Electrode wires and medical equipment

Abstract

The present invention discloses an electrode wire and a medical device, wherein the electrode wire comprises a wire main body section, an electrode head and a connector, wherein the electrode head is arranged at the first end of the wire main body section; the connector is arranged at the second end of the wire main body section and is suitable for plugging with a connection interface of the medical device; the first signal connector of the connector is rotatably inserted at the other end of the communication channel and connected to the inner multi-strand wire; the second signal connector is arranged at the connector body and connected to the outer multi-strand wire; wherein the electrical contact section of the first signal connector is suitable for electrically connecting to the connection interface of the medical device, and the insertion section of the first signal connector is inserted in the communication channel and connected to the inner multi-strand wire. The present invention improves the connector structure of the electrode wire, reduces the parts of the electrode wire connector, improves the convenience of connector assembly, ensures that the connector pin can smoothly transmit torque, reduces the degree of deflection of the connector pin relative to the connector ring, and strengthens the insulation reliability of the electrode wire.

Description

Technical Field

[0001] The invention relates to the technical field of medical electric wire connectors, and in particular to an electrode wire and medical equipment. Background Art

[0002] At present, the electrode leads of medical devices such as pacemakers are mainly divided into active electrode leads and passive electrode leads. The electrode end of the passive electrode has a barb-like structure that can be directly hung on the myocardial trabeculae. Over time, the electrode end will be wrapped by the myocardium and gradually stabilize. The electrode end of the active electrode is a spiral structure, which is telescopically screwed into the myocardium and fixed in the atrium or ventricle.

[0003] The connector of the existing active electrode lead mainly includes a shell and internal components arranged in the shell. There are many internal components, generally including a connector needle, an insulating component, an internal conductor or coil, a needle sleeve, etc. Since the ribs that constitute the shell seal are arranged radially along the internal center hole, they interfere with other components. In addition, the large number of internal components leads to a large rotation resistance of the connector needle, which makes the connector needle rotate unsmoothly, the electrode lead is less comfortable to use, and it is easy to cause irritation to the patient. Summary of the invention

[0004] The main purpose of the present invention is to provide an electrode wire and a medical device, aiming to improve the rotation smoothness of the first signal connector of the connector, so as to enhance the comfort of use of the electrode wire and reduce the irritation caused to the patient.

[0005] To achieve the above object, the present invention provides an electrode wire, the electrode wire comprising:

[0006] A conductor body section has a first end and a second end opposite to each other, the conductor body section comprising an outer insulating tube and an outer multi-strand wire, an inner insulating tube and an inner multi-strand wire sequentially arranged in the outer insulating tube;

[0007] an electrode head, disposed at a first end of the wire body segment; and

[0008] A connector, the connector is arranged at the second end of the wire body segment and is suitable for plugging with the connection interface of the medical device; the connector comprises a connector body, a first signal connector and a second signal connector, the connector body is provided with a communication channel, the second end of the wire body segment is plugged into one end of the communication channel; the first signal connector is plugged into the other end of the communication channel and connected to the inner multi-strand wire; the second signal connector is arranged on the connector body and connected to the outer multi-strand wire;

[0009] Wherein, the first signal connector comprises an electrical contact section and an insertion section connected to the electrical contact section, the electrical contact section is suitable for being electrically connected to the connection interface of the medical device, and the insertion section is inserted into the communication channel and connected to the inner multiple strands of wire;

[0010] The electrical contact section and the insertion section are both cylindrical, the outer diameter of the electrical contact section is larger than the outer diameter of the insertion section, and there is a gap between the insertion section and the inner wall of the communication channel, so that the first signal connector can be rotatably inserted in the communication channel.

[0011] Optionally, the first signal connector further comprises a clamping portion, the clamping portion is arranged at the end of the insertion section, and a matching mating portion is arranged on the inner wall of the connector body at a position corresponding to the clamping portion, and the clamping portion is clamped into the mating portion;

[0012] A first limiting step is formed at the connection between the electrical contact section and the insertion section, and the first limiting step is spaced apart from the end of the connector body; a second limiting step is formed between the locking portion and the insertion section, and an inner step surface is provided on the inner wall of the connector body corresponding to the second limiting step to limit the insertion section from escaping from the connecting channel along its axial direction.

[0013] Optionally, the first signal connector is provided with a socket extending through the length direction thereof, suitable for allowing an electrode auxiliary device to be inserted into the inner multiple strands of wire.

[0014] Optionally, a connecting portion is provided at one end of the insertion section, and the inner multiple wires are fixed to the connecting portion by welding.

[0015] Optionally, the first signal connector is made of platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

[0016] Optionally, the second signal connector includes a ring electrical contact segment and a bonding segment connected to the ring electrical contact segment, the ring electrical contact segment is suitable for being electrically connected to a connection interface of the medical device, and an end of the ring electrical contact segment is bonded and fixed to the connector body; an inner wall of the bonding segment is bonded and fixed to the connector body, and an end of the bonding segment is fixed to the connector body by welding.

[0017] Optionally, the bonding section is provided with an injection port suitable for injecting adhesive.

[0018] Optionally, the second signal connecting member is in a hollow tubular shape, and is provided with a third limiting step suitable for limiting the axial movement of the second signal connecting member.

[0019] Optionally, the material of the second signal connection is platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

[0020] Optionally, the connector body comprises:

[0021] an insulating member, which is in a hollow tubular shape, and the second signal connecting member is disposed around the insulating member; and

[0022] A signal connection seat is abutted against the insulating member, and the second signal connection member is connected to the outer multiple strands of wire through the signal connection seat.

[0023] Optionally, the insulating member includes a first pipe segment and a second pipe segment connected to the first pipe segment, the outer diameter of the first pipe segment is larger than the outer diameter of the second pipe segment, and a fourth limiting step is formed at the outer connection between the first pipe segment and the second pipe segment, which is suitable for limiting the axial movement of the insulating member.

