CN217366903U - Pace-making lead and implantation device thereof - Google Patents

Abstract

The utility model provides a pacing lead and an implanting device 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 L-shaped shaping leads, electrodes and an insulating outer layer, the L-shaped shaping leads comprise 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 leads to be a straight line, the L-shaped shaping leads automatically recover 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 leads to form a positive electrode and a negative electrode, the insulating outer layer wraps the L-shaped shaping leads, 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 utility model discloses can directly implant the chest fast by the suitable breastbone of patient with the wire that paces in, through electrode and epicardium contact, can be connected with current external pacemaker, can realize cardiac pacing.

Description

Pacing lead and implantation device thereof

Technical Field

The utility model relates to a heart electrode especially relates to a pacing lead and implantation device 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 conventional temporary pacing leads are commonly installed by the following methods: 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 easily removed 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, and the success rate is 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. Via esophageal atrial pacing, 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 implants: 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 utility model patent CN110681053A discloses an epicardial temporary pacing lead and assembly, the myocardium fixing device of which needs to be inserted into the myocardium and fixed at the corresponding position. Chinese utility model patent CN209075859U discloses a temporary pacing lead structure, which is designed with barbs and suture needles. Both the two pacing leads need to be sutured and fixed on the surface of cardiac muscle in the implantation process, so that certain damage can be caused to the cardiac muscle, and the pacing leads are complex in implantation and installation, long in time consumption and incapable of being implanted quickly in emergency.

SUMMERY OF THE UTILITY MODEL

In order to solve the above problems of the existing extracardiac pacing system, the utility model provides a pacing lead and its implantation device, it can be under the condition of no any medical imaging, not pass through vein and heart, utilize implantation device, implant the pacing lead into the epicardium under the sternum directly fast by the fourth, five or six suitable sternums of patient, need not place any hardware in the heart or surface fixation, only through electrode and epicardial contact, be connected the lead with any external pacemaker that markets, can realize the effect of cardiac pacing.

The utility model provides a technical scheme that its technical problem adopted is:

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 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.

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.

A second aspect, the utility model provides a pacing lead implants device for implant the thorax with arbitrary pacing lead of the aforesaid, the device includes casing, push mechanism and puncture head, vertically be equipped with in the casing and supply the wire passageway that pacing lead runs through, push mechanism sets up along longitudinal sliding on the casing, be provided with in the push mechanism and loosen and press from both sides tight clamping unit to the pacing lead of placing in the wire passageway, the puncture head sets up the bottom at the casing, the inner chamber of puncture head with wire passageway intercommunication.

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.

The utility model discloses the beneficial effect who produces is:

the utility model provides a pair of pace-making wire, connecting wire is adopted to the part on its inner conductor, lower part adopts L type design wire to be used for fixed electrode, its shape memory characteristic that utilizes L type design wire, can make pace-making wire take place deformation under the exogenic action, and automatic recovery is primitive shape under free state, this pace-making wire can be under the condition of no any medical imaging, not pass through vein and heart, but get into the thorax (can find the preceding longitudinal separation of at least one entry point entering) by the clearance between 4 th and 5 th rib bone or between 5 th and 6 th rib bone under the cooperation of implanting device, and make electrode and the epicardial contact that lie in L type design wire short-end, thereby make it beat and realize cardiac pacing along with the epicardium.

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

The pacing lead provided by the utility model 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 utility model can be used without medical images and can be connected to any external pacemaker sold in the market.

Drawings

The invention will be further explained with reference to the drawings and examples, wherein:

fig. 1 is a schematic structural diagram of an embodiment of a pacing lead according to the present invention;

fig. 2 is a schematic structural view of an embodiment of a pacing lead implanting device provided by the present invention;

fig. 3 is a schematic structural view of a pacing lead wire built in a pacing lead wire implanting device provided by the present invention;

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

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

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

fig. 5 is a schematic view of the sliding stroke of the pushing mechanism in the pacing lead implanting device according to the present invention;

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

fig. 7 is a state diagram of step S5 in an embodiment of a method for implanting a pacing lead according to 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 accompanying 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 for purposes of illustration only and are not intended to limit the invention. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative efforts belong to the protection 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 tab 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 the preferred embodiment of the present invention, the L-shaped shaping wire is made of memory metal, preferably, the L-shaped shaping wire is made of 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 is pushed out to be restored to the L shape.

In the preferred embodiment of the present invention, as shown in fig. 1, the wire connecting section 102 includes an inner wire 102.1 and an insulating outer layer 102.2, and the insulating outer layer is wrapped 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 electric conduction effect. The connecting lead can also be made of nickel-titanium alloy and is integrally formed with the L-shaped shaping lead.

In the preferred embodiment of the present invention, as shown in fig. 1, the L-shaped wire segment further includes a flexible head end 104, the flexible head end is disposed at the end of the short end of the insulating outer layer, and when contacting the inner cavity, the flexible head end can be in soft contact without harming 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 at two sides in the pushing mechanism 202, and the clamping units may adopt an existing spring clamping structure, including buttons, springs and clamping blocks, and push the springs to compress by pressing the buttons at two sides, so that the clamping blocks move towards the middle at the same time to clamp the pacing lead in the lead channel, and release the buttons, and the springs reset, so that the pacing lead can be released.

In the preferred embodiment of the present invention, as shown in fig. 2, the device further includes 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 the preferred embodiment of the present invention, as shown in fig. 2, the device further comprises a handle 205 disposed outside the housing 201 for easy grasping.

The utility model provides an among the implantation device, the structure that adopts in this embodiment is both sides fixed wire and downward propelling movement, can also adopt the propelling movement mode from top to bottom.

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 utility model discloses still provide a pacing lead implantation method, this method includes following step:

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

s2, placing a pushing mechanism of the device at one end (which can be the initial position in figure 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 figure 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 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);

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.

The utility model provides a pair of pacing lead implantation method, cooperation through pacing lead and pacing lead implantation device, can be under the condition that does not have any medical imaging, do not pass through vein and heart, but at chest skin wicresoft between patient's chest 4 th and the 5 th rib bone or between the 5 th and the 6 th rib bone, utilize implantation device to directly implant the pacing lead to the epicardial department under the sternum from the wicresoft mouth fast, need not place any hardware at heart inside or fixed surface, only contact through electrode and epicardial membrane, and can be connected with any external pacemaker that sells, can realize extracardiac pacing in the thorax.

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", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of the description, but do not indicate or imply that the device or element referred to 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 is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; 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 meaning 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 considered to be within the scope of the invention as defined by the following claims.

Claims (8)

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.

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