WO2021179774A1 - 一种心脏起搏电极导线 - Google Patents

一种心脏起搏电极导线 Download PDF

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Publication number
WO2021179774A1
WO2021179774A1 PCT/CN2020/142587 CN2020142587W WO2021179774A1 WO 2021179774 A1 WO2021179774 A1 WO 2021179774A1 CN 2020142587 W CN2020142587 W CN 2020142587W WO 2021179774 A1 WO2021179774 A1 WO 2021179774A1
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WIPO (PCT)
Prior art keywords
head
electrode lead
driving
cardiac pacing
implant
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PCT/CN2020/142587
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English (en)
French (fr)
Inventor
江隆福
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中国科学院大学宁波华美医院
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from CN202020301357.4U external-priority patent/CN212730725U/zh
Priority claimed from CN202021399395.4U external-priority patent/CN214158287U/zh
Application filed by 中国科学院大学宁波华美医院 filed Critical 中国科学院大学宁波华美医院
Publication of WO2021179774A1 publication Critical patent/WO2021179774A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode

Definitions

  • the invention belongs to the technical field of artificial cardiac pacemakers, and particularly relates to a cardiac pacing electrode lead.
  • a cardiac pacemaker is an electronic therapy device implanted in the body.
  • the pulse generator emits electrical pulses powered by the battery. Through the conduction of the lead electrodes, it stimulates the myocardium contacted by the electrodes, and stimulates and contracts the myocardium to achieve treatment.
  • the purpose of cardiac dysfunction due to certain arrhythmias and heart failure.
  • the existing conventional electrode wire needs to rotate the entire electrode wire, which is inconvenient to rotate and fix, and the operation is difficult.
  • the present invention provides a cardiac pacing electrode lead that is convenient to fix and simple to operate.
  • a cardiac pacing electrode lead including a connecting wire, an implant end arranged on one end of the connecting wire, and a connecting end arranged on the other end of the connecting wire;
  • the implanted end includes
  • the implant head can be rotated and retracted back and forth relative to the housing;
  • the implant drive structure is used to drive the implant head to rotate and retract back and forth;
  • the implant drive structure can be used to drive the implant head to rotate and expand, and then there is no need to rotate the entire electrode lead. Only the implant head part rotates and expands to achieve the connection with the myocardium. The fixed, easy to operate and firm fixed.
  • the implant head can be at least partially implanted into the left bundle branch area; so that the implant head can be screwed in from the ventricular septal surface of the right ventricle, and screwed deeply to the left bundle branch area under the inner membrane of the left ventricle ventricular septum,
  • the pacing of the left bundle branch area is realized, so that the pacing site is closer to the physiological pacing site, so that the pacing effect is better, it is not easy to cause the problem of asynchrony of cardiac contraction, and it is not easy to cause the disorder of the local myocardial tissue structure.
  • It also avoids the problems of inducing heart failure and atrial fibrillation. It can not only solve the problems of slow heartbeat and arrest, but also avoid the occurrence of pacing complications. At the same time, it can also provide patients with heart failure with left bundle branch block. New treatment options.
  • the maximum distance between the end of the implant head away from the connecting line and the end of the housing away from the connecting line is greater than or equal to 10 mm; the configuration of the above structure allows the implant head to reach deep
  • the left bundle branch area realizes pacing in the left bundle branch area, which is closer to the physiological pacing site, and the pacing effect is better.
  • the connecting end includes a driving member that can rotate and retract back and forth, and an electrode driving structure for driving the driving member to rotate and retract; the arrangement of the above structure realizes the driving of the implant head, so that the surgeon The operation is more convenient.
  • the connecting end further includes an anti-seize structure for allowing the guide wire to be smoothly penetrated and withdrawn; through the arrangement of the above structure, the guide wire can be smoothly penetrated into or taken out of the connecting wire, It is not easy to get stuck, which makes the operation proceed more smoothly and improves the fault tolerance rate.
  • the electrode driving structure includes an electrode head that is rotationally locked and matched with the drive member and a drive sleeve that is rotationally matched with the electrode head; the drive member can be driven by the electrode head relative to the The axial movement of the driving sleeve and the electrode head; through the arrangement of the above structure, the rotation and expansion of the implant head can be realized only by rotating the electrode head, and the operation is more convenient.
  • the anti-jamming structure includes an extension part arranged in the electrode head.
  • the implanted end also includes an anode part arranged at the end of the housing; the arrangement of the above structure makes it possible to switch between unipolar pacing and bipolar pacing, with more comprehensive functions and adaptability. Sex is better.
  • the implanted end further includes a hormone part for releasing hormones to the myocardium; through the setting of the hormone part, after the implant head is screwed into the myocardium, the hormone part adhering to the myocardium can release the hormone to the myocardial tissue It has an anti-inflammatory effect on the myocardial tissue, prevents the problem of increased threshold in the acute phase, reduces the impedance, and makes the detection result more accurate.
  • the implant end further includes a measuring part for observing the screw-in depth of the implant head; the setting of the measuring part facilitates the observation of the screw-in depth of the implant head and facilitates the judgment of the surgeon.
  • the present invention makes the implantation of the electrode lead and the connection with the myocardium more convenient and quick, the operation is more convenient, and the operation efficiency is improved.
  • FIG. 1 is a schematic diagram of the three-dimensional structure of Embodiment 1 of the present invention.
  • Fig. 2 is an enlarged schematic diagram of A in Fig. 1;
  • Fig. 3 is an enlarged schematic diagram of B in Fig. 1;
  • FIG. 4 is a schematic diagram of the cooperation between the connecting end and the connecting wire in Embodiment 1 of the present invention.
  • Fig. 5 is an enlarged schematic diagram of C in Fig. 4;
  • Fig. 6 is an enlarged schematic diagram of D in Fig. 4;
  • Fig. 7 is an enlarged schematic diagram of E in Fig. 4;
  • FIG. 8 is a schematic diagram of a three-dimensional cross-sectional structure of the outer connecting layer in Embodiment 1 of the present invention.
