A removable leadless pacemaker system that can pace a cardiac conduction bundle

Abstract

The application discloses a detachable leadless pacemaker system which can pace cardiac conduction bundle. The specific embodiment of the system comprises: a detachable leadless pacemaker, the detachable leadless pacemaker is provided with a first data interface; a passive leadless pacemaker, the passive leadless pacemaker is provided with a second data interface; a signal line, which is connected with the first data interface and the second data interface respectively, so as to realize power supply of the detachable leadless pacemaker for the passive leadless pacemaker and data communication between the two. The detachable leadless pacemaker can be arranged in a ventricle to realize atrioventricular dual chamber pacing with the passive leadless pacemaker arranged in an atrium. An unpackaged circuit can be arranged in the passive leadless pacemaker, which is used as an electrode carrier for sensing atrial electrical signals and implementing electrical stimulation. The detachable leadless pacemaker and the passive leadless pacemaker are connected by a tensile-resistant reinforcing line, which is used for recovery operation when the detachable leadless pacemaker is repositioned.

Description

TECHNICAL FIELD

[0001] Embodiments of the present disclosure relate to the technical field of medical devices, and in particular to a detachable leadless pacemaker system for pacing a cardiac conduction bundle. BACKGROUND

[0002] Implanting micro devices into heart cavities is the latest diagnostic and therapeutic method in modern medicine. Micro devices in heart cavities include sensors for obtaining parameters such as heart electricity, blood pressure, blood flow, and blood biochemistry, and micro therapeutic devices for performing drug release and cardiac pacing. In order to place micro devices into heart cavities, a catheter intervention surgery is needed to deliver the devices to a specific location in the heart cavity and fix them to prevent the micro devices from shifting or falling off, causing device failure or embolism.

[0003] Cardiac pacemakers are widely used implants in the human body. Today, millions of people around the world have their normal heartbeats maintained by implanting artificial cardiac pacemakers every year. When doctors install a cardiac pacemaker for a patient, they usually place the pacemaker under the pectoral muscle and use one or more leads and electrodes to place it in the heart cavity to sense heart activity and stimulate myocardial contractions. These leads affect the opening and closing of heart valves with every heartbeat, changing the hemodynamics of the heart, and over time causing complications such as heart failure. Recently, wireless micro pacemakers have been developed internationally, which are as small as a drug capsule, eliminating the need for leads and can be placed directly in the heart cavity without affecting the opening and closing of heart valves, reducing complications, and simplifying operations. Since wireless pacemakers are small in size, they provide a new implant experience for patients and significantly reduce the infection rate of implant systems.

[0004] The implantation of wireless micro pacemakers in a predetermined location in the heart cavity and the implantation method are a new challenge. Due to the effects of heartbeat and blood flow impact, wireless micro pacemakers are prone to detach from the myocardium and shift and move within the heart cavity. It has been proven that the delivery tool of the wireless pacemaker itself is a major technical challenge, which limits the further development and popularization of this new technology.

[0005] Existing wireless micro pacemakers use a tip fixation method, such as forming a spiral metal wire or hook body at one end of the shell, which is screwed into the myocardium or hooked onto the reticular myocardial structure in the ventricle to achieve fixation. Due to the effects of heartbeat and blood flow impact, wireless micro pacemakers are prone to detach from the myocardium and shift and move within the heart cavity, causing embolism or poor contact between the electrode and the myocardium, affecting the sensing of heart electricity and the pacing effect, and the atrium lacks reticular tissue, making it impossible to achieve atrial pacing and dual chamber pacing, and the effectiveness and safety of pacing cannot be guaranteed. SUMMARY

[0006] This summary of the disclosure is presented in a simplified form to introduce some concepts that will be described in more detail below in the detailed description section. This summary of the disclosure is not intended to identify key or essential features of the claimed technology nor is it intended to be used to limit the scope of the claimed technology.

[0007] Some embodiments of the present disclosure propose a detachable leadless pacemaker system that can pace a cardiac conduction bundle to solve the technical problems mentioned in the background section.

[0008] Some embodiments of the present disclosure provide a detachable leadless pacemaker system that can pace a cardiac conduction bundle, comprising: a detachable leadless pacemaker, wherein the detachable leadless pacemaker is provided with a first data interface; a passive leadless pacemaker, wherein the passive leadless pacemaker is provided with a second data interface; and a signal line connected with the first data interface and the second data interface respectively, for realizing power supply of the passive leadless pacemaker by the detachable leadless pacemaker and data communication between the detachable leadless pacemaker and the passive leadless pacemaker.

[0009] Optionally, the detachable leadless pacemaker comprises: a first pacemaker body, wherein the first pacemaker body is provided with a first detachable structure; and a first side wall hook electrode, which is fixed to the first pacemaker body through the first detachable structure, and is arranged in parallel with the first pacemaker body at a first set distance.

