Heart pacing structure and lead-free pacemaker

Abstract

The utility model relates to a heart pace-making structure and a lead-free pacemaker, the heart pace-making structure comprises a flexible battery part, a head part used for being connected with a fixing structure and an electrode installed on the battery part or the head part, the head part is used for bearing a control system, and the electrode is electrically connected with the control system. The battery part is connected to the head part and is used for providing a power supply for the control system, and the battery part has a preassembled state and an unfolded state; in a preassembled state, the battery part is shrunk in the sheath tube; and in the unfolding state, the battery part is unfolded around the head part and is flat as a whole. The pacemaker can be designed to have a larger battery space than a traditional similar product, the service life is longer, the follow-up replacement cost of a patient is reduced, the installation page is more stable, and the risk that the pacemaker shifts or falls off can be effectively reduced.

Description

Technical Field

[0001] This utility model relates to the field of cardiac pacing technology, and in particular to a cardiac pacing structure and a leadless pacemaker. 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 generally adopt a slender cylindrical structure to achieve miniaturization. However, this structure compresses the battery space, which affects the pacemaker's lifespan and also makes it prone to pacemaker displacement or even detachment. Utility Model Content

[0004] Based on this, the present invention provides a cardiac pacing structure and a leadless pacemaker, which has a larger battery design space, a longer service life, and is not easily displaced or detached.

[0005] Specifically, the present invention provides a cardiac pacing structure, including a flexible battery section, a head for connection with a fixed structure, and electrodes mounted on the battery section or the head. The head is used to carry a control system, the electrodes are electrically connected to the control system, the battery section is connected to the head and is used to provide power to the control system, and the battery section has a pre-installed state and an unfolded state.

[0006] In the pre-installed state, the battery section is retracted into the sheath;

[0007] In the unfolded state, the battery unit unfolds around the head and is flat overall.

[0008] In one embodiment, the battery unit includes a strip-shaped frame made of shape memory material and a battery assembly mounted in the frame, the battery assembly being electrically connected to the control system, and one end of the frame being connected to the head.

[0009] In one embodiment, the battery assembly includes a plurality of individual cells connected by wires; or the battery assembly is a flexible battery that is deformable.

[0010] In one embodiment, the electrodes include 4-8 electrodes, which are arranged at different positions around the head in the unfolded state.

[0011] In one embodiment, the cardiac pacing structure further includes a tail and a retrieval rope, the tail being connected to the end of the battery unit away from the head, and the retrieval rope being installed on the tail.

[0012] In one embodiment, the tail is tapered, wider at the front and narrower at the back, with the front end of the tail connected to the end of the battery unit furthest from the head, and the rear end of the tail connected to the retrieval rope.

[0013] A leadless pacemaker includes a fixation structure and a cardiac pacing structure, wherein the cardiac pacing structure is connected to the fixation structure via the head.

[0014] In one embodiment, the fixing structure includes a fixing part, a connecting part, and an mounting part connected in sequence. The fixing part is used to fix it inside the heart, and the mounting part is detachably connected to the head.

[0015] In one embodiment, the fixing part includes multiple metal rings or metal hooks made of shape memory material, one end of each metal ring or metal hook being connected to the connecting part, having a pre-installed state and an unfolded state.

[0016] In the pre-installed state, the metal ring or metal hook is retracted into the conveying sheath;

[0017] In the unfolded state, the metal ring or metal hook unfolds around the connecting part and is wing-shaped as a whole.

[0018] In one embodiment, the mounting part is provided with a plurality of first conductive positions that are insulated from each other, and the metal ring or metal hook is respectively connected to the first conductive positions. The head is provided with a plurality of second conductive positions that are electrically connected to the control system. When the head is connected to the mounting part, the second conductive positions contact the first conductive positions respectively.

