CN106994207A - A kind of bipolar electrode sub-assembly and stimulating system - Google Patents
A kind of bipolar electrode sub-assembly and stimulating system Download PDFInfo
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- CN106994207A CN106994207A CN201710300148.0A CN201710300148A CN106994207A CN 106994207 A CN106994207 A CN 106994207A CN 201710300148 A CN201710300148 A CN 201710300148A CN 106994207 A CN106994207 A CN 106994207A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/0565—Electrode heads
- A61N1/0568—Electrode heads with drug delivery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/3625—External stimulators
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Abstract
The present invention relates to medical instruments field, a kind of bipolar electrode sub-assembly and a kind of stimulating system are disclosed, it is intended to tissue 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（Abbreviation " double-core " pacemaker when being used in heart）, it is alternately to provide electric pulse in opposite direction there is provided a kind of new stimulation mode.Present invention preferably uses in cardiac septum, implement cardiac synchronousization treatment；Two kinds of brand-new cardiac synchronous modes are provided：One kind is to provide the control biventricular electromechanical activity of Ventricular electric stimulation pulse respectively；Another is to stimulate cardiac muscle between interventricular septum inner cathode anode, excitement is expanded cloth to biventricular by interventricular septum.
Description
Technical field
The present invention relates to medical instruments field, in particular it relates to a kind of bipolar electrode sub-assembly and stimulating system.
Background technology
Existing cardiac synchronousization treatment（CRT）The double-ventricle pacemaker system cost that method is used is expensive and curative effect is remote 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
During stimulation, pacing threshold is high, electric energy exhausts fast, is still easily caused malignant arrhythmia；3rd, right ventricular apical, outside
Basal part Epicardial pacing, is contrary to normal physiological depolarization order, it is necessary to improve.In addition, this method needs to put left ventricular electrode
It is placed in coronary sinus vein system, cumbersome and easily occur loose electrode placement, some cases are because dissection reason can not successfully pacify
Putting causes operative failure.
In recent years, the global evolution new method of a variety of left ventricular pacings, it is predominantly following three kinds：1）Left ventricle multiple location
Pace-making, defect is that electric energy is exhausted faster and still needs transexocardial pace-making；2）Endocardium of left ventricle is paced, and defect is to need
Atrial septum is punctured, operation risk is added, because needing that electrode is implanted into left ventricle lining endothelium, the point of influence two by mitral orifice
Valve function, while adding left ventricle lateral thrombus complication；3）Paced by Xi Shi (his) beams or his beams, defect is to need
Mapping his beams are wanted, pace-making vector threshold value is high, and battery life significantly shortens, and the stability paced for a long time is not known, it is necessary to place the heart
Room backup electrode, and invalid is blocked to his beams distal section.
At present in practical operation aspect, the method for pacing left ventricle is still mainly the external membrane of heart through coronary sinus vein path
Pace-making.
For example, disclosed in Chinese patent CN101238996A, in order to stimulate left ventricle, coronary sinus vein is passed through by conduit
And enter connection side shoot, so that electrode is fixed on into connection side shoot.
For another example, disclosed in Chinese patent CN104220130A, in order to pace heart, three leads are designed with, 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 leads to
Cross vein and atrium dextrum and enter coronary sinus vein, reach the region adjacent with the free wall of left ventricle.
And for example, Chinese patent CN10599950A along along coronary sinus vein pedicle screw sample electrode for not allowing what is be fixed easily
Defect, and the solution that a kind of active proposed is fixed.
In summary, the implantation of current left ventricular electrode is mostly the coronary sinus vein external membrane of heart path of heart, no
Have that implantation difficulty is larger with can avoiding, easily occur electrode after implantation and dissociate movement, pacing threshold high, QT interval prolongations and rush
Send out the number of drawbacks such as malignant arrhythmia.
In view of this, the technology of left ventricular pacing how is further improved to overcome lacking for above-mentioned cardiac synchronousization treatment
Fall into, as this area technical problem urgently to be resolved hurrily.
The content of the invention
It is an object of the invention to provide a kind of bipolar electrode sub-assembly and stimulating system, it is it is critical that double stimulate electricity
The improvement of boost pulse pattern is provided in the design and stimulus generator of pole, so as at the controllable sexual stimulus depth two or the group of many places
Knit and reduce tissue reactive；It can be used synchronizes mode in heart there is provided two kinds of brand-new Ventriculars, it is possible to increase
Biventricular synchronization therapy effect, while reducing polarization impedance, reduces stimulus threshold, extends the stimulus generator life-span.
