Heart leadless pace-making device and system

Abstract

The invention relates to a heart leadless pace-making device and system.The heart leadless pace-making device comprises a fixing structure used for being fixed in the heart and a pace-making structure detachably connected with the fixing structure; the pace-making structure comprises a body bearing a control assembly, a battery body used for providing a power source for the control assembly and a plurality of electrodes electrically connected with the control assembly, the battery body is in a deformable long strip shape, one end of the battery body is connected with the body, and the electrodes are arranged at intervals in the length direction of the battery body; and when the battery body is unfolded around the body and is flat as a whole, the plurality of electrodes are arranged at different positions on the periphery of the body by taking the body as a center. A plurality of pace-making points can be selected, so that the probability of repeatedly adjusting the pace-making sites is reduced, and the risk of myocardial injury caused by repeatedly adjusting the pace-making sites is reduced; the fixing structure is detachably connected with the pace-making structure, so that the risk of myocardial injury in the process of assembling and replacing the pace-making structure is further reduced.

Description

Technical Field

[0001] The present invention relates to the field of cardiac pacing technology, and in particular to a leadless cardiac pacing device and system. Background Art

[0002] The heart is one of the most important organs in the human body. Only when the heart beats regularly can the body function normally. However, the heart's pacing function can become slow or stop due to disease or aging. Modern medicine uses pacemakers placed in the heart cavity to sense cardiac electrical activity and stimulate myocardial beating, thereby achieving the purpose of treating arrhythmias.

[0003] The more common leadless pacemakers on the market are generally designed as slender cylinders, with most of the cylinder suspended in the heart cavity. The contact area between the pacemaker and the myocardium is small, and only single-point pacemaking can be performed. During implantation, the pacemaker needs to be repeatedly disassembled and assembled, and the pacing site needs to be adjusted, which can easily cause myocardial damage. Summary of the invention

[0004] Based on this, the present invention provides a leadless cardiac pacing device and system, which can effectively reduce the risk of myocardial damage.

[0005] A cardiac leadless pacemaker device comprises a fixing structure for fixing to a cardiac cavity and a pacemaking structure detachably connected to the fixing structure, the pacemaking structure comprising a main body, a battery body and a plurality of electrodes, the main body being provided with a control component, the control component being electrically connected to the battery body and the electrodes, the battery body being in the shape of a deformable long strip, one end of the battery body being connected to the main body, a plurality of the electrodes being arranged at intervals along the length direction of the battery body, and when the battery body is unfolded around the main body and is flat as a whole, the plurality of the electrodes are arranged at different positions on its periphery with the main body as the center.

[0006] In one embodiment, the fixing structure includes a plurality of metal rings or metal hooks preformed from a memory material, and the metal rings or metal hooks are electrically connected to the control component.

[0007] In one embodiment, the fixed structure also includes a mounting portion, on which a plurality of first conductive positions insulated from each other are provided, the metal ring or the metal hook is electrically connected to the first conductive positions respectively, a mounting hole is provided on the main body, and an inner wall of the mounting hole is provided with a plurality of second conductive positions electrically connected to the control component, and when the fixed structure and the pacing structure are threadedly connected through the mounting portion and the mounting hole, the second conductive positions are in contact with the first conductive positions respectively.

[0008] In one embodiment, the fixing structure further includes a transition portion and a first recovery rope, one end of the transition portion is connected to the metal ring or metal hook, the other end of the transition portion is connected to the mounting portion, and the first recovery rope is installed at one end of the mounting portion away from the transition portion; and / or,

[0009] The pacing structure further includes a tail and a second recovery rope, wherein the tail is connected to an end of the battery body away from the main body, and the second recovery rope is installed on the tail;

[0010] And / or, the body is further provided with a fastening position, and the fastening position is used to fasten or loosen the pacing structure and the fixing structure by means of a tool.

[0011] In one embodiment, the transition portion has a diameter of 3mm-5mm and a length of 2mm-15mm; and / or the mounting portion has a length of 5mm-7mm.

[0012] In one embodiment, the battery body includes a strip-shaped frame body preformed from a memory material and a battery assembly installed in the frame body, the battery assembly is electrically connected to the control assembly, and one end of the frame body is connected to the main body; the battery assembly includes a plurality of single cells connected by wires or the battery assembly is a flexible battery that is deformable itself.

[0013] In one embodiment, the control component includes a sensing module, a processing module, an output module and a wireless communication module. The sensing module is used to sense the ECG signal and transmit it to the processing module. The processing module is used to analyze the ECG signal and transmit the analysis result to the output module. The output module is used to transmit control instructions to the electrode according to the analysis result. The wireless communication module is used to enable the control component to achieve internal and / or external communication connection.

