Leadless cardiac pacing device and system

Abstract

This utility model relates to a leadless cardiac pacing device and system. The leadless cardiac pacing device includes a fixing structure and a pacing structure. The pacing structure includes a body, a control component, and multiple electrodes. The control component is disposed within the body and electrically connected to the electrodes. The body is elongated, with one side along its length designated as a first surface. The multiple electrodes are spaced apart on the first surface. One end of the fixing structure passes through the first surface and is detachably connected to the pacing structure. The other end of the fixing structure is used to fix the body to the myocardium, with the first surface facing the myocardium. This design features a large contact area with the myocardium, resulting in more stable overall assembly and a lower risk of detachment. Furthermore, the multiple electrodes spaced apart on the first surface provide multiple pacing points to choose from, reducing the likelihood of repeated adjustments to the pacing site and effectively lowering the risk of myocardial damage caused by repeated pacing site adjustments.

Description

Technical Field

[0001] This utility model relates to the field of cardiac pacing technology, and in particular to a leadless cardiac pacing device and system. Background Technology

[0002] The heart is one of the most important organs in the human body; only with a regular heartbeat can the body function normally. However, the heart's pacing function can slow down or stop due to disease or aging. Modern medicine uses pacemakers placed in the heart chambers to sense electrical activity and stimulate the heart muscle to beat, thereby treating arrhythmias.

[0003] Currently, the most common leadless pacemakers on the market are generally designed as slender cylinders, with one end fixed to the myocardium and most of the rest suspended in the heart chamber. However, this type of pacemaker has a small contact area with the myocardium, making the overall assembly unstable and posing a risk of dislodgement. In addition, it can only pace at a single point, and the pacemaker needs to be repeatedly disassembled and reassembled during implantation to adjust the pacing site, which can easily cause myocardial damage. Utility Model Content

[0004] Based on this, the present invention provides a leadless cardiac pacing device and system that is stably assembled and effectively reduces the risk of dislodgement.

[0005] A leadless cardiac pacing device includes a fixing structure and a pacing structure. The pacing structure includes a body, a control component, and multiple electrodes. The control component is disposed within the body and electrically connected to the electrodes. The body is elongated, with one side along its length designated as a first surface. The multiple electrodes are spaced apart on the first surface. One end of the fixing structure passes through the first surface and is detachably connected to the pacing structure. The other end of the fixing structure is used to fix the cardiac muscle, with the first surface facing the cardiac muscle.

[0006] In one embodiment, the pacing structure further includes a fastener, the body has a through hole penetrating the first surface, and the fixing structure includes a connecting part, a positioning part and a fixing part connected in sequence. The fixing part is used to fix the myocardium, the connecting part and the positioning part extend into the through hole, and the connecting part is detachably connected to the body through the fastener.

[0007] In one embodiment,

[0008] The through hole includes a first section and a second section. The inner wall of the first section is provided with a first contact that is electrically connected to the control component. The outer wall of the positioning part is provided with a second contact that is electrically connected to the fixing part. The fastener is located in the second section. When the fixing structure is connected to the pacing structure through the fastener, the second contact and the first contact make contact and conduct.

[0009] In one embodiment, the fastener includes a bolt or a clip, wherein the stud of the bolt is threaded to the connecting portion; or the clip's locking lug engages with the connecting portion; the bolt or clip is provided with a fastening position for fastening or loosening the pacing structure to the fixing structure using a tool.

[0010] In one embodiment, the body is a cuboid, wherein two opposite sides along the length direction are the first surface and the second surface, the through hole penetrates the first surface and the second surface, a plurality of electrodes are arranged at intervals along the length direction of the body on the first surface, and the fastener is connected to the second surface.

[0011] In one embodiment, the fixing structure further includes a limiting portion connected to the positioning portion and located near one end of the fixing portion, the outer diameter of the limiting portion being larger than the aperture of the first segment; and / or,

[0012] The cross-section of the positioning part is a regular polygon, and the first segment is a regular polygonal hole that matches the positioning part.

[0013] In one embodiment, the fixing structure further includes a first tail portion and a retrieval rope, the first tail portion being connected to the connecting portion, and the retrieval rope being installed on the first tail portion; and / or,

[0014] The pacing structure also includes a second tail for connection with a snare, and one side of the body along the width direction is a third surface, on which the second tail is disposed.

