A lead for pacing

Abstract

The application relates to a lead for pacing, comprising an insulation layer, an electrode head assembly and an anchoring member, the electrode head assembly comprising an operating part and an electrode head, the electrode head being arranged at the distal end of the operating part, the electrode head assembly being movable relative to the insulation layer between a first position and a second position, the electrode head assembly in the first position being located in the insulation layer, the electrode head assembly in the second position, the electrode head extending out of the insulation layer, the electrode head being a non-smooth surface, and the area of the minimum cross section of the electrode head being 4.0mm 2 The lead for pacing of the application is arranged with a non-smooth surface of the electrode head, so that the electrode head can be slowly inserted into the interventricular septal myocardial tissue and easily screwed in even without a tapered structure. The arrangement can ensure that the cross section is not similar to a tapered structure with a small cross section area, so that the electrode head is not easy to break when inserted into the cardiac tissue, and the removal of the lead causes less damage to the normal myocardium due to the small cross section area.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of implantable medical devices, in particular to a lead for pacing applied to the left bundle branch conduction area of the heart. BACKGROUND

[0002] Implanting a permanent cardiac pacemaker is an effective and mature technical means for treating arrhythmia diseases. Usually, a cardiac pacing lead is implanted in the right ventricular apex or septal myocardial tissue to pace the local myocardium in the form of electrical pulses. However, years of clinical practice have found that this traditional right ventricular myocardial pacing method can cause electrical asynchrony between the left and right ventricles, increasing the risk of long-term chronic heart failure or atrial fibrillation in patients. In 2017, scholars first threaded a cardiac pacing lead through the interventricular septum of the heart and directly paced the left bundle branch conduction system under the endocardial surface of the left ventricle (rather than only acting on the myocardial tissue), thereby pioneering a physiological left bundle branch area pacing (LBBAP) method. This pacing method can ensure that the electrical pulses directly pace the normal electrical conduction system of the heart, so that the left ventricular contraction remains synchronized, and is currently considered the most feasible, most promising, and effective physiological pacing method.

[0003] The cardiac pacing lead currently used for LBBAP in clinical practice is a spiral active lead (model 3830) produced by Medtronic Company. Clinical practice shows that its limitations mainly include: 1) it is relatively difficult to twist the pacing lead into the left bundle branch area deep in the interventricular septum: the lead as a whole is relatively soft, and the overall support is weak. The myocardial tissue wrapped around the inside of the spiral will block the lead from entering deeper into the septal myocardium. When the support of the outer sheath is insufficient or the angle of the septum is not correct, the lead cannot be twisted into a deeper interventricular septal area. 2) long-term removal is difficult, and the damage to the myocardium is large: since the lead head is completely twisted deep into the interventricular septum, the design of the head spiral ensures that the lead is secure, but the problem is that the surrounding myocardium and fibrous tissue are repeatedly entangled with the spiral wire, making it extremely difficult to remove the spiral active lead implanted in the left bundle branch area. If forcibly removed, the damage area to the interventricular septum is large. SUMMARY

[0004] In order to overcome at least one of the defects of the prior art described above, the purpose of the present application is to provide a lead for pacing which is relatively easy to insert into the target tissue, not easy to break, and the damage to the myocardium is as small as possible during long-term removal.

[0005] The lead for pacing provided by the present application comprises an insulation layer, an electrode head assembly and an anchoring member, the electrode head assembly comprises an operating part and an electrode head, the electrode head is arranged at the distal end of the operating part, the electrode head assembly can move relative to the insulation layer between a first position and a second position, the electrode head assembly in the first position is located in the insulation layer, the electrode head of the electrode head assembly in the second position extends out of the insulation layer, the electrode head is not a smooth surface, and the area of the minimum cross section of the electrode head is 4.0mm 2 .

[0006] Optionally, the electrode head extends helically around an electrode head axis, the electrode head axis extends from the proximal end to the distal end.

