CN113975626A - Pacing lead, implantation device and implantation method thereof - Google Patents

Abstract

The invention provides a pacing lead, an implanting device and an implanting method thereof, wherein the pacing lead comprises an L-shaped lead section, a lead connecting section and an electric coupling joint; the L-shaped lead section comprises an L-shaped shaping lead, electrodes and an insulating outer layer, the L-shaped shaping lead comprises a long end and a short end which form an L shape, the short end deforms under the action of external force to enable the L-shaped shaping lead to become a straight line, the L-shaped shaping lead automatically restores to the original L shape after the external force is cancelled, the two electrodes are arranged on the short end of the L-shaped shaping lead to form a positive electrode and a negative electrode, the insulating outer layer is wrapped outside the L-shaped shaping lead, and the electrodes extend out of the insulating outer layer; one end of the wire connecting section is connected with the long end, and the other end of the wire connecting section is connected with the electric coupling joint. The invention can directly and quickly implant a pacing lead into the chest cavity from the proper sternum of a patient, and the pacing lead can be connected with the existing external pacemaker by contacting the electrode with the epicardium, thereby realizing cardiac pacing.

Description

Pacing lead, implantation device and implantation method thereof

Technical Field

The invention relates to a cardiac electrode, in particular to a pacing lead, an implanting device and an implanting method thereof.

Background

Conventional temporary pacing leads, typically implanted intravenously into the heart and secured inside the heart; in the case of pericardial pacing, a pacing lead is sutured to the outer surface of the heart.

The following methods are commonly used for the placement of conventional temporary pacing leads: transvenous endocardial pacing; pericardial pacing; transcutaneous pacing; pacing via the esophagus.

All venipuncture sites (internal, external, subclavian, median, femoral) in transvenous endocardial pacing have their particular problems, including: stability of lead fixation, infection, bleeding, pneumothorax, patient discomfort, etc. Transvenously implanted leads take a relatively long time to implant and require a specialized cardiology team to operate with medical imaging equipment such as X-ray, echocardiography, and the like.

Pericardial pacing is used during cardiac surgery, directly accessing the outer surface of the myocardium. The lead electrode is placed within the myocardium on the pericardial side. The electrodes can be removed lightly when not needed; their electrical activity signals decline rapidly over time, often losing pacing capacity within 5-10 days, especially for atrial pacing.

Transcutaneous pacing is a part of advanced cardiac life support and can be handled by simple training of the operator and without the need to move the patient. Clinical studies have reported that the Zoll type noninvasive pacemaker can effectively maintain cardiac pacing for 14 hours, with a success rate of 78-94%. This pacing method provides a bridge to transvenous pacing in cases where the patient cannot be carried or there is temporarily no experienced transvenous pacing medical staff present.

Pacing through the esophagus or pacing through the gastro-esophagus has been advocated for ventricular pacing in emergency treatment with a success rate of about 90%, with a bendable electrode placed at the bottom of the stomach to stimulate ventricular pacing through the diaphragm. Through esophagus atrial pacing, the electrodes are placed in the middle and lower parts of the esophagus to obtain atrial capture, but the stability of the electrodes is difficult to achieve, and the atrioventricular block is not protected.

Common complications of existing lead implantation: including venipuncture lesions, mechanical stimulation of leads in the heart, electrical activity of pacemaker leads, hematoma, infection or thrombosis, failed pacing, and the like. Complications related to temporary pacing may be related to a number of factors, with a complication rate of approximately 14-36%, most of which are the formation of perforations, ventricular arrhythmias caused by electrode mechanical stimulation or infection.

A complete extracardiac pacing system has potential clinical advantages over conventional temporary pacemakers. Experiments have verified that an anatomical pathway: the anterior mediastinum is accessed through at least one parasternal access point, which is located at the level of the 4 th, 5 th or 6 th intercostal space, without contacting the left lung or the internal thoracic vein/artery.

Chinese patent CN110681053A discloses an epicardial temporary pacing lead and assembly, wherein the myocardial fixation device needs to be inserted into the myocardium and fixed at the corresponding position. Chinese patent CN209075859U discloses a temporary pacing lead structure, which is designed with barbs and a suture needle. The two pacing leads need to be sutured and fixed on the surface of the myocardium in the implantation process, certain damage can be caused to the heart, and the implantation and installation of the pacing leads are complex and time-consuming, and the pacing leads cannot be implanted quickly in emergency.

