CN215841225U

CN215841225U - Electrode lead and medical equipment

Info

Publication number: CN215841225U
Application number: CN202121838013.8U
Authority: CN
Inventors: 俞佳威; 程灿; 陶永昶; 陈正栋; 高梅
Original assignee: Danyuan Medical Technology Hangzhou Co ltd
Current assignee: Danyuan Medical Technology Hangzhou Co ltd
Priority date: 2021-08-06
Filing date: 2021-08-06
Publication date: 2022-02-18
Anticipated expiration: 2031-08-06

Abstract

The utility model discloses an electrode lead and medical equipment, wherein the electrode lead comprises a lead main body section, an electrode tip and a connector, wherein the electrode tip is arranged at the first end of the lead main body section; the connector is arranged at the second end of the lead main body section and is suitable for being plugged with a connecting interface of the medical equipment; the first signal connecting piece of the connector is rotatably inserted into the other end of the communicating channel and is connected with the inner multi-strand wires; the second signal connecting piece is arranged on the connector body and is connected with the outer multi-strand wires; the electric contact section of the first signal connecting piece is suitable for being connected with a connecting interface of the medical equipment, and the insertion section of the first signal connecting piece is inserted into the communicating channel and connected with the inner multi-strand wire. The utility model improves the connector structure of the electrode lead, reduces the parts of the electrode lead connector, improves the convenience of the connector assembly, ensures that the connector pin can smoothly transmit torque, reduces the deflection degree of the connector pin relative to the connector ring, and enhances the insulation reliability of the electrode lead.

Description

Electrode lead and medical equipment

Technical Field

The utility model relates to the technical field of medical electric lead connectors, in particular to an electrode lead and medical equipment.

Background

Currently, 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 is provided with a barb-like structure and can be directly hung on the cardiac muscle trabecula, and the electrode end is wrapped by cardiac muscle and is gradually stabilized along with the lapse of time. The electrode end of the active electrode is of a spiral structure, and the electrode end is telescopically screwed into cardiac muscle and fixed in an atrium or a ventricle.

The connector of current initiative electrode wire mainly includes the casing and locates the internals in the casing, and the internals is more, generally contains connector needle, insulating part, internal conductor or coil, needle sleeve pipe etc. because the rib that constitutes the casing sealing member radially sets up to produce the interference to other parts along inside centre bore, and the internals is more to lead to the connector needle to rotate the resistance great for the connector needle is rotatory not smooth and easy, and electrode wire's use comfort is lower, causes the amazing to the patient easily.

SUMMERY OF THE UTILITY MODEL

The utility model mainly aims to provide an electrode lead and medical equipment, aiming at improving the rotation smoothness of a first signal connecting piece of a connector so as to improve the use comfort of the electrode lead and reduce the irritation to a patient.

In order to achieve the above object, the present invention provides an electrode lead including:

the main lead section comprises an outer insulating tube, and an outer multi-strand wire, an inner insulating tube and an inner multi-strand wire which are sequentially arranged in the outer insulating tube;

the electrode tip is arranged at the first end of the lead main body section; and

the connector is arranged at the second end of the lead main body section and is suitable for being plugged with a connecting interface of medical equipment; the connector comprises a connector body, a first signal connecting piece and a second signal connecting piece, wherein the connector body is provided with a communicating channel, and the second end of the wire main body section is inserted into one end of the communicating channel; the first signal connecting piece is inserted at the other end of the communicating channel and is connected with the inner multi-strand wires; the second signal connecting piece is arranged on the connector body and is connected with the outer multi-strand wires;

the first signal connecting piece comprises an electric contact section and an insertion section connected with the electric contact section, the electric contact section is suitable for being electrically connected with a connecting interface of the medical equipment, and the insertion section is inserted into the communicating channel and connected with the inner multi-strand wires;

the electric contact section and the insertion section are both arranged in a cylindrical shape, the outer diameter of the electric contact section is larger than that of the insertion section, and a gap is reserved between the insertion section and the inner wall of the communication channel, so that the first signal connecting piece can be rotatably inserted into the communication channel.

Optionally, the first signal connector further includes a clamping portion, the clamping portion is disposed at an end of the insertion section, a matching portion adapted to the inner wall of the connector body is disposed at a position corresponding to the clamping portion, and the clamping portion is clamped into the matching portion;

a first limiting step is formed at the joint of the electric contact section and the insertion section, and the first limiting step and the end part of the connector body are arranged at intervals; a second limiting step is formed between the clamping portion and the insertion section, and an inner step surface is arranged on the inner wall of the connector body corresponding to the second limiting step to limit the insertion section to be separated from the communication channel along the axial direction of the insertion section.

Optionally, the first signal connector is provided with a jack penetrating along the length direction thereof, and is suitable for inserting an electrode auxiliary instrument into the inner multi-strand wire.

Optionally, a connecting portion is arranged at one end of the insertion section, and the inner multi-strand wires are welded and fixed to the connecting portion.

