CN208599000U - A kind of bipolar electrode sub-assembly and stimulating system - Google Patents

Abstract

The utility model relates to medical instruments fields, disclose a kind of bipolar electrode sub-assembly and a kind of stimulating system, it is intended to organize and reduce tissue reaction, polarization impedance for stimulating deep tissue, at controllable sexual stimulus two.Bipolar electrode sub-assembly includes screw sample electrode or fusiform electrode and spiral sample electrode；Bipolar electrode sub-assembly, stimulus generator and wire body constitute a kind of stimulating system.The stimulus generator includes pulse-pair output circuit when heart (is used in referred to as " double-core " pacemaker), provides a kind of new stimulation mode and replaces and provides contrary electric pulse.The utility model is preferably used for cardiac septum, implements cardiac synchronousization treatment；There is provided two kinds of completely new cardiac synchronous modes: one is provide Ventricular electric stimulation pulse respectively to control the activity of biventricular electromechanical；Another kind is cardiac muscle between stimulation interventricular septum inner cathode anode, and excitement is made to expand cloth to biventricular by interventricular septum.

Description

A kind of bipolar electrode sub-assembly and stimulating system

Technical field

The utility model relates to medical instruments fields, and in particular, to a kind of bipolar electrode sub-assembly and stimulating system.

Background technique

Existing cardiac synchronousization treats double-ventricle pacemaker system cost valuableness used by (CRT) method and curative effect is far not It is enough satisfied.First, the crowd 30-40% patient treatment recommended according to existing Medical guidelines is reactionless；Second, the left ventricle external membrane of heart When stimulation, pacing threshold is high, electric energy is exhausted fastly, still easily leads to malignant arrhythmia；Third, right ventricular apical, outside Basal part Epicardial pacing is contrary to normal physiological depolarization sequence, needs to improve.In addition, this method needs to put left ventricular electrode It is placed in coronary sinus vein system, cumbersome and be easy to happen loose electrode placement, some cases are because dissection reason can not successfully pacify Setting leads to operative failure.

In recent years, the global evolution new method of a variety of left ventricular pacings, it is predominantly three kinds following: 1) left ventricle multiple location Pace-making, defect are that electric energy is exhausted faster and there is still a need for transexocardial pace-makings；2) endocardium of left ventricle paces, and defect is to need Atrial septum is punctured, operation risk is increased, because needing that electrode is implanted into left ventricle lining endothelium by mitral orifice, influences two points Valve function, while increasing left ventricle lateral thrombus complication；3) it is paced by Xi Shi (his) beam or his beam, defect is to need Mapping his beam, pace-making vector threshold value is high, and battery life significantly shortens, and the stability paced for a long time is uncertain, it is necessary to place ventricle Backup electrode, and his beam distal section is blocked in vain.

At present in practical operation level, the method for pacing left ventricle is still mainly the external membrane of heart through coronary sinus vein path Pace-making.

For example, in order to stimulate left ventricle, passing through coronary sinus vein by conduit disclosed in Chinese patent CN101238996A And enter connection side shoot, so that electrode is fixed on connection side shoot.

For another example, disclosed in Chinese patent CN104220130A, in order to pace heart, design has three leads, and atrium dextrum is drawn Line enters the atrium dextrum of heart by vein, and right ventricular lead enters right ventricle by vein and atrium dextrum, and left ventricle lead is logical It crosses vein and atrium dextrum and enters coronary sinus vein, reach the region adjacent with the free wall of left ventricle.

For another example, Chinese patent CN10599950A, which is directed to, does not allow to be fixed easily along coronary sinus vein pedicle screw sample electrode Defect, and the solution that a kind of active proposed is fixed.

In conclusion the implantation of left ventricular electrode is mostly the coronary sinus vein external membrane of heart path of heart at present, no It is easy to appear the free movement of electrode, pacing threshold height, QT interval prolongation and rush after larger, implantation in the presence of implantation difficulty avoidablely Send out the number of drawbacks such as malignant arrhythmia.

In view of this, how to be further improved the technology of left ventricular pacing to overcome lacking for above-mentioned cardiac synchronousization treatment It falls into, becomes this field technical problem urgently to be resolved.

Utility model content

The purpose of this utility model is to provide a kind of bipolar electrode sub-assembly and stimulating systems, it is critical that double thorns The improvement of boost pulse mode is provided in the design and stimulus generator that swash electrode, so as at the controllable sexual stimulus depth two or more Locate tissue and reduces tissue reactive；It, which can be used, provides two kinds of completely new Ventriculars synchronization modes in heart, can Biventricular synchronization therapy effect is improved, while reducing polarization impedance, reduces stimulus threshold, extends the stimulus generator service life.