Disclosure of Invention

In order to solve the above problems of the existing extracardiac pacing system, the present invention provides a pacing lead, an implanting device and an implanting method thereof, which can directly and rapidly implant the pacing lead from the fourth, fifth or sixth suitable sternums of a patient to the epicardium under the sternum by using the implanting device without any medical imaging, without any hardware fixed in the heart or on the surface, and the lead is connected with any commercially available extracardiac pacemaker only by contacting the electrode and the epicardium, thus realizing the effect of cardiac pacing.

The technical scheme adopted by the invention for solving the technical problems is as follows:

in a first aspect, the present invention provides a pacing lead, including an L-shaped lead segment, a lead connection segment, and an electrical coupling connector;

the L-shaped lead section comprises an L-shaped shaping lead, electrodes and an insulating outer layer, the L-shaped shaping lead comprises a long end and a short end which form an L shape, the short end deforms under the action of external force to enable the L-shaped shaping lead to become a straight line, the L-shaped shaping lead automatically restores to the original L shape after the external force is cancelled, the two electrodes are arranged on the short end of the L-shaped shaping lead to form a positive electrode and a negative electrode, the insulating outer layer is wrapped outside the L-shaped shaping lead, and the electrodes extend out of the insulating outer layer;

one end of the wire connecting section is connected with the long end, and the other end of the wire connecting section is connected with the electric coupling joint.

According to the technical scheme, the L-shaped shaping lead is made of nickel-titanium alloy.

According to the technical scheme, the wire connecting section comprises an inner wire and an insulating outer layer, and the insulating outer layer is wrapped outside the inner wire.

According to the technical scheme, the inner lead comprises at least one copper wire.

According to the technical scheme, the L-shaped conductor segment further comprises a flexible head end, and the flexible head end is arranged at the end part of the short end of the insulating outer layer.

In a second aspect, the invention provides a pacing lead implanting device, which is used for implanting any one of the pacing leads into a thoracic cavity, and comprises a shell, a pushing mechanism and a puncture head, wherein a lead channel for the pacing lead to penetrate through is longitudinally arranged in the shell, the pushing mechanism is longitudinally and slidably arranged on the shell, a clamping unit capable of loosening and clamping the pacing lead arranged in the lead channel is arranged in the pushing mechanism, the puncture head is arranged at the bottom of the shell, and an inner cavity of the puncture head is communicated with the lead channel.

According to the technical scheme, the device further comprises a guide rod which is longitudinally arranged on the shell, and the pushing mechanism is slidably arranged on the guide rod.

According to the technical scheme, the device further comprises a handle arranged outside the shell.

In a third aspect, the present invention provides a pacing lead implantation method, the method comprising the steps of:

s1, preparing the pacing lead of any one of the above and the pacing lead implanting device of any one of the above;

s2, placing a pushing mechanism of the device at one end of the shell far away from the puncture head, inserting the pacing lead into a lead channel of the device, enabling the short end of the L-shaped lead to deform so that the L-shaped lead which becomes a straight line can smoothly enter the lead channel, and clamping the pacing lead through a clamping unit when the short end of the pacing lead does not extend out of the puncture head;

s3, vertically inserting the puncture head of the device into the chest along the minimally invasive opening between the 4 th and 5 th costal bones or between the 5 th and 6 th costal bones of the chest;

s4, pushing the pushing mechanism to enable the short end of the L-shaped lead to completely extend out of the puncture head and automatically recover to the original L-shaped shape;

s5, continuously moving the pushing mechanism until two electrodes of the pacing lead are contacted with the epicardium, and stopping pushing the pushing mechanism;

and S6, loosening the clamping unit, withdrawing the pacing lead implanting device, and fixing the pacing lead between ribs to complete the implantation of the pacing lead.

The invention has the following beneficial effects:

the invention provides a pacing lead, wherein the upper part of an inner lead adopts a connecting lead, the lower part adopts an L-shaped lead for fixing an electrode, the pacing lead can be deformed under the action of external force by utilizing the shape memory characteristic of the L-shaped lead and automatically restores to the original shape under the free state, the pacing lead can enter a thoracic cavity (at least one entry point can be found to enter a front longitudinal partition) from a gap between a 4 th rib bone and a 5 th rib bone or between the 5 th rib bone and a 6 th rib bone under the coordination of an implant device without any medical imaging, and the electrode positioned on the short end of the L-shaped lead is contacted with an epicardium, so that the pacing lead beats along with the heart to realize cardiac pacing.