[0019] This invention relates to a cardiac pacing structure and a leadless pacemaker. The flexible, deformable battery section, in its pre-installed state, retracts within a sheath and can be delivered to the atrium or ventricle through a small-diameter sheath. In its unfolded state, the battery section expands around the head and becomes flat, allowing for a larger battery space than traditional products, resulting in a longer lifespan and reduced replacement costs for patients. Furthermore, compared to most traditional cylindrical pacing devices suspended in the heart chamber, the flattened cardiac pacing structure has a larger contact area with the myocardium after unfolding, providing a more stable installation and effectively reducing the risk of pacemaker displacement or dislodgement. The head connects to a fixed structure for installation within the heart chamber. The battery section provides power to the control system mounted on the head, which in turn controls the electrodes to achieve the pacing function. 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 pre-installed cardiac pacing structure according to an embodiment;

[0022] Figure 2 This is a schematic diagram from a first-view perspective of a cardiac pacing structure in its deployed state according to an embodiment;

[0023] Figure 3 This is a schematic diagram from a second perspective of the cardiac pacing structure in its deployed state according to one embodiment;

[0024] Figure 4 This is a schematic diagram of the battery section of a cardiac pacing structure according to one embodiment;

[0025] Figure 5 This is a schematic diagram of a fixed structure in a pre-assembled state according to one embodiment;

[0026] Figure 6 This is a schematic diagram of the fixed structure in a pre-assembled state according to another embodiment;

[0027] Figure 7 This is an assembly diagram of a leadless pacemaker according to one embodiment;

[0028] Figure 8 This is an assembly diagram of another embodiment of a leadless pacemaker;

[0029] Figure 9 This is a schematic diagram of a leadless pacemaker installed in the heart chamber according to an embodiment.

[0030] The attached figures are labeled as follows:

[0031] 01. Cardiac pacing structure; 10. Head; 110. Second conductive position; 120. Fastening position; 20. Battery section; 210. Frame body; 221. Individual battery cell; 222. Wire; 30. Electrode; 40. Tail end; 50. Retrieval rope; 02. Fixing structure; 60. Fixing part; 610. Metal ring; 620. Metal hook; 70. Connecting part; 80. Mounting part; 810. First conductive position; 91. Retrieval part; 92. Retrieval belt; 101. Sheath; 102. First pusher; 103. Delivery sheath; 104. Second pusher; 100. Atrial pacemaker; 200. Ventricular pacemaker. Detailed Implementation

[0032] 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.

[0033] The specific embodiments of this disclosure will now be described in detail with reference to the accompanying drawings.

[0034] Reference Figure 1-3 This utility model provides a cardiac pacing structure 01, including a flexible battery section 20, a battery section 20 for connection to a fixed structure 02, and electrodes 30 mounted on the battery section 20 or a head 10. The electrodes 30 have pacing and sensing functions. The head 10 is used to carry a control system, and the electrodes 30 are electrically connected to the control system. The battery section 20 is connected to the head 10 and provides power to the control system; the battery section 20 has a pre-installed state and an deployed state. The electrical connection can be a circuit connection achieved through wireless or wired technology.

[0035] Reference Figure 1 In its pre-installed state, the battery section 20 retracts into the sheath 101. The battery section 20 is designed as a flexible, elongated shape, deformable and spirally retracting into the sheath 101, facilitating miniaturization and subsequent installation within the body. (Refer to...) Figure 2 , 3 In the unfolded state, the battery section 20 unfolds around the head 10 and is flat overall. Figure 2 This is a schematic diagram viewed from the perspective of the battery section 20 towards the head 10, for reference. Figure 9 This is a schematic diagram showing the cardiac pacing structure 01 when it is installed in the heart chamber, viewed from the atrial / ventricular cavity towards the atrial / ventricular septum. Figure 3 This is a schematic diagram viewed from the perspective of the head 10 facing the battery section 20; see reference. Figure 9 This is a schematic diagram showing the cardiac pacing structure 01 installed in the heart chambers, viewed from the atrial septum / ventricular septum towards the atrial / ventricular cavity. The battery unit 20 can be made of a material with memory properties. After the sheath 101 is pushed out by the first pusher 102, the battery unit 20 automatically unfolds into a flat shape, which can be placed against the atrial septum or ventricular septum without affecting the tricuspid valve activity and has minimal impact on the patient's cardiac function.

[0036] The control system can be implemented using existing technologies and has functions such as sensing and analyzing cardiac electrical signals, outputting pacing signals, external programming, and communication between pacemakers.