[0010] Optionally, the first pacemaker body comprises a first shell, wherein the first shell comprises a body structure and the first detachable structure arranged at one end of the body structure; and the body structure is provided with at least one first ring electrode, and a first ring insulating member is arranged between adjacent first ring electrodes in the at least one first ring electrode.

[0011] Optionally, the first detachable structure comprises a first through hole, a second through hole and a limiting clamping needle, the first through hole has at least one first clamping groove structure, the second through hole passes through the first through hole in a direction perpendicular to a plane formed by an axial direction of the body structure and an axial direction of the first through hole, a diameter of the second through hole is smaller than a diameter of the first through hole, and the limiting clamping needle comprises a limiting column and a limiting handle, the limiting column is arranged in the second through hole, and the limiting handle is exposed outside the first detachable structure.

[0012] Optionally, the first side wall hook electrode comprises a second shell; the second shell comprises a first end, an electrode body and a second end arranged in sequence; the first end is a first curved structure comprising a fixing column, the fixing column comprises a third through hole and at least one second clamping groove structure, the at least one second clamping groove structure matches the at least one first clamping groove structure in the state that the fixing column is inserted into the first through hole, and the third through hole matches the second through hole so that the limiting column of the limiting clamping needle is inserted into the second through hole and the third through hole; the electrode body is provided with at least one second annular electrode, second annular insulating members are arranged between adjacent second annular electrodes in the at least one second annular electrode, and the at least one second annular electrode is arranged in correspondence with the at least one first annular electrode; and the second end is a conical structure.

[0013] Optionally, the first pacemaker body comprises an internal circuit, and the internal circuit is arranged in the first shell; the internal circuit comprises a circuit board and a battery, the battery is connected with the circuit board, the battery supplies power for the circuit board, the circuit board is arranged on the side close to the first detachable structure, and the battery is arranged on the side away from the first detachable structure; and the circuit board comprises at least one first contact for connecting the at least one first annular electrode.

[0014] Optionally, the first pacemaker body further comprises at least one first electrode lead arranged in correspondence with the at least one first annular electrode, the at least one first electrode lead is arranged in the first shell, one end of a first electrode lead in the at least one first electrode lead is connected with a corresponding first annular electrode in the at least one first annular electrode, and the other end of the first electrode lead is connected with a corresponding first contact in the at least one first contact.

[0015] Optionally, a wireless communication module is arranged on the circuit board, and the wireless communication module is used for information interaction with an external programmer.

[0016] Optionally, a first switch is arranged between the circuit board and each first annular electrode in the at least one first annular electrode, and the first switch is used for controlling on-off between the circuit board and the first annular electrode.

[0017] Optionally, at least one second contact is arranged on the side of the body structure close to the first detachable structure, and the at least one second contact is connected with the circuit board.

[0018] Optionally, a second switch is arranged between the circuit board and each second contact in the at least one second contact, and the second switch is used for controlling on-off between the circuit board and the second contact.

[0019] Optionally, the first side wall hook electrode comprises at least one second electrode lead wire corresponding to the at least one second annular electrode, the at least one second electrode lead wire is arranged in the second shell, one end of the second electrode lead wire is connected with the corresponding second annular electrode, and the other end of the second electrode lead wire is arranged in the fixed column; in the state that the fixed column is inserted into the first through hole, the at least one second electrode lead wire is connected with the corresponding second contact.

[0020] Optionally, the first annular electrode is connected with the first power supply end of the corresponding battery on the circuit board through the corresponding first contact, and the second annular electrode is connected with the second power supply end of the corresponding battery on the circuit board through the corresponding second contact.

[0021] Optionally, the first annular insulating member is provided with a hole groove matrix on the side close to the first side wall hook electrode, the hole groove matrix comprises at least one hole groove, and the hole groove is used for placing a medicine.

[0022] Optionally, the second end of the second shell is provided with at least one first positioning structure on the side close to the first pacemaker body.

[0023] Optionally, the passive and leadless pacemaker comprises a second pacemaker body, the second pacemaker body is provided with a second detachable structure; a second side wall hook electrode is fixed with the second pacemaker body through the second detachable structure, and the second side wall hook electrode is arranged in parallel with the second pacemaker body at a second set distance.

[0024] Optionally, the detachable leadless pacemaker is provided with a first connecting part, and the first connecting part is arranged on the first detachable structure; the passive and leadless pacemaker is provided with a second connecting part, and the second connecting part is arranged on the second detachable structure; and the first connecting part and the second connecting part are used for fixedly connecting the detachable leadless pacemaker and the passive and leadless pacemaker.

