Wire-free cardiac pacemaker

Abstract

The utility model provides a lead-free cardiac pacemaker. The lead-free cardiac pacemaker comprises a shell, an insulating base, an antenna, an insulating sealing structure and an electrical component, the insulating base is arranged on the outer surface of the shell; the antenna comprises an external part and a built-in part which are connected with each other, the external part is limited on the outer surface of the insulating base, and the built-in part extends in the insulating base, penetrates through the insulating sealing structure and then enters the shell to be electrically connected with the electrical assembly; the insulation sealing structure is arranged at the far end of the shell and is respectively connected with the far end of the shell and the built-in part in a sealing manner; the electrical assembly is contained in the shell and comprises a Bluetooth module, and the Bluetooth module is used for sending and receiving wireless signals through the antenna. According to the application, the application of low-power-consumption Bluetooth communication on the lead-free cardiac pacemaker can be realized, meanwhile, the shape stability and consistency of the antenna are maintained through the insulating base, and the lead-free cardiac pacemaker is ensured to meet the standard requirements of sealing and insulating.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to a leadless cardiac pacemaker based on low-power Bluetooth communication technology. Background Art

[0002] In the prior art, the communication method of cardiac pacemakers is mainly wireless communication. The pacemaker communicates with external devices, and the external devices (such as programmers or patient monitoring systems) can send data to the in-body pacemaker or receive data from the in-body pacemaker. For example, medical technicians can use a specific programmer to send programming instructions to the pacemaker or receive diagnostic data from the pacemaker. The commonly used wireless communication technologies on cardiac pacemakers are mainly radio frequency communication and low-power Bluetooth technology. Compared with radio frequency communication, low-power Bluetooth technology has the following advantages:

[0003] 1. Transmission distance

[0004] In the follow-up process of pacemaker patients using radio frequency communication, the patient needs to be in very close contact with the programmer. Usually, after the patient lies flat, part of the programmer's device is closely attached to the implantation position of the patient's pacemaker. However, the communication method of low-power Bluetooth has a longer communication distance and stronger anti-interference ability, enabling the patient to move freely within a larger range without affecting communication, and significantly improving the follow-up experience.

[0005] 2. Transmission efficiency

[0006] Low-power Bluetooth technology has higher flexibility compared with radio frequency communication, supporting multiple data transmission rates and communication modes. This enables the cardiac pacemaker to adjust its communication performance according to needs to adapt to different application scenarios and requirements, taking into account both the transmission efficiency of data transmission and the low-power requirements of the device. It can send and receive data faster when needed, enabling real-time data transmission, and thus more timely reflecting the patient's health status and the working state of the pacemaker.

[0007] 3. Volume size

[0008] Low-power Bluetooth chips are small in size and high in efficiency, and since Bluetooth communication is a high-frequency signal, compared with radio frequency communication of low-frequency signals, the antenna module has a smaller volume.

[0009] 4. Compatibility

[0010] Bluetooth communication technology has good compatibility and scalability, and can be integrated and interoperated with other medical devices and technologies. This means that a cardiac pacemaker can be seamlessly connected to other medical systems (such as electronic medical record systems, remote monitoring systems, etc.) to achieve broader medical information sharing and collaboration. Through Bluetooth communication technology, the function of remote follow-up can be realized. Doctors can remotely monitor and manage patients' cardiac pacemakers, and patients no longer need to carry additional remote follow-up devices. They only need to install the corresponding APP on their mobile phones to transmit their physical information to doctors, medical centers or relatives. This improves the patient experience, reduces the number of patient visits to the hospital, improves medical efficiency, and reduces the medical burden.

[0011] 5. Security

[0012] By adopting advanced encryption and authentication technologies, the security and privacy protection during data transmission can be ensured. This helps prevent unauthorized access and data leakage, protecting patients' privacy and security.

