CN112370657A

CN112370657A - Electrode lead

Info

Publication number: CN112370657A
Application number: CN202011217550.0A
Authority: CN
Inventors: 江隆福
Original assignee: University of Chinese Academy of Sciences
Current assignee: University of Chinese Academy of Sciences
Priority date: 2020-11-04
Filing date: 2020-11-04
Publication date: 2021-02-19

Abstract

The invention discloses an electrode lead, which includes a connecting wire and an implantation end; the implantation end includes an implantation head that can move back and forth; the implantation head penetrates into body tissue by puncturing; The way that the head penetrates the body tissue is set to puncture, so that the implant head can easily break through the endocardium, making the implant head more convenient and labor-saving, and the selection of pacing sites is more diverse .

Description

Electrode lead

Technical Field

The invention belongs to the technical field of artificial cardiac pacemakers, and particularly relates to an electrode lead.

Background

The heart pacemaker is an electronic therapeutic apparatus implanted in a human body, and electric pulses powered by a battery are delivered by a pulse generator, and conducted by a lead electrode to stimulate cardiac muscle contacted by the electrode so as to excite and contract the cardiac muscle, thereby achieving the purpose of treating cardiac dysfunction caused by certain arrhythmia and heart failure.

One end of the existing electrode lead implanted into organism tissues is made into a spiral shape, so that the implanted end can break through endocardium and directly reach a pacing site in a spiral screwing mode; however, the conventional helical implant head is difficult to break through and the implantation effect is not ideal because the closer the his bundle region is to the physiological pacing site in the ventricle, the more developed the fibrous scaffold system is, the closer the his bundle region is.

Disclosure of Invention

The invention provides an electrode lead convenient to implant in order to overcome the defects of the prior art.

In order to achieve the purpose, the invention adopts the following technical scheme: an electrode lead comprises a connecting wire and an implanting end; the implantation end comprises

An implant head that can move back and forth;

the implantation head penetrates into organism tissues in a puncture mode;

the mode that the implantation head penetrates through the organism tissue is set to be a puncture type, so that the implantation head is less obstructed by a fiber scaffold system, the implantation head can break through an endocardium very easily and then enters the organism tissue to reach a preset pacing site, the implantation of the implantation head is more convenient and labor-saving, and the selection of the pacing site is more diversified; and because the adopted puncture mode breaks through the endocardium, the implantation head is not easy to hook on the fibrous tissue, so that when the first implantation site is not ideal, the implantation head is more smooth when retreating from the body tissue, and is not easy to clamp on the fibrous tissue, thereby ensuring the operation to be smoother.

Furthermore, the implantation head comprises a rod part and a tip arranged on the rod part, and the tip is arranged in a sharp-pointed structure; through the structure setting, make implant the head and comprise pole portion and pointed end at least to the pointed end is sharp-pointed form, thereby makes implant the head whole and be slender sharp-pointed shaft-like, is similar to object structures such as syringe needle, spine of syringe, makes then implant the head and can adopt the mode of puncture to pierce through the endocardium, makes the implantation of implanting the head more simple and convenient, labour saving and time saving.

Further, the implantation head is at least partially implantable to the left bundle branch region; the pacing of the left bundle branch region is realized, the pacing is closer to a physiological pacing site, and the pacing effect is better.

Further, the maximum distance of the implantation head penetrating into organism tissues is more than or equal to 10 mm; the implantation head has enough length to penetrate into the left restraint area, and even if the implantation head obliquely penetrates into body tissues, the implantation head also has enough length to reach the left restraint area, so that an ideal implantation effect can be always achieved.

Furthermore, the device also comprises a positioning structure for realizing the connection and fixation between the implantation end and the organism tissue; through location structure's setting for implant the head in implanting organism tissue back, location structure can fix the end of implanting on organism tissue, thereby makes and to realize stable pacing.

Furthermore, the positioning structure comprises an anode part arranged in a spiral structure and a sharp part arranged on the anode part; set up to helical structure through positive pole portion, and sharp portion has been seted up on positive pole portion, thereby make positive pole portion can twist organism tissue, can enough play the electrically conductive effect of positive pole portion itself, can also play the fixed action simultaneously, moreover, the steam generator is simple in structure, high durability and convenient operation, utilize the shortcoming that is difficult to the separation that exists itself between helical structure and the fibrous tissue in the conventional helical electric machine wire, it utilizes to be used for realizing implanting in this application and holds and organism tissue between be connected fixedly, it is capable to the contrary way, possess unexpected effect.

Further, the positioning structure comprises a secondary implantation head which can penetrate into body tissues at least partially and a radial lock head which is used for realizing the anti-disengagement matching between the secondary implantation head and the body tissues; through the arrangement of the structure, the auxiliary implanting head is matched with the radial lock head, so that the fixation of the implanting end and the organism tissue is realized, the structure is simple, and the operation is convenient.

Further, the device also comprises a breakthrough mechanism which can repeatedly provide explosive force for the implantation head; through the arrangement of the breaking-through mechanism, explosive force can be provided for the implantation head, so that the implantation head can rapidly penetrate the endocardium by virtue of the explosive force, the clamping is avoided, and the subsequent implantation is more convenient and labor-saving; if the implantation site does not need to be implanted again, the breakthrough mechanism can be repeatedly used, and the explosive force is provided again during subsequent implantation, so that the use is more convenient.