The technical solution that the utility model is taken first is that:

A kind of bipolar electrode sub-assembly, it is characterised in that it includes the first electrode and the second electricity using conductive material production Pole, the first electrode are in the shape of a rod comprising top, middle part and bottom end are equipped in the top end and pierce for direct energy Swash deep tissue and play the piercing structure of fixed function, the bottom end is equipped with fixing piece；The second electrode is spiral sample Electrode, and its periphery for being wrapped in the first electrode, one end of second electrode are fixed by fixing piece, the other end is towards the The top orientation of one electrode extends.

Preferably, the first electrode is screw sample electrode or fusiform electrode, and when being screw sample electrode, first electrode The piercing structure on top is tapping screw spline structure.When for fusiform electrode, the piercing structure on first electrode top is fusiform Piercing structure.Further, the top of the screw sample electrode includes the sharp piercing face of end face and/or is formed in described The threaded portion in top periphery face, the hand of spiral of the threaded portion are dextrorotation or left-handed.The screw sample electrode head end is designed to The benefit of screw sample is to provide onward impulse for electrode；Direction of advance has controllability；There is provided electrode the contact bigger with cardiac muscle Area prevents electrode back off moreover it is possible to play fixed function.

Preferably, the middle part of the first electrode and the outer peripheral surface of bottom end are coated with insulation material layer, the insulation Material layer is used for slow release drug；The bottom end connects first lead.The middle part of first electrode has certain length and cuts Area reduces, and is conducive to stimulate deep tissue and completely cuts off irrelevant electro photoluminescence region.

Preferably, the first electrode outer surface is provided with the first score structure for carrying medicine, the first indentation knot Structure is slot and/or hole；Further, the surface of first score structure is covered with the polymeric membrane made of degradation material. This be in order to electrode can after going deep into tissue drug-carrying, and make that drug is long-term, slow release, action time prolongs enough It is long.These drugs include the anti-inflammatory drug such as dexamethasone of anti-tissue reaction, and can also carry to have improves tissue cell biology The drug of characteristic or the drug for playing therapeutic effect.

Preferably, the outer peripheral surface fixation of the bottom end of the first electrode is coated with the fixing piece being made of plastic layer, institute The end for stating fixing piece towards the top orientation is embedded with the medicine controlled releasing part of the middle part setting around the first electrode. The medicine controlled releasing part carries drug to the stability and other therapeutic effects for improving stimulation parameter.

Preferably, be to be provided with external thread structure on the fixing piece outer peripheral surface convenient for being sent the screw sample electrode, The external thread structure is preferably trapezoidal thread.The hand of spiral of the external thread structure is dextrorotation or left-handed simultaneously.

Preferably, the fixing piece end face adjacent with first electrode bottom end is provided with the first marker, described first Marker is made of radiopaque material, and first marker is annular element.Electrode is facilitated deciding in this way enters tissue Depth.

Preferably, the spiral sample electrode is electrically insulated relative to the first electrode, and the spiral sample electrode edge The development length of axial direction is shorter than the length of the first electrode.Further, the spiral sample electrode include basic part and Helical member, the basic part are fixed on the fixing piece；The helical member is since the basic part and towards first electrode Top orientation and extend forward around the central axis spiral of first electrode.The hand of spiral of the helical member and the spiral shell The hand of spiral for following closely sample electrode thread portion is consistent.

Preferably, the surface of the helical member is provided with the second score structure for carrying medicine, second score structure For slot and/or hole；Second score structure carries medicine rear surface and is covered with the polymeric membrane made of degradation material, is conducive to take Band drug simultaneously makes drug play a role for a long time, slowly.

The of the first electrode bottom end is stretched out in preferably, being connected on the spiral sample electrode from the fixing piece Two leads.

Bipolar electrode sub-assembly provided by the utility model has the advantages that compared with existing electrode

Bipolar electrode is fixed as inner core entirety, bipolar electrode through plastic fixtures by bipolar electrode sub-assembly provided by the utility model It is common to retreat, the effect of there is short transverse controllability, still prevent screw sample electrode from excessively going deep into tissue.

Most of existing active fixation electrode is designed to spiral sample or electrode is on the basis of traditional screw electrode Upper lengthening is made, in order to stimulate deep tissue, but it is dramatically different with tapping screw sample electrode provided by the utility model.It is involved And the screw electrode lengthened, it is difficult to control direction of advance, drug cannot be carried.Also have by electrode design be it is acicular, equally with Screw sample electrode provided by the utility model is dramatically different, does not have autonomous offer onward impulse and fixed function, does not also have Carry pharmic function.

The bipolar electrode sub-assembly simultaneously, as one kind, it is preferable to use be used in interventricular septum to implement cardiac synchronousization treatment. With it is traditional by the left ventricular electrode in coronary sinus vein path compared with, screw sample electrode provided by the utility model pass through room between Left ventricle is paced every path, Epicardial pacing and direct left ventricular cavity endocardial pacing bring complication can not only be avoided, And pace-making sequence is closer physiology (normal ventricle depolarization starts from 1/3 left side in interventricular septum), because using pace-making in cardiac muscle, Pacing threshold is low, and pacing parameter at a specified future date is more stable.