[0014] In one embodiment, the end of the electrode is made of metal, and the electrode protrudes outward from the battery body by 1 mm-3 mm.

[0015] In one embodiment, the leadless cardiac pacing device further includes a first sheath, a first pushing member, a second sheath and a second pushing member, the fixed structure is preinstalled on the first sheath, the first pushing member is placed at the end of the fixed structure, and is used to push the fixed structure out of the first sheath; the pacing structure is preinstalled on the second sheath, the second pushing member is placed at the end of the pacing structure, and is used to push the pacing structure out of the second sheath.

[0016] A cardiac wireless pacing system comprises two leadless cardiac pacing devices, one of which is an atrial pacemaker and the other is a ventricular pacemaker, wherein the control component of the atrial pacemaker is communicatively connected with the control component of the ventricular pacemaker.

[0017] The leadless cardiac pacemaker device and system of the present invention punctures the atrial septum or ventricular septum to establish a delivery channel, first implants a fixed structure into the heart cavity to connect to the myocardium, then implants a pacing structure into a corresponding position, and then fully releases the battery body. At this time, the battery body is unfolded around the main body and is flat as a whole. The battery body provides power to the control component, and the control component controls the electrodes to sense the electrocardiographic activity and stimulate the myocardium to beat. After the accurate position of the electrodes is detected, the pacing structure is connected to the fixed structure. Compared with traditional pacemakers, the cardiac leadless pacing device and system of the present invention, on the one hand, has a large contact area between the flat battery body and the myocardial surface after unfolding, and multiple electrodes accompanying the battery body are arranged at different positions on the periphery of the main body with the main body as the center, and multiple pacing points are available, which reduces the probability of repeated adjustment of the pacing site and effectively reduces the risk of myocardial damage caused by repeated adjustment of the pacing site; on the other hand, since the fixed structure and the pacing structure are detachably connected, during assembly, the electrode position of the pacing structure is detected to be accurate before it is connected to the fixed structure. When replaced, the connection between the pacing structure and the fixed structure can be released, further reducing the risk of myocardial damage caused by repeated disassembly of the fixed structure during assembly and replacement of the pacing structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] By reading the detailed description below with reference to the accompanying drawings, the above and other purposes, features and advantages of the exemplary embodiments of the present disclosure will become readily understood. In the accompanying drawings, several embodiments of the present disclosure are shown in an exemplary and non-limiting manner, and the same or corresponding reference numerals represent the same or corresponding parts, wherein:

[0019] Figure 1 is a schematic diagram of a leadless cardiac pacemaker device installed in a cardiac chamber according to an embodiment;

[0020] Figure 2 is a schematic diagram of a pacing structure in a pre-installed state according to an embodiment;

[0021] Figure 3 is a schematic diagram of a first-view of a pacing structure in an expanded state according to an embodiment;

[0022] Figure 4 is a schematic diagram of a second viewing angle of a pacing structure in an expanded state according to an embodiment;

[0023] Figure 5 is a schematic diagram of a fixed structure of an embodiment in a pre-installed state;

[0024] Figure 6 is a schematic diagram of a fixed structure of another embodiment in a pre-installed state;

[0025] Figure 7 is a schematic diagram of the assembly of a leadless cardiac pacemaker device according to an embodiment;

[0026] Figure 8 is a schematic diagram of the assembly of a leadless cardiac pacemaker device according to another embodiment;

[0027] Fig. 9 is a schematic diagram of a battery body of a pacing structure according to an embodiment;

[0028] Fig.10 is a schematic block diagram of a control component of a leadless cardiac pacemaker device according to an embodiment.

[0029] The reference numerals are as follows:

[0030] 01. Pacemaker structure; 10. Main body; 110. Second conductive position; 120. Fastening position; 20. Battery body; 210. Frame body; 221. Single battery; 222. Wire; 30. Electrode; 40. Tail; 50. Second recovery rope; 02. Fixed structure; 610. Metal ring; 620. Metal hook; 70. Transition part; 80. Installation part; 810. First conductive position; 90. First recovery rope; 103. First sheath; 104. First pushing member; 101. Second sheath; 102. Second pushing member; 100. Atrial pacemaker; 200. Ventricular pacemaker. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of the present disclosure to clearly and completely describe the technical solutions in the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, rather than all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present disclosure.

[0032] The specific embodiments of the present disclosure are described in detail below with reference to the accompanying drawings.