One of technical scheme that the present invention takes is：
A kind of bipolar electrode sub-assembly, it is characterised in that it includes the first electrode and second electrode made using conductive material, institute
It is in shaft-like to state first electrode, and it includes top, pars intermedia and bottom, and being provided with the top end is used for direct energy stimulation deep
The piercing structure of fixation is organized and plays, the bottom end is provided with fixture；The second electrode is spiral sample electrode, and
And it is wrapped in the periphery of the first electrode, one end of second electrode is fixed by fixture, and the other end is towards first electrode
Top orientation extension.
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.During for fusiform electrode, the piercing structure on first electrode top is fusiform
Piercing structure.Further, the top of described screw sample electrode includes the sharp piercing face of end face and/or is formed at described
The threaded portion in top periphery face, the hand of spiral of the threaded portion is 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, moreover it is possible to play fixation, prevents electrode back off.
Preferably, the pars intermedia of the first electrode and the outer peripheral face of bottom are coated with insulation material layer, the insulation
Material layer is used to delay Slow release；The bottom connects the first lead.The pars intermedia of first electrode has certain length and cut
Area reduces, and is conducive to stimulating 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 groove and/or hole；Further, the surface of first score structure is covered with the polymeric membrane being made up of degradation material.
This be in order to electrode can after tissue is goed deep into drug-carrying, and make that medicine is long-term, slow release, action time prolongs enough
It is long.These medicines include the anti-inflammatory drug such as dexamethasone of anti-tissue reaction, can also carry with improvement tissue cell biology
The medicine of characteristic or the medicine for playing therapeutic action.
Preferably, the outer peripheral face of the bottom of the first electrode fixes the fixture for being coated with and being made up of plastic layer, institute
State the medicine controlled releasing part that fixture is embedded with the pars intermedia setting around the first electrode towards the end of the top orientation.
The medicine controlled releasing part carries medicine to the stability for improving stimulation parameter and other therapeutic actions.
Preferably, external thread structure is provided with for ease of being sent on the screw sample electrode, the fixture outer peripheral face,
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 fixture end face adjacent with first electrode bottom is provided with the first mark part, described first
Mark part is made up of radiopaque material, and the first mark part is annular element.So facilitate deciding on electrode and enter 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 is fixed on the fixture；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 groove and/or hole；Second score structure carries surface after medicine and, covered with the polymeric membrane being made up of degradation material, is conducive to taking
Band medicine simultaneously makes medicine play a role for a long time, slowly.
The of the first electrode bottom is stretched out in from the fixture preferably, being connected with the spiral sample electrode
Two leads.
The bipolar electrode sub-assembly that the present invention is provided has the following advantages that compared with existing electrode：
Bipolar electrode is fixed as inner core entirety by the bipolar electrode sub-assembly that the present invention is provided through plastic fixtures, and bipolar electrode enters jointly
Move back, with 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 dramatically different with the tapping screw sample electrode that the present invention is provided.It is involved to add
Long screw electrode, is difficult to control direction of advance, it is impossible to carry medicine.Also it is needle-like to have electrode design, equally with this hair
The screw sample electrode of bright offer is dramatically different, does not possess autonomous offer onward impulse and fixation, also without carrying medicine
Function.
The bipolar electrode sub-assembly, is preferably used as one kind simultaneously, is used in interventricular septum to implement cardiac synchronousization treatment.
Compared with traditional left ventricular electrode by coronary sinus vein path, the screw sample electrode that the present invention is provided passes through interventricular septum road
Footpath pace-making left ventricle, the complication that Epicardial pacing and direct left ventricular cavity endocardial pacing can not only be avoided to bring, and
The closer physiology of pace-making order（Normal ventricle depolarization starts from 1/3 left surface in interventricular septum）, because using being paced in cardiac muscle, pacing
Threshold value is low, and pacing parameter at a specified future date is more stable.
The bipolar electrode sub-assembly that the present invention is provided, which does not limit to, is used in cardiac septum, and its application includes any need
The position of electro photoluminescence and/or perception is such as：Atrium, ventricle, atrioventricular septum, or other heart external structures are such as：It is brain, blood vessel, outer
All nerves etc..
Bipolar electrode sub-assembly when in use, the screw sample electrode and the spiral sample electrode separately as stimulation, and/or
Perceive, and/or defibrillating function is used, and can also cooperate with other any position electrodes as stimulation, and/or perceive, and/or defibrillation
Function is used.When in particular cases, such as complete left bundle branch block, right ventricular electrode can be not used in granting electro photoluminescence arteries and veins
Punching, and fixation is played, or/and perceptional function, or/and defibrillating function, or/and diagnostic function.