Bipolar electrode sub-assembly provided by the utility model, which does not limit to, is used in cardiac septum, and application range includes any Need the position of electro photoluminescence and/or perception such as: atrium, ventricle, atrioventricular septum, or other heart external structures are such as: brain, blood Pipe, peripheral nerve etc..

Bipolar electrode sub-assembly when in use, the screw sample electrode and the spiral sample electrode separately as stimulation, and/or Perception and/or defibrillating function use, and other any position electrodes can also be cooperateed with as stimulation, and/or perception and/or defibrillation Function uses.When in special circumstances, such as complete left bundle branch block, right ventricular electrode, which can be not used in, provides electro photoluminescence arteries and veins Punching, and play fixed function or/and perceptional function or/and defibrillating function or/and diagnostic function.

The technical solution that the utility model is taken second is that:

A kind of stimulating system comprising above-mentioned bipolar electrode sub-assembly and wire body and stimulus generator.Wherein conducting wire Body and stimulus generator can use existing wire body and stimulus generator.

This case is preferred, and the wire body includes wire body inside conductor layer and wire body outer conductor layer；In the wire body Conductor layer includes the first lead, the second lead and insulating materials；The wire body outer conductor layer includes annular electrode and ring The third lead and insulating materials that shape electrode is connected；Phase between the annular electrode and the first electrode and second electrode Mutually insulation, the first lead, the second lead and third lead are respectively connected to the pulse output end of stimulus generator；As excellent It selects, is provided with the second marker at the wire body outer conductor layer port, which is made of radiopaque material； The wire body outer conductor layer is provided with third marker in the position adjacent with the port, and the third marker is by impermeable The material of x-ray is made；Second marker and the third marker are annular element；Wherein: being led described in being stretched out first During wire body outer conductor layer, first marker is no more than the third marker.Preferably, it is led outside the wire body The distal end of line layer is equipped with internal thread structure, crest, tooth bottom and the external screw thread on the outer peripheral surface of the fixing piece of the internal thread structure The tooth bottom of structure, crest are tangent；And the hand of spiral one of the hand of spiral of the internal thread structure and the external thread structure It causes；The threaded portion on top of the screw sample electrode, the helical member of the external screw thread of bottom end and the spiral sample electrode and described The hand of spiral of the internal thread structure of wire body outer conductor layer is consistent；The bipolar electrode sub-assembly it is removable by fixing piece and It is rotatablely arranged in the distal chamber of the wire body outer conductor layer.

Preferably, stimulus generator provided by the utility model includes: double pulse generator, referred to as " double-core " stimulation is sent out Raw device is referred to as " double-core " pacemaker when being used in heart；It includes two or more impulse output circuits and extremely Few one perception control circuit.The stimulus generator alternately can provide contrary impulse stimulation electric current, equivalent It can be with alternate change in cathode and anode polarity.The component connection circuit of the stimulus generator includes pulse-pair output electricity The connection circuit of any mode on road.

Special instruction, stimulus generator provided by the utility model and Patent No. US4402322-A, Stimulus generator provided by JP2001190695-A with US6341235 B1 is different.Patent No. US4402322-A, The generated electricity pulse of stimulus generator provided by JP2001190695-A and US6341235 B1 is by two phase wave (two-phase Or biphase) the single boost pulse that constitutes, the first phase and the second phase wave form, wave amplitude, time is different.And this reality Send out impulse stimulation each with novel stimulus generator and be single-phase rectangular wave, when alternate change shows as two single and directions Different boost pulses, pulse duration, amplitude are adjustable.

Preferably, the stimulating system provides two kinds of electrical stimulus patterns: a kind of electrical stimulus patterns are by described the One electrode and the second electrode provide tissue at the electric stimulation pulse stimulation two of identical or different property respectively；Another electricity thorn Sharp mode is to provide electric pulse stimulation using the first electrode and the second electrode as one in anode and cathode One section of tissue between cathode and anode.

Stimulating system provided by the utility model has the advantage that compared with prior art

Stimulus generator provided by the utility model alternately can provide contrary pulse current, this is that this is practical new The new electric stimulation pulse mode of one kind that type provides.It is compared with one direction boost pulse, the thorn of this checker pulse direction The histio-irritative reactivity of institute can be greatly reduced by swashing, and reduced tissue polarity current potential and polarization impedance, reduced stimulus threshold, together When facilitate implement stimulus generator threshold value autocapture function, make the stimulus generator service life extend.