[0013] Different from traditional cardiac pacemakers, leadless pacemakers are a new type of pacemaker that integrates a pulse generator and a pacing lead, with a volume and weight that are 1 / 10 of traditional pacemakers. Traditional pacemakers require a pocket to be made in the chest to place the pacemaker and are connected to the heart through implanted leads. Leadless pacemakers are implanted as a whole in the right ventricle through venous puncture using a dedicated delivery system.

[0014] Currently, the main communication method of leadless pacemakers is radio frequency communication for the following reasons:

[0015] Radio frequency communication is a low-frequency wireless communication technology, while Bluetooth communication is a high-frequency wireless communication technology. The ways and degrees of the influence of metal shielding on high-frequency and low-frequency wireless communication technologies are different. For low-frequency wireless communication technologies, the influence of metal shielding is relatively small. Low-frequency signals have longer wavelengths and larger fluctuation periods, and they are more likely to penetrate or bypass objects, so they transmit stably with less environmental interference. For high-frequency wireless communication technologies, metal materials have a strong shielding effect on them because high-frequency signals will be reflected and absorbed on the metal surface, reducing the ability to penetrate and propagate. This shielding effect can effectively block the transmission of wireless signals, making the signals unable to penetrate the metal shielding body. Therefore, if radio frequency communication is used, the antenna module can be placed inside the metal housing. However, if Bluetooth communication is used, the antenna must be led out and placed outside the housing, in direct contact with the blood. This poses great challenges in terms of structural space, biocompatibility of material selection, and product sealing requirements.

[0016] Copper is one of the most commonly used antenna materials, with advantages such as good electrical conductivity, high strength, and strong corrosion resistance, and is widely used in the RF antennas of pacemakers. However, considering the biocompatibility of long-term implantation, the material selection for Bluetooth antennas is restricted to medical materials that can be implanted long-term, such as gold, platinum, platinum-iridium, platinum-tungsten, tantalum, titanium, implant-grade stainless steel, etc. However, the processability and consistency of using long-term implantable medical materials to make antennas are a major challenge. For example, how to keep a softer antenna material in a stable shape, and how to ensure extremely high sealing of the pacemaker while connecting the antenna to the internal circuit board, etc.

[0017] It should be noted that the information disclosed in the background art section of this application is intended to deepen the understanding of the general background art of this application, and should not be regarded as an admission or any form of suggestion that this information constitutes the prior art known to those skilled in the art. Summary of the Utility Model

[0018] The purpose of this application is to provide a leadless cardiac pacemaker to realize the application of low-power Bluetooth communication on the leadless cardiac pacemaker, while solving the problem that it is difficult to maintain a stable shape during the processing of the soft antenna, and at the same time meeting the sealing requirements and insulation requirements when the antenna is external.

[0019] To achieve the above purpose, this application provides a leadless cardiac pacemaker, including: a housing, an insulating base, an antenna, an insulating sealing structure, and electrical components;

[0020] The insulating base is disposed on the outer surface of the housing;

[0021] The antenna includes an external part and an internal part connected to each other; the external part is limited to the outer surface of the insulating base; the internal part extends through the insulating sealing structure within the insulating base and then enters the housing to be electrically connected to the electrical components;

[0022] The insulating sealing structure is disposed at the distal end of the housing and is hermetically connected to the distal end of the housing and the internal part of the antenna respectively;

[0023] The electrical components are accommodated in the housing and include a Bluetooth module, and the Bluetooth module is used to send and receive wireless signals through the antenna.

[0024] Optionally, grooves are provided on the outer surface of the insulating base, and the external part is limited in the grooves.

[0025] Optionally, the insulating base is disposed at the distal end of the housing and is connected to the end cap of the housing, or the insulating base is sleeved on the outer surface of the distal end of the housing and exposes the outer surface of the proximal end of the housing.

[0026] Optionally, when the insulating base is disposed at the distal end of the housing and connected to the end cap of the housing, a hollow outer column is sleeved outside the insulating base, the external portion is received between the hollow outer column and the insulating base, and the hollow outer column and the insulating base are potted with glue. A fixing portion is provided on the outer surface of the hollow outer column, and the fixing portion is used for fixing on a target tissue.

