CN113457016B

CN113457016B - Electrode wires and medical equipment

Info

Publication number: CN113457016B
Application number: CN202110906062.9A
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: 2025-03-21
Anticipated expiration: 2041-08-06
Also published as: CN113457016A

Abstract

The invention discloses an electrode lead and medical equipment, wherein the electrode lead comprises a lead main body section, an electrode head and a connector, the electrode head is arranged at a first end of the lead main body section, the connector is arranged at a second end of the lead main body section and is suitable for being spliced with a connecting interface of the medical equipment, a first signal connecting piece of the connector is rotatably inserted at the other end of a communication channel and is connected with an inner multi-strand wire, a second signal connecting piece of the connector is arranged on a connector body and is connected with an outer multi-strand wire, an electric contact section of the first signal connecting piece is suitable for being electrically connected with the connecting interface of the medical equipment, and an inserting section of the first signal connecting piece is inserted in the communication channel and is connected with the inner multi-strand wire. The invention improves the connector structure of the electrode wire, reduces parts of the electrode wire connector, improves the convenience of connector assembly, ensures that the connector needle can smoothly transmit torque, reduces the deflection degree of the connector needle relative to the connector ring, and enhances the insulation reliability of the electrode wire.

Description

Electrode lead and medical equipment

Technical Field

The invention 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 classified into active electrode leads and passive electrode leads. The electrode end of the passive electrode has a barb-like structure, can be directly hung on the myocardial trabecula, and is wrapped by the cardiac muscle gradually and stably along with the time. The electrode end of the active electrode is of a spiral structure, is telescopically screwed into cardiac muscle and is fixed in an atrium or a ventricle.

The connector of current initiative electrode wire mainly includes the casing and locates the interior part in the casing, and interior part is more, generally contains connector needle, insulating part, inner conductor or coil, needle sleeve pipe etc. because the rib that constitutes the casing sealing member radially sets up along inside centre bore and produces the interference to other parts, and interior part is more to lead to the connector needle to rotate resistance great for the connector needle is rotatory unsmooth, and electrode wire's use comfort is lower, causes the stimulation to the patient easily.

Disclosure of Invention

The invention mainly aims to provide an electrode lead and medical equipment, which aim to improve 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 stimulation to a patient.

To achieve the above object, the present invention provides an electrode lead comprising:

The wire main body section is provided with a first end and a second end which are opposite, and 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;

An electrode tip disposed at a first end of the lead body segment, and

The connector is arranged at the second end of the lead main body section and is suitable for being spliced 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 communication channel, and the second end of the wire main body section is inserted into one end of the communication channel;

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 communication channel and connected with the inner multi-strand wire;

The electric contact section and the insertion section are all in cylindrical arrangement, 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 position of the inner wall of the connector body corresponding to the clamping portion is provided with an adaptive matching portion, and the clamping portion is clamped in the matching portion;

The connector comprises an electric contact section, an insertion section, a clamping part, a connector body, a first limiting step, a second limiting step and an inner step surface, wherein the first limiting step is formed at the joint of the electric contact section and the insertion section, the first limiting step is arranged at the end part of the connector body at intervals, the second limiting step is formed between the clamping part and the insertion section, and the inner wall of the connector body is provided with the inner step surface corresponding to the second limiting step so as to limit the insertion section to deviate from the communication channel along the axial direction of the insertion section.

Optionally, the first signal connector is provided with a jack penetrating along its length direction, adapted for insertion of an electrode auxiliary instrument into the inner multi-strand wire.

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

Optionally, the material of the first signal connection piece is platinum iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

Optionally, the second signal connector comprises a ring electric contact section and an adhesive section connected with the ring electric contact section, the ring electric contact section is suitable for being electrically connected with a connection interface of the medical equipment, the end part of the ring electric contact section is adhered and fixed with the connector body, the inner wall of the adhesive section is adhered and fixed with the connector body, and the end part of the adhesive section is welded and fixed with the connector body.

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

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

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

Optionally, the connector body includes:

An insulating member arranged in a hollow tubular shape, the second signal connection member being circumferentially arranged on the insulating member, and

The signal connection seat is in butt joint with the insulating piece, and the second signal connection piece passes through the signal connection seat is connected with outer stranded silk.