  • FIG. 9 is a schematic diagram of a three-dimensional cross-sectional structure of the inner connecting layer in Embodiment 1 of the present invention.
  • FIG. 10 is a schematic diagram of the fit between the implanted end and the connecting wire in Embodiment 1 of the present invention.
  • Fig. 11 is an enlarged schematic diagram of F in Fig. 10;
  • Figure 12 is a schematic diagram of the fit between the implanted end and the connecting wire in Embodiment 2 of the present invention.
  • FIG. 13 is a schematic diagram of the cooperation between the connecting end and the connecting wire in Embodiment 2 of the present invention.
  • a cardiac pacing electrode lead includes a connecting wire 1, an implanted end 2 and a connecting end 3.
  • the implanted end 2 is used to connect to the patient’s myocardial tissue, and the connecting end is used to connect to the heart
  • the pacemaker is connected, and the connecting wire is used to connect the implanted terminal and the connecting terminal; specifically, the connecting wire 1 includes an inner connecting layer 11, an inner insulating layer 12, an outer connecting layer 13, and an outer insulating layer 14.
  • the connecting layers are all made of conductive materials, and the specific material types are not limited, as long as they meet the medical standards; the inner connecting layer and the outer connecting layer are made of multiple metal wires simultaneously crimped in a spiral structure, which is flexible
  • the outer connecting layer 13 is formed by bending and winding 4 metal wires (the 4 metal wires are represented by reference numerals 131, 132, 133, and 134), and the 4 metal wires are bent into a spiral shape Each turn of the metal wire is closely attached to each other, so that the outer connecting layer composed of four metal wires is similar to the shape of a hollow tube; while the inner connecting layer 11 is composed of 3 metal wires (the 3 metal wires are respectively marked with 111, 112 and 113) are bent and wound, and each turn of the 3 metal wires bent into a spiral shape is close to each other, so that the inner connecting layer composed of the 3 metal wires has a shape similar to a hollow tube;
  • the outer connecting layer and the inner connecting layer can play a conductive role, and the
  • both the inner insulating layer 12 and the outer insulating layer 14 are made of silicone material, which conforms to the medical material standard.
  • the inner insulating layer is sleeved outside the inner connecting layer, and the outer connecting layer is sleeved on Outside the inner insulating layer, the outer insulating layer is sheathed outside the outer connecting layer, and the inner connecting layer can rotate and slide back and forth relative to the inner insulating layer, while the outer connecting layer and the inner insulating layer are relatively static; in other embodiments, It can also be that the inner connecting layer and the inner insulating layer are relatively static, while the inner insulating layer can rotate and slide back and forth relative to the outer connecting layer; preferably, a lubricating layer is also provided between the outer connecting layer and the inner insulating layer, so that The relative rotation and sliding between the outer connecting layer and the inner insulating layer are smoother; the lubricating layer can be formed by applying a lubricating oil that meets medical standards, and the specific type of lubricating oil is not limited; and the outer surface and the inner insulating layer 12 The inner surface of the outer insulating layer 14 is provided with a
  • the connecting end 3 includes a driving member 32, an electrode driving structure, a first plug sleeve 34, an anode ring 35, and a second plug sleeve 36;
  • the electrode driving structure includes an electrode head 31 and a driving sleeve 33;
  • the anode ring 35 is made of metal It is made of material, has conductive properties, and is opened in a hollow cylindrical structure; at least part of the ends of the inner connecting layer 11, the inner insulating layer 12, and the outer connecting layer 13 penetrate into the anode ring, and at least part of the outer connecting layer
  • the surface is in close contact with at least part of the inner surface of the anode ring, and the two are connected and fixed by one or more methods such as clamping, gluing, welding, etc., and at the same time, the electrical connection between the outer connecting layer and the anode ring is realized.
  • connection method is the prior art and will not be repeated here; the second plug sleeve 36 is formed by extending at least part of the surface of the outer insulating layer 14 outward, and the inner surface of the second plug sleeve is attached to the outer surface of the anode ring.
  • At least part of the inner surface of the two plug sleeves extends outward to form an anti-dropping convex portion 361, at least a part of the surface of the anode ring 35 is recessed inward to form an anti-dropping groove 351, and the anti-dropping convex portion is just inserted into the anti-dropping groove, so that An anti-drop fit is formed between the second plug sleeve and the anode ring; preferably, an adhesive layer is also provided between the second plug sleeve and the anode ring.
  • the drive sleeve 33 is opened in a hollow cylindrical structure, made of medical grade plastic material, one end of which penetrates at least partially into the anode ring 35, and at least part of the drive sleeve
  • the outer surface is attached to at least part of the inner surface of the anode ring to realize the connection and fixation between the driving sleeve and the anode ring
  • the first plug sleeve 34 is made of silicone material, has elasticity, is opened in a hollow cylindrical structure, and is sleeved On the outer surface of the driving sleeve, preferably, at least part of one end of the first plug sleeve penetrates into the anode ring; at least part of the outer surface of the first plug sleeve 34 and the second plug sleeve 36 extends outward to form a convex Ring 37.
  • the first plug sleeve and the second plug sleeve are provided with two rings of convex rings.
  • the convex ring can play a sealing role to avoid the patient
  • the blood enters the pacemaker to ensure that the pacemaker can always work normally, which is more stable and safer.
  • the driving member 32 is opened in a hollow cylindrical structure, made of metal material, and has conductivity; the driving member penetrates from one end of the driving sleeve 33 and then passes through the other end and is placed in the anode ring 35.