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

Optionally, the second signal connector comprises a ring electrical contact section and an adhesive section connected with the ring electrical contact section, the ring electrical contact section is suitable for being electrically connected with the connection interface of the medical device, and the end of the ring electrical contact section is fixedly adhered with the connector body; the inner wall of the bonding section is fixedly bonded with the connector body, and the end part of the bonding section is fixedly welded with the connector body.

Optionally, an injection port suitable for injecting the adhesive is formed on the bonding segment.

Optionally, the second signal connector is arranged in a hollow tubular shape, and the second signal connector is provided with a third limiting step suitable for limiting the second signal connector to move along the axial direction of the second signal connector.

Optionally, the second signal connection is made of platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

Optionally, the connector body comprises:

the insulating part is arranged in a hollow tubular shape, and the second signal connecting part is arranged on the insulating part in a surrounding mode; and

the signal connecting seat is abutted to the insulating part, and the second signal connecting piece is connected with the outer multi-strand wire through the signal connecting seat.

Optionally, the insulating member includes a first pipe section and a second pipe section connected to the first pipe section, an outer diameter of the first pipe section is larger than an outer diameter of the second pipe section, and a fourth limiting step is formed at a connection position of an outer side of the first pipe section and the second pipe section, and is adapted to limit the insulating member from moving in an axial direction thereof.

Optionally, the inner step surface is arranged at the position, corresponding to the second limit step, of the inner side connection part of the first pipe section and the second pipe section;

the inner wall of the insulating part is provided with the matching part at a position corresponding to the clamping part, and the matching part is arranged in a conical shape.

Optionally, the insulating member is made of polycarbonate, thermoplastic polyurethane elastomer, polysulfone, polyphenylene sulfone, or polyether ether ketone.

Optionally, the signal connecting seat is formed with an inner hole for the inner insulating tube to penetrate through;

the signal connecting seat including penetrate the section and with penetrate the welding section that the section is connected, penetrate the section with the junction of welding section is equipped with the butt joint arm, penetrate the section penetrate to in the second signal connecting piece just the butt joint arm with the tip butt of second signal connecting piece passes through welded fastening, the welding section with outer stranded silk welded fastening.

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

Optionally, the connector further comprises a first seal adapted to seal off the connection interface of the medical device, the first seal being circumferentially disposed on the second tubing segment.

Optionally, the connector further comprises a second sealing member adapted to seal the connection interface of the medical device, the second sealing member is disposed around the second signal connector and fixed by adhesion, and the second sealing member is formed with a through hole for the outer insulating tube to penetrate through.

Optionally, the second signal connector and the first pipe section, the first sealing element and the second pipe section, and the second sealing element and the second signal connector are fixed by bonding with a first adhesive.

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

Optionally, the electrode head comprises a helical head and an electrode ring;

the spiral head is connected with the first end of the inner multi-strand wire, and when the first signal connecting piece of the connector is rotated, the spiral head is screwed into the heart muscle of a patient and is fixed in the atrium or the ventricle;

the electrode ring is arranged on the outer insulating tube and connected with the outer multi-strand wires.

Optionally, the inner insulating tube and the connector body, and the outer insulating tube and the connector body are fixed by bonding with a second adhesive.

Optionally, the second adhesive is made of silica gel or epoxy resin.

In order to achieve the above object, the present invention also proposes a medical apparatus comprising:

a machine body provided with a connection interface; and

the electrode wire, the electrode wire is as above, the connector of electrode wire is inserted and is located connect the interface, the electrode wire includes:

In the technical scheme of the utility model, the electrode lead comprises a lead main body section, an electrode tip and a connector, wherein the lead main body section is provided with a first end and a second end which are opposite to each other; the electrode tip is arranged at the first end of the lead main body section; the connector is arranged at the second end of the lead main body section and is suitable for being plugged with a connecting interface of the medical equipment; the connector comprises a connector body, a first signal connecting piece and a second signal connecting piece, wherein the connector body is provided with a communicating channel, and the second end of the wire main body section is inserted into one end of the communicating channel; the first signal connecting piece is inserted at the other end of the communicating channel and is connected with the inner multi-strand wire; the second signal connecting piece is arranged on the connector body and is connected with the outer multi-strand wires; the first signal connecting piece comprises an electric contact section and an insertion section connected with the electric contact section, the electric contact section is suitable for being electrically connected with a connecting interface of the medical equipment, and the insertion section is inserted into the communicating channel and connected with the inner multi-strand wires; the electric contact section all is cylindric setting with the insertion section, the external diameter of electric contact section is greater than the external diameter of insertion section, and have the clearance between the inner wall of insertion section and intercommunication passageway, so that first signal connecting piece rotationally inserts and locates the intercommunication passageway, interference of first signal connecting piece and other parts or structure is less, the rotation resistance is lower relatively, the rotation smoothness nature of the first signal connecting piece of connector has been improved, and then the use comfort of electrode wire has been promoted, the excitement that causes the patient has been reduced.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the structures shown in the drawings without creative efforts.