Furthermore, the breakthrough mechanism comprises an elastic piece for providing explosive force for the implantation head, a locking structure for keeping the elastic piece in an elastic deformation state and a resetting structure for enabling the elastic piece to recover the elastic deformation state; through the arrangement of the structure, when the endocardium is not required to be broken through, the elastic piece can be locked by the locking structure and is kept in the state of elastic deformation, when the endocardium is required to be broken through, the locking of the locking structure on the elastic piece is released, and when the elastic piece is restored to the initial state, explosive elasticity is provided, so that the implantation head can quickly break through the endocardium; when the implantation is needed again, the elastic piece can elastically deform by using the reset structure, so that the next implantation of the implantation head can provide explosive force again, and repeated use is realized.

Further, the locking structure comprises a locking column connected with the implant head, an extension column capable of moving back and forth relative to the locking column and a locking convex part for realizing relative rest between the extension column and the locking column; or the reset structure comprises a turning groove for driving the locking convex part to move and a reset track matched with the locking convex part; through the arrangement of the structure, the locking and resetting of the elastic piece are realized, the structure is simple and effective, the operation is convenient, and the failure rate is low.

In conclusion, the invention sets the mode that the implantation head penetrates through the organism tissue to be a puncture type, so that the implantation head can break through the endocardium very easily, the implantation of the implantation head is more convenient and labor-saving, and the selection of the pacing sites is more diversified.

Drawings

Fig. 1 is a schematic perspective view of embodiment 1 of the present invention;

fig. 2 is a schematic perspective cross-sectional view of an external connection layer in embodiment 1 of the present invention;

FIG. 3 is a schematic cross-sectional view of an interconnect layer in example 1 of the present invention;

fig. 4 is a schematic perspective cross-sectional structure view of the connection end and the connection line in embodiment 1 of the present invention;

FIG. 5 is an enlarged schematic view at A in FIG. 4;

FIG. 6 is an enlarged schematic view at B of FIG. 4;

FIG. 7 is an enlarged schematic view at C of FIG. 4;

FIG. 8 is an enlarged schematic view at D of FIG. 4;

FIG. 9 is a schematic view of a matching structure of an implantation terminal and a connection line in embodiment 1 of the present invention;

FIG. 10 is a schematic perspective cross-sectional view taken along line A-A in FIG. 9;

FIG. 11 is an enlarged schematic view at E of FIG. 10;

FIG. 12 is an enlarged schematic view at F of FIG. 10;

fig. 13 is a schematic perspective view of a locking column in embodiment 1 of the present invention;

FIG. 14 is a schematic perspective cross-sectional view taken along line B-B of FIG. 9;

FIG. 15 is an enlarged schematic view at G of FIG. 14;

FIG. 16 is a schematic perspective cross-sectional view taken along line C-C in FIG. 9;

FIG. 17 is an enlarged schematic view at H in FIG. 16;

fig. 18 is a schematic structural view of a positioning structure in embodiment 2 of the present invention;

FIG. 19 is an enlarged schematic view at I of FIG. 18;

fig. 20 is an enlarged schematic view at J in fig. 18.

Detailed Description

Further description of the structures referred to in this application, or the terms of art used, are understood and interpreted as generic terms commonly used in the art unless otherwise indicated.

Puncture needle

The commonly used medical operation term is a diagnosis and treatment technology that a puncture needle is punctured into a body cavity to extract secretion for testing, gas or contrast agent is injected into the body cavity to carry out contrast examination, or medicine is injected into the body cavity; in the present application, the term puncturing merely refers to the manner or action of penetrating the endocardium and penetrating the body tissue with a sharp object along a straight or nearly straight path; wherein a sharp object is referred to as the implantation head 21 or the tip 211.

Sharp shape

Sharp refers to sharp, and in this application, sharp, i.e., fingertip, sharp, includes, but is not limited to, needle-point, blade-like, and the like.

Explosive power

Explosive force refers to the maximum work done in a short time; as the name suggests, the force is just like gunpowder explosion, and can burst out and emit huge energy in one moment; the break-through mechanism can provide a large amount of kinetic energy for the implantation head in a short time, so that the implantation head can suddenly advance forwards to break through the endocardium.

Example 1:

as shown in fig. 1-17, an electrode lead includes a connection wire 1, an implantation end 2, and a connection end 3; implanting end 2 is used for linking to each other with patient's cardiac muscle tissue, and the link then is used for linking to each other with cardiac pacemaker, and the connecting wire then is used for connecting implanting end and link.