[0007] Optionally, the electrode head comprises a body, the outside of the body is formed with a first thread, or

[0008] The outside of the body is formed with a protrusion, the protrusion gradually decreases from inside to outside, and the protrusion extends helically from the proximal end of the body to the distal end around the outside of the body.

[0009] Optionally, the distance of the electrode head in the second position extending out of the insulation layer is greater than the distance of the anchoring member extending out of the insulation layer.

[0010] Optionally, the insulation layer is formed with a mounting channel to mount the electrode head assembly, wherein the proximal end of the operating part is formed with a second thread, the mounting channel is formed with a third thread to threadedly connect with the operating part; the electrode head assembly can be moved from the first position to the second position by rotating the operating part relative to the mounting channel.

[0011] Optionally, it further comprises a mounting member, the distal end of the mounting member can be clamped with the proximal end of the operating part, and the operating part is rotated into the mounting channel by rotating the mounting member to drive the operating part to rotate.

[0012] Optionally, the outer diameter of the electrode head is 0.8-1.0mm, and the outer diameter of the operating part is 3.2mm.

[0013] Optionally, the outer diameter of the operating part is the same as that of the electrode head, and the operating part is formed with a non-smooth surface consistent with the electrode head.

[0014] Optionally, the anchoring member is in a spiral shape.

[0015] Optionally, when the anchoring member is used to secure the pacing lead to the heart tissue, the electrode head assembly can be rotated to move from the first position to the second position for insertion into the heart tissue.

[0016] The pacing lead of this application has a non-smooth electrode tip, which allows for slow insertion into the heart tissue even without a tapered structure. This design ensures that its cross-section does not have the small cross-sectional area characteristic of a tapered structure, reducing the risk of breakage during insertion into the heart tissue. Furthermore, the electrode tip of this disclosure is relatively non-sharp, eliminating the need for additional development of a specific delivery sheath to protect the lead before delivery to the heart tissue. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figures 1-3 A schematic diagram of the structure of a pacing lead in different states in one embodiment is shown.

[0019] Figures 4-6 A schematic diagram of the structure of a local pacing lead in a different state in another embodiment is shown.

[0020] Figure 7 This is a schematic diagram of the structure of a pacing lead according to another embodiment of the present disclosure.

[0021] Figure 8 for Figure 7 Enlarged view of part B in the image.

[0022] Figure 9 This is a partial structural diagram of a pacing lead according to one embodiment of the present disclosure.

[0023] Figure 10 for Figure 9 Enlarged view of a local structure.

[0024] Figure 11 This is an electrode head assembly according to another embodiment of the present disclosure.

[0025] Figure 12 This is an electrode head assembly in one embodiment of the present disclosure.

[0026] Figure 13Structure diagram of the lead for pacing in another embodiment of the present disclosure.

[0027] Figure 14 Structure diagram of the mounting member.

[0028] Figure 15 Structure diagram of the lead for pacing in another embodiment of the present disclosure. Figure 13 Structure diagram of the lead for pacing in another embodiment of the present disclosure

[0029] Identified in the figure: 1, insulating layer; 11, fixing member; 2, electrode head assembly; 21, operating part; 210, mounting channel; 211, first mounting channel area; 212, second mounting channel area; 213, first groove; 214, second thread; 22, electrode head; 221, first thread; 222, body; 223, electrode head axis; 23, proximal end part; 3, anchoring member; 4, mounting member; 410, mounting protrusion. DETAILED DESCRIPTION

[0030] In order to make the objects, technical solutions and advantages of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0031] In the description of the present application, it should be understood that the orientations or positional relationships indicated by the terms "X-axis", "Y-axis", "Z-axis", "vertical", "parallel", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements indicated must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second" are only for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features limited by "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, unless otherwise specified, the meaning of "a plurality of" is two or more.

