Medical electrode wire

Abstract

The present invention relates to a medical electrode wire, comprising a wire distal end, the wire distal end comprising a head end portion, the head end portion comprising an electrode, the electrode is used to axially extend out of the head end portion to engage a target tissue, and the electrode has a variable outer diameter; when engaging the target tissue, the electrode wire causes less trauma to the target tissue and has higher safety.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a medical electrode lead. Background Art

[0002] The heart is the center of the human circulatory system. It includes an electromechanical system that performs two main pumping functions. The left half of the heart, including the left atrium (LA) and the left ventricle (LV), extracts oxygenated blood from the lungs and pumps it into the organs of the human body to provide them with their metabolic needs for oxygen. The right half of the heart, including the right atrium (RA) and the right ventricle (RV), extracts deoxygenated blood from the organs of the body and pumps it into the lungs, where the blood is oxygenated. These pumping functions are caused by the contraction of the myocardium (heart muscle). In a normal heart, the sinoatrial node (SA node), the natural pacemaker of the heart, generates an electrical pulse called an action potential, which is propagated to various regions of the heart through a natural electrical conduction path to stimulate the myocardial tissue of the heart. For example, the action potential originating from the SA node propagates to the ventricular muscle through the atrioventricular node (AV), the bundle of His (also called Bundle of His), the bundle branch and the Purkinje (Purkinje) fiber, thereby causing the coordinated contraction of the two ventricles.

[0003] Traditional right ventricular apical pacing can cause ventricular electromechanical asynchrony and ventricular remodeling. Long-term pacing can have adverse effects on cardiac function and even increase the mortality rate of patients. His bundle pacing maintains the normal ventricular electrical activation sequence and synchronization of ventricular contraction. It is an ideal physiological pacing method and has become a research hotspot in the field of pacing. However, it still has defects such as difficult operation, high pacing threshold, and difficulty in ensuring long-term safety, and its clinical application is subject to certain restrictions. Especially for patients whose partial block site is below or more distal to the His bundle, how to safely and physiologically achieve conduction bundle pacing across the block site is the biggest difficulty in clinical practice. Left and right bundle branch pacing makes up for the shortcomings of His bundle pacing and is another major innovation in the field of pacing.

[0004] Whether it is His bundle pacing or left and right bundle branch pacing, or pacing at other locations, it is necessary to implant electrode leads. The electrodes at the head of these electrode leads are usually constructed as spiral structures or needle structures to engage the treatment site. However, these electrode leads, especially the electrode leads for pacing the His bundle and left and right bundle branches, still have the following problems in actual use:

[0005] (1) When a spiral structure is used, the spiral will cause greater trauma when it is rotated into the treatment site (such as the myocardium, ventricular septum, and atrial septum);

[0006] (2) When a needle-like structure is used, since the needle-like structure contacts the treatment site through a point in the radial direction, the contact area is small, the positioning effect is poor, and it is easy to cause displacement. In addition, it is easy to scratch the myocardium during the beating of the heart, and it is also easy to break and remain in the treatment site, resulting in low safety and reliability. Summary of the invention

[0007] In order to solve at least one of the above technical problems, the purpose of the present invention is to provide a medical electrode wire that can ensure that the head end does not cause major trauma when connected to the target tissue, can be firmly positioned, and reduces the risk of electrode breakage, thereby improving the safety and reliability of the operation.

[0008] In order to achieve the above objectives, the present invention provides a medical electrode wire, including a wire distal end, the wire distal end including a head end portion, the head end portion including an electrode, the electrode is used to axially extend out of the head end portion to engage a target tissue, and the electrode has a varying outer diameter.

[0009] Optionally, the outer diameter of the proximal portion of the electrode is greater than the outer diameter of the distal portion.

[0010] Optionally, the outer diameter of the electrode decreases gradually from the proximal part to the distal part, or the outer diameter of the electrode first increases and then decreases from the proximal part to the distal part, or the outer diameter of the proximal part of the electrode is the same or decreases gradually and the outer diameter of the distal part of the electrode is the same.

[0011] Optionally, the distal portion of the electrode is configured to be at least partially disposed distal to the proximal portion, and the distal portion is configured to be stationary or movable relative to the proximal portion.

[0012] Optionally, the head end portion further includes a base, the base is used to be connected to the wire, and the electrode is connected to the base; the proximal portion and the distal portion are connected as a whole, the proximal end of the proximal portion is fixedly connected to the base, the distal end of the proximal portion is fixedly connected to the proximal end of the distal portion, and the base is used to drive the electrode to extend or retract the head end portion.

[0013] Optionally, the electrode is configured as a variable diameter spiral structure.

[0014] Optionally, the head end portion also includes a base, the base is used to connect to the wire, and the electrode is connected to the base; the proximal portion is arranged outside the distal portion and fixedly arranged; the distal portion passes through the proximal portion and is fixedly connected to the base at the proximal end; the base is used to drive the distal portion to extend or retract the head end portion, and the distal end of the proximal portion extends out of the head end portion.

[0015] Optionally, the proximal portion is divided into a spiral structure, and the distal portion is divided into a puncture structure; the spiral structure is arranged outside the puncture structure and fixedly arranged; the puncture structure passes through the spiral structure and is fixedly connected to the base at the proximal end; the base is used to drive the puncture structure to extend or retract the head end portion, and the spiral structure extends out of the head end portion by at least part of its length.

[0016] Optionally, the spiral structure is a variable diameter spiral or a constant diameter spiral.

[0017] Optionally, the puncture structure is configured as an elastic structure.

[0018] Optionally, the puncture structure is formed by spirally winding or braiding a single or multiple metal wires, or the puncture structure is a bellows structure.