[0027] Optionally, the insulating and sealing structure includes an outer ring flange and an insulating seal; the outer ring flange is received in a reserved hole at the distal end of the housing and welded and fixed; the insulating seal is received in the outer ring flange and is penetrated by the internal portion; the insulating seal is respectively and insulatingly and sealingly connected to the outer ring flange and the internal portion.

[0028] Optionally, a glass sintered material is filled between the outer ring flange and the internal portion to form the insulating seal.

[0029] Optionally, the insulating seal includes an insulator and a brazing filler metal; the outer ring flange and the insulator are fixedly connected and sealed through the brazing filler metal; the insulator and the internal portion are fixedly connected and sealed through the brazing filler metal.

[0030] Optionally, a lead wire is connected to the inner surface of the housing, and the lead wire is electrically connected to the electrical component so that the housing is grounded as a neutral point.

[0031] Optionally, the housing is formed by splicing an end cap, a housing top and a housing bottom; the end cap is located at the distal end of the housing; the end cap is provided with a reserved hole; the insulating and sealing structure is disposed in the reserved hole and welded and fixed; the lead wire is pre-welded to the inner surface of the end cap.

[0032] Optionally, the electrical component further includes a circuit board and a battery, the Bluetooth module is integrated on the circuit board, the battery is electrically connected to the circuit board, and the antenna is electrically connected to the circuit board.

[0033] In summary, in the leadless cardiac pacemaker provided in the present application, it includes: a housing, an insulating base, an antenna, an insulating and sealing structure and an electrical component; the insulating base is disposed on the outer surface of the housing; the antenna includes an external portion and an internal portion connected to each other; the external portion is limited on the outer surface of the insulating base; the internal portion extends in the insulating base, passes through the insulating and sealing structure and then enters the housing to be electrically connected to the electrical component; the insulating and sealing structure is disposed at the distal end of the housing and is respectively and sealingly connected to the distal end of the housing and the internal portion of the antenna; the electrical component is received in the housing and includes a Bluetooth module, and the Bluetooth module is used for sending and receiving wireless signals through the antenna.

[0034] With such a configuration, on the one hand, based on the setting of the insulating base, the shape stability and consistency of the external part of the antenna can be maintained, thereby reducing the processing and forming difficulty of the flexible antenna and ensuring the signal reception and transmission quality. On the other hand, based on the setting of the insulating sealing structure, it can ensure that the pacemaker meets the standard requirements of sealing and insulation, and finally realizes the application of low-power Bluetooth communication on the leadless cardiac pacemaker.

[0035] In addition, compared with radio frequency communication, the leadless cardiac pacemaker of the present application has a greater transmission distance, faster transmission efficiency, smaller volume size, better compatibility and scalability, and better security. Additionally, compared with radio frequency communication, since a part of the antenna (i.e., the external part) in the present application is arranged outside the housing, the space vacated by the antenna in the housing can be left for the battery in the electrical components. Since the entire working cycle of the pacemaker depends on the battery, the end of the battery power consumption means that the pacemaker cannot work. Therefore, with the same housing size, when the battery volume increases, the life of the pacemaker is extended. Description of the Drawings

[0036] Those of ordinary skill in the art will understand that the provided drawings are used to better understand the present application and do not constitute any limitation to the scope of the present application. Among them:

[0037] Figure 1 is the front view structural schematic diagram of the leadless cardiac pacemaker provided in the first embodiment of the present application;

[0038] Figure 2 is the axial sectional schematic diagram of the leadless cardiac pacemaker provided in the first embodiment of the present application;

[0039] Figure 3 is the exploded structural schematic diagram of the leadless cardiac pacemaker provided in the first embodiment of the present application;

[0040] Figure 4 is the structural schematic diagram of prefabricating an insulating sealing structure on the antenna wire provided in the first embodiment of the present application;

[0041] Figure 5 For Figure 4 is the structural schematic diagram of forming a spiral external part by shaping a part of the antenna wire in it;