The invention provides a pacing lead implanting device, which is characterized in that a lead channel is arranged in a shell and used for placing a pacing lead; the puncture head is arranged, so that the puncture head is vertically inserted into the thoracic cavity at a minimally invasive opening between the 4 th and 5 th costal bones or between the 5 th and 6 th costal bones of the thoracic cavity, and the pacing lead is ensured to smoothly enter the thoracic cavity; through setting up push mechanism, firstly can realize the elasticity to the wire of pacing through its clamping unit, press from both sides tight wire of pacing and can make the wire of pacing move along with push mechanism, loosen the wire of pacing and can realize withdrawing of implanting the device, secondly push mechanism can drive the wire of pacing and move together to send the wire of pacing into the thorax.

According to the pacing lead implanting method provided by the invention, through the cooperation of the pacing lead and the pacing lead implanting device, the pacing lead can be directly and quickly implanted into the epicardium under the sternum from a minimally invasive port by utilizing the implanting device under the condition of no medical imaging without passing through a vein and the heart but in a minimally invasive manner on the thoracico-cutaneous between the 4 th and the 5 th costal bones or between the 5 th and the 6 th costal bones of the chest of a patient, no hardware is required to be fixedly placed in the heart or on the surface of the heart, the pacing lead is only contacted with the epicardium through an electrode, and the pacing lead can be connected with any commercially available external pacemaker, so that the cardiac pacing on the extracardia in the chest can be realized.

The pacing lead provided by the invention is implanted from the intercostal muscle gap of the chest under the cooperation of the implantation device, so that the rapid implantation of the pacing lead can be realized; meanwhile, the implantation of the path avoids the defects of complications of vein implantation and the like and other methods; in addition, the present invention can also be used without medical imaging and can be connected to any commercially available external pacemaker.

Drawings

The invention will be further described with reference to the accompanying drawings and examples, in which:

FIG. 1 is a schematic structural diagram of an embodiment of a pacing lead provided by the present invention;

FIG. 2 is a schematic structural diagram of an embodiment of a pacing lead implanting device according to the present invention;

fig. 3 is a schematic structural diagram of a pacing lead wire built in a pacing lead wire implanting device according to the present invention;

FIG. 4a is a front view of a pushing mechanism in a pacing lead implant device according to the present invention;

FIG. 4b is a side view of a pushing mechanism in a pacing lead implant device according to the present invention;

FIG. 4c is a top view of a pushing mechanism of a pacing lead implant device according to the present invention;

FIG. 5 is a schematic diagram of the sliding travel of the pushing mechanism of a pacing lead implantation device according to the present invention;

fig. 6 is a state diagram of step S4 in an embodiment of a pacing lead implantation method provided by the present invention;

fig. 7 is a state diagram of step S5 in an embodiment of a pacing lead implantation method provided by the present invention;

fig. 8 is a state diagram of step S6 in an embodiment of a method for implanting a pacing lead according to the present invention.

In the figure: 100-pacing lead, 101-L type lead segment, 101.1-L type shaping lead, 101.1.1-long end, 101.1.2-short end, 101.2-electrode, 101.4-insulating outer layer, 102-lead connecting segment, 102.1-inner lead, 102.2-insulating outer layer, 103-electric coupling joint, 104-flexible head end;

200-a pacing lead implantation device, 201-a housing, 201.1-a lead channel, 202-a pushing mechanism, 202.1-a clamping unit, 203-a puncture head, 204-a guide rod, 205-a handle;

a-the initial position of the pushing mechanism, B-the locking position of the wire, C-the fixed pushing track and D-the termination releasing position;

300-ribs, 400-chest, 500-heart, 600-external pacemaker.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.

As shown in fig. 1, a pacing lead 100 includes an L-shaped lead segment 101, a lead connection segment 102, and an electrical coupling connector 103;

the L-shaped lead section 101 comprises an L-shaped shaping lead 101.1, electrodes 101.2 and an insulating outer layer 101.4, the L-shaped shaping lead comprises a long end 101.1.1 and a short end 101.1.2 which form an L shape, the short end 101.1.2 deforms under the action of external force to enable the L-shaped shaping lead to become a straight line, the L-shaped shaping lead automatically restores to the original L shape after the external force is removed, the two electrodes 101.2 are arranged on the short end of the L-shaped shaping lead to form a positive electrode and a negative electrode, the two electrodes are respectively electrically connected with corresponding parts of an electric coupling joint, in the example, the electrodes are subjected to fillet treatment, the surface is smooth and has no sharp edge, the insulating outer layer 101.4 is wrapped outside the L-shaped shaping lead, and the two electrodes 101.2 extend out of the insulating outer layer 101.4;

the wire connecting section 102 is connected at one end to the long end 101.1.1 and at the other end to the electric coupling terminal 103.