Specifically, the connecting wire 1 comprises an inner connecting layer 11, an inner insulating layer 12, an outer connecting layer 13 and an outer insulating layer 14, wherein the inner connecting layer and the outer connecting layer are both made of conductive materials, and the specific material types are not limited and only need to meet medical standards; the inner connecting layer and the outer connecting layer are formed by synchronously curling a plurality of metal wires, are arranged in a spiral structure and have elasticity; in this embodiment, the outer connection layer 13 is formed by bending and winding 4 metal wires (the 4 metal wires are respectively represented by

reference numerals

131, 132, 133 and 134), and each turn of the 4 metal wires bent into a spiral shape is closely attached to each other, so that the outer connection layer formed by four metal wires is in a shape similar to a hollow tube; the inner connecting layer 11 is formed by winding 3 metal wires (the 3 metal wires are respectively represented by

reference numerals

111, 112 and 113) in a bending way, and each turn of the 3 metal wires which are bent into a spiral shape is attached to each other, so that the inner connecting layer formed by the 3 metal wires is in a shape similar to a hollow pipe; the outer connecting layer and the inner connecting layer can play a role in conducting electricity, and meanwhile, the outer connecting layer and the inner connecting layer can be bent randomly, so that the operation is convenient to carry out; the outer connecting layer has larger diameter and the inner connecting layer has smaller diameter, so the outer connecting layer has better flexibility and is easier to bend; the rigidity of the inner connecting layer is higher than that of the outer connecting layer, a certain supporting effect is achieved, and meanwhile, due to the fact that the plurality of metal wires are tightly wound, when one end of the inner connecting layer receives rotating force and rotates, the other end of the inner connecting layer can be synchronously driven to rotate; the inner insulating layer 12 and the outer insulating layer 14 are both made of silica gel materials and accord with the medical material standard, the inner insulating layer is sleeved outside the inner connecting layer, the outer connecting layer is sleeved outside the inner insulating layer, the outer insulating layer is sleeved outside the outer connecting layer, the inner connecting layer can rotate and slide back and forth relative to the inner insulating layer, and the outer connecting layer and the inner insulating layer are relatively static; in other embodiments, the inner connecting layer and the inner insulating layer may be stationary, and the inner insulating layer may rotate and slide back and forth relative to the outer connecting layer; preferably, a lubricating layer is further arranged between the outer connecting layer and the inner insulating layer, so that relative rotation and sliding between the outer connecting layer and the inner insulating layer are smoother; the lubricating layer can be formed by smearing lubricating oil meeting medical standards, and the specific type of the lubricating oil is not limited; and the outer surface of the inner insulating layer 12 and the inner surface of the outer insulating layer 14 are provided with thread grooves, so that the outer connecting layer 13 can be just embedded in the thread grooves, and further, every two of the inner insulating layer, the outer insulating layer and the outer connecting layer are relatively static.

Specifically, the connection end 3 includes a driving member 32, an electrode driving structure, a first plug bush 34, an anode ring 35 and a second plug bush 36; the electrode driving structure comprises an electrode head 31 and a connecting sleeve 33; the anode ring 35 is made of a metal material, has conductivity, and is provided in a hollow cylindrical structure; at least parts of the end parts of the inner connecting layer 11, the inner insulating layer 12 and the outer connecting layer 13 penetrate into the anode ring, at least part of the outer surface of the outer connecting layer is attached to at least part of the inner surface of the anode ring, the inner connecting layer and the outer connecting layer are connected and fixed in one or more modes of clamping, gluing, welding and the like, and meanwhile, the outer connecting layer and the anode ring are electrically connected, and the specific connecting mode is the prior art and is not described in detail herein; the second plug bush 36 is formed by extending at least part of the surface of the outer insulating layer 14 outwards, the inner surface of the second plug bush is attached to the outer surface of the anode ring, at least part of the inner surface of the second plug bush extends outwards to form an anti-drop convex portion 361, at least part of the surface of the anode ring 35 is recessed inwards to form an anti-drop groove 351, and the anti-drop convex portion is just embedded into the anti-drop groove, so that anti-drop fit is formed between the second plug bush and the anode ring; preferably, an adhesive layer is further arranged between the second plug bush and the anode ring, and the second plug bush and the anode ring are connected more firmly and form sealing fit through the adhesive layer; the connecting sleeve 33 is arranged in a hollow cylindrical structure and made of medical grade plastic materials, one end of the connecting sleeve at least partially penetrates into the anode ring 35, and at least part of the outer surface of the connecting sleeve is attached to at least part of the inner surface of the anode ring, so that the connecting and fixing between the connecting sleeve and the anode ring are realized; the first plug bush 34 is made of a silica gel material, has elasticity, is provided in a hollow cylindrical structure, is sleeved on the outer surface of the plug bush, and preferably, at least part of one end of the first plug bush penetrates into the anode ring; at least part surface of first plug bush 34 and second plug bush 36 has outwards extended and has formed bulge loop 37, and in this embodiment, first plug bush and second plug bush have all seted up two rings of bulge loops, and when connecting end 3 and pacemaker be connected fixed back, the bulge loop can play sealed effect, avoids in patient's blood gets into the pacemaker, guarantees that the pacemaker can normally work all the time, and is more stable, and the security is higher.

