CN115518295A - Separated leadless pacing system - Google Patents

Abstract

The invention relates to a separated leadless pacemaker system, which comprises an ultrasonic device and a plurality of pacing heads, wherein the ultrasonic device comprises an ultrasonic emission module; the multiple pacing heads are respectively implanted into at least 2 of the right atrium, the right ventricle and the left ventricle, each pacing head comprises a receiving unit, the natural frequencies of the receiving units of the multiple pacing heads are different so as to receive ultrasonic waves with corresponding frequencies sent by the ultrasonic emission module, and the pacing heads receive the ultrasonic waves with the corresponding frequencies and then pace as pacing points. Each pacing head can sense the electric signal of the cavity of the pacing head and feed the electric signal back to the ultrasonic device, and the ultrasonic device determines ultrasonic waves with different frequencies to be distributed according to the signals fed back by different cavities, so that multi-cavity cooperative physiological pacing is realized.

Description

Separated leadless pacing system

Technical Field

The present invention relates to implantable medical devices, and more particularly to implantable medical devices for cardiac therapy from the atrium to the ventricle, and more particularly to a separate leadless pacemaker system for achieving multi-chamber coordinated physiologic pacing.

Background

Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, can alleviate symptoms and recurrence of syncope, and improve survival rates in high risk populations. Since the 1960 s, pacemakers have been shrinking in size and becoming more and more sophisticated in function. Conventional pacing systems consist of a pacemaker containing electronics and a battery implanted in the subcutaneous pocket of the chest, and an electrode lead. One or more lead wires from the device are threaded through veins into the heart to direct pacing therapy pulses to the desired site. Although complications are reduced due to technological advances, serious adverse events may still be encountered. A 20% proportion of adverse events within 5 years has been reported, with 11% being associated with pacing leads and 8% being associated with the capsular bag, including emphysema, hemothorax, erosion or infection, endocarditis, connectivity faults, lead breakage and other faults following subclavian venipuncture.

Leadless pacing systems are small single-chamber pacemakers delivered through a catheter, through the femoral vein and implanted directly into the Right Ventricle (RV) of the heart. Due to the use of high density batteries, low power electronics, catheter delivery systems, novel materials (nitinol) and electrodes placed directly on the pacemaker capsule, this new technology not only greatly reduces the size of the pacing system, but also eliminates the device pouch and pacing electrode leads, thereby avoiding the important complications associated with conventional pacing systems. However, with conventional leadless pacemakers, the battery still occupies a large amount of internal space inside the pacemaker, making the overall size of the leadless pacemaker difficult to make small. At present, related patents and products adopt a mode of separating a pacing head from an energy storage element, and ultrasonic waves are utilized to wirelessly transmit energy to the pacing head, so that the size of the pacing head implanted into the heart is greatly reduced.

While the development of leadless pacemakers has advanced a new step toward using ultrasound to wirelessly transmit energy, single chamber leadless pacing is currently only available. To realize multi-chamber physiological pacing, the traditional CRT-D matched electrode lead scheme is still needed.

Disclosure of Invention

Based on this, in view of the problem that it is difficult to implement multi-lumen leadless pacing in the prior art, it is necessary to provide a separate leadless pacemaker system for implementing multi-lumen collaborative physiological pacing.

A split leadless pacemaker system, an ultrasound device and a plurality of pacing heads, the ultrasound device comprising an ultrasound emitting module; the multiple pacing heads are respectively implanted into at least 2 of the right atrium, the right ventricle and the left ventricle, each pacing head comprises a receiving unit, the natural frequencies of the receiving units of the multiple pacing heads are different so as to receive ultrasonic waves with corresponding frequencies sent by the ultrasonic emission module, and the pacing heads receive the ultrasonic waves with the corresponding frequencies and then pace as pacing points.

When the separated leadless pacemaker system works: each pace-making head can perceive the signal of telecommunication of self cavity, carry out effective perception, and feed back to ultrasonic device, ultrasonic device is according to the signal of different cavity feedbacks, the ultrasonic wave of deciding different frequency is provided, each pace-making head receives the ultrasonic wave back that should the frequency and is regarded as pace-making point pace-making, the natural frequency of the receiving element of each pace-making head is different, can avoid the mutual interference among the energy transmission process, make ultrasonic energy orientation reach specific pace-making head, then can realize the pace-making head collaborative work in different cavities, realize physiological pace-making, only can implant in the right ventricle in the design of conventional no wire pacemaker, can't multicavity pace-making, the problem of physiological pace-making.