In a preferred embodiment of the present invention, the L-shaped wire is made of a memory metal, and in a preferred embodiment, the L-shaped wire is made of a nickel-titanium alloy. The L-shaped shaping lead can also be made of a nickel-titanium sheet, or other memory metals, or other shaping modes, so that the L-shaped shaping lead can be ensured to be in a linear shape in the linear channel and be restored to the L shape after being pushed out.

In a preferred embodiment of the invention, as shown in fig. 1, the wire connecting section 102 comprises an inner wire 102.1 and an insulating outer layer 102.2, which is disposed around the inner wire. Wherein, the inner conductor includes at least one, and 2 are adopted in this embodiment. The wire connecting section can adopt a common copper wire as an inner wire to connect the L-shaped shaping wire and the electric coupling joint, and has low manufacturing cost and good conductive effect. The connecting lead can also be made of nickel-titanium alloy and is integrally formed with the L-shaped shaping lead.

In a preferred embodiment of the present invention, as shown in fig. 1, the L-shaped wire segment further comprises a flexible tip 104 disposed at the end of the short end of the insulating outer layer, which can be in soft contact with the lumen without injuring the body.

As shown in fig. 2-5, a pacing lead implanting device is used for implanting the pacing lead into a thoracic cavity, and the device includes a housing 201, a pushing mechanism 202 and a puncturing head 203, wherein a lead channel 201.1 for the pacing lead to pass through is longitudinally arranged in the housing 201, a pacing lead inlet is arranged at the top of the lead channel, the pushing mechanism 202 is longitudinally slidably arranged on the housing 201, a clamping unit 202.1 capable of loosening and clamping the pacing lead arranged in the lead channel is arranged in the pushing mechanism 202, the puncturing head 203 is arranged at the bottom of the housing 201, and an inner cavity of the puncturing head is communicated with the lead channel.

As shown in fig. 4 a-4 c, clamping units 202.1 are disposed on two sides in the pushing mechanism 202, the clamping units may adopt an existing spring clamping structure, and include buttons, springs and clamping blocks, the clamping blocks are moved towards the middle by pressing the buttons on the two sides to push the springs to compress, so as to clamp the pacing lead in the lead channel, the buttons are released, and the springs are reset, so that the pacing lead can be released.

In a preferred embodiment of the present invention, as shown in fig. 2, the device further comprises a guide rod 204 longitudinally mounted on the housing, and the pushing mechanism 202 is slidably mounted on the guide rod 204. The guide rod can guide the sliding of the pushing mechanism, so that the pushing mechanism can smoothly slide up and down.

In a preferred embodiment of the present invention, as shown in FIG. 2, the device further comprises a handle 205 disposed outside the housing 201 to facilitate grasping.

In the implantation device provided by the present invention, the structure adopted in this embodiment is to fix the wires at two sides and push them downward, and a push manner from top to bottom can also be adopted.

As shown in fig. 5, the sliding stroke of the pushing mechanism comprises an initial position, a locking position, a fixed pushing track and a final releasing position.

As shown in fig. 3 and 5, before use, the pushing mechanism is in the initial position, the pacing lead is inserted from the lead channel until the lead tip just enters the puncture head, and the pacing lead with the L-shaped tip is in the straight-off state in the lead channel.

As shown in fig. 5, the initial position a of the pushing mechanism: the pushing mechanism is in a released state, at which time, a pacing lead can be implanted in the lead channel of the device; locking position B of wire: adjusting the pushing mechanism to a locking position, and clamping and fixing the pacing lead by a clamping unit of the pushing mechanism; fixing a pushing track C: when the pacing lead needs to be pushed, the pushing device is pushed to the position, and the pacing lead is implanted into the corresponding position; terminating the relaxed position D: when the pushing mechanism sends the lead to the corresponding position along the track, the pushing mechanism automatically enters the stopping position and releases the lead, and the implantation device can be pushed out at the moment.

