A medical pacing electrode lead

Abstract

The present invention discloses a medical pacing electrode lead, which comprises an electrode head, a lead body section and a connector connected in sequence. The electrode head includes an external structure and an internal structure. The external structure includes a drug plug, an electrode sleeve, an electrode insulation connector and an electrode ring connected in sequence. The internal structure includes a straight rod, a first radiopaque ring, a second radiopaque ring, a platinum-iridium limiting member and a silica gel limiting member. The first radiopaque ring is sleeved and fixed at the front end of the straight rod, and a spiral head is fixed on the front end face of the first radiopaque ring. The second radiopaque ring is sleeved and fixed at a position near the rear end of the straight rod, and the rear end face of the second radiopaque ring is fixed to the front end of the inner stranded wire. Two platinum-iridium limiting members sandwich a silica gel limiting member and are then sleeved on the straight rod at a position between the two radiopaque rings. The present invention can reduce the parts of the electrode head, simplify the assembly process, ensure that the spiral head can rotate smoothly with the torque transmitted by the rotation of the connector pin, and improve the insulation reliability of the electrode lead at the same time.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to a medical pacing electrode lead wire. Background Art

[0002] A pacing electrode lead wire is a medical implantable electrical wire with one end connected to an electrical stimulation medical device such as a pacemaker or defibrillator, and the other end directly connected to a part of the body such as the heart that needs to receive electrical stimulation. The electrical signal emitted by the electrical stimulation medical device is transmitted to the cardiac structure to be stimulated through the electrical wire.

[0003] The electrical wire generally includes an electrode end, a wire body, and a connector end. The electrode is the non-insulated end of the wire that directly contacts the heart, and the connector is the other non-insulated end of the wire that connects to an electrical stimulation medical device such as a pacemaker or defibrillator.

[0004] Currently, pacing electrode lead wires are mainly divided into active electrode lead wires and passive electrode lead wires. The electrode end of the passive electrode has a barbed structure and can be directly hooked on the trabeculae carneae. Over time, the electrode end will be wrapped by the myocardium and gradually stabilized. The electrode end of the active electrode is a spiral structure. By rotating the connector pin at the connector end, the outer spiral at the electrode end is screwed into the myocardium and fixed in the atrium or ventricle.

[0005] Chinese patent document with publication number CN102858403A discloses a medical lead assembly. The medical lead assembly includes a lead body having a proximal end and a distal end configured to be coupled to an implantable medical device. The lead assembly further includes an electrode assembly located at the proximal end of the lead body. The electrode assembly includes a tip electrode, a conductive electrode shaft electrically coupled to the tip electrode, and an energy dissipation structure that is non-conductively coupled to at least a portion of the conductive electrode shaft at high frequencies to redirect at least a portion of the current induced in the lead by a high-frequency signal from the tip electrode to the energy dissipation structure.

[0006] The Chinese patent document with the publication number CN209771105U discloses an active fixed pacemaker electrode lead, which includes an inner insulating sleeve. An outer insulating sleeve, an annular electrode, and a soft connection rubber sleeve are sequentially arranged on the inner insulating sleeve. An outer wire is arranged between the outer insulating sleeve and the inner insulating sleeve. An inner core of the annular electrode in contact with the outer wire is arranged between the outer insulating sleeve and the inner insulating sleeve. Part of the inner core of the annular electrode is located between the annular electrode and the inner insulating sleeve. An inner wire is arranged in the inner insulating sleeve. A spiral tube with an inner spiral groove is arranged at the end of the inner insulating sleeve. An outer tube of the electrode head is arranged outside the spiral tube. A rotating shaft connected to the inner wire is arranged in the spiral tube. A pin is arranged on the rotating shaft and placed in the inner spiral groove of the spiral tube. A sealing ring and a drug plug are arranged in the outer tube of the electrode head at one end of the spiral tube. The rotating shaft passes through the sealing ring and the drug plug, and a spiral electrode head is connected to the end of the rotating shaft after passing through. A bushing of the spiral electrode head and a mapping ring arranged at the end of the outer tube of the electrode head are arranged between the outer tube of the electrode head and the spiral electrode head.