[0015] In one embodiment, the fixing part includes a plurality of metal rings or metal hooks pre-formed from shape memory material, the metal rings or metal hooks being electrically connected to the control component; and / or,

[0016] The control component includes a sensing module, a processing module, an output module, a wireless communication module, and a battery. The sensing module senses electrocardiogram (ECG) signals and transmits them to the processing module. The processing module analyzes the ECG signals and transmits the analysis results to the output module. The output module transmits control commands to the electrodes based on the analysis results. The wireless communication module enables the control component to achieve internal and / or external communication connections. The battery provides power to the control component.

[0017] In one embodiment, the leadless cardiac pacing device further includes a first sheath, a first pusher, a second sheath, and a second pusher. The fixing structure is pre-installed in the first sheath, and the first pusher is placed at the end of the fixing structure to push the fixing structure out of the first sheath. The pacing structure is pre-installed in the second sheath along its length, and the second pusher is placed on the fastener of the pacing structure to push the pacing structure out of the second sheath and adjust the direction of the pacing structure.

[0018] A leadless cardiac pacing system includes 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 to the control component of the ventricular pacemaker.

[0019] This invention relates to a leadless cardiac pacing device and system. A delivery channel is established by puncturing the atrial or ventricular septum. A fixed structure is first implanted into the heart chamber along the delivery channel and connected to the myocardium. Then, the pacing structure is implanted in the corresponding position and its orientation is adjusted so that the first surface of the pacing structure faces the fixed structure and is close to the myocardium. A control component controls the electrodes to sense cardiac electrical activity and stimulate myocardial beating. Once the electrode position is detected as accurate, the pacing structure is connected to the fixed structure. Because the main body is elongated, the first surface has a large contact area with the myocardium, resulting in more stable assembly and a lower risk of detachment. Furthermore, multiple electrodes are spaced apart on the first surface, providing multiple pacing points to choose from, reducing the likelihood of repeated adjustments to the pacing site and effectively lowering the risk of myocardial damage caused by repeated adjustments. Attached Figure Description

[0020] The above and other objects, features, and advantages of exemplary embodiments of the present disclosure will become readily apparent upon reading the following detailed description with reference to the accompanying drawings. In the drawings, several embodiments of the present disclosure are illustrated by way of example and not limitation, and like or corresponding reference numerals denote like or corresponding parts, wherein:

[0021] Figure 1 This is a schematic diagram of a leadless cardiac pacemaker installed in a heart chamber according to an embodiment.

[0022] Figure 2 This is a schematic diagram of a pacing structure pre-installed in a second sheath according to one embodiment;

[0023] Figure 3 This is a schematic diagram of the pacing structure extending the second sheath in one embodiment;

[0024] Figure 4 This is a cross-sectional schematic diagram of a pacing structure according to one embodiment;

[0025] Figure 5This is a top view schematic diagram of a pacing structure according to one embodiment;

[0026] Figure 6 This is a bottom view schematic diagram of a pacing structure according to one embodiment;

[0027] Figure 7 This is a schematic diagram of a fixing structure pre-installed in the first sheath in one embodiment;

[0028] Figure 8 This is a schematic diagram of a fixing structure pre-installed in the first sheath according to another embodiment;

[0029] Figure 9 This is an assembly schematic diagram of a leadless cardiac pacemaker according to one embodiment;

[0030] Figure 10 This is an assembly diagram of another embodiment of a leadless cardiac pacemaker.

[0031] The attached figures are labeled as follows:

[0032] 01. Pacing structure; 10. Body; 101. First surface; 102. Second surface; 103. Third surface; 104. Through hole; 1041. First section; 1042. Second section; 11. Fastener; 111. Fastening position; 20. Control component; 30. Electrode; 40. Second tail; 02. Fixing structure; 50. Connecting part; 60. Positioning part; 70. Fixing part; 80. Limiting part; 91. First tail; 92. Retrieval rope; 210. First sheath; 220. First pusher; 230. Second sheath; 240. Second pusher; 242. Main rod; 244. Branch rod; 100. Atrial pacemaker; 200. Ventricular pacemaker. Detailed Implementation

[0033] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0034] The specific embodiments of this disclosure will now be described in detail with reference to the accompanying drawings.