[0033] Reference Figure 1-8An embodiment of the present invention provides a cardiac leadless pacemaker, comprising a fixed structure 02 for fixing inside the heart and a pacemaker structure 01 detachably connected to the fixed structure 02. The pacemaker structure 01 comprises a main body 10 carrying a control component, a battery body 20 for providing power to the control component, and a plurality of electrodes 30 electrically connected to the control component. The battery body 20 is in the shape of a deformable long strip, one end of the battery body 20 is connected to the main body 10, and a plurality of the electrodes 30 are arranged at intervals along the length direction of the battery body 20. When the battery body 20 is unfolded around the main body 10 and is flat as a whole, the plurality of the electrodes 30 are arranged at different positions on the periphery of the main body 10 with the main body 10 as the center. The electrical connection may be a circuit connection achieved by wireless or wired technology.

[0034] During implantation, the atrial or ventricular septum is first punctured to establish a delivery channel. Figure 5 or Figure 6 , first implant the fixing structure 02 into the heart cavity and connect it to the myocardium; Figure 2 , and then implant the pacing structure 01 into the corresponding position; refer to Figure 3 , 4 , then the battery body 20 is fully released, and the battery body 20 is unfolded around the main body 10 and is flat as a whole; the battery body 20 provides power to the control component, and the control component controls the electrode 30 to sense the electrocardiographic activity and stimulate the myocardial beating; after detecting that the position of the electrode 30 is accurate, refer to Figure 7 or Figure 8 , and then connect the pacing structure 01 to the fixed structure 02. Compared with the traditional pacemaker, on the one hand, the leadless cardiac pacing device of this embodiment has a large contact area between the flat battery body 20 and the myocardial surface after unfolding, and the multiple electrodes 30 accompanying the battery body 20 are arranged at different positions on the periphery of the main body 10 with the main body 10 as the center, and multiple pacing points are available, which reduces the probability of repeatedly adjusting the pacing site and effectively reduces the risk of myocardial damage caused by repeated adjustment of the pacing site; on the other hand, since the fixed structure 02 and the pacing structure 01 are detachably connected, during assembly, the electrodes 30 of the pacing structure 01 are detected to be accurately positioned before being connected to the fixed structure 02. When replaced, the connection between the pacing structure 01 and the fixed structure 02 can be released, further reducing the risk of myocardial damage caused by repeated disassembly and assembly of the fixed structure 02 during assembly and replacement of the pacing structure 01.

[0035] Optionally, in one embodiment, the electrodes 30 include 4-8 electrodes, such as 4, 5, 6, 7 or 8 electrodes 30 are set according to the use requirements, and the pacemaker point of each corresponding electrode 30 can be programmed respectively. Figure 4In this embodiment, the number of electrodes 30 is set to 8. In the unfolded state, the 8 electrodes 30 are arranged at different positions on the periphery of the body 10 with the body 10 as the center. In the unfolded state, the battery body 20 is flat, and the electrodes 30 connected to the battery body 20 are accompanied by the battery body 20. The flat arrangement has a larger contact area with the myocardial surface. The pacing structure 01 has multiple electrodes 30 and multiple pacing points to choose from. There is no need to repeatedly adjust the leadless cardiac pacemaker, which reduces the operation time, thereby reducing the amount of radiation received by the patient and the doctor and reducing the risk of infection. In addition, the flat arrangement has a larger contact area with the myocardial surface, and the leadless cardiac pacemaker is not easy to shift or fall off.

[0036] Furthermore, in one embodiment, the end of the electrode 30 is made of metal, and the electrode 30 protrudes outward from the battery body 20 by 1mm-3mm, such as 2mm. Multiple electrodes 30 are accompanied by the battery, and are distributed in multiple directions with the body 10 as the center after the battery is coiled into a flat disc. The end of the electrode 30 is made of metal and protrudes toward the myocardial surface by 1mm-3mm relative to the battery body 20 to ensure that the end of the electrode 30 contacts the myocardium, and the other end of the electrode 30 is connected to the electronic component to achieve the purpose of selecting a suitable pacing point and pacing mode.

[0037] In one embodiment, the leadless cardiac pacing device further includes a first sheath tube 103 and a first pusher 104; Figure 5 or Figure 6 , the fixing structure 02 is pre-installed in the first sheath tube 103, and the first pushing member 104 is placed at the end of the fixing structure 02 to push the fixing structure 02 out of the first sheath tube 103; Figure 2 The leadless cardiac pacemaker device also includes a second sheath 101 and a second pusher 102. The pacing structure 01 is preinstalled in the second sheath 101. The second pusher 102 is placed at the end of the pacing structure 01 to push the pacing structure 01 out of the second sheath 101. The first sheath 103, the first pusher 104, the second sheath 101 and the second pusher 102 are part of the delivery device. The delivery device also includes a puncture needle, a tearable sheath and an adjustable curved sheath in the prior art. Before implantation, the femoral vein is punctured, the puncture port is gradually expanded, and the adjustable curved sheath is inserted, with the tearable sheath and the atrial septal puncture needle inside, to reach the oval fossa of the atrial septum / the membrane of the ventricular septum, and puncture is performed. After confirmation that it is in place, the tearable sheath is inserted along the puncture needle to establish a delivery channel.