Correspondingly, the invention also provides a pacing lead implanting method, which comprises the following steps:

s1, preparing pacing lead 100 and pacing lead implanting device 200;

s2, placing a pushing mechanism of the device at one end (which can be the initial position in fig. 5) of the shell far away from the puncture head, inserting the pacing lead into a lead channel of the device, enabling the L-shaped lead which becomes a straight line to smoothly enter the lead channel due to the deformation of the short end of the L-shaped lead, and clamping the pacing lead through a clamping unit when the short end of the pacing lead does not extend out of the puncture head (which can be the locking position in fig. 5);

s3, finding a proper position among the 4 th, 5 th and 6 th costal bones in the chest right above the heart of the patient, opening a minimally invasive wound, and vertically inserting the puncture head of the device into the chest cavity 400 along the minimally invasive opening formed between the 4 th and 5 th costal bones or between the 5 th and 6 th ribs (the 4 th, 5 th and 6 th ribs are all represented by ribs 300) of the chest;

s4, as shown in figure 6, pushing the pushing mechanism to make the short end of the L-shaped guide wire extend out of the puncture head completely and automatically recover to the original L-shaped shape;

s5, as shown in fig. 7, continuing to move the pushing mechanism until the electrode of the pacing lead contacts with the epicardium (which may be the terminal relaxed position in fig. 5), and stopping pushing the pushing mechanism;

s6, as shown in figure 8, loosening the clamping unit, withdrawing the pacing lead implanting device, fixing the pacing lead between ribs, namely completing the implantation of the pacing lead, and connecting the electric connector of the pacing lead with any commercially available external pacemaker 600, namely realizing the cardiac pacing.

In the description of the present invention, it should be noted that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art. In addition, in the description of the present invention, "a plurality" means two or more unless otherwise specified.

It will be understood that modifications and variations can be made by persons skilled in the art in light of the above teachings and all such modifications and variations are intended to be included within the scope of the invention as defined in the appended claims.

Claims (9)

1. A pacing lead is characterized by comprising an L-shaped lead segment, a lead connecting segment and an electric coupling joint;

the L-shaped lead section comprises an L-shaped shaping lead, electrodes and an insulating outer layer, the L-shaped shaping lead comprises a long end and a short end which form an L shape, the short end deforms under the action of external force to enable the L-shaped shaping lead to become a straight line, the L-shaped shaping lead automatically restores to the original L shape after the external force is cancelled, the two electrodes are arranged on the short end of the L-shaped shaping lead to form a positive electrode and a negative electrode, the insulating outer layer is wrapped outside the L-shaped shaping lead, and the electrodes extend out of the insulating outer layer;

one end of the wire connecting section is connected with the long end, and the other end of the wire connecting section is connected with the electric coupling joint.

2. The pacing lead according to claim 1, wherein the L-shaped lead is made of nitinol.

3. The pacing lead of claim 1 wherein the lead connection section includes an inner lead and an insulating outer layer disposed about the inner lead.

4. The pacing lead of claim 3 wherein the inner lead includes at least one copper wire.

5. The pacing lead according to claim 1 wherein the L-shaped lead segment further includes a flexible tip disposed at an end of the short end.

6. A pacing lead implanting device is used for implanting the pacing lead according to any one of claims 1 to 5 into a thoracic cavity, and is characterized in that the device comprises a shell, a pushing mechanism and a puncture head, wherein a lead channel for the pacing lead to penetrate through is arranged in the shell along the longitudinal direction, the pushing mechanism is arranged on the shell along the longitudinal sliding direction, a clamping unit capable of loosening and clamping the pacing lead arranged in the lead channel is arranged in the pushing mechanism, the puncture head is arranged at the bottom of the shell, and an inner cavity of the puncture head is communicated with the lead channel.

7. The pacing lead implant device of claim 6, further comprising a guide rod longitudinally mounted on the housing, the push mechanism being slidably mounted on the guide rod.

8. The pacing lead implant device of claim 6, further comprising a handle disposed outside the housing.

9. A method of pacing lead implantation, the method comprising the steps of:

s1, preparing the pacing lead of any one of claims 1-5 and the pacing lead implant device of any one of claims 6-8;

s2, placing a pushing mechanism of the device at one end of the shell far away from the puncture head, inserting the pacing lead into a lead channel of the device, enabling the short end of the L-shaped lead to deform so that the L-shaped lead which becomes a straight line can smoothly enter the lead channel, and clamping the pacing lead through a clamping unit when the short end of the pacing lead does not extend out of the puncture head;

s3, vertically inserting the puncture head of the device into the chest along the minimally invasive opening between the 4 th and 5 th costal bones or between the 5 th and 6 th costal bones of the chest;

s4, pushing the pushing mechanism to enable the short end of the L-shaped lead to completely extend out of the puncture head and automatically recover to the original L-shaped shape;

s5, continuously moving the pushing mechanism until the electrode of the pacing lead contacts with the epicardium, and stopping pushing the pushing mechanism;

and S6, loosening the clamping unit, withdrawing the pacing lead implanting device, and fixing the pacing lead between ribs to complete the implantation of the pacing lead.

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