The two of the technical scheme that the present invention takes are：
A kind of stimulating system, it includes above-mentioned bipolar electrode sub-assembly, and wire body and stimulus generator.Wherein 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 first lead, the second lead and insulating materials；The wire body outer conductor layer includes annular electrode and ring
The 3rd lead and insulating materials that shape electrode is connected；Phase between the annular electrode and the first electrode and second electrode
Mutually insulation, first lead, the second lead and the 3rd lead are respectively connecting to the pulse output end of stimulus generator；As excellent
Choosing, the wire body outer conductor layer port is provided with the second mark part, and the second mark part is made up of radiopaque material；
Described wire body outer conductor layer is provided with the 3rd mark part in the position adjacent with the port, and the 3rd mark part is by impermeable
The material of x-ray is made；The second mark part and the described 3rd marks part to be annular element；Wherein：Led described in being stretched out first
During wire body outer conductor layer, the first mark part is no more than the described 3rd mark part.Preferably, the wire is led in vitro
The distal end of line layer is provided with female thread structure, crest, tooth bottom and the external screw thread on the outer peripheral face of the fixture of the female thread structure
The tooth bottom of structure, crest are tangent；And the hand of spiral of the female thread structure and the hand of spiral one of described external thread structure
Cause；The threaded portion on top of the screw sample electrode, the helical member of the external screw thread of bottom and the spiral sample electrode and described
The hand of spiral of the female thread structure of wire body outer conductor layer is consistent；The bipolar electrode sub-assembly by fixture it is removable and
In the distal chamber for being rotatablely arranged at the wire body outer conductor layer.
Preferably, the stimulus generator that the present invention is provided includes：Double pulse generator, referred to as " double-core ", which are stimulated, to be occurred
Device, is referred to as " double-core " pacemaker when being used in heart；It includes two or more impulse output circuits and at least
The perception control circuit of one.Described stimulus generator alternately can provide impulse stimulation electric current in opposite direction, be equal to
Negative electrode and anode polarity can be with alternate changes.The component connection circuit of described stimulus generator includes pulse-pair output circuit
Any mode connection circuit.
Special instruction, the stimulus generator provided and Patent No. US4402322-A of the invention,
The stimulus generator that JP2001190695-A with US6341235 B1 are provided is different.Patent No. US4402322-A,
The stimulus generator that JP2001190695-A and US6341235 B1 the are provided pulse that generates electricity is by two phase waves（two-phase
Or biphase）The single boost pulse constituted, its first phase and the second phase wave form, wave amplitude, time are different.And this hair
It is single-phase rectangular wave that bright stimulus generator, which sends out impulse stimulation each, shows as that two single and direction is different during alternate change
Boost pulse, pulse duration, amplitude can adjust.
Preferably, described stimulating system provides two kinds of electrical stimulus patternses：A kind of electrical stimulus patternses are by described
The electric stimulation pulse that one electrode and the second electrode provide identical or different property respectively stimulates tissue at two；Another electricity thorn
Sharp mode is, using the first electrode and the second electrode as one in anode and negative electrode, to provide electric pulse stimulation
One section of tissue between negative electrode and anode.
The stimulating system that the present invention is provided has following advantage compared with prior art：
The stimulus generator that the present invention is provided alternately can provide pulse current in opposite direction, and this is one kind that the present invention is provided
New electric stimulation pulse mode.Compared with one direction boost pulse, the stimulation of this checker pulse direction can be significantly
The histio-irritative reactivity of institute is reduced, tissue polarity current potential and polarization impedance is reduced, reduces stimulus threshold, while convenient implement thorn
Swash the threshold value autocapture function of generator, make stimulus generator life.
The present invention also provides two kinds of brand-new Ventriculars and synchronizes mode.Screw sample electrode and spiral sample electrode are pacified
Put in interventricular septum left and right sides cardiac muscle, screw sample electrode is as left ventricular electrode, and spiral sample electrode is as right ventricular electrode, by electricity
Polar conductor is connected with pacemaker.A kind of synchronization mode is：Screw sample electrode and spiral sample electrode as negative electrode, meanwhile, ring
Shape electrode or pacemaker shell provide Ventricular electric stimulation pulse, so as to control respectively as anode by pacemaker sequencing
Biventricular electricity processed, mechanical activity；Another synchronization mode is：Screw sample electrode and spiral sample electrode any one be used as the moon
Pole, while another is as anode, pacemaker sequencing provides boost pulse, makes the section between interventricular septum inner cathode and anode
The ventricular muscle cell, bundle branch and Purkinje fiber that include volume in the range of electric depolarization activity, the interventricular septum of pace-making occur for cardiac muscle
System, can so search out an optimal pacing threshold, and electrical activity is expanded rapidly to cloth to biventricular by pacing interventricular septum,
Realize left and right ventricles electromechanical active synchronization.