Furthermore, the driving member 32 is formed in a hollow cylindrical structure, is made of a metal material, and has electrical conductivity; the driving member penetrates through one end of the connecting sleeve 33 and then penetrates out of the other end of the connecting sleeve and is placed in the anode ring 35, and the outer diameter of the driving member is smaller than the inner diameter of the inner insulating layer 12, so that the driving member can freely rotate and slide relative to the inner insulating layer (in other embodiments, the outer diameter of the driving member is smaller than the inner diameter of the outer connecting layer 12, so that the driving member can freely rotate and slide relative to the outer connecting layer); at least part of the surface of one end of the driving piece, which is positioned in the anode ring, extends outwards to form a fixing part 321, and one end of the internal connecting layer 11 is sleeved on the fixing part to realize the electric connection between the two parts; the outer diameter of the fixing part is slightly larger than the inner diameter of the inner connecting layer 11, so that the fixing part and the inner connecting layer can form interference fit; preferably, the fixing portion and the inner connecting layer are doubly fixed through welding or other modes, so that the electric connection between the fixing portion and the inner connecting layer is not influenced while the fixing effect is better.

Further, the electrode tip 31 is made of a metal material, has conductivity, has a hemispherical surface at one end, is provided with the insertion hole 312, and has a cylindrical structure with a slot at the other end, and the end of the driving member 32 away from the connecting wire 1 penetrates into the slot on the electrode tip; one end of the electrode head 31 is connected with the connecting sleeve 33, and the electrode head can rotate back and forth relative to the connecting sleeve; at least part of the inner wall of the electrode tip slot is recessed inwards to form a sliding slot 311, at least part of the outer surface of the driving element 32 extends outwards to form a sliding rod 322, and the sliding rod is just arranged in the sliding slot and can slide back and forth along the sliding slot, so that the driving element and the electrode tip are in sliding rotation-stopping fit; at least part of the inner wall of the connecting sleeve 33 extends inwards to form a driving track 331, the driving track is formed along the inner wall of the connecting sleeve in a spiral structure, at least part of the surface of the driving member 32 extends outwards to form a driving convex part 323, and the driving convex part can move back and forth along the driving track; an annular groove 332 is also provided at the end of the connecting sleeve 33 close to the electrode head 31, along which annular groove 332 the driving protrusion 323 can move.

When the operator rotates the electrode tip 31, the operator will drive the driving member 32 to rotate together, and when the driving member rotates, the driving protrusion 323 will move along the spiral driving track 331 (equivalent to thread fit), so that the driving member rotates while rotating under the fit of the driving protrusion and the driving track, and moves forward or backward, and further drives the inner connecting layer 11 to move forward or backward, so that the driving member realizes rotary extension and retraction under the drive of the electrode tip, and thus drives the inner connecting layer 11 connected with the driving member to rotate and retract; in this embodiment, the electrode tip 31 can be rotated clockwise to drive the driving member to rotate forward, and the electrode tip 31 can be rotated counterclockwise to drive the driving member to rotate backward; when the electrode tip 31 is rotated counterclockwise until the driving protrusion 323 moves into the annular groove 332, the electrode tip 31 is rotated counterclockwise, and the driving member 32 is driven to rotate counterclockwise only, so that the driving protrusion 323 rotates along the annular groove 332, and the driving member cannot move forward or backward.

Further, in order to allow the guide wire to be smoothly inserted into and removed from the insertion hole, an anti-seize structure is installed in the connection end 3, and the anti-seize structure includes an extension part 313 provided in the electrode head 31, which is opened in a ring structure, communicates with the insertion hole 312, and has an inner diameter identical to that of the insertion hole 312; in other embodiments, the extension portion may also be a tubular structure mounted on the inner wall of the insertion hole (it should be noted that, for clarity, the drawing of the drawings in the specification is specially performed with an increased structural thickness, and the actual thickness is based on actual production), a gap is left between the extension portion and the inner wall of the electrode tip, the gap is a slot, one end of the driving member 32 is placed in the slot, and the inner diameter of the driving member is equal to or slightly greater than the outer diameter of the extension portion, so that the driving member can move back and forth in the slot; the extension 313 is at least partially located within the connection sleeve 33; in other embodiments, the slot may also be a groove or a sandwich layer formed on the electrode head, the driving member 32 is installed in the sandwich layer, and the wall thickness of the portion between the inner wall of the electrode head and the sandwich layer is the anti-seize structure.

Specifically, the implanting end 2 comprises a shell 20, an implanting head 21, an anode part 23, a limiting mechanism and a breakthrough mechanism; the shell 20 is made of plastic materials and is provided with a hollow cylindrical structure, at least part of the shell is connected with the outer connecting layer 13, and the shell and the outer connecting layer are connected and fixed through glue joint or other connecting modes; the end part of the inner insulating layer 12 is abutted against one end of the shell, and the two are connected and fixed through glue joint or other connection modes; the implantation head 21 is arranged in the shell 20 and can rotate and telescope back and forth relative to the shell 20; the anode part 23 is connected with the outer connecting layer 13 to realize electric connection, the anode part 23 is arranged in a spiral structure, and one end of the anode part 23, which is far away from the shell 20, is provided with a sharp part, so that the spiral anode part can be screwed into the endocardium by rotating the whole electrode lead to realize connection and fixation with the endocardium, a connection and fixation structure is not required to be additionally arranged, the connection and fixation structure is convenient and rapid, and the anode part 23 arranged in the spiral structure is a positioning structure and is used for connecting and fixing an implantation end with organism tissues; since the present invention is a hollow electrode lead, the anode portion 23 is coated with mannitol crystals.

