CN113289244A

CN113289244A - Quadrupole spiral active lead for pacing of Hipu system

Info

Publication number: CN113289244A
Application number: CN202110723810.XA
Authority: CN
Inventors: 陈学颖; 宿燕岗; 刘恩涛; 葛均波
Original assignee: Zhongshan Hospital Fudan University
Current assignee: Zhongshan Hospital Fudan University
Priority date: 2021-06-29
Filing date: 2021-06-29
Publication date: 2021-08-24

Abstract

The invention relates to a quadrupole spiral active lead for pacing of a Hipu system, which comprises a head part inserted into a body and a tail part connected with a pulse generator, wherein the head part and the tail part are connected with each other, the head part is sequentially sleeved with a spiral electrode lead, a hollow inner insulating guide pipe and a hollow outer insulating sleeve from inside to outside, the end part of the outer insulating sleeve pipe extends outwards to be provided with a spiral electrode tip, the end part of the spiral electrode lead is provided with an electrode body with a tip, part of the electrode body extends out of the inner insulating guide pipe and is positioned in the spiral electrode tip, the outer insulating sleeve pipe is sleeved with a plurality of annular ring electrodes, the plurality of ring electrodes are sequentially distributed at intervals along the axis direction, and the inner insulating guide pipe is wound with a plurality of spiral ring electrode leads which are connected with the ring electrodes one by one. Compared with the prior art, the invention improves the structure of the lead, so that the head of the lead is easy to screw into the myocardium, the success rate of the Hipu system pacing is improved, and the damage to the myocardium in the screwing process is reduced.

Description

Quadrupole spiral active lead for pacing of Hipu system

Technical Field

The invention relates to the field of medical instruments, in particular to a quadrupole spiral active lead for pacing of a Hipu system.

Background

The pacing of the Hipu system is a new technology in the field of cardiac pacing in recent years, and comprises Hipu bundle pacing and left bundle branch pacing, namely, a lead is sent to a Hipu bundle or a left bundle branch region through a sheath tube with a specific shape, so that ventricular excitation is transmitted down along a normal conduction bundle, and contraction of left and right ventricles and contraction in the left ventricle are kept synchronous, so that ideal ventricular physiological pacing in the true sense is realized. The anatomic bundle of his is located at the junction of the atria and ventricles, is relatively limited, is about 2cm long, and branches into the left bundle branch and its branches under the left ventricular septal plane after passing through the membranous ventricular septum. The his bundle and the left bundle branch both have a certain depth in the ventricular septum, and the pacing lead is implanted into the area of the his bundle or the left bundle branch to realize the pacing of the ventricular physiological conduction system. Due to the anatomical characteristics, the pacing operation difficulty of the Hipu system is obviously higher than that of the conventional endocardial pacing, the requirement on the operation skill of an operator is high, and the operation time and the stability of long-term pacing parameters are still to be improved.

The lead used for pacing of a Hipu system clinically at present is a spiral active lead (model 3830) produced by Meidunli corporation (as shown in figure 1, the left end is a ring end, and the right end is a tip end), the head end is provided with a conductive electrode body and a spiral steel wire arranged outside the electrode body in a surrounding manner, the lead is thin, the lead is convenient to be deeply screwed and fixed at an interval part under the guidance of a sheath, and the lead has the defects that a lead main body is solid, the inner part does not have the steel wire, the lead is soft, and partial patient is difficult to screw in, so that the implantation failure is caused. The effect after this wire screw in myocardium is as shown in fig. 2 (the cube shows the myocardium tissue, it is the electrode conduit to expose outside the myocardium tissue, be the cylindrical myocardium tissue that is destroyed by the electrode body screw in the myocardium tissue, the part of winding on the cylinder is the spiral steel wire), after this wire spiral gets into the myocardium completely, the central part of myocardium has a complete column myocardium tissue, this myocardium post can block the electrode body and continue to get into the myocardium, the electrode body is revolved hard this moment, the spiral steel wire can drive the electrode body extrusion and destroy the myocardium post, along with the electrode body continues to go deep into the myocardium, the myocardium of destruction constantly increases, this method can bring two main problems: firstly, the resistance to screwing in can be very large; second, it causes significant myocardial damage. When the supporting force of the outer sheath is insufficient, the spiral steel wire cannot enter deeper cardiac muscle, the electrode body lacks forward force, the spiral steel wire can rotate in situ, therefore, more cardiac muscle tissues are damaged, and when a proper pacing site needs to be repeatedly searched for many times, the method can cause larger damage to the cardiac muscle tissues.