Brief description of the drawings
Accompanying drawing is, for providing a further understanding of the present invention, and to constitute a part for specification, with following tool
Body embodiment is used to explain the present invention together, but is not construed as limiting the invention.
Fig. 1 is a kind of structural representation of embodiment of screw sample electrode of the present invention.
Fig. 2 is the section of structure of screw sample electrode of the present invention.
Fig. 3 is the schematic diagram that screw sample electrode bottom is combined with fixture in the present invention.
Fig. 4 is the schematic diagram that spiral sample electrode is connected with fixture in the present invention.
Fig. 5 is the another embodiment of one of bipolar electrode sub-assembly electrode（Fusiform electrode）Structural representation.
Fig. 6 is bipolar electrode sub-assembly and wire body attachment structure schematic diagram in the present invention.
Fig. 7 is one kind " double-core " stimulus generator working mode figure that the present invention is provided.
Fig. 8 is the wiring system structural representation of the present invention.
Fig. 9 is that the wiring system of the present invention is implanted into the schematic diagram of heart.
Figure 10 is that the electrode of the present invention is implanted into the state diagram of heart.
Description of reference numerals：10- first electrodes, 101- tops, 102- bottoms, 103- pars intermedias, 104- is pierced into face, 105-
First score structure, 106- threaded portions, the leads of 107- first, 108- external thread structures, the mark parts of 109- first, 110- insulation materials
The bed of material, 111- fixtures, 112- medicine controlled releasing parts, 20- second electrodes（Spiral sample electrode）, 201- basic parts, 202- helical members,
The score structures of 203- second, the leads of 204- second, 30- wire bodies inside conductor layer, 40- annular electrodes, the leads of 401- the 3rd, 50-
Stimulus generator joint, 501- screw sample electrode access interface, 502- spiral sample electrode access interface, the access of 503- annular electrodes
Port, 60- wire bodies outer conductor layer, 601- female thread structures, the mark parts of 602- second, the mark parts of 603- the 3rd, 70- atrium dextrums
Pacing electrode.
Embodiment
The present invention is described in detail with specific embodiment below in conjunction with the accompanying drawings.
Embodiment one.
First aspect present invention provides a kind of bipolar electrode sub-assembly, and it includes the first electrode made using conductive material
10 and second electrode 20, the first electrode 10 is in shaft-like, and it includes top 101, pars intermedia 103 and bottom 102, on the top
Hold and be provided with the piercing structure for being provided with 101 and being used for direct energy stimulation deep tissue and playing fixation, the bottom 102
Fixture 111；The second electrode 20 is spiral sample electrode, and it is wrapped in the periphery of the first electrode 10, the second electricity
One end of pole 20 is fixed by fixture 111, and the other end extends towards the direction of top 101 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, the body of rod 10 include top 101, bottom
102 and the pars intermedia 103 between the top 101 and bottom 102, the top 101 of the body of rod 10 forms spinosity
Enter structure, as shown in Figure 1.
Position deep tissue for the ease of the screw sample electrode 10, the length of the body of rod 10 be preferably 3mm to 18mm,
More preferably 7mm 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 groove and/or hole, and surface is covered with gathering for being made up of degradation material preferably after the score structure carries medicine
Close film.
The screw sample electrode 10 includes the sharp circular conical surface 105 for being formed at the end face of top 101 or formed
In the threaded portion 106 of the outer peripheral face of top 101, the sharp circular conical surface for being formed at the end face of top 101 can also be included
105 and it is formed at the threaded portion 106 of the outer peripheral face of top 101.
In order that the performance of the screw sample electrode 10 is more superior, preferably, the geometric parameters of the screw sample electrode 10
Number meets at least one in following condition：
The 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 length sum l of the threaded portion 106 and the circular conical surface 105 is 1mm to 6mm, preferably 1.5mm to 2.5mm.