Optionally, the insulating piece includes first pipeline section and with the second pipeline section of first pipeline section connection, the external diameter of first pipeline section is greater than the external diameter of second pipeline section, and first pipeline section with the outside junction of second pipeline section is formed with fourth spacing step, is suitable for limiting the insulating piece moves along its axial.

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

the position of the inner wall of the insulating piece, which corresponds to the clamping part, is provided with the matching 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 connection base is formed with an inner hole for the inner insulating tube to penetrate;

The signal connection seat comprises a penetrating section and a welding section connected with the penetrating section, wherein an abutting arm is arranged at the joint of the penetrating section and the welding section, the penetrating section penetrates into the second signal connection piece and the abutting arm abuts against the end part of the second signal connection piece and is fixed through welding, and the welding section is fixed with the outer multi-strand wire through welding.

Optionally, the material of the signal connection seat is 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 tube 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 circumferentially arranged on the second signal connection member and is fixed by bonding, and the second sealing member is formed with a through hole for the penetration of the external insulation tube.

Optionally, the second signal connection piece is adhered and fixed with the first pipe section, the first sealing piece is adhered and fixed with the second pipe section, and the second sealing piece is adhered and fixed with the second signal connection piece through a first adhesive.

Optionally, the material of the first adhesive is silica gel or epoxy resin.

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

The screw 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 screw head is screwed into cardiac muscle of a patient and is fixed in an atrium or a ventricle;

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

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

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

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

A machine body provided with a connection interface, and

The electrode wire, the electrode wire is as above, the connector of electrode wire inserts and locates the connection interface, the electrode wire includes:

An electrode tip disposed at a first end of the lead body segment, and

The electrode lead comprises a lead main body section, an electrode head and a connector, wherein the lead main body section is provided with a first end and a second end which are opposite, the lead main body section comprises an outer insulating tube, 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 head 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 connected with a connecting interface of medical equipment in an inserting mode, the connector comprises a connector body, a first signal connecting piece and a second signal connecting piece, the connector body is provided with a communicating channel, the second end of the lead main body section is inserted at 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 wire, the first signal connecting piece comprises an electric contact section and an inserting section connected with the electric contact section, the electric contact section is suitable for being electrically connected with the connecting interface of the medical equipment, the inserting section is inserted into the communicating channel and is connected with the inner multi-strand wire, the electric contact section and the inserting section is arranged in a cylindrical shape, the electric contact section and the electric contact section is connected with the inserting section, the electric contact section is relatively has a cylindrical shape, the first signal connecting section and the electrode has a small outer diameter and a rotating diameter, and a relatively small outer diameter, and a signal conducting section can be connected with the electrode.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to the structures shown in these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view 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 present invention;

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

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

FIG. 5 is a schematic view of a second signal connector 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 member of the connector in one embodiment of an electrode lead of the present invention;

FIG. 7 is a schematic view of the insulation 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 connection base of a connector according to an embodiment of the electrode lead of the present invention;

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

FIG. 11 is a schematic view of the structure of the second seal of the connector according to 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 lead body segment in one embodiment of the electrode lead of the present invention;

FIG. 13 is a schematic view of the structure of the outer multi-strand wire of the lead body segment in one embodiment of the electrode lead of the present invention;

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

fig. 15 is a schematic view of the structure of the outer insulating tube of the lead body section in an embodiment of the electrode lead according to the present invention.

Reference numerals illustrate:

the achievement of the objects, functional features and advantages of the present invention will be further described with reference to the accompanying drawings, in conjunction with the embodiments.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without any inventive effort, are intended to be within the scope of the invention.

It should be noted that all directional indicators (such as up, down, left, right, front, and rear are used in the embodiments of the present invention) are merely for explaining the relative positional relationship, movement conditions, and the like between the components in a certain specific posture (as shown in the drawings), and if the specific posture is changed, the directional indicators are changed accordingly.