  • the outer diameter is smaller than the inner diameter of the inner insulating layer 12, so that the driving member can rotate and slide freely with respect to the inner insulating layer (in other embodiments, the outer diameter of the driving member may also be smaller than the inner diameter of the outer connecting layer 12, thereby The driving member can rotate and slide freely relative to the outer connecting layer); at least part of the surface of the end of the driving member located in the anode ring extends outward to form a fixed portion 321, and one end of the inner connecting layer 11 is sleeved on the fixed portion , The electrical connection between the two is realized; the outer diameter of the fixing part is slightly larger than the inner diameter of the inner connecting layer 11, so that the fixing part can form an interference fit with the inner connecting layer; preferably, the fixing part and the inner connecting layer Double fix
  • At least part of the outer surface of the driving member 32 is also formed with external threads.
  • An internal thread is formed on the inner wall of the driving sleeve 33, so that a threaded fit is formed between the driving part and the driving sleeve; the driving part 32 is provided with a through groove 322, and the electrode head 31 is provided with a through hole communicating with the through groove 322 312.
  • the electrode head 31 is made of metal material and has conductive properties. It has a cylindrical structure with a hemispherical surface at one end, a socket 312 and a slot at the other end, and the driving member 32 is far away from the connecting line.
  • One end of 1 penetrates into the slot on the electrode head; one end of the electrode head is connected to the drive sleeve 33, and the electrode head can rotate back and forth relative to the drive sleeve; at least part of the inner wall of the electrode head slot is recessed inward to form a sliding groove 311, At least part of the outer surface of the driving member 32 extends outward to form a sliding rod 322.
  • the sliding rod is just placed in the sliding groove and can slide back and forth along the sliding groove, so that a sliding anti-rotation fit is formed between the driving member and the electrode head;
  • a sliding anti-rotation fit is formed between the driving member and the electrode head;
  • the implant end 2 includes a housing 20, an implant head 21, and an implant drive structure;
  • the implant drive structure includes a transmission member 22 and a limiting component;
  • the housing 20 is made of plastic material and is opened in a hollow cylindrical structure.
  • One end of the shell at least partially penetrates into the outer connecting layer 13, and the two are connected and fixed by adhesive bonding or other connection methods; the end of the inner insulating layer and the end of the shell penetrating into the outer connecting layer conflict, The connection and fixation are also achieved by glueing or other connection methods.
  • the end of the inner insulating layer may be at least partially penetrated into the housing and then connected and fixed with the housing;
  • the transmission member 22 has a cylindrical structure. It is made of metal material.
  • the housing 20 is provided with a through groove 202.
  • the transmission member is installed in the through groove and can rotate and slide back and forth relative to the housing; one end of the inner connecting layer 11 is sleeved on the transmission member 22 On one end, so that when the inner connecting layer rotates and expands with the rotation of the electrode head 31, it will drive the transmission member to rotate and expand together;
  • the implant head 21 is made of metal material and is opened in a spiral structure, and the transmission member 22 At least part of the surface of the end away from the inner connecting layer 11 extends outward to form a connecting protrusion 221, the implant head is sleeved outside the connecting protrusion, and the two are connected by welding or other connection methods, thereby realizing the implant head
  • the transmission connection and electrical connection with the transmission member enable the implant head to rotate and expand synchronously with the rotation and expansion of the transmission member.
  • An implant tip 211 is provided on the end of the implant head far away from the transmission member 22, so that the implantation
  • the head can break open the endocardium and myocardium on the ventricular septum of the heart, realize the connection between the implant head and the heart, and ensure that the pacing position will not fall off after the pacing position is determined; the implant head 21 can be driven by the transmission member 22, While rotating, it protrudes from the end of the housing 20 away from the connecting line 1.
  • the implant head can extend out of the housing at least 10mm (that is, the maximum length of the part that the implant head can extend out of the housing is greater than or equal to 10mm. In actual use, , The implant head does not have to be in the maximum extension state.
  • the implant head when performing right ventricular pacing, can only be rotated out of the housing 1.8mm as needed, which is more flexible and has better applicability).
  • the implant head can break through the endocardium and myocardium on the right ventricular septum, deep into the left bundle branch area under the inner membrane of the left ventricular septum, and then achieve pacing in the left bundle branch area, making the pacing position of artificial heart pacing The point is closer to the physiological pacing site, to avoid long-term right ventricular pacing causing asynchrony of cardiac contraction, local myocardial tissue structural disorder, and promoting heart failure and atrial fibrillation problems, making the effect of artificial heart pacing better; preferably, Since the myocardial thickness of the ventricular septum in the left bundle branch region is about 10 mm, the implant head 21 in the present application can extend out of the housing by 15 mm at the longest, so that even when the implant head is implanted into the ventricular septum, the implant end 2 is The tilted state can still
  • an insulating sleeve 29 is sheathed outside the implant head 21, the insulating sheath may be made of plastic or other materials, and the insulating sheath is sheathed outside the implant head so that the implant head is close to the connecting protrusion 221
  • the side of the implant head is completely covered in the insulating sleeve, and the side of the implant head close to the implant tip 211 has at least part of the insulating sleeve exposed.
  • the length of the exposed part is about 1.8mm, so that the implant head can be screwed into In the myocardial tissue, it forms an electrical connection with the myocardial tissue, and the current flows into the myocardial tissue through the exposed part to stimulate the heart for pacing, avoiding the situation that the current flows directly from the implant head into the anode part 23 and does not flow through the myocardial tissue, ensuring pacing work It can be performed normally; preferably, the end of the insulating sleeve 29 close to the implant tip 211 is provided with a bevel, so that when the implant head is screwed into the myocardial tissue, the insulating sleeve can also be screwed into the myocardial tissue without hindering the implant head.
  • the diameter of the part of the implant head cover where the insulating cover is provided is smaller than the diameter of the exposed part of the insulating cover, so that after the insulating cover is sheathed on the implant head, the outer diameter of the insulating cover is equal to or slightly smaller than the exposed implant head The diameter of the insulating sleeve part, so that the insulating sleeve will not affect the insertion of the implant head into the myocardial tissue.