In addition, the current lead design is bipolar, i.e. the tip is used as the cathode, the housing is used as the anode (tip-can) or the tip is used as the cathode, the ring is used as the anode (tip-ring) for pacing, and the adjustable pacing vector is limited. In addition, the distance between the head end tip and the ring end ring is 10.8mm (as shown in fig. 1), the length of the spiral steel wire is 1.8mm, and for a part of patients with thinner ventricular septum, after the head end tip is screwed into the septum, the ring end ring still can not contact the septal myocardium, and can not participate in the adjustment of the pacing vector.

Disclosure of Invention

The invention aims to provide a quadripolar spiral active lead for pacing of a Hipu system, which is used for implanting a Hipu bundle or a left bundle branch region in a ventricular septum to realize the pacing of the Hipu system.

The purpose of the invention is realized by the following technical scheme:

a quadrupole spiral active lead for pacing of a Hipu system comprises a head part inserted into a human body and a tail part used for being connected with a pulse generator, wherein the head part and the tail part are connected with each other, a spiral electrode lead, a hollow inner insulating guide pipe and a hollow outer insulating sleeve are sequentially sleeved on the head part from inside to outside, a spiral electrode tip is arranged at the end part of the outer insulating sleeve in an extending mode, an electrode body with a tip is arranged at the end part of the spiral electrode lead, the electrode body partially extends out of the inner insulating guide pipe and is located in the spiral electrode tip, a plurality of annular ring electrodes are sleeved on the outer insulating sleeve in a sleeved mode, the ring electrodes are sequentially distributed at intervals in the axis direction, and a plurality of spiral ring electrode leads which are connected with the ring electrodes one by one are wound on the inner insulating guide pipe. The number and spacing of the ring electrodes may be defined as practical.

The tail IS an IS-4 interface common to all pacing leads.

The plurality of ring electrodes comprise a first ring electrode lead, a second ring electrode lead and a third ring electrode lead, the plurality of ring electrode leads comprise a first ring electrode lead, a second ring electrode lead and a third ring electrode lead, the first ring electrode lead, the second ring electrode lead and the third ring electrode lead are sequentially distributed at intervals along the axis direction, the first ring electrode lead is arranged close to the electrode body, the first ring electrode lead is connected with the first ring electrode lead, the second ring electrode lead is connected with the second ring electrode lead, the third ring electrode lead is connected with the third ring electrode lead, and the first ring electrode lead, the second ring electrode lead and the third ring electrode lead are spirally wound on the inner insulating guide pipe. The components such as the spiral electrode tip and the electrode body in the quadrupole spiral active lead, which are screwed into the cardiac muscle, the spiral electrode lead connected with the pulse connector, the first ring electrode lead, the second ring electrode lead, the third ring electrode lead, the first ring electrode, the second ring electrode and the third ring electrode are conductive, and other components and parts are insulated, so that the cardiac muscle is stimulated to pace.

The first ring electrode lead, the second ring electrode lead and the third ring electrode lead are all obtained by winding a plurality of steel wires in parallel to form a hollow coil shape, and have conductivity.

The spiral electrode lead is formed by winding a plurality of strands of alloy steel wires around a hollow coil-shaped reinforcing support.

The outer wall of the outer insulating sleeve is sequentially provided with a first concave ring, a second concave ring and a third concave ring at intervals along the circumferential direction, the first ring electrode is located in the first concave ring, the second ring electrode is located in the second concave ring, and the third ring electrode is located in the third concave ring.

The distance between the first ring electrode and the second ring electrode is equal to the distance between the second ring electrode and the third ring electrode.