Furthermore, the description of "first," "second," etc. in this disclosure is for descriptive purposes only and is not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In addition, the meaning of "and/or" as it appears throughout is meant to include three side-by-side schemes, for example, "A and/or B", including the A scheme, or the B scheme, or the scheme where A and B meet at the same time. In addition, the technical solutions of the embodiments may be combined with each other, but it is necessary to base that the technical solutions can be realized by those skilled in the art, and when the technical solutions are contradictory or cannot be realized, the combination of the technical solutions should be considered to be absent and not within the scope of protection claimed in the present invention.

In some exemplary techniques, the connector of the active electrode lead includes a housing and an inner member disposed in the housing, the inner member is more, including a connector pin, an insulating member, an inner conductor or coil, a pin sleeve, etc., because the ribs constituting the housing seal radially set up along the inner center hole to interfere with other members, and the inner member is more to cause a larger rotational resistance of the connector pin, so that the connector pin is not rotated smoothly, the use comfort of the electrode lead is lower, and the stimulation to the patient is easily caused.

In order to improve the smoothness of rotation of the first signal connecting piece of the connector, so as to improve the use comfort of the electrode lead and reduce the stimulation to a patient, the invention provides an electrode lead which is applicable to various medical equipment, particularly a defibrillator, a pacemaker or other electric stimulation devices, but not limited thereto.

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 insulating tube 11 and an outer multi-strand wire 12, an inner insulating tube 13 and an inner multi-strand wire 14 sequentially disposed within the outer insulating tube 11, the electrode tip 20 being disposed at the first end of the lead body section 10, the connector 30 being disposed at the second end of the lead body section 10 and adapted to be plugged with a connection interface of a medical device, the connector 30 including a connector body 31, a first signal connector 32 and a second signal connector 33, the connector body 31 being provided with a communication channel 31a, the second end of the lead body section 10 being plugged at one end of the communication channel 31a, the first signal connector 32 being plugged at the other end of the communication channel 31a and connected with the inner multi-strand wire 14, and the second signal connector 33 being disposed on the connector body 31 and connected with 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 suitable for being electrically connected to a connection interface of a medical device, 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 cylindrically arranged, the outer diameter of the electrical contact section 321 is larger than the outer diameter of the insertion section 322, and a gap is provided between the insertion section 322 and an inner wall of the communication channel 31a, so that the first signal connector 32 is rotatably inserted into the communication channel 31a.

It should be noted that in this embodiment, the electrode lead may be an implantable active medical lead provided with an active mechanism at the free end, and the free end of the implantable active medical lead may include a helical fixation mechanism for being braked and extending axially and/or rotating out of the top of the lead for engagement or embedding into the patient's myocardium and being fixed within the atrium or ventricle.

Referring to fig. 1 and 3, a lead body segment 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 within the outer insulating tube 11, an inner insulating tube 13, and an inner multi-strand wire 14. The inner multi-strand wire 14 is arranged at the innermost layer of the cable, the inner insulating tube 13 wraps the inner multi-strand wire 14 and the outer multi-strand wire 12, and the inner insulating tube 13 and the outer insulating tube 11 form a space for accommodating the outer multi-strand wire 12 while insulating and protecting the outer insulating tube 11.

Referring to fig. 3 and 12, the inner multi-strand wire 14 is disposed in the inner insulating tube 13, and one end of the inner multi-strand wire 14 may be connected to the first signal connector 32 by means of resistance welding, bonding, laser welding, or the like, 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 means of resistance welding, bonding, 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 wire 14 and the outer multi-strand wire 12, the inner multi-strand wire 14 is rotatable within the lumen of the inner insulating tube 13, and the outer multi-strand wire 12 is 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 wire main body section 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 part of the outer wall of the other end is fixed to the connector body 31 by bonding or the like.

In this embodiment, as shown in fig. 1, the electrode tip 20 may be disposed at a first end of the lead body segment 10 to form an active mechanism. The motor head may include one or more electrode members, may be made of a solid electrical conductor material such as 316L stainless steel or noble metal, and the specific structure may be set according to signal detection requirements of medical equipment, etc., and is not limited herein.