The utility model also provides two kinds of completely new Ventriculars and synchronizes mode.By screw sample electrode and spiral sample electricity Pole is placed in cardiac muscle at left and right sides of interventricular septum, screw sample electrode as left ventricular electrode, spiral sample electrode as right ventricular electrode, Electrode cable is connected with pacemaker.A kind of synchronization mode is: screw sample electrode and spiral sample electrode are used as cathode, together When, annular electrode or pacemaker shell provide Ventricular electric stimulation pulse by pacemaker sequencing as anode respectively, To control biventricular electricity, mechanical activity；Another synchronization mode is: any one of screw sample electrode and spiral sample electrode are made For cathode, while another as anode, pacemaker sequencing is provided boost pulse, is made between interventricular septum inner cathode and anode Electric depolarization activity occurs for segment cardiac muscle, includes the ventricular muscle cell, bundle branch and Purkinje of volume within the scope of the interventricular septum of pace-making Fiber system can so search out an optimal pacing threshold, and electrical activity is expanded rapidly to cloth to double by pace-making interventricular septum Ventricle realizes left and right ventricles electromechanical active synchronization.

Detailed description of the invention

Attached drawing is to be used to provide a further understanding of the present invention, and constitute part of specification, and following Specific embodiment be used to explain the utility model together, but do not constitute limitations of the present invention.

Fig. 1 is a kind of structural schematic diagram of embodiment of the utility model screw sample electrode.

Fig. 2 is the cross-sectional view of the structure of the utility model screw sample electrode.

Fig. 3 is schematic diagram of the screw sample electrode bottom end in conjunction with fixing piece in the utility model.

Fig. 4 is the schematic diagram that spiral sample electrode is connect with fixing piece in the utility model.

Fig. 5 is another embodiment (fusiform electrode) structural schematic diagram of one of bipolar electrode sub-assembly electrode.

Fig. 6 is bipolar electrode sub-assembly and wire body attachment structure schematic diagram in the utility model.

Fig. 7 is a kind of " double-core " stimulus generator working mode figure provided by the utility model.

Fig. 8 is the wiring system structural schematic diagram of the utility model.

Fig. 9 is the schematic diagram of the wiring system implantation heart of the utility model.

Figure 10 is the state diagram of the electrode implantation heart of the utility model.

Description of symbols: 10- first electrode, the top 101-, the bottom end 102-, 103- middle part, 104- are pierced into face, 105- First score structure, the threaded portion 106-, 107- first lead, 108- external thread structure, the first marker of 109-, 110- insulation material The bed of material, 111- fixing piece, 112- medicine controlled releasing part, 20- second electrode (spiral sample electrode), 201- basic part, 202- helical member, The second score structure of 203-, the second lead of 204-, 30- wire body inside conductor layer, 40- annular electrode, 401- third lead, 50- Stimulus generator connector, 501- screw sample electrode access interface, 502- spiral sample electrode access interface, the access of 503- annular electrode Port, 60- wire body outer conductor layer, 601- internal thread structure, the second marker of 602-, 603- third marker, the right heart of 70- Room pacing electrode.

Specific embodiment

The utility model is described in detail in the following with reference to the drawings and specific embodiments.

Embodiment one.

The utility model first aspect provides a kind of bipolar electrode sub-assembly comprising using the first of conductive material production Electrode 10 and second electrode 20, the first electrode 10 are in the shape of a rod comprising top 101, middle part 103 and bottom end 102, in institute State the piercing structure that fixed function is equipped with for direct energy stimulation deep tissue and played at top 101, the bottom end 102 Place is equipped with fixing piece 111；The second electrode 20 is spiral sample electrode, and its periphery for being wrapped in the first electrode 10, One end of second electrode 20 is fixed by fixing piece 111, and the other end extends towards 101 direction of the top of first electrode 10.

As the preferred of the present embodiment, above-mentioned first electrode 10 is preferably screw sample electrode or fusiform electrode.

Wherein, screw sample electrode 10, including the body of rod 10 being made of an electrically conducting material, which includes top 101, bottom end 102 and the middle part 103 between the top 101 and bottom end 102, the top 101 of the body of rod 10 forms spinosity Enter structure, as shown in Figure 1.

For the ease of the screw sample electrode 10 position deep tissue, the length of the body of rod 10 be preferably 3mm extremely 18mm, more preferably 7mm are to 11mm.

The outer surface of the screw sample electrode 10 is provided with the first score structure 104 for carrying medicine, the first indentation knot Structure 104 is preferably slot and/or hole, preferably carries medicine rear surface in the score structure and is covered with made of degradation material Polymeric membrane.

The screw sample electrode 10 includes the sharp circular conical surface 105 either formation for being formed in 101 end face of top It also may include the sharp circular conical surface for being formed in 101 end face of top in the threaded portion 106 of 101 outer peripheral surface of top 105 and it is formed in the threaded portion 106 of 101 outer peripheral surface of top.