In other embodiments, the solid electrode lead can be designed as a solid electrode lead, and a solid electrode is implanted through the sheath, specifically, after the solid electrode lead is guided and positioned through the sheath, the electrode lead integrally extends out of the sheath, and then the anode helical head is screwed into the endocardium myocardium by about 1.8mm in a limited way (actually, the anode helical head can be adjusted as required), so that the whole electrode catheter is fixed.

Preferably, dexamethasone sodium phosphate hormone is coated on the anode part 23, so that the dexamethasone sodium phosphate hormone can be released after the anode part is contacted with the cardiac muscle, the anti-inflammatory effect is achieved, the increase of the acute phase threshold value is prevented, the impedance is reduced, the loss of capture of the anode part 23 is avoided, and the smooth implementation of cardiac pacing is ensured.

Further, the implantation head 21 includes a tip 211, a shaft 212, and an insulation part 213; the tip 211 is a sharp-pointed structure, and the sharp-pointed fingertip is in a sharp object shape, in this embodiment, the tip is a cone structure, so as to penetrate the endocardium (since the closer to the his bundle region in the ventricle, the closer to the physiological pacing site, the more developed the fibrous scaffold system, the more difficult the conventional spiral implant head penetrates, the tip of the implant head in this application is a cone, and can directly penetrate the fibrous tissue, and can penetrate the endocardium more easily), and the length of the tip is 1.8 mm; in other embodiments, the whole implant head may be in the form of a syringe needle, or other structures, as long as the implant head can penetrate the endocardium by puncturing.

Further, the shaft portion 212 is connected to the tip 211, both of which are made of a metal material, have conductivity, and are electrically connected to the inner connection layer 11; the diameter of the rod part 212 is smaller than the maximum diameter of the tip 211, and the length of the rod part extending out of the shell is 13mm (in the actual use process, the implantation head is not necessarily in the maximum extending state and can be selected according to needs, the use is more flexible, and the applicability is better), so that the implantation head can break through the endocardium and the cardiac muscle on the right ventricular septum and extend into the left bundle branch region under the left ventricular septum, and then the pacing of the left bundle branch region is realized, the pacing site of the artificial cardiac pacing is closer to the physiological pacing part, the problem of asynchrony of cardiac contraction caused by long-term right ventricular pacing, local cardiac muscle tissue structure disorder, the occurrence of heart failure and atrial fibrillation is avoided, and the effect of the artificial cardiac pacing is better; insulating part 213 parcel is in pole portion 212 outside, be made by plastic materials, its external diameter slightly is less than or equal to the maximum diameter of pointed end 211, the setting of insulating part makes implant head screw in cardiac muscle tissue in, when forming the electricity with cardiac muscle tissue and connecting, guarantee that the electric current can directly flow to predetermined pacing site and pace, avoided the electric current to flow to other tissues and lead to not pacing the condition appearance that flows back promptly, directly flow into anodal portion 23 and the condition appearance that does not flow through cardiac muscle tissue from implanting the head, guarantee the normal clear of work of pacing.

Preferably, since the thickness of the myocardium at the ventricular interval of the left bundle branch region is about 10mm, the maximum distance of penetration of the implant head 21 into the body tissue is greater than or equal to 10 mm; the longest length of the implantation head 21 in the application can extend out of the shell by 15mm, so that when the implantation head is implanted into the compartment, even if the implantation end 2 is in an inclined state, the implantation head still can be ensured to have enough length to be inserted into the left bundle branch region, the operation is more convenient for an operator, and the success rate of the operation is improved; and the ventricular septum thickness of the his bundle is less than that of the left bundle branch region, so the length of the implant head extending out of the shell can be reduced, the scope of selection is wider, and the applicability is better.

When the anode part is connected with the chamber interval of the right ventricle and the implant head is implanted into the left bundle branch region, the unipolar pacing and the bipolar pacing can be performed; when the unipolar pacing is needed, the implantation head 21 is used as a cathode, the pacemaker shell buried under the chest skin of a patient is used as an anode, current flows into the connecting end 3 from the pacemaker and then flows to the implantation head 2 through the inner connecting layer 11, after the artificial pacing of the heart is realized, the current flows back into the pacemaker shell through the body tissue of the patient, and complete current circulation is formed; when bipolar pacing is performed, the implantation head is used as a cathode, the anode part 23 is used as an anode, current flows into the connection end 3 from the pacemaker, then flows to the implantation head through the inner connection layer 11, flows into the anode ring after artificial pacing of the heart is realized, and flows to the anode ring 35 through the outer connection layer 13, so that the current flows back into the pacemaker, and complete current circulation is formed.

In other embodiments, the insulation 213 may be a medical insulation coating applied to the outer surface of the shaft 212.