[0019] Optionally, the head end component further comprises a guide liner, a buffer support, a head end buffer and a jacket; the jacket has an axially through inner cavity; the base can be movably accommodated in the inner cavity; the buffer support is tubular and is arranged at the distal end of the jacket and fixedly connected to the jacket, a part of the buffer support is inserted into the jacket, and the other part is exposed outside the jacket and sleeved on the head end buffer; the proximal end face of the head end buffer is sealed and fixedly connected to the distal end face of the jacket; the guide liner is located between the buffer support and the puncture structure, and is fixedly connected to the buffer support and coaxially arranged;

[0020] The spiral structure is arranged on the guide lining, and the proximal end of the spiral structure is fixedly connected to the guide lining and / or the buffer support; the puncture structure passes through the spiral structure, the guide lining and the buffer support in sequence and then is fixedly connected to the base.

[0021] Optionally, when the spiral structure is an equal-diameter spiral, the length of the distal end of the spiral structure extending beyond the head end portion is 1 to 3 spiral turns.

[0022] Optionally, the distal end of the spiral structure extends beyond the head end portion by a length of 1.5 spiral turns.

[0023] Optionally, the head end portion also includes a head end buffer, a buffer support, a sleeve and a base; the sleeve has an axially through-going inner cavity; the base can be movably accommodated in the inner cavity and is used to connect to the wire; the electrode is connected to the base; the buffer support is tubular and is arranged at the distal end of the sleeve and is fixedly connected to the sleeve, a part of the buffer support is inserted into the sleeve, and the other part is exposed outside the sleeve and is sleeved on the head end buffer; the proximal end face of the head end buffer is sealed and fixedly connected to the distal end face of the sleeve, and the buffer support is configured to limit the maximum displacement of the base toward the distal end.

[0024] Optionally, the sleeve includes a main body and a distal extension portion located at the distal end of the main body, the outer diameter of the distal extension portion is smaller than the outer diameter of the distal end of the main body; the buffer support member has an annular flange and an axial extension portion, the proximal surface of the annular flange is in contact with the distal surface of the distal extension portion, the axial extension portion is inserted into the sleeve, the head end buffer member is sleeved on the annular flange and the distal extension portion, and the outer diameter of the annular flange is the same as the outer diameter of the distal extension portion.

[0025] Optionally, the head end portion also includes a ring electrode, a ring electrode support, a sleeve and a base; the sleeve has an axially through-going inner cavity; the base can be movably accommodated in the inner cavity and is used to connect with the wire; the electrode is connected to the base; the ring electrode is sleeved on the proximal end of the sleeve; the ring electrode support is tubular and is arranged at the proximal end of the sleeve, the ring electrode support is fixedly connected to the proximal end of the sleeve and is located on the inner side of the ring electrode for support; and the ring electrode support is configured to limit the maximum displacement of the base toward the proximal end.

[0026] Optionally, the sleeve includes a main body and a proximal extension located at the proximal end of the main body, the outer diameter of the proximal extension is smaller than the outer diameter of the proximal end of the main body; the ring electrode is sleeved on the proximal extension, and the ring electrode support has an annular flange and an axial extension, a portion of the surface of the annular flange is sunken and the proximal extension is placed, and another portion of the surface of the annular flange is in contact with the inner surface of the ring electrode.

[0027] Optionally, the head end portion further includes a sleeve, a base and a guide structure, the sleeve having an axially through inner cavity; the base can be movably accommodated in the inner cavity and used to connect to the wire; the electrode is connected to the base; and the guide structure is used to guide the movement of the base.

[0028] Optionally, the guide structure includes a guide spring, and at least a portion of the surface of the base is provided with a guide groove, and the guide groove cooperates with the guide spring; or, the guide structure includes a spiral groove, and one of the base and the sleeve is provided with the spiral groove, and the other is provided with a guide protrusion that cooperates with the spiral groove.

[0029] Optionally, the outer shell is made of polymer material.

[0030] Optionally, the electrode is made of an elastic material, and / or the electrode is a spiral structure, and different outer diameter parts of the spiral structure have different pitches.

[0031] Because the above-mentioned medical electrode wire has a variable outer diameter, especially when the outer diameter of the distal part is smaller than the outer diameter of the proximal part, compared with the existing electrode structure of the same size, this electrode causes less trauma to the target tissue when engaging the target tissue, and has higher safety and reliability. In particular, when the outer diameter of the distal part of the electrode is smaller than the outer diameter of the proximal part, the small outer diameter of the distal part of the electrode acts on the target tissue first, and the large outer diameter of the proximal part acts on the target tissue later, which causes less trauma to the target tissue.

[0032] When the above-mentioned medical electrode wire adopts a spiral structure and a puncture structure, the cooperation of the puncture structure and the spiral structure can achieve a firm positioning of the distal end of the wire, and it is not easy to cause displacement. Especially when the puncture structure is an elastic structure, the puncture structure has good toughness, is not easy to scratch the myocardium, and is not easy to break. Therefore, it has high safety and reliability.

[0033] The outer sheath of the above-mentioned medical electrode wire is made of polymer material and constitutes an insulating shell alone, without the need for a metal sheath and insulating rubber or silicone sheaths inside and outside the metal sheath. Such a structure not only simplifies the structure of the distal end of the wire and reduces the difficulty of manufacturing, but also avoids the risk of leakage caused by damage to the insulating rubber or silicone sheath. At the same time, it also improves the flexibility of the distal end of the wire, improves the pushing performance and delivery performance during the implantation of the electrode wire, and reduces the risk of the outer sheath penetrating the target tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation of the present invention.