The surface areas of the first ring electrode, the second ring electrode and the third ring electrode are all equal.

When the total axial length of the quadrupole helical active lead is 69mm, the axial farthest distance between the helical electrode tip and the third ring electrode is 16.8mm (this part contacts the ventricular septal myocardium, the ventricular septal thickness is generally 10-12m), the axial distance between the first ring electrode and the second ring electrode is 5.0mm, the distance between the second ring electrode and the third ring electrode is 5.0mm, the axial lengths of the first ring electrode, the second ring electrode and the third ring electrode are all 0.6mm, and the axial length of the helical electrode tip is 2.4 mm.

The inner insulating conduit is stepped, and the part with the large outer diameter is arranged adjacent to the spiral electrode head.

The electrode body comprises a first connecting column, a second connecting column, a third connecting column and a cone which are sequentially connected, the diameter of the first connecting column is smaller than that of the second connecting column, the first connecting column is located in the inner insulating conduit and connected with the spiral electrode lead, the second connecting column, the third connecting column and the cone extend out of the inner insulating conduit, and the spiral electrode tip is connected with the second connecting column. The integrally formed connecting column II, connecting column III and cone are wedge-shaped, and the tip of the cone is the tip of the electrode tip. When the total axial length of the quadrupole spiral active lead is 69mm, the axial distance between the first ring electrode and the second connecting column is 2mm, and the axial length of the second connecting column is 0.6 mm.

The axial length of the spiral electrode head is greater than the total axial length of the third connecting column and the cone.

The inner insulation catheter is made of silicon rubber, and the outer insulation sleeve is made of polyurethane. Structures of different materials may constitute a support structure that is moderately flexible and has sufficient strength to withstand damage from external stresses.

The lead wire of the invention is provided with four electrodes which can release current and sense myocardial electrical signals, namely a first ring electrode, a second ring electrode, a third ring electrode and an electrode body, wherein the electrode body positioned at the most end part has the fixing function, is conductive, can release electric energy to excite myocardial tissues and sense the electrical activity of the myocardium.

The quadrupole spiral active lead is designed to be hollow inside, a steel wire is used as a raw material to manufacture a spiral electrode lead, a first ring electrode lead, a second ring electrode lead and a third ring electrode lead for strengthening and supporting, and the spiral electrode tip is lengthened, when the quadrupole spiral active lead is used, other auxiliary steel wires are inserted into the inner insulation catheter to rotate the whole quadrupole spiral active lead, during rotation, force can be transmitted to the head part (comprising the spiral electrode tip and the electrode body) of the quadrupole spiral active lead from the tail part of the quadrupole spiral active lead, so that the tip of the electrode body can be screwed into the interval, the electrode body can push away myocardial tissues immediately after the spiral electrode tip is screwed into the myocardial, the lengthened spiral electrode tip can be screwed into more undamaged myocardial tissues, thereby generating greater pulling force and helping the tip to deeply penetrate into the myocardial tissues, and obviously reducing the injury of myocardial tissues, under the effect that the spiral electrode tip was pulled forward and is pushed backward, the electrode body bored into cardiac muscle more easily and reachd the target position, in addition, the head of the soft supplementary steel wire of head be convenient for four-pole spiral initiative wire is carried out propelling movement and rotation in the sheath pipe of the three-dimensional shape of preforming shape, and the design of wire head point makes the wire of pacing easily twist at the interval position, improves the operation success rate, and four-pole spiral initiative wire implants cardiac muscle and targets in place after, supplementary steel wire just withdraws.

The four electrodes can be respectively used as cathodes for pacing, and can also be used as bipolar pacing between every two electrodes, the implantation depths of the four electrodes are different, so that more pacing sites can be provided, more pacing sites can be selected and adjusted for patients with ventricular intervals of different thicknesses, and the safety of long-term pacing is improved. The invention improves the structure of the lead, leads the head of the lead to be easily screwed into the cardiac muscle, improves the success rate of pacing of the Hipu system, reduces the damage of the screwing process to the cardiac muscle, and can select the polarity and the vector of pacing according to pacing parameters and graphs after operation.