  • the implant end 2 also includes an anode portion 23, which is made of a metal material and is installed on the end of the housing 20 away from the connecting wire 1.
  • anode portion 23 which is made of a metal material and is installed on the end of the housing 20 away from the connecting wire 1.
  • either unipolar pacing or bipolar pacing can be performed; when unipolar pacing is required, the implant head 21 is used as the cathode, the patient’s muscle tissue is the anode, and the current is from the pacing After the device flows into the connecting end 3, and then flows to the implant head through the inner connecting layer 11, after realizing the artificial pacing of the heart, it flows back into the pacemaker through the patient’s muscle tissue to form a complete current cycle; In bipolar pacing, the implant head is used as the cathode and the anode part 23 is used as the anode.
  • the current flows from the pacemaker into the connection terminal 3, it flows through the inner connecting layer 11 to the implant head to achieve artificial pacing of the heart. Then, it flows into the anode ring, and flows to the anode ring 35 through the outer connecting layer 13, so as to flow back into the pacemaker to form a complete current cycle.
  • the limiting component includes a first gasket 24, a second gasket 25, a third gasket 26, and a stop piece 27; the first gasket, the second gasket, and the third gasket are all opened in a ring structure, and Both are sleeved on the transmission member 22 and can slide back and forth relative to the transmission member.
  • the first gasket and the second gasket are made of metal materials, and the third gasket is made of silicone material or other elastic materials, and The third gasket is located between the first gasket and the second gasket; a limiting groove 201 is also provided in the housing 20, and the first gasket, the second gasket and the third gasket are all embedded in the limiting groove Inside; the baffle is opened on the transmission member, a total of two baffles are opened, one baffle is located on the side of the first gasket close to the implant head, and the other is located on the side of the second gasket away from the implant head , And the diameter of the baffle is the same as the diameter of the through groove 202, so that the baffle can slide and rotate back and forth in the through groove with the transmission member; the housing 20 is also provided with a step 203, when the implant head 21 is stored in When in the through groove, the stop piece on the side of the second gasket away from the implant head will interfere with the step part, and the other stop piece will interfere with the first gasket to prevent the transmission
  • a support 28 is also installed in the housing 20.
  • the support 28 is made of silicone material or other materials, has elasticity, and is installed on the connecting protrusion 221. The two can be connected and fixed by glue or other means.
  • the support member is located inside the implant head 21, so that when the implant head protrudes from the housing more and is prone to bend, the support member can be elastically deformed as the implant head is bent, so that the support member At least part of it will be embedded in the gap of the helical implant head during the deformation process to prevent the implant head from bending.
  • a hormone portion 41 is installed on the end of the anode portion 23.
  • the hormone portion 41 is a hormone releasing ring and contains dexamethasone sodium phosphate hormone. So that when the hormone part comes into contact with the myocardium, it can release the dexamethasone sodium phosphate hormone, play an anti-inflammatory effect, prevent the acute phase threshold from rising, and reduce the impedance, and the hormone part 41 is made of insulating material, making the anode part It will not directly contact the myocardium, avoiding the capture of the anode part 23, so that the current output from the implant head 21 will not directly enter the anode part, ensuring the smooth progress of cardiac pacing.
  • the dexamethasone sodium phosphate hormone can also be directly applied to the anode portion 23.
  • the implant head 21 is only 1.8mm, one end of which is fixedly connected to one end of the transmission member 22, and the transmission member is only conductive with the implant head, but the transmission member itself is not conductive with the myocardial tissue (it can be used Brush the insulating coating on the outer surface of the transmission part; or the outer layer of the transmission part is made of insulating material, the inner core is made of conductive material, and the implant head is connected to the inner core; or the transmission part is covered with insulating material, etc.);
  • the other end of the transmission member 22 is connected to the inner connection layer 11, so that the transmission member 22 can rotate and expand while rotating under the drive of the inner connection layer 11.
  • the end of the transmission member 22 away from the inner connection layer 11 can extend out of the housing 20.
  • the protruding length of the transmission member is at least 8 mm and the longest is 13 mm. In other embodiments, the protruding length of the transmission member can also be modified as required.
  • a measuring part 231 is installed on the transmission member 22.
  • the measuring part is arranged in a ring structure and is made of X-ray opaque material, while the transmission part is made of X-ray transparent material.
  • the specific material type is not specified. The limitation is that through this structural setting, the surgeon can intuitively observe the extension length of the transmission member, so as to quickly determine the screwing depth of the implant head, which is convenient for the operation; in this embodiment, the measuring part 231 is impervious
  • the X-ray material is engraved on the scale on the transmission member 22; in other embodiments, the measuring part may also be a plurality of rings embedded on the surface of the transmission member, and the distance between two adjacent rings is 1 mm.
  • the motor wire in this application is of a hollow structure, a guide wire is needed.
  • an anti-seize structure is installed in the connecting end 3.
  • the anti-seize structure includes a device
  • the extension portion 313 in the electrode head 31 is opened in a ring structure and communicates with the insertion hole 312, and its inner diameter is the same as the inner diameter of the insertion hole 312; in other embodiments, the extension portion may also be installed in the insertion hole
  • the tubular structure on the inner wall (it should be noted that the drawings in the specification have specially increased the thickness of the structure when drawing for clarity, and the actual thickness is subject to actual production), and there is a gap between the extension and the inner wall of the electrode tip.
  • the gap is the slot, one end of the driver 32 is placed in the slot, and the inner diameter of the driver is equal to or slightly larger than the outer diameter of the extension, so that the driver can slide back and forth in the slot; the extension 313 is at least partially It is located in the driving sleeve 33; in other embodiments, the slot can also be a groove or a sandwich layer opened on the electrode head, the driving member 32 is installed in the sandwich layer, and the part between the inner wall of the electrode head and the sandwich layer The wall thickness is the anti-jamming structure.