FIG. 1 is a schematic structural diagram of an embodiment of an electrode lead according to the present invention;

FIG. 2 is a schematic view of a connector according to an embodiment of the electrode lead of the present invention;

FIG. 3 is a cross-sectional view of a connector in an embodiment of an electrode lead of the present invention;

FIG. 4 is a schematic diagram of a first signal connection element of the connector according to an embodiment of the electrode lead of the present invention;

FIG. 5 is a schematic diagram of a second signal connection of the connector according to an embodiment of the electrode lead of the present invention;

FIG. 6 is a cross-sectional view of a second signal connection of the connector in an embodiment of an electrode lead of the present invention;

FIG. 7 is a schematic view of the structure of the insulator of the connector according to an embodiment of the electrode lead of the present invention;

FIG. 8 is a cross-sectional view of the insulator of the connector in one embodiment of the electrode lead of the present invention;

FIG. 9 is a schematic diagram of a signal connecting socket of a connector according to an embodiment of the electrode lead of the present invention;

FIG. 10 is a schematic view of a first seal of a connector according to an embodiment of the electrode lead of the present invention;

FIG. 11 is a schematic view of a second seal of the connector in an embodiment of the electrode lead of the present invention;

FIG. 12 is a schematic view of the structure of the inner multi-strand wire of the main body segment of the electrode lead according to an embodiment of the present invention;

FIG. 13 is a schematic structural view of the outer multi-strand wire of the main body segment of the electrode lead in accordance with an embodiment of the present invention;

FIG. 14 is a schematic view of the structure of the inner insulating tube of the main body segment of the electrode lead according to an embodiment of the present invention;

FIG. 15 is a schematic view of the outer insulating tube of the main body segment of the electrode lead according to an embodiment of the present invention.

The reference numbers illustrate:

the implementation, functional features and advantages of the objects of the present invention will be further explained with reference to the accompanying drawings.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

It should be noted that all the directional indicators (such as up, down, left, right, front, and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indicator is changed accordingly.

In addition, the descriptions related to "first", "second", etc. in the present invention are for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, the meaning of "and/or" appearing throughout is to include three juxtapositions, exemplified by "A and/or B" including either scheme A, or scheme B, or a scheme in which both A and B are satisfied. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.

In some exemplary techniques, the connector of the active electrode lead includes a housing and internal parts disposed in the housing, the internal parts are many, including a connector pin, an insulating part, an internal conductor or coil, a pin bushing, etc., since the ribs constituting the housing sealing member radially set up along the internal center hole to interfere with other parts, and the internal parts are many to cause the connector pin to rotate with a large resistance, so that the connector pin is not smooth in rotation, the comfort level of use of the electrode lead is low, and stimulation is easily caused to a patient.

In order to improve the rotation smoothness of the first signal connecting part of the connector, so as to improve the use comfort of the electrode lead and reduce the stimulation to a patient, the utility model provides the electrode lead which is suitable for various medical devices, in particular to a defibrillator, a pacemaker or other electrical stimulation devices, and the utility model is not limited in the above.

Referring to fig. 1 to 3, in some embodiments, the electrode lead includes a lead body section 10, an electrode tip 20, and a connector 30, the lead body section 10 having opposite first and second ends, the lead body section 10 including an outer insulation tube 11, and an outer multi-strand wire 12, an inner insulation tube 13, and an inner multi-strand wire 14 sequentially disposed inside the outer insulation tube 11; the electrode tip 20 is provided at a first end of the wire body section 10; the connector 30 is arranged at the second end of the lead main body section 10 and is suitable for being plugged with a connection interface of a 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 passage 31a, and the second end of the wire main body section 10 is inserted into one end of the communication passage 31 a; the first signal connecting piece 32 is inserted into the other end of the communicating channel 31a and connected with the inner multi-strand wire 14; the second signal connector 33 is disposed on the connector body 31 and connected to the outer multi-strand wire 12.

As shown in fig. 3 and 4, 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 adapted to be electrically connected to the connection interface of the medical device, and the insertion section 322 is inserted into the communication channel 31a and connected to the inner multi-strand wire 14; the electrical contact section 321 and the insertion section 322 are both disposed in a cylindrical shape, the outer diameter of the electrical contact section 321 is larger than the outer diameter of the insertion section 322, and a gap is formed between the insertion section 322 and the inner wall of the communication channel 31a, so that the first signal connector 32 is rotatably inserted into the communication channel 31 a.

It should be noted that in this embodiment, the electrode lead may be an implantable active medical electrical lead having an active mechanism at a free end thereof, and the free end of the implantable active medical electrical lead may include a helical fixation mechanism for being arrested and extending axially and/or rotating out of the tip of the lead for engagement or insertion into the myocardium of a patient and fixation within the atrium or ventricle.