[0032] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0033] It's important to note that, unlike traditional pacing methods, LBBAP directly paces the left bundle branch conduction system beneath the endocardial surface of the left ventricle. This method ensures that the electrical pulses travel along the heart's normal conduction system, maintaining synchronized left ventricular contraction. It is currently considered the most feasible, promising, and effective physiological pacing method. In contrast, with left bundle branch pacing, the pacing lead is inserted via the venous system and reaches the right side of the interventricular septum. The electrode tip is then moved forward until it reaches the left bundle branch region. At this point, the electrode tip needs to move approximately 10mm within the myocardial tissue to reach the left bundle branch region. For most pacing leads, the user needs to apply force from the proximal end to push the distal electrode tip, which is approximately 52-58cm long. Therefore, the operation is quite challenging, and there is a high risk of misplacement or damage to the electrode tip during this process. To address the issue of damaged electrode tips, the common practice is to increase the diameter of the electrode tip to enhance its strength, but this approach would cause greater damage to the human body.

[0034] To address the above problems, this disclosure provides a lead for pacing, such as... Figures 1-6 As shown, the conductor includes: an insulating layer 1, an electrode head assembly 2, and an anchoring member 3. The electrode head assembly 2 includes an operating part 21 and an electrode head 22. The electrode head assembly 2 is movable relative to the insulating layer 1 between a first position and a second position. In the first position, the electrode head assembly 2 is located inside the insulating layer 1. In the second position, the electrode head 22 extends outside the insulating layer 1. The electrode head 22 is not a smooth surface, and the minimum cross-sectional area of ​​the electrode head 22 is 4.0 mm². 2 .

[0035] In some alternative implementations, such as Figure 7 and Figure 8As shown, the electrode head 22 is not a smooth surface because it includes a body 222. A first thread 221 is formed on the outer side of the body 222. More specifically, a protrusion is formed on the outer side of the body 222, gradually decreasing in size from the inside out, and spiraling from the proximal end of the electrode head 22 towards the distal end. More specifically, the body 222 of the electrode head 22 has a cylindrical structure with the first thread 221 or the aforementioned protrusion for cutting. The advantage of this design is that when the distal end of the electrode head 22 contacts the myocardial tissue, rotating the electrode head 22 allows it to cut the myocardial tissue through the first thread 221 or the protrusion, enabling the electrode head 22 to be smoothly inserted into the myocardial tissue. Furthermore, when the electrode head 22 is inserted into the myocardial tissue, it cuts circumferentially through rotation, eliminating the need for a tapered head. This reduces the cross-sectional area of ​​the electrode head 22, making it less likely to be damaged during insertion and remain in the myocardial tissue.

[0036] For ease of understanding, in this disclosure Figures 1-7 The diagram is marked with a first direction A, which extends from the proximal end to the distal end of the pacing lead. The cross-section is perpendicular to the first direction A.

[0037] and Figure 8 The difference in the illustrated structure is that, in some alternative embodiments, the electrode head 22 extends helically around an electrode head axis 223, which extends from the proximal end to the distal end. More specifically, as shown... Figure 9 and Figure 10 As shown, the electrode head axis 223 is located on the central axis of the insulating layer and extends from the proximal end to the distal end. The middle portion of the electrode head 22 can be hollow. Therefore, the electrode head is formed by spirally extending around the central axis of the insulating layer. In this embodiment, since the electrode head 22 itself no longer needs a columnar body, the outer diameter of the spiral electrode head 22 (i.e., the distance between the two outer edges of the electrode head where a straight line passing through the center intersects the electrode head) can be smaller, resulting in a smaller cross-sectional area and less damage to the body. It should be noted that the cross-section of the electrode head mentioned above is perpendicular to the electrode head axis 223. Furthermore, as... Figure 10 As shown, the electrode head 22 gradually tapers from the inside to the outside. The inside of the electrode head 22 refers to the side facing the electrode head axis 223, and the outside of the electrode head 22 refers to the side facing away from the electrode head axis 223. It should be noted that for ease of drawing, the electrode head axis 223 is entirely exposed outside the electrode head 22, but in reality, this electrode head axis 223 is located inside the electrode head 22, specifically at its center. This electrode head axis 223 can be a virtual axis. Furthermore, in some embodiments, it is possible that the electrode head axis 223 is an actual linear object.