[0037] The cardiac pacing structure 01 of this embodiment features a flexible battery section 20 that can change its external shape. In its pre-installed state, the battery section 20 retracts within the sheath 101 and can be delivered to the atrium or ventricle through the smaller diameter sheath 101. In its unfolded state, the battery section 20 expands around the head 10 and becomes flat. The flexible battery section 20 is connected to the head 10, allowing for a larger battery space than traditional similar products, resulting in a longer lifespan and reduced replacement costs for patients. Furthermore, compared to most traditional cylindrical pacing products suspended in the heart chambers, the flattened cardiac pacing structure 01 has a larger contact area with the myocardium after unfolding, providing a more stable installation and effectively reducing the risk of pacemaker displacement or dislodgement. The cardiac pacing structure 01 is connected to the fixing structure 02 via the head 10, allowing it to be installed within the heart chambers. The battery section 20 provides power to the control system mounted on the head 10, and the control system controls the electrodes 30 to perform the pacing function.

[0038] Reference Figure 4 In one embodiment, the battery unit 20 includes a strip-shaped frame 210 made of shape memory material and a battery assembly installed within the frame 210. The battery assembly is electrically connected to the control system, and one end of the frame 210 is connected to the head 10. The frame 210 can be manufactured using existing shape memory materials and has shape memory characteristics. Under the constraint of the sheath 101, it can be completely folded up, and after being detached from the sheath 101, it can automatically unfold into a preset flat shape.

[0039] Optionally, in one embodiment, the battery assembly includes a plurality of individual battery cells 221 connected by wires 222. The individual battery cells 221 may be rigid batteries of the prior art, connected section by section by flexible wires 222, allowing the battery assembly to deform with the frame 210 without affecting the performance of the individual battery cells 221. In other embodiments, the battery assembly is a flexible battery that is itself deformable. The battery assembly may also directly use a flexible battery with inherent variability, thereby allowing the battery assembly to deform with the frame 210 without affecting the battery's performance.

[0040] Optionally, in one embodiment, the electrode 30 includes 4-8 electrodes. For example, the number of electrodes 30 can be set to 4, 5, 6, 7, or 8 depending on the usage requirements, allowing for individual programming of each corresponding pacemaker. (Refer to...) Figure 3In this embodiment, eight electrodes 30 are provided. In the unfolded state, the eight electrodes 30 are arranged at different positions around the head 10. In the unfolded state, the battery section 20 is flat, and the electrodes 30 installed on the battery section 20 or the head 10 accompany the battery section 20. The flat arrangement also results in a larger contact area with the myocardial surface. The cardiac pacing structure 01 has multiple electrodes 30 and multiple pacing points to choose from, eliminating the need for repeated adjustments to the position of the cardiac pacing structure 01, reducing surgical time, and thus reducing the radiation dose received by the patient and doctor, and reducing the risk of infection.

[0041] Furthermore, refer to Figure 1-3 In one embodiment, the cardiac pacing structure 01 further includes a tail 40 and a retrieval rope 50. The tail 40 is connected to the end of the battery unit 20 away from the head 10, and the retrieval rope 50 is installed on the tail 40. After the cardiac pacing structure 01 is deployed, the electrode 30 contacts the myocardium and is fixed by an outer sheath. The pacing electrode 30 can be tested. If the parameters are satisfactory, the retrieval rope 50 is cut, and the cardiac pacing structure 01 remains inside the heart. The parameters of the control system can be remotely controlled via an external programming device. If the parameters are not satisfactory, the cardiac pacing structure 01 can be retrieved by pulling the retrieval rope 50, adjusted in position, and repositioned until the parameters are satisfactory before cutting the retrieval rope 50.

[0042] Specifically, in one embodiment, the tail 40 is tapered, wider at the front and narrower at the back. The front end of the tail 40 is connected to the end of the battery 20 away from the head 10, and the rear end of the tail 40 is connected to the retrieval rope 50. This design facilitates pulling the heart pacing structure 01 outward via the retrieval rope 50.

[0043] Reference Figure 9One embodiment of this application provides a leadless pacemaker, including a fixing structure 02 and a cardiac pacing structure 01. The cardiac pacing structure 01 is connected to the fixing structure 02 via a head 10. The fixing structure 02 can be firmly attached to the myocardium, mainly serving the purpose of installing the cardiac pacing structure 01 within the heart chamber. In the pre-installed state, the fixing structure 02 and the cardiac pacing structure 01 of the leadless pacemaker are pre-installed within a sheath 101. The flexible battery section 20 can change its external shape and retract into the sheath 101, allowing delivery to the atrium or ventricle using a smaller diameter sheath 101. When the leadless pacemaker is detached from the sheath 101 and placed within the heart, the fixing structure 02 connects to the myocardium, thereby fixing the entire leadless pacemaker within the heart chamber. In its unfolded state, the battery unit 20 unfolds around the head 10 and is flat overall. The flexible battery unit 20 is connected to the head 10 and provides power to the control system mounted on the head 10. The control system controls the electrodes 30 to realize the pacing function. It can be designed with a larger battery space than traditional similar products, resulting in a longer service life and reducing subsequent replacement costs for patients. In addition, compared with most traditional cylindrical pacing products suspended in the heart chamber, the flat cardiac pacing structure 01 has a larger contact area with the myocardium after unfolding, and the fixing structure 02 and cardiac pacing structure 01 are installed more stably, which can effectively reduce the risk of pacemaker displacement or dislodgement.

