first electrode 210, and implant the first electrode 210 on the endocardium, and fix the first electrode 210 on the endocardium through the fixing member 110. By arranging the first guide wire channel 104 in the lead tube 100, the operation difficulty of the electrode lead implantation is reduced, and the medical staff is more easy to operate.

[0036] Further, as shown in Figure 2 and Figure 3As shown, the lead tube 100 further comprises an outer tube layer 120, an inner tube layer 130, and a conductive layer 140 arranged between the outer tube layer 120 and the inner tube layer 130, the inner tube layer 130 surrounds the first lead wire channel 104, the first electrode 210 and the second electrode 220 are arranged between the outer tube layer 120 and the inner tube layer 130 and are electrically connected with the conductive layer 140, the first electrode 210 and the second electrode 220 are exposed outside the outer tube layer 120, and the outer tube layer 120 is arranged as an insulating layer. In the embodiment, the first electrode 210 and the second electrode 220 are arranged as annular electrodes and are respectively embedded in the outer wall of the lead tube 100, and the outer diameters of the first electrode 210 and the second electrode 220 are substantially equal to the outer diameter of the outer tube layer 120, so as to facilitate the continuity and consistency of the outer periphery of the lead tube 100, and to enable the lead tube 100 to better pass through the corresponding venous blood vessels and be implanted into the human body; the first electrode 210 is arranged as a cathode, the second electrode 220 is arranged as an anode, the first electrode 210 and the second electrode 220 form a double-electrode head in the lead tube 100, the conductive layer 140 is electrically connected with the first electrode 210 and the second electrode 220, and the conductive layer 140 is used to conduct the pulse current emitted by the pacemaker 500 to the first electrode 210, so as to realize the transmission of the pulse current to the patient's heart through the first electrode 210. In addition, the first electrode 210 and the second electrode 220 are separated by part of the lead tube 100 to prevent short circuit.

[0037] Further, in order to protect the safety of the patient, the outer tube layer 120 and the inner tube layer 130 are arranged as insulating layers, the structural strength of the lead tube 100 is improved, electrical faults such as electric leakage and short circuit are prevented, the accurate transmission of the electrical signal is ensured, and the safety and effectiveness of the operation of the pacemaker 500 are ensured. In some embodiments, a polyurethane coating layer is arranged outside the outer tube layer 120 of at least the head 101 in the lead tube 100; or, the outer tube layer 120 of at least the head 101 in the lead tube 100 is arranged as a polyurethane layer. The polyurethane layer has excellent insulation, high temperature resistance, corrosion resistance and biocompatibility, and can ensure the long-term stable operation of the pacemaker 500 electrode lead and the safety of the patient. Preferably, the entire outer tube layer 120 is arranged as a polyurethane coating layer.

[0038] On the other hand, in this embodiment, one end of the lead tube 100 is provided with an electrode assembly 200, and the other end is connected to the pacemaker 500. Specifically, the end of the tail 102 away from the head 101 is provided with a connector 300. The connector 300 is provided with a second guidewire channel 310 communicating with the first guidewire channel 104. The end of the connector 300 away from the tail 102 is connected to the pacemaker 500 through a connecting lead assembly 400. The connecting lead assembly 400 includes a connecting lead 410 and a connector 420. The connecting lead 410 is connected between the connector 300 and the connector 420, and the connection point between the connector 410 and the connector 300 is located on one side of the second guidewire channel 310. The connector 420 is used to connect to the pacemaker 500, thereby electrically connecting the electrode lead to the pacemaker 500, thereby achieving the purpose of transmitting pulse current to the patient's heart through the electrode lead. The second guidewire channel 310 is used for the guidewire to pass through, so that medical staff can directly pull the guidewire out of the human body along the first guidewire channel 104 and the second guidewire channel 310, without affecting the connection between the lead tube 100 and the pacemaker 500, thus ensuring the normal operation of the pacemaker 500.