Drawings

FIG. 1 is a schematic view of 3830 wire from Meindon force;

FIG. 2 is a schematic view of 3830 lead wire entering myocardial tissue;

FIG. 3 is an assembled view of a quadripolar helical active lead for pacing by the Hipu system;

FIG. 4 is a cross-sectional view of a quadripolar helical active lead for pacing by a Hipu system;

FIG. 5 is a schematic structural view of the outer insulating sleeve and the helical electrode tip;

FIG. 6 is a schematic view of the structure of the spiral electrode lead and the electrode body;

FIG. 7 is a schematic view of the construction of an inner insulated conduit;

FIG. 8 is a schematic view of the structure of a third ring electrode and a third ring electrode lead;

FIG. 9 is a schematic view of the structure of a second ring electrode and a second ring electrode lead;

FIG. 10 is a schematic view of the structure of the first ring electrode and the first ring electrode lead;

fig. 11 is a sectional view showing a positional relationship between the inner insulating tube and the outer insulating sleeve.

In the figure: 1-a helical electrode lead; 2-an inner insulated conduit; 3-external insulation sleeve; 301-a first concave ring; 302-a second female ring; 303-a third concave ring; 4-a helical electrode head; 5-an electrode body; 501-connecting column I; 502-connecting column number two; 503-connecting column III; 504-cone; 6-a first ring electrode; 601-a first ring electrode lead; 7-a second ring electrode; 701-a second ring electrode lead; 8-a third ring electrode; 801-third ring electrode lead.

Detailed Description

The invention is described in detail below with reference to the figures and specific embodiments.

Examples

As shown in fig. 3, 4, 5, 6, 7, 8, 9, 10, 11, a quadrupole helical active lead for pacing by a pumping system comprises a head portion for inserting into a body and a tail portion for connecting a pulse generator, the head portion and the tail portion are connected with each other, the tail portion IS an IS-4 interface common to all pacing leads, the head portion IS sequentially sleeved with a helical electrode lead 1, a hollow inner insulating conduit 2 and a hollow outer insulating sleeve 3 from inside to outside, the end portion of the outer insulating sleeve 3 extends outwards to be provided with a helical electrode tip 4 (the helical electrode tip 4 IS helical and IS a fixing device and can conduct electricity at the same time, the specific shape IS shown in fig. 3, 4 and 5), the end portion of the helical electrode lead 1 IS provided with an electrode body 5 having a tip, the electrode body 5 partially extends out of the inner insulating conduit 2 and IS located in the helical electrode tip 4, the electrode tip 5 and the helical electrode tip 4 are not in contact, the spiral electrode head 4 is coil-shaped, the first ring electrode 6, the second ring electrode 7 and the third ring electrode 8 are annularly arranged outside the outer insulating sleeve 3, the first ring electrode 6, the second ring electrode 7 and the third ring electrode 8 are sequentially distributed at intervals along the axial direction, the first ring electrode 6 is arranged adjacent to the electrode body 5, the inner insulating guide pipe 2 is wound with a first ring electrode lead 601, a second ring electrode lead 701 and a third ring electrode lead 801 which are all spirally shaped, the first ring electrode lead 601 is connected with the first ring electrode 6, the second ring electrode lead 701 is connected with the second ring electrode 7, the third ring electrode lead 801 is connected with the third ring electrode 8 (holes for the first ring electrode lead 601, the second ring electrode lead 701 and the third ring electrode lead 801 to extend out can be arranged on the pipe wall of the outer insulating sleeve 3), wherein the axial lengths of the first ring electrode lead 601, the second ring electrode lead 701 and the third ring electrode lead are sequentially reduced, the distance between the first ring electrode 6 and the second ring electrode 7 is equal to the distance between the second ring electrode 7 and the third ring electrode 8, and the surface areas of the first ring electrode 6, the second ring electrode 7 and the third ring electrode 8 are all equal.