[0044] Optionally, in one embodiment, the fixation structure 02 is directly connected to the head 10, i.e., the two are integrated. The fixation structure 02 has parts such as hooks, threads, or rings that can connect to the myocardium. During assembly, the fixation structure 02 and the cardiac pacing structure 01 are delivered into the body together through a puncture of the atrial septum or ventricular septum using a delivery device, and then the fixation structure 02 and the cardiac pacing structure 01 are released sequentially from the sheath 101.

[0045] Optionally, refer to Figure 5 , 6 In another embodiment, the fixation structure 02 includes a fixation part 60, a connecting part 70, and an installation part 80 connected in sequence. The fixation part 60 is used to fix it inside the heart, and the installation part 80 is detachably connected to the head 10. In this embodiment, the fixation structure 02 and the cardiac pacing structure 01 are separate structures. During assembly, the fixation structure 02 is first implanted into the body through a delivery device after puncturing the atrial septum or ventricular septum. The fixation part 60 is first connected to the myocardium, and then the cardiac pacing structure 01 is implanted into the corresponding position through the delivery device. After detecting that the electrode 30 is in the correct position, the installation part 80 is connected to the cardiac pacing structure 01. If the cardiac pacing structure 01 needs to be replaced, the connection between the installation part 80 and the cardiac pacing structure 01 can be disconnected using a tool, and then the cardiac pacing structure 01 can be removed. The atrial septum / ventricular septum puncture technique can be used to implant the structure at different locations in the atrial septum and ventricular septum, ensuring a high success rate.

[0046] Optionally, the head 10 of the cardiac pacing structure 01 is provided with a mounting hole with internal threads, and the mounting portion 80 of the fixing structure 02 is provided with external threads. The cardiac pacing structure 01 and the fixing structure 02 are connected to the mounting portion 80 through the mounting hole, facilitating disassembly and installation. Further, refer to... Figure 1 , 7 8. The head 10 of the cardiac pacing structure 01 is also provided with a fastening position 120. The fastening position 120 is operated with a tool to fasten or loosen the head 10 and the mounting part 80. Specifically, the fastening position 120 is a hexagonal knob.

[0047] Specifically, refer to Figure 5 , 6 The fixing part 60 includes a plurality of metal rings 610 or metal hooks 620 made of shape memory material. One end of each metal ring 610 or metal hook 620 is connected to the connecting part 70, and has a pre-installed state and an unfolded state.

[0048] In one embodiment, reference is made to Figure 5 In the pre-installed state, the metal ring 610 is retracted into the delivery sheath 103; refer to Figure 7 In its unfolded state, the metal ring 610 unfolds around the connecting portion 70 and takes on a wing-like shape. In this embodiment, two metal rings 610 are used; in other embodiments, three or four metal rings 610 may be used. During implantation, the second pusher 104 pushes forward, and the metal rings 610 are first pushed out of the delivery sheath 103. After being pushed out, multiple metal rings 610 unfold around the connecting portion 70, forming a wing-like shape that presses inverted onto the myocardium, thereby securing them firmly to the myocardium. The annular structure of the metal ring 610 provides a large fixed contact area, making it suitable for installation in the atrial septum region and reducing the possibility of atrial septal myocardial perforation.