[0024] Optionally, the inner step surface is provided at a position corresponding to the second limiting step at the inner connection between the first pipe section and the second pipe section;

[0025] The matching portion is provided on the inner wall of the insulating member at a position corresponding to the engaging portion, and the matching portion is arranged in a cone shape.

[0026] Optionally, the insulating member is made of polycarbonate, thermoplastic polyurethane elastomer, polysulfone, polyphenylene sulfone or polyetheretherketone.

[0027] Optionally, the signal connection seat is formed with an inner hole for the inner insulating tube to penetrate;

[0028] The signal connection seat includes an insertion section and a welding section connected to the insertion section, and a contact arm is provided at the connection between the insertion section and the welding section. The insertion section is inserted into the second signal connector and the contact arm contacts the end of the second signal connector and is fixed by welding. The welding section is fixed to the outer multiple strands of wire by welding.

[0029] Optionally, the signal connection socket is made of platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

[0030] Optionally, the connector further comprises a first seal adapted to seal a connection interface of the medical device, wherein the first seal is disposed around the second tube segment.

[0031] Optionally, the connector further comprises a second seal adapted to seal the connection interface of the medical device, the second seal being disposed around the second signal connector and fixed by bonding, the second seal forming a through hole for the outer insulating tube to penetrate.

[0032] Optionally, the second signal connector and the first tube segment, the first seal and the second tube segment, and the second seal and the second signal connector are all bonded and fixed by a first adhesive.

[0033] Optionally, the first adhesive is made of silicone or epoxy resin.

[0034] Optionally, the electrode head includes a spiral head and an electrode ring;

[0035] The spiral head is connected to the first end of the inner multi-strand wire, and when the first signal connector of the connector is rotated, the spiral head is screwed into the myocardium of the patient and fixed in the atrium or ventricle;

[0036] The electrode ring is arranged on the outer insulating tube and connected to the outer multiple strands of wire.

[0037] Optionally, the inner insulating tube and the connector body, as well as the outer insulating tube and the connector body are bonded and fixed by a second adhesive.

[0038] Optionally, the second adhesive is made of silicone or epoxy resin.

[0039] In order to achieve the above object, the present invention further provides a medical device, comprising:

[0040] A machine body having a connection interface; and

[0041] An electrode wire, wherein the electrode wire is the electrode wire as described above, a connector of the electrode wire is plugged into the connection interface, and the electrode wire comprises:

[0042] A conductor body section has a first end and a second end opposite to each other, the conductor body section comprising an outer insulating tube and an outer multi-strand wire, an inner insulating tube and an inner multi-strand wire sequentially arranged in the outer insulating tube;

[0043] an electrode head, disposed at a first end of the wire body segment; and

[0044] A connector, the connector is arranged at the second end of the wire body segment and is suitable for plugging with the connection interface of the medical device; the connector comprises a connector body, a first signal connector and a second signal connector, the connector body is provided with a communication channel, the second end of the wire body segment is plugged into one end of the communication channel; the first signal connector is plugged into the other end of the communication channel and connected to the inner multi-strand wire; the second signal connector is arranged on the connector body and connected to the outer multi-strand wire;

[0045] Wherein, the first signal connector comprises an electrical contact section and an insertion section connected to the electrical contact section, the electrical contact section is suitable for being electrically connected to the connection interface of the medical device, and the insertion section is inserted into the communication channel and connected to the inner multiple strands of wire;

[0046] The electrical contact section and the insertion section are both cylindrical, the outer diameter of the electrical contact section is larger than the outer diameter of the insertion section, and there is a gap between the insertion section and the inner wall of the communication channel, so that the first signal connector can be rotatably inserted in the communication channel.

[0047] In the technical solution of the present invention, the electrode wire includes a wire main body section, an electrode head and a connector, the wire main body section has a first end and a second end opposite to each other, the wire main body section includes an outer insulating tube and an outer multi-strand wire, an inner insulating tube and an inner multi-strand wire sequentially arranged in the outer insulating tube; the electrode head is arranged at the first end of the wire main body section; the connector is arranged at the second end of the wire main body section and is suitable for plugging with the connection interface of the medical device; the connector includes a connector body, a first signal connector and a second signal connector, the connector body is provided with a communication channel, the second end of the wire main body section is inserted into one end of the communication channel; the first signal connector is inserted into the other end of the communication channel and connected to the inner multi-strand wire; the second signal connector is arranged in the connector body The first signal connector comprises an electrical contact section and an insertion section connected to the electrical contact section, the electrical contact section is suitable for being electrically connected to a connection interface of a medical device, the insertion section is inserted in the connecting channel and connected to the inner multi-strand wire; the electrical contact section and the insertion section are both cylindrically arranged, the outer diameter of the electrical contact section is larger than the outer diameter of the insertion section, and there is a gap between the insertion section and the inner wall of the connecting channel, so that the first signal connector can be rotatably inserted in the connecting channel, the first signal connector has less interference with other components or structures, and the rotational resistance is relatively low, which improves the rotation smoothness of the first signal connector of the connector, thereby improving the comfort of use of the electrode wire and reducing the irritation caused to the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying creative work.