[0035] Reference Figure 9 , 10 This utility model provides a leadless cardiac pacing device, including a fixing structure 02 and a pacing structure 01. (See reference...) Figure 2-6The pacing structure 01 includes a body 10, a control component 20, and multiple electrodes 30. The control component 20 is disposed within the body 10 and electrically connected to the electrodes 30. The body 10 is elongated, with one side along its length designated as a first surface 101. The multiple electrodes 30 are spaced apart on the first surface 101. One end of a fixing structure 02 passes through the first surface 101 and is detachably connected to the pacing structure 01; the other end of the fixing structure 02 is used to fix the pacing structure to the myocardium, with the first surface 101 facing the myocardium. The electrical connection can be a circuit connection achieved through wireless or wired technology. The first surface 101 of the pacing structure 01 has multiple electrodes 30, which, after implantation, contact the myocardium for sensing myocardial electrical signals and delivering pacing signals.

[0036] The control component 20 is the part that performs circuit control of the pacing device, and can adopt the control principles and components of existing pacemakers. Specifically, the control component 20 includes a sensing module, a processing module, an output module, a wireless communication module, and a battery. The sensing module is used to sense electrocardiogram (ECG) signals and transmit them to the processing module. The processing module is used to analyze the ECG signals and transmit the analysis results to the output module. The output module is used to transmit control commands to the electrodes 30 based on the analysis results. The wireless communication module is used to enable communication connections between multiple internal components and / or external components of the control component 20. The battery is used to provide power to the control component 20.

[0037] When implanting the leadless pacemaker of this embodiment, a delivery channel is first established by puncturing the atrial septum or ventricular septum of the heart using a tool, referring to... Figure 7 , 8 First, the fixed structure 02 is implanted into the heart chamber along the delivery channel and connected to the myocardium, referring to... Figure 2 , 3 Next, the pacing structure 01 is implanted in the corresponding position and its orientation is adjusted so that the first surface 101 of the pacing structure 01 faces the fixed structure 02 and is close to the myocardium. The control component 20 controls the electrode 30 to sense cardiac electrical activity and stimulate myocardial beating. After detecting that the electrode 30 is in an accurate position, refer to Figure 9 , 10 Then connect the pacing structure 01 to the fixed structure 02, referring to... Figure 1Because the body 10 is elongated, the first surface 101 has a large contact area with the myocardium, resulting in more stable overall assembly and a lower risk of detachment. Furthermore, multiple electrodes 30 are spaced apart on the first surface 101, providing multiple pacing sites to choose from, reducing the likelihood of repeated adjustments to the pacing site and effectively lowering the risk of myocardial damage caused by such adjustments. Moreover, since the fixing structure 02 and the pacing structure 01 are detachably connected, during assembly, the electrode 30 of the pacing structure 01 is connected to the fixing structure 02 only after its position is confirmed to be accurate. During replacement, the connection between the pacing structure 01 and the fixing structure 02 can be disconnected, further reducing the risk of myocardial damage caused by repeated disassembly and reassembly of the fixing structure 02 during the assembly and replacement of the pacing structure 01.

[0038] Furthermore, in one embodiment, the pacing structure 01 further includes a fastener 11. The body 10 has a through hole 104 penetrating the first surface 101. The fixing structure 02 includes a connecting part 50, a positioning part 60, and a fixing part 70 connected in sequence. The fixing part 70 is used to fix the myocardium. The connecting part 50 and the positioning part 60 extend into the through hole 104. The connecting part 50 is detachably connected to the body 10 via the fastener 11. Using a tool, force is applied to the fastener 11 to connect or loosen the fixing structure 02 and the pacing structure 01. The body 10 is fixed to the connecting part 50 by means of threads, snaps, etc.

[0039] In one embodiment, the leadless cardiac pacing device further includes a first sheath 210, a first pusher 220, a second sheath 230, and a second pusher 240. A fixing structure 02 is pre-installed in the first sheath 210, and the first pusher 220 is positioned at the end of the fixing structure 02 to extend the fixing structure 02 out of the first sheath 210. A pacing structure 01 is pre-installed along its length in the second sheath 230, and the second pusher 240 is positioned in the fastener 11 of the pacing structure 01. The second pusher, in a retracted state, is placed within the second sheath 230 pre-installed with fastener 11. It is used to push the pacing structure 01 out of the second sheath 230. After the pacing structure 01 is pushed out, the second pusher 240 and the second sheath 230 work together to adjust the angle and direction of the pacing structure 01, aligning its first surface 101 with the fixed structure 02 and fitting it onto the fixed structure 02. Rotating the second pusher 240 causes the fastener 11 to rotate, thus fixing and releasing the fixed structure 02 from the pacing structure 01. After the fixed structure 02 and the pacing structure 01 are fixed, the connection between the second pusher and the pacing structure 01 is released, leaving the pacing structure 01 inside the heart.