[0049] Reference Figure 9The leadless pacemaker implanted in the interatrial septum is an atrial pacemaker 100, and the fixation part 60 of the atrial pacemaker 100 uses a metal ring 610. The fixation structure 02 of the atrial pacemaker 100 is a button-type structure, including a pre-formed metal ring 610 made of ring-shaped shape memory metal, a connecting part 70 with a length greater than or equal to the thickness of the interatrial septum, and a mounting part 80 connected to the head 10. Optionally, the fixation structure of the atrial pacemaker 100 also includes a retrieval part 91 and a retrieval strap 92. Before implantation, the fixation structure 02 is pre-installed in the delivery sheath 103 in a tightened state and enters through the femoral vein. It is then inserted into the left atrium via a transatrial septal puncture technique from the right atrium. The delivery sheath 103 is then withdrawn to the connecting part 70. At this point, the metal ring 610 opens and is fixed to the left atrial surface of the transatrial septum. If the release is unsatisfactory, the retrieval strap 92 is tightened, and the metal ring 610 can be completely retracted into the delivery sheath 103. After the pacing structure is placed in place, the head 10 is connected to the mounting part 80, achieving a tight fixation between the fixation structure 02 and the pacing structure. Optionally, the diameter of the connecting part 70 is 3mm-5mm; in this embodiment, the diameter is 4mm. The length of the connecting part 70 is 2-4mm; in this embodiment, the diameter is 3mm. Optionally, the length of the mounting part 80 is 5mm-7mm; in this embodiment, the length is 6mm.

[0050] Furthermore, referring to Figure 5 , 7 The mounting portion 80 is provided with a plurality of mutually insulated first conductive positions 810, and a plurality of metal rings 610 are respectively connected to the first conductive positions 810. The head 10 is provided with a plurality of second conductive positions 110 electrically connected to the control system. When the head 10 is connected to the mounting portion 80, the second conductive positions 110 respectively contact the corresponding first conductive positions 810, thereby enabling the metal rings 610 to be electrically connected to the control system. The first conductive positions 810 are annular or sheet-shaped conductive areas, and the second conductive positions 110 are sheet-shaped or annular conductive areas. Since the metal rings 610 are in contact with the myocardium, the control system controls the metal rings 610 to realize sensing and pacing functions according to usage requirements, increasing the pacing sites.

[0051] In another embodiment, reference Figure 6 In its pre-installed state, the metal hook 620 is retracted into the conveyor sheath 103; see reference. Figure 8 In its unfolded state, the metal hook 620 unfolds around the connecting portion 70 and takes on a wing-like shape. During implantation, the second pusher 104 pushes forward, and the metal hook 620 is first pushed out of the delivery sheath 103. After being pushed out, multiple metal hooks 620 unfold around the connecting portion 70, hooking onto the myocardium in a wing-like shape, thereby securing a stable connection to the myocardium. The hook-like structure of the metal hook 620 provides a more stable connection and is suitable for installation in areas with thicker myocardium or interventricular septum.

[0052] Furthermore, referring to Figure 6 , 8 The mounting portion 80 is provided with a plurality of mutually insulated first conductive positions 810, and a plurality of metal hooks 620 are respectively connected to the first conductive positions 810. The head 10 is provided with a plurality of second conductive positions 110 electrically connected to the control system. When the head 10 is connected to the mounting portion 80, the second conductive positions 110 respectively contact the first conductive positions 810. The first conductive positions 810 are annular or sheet-like conductive areas, and the second conductive positions 110 are sheet-like or annular conductive areas. Since the metal hooks 620 are in contact with the myocardium, the control system controls the metal hooks 620 to realize the sensing and pacing functions according to the usage requirements, increasing the pacing sites.

[0053] Reference Figure 9 The leadless pacemaker implanted in the interventricular septum is a ventricular pacemaker 200, and the fixation part 60 of the ventricular pacemaker 200 uses a metal hook 620. The fixation structure 02 of the ventricular pacemaker 200 is a button-type structure, including a pre-formed metal hook 620 made of hook-shaped shape memory metal, a connecting part 70 with a length greater than or equal to the thickness of the interventricular septum, and a mounting part 80 that connects to the head 10. Optionally, the fixation structure of the ventricular pacemaker 200 also includes a retrieval part 91 and a retrieval strap 92. Before implantation, the fixation structure 02 is pre-installed in the delivery sheath 103 in a tightened state and enters through the femoral vein. It is then inserted into the left ventricle via ventricular septal puncture. The delivery sheath 103 is then withdrawn to the connecting part 70, at which point the metal hook 620 opens and is fixed to the left ventricular surface of the ventricular septum. If the release is unsatisfactory, the retrieval strap 92 is tightened, and the metal hook 620 can be completely retracted into the delivery sheath 103. After the pacing structure is placed in position, the head 10 is connected to the mounting part 80, achieving a tight fixation between the fixation structure 02 and the pacing structure. Optionally, the diameter of the connecting part 70 is 5mm-15mm; in this embodiment, the diameter is 10mm. Optionally, the length of the mounting part 80 is 5mm-7mm; in this embodiment, the length is 6mm.