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Abstract

本发明公开了一种心脏起搏电极导线，包括连接线、设于所述连接线一端上的植入端及设于所述连接线另一端上连接端；所述植入端包括壳体；植入头，可相对于所述壳体来回旋转和伸缩，该植入头至少部分可植入至左束支区域；植入驱动结构，用于带动所述植入头来回旋转和伸缩；激素部，用于将激素释放至心肌；本发明通过植入头和植入驱动结构的设置，使得能够实现对左束支区域的起搏，使得起搏部位更接近生理起搏部位，起搏效果更好。

Description

一种心脏起搏电极导线 技术领域
本发明属于人工心脏起搏器技术领域，尤其是涉及一种心脏起搏电极导线。
背景技术
心脏起搏器是一种植入于体内的电子治疗仪器，通过脉冲发生器发放由电池提供能量的电脉冲，通过导线电极的传导，刺激电极所接触的心肌，使心肌激动和收缩，从而达到治疗由于某些心律失常与心力衰竭所致的心脏功能障碍的目的。
然而现有的常规电极导线需要旋转整根电极导线，旋转固定不方便，操作难度大。
发明内容
本发明为了克服现有技术的不足，提供一种固定方便、操作简单的心脏起搏电极导线。
为了实现上述目的，本发明采用以下技术方案：一种心脏起搏电极导线，包括连接线、设于所述连接线一端上的植入端及设于所述连接线另一端上连接端；所述植入端包括
壳体；
植入头，可相对于所述壳体来回旋转和伸缩；
植入驱动结构，用于带动所述植入头来回旋转和伸缩；
通过植入头和植入驱动结构的设置，使得通过植入驱动结构能够使驱动植入头旋转和伸缩，继而无需旋转整根电极导线，只有植入头 部分旋转和伸缩，即可实现与心肌的固定，操作方便，固定牢固。
进一步的，所述植入头至少部分可植入至左束支区域；使得植入头可以从右心室的室间隔面拧入，深拧至左心室室间隔内膜下的左束支区域，从而实现对左束支区域的起搏，使得起搏部位更接近生理性起搏部位，进而使得起搏效果更好，不易造成心脏收缩不同步的问题，也不易导致局部心肌组织结构的紊乱，也避免了诱发心力衰竭和心房颤动的问题，既能够为患者解决心跳变慢、停搏的问题，又避免起搏并发症的发生，同时还为合并左束支传导阻滞的心力衰竭患者提供了新的治疗选择。
进一步的，所述植入头远离所述连接线的一端与所述壳体远离所述连接线的一端之间的最大距离长度大于等于10mm；通过上述结构的设置，使得植入头可以深入至左束支区域，实现对左束支区域的起搏，更为接近生理起搏位点，起搏效果更好。
进一步的，所述连接端包括可来回旋转和伸缩的驱动件和用于驱动所述驱动件旋转和伸缩的电极驱动结构；通过上述结构的设置，实现了对植入头的驱动，使得术者的操作更为方便。
进一步的，所述连接端还包括用于使得导引钢丝能顺畅穿入和抽出的防卡结构；通过上述结构的设置，使得导引钢丝能够顺畅的穿入连接线或从连接线内取出，不易卡住，使得手术进行的更为顺利，提高容错率。
进一步的，所述电极驱动结构包括与所述驱动件止转配合的电极头和与所述电极头转动配合的驱动套；所述驱动件可在所述电极头的 驱动下产生相对于所述驱动套和所述电极头的轴向移动；通过上述结构的设置，使得仅通过转动电极头即能够实现植入头的旋转和伸缩，操作更为方便。
进一步的，所述防卡结构包括设于所述电极头内的延伸部。
进一步的，所述植入端还包括设于所述壳体端部的阳极部；通过上述结构的设置，使得可以在单极起搏和双极起搏之间切换，功能更为全面，适应性更好。
进一步的，所述植入端还包括用于将激素释放至心肌的激素部；通过激素部的设置，使得植入头拧入心肌后，与心肌相贴的激素部可以将激素释放到心肌组织上，从而起到对心肌组织的消炎作用，防止急性期阀值升高的问题出现，降低阻抗，使得检测结果更为准确。
进一步的，所述植入端还包括用于观测所述植入头的拧入深度的测量部；通过测量部的设置，方便观测植入头的拧入深度，便于术者的判断。
综上所述，本发明通过植入头和植入驱动结构的设置，使得电极导线的植入和与心肌的连接更为方便快捷，操作更为方便，提高了手术效率。
附图说明
图1为本发明实施例1的立体结构示意图；
图2为图1中A处的放大示意图；
图3为图1中B处的放大示意图；
图4为本发明实施例1中连接端与连接线的配合示意图；
图5为图4中C处的放大示意图；
图6为图4中D处的放大示意图；
图7为图4中E处的放大示意图；
图8为本发明实施例1中外连接层的立体剖视结构示意图；
图9为本发明实施例1中内连接层的立体剖视结构示意图；
图10为本发明实施例1中植入端与连接线的配合示意图；
图11为图10中F处的放大示意图；
图12为本发明实施例2中植入端与连接线的配合示意图；
图13为本发明实施例2中连接端与连接线的配合示意图。
具体实施方式
实施例1：