[0025] Optionally, in the state that the first connecting part and the second connecting part are fixedly connected, the insertion direction of the first side wall hook electrode is opposite to the insertion direction of the second side wall hook electrode.

[0026] Optionally, the detachable leadless pacemaker system of the above-mentioned paceable cardiac conduction bundle further comprises a mounting wire, a first wire end of the mounting wire comprises a first loop, the first loop is sleeved on the first curved structure of the first side wall hook electrode of the detachable leadless pacemaker, and a second wire end of the mounting wire comprises a second loop, the second loop is sleeved on the second curved structure of the second side wall hook electrode of the passive leadless pacemaker.

[0027] Optionally, the second pacemaker body comprises at least one third ring electrode, and a third ring insulating member is arranged between adjacent third ring electrodes in the at least one third ring electrode; the second side wall hook electrode comprises at least one fourth ring electrode, and a fourth ring insulating member is arranged between adjacent fourth ring electrodes in the at least one fourth ring electrode; and the passive leadless pacemaker comprises an encapsulated circuit connected with the at least one third ring electrode and the at least one fourth ring electrode respectively.

[0028] The detachable leadless pacemaker system of the paceable cardiac conduction bundle of some embodiments of the present disclosure has the following beneficial effects: the detachable leadless pacemaker is arranged in the ventricle, the passive leadless pacemaker is arranged in the atrium, and the detachable leadless pacemaker supplies power and signals to the passive leadless pacemaker through the signal wire. After the first side wall hook electrode is inserted into the interventricular septum, the first pacemaker body closely adheres to the inner wall of the ventricle, thereby improving the contact area and stability of the detachable leadless pacemaker and the inner wall of the ventricle. A plurality of groups of ring electrodes are arranged on the first side wall hook electrode and the first pacemaker body, and the most suitable group of electrodes can be selected for pacing according to actual needs. The ring structure greatly improves the contact area of the electrodes and the inner wall of the ventricle, thereby improving the effectiveness of pacing. The second side wall hook electrode of the passive leadless pacemaker is connected with the detachable leadless pacemaker through the connecting wire socket, senses the atrial electrical signal, and implements electrical stimulation to achieve atrioventricular dual chamber pacing. The detachable leadless pacemaker and the passive leadless pacemaker are connected by the anti-tension reinforcing wire, which is used for recovery operation when the detachable leadless pacemaker is repositioned. BRIEF DESCRIPTION OF DRAWINGS

[0029] The above and other features, advantages, and aspects of the embodiments of the present disclosure will become more apparent with reference to the following detailed description in conjunction with the accompanying drawings. Throughout the drawings, the same or similar reference numerals denote the same or similar elements. It should be understood that the drawings are schematic, and elements and elements are not necessarily drawn to scale.

[0030] Figure 1 is a structural schematic diagram of the detachable leadless pacemaker system of the paceable cardiac conduction bundle of some embodiments of the present disclosure;

[0031] Figure 2This is a structural schematic diagram of the first pacemaker body according to the present disclosure;

[0032] Figure 3 This is a structural schematic diagram of the first detachable structure 1011 according to the present disclosure;

[0033] Figure 4 This is a structural schematic diagram of the first sidewall hook electrode according to the present disclosure;

[0034] Figure 5 This is a cross-sectional view of a detachable leadless pacemaker based on this disclosure;

[0035] Figure 6 This is a schematic diagram of the structure of the second pacemaker body according to this disclosure;

[0036] Figure 7 This is a schematic diagram of the structure of the second sidewall hook electrode according to this disclosure;

[0037] Figure 8 This is a schematic diagram of a detachable leadless pacemaker system with a pacemaker conduction bundle inserted into the heart according to this disclosure. Detailed Implementation

[0038] Embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. While some embodiments of this disclosure are shown in the drawings, it should be understood that this disclosure can be implemented in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to provide a more thorough and complete understanding of this disclosure. It should be understood that the accompanying drawings and embodiments of this disclosure are for illustrative purposes only and are not intended to limit the scope of protection of this disclosure.

[0039] It should also be noted that, for ease of description, only the parts relevant to the invention are shown in the accompanying drawings. Unless otherwise specified, the embodiments and features described in this disclosure can be combined with each other.

[0040] It should be noted that the concepts of "first" and "second" mentioned in this disclosure are used only to distinguish different devices, modules or units, and are not used to limit the order of functions performed by these devices, modules or units or their interdependencies.

[0041] It should be noted that the terms "a" and "a plurality of" used in this disclosure are illustrative rather than restrictive, and those skilled in the art should understand that, unless otherwise expressly indicated in the context, they should be understood as "one or more".

[0042] The names of messages or information exchanged between multiple devices in the embodiments of this disclosure are for illustrative purposes only and are not intended to limit the scope of such messages or information.