[0049] Figure 1 It is a structural schematic diagram of an embodiment of an electrode wire of the present invention;

[0050] Figure 2 This is a schematic diagram of the structure of a connector in an embodiment of an electrode wire of the present invention;

[0051] Figure 3 A cross-sectional view of a connector in an embodiment of an electrode wire of the present invention;

[0052] Figure 4 It is a structural schematic diagram of a first signal connecting member of a connector in an embodiment of an electrode wire of the present invention;

[0053] Figure 5 It is a schematic structural diagram of a second signal connecting member of a connector in an embodiment of an electrode wire of the present invention;

[0054] Figure 6 A cross-sectional view of a second signal connector of a connector in an embodiment of an electrode conductor of the present invention;

[0055] Figure 7 It is a schematic structural diagram of an insulating member of a connector in an embodiment of an electrode conductor of the present invention;

[0056] Figure 8 A cross-sectional view of an insulating member of a connector in an embodiment of an electrode wire of the present invention;

[0057] Fig. 9 It is a structural schematic diagram of a signal connection seat of a connector in an embodiment of an electrode wire of the present invention;

[0058] Fig.10 It is a structural schematic diagram of a first sealing member of a connector in an embodiment of an electrode wire of the present invention;

[0059] Fig.11 It is a schematic structural diagram of a second sealing member of a connector in an embodiment of an electrode wire of the present invention;

[0060] Fig.12 It is a schematic diagram of the structure of the inner multiple strands of the wire main body section in one embodiment of the electrode wire of the present invention;

[0061] Fig.13 It is a schematic diagram of the structure of the outer multi-strand wire of the main body section of the electrode wire in one embodiment of the present invention;

[0062] Fig.14 It is a schematic structural diagram of an inner insulating tube of a wire main body section in an embodiment of an electrode wire of the present invention;

[0063] Fig.15 This is a schematic diagram of the structure of the outer insulating tube of the wire main body section in an embodiment of the electrode wire of the present invention.

[0064] Description of Figure Numbers:

[0065]

[0066]

[0067] The realization of the purpose, functional features and advantages of the present invention will be further explained in conjunction with embodiments and with reference to the accompanying drawings. DETAILED DESCRIPTION

[0068] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0069] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0070] In addition, the descriptions of "first", "second", etc. in the present invention are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the meaning of "and / or" appearing in the full text is to include three parallel solutions. Taking "A and / or B" as an example, it includes solution A, or solution B, or a solution that satisfies both A and B. In addition, the technical solutions between the various embodiments can be combined with each other, but it must be based on the ability of ordinary technicians in this field to implement. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0071] At present, the electrode leads of medical devices such as pacemakers are mainly divided into active electrode leads and passive electrode leads. The electrode end of the passive electrode has a barb-like structure that can be directly hung on the myocardial trabeculae. Over time, the electrode end will be wrapped by the myocardium and gradually stabilize. The electrode end of the active electrode is a spiral structure, which is telescopically screwed into the myocardium and fixed in the atrium or ventricle.

[0072] In some exemplary technologies, the connector of the active electrode lead includes a shell and internal components disposed in the shell. There are many internal components, including a connector pin, an insulating component, an internal conductor or coil, a needle cannula, etc. Since the ribs that constitute the shell seal are radially arranged along the internal center hole, they interfere with other components. In addition, the large number of internal components leads to a large resistance to rotation of the connector needle, which makes the connector needle rotate unsmoothly, and the electrode lead is less comfortable to use and is prone to irritation to the patient.

[0073] In order to improve the rotation smoothness of the first signal connector of the connector, to enhance the comfort of use of the electrode lead, and to reduce the stimulation caused to the patient, the present invention proposes an electrode lead suitable for a variety of medical devices, especially defibrillators, pacemakers or other electrical stimulation devices, but not limited here.

[0074] Reference Figures 1 to 3 In some embodiments, the electrode wire includes a wire body section 10, an electrode head 20 and a connector 30, the wire body section 10 has a first end and a second end opposite to each other, the wire body section 10 includes an outer insulating tube 11 and an outer multi-strand wire 12, an inner insulating tube 13 and an inner multi-strand wire 14 arranged in sequence in the outer insulating tube 11; the electrode head 20 is arranged at the first end of the wire body section 10; the connector 30 is arranged at the second end of the wire body section 10 and is suitable for plugging with the connection interface of the medical device; the connector 30 includes a connector body 31, a first signal connector 32 and a second signal connector 33, the connector body 31 is provided with a connecting channel 31a, and the second end of the wire body section 10 is inserted into one end of the connecting channel 31a; the first signal connector 32 is inserted into the other end of the connecting channel 31a and is connected to the inner multi-strand wire 14; the second signal connector 33 is arranged on the connector body 31 and is connected to the outer multi-strand wire 12.

[0075] Among them, Figure 3 and Figure 4 As shown, the first signal connector 32 includes an electrical contact segment 321 and an insertion segment 322 connected to the electrical contact segment 321, the electrical contact segment 321 is suitable for being electrically connected to the connection interface of the medical device, and the insertion segment 322 is inserted into the connecting channel 31a and connected to the inner multi-strand wire 14; the electrical contact segment 321 and the insertion segment 322 are both cylindrically arranged, the outer diameter of the electrical contact segment 321 is larger than the outer diameter of the insertion segment 322, and there is a gap between the insertion segment 322 and the inner wall of the connecting channel 31a, so that the first signal connector 32 can be rotatably inserted into the connecting channel 31a.

[0076] It should be noted that, in this embodiment, the electrode wire may be an implantable active medical electrical wire, which is provided with an active mechanism at the free end. The free end of the implantable active medical electrical wire may include a spiral fixing mechanism, which is used to be braked and axially extend and / or rotate out of the top of the wire to engage or embed into the patient's myocardium and be fixed in the atrium or ventricle.

[0077] Combination Figure 1 and Figure 3The lead body 10 of the electrode lead is a medical electrical lead, generally comprising an outer insulating tube 11, an outer multi-strand wire 12 arranged in the outer insulating tube 11, an inner insulating tube 13 and an inner multi-strand wire 14. The outer insulating tube 11 is located on the outer peripheral side of the lead body 10 and wraps other components for insulation protection; the inner multi-strand wire 14 is placed in the innermost layer of the cable, the inner insulating tube 13 wraps it, and is arranged between the inner multi-strand wire 14 and the outer multi-strand wire 12 for insulation protection, while the inner insulating tube 13 and the outer insulating tube 11 form a space for accommodating the outer multi-strand wire 12.