[0054] The leadless pacemaker of this application embodiment has two design forms: an atrial pacemaker 100 and a ventricular pacemaker 200, depending on the application scenario. The atrial pacemaker 100 and the ventricular pacemaker 200 can communicate wirelessly via technology such as Bluetooth and pace in a preset sequence; they can be implanted individually or simultaneously as needed based on the patient's condition. Both pacemakers are implanted via puncture of the atrial septum / ventricular septum, with a button-type fixing structure 02 placed in the left atrium / left ventricle, and a variable pacing structure placed in the right atrium / ventricle.

[0055] In one embodiment, the fixing part 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; the fixing part 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 is provided with four electrodes; each contact and electrode can be communicated and connected, and various pacing modes such as His bundle pacing, left bundle branch pacing, and ventricular septal pacing can be implemented by programming pacing parameters.

[0056] The implantation steps of the leadless pacemaker in the above embodiment are as follows:

[0057] 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.

[0058] 2.Reference Figure 5 , 6 The fixed structure 02 is inserted along the torn sheath, and the second pusher 104 is pushed forward. Under fluoroscopy, the fixed part 60 is visible in an unfolded state. The delivery sheath 103 is then withdrawn, and tension and a heartbeat are felt, confirming that the fixed part 60 is accurately in place. If the position is not ideal, the fixed part 60 is retracted into the delivery sheath 103 by tightening the retraction belt 92, and the position is adjusted and repositioned. After accurate placement, the torn sheath is withdrawn, leaving the adjustable curved sheath.

[0059] 3.Reference Figure 1 The pacing structure's sheath 101 is inserted along the adjustable curved sheath and retrieval band 92. Its position is carefully adjusted, and it is slowly advanced using the first pusher 102. Once in the appropriate position, the sheath 101 is fixed, and the first pusher 102 is pushed forward. Under fluoroscopy, the pacing structure's fully released battery section 20 appears as a flat disc. If the pacing structure's release is unsatisfactory, it can be completely retracted into the sheath 101 by pulling the retrieval rope 50, and then re-released after adjusting its position.

[0060] 4. Continue to slowly advance the sheath 101 and tighten the retrieval band 92 to ensure the fully released pacing structure is in close contact with 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 can be retrieved as in step 3, its position adjusted, and then released again. Repeat the testing until satisfactory results are achieved.

[0061] 5.Reference Figure 7 , 8 Insert the hexagonal tool and tighten the hexagonal knob of the pacing structure to secure structure 02 tightly to the pacing structure.

[0062] 6. Withdraw the sheath 101 and the adjustable curved sheath, and pull the retrieval strap 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 rope 50 and the retrieval strap 92, withdraw the sheath 101 and the adjustable curved sheath, suture the puncture site with a figure-eight suture, and apply local pressure bandage.

[0063] Traditional leadless pacemakers typically employ a slender cylindrical design. This miniaturization, aimed at reducing the risk of dislocation, minimizes battery space, significantly impacting pacemaker lifespan. Furthermore, the cylindrical design, mostly suspended within the heart chambers, creates a leverage effect due to the relative movement of the pacemaker and myocardium during heartbeats, blood flow, and daily activities. This leads to repeated damage to the myocardium at the contact surface, causing myocardial fibrosis, elevated pacing thresholds, and even pacemaker displacement or dislodgement. Moreover, the cylindrical design results in a small contact area with the myocardium, generally enabling single-point pacing. Repeated adjustments to the pacing site during implantation further damage the myocardium and prevent the implementation of His bundle pacing, biventricular pacing, and other similar functions. Implantation sites are also limited, typically placed in the lower middle part of the interventricular septum or at the apex. In some patients with smaller hearts, the slender pacemaker can interfere with tricuspid valve activity.