As shown in FIGS. 3, 4 and 6, the spiral electrode wire 1 is formed in a hollow coil shape by winding a plurality of strands of alloy steel wires having a size of

As shown in fig. 3 and 5, the outer wall of the outer insulating sleeve 3 is sequentially provided with a first concave ring 301, a second concave ring 302 and a third concave ring 303 at intervals along the circumferential direction, the first ring electrode 6 is located in the first concave ring 301, the second ring electrode 7 is located in the second concave ring 302, and the third ring electrode 8 is located in the third concave ring 303.

As shown in fig. 3 and 7, the inner insulating conduit 2 is stepped, and a portion having a large outer diameter is disposed adjacent to the helical electrode head 4. The electrode body 5 comprises a first connecting column 501, a second connecting column 502, a third connecting column 503 and a cone 504 which are connected in sequence, the diameter of the first connecting column 501 is smaller than that of the second connecting column 502, the first connecting column 501 is positioned in the inner insulating guide pipe 2 and connected with the spiral electrode lead 1, the second connecting column 502, the third connecting column 503 and the cone 504 extend out of the inner insulating guide pipe 2, the spiral electrode head is connected with the second connecting column, and the axial length of the spiral electrode head 4 is greater than the total axial length of the third connecting column 503 and the cone 504.

In this embodiment, the total axial length of the quadrupole helical active lead is 69mm, the axial farthest distance between the helical electrode tip 4 and the third ring electrode 8 is 16.8mm, the overall diameter is 1.5mm (5F) (i.e. the outer diameter of the outer insulating sleeve is 1.5mm), the axial distance between the first ring electrode 6 and the second ring electrode 7 is 5.0mm, the axial distance between the second ring electrode 7 and the third ring electrode 8 is 5.0mm, the axial lengths of the first ring electrode 6, the second ring electrode 7 and the third ring electrode 8 are 0.6mm, the first ring electrode lead 601, the second ring electrode lead 701 and the third ring electrode lead 801 are all obtained by winding three steel wires together to form a hollow coil shape (using the same diameter method), the axial distance between the first ring electrode 6 and the second connection column 502 is 2mm, the axial electrode tip of the second connection column 502 is 0.6mm, the axial length of the helical electrode tip 4 is 2.4mm, the axial length of the electrode body 5 was 0.6 mm. The inner insulating conduit 2 is made of silicon rubber, and the outer insulating sleeve 3 is made of polyurethane.

The use mode of the invention is as follows: the quadripolar spiral active lead is positioned at an implanted part under the guidance of a sheath tube, an auxiliary steel wire is required to be additionally inserted for strengthening and supporting during implantation, the head part and the tail part of the inserted auxiliary steel wire are soft, the body part and the tail part of the lead are hard after the auxiliary steel wire is inserted, force is transmitted to the head part of the lead when the tail part of the lead is rotated clockwise, so that a spiral electrode tip and an electrode body on the lead puncture an endocardium and enter the deep part of a ventricular septum or the lower part of a left ventricular septum, the ventricular septum myocardium, the right ventricular chamber, the right atrium, the superior vena cava, the subclavian vein and a puncture point in a capsular bag are sequentially contacted from the head part to the tail part of the lead, and then the lead is in vitro, and whether a Hippe system is captured or not is judged according to a pacing graph. When the Hipu system IS determined to be captured by pacing, the lead IS stopped to be screwed in, the guiding sheath and the auxiliary steel wire inserted into the lead are removed, the lead IS fixed, the tail part of the lead, namely an IS-4 interface, IS directly connected with the pulse generator, and the lead positioned outside the body and the pulse generator are coiled together and placed in a subcutaneous pocket under the clavicle, so that the pacing of the Hipu system IS realized.

The embodiments described above are described to facilitate an understanding and use of the invention by those skilled in the art. It will be readily apparent to those skilled in the art that various modifications to these embodiments may be made, and the generic principles described herein may be applied to other embodiments without the use of the inventive faculty. Therefore, the present invention is not limited to the above embodiments, and those skilled in the art should make improvements and modifications within the scope of the present invention based on the disclosure of the present invention.