[0043] Figure 1 is a structural schematic diagram of a detachable leadless pacemaker system for pacing a cardiac conduction bundle according to some embodiments of the present disclosure. The detachable leadless pacemaker system for pacing a cardiac conduction bundle can include a detachable leadless pacemaker 101 and a passive leadless pacemaker 102, which are connected through a signal line 103. The detachable leadless pacemaker 101 is arranged in a ventricle, and the passive leadless pacemaker 102 is arranged in an atrium. The detachable leadless pacemaker 101 is provided with a first data interface 1014. The passive leadless pacemaker 102 is provided with a second data interface 1025. The signal line 103 is connected with the first data interface 1014 and the second data interface 1025 respectively, so as to realize power supply of the passive leadless pacemaker 102 by the detachable leadless pacemaker 101 and data communication between the detachable leadless pacemaker 101 and the passive leadless pacemaker 102.

[0044] The detachable leadless pacemaker 101 can include a first pacemaker body and a first side wall hook electrode. A structural schematic diagram of the first pacemaker body is shown in Figure 2 A structural schematic diagram of the first side wall hook electrode is shown in Figure 4 The first pacemaker body is provided with a first detachable structure 1011. The first side wall hook electrode is arranged in parallel with the first pacemaker body at a first set distance through the first detachable structure 1011. Figure 2 It can be known that the detachable leadless pacemaker 101 is implanted in the heart. The first side wall hook electrode can be inserted into the interventricular septum, so that the side of the first pacemaker body is tightly attached to the inner wall of the ventricle. When the myocardium moves, the detachable leadless pacemaker 101 can move synchronously with the myocardium (i.e., the detachable leadless pacemaker and the myocardium are relatively static).

[0045] The first pacemaker body is fixed by the first side wall hook electrode in the present application, and the first pacemaker body is tightly attached to the inner wall of the ventricle, so that the contact area of the detachable leadless pacemaker 101 in the present application and the myocardium is larger, and the detachable leadless pacemaker 101 can move synchronously with the myocardium. In this way, the stability of the detachable leadless pacemaker 101 in the ventricle is improved, and the possibility of the detachable leadless pacemaker 101 falling off is greatly reduced.

[0046] Meanwhile, the length of the detachable leadless pacemaker 101 in the present application is about 40 mm (millimeters), and the first side wall hook electrode can be inserted into the left bundle branch and the right bundle branch near the interventricular septum, and the left bundle branch and the right bundle branch are the "fast channel" of the heart signal. Therefore, the first side wall hook electrode in the present application can be more effective in pacing. Meanwhile, the first side wall hook electrode can also realize the function of collecting the electrical signal of the heart, so as to analyze the electrical signal of the heart.

[0047] The first outer shell of the first pacemaker body described in this application includes a body structure and a first detachable structure 1011 disposed at one end of the body structure. The body structure may be provided with at least one first annular electrode 1012. Figure 2 (There are four in total), and a first annular insulating member 1013 is provided between adjacent first annular electrodes 1012. The at least one first annular electrode 1012 can be equidistantly arranged. The electrode of this application has an annular structure with a large electrode contact surface, and the contact point between the first annular electrode 1012 and the myocardium can be automatically adjusted according to the position of the detachable leadless pacemaker 101 in the ventricle. This avoids repeated adjustments to the position of the detachable leadless pacemaker 101, ensuring the effectiveness of pacing.

[0048] Figure 3 This is a schematic diagram of the first detachable structure 1011. The first detachable structure 1011 includes a first through hole 10111, a second through hole 10112, and a limiting pin 10113. The first through hole 10111 contains at least one first slot structure 10115. The second through hole 10112 passes through the first through hole 10111 in a direction perpendicular to the plane formed by the axial direction of the main body structure and the axial direction of the first through hole 10111. Typically, the diameter of the second through hole 10112 is smaller than the diameter of the first through hole 10111. The limiting pin 10113 includes a limiting post and a limiting handle. The limiting post is disposed within the second through hole 10112, and the limiting handle is exposed outside the first detachable structure 1011.

[0049] Figure 4 In the above-mentioned first sidewall hook electrode, a second housing is included, and the second housing may include a first end 1015, an electrode body and a second end 1018 arranged sequentially.

[0050] The first end 1015 is a first curved structure, including a fixing post 10151. The fixing post 10151 includes a third through hole 10152 and at least one second slot structure 10153. When the fixing post 10151 is inserted into the first through hole 10111, the at least one second slot 10153 matches the at least one first slot structure 10115, and the third through hole 10152 matches the second through hole 10112. Figure 3In the above-mentioned, the third through hole 10152 and the second through hole 10112 overlap, so that the limiting post of the limiting pin 10113 is inserted into the second through hole 10112 and the third through hole 10152. At least one second annular electrode 1016 is provided on the electrode body, and a second annular insulating member 1017 is provided between adjacent second annular electrodes 1016. The at least one second annular electrode 1016 is correspondingly provided with the at least one first annular electrode 1012, such as... Figure 1 As shown. The second end 1018 is a conical structure used for insertion into the myocardium.