[0038] Reference Figure 2 In the pre-installed state, the battery body 20 is retracted in the second sheath tube 101. The battery body 20 is designed to be flexible and long, and can be deformed and spirally retracted in the second sheath tube 101, so that it can be installed in the body after miniaturization. Figure 3 , 4In the unfolded state, the battery body 20 is unfolded around the main body 10 and is flat as a whole. Figure 3 is a schematic diagram of the observation from the perspective of the battery body 20 to the main body 10, referring to Figure 1 , that is, a schematic diagram of observation from the atrial cavity / ventricular cavity to the atrial septum / ventricular septum when the leadless cardiac pacemaker is installed in the heart cavity; Figure 4 is a schematic diagram of the observation from the main body 10 to the battery body 20, referring to Figure 1 , that is, a schematic diagram of observing from the atrial septum / ventricular septum to the atrial cavity / ventricular cavity when the leadless cardiac pacemaker is installed in the heart cavity. The battery body 20 can be made of a material with memory properties. After the second sheath 101 is pushed out by the second pushing member 102, the battery body 20 automatically unfolds and becomes flat as a whole, which can be close to the atrial septum or ventricular septum, without affecting the activity of the tricuspid valve, and has less impact on the patient's cardiac function; the flat structure is also more stable to install, which can effectively reduce the risk of pacemaker displacement or detachment. The flexible battery body 20 is connected to the main body 10, and can be designed to have a larger battery space than traditional similar products, with a longer service life, reducing the patient's subsequent replacement costs.

[0039] Reference Fig. 9 In one embodiment, the battery body 20 includes a frame body 210 preformed from a memory material and a battery assembly installed in the frame body 210. The battery assembly is electrically connected to the control assembly, and one end of the frame body 210 is connected to the body 10. The frame body 210 can be made of existing memory materials, has shape memory characteristics, can be folded as a whole under the constraint of the second sheath tube 101, and can automatically unfold into a preset flat shape after being separated from the second sheath tube 101. Optionally, the battery assembly includes a plurality of single cells 221 connected by wires 222 or the battery assembly is a flexible battery that is deformable by itself. The single cell 221 can be a hard battery of the prior art, and the single cell 221 is connected one by one by a flexible wire 222, so that the battery assembly can follow the deformation of the frame body 210 without affecting the performance of the single cell 221. In other embodiments, the battery assembly is a flexible battery that is deformable by itself. The battery assembly can also directly use a flexible battery that is inherently deformable, so that the battery assembly can follow the deformation of the frame body 210 without affecting the performance of the battery.

[0040] Refer to 5 or Figure 6 In one embodiment, the fixing structure 02 includes a plurality of metal rings 610 or metal hooks 620 preformed from memory material, and the metal rings 610 or metal hooks 620 are electrically connected to the control component. The metal rings 610 or metal hooks 620 have a pre-installed state and an expanded state. In the pre-installed state, the metal rings 610 or metal hooks 620 are retracted in the first sheath tube 103; refer to Figure 7 or Figure 8 In the unfolded state, the metal ring 610 or the metal hook 620 unfolds to form a wing shape. During implantation, the first pusher 104 pushes forward, and the metal ring 610 or the metal hook 620 is first pushed out of the first sheath tube 103. After being pushed out, multiple metal rings 610 or metal hooks 620 unfold to form a wing shape. The metal ring 610 is buckled and pressed on the myocardium or the metal hook 620 is hooked on the myocardium, thereby firmly connecting to the myocardium. Figure 1 , 5 7. The ring structure of the metal ring 610 provides a larger fixed contact area, which is suitable for installation in the atrial septum area to reduce the possibility of atrial septal myocardial perforation. Figure 1 , 6 8. The hook-shaped structure of the metal hook 620 provides a more stable connection and is suitable for installation in areas with thicker myocardium or ventricular septum.

[0041] In this embodiment, the number of metal rings 610 is 2, and in other embodiments, the number of metal rings 610 may be 3 or 4. The number of metal hooks is 4, and in other embodiments, the number of metal hooks may be 2, 3, 5 or 6.