In above-mentioned, the diameter of thread d of the threaded portion 1061More than or equal to the external diameter of the pars intermedia 103 of the body of rod 10
C, external 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 present invention is also in the pars intermedia 103 of the body of rod 10
With the outer peripheral face coated insulation material of bottom 102, in addition, being also connected with the first lead 107 in the bottom 102.Wherein, it is described
Insulating materials can be polyurethane.
Preferably, the outer peripheral face of the pars intermedia 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 face of the bottom 102 of the body of rod 10 is fixed and is coated with fixture
111, wherein, the thickness of the fixture 111 is 0.5mm to 2.0mm, and the length b of the plastic layer 111 is 2mm to 10mm, excellent
4mm is elected as to 5mm；And/or the end on the direction top 101 of the fixture 111 is embedded with around the body of rod 10
Medicine controlled releasing part 112, as shown in Figure 2.
Preferably, the head end of the body of rod 10 described in the fixture 111 towards the end face distance on the top of the body of rod 10 away from
From about 8.0mm.
External thread structure is provided with for the ease of being sent on the screw sample electrode 10, the outer peripheral face of the fixture 111
108, the external thread structure 108 is preferably trapezoidal thread, as shown in Figure 3.
Wherein, the external diameter h of the external thread structure 108 is preferably 1.5mm to 2.5mm, more preferably 1.8mm to 2.0mm,
The pitch e of the external thread structure 108 is preferably 1.0mm to 1.5mm, more preferably 1.1mm to 1.4mm.
In addition, the end face adjacent with the bottom of the body of rod 10 of the insulating materials is provided with the first mark part 109, this
One mark part 109 is made up of radiopaque material.Preferably, the first mark part 109 is formed as annular element.
As it is another preferably, first electrode use fusiform electrode when, the fusiform electrode be conductive material band is made
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 groove 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 fixture 111, and towards the body of rod 10 the direction of the top 101 extend, the spiral sample electrode 20 relative to
The screw sample electrode 10 is electrically insulated, and 20 development length in axial direction of the spiral sample electrode is shorter than the body of rod 10
Length.
The present invention can be easy to by the way that the screw sample electrode 10 and the spiral sample electrode 20 are designed into inner core is overall
Fix and make bipolar electrode synchronously advance and retreat, moreover it is possible to limit screw sample electrode 10 and excessively go deep into tissue, pass to left ventricular cavity.
In above-mentioned, the development length f of the spiral sample electrode 20 in axial direction be preferably 1mm to 5mm, more preferably
1.5mm to 2.5mm.
For the structure of the spiral sample electrode 20, according to one embodiment of the present invention, specifically, the spiral sample
Electrode 20 includes basic part 201 and needle-like piece 202, and the basic part 201 is fixed on the fixture 111, the needle-like piece 202
Spirally extend from the basic part 201 towards central axis of the top of the body of rod 10 around the body of rod 10, in order to
Riveting enters and is fixed to cardiac muscular tissue, as shown in figs. 4 and 6.
In order that the pacing parameter at a specified future date for obtaining the spiral sample electrode 20 is more stable, the present invention is also in the helical member
Be provided with the second score structure 203 for carrying medicine on 202 outer surface, second score structure 203 be preferably groove and/or
Surface is covered with the polymeric membrane being made up of degradation material after hole, preferably described second score structure load medicine；And/or the pin
Covered with platinum black coating on the outer surface of shape part 202.
In addition, the spiral sample electrode 20 is also associated with stretching out in the bottom 102 of the body of rod 10 from the fixture 111
The second lead 204.
In the present invention, the bottom 102 of the body of rod 10 is fixedly connected with the elongated core body being made from a material that be electrically non-conductive,
I.e. wire body inside conductor layer 30, the lead 204 of the first lead 107 and second is fixedly installed on the core body insulated from each otherly
And extend along the core body, as shown in Figure 6.
Embodiment two.
Second aspect of the present invention provides a kind of stimulus generator.The stimulus generator includes double pulse generator and combines work
Operation mode, referred to as " double-core " stimulus generator, are referred to as " double-core " pacemaker when being used in heart；And/or multipulse generator
（≤ 3 impulse generators）Associated working pattern, referred to as " multinuclear " stimulus generator, are referred to as " multinuclear " and rise when being used in heart
Fight device；The feature of the stimulus generator includes：Pulse current in opposite direction, i.e. alternating polarity can be alternately provided to convert
Provide boost pulse.
The stimulus generator also includes：The impulse circuit of 2 or more than 2, as shown in Figure 7.
Component connection circuit included by the stimulus generator that the present invention is provided should not be only understood shown in Fig. 7, it should managed
Solution is the connection circuit for any mode for including double pulse generator or multipulse generator.