Referring to fig. 1 and 3, a lead body section 10 of an electrode lead is a medical electrical lead, and generally includes an outer insulating tube 11, an outer multi-strand wire 12 disposed inside 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 periphery of the main lead body section 10 and wraps other components to perform insulation protection; the inner multi-strand wire 14 is arranged on the innermost layer of the cable, wrapped by the inner insulating tube 13 and arranged between the inner multi-strand wire 14 and the outer multi-strand wire 12, so that the inner insulating tube 13 and the outer insulating tube 11 form a space for accommodating the outer multi-strand wire 12 while insulation protection is performed.

Referring to fig. 3 and 12, the inner multi-strand wire 14 is disposed in the inner insulating tube 13, one end of the inner multi-strand wire 14 is connected to the first signal connector 32 by resistance welding, adhesion or laser welding, and the other end is connected to the screw head 21 of the electrode tip 20 to transmit an electrical signal received by the first signal connector 32 from a medical device such as a pacemaker or a defibrillator.

Referring to fig. 3 and 13, the outer multi-strand wire 12 is disposed between the inner insulating tube 13 and the outer insulating tube 11, and has one end connected to the signal connection socket 320 by resistance welding, adhesion, laser welding, or the like, and the other end connected to the electrode ring 22 of the electrode tip 20 to transmit the electrical signal received by the second signal connection member 33.

Referring to fig. 3 and 14, the inner insulating tube 13 is disposed between the inner multi-strand wires 14 and the outer multi-strand wires 12, the inner multi-strand wires 14 are rotatable in the inner insulating tube 13 of the inner insulating tube 13, and the outer multi-strand wires 12 are wound around the outer wall of the inner insulating tube 13.

Referring to fig. 3 and 15, the outer insulating tube 11 at the second end of the main body segment 10 is disposed 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 tip 20, and a portion of the outer wall of the other end is fixed to the connector body 31 by adhesion or the like.

In this embodiment, as shown in fig. 1, an electrode tip 20 may be provided at a first end of the wire body segment 10 to form an active mechanism. The motor head may include one or more electrode components, may adopt solid conductor materials such as 316L stainless steel or noble metal, and the specific structure may be set according to the signal detection requirement of the medical equipment, and is not limited here.

In this embodiment, as shown in fig. 1, a connector 30 may be provided at the second end of the lead body segment 10 for plugging with a connection interface of a medical device, which serves as a connection means for connecting the conductors (i.e., the inner and outer multi-filars 14, 12) of the lead body segment 10 with the connection interface of the medical device, and the physician may rotate the first signal connection element 32 of the connector 30 to screw the electrode tip 20 at the first end of the lead body segment 10 into the myocardium of a patient and fix it in the atrium or ventricle.

During assembly, the electrode tip 20 may be fixed to the first end of the main body segment 10 by welding, winding, or the like, and then the second end of the main body segment 10 is cut open to expose the outer insulating tube 11, the outer multi-strand wire 12, the inner insulating tube 13, and the inner multi-strand wire 14 at the end thereof, then the inner multi-strand wires 14 at the end part are fixed on the first signal connecting piece 32 by welding or bonding or the like or are connected and fixed by the connecting part, the inner insulating tube 13 at the end part is inserted and fixed in the communicating channel 31a of the connector body 31 by bonding, clamping or the like, the outer multi-strand wires 12 at the end part are fixed on the second signal connecting piece 33 by welding or bonding or the like or are connected and fixed by the connecting part, then, the end portion of the outer insulating tube 11 is inserted and fixed into the communicating passage 31a of the connector body 31 by means of bonding, clamping, or the like.

It can be understood that, in the technical solution of the present application, the electrode lead includes a lead body section 10, an electrode tip 20 and a connector 30, the lead body section 10 has opposite first and second ends, the lead body section 10 includes an outer insulation tube 11, and an outer multi-strand wire 12, an inner insulation tube 13 and an inner multi-strand wire 14 which are sequentially disposed inside the outer insulation tube 11; the electrode tip 20 is provided at a first end of the wire body section 10; the connector 30 is arranged at the second end of the lead main body section 10 and is suitable for being plugged with a connection interface of a 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 passage 31a, and the second end of the wire main body section 10 is inserted into one end of the communication passage 31 a; the first signal connecting piece 32 is inserted into the other end of the communicating channel 31a and connected with the inner multi-strand wire 14; the second signal connector 33 is arranged on the connector body 31 and connected with the outer multi-strand wire 12; 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 adapted to be electrically connected to a connection interface of the medical device, and the insertion section 322 is inserted into the communication channel 31a and connected to the inner multi-strand wire 14; the electric contact section 321 and the insertion section 322 are both in cylindrical arrangement, the outer diameter of the electric contact section 321 is larger than that of the insertion section 322, a gap is formed between the insertion section 322 and the inner wall of the communication channel 31a, so that the first signal connecting piece 32 can be rotatably inserted into the communication channel 31a, the interference between the first signal connecting piece 32 and other parts or structures is small, the rotation resistance is relatively low, the rotation smoothness of the first signal connecting piece 32 of the connector 30 is improved, the use comfort of the electrode lead is further improved, and the irritation to a patient is reduced.