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 mating with a connection interface of a medical device, which serves as a connection means for connecting conductors of the lead body segment 10 (i.e., the inner multi-strand wire 14 and the outer multi-strand wire 12) with a connection interface of a medical device, and a physician may screw the electrode tip 20 at the first end of the lead body segment 10 into the patient's myocardium and secure it in the atrium or ventricle by rotating the first signal connection 32 of the connector 30.

During assembly, the electrode tip 20 may be fixed to the first end of the wire main body section 10 by welding, winding connection, or the like, the second end of the wire main body section 10 is cut 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 of the end, the inner multi-strand wire 14 of the end is fixed to the first signal connector 32 by welding or bonding, or the two are connected and fixed by a connecting member, the inner insulating tube 13 of the end is inserted and fixed into the communication channel 31a of the connector body 31 by bonding, clamping, or the like, the outer multi-strand wire 12 of the end is fixed to the second signal connector 33 by welding or bonding, or the two are connected and fixed by a connecting member, and the outer insulating tube 11 of the end is inserted and fixed into the communication channel 31a of the connector body 31 by bonding, clamping, or the like.

It will be appreciated that in the technical solution of the present application, the electrode lead comprises 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 comprising 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 within the outer insulating tube 11; the electrode tip 20 is arranged at the first end of the lead body section 10; the connector 30 is arranged at the second end of the lead main body section 10 and is suitable for being inserted into a connecting interface of medical equipment, the connector 30 comprises a connector body 31, a first signal connecting piece 32 and a second signal connecting piece 33, the connector body 31 is provided with a communicating channel 31a, the second end of the lead main body section 10 is inserted into one end of the communicating channel 31a, the first signal connecting piece 32 is inserted into the other end of the communicating channel 31a and is connected with the inner stranded wires 14, the second signal connecting piece 33 is arranged on the connector body 31 and is connected with the outer stranded wires 12, wherein the first signal connecting piece 32 comprises an electric contact section 321 and an inserting section 322 connected with the electric contact section 321, the electric contact section 321 is suitable for being electrically connected with the connecting interface of the medical equipment, the inserting section 322 is inserted into the communicating channel 31a and is connected with the inner stranded wires 14, the electric contact section 321 and the inserting section 322 are in cylindrical shape, the outer diameter of the electric contact section 321 is larger than the outer diameter of the inserting section 322, a gap is reserved between the inserting section 322 and the inner wall of the communicating channel 31a, so that the first signal connecting piece 32 can be rotatably inserted into the communicating channel 31a, the first signal connecting piece 32 is connected with the first signal connecting piece 32 in a rotating mode, the rotating resistance of the electrode is improved, and the electrode is connected with the rotating resistance of the electrode is improved, and the electrode is compared with the rotating resistance, and the electrode is 32, the stimulation to the patient is reduced.

In order to avoid the first signal connection member 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 connection member 32 may further include a locking portion 323, the locking portion 323 is disposed at an end of the insertion section 322, and an adaptive mating portion 313 is disposed on an inner wall of the connector body 31 at a position corresponding to the locking portion 323, as shown in fig. 8, the locking portion 323 is locked in the mating portion 313. Referring mainly to fig. 4 and 8, a first limiting step 324 is formed at the connection between the electrical contact section 321 and the insertion section 322, the first limiting step 324 is spaced from the end of the connector body 31, a second limiting 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 limiting step 325 to limit the insertion section 322 from being separated from the communication channel 31a along the axial direction thereof.

In this embodiment, the first signal connector 32 may be provided in a cylindrical needle shape, and may be made of a conductive material, which is not particularly limited herein. The first signal connector 32 may be provided with a receptacle 32a extending therethrough along its length adapted for insertion of an electrode auxiliary instrument into the inner multi-strand wire 14.

In practice, the electrode auxiliary device may be threaded into the inner multi-strand wire 14 through the insertion hole 32a of the first signal connector 32.

Further, as shown in FIG. 4, one end of insertion section 322 may be provided with a connector 326, and inner strand wire 14 may be welded to connector 326.