[0078] Combination Figure 3 and Fig.12 The inner multi-strand wire 14 is arranged in the inner insulating tube 13. One end of the inner multi-strand wire 14 can be connected to the first signal connector 32 by resistance welding, bonding or laser welding, and the other end is connected to the spiral head 21 of the electrode head 20 to transmit the electrical signal received by the first signal connector 32 from medical devices such as pacemakers or defibrillators.

[0079] Combination Figure 3 and Fig.13 The outer multi-strand wire 12 is arranged between the inner insulating tube 13 and the outer insulating tube 11, one end of which is connected to the signal connection seat 320 by resistance welding, bonding or laser welding, and the other end is connected to the electrode ring 22 of the electrode head 20 to transmit the electrical signal received by the second signal connector 33.

[0080] Combination Figure 3 and Fig.14 The inner insulating tube 13 is arranged between the inner multi-strand wire 14 and the outer multi-strand wire 12 , the inner multi-strand wire 14 can rotate in the inner insulating tube 13 cavity of the inner insulating tube 13 , and the outer multi-strand wire 12 can be wound on the outer wall of the inner insulating tube 13 .

[0081] Combination Figure 3 and Fig.15 The outer insulating tube 11 at the second end of the wire main section 10 is arranged between the connector body 31 and the outer multi-strand wire 12. The outer multi-strand wire 12 is fixed in the cavity of the outer insulating tube 11. One end of the outer insulating tube 11 is connected to the electrode head 20, and a part of the outer wall at the other end is fixed to the connector body 31 by bonding or the like.

[0082] In this embodiment, if Figure 1 As shown, the electrode head 20 can be arranged at the first end of the wire main body section 10 to form an active mechanism. The motor head can include one or more electrode components, which can be made of solid conductive materials such as 316L stainless steel or precious metals. The specific structure can be set according to the signal detection requirements of medical equipment, etc., and is not limited here.

[0083] In this embodiment, if Figure 1As shown, the connector 30 can be arranged at the second end of the wire main body segment 10 for plugging into the connection interface of the medical device. It serves as a connecting device for connecting the conductor of the wire main body segment 10 (i.e., the inner multi-strand wire 14 and the outer multi-strand wire 12) and the connection interface of the medical device. The doctor can rotate the first signal connector 32 of the connector 30 to rotate the electrode head 20 located at the first end of the wire main body segment 10 into the patient's myocardium and fix it in the atrium or ventricle.

[0084] During assembly, the electrode head 20 can be first fixed to the first end of the wire main body section 10 by welding, winding connection, etc., and then the second end of the wire main body section 10 is cut open to expose the outer insulating tube 11, outer multi-strand wire 12, inner insulating tube 13 and inner multi-strand wire 14 at its end respectively, and then the inner multi-strand wire 14 at the end is fixed to the first signal connector 32 by welding or bonding, or the two are connected and fixed by a connecting component, and then the inner insulating tube 13 at the end is inserted and fixed into the connecting channel 31a of the connector body 31 by bonding, clamping, etc., and then the outer multi-strand wire 12 at the end is fixed to the second signal connector 33 by welding or bonding, or the two are connected and fixed by a connecting component, and then the outer insulating tube 11 at the end is inserted and fixed into the connecting channel 31a of the connector body 31 by bonding, clamping, etc.

[0085] It can be understood that in the technical solution of the present application, the electrode wire includes a wire main section 10, an electrode head 20 and a connector 30, the wire main section 10 has a first end and a second end opposite to each other, the wire main section 10 includes an outer insulating tube 11 and an outer multi-strand wire 12, an inner insulating tube 13 and an inner multi-strand wire 14 sequentially arranged in the outer insulating tube 11; the electrode head 20 is arranged at the first end of the wire main section 10; the connector 30 is arranged at the second end of the wire main section 10 and is suitable for plugging with the connection interface of the medical device; the connector 30 includes a connector body 31, a first signal connector 32 and a second signal connector 33, the connector body 31 is provided with a connecting channel 31a, the second end of the wire main section 10 is inserted into one end of the connecting channel 31a; the first signal connector 32 is inserted into the other end of the connecting channel 31a and is connected to the inner multi-strand wire 14; the second signal connector 33 is arranged The connector body 31 is connected to the outer multi-strand wire 12; wherein the first signal connector 32 includes an electrical contact section 321 and an insertion section 322 connected to the electrical contact section 321, the electrical contact section 321 is suitable for being electrically connected to the connection interface of the medical device, and the insertion section 322 is inserted into the connecting channel 31a and connected to the inner multi-strand wire 14; the electrical contact section 321 and the insertion section 322 are both cylindrically arranged, the outer diameter of the electrical contact section 321 is larger than the outer diameter of the insertion section 322, and there is a gap between the insertion section 322 and the inner wall of the connecting channel 31a, so that the first signal connector 32 can be rotatably inserted into the connecting channel 31a, the first signal connector 32 has less interference with other components or structures, and the rotational resistance is relatively low, which improves the rotation smoothness of the first signal connector 32 of the connector 30, thereby improving the comfort of using the electrode wire and reducing the irritation caused to the patient.

[0086] In order to prevent the first signal connector 32 from being separated from the communication channel 31a of the connector body 31 and improve the connection stability of the connector 30, in one embodiment, as shown in FIG. Figure 3 and Figure 4 As shown, the first signal connector 32 may further include a snap-fit ​​portion 323, which is disposed at the end of the insertion section 322, and a matching mating portion 313 is disposed at a position of the inner wall of the connector body 31 corresponding to the snap-fit ​​portion 323, as shown in FIG. Figure 8 As shown, the engaging portion 323 is engaged with the matching portion 313. Figure 4 and Figure 8 A first limiting step 324 is formed at the connection between the electrical contact section 321 and the insertion section 322, and the first limiting step 324 is spaced apart from the end of the connector body 31; a second limiting step 325 is formed between the locking portion 323 and the insertion section 322, and an inner step surface 315 is provided on the inner wall of the connector body 31 corresponding to the second limiting step 325 to limit the insertion section 322 from escaping from the connecting channel 31a along its axial direction.