[0007] However, the electrode heads of the existing active electrode leads on the current market mainly have the following disadvantages: there are many parts, especially many precious metal parts, resulting in high processing costs; there are many metal parts, especially magnetic components, and they cannot pass magnetic resonance examinations; the assembly process is complex and requires various welding, crimping, and bonding to complete the assembly; the rotation of the electrode head is not smooth, the component design and assembly are cumbersome, and there are many components with low insulation reliability, and it is not easy to observe the fixation of the electrode head under fluoroscopy. Summary of the Invention

[0008] The present invention provides a medical pacing electrode lead, which can reduce the components of the electrode head, simplify the assembly process of the electrode head, ensure that the spiral head can rotate smoothly with the torque transmitted by the rotation of the connector pin, and improve the insulation reliability of the electrode lead at the same time.

[0009] A medical pacing electrode lead includes an electrode head, a wire body section, and a connector connected in sequence;

[0010] The electrode head includes an external structure and an internal structure. The external structure includes a drug plug, an electrode sleeve, an electrode insulation connector, and an electrode ring connected in sequence. The internal structure includes a straight rod, a first imaging ring, a second imaging ring, a platinum-iridium limiting member, and a silica gel limiting member. Among them, the first imaging ring is welded and fixed at the front end of the straight rod, and a spiral head is fixed on the front end face of the first imaging ring. The second imaging ring is welded and fixed at a position near the rear end of the straight rod. Two platinum-iridium limiting members sandwich a silica gel limiting member and are sleeved on the straight rod at a position between the two imaging rings. The straight rod is made of a non-imaging metal material;

[0011] The rear end part of the electrode sleeve is sleeved on the outer side surface of the front end of the electrode insulation connector, and an inner step is arranged on the inner wall of the electrode sleeve. Two platinum-iridium limiting members are arranged in an annular groove formed by the rear end face of the inner step of the electrode sleeve and the front end face of the electrode insulation connector;

[0012] The two platinum-iridium limit members are respectively engaged with the first developing ring and the second developing ring on the straight rod, and are used for limiting the front and rear positions of the first developing ring and the second developing ring during the process of the straight rod driving the screw head, and positioning the position of the screw head according to the developing distance between the two platinum-iridium limit members and the developing ring.

[0013] In the present invention, by using the cooperation of the developing ring and the platinum-iridium limit member, the release of the screw head can be limited; by using the developability of the developing ring and the platinum-iridium limit member, it is convenient to position the screw head under development; at the same time, by using the welding of the straight rod and the developing ring instead of an integral part, the precious metal parts for machining can be reduced. In addition, the electrode head body is made of plastic and platinum-iridium parts to reduce heat generation under nuclear magnetic resonance; the silicone limit member gives a certain damping during the movement of the screw head to enhance the release stability; the silicone limit member absorbs the mechanical vibration caused by the heartbeat inside the wire, which can improve the fatigue resistance of the electrode lead.

[0014] Further, the wire main body section includes an outer insulating tube, an outer stranded wire, an inner insulating tube and an inner stranded wire from outside to inside;

[0015] A gap is provided between the inner stranded wire and the inner insulating tube. The front end of the inner stranded wire is fixed to the rear end face of the second developing ring, and the rear end of the inner stranded wire is fixed to the connector pin in the connector; the outer stranded wire is wound and fixed on the outer surface of the inner insulating tube, and the front end of the outer stranded wire is fixed to the rear end part of the electrode ring.

[0016] Further, the outer side surface of the rear end of the electrode insulating connector is fixed to the inner groove surface of the front end of the electrode ring.

[0017] Further, an electrode ring step is provided on the outer wall of the electrode ring near the rear end. The rear step end face of the electrode ring step and the outer side surface of the rear part of the electrode ring are connected to the outer stranded wire, and the rear step end face abuts against the front end of the outer stranded wire.

[0018] Further, the outer diameter of the outer side surface of the front end of the electrode ring is close to the outer diameter of the outer insulating tube.

[0019] Further, a side hole for injecting silicone binder is provided at the position of the electrode ring on one side of the electrode ring step.

[0020] Further, a drug cavity for fixing a drug plug is provided at the front end of the electrode sleeve; a limit member for axially limiting the screw head is provided inside the electrode sleeve near the drug cavity.

[0021] Further, the circumferential side surface of the silicone limit member is in interference fit with the inner cavity of the electrode sleeve, and the inner cavity of the silicone limit member is in clearance fit with the straight rod; the front side and the rear side of the silicone limit member are respectively in close fit with the corresponding platinum-iridium limit members.