如图1-11所示，一种心脏起搏电极导线，包括连接线1、植入端2及连接端3；植入端2用于与患者的心肌组织相连，连接端则用于与心脏起搏器相连，连接线则用于连接植入端和连接端；具体的，连接线1包括内连接层11、内绝缘层12、外连接层13及外绝缘层14，内连接层和外连接层均由导电材料制成，具体材料种类不做限定，只需满足医用标准即可；内连接层和外连接层均由多根金属丝同步卷曲而成，呈螺旋状结构开设，具有弹性；本实施例中，外连接层13由4根金属丝(4根金属丝分别用附图标号131、132、133及134表示)弯曲缠绕而成，且弯曲成螺旋状后的4根金属丝的每一匝均相互紧贴，从而使得四根金属丝组成的外连接层呈类似中空管的形状；而内连接层11由3根金属丝(3根金属丝分别用附图标号111、112及 113表示)弯曲缠绕而成，且弯曲成螺旋状后的3根金属丝的每一匝均相互紧贴，从而使得3根金属丝组成的内连接层呈类似中空管的形状；使得外连接层和内连接层能够起到导电作用，同时外连接层和内连接层能够任意弯曲，方便手术的进行；而由于外连接层的直径较大，而内连接层的直径较小，故而外连接层的柔韧性较好，弯曲更为容易；而内连接层的刚性较大，不易弯曲，起到一定的支撑作用，同时由于多根金属丝缠绕紧密，所以内连接层一端收到旋转力而旋转时，会同步带动另一端旋转；内绝缘层12和外绝缘层14均由硅胶材料制成，符合医用材料标准，内绝缘层套设在内连接层外侧，外连接层套设在内绝缘层外侧，外绝缘层则套设在外连接层外侧，且内连接层可相对于内绝缘层来回转动和滑动，而外连接层与内绝缘层之间相对静止；于其他实施例中，也可以是内连接层与内绝缘层之间相对静止，而内绝缘层可相对于外连接层来回转动和滑动；优选的，外连接层与内绝缘层之间还开设有润滑层，从而使得外连接层与内绝缘层之间的相对转动和滑动更为顺畅；其中润滑层可由满足医用标准的润滑油涂抹形成，润滑油的具体种类不做限定；而在内绝缘层12的外表面和外绝缘层14的内表面上开设有螺纹槽，从而使得外连接层13能够正好嵌设在该螺纹槽内，进而使得内绝缘层、外绝缘层及外连接层三者之间两两相对静止。
具体的，连接端3包括驱动件32、电极驱动结构、第一插接套34、阳极环35及第二插接套36；电极驱动结构包括电极头31和驱动套33；阳极环35由金属材料制成，具有导电性能，呈中空圆柱体 结构开设；内连接层11、内绝缘层12及外连接层13的端部的至少部分穿入至阳极环内，且外连接层的至少部分外表面与阳极环的至少部分内表面紧贴，两者通过卡接、胶接、焊接等一种或多种方式实现连接固定，同时也实现了外连接层与阳极环之间的电连接，具体连接方式为现有技术，在此不做赘述；第二插接套36由外绝缘层14的至少部分表面向外延伸形成，第二插接套的内表面与阳极环的外表面相贴，第二插接套的至少部分内表面向外延伸形成了防脱凸部361，阳极环35的至少部分表面向内凹陷形成了防脱槽351，防脱凸部正好嵌入防脱槽内，从而使得第二插接套与阳极环之间形成防脱配合；优选的，第二插接套与阳极环之间还设有粘接层，通过粘接层的设置，使得第二插接套与阳极环之间的连接更为牢固的同时，形成密封配合；驱动套33呈中空的圆柱体结构开设，由医用级塑料材料制成，其一端至少部分穿入阳极环35内，驱动套的至少部分外表面与阳极环的至少部分内表面相贴，实现驱动套与阳极环之间的连接固定；第一插接套34由硅胶材料制成，具有弹性，呈中空的圆柱体结构开设，套设在驱动套的外表面上，优选的，第一插接套一端的至少部分穿入至阳极环内；第一插接套34和第二插接套36的至少部分外表面向外延伸形成了凸环37，本实施例中，第一插接套和第二插接套上均开设了两圈凸环，当连接端3与起搏器连接固定后，凸环能够起到密封作用，避免患者的血液进入起搏器内，保证起搏器始终能够正常工作，更为稳定，安全性更高。
进一步的，驱动件32呈中空的圆柱体结构开设，由金属材料制 成，具有导电性能；驱动件从驱动套33的一端穿入后从另一端穿出并置于阳极环35内，驱动件的外径小于内绝缘层12的内径，从而使得驱动件可以相对于内绝缘层自由的转动和滑动(于其他实施例中，也可以是驱动件的外径小于外连接层12的内径，从而使得驱动件可以相对于外连接层自由的转动和滑动)；驱动件位于阳极环内的一端的至少部分表面向外延伸形成了固定部321，内连接层11的一端即套设在固定部上，实现了两者之间的电连接；固定部的外径略大于内连接层11的内径，从而使得固定部能够与内连接层之间形成过盈配合；优选的，固定部与内连接层之间再通过焊接或其他方式进行双重固定，固定效果更好的同时，又不会影响到固定部与内连接层之间的电连接；驱动件32的至少部分外表面上还形成有外螺纹，驱动套33的内壁上形成有内螺纹，从而使得驱动件与驱动套之间形成螺纹配合；驱动件32上开设有通槽322，电极头31上开设有与通槽322相连通的通孔312。
进一步的，电极头31由金属材料制成，具有导电性能，其呈一端开设有半球面，其上开设有插孔312，另一端开设有插槽的圆柱体结构开设，驱动件32远离连接线1的一端穿入电极头上的插槽内；电极头一端与驱动套33相连，且电极头可相对于驱动套来回转动；电极头插槽的至少部分内壁向内凹陷形成了滑槽311，而驱动件32的至少部分外表面向外延伸形成了滑杆322，滑杆正好置于滑槽内，可以沿着滑槽来回滑动，从而使得驱动件与电极头之间形成滑动止转配合；当术者转动电极头时，即会带动驱动件一起转动，而驱动件转 动时，由于驱动件与驱动套之间的螺纹配合，驱动件即会一边转动，一边在内外螺纹的作用下，相对于驱动套和电极头的轴向方向来回移动，实现驱动件的旋转伸缩，从而带动与驱动件相连的内连接层11旋转伸缩。