The stimulus generator that the present invention is provided alternately is provided electric pulse in opposite direction and meant：Interval it is certain or not etc.
Number of times or interval is certain or after time that do not wait, the electric pulse of granting different directions.
It is single-phase that the stimulus generator, which sends out impulse stimulation, and feature includes showing as direction difference during alternate change.
The number of electrodes for the granting impulse stimulation being connected with stimulus generator/of the present invention or pacemaker, should not be only
2 are interpreted as, should be included multiple（≤ 3 electrodes）, multiple electrodes can be derived from electrode 10 and/or counter electrode 20, are realized
Multipole（≤ 3 electrodes）Reversal is paced, as shown in Figure 7.
" double-core " stimulus generator or pacemaker that the present invention is provided, its function, which should not be understood merely as providing, stimulates arteries and veins
Punching, should also include：Perceptional function, diagnostic function and defibrillating function.
A kind of new electric stimulation pulse mode and/or " double-core " stimulus generator/or pacemaker that the present invention is provided：
Preferably used as one kind in heart, but be not limited to heart, it is understood that be applicable any heart outside need electro photoluminescence and/or
The tissue of perception, such as：Blood vessel, brain and peripheral nerve etc..
Embodiment three.
Third aspect present invention provides a kind of stimulating system, including：Bipolar electrode sub-assembly, and wire body and stimulation are sent out
Raw device, wherein bipolar electrode sub-assembly, stimulus generator are provided by first aspect present invention, second aspect.
The wire body includes wire body inside conductor layer（30）With wire body outer conductor layer（60）.The wire body inside conductor
Layer 30 includes first lead 107, second lead 204 and insulating materials, as shown in Figure 6 and Figure 8.The wire is external
Conductor layer 60 includes annular electrode（40）With annular electrode（40）The 3rd lead being connected（401）And insulating materials.It is described
Annular electrode 40, the screw sample electrode and the mutually insulated of spiral sample electrode 20.
Female thread structure 601 is provided with the inner peripheral surface of 60 distal end outer section of the wire body outer conductor layer, in order to more
Power, preferably trapezoidal thread are transmitted well.Crest, tooth bottom and the external screw thread of the bottom of screw sample electrode 10 of the internal thread 601
108 tooth bottom, crest are tangent.Preferably, the hand of spiral of the female thread structure 601 and the external screw thread of the bottom of screw sample electrode 10
The hand of spiral of 108 structures is consistent.By rotating the external thread structure 108 and female thread structure 601, the screw can be made
Sample electrode 10 and spiral sample electrode 20 advance or retreated as an entirety.
The stimulating system has the combination of four kinds of polarities of electrode when providing electric stimulation pulse：The annular electrode
40 be anode, and the screw sample electrode 10 and the spiral sample electrode 20 are negative electrode；The annular electrode 40 is negative electrode, described
Screw sample electrode 10 and the spiral sample electrode 20 are anode；The screw sample electrode 10 is negative electrode, the spiral sample electrode 20
For anode；The screw sample electrode 10 is anode, and the spiral sample electrode 20 is negative electrode；Or the screw sample electrode 10 and spiral shell
The alternating polarity for revolving sample electrode 20 is exchanged.
For the ease of understanding the position of electrode under x-ray, the end face that the bottom 102 of the screw sample electrode 10 is adjacent is set
There is the first mark part 109, the first mark part 109 is made up of radiopaque material；The wire body outer conductor layer 60 is in port
Place is provided with the second mark part 602, and the second mark part 602 is made up of radiopaque material；The wire body outer conductor layer 60
The 3rd mark part 603 is provided with the position adjacent with the port, the 3rd mark part 603 is made up of radiopaque material.
Wherein, during the screw sample electrode 10 stretches out in the wire body outer conductor layer 60, the first mark part 109 is not
More than the described 3rd mark part 603.For example, when the described first mark part 109 is overlapped with the described 3rd mark part 603, it is described
The port of the bottom of spiral sample electrode 20 and the wire body outer conductor layer 60 is flushed or closely.Preferably, described
The one mark mark mark part 603 of part 602 and the 3rd of part 109, second is annular element.
As a preferred embodiment, the electric stimulation is used in cardiac septum, cardiac synchronousization treatment is implemented.The present invention is carried
Mode is synchronized for two kinds of brand-new Ventriculars.