[0022] Preferably, the material of the helical head is platinum-iridium alloy or platinum alloy. The material of the straight rod is a non-visualizing metal material, such as stainless steel, nitinol alloy or MP35N.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] 1. The visualizing part of the electrode head of the conventional electrode lead has an electrode ring, a helical head, a rotating shaft, and a platinum-iridium limiting member. Most of the above-mentioned visualizing components are made of precious metal materials such as platinum-iridium alloy. The processing of the rotating shaft requires a large-diameter platinum-iridium alloy rod to be machined by a metal machine into a shape with thick ends and a thin middle, resulting in extremely large material waste. The present invention uses non-visualizing metal materials such as stainless steel, nitinol, and MP35N, and a visualizing ring with visualizing properties is welded at both ends to form a rotating shaft. It can be visualized and positioned through the visualizing ring and the platinum-iridium limiting member, and greatly reduces the usage of precious metals and lowers the production cost.

[0025] 2. In the present invention, the electrode head body is made of plastic and platinum-iridium alloy. The external part mainly includes an electrode sleeve, an electrode insulating connector, and a silicone drug plug made of plastic, and the internal part is mainly made of platinum-iridium alloy. The plastic material itself has no thermal effect on nuclear magnetic resonance, and platinum-iridium alloy is also a preferred metal material for nuclear magnetic resonance, which can effectively reduce the heating effect of the electrode lead under nuclear magnetic resonance.

[0026] 3. By assembling a silicone limiting member in the middle of the platinum-iridium limiting member, due to the high elasticity of the silicone limiting member, it can be properly displaced and fitted when cooperating with hard contact components such as the electrode sleeve and the electrode insulator, which can reduce the assembly difficulty, lower the processing precision requirements for the electrode sleeve and the electrode insulator, improve the qualified rate of raw material processing, and reduce the production cost of the electrode lead from the source. At the same time, the silicone limiting member can provide damping during the release process of the helical head, improving the stability of the helical head release.

[0027] 4. After the electrode is implanted, the helical head undergoes a bending movement with the beating of the heart. The electrode lead will work in the human body for more than ten years or even decades. The long-term bending movement will affect the connection strength of the metal parts or plastic parts with rigid connections inside the electrode lead. In the present invention, the highly elastic silicone limiting member can absorb the bending vibration mechanical energy transmitted from the helical head of the electrode lead, play a buffering role, reduce the influence of the long-term bending vibration of the electrode lead on the connection strength and reliability of the internal parts, and improve the fatigue resistance of the electrode lead. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a schematic diagram of the overall structure of a medical pacing electrode lead in the present invention;

[0029] Figure 2 is a schematic diagram of the structure of the electrode head and the wire main body section in the present invention;

[0030] Figure 3 This is a cross-sectional view of the electrode head and the main wire segment in the present invention;

[0031] Figure 4a is Figure 3 the external view of the loop electrode connected to the external multi-strand wire in

[0032] Figure 4b is Figure 3 the cross-sectional view of the loop electrode connected to the external multi-strand wire in

[0033] Figure 5a is Figure 3 the external view of the electrode insulator connected to the loop electrode in

[0034] Figure 5b is Figure 3 the cross-sectional view of the electrode insulator connected to the loop electrode in

[0035] Figure 6a is Figure 3 the external view of the electrode sleeve connected to the electrode insulator in

[0036] Figure 6b is Figure 3 the cross-sectional view of the electrode sleeve connected to the electrode insulator in

[0037] Figure 7 is Figure 3 the external view of the silicone limiting part in

[0038] Figure 8 is Figure 3 the external view of the spiral head connected to the developing ring in

[0039] Figure 9 is Figure 3 the external view of the internal multi-strand wire connected to the straight rod in

[0040] Figure 10 is Figure 3 the external view of the external multi-strand wire connected to the loop electrode in

[0041] Figure 11 is Figure 3 the external view of the internal insulating tube connected to the electrode insulating connector in

[0042] Figure 12 is Figure 3 the external view of the external insulating tube connected to the electrode ring in

[0043] Figure 13 is Figure 3 the external view of the developing ring connected to the straight rod in

[0044] Figure 14 is Figure 3 Schematic diagram of the appearance of the platinum-iridium limit member adjacent to the silica gel limit member in

[0045] Figure 15 is Figure 2 and Figure 3 Schematic diagram of the appearance of the drug plug connected to the electrode sleeve in

[0046] Figure 16 is Figure 3 Schematic diagram of the appearance of the straight rod connected to the inner multi-strand wire in

[0047] Figure 17a Schematic diagram of the effect of the spiral head not being released under X-ray imaging of the present invention;

[0048] Figure 17b Schematic diagram of the effect of the spiral head being completely released under X-ray imaging of the present invention. Detailed implementation manners

[0049] The present invention will be further described in detail below in conjunction with the drawings and embodiments. It should be noted that the following embodiments are intended to facilitate the understanding of the present invention and do not impose any limitation on it.