In actual assembly, the inner wire 14 may be threaded onto the connection 326 of the first signal connector 32 and aligned with the second stop step 325, and then resistance welded, laser welded, glued, or the like to secure the inner 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 face of the first limiting step 324 and the end face of the second limiting step 325, so that the first signal connector and the connector body 31 are prevented from slipping.

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

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

In the present embodiment, the material of the first signal connector 32 is preferably platinum iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy, etc., but is not limited thereto.

It should be noted that, the inner and outer strands 12 of the conventional electrode lead wire need to be crimped and fixed by four metal pieces, particularly, the magnetic components, which are more, complex to assemble, higher in cost and not easy to pass nuclear magnetic resonance inspection. 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 process is reduced, and the nuclear magnetic resonance inspection is easier to pass. Also, the connection of the insulating member of the conventional electrode lead to the first signal connector 32 requires a plurality of fitting structures, even the fitting of a plurality of insulating members, the fitting process is complicated, and the accumulated tolerance caused by the fitting of a plurality of members is large and the cost is high. The first signal connector 32 and the insulating part of the electrode wire connector 30 adopt a clamping structure, and the two parts can ensure the axial limit and the circumferential free rotation of the first signal connector 32, so that the assembly parts and the working procedures are 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, wherein the ring electrical contact section 331 is adapted to be electrically connected to a connection interface of a medical device, an end of the ring electrical contact section 331 is adhesively fixed to the connector body 31, an inner wall of the adhesive section 332 is adhesively fixed to the connector body 31, and an end of the adhesive section 332 is fixedly welded to the connector body 31. Thus, the assembly is facilitated and the stability of the signal transmission of the connector 30 is improved.

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

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

It will be appreciated that during assembly of the connector 30 with the second end of the conductive body section, an adhesive such as silicone may be injected through the injection port 332a to secure the insulator 310 of the connector body 31.

In this embodiment, referring to fig. 6, the second signal connector 33 may be provided with a third limiting step 333 adapted to limit the second signal connector 33 from moving along the axial direction thereof.

It can be understood that the second signal connector 33 limits the front side of the insulating member 310 of the connector body 31 in the axial direction through the center hole and the third limiting step 333, and fixes the insulating member 310 by injecting an adhesive such as silica gel through the injection port 332 a. The front end surface of the second signal connector 33 can be bonded to the first seal 34 of the connector 30, and the rear end surface of the second signal connector 33 can be laser welded to the signal connector 320 of the connector body 31 to limit the rear side of the insulator 310 in the axial direction. In addition, the second sealing member 35 may be connected to the second signal connecting member 33 by applying a silicone adhesive to the bonding surface between the outer stepped end surface of the second signal member and the step.

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

In the present 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 socket 320, the insulating member 310 is disposed in a hollow tube shape, the second signal connection member 33 is disposed around the insulating member 310, the signal connection socket 320 abuts against the insulating member 310, and the second signal connection member 33 is connected with the outer multi-strand wire 12 through the signal connection socket 320.

It should be noted that, compared with the numerous parts in the prior art, the electrode lead has fewer external parts and internal parts, so that the normal signal transmission function of the connector 30 is ensured, the structure of the connector 30 is simplified, the production and manufacturing costs are saved, the use by doctors is convenient, the use comfort of the electrode lead is improved, and the discomfort to patients is reduced.

In an embodiment, as shown in fig. 7 and 8, the insulating member 310 may include a first pipe section 311 and a second pipe section 312 connected to the first pipe section 311, the first pipe section 311 has an outer diameter larger than that of the second pipe section 312, and a fourth limiting step 314 is formed at the connection between the first pipe section 311 and the outer side of the second pipe section 312, and is adapted to limit the movement of the insulating member 310 in the axial direction thereof. Thus, the stability of the connector 30 can be improved, and the production and assembly can be facilitated.

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

The insulator 310 engages the first signal connector 32 into the communication channel 31a of the connector body 31 by using the inner conical mating portion 313 and the inner stepped surface 315 thereof, and enables the first signal connector 32 to be freely rotatable in the circumferential direction while being axially limited. The rear side of the insulating member 310 may be coated with an adhesive and penetrates 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, so that the portion of the annular electric 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 and penetrates into the first sealing member 34 and is adhered and fixed.