In order to keep the performance of the screw sample electrode 10 more superior, preferably, the geometric parameters of the screw sample electrode 10 Number meets at least one in following condition:

The screw pitch p of the threaded portion 106 is 0.2mm to 0.8mm, preferably 0.3mm to 0.5mm；

The Major Diam d of the threaded portion 106 is 0.6mm to 2.0mm, preferably 1mm to 1.2mm；

The diameter of thread d of the threaded portion 106₁For 0.3mm to 1.6mm, preferably 0.5mm to 0.6mm；

The sum of the length of the threaded portion 106 and the circular conical surface 105 l is 1mm to 6mm, preferably 1.5mm to 2.5mm.

Among the above, the diameter of thread d of the threaded portion 106₁More than or equal to the outer diameter of the middle part 103 of the body of rod 10 C, outer diameter c are preferably 0.2mm to 2.0mm, more preferably 0.4mm to 0.6mm.

In order to ensure being electrically insulated with other electrodes and/or its hetero-organization, the utility model is also in the centre of the body of rod 10 The outer peripheral surface of portion 103 and bottom end 102 coats insulating materials, in addition, being also connected with first lead 107 in the bottom end 102.Its In, the insulating materials can be polyurethane.

Preferably, the outer peripheral surface of the middle part 103 of the body of rod 10 is coated with insulation material layer 110, the insulating materials The thickness of layer 110 is preferably 0.02mm to 0.2mm.The outer peripheral surface fixation of the bottom end 102 of the body of rod 10 is coated with fixing piece 111, wherein the fixing piece 111 is 2mm to 10mm with a thickness of 0.5mm to 2.0mm, the length b of the plastic layer 111, Preferably 4mm to 5mm；And/or the end towards the top 101 of the fixing piece 111 is embedded with around the body of rod 10 Medicine controlled releasing part 112, as shown in Figure 2.

Preferably, the fixing piece 111 towards 10 top of the body of rod end face apart from 10 head end of the body of rod away from From about 8.0mm.

For the ease of being sent the screw sample electrode 10, external thread structure is provided on the outer peripheral surface of the fixing piece 111 108, which is preferably trapezoidal thread, as shown in Figure 3.

Wherein, the outer diameter h of the external thread structure 108 be preferably 1.5mm to 2.5mm, more preferably 1.8mm extremely 2.0mm, the screw pitch e of the external thread structure 108 are preferably 1.0mm to 1.5mm, more preferably 1.1mm to 1.4mm.

In addition, the end face adjacent with 10 bottom end of the body of rod of the insulating materials is provided with the first marker 109, this One marker 109 is made of radiopaque material.Preferably, first marker 109 is formed as annular element.

As another preferred embodiment, the fusiform electrode is that band is made in conductive material when first electrode uses fusiform electrode There is fusoid piercing structure；The outer surface of fusiform electrode is provided with the score structure for carrying medicine, and the score structure is preferred For slot and/or hole, as shown in Figure 5.

In the present embodiment, second electrode is spiral sample electrode 20.The spiral sample electrode 20 is made of an electrically conducting material, fixed In the fixing piece 111, and towards 101 direction of the top of the body of rod 10 extend, the spiral sample electrode 20 relative to The screw sample electrode 10 is electrically insulated, and the development length of the spiral sample electrode 20 in axial direction is shorter than the body of rod 10 Length.

The utility model, can by the way that the screw sample electrode 10 and the spiral sample electrode 20 are designed to inner core entirety Convenient for fixing and making bipolar electrode is synchronous to retreat, moreover it is possible to limit screw sample electrode 10 and excessively go deep into tissue, be pierced by left ventricular cavity.

Among the above, the development length f of the spiral sample electrode 20 in axial direction is preferably 1mm to 5mm, more preferably 1.5mm to 2.5mm.

For the structure of the spiral sample electrode 20, a kind of embodiment according to the present utility model, specifically, the spiral shell Revolving sample electrode 20 includes basic part 201 and needle-like piece 202, and the basic part 201 is fixed on the fixing piece 111, described needle-shaped Central axis of the part 202 from the basic part 201 towards the top of the body of rod 10 around the body of rod 10 spirally extends, with Enter and be fixed to cardiac muscular tissue convenient for riveting, as shown in figs. 4 and 6.

In order to enable the pacing parameter at a specified future date of the spiral sample electrode 20 is more stable, the utility model is also in the spiral Be provided with the second score structure 203 for carrying medicine on the outer surface of part 202, second score structure 203 be preferably slot and/ Or hole, preferably described second score structure carry medicine rear surface and are covered with the polymeric membrane made of degradation material；And/or it is described Platinum black coating is covered on the outer surface of needle-like piece 202.

In addition, the spiral sample electrode 20 is also connected with the bottom end 102 for stretching out in the body of rod 10 from the fixing piece 111 The second lead 204.

In the present invention, the bottom end 102 of the body of rod 10 be fixedly connected be made from a material that be electrically non-conductive it is elongated Core, i.e. wire body inside conductor layer 30, the first lead 107 and the second lead 204 it is insulated from each other be fixedly installed on it is described Extend on core and along the core, as shown in Figure 6.

Embodiment two.