Furthermore, the insulation part 213 is provided with a limiting sliding groove 214, and at least part of the surface of the limiting sliding groove 214 extends outwards to form a limiting convex part 215; the limiting mechanism comprises a first gasket 24, a second gasket 25 and a third gasket 26; the first gasket, the second gasket and the third gasket are all arranged in an annular structure, are all sleeved on the implantation head 21, are positioned in the limiting sliding groove 214 and can slide back and forth relative to the limiting sliding groove, are both made of metal materials, are made of silica gel materials or other materials with elasticity, and are positioned between the first gasket and the second gasket; a limiting groove 201 is further formed in the housing 20, and the first gasket, the second gasket and the third gasket are all embedded in the limiting groove; when the implant head 21 is accommodated in the through groove, one side of the limiting sliding groove 214 close to the tip 211 is abutted against the first gasket 24; and when implanting head department when the biggest state of stretching out, then spacing convex part 215 can be inconsistent with the second gasket, because the separation blade is to the extrusion of second gasket this moment, the third gasket can be under the effect of first separation blade and second separation blade, takes place elastic deformation toward radial direction to make the contact between third gasket and the driving medium more inseparable, play sealed effect.

Specifically, the present application further provides a breakthrough mechanism (where the breakthrough mechanism is repeated once and again, and is repeated many times) capable of repeatedly providing explosive force for the implant head 21, the breakthrough mechanism includes an elastic member 41, a locking structure and a reset structure, the elastic member utilizes its own elastic force to provide the explosive force for the implant head, in the present application, the elastic member 41 is a spring, one end of the spring is connected and fixed with the housing 20, when the implant head 21 is contracted in the housing 20, the other end of the spring is abutted against the limiting convex part 215, and the spring is in a compressed state (i.e. an elastic deformation state), the locking structure is used to keep the implant head contracted in the housing, and then the spring is kept in the compressed state (i.e. the locking structure is used to keep the elastic member in the elastic deformation state), after the locking structure is unlocked to the implant head, the implant head can be instantaneously rushed forward under the action of the spring, the endocardium is broken through and penetrated quickly by instant explosive force, so that the implantation of the implantation head is simpler and more convenient, and the implantation can be carried out smoothly; in other embodiments, the elastic element 41 may also be a metal spring or other elastic structure.

Further, the locking structure includes a locking protrusion 42, a locking post 43 and an extension post 44; the rod part 212 is provided with an installation groove, the locking column 43 is installed and fixed in the installation groove and fixedly connected with the rod part through threads, and in other embodiments, the locking column 43 and the rod part 212 can be integrally formed or connected and fixed in other manners; the extension column 44 is provided in a hollow cylindrical structure, is sleeved outside the locking column 43, and can rotate and slide back and forth relative to the locking column; the extending post 44 is provided with a through hole 441, the locking convex part 42 is installed in the through hole 441 and can slide back and forth in the through hole, and one end of the extending post close to the connecting wire 1 is fixedly connected with the inner connecting layer 11 and is also electrically connected with the inner connecting layer; a locking groove 431 and an unlocking groove 432 are formed in the locking column 43, wherein the locking groove is positioned on one side of the locking column, which is far away from the connecting line 1, and the unlocking groove is formed in the axial direction of the locking column; when implant head 21 is retracted within housing 20, one end of locking tab 42 passes through hole 441 and is positioned within locking slot 431 such that the post cannot slide relative to the locking post, thereby locking post 44 relative to locking post 43.

When the electrode tip 3 is rotated clockwise, the inner connecting layer 11 rotates and advances along with the rotation of the electrode tip 3, and then not only can drive the implant head 21 to advance, but also can drive the extension column 44 to rotate, when the extension column rotates until the locking protrusion 42 corresponds to the unlocking groove 432, the elastic force of the elastic element 41 can push the limiting protrusion 215 to instantly advance forwards, so that the tip 211 can rapidly penetrate through the fascia, and the fascia is broken through, and at the moment, the locking protrusion 42 has moved to one side of the locking column 43 close to the connecting line 1 along the unlocking groove, and meanwhile, the extension column 44 also slides to one side of the locking column 43 close to the connecting line 1 along the outer surface of the locking column 43; at this time, the electrode terminal 3 continues to rotate, and the inner connection layer 11 drives the extension post 44 to move forward while rotating.

Furthermore, when the implanted site of the implantation head is incorrect for the second time and needs to be implanted again, the elastic element 41 is compressed again to be in an elastic deformation state through the arrangement of the reset structure, so that when the implantation head is implanted again, the elastic element can provide explosive force for the implantation head again; the reset structure comprises a direction-changing groove 433, a reset track 216, a direction-changing convex part 217, a guiding convex part 218 and a rotation stopping block 219; the turning groove 433 is formed in the locking column 43 and is located on one side, close to the connecting line 1, of the locking column, and the turning groove is shallower and shallower in the counterclockwise direction; the reset track 216 is arranged on the rod part 212 and is positioned on the inner wall of the mounting groove on the rod part, and the reset track is arranged in a spiral structure; the turning convex part 217 is arranged in the mounting groove, is positioned on one side of the mounting groove, which is far away from the connecting wire 1, corresponds to the locking groove 431, and is thicker and thicker along the anticlockwise direction; two guide protrusions 218 are symmetrically and fixedly arranged on the limit protrusion 215; two rotation stopping blocks 219 are arranged, are long, are symmetrically arranged in the limiting sliding groove 214, are fixedly arranged on the shell 20, and can slide relative to the guide convex parts 218, the rotation stopping blocks 219 are arranged along the axial direction of the implant head, and the length of the guide convex parts 218 along the axial direction of the implant head is far smaller than that of the rotation stopping blocks 219; preferably, when the implant head is momentarily advanced to perform a breakthrough by the action of the breakthrough mechanism, the guide protrusion 218 is separated from the rotation stop block 219 to release the rotation stop fit therebetween, so that the implant head can rotate and advance at the same time, thereby facilitating the breakthrough of the body tissue.