In order to avoid 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 an embodiment, as shown in fig. 3 and 4, the first signal connector 32 may further include a clamping portion 323, the clamping portion 323 is disposed at an end of the insertion section 322, a matching portion 313 is disposed on an inner wall of the connector body 31 at a position corresponding to the clamping portion 323, and as shown in fig. 8, the clamping portion 323 is clamped in the matching portion 313. Referring mainly to fig. 4 and 8, a first limit step 324 is formed at the connection of the electrical contact section 321 and the insertion section 322, and the first limit step 324 is spaced from the end of the connector body 31; a second limit step 325 is formed between the engaging 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 limit step 325 to limit the insertion section 322 from coming out of the communication passage 31a along the axial direction thereof.

In this embodiment, the first signal connector 32 may be disposed in a cylindrical needle shape, and may be made of an electrically conductive material, which is not limited herein. The first signal connector 32 may be formed with an insertion hole 32a extending through the length thereof for inserting an electrode-assisted instrument into the inner multi-strand wire 14.

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

Further, as shown in fig. 4, the insertion section 322 may be provided with a connecting portion 326 at one end, and the inner multi-strand wires 14 are welded and fixed to the connecting portion 326.

In actual assembly, the inner multi-strand wire 14 may be threaded onto the connecting portion 326 of the first signal connector 32, aligned with the second retention step 325, and then resistance welded, laser welded, or bonded to secure the inner multi-strand wire 14 to the first signal connector 32. Then, the first signal connector 32 is clamped into the connector body 31 by the tapered clamping portion 323, and the clamped first signal connector 32 is limited by the end surface of the first limiting step 324 and the end surface of the second limiting step 325, so that the first signal connector and the connector body 31 are prevented from slipping off.

In actual use, the exposed electrical contact surface of the first signal connector 32 can be used to receive electrical signals from medical devices such as pacemakers and defibrillators.

It can be understood that, since the middle side of the first signal connector 32 is in clearance fit with the connector body 31, the inner multi-strand wire 14 and the electrode spiral head 21 can be driven to rotate freely in the circumferential direction while the axial direction of the first signal connector 32 is ensured to be limited.

In this embodiment, the material of the first signal connector 32 is preferably platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy, etc., without limitation.

It is worth mentioning that the inner and outer multi-strand wires 12 of the conventional electrode lead are fixed by crimping by using four metal parts, and the metal parts, particularly the magnetic components, are more, the assembly is complex, the cost is higher, and the nuclear magnetic resonance examination cannot be easily passed. However, the electrode lead connector 30 is connected and fixed with the inner and outer multi-strand wires 12 by adopting a laser welding structure and process, so that the number of metal parts is reduced, the assembly difficulty is reduced, the assembly procedures are reduced, and nuclear magnetic resonance examination is easier to pass. Moreover, the connection between the insulating part of the conventional electrode lead and the first signal connector 32 requires a plurality of matching structures, even the matching of a plurality of insulating parts, the assembly process is complicated, the accumulated tolerance caused by the assembly of a plurality of parts is large, and the cost is high. The first signal connecting part 32 and the insulating part of the electrode lead connector 30 adopt a clamping structure, and the two parts can ensure the axial spacing and circumferential free rotation of the first signal connecting part 32, so that the number of assembling parts and procedures is reduced, and the product cost is reduced.

Referring to fig. 5 and 6, in some embodiments, the second signal connector 33 may include a ring electrical contact section 331 and an adhesive section 332 connected to the ring electrical contact section 331, the ring electrical contact section 331 is adapted to be electrically connected to a connection interface of a medical device, and an end of the ring electrical contact section 331 is adhesively fixed to the connector body 31; the inner wall of the bonding segment 332 is bonded and fixed to the connector body 31, and the end of the bonding segment 332 is fixed to the connector body 31 by welding. Thus, assembly is facilitated, and the stability of signal transmission of the connector 30 is improved.

In this embodiment, the second signal connector 33 may be disposed in a hollow tubular shape, and the ring electrical contact section 331 and the bonding section 332 may be manufactured by integral molding, or may be assembled by welding, and the like, but is not limited thereto. The material of the ring electrical contact section 331 and the bonding section 332 of the second signal connector 33 may be the same conductive material, such as platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy, or may be different conductive materials, which is not limited herein.

Further, in the present embodiment, as shown in fig. 5 and 6, the bonding segment 332 of the second signal connector 33 is provided with an injection port 332a suitable for injecting an adhesive, so as to improve the convenience of assembly.

It is understood that during the process of assembling the connector 30 with the second end of the conductive body segment, an adhesive such as silicon gel may be injected through the injection port 332a to fix the insulating member 310 of the connector body 31.

In this embodiment, referring to fig. 6, the second signal connector 33 may have a third limiting step 333 adapted to limit the axial movement of the second signal connector 33.