[0039] In some embodiments, such as Figure 1 As shown, in the lead wire 100, there is a second preset angle 103 between the head 101 and the tail 102. The head 101 of the lead wire 100 is curved relative to the tail 102, making it easier for the head 101 of the lead wire 100 to enter the apex of the right ventricle of the patient's heart. This allows the first electrode 210 to be implanted more accurately into the endocardium, further enhancing the stability of the first electrode 210 fixed in the endocardium. Preferably, the second preset angle 103 is 120°, allowing the electrode lead to better adapt to the shape of the heart, thereby accurately fixing the first electrode 210 in the endocardium, reducing the difficulty of electrode lead implantation, and preventing the first electrode 210 from shifting position. In actual operation, when the lead tube 100 is inserted through the first guidewire channel 104 outside the guidewire and into the blood vessel along the guidewire, the lead tube 100 is deformed into a roughly straight shape due to the restriction of the guidewire, so as to facilitate the lead tube 100 passing through the blood vessel smoothly. When the lead tube 100 reaches the apex of the right ventricle of the patient's heart and the guidewire is withdrawn, the head 101 of the lead tube 100 can spring back to form the second preset angle 103. Preferably, the outer tube layer 120 and the inner tube layer 130 of the lead tube 100 are made of polyurethane material, so that the lead tube 100 as a whole has good elasticity.

[0040] Example 2:

[0041] The difference between the second embodiment and the first embodiment is only that Figure 5 and Figure 6 As shown in the figure, the fixing members 110 are provided in layers between the first electrode 210 and the second electrode 220, and the layers include at least a first fixing member layer 112 and a second fixing member layer 113. The first fixing member layer 112 and the second fixing member layer 113 are arranged in a direction from the first electrode 210 to the second electrode 220. The first fixing member layer 112 and the second fixing member layer 113 each include at least two fixing members 110, and the fixing members 110 in the first fixing member layer 112 and the second fixing member layer 113 are arranged in a circumferential direction of the lead tube 100. In this embodiment, the first fixing member layer 112 includes two first fixing members 1121 symmetrically arranged at the outer periphery of the lead tube 100, and the second fixing member layer 113 includes two second fixing members 1131 symmetrically arranged at the outer periphery of the lead tube 100, so that the outer side of the head 101 of the lead tube 100 forms a double-layer structure of the fixing members 110, further increasing the contact area of the fixing members 110 with the endocardial surface, improving the stability of the electrode lead implanted in the heart of the patient, reducing the risk of electrode dislocation, forming a closer fit between the first electrode 210 and the endocardium, and reducing complications such as arrhythmia or failure of the pacemaker 500 caused by displacement of the electrode lead.

[0042] Further, the first preset angle 111 between the fixing members 110 in the first fixing member layer 112 and the lead tube 100 is greater than or equal to the first preset angle 111 between the fixing members 110 in the second fixing member layer 113 and the lead tube 100, i.e., the first fixing members 1121 and the second fixing members 1131 are arranged outwardly relative to the lead tube 100, and the first preset angle 111 between the first fixing members 1121 and the lead tube 100 is greater than the first preset angle 111 between the second fixing members 1131 and the lead tube 100, which can further improve the adhesion and grip of the head 101 of the lead tube 100 in the endocardium. In addition, the length of the fixing members 110 in the first fixing member layer 112 is less than or equal to the length of the fixing members 110 in the second fixing member layer 113, i.e., the length of the first fixing members 1121 is less than or equal to the length of the second fixing members 1131, so as to prevent the first fixing members 1121 from blocking the second fixing members 1131, thereby ensuring that the second fixing members 1131 can also be fixed in the endocardium.

[0043] The above only further illustrates the technical content of the utility model with examples, so that the reader can more easily understand, but does not represent that the embodiment of the utility model is limited to this, and any technical extension or re-creation made according to the utility model is protected by the utility model. The protection scope of the utility model is subject to the patent claim.