[0038] Optionally, the electrode head 22 in the second position extends outwardly from the insulating layer 1 by a distance greater than the distance by which the anchoring member 3 extends outwardly from the insulating layer 1. It should be noted that the anchoring member 3 is mainly used to preliminarily fix the pacing lead of the present disclosure in the myocardial tissue. The electrode head 22, however, needs to be inserted into the myocardial tissue to the left bundle branch area for pacing in the left bundle branch area. Therefore, the anchoring member 3 does not need to be inserted deeply into the myocardial tissue, thereby avoiding greater damage to the myocardial tissue. Specifically, the electrode head 22 extends outwardly by about 10 mm.

[0039] Since the pacing lead of the present disclosure adopts the cylindrical electrode head 22 with lateral cutting protrusions or a spiral electrode head, mainly relying on the cutting force caused by rotation to be inserted into the myocardial tissue, the outer diameter of the electrode head 22 of the present disclosure can be set to be smaller and will not easily break. Specifically, the outer diameter of the electrode head 22 of the present disclosure is 0.8-1.0 mm. In addition, the outer diameter of the operating portion 21 is 3.2 mm.

[0040] Specifically, reference can be made to Figure 1 Under normal circumstances, the electrode head 22 is located in the insulating layer 1, i.e., in the first position. After rotation, the electrode head 22 can be rotated forward to be inserted into the myocardial tissue. At this time, since the anchoring member 3 is first fixed in the myocardial tissue, the electrode head 22 is not easy to deviate when being rotated and inserted into the myocardial tissue. Figure 2 This is a partial structure diagram of the pacing lead when the electrode head 22 moves to the distal end. At this time, the electrode head 22 has already extended outwardly from the insulating layer 1, but has not yet reached the terminal point and can still move to the distal end. Figure 3 This is a partial structure diagram of the pacing lead when the electrode head 22 reaches the terminal point. At this time, the electrode head 22 has reached the second position.

[0041] Optionally, the insulating layer 1 is formed with a mounting channel 210 to mount the electrode head assembly 2. Among them, as shown in Figure 11As shown, a second thread is formed at the proximal end of the operating part 21. A third thread is formed in the mounting channel 210 for threaded connection with the operating part 21. First, the mounting channel 210 has a guiding function, used to guide the movement of the electrode head assembly 2. Second, since the operating part 21 is threadedly connected to the mounting channel 210, the movement of the operating part 21 and the electrode head 22 within the mounting channel 210 is restricted. More specifically, the operating part 21 needs to be continuously rotated to screw it into the mounting channel 210, at which point the electrode head 22, located at the distal end of the operating part 21, can move further away. This ensures that the electrode head 22 moves in a rotational manner, preventing damage caused by direct forward movement under force. More specifically, the user can rotate the operating part 21 relative to the mounting channel 210 to move the entire electrode head assembly 2 towards the distal end, allowing the electrode head assembly 2 to move from a first position to a second position, causing the electrode head 22 to extend beyond the insulating layer 1. At the same time, the entire electrode head assembly 2 can be moved toward the proximal end by rotating the operating part 21 in the opposite direction relative to the mounting channel 210. Thus, the electrode head assembly 2 can be moved from the second position to the first position, so that the electrode head 22 can be retracted back into the insulating layer 1.

[0042] Furthermore, the mounting channel has a third thread for threaded connection with the operating part 21.

[0043] In some alternative implementations, such as Figure 12 As shown, the operating portion 21 of the electrode head assembly 2 has the same outer diameter as the electrode head 22, and the operating portion 21 has a non-smooth surface consistent with that of the electrode head 22. It should be noted that, for ease of manufacturing, the operating portion 21 and the electrode head 22 are normally integrally formed. For example, if the electrode head 22 is a cylindrical body with a first thread formed on its outer side, then the operating portion 21 will also be a cylindrical structure with a thread formed on its outer side. When the electrode head has a helical structure, the operating portion will also be a helical structure. It should be noted that for... Figure 12 The electrode head assembly 2 shown can be categorized as follows: the portion of the electrode head assembly 2 extending out of the insulating layer 1 in the second position can be considered as the electrode head 22, and the portion located within the insulating layer 1 can be considered as the operating part 21. The outer diameter of the electrode head 22 and the operating part in the electrode head assembly 2 is 0.8-1.0 mm.