[0042] In one embodiment, the control component includes a sensing module, a processing module, an output module and a wireless communication module. The sensing module is used to sense the ECG signal and transmit it to the processing module. The processing module is used to analyze the ECG signal and transmit the analysis result to the output module. The output module is used to transmit a control instruction to the electrode 30 according to the analysis result. The wireless communication module is used to enable the control component to achieve internal and / or external communication. The sensing module, processing module, output module and wireless communication module can use existing technologies to achieve corresponding functions. Fig.10 The control component is electrically connected to the electrode 30, the metal ring 610 or the metal hook 620, and has the functions of sensing and analyzing cardiac electrical signals, outputting pacing signals, external programming, and communication between pacemakers.

[0043] Further, refer to Figure 2 and Figure 5-8In one embodiment, the fixing structure 02 further includes a mounting portion 80, on which a plurality of first conductive positions 810 insulated from each other are disposed, and the metal ring 610 or the metal hook 620 is electrically connected to the first conductive positions 810, respectively. A mounting hole is provided on the body 10, and a plurality of second conductive positions 110 electrically connected to the control component are disposed in the mounting hole. When the fixing structure 02 and the pacing structure 01 are threadedly connected through the mounting portion 80 and the mounting hole, the second conductive positions 110 are in contact with the first conductive positions 810, respectively. The first conductive position 810 is a ring-shaped or sheet-shaped conductive area, and the second conductive position 110 is a sheet-shaped or ring-shaped conductive area. Since the metal ring 610 or the metal hook 620 is in contact with the myocardium, according to the use requirements, the control component controls the sensing module, the processing module, the output module and the wireless communication module to realize the sensing and pacing functions, thereby increasing the pacing sites.

[0044] Specifically, the mounting hole is provided with an internal thread, the mounting portion 80 has an external thread, and the pacing structure 01 and the fixing structure 02 are threadedly connected to the mounting portion 80 through the mounting hole, which is convenient for disassembly and installation. Figure 2 , 7 8. The body 10 of the pacing structure 01 is further provided with a fastening position 120, which is operated by a tool to fasten or loosen the body 10 and the mounting portion 80. Specifically, the fastening position 120 is a hexagonal knob.

[0045] Optionally, in one embodiment, the length of the mounting portion 80 is 5 mm-7 mm. For example, the length of the mounting portion 80 is 6 mm, which ensures the effective connection between the mounting portion 80 and the body 10.

[0046] Reference Figure 5 , 6 In one embodiment, the fixing structure 02 further includes a transition portion 70, one end of which is connected to the metal ring 610 or the metal hook 620, and the other end of which is connected to the mounting portion 80. The length of the transition portion 70 is greater than or equal to the thickness of the atrial / ventricular septum, and the transition portion 70 is penetrated on the atrial / ventricular septum, the metal ring 610 or the metal hook 620 is located on one side of the atrial / ventricular septum, and the mounting portion 80 is located on the other side of the atrial / ventricular septum. The pacemaker is fixed by puncturing the atrial / ventricular septum, which effectively reduces the risk of pacemaker displacement, and can be implanted in different parts of the atrial septum and ventricular septum to ensure the success rate of implantation.

[0047] Optionally, in one embodiment, the transition portion 70 has a diameter of 3mm-5mm and a length of 2mm-15mm. For example, if the thickness of the atrial septum is small, the length of the transition portion 70 of the pacemaker device implanted in the atrium is 2mm-4mm. If the thickness of the ventricular septum is large, the length of the transition portion 70 of the pacemaker device implanted in the ventricle is 5mm-15mm. The diameter of the transition portion 70 is 4mm.

[0048] Furthermore, the fixing structure 02 also includes a first recovery rope 90, which is installed at one end of the mounting portion 80 away from the transition portion 70. Before implantation, the fixing structure 02 is pre-installed in the first sheath tube 103 in a tightened state, and enters from the femoral vein. Referring to 1 and 5, the left atrium is entered from the right atrium through the atrial septum puncture technique, and the first sheath tube 103 is withdrawn to the transition portion 70. At this time, the metal ring 610 is opened and fixed to the left atrial surface of the atrial septum; referring to 1 and 6, the left ventricle is entered from the right ventricle through the ventricular septum puncture technique, and the first sheath tube 103 is withdrawn to the transition portion 70. At this time, the metal hook 620 is opened and fixed to the left ventricular surface of the ventricular septum; if the release is not satisfactory, tighten the first recovery rope 90, and the metal ring 610 or the metal hook 620 can be completely retracted into the first sheath tube 103; after the pacing structure 01 is placed in place, the main body 10 is connected to the mounting portion 80, and the fixing structure 02 and the pacing structure 01 are tightly fixed.