[0035] Figure 1 is a schematic structural diagram of a medical electrode lead provided in Embodiment 1 of the present invention, wherein the electrode extends out of the head end portion;

[0036] Figure 2 is a schematic structural diagram of a medical electrode lead provided in Embodiment 1 of the present invention, wherein the electrode is retracted into the head end portion;

[0037] Figure 3 is a schematic structural diagram of a head end portion provided in Embodiment 1 of the present invention, wherein an electrode extends out of the head end portion;

[0038] Figure 4 yes Figure 3 An axial cross-sectional view of the head end portion shown along the line AA;

[0039] Figure 5 1 is a schematic diagram of the structure of a medical electrode lead provided in Embodiment 1 of the present invention, wherein the electrode extends out of the head end portion, and a broken line is used to indicate the length of the proximal end of the lead;

[0040] Figure 6 yes Figure 5 The axial cross-sectional view of the medical electrode wire shown is cut along the BB line;

[0041] Figure 7 is a schematic structural diagram of a medical electrode lead provided in Embodiment 2 of the present invention, wherein the puncture structure extends out of the head end portion;

[0042] Figure 8 is a schematic structural diagram of a medical electrode lead provided in Embodiment 2 of the present invention, wherein the puncture structure is retracted into the head end portion;

[0043] Fig. 9 is a schematic structural diagram of the head end portion provided in the second embodiment of the present invention, wherein the puncture structure extends out of the head end portion;

[0044] Fig.10 yes Fig. 9 An axial cross-sectional view of the head end portion shown along the CC line;

[0045] Fig.11 1 is a schematic diagram of the structure of a medical electrode wire provided in Embodiment 2 of the present invention, wherein the puncture structure extends out of the head end portion, and a break line is used to indicate the length of the proximal end of the wire;

[0046] Fig.12 yes Fig.11 The axial cross-sectional view of the medical electrode wire cut along the DD line shown;

[0047] Fig.13 is a schematic diagram of inserting a guide wire into the superior vena cava in an embodiment of the present invention;

[0048] Fig.14 is a schematic diagram of advancing the guide sheath along the guide wire and reaching the right ventricle in an embodiment of the present invention;

[0049] Fig.15 It is a schematic diagram of the medical electrode wire in the second embodiment of the present invention being installed into the guide sheath and pushed to the right ventricle, and the spiral structure being screwed into the ventricular septum;

[0050] Fig.16 is a schematic diagram of puncturing a puncture structure into the interventricular septum in an embodiment of the present invention;

[0051] Fig.17 is a schematic diagram of the medical electrode wire in Embodiment 2 being implanted into the heart after the guide sheath is withdrawn in the embodiment of the present invention;

[0052] Fig.18 It is a schematic diagram of the medical electrode wire in Example 1 being implanted into the heart after the guide sheath is withdrawn in an embodiment of the present invention.

[0053] In the figure:

[0054] 1-guide wire; 2-guide sheath;

[0055] 10-the first type of medical electrode wire; 11-the proximal end of the wire; 12-the distal end of the wire; 13, 21-the head end portion; 131-the variable diameter spiral structure; 132, 214-the outer jacket; 133, 213-the base; 134, 215-the head end buffer; 135, 216-the buffer support; 136, 217-the ring electrode; 137, 218-the ring electrode support; 138, 219-the guide spring; 220-the guide lining; 111-the connector needle; 112-the inner wire;

[0056] 20 - the second type of medical electrode wire; 211 - spiral structure; 212 - puncture structure. DETAILED DESCRIPTION

[0057] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the accompanying drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0058] In this document, the terms "proximal" and "distal" refer to the relative orientation, relative position, and direction of elements or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" and "proximal portion" generally refer to the end of the medical device that is close to the doctor during normal operation, while "distal" and "distal portion" generally refer to the end that first enters the patient's body. As used in this specification, the singular forms "a", "an", and "the" include plural objects unless the context clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or" unless the context clearly indicates otherwise.

[0059] The present invention relates to an implantable medical electrode lead, which includes a lead distal end, the lead distal end includes a head end portion, the head end portion includes an electrode with a variable outer diameter, and the electrode axially extends out of the head end portion to engage a target tissue, thereby transmitting electrical stimulation to the target tissue or receiving an electrical signal from the target tissue. It should be understood that the medical electrode lead of the present invention may include a system of components on its proximal end, which is mainly suitable for connection and electrical communication with a defibrillator, a pacemaker or other electrical stimulation devices, and the present invention does not involve improvements to the system, so it will not be described in detail. Moreover, when the medical electrode lead is used for cardiac pacing, it can be His bundle pacing, left and right bundle branch pacing or pacing at other locations in the heart, and the present application does not limit it.

[0060] In more detail, the head end portion of the medical electrode wire of the present invention generally further includes a jacket and a base, wherein the jacket has an axially through inner cavity, wherein the base can be movably accommodated in the inner cavity, wherein the base is used to connect with the wire to transmit electrical signals, and wherein the electrode is connected with the base and is used to axially extend the head end portion to engage the target tissue, wherein the target tissue is, for example, the atrial septum, the ventricular septum, the right ventricular apex or other suitable position. In particular, the electrode has a variable outer diameter, so that the electrode causes less trauma to the target tissue after being implanted in the target tissue, thereby improving the safety of the operation and facilitating the improvement of the treatment effect.

[0061] In a preferred embodiment, the outer diameter of the distal portion of the electrode is smaller than the outer diameter of the proximal portion, so that the distal portion can enter the target tissue more smoothly and cause less damage to the target tissue. The present invention does not limit the setting mode in which the outer diameter of the proximal portion of the electrode is smaller than the outer diameter of the distal portion. Generally, the outer diameter of the electrode can be reduced from the proximal portion to the distal portion. For example, the outer diameter of the electrode decreases from the proximal portion to the distal portion, or first decreases and then remains unchanged, or first remains unchanged and then decreases in sequence, or first remains unchanged, then decreases in sequence and then remains unchanged again, or first increases and then decreases, or other changes; no matter which change mode, it is only necessary to ensure that the outer diameter of the distal portion of the electrode is the smallest. Moreover, the change in the outer diameter of the electrode can be one or a combination of uniform and non-uniform; "uniform" means that the outer diameter changes continuously without sudden changes, so that the outer surface of the electrode transitions smoothly; "non-uniform" means that there is a sudden change in the outer diameter, so that there are steps on the outer surface of the electrode.

[0062] The electrode can be an integrated structure or a split structure. "Integrated structure" means that the electrode is composed of one component as a whole; "split structure" means that the electrode is composed of two components, and the two components can move relative to each other.