[0050] As Figure 1 shown, a medical pacing electrode lead is divided into three parts: an electrode head 6, a lead body segment 7, and a connector 800 from front to back. Among them, the electrode head 6 includes a spiral head 2 and a ring electrode 3, and the outer side of the lead body segment 7 is insulated and protected by an outer insulating tube 68. By rotating the connector pin 130 in the connector 800, the screwing in and out of the spiral head 2 in the electrode head 6 can be controlled.

[0051] In actual application, the medical pacing electrode lead is usually used in cooperation with a cardiac pacemaker and a defibrillator. First, the spiral head 2 will be screwed into the targeted treatment site in the heart, and then the muscle tissue in the heart will gradually grow together with the electrode head 6. The connector 800 is connected to the cardiac pacemaker or defibrillator, and finally, through the connector 800, the electrode head 6, and the lead body segment 7, the electrical signal emitted by the cardiac pacemaker or defibrillator is transmitted to the targeted treatment site in the heart to be electrically stimulated.

[0052] As Figure 2 and Figure 3As shown, the external structure of the electrode head 6 mainly consists of a spiral head 2, a drug plug 9, an electrode sleeve 40, an electrode insulating connector 30, and a ring electrode 3. The internal structure mainly consists of a first imaging ring 60, a straight rod 600, a platinum-iridium limiting member 400, a silica gel limiting member 500, and a second imaging ring 61, and is connected to the inner insulating tube 58, the outer insulating tube 68, the inner stranded wires 18, and the outer stranded wires 28 of the wire main body section 7. The electrode head 6 and the wire main body section 7 together form the distal end 700 of the electrode wire.

[0053] As Figure 3 shown, the sealing and insulating performance of the electrode head 6 is mainly achieved through the following means:

[0054] The inner stranded wires 18 are assembled in the inner cavity of the inner insulating tube 58, the inner insulating tube 58 is assembled in the inner cavity of the outer stranded wires 28, and the outer stranded wires 28 are assembled in the inner cavity of the outer insulating tube 68. The above assembly structure insulates the inner stranded wires 18 from the outer stranded wires 28. The gap between the outer side surface 305 at the rear end of the electrode insulating connector 30 and the inner groove surface 35 at the front end of the electrode ring 3 is filled and bonded with silica gel adhesive. The inner insulating tube 58 and the inner cavity 88 of the electrode ring 3 are filled and bonded with silica gel adhesive; the front end surface 608 of the outer insulating tube 68 and the rear end surface 105 of the electrode ring 3 are bonded with silica gel adhesive. The front end surface 55 of the electrode ring 3 and the rear step end surface 335 of the electrode insulating member 30 are bonded with silica gel adhesive.

[0055] The electrical connection performance of the electrode head 6 is mainly achieved through the following means:

[0056] Head-end electrode part: Two imaging rings are welded to the straight rod 600, the spiral head 2 is welded to the first imaging ring 60 at the front end of the straight rod 600, and the inner stranded wires 18 are welded to the second imaging ring 61 at the rear end of the straight rod 600.

[0057] Ring electrode part: The electrode ring 3 is welded to the outer stranded wires 28.

[0058] As Figure 3 shown, the rotation function of the spiral head 2 is mainly achieved by the rotation of the inner stranded wires 18 connected to the straight rod 600. There is a certain gap between the inner stranded wires 18 and the inner insulating tube 58, ensuring that the inner stranded wires 18 can rotate smoothly.