[0049] Reference Figure 2 In one embodiment, the pacing structure 01 further includes a tail 40 and a second recovery rope 50, wherein the tail 40 is connected to an end of the battery body 20 away from the main body 10, and the second recovery rope 50 is installed on the tail 40. After the pacing structure 01 is unfolded, the electrode 30 contacts the myocardium and is fixed with an outer sheath. The pacing electrode 30 can be tested. When the parameters are satisfactory, the second recovery rope 50 is cut off, and the pacing structure 01 remains in the heart. The parameters of the control component can be remotely controlled by an external programmable device. If the parameters are not satisfactory, the pacing structure 01 can be retracted by pulling the second recovery rope 50, and the position can be adjusted and re-placed until the parameters are satisfactory and then the second recovery rope 50 is cut off.

[0050] Specifically, in one embodiment, the tail portion 40 is in a cone shape with a larger front portion and a smaller rear portion. The front end of the tail portion 40 is connected to an end of the battery body 20 away from the main body 10, and the rear end of the tail portion 40 is connected to the second recovery rope 50. Such a design facilitates pulling the cardiac pacing structure 01 toward the outside of the body through the second recovery rope 50.

[0051] The implantation steps of the leadless cardiac pacemaker device in the above embodiment are as follows:

[0052] 1. Puncture the femoral vein, gradually expand the puncture port, insert the adjustable curved sheath with a tear-off sheath and the atrial septal puncture needle, reach the oval fossa of the atrial septum / the membrane of the ventricular septum, puncture, and after confirming that it is in place, insert the tear-off sheath along the puncture needle to establish a delivery channel.

[0053] 2.Reference Figure 5 , 6 , send it into the fixed structure 02 along the tear sheath, push the first pusher 104 forward; under perspective, the metal ring 610 or metal hook 620 can be seen to be in an unfolded state, withdraw the first sheath tube 103, feel tension and heart beat, and confirm that the metal ring 610 or metal hook 620 is accurately in place. If the position is not ideal, tighten the first recovery rope 90 to retract the metal ring 610 or metal hook 620 into the first sheath tube 103, adjust the position and re-place it. After it is accurately in place, withdraw the tear sheath and keep the adjustable bending sheath.

[0054] 3.Reference Figure 2 , insert the pacing structure 01 and the second sheath tube 101 along the adjustable curved sheath and the first recovery rope 90, carefully adjust the position, slowly push through the second pusher 102, and after reaching the appropriate position, fix the second sheath tube 101, push the second pusher 102 forward, and it can be seen under perspective that the pacing structure 01 fully releases the battery body 20 to form a flat disc. If the release of the pacing structure 01 is not satisfactory, the pacing structure 01 can be completely recovered into the second sheath tube 101 by pulling the second recovery rope 50, and released again after adjusting the position.

[0055] 4. Continue to slowly push the second sheath 101 and tighten the first retraction rope 90 to allow the fully released pacing structure 01 to be close to the myocardium. At this time, the pacing parameters can be tested by the external program control device. If the parameters are not satisfactory, the pacing structure 01 can be retracted according to step 3, and the position can be adjusted before release, and each test can be tested until satisfactory.

[0056] 5.Reference Figure 7 , 8 , insert the hexagonal tool to tighten the hexagonal knob of the pacing structure 01, and the fixing structure 02 is tightly fixed to the pacing structure 01.

[0057] 6. Withdraw the second sheath tube 101 and the adjustable curved sheath, pull the first recovery rope 90 for a traction test, and confirm that the pacemaker is firmly fixed to the atrial septum / ventricular septum of the heart. Test the impedance, sensing, pacing threshold and other parameters of each electrode 30 again. When the parameters are satisfactory, cut the second recovery rope 50 and the first recovery rope 90, withdraw the second sheath tube 101 and the adjustable curved sheath, suture the puncture point with an 8-shaped suture, and apply local pressure bandage.

[0058] Traditional leadless pacemakers are generally designed with a slender cylinder. Most of the cylinder is suspended in the heart cavity, with a small contact area with the myocardium. It is generally a single-point pacemaker. The pacing site needs to be adjusted repeatedly during implantation, causing myocardial damage. It is also impossible to implement functions such as His bundle pacing and biventricular pacing. In addition, during heartbeats, blood flow shocks, and daily activities of patients, the relative movement of the pacemaker and the myocardium produces a lever effect, resulting in repeated damage to the contact surface myocardium, causing myocardial fiber inflammation, increased pacing thresholds, and even pacemaker displacement and detachment. In addition, the cylindrical design has a limited implant site, usually placed in the middle and lower part of the ventricular septum and the apex. Some patients have small hearts, and slender pacemakers are prone to affect tricuspid valve activity.