In one embodiment, the plurality of pacing heads include a first pacing head, the first pacing head includes a first housing, a first connecting structure and a first fixing structure are respectively disposed at two ends of the first housing, the two ends of the first housing are disposed opposite to each other, the first connecting structure is used for being connected with an implantation assisting mechanism, the first fixing structure is used for being connected with a myocardium, the first housing is internally provided with the receiving unit, and the receiving unit is used for receiving the ultrasonic waves emitted by the ultrasonic emission module.

In one embodiment, the first fixing structure comprises a screw structure, a hook or a wing structure, and the first connecting structure comprises an external screw mechanism.

In one embodiment, the plurality of pacing heads includes a second pacing head including a piercing structure for crossing a ventricular septum, the second pacing head for pacing a right ventricle and a left ventricle simultaneously.

In one embodiment, the second pacing head includes a second housing, a first end of two opposite ends of the second housing is provided with a second connection structure, a second end of the second housing is provided with a second fixing structure and the puncturing structure, the second connection structure is used for being connected with an implantation assisting mechanism, the second fixing structure is used for being connected with a myocardium, the puncturing structure penetrates through the second fixing structure, the receiving unit is arranged inside the second housing, and the receiving unit is used for receiving the ultrasonic wave emitted by the ultrasonic emission module.

In one embodiment, the second securing structure comprises a helix, hook or wing structure and the second connecting structure comprises an external screw mechanism.

In one embodiment, the puncture structure includes a needle body including a top end and a bottom end disposed opposite to each other, wherein the needle body is movably inserted through the housing, so that the top end can extend out of the second connecting structure and/or the bottom end passes over the second fixing structure.

In one embodiment, the needle body has an externally threaded portion at a location adjacent the tip.

In one embodiment, a guide groove is formed in the housing along the arrangement direction from the first end to the second end, a first guide block and a second guide block which are in sliding fit with the guide groove are arranged on the needle body, a first positioning block and a second positioning block are further arranged on the second pacing head on two sides of the guide groove and correspond to the first guide block and the second guide block respectively, the first positioning block is used for limiting the first guide block to move towards the top end, and the second positioning block is used for limiting the second guide block to move towards the bottom end. In one embodiment, the receiving unit includes: a heart rate sensor for sensing cardiac electrical signals; a communication module to transmit the cardiac electrical signal to the ultrasound device; the receiver is used for receiving the ultrasonic waves emitted by the ultrasonic device; and the energy converter is used for converting the energy of the ultrasonic waves into electric energy.

In one embodiment, the ultrasound device further comprises: a battery; the signal collector is used for receiving the cardiac electric signal; the signal processor is used for processing the cardiac electric signal and controlling the ultrasonic transmitting module to send out ultrasonic waves; the ultrasonic transmitting module comprises an ultrasonic wave transduction unit which is used for converting the electric energy of the battery into ultrasonic waves.

Drawings

Fig. 1 is a schematic diagram of a split leadless pacemaker system according to an embodiment of the present invention.

Fig. 2 is a schematic diagram of the hardware configuration of the ultrasound apparatus.

Fig. 3 is a schematic structural diagram of a first pacing head.

Fig. 4 isbase:Sub>A sectional view taken along linebase:Sub>A-base:Sub>A in fig. 3.

Fig. 5 is a schematic implantation diagram of the first pacing head implanted in a ventricle.

Fig. 6 is a schematic diagram of a hardware structure of the receiving unit.

Fig. 7 is a schematic diagram of a separate leadless pacemaker system according to another embodiment of the present invention.

Fig. 8 is a schematic structural diagram of an embodiment of the second pacing head in fig. 7.

Fig. 9 is a schematic structural diagram of another embodiment of the second pacing head in fig. 7.

Fig. 10 is a sectional view taken along line C-C in fig. 9.

Fig. 11 is an enlarged view of the portion X in fig. 10.

Fig. 12 is an enlarged view of a portion Y in fig. 10.

Fig. 13 is a schematic diagram of the implantation of the second pacing head in a ventricle.