[0087] In this embodiment, the first signal connector 32 may be in the shape of a cylindrical needle and may be made of a conductive material, which is not specifically limited here. The first signal connector 32 may be provided with a plug hole 32a extending along its length, suitable for inserting an electrode auxiliary device into the inner multi-strand wire 14.

[0088] It should be noted that, in practical applications, the electrode auxiliary device can be inserted into the inner multi-strand wire 14 through the insertion hole 32 a of the first signal connector 32 .

[0089] Furthermore, if Figure 4 As shown, a connecting portion 326 may be provided at one end of the insertion section 322 , and the inner multiple strands of wire 14 are welded and fixed to the connecting portion 326 .

[0090] During actual assembly, the inner multi-strand wire 14 can be passed through the connection portion 326 of the first signal connector 32 and aligned with the second limiting step 325, and then resistance welding, laser welding or bonding can be performed to fix the inner multi-strand wire 14 and the first signal connector 32 together. Then, the first signal connector 32 is inserted into the connector body 31 using the tapered engaging portion 323, and the first limiting step 324 and the second limiting step 325 end faces of the first signal connector 32 are used to limit the engaged first signal connector 32, ensuring that it does not slip off the connector body 31.

[0091] In actual use, the exposed electrical contact surface of the first signal connector 32 can be used to receive electrical signals sent by medical devices such as a pacemaker or a defibrillator.

[0092] It can be understood that since the middle side of the first signal connector 32 is clearance-matched with the connector body 31, the first signal connector 32 is axially limited while being able to drive the inner multi-strand wire 14 and the electrode spiral head 21 to rotate freely in the circumferential direction.

[0093] In this embodiment, the material of the first signal connection member 32 is preferably platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy, etc., which is not limited here.

[0094] It is worth mentioning that the inner and outer multi-strand wires 12 of the conventional electrode wire need to be crimped and fixed with four metal parts. There are many metal parts, especially magnetic components, which makes the assembly complicated, the cost is high and it is not easy to pass the nuclear magnetic resonance inspection. However, the connector 30 of the electrode wire adopts the structure and process of laser welding to connect and fix with the inner and outer multi-strand wires 12, which reduces the number of metal parts, reduces the difficulty of assembly, reduces the assembly process, and is easier to pass the nuclear magnetic resonance inspection. In addition, the connection between the insulating component of the conventional electrode wire and the first signal connector 32 requires multiple matching structures, or even the matching of multiple insulating components. The assembly process is complicated, the cumulative tolerance caused by the assembly of multiple components is large, and the cost is high. The first signal connector 32 and the insulating component of the electrode wire connector 30 adopt a snap-fit ​​structure, and the two components can ensure the axial limitation and circumferential free rotation of the first signal connector 32, reduce assembly components and processes, and reduce product costs.

[0095] Please refer to Figure 5 and Figure 6 In some embodiments, the second signal connector 33 may include a ring electrical contact section 331 and a bonding section 332 connected to the ring electrical contact section 331, the ring electrical contact section 331 is suitable for being electrically connected to the connection interface of the medical device, the end of the ring electrical contact section 331 is bonded and fixed to the connector body 31; the inner wall of the bonding section 332 is bonded and fixed to the connector body 31, and the end of the bonding section 332 is fixed to the connector body 31 by welding. In this way, assembly is convenient and the stability of signal transmission of the connector 30 is improved.

[0096] In this embodiment, the second signal connector 33 can be configured as a hollow tube, and its annular electrical contact section 331 and bonding section 332 can be manufactured by integral molding, or assembled by welding or the like, which is not limited here. The material of the annular electrical contact section 331 and bonding section 332 of the second signal connector 33 can be the same conductor material such as platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy, or different conductor materials can be used, which is not limited here.

[0097] Furthermore, in this embodiment, if Figure 5 and Figure 6 As shown, the bonding section 332 of the second signal connector 33 is provided with an injection port 332 a suitable for injecting adhesive to improve the convenience of assembly.

[0098] It can be understood that during the assembly of the connector 30 and the second end of the conductive body segment, an adhesive such as silicone can be injected through the injection port 332 a to fix the insulating member 310 of the connector body 31 .

[0099] In this embodiment, please refer to Figure 6The second signal connector 33 may be provided with a third limiting step 333, which is suitable for limiting the axial movement of the second signal connector 33.

[0100] It can be understood that the second signal connector 33 uses its center hole and the third limiting step 333 to limit the axial front side of the insulating member 310 of the connector body 31, and injects adhesives such as silicone through the injection port 332a to fix the insulating member 310. In addition, the front end face of the second signal connector 33 can be bonded to the first sealing member 34 of the connector 30, and the rear end face of the second signal connector 33 can be laser welded and fixed to the signal connection seat 320 of the connector body 31 to complete the axial rear side limiting of the insulating member 310. In addition, the second sealing member 35 can be connected to the second signal connector 33 by coating the outer step end face of the second signal member and the bonding surface between the steps with silicone adhesive.

[0101] It should be noted that, in the process of using the electrode wire, the second signal connector 33 will receive the electrical signal sent by the medical device such as the pacemaker or defibrillator through the exposed annular electrical contact surface.

[0102] In this embodiment, the material of the second signal connection member 33 may be platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy, etc., which is not limited here.

[0103] refer to Figure 3 , Figures 7 to 9 In some embodiments, the connector body 31 may include an insulating member 310 and a signal connection seat 320, the insulating member 310 is arranged in a hollow tubular shape, and the second signal connection member 33 is arranged around the insulating member 310; the signal connection seat 320 is abutted against the insulating member 310, and the second signal connection member 33 is connected to the outer multi-strand wire 12 through the signal connection seat 320.