[0040] The first sheath 210, the first pusher 220, the second sheath 230, and the second pusher 240 are delivery devices for implanting the pacing structure 01 and the fixation structure 02 into the heart chamber. Existing delivery devices can be used or adapted to existing methods. The delivery device also includes existing puncture needles, tearable sheaths, and adjustable bending sheaths. Before implantation, a femoral vein is punctured, the puncture site is gradually dilated, and an adjustable bending sheath containing a tearable sheath and an atrial septum puncture needle is inserted. The needle reaches the fossa ovalis / membranous septum of the atrial septum, is punctured, and after confirmation of placement, the tearable sheath is inserted along the puncture needle to establish a delivery channel.

[0041] Optionally, in one embodiment, the fastener 11 includes a bolt. The bolt is engaged with the body 10 and is rotatable relative to the body 10. The bolt's shank is threadedly connected to the connecting portion 50. The bolt has a fastening position 111, which is used to fasten or loosen the pacing structure 01 and the fixing structure 02 using a tool. Specifically, the bolt's shank is annular, with an internal thread on its inner ring and an external thread on the connecting portion. The pacing structure 01 and the fixing structure 02 are threadedly connected to the connecting portion 50 via the fastener 11, facilitating disassembly and installation. The bolt includes a connected nut, a flange, and a shank. The shank is annular and is used to connect the body 10 and the connecting portion 50. The nut is the fastening position 111, and the tool applies force to the nut to drive the shank to rotate. The flange is engaged with the body 10 and is rotatable relative to the body 10. Further, referring to... Figure 2 , 3 With the aid of tools such as a second push rod or a clamping device that can be held in the fastening position 111, the fastener 11 is rotated, thereby fastening or loosening the body 10 and the connecting part 50. The second push rod includes a main rod 242 and a branch rod 244. One end of the main rod 242 and one end of the branch rod 244 are respectively locked on one side of the fastening position 111. The other end of the main rod 242 is the operating end, used to apply force to push the pacing structure 01 to move, adjust its direction, and rotate the fastener 11. The other end of the branch rod 244 is rotatably connected to the main rod 242. In the pre-installed state, the branch rod 244 is retracted close to the main rod 242 and placed inside the second sheath 230, which facilitates the main rod 242 to apply force to push the pacing structure 01 out of the second sheath 230. After the pacing structure 01 is pushed out of the second sheath 230, the branch rod 244 rotates to form a certain angle with the main rod 242. The two work together in the fastening position 111, which facilitates the application of force to rotate the fastener 11. In other embodiments, the fastener 11 can be rotated using a tool fitted over the fastener 11, which is a tool of the prior art.

[0042] In other embodiments, the fastener 11 can also be a snap-fit. The snap-fit ​​is engaged with the body 10. The snap-fit's locking tab engages with the connecting portion 50. The snap-fit ​​has a fastening position 111, which is used to fasten or loosen the pacing structure 01 and the fixing structure 02 using a tool. The locking tab is located on one side of the fastening position 111, and the other side of the fastening position 111 protrudes to facilitate the application of force by a tool on the fastener 11.

[0043] Optionally, in one embodiment, the electrodes 30 include 4-8, such as 4, 5, 6, 7 or 8 electrodes 30 as needed, allowing for individual programming of the pacing point of each corresponding electrode 30. (Refer to...) Figure 4 , 6 In this embodiment, four electrodes 30 are provided. In this embodiment, the four electrodes 30 are arranged at intervals along the length of the body 10 on the first surface 101. The long strip body 10 has a larger contact area with the myocardial surface. The pacing structure 01 has multiple electrodes 30 and multiple pacing points to choose from. It is not necessary to repeatedly adjust the leadless pacing device of the heart, which reduces the operation time, thereby reducing the radiation dose received by the patient and doctor and reducing the risk of infection.