[0063] When the electrode is an integrated structure, the electrode is constructed as a variable diameter spiral structure, which can be formed by spirally winding the body or by cutting a metal pipe. The outer diameters of the variable diameter spiral structure are different, and preferably the outer diameter of the distal part is smaller than the outer diameter of the proximal part. The variable diameter spiral structure can be understood as the proximal part and the distal part of the electrode being connected as one. Further, the proximal end of the proximal part is fixedly connected to the base, and the distal end of the proximal part is fixedly connected to the proximal end of the distal part. The base drives the entire variable diameter spiral structure to extend or retract the head end part, so that the variable diameter spiral structure is engaged with the target tissue, and the distal end of the wire is positioned and fixed to the target tissue. The outer diameter of the variable diameter spiral structure can be changed in the manner described above or in other suitable ways. Preferably, the outer diameter of the variable diameter spiral structure decreases from the proximal part to the distal part in sequence. At this time, the outer diameter of the variable diameter spiral structure is smaller and the damage to the target tissue is minimized. Compared with the equal diameter spiral of the same size, this variable diameter spiral structure has less trauma to the myocardium and can also be firmly positioned in the myocardium, so it has better safety and reliability.

[0064] When the electrode is a split structure, the electrode is constructed to include a spiral structure and a puncture structure, and the outer diameter of the puncture structure is smaller than the inner diameter of the spiral structure, so that the puncture structure penetrates the spiral structure and moves relative to the spiral structure. Specifically, the spiral structure is arranged outside the puncture structure and fixedly arranged; the puncture structure passes through the spiral structure and is fixedly connected to the base at the proximal end; the base drives the puncture structure to extend or retract the head end portion, and the distal end of the spiral structure extends from the head end portion to engage the target tissue. Of course, the puncture structure is also used to puncture the target tissue. At this time, it can be understood that the puncture structure is the distal end portion of the electrode, and the spiral structure is the proximal end portion of the electrode. When the puncture structure extends from the head end portion, at least a part of the length of the puncture structure is located at the distal end of the spiral structure. When the puncture structure retracts the head end portion, the entire length of the puncture structure is located inside the spiral structure. This electrode penetrates the target tissue through the needle-like puncture structure on the one hand, and engages with the target tissue with the help of a part of the length of the spiral structure, so that the distal end of the wire can be firmly positioned, and the trauma to the target tissue is also small.

[0065] In a preferred embodiment, the puncture structure is configured as an elastic structure to enhance the toughness and elasticity of the puncture structure, reduce the risk of its breakage, and avoid scratching the myocardium during the beating of the heart, with better safety and reliability. The present application does not limit the elasticity of the puncture structure. For example, the puncture structure is formed by spirally winding or weaving a single or multiple metal wires, or the puncture structure is made by a bellows structure. It should be understood that the puncture structure of the present application is small in size, roughly as thin as a puncture needle. In addition, it should also be understood that the spiral structure in this scheme can be a constant diameter spiral or a variable diameter spiral. The variable diameter spiral can extend the entire length or part of the length of the head end portion, and the constant diameter spiral only extends a shorter length of the head end portion, for example, 1 to 3 turns of the spiral are exposed to the outside and can engage with the myocardium, and more preferably 1.5 turns of the spiral are exposed to the outside.

[0066] Next, the structure and operation mode of the medical electrode lead proposed by the present invention will be described in more detail in conjunction with the accompanying drawings and preferred embodiments.

[0067] <Example 1>

[0068] Figure 1 and Figure 2 This is a front view of the medical electrode lead 10 according to the first embodiment of the present invention, wherein Figure 1 The variable diameter spiral structure in the medical electrode wire 10 extends out of the head end portion, Figure 2 The diameter-reducing spiral structure in the medical electrode wire 10 is retracted into the head end portion.

[0069] like Figure 1 and Figure 2 As shown, this embodiment relates to a first medical electrode wire 10, including a wire proximal end 11 and a wire distal end 12. A head end portion 13 is provided at the wire distal end 12, and the head end portion 13 includes an electrode. In this embodiment, the electrode is constructed as an integrated variable diameter spiral structure 131. The variable diameter spiral structure 131 is designed to extend axially out of the head end portion 13 to engage the patient's myocardium, such as the ventricular septum, the atrial septum, etc. The variable diameter spiral structure 131 can also be retracted into the head end portion 13.

[0070] In operation, the connector needle 111 at the proximal end 11 of the wire can be rotated to drive the components at the head end portion 13, and finally the reducing helical structure 131 extends out of the head end portion 13 or retracts into the head end portion 13. Figure 2 As shown, when the variable diameter spiral structure 131 is not screwed out, it is located inside the head end portion 13; Figure 1 As shown, if the proximal connector needle 111 is operated, the reducing helical structure 131 is screwed out of the head end portion 13. The rotational extension of the reducing helical structure 131 can engage (ie, screw into) the myocardium of the patient.

[0071] It should be understood that the proximal end 11 of the lead generally includes a system of components or parts that can be divided into three categories, including: internal components regarding the inner conductor, external components regarding the outer conductor, and insulating components for electrically separating the internal components from the external components.

[0072] refer to Figure 5 and Figure 6 , the internal components may include a connector needle 111 and an internal wire 112. The distal end of the connector needle 111 is mechanically and electrically connected to the internal wire 112, and is electrically connected to the base at the distal end 12 of the wire through the internal wire 112; the proximal end of the connector needle 111 can be configured to be electrically engaged with a defibrillator, a pacemaker or other electrical stimulation device, and to transmit electrical pulses to the internal wire 112. The external components include a ring connector and an external wire, the ring connector is mechanically and electrically connected to the external wire, and is electrically connected to the ring electrode at the distal end through the external wire. The internal and external components can be substantially electrically separated by an insulating component. Since the present invention does not involve improvements to these internal components, external components and insulating components, the structures of these components will not be described in detail.

[0073] refer to Figure 3 and Figure 4 , the head end portion 13 at the distal end 12 of the wire is described in detail. The head end portion 13 includes a jacket 132, a base 133, and a variable diameter spiral structure 131. The jacket 132 has an axially through inner cavity (not marked), and the base 133 can be movably accommodated in the inner cavity of the jacket 132. The base 133 is used to mechanically and electrically connect with the internal wire 112. The proximal end of the variable diameter spiral structure 131 is connected to the base 133 (including mechanical and electrical connections), so that the base 133 drives the variable diameter spiral structure 131 to extend or retract the head end portion 13.