Screw sample electrode 10 and spiral sample electrode 20 are placed in interventricular septum left and right sides cardiac muscle, connected with stimulus generator
Connect.It can realize that Ventricular synchronizes pace-making using two kinds of new ways：One kind is：Screw sample electrode 10 and spiral sample electricity
Pole 20 as negative electrode, meanwhile, annular electrode 40 or stimulus generator shell are provided respectively as anode by stimulus generator
Ventricular electric pulse controls biventricular electromechanical activity；It is another to be：Screw sample electrode 10 and spiral sample electrode 20 any one
It is individual as negative electrode, while another is as anode, stimulus generator sequencing provide electric pulse make interventricular septum negative electrode and anode it
Between section cardiac muscle occur the ventricular muscle cell, bundle branch and Purkinje that include volume in the range of electric depolarization, the interventricular septum of pace-making
Fiber system, can search out an optimal pacing threshold, and electrical activity is expanded rapidly into cloth to biventricular by interventricular septum, realized
Left and right ventricles electromechanical active synchronization.
In a word, compared with traditional CRT system, due to use in cardiac muscle and/or endocardial electrode stimulate, Neng Gouxian
Write and lower 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
Power consumption is reduced, final extension stimulus generator or life span.
The method for implantation of wiring system of the present invention is elaborated below：
As shown in figure 9, under X-ray examination, through venous system, the wiring system is inserted to the interventricular septum face of right ventricle, left front
Oblique 45 ° of position x-rays are thrown shine under, row left ventricle chambers of the heart radiography is guided, rotary wire system, by screw sample electrode 10 towards left ventricle
Part precession is to interventricular septum.When the distal end of screw sample electrode 10 is concordant with the described second mark part 602, screw sample electrode 10 is indicated
It will screw in cardiac muscular tissue, continue rotary wire system, when the described first mark mark part 603 of part 109 and the 3rd is overlapping, then institute
Spiral sample electrode 20 is stated completely into right ventricle interventricular septum side, while the screw sample electrode 10 is fully advanced to left ventricle inner membrance
Under, as shown in Figure 10；Fixed and detecting electrode parameter, connection cardiac stimulation generator or pacemaker, skin suture.From there through
A piece electrode wires are that biventricular synchronous pacing can be achieved.
The basic principles, principal features and advantages of the present invention have been shown and described above.One of ordinary skill in the art
It should be appreciated that above-described embodiment protection domain that the invention is not limited in any way, the mode such as all use equivalent substitutions is obtained
The technical scheme obtained, falls within protection scope of the present invention.
Part that the present invention does not relate to is same as the prior art or can be realized using prior art.
Claims (20)
1. a kind of bipolar electrode sub-assembly, it is characterised in that it includes the first electrode made using conductive material（10）With the second electricity
Pole（20）, the first electrode（10）In shaft-like, it includes top（101）, pars intermedia（103）And bottom（102）, on the top
End（101）Place is provided with the piercing structure for being used for direct energy stimulation deep tissue and playing fixation, the bottom（102）Place
Provided with fixture（111）；The second electrode（20）For spiral sample electrode, and it is wrapped in the first electrode（10）It is outer
Enclose, second electrode（20）One end pass through fixture（111）Fixed, the other end is towards first electrode（10）Top（101）Side
To extension.
2. a kind of bipolar electrode sub-assembly according to claim 1, it is characterised in that the first electrode（10）For screw sample
Electrode, first electrode（10）Top（101）Piercing structure be tapping screw spline structure.
3. a kind of bipolar electrode sub-assembly according to claim 2, it is characterised in that the top of described screw sample electrode
（101）Sharp piercing face including end face（104）And/or it is formed at the top（101）The threaded portion of outer peripheral face（106）, institute
State threaded portion（106）Hand of spiral be 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）For fusiform
Electrode, first electrode（10）Top（101）Piercing structure be 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）Pars intermedia（103）And bottom（102）Outer peripheral face be coated with insulation material layer（110）, the insulation material layer（110）
For delaying Slow release；The bottom（102）Connect the 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 for carrying medicine（105）, first score structure（105）For groove and/or hole；Institute
State the first score structure（105）Surface covered with the polymeric membrane being made up 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）Bottom（102）Outer peripheral face fix and be coated with the fixture that is made up of plastic layer（111）, the fixture（111）Court
To the top（101）The end in direction is embedded with around the first electrode（10）Pars intermedia（103）The medicine control of setting
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 fixture
（111）Outer peripheral face on be provided with external thread structure（108）, the external thread structure（108）For trapezoidal thread, the external screw thread knot
Structure（108）Hand of spiral be 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 fixture
（111）With first electrode bottom（102）Adjacent end face is provided with the first mark part（109）, the first mark part（109）By
Radiopaque material is made, and the first mark part（109）For 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（20）
Relative to the first electrode（10）Electric insulation, and the spiral sample electrode（20）Development length in axial direction is shorter than institute
State first electrode（10）Length.