It can be understood that the second signal connector 33 axially limits the front side of the insulator 310 of the connector body 31 through the center hole thereof and the third limiting step 333, and an adhesive such as silicone gel is injected through the injection port 332a to fix the insulator 310. The front end surface of the second signal connector 33 can be bonded to the first sealing member 34 of the connector 30, and the rear end surface of the second signal connector 33 can be fixed to the signal connection holder 320 of the connector body 31 by laser welding to complete the axial rear side restriction of the insulator 310. In addition, the second sealing member 35 and the second signal connector 33 can be connected by coating a silica gel adhesive on the adhesive surface between the outer step end surface and the step of the second signal member.

During use of the electrode lead, the second signal connector 33 receives an electrical signal from a medical device, such as a pacemaker or defibrillator, through the exposed ring electrical contact surface.

In this embodiment, the material of the second signal connector 33 may be platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy, etc., which is not limited herein.

Referring to fig. 3, 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 disposed in a hollow tubular shape, and the second signal connection member 33 is disposed around the insulating member 310; the signal connecting base 320 abuts against the insulating member 310, and the second signal connecting member 33 is connected to the outer multi-strand wire 12 through the signal connecting base 320.

It is worth mentioning that, relative to a great number of parts in the prior art, the external part and the internal part of the electrode lead are fewer, so that the structure of the connector 30 is simplified, the production and manufacturing cost is saved, the use by a doctor is facilitated, the use comfort level of the electrode lead is improved, and the discomfort caused to a patient is reduced, besides the normal signal transmission function of the connector 30 is guaranteed.

In an embodiment, as shown in fig. 7 and 8, the insulation member 310 may include a first pipe segment 311 and a second pipe segment 312 connected to the first pipe segment 311, an outer diameter of the first pipe segment 311 is greater than an outer diameter of the second pipe segment 312, and a fourth limit step 314 adapted to limit the insulation member 310 from moving axially along is formed at an outer side connection of the first pipe segment 311 and the second pipe segment 312. Thus, the stability of the connector 30 can be improved, and the production and assembly can be facilitated.

Further, referring mainly to fig. 8, an inner step surface 315 may be disposed at a position corresponding to the second limiting step 325 at the inner side connection of the first pipe section 311 and the second pipe section 312; the inner wall of the insulating member 310 may have a fitting portion 313 corresponding to the engaging portion 323, and the fitting portion 313 may be tapered.

The insulator 310 engages the first signal connector 32 into the communication channel 31a of the connector body 31 by the inner tapered engaging portion 313 and the inner step surface 315 thereof, so that the first signal connector 32 is axially limited and can rotate freely in the circumferential direction. The rear side of the insulating member 310 may be coated with an adhesive and penetrate into the second signal connector 30, and the fourth limiting step 314 may be used to limit the axial front side of the insulating member 310, so that the portion of the ring electrical contact section 331 of the second signal connector 33 exposed from the front side of the insulating member 310 may be coated with an adhesive, penetrate into the first sealing member 34, and be adhesively fixed.

In this embodiment, the insulating member 310 may be an implant-grade polymer insulating material with certain elasticity and hardness, and is preferably Polycarbonate (PC), thermoplastic polyurethane elastomer (TPU), Polysulfone (PSU), polyphenylene sulfone (PPSU), or polyether ether ketone (PEEK), without limitation.

Referring to fig. 3 and 9, in an embodiment, the signal connecting socket 320 may be formed with an inner hole 320a for the inner insulating tube 13 to penetrate; the signal connecting seat 320 may include a penetrating section 327 and a welding section 328 connected to the penetrating section 327, a joint of the penetrating section 327 and the welding section 328 may be provided with an abutting arm 329, the penetrating section 327 penetrates into the second signal connector 33, and the abutting arm 329 abuts against an end of the second signal connector 33 and may be fixed by welding, and the welding section 328 and the outer multi-strand wire 12 may also be fixed by welding. Therefore, the connection stability can be improved, the signal disconnection is avoided, and the signal transmission stability of the connector 30 is improved.

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

During assembly, the outer multi-strand wire 12 can be firstly threaded on the rear side surface of the welding section 328 of the signal connecting base 320, one end of the outer multi-strand wire is aligned with the outer step 330 on the welding section 328, resistance welding, laser welding or bonding and the like are carried out, and the outer multi-strand wire 12 and the welding section 328 are welded and fixed; an inner hole 320a of the signal connecting base 320 penetrates through the outer insulating tube 11, and the front side surface of the signal connecting base 320 penetrates into the second signal connecting piece 33; the front end face of the signal connecting seat 320 abuts against the insulating member 310, and the ring step (i.e., the abutting arm 329) abuts against the second signal connecting member 33 and is fixed by laser welding, so that the rear side of the insulating member 310 in the axial direction is limited, and the electrical connection between the outer multi-strand wire 12 and the second signal connecting member 33 is completed.