The relevant elements in the figures are numbered correspondingly as follows:

1. the right atrium; 2. a right ventricle; 3. a left ventricle; 4. the inferior vena cava; 5. the superior vena cava; 6. a delivery sheath; (ii) a 7. A guiding sheath; 8. rotating the sheath; 81. an inner rotating sheath; 82. an outer rotating sheath; 100. a separate leadless pacemaker system; 10. an ultrasonic device; 110. a battery; 120. an ultrasonic transmission module; 130. a signal collector; 140. a signal processor; 20. a first pacing head; 210. a first housing; 220. a first connecting structure; 230. a first fixed structure; 30. a receiving unit; 310. a heart rate sensor; 320. a communication module; 330. a receiver; 340. an energy converter; 40. a second pacing head; 410. a second housing; 411. a first end; 412. a second end; 420. a second connecting structure; 421. a first positioning block; 422. a first through hole; 430. a second fixed structure; 431. a second positioning block; 432. a second through hole; 440. a puncture structure; 441. a needle body; 4411. a top end; 4412. a bottom end; 4413. an external threaded portion; 4414. a relief structure; 442. a first guide block; 443. a second guide block; 450. a guide groove; 460. a cylinder.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or to implicitly indicate the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless explicitly specified otherwise.

In the present invention, unless otherwise explicitly stated or limited, the terms "mounted," "connected," "fixed," and the like are to be construed broadly, e.g., as being permanently connected, detachably connected, or integral; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.

In the present invention, unless expressly stated or limited otherwise, the first feature "on" or "under" the second feature may be directly contacting the second feature or the first and second features may be indirectly contacting each other through intervening media. Also, a first feature "on," "above," and "over" a second feature may be directly on or obliquely above the second feature, or simply mean that the first feature is at a higher level than the second feature. A first feature "under," "beneath," and "under" a second feature may be directly under or obliquely under the second feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

As described in the background, it is currently difficult to achieve multi-lumen leadless pacing. In this regard, the applicant has found that the biggest bottleneck in achieving multi-lumen leadless pacing is how to avoid the problem of interference between different pacing heads.

As shown in fig. 1, a split leadless pacemaker system 100 is illustrated in accordance with one embodiment of the present invention. The separated leadless pacemaker system 100 includes an ultrasound device 10 and a plurality of first pacing heads 20, specifically 3, configured to be implanted in the right atrium 1, the right ventricle 2, and the left ventricle 3, respectively. The ultrasound device 10 may be configured to be implanted within subcutaneous tissue, such as within subcutaneous tissue of the chest, or placed outside the body. The ultrasonic device 10 is used to generate ultrasonic waves of different frequencies. The plurality of first pacing heads 20 have the receiving units 30 shown in fig. 6, but their natural frequencies are different, and can receive electromagnetic waves of different frequencies to receive the ultrasonic waves of corresponding frequencies emitted by the ultrasonic emission module 120.

The principle of operation of the split leadless pacemaker system 100 is: the ultrasound apparatus 10 generates ultrasound waves of different frequencies corresponding to the natural frequencies of the receiving units 30 inside the plurality of first pacing heads 20, respectively. By using the frequency resonance principle, when the frequency of the transmitted ultrasonic wave is consistent with the natural frequency of the receiving unit 30 of the pacing head, a resonance effect is caused, so that the energy transmission efficiency is maximized, thereby realizing the targeted transmission of the ultrasonic energy. Natural frequency f _n The calculation formula of (c) is as follows:

where k is the modulus of elasticity of the material, m is the mass of the material (e.g., the mass of the receiving unit 30), and ε is the damping rate. In specific implementation, the receiving units 30 of the pacing heads with different materials and qualities can be reasonably selected, so that the inherent frequencies of the receiving units 30 are sufficiently different, mutual interference in the energy transmission process is avoided, ultrasonic energy is directionally transmitted to the specific pacing heads, the first pacing heads 20 in different cavities can cooperatively work, physiological pacing is realized, and the problems that only the right ventricle can be implanted, and multi-cavity pacing and physiological pacing cannot be realized in the design of a conventional leadless pacemaker are solved. Specifically, for a chamber requiring pacing, the ultrasound apparatus 10 may send ultrasound waves of corresponding frequencies to control the pacing head of the chamber to pace, if multiple chambers need to work simultaneously, the ultrasound apparatus may send ultrasound waves of corresponding frequencies to the pacing heads of multiple chambers simultaneously to control the pacing heads to pace simultaneously, and if only one chamber needs pacing, the ultrasound apparatus may control the pacing head of the chamber to pace alone.