The utility model second aspect provides a kind of stimulus generator.The stimulus generator includes double pulse generator connection Operating mode, referred to as " double-core " stimulus generator are closed, is referred to as " double-core " pacemaker when being used in heart；And/or multiple-pulse hair Raw device (≤3 impulse generator) associated working mode, referred to as " multicore " stimulus generator, it is used in referred to as " more when heart Core " pacemaker；The feature of the stimulus generator includes: that can alternately provide contrary pulse current, i.e. alternating polarity Property transformation provide boost pulse.

The stimulus generator further include: 2 or 2 or more impulse circuits, as shown in Figure 7.

The connection circuit of component included by stimulus generator provided by the utility model should not only understand shown in Fig. 7, answer This be interpreted as include any mode of double pulse generator or multipulse generator connection circuit.

Stimulus generator provided by the utility model is alternately provided contrary electric pulse and is meant: being spaced certain or not Deng after number or interval be certain or time not etc., provide the electric pulse of different directions.

The sent out impulse stimulation of the stimulus generator be it is single-phase, shown as when feature includes alternate change direction difference.

The number of electrodes for the granting impulse stimulation being connected with stimulus generator/described in the utility model or pacemaker, no 2 should be only interpreted as, should include multiple (≤3 electrodes), multiple electrodes can be derived from electrode 10 and/or counter electrode 20, Realize multipole (≤3 electrode) reversal pace-making, as shown in Figure 7.

" double-core " stimulus generator or pacemaker provided by the utility model, function should not be understood merely as providing stimulation Pulse should also include: perceptional function, diagnostic function and defibrillating function.

The new electric stimulation pulse mode of one kind provided by the utility model and/or " double-core " stimulus generator/rise It fights device: as one kind it is preferable to use in heart, but being not limited to heart, it is understood that be applicable in outside any heart and need electro photoluminescence And/or the tissue of perception, such as: blood vessel, brain and peripheral nerve.

Embodiment three.

The utility model third aspect provides a kind of stimulating system, comprising: bipolar electrode sub-assembly and wire body and thorn Swash generator, wherein bipolar electrode sub-assembly, stimulus generator are provided by the utility model first aspect, second aspect.

The wire body includes wire body inside conductor layer (30) and wire body outer conductor layer (60).The wire body inside conductor Layer 30 includes the first lead 107, second lead 204 and insulating materials, as shown in Figure 6 and Figure 8.Outside the wire body The third lead (401) and insulating materials that conductor layer 60 includes annular electrode (40), is connected with annular electrode (40).It is described Annular electrode 40, the screw sample electrode and 20 mutually insulated of spiral sample electrode.

It is provided with internal thread structure 601 on the inner peripheral surface of the 60 distal end outer section of wire body outer conductor layer, in order to more Power, preferably trapezoidal thread are transmitted well.The crest of the internal screw thread 601, tooth bottom and 10 bottom end of screw sample electrode external screw thread 108 tooth bottom, crest are tangent.Preferably, the external screw thread of the hand of spiral of the internal thread structure 601 and 10 bottom end of screw sample electrode The hand of spiral of 108 structures is consistent.By rotating the external thread structure 108 and internal thread structure 601, the screw can be made Sample electrode 10 and spiral sample electrode 20 move forward or back as a whole.

For the stimulating system when providing electric stimulation pulse, there are four types of the combinations of polarity of electrode: the annular electrode 40 be anode, and the screw sample electrode 10 and the spiral sample electrode 20 are cathode；The annular electrode 40 is cathode, institute It states screw sample electrode 10 and the spiral sample electrode 20 is anode；The screw sample electrode 10 is cathode, the spiral sample electrode 20 be anode；The screw sample electrode 10 is anode, and the spiral sample electrode 20 is cathode；Or 10 He of screw sample electrode The alternating polarity of spiral sample electrode 20 exchanges.

For the ease of understanding the position of electrode, the adjacent end face setting in the bottom end 102 of the screw sample electrode 10 under x-ray There is the first marker 109, which is made of radiopaque material；The wire body outer conductor layer 60 is being held It is provided with the second marker 602 at mouthful, which is made of radiopaque material；The wire body outer conductor layer 60 are provided with third marker 603 in the position adjacent with the port, and the third marker 603 is by not radiotransparent material system At.Wherein, during the screw sample electrode 10 stretches out in wire body outer conductor layer 60, first marker 109 are no more than the third marker 603.For example, when first marker 109 is overlapped with the third marker 603, The bottom end of the spiral sample electrode 20 flushes or closely with the port of the wire body outer conductor layer 60.Preferably, institute Stating the first marker 109, the second marker 602 and third marker 603 is annular element.

As a preference, the electric stimulation is used in cardiac septum, cardiac synchronousization treatment is implemented.This is practical new Type provides two kinds of completely new Ventriculars and synchronizes mode.