[0051] The aforementioned first pacemaker body also includes internal circuitry, which is disposed within the aforementioned first housing. Figure 5 This is a cross-sectional view of the cylindrical pacemaker body. The internal circuitry includes a circuit board 101-1 and a battery 101-2. The battery 101-2 is connected to the circuit board 101-1 and supplies power to it. The circuit board 101-1 is located on the side closer to the first detachable structure 1011, and the battery 101-2 is located on the side away from the first detachable structure 1011. The circuit board 101-1 includes at least one first contact 101-3 for connecting at least one first annular electrode 1012. This allows the circuit board 101-1 to supply power to at least one first annular electrode 1012 via the at least one first contact 101-3. Typically, the battery 101-2 is heavier than the circuit board 101-1 when the leadless pacemaker 101 is mounted in the ventricle. Figure 5 When the ventricular septum is inserted downwards in the direction shown, the center of gravity of the detachable leadless pacemaker 101 is lower, which further reduces the possibility of the detachable leadless pacemaker 101 falling off the ventricular septum and improves the stability of the detachable leadless pacemaker 101 installation.

[0052] The aforementioned circuit board 101-1 may be equipped with a wireless communication module for information exchange with an external programmer. The external programmer can be placed on the body surface near the heart to establish information exchange with the wireless communication module.

[0053] The first pacemaker body further comprises at least one first electrode lead corresponding to the at least one first ring electrode 1012, the at least one first electrode lead is arranged in the first housing, one end of the first electrode lead in the at least one first electrode lead is connected to the corresponding first ring electrode 1012 in the at least one first ring electrode 1012, and the other end of the first electrode lead in the at least one first electrode lead is connected to the corresponding first contact 101-3 in the at least one first contact 101-3. In this way, the circuit board 101-1 can supply power to the first ring electrode 1012 through the first electrode lead and the first contact 101-3.

[0054] The detachable leadless pacemaker 101 of the present application is provided with a plurality of first ring electrodes 1012 and a plurality of corresponding second ring electrodes 1016. In actual use, the most reasonable one of the first ring electrodes 1012 and the second ring electrode 1016 can be selected to achieve pacing. Therefore, each group of first ring electrodes 1012 and second ring electrodes 1016 needs to be tested. Therefore, when testing a group of first ring electrodes 1012 and second ring electrodes 1016, other first ring electrodes 1012 and second ring electrodes 1016 need to be disconnected from the signal. Therefore, a first switch can be provided between the circuit board 101-1 and each of the at least one first ring electrode 1012, and the first switch is used to control the on-off between the circuit board 101-1 and the first ring electrode 1012. Similarly, a second switch is provided between the circuit board 101-1 and each of the at least one second contact 101-4, and the second switch is used to control the on-off between the circuit board 101-1 and the second contact 101-4.

[0055] The circuit board 101-1 also needs to supply power to the second ring electrode 1016 on the first side wall hook electrode. Therefore, the first detachable structure 1011 of the present application is provided with at least one second contact 101-4 near one side of the body structure, wherein the at least one second contact 101-4 is connected to the circuit board 101-1.

[0056] The aforementioned first sidewall hook electrode may further include at least one second electrode lead corresponding to the aforementioned at least one second annular electrode 1016, and the aforementioned at least one second electrode lead is disposed within the aforementioned second housing. One end of the aforementioned at least one second electrode lead is connected to the corresponding second annular electrode 1016 among the aforementioned at least one second annular electrode 1016, and the other end of the aforementioned at least one second electrode lead is disposed within the aforementioned fixing post 10151. When the aforementioned fixing post 10151 is inserted into the aforementioned first through hole 10111, the aforementioned at least one second electrode lead is connected to the corresponding second contact 101-4 among the aforementioned at least one second contact 101-4. In this way, the circuit board 101-1 provides power to the second annular electrode 1016 through the second electrode lead and the second contact 101-4.

[0057] In practice, to achieve pacing, the first ring electrode 1012 and the second ring electrode 1016 need to be connected to electrodes with different power supplies. When the first ring electrode 1012 is connected to the positive terminal of the power supply, the second ring electrode 1016 needs to be connected to the negative terminal. That is, the first ring electrode 1012 is connected to the first power supply terminal of the corresponding battery 101-2 on the circuit board 101-1 through the corresponding first contact 101-3, and the second ring electrode 1016 is connected to the second power supply terminal of the corresponding battery 101-2 on the circuit board 101-1 through the corresponding second contact 101-4.