As shown in fig. 2, in one example, the ultrasound apparatus 10 includes a battery 110, an ultrasound transmission module 120, a signal collector 130, and a signal processor 140. In practice, the ultrasound device 10 may further include a housing, and the above-mentioned components are integrated into the housing, so that the ultrasound device 10 is convenient to carry, transfer and implant subcutaneously. The battery 110 is used to provide electric energy, and the specific type is not limited, and preferably a button battery can be selected. The ultrasonic transmission module 120 includes an ultrasonic wave transduction unit for converting the electric energy of the battery 110 into an ultrasonic wave and transmitting it. The ultrasonic wave transduction unit may be a piezoelectric module, and when the ultrasonic wave energy is transmitted, a high frequency electric field is introduced through a driving circuit, and the high frequency electric field causes the piezoelectric module to mechanically oscillate to generate an ultrasonic wave. The signal collector 130 is used for receiving cardiac electrical signals. The signal processor 140 is used for processing the cardiac electrical signal and controlling the ultrasound emitting module 120 to emit the ultrasound wave. Cardiac electrical signals are sensed and transmitted by the receiving unit 30.

As shown in fig. 6, in one example, the receiving unit 30 in each pacing head includes a heart rate sensor 310, a communication module 320, a receiver 330, and an energy converter 340. The heart rate sensor 310 is used to send the cardiac electrical signal sensed by the pacing head to the communication module 320, and then the communication module 320 sends the cardiac electrical signal to the signal collector 130 of the ultrasound apparatus 10. The receiver 330 is used for receiving the ultrasonic wave emitted from the ultrasonic device 10. The energy converter 340 is used for converting the energy of the ultrasonic wave into electric energy. The energy converter 340 is an ultrasonic transducer, and specifically, the ultrasonic transducer may be a piezoelectric material, which receives ultrasonic oscillation and generates electric charge, and may cooperate with a circuit such as a filter rectifier to form an output current.

When the separated leadless pacemaker system 100 works, the pacing head in the corresponding chamber of the heart senses the cardiac electrical signal and sends the cardiac electrical signal to the signal collector 130 of the ultrasound device 10 through the heart rate sensor 310 and the communication module 320, then the signal processor 140 is used for processing the cardiac electrical signal, and when it is determined that the heart needs pacing, the signal processor 140 controls the ultrasound emitting module 120 to emit ultrasound with a corresponding frequency. In turn, the receiving unit 30 in the respective first pacing head 20 converts the ultrasound energy into electrical energy and paces the heart. Because the heart rate sensor 310 of each pacing head can sense the electrical signal of its own chamber, perform effective sensing, and feed back to the ultrasound apparatus 10, the ultrasound apparatus 10 determines the ultrasound waves with different frequencies to be delivered according to the signals fed back from different chambers, thereby realizing multi-chamber cooperative physiological pacing. Because the intrinsic frequencies of the pacing heads of the chambers are different, the ultrasonic waves with different frequencies can be transmitted at the same time, and the pacing of the pacing heads can be realized at the same time.

The first pacing head 20 may be implanted in the respective chamber and sense cardiac electrical signals. The receiving unit 30 shown in fig. 6 is an electronic module part of the first pacing head 20. As shown in fig. 3 and 4, the mechanical structure of the first pacing head 20 in one embodiment is illustrated. The first pacing head 20 includes a first housing 210, and a first connection structure 220 and a first fixing structure 230 are respectively disposed at two ends of the first housing 210, which are opposite to each other. When the first pacing head 20 is assembled, the receiving unit 30 is mounted inside the first housing 210. The first connecting structure 220 is used for connecting with an implantation assisting mechanism when the first pacing head 20 is implanted in a chamber of the heart, and the first fixing structure 230 is used for fixing with the myocardium. Thus, the contact of the first housing 210 with the myocardium enables the sensing of cardiac electrical signals and the emission through the communication module 320. Preferably, the first outer case 210, the first connecting structure 220 and the first fixing structure 230 are made of metal materials, and may be connected together by a welding process (but not limited thereto).