[0059] As Figure 3 , Figure 4a and Figure 4bAs shown, the electrode ring step 85 on the electrode ring 3 and the rear outer side surface 115 of the electrode ring are connected to the outer stranded wire 28, and the rear step end surface 86 of the electrode ring abuts against one end of the outer stranded wire 28, and the outer diameter of the front side surface 65 of the electrode ring 3 should be close to that of the outer insulating tube 68. The front end surface 55 of the electrode ring 3 is connected to the rear step end surface 335 of the electrode insulation connector 30. And the inner insulating tube 58 is assembled in the inner cavity 88 of the electrode ring 3, and the inner stranded wire 18 is assembled in the inner insulating tube 58. It is fixed and axially positioned by applying a silicone adhesive to the rear step end surface 335 of the electrode insulation member 30 and assembling it into the front inner groove surface 35 of the electrode ring 3, and the silicone adhesive is injected through the side hole 75 on the side hole surface 95 of the electrode ring 3 to fill the gap between the inner cavity 88 of the electrode ring 3 and the inner insulating tube 58, ensuring the insulation performance between the inner stranded wire 18 and the outer stranded wire 28. The material of the electrode ring 3 is preferably a biocompatible implantable grade imaging metal material such as platinum-iridium alloy and platinum alloy that have an imaging effect under X-ray irradiation.

[0060] The connection between the rear step end surface 86 of the electrode ring 3 and the outer stranded wire 28 can be connected by means such as laser welding and resistance welding. The connection between the front end surface 55 of the electrode ring 3 and the rear step end surface 335 of the electrode insulation member 30 can be adhesively fixed by a biocompatible adhesive material such as silicone adhesive.

[0061] As Figure 3 , Figure 5a , Figure 5b shown: The inner stranded wire 18 passes through the inner cavity 312 of the electrode insulation connector 30, and the inner insulating tube 58 is also adhesively bonded therein. The rear step end surface 335 of the electrode insulation connector 30 is connected to the front end surface 55 of the electrode ring 3 for axial limit at the rear side, and the front step end surface 345 of the electrode insulation connector 30 is connected to the rear end surface 410 of the electrode sleeve 40 for axial limit at the front side. The connection method between the electrode insulation connector 30 and the electrode ring 3 and the electrode sleeve 40 is preferably adhesively fixed by a biocompatible silicone adhesive. The fixing method is to apply the silicone adhesive to the front outer side surface 310 and the front step end surface 345 of the electrode insulation connector 30 and assemble it into the electrode sleeve 40, so that the front step end surface 345 of the electrode insulation member 30 is fitted and fixed with the rear end surface 410 of the electrode sleeve 40. The outer diameter of the connector step 325 should be close to the outer diameters of the electrode sleeve 40 and the outer insulating tube 68.

[0062] The material of the electrode insulation connector 30 should be a biocompatible implantable material, such as polyetheretherketone (PEEK), polycarbonate (PC), etc.

[0063] As Figure 3 , Figure 6a and Figure 6bAs shown, the electrode sleeve 40 is located between the drug plug 9 and the electrode insulator 30. The drug cavity 445 of the electrode sleeve 40 is used to fix the drug plug 9. The limiting member 435 of the electrode sleeve 40 cooperates with the screw head 2. As Figure 1 shown, by rotating the connector pin 130 to drive the circumferential rotation of the screw head 2, the limiting member 435 of the electrode sleeve 40 can provide a limit for the axial movement of the screw head 2.

[0064] As Figure 3 and Figure 7 shown, the silicone limiting member 500 is assembled inside the electrode sleeve 40. The circumferential side surface 506 of the silicone limiting member 500 is in interference fit with the inner cavity of the electrode sleeve 40 to ensure the axial stability of the silicone limiting member 500, and the inner cavity 502 of the silicone limiting member 500 is in clearance fit with the straight rod 600, so that the straight rod 600 can rotate circumferentially in the inner cavity 502 of the silicone limiting member 500. One platinum-iridium limiting member 400 is respectively assembled on the front small end face 504 and the rear large end face 508 of the silicone limiting member 500 and is tightly fitted. The platinum-iridium limiting member 400 cooperating with the front small end face 504 of the silicone limiting member 500 is in front axial limit cooperation with the rear end face 425 of the inner step of the electrode sleeve 40, and the platinum-iridium limiting member 400 cooperating with the rear large end face 508 of the silicone limiting member 500 is in rear axial limit cooperation with the front end face 320 of the electrode insulating connection member 30, so that the silicone limiting member 500 is axially fixed. The material of the silicone limiting member 500 should be implantable silicone with biocompatibility.