11. a kind of bipolar electrode sub-assembly according to Claims 2 or 3, it is characterised in that the spiral sample electrode（20）Bag
Include basic part（201）And helical member（202）, the basic part（201）It is fixed on the fixture（111）On；The helical member
（202）From the basic part（201）Start and towards first electrode（10）Top（101）Direction and around first electrode
（10）Central axis spiral extend forward.
12. a kind of bipolar electrode sub-assembly according to claim 11, it is characterised in that the helical member（202）Spiral side
To with the screw sample electrode（10）Threaded portion（106）The hand of spiral it is consistent.
13. a kind of bipolar electrode sub-assembly according to claim 11, it is characterised in that the helical member（202）Surface set
It is equipped with the second score structure for carrying medicine（203）, second score structure（203）For groove and/or hole；The second indentation knot
Structure（203）Surface is covered with the polymeric membrane being made up of degradation material after load medicine.
14. a kind of bipolar electrode sub-assembly according to claim 1, it is characterised in that be connected with the spiral sample electrode from
The fixture stretches out in the first electrode bottom（102）The second lead（204）.
15. a kind of stimulating system, it is characterised in that including the bipolar electrode sub-assembly any one of above-mentioned power 1 to 14, 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）With wire body outer conductor layer（60）；The wire body inside conductor layer（30）Including first lead（107）, second draw
Line（204）And insulating materials；The wire body outer conductor layer（60）Including annular electrode（40）With annular electrode（40）It is connected
The 3rd lead（401）And insulating materials；The annular electrode（40）With the first electrode（10）And second electrode（20）
Between mutually insulated, first lead（107）, the second lead（204）With the 3rd lead（401）It is respectively connecting to stimulation
The pulse output end of device.
17. a kind of stimulating system according to claim 15, it is characterised in that：The stimulus generator stimulates for " double-core "
Generator, it includes the impulse output circuit and the perception control circuit of at least one of 2 or more than 2, and the stimulation occurs
Device alternately can provide impulse stimulation electric current in opposite direction, polarity of electrode is made checker.
18. a kind of stimulating system according to claim 15, it is characterised in that：The wire body outer conductor layer（60）Port
Place is provided with the second mark part（602）, the second mark part（602）It is made up of radiopaque material；Described wire is led in vitro
Line layer（60）The 3rd mark part is provided with the position adjacent with the port（603）, the 3rd mark part（603）By impermeable X
The material of line is made；The second mark part（602）With the described 3rd mark part（603）It is annular element；Wherein：Stretched first
Go out the wire body outer conductor layer（60）During, the first mark part（109）No more than the described 3rd mark part
（603）.
19. a kind of stimulating system according to claim 15, it is characterised in that：The wire body outer conductor layer（60）It is remote
End is provided with female thread structure（601）, the female thread structure（601）Crest, outer spiral shell on the outer peripheral face of tooth bottom and the fixture
Line structure（108）Tooth bottom, crest it is tangent；And the female thread structure（601）The hand of spiral and described external thread structure
（108）The hand of spiral it is consistent；The screw sample electrode（10）Top threaded portion（106）, bottom external screw thread（108）With
And the spiral sample electrode（20）Helical member（202）With wire body outer conductor layer（60）Female thread structure（603）'s
The hand of spiral is consistent；The bipolar electrode sub-assembly may move by fixture and be rotatablely arranged at the wire and leads in vitro
Line layer（60）Distal chamber in.
20. a kind of stimulating system according to claim 15, it is characterised in that described stimulating system provides two kinds of electricity thorns
Swash mode：A kind of electrical stimulus patternses are by the first electrode（10）With the second electrode（20）Provide identical or not respectively
Connatural electric stimulation pulse is stimulated and organized at two；Another electrical stimulus patternses are by the first electrode（10）With described second
Electrode（20）Respectively as one in anode and negative electrode, the tissue between electric pulse stimulation negative electrode and anode is provided.
Applications Claiming Priority (2)
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| CN201710154785 | 2017-03-15 | ||
| CN2017101547851 | 2017-03-15 |
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| CN201710300010.0A Pending CN106902461A (en) | 2017-03-15 | 2017-05-02 | A kind of stimulus generator |
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