In this embodiment, the insulating member 310 may be an implant polymer insulating material having a certain elasticity and hardness, preferably, polycarbonate (PC), thermoplastic polyurethane elastomer (TPU), polysulfone (PSU), polyphenylene sulfone (PPSU), or Polyetheretherketone (PEEK), etc., which are not limited.

Referring to fig. 3 and 9, in an embodiment, the signal connection socket 320 may be formed with an inner hole 320a through which the inner insulating tube 13 penetrates, the signal connection socket 320 may include a penetrating section 327 and a welding section 328 connected to the penetrating section 327, an abutment arm 329 may be disposed at a connection portion between the penetrating section 327 and the welding section 328, the penetrating section 327 penetrates into the second signal connection member 33, the abutment arm 329 abuts against an end portion of the second signal connection member 33 and may be fixed by welding, and the welding section 328 may be fixed by welding with the outer multi-strand wire 12. Therefore, the connection stability can be improved, the occurrence of signal disconnection is avoided, and the stability of signal transmission of the connector 30 is improved.

In this embodiment, the material of the signal connection seat 320 may be platinum iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

During assembly, the outer multi-strand wire 12 can be first threaded onto the rear side surface of the welding section 328 of the signal connection seat 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 performed, the outer multi-strand wire 12 and the welding section 328 are welded and fixed, the inner hole 320a of the signal connection seat 320 penetrates through the outer insulating tube 11, the front side surface of the signal connection seat 320 penetrates into the second signal connection piece 33, the front end surface of the signal connection seat 320 abuts against the insulating piece 310, the annular step (i.e. the abutting arm 329) abuts against the second signal connection piece 33 and is subjected to laser welding and fixing, and therefore the rear side of the insulating piece 310 in the axial direction is limited, and the electric connection between the outer multi-strand wire 12 and the second signal connection piece 33 is completed.

In this embodiment, the electrical connection of the connector 30 is achieved mainly by the electrical connection of the first signal connector 32 by welding or bonding the inner wire strands 14, the electrical connection of the second signal connector 33 by laser welding or bonding the signal connector holder 320, and the electrical connection of the signal connector holder 320 by welding or bonding the outer wire strands 12.

In this technical scheme, the insulating member 310 is fixed in the second signal connecting member 33 while the outer multi-strand wire 12 is electrically connected with the second signal connecting member 33, and the signal connecting seat 320 serves multiple purposes, so that the number of parts is reduced, and the product cost is reduced.

To further enhance the stability of the connector 30, facilitate assembly of the connector 30 and prevent body fluids from entering the connection interface of the patient during the procedure, and enhance the sealing performance 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 seal off 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 member 34 may be preferably thermoplastic polyurethane elastomer (TPU), silicone or a blend of silicone and polyurethane, so as to ensure certain elasticity and biocompatibility.

In this embodiment, the front side of the insulator 310 may be disposed in the inner hole 320a of the first seal 34 and bonded and fixed by an adhesive such as silicone.

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 being circumferentially disposed on the second signal connection member 33 and fixed by bonding, the second sealing member 35 being formed with a through hole through which the outer insulation tube 11 is inserted. In this way, 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 process, so that the sealing performance of the medical device can be improved.

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

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

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, and the long and soft characteristic of the second sealing member 35 can be used to help the connector 30 achieve stress relief.

In this embodiment, the second signal connection member 33, the first pipe section 311, the first sealing member 34, the second pipe section 312, and the second sealing member 35 may be adhered and fixed to the second signal connection member 33 by a first adhesive. The material of the first adhesive may be silica gel or epoxy resin, but is not limited thereto.

In this embodiment, the sealing and insulating aspects of the connector 30 are mainly achieved by the bonding of the first sealing member 34 to the front side of the insulating member 310, the filling and bonding of the silica gel between the insulating member 310 and the second signal connecting member 33, the filling or bonding of the silica gel between the inner insulating tube 13 and the insulating member 310, the bonding of the silica gel between the second sealing member 35 and the second signal connecting member 33, and the filling or bonding of the silica gel between the second sealing member 35 and the space of the outer insulating tube 11.