[0058] The insertion of the first sidewall hook electrode into the interventricular septum inevitably damages the septal tissue. The septum itself will repair the damaged tissue, typically by covering the damaged area with a new layer of tissue. However, this new tissue can reduce or even block signal transmission between the first ring electrode 1012 and the second ring electrode 1016, resulting in a weak pacing signal or even failure to pace. Therefore, the first ring insulating member 1013 is provided with a slot matrix 1014 on the side near the first sidewall hook electrode. The slot matrix 1014 includes at least one slot for placing medication. The medication placed in the slot can slow down the formation of new tissue in the interventricular septum, ensuring normal pacing by the first ring electrode 1012 and the second ring electrode 1016. Furthermore, as described above, this application has multiple sets of first ring electrodes 1012 and second ring electrodes 1016. As long as these multiple sets of first ring electrodes 1012 and second ring electrodes 1016 are not completely covered, the detachable leadless pacemaker 101 of this application can achieve pacing. This greatly improves the effectiveness of pacing.

[0059] Depend on Figure 2 As can be seen, the first annular insulating member 1013 of this application has a large space, and various sensors can be set on the first annular insulating member 1013 according to actual needs.

[0060] In order to further improve the stability of the detachable leadless pacemaker 101, the second end 1018 of the second shell is provided with at least one first positioning structure 1019 close to one side of the first pacemaker body. The first positioning structure 1019 of the present application is as shown in Figure 4 The angle of the first positioning structure 1019 in the insertion direction is smaller than that in the exit direction, so that the first side wall hook electrode can be inserted into the interventricular septum, and the first side wall hook electrode can be clamped to avoid falling off from the interventricular septum. At the same time, the second end 1018 of the second shell exceeds the first pacemaker body, which can reduce the pressure on the installation catheter to a certain extent when the detachable leadless pacemaker 101 is implanted. When the detachable leadless pacemaker 101 enters the ventricle, the second end 1018 of the first pacemaker body usually contacts the myocardial tissue (interventricular septum or other positions) first, so as to facilitate the insertion of the myocardial tissue.

[0061] As shown in Figure 1 The passive leadless pacemaker 102 can include a second pacemaker body and a second side wall hook electrode. The structural schematic diagram of the second pacemaker body is as shown in Figure 6 The structural schematic diagram of the second side wall hook electrode is as shown in Figure 7 .

[0062] As can be seen from Figure 6 , the second pacemaker body is provided with a second detachable structure 1024, and the second side wall hook electrode is fixed to the second pacemaker body through the second detachable structure 1024. The second side wall hook electrode is arranged in parallel with the second pacemaker body at a second set distance. The second pacemaker body can further include at least one third ring electrode 1021 Figure 6 (two in the embodiment), a third ring insulating member 1022 arranged between the third ring electrodes 1021, and a hole slot 1023 arranged close to one side of the second side wall hook electrode. The second side wall hook electrode can include at least one fourth ring electrode 1027 Figure 7 (two in the embodiment), a fourth ring insulating member 1028, and a second positioning structure 1029. The fourth ring insulating member 1028 is arranged between the at least one fourth ring electrode 1027. The third ring electrode 1021 and the fourth ring electrode 1027 are correspondingly arranged, which can realize the pacing of the atrium.

[0063] The second pacemaker body of the passive leadless pacemaker 102 can have a packaging circuit, which is connected with the at least one third ring electrode and the at least one fourth ring electrode respectively, can sense the cardiac electrical signal of the fourth ring electrode, and serves as a carrier of the at least one third ring electrode and the at least one fourth ring electrode.

[0064] It should be noted that the second pacing device body of the passive leadless pacing device 102 can also not have corresponding packaging circuit, battery and other components, and can receive power from the battery 101-2 in the detachable leadless pacing device 101 through the signal line 103. In this way, the structure of the passive leadless pacing device 102 can be simplified, and the weight of the passive leadless pacing device 102 can be reduced.

[0065] The detachable leadless pacing device 101 is provided with a first connecting portion 10116, which is arranged on the first detachable structure 1011, as shown in Figure 5 The passive leadless pacing device 102 is provided with a second connecting portion 1026, which is arranged on the second detachable structure 1024. The first connecting portion 10116 and the second connecting portion 1026 are used to realize the fixed connection of the detachable leadless pacing device 101 and the passive leadless pacing device 102.