[0044] Reference Figure 7-10 In one embodiment, the fixing part 70 includes a plurality of metal rings or metal hooks pre-formed from a shape memory material, the metal rings or metal hooks being electrically connected to the control component 20. The metal rings or metal hooks have a pre-installed state and an extended state, as shown in the figure. Figure 7 , 8 In the pre-installed state, the metal ring or metal hook is retracted into the first sheath 210; refer to 9 or Figure 10 In its unfolded state, the metal rings or hooks unfold into a wing-like shape. During implantation, the first pusher 220 pushes forward, and the metal rings or hooks are first pushed out of the first sheath 210. After being pushed out, multiple metal rings or hooks unfold into a wing-like shape, with the metal rings pressing inward onto the myocardium or the metal hooks hooking onto the myocardium, thereby securing a stable connection to the myocardium. Figure 1 , 9 The ring-shaped structure of the metal ring provides a larger fixed contact area, making it suitable for installation in the atrial septum region and reducing the possibility of atrial septal myocardial perforation. The hook-shaped structure of the metal hook provides a more stable connection, suitable for installation in areas with thicker myocardium or the interventricular septum region. The control component 20 is electrically connected to the electrode 30, the metal ring, or the metal hook, and has functions such as sensing and analyzing cardiac electrical signals, outputting pacing signals, external programming, and communication between pacemakers.

[0045] In one embodiment, two metal rings are provided; in other embodiments, three or four metal rings may be provided. Four metal hooks are provided; in other embodiments, two, three, five, or six metal hooks may be provided.

[0046] Reference Figure 4 , 9 10. In one embodiment, the through hole 104 includes a first segment 1041 and a second segment 1042. The inner wall of the first segment 1041 is provided with a first contact electrically connected to the control component 20, and the outer wall of the positioning part 60 is provided with a second contact electrically connected to the fixing part 70. The second contact and the fastener 11 are located in the second segment 1042. When the fixing structure 02 is connected to the pacing structure 01 through the fastener 11, the second contact and the first contact make contact and conduct. The first contact and the second contact are linear, annular, sheet-like, or dot-shaped conductive areas. Since the fixing part 70 is in contact with the myocardium, the control component 20 controls the fixing part 70 to realize the sensing and pacing functions according to the usage requirements, increasing the pacing sites.

[0047] In one embodiment, the positioning part 60 has a regular polygonal cross-section. The first segment 1041 has a regular polygonal hole that matches the positioning part 60. This design allows the positioning part 60, with its regular polygonal outer periphery, to more securely connect to the myocardium after the fixation structure 02 is implanted, preventing rotation. Furthermore, the regular polygonal structure facilitates the implantation of the pacing structure 01. The positioning part 60 and the first segment 1041 work together to quickly position the pacing structure 01 initially onto the fixation structure 02, and then force is applied to the fastener 11 to lock or release the pacing structure 01 from the fixation structure 02. Optionally, the positioning part 60 has a regular 12-sided cross-section, and the first segment 1041 has a regular 12-sided hole that matches the positioning part 60. In other embodiments, the cross-section of the positioning part 60 can also be a regular pentagon, hexagon, heptagon, etc.

[0048] Reference Figure 7-10 In one embodiment, the fixing structure 02 further includes a limiting part 80, which is connected to the positioning part 60 and located near the fixing part 70. The outer diameter of the limiting part 80 is larger than the aperture of the first segment 1041. This limits the position of the fixing structure 02 extending into the through hole 104, enabling rapid positioning and assembly.

[0049] In one embodiment, the fixation structure 02 further includes a first tail 91 and a retrieval rope 92. The first tail 91 is connected to the connecting part 50, and the retrieval rope 92 is installed on the first tail 91. Before implantation, the fixation structure 02 is pre-installed in the first sheath 210 in a tightened state and enters through the femoral vein. It is then inserted from the right atrium to the left atrium via interatrial septal puncture. The first sheath 210 is then withdrawn to the positioning part 60, at which point the metal ring opens and is fixed to the left atrial surface of the interatrial septum. Similarly, it is inserted from the right ventricle to the left ventricle via interventricular septal puncture. The first sheath 210 is then withdrawn to the positioning part 60, at which point the metal hook opens and is fixed to the left ventricular surface of the interventricular septum. If the release is unsatisfactory, the retrieval rope 92 is tightened, and the metal ring or metal hook can be completely retracted into the first sheath 210. Subsequently, after the pacing structure 01 is placed in place, the pacing structure 01 is connected to the fixation structure 02.