[0074] In a preferred embodiment, the outer jacket 132 is made of a polymer material, and the specific material is not limited, so that the outer jacket 132 alone constitutes an insulating shell, and there is no need to configure a metal sleeve and an insulating rubber or silicone sleeve inside and outside the metal sleeve. Such a structure not only simplifies the structure of the distal end of the wire and reduces the difficulty of manufacturing, but also avoids the risk of leakage caused by damage to the insulating rubber or silicone sleeve, and also improves the flexibility of the distal end of the wire, and improves the pushing performance and delivery performance during the electrode wire implantation process. The outer jacket 132 is generally cylindrical, and can also be truncated.

[0075] The base 133 is mainly made of conductive materials, including but not limited to stainless steel, or precious metals (platinum or iridium), or metal alloys (platinum-iridium alloy or nickel-cobalt alloy), or other conductive, biocompatible materials. The base 133 is generally cylindrical and may have a proximal shaft portion to engage the internal wire 112, and the internal wire 112 is sleeved on the proximal shaft portion. In addition, the base 113 may also have a distal shaft portion, and the variable diameter spiral structure 131 is sleeved on the distal shaft portion and fixedly connected (such as fixedly connected by welding, crimping, etc.). An annular flange may be formed between the proximal shaft portion and the distal shaft portion of the base 133, and a structure that cooperates with the guide groove or the guide protrusion may be formed on the annular flange.

[0076] In this embodiment, the outer diameter of the variable diameter spiral structure 131 decreases from the proximal part to the distal part, so that the outer diameter of the distal part of the variable diameter spiral structure 131 is the smallest. Here, the outer diameter of the variable diameter spiral structure 131 can be gradually reduced from the proximal part to the distal part, or it can be increased first and then reduced. It can also be a constant diameter section, a variable diameter section and a constant diameter section from the proximal part to the distal part. It can also be a constant diameter section and a variable diameter section from the proximal part to the distal part. The variable diameter section has an outer diameter that decreases from the proximal part to the distal part, and the outer diameter of the connection between the constant diameter section and the variable diameter section is equal. It is not limited to this, and it can also be other transformation methods. The present application does not limit this. It should be understood that this variable diameter spiral structure 131 has a small outer diameter, so that it causes less trauma to the tissue after being screwed into the myocardium, so the damage to the myocardium is minimized, and it can also be firmly positioned. The material of the variable diameter spiral structure 131 is a conductive material, such as stainless steel, platinum or iridium metal or an alloy of the two or other conductive materials, and the surface of the variable diameter spiral structure 131 is preferably covered with a titanium nitride coating. Preferably, the variable diameter spiral structure 131 is made of elastic material, and more preferably, the pitches of the parts with different outer diameters are different, so as to achieve the effect of different stiffness of the parts with different outer diameters, thereby ensuring penetration and toughness.

[0077] Continue to refer Figure 3 and Figure 4, the head end portion 13 also includes a head end buffer 134. The head end buffer 134 is joined to the distal end of the outer sleeve 132. The head end buffer 134 can make the distal end 12 of the wire form a non-traumatic head, minimizing the trauma to blood vessels and tissues. The head end buffer 134 is a polymer material, and the specific material is not limited. It can usually be formed by injection molding, biocompatible, and elastic materials. The outer surface of the head end buffer 134 is generally cylindrical, or it can be truncated. Preferably, the proximal outer diameter of the head end buffer 134 is the same as the distal outer diameter of the outer sleeve 132. The head end buffer 134 is provided with a through inner cavity. When the variable diameter spiral structure 131 extends out, the inner cavity of the head end buffer 134 can accommodate at least part of the variable diameter spiral structure 131. The head end buffer 134 is sealed and fixedly connected to the outer sleeve 132, preferably by glue, a cross-linking agent, a mechanical method, etc.

[0078] In a preferred embodiment, the head end portion 13 further includes a buffer support 135, and the head end buffer 134 is used to be sleeved on the buffer support 135, and the buffer support 135 is fixedly connected to the outer sleeve 132. Such a structure enhances the stability of the connection and makes it difficult for the head end buffer 134 to fall off. The buffer support 135 is tubular, and the inner cavity of the buffer support 135 is axially connected to the inner cavity of the head end buffer 134, so that the variable diameter spiral structure 131 can be extended and retracted in these inner cavities. More specifically, the buffer support 135 is arranged at the distal end of the outer sleeve 132, a part of the buffer support 135 is inserted into the outer sleeve 132 and fixedly connected to the outer sleeve 132, and the other part is exposed outside the outer sleeve 132 and sleeved on the head end buffer 134. The proximal end face of the head end buffer 134 is preferably sealed and fixedly connected to the distal end face of the outer sleeve 132. More preferably, the buffer support 135 is configured to limit the maximum displacement of the base 133 toward the distal end of the wire, that is, to limit the maximum length of the variable diameter spiral structure 131 extending out of the head end portion 13, thereby limiting the length of its rotation into the myocardium, which is safer and more convenient to operate.

[0079] The head end portion 13 preferably also includes a ring electrode 136 for sensing ECG signals, and the variable diameter spiral structure 131 is mainly used to transmit electrical stimulation signals to the myocardium. The ring electrode 136 is sleeved on the proximal end of the jacket 132. The jacket 132 may include a body and a proximal extension (not marked) located at the proximal end of the body, and the outer diameter of the proximal extension is smaller than the outer diameter of the proximal end of the body of the jacket 132. The ring electrode 136 is sleeved on the proximal extension. The jacket 132 may also include a distal extension located at the distal end of its body, the outer diameter of the distal extension is smaller than the outer diameter of the distal end of the body of the jacket 132, and the distal extension is used to sleeve at least a portion of the length of the head end buffer 134. The material of the ring electrode 136 is a conductive material, such as stainless steel, platinum or iridium metal or an alloy of the two or other conductive materials. Preferably, the surface of the ring electrode 136 is covered with a titanium nitride coating.