The first pacing head 20 of the present embodiment does not need to add a battery inside, and the first pacing head 20 is configured with only the heart rate sensor 310, the communication module 320, the receiver 330, the energy converter 340 and the first fixing structure 230. The pacing head and the battery are separated in space, and wireless energy transmission is carried out by using ultrasonic waves as a medium, so that the volume of a part implanted into the heart is reduced remarkably, and the part can be fixed in different chambers. By utilizing the ultrasonic frequency resonance principle, the ultrasonic energy transmission efficiency is greatly improved, and the directional transmission of energy is realized. The pacemaker in different chambers can work cooperatively, physiological pacing is realized, and the problems that the pacemaker can only be implanted in the right chamber and multi-chamber pacing and physiological pacing cannot be realized in the conventional leadless pacemaker design are solved. Because first pacing head 20 is leadless, the limitations of using electrode leads and the potential for complications in Cardiac Resynchronization Therapy (CRT) are also overcome. It should be noted that the first pacing head 20 of the present application may not use a battery, because the ultrasound transmitted by the ultrasound device 10 is transmitted to the receiving unit 30, and the energy converter in the receiving unit 30 can convert the ultrasound energy into electric energy for the components in the pacing head to work.

The first housing 210 is provided in a substantially cylindrical shape, but is not limited thereto. The first connection structure 220 and the first fixing structure 230 are specifically configured to be located at two sides of the first housing 210 and connected to the first housing 210, so that when the first pacing head 20 is implanted, the first fixing structure 230 faces the inside of the heart, and the first connection structure 220 faces the outside of the heart for connection with the implantation assisting mechanism.

The first coupling structure 220 includes an externally threaded mechanism, i.e., a coupling structure having an external thread, for detachably coupling with the threaded structure of the implantation assistance mechanism by way of a screw fit. The first connecting structure 220 may also be another structure capable of detachably connecting the implantation assistance mechanism, and may be specifically adapted according to the structure of the implantation assistance mechanism.

The first fixation structure 230 includes a threaded structure that can be threaded into the myocardium and secured in the myocardium, which in turn secures the first pacing head 20 to the myocardium. In another embodiment, the first fixing structure 230 may be a hook, and may be configured in any shape that can penetrate into the myocardium and hook the myocardium without limitation. For example, the first fastening structure 230 may be wing-shaped.

As shown in fig. 5, a schematic illustration of the implantation of the first pacing head 20 into the right ventricle 2 is illustrated, the process being briefly described below.

Before implantation, the rotating sheath 8 of the implantation assisting mechanism and the first pacing head 20 are in a connected state. Specifically, the rotating sheath 8 has a screw structure therein, and is connected to the first connection structure 220. The operator firstly penetrates a guide wire through the axillary vena cava 4, simultaneously penetrates a guide sheath tube 7 and an expansion sheath tube (not shown in the drawing, the expansion sheath tube is an element which is provided with a through hole in the middle and can penetrate through the guide wire) through the guide wire, slowly conveys the sheath tube into the junction of the inferior vena cava 4 and an atrium under X-ray, slowly draws out the expansion sheath tube and the guide wire after the sheath tube reaches a proper position, keeps the guide sheath tube 7 in the junction area, slowly conveys a conveying sheath tube 6 and a rotating sheath tube 8 which are provided with a first pacing head 20 inwards through the guide sheath tube 7, connects the rotating sheath tube 8 and the first pacing head 20 in the conveying sheath tube 6, slowly moves the two together under X-ray, bends and moves, slowly rotates the rotating sheath tube 8 after the conveying sheath tube 6 reaches the proper position, rotationally fixes the first head 20 in myocardium, and sequentially retracts the conveying sheath tube 6 and the guide sheath tube 7 after implantation. After implantation is complete as shown in figure 1.

Referring to fig. 7, another embodiment of a split leadless pacemaker system 100 of the present invention is illustrated. The separate leadless pacemaker system 100 includes the ultrasound device 10 and the first pacing head 20 described above, and further includes the second pacing head 40, and the first pacing head 20 and the second pacing head 40 respectively include the receiving unit 30 described above. First pacing head 20 is configured to be implanted in right atrium 1. The second pacing head 40 further comprises a piercing structure 440 (see fig. 8), the second pacing head 40 being configured to be implanted in the right ventricle 2 with the piercing structure 440 penetrating the left ventricle 3. The natural frequency of the receiving unit 30 provided in the second pacing head 40 is different from the natural frequency of the receiving unit 30 provided in the first pacing head 20 to receive the ultrasonic waves of different frequencies emitted by the ultrasonic emitting module 120. Similar to the previous embodiment, the ultrasound device 10 may be configured to be implanted within subcutaneous tissue, such as within subcutaneous tissue of the thorax, or placed outside the body. The ultrasonic apparatus 10 is used to generate ultrasonic waves of different frequencies.