[0066] Figure 8 The detachable leadless pacing device system for pacing the cardiac conduction bundle is shown in the figure. In order to facilitate installation, the insertion direction of the first side wall hook electrode is opposite to the insertion direction of the second side wall hook electrode in the state of fixed connection of the first connecting portion 10116 and the second connecting portion 1026, as shown in Figure 1 In this way, when the detachable leadless pacing device 101 is arranged in the atrium, the passive leadless pacing device 102 can be arranged in the atrium by the same force, as shown in Figure 8

[0067] The detachable leadless pacing device system for pacing the cardiac conduction bundle also includes a mounting line 104, the first line end of the mounting line 104 includes a first loop, the first loop is sleeved on the first curved structure of the first side wall hook electrode of the detachable leadless pacing device 101, and the second line end of the mounting line 104 includes a second loop, the second loop is sleeved on the second curved structure of the second side wall hook electrode of the passive leadless pacing device 102, as shown in Figure 1

[0068] The above description is only some preferred embodiments of the present disclosure and an explanation of the technical principles applied. Those skilled in the art should understand that the scope of the application involved in the embodiments of the present disclosure is not limited to the technical solutions formed by the specific combinations of the above technical features, and should also cover other technical solutions formed by any combination of the above technical features or equivalent features without departing from the above inventive concept. For example, the above features are replaced with the technical features disclosed in the embodiments of the present disclosure (but not limited to) having similar functions to form technical solutions.​​

Claims

1. A detachable leadless pacemaker system for pacing a cardiac conduction bundle, comprising: a detachable leadless pacemaker, the detachable leadless pacemaker being provided with a first data interface; a passive leadless pacemaker, the passive leadless pacemaker being provided with a second data interface; a signal line connected with the first data interface and the second data interface respectively, for realizing power supply of the passive leadless pacemaker by the detachable leadless pacemaker and data communication between the detachable leadless pacemaker and the passive leadless pacemaker, wherein the detachable leadless pacemaker comprises: a first pacemaker body, the first pacemaker body being provided with a first detachable structure, the first pacemaker body comprising a first shell, the first shell comprising a body structure and the first detachable structure provided at one end of the body structure, the first detachable structure comprising a first through hole, a second through hole and a limiting needle, the first through hole having at least one first clamping groove structure, the second through hole penetrating the first through hole in a direction perpendicular to a plane formed by an axial direction of the body structure and an axial direction of the first through hole, the second through hole having a diameter smaller than that of the first through hole, the limiting needle comprising a limiting column and a limiting handle, the limiting column being provided in the second through hole, and the limiting handle being exposed outside the first detachable structure; a first side wall hook electrode fixed with the first pacemaker body through the first detachable structure, the first side wall hook electrode being provided in parallel with the first pacemaker body at a first set distance.

2. The removable leadless pacemaker system that can pace a cardiac conduction bundle according to claim 1, wherein, The first pacemaker body is cylindrical.

3. The detachable leadless pacemaker system for pacing a cardiac conduction bundle according to claim 1, wherein: the body structure is provided with at least one first ring-shaped electrode, and first ring-shaped insulating members are arranged between adjacent first ring-shaped electrodes of the at least one first ring-shaped electrode.

4. The removable, leadless pacemaker system that can pace a cardiac conduction bundle of claim 1, wherein, The first pacemaker body further comprises an internal circuit, and the internal circuit is arranged in the first shell. The internal circuit comprises a circuit board and a battery, the battery is connected with the circuit board, the battery supplies power to the circuit board, the circuit board is arranged at a side close to the first detachable structure, and the battery is arranged at a side away from the first detachable structure. The circuit board comprises at least one first contact for connecting the at least one first ring-shaped electrode.

5. The removable leadless pacemaker system for pacing a heart conduction bundle according to claim 4, wherein, The first pacemaker body further comprises at least one first electrode lead corresponding to the at least one first ring-shaped electrode, the at least one first electrode lead is arranged in the first shell, one end of a first electrode lead of the at least one first electrode lead is connected with a corresponding first ring-shaped electrode of the at least one first ring-shaped electrode, and the other end of the first electrode lead is connected with a corresponding first contact of the at least one first contact.

6. The removable, leadless pacemaker system that can pace a cardiac conduction bundle of claim 4, wherein, The circuit board is provided with a wireless communication module for information interaction with an external programmer.

7. The removable leadless pacemaker system for pacing a heart conduction bundle of claim 4, wherein, A first switch is arranged between the circuit board and each of the at least one first ring-shaped electrode, and is used to control the on-off between the circuit board and the first ring-shaped electrode.

8. The removable leadless pacemaker system of any one of claims 4-7, wherein, The first side wall hook electrode comprises a second shell. The second shell comprises a first end, an electrode body and a second end arranged in sequence. The first end is a first curved structure, comprising a fixing column, the fixing column comprises a third through hole and at least one second clamping groove structure, in the state that the fixing column is inserted into the first through hole, the at least one second clamping groove structure matches the at least one first clamping groove structure, and the third through hole and the second through hole match, so that the limiting column of the limiting clamping needle is inserted into the second through hole and the third through hole. At least one second ring-shaped electrode is arranged on the electrode body, and a second ring-shaped insulating member is arranged between adjacent second ring-shaped electrodes of the at least one second ring-shaped electrode, and the at least one second ring-shaped electrode is arranged corresponding to the at least one first ring-shaped electrode. The second end is a conical structure.