[0050] Reference Figure 2-6 In one embodiment, the body 10 is cuboid, with two opposite sides along its length being the first surface 101 and the second surface 102. The through-hole 104 penetrates both the first surface 101 and the second surface 102. A plurality of electrodes 30 are spaced apart along the length of the body 10 on the first surface 101, and the fastener 11 is fastened to the second surface 102. The cuboid body 10 rests against one side of the myocardium with its long side facing it, while the fixing structure 02 is positioned on the other side of the myocardium, resulting in a larger contact area and a more stable and less prone-to-detachment installation of the entire pacing device.

[0051] The pacing structure 01 also includes a second tail 40 for connection with a snare. One side of the body 10 along its width is a third surface 103, and the second tail 40 is disposed on the third surface 103. The second tail 40 is a T-shaped protrusion that can be captured by the snare for pacemaker replacement. After implantation, the electrode 30 of the pacing structure 01 contacts the myocardium and is fixed in place by an outer sheath. The pacing electrode 30 can be tested. If the parameters are satisfactory, the pacing structure 01 remains in the heart, and the parameters of the control component 20 can be remotely controlled via an external programming device. If the parameters are unsatisfactory, the pacing structure 01 can be retrieved by placing the snare on the second tail 40, adjusted in position, and then repositioned.

[0052] Combination Figure 1One embodiment of this application provides a leadless cardiac pacing system, comprising two leadless cardiac pacing devices, one of which is an atrial pacemaker 100 and the other is a ventricular pacemaker 200. The control component 20 of the atrial pacemaker 100 is communicatively connected to the control component 20 of the ventricular pacemaker 200. The atrial pacemaker 100 and the ventricular pacemaker 200 can communicate wirelessly via technology such as Bluetooth and pace in a pre-set sequence; they can be implanted individually or simultaneously as needed. Both pacemakers are placed via puncture of the atrial septum / ventricular septum, with a fixed structure 02 placed in the left atrium / left ventricle and a long strip-shaped pacing structure 01 placed in the right atrium / ventricle.

[0053] In one embodiment, the metal ring of the atrial pacemaker 100 has two contacts with sensing and pacing functions, and the pacing structure 01 of the atrial pacemaker 100 has four electrodes 30; the metal hook of the ventricular pacemaker 200 has 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 be communicated and connected to implement various pacing modes such as His bundle pacing, left bundle branch pacing, and ventricular septal pacing by programming pacing parameters.

[0054] The implantation steps of the leadless cardiac pacemaker and system described in the above embodiments are as follows:

[0055] 1. Femoral vein puncture, gradually dilate the puncture site, insert an adjustable curved sheath containing a tear-off sheath and an atrial septum puncture needle, reach the fossa ovalis / membranous septum of the atrial septum, puncture, and after confirming that the position is in place, insert the tear-off sheath along the puncture needle to establish a delivery channel.

[0056] 2.Reference Figure 7 , 8 Insert the device into the fixed structure 02 along the torn sheath, and push the first pusher 220 forward; under fluoroscopy, the metal ring or metal hook can be seen in an unfolded state. Retract the first sheath 210, feel tension and a heartbeat, confirming that the metal ring or metal hook is accurately in place. If the position is not ideal, tighten the recovery rope 92 to retract the metal ring or metal hook into the first sheath 210, adjust the position, and reposition it. After accurate placement, remove the torn sheath and retain the adjustable curved sheath.

[0057] 3.Reference Figure 2 The pacing structure 01 and the second sheath 230 are inserted along the adjustable curved sheath and retrieval rope 92. The position is carefully adjusted, and the second pusher 240 is used to slowly advance the pacing structure. Once the desired position is reached, the second sheath 230 is fixed, and the second pusher 240 is pushed forward. Under fluoroscopy, the pacing structure 01 can be seen fully released, with its first surface 101 facing the myocardium. If the release of the pacing structure 01 is unsatisfactory, the angle and position of the pacing structure 01 can be adjusted and it can be re-released using the second pusher rod in conjunction with the second sheath 230.

[0058] 4. Continue to slowly advance the second sheath 230, allowing the fully released pacing structure 01 to adhere tightly to the myocardium. At this point, various pacing parameters can be tested using an external programming device. If the parameters are not satisfactory, the pacing structure 01 can be retrieved according to step 3, its position adjusted, and then released again. Test all parameters until satisfactory results are achieved.