[0080] Further, if Figure 4 As shown, the buffer support 135 has an annular flange and an axial extension portion, the proximal surface of the annular flange of the buffer support 135 abuts against the distal surface of the distal extension portion of the outer sleeve 132 (preferably fixedly connected, such as bonding or other suitable methods), the axial extension portion of the buffer support 135 is inserted into the outer sleeve 132, the head end buffer 134 is sleeved on the annular flange of the buffer support 135 and the distal extension portion of the outer sleeve 132, and the outer diameter of the annular flange of the buffer support 135 is preferably the same as the outer diameter of the distal extension portion of the outer sleeve 132.

[0081] Further, the head end portion 13 further includes a ring electrode support 137, a portion of the ring electrode 136 is sleeved on the ring electrode support 137, and the ring electrode support 137 is fixedly connected to the outer sleeve 132. With such a structure, the ring electrode support 137 supports the inner side of the ring electrode 136, thereby enhancing the stability of the connection and preventing the ring electrode 136 from falling off easily. Preferably, the ring electrode support 137 is configured to limit the maximum displacement of the base 133 toward the proximal end of the wire, so as to ensure that the variable diameter spiral structure 131 can be fully retracted into the head end portion 13. For example, when the distal end surface of the annular flange of the base 133 contacts the proximal end surface of the buffer support 135, it indicates that the variable diameter spiral structure 131 has been extended to the maximum length, and when the proximal end surface of the annular flange of the base 133 contacts the distal end surface of the ring electrode support 137, it indicates that the variable diameter spiral structure 131 has been fully retracted into the head end portion 13.

[0082] Further, the ring electrode support 137 has an annular flange and an axial extension (see Figure 4 , not marked), a portion of the surface of the annular flange of the ring electrode support 137 sinks and is placed on the proximal extension of the outer sleeve 132, and another portion of the surface of the annular flange of the ring electrode support 137 is in contact with the inner surface of the ring electrode 136 (preferably fixedly connected). The buffer support 135 and the ring electrode support 137 are both insulators, preferably made of a polymer material with good biocompatibility.

[0083] In a preferred embodiment, the head end portion 13 further includes a guide structure for guiding the movement of the base 133 to control the movement direction of the base 133 and avoid deviation. In this embodiment, the guide structure includes a guide spring 138, and at least a portion of the surface of the base 133 is provided with a guide groove, and the guide groove cooperates with the guide spring 138 to make the base 133 move forward or backward along the guide spring 138. For example, the guide groove can be provided on the surface of the annular flange of the base 133. Of course, in other embodiments, the guide groove can also be used to replace the guide spring 138. Specifically, the spiral guide groove (i.e., the spiral groove) is provided on the inner wall of the outer sleeve 132. In this case, at least a portion of the surface of the base 133 is provided with a guide protrusion that cooperates with the spiral guide groove. In this embodiment, the guide spring 138 is fixed on the inner wall of the outer sleeve 132, and the guide spring 138 can extend from the proximal end to the distal end of the outer sleeve 132. The guide spring 138 can be connected to the outer sleeve 132 by injection molding or by glue. The material of the guide spring 138 is preferably a metal material with good wear resistance, such as stainless steel or nickel-cobalt-chromium alloy.

[0084] The present application does not limit the connection method between the internal wire 112 and the base 133, and the connection method between the base 133 and the variable diameter spiral structure 131. For example, these components can be connected by welding or crimping. In actual operation, when the connector needle 111 is rotated, the internal wire 112, the base 133 and the variable diameter spiral 131 can be rotated together, so that the base 131 moves forward or backward along the axial direction of the outer sleeve 132, so that the variable diameter spiral structure 131 is screwed into or out of the head end portion 13. The conductive material and structure of the internal wire 112 are not limited, such as stainless steel or nickel-cobalt-chromium alloy.

[0085] <Example 2>

[0086] Figure 7 and Figure 8 FIG. 2 is a front view of a medical electrode wire 20 according to a second embodiment of the present invention, wherein Figure 7 The puncture structure of the medical electrode wire 20 extends out of the head end portion, Figure 8 The puncture structure in the medical electrode wire 20 is retracted into the head end portion, Fig. 9 is a schematic structural diagram of the head end portion of the second embodiment of the present invention, Fig.10 yes Fig. 9 The axial cross-sectional view of the head end portion cut along the CC line is shown. Fig.11 is a schematic structural diagram of a medical electrode lead according to a second embodiment of the present invention, Fig.12 yes Fig.11 The shown figure is an axial cross-sectional view of the medical electrode wire cut along the DD line.

[0087] like Figures 7 to 12As shown, this embodiment relates to a second medical electrode wire 20, including a wire proximal end 11 and a wire distal end 12. A head end portion 21 is provided at the wire distal end 12. The following mainly describes the parts different from the first embodiment, and the same parts can refer to the first embodiment.

[0088] The head end portion 21 includes a split electrode, the proximal end portion of the electrode is configured as a spiral structure 211, and the spiral structure 211 is formed by spirally winding the body or cutting the tube; the distal end portion of the electrode is configured as a puncture structure 212. The spiral structure 211 is arranged outside the puncture structure 212 and is fixedly arranged. The puncture structure 212 passes through the spiral structure 211 and is fixedly connected to the base 213 at the proximal end. The base 213 drives the puncture structure 212 to extend or retract the head end portion 21, and the distal end of the spiral structure 211 extends out of the head end portion 21. Here, the spiral structure 211 can be a spiral of equal diameter or a spiral of variable diameter; if the spiral structure 211 is a spiral of variable diameter, the way of changing the outer diameter can refer to the spiral structure 131 of the first embodiment; if the spiral structure 211 is a spiral of equal diameter, the outer diameter of the spiral structure 211 is the same. In addition, only a part of the spiral of the spiral structure 211 extends out of the head end portion 21, preferably 1 to 3 turns of the spiral extend out of the head end portion 21, and more preferably 1.5 turns of the spiral extend out of the head end portion 21, so as to further reduce the size of the electrode implanted in the myocardium and reduce the trauma to the myocardium. The puncture structure 212 usually has a sharper head and can smoothly penetrate the myocardium, such as the ventricular septum and the atrial septum. The puncture structure 212 is generally slender and small in size.