When the current implantation site is not right and a new site needs to be found again, the electrode terminal 3 is rotated counterclockwise, so that the inner connection layer 11 rotates counterclockwise along with the rotation of the electrode terminal, retreats while driving the implantation head 21 to retreat together, and simultaneously drives the extension column 44 to rotate counterclockwise, at this time, the locking protrusion 42 rotates counterclockwise along with the extension column 44, and at the same time, the locking protrusion 42 moves along the direction-changing groove 433, so that the locking protrusion 42 moves along the through hole 441 under the action of the direction-changing groove 433 until one end of the locking protrusion close to the locking column 43 is flush with the inner surface of the extension column 44, and one end of the locking protrusion far from the locking column 43 extends out of the through hole 441 and into the reset track 216, at this time, the extension column 44 continues to rotate counterclockwise, the locking protrusion 42 moves along the reset track 216, and the guiding protrusion 218 contacts with the rotation stop block 219, and relatively sliding along the length direction of the rotation stopping block 219, so that the extension column 44 moves into the mounting groove, and the elastic element 41 is compressed until the locking convex part 42 moves to be in contact with the direction-changing convex part 217, and moves along the through hole 441 again under the action of the direction-changing convex part, so that one end of the locking convex part 42 close to the direction-changing convex part is gradually flush with the outer surface of the extension column 44, and one end of the locking convex part 42 far away from the direction-changing convex part 217 extends out of the through hole 441 and into the locking groove 431, so that the relative locking between the extension column 44 and the locking column 43 is realized, and the re-piercing and breaking through of a tendon film.

Preferably, the measuring part is arranged on the rod part 212, the measuring part is arranged in an annular structure and is made of a material which is not transparent to X rays, the rod part is made of a material which is transparent to X rays, the specific material type is not limited, and through the structural arrangement, an operator can visually observe the extending length of the transmission part, so that the screwing depth of the implant head can be rapidly judged, and the operation is convenient to carry out; in this embodiment, the measuring portion is a scale marked on the shaft portion 212 with a material opaque to X-rays; in other embodiments, the measuring portion may be a plurality of rings embedded on the surface of the rod portion, and the distance between two adjacent rings is 1 mm.

In other embodiments, the breakthrough mechanism may also be an external device, and the device principle similar to that of an electric drill or an electric screwdriver is adopted, and the mounting hole on the electric drill or the electric screwdriver for mounting a drill bit or a screwdriver bit is changed to be capable of realizing rotation-stopping connection with the electrode tip 31 of the electrode lead; then by starting the drill-like break-through mechanism, the electrode head 31 is driven to rotate a preset number of turns rapidly in a short time, thereby achieving the purpose that the implant head 21 can rapidly plunge and penetrate the endocardium in a short time; this approach is applicable not only to the implant head of the present application, but also to conventional helical head electrode leads.

The principle of the electric drill and the electric screwdriver is the prior art, and therefore, the details are not described herein; the mounting hole is changed to be connected with the electrode tip in a rotation stopping manner, so that the simple adaptive deformation is realized, and no technical difficulty exists, so that the repeated description is omitted in the application.

Example 2:

as shown in fig. 18-20, the implanting end further includes a plurality of sets of positioning structures disposed at the end of the housing 20, the positioning structures including a sliding groove 271, a secondary implanting head 272, a radial hole 273, a radial locking head 274, a position-limiting locking head 275, and a position-limiting hole 276; a plurality of sliding grooves 271 are uniformly arranged at the end of the casing 20, and abdicating grooves are arranged on the side wall of the sliding grooves 271 along the radial direction of the casing 20 and penetrate through the side wall of the casing 20; the auxiliary implantation head 272 is slidably arranged in the sliding groove 271 and has a hollow cylindrical structure; two radial holes 273 are formed in the secondary implant head 272 along the length direction of the secondary implant head 272, and the openings are arranged along the radial direction of the shell 20; the radial lock head 274 can be slidably arranged in the radial hole 273 on one side far away from the connecting line 1, at least part of the radial lock head is positioned in the shell, the part positioned in the shell is arranged in a spherical structure, one side of the spherical body far away from the connecting line 1 is provided with a knife edge-shaped structure which is equivalent to a blade and can cut myocardial tissues, and the implantation of the auxiliary implantation head is facilitated; the part of the radial lock head 274 positioned in the auxiliary implantation head is provided with a convex column and a return spring, one side of the return spring is clamped with the convex column, and the other end of the return spring is abutted against the inner wall of the auxiliary implantation head; the limiting lock head 275 can be slidably arranged in a radial hole 273 at the tail end (the side close to the connecting line 1) of the auxiliary implanting head 272, both ends are arc-shaped, and the sliding friction between the limiting lock head and the outer connecting layer 13 can be reduced in the movement process; the limiting hole 276 is opened on the outer connecting layer 13 and can be matched with a radial locking head 274 at the tail end of the auxiliary implanting head 272, and the limiting hole is limited after the auxiliary implanting head 272 slides to a set position.