[0059] The leadless pacemaker of the above embodiment of the present application has at least one of the following beneficial effects:

[0060] 1. The pacemaker is flat, has a large contact area with the myocardium, comes with multiple electrodes 30, and has multiple pacing points to choose from. There is no need to repeatedly adjust the pacemaker position, which reduces the operation time, reduces the amount of radiation received by patients and doctors, and reduces the risk of infection.

[0061] 2. The pacemaker is deformable and can be delivered to the atria and ventricles through a sheath with a smaller diameter. When unfolded, the pacemaker is disc-shaped and can be designed with a larger battery space than existing similar products. It can achieve more pacing functions and has a longer service life, reducing the patient's subsequent replacement costs.

[0062] 3. The pacemaker is flat and close to the atrial septum or ventricular septum, which does not affect the activity of the tricuspid valve and has less impact on the patient's cardiac function.

[0063] 4. Pacemakers are implanted in the atria and ventricles at the same time. The two pacemakers can communicate with each other through wireless modes such as Bluetooth. On the one hand, they can achieve physiological pacing by sequential stimulation of the atria and ventricles. On the other hand, they can better identify various arrhythmias and intervene in time.

[0064] 5. Improvement of implantation method: Through the technology of puncturing the atrial septum / ventricular septum, implantation can be performed in different parts of the atrial septum and ventricular septum to ensure the success rate of implantation.

[0065] 6. Improved fixation method: Fix the pacemaker by puncturing the atrial septum / ventricular septum, effectively reducing the risk of pacemaker displacement.

[0066] 7. Improvement of pacing method:

[0067] a. The left atrial electrode 30 is integrated to increase the site of atrial pacing, increase the success rate of atrial pacing, and realize the bi-atrial pacing function.

[0068] b. The integrated left ventricular electrode 30 can realize physiological pacing functions such as His bundle pacing, left bundle branch pacing, biventricular pacing, cardiac resynchronization, etc.

[0069] 8. Can realize defibrillator (ICD) function.

[0070] 9. It can realize the function of cardiac contractility regulator (CCM).

[0071] Combination Figure 1 An embodiment of the present application provides a cardiac wireless pacing system, comprising two cardiac leadless pacing devices of the above-mentioned embodiments, wherein one cardiac leadless pacing device is an atrial pacemaker 100, and the other cardiac leadless pacing device is a ventricular pacemaker 200, and the control component of the atrial pacemaker 100 is communicatively connected with the control component of the ventricular pacemaker 200. The atrial pacemaker 100 and the ventricular pacemaker 200 can communicate with each other through wireless technology such as Bluetooth, and pace according to a set sequence; they can be implanted separately or simultaneously according to the needs of the disease. Both pacemakers are implanted by puncturing the atrial septum / ventricular septum, and a button-type fixed structure 02 is placed in the left atrium / left ventricle, and a variable pacing structure 01 is placed in the right atrium / ventricle.

[0072] In one embodiment, the metal ring 610 of the atrial pacemaker 100 is provided with two contacts with sensing and pacing functions, and the pacing structure 01 of the atrial pacemaker 100 is provided with four electrodes 30; the metal hook 620 of the ventricular pacemaker 200 is provided with four contacts with sensing and pacing functions, and the pacing structure 01 of the ventricular pacemaker 200 has four electrodes 30; each contact and electrode 30 can communicate with each other, and various pacing modes such as His bundle pacing, left bundle branch pacing, and ventricular septum pacing can be implemented through programmed pacing parameters.

[0073] In the above description of this specification, unless otherwise clearly specified and limited, the terms "fixed", "installed", "connected" or "connected" should be understood in a broad sense. For example, with regard to the term "connection", it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal connection of two elements or the interaction relationship between two elements. Therefore, unless otherwise clearly defined in this specification, those skilled in the art can understand the specific meanings of the above terms in the present invention according to the specific circumstances.

[0074] According to the above description of this specification, those skilled in the art may also understand that the terms used below, such as "up", "down", "front", "back", "left", "right", "length", "width", "thickness", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential", "center", "longitudinal", "lateral", "clockwise" or "counterclockwise", etc., which indicate the orientation or position relationship, are based on the orientation or position relationship shown in the drawings of this specification, and are only for the purpose of facilitating the explanation of the scheme of the present invention and simplifying the description, rather than explicitly or implicitly indicating that the device or element involved must have the specific orientation, be constructed and operate in a specific orientation. Therefore, the above-mentioned orientation or position relationship terms cannot be understood or interpreted as limitations on the scheme of the present invention.

[0075] In addition, the terms "first" or "second" used in this specification to refer to numbers or ordinals are only used for descriptive purposes and cannot be understood as explicitly or implicitly indicating relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of this specification, the meaning of "plurality" is at least two, such as two, three or more, etc., unless otherwise clearly and specifically defined.