[0089] Preferably, the puncture structure 212 is configured as an elastic structure. Preferably, the spiral structure 211 is made of an elastic material, and more preferably, the pitches of the parts of the spiral structure 211 with different outer diameters are different. It should be understood that the existing needle-shaped electrodes used for puncture are usually simple hard puncture needles, which are easy to scratch the heart when the heart moves, while the puncture structure 212 of the present application is elastic and softer than the hard puncture needle. While ensuring sufficient penetrating power, it also has excellent toughness. During the beating of the heart, it is not easy to scratch the myocardium, and it has good toughness and is not easy to break. Furthermore, the puncture structure 212 can be formed by a single or multiple metal wires spirally wound or woven, or by a metal bellows. Moreover, the puncture structure 212 cooperates with the spiral structure 211 for positioning, and the positioning effect is good.

[0090] like Fig.10As shown, the head end portion 21 of the present embodiment may also include a base 213, a sleeve 214, a guide structure (such as the guide spring 318 of the first embodiment), a head end buffer 215, a buffer support 216, a ring electrode 217 and a ring electrode support 218. The implementation methods of these components are generally the same as those of the first embodiment, but it should not be absolutely understood that the structures of these components are exactly the same as the structures of the corresponding components in the first embodiment. In fact, certain differences are allowed in the details to match the structural changes of different parts, but these changes in details are easy to implement by those skilled in the art on the basis of the contents disclosed in this application, so these changes in details are not described in detail.

[0091] In this embodiment, the spiral structure 211 is arranged on a guide liner 220, and the guide liner 220 is fixedly connected to the buffer support 216 and arranged coaxially. The guide liner 220 has an axially through inner hole so that the puncture structure 212 can pass through. The guide liner 220 is located between the buffer support 216 and the puncture structure 212. The spiral structure 211 is sleeved on the guide liner 220, and the proximal end of the spiral structure 211 is fixedly connected to the guide liner 220 and / or the buffer support 216 (such as welding, crimping, etc.). During assembly, the puncture structure 212 passes through the spiral structure 211, the guide liner 220 and the buffer support 216 in sequence and is fixedly connected to the base 213. The distal end of the base 213 can provide a mounting hole, and the proximal end of the puncture structure 212 is inserted into the mounting hole and fixedly connected. During operation, when the connector needle 111 rotates, the internal wire 112, the base 231 and the puncture structure 212 rotate together, while the spiral structure 211 remains stationary. The entire electrode wire is rotated to drive the spiral structure 211 to rotate into or out of the myocardium. The guide liner 220 can guide the movement of the puncture structure 212 to prevent deviation. The material of the guide liner 220 is preferably a polymer material.

[0092] <Example 3>

[0093] This embodiment further illustrates the surgical operation process in combination with any of the above-mentioned medical electrode wires.

[0094] It should be understood that the medical electrode lead 10 in the first embodiment can be implanted and positioned using a plastic steel wire, and the operation method is similar to the traditional pacing electrode lead implantation process, and a guide sheath can also be used for guidance and positioning; while the medical electrode lead 20 in the second embodiment needs to be guided and positioned using a guide sheath. The plastic steel wire is inserted into the medical electrode lead, which is a conventional surgical operation method and will not be described in detail.

[0095] When the guiding sheath tube 2 is used for guiding and positioning, taking the medical electrode wire 20 in the second embodiment as an example, the surgical process is as follows:

[0096] The operator first inserts a guidewire 1 through the superior vena cava (SVC). Fig.13 Then, the guide sheath 2 is inserted along the guide wire 1. During this process, the guide sheath 2 is slowly moved under the X-ray, and the guide sheath 2 is slowly sent into the right ventricle (RV) through the right atrium (RA), as shown in FIG. Fig.14 As shown; when the guide sheath 2 reaches the appropriate position, remove the guide wire 1 ( Fig.14 (not shown), the medical electrode wire 20 inserted with the shaping wire is slowly inserted through the guide sheath 2, and slowly moved under the X-ray. When it reaches the appropriate position, the entire medical electrode wire 20 is rotated to rotate and fix the spiral structure 211 in the myocardium, as shown in FIG. Fig.15 Then rotate the connector needle 111 so that the puncture structure 212 penetrates the ventricular septum for positioning, such as Fig.16 After fixation is completed, the guide sheath 2 is removed, and finally the medical electrode wire 20 is retained in the ventricle, as shown Fig.17 shown.

[0097] If the electrode is a variable diameter spiral structure 131, when the medical electrode wire 10 reaches a suitable position during implantation, the connector needle 111 is rotated to screw the variable diameter spiral structure 131 directly into the ventricular septum, and then the guide sheath 2 is removed. Fig.18 shown.

[0098] It should be understood that the above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation to the present invention. Moreover, although the innovation of the present invention comes from the field of pacing electrode wire and pacing technology, those skilled in the art can understand that the medical electrode wire of the present invention can also be applied to defibrillation or other cardiac electrical stimulation technologies. It should also be understood that the above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation to the present invention. Moreover, although the innovation of the present invention comes from His bundle or left and right bundle branch pacing, those skilled in the art can understand that the present invention can also be applied to pacing of different parts such as apex pacing and sinoatrial node, and the present invention does not limit this.