具体的，植入端2包括壳体20、植入头21及植入驱动结构；植入驱动结构包括传动件22和限位部件；壳体20由塑料材料制成，呈中空圆柱体结构开设，壳体的一端至少部分穿入至外连接层13内，两者通过胶接或其他连接方式实现连接固定；内绝缘层的端部与壳体穿入外连接层内的一端向抵触，两者也通过胶接或其他连接方式实现连接固定，于其他实施例中，也可以是内绝缘层的端部至少部分穿入至壳体内后再与壳体连接固定；传动件22呈圆柱体结构开设，由金属材料制成，壳体20内开设有通槽202，传动件即安装在通槽内，可以相对于壳体来回转动和滑动；内连接层11的一端套设在传动件22的一端上，从而使得当内连接层随着电极头31的转动而旋转和伸缩时，会带动传动件一起旋转和伸缩；植入头21由金属材料制成，呈螺旋状结构开设，传动件22远离内连接层11的一端的至少部分表面向外延伸形成了连接凸部221，植入头即套设在该连接凸部外，两者通过焊接或其他连接方式相连，从而实现了植入头与传动件之间的传动连接和电连接，使得植入头能够随着传动件的旋转伸缩而同步旋转伸缩，在植入头远离传动件22的一端上开设有植入尖端211，使得植入头可以破开心脏室间隔上的心内膜和心肌，实现植入头与心脏之间的连接，保证起搏位置确定后不会脱落分离；植入头21可在传 动件22的带动下，一边旋转一边从壳体20远离连接线1的一端伸出，植入头至少可伸出壳体10mm(即植入头可以伸出壳体的部分的最大长度大于等于10mm，在实际使用过程中，植入头并非一定要处于最大伸出状态，如进行右室起搏时，可以根据需要，仅将植入头旋出壳体1.8mm，使用更为灵活，适用性更好)，进而使得植入头能够突破右心室室间隔上的心内膜和心肌，深入至左心室间隔内膜下的左束支区域，继而实现左束支区域的起搏，使得人工心脏起搏的起搏位点更接近生理起搏部位，避免长期的右心室起搏造成心脏收缩不同步，局部心肌组织结构紊乱，促进心力衰竭和心房颤动发生的问题，使得人工心脏起搏的效果更好；优选的，由于左束支区域室间隔的心肌厚度约为10mm，本申请中的植入头21最长可伸出壳体15mm，从而使得即使在将植入头植入室间隔时，植入端2为倾斜状态，也仍旧能够保证植入头具有足够的长度能够深入至左束支区域，使得术者在操作时更为方便，提高了手术成功率；而希氏束的室间隔厚度比左束支区域的室间隔厚度要小，所以本申请也可通过减小植入头伸出壳体的长度，从而用于希氏束起搏，选择范围更广，适用性更好。
进一步的，在植入头21外还套设了一个绝缘套29，该绝缘套可由塑料材料或其他材料制成，该绝缘套套设在植入头外侧后，使得植入头靠近连接凸部221的一侧全部被包覆在绝缘套内，而植入头靠近植入尖端211的一侧则至少有部分露出绝缘套，该露出部分的长度约为1.8mm，从而使得植入头可以旋入心肌组织内，与心肌组织形成电连接，电流通过露出部分流入心肌组织刺激心脏进行起搏，避免了电 流直接从植入头流入阳极部23而不流经心肌组织的情况出现，保证起搏工作能够正常进行；优选的，绝缘套29靠近植入尖端211的一端开设有斜面，从而使得植入头在旋入心肌组织时，绝缘套也能够旋入心肌组织，不会阻碍到植入头的植入；
于其他实施例中，植入头套设有绝缘套的部分的直径小于露出绝缘套部分的直径，从而使得绝缘套套设在植入头上后，绝缘套的外径等于或略小于植入头露出绝缘套部分的直径，从而使得绝缘套不会影响到植入头旋入心肌组织。
进一步的，植入端2还包括有阳极部23，该阳极部由金属材料制成，安装在壳体20远离连接线1的一端上，阳极部一端与外连接层13相连，实现两者之间的电连接；当植入端2与右心室的室间隔相贴进行植入头的植入时，安装在壳体端部的阳极部即会与室间隔相贴，从而使得植入头植入左束支区域后，既可以进行单极起搏，也可以进行双极起搏；当需要进行单极起搏时，以植入头21为阴极，患者肌肉组织为阳极，电流从起搏器流入连接端3后，再通过内连接层11流至植入头处，实现对心脏的人工起搏后，通过患者的肌肉组织流回起搏器内，形成完整的电流循环；而当进行双极起搏时，以植入头为阴极，阳极部23为阳极，电流从起搏器流入连接端3后，再通过内连接层11流至植入头处，实现对心脏的人工起搏后，再流入阳极环内，通过外连接层13流至阳极环35处，从而流回起搏器内，形成完整的电流循环。
具体的，限位部件包括第一垫片24、第二垫片25、第三垫片26 及挡片27；第一垫片、第二垫片及第三垫片均呈环形结构开设，且均套设在传动件22上，可以相对于传动件来回滑动，第一垫片和第二垫片均由金属材料制成，第三垫片由硅胶材料或其他具有弹性的材料制成，且第三垫片位于第一垫片和第二垫片之间；在壳体20内还开设有限位槽201，第一垫片、第二垫片及第三垫片均嵌设在限位槽内；挡片开设在传动件上，共开设了两个挡片，一个挡片位于第一垫片靠近植入头的一侧，另一个挡片位于第二垫片远离植入头的一侧，且挡片的直径与通槽202的直径相同，从而使得挡片能够随着传动件在通槽内来回滑动和转动；壳体20内还开设有台阶部203，当植入头21收纳在通槽内时，位于第二垫片远离植入头的一侧的挡片会与台阶部相抵触，另一个挡片会与第一垫片相抵触，防止传动件从通槽内脱出；而当植入头处在最大伸出状态时，则位于第二垫片远离植入头的一侧的挡片会与第二垫片相抵触，此时由于挡片对第二垫片的挤压，第三垫片会在第一挡片和第二挡片的作用下，往径向方向发生弹性形变，从而使得第三垫片与传动件之间的接触更为紧密，起到密封效果。
优选的，在壳体20内还安装了一个支撑件28，该支撑件由硅胶材料或其他材料制成，具有弹性，安装在连接凸部221上，两者可通过胶接或其他方式连接固定，该支撑件位于植入头21内侧，从而使得当植入头伸出壳体的部分较多而容易发生弯曲时，支撑件可以随着植入头的弯曲而发生弹性形变，从而使得支撑件至少部分会在形变过程中嵌入螺旋状的植入头的缝隙中，起到阻止植入头弯曲的作用。