[0076] Although this specification has shown and described a plurality of embodiments of the present invention, it is apparent to those skilled in the art that such embodiments are provided by way of example only. Those skilled in the art will think of many changes, modifications and alternatives without departing from the thought and spirit of the present invention. It should be understood that in the process of practicing the present invention, various alternatives to the embodiments of the present invention described herein may be adopted. The attached claims are intended to define the scope of protection of the present invention, and therefore cover the modular composition, equivalent or alternatives within the scope of these claims.

Claims

1. A leadless cardiac pacing device, characterized in that: It includes a fixing structure for fixing to a cardiac cavity and a pacing structure detachably connected to the fixing structure, the pacing structure includes a main body, a battery body and a plurality of electrodes, the main body is provided with a control component, the control component is electrically connected to the battery body and the electrodes, the battery body is in a deformable strip shape, one end of the battery body is connected to the main body, a plurality of electrodes are arranged at intervals along the length direction of the battery body, and when the battery body is unfolded around the main body and is flat as a whole, the plurality of electrodes are arranged at different positions on its periphery with the main body as the center.

2. The leadless cardiac pacing device according to claim 1, characterized in that: The fixing structure includes a plurality of metal rings or metal hooks preformed from memory material, and the metal rings or metal hooks are electrically connected to the control component.

3. The leadless cardiac pacing device according to claim 2, characterized in that: The fixed structure also includes a mounting portion, on which a plurality of first conductive positions insulated from each other are provided, and the metal rings or metal hooks are electrically connected to the first conductive positions respectively. A mounting hole is provided on the main body, and a plurality of second conductive positions electrically connected to the control component are provided on the inner wall of the mounting hole. When the fixed structure and the pacing structure are threadedly connected through the mounting portion and the mounting hole, the second conductive positions are in contact with the first conductive positions respectively.

4. The leadless cardiac pacing device according to claim 3, characterized in that: The fixing structure further includes a transition portion and a first recovery rope, one end of the transition portion is connected to the metal ring or metal hook, the other end of the transition portion is connected to the mounting portion, and the first recovery rope is mounted on an end of the mounting portion away from the transition portion; And / or, the pacing structure further includes a tail and a second recovery rope, the tail is connected to an end of the battery body away from the main body, and the second recovery rope is installed on the tail; And / or, the body is further provided with a fastening position, and the fastening position is used to fasten or loosen the pacing structure and the fixing structure by means of a tool.

5. The leadless cardiac pacing device according to claim 4, characterized in that: The transition portion has a diameter of 3mm-5mm and a length of 2mm-15mm; and / or the mounting portion has a length of 5mm-7mm.

6. The leadless cardiac pacing device according to any one of claims 1 to 5, characterized in that: The battery body includes a strip-shaped frame body preformed from memory material and a battery assembly installed in the frame body, the battery assembly is electrically connected to the control assembly, and one end of the frame body is connected to the main body; the battery assembly includes a plurality of single cells connected by wires or the battery assembly is a flexible battery that is deformable itself.

7. The leadless cardiac pacing device according to any one of claims 1 to 5, characterized in that: The control component includes a sensing module, a processing module, an output module and a wireless communication module. The sensing module is used to sense the ECG signal and transmit it to the processing module. The processing module is used to analyze the ECG signal and transmit the analysis result to the output module. The output module is used to transmit control instructions to the electrodes according to the analysis result. The wireless communication module is used to enable the control component to achieve internal and / or external communication connections.

8. The leadless cardiac pacing device according to any one of claims 1 to 5, characterized in that: The end of the electrode is made of metal, and the electrode protrudes outward from the battery body by 1 mm to 3 mm.

9. The leadless cardiac pacing device according to any one of claims 1 to 5, characterized in that: It also includes a first sheath tube, a first pushing member, a second sheath tube and a second pushing member, wherein the fixing structure is preinstalled on the first sheath tube, and the first pushing member is disposed at the end of the fixing structure to push the fixing structure out of the first sheath tube; The pacing structure is preinstalled on the second sheath tube, and the second pushing member is disposed at the end of the pacing structure to push the pacing structure out of the second sheath tube.

10. A cardiac wireless pacing system, characterized in that: The invention comprises two leadless cardiac pacemaker devices as described in any one of claims 1 to 9, wherein one of the leadless cardiac pacemaker devices is an atrial pacemaker, and the other leadless cardiac pacemaker device is a ventricular pacemaker, and the control component of the atrial pacemaker is communicatively connected with the control component of the ventricular pacemaker.

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