[0099] It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any technician familiar with this profession can make some changes, modifications and evolutions of the technical content disclosed above without departing from the spirit and scope of the present invention, which are equivalent embodiments of the present invention; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A medical electrode lead, comprising a lead distal end, wherein the lead distal end comprises a head end portion, characterized in that: The head end portion includes an electrode, the electrode is used to axially extend out of the head end portion to engage the target tissue, and the electrode has a variable outer diameter; the head end portion also includes a head end buffer, a buffer support, a jacket and a base; the jacket has an axially through inner cavity; the base can be movably accommodated in the inner cavity and is used to connect with the wire; the electrode is connected to the base; The buffer support is tubular and is arranged at the distal end of the outer sleeve and fixedly connected to the outer sleeve. A part of the buffer support is inserted into the outer sleeve, and the other part is exposed outside the outer sleeve and sleeved on the head end buffer; the proximal end face of the head end buffer is sealed and fixedly connected to the distal end face of the outer sleeve.

2. The medical electrode lead according to claim 1, characterized in that: The outer diameter of the proximal portion of the electrode is greater than the outer diameter of the distal portion.

3. The medical electrode lead according to claim 2, characterized in that: The outer diameter of the electrode decreases gradually from the proximal part to the distal part, or the outer diameter of the electrode first increases and then decreases from the proximal part to the distal part, or the outer diameter of the proximal part of the electrode is the same or decreases gradually and the outer diameter of the distal part of the electrode is the same.

4. The medical electrode lead according to claim 2 or 3, characterized in that: The distal portion of the electrode is configured to be at least partially disposed distal to the proximal portion, and the distal portion is configured to be stationary or movable relative to the proximal portion.

5. The medical electrode lead according to claim 4, characterized in that: The proximal part and the distal part are connected as a whole, the proximal end of the proximal part is fixedly connected to the base, the distal end of the proximal part is fixedly connected to the proximal end of the distal part, and the base is used to drive the electrode to extend or retract the head end part.

6. The medical electrode lead according to claim 5, characterized in that: The electrode is configured as a variable diameter spiral structure.

7. The medical electrode lead according to claim 4, characterized in that: The proximal part is arranged outside the distal part and fixedly arranged; the distal part passes through the proximal part and is fixedly connected to the base at the proximal end; the base is used to drive the distal part to extend or retract the head part, and the distal end of the proximal part extends out of the head part.

8. The medical electrode lead according to claim 7, characterized in that: The proximal portion is divided into a spiral structure, and the distal portion is divided into a puncture structure; the spiral structure is arranged outside the puncture structure and is fixedly arranged; the puncture structure passes through the spiral structure and is fixedly connected to the base at the proximal end; the base is used to drive the puncture structure to extend or retract the head end portion, and the spiral structure at least partially extends out of the head end portion.

9. The medical electrode lead according to claim 8, characterized in that: The spiral structure is a variable diameter spiral or a constant diameter spiral.

10. The medical electrode lead according to claim 8 or 9, characterized in that: The puncture structure is configured as an elastic structure.

11. The medical electrode lead according to claim 10, characterized in that: The puncture structure is formed by spirally winding or braiding a single or multiple metal wires, or the puncture structure is a bellows structure.

12. The medical electrode lead according to claim 8, characterized in that: The head end portion further comprises a guide liner, which is located between the buffer support and the puncture structure, and is fixedly connected to the buffer support and coaxially arranged; The spiral structure is arranged on the guide lining, and the proximal end of the spiral structure is fixedly connected to the guide lining and / or the buffer support; the puncture structure passes through the spiral structure, the guide lining and the buffer support in sequence and then is fixedly connected to the base.

13. The medical electrode lead according to claim 8 or 9, characterized in that: When the spiral structure is an equal-diameter spiral, the length of the distal end of the spiral structure extending from the head end portion is 1 to 3 spiral turns.

14. The medical electrode lead according to claim 13, characterized in that: The distal end of the spiral structure extends out of the head end portion by a length of 1.5 spiral turns.

15. The medical electrode lead according to any one of claims 1 to 3, characterized in that: The cushioning support is configured to limit a maximum displacement of the base in a distal direction.

16. The medical electrode lead according to claim 15, characterized in that: The outer sleeve includes a main body and a distal extension portion located at the distal end of the main body, and the outer diameter of the distal extension portion is smaller than the outer diameter of the distal end of the main body; the buffer support member has an annular flange and an axial extension portion, the proximal surface of the annular flange is in contact with the distal surface of the distal extension portion, the axial extension portion is inserted into the outer sleeve, and the head end buffer member is sleeved on the annular flange and the distal extension portion, and the outer diameter of the annular flange is the same as the outer diameter of the distal extension portion.

17. The medical electrode lead according to any one of claims 1 to 3, characterized in that: The head end portion also includes a ring electrode and a ring electrode support; the ring electrode is sleeved on the proximal end of the outer sleeve; the ring electrode support is tubular and is arranged at the proximal end of the outer sleeve, the ring electrode support is fixedly connected to the proximal end of the outer sleeve and is located on the inner side of the ring electrode for support; and the ring electrode support is configured to limit the maximum displacement of the base toward the proximal end.

18. The medical electrode lead according to claim 17, characterized in that: The sleeve includes a main body and a proximal extension located at the proximal end of the main body, wherein the outer diameter of the proximal extension is smaller than the outer diameter of the proximal end of the main body; the ring electrode is sleeved on the proximal extension, and the ring electrode support has an annular flange and an axial extension, a portion of the surface of the annular flange is sunken and the proximal extension is placed, and another portion of the surface of the annular flange is in contact with the inner surface of the ring electrode.

19. The medical electrode lead according to any one of claims 1 to 3, characterized in that: The head end portion further comprises a guide structure for guiding the movement of the base.

20. The medical electrode lead according to claim 19, characterized in that: The guide structure includes a guide spring, and at least a portion of the surface of the base is provided with a guide groove, and the guide groove cooperates with the guide spring; or, the guide structure includes a spiral groove, and one of the base and the sleeve is provided with the spiral groove, and the other is provided with a guide protrusion that cooperates with the spiral groove.

21. The medical electrode lead according to any one of claims 1 to 3, characterized in that: The electrode is at least partially arranged in the outer shell; and the outer shell is made of a polymer material.

22. The medical electrode lead according to any one of claims 1 to 3, characterized in that: The electrode is made of an elastic material, and / or the electrode is a spiral structure, and the pitches of different outer diameter parts of the spiral structure are different.

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