In the forward process of the implantation head 21, the tip 211 is abutted against the limit lock head 275, the auxiliary implantation head 272 is pushed by the limit lock head 275 to rapidly penetrate through fascia and enter myocardial tissues, when the limit lock head 275 moves to a position opposite to the position of the limit hole 276, under the action of the pressure of the tip 211, at least part of the limit lock head 275 enters the limit hole 276, the relative position of the auxiliary implantation head 272 and the outer connecting layer 13 is locked, the auxiliary implantation head 272 stops forward, the auxiliary implantation head 272 is implanted into the myocardial tissues more earlier to play a role in guiding the forward movement of the subsequent tip 211, the movement precision of the implantation head 21 is improved, and the preset position is ensured to be reached; the tip 211 advances relative to the auxiliary implantation head 272, and after colliding with the radial locking head 274, the radial locking head 274 can enter the myocardial tissue along the radial direction of the implantation head, when the implantation head is positioned in the myocardial tissue, the outer insulation layer 14 always keeps the pressure on the radial locking head 274, the relative position with the myocardial tissue is locked, a connection and fixation structure is not needed to be additionally arranged, the connection and fixation with the myocardial tissue are realized, the implantation head is difficult to withdraw from the body tissue, and the purpose of fixing the implantation head is achieved.

In the process that the implant head exits from the myocardial tissue, after the positions of the implant head 21 and the radial lock head 274 are staggered, the radial lock head 274 returns to the initial position under the action of the reset spring, exits from the myocardial tissue and releases radial locking, after the tip 211 exits into the shell 20, the limit lock head 275 exits from the limit hole 276 under the action of the reset spring, the auxiliary implant head 272 can exit into the sliding groove 271 again, and the auxiliary implant head can be pushed into the sliding groove 271 by abutting the auxiliary implant head against the wall of the ventricle when the next implantation is carried out; in other embodiments, the tail end of the secondary implantation head can be connected with the bottom wall of the sliding groove through a return spring, and the secondary implantation head is pulled back into the sliding groove by the return spring so as to facilitate the next implantation operation.

The other structure and the movement process are the same as those of embodiment 1.

It is to be understood that the described embodiments are merely a few embodiments of the invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Claims

1. An electrode lead comprises a connecting wire (1), an implanting end (2) arranged at one end of the connecting wire (1) and a connecting end (3) arranged at the other end of the connecting wire (1); the method is characterized in that: the implantation end (2) comprises

A housing (20);

an implant head (21) which can move back and forth;

the implantation head (21) can penetrate into body tissue along a straight or nearly straight trajectory.

2. The electrode lead according to claim 1, wherein: the implantation head (21) comprises a rod part (212) and a tip (211) arranged on the rod part (212), wherein the tip is arranged in a sharp-pointed structure.

3. The electrode lead according to claim 1, wherein: the implantation head (21) is at least partially implantable in the region of the left bundle branch.

4. The electrode lead according to claim 3, wherein: the maximum distance of the implantation head (21) penetrating into organism tissues is more than or equal to 10 mm.

5. The electrode lead according to claim 1, wherein: the implantation device also comprises a positioning structure for realizing the connection and fixation between the implantation end (2) and the organism tissue.

6. The electrode lead according to claim 5, wherein: the positioning structure comprises an anode part (23) which is arranged in a spiral structure and a sharp part which is arranged on the anode part (23).

7. The electrode lead according to claim 5, wherein: the positioning structure comprises a secondary implant head (272) which can penetrate into the body tissue at least partially and a radial lock head (274) for realizing the anti-disengagement between the secondary implant head (272) and the body tissue.

8. The electrode lead according to any one of claims 1 to 7, wherein: also included is a breaching mechanism that can repeatedly provide a burst force to the implant head (21).

9. The electrode lead according to claim 8, wherein: the breaking mechanism comprises an elastic piece (41) used for providing explosive force for the implantation head (21), a locking structure used for keeping the elastic piece (41) in an elastic deformation state, and a resetting structure used for enabling the elastic piece (41) to recover the elastic deformation state.

10. The electrode lead according to claim 9, wherein: the locking structure comprises a locking column (43) connected with the implantation head (21), an extension column (44) capable of moving back and forth relative to the locking column (43), and a locking convex part (42) used for realizing relative rest between the extension column (44) and the locking column (43); or the reset structure comprises a direction-changing groove (433) for driving the locking convex part (42) to move and a reset track (216) matched with the locking convex part (42).