[0104] It is worth mentioning that compared with the numerous parts in the prior art, the electrode wire of the present application has fewer external and internal parts, which not only ensures the normal signal transmission function of the connector 30, but also simplifies the structure of the connector 30, saves the cost of production and manufacturing, and facilitates the use of doctors. At the same time, it also improves the comfort of using the electrode wire and reduces the discomfort caused to patients.

[0105] In one embodiment, if Figure 7 and Figure 8As shown, the insulating member 310 may include a first pipe segment 311 and a second pipe segment 312 connected to the first pipe segment 311, the outer diameter of the first pipe segment 311 is greater than the outer diameter of the second pipe segment 312, and a fourth limiting step 314 is formed at the outer connection between the first pipe segment 311 and the second pipe segment 312, which is suitable for limiting the axial movement of the insulating member 310. In this way, the stability of the connector 30 can be improved and the production and assembly can be facilitated.

[0106] Furthermore, the main reference Figure 8 An inner step surface 315 may be provided at the inner side connection between the first tube section 311 and the second tube section 312 at a position corresponding to the second limiting step 325; a matching portion 313 may be provided at an inner wall of the insulating member 310 at a position corresponding to the locking portion 323, and the matching portion 313 may be conical.

[0107] The insulating member 310 uses the inner conical mating portion 313 and its inner step surface 315 to engage the first signal connector 32 into the connecting channel 31a of the connector body 31, and allows the first signal connector 32 to be axially limited while being able to rotate freely in the circumferential direction. The rear side of the insulating member 310 can be coated with adhesive and inserted into the second signal connector 30, and then the fourth limiting step 314 is used to limit the front side of the insulating member 310 in the axial direction, and the ring electrical contact section 331 of the second signal connector 33 exposed on the front side of the insulating member 310 can be coated with adhesive, inserted into the first sealing member 34 and fixed by bonding.

[0108] In this embodiment, the insulating member 310 can be an implantable polymer insulating material with certain elasticity and hardness, preferably polycarbonate (PC), thermoplastic polyurethane elastomer (TPU), polysulfone (PSU), polyphenylene sulfone (PPSU) or polyetheretherketone (PEEK), etc., but is not limited here.

[0109] Please refer to Figure 3 and Fig. 9 In one embodiment, the signal connection seat 320 may be formed with an inner hole 320a for the inner insulating tube 13 to penetrate; the signal connection seat 320 may include a penetration section 327 and a welding section 328 connected to the penetration section 327, and a contact arm 329 may be provided at the connection between the penetration section 327 and the welding section 328. The penetration section 327 penetrates into the second signal connection member 33 and the contact arm 329 contacts the end of the second signal connection member 33 and can be fixed by welding. The welding section 328 and the outer multi-strand wire 12 can also be fixed by welding. In this way, the connection stability can be improved, the signal disconnection can be avoided, and the stability of the signal transmission of the connector 30 can be improved.

[0110] In this embodiment, the signal connection socket 320 may be made of platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

[0111] During assembly, the outer multi-strand wire 12 can be first passed through the rear side surface of the welding section 328 of the signal connection seat 320, and one end can be aligned with the outer step 330 on the welding section 328, and resistance welding, laser welding or bonding can be performed to weld and fix the outer multi-strand wire 12 to the welding section 328; the inner hole 320a of the signal connection seat 320 passes through the outer insulating tube 11, and the front side surface of the signal connection seat 320 is inserted into the second signal connector 33; the front end surface of the signal connection seat 320 abuts against the insulating member 310, and the annular step (i.e., the abutting arm 329) abuts against the second signal connector 33 and is fixed by laser welding, thereby limiting the axial rear side of the insulating member 310 and completing the electrical connection between the outer multi-strand wire 12 and the second signal connector 33.

[0112] In this embodiment, the electrical connection of the connector 30 is mainly achieved through the following connections: electrical connection such as welding or bonding of the first signal connector 32 and the inner multi-strand wire 14; electrical connection such as laser welding or bonding of the second signal connector 33 and the signal connection seat 320; electrical connection such as welding or bonding of the signal connection seat 320 and the outer multi-strand wire 12.

[0113] In this technical solution, while the outer multi-strand wire 12 is electrically connected to the second signal connector 33, the insulating member 310 is fixed inside the second signal connector 33, and the signal connector seat 320 serves multiple purposes, reducing the number of parts and lowering product costs.

[0114] In order to further improve the stability of the connector 30, facilitate the assembly of the connector 30, prevent the patient's body fluids from entering the connection interface during surgery, and improve the sealing performance of the medical device, in some embodiments, such as Figure 3 and Fig.10 As shown, the connector 30 may further include a first sealing member 34 adapted to seal a connection interface of the medical device, and the first sealing member 34 is disposed around the second tube segment 312 .

[0115] In this embodiment, the material of the first sealing member 34 may preferably be thermoplastic polyurethane elastomer (TPU), silicone or a blend of silicone and polyurethane to ensure that it has certain elasticity and biocompatibility.

[0116] In this embodiment, the front side surface of the insulating member 310 can be disposed in the inner hole 320a of the first sealing member 34 and bonded and fixed by using an adhesive such as silicone.

[0117] In this embodiment, if Figure 3 and Fig.11As shown, the connector 30 may further include a second sealing member 35 suitable for sealing the connection interface of the medical device. The second sealing member 35 is disposed around the second signal connector 33 and fixed by bonding. The second sealing member 35 is formed with a through hole for the outer insulating tube 11 to penetrate. In this way, the stability of the connector 30 can be further improved, and the patient's body fluids can be prevented from entering the connection interface during surgery, thereby improving the sealing performance of the medical device.