[0065] In actual application, during the assembly process of the medical pacing electrode lead, the electrode ring 3, the electrode insulating connection member 30, and the electrode sleeve 40 are all rigidly connected during cooperation. Processing tolerances are inevitable in the manufacturing processes of the electrode ring 3, the electrode insulating connection member 30, and the electrode sleeve 40. The rubber elasticity of the silicone limiting member 500 can ensure normal assembly when there are processing tolerances in each assembled part.

[0066] During the release process of the screw head 2, the silicone limiting member 500 can provide a certain damping, improving the release stability of the screw head 2; at the same time, the screw head 2 is screwed into the targeted treatment site in the heart to fix the electrode end of the electrode lead, and the connector end is fixed in the electrode cavity of the cardiac pacemaker or defibrillator. The screw head 2 will drive the electrode lead to bend with the beating of the heart. The silicone limiting member 500 has the unique high elasticity of silicone material, which can reduce the vibration of the internal structure of the electrode head 6 caused by the beating of the heart, ensure the reliability of the screw head 2 at the targeted fixation position in the heart, and also improve the reliability of the internal connection of the electrode lead.

[0067] As Figure 2 、 Figure 3 、 Figure 8As shown, the helical head 2 is fixed to the first developing ring 60. Optionally, the connection method between the helical head 2 and the first developing ring 60 is laser welding, resistance welding, crimping, etc. The material of the helical head 2 is preferably a developing metal material with biocompatibility such as platinum-iridium alloy, platinum alloy, etc.

[0068] In practical applications, the helical head 2 drives the rotation of the inner multi-strand wire 18 through the connector pin 130 and screws outwards into the heart target site. The degree of screwing out of the helical head 2 in the heart can be judged by changing the distance between the helical head 2 and the platinum-iridium limiting member 400.

[0069] As Figure 2 , Figure 3 and Figure 9 shown, the inner multi-strand wire 18 is arranged inside the inner insulating tube 58. One end of the inner multi-strand wire 18 is connected to the connector pin 130 by resistance welding, bonding or laser welding, and the other end is connected to the helical head 2 to transmit the electrical signal received by the connector pin 130 from the pacemaker or defibrillator.

[0070] As Figure 2 , Figure 3 and Figure 10 shown, the outer multi-strand wire 28 is arranged between the inner insulating tube 58 and the outer insulating tube 68. One end is connected to the electrode ring 3 by laser welding or resistance welding, and the other end is conducted to the connector 800 to transmit the electrical signal received by the connector 800.

[0071] The functions of the inner multi-strand wire 18 and the outer multi-strand wire 28 are to make electrical connections with the electrode head 6 and are not part of the electrode head 6. Therefore, the materials and structures of the inner multi-strand wire 18 and the outer multi-strand wire 28 are not limited in the present invention.

[0072] As Figure 2 , Figure 3 and Figure 11 shown, the inner insulating tube 58 is arranged between the outer multi-strand wire 28 and the inner multi-strand wire 18. The inner multi-strand wire 18 can rotate in the inner insulating tube cavity 508 of the inner insulating tube 58, and the outer multi-strand wire 28 is wound around the outer surface 518 of the inner insulating tube.

[0073] As Figure 3 , Figure 11 shown, one end of the inner insulating tube 58 is connected to the electrode ring 3, and a biocompatible silicone adhesive is injected through the side hole 75 on the side hole surface 95 of the electrode ring 3 to fill the gap between the outer surface 518 of the inner insulating tube 58 and the inner cavity 88 of the electrode ring 3, so that the inner insulating tube 58 is adhesively fixed to the electrode ring 3, and at the same time, the electrical insulation between the inner multi-strand wire 18 and the outer multi-strand wire 28 is ensured.

[0074] As Figure 1 , Figure 2 , Figure 3 andFigure 12 As shown, the outer insulating tube 68 is disposed between the long sealing ring 550 and the outer stranded wire 28. The outer stranded wire 28 is fixed within the inner cavity 618 of the outer insulating tube. One end of the outer insulating tube 68 and a part of the outer wall 628 of the outer insulating tube are bonded to the long sealing ring 550, and one end is connected to the electrode head 6.

[0075] As Figure 3 , Figure 13 shown, two developing rings are assembled inside the electrode head 6, and are both disposed between the electrode sleeve 40 and the straight rod 600. The first developing ring 60 is fixed to one end of the straight rod 600 connected to the spiral head 2, and the second developing ring 61 is fixed to one end of the straight rod 600 connected to the inner stranded wire 18. Optionally, the fixing method can be laser welding or resistance welding. The materials of the two developing rings are preferably metal materials with developability such as platinum-iridium alloy and platinum alloy.