In operation of split-type leadless pacemaker system 100, ultrasound device 10 generates ultrasound waves of different frequencies corresponding to the natural frequency of receiving element 30 within first pacing head 20 and the natural frequency of element 3 of second pacing head 40, respectively. By utilizing the frequency resonance principle, when the frequency of the transmitted ultrasonic wave is consistent with the inherent frequency of the pacing head receiving module, the resonance effect is caused, the energy transmission efficiency is maximized, and the targeted transmission of the ultrasonic energy is realized. First pacing head 20 may achieve right atrium 1 pacing and second pacing head 40 may achieve synchronous pacing of right ventricle 2 and right atrium 1. Therefore, the multi-cavity cooperative physiological pacing of the right atrium 1, the right ventricle 2 and the right atrium 1 is realized, and mutual interference is avoided.

As shown in fig. 8, the structure of the first embodiment of second pacing head 40 is illustrated. The second pacing head 40 comprises a second housing 410, a first end 411 of two opposite ends of the second housing 410 is provided with a second connecting structure 420, a second end 412 is provided with a second fixing structure 430 and a puncturing structure 440, and the puncturing structure 440 passes through the second fixing structure 430. When second pacing head 40 is assembled, receiving unit 30 is mounted inside second housing 410. Second connection structure 420 is used to connect to an implantation assistance mechanism when second pacing head 40 is implanted in a chamber of the heart, and second fixation structure 430 is used to fix to the myocardium. Thus, contact of the second housing 410 with the myocardium enables sensing of cardiac electrical signals and transmission through the communication module 320. Preferably, the second outer case 410, the second connecting structure 420 and the second fixing structure 430 are made of metal materials, and may be connected together through a welding process (but not limited thereto). The outer surface of the piercing structure 440 may be a completely smooth structure or may include a raised plateau structure. Further, the mesa structure may be uniform or non-uniform.

The second housing 410 is provided in a substantially cylindrical shape, but is not limited thereto. The second connection structure 420 and the first fixation structure 230 are specifically configured to be positioned on opposite sides of the second housing 410 and to be coupled to the second housing 410 such that when the second pacing head 40 is implanted, the second fixation structure 430 faces the interior of the heart and the second connection structure 420 faces the exterior of the heart to facilitate coupling to an implantation aid.

The second coupling structure 420 includes an externally threaded mechanism, i.e., a coupling structure having external threads, for detachably coupling with the threaded structure of the implantation aid in a screw-fit manner. The second coupling structure 420 can also be other structures that can detachably couple with the implant aid, and can be adapted according to the structure of the implant aid.

The second fixation structure 430 may be screwed into the myocardium and fixated in the myocardium, which in turn fixates the second pacing head 40 on the myocardium. In another embodiment, the second fixing structure 430 may be a hook, and may be formed in any shape that can penetrate into the myocardium and hook the myocardium. Such as second securing structure 430 may be wing-shaped.

In this embodiment, the second pacing head 40 is provided with a puncturing structure 440, and the head end of the puncturing structure 440 can penetrate into the his bundle region in the right ventricle 2 or penetrate into the left and right bundle branch regions of the left ventricle 3 after ventricular separation to pace left and right bundle branches, thereby realizing synchronous pacing of the right ventricle 2 and the left ventricle 3. By providing the piercing structure 440, the second pacing head 40 may achieve pacing of the left ventricle 3 without implanting the left ventricle 3.

The second pacing head 40 of the first embodiment is implanted in a manner similar to that of the first pacing head 20, and for details, reference may be made to the process described above with reference to fig. 5, and details are not repeated here.

As shown in fig. 9 to 12, the structure of the second embodiment of the second pacing head 40 is illustrated, which can be regarded as a further improvement on the structure of the first embodiment.

Specifically, the piercing structure 440 is movably disposed through the housing. Piercing structure 440 includes a needle body 441, needle body 441 including opposing top and bottom ends 4411 and 4412, needle body 441 being movable upward to allow top end 4411 to extend out of second attachment structure 420, and needle body 441 being movable downward to allow bottom end 4412 to pass over second attachment structure 430. By the above means, when second pacing head 40 is not implanted, top end 4411 of needle body 441 is in a state of being extended out of second connection structure 420, and bottom end 4412 of needle body 441 is not in a protected state beyond second fixation structure 430. When it is necessary to pierce needle 441 into left ventricle 3, tip 4411 of needle 441 is driven so that base 4412 of needle 441 reaches the left and right bundle branch regions of the ventricle after piercing the ventricular septum in right ventricle 2.