9. The removable leadless pacemaker system for pacing a heart conduction bundle according to claim 8, wherein, At least one second contact is arranged on one side of the first detachable structure close to the body structure, and the at least one second contact is connected with the circuit board.

10. The removable leadless pacemaker system that can pace a cardiac conduction bundle according to claim 9, wherein, A second switch is arranged between the circuit board and each of the at least one second contact, and is used to control the on-off between the circuit board and the second contact.

11. The removable leadless pacemaker system that can pace a cardiac conduction bundle according to claim 10, wherein, The first side wall hook electrode comprises at least one second electrode lead wire arranged corresponding to the at least one second ring-shaped electrode, the at least one second electrode lead wire is arranged in the second shell, one end of the second electrode lead wire of the at least one second electrode lead wire is connected with the corresponding second ring-shaped electrode of the at least one second ring-shaped electrode, and the other end of the second electrode lead wire of the at least one second electrode lead wire is arranged in the fixing column. In the state that the fixing column is inserted into the first through hole, the at least one second electrode lead wire is connected with the corresponding second contact of the at least one second contact.

12. The removable leadless pacemaker system of a paced cardiac conduction bundle according to claim 11, wherein, The first ring-shaped electrode is connected with the first power supply end of the corresponding battery on the circuit board through the corresponding first contact, and the second ring-shaped electrode is connected with the second power supply end of the corresponding battery on the circuit board through the corresponding second contact.

13. The removable, leadless pacemaker system for paceable cardiac conduction bundle of claim 3, wherein, A hole slot matrix is arranged on one side of the first ring-shaped insulating member close to the first side wall hook electrode, the hole slot matrix comprises at least one hole slot, and the hole slot is used to place medicine.

14. The removable, leadless pacemaker system that can pace a cardiac conduction bundle of claim 8, wherein, At least one first positioning structure is arranged on one side of the second end of the second shell close to the first pacemaker body.

15. The removable, leadless pacemaker system that can pace a cardiac conduction bundle of claim 8, wherein, The passive and wire-free pacemaker comprises: A second pacemaker body, the second pacemaker body is provided with a second detachable structure; A second side wall hook electrode is fixed with the second pacemaker body through the second detachable structure, and the second side wall hook electrode is arranged in parallel with the second pacemaker body at a second set distance.

16. The removable, leadless pacemaker system of a paced cardiac conduction bundle according to claim 15, wherein, The second pacemaker body is a cylindrical shape.

17. The removable, leadless pacemaker system of a paced cardiac conduction bundle according to claim 15, wherein, A first connecting part is arranged on the first detachable structure of the detachable wire-free pacemaker; The passive leadless pacemaker is provided with a second connecting part, and the second connecting part is arranged on the second detachable structure; The first connecting part and the second connecting part are used to realize the fixed connection of the detachable leadless pacemaker and the passive leadless pacemaker.

18. The removable, leadless pacemaker system of a paced cardiac conduction bundle according to claim 17, wherein, In the state of the fixed connection of the first connecting part and the second connecting part, the insertion direction of the first side wall hook electrode is opposite to the insertion direction of the second side wall hook electrode.

19. The removable, leadless pacemaker system that can pace a heart conduction bundle of claim 8, wherein, The detachable leadless pacemaker system further comprises a mounting wire, a first wire end of the mounting wire comprises a first thimble, the first thimble is sleeved on the first curved structure of the first side wall hook electrode of the detachable leadless pacemaker, and a second wire end of the mounting wire comprises a second thimble, the second thimble is sleeved on the second curved structure of the second side wall hook electrode of the passive leadless pacemaker.

20. The removable, leadless pacemaker system that can pace a heart conduction bundle of claim 15, wherein, The second pacemaker body comprises at least one third ring-shaped electrode, and third ring-shaped insulating members are arranged between adjacent third ring-shaped electrodes in the at least one third ring-shaped electrode; The second side wall hook electrode comprises at least one fourth ring-shaped electrode, and fourth ring-shaped insulating members are arranged between adjacent fourth ring-shaped electrodes in the at least one fourth ring-shaped electrode. The passive leadless pacemaker comprises encapsulated circuit electronic elements connected with the at least one third ring-shaped electrode and the at least one fourth ring-shaped electrode respectively.

21. The detachable leadless pacemaker system for pacing a heart conduction bundle according to claim 15, wherein the second pacemaker body is provided with no encapsulated circuit electronic elements, and signal lines are directly connected with the at least one third and the at least one fourth ring-shaped electrodes.

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