[0118] The material of the second sealing member 35 may also preferably be thermoplastic polyurethane elastomer (TPU), silicone or a blend of silicone and polyurethane to ensure that it has certain elasticity and biocompatibility.

[0119] In this embodiment, a plurality of first annular protrusions 341 may be provided on the outer wall of the first seal 34, and a plurality of second annular protrusions 351 may be provided on the outer wall of the second seal 35. The protrusion structure may be designed to be compatible with the connection interface of the medical device, which is not limited here.

[0120] It should be noted that, in the present embodiment, the length of the second sealing member 35 is longer than that of the first sealing member 34 . The long and soft characteristics of the second sealing member 35 can be utilized to help the connector 30 achieve stress release.

[0121] It should also be noted that, in this embodiment, the second signal connector 33 and the first tube section 311, the first seal 34 and the second tube section 312, and the second seal 35 and the second signal connector 33 can be bonded and fixed by a first adhesive. The material of the first adhesive can be silicone or epoxy resin, etc., which is not limited here.

[0122] In this embodiment, the sealing and insulation of the connector 30 is mainly achieved through the following connections: bonding of the first sealing member 34 to the front side of the insulating member 310, silicone filling and bonding between the insulating member 310 and the second signal connector 33, silicone filling or bonding between the inner insulating tube 13 and the insulating member 310, silicone bonding between the second sealing member 35 and the second signal connector 33, and silicone filling or bonding between the second sealing member 35 and the gap between the outer insulating tube 11.

[0123] In addition, in order to facilitate the installation of the various components of the connector 30 and ensure a certain connection strength, in some embodiments, the inner insulating tube 13 and the connector body 31, and the outer insulating tube 11 and the connector body 31 can also be bonded and fixed by a second adhesive. The material of the second adhesive can also be silicone or epoxy resin, etc., which is not limited here.

[0124] refer to Figure 1In some embodiments, the electrode head 20 may include a spiral head 21 and an electrode ring 22; the spiral head 21 is connected to the first end of the inner multi-strand wire 14, and when the first signal connector 32 of the connector 30 is rotated, the spiral head 21 is screwed into the patient's myocardium and fixed in the atrium or ventricle; the electrode ring 22 is arranged on the outer insulating tube 11 and connected to one end of the outer multi-strand wire 12.

[0125] It can be understood that the spiral head 21 is spiral-shaped, which can be easily implanted into the patient's myocardium to enhance the connection stability and avoid signal disconnection. The electrode ring 22 is arranged in a long ring shape, which can increase its contact area with the myocardium, thereby enhancing the connection stability and avoiding signal disconnection.

[0126] In actual application, the electrode wire is usually used in conjunction with the machine body of medical equipment such as a pacemaker or defibrillator. The spiral head 21 can be screwed into the targeted treatment site in the heart through the rotating connector 30, and then the muscle tissue in the heart will gradually grow together with the electrode head 20, and the connector 30 is connected to the connection interface of the pacemaker or defibrillator, and finally the electrical signal emitted by the pacemaker or defibrillator is transmitted to the targeted treatment site to be electrically stimulated in the heart through the connector 30, the electrode head 20 and the wire body segment 10.

[0127] The present invention also proposes a medical device, which includes a machine body and an electrode wire. The machine body is provided with a connection interface, and a connector 30 of the electrode wire is inserted into the connection interface. The specific structure of the electrode wire refers to the above embodiment. Since the medical device proposed by the present invention includes all schemes of all embodiments of the above-mentioned electrode wire, it has at least the same technical effect as the electrode wire, which will not be elaborated here one by one.

[0128] In this embodiment, the medical device may be an electrical stimulation device such as a defibrillator or a pacemaker, which is not limited here.

[0129] Reference Figures 1 to 3In one embodiment of the present invention, the electrode wire includes a wire main section 10, an electrode head 20 and a connector 30. The wire main section 10 has a first end and a second end opposite to each other. The wire main section 10 includes an outer insulating tube 11 and an outer multi-strand wire 12, an inner insulating tube 13 and an inner multi-strand wire 14 sequentially arranged in the outer insulating tube 11; the electrode head 20 is arranged at the first end of the wire main section 10; the connector 30 is arranged at the second end of the wire main section 10 and is suitable for plugging with the connection interface of the medical device; the connector 30 includes a connector body 31, a first signal connector 32 and a second signal connector 33. The connector body 31 is provided with a communication channel 31a. The second end of the wire main section 10 is inserted into one end of the communication channel 31a; the first signal connector The first signal connector 32 is inserted at the other end of the connecting passage 31a and connected to the inner multi-strand wire 14; the second signal connector 33 is arranged on the connector body 31 and connected to the outer multi-strand wire 12; wherein, the first signal connector 32 includes an electrical contact section 321 and an insertion section 322 connected to the electrical contact section 321, the electrical contact section 321 is suitable for being electrically connected to the connection interface of the medical device, and the insertion section 322 is inserted in the connecting passage 31a and connected to the inner multi-strand wire 14; the electrical contact section 321 and the insertion section 322 are both cylindrically arranged, the outer diameter of the electrical contact section 321 is larger than the outer diameter of the insertion section 322, and there is a gap between the insertion section 322 and the inner wall of the connecting passage 31a, so that the first signal connector 32 can be rotatably inserted in the connecting passage 31a.

[0130] The above descriptions are only optional embodiments of the present invention, and are not intended to limit the patent scope of the present invention. All equivalent structural changes made using the contents of the present invention's specification and drawings, or directly / indirectly applied in other related technical fields, are included in the patent protection scope of the present invention.