To facilitate driving of needle body 441, needle body 441 has male screw portion 4413 at a position near tip 4411 as shown in fig. 10. Male threaded portion 4413 is adapted to couple with a corresponding member of an implant assist mechanism to facilitate movement of needle body 441 by an operator. Male thread 4413 extends in the longitudinal direction of needle body 441 for a certain length to ensure the reliability of the connection of the counter elements of the implant aid. The needle body 441 is further provided with a concave-convex structure 4414, and the concave-convex structure 4414 can firmly engage with cardiac muscle.

Further, in order to smoothly move the needle body 441 and control the penetration depth of the needle body 441, fig. 9 and 11 are combined. Along the arrangement direction from the first end 411 to the second end 412, a guide groove 450 is formed in the second housing 410, a first guide block 442 and a second guide block 443 slidably engaged with the guide groove 450 are disposed on the needle body 441, and a first positioning block 421 and a second positioning block 431 are disposed on two sides of the guide groove 450 of the second pacing head 40 corresponding to the first guide block 442 and the second guide block 443, respectively. First guide block 442 and second guide block 443 are in sliding fit with guide slot 450, so that needle body 441 can be prevented from shaking during moving, and needle body 441 can run stably. First locating block 421 is located the top of first guide block 442 for carry on spacingly to first guide block 442 when needle body 441 upward movement, can avoid needle body 441 excessive motion upwards and cause unexpected damage. Second locating piece 431 is located the below of second guide block 443 for spacing second guide block 443 when needle body 441 moves down, thereby avoiding being able to control the penetration depth of needle body 441, and then avoiding damaging the heart.

In this embodiment, the arrangement direction of the first end 411 to the second end 412 is specifically the length direction of the second housing 410. When the second housing 410 is a cylindrical member, the arrangement direction of the first end 411 to the second end 412 is exactly the axial direction of the second housing 410.

In one example, the guide groove 450 in the second housing 410 is formed by providing a cylinder 460 in the second housing 410. As shown in fig. 11, the inner wall of the cylinder 460 forms the side wall of the guide groove 450.

Referring to fig. 11 and 12, the first connecting structure 220 has a first through hole 422 through which the top end 4411 of the needle body 441 can pass, and the first positioning block 421 is disposed on an inner wall of the first through hole 422 (protruding from the inner wall of the first through hole 422). The second fixing structure 430 has a second through hole 432 through which the bottom end 4412 of the pin body 441 can pass, and the second positioning block 431 is disposed on an inner wall of the second through hole 432 (protruding from the inner wall of the second through hole 432). Specifically, the first positioning block 421 is disposed on the first connecting structure 220, and after the first connecting structure 220 is connected to the second housing 410, the first positioning block 421 is just located on the moving path of the first guiding block 442. The second positioning block 431 is disposed on the second fixing structure 430, and after the second fixing structure 430 is connected to the second housing 410, the second positioning block 431 is located on a moving path of the second guiding block 443.

As shown in fig. 13, a schematic view of the implantation of the second pacing head 40 of the second embodiment into the right ventricle 2 is illustrated, and the process is briefly described as follows.

The operator firstly penetrates the guide wire through the axillary vena cava 4, simultaneously penetrates the guide sheath tube 7 and the expansion sheath tube (a through hole is arranged in the middle of the expansion sheath tube and can penetrate the guide wire) through the guide wire, slowly moves under X-ray, slowly sends the sheath tube into the junction of the inferior vena cava 4 and the atrium, slowly draws out the expansion sheath tube and the guide wire after the sheath tube reaches a proper position, keeps the guide sheath tube 7 in the junction area, and slowly conveys the conveying sheath tube 6 provided with the second pacing head 40 inwards through the guide sheath tube 7, wherein the conveying sheath tube 6 comprises an inner rotating sheath 81 and an outer rotating sheath 82, the inner rotating sheath 81 is connected with an outer thread part 4413, the outer rotating sheath 82 is connected with the first connecting structure 220, and the connecting mode is not limited. The catheter is slowly moved under X-ray, curved and moved, when the delivery sheath 6 reaches a proper position, the outer rotating sheath 82 is slowly rotated, the head end of the needle body 441 is spirally fixed in the myocardium, the entire pacing head is rotationally fixed in the myocardium, the outer rotating sheath 82 is slowly rotated to gradually separate the outer rotating sheath 82 from the second pacing head 40, the inner rotating sheath 81 is rotated to slowly puncture the needle body 441 through the ventricular septum to the left and right ramus regions of the left ventricle, as shown in fig. 13, when the position is fixed, the inner rotating sheath 81 is slowly rotated to separate the inner rotating sheath 81 from the second pacing head 40. After implantation, the conveying sheath 6 and the guiding sheath 7 are withdrawn slowly in sequence. The effect after implantation is completed is shown with reference to fig. 7.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that various changes and modifications can be made by those skilled in the art without departing from the spirit of the invention, and these changes and modifications are all within the scope of the invention. Therefore, the protection scope of the present patent should be subject to the appended claims.