Claims

1. A pacemaker electrode lead, characterized by, The utility model provides a kind of lead tube (100), the lead tube (100) includes connected head (101) and tail (102), the head (101) is provided with electrode assembly (200), the electrode assembly (200) includes first electrode (210) and second electrode (220) are electrically connected, the first electrode (210) and second electrode (220) are spaced apart in the direction of the head (101) to the tail (102), the lead tube (100) outside is equipped with between the first electrode (210) and second electrode (220) fixing piece (110).

2. The pacemaker electrode lead of claim 1, wherein, The first electrode (210) is arranged at the end of the head (101), the fixing piece (110) extends from the first electrode (210) to the direction of the second electrode (220), and the extension direction of the fixing piece (110) has a first preset angle (111) with the lead tube (100).

3. The pacemaker electrode lead of claim 2, wherein, The fixing piece (110) is provided with several, and each fixing piece (110) is spaced apart along the circumference of the lead tube (100).

4. The pacemaker electrode lead of claim 2, wherein, The fixing piece (110) is provided with several, and each fixing piece (110) is arranged in a layered structure between the first electrode (210) and the second electrode (220), the layered structure includes at least a first fixing piece layer (112) and a second fixing piece layer (113), the first fixing piece layer (112) and the second fixing piece layer (113) are spaced apart from the first electrode (210) to the second electrode (220), and the first fixing piece layer (112) and the second fixing piece layer (113) each include at least two fixing pieces (110), the fixing pieces (110) in the first fixing piece layer (112) and the second fixing piece layer (113) are respectively spaced apart along the circumference of the lead tube (100).

5. The pacemaker electrode lead of claim 4, wherein the distal tip electrode is formed of a material selected from the group consisting of platinum, platinum-iridium, gold, silver, and alloys thereof. The first preset angle (111) between the fixing piece (110) in the first fixing piece layer (112) and the lead tube (100) is greater than or equal to the first preset angle (111) between the fixing piece (110) in the second fixing piece layer (113) and the lead tube (100). The length of the fixing piece (110) in the first fixing piece layer (112) is less than or equal to the length of the fixing piece (110) in the second fixing piece layer (113).

6. The pacemaker electrode lead of claim 1, wherein, The lead tube (100) is provided with a first guide wire channel (104) for the guide wire, the first guide wire channel (104) penetrates the head (101) and the tail (102), and the first guide wire channel (104) is connected with the outside.

7. The pacemaker electrode lead of claim 6, wherein, The lead tube (100) further comprises an outer tube layer (120), an inner tube layer (130), and a conductive layer (140) arranged between the outer tube layer (120) and the inner tube layer (130), the inner tube layer (130) surrounds the first lead wire channel (104), the first electrode (210) and the second electrode (220) are arranged between the outer tube layer (120) and the inner tube layer (130) and are electrically connected with the conductive layer (140), the first electrode (210) and the second electrode (220) are exposed outside the outer tube layer (120), and the outer tube layer (120) is arranged as an insulating layer.

8. The pacemaker electrode lead of claim 7, wherein, An outer tube layer (120) of at least the head portion (101) of the lead tube (100) is provided with a polyurethane coating layer outside the outer tube layer (120). Alternatively, an outer tube layer (120) of at least the head portion (101) of the lead tube (100) is arranged as a polyurethane layer.

9. The pacemaker electrode lead of claim 6, wherein, An end of the tail portion (102) away from the head portion (101) is provided with a connecting seat (300), the connecting seat (300) is provided with a second lead wire channel (310) in communication with the first lead wire channel (104), and the connecting seat (300) is connected with a pacemaker through a connecting lead wire assembly (400) at an end away from the tail portion (102).

10. The pacemaker electrode lead of any of claims 1-9, wherein, A second preset included angle (103) exists between the head portion (101) and the tail portion (102).

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