Claims

1. A quadripolar helical active lead for pacing by a Hipu's system, the lead comprising a head for insertion into a body and a tail for connection to a pulse generator, the head part and the tail part are mutually connected, the head part is sequentially sleeved with a spiral electrode lead (1), a hollow inner insulating conduit (2) and a hollow outer insulating sleeve (3) from inside to outside, the end part of the outer insulating sleeve (3) extends outwards to be provided with a spiral electrode tip (4), the end part of the spiral electrode lead (1) is provided with an electrode body (5) with a tip, the electrode body (5) partially extends out of the inner insulating guide pipe (2) and is positioned in the spiral electrode head (4), a plurality of annular ring electrodes are sleeved outside the outer insulating sleeve (3) and are sequentially distributed at intervals along the axis direction, a plurality of spiral ring electrode leads which are connected with the ring electrodes one by one are wound on the inner insulating conduit (2).

2. The quadripolar helical active lead of claim 1, wherein the plurality of ring electrodes comprises a first ring electrode (6), a second ring electrode (7) and a third ring electrode (8), the plurality of ring electrodes comprises a first ring electrode lead (601), a second ring electrode lead (701) and a third ring electrode lead (801), the first ring electrode (6), the second ring electrode (7) and the third ring electrode (8) are sequentially distributed at intervals along the axial direction, the first ring electrode (6) is arranged adjacent to the electrode body (5), the first ring electrode lead (601) is connected with the first ring electrode (6), the second ring electrode lead (701) is connected with the second ring electrode (7), and the third ring electrode lead (801) is connected with the third ring electrode (8).

3. The quadripolar helical active lead for pacing of a hupu system according to claim 2, wherein the outer wall of the outer insulating sleeve (3) is sequentially provided with a first concave ring (301), a second concave ring (302) and a third concave ring (303) at intervals along the circumferential direction, the first ring electrode (6) is located in the first concave ring (301), the second ring electrode (7) is located in the second concave ring (302), and the third ring electrode (8) is located in the third concave ring (303).

4. The quadripolar helical active lead of claim 2, wherein the spacing between the first ring electrode (6) and the second ring electrode (7) is equal to the spacing between the second ring electrode (7) and the third ring electrode (8).

5. The quadripolar helical active lead of claim 2, wherein the surface areas of the first ring electrode (6), the second ring electrode (7) and the third ring electrode (8) are all equal.

6. The quadripolar helical active lead according to claim 2, wherein when the total axial length of the quadripolar helical active lead is 69mm, the axial farthest distance between the helical electrode tip (4) and the third ring electrode (8) is 16.8mm, the axial distance between the first ring electrode (6) and the second ring electrode (7) is 5.0mm, the axial distance between the second ring electrode (7) and the third ring electrode (8) is 5.0mm, the axial lengths of the first ring electrode (6), the second ring electrode (7) and the third ring electrode (8) are all 0.6mm, and the axial length of the helical electrode tip (4) is 2.4 mm.

7. The quadripolar helical active lead for pacing of the hupu system according to claim 1, wherein the inner insulating catheter (2) is stepped, and the part with the larger outer diameter is placed adjacent to the helical electrode tip (4).

8. The quadrupole helical active lead for pacing of a hupu system according to claim 1, wherein the electrode body (5) comprises a connection column number one (501), a connection column number two (502), a connection column number three (503) and a cone (504) which are connected in sequence, the diameter of the connection column number one (501) is smaller than that of the connection column number two (502), the connection column number one (501) is located in the inner insulating conduit (2) and connected with the helical electrode lead (1), the connection column number two (502), the connection column number three (503) and the cone (504) all extend out of the inner insulating conduit (2), and the helical electrode head (4) and the connection column number two (502) are connected.

9. The quadripolar helical active lead for pacing of the hupu system according to claim 8, wherein the axial length of the helical electrode tip (4) is greater than the total axial length of both the connecting post three (503) and the cone (504).

10. The quadripolar helical active lead for pacing of a hupu system according to claim 1, wherein the inner insulating catheter (2) is made of silicone rubber, and the outer insulating sleeve (3) is made of polyurethane.