[0059] 5. Rotate the second push rod to secure the fixed structure 02 to the pacing structure 01.

[0060] 6. Withdraw the second sheath 230 and the adjustable curved sheath, and pull the retrieval cord 92 to perform a traction test to confirm that the pacemaker is firmly fixed to the atrial / ventricular septum. Test the impedance, sensing, pacing threshold, and other parameters of each electrode 30 again. After the parameters are satisfactory, cut the retrieval cord 92, withdraw the second sheath 230 and the adjustable curved sheath, suture the puncture site with a figure-eight suture, and apply local pressure bandage.

[0061] Traditional leadless pacemakers typically employ a slender cylindrical design, with most of the cylinder suspended within the heart chambers. This results in a small contact area with the myocardium, generally leading to single-point pacing. Repeated adjustments to the pacing site during implantation can cause myocardial damage. They also cannot perform His bundle pacing or biventricular pacing. Furthermore, the relative movement of the pacemaker and myocardium during heartbeats, blood flow, and daily activities creates a leverage effect, causing repeated damage to the myocardium at the contact surface, leading to myocardial fibrosis, elevated pacing threshold, and even pacemaker displacement or dislodgement. Additionally, the cylindrical design limits implantation sites, typically placing it in the lower middle part of the interventricular septum or at the apex. In some patients with smaller hearts, the slender pacemaker can easily interfere with tricuspid valve activity.

[0062] The leadless cardiac pacing device and system of the above embodiments of this application have at least one of the following beneficial effects:

[0063] 1. The pacing structure 01 is elongated and has a large contact area with the myocardium. It has multiple electrodes 30 and multiple pacing points to choose from. It does not require repeated adjustment of the pacemaker position, reducing operation time, radiation exposure to patients and doctors, and reducing the risk of infection.

[0064] 2. The elongated pacing structure 01 can be delivered to the atria and ventricles through a smaller diameter sheath. It can be designed with a larger battery space than existing similar products, enabling more pacing functions and a longer service life, reducing subsequent replacement costs for patients.

[0065] 3. The pacing structure 01 is attached to the atrial or ventricular septum, does not affect the activity of the tricuspid valve, and has little impact on the patient's cardiac function.

[0066] 4. Simultaneously implanting pacemakers in both the atrium and ventricle, the two pacemakers can communicate wirelessly via Bluetooth or other methods. This enables sequential atrial and ventricular stimulation for physiological pacing and also allows for better identification and timely intervention of various arrhythmias.

[0067] 5. Improved implantation method: By using the puncture technique of the atrial septum / ventricular septum, implantation can be performed at different sites in the atrial septum and ventricular septum, ensuring a high success rate of implantation.

[0068] 6. Improved fixation method: The pacemaker is fixed by puncturing the atrial septum / ventricular septum, which effectively reduces the risk of pacemaker displacement.

[0069] 7. Improved pacing method:

[0070] a. Integrating a left atrial electrode increases the number of atrial pacing sites, improves the success rate of atrial pacing, and enables dual atrial pacing function.

[0071] b. Integrated left ventricular electrode, enabling physiological pacing functions such as His bundle pacing, left bundle branch pacing, biventricular pacing, and cardiac resynchronization.

[0072] 8. It can perform defibrillation (ICD) function.

[0073] 9. It can realize the function of cardiac contractility modulator (CCM).

[0074] In the foregoing description of this specification, unless otherwise expressly specified and limited, the terms "fixed," "installed," "connected," or "joined" should be interpreted broadly. For example, the term "joined" can refer to a fixed connection, a detachable connection, or an integral connection; 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 refer to the internal communication of two components or the interaction between two components. Therefore, unless otherwise expressly limited in this specification, those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0075] Based on the above description in this specification, those skilled in the art will also understand that terms used, such as "upper," "lower," "front," "rear," "left," "right," "length," "width," "thickness," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," "circumferential," "center," "longitudinal," "transverse," "clockwise," or "counterclockwise," are terms indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings of this specification. They are only for the purpose of facilitating the explanation of the present invention and simplifying the description, and do not imply that the device or element involved must have the specific orientation, or be constructed and operated in a specific orientation. Therefore, the above-mentioned orientation or positional relationship terms should not be understood or interpreted as limitations on the present invention.