[0064] The leadless pacemaker of the above embodiments of this application has at least one of the following beneficial effects:

[0065] 1. The pacemaker is deformable and can be delivered to the atria and ventricles through a smaller diameter sheath 101. When unfolded, the pacemaker is disc-shaped and can be designed with a larger battery space than existing similar products, enabling more pacing functions and a longer service life, thus reducing the cost of subsequent replacements for patients.

[0066] 2. The pacemaker is flat and has a large contact area with the myocardium. It comes with multiple electrodes and multiple pacing points to choose from. It does not require repeated adjustment of the pacemaker position, reducing surgery time, radiation exposure to patients and doctors, and the risk of infection.

[0067] 3. The pacemaker is flat and rests against the atrial or ventricular septum, does not affect the activity of the tricuspid valve, and has little impact on the patient's cardiac function.

[0068] 4. Simultaneously implanting an atrial pacemaker 100 and a ventricular pacemaker 200, the two pacemakers can communicate wirelessly via Bluetooth or other modes. On the one hand, this enables sequential atrial and ventricular stimulation for physiological pacing, and on the other hand, it allows for better identification of various arrhythmias and timely intervention.

[0069] 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.

[0070] 6. Improved fixation method: The pacemaker is fixed by puncturing the atrial septum / ventricular septum, which effectively reduces the risk of pacemaker displacement.

[0071] 7. Improved pacing method:

[0072] a. The integrated left atrial electrode 30 increases the number of atrial pacing sites, increases the success rate of atrial pacing, and enables dual atrial pacing function.

[0073] b. The integrated left ventricular electrode 30 can realize physiological pacing functions such as His bundle pacing, left bundle branch pacing, biventricular pacing, and cardiac resynchronization.

[0074] 8. It can perform defibrillation (ICD) function.

[0075] 9. It can realize the function of cardiac contractility modulator (CCM).

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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 cardiac pacing structure, characterized in that, It includes a flexible battery section, a head for connection to a fixed structure, and electrodes mounted on the battery section or the head. The head is used to carry a control system, the electrodes are electrically connected to the control system, the battery section is connected to the head and is used to provide power to the control system, and the battery section has a pre-installed state and an unfolded state. In the pre-installed state, the battery section is retracted into the sheath; In the unfolded state, the battery unit unfolds around the head and is flat overall.

2. The cardiac pacing structure according to claim 1, characterized in that, The battery unit includes a strip-shaped frame made of shape memory material and a battery assembly installed within the frame. The battery assembly is electrically connected to the control system, and one end of the frame is connected to the head.

3. The cardiac pacing structure according to claim 2, characterized in that, The battery assembly includes multiple individual cells connected by wires; or the battery assembly is a flexible battery that is deformable.

4. The cardiac pacing structure according to claim 1, characterized in that, The electrodes comprise 4-8 electrodes, which are arranged at different positions around the head in the unfolded state.

5. The cardiac pacing structure according to claim 1, characterized in that, The cardiac pacing structure also includes a tail and a retrieval rope, the tail being connected to the end of the battery unit away from the head, and the retrieval rope being installed on the tail.

6. The cardiac pacing structure according to claim 5, characterized in that, The tail is tapered, wider at the front and narrower at the back. The front end of the tail is connected to the end of the battery unit furthest from the head, and the rear end of the tail is connected to the retrieval rope.

7. A leadless pacemaker, characterized in that, It includes a fixation structure and a cardiac pacing structure as described in any one of claims 1 to 6, wherein the cardiac pacing structure is connected to the fixation structure via the head.

8. The leadless pacemaker according to claim 7, characterized in that, The fixing structure includes a fixing part, a connecting part, and an mounting part connected in sequence. The fixing part is used to fix it inside the heart, and the mounting part is detachably connected to the head.

9. The leadless pacemaker according to claim 8, characterized in that, The fixing part includes multiple metal rings or metal hooks made of shape memory material, one end of each metal ring or metal hook being connected to the connecting part, and has a pre-installed state and an unfolded state. In the pre-installed state, the metal ring or metal hook is retracted into the conveying sheath; In the unfolded state, the metal ring or metal hook unfolds around the connecting part and is wing-shaped as a whole.

10. The leadless pacemaker according to claim 9, characterized in that, The mounting part is provided with a plurality of first conductive positions that are insulated from each other. The metal ring or metal hook is connected to the first conductive positions respectively. The head is provided with a plurality of second conductive positions that are electrically connected to the control system. When the head is connected to the mounting part, the first conductive positions contact the second conductive positions respectively.

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