In addition, in order to facilitate the installation of the components of the connector 30 and to 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 adhered and fixed by a second adhesive. The material of the second adhesive may be silica gel, epoxy resin, or the like, which is not limited herein.

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

It will be appreciated that the helical head 21 is helical and may be conveniently implanted in the patient's myocardium to enhance connection stability and avoid signal disconnection. The electrode ring 22 is arranged in a strip ring shape, so that the contact area between the electrode ring and the cardiac muscle can be increased, the connection stability is enhanced, and signal disconnection is avoided.

In practice, electrode leads are often used in combination with the main body of medical equipment such as cardiac pacemakers, defibrillators, and the like. The screw head 21 can be screwed into the targeted treatment site in the heart by rotating the connector 30, then the muscle tissue in the heart will gradually grow together with the electrode tip 20, the connector 30 is connected with the connecting interface of the cardiac pacemaker or defibrillator, and finally the electric signal sent by the cardiac pacemaker or defibrillator is transmitted to the targeted treatment site to be stimulated electrically in the heart through the connector 30, the electrode tip 20 and the lead body section 10.

The invention also proposes a medical device comprising a machine body provided with a connection interface, and an electrode lead, the connector 30 of which is inserted in the connection interface, the specific structure of which refers to the above-mentioned embodiments, since the medical device proposed by the invention comprises all the solutions of all the embodiments of the electrode lead described above, it has at least the same technical effects as the electrode lead, which are not described herein.

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

Referring to fig. 1 to 3, in an embodiment of the present invention, the electrode lead comprises a lead body section 10, an electrode tip 20 and a connector 30, wherein the lead body section 10 is provided with a first end and a second end which are opposite, the lead body section 10 comprises an outer insulating tube 11 and an outer multi-strand wire 12, an inner insulating tube 13 and an inner multi-strand wire 14 which are sequentially arranged in the outer insulating tube 11, the electrode tip 20 is arranged at the first end of the lead body section 10, the connector 30 is arranged at the second end of the lead body section 10 and is suitable for being connected with a connecting interface of a medical device, the connector 30 comprises a connector body 31, a first signal connector 32 and a second signal connector 33, the connector body 31 is provided with a communicating channel 31a, the second end of the lead body section 10 is inserted at one end of the communicating channel 31a, the first signal connector 32 is inserted at the other end of the communicating channel 31a and is connected with the inner multi-strand wire 14, the second signal connector 33 is arranged on the connector body 31 and is connected with the outer multi-strand wire 12, the first signal connector 32 comprises an electric contact section 321 and an inserting section 321 connected with the electric contact section 321, and an inserting section 321 connected with the electric contact section 321 is arranged in the inner wall 322 a, which is in a cylindrical shape and is suitable for being connected with the inner diameter of the communicating channel 322 a, and is in a communicating channel, and the communicating channel is provided with the communicating channel 31.

The foregoing description is only of the optional embodiments of the present invention, and is not intended to limit the scope of the invention, and all the equivalent structural changes made by the description of the present invention and the accompanying drawings or the direct/indirect application in other related technical fields are included in the scope of the invention.

Claims

1. An electrode lead, characterized in that the electrode lead comprises:

An electrode tip disposed at a first end of the lead body segment, and

The connector is arranged at the second end of the lead main body section and is suitable for being spliced 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 communication channel, the second end of the wire main body section is inserted into one end of the communication channel, the first signal connecting piece is inserted into the other end of the communication 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 wire, the connector body comprises an insulating piece and a signal connecting seat, the insulating piece is in a hollow tubular shape, the second signal connecting piece is arranged on the insulating piece in a surrounding manner, the signal connecting seat is in abutting connection with the insulating piece, the second signal connecting piece is connected with the outer multi-strand wire through the signal connecting seat, an inner hole for the inner insulating tube to penetrate is formed in the signal connecting seat, the signal connecting seat comprises a penetrating section and a welding section connected with the penetrating section, an abutting arm is arranged at the joint of the penetrating section and the welding section, and the penetrating section penetrates into the second signal connecting piece and is in abutting connection with the second signal connecting section and is in abutting connection with the outer multi-strand wire, and the welding section is fixed by the abutting joint;