[0076] Furthermore, the terms "first" or "second," etc., used in this specification to refer to numbers or ordinal numbers are for descriptive purposes only and should not be construed as indicating, explicitly or implicitly, relative importance or specifying the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this specification, "a plurality of" means at least two, such as two, three, or more, unless otherwise explicitly specified.

[0077] While this specification has shown and described various embodiments of the present invention, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Many modifications, alterations, and alternatives will occur to those skilled in the art without departing from the spirit and essence of the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed in the practice of the present invention. The appended claims are intended to define the scope of protection of the present invention and therefore cover the modular compositions, equivalents, or alternatives within the scope of these claims.

Claims

1. A leadless cardiac pacing device, characterized in that, The device includes a fixation structure and a pacing structure. The pacing structure includes a body, a control component, and multiple electrodes. The control component is disposed within the body and electrically connected to the electrodes. The body is elongated, with one side along its length being a first surface. Multiple electrodes are spaced apart on the first surface. One end of the fixation structure passes through the first surface and is detachably connected to the pacing structure. The other end of the fixation structure is used to fix the device to the myocardium, with the first surface facing the myocardium.

2. The leadless cardiac pacing device according to claim 1, characterized in that, The pacing structure also includes a fastener. The body has a through hole penetrating the first surface. The fixing structure includes a connecting part, a positioning part, and a fixing part connected in sequence. The fixing part is used to fix the myocardium. The connecting part and the positioning part extend into the through hole. The connecting part is detachably connected to the body through the fastener.

3. The leadless cardiac pacing device according to claim 2, characterized in that, The through hole includes a first section and a second section. The inner wall of the first section is provided with a first contact that is electrically connected to the control component. The outer wall of the positioning part is provided with a second contact that is electrically connected to the fixing part. The fastener is located in the second section. When the fixing structure is connected to the pacing structure through the fastener, the second contact and the first contact make contact and conduct.

4. The leadless cardiac pacing device according to claim 3, characterized in that, The fastener includes a bolt or a clip, wherein the stud of the bolt is threaded to the connecting part; or the clip's locking lug engages with the connecting part; the bolt or clip is provided with a fastening position, which is used to fasten or loosen the pacing structure to the fixing structure using a tool.

5. The leadless cardiac pacing device according to claim 4, characterized in that, The body is a cuboid, with two opposite sides along its length being the first side and the second side, respectively. The through hole penetrates the first side and the second side. A plurality of electrodes are arranged at intervals along the length of the body on the first side, and the fasteners are connected to the second side.

6. The leadless cardiac pacing device according to claim 5, characterized in that, The fixing structure further includes a limiting part, which is connected to the positioning part and located at one end near the fixing part. The outer diameter of the limiting part is larger than the aperture of the first segment; and / or, The cross-section of the positioning part is a regular polygon, and the first segment is a regular polygonal hole that matches the positioning part.

7. The leadless cardiac pacing device according to claim 6, characterized in that, The fixing structure further includes a first tail section and a retrieval rope, wherein the first tail section is connected to the connecting portion, and the retrieval rope is installed on the first tail section; and / or The pacing structure also includes a second tail for connection with a snare, and one side of the body along the width direction is a third surface, on which the second tail is disposed.

8. The leadless cardiac pacing device according to any one of claims 2-7, characterized in that, The fixing part includes multiple metal rings or metal hooks pre-formed from shape memory material, the metal rings or metal hooks being electrically connected to the control component; and / or, The control component includes a sensing module, a processing module, an output module, a wireless communication module, and a battery. The sensing module senses electrocardiogram (ECG) signals and transmits them to the processing module. The processing module analyzes the ECG signals and transmits the analysis results to the output module. The output module transmits control commands to the electrodes based on the analysis results. The wireless communication module enables the control component to achieve internal and / or external communication connections. The battery provides power to the control component.

9. The leadless cardiac pacing device according to any one of claims 2-7, characterized in that, It also includes a first sheath, a first pusher, a second sheath, and a second pusher. The fixing structure is pre-installed in the first sheath, and the first pusher is placed at the end of the fixing structure to push the fixing structure out of the first sheath. The pacing structure is pre-installed on the second sheath along its length, and the second pusher is placed on the fastener of the pacing structure for pushing the pacing structure out of the second sheath and adjusting the direction of the pacing structure.

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

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