In the present embodiment, the electrical connection aspect of the connector 30 is mainly realized by the following connections: the first signal connecting piece 32 is electrically connected with the inner multi-strand wire 14 by welding or bonding; the second signal connector 33 is electrically connected with the signal connecting seat 320 by laser welding or bonding, and the signal connecting seat 320 is electrically connected with the outer multi-strand wire 12 by welding or bonding.

In this technical solution, the outer multi-strand wire 12 is electrically connected to the second signal connector 33, and the insulating member 310 is fixed in the second signal connector 33, so that the signal connector holder 320 serves a plurality of purposes, thereby reducing the number of parts and reducing the product cost.

To further enhance the stability of the connector 30, facilitate assembly of the connector 30, and prevent body fluids from entering the connection interface during a surgical procedure, and improve the sealing properties of the medical device, in some embodiments, as shown in fig. 3 and 10, the connector 30 may further include a first seal 34 adapted to block the connection interface of the medical device, the first seal 34 being circumferentially disposed on the second tube segment 312.

In this embodiment, the material of the first sealing element 34 may preferably be thermoplastic polyurethane elastomer (TPU), silicone rubber, or a blend of silicone rubber and polyurethane, which ensures a certain elasticity and biocompatibility.

In this embodiment, the front side of the insulating member 310 may be disposed in the inner hole 320a of the first sealing member 34 and fixed by adhesive such as silicone rubber.

In this embodiment, as shown in fig. 3 and 11, the connector 30 may further include a second sealing member 35 adapted to seal the connection interface of the medical device, the second sealing member 35 is disposed around the second signal connector 33 and fixed by adhesion, and the second sealing member 35 is formed with a through hole for the outer insulating tube 11 to pass through. Thus, the stability of the connector 30 can be further improved, and the body fluid of the patient can be prevented from entering the connection interface during the operation, thereby improving the sealing performance of the medical equipment.

The material of the second sealing element 35 may also be thermoplastic polyurethane elastomer (TPU), silicone rubber, or a blend of silicone rubber and polyurethane, so as to ensure certain elasticity and biocompatibility.

In this embodiment, the outer peripheral wall of the first sealing member 34 may be provided with a plurality of first annular protrusions 341, the outer peripheral wall of the second sealing member 35 may be provided with a plurality of second annular protrusions 351, and the protrusion structure may be designed to be adapted to the connection interface of the medical device, which is not limited herein.

It should be noted that in this embodiment, the length of the second sealing element 35 is longer than that of the first sealing element 34, and the characteristic of the second sealing element 35 being long and flexible can be utilized to help the connector 30 achieve stress relief.

It should be further noted that, in the present embodiment, the second signal connector 33 and the first pipe section 311, the first sealing member 34 and the second pipe section 312, and the second sealing member 35 and the second signal connector 33 can be fixed by bonding with the first adhesive. The material of the first adhesive may be silica gel or epoxy resin, and the like, which is not limited herein.

In the present embodiment, the hermetic insulation aspect of the connector 30 is mainly achieved by the following connections: the first sealing element 34 is bonded to the front side surface of the insulating element 310, the insulating element 310 is filled and bonded to the second signal connecting element 33 through silica gel, the inner insulating tube 13 is filled or bonded to the insulating element 310 through silica gel, the second sealing element 35 is bonded to the second signal connecting element 33 through silica gel, and the second sealing element 35 is filled or bonded to the gap between the outer insulating tube 11 through silica gel.

In addition, in order to facilitate the installation of the 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 may be fixed by bonding with a second adhesive. The second adhesive may also be made of silica gel or epoxy resin, and the material is not limited herein.

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

It can be appreciated that the spiral head 21 is spiral, and can be conveniently implanted into the myocardium of a patient to enhance the connection stability and avoid signal disconnection. The electrode ring 22 is in a long-strip annular shape, which can increase the contact area with the myocardium, thereby enhancing the connection stability and avoiding signal disconnection.

In practical applications, the electrode lead is generally used in conjunction with a machine body of a medical device such as a cardiac pacemaker or a defibrillator. The screw head 21 can be screwed into the target treatment position in the heart by rotating the connector 30, then the muscle tissue in the heart gradually grows together with the electrode head 20, the connector 30 is connected with the connecting interface of the cardiac pacemaker or the defibrillator, and finally the electric signal sent by the cardiac pacemaker or the defibrillator is transmitted to the target treatment position to be electrically stimulated in the heart through the connector 30, the electrode head 20 and the lead main body section 10.

The present invention further provides a medical apparatus, which includes a machine main body and an electrode lead, wherein the machine main body is provided with a connection interface, the connector 30 of the electrode lead is inserted into the connection interface, and the specific structure of the electrode lead is as described in the above embodiments.

In this embodiment, the medical device may be an electrical stimulation apparatus such as a defibrillator and a pacemaker, which is not limited herein.