[0042] Figure 6 is the structural schematic diagram of the distal external antenna structure formed by the combination and assembly of the antenna, the insulating sealing structure and the insulating base provided in the first embodiment of the present application;

[0043] Figure 7Axial sectional view of the combined assembly of the antenna, insulating and sealing structure, and insulating base provided in Embodiment 1 of the present application to form a distal external antenna structure;

[0044] Figure 8 Schematic structural view of the insulating and sealing using glass sintering provided in Embodiment 1 of the present application;

[0045] Figure 9 Schematic structural view of the sealing using ceramic rings and gold brazing provided in Embodiment 1 of the present application;

[0046] Figure 10 Overall structural view of the distal external antenna structure provided in Embodiment 1 of the present application;

[0047] Figure 11 is Figure 10 axial sectional view of the distal external antenna structure in

[0048] Figure 12 Schematic structural view of the shell - less communication system provided in Embodiment 1 of the present application;

[0049] Figure 13 Schematic structural view of the assembly of the shell - less communication system and the shell in Embodiment 1 of the present application;

[0050] Figure 14 is Figure 13 schematic structural view of the assembled shell - less communication system and the shell in

[0051] Figure 15 Schematic structural view of the leadless cardiac pacemaker with a spiral fixing part in Embodiment 1 of the present application;

[0052] Figure 16 Exploded structural view of the leadless cardiac pacemaker provided in Embodiment 2 of the present application;

[0053] Figure 17 is Figure 16 overall structural view of the leadless cardiac pacemaker in

[0054] Figure 18 Axial sectional view of the leadless cardiac pacemaker provided in Embodiment 2 of the present application.

[0055] Wherein, Figures 1 - 18 in:

[0056] 1. 8 - antenna; 11 - antenna wire; 2 - insulating and sealing structure; 21 - outer ring flange; 22 - insulating seal; 221 - insulator; 222 - brazing filler metal; 3, 9 - insulating base; 31 - groove; 32 - bayonet; 4 - housing; 401 - conveying and connecting part; 402 - fixing part; 5 - electrical component; 51 - circuit board; 52 - battery; 53 - Bluetooth module; 6 - lead wire; 7 - hollow outer column. Detailed implementation mode

[0057] To make the objectives, advantages, and features of this application clearer, the following further elaborates on this application in combination with the accompanying drawings and specific embodiments. It should be noted that the accompanying drawings are in extremely simplified forms and not drawn to scale, solely for the purpose of facilitating and clearly assisting in explaining the objectives of the embodiments of this application. In addition, the structures shown in the accompanying drawings are often part of the actual structures. In particular, the accompanying drawings need to show different focuses and sometimes use different scales.

[0058] As used in the present application, the singular forms "a", "an", "one" and "the" include plural referents, the term "or" is generally used in the sense of including "and / or", the term "several" is generally used in the sense of including "at least one", the term "at least two" is generally used in the sense of including "two or more", in addition, the terms "first", "second", "third" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined with "first", "second", "third" may explicitly or implicitly include one or at least two of such features. "One end" and "the other end" as well as "proximal end" and "distal end" generally refer to two corresponding parts, which not only include the endpoints. In a manual or hand-operated application scenario, the terms "proximal end" and "distal end" are defined herein relative to an operator such as a surgeon or clinician. The term "proximal end" refers to a position closer to the operator, and the term "distal end" refers to a position closer to the affected area and thus farther from the operator. In addition, as used in the present application, "mounted", "connected", "coupled", an element "disposed" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the two elements can be directly or indirectly connected, coupled, cooperated or transmitted through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, an element can be in any orientation such as inside, outside, above, below or on one side of another element, unless otherwise explicitly stated in the content. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used relative to the exemplary embodiments as shown in the figures, and the upward or upper direction faces the top of the corresponding figure, and the downward or lower direction faces the bottom of the corresponding figure.