The first signal connecting piece comprises an electric contact section and an insertion section connected with the electric contact section, wherein the electric contact section is suitable for being electrically connected with a connecting interface of the medical equipment, the insertion section is inserted into the communication channel and is connected with the inner multi-strand wires, one end of the insertion section is provided with a connecting part, and the inner multi-strand wires are welded and fixed on the connecting part;

The second signal connecting piece comprises a ring electric contact section, an adhesion section and a clamping part, wherein the adhesion section and the clamping part are connected with the ring electric contact section, the ring electric contact section is suitable for being electrically connected with a connecting interface of the medical equipment, the end part of the ring electric contact section is adhered and fixed with the connector body, the inner wall of the adhesion section is adhered and fixed with the connector body, the end part of the adhesion section is fixed with the connector body through welding, the clamping part is arranged at the end part of the insertion section, an adaptive matching part is arranged at the position of the inner wall of the connector body corresponding to the clamping part, the clamping part is clamped in the matching part, a first limiting step is formed at the joint of the electric contact section and the insertion section, the first limiting step is arranged at intervals with the end part of the connector body, a second limiting step is formed between the clamping part and the insertion section, and the inner wall of the connector body is provided with an inner step surface corresponding to the second limiting step so as to limit the insertion section to be axially separated from the inner communicating channel of the insertion section.

2. The electrode lead of claim 1, wherein the first signal connector has a receptacle extending therethrough along a length thereof adapted for insertion of an electrode auxiliary instrument into the inner multi-strand wire.

3. The electrode lead of claim 1, wherein the first signal connection member is made of platinum iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

4. The electrode lead according to claim 1, wherein the bonding section is provided with an injection port adapted for injection of an adhesive.

5. The electrode lead according to claim 1, wherein the second signal connection member is provided in a hollow tubular shape, and the second signal connection member is provided with a third limiting step adapted to limit the second signal connection member from moving in an axial direction thereof.

6. 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.

7. The electrode lead according to claim 1, wherein the insulating member comprises a first tube section and a second tube section connected to the first tube section, the outer diameter of the first tube section is larger than the outer diameter of the second tube section, and a fourth limit step is formed at the connection of the first tube section and the outer side of the second tube section, and is adapted to limit the insulating member to move in the axial direction thereof.

8. The electrode lead according to claim 7, wherein the inner step surface is provided at a position corresponding to the second limit step at the inner side connection of the first tube section and the second tube section;

9. The electrode lead according to claim 1, wherein the insulating member is made of polycarbonate, thermoplastic polyurethane elastomer, polysulfone, polyphenylene sulfone or polyether ether ketone.

10. The electrode lead according to claim 1, wherein the signal connection base is made of platinum iridium alloy, stainless steel, MP35N alloy, titanium or titanium alloy.

11. The electrode lead of claim 7, wherein the connector further comprises a first seal adapted to seal off a connection interface of the medical device, the first seal being disposed circumferentially on the second tube segment.

12. The electrode lead of claim 11, wherein the connector further comprises a second seal adapted to seal the connection interface of the medical device, the second seal being circumferentially disposed on the second signal connection and secured by bonding, the second seal being formed with a through hole for the outer insulating tube to pass through.

13. The electrode lead of claim 12, wherein the second signal connection member is adhesively secured to the first tube segment, the first seal member and the second tube segment, and the second seal member and the second signal connection member by a first adhesive.

14. The electrode lead according to claim 13, wherein the first binder is silica gel or epoxy.

15. The electrode lead of claim 1, wherein the electrode head comprises a screw head and an electrode ring;

16. The electrode lead according to claim 15, wherein the inner insulating tube is bonded and fixed to the connector body and the outer insulating tube is bonded and fixed to the connector body by a second adhesive.

17. The electrode lead according to claim 16, wherein the material of the second binder is silica gel or epoxy.

18. A medical device, the medical device comprising:

A machine body provided with a connection interface, and

An electrode wire according to any one of claims 1 to 17, wherein a connector of the electrode wire is inserted into the connection interface.