[0044] Furthermore, in some alternative embodiments, the outer diameter of the electrode head 22 is small, making operation extremely difficult if the outer diameter of the entire electrode head assembly 2 is the same. In other embodiments, the outer diameter of the operating part 21 is large, allowing the user to grip and rotate the larger cross-sectional area of ​​the operating part 21, thereby rotating the electrode head 22. Optionally, the outer diameter of the electrode head is 0.8-1.0 mm, and the outer diameter of the operating part is 3.2 mm.

[0045] More specifically, for the electrode tip assembly with different outer diameters of the electrode tip and the operating portion, as shown in Figures 4-5 The installation channel 210 can optionally comprise a first installation channel region 211 and a second installation channel region 212, which are sequentially communicated from the distal end to the proximal end. The first installation channel region 211 is used for installing the electrode tip 22, and the second installation channel region 212 is used for installing the operating portion 21. The inner diameter of the first installation channel region 211 is substantially the same as the diameter of the electrode tip 22, and the inner diameter of the second installation channel region 212 is substantially the same as the operating portion 21. Therefore, when the electrode tip assembly 2 continues to rotate forward to a certain distance, the operating portion 21 cannot be inserted into the first installation channel region 211, thereby limiting the electrode tip assembly 2 from continuing to move forward.

[0046] In addition, for the electrode tip assembly with the same outer diameters of the electrode tip and the operating portion, as shown in Figures 1-3 The installation channel 210 can optionally be a channel extending from the proximal end to the distal end with a consistent inner diameter. Specifically, a threaded or spiral channel can be formed in the installation channel 210 to allow the electrode tip assembly 2 to only advance to the distal end or retreat by rotating, so as to ensure that the advancing manner of the electrode tip assembly 2 is not directly forward or backward, thereby reducing the possibility of damage to the electrode tip.

[0047] Optionally, as shown in Figures 13-15 The lead for pacing further comprises a mounting member 4, the distal end of which can be clamped with the proximal end of the operating portion 21. The operating portion 21 is rotated by rotating the mounting member 4 to make the operating portion 21 rotate into the installation channel to the distal end. Specifically, the proximal end of the operating portion 21 is formed with a first groove 213, and the distal end of the mounting member 4 is provided with a mounting protrusion 410. The first groove 213 and the mounting protrusion 410 are matched in shape, and the mounting member 4 and the operating portion 21 are mounted together through the mounting protrusion 410 and the first groove 213. The user can rotate the mounting member 4 to drive the operating portion 21 to rotate. The cross section of the mounting protrusion 410 can be rectangular, pentagonal, triangular, etc., which is not circular. Specifically, the side wall of the mounting member 4 is provided with a second groove for installing a sealing ring, and the mounting member 4 is sealed and fitted with the installation channel through the sealing ring to install and fix the mounting member 4.

[0048] For the electrode tip assembly 2 as shown in Figure 12 The proximal end of the electrode tip assembly 2 can be formed with a proximal end portion 23, which is formed with a groove to clamp with the mounting protrusion 410 of the mounting member 4.