[0076] As Figure 3 , Figure 6a , Figure 6b and Figure 14 shown, two platinum-iridium limit members 400 are assembled inside the electrode head 6, and are disposed between the electrode sleeve 40 and the straight rod 600. A silica gel limit member 500 is assembled between the two platinum-iridium limit members 400. One platinum-iridium limit member 400 cooperates with the rear end face 425 of the inner step of the electrode sleeve 40, and the other platinum-iridium limit member 400 cooperates with the front end face 320 of the electrode insulating connector 30 to achieve the axial positioning of the platinum-iridium limit member 400. The material of the platinum-iridium limit member is preferably platinum-iridium alloy.

[0077] As Figure 3 and Figure 15 shown, the drug plug 9 is disposed in the drug cavity 445 of the electrode sleeve 40, and a spiral head 2 is assembled in the drug plug inner cavity 93 of the drug plug 9. The stepped end face 91 of the drug plug 9 and the front end face 415 of the electrode sleeve 40 are bonded by a biocompatible silica gel binder to achieve the axial positioning of the drug plug 9. The drug plug 9 is made by blending a steroid carrier and a medicament. The steroid carrier is preferably biocompatible silica gel, and the medicament is an anti-inflammatory medicament with bactericidal and anti-inflammatory effects, preferably dexamethasone acetate and sodium dexamethasone phosphate. By blending the anti-inflammatory medicament and silica gel, the anti-inflammatory medicament can be slowly released in the human body to reduce the inflammatory reaction.

[0078] In practical applications, when the electrode wire is implanted, the spiral head 2 will be screwed into the target site of the atrium or ventricle. As a foreign object implanted, the spiral head 2 may cause inflammation at the targeted screwing position. By slowly releasing the anti-inflammatory medicament from the drug plug 9 outside the spiral head 2, the inflammatory reaction of the damaged part of the myocardium can be effectively alleviated to help the damaged part heal.

[0079] As Figure 3 and Figure 16As shown in the figure, the straight rod 600 is arranged inside the electrode sleeve. One end is spot-welded to the first imaging ring 60 by means of laser welding, resistance welding or the like, and the other end is circumferentially welded to the inner stranded wire 18 by means of laser welding, resistance welding or the like. The straight rod 600 is made of a non-imaging metal material, preferably stainless steel, nitinol alloy, MP35N or the like with biocompatibility.

[0080] As Figure 17a and 17b shown in the figure, by changing the commonly used platinum-iridium alloy material of the straight rod 600 to other non-imaging metal materials with biocompatibility, and separately welding the imaging first imaging ring 60 and the second imaging ring 61 on the straight rod 600, the positioning of the screw head 2 can be achieved through the imaging of the imaging ring and the platinum-iridium limiting member 400, and the usage amount of precious metal parts in the machining process can be significantly reduced to reduce the production cost of the instrument and the economic pressure on patients.

[0081] In practical applications, when the screw head 2 is screwed outwards by the rotation of the connector pin 130 and inserted into the cardiac target site, the first imaging ring 60 connected to the screw head 2 moves away from the adjacent platinum-iridium limiting member 400, and the second imaging ring 60 connected to the inner stranded wire 18 moves closer to the adjacent platinum-iridium limiting member 400. By observing the change in the distance between the two imaging rings and the platinum-iridium limiting member 400 under X-ray imaging, the degree of the screw head 2 being screwed out can be evaluated. And during the process of the screw head 2 being screwed out, the rear end face 420 of the rear platinum-iridium limiting member 400 can limit the front end face 69 of the second imaging ring 61 connected to the inner stranded wire 18, restricting the axial movement of the second imaging ring 61, thereby limiting the screwing-out limit of the screw head 2.