Screw sample electrode 10 and spiral sample electrode 20 are placed in cardiac muscle at left and right sides of interventricular septum, connected with stimulus generator It connects.Two kinds of new ways can be used and realize that Ventricular synchronizes pace-making: one is: screw sample electrode 10 and spiral sample electricity Pole 20 is used as cathode, meanwhile, annular electrode 40 or stimulus generator shell are provided as anode by stimulus generator respectively Ventricular electric pulse controls the activity of biventricular electromechanical；Another kind is: screw sample electrode 10 and spiral sample electrode 20 are any One is used as cathode, while another as anode, electric pulse is provided in stimulus generator sequencing makes interventricular septum cathode and anode Between segment cardiac muscle electric depolarization occurs, include that the ventricular muscle cell, bundle branch and Pu of volume is agreed within the scope of the interventricular septum of pace-making Wild fiber system can search out an optimal pacing threshold, and electrical activity is expanded rapidly cloth to biventricular, reality by interventricular septum Existing left and right ventricles electromechanical active synchronization.

In short, compared with traditional CRT system, due to using in cardiac muscle and/or endocardial electrode stimulates, Neng Gouxian It writes and lowers pacing threshold, so that pacing parameter at a specified future date is more stable, electric shock is dynamic sequentially closer to physiology, stimulus generator or pacemaker Energy consumption is reduced, final to extend stimulus generator or life span.

It elaborates below to the method for implantation of the utility model wiring system:

As shown in figure 9, under X-ray examination, through venous system, it is inserted into the wiring system to the interventricular septum face of right ventricle, 45 ° of position x-rays of left front oblique are thrown shine under, row left ventricle chambers of the heart radiography guides, rotary wire system, by screw sample electrode 10 towards a left side Ventricular section precession is to interventricular septum.When 10 distal end of screw sample electrode is concordant with second marker 602, screw sample electricity is indicated Pole 10 will screw in cardiac muscular tissue, continue rotary wire system, when first marker 109 and third marker 603 are overlapped, Then the spiral sample electrode 20 is completely into right ventricle interventricular septum side, while the screw sample electrode 10 is fully advanced to left ventricle Under inner membrance, as shown in Figure 10；Fixed and detecting electrode parameter connects cardiac stimulation generator or pacemaker, skin suture.Thus Biventricular synchronous pacing can be realized by an electrode wires.

The basic principles and main features and advantage of the utility model have been shown and described above.The ordinary skill of this field Personnel are not it should be appreciated that above-described embodiment limits the protection scope of the utility model, all use equivalent replacements etc. in any form Mode technical solution obtained, falls in the protection scope of the utility model.

The parts not involved in the utility model is the same as those in the prior art or can be realized by using the prior art.

Claims (20)

1. a kind of bipolar electrode sub-assembly, it is characterised in that it includes the first electrode (10) and the second electricity using conductive material production Pole (20), the first electrode (10) are in the shape of a rod comprising top (101), middle part (103) and bottom end (102), on the top It is equipped at end (101) for direct energy stimulation deep tissue and plays the piercing structure of fixed function, at the bottom end (102) Equipped with fixing piece (111)；The second electrode (20) is spiral sample electrode, and it is wrapped in the outer of the first electrode (10) It encloses, one end of second electrode (20) is fixed by fixing piece (111), top (101) side of the other end towards first electrode (10) To extension.

2. a kind of bipolar electrode sub-assembly according to claim 1, it is characterised in that the first electrode (10) is screw sample Electrode, the piercing structure on first electrode (10) top (101) are tapping screw spline structure.

3. a kind of bipolar electrode sub-assembly according to claim 2, it is characterised in that the top of the screw sample electrode It (101) include the sharp piercing face (104) of end face and/or the threaded portion (106) for being formed in the top (101) outer peripheral surface, institute The hand of spiral for stating threaded portion (106) is dextrorotation or left-handed.

4. a kind of bipolar electrode sub-assembly according to claim 1, it is characterised in that the first electrode (10) is fusiform Electrode, the piercing structure on first electrode (10) top (101) are fusoid piercing structure.

5. a kind of bipolar electrode sub-assembly according to any one of claim 2 to 4, it is characterised in that the first electrode (10) outer peripheral surface of middle part (103) and bottom end (102) is coated with insulation material layer (110), the insulation material layer (110) For slow release drug；The bottom end (102) connects first lead (107).

6. a kind of bipolar electrode sub-assembly according to any one of claim 2 to 4, it is characterised in that the first electrode (10) outer surface is provided with the first score structure (105) for carrying medicine, which is slot and/or hole；Institute The surface for stating the first score structure (105) is covered with the polymeric membrane made of degradation material.

7. a kind of bipolar electrode sub-assembly according to any one of claim 2 to 4, it is characterised in that the first electrode (10) the outer peripheral surface fixation of bottom end (102) is coated with the fixing piece (111) being made of plastic layer, fixing piece (111) court The drug control that the middle part (103) around the first electrode (10) is arranged is embedded with to the end in the top (101) direction Release part (112).