实施例2：
如图12-13所示，本实施例与实施例1的区别在于：在阳极部23的端部上安装有激素部41，该激素部41为激素释放环，含有地塞米松磷酸钠激素，从而使得当激素部与心肌接触后，能够释放地塞米松磷酸钠激素，起到消炎的作用，防止急性期阀值升高，降低阻抗，并且该激素部41为绝缘材料制成，使得阳极部不会直接与心肌接触，避免了阳极部23的夺获，使得从植入头21中输出的电流不会直接进入阳极部，保证了心脏起搏的顺利进行。
于其他实施例中，也可以直接将地塞米松磷酸钠激素涂抹在阳极部23上。
进一步的，本实施例中，植入头21仅为1.8mm，其一端与传动件22的一端固定连接，且传动件仅与植入头导电，但是传动件本身不与心肌组织导电(可采用在传动件外表面上刷涂绝缘涂层；或传动件外层为绝缘材料，内芯为导电材料，植入头与内芯相连；或在传动件外包覆绝缘材料等方式来实现)；传动件22的另一端与内连接层11相连，使得传动件22可以在内连接层11的带动下一边旋转一边伸缩，传动件22远离内连接层11的一端可以伸出壳体20，本实施例中，传动件的伸出长度最少为8mm，最长为13mm，于其他实施例中，传动件的伸出长度也可以根据需要修改。
优选的，在传动件22上安装了测量部231，该测量部呈环形结构设置，由不透X光线的材料制成，而传动件则由透X光线的材料制成，具体材料种类不做限定，通过该结构设置，使得术者可以直观的 观察到传动件的伸出长度，从而快速判断植入头的拧入深度，方便手术的进行；本实施例中，测量部231为用不透X光线的材料刻印在传动件22上的刻度；于其他实施例中，测量部也可以是镶嵌在传动件表面上的多个环，相邻两个环之间的间距为1mm。
优选的，由于本申请中的电机导线为中空结构，需要用到导引钢丝，为了使得导引钢丝顺利的穿入和取出，在连接端3内安装了防卡结构，该防卡结构包括设于电极头31内的延伸部313，该延伸部呈环形结构开设，与插孔312相连通，其内径与插孔312的内径相同；于其他实施例中，延伸部也可以为安装在插孔内壁上的管状结构(需要注意的是，说明书附图为了表述清晰，特地在绘制时增加了结构厚度，实际厚度以实际生产为准)，延伸部与电极头的内壁之间留有间隙，该间隙即为插槽，驱动件32的一端即置于该插槽内，且驱动件的内径等于或略大于延伸部的外径，使得驱动件可以在插槽内来回滑动；延伸部313至少部分位于驱动套33内；于其他实施例中，所述插槽也可以为开设在电极头上的凹槽或夹层，驱动件32安装在该夹层内，而电极头内壁与该夹层之间的部分壁厚即为防卡结构。
显然，所描述的实施例仅仅是本发明的一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都应当属于本发明保护的范围。

Claims (10)

  1. 一种心脏起搏电极导线，包括连接线(1)、设于所述连接线(1)一端上的植入端(2)及设于所述连接线(1)另一端上连接端(3)；其特征在于：所述植入端(2)包括
    壳体(20)；
    植入头(21)，可相对于所述壳体(20)来回旋转和伸缩；
    植入驱动结构，用于带动所述植入头(21)来回旋转和伸缩。
  2. 根据权利要求1所述的心脏起搏电极导线，其特征在于：所述植入头(21)至少部分可植入至左束支区域。
  3. 根据权利要求2所述的心脏起搏电极导线，其特征在于：所述植入头(21)远离所述连接线(1)的一端与所述壳体(20)远离所述连接线(1)的一端之间的最大距离长度大于等于10mm。
  4. 根据权利要求3所述的心脏起搏电极导线，其特征在于：所述连接端(3)包括可来回旋转和伸缩的驱动件(32)和用于驱动所述驱动件(32)旋转和伸缩的电极驱动结构。
  5. 根据权利要求4所述的心脏起搏电极导线，其特征在于：所述连接端(3)还包括用于使得导引钢丝能顺畅穿入和抽出的防卡结构。
  6. 根据权利要求5所述的心脏起搏电极导线，其特征在于：所述电极驱动结构包括与所述驱动件(32)止转配合的电极头(31)和与所述电极头(31)转动配合的驱动套(33)；所述驱动件(32)可在所述电极头(31)的驱动下产生相对于所述驱动套(33)和所述电极头(31)的轴向移动。
  7. 根据权利要求6所述的心脏起搏电极导线，其特征在于：所述防卡结构包括设于所述电极头(31)内的延伸部(313)。
  8. 根据权利要求1-7中任意一项所述的心脏起搏电极导线，其特征在于：所述植入端(2)还包括设于所述壳体(20)端部的阳极部(23)
  9. 根据权利要求1-7中任意一项所述的心脏起搏电极导线，其特征在于：所述植入端(2)还包括用于将激素释放至心肌的激素部(41)。
  10. 根据权利要求7所述的心脏起搏电极导线，其特征在于：所述植入端(2)还包括用于观测所述植入头(21)的拧入深度的测量部(231)。
PCT/CN2020/142587 2020-03-12 2020-12-31 一种心脏起搏电极导线 WO2021179774A1 (zh)

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