[0059] The object of the present application is to provide a leadless cardiac pacemaker to realize the application of low-power Bluetooth communication on the leadless cardiac pacemaker, solve the problem that it is difficult to maintain shape stability and design consistency during the processing of the flexible antenna, and at the same time ensure that the leadless cardiac pacemaker meets the requirements of sealing and insulation. The following will be described with reference to the accompanying drawings.

[0060]

Embodiment 1

[0061] Please refer to Figures 1 to 3 , in Embodiment 1 of the present application, a leadless cardiac pacemaker is provided, which includes: an antenna 1, an insulating and sealing structure 2, an insulating base 3, a housing 4 and an electrical component 5. The electrical component 5 is accommodated in the housing 4 and includes a low-power consumption Bluetooth module 53, and the Bluetooth module 53 is used to send and receive wireless signals through the antenna 1.

[0062] Since Bluetooth technology is well-known to those skilled in the art, the structure and principle of the Bluetooth module 53 will not be described in detail in this application. In addition to the Bluetooth module 53, the electrical component 5 generally also includes other components necessary for a pacemaker that are well-known to those skilled in the art, such as leads, pulse generators, batteries, etc. The pulse generator emits electrical pulses provided by the battery and conducts them through the leads to the electrodes arranged outside the housing, stimulating the myocardium contacted by the electrodes to make the heart excited and contract, so as to achieve the purpose of treating heart dysfunction caused by certain arrhythmias. Since these are all prior arts, the structure and principle thereof will not be elaborated in this embodiment one by one.

[0063] In an exemplary embodiment, the electrical component 5 further includes a circuit board 51 and a battery 52, and the Bluetooth module 53 is integrated on the circuit board 51. The battery 52 is electrically connected to the circuit board 51, and the battery 52 provides electrical energy for the entire leadless pacemaker. In addition, a microcontroller, a pulse generator, etc. may be integrated on the circuit board 51, and the specific type of the circuit board 51 is not limited. For example, a flexible circuit board or a printed circuit board may be used.

[0064] The housing 4 serves as a sealed housing for the electrical component 5 and is preferably a metal housing, more commonly a titanium housing or a titanium alloy housing. Please refer to Figure 15 , a delivery connection portion 401 is often provided at the proximal end of the housing 4 for detachably connecting to a delivery system to achieve the implantation or retrieval of the leadless pacemaker. Continuing to refer to Figure 15 , in this embodiment, a fixing portion 402 may be provided at the distal end of the housing 4, which is used to fix on myocardial tissue (i.e., the target tissue), such as on the ventricular wall. For example, the fixing portion 402 may be fixed at the apex of the right ventricle or the interventricular septum between the right ventricle and the left ventricle and other regions. In some embodiments, the fixing portion 402 is arranged as a spiral structure and can be screwed into the myocardial tissue based on rotation. In some other embodiments, the fixing portion 402 is arranged as other forms of hook structures to achieve connection and fixation with the myocardial tissue. The fixing portion 402 may be arranged to have the function of sensing and transmitting electrical signals. For example, the fixing portion 402 is set as an electrode and has the function of an electrode. The fixing portion 402 may also be set as a simple mechanical structure.

[0065] Return to reference Figures 1 to 3, the insulating base 3 is disposed on the outer surface of the housing 4. In this embodiment, the insulating base 3 is directly disposed at the distal end of the housing 4 and is connected to the end cap 41 of the housing 4, such as by glue bonding. Optionally, the insulating base 3 is a hollow structure. The insulating base 3 is made of an insulating material, specifically a hard non-metallic material that can be implanted into the human body for a long time, so that the material of the insulating base 3 meets the requirements of being hard and having a high anti-deformation ability. Hard materials usually have high hardness and rigidity and are not easily deformed. The specific material for preparing the insulating base 3 is not limited. Commonly used non-metallic materials for long-term implantation into the human body include, for example, polyetheretherketone, bioceramics, ultra-high molecular weight polyethylene, etc.