[0049] In some embodiments, the insulation layer 1 is formed with a first cathode interface, a second cathode interface, a first anode interface, and a second anode interface, wherein the first cathode interface and the second cathode interface are in communication through a cathode conductive coil inside the insulation layer 1. The first anode interface and the second anode interface are in communication through an anode conductive coil inside the insulation layer 1. It is noted that when the electrode head 22 of the lead wire is inserted into the left bundle branch region of the myocardium, the proximal end of the lead wire is connected to the pulse generator. At this time, the pulse generator contacts and communicates with the first cathode interface and the first anode interface at the proximal end. When the electrode head 22 moves distally to contact the left bundle branch region, the electrode head 22 contacts the second cathode interface at the distal end of the insulation layer 1. At the same time, since the second anode interface is located on the outside of the lead wire, the blood outside the lead wire communicates the second cathode interface and the second anode interface, so that the left bundle branch region and the pulse generator form a loop, thereby allowing the pulse generator to deliver electrical pulses to the left bundle branch region. In addition, the pacing coil is composed of an anode conductive coil and a cathode conductive coil, which is a hollow coil shape formed by winding multiple steel wires or copper wires, has conductivity, and ensures that the pulse generator current reaches the electrode head 22 to play a pacing function.

[0050] It is noted that the energization method of the electrode head 22 is various and is not limited to the conventional energization method described above. In addition, the energization position of the electrode head 22 is not limited to the left bundle branch region, and it can be electrically shocked to other regions in the myocardium according to different situations.

[0051] In addition, in order to facilitate installation, a fixing member 11 can be provided on the outside of the proximal end of the lead wire to connect with the pulse generator.

[0052] Optionally, the material of the electrode head 22 is nickel alloy, and the material of the anchoring member 3 is titanium nitride plated platinum alloy.

[0053] In some embodiments, when the anchoring member 3 is used to fix the lead wire for pacing to the heart tissue, the rotatable electrode head assembly 2 is moved from the first position to the second position to be inserted into the heart tissue. As described above, in some embodiments, the operation part 21 of the electrode head assembly 2 is threadedly connected with the installation channel, so that the user can rotate the electrode head assembly 2 to rotate forward and advance distally, thereby moving from the first position to the second position and allowing the electrode head 22 to leak out of the insulation layer 1.

[0054] It is noted that the proximal end is the end close to the user of the lead wire, and the distal end is the end away from the user of the lead wire (i.e., close to the heart).

[0055] In use, first, the lead for pacing of the present disclosure is sent into the body through the venous system, in particular, the distal end of the lead reaches the right myocardial surface of the interventricular septum under the guidance of a 9Fr inner diameter sheath. First, rotate the lead operation part 21, the helical anchoring member 3 at the distal end thereof can be embedded in the myocardium for preliminary anchoring. Then, the proximal end of the electrode head assembly 2 is inserted with the mounting piece 4, and is uniformly rotated so that the electrode head assembly 2 and the insulating layer 1 rotate relative to each other, and then the electrode head assembly 2 is helically moved to the distal end and gradually rotated out to the depth of the interventricular septum, and stops after reaching the left bundle branch area.

[0056] Optionally, the length of the insulating layer 1 is 60 cm, and the inner diameter is 2.4 mm. The insulating layer 1 is made of a biocompatible and blood compatible insulating material, such as polylactic acid, polyurethane material, etc., to ensure the electrical insulation of the whole lead and to be safe for use in the human body.

[0057] In addition, the helical distribution density of the anchoring member 3 is relatively low, while the distribution density of the first thread 221 of the electrode head 22 is relatively high or the helical density of the electrode head 22 is relatively high, in particular, the pitch of the first thread 221 of the electrode head 22 (or the pitch of the helix of the electrode head) is greater than the pitch of the anchoring member 3. The pitch refers to the distance between two adjacent helical peaks in the same direction on the helical line.

[0058] Moreover, the anchoring member 3 and the electrode head 22 are both coated with dexamethasone acetate, which helps to reduce the pacing threshold of the lead contacting the myocardium and reduce the threshold fluctuation range. The combination of the above different materials ensures that the whole pacing lead has moderate hardness, certain supporting force and flexibility, and small surface friction.