8. a kind of bipolar electrode sub-assembly according to any one of claim 2 to 4, it is characterised in that the fixing piece (111) external thread structure (108) are provided on outer peripheral surface, which is trapezoidal thread, the external screw thread knot The hand of spiral of structure (108) is dextrorotation or left-handed.

9. a kind of bipolar electrode sub-assembly according to any one of claim 2 to 4, it is characterised in that the fixing piece (111) be provided with the first marker (109) with first electrode bottom end (102) adjacent end face, first marker (109) by Radiopaque material is made, and first marker (109) is annular element.

10. a kind of bipolar electrode sub-assembly according to claim 1 or 2 or 4, it is characterised in that the spiral sample electrode is opposite It is electrically insulated in the first electrode (10), and the development length of the spiral sample electrode in axial direction is shorter than first electricity The length of pole (10).

11. a kind of bipolar electrode sub-assembly according to claim 2 or 3, it is characterised in that the spiral sample electrode includes base Plinth part (201) and helical member (202), the basic part (201) are fixed on the fixing piece (111)；The helical member (202) Since the basic part (201) and towards the top of first electrode (10) (101) direction and around first electrode (10) Central axis spiral extends forward.

12. a kind of bipolar electrode sub-assembly according to claim 11, it is characterised in that the spiral side of the helical member (202) To consistent with the hand of spiral of the screw sample electrode thread portion (106).

13. a kind of bipolar electrode sub-assembly according to claim 11, it is characterised in that the surface of the helical member (202) is set It is equipped with the second score structure (203) for carrying medicine, which is slot and/or hole；The second indentation knot Structure (203) carries medicine rear surface and is covered with the polymeric membrane made of degradation material.

14. a kind of bipolar electrode sub-assembly according to claim 1, it is characterised in that be connected on the spiral sample electrode from The fixing piece stretches out in the second lead (204) of the first electrode bottom end (102).

15. a kind of stimulating system, it is characterised in that combined including bipolar electrode described in any one of the claims 1 to 14 Part and wire body and stimulus generator.

16. a kind of stimulating system according to claim 15, it is characterised in that: the wire body includes wire body inside conductor Layer (30) and wire body outer conductor layer (60)；The wire body inside conductor layer (30) includes first lead (107), the second lead (204) and insulating materials；The wire body outer conductor layer (60) includes annular electrode (40), is connected with annular electrode (40) Third lead (401) and insulating materials；The annular electrode (40) and the first electrode (10) and second electrode (20) it Between mutually insulated, first lead (107), the second lead (204) and third lead (401) are respectively connected to the arteries and veins of stimulus generator Rush output end.

17. a kind of stimulating system according to claim 15, it is characterised in that: the stimulus generator is " double-core " stimulation Generator comprising 2 or 2 or more impulse output circuits and the perception control circuit of at least one, the stimulation occur Device alternately can provide contrary impulse stimulation electric current, and polarity of electrode is made to make checker.

18. a kind of stimulating system according to claim 16, it is characterised in that: wire body outer conductor layer (60) port Place is provided with the second marker (602), which is made of radiopaque material；It is led outside the wire body Line layer (60) is provided with third marker (603) in the position adjacent with the port, and the third marker (603) is by impermeable X The material of line is made；Second marker (602) and the third marker (603) are annular element；The fixing piece (111) first electrode bottom end (102) adjacent end face is provided with the first marker (109), in which: lead in first electrode stretching During wire body outer conductor layer (60), first marker (109) is no more than the third marker (603).

19. a kind of stimulating system according to claim 16, it is characterised in that: the wire body outer conductor layer (60) Distal end is equipped with internal thread structure (601), outer on the outer peripheral surface of the crest of the internal thread structure (601), tooth bottom and the fixing piece The tooth bottom of helicitic texture (108), crest are tangent；And the hand of spiral of the internal thread structure (601) and the external screw thread knot The hand of spiral of structure (108) is consistent；The first electrode (10) is screw sample electrode, the threaded portion on the top of screw sample electrode (106), the external thread structure (108) of bottom end and the helical member (202) of spiral sample electrode and the wire body outer conductor layer (60) hand of spiral of internal thread structure (601) is consistent；The bipolar electrode sub-assembly is removable by fixing piece and can turn It is set in the distal chamber of the wire body outer conductor layer (60) dynamicly.

20. a kind of stimulating system according to claim 15, it is characterised in that the stimulating system provides two kinds of electricity thorns Swash mode: a kind of electrical stimulus patterns be provided respectively by the first electrode (10) and the second electrode (20) it is identical or not It is organized at connatural electric stimulation pulse stimulation two；Another electrical stimulus patterns are by the first electrode (10) and described second Electrode (20) provides the tissue between electric pulse stimulation cathode and anode respectively as one in anode and cathode.