Claims (11)

1. A split leadless pacemaker system, comprising: an ultrasound device and a plurality of pacing heads,

the ultrasonic device comprises an ultrasonic transmitting module;

the multiple pacing heads are respectively implanted into at least 2 of the right atrium, the right ventricle and the left ventricle, each pacing head comprises a receiving unit, the natural frequencies of the receiving units of the multiple pacing heads are different so as to receive ultrasonic waves with corresponding frequencies sent by the ultrasonic emission module, and the pacing heads receive the ultrasonic waves with the corresponding frequencies and then pace as pacing points.

2. The separated leadless pacemaker system of claim 1, wherein the plurality of pacing heads comprises a first pacing head, the first pacing head comprises a first housing, the opposite ends of the first housing are respectively provided with a first connecting structure and a first fixing structure, the first connecting structure is used for connecting with an implantation auxiliary mechanism, the first fixing structure is used for connecting with myocardium, the first housing is internally provided with the receiving unit, and the receiving unit is used for receiving ultrasonic waves emitted by the ultrasonic emission module.

3. The discrete leadless pacemaker system of claim 2, wherein the first fixation structure comprises a helical structure, a hook or a wing structure and the first connection structure comprises an external threaded mechanism.

4. A split-leadless pacemaker system of claim 1 or 2, wherein said plurality of pacing heads comprises a second pacing head comprising a piercing structure for crossing a ventricular septum, said second pacing head for pacing a right ventricle and a left ventricle simultaneously.

5. The separated leadless pacemaker system of claim 4, wherein the second pacing head comprises a second housing, a first end of the two opposite ends of the second housing is provided with a second connection structure, a second end of the second housing is provided with a second fixing structure and the puncture structure, the second connection structure is used for connecting with an implantation assisting mechanism, the second fixing structure is used for connecting with a myocardium, the puncture structure passes through the second fixing structure, the second housing is internally provided with the receiving unit, and the receiving unit is used for receiving the ultrasonic wave emitted by the ultrasonic emission module.

6. The split leadless pacemaker system of claim 5, wherein the second fixation structure comprises a helix, hook or wing structure and the second connection structure comprises an external helical mechanism.

7. The discrete leadless pacemaker system of claim 5, wherein the piercing structure comprises a needle comprising a top end and a bottom end disposed opposite one another, wherein the needle is movably disposed through the housing to enable the top end to extend beyond the second connecting structure and/or the bottom end to pass beyond the second securing structure.

8. The split leadless pacemaker system of claim 7 wherein the needle body has an externally threaded portion proximate the tip.

9. The detachable leadless pacemaker system of claim 7, wherein a guide groove is formed in the housing along an arrangement direction from the first end to the second end, the needle body is provided with a first guide block and a second guide block which are slidably engaged with the guide groove, the second pacing head is further provided with a first positioning block and a second positioning block at two sides of the guide groove corresponding to the first guide block and the second guide block, respectively, the first positioning block is configured to limit the first guide block from moving to the top end, and the second positioning block is configured to limit the second guide block from moving to the bottom end.

10. The split leadless pacemaker system of claim 1, wherein the receiving unit comprises:

a heart rate sensor for sensing cardiac electrical signals;

a communication module to transmit the cardiac electrical signal to the ultrasound device;

the receiver is used for receiving the ultrasonic waves emitted by the ultrasonic device;

and the energy converter is used for converting the energy of the ultrasonic waves into electric energy.

11. The split leadless pacemaker system of claim 1, wherein the ultrasound device further comprises:

a battery;

the signal collector is used for receiving the cardiac electrical signal; and

the signal processor is used for processing the cardiac electric signal and controlling the ultrasonic transmitting module to send out ultrasonic waves;

the ultrasonic transmitting module comprises an ultrasonic wave transduction unit which is used for converting the electric energy of the battery into ultrasonic waves.

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