[0059] The lead for pacing of the present disclosure applied to LBBAP has the following advantages: (1) easy to access the left bundle branch area in the deep interventricular septum, and simple operation. Specifically, the tight thread 221 structure on the electrode head 22 can effectively provide radial cutting force to screw into the deep interventricular septum by twisting at the proximal end of the lead; (2) long-term pacing is stable and not easy to dislodge, and the tight thread 221 design of the lead that enters the interventricular septal myocardial tissue and the contact surface of the interventricular septal myocardium is not easy to break: the material selected for the entire pacing lead ensures that it has moderate hardness, certain support and flexibility, and the surface of the insulating layer 1 is smooth and has small friction, the design of the helical anchoring member 3 at the distal end of the lead plus the electrode head assembly 2 with external threads 221 can ensure stability and will not be displaced due to the spontaneous contraction and diastole of the heart; (3) long-term removal is convenient and has little damage to the myocardium. Specifically, the distal end of the lead can be screwed into the deep myocardial tissue through the external thread 221 of the head electrode, so the diameter is small and it can be directly pulled out. And after pulling out, since the contraction of the interventricular septal myocardium itself will drive the closure of its pull-out hole, the damage is relatively small. And the outer spiral anchoring member 3 only enters the right superficial part of the interventricular septum, which will only damage the local myocardium on the right surface, and the right ventricular hemodynamics is slower than the left ventricle, and is venous blood, which generally will not cause serious embolic events due to inflammatory reaction; (4) compatible with all existing pulse generator types on the market: the design of the proximal end of the lead connects the pulse generator end, which can retain the original interface design, so it can be directly applied to the existing pulse generator type, without the need for additional research and development of new supporting pulse generator lead interface.

[0060] It should be understood that the above-described figures and specific embodiments described in the detailed description are only exemplary embodiments of the present application, and are not exhaustive of the possible embodiments of the present application, and those skilled in the art can make various modifications to the above-described specific embodiments within the scope of the present application without departing from the spirit of the present application.

Claims

1. A pacing lead, comprising: An insulating layer, an electrode head assembly, and an anchoring member are characterized in that the electrode head assembly includes an operating part and an electrode head, the electrode head being disposed at the distal end of the operating part, and the electrode head assembly being movable relative to the insulating layer between a first position and a second position. In the first position, the electrode head assembly is located within the insulating layer; in the second position, the electrode head of the electrode head assembly extends beyond the insulating layer, the electrode head is not a smooth surface, and the minimum cross-sectional area of ​​the electrode head is 4.0 mm². 2 ,in, The electrode head includes a body, on the outer side of which a protrusion is formed. The protrusion gradually decreases in size from the inside to the outside and extends spirally from the proximal end of the body to the distal end around the outer side of the body. Alternatively, the electrode head extends spirally around the electrode head axis, which extends from the proximal end to the distal end and the electrode head gradually decreases in size from the inside to the outside. When the electrode head is inserted into the myocardial tissue, it is inserted into the myocardial tissue by rotating and circumferentially cutting; The electrode head has a non-conical structure; The insulating layer forms a mounting channel for mounting the electrode head assembly, wherein the proximal end of the operating part forms a second thread, and the mounting channel forms a third thread for threaded connection with the operating part; by rotating the operating part relative to the mounting channel, the electrode head assembly can be moved from the first position to the second position.

2. The pacing lead according to claim 1, characterized in that, The distance by which the electrode head in the second position extends beyond the insulating layer is greater than the distance by which the anchoring member extends beyond the insulating layer.

3. The pacing lead according to claim 1, characterized in that, It also includes a mounting component, the distal end of which can engage with the proximal end of the operating part. By rotating the mounting component, the operating part is rotated so that the operating part is screwed into the mounting channel.

4. The pacing lead according to claim 1, characterized in that, The outer diameter of the electrode head is 0.8-1.0 mm, and the outer diameter of the operating part is 3.2 mm.

5. The pacing lead according to claim 1, characterized in that, The operating part has the same outer diameter as the electrode head, and the operating part has a non-smooth surface consistent with the electrode head.

6. The pacing lead according to claim 1, characterized in that, The anchoring component is spiral-shaped.

7. The pacing lead according to any one of claims 1-6, characterized in that, When the anchoring member is used to secure the pacing lead to the heart tissue, the electrode head assembly can be rotated to move the electrode head assembly from the first position to the second position for insertion into the heart tissue.

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