[0082] The above-described embodiments have detailed the technical solutions and beneficial effects of the present invention. It should be understood that the above are only specific embodiments of the present invention and are not used to limit the present invention. Any modifications, supplements and equivalent replacements made within the scope of the principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A medical pacing electrode lead, comprising an electrode head (6), a lead body section (7) and a connector (800) connected in sequence, characterized in that: The electrode head (6) includes an external structure and an internal structure. The external structure includes a drug plug (9), an electrode sleeve (40), an electrode insulation connector (30) and an electrode ring (3) connected in sequence; the internal structure includes a straight rod (600), a first imaging ring (60), a second imaging ring (61), a platinum-iridium limiting member (400) and a silicone limiting member (500); wherein, the first imaging ring (60) is welded and fixed to the front end of the straight rod (600), and a spiral head (2) is fixed to the front end face of the first imaging ring (60); the second imaging ring (61) is welded and fixed at a position closer to the rear end of the straight rod (600); two platinum-iridium limiting members (400) clamp a silicone limiting member (500) and then are sleeved on the straight rod (600) at a position between the two imaging rings; the straight rod (600) is made of a non-imaging metal material; The front end of the electrode sleeve (40) is provided with a drug cavity (445) for fixing the drug plug (9); inside the electrode sleeve (40) at a position close to the drug cavity (445), a limiting member (435) for axially limiting the spiral head (2) is provided; The circumferential side surface of the silicone limiting member (500) is in interference fit with the inner cavity of the electrode sleeve (40), and the inner cavity of the silicone limiting member (500) is in clearance fit with the straight rod (600); the front side and the rear side of the silicone limiting member (500) are respectively in close fit with the corresponding platinum-iridium limiting members (400), so as to absorb the mechanical vibration caused by the heart beating to the inside of the lead; The rear end part of the electrode sleeve (40) is sleeved on the front outer side surface of the electrode insulation connector (30), and an inner step is provided on the inner wall of the electrode sleeve (40); two platinum-iridium limiting members (400) are arranged in an annular groove formed by the rear end face (425) of the inner step of the electrode sleeve (40) and the front end face of the electrode insulation connector (30); The two platinum-iridium limiting members (400) are respectively matched with the first imaging ring (60) and the second imaging ring (61) on the straight rod (600), so as to perform front and rear limiting on the first imaging ring (60) and the second imaging ring (61) during the process of the straight rod (600) driving the spiral head (2), and position the position of the spiral head (2) according to the imaging distance between the two platinum-iridium limiting members (400) and the imaging rings; In actual application, when the spiral head (2) is screwed outwards by the rotation of the connector pin (130) and inserted into the heart target site, by the first imaging ring (60) moving away from the adjacent platinum-iridium limiting member (400) and the second imaging ring (61) moving closer to the adjacent platinum-iridium limiting member (400), the degree of the spiral head (2) being screwed out is evaluated by observing the change in the distance between the two imaging rings and the platinum-iridium limiting member (400) under X-ray imaging.

2. The medical pacing electrode lead according to claim 1, characterized in that, The lead body section (7) from outside to inside includes an outer insulating tube (68), an outer stranded wire (28), an inner insulating tube (58) and an inner stranded wire (18); A gap is provided between the inner stranded wire (18) and the inner insulating tube (58). The front end of the inner stranded wire (18) is fixed to the rear end face of the second developing ring (61), and the rear end of the inner stranded wire (18) is fixed to the connector pin (130) in the connector (800); the outer stranded wire (28) is wound and fixed on the outer surface of the inner insulating tube (58), and the front end of the outer stranded wire (28) is fixed to the rear end portion of the electrode ring (3).

3. The medical pacing electrode lead according to claim 1, characterized in that, The outer side face (305) at the rear end of the electrode insulating connector (30) is fixed to the inner groove face (35) at the front end of the electrode ring (3).

4. The medical pacing electrode lead according to claim 1, characterized in that, An electrode ring step (85) is provided on the outer wall of the electrode ring (3) near the rear end. The rear step end face (86) of the electrode ring step (85) and the outer side face (115) at the rear of the electrode ring (3) are connected to the outer stranded wire (28), and the rear step end face (86) abuts against the front end of the outer stranded wire (28).

5. The medical pacing electrode lead according to claim 2, characterized in that, The outer diameter of the outer side face (65) at the front end of the electrode ring (3) is close to the outer diameter of the outer insulating tube (68).

6. The medical pacing electrode lead according to claim 4, characterized in that, A side hole (75) for injecting silicone binder is provided at a position on one side of the electrode ring step (85) of the electrode ring (3).

7. The medical pacing electrode lead according to claim 1, characterized in that, The material of the spiral head (2) is platinum alloy.

8. The medical pacing electrode lead according to claim 1, wherein, The material of the straight rod (600) is stainless steel or nitinol alloy.

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