Claims

1. An electrode lead, characterized in that: The electrode wire comprises: A conductor body section has a first end and a second end opposite to each other, the conductor body section comprising an outer insulating tube and an outer multi-strand wire, an inner insulating tube and an inner multi-strand wire sequentially arranged in the outer insulating tube; an electrode head, disposed at a first end of the wire body segment; and A connector, the connector is arranged at the second end of the wire body segment and is suitable for plugging with the connection interface of the medical device; the connector includes a connector body, a first signal connector and a second signal connector, the connector body is provided with a communication channel, the second end of the wire body segment is inserted into one end of the communication channel; the first signal connector is inserted into the other end of the communication channel and connected to the inner multi-strand wire; the second signal connector is arranged on the connector body and connected to the outer multi-strand wire; the connector body includes an insulating member and a signal connection seat, the insulating member is arranged in a hollow tubular shape , the second signal connector is arranged around the insulating member; the signal connector seat is in contact with the insulating member, and the second signal connector is connected to the outer multi-strand wire through the signal connector seat; the signal connector seat is formed with an inner hole for the inner insulating tube to penetrate; the signal connector seat includes a penetration section and a welding section connected to the penetration section, and an abutment arm is provided at the connection between the penetration section and the welding section, the penetration section penetrates into the second signal connector and the abutment arm abuts against the end of the second signal connector and is fixed by welding, and the welding section is fixed to the outer multi-strand wire by welding; Wherein, the first signal connector comprises an electrical contact section and an insertion section connected to the electrical contact section, the electrical contact section is suitable for being electrically connected to the connection interface of the medical device, the insertion section is inserted into the communication channel and connected to the inner multi-strand wire, one end of the insertion section is provided with a connection portion, the inner multi-strand wire is welded and fixed to the connection portion; the electrical contact section and the insertion section are both cylindrically arranged, the outer diameter of the electrical contact section is larger than the outer diameter of the insertion section, and there is a gap between the insertion section and the inner wall of the communication channel, so that the first signal connector can be rotatably inserted into the communication channel; The second signal connector includes a ring electrical contact section, a bonding section connected to the ring electrical contact section, and a snap-fitting portion, wherein the ring electrical contact section is suitable for being electrically connected to the connection interface of the medical device, and the end of the ring electrical contact section is bonded and fixed to the connector body; the inner wall of the bonding section is bonded and fixed to the connector body, and the end of the bonding section is fixed to the connector body by welding; the snap-fitting portion is provided at the end of the insertion section, and a matching mating portion is provided at a position of the inner wall of the connector body corresponding to the bonding section, and the bonding section is snapped into the mating portion; a first limiting step is formed at the connection between the electrical contact section and the insertion section, and the first limiting step is spaced apart from the end of the connector body; a second limiting step is formed between the snap-fitting portion and the insertion section, and an inner step surface is provided on the inner wall of the connector body corresponding to the second limiting step to limit the insertion section from escaping from the connecting channel along its axial direction.

2. The electrode lead according to claim 1, characterized in that: The first signal connector is provided with a plug hole penetrating along the length direction thereof, which is suitable for an electrode auxiliary device to be inserted into the inner multiple strands of wire.

3. The electrode lead according to claim 1, characterized in that: The first signal connector is made of platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

4. The electrode lead according to claim 1, characterized in that: The bonding section is provided with an injection port suitable for injecting adhesive.

5. The electrode lead according to claim 1, characterized in that: The second signal connecting member is in a hollow tubular shape and is provided with a third limiting step suitable for limiting the movement of the second signal connecting member along its axial direction.

6. The electrode lead according to claim 1, characterized in that: The material of the second signal connection is platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

7. The electrode lead according to claim 1, characterized in that: The insulating member includes a first pipe segment and a second pipe segment connected to the first pipe segment. The outer diameter of the first pipe segment is greater than the outer diameter of the second pipe segment. A fourth limiting step is formed at the outer connection between the first pipe segment and the second pipe segment, which is suitable for limiting the axial movement of the insulating member.

8. The electrode lead according to claim 7, characterized in that: The inner step surface is provided at a position corresponding to the second limiting step at the inner connection between the first pipe section and the second pipe section; The matching portion is provided on the inner wall of the insulating member at a position corresponding to the engaging portion, and the matching portion is arranged in a cone shape.

9. The electrode lead according to claim 1, characterized in that: The insulating member is made of polycarbonate, thermoplastic polyurethane elastomer, polysulfone, polyphenylene sulfone or polyetheretherketone.

10. The electrode lead according to claim 1, characterized in that: The signal connection socket is made of platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

11. The electrode lead according to claim 7, characterized in that: The connector further comprises a first sealing member adapted to seal a connection interface of the medical device, wherein the first sealing member is disposed around the second tube segment.

12. The electrode lead according to claim 11, characterized in that The connector also includes a second seal member suitable for sealing the connection interface of the medical device. The second seal member is disposed around the second signal connector and fixed by bonding. The second seal member is formed with a through hole for the outer insulating tube to pass through.

13. The electrode lead according to claim 12, characterized in that: The second signal connector and the first tube section, the first seal and the second tube section, and the second seal and the second signal connector are all bonded and fixed by a first adhesive.

14. The electrode lead according to claim 13, characterized in that: The first adhesive is made of silicone or epoxy resin.

15. The electrode lead according to claim 1, characterized in that: The electrode head comprises a spiral head and an electrode ring; The spiral head is connected to the first end of the inner multi-strand wire, and when the first signal connector of the connector is rotated, the spiral head is screwed into the myocardium of the patient and fixed in the atrium or ventricle; The electrode ring is arranged on the outer insulating tube and connected to the outer multiple strands of wire.

16. The electrode lead according to claim 15, characterized in that The inner insulating tube and the connector body, as well as the outer insulating tube and the connector body, are bonded and fixed by a second adhesive.

17. The electrode lead according to claim 16, characterized in that: The second adhesive is made of silicone or epoxy resin.

18. A medical device, characterized in that: The medical equipment includes: A machine body having a connection interface; and An electrode wire, wherein the electrode wire is the electrode wire as described in any one of claims 1 to 17, and a connector of the electrode wire is inserted into the connection interface.

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