Referring to fig. 1 to 3, in an embodiment of the present invention, the electrode lead includes a lead body section 10, an electrode tip 20 and a connector 30, the lead body section 10 having opposite first and second ends, the lead body section 10 including an outer insulation tube 11, and an outer multi-strand wire 12, an inner insulation tube 13 and an inner multi-strand wire 14 sequentially disposed in the outer insulation tube 11; the electrode tip 20 is provided at a first end of the wire body section 10; the connector 30 is arranged at the second end of the lead main body section 10 and is suitable for being plugged with a connection interface of a 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 passage 31a, and the second end of the wire main body section 10 is inserted into one end of the communication passage 31 a; the first signal connecting piece 32 is inserted into the other end of the communicating channel 31a and connected with the inner multi-strand wire 14; the second signal connector 33 is arranged on the connector body 31 and connected with the outer multi-strand wire 12; 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 adapted to be electrically connected to a connection interface of the medical device, and the insertion section 322 is inserted into the communication channel 31a and connected to the inner multi-strand wire 14; the electrical contact section 321 and the insertion section 322 are both disposed in a cylindrical shape, the outer diameter of the electrical contact section 321 is larger than the outer diameter of the insertion section 322, and a gap is formed between the insertion section 322 and the inner wall of the communication channel 31a, so that the first signal connector 32 is rotatably inserted into the communication channel 31 a.

The above description is only an alternative embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications and equivalents of the present invention, which are made by the contents of the present specification and the accompanying drawings, or directly/indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims

1. An electrode lead, comprising:

2. The electrode lead of claim 1, wherein the first signal connector further comprises a clamping portion, the clamping portion is disposed at an end of the insertion section, a matching portion adapted to the clamping portion is disposed on an inner wall of the connector body, and the clamping portion is clamped into the matching portion;

3. The electrode lead of claim 1, wherein the first signal connector is provided with a receptacle disposed therethrough along a length thereof adapted for insertion of an electrode-assisting instrument into the inner plurality of wires.

4. The electrode lead according to claim 1, wherein the insertion section is provided at one end thereof with a connection part to which the inner multi-strand wire is welded and fixed.

5. The electrode lead of claim 1, wherein the first signal connector is made of platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

6. The electrode lead of claim 1, wherein the second signal connector includes a ring electrical contact section and an adhesive section coupled to the ring electrical contact section, the ring electrical contact section being adapted to electrically couple to a connection interface of the medical device, an end of the ring electrical contact section being adhesively secured to the connector body; the inner wall of the bonding section is fixedly bonded with the connector body, and the end part of the bonding section is fixedly welded with the connector body.

7. The electrode lead according to claim 6, wherein the adhesive segment has an injection port adapted for injecting an adhesive.

8. The electrode lead of claim 6, wherein the second signal connector is configured in a hollow tubular configuration, the second signal connector having a third retention step adapted to limit axial movement of the second signal connector.

9. The electrode lead of claim 1, wherein the second signal connection is made of platinum-iridium alloy, stainless steel, MP35N alloy, titanium, or titanium alloy.

10. The electrode lead of any of claims 2-9, wherein the connector body comprises:

11. The electrode lead according to claim 10, wherein the insulating member comprises a first tube segment and a second tube segment connected to the first tube segment, the first tube segment has an outer diameter larger than that of the second tube segment, and a fourth limiting step is formed at a junction of an outer side of the first tube segment and the second tube segment and adapted to limit the insulating member from moving in an axial direction thereof.

12. The electrode lead of claim 11, wherein the inner step surface is provided at the position where the inner side of the first tube section is connected with the inner side of the second tube section corresponding to the second limiting step;

13. The electrode lead according to claim 10, wherein the insulating member is made of polycarbonate, thermoplastic polyurethane elastomer, polysulfone, polyphenylsulfone, or polyetheretherketone.

14. The electrode lead according to claim 10, wherein the signal connection socket is formed with an inner hole through which the inner insulating tube is inserted;

15. The electrode lead of claim 10, wherein the signal connector socket is made of platinum-iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

16. The electrode lead of claim 11, wherein the connector further comprises a first seal adapted to seal off a connection interface of the medical device, the first seal being circumferentially disposed on the second tube segment.

17. The electrode lead according to claim 16, wherein the connector further comprises a second sealing member adapted to seal off the connection port of the medical device, the second sealing member being circumferentially disposed on the second signal connector and fixed thereto by adhesion, the second sealing member being formed with a through hole through which the outer insulating tube passes.

18. The electrode lead of claim 17, wherein 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 adhesively secured together by a first adhesive.

19. The electrode lead according to claim 18, wherein the first adhesive is made of silicone or epoxy.

20. The electrode lead of claim 1, wherein the electrode head includes a helical head and an electrode ring;

21. The electrode lead according to claim 20, wherein the inner insulating tube and the connector body, and the outer insulating tube and the connector body are adhesively fixed by a second adhesive.

22. The electrode lead according to claim 21, wherein the second adhesive is made of silicone or epoxy.

23. A medical device, characterized in that it comprises:

a machine body provided with a connection interface; and

the electrode lead wire according to any one of claims 1 to 22, wherein a connector of the electrode lead wire is inserted into the connection interface.