[0066] Here, since the material of the antenna 1 is restricted to medical materials that can be implanted into the human body for a long time, and most of these materials are soft materials, which are easily deformed and difficult to process and form, especially for an antenna with a short overall length, the difficulty is even greater. Therefore, the insulating base 3 needs to be made of a hard material that is not easily deformed, so as to better limit and fix the antenna 1, ensure the shape stability and design consistency of the antenna 1, reduce the processing and forming difficulty of the soft antenna, and ensure the signal reception and transmission quality.

[0067] Actually, the antenna 1 includes an external part and an internal part connected to each other. The external part is the part exposed outside the insulating base 3, and the internal part is the part accommodated inside the insulating base 3 and the part passing through the insulating and sealing structure 2 and entering the housing 4. Therefore, the insulating base 3 is used to limit and fix the external part of the antenna 1, ensuring the shape stability and design consistency of the external part.

[0068] In addition, for the insulating and sealing aspect, please refer to Figures 2 - 3 , and in combination with Figure 5 and Figure 11 , the insulating and sealing structure 2 is disposed at the distal end of the housing 4 and is hermetically connected to the distal end of the housing 4 and the internal part of the antenna 1 respectively. In this way, the sealing problem of the housing 4 when the antenna 1 is external is solved, and finally it can be ensured that the external antenna 1 meets the standard requirements of sealing and insulation. That is to say, the insulating and sealing structure 2 has both insulating and sealing functions, not only ensuring that there is no electrical conduction between the housing 4 and the antenna 1, but also being able to seal the housing 4.

[0069] Please continue to refer to Figures 2 - 3 , and in combination with Figures 5 to 11 , more specifically, the external part of the antenna 1 is limited on the outer surface of the insulating base 3, and the internal part of the antenna 1 extends through the insulating and sealing structure 2 inside the insulating base 3 and then enters the housing 4 to be electrically connected to the electrical component 5. In this way, the application of low-power Bluetooth communication on a leadless cardiac pacemaker can be realized. Finally, the sealing performance requirement that the leadless cardiac pacemaker of this application needs to achieve is: tested with a helium mass spectrometer leak detector, the leak rate is lower than 5×10 -9ATM·CC / SEC, and the antenna 1 is not electrically connected to the housing 4.

[0070] It should also be understood that the shape of the leadless cardiac pacemaker of the present application is similar to a capsule and has a volume only the size of a capsule. Therefore, the entire leadless cardiac pacemaker is generally cylindrical. Specifically, the insulating base 3 and the housing 4 are both generally cylindrical.

[0071] In addition, the material selection of the antenna 1 meets the characteristics of high transmission efficiency, long-term implantation in the human body, and MRI compatibility, such as gold, platinum, platinum-iridium, platinum-tungsten, tantalum, non-magnetic MP35N nickel-cobalt alloy, pure titanium, titanium alloy, nickel-titanium alloy, cobalt-chromium alloy, etc. In other words, the antenna 1 is a flexible antenna, but the specific material is not limited. The shape of the antenna 1 is also not limited, mainly referring to the shape of the external part. In this embodiment, the external part of the antenna 1 is in a spiral shape (see Figure 3 ). The antenna 1 can be processed from the antenna wire 11.

[0072] Furthermore, in the actual manufacturing process, the assembly of the antenna 1 and the insulating base 3, and the assembly of the antenna 1 and the insulating and sealing structure 2 are involved. Specifically, the entire antenna wire 11 can be pre-assembled with the insulating and sealing structure 2, and then a part of the antenna wire 11 is disposed on the outer surface of the insulating base 3 to form the external part. It can also be that a section of the antenna wire 11 is pre-assembled with the insulating and sealing structure 2, and then connected to another section of the antenna wire 11 disposed on the outer surface of the insulating base 3 through a suitable method (such as welding or other methods) to obtain a whole antenna 1.

[0073] Please refer to Figure 8 and Figure 9 , in some embodiments, the insulating and sealing structure 2 includes an outer ring flange 21 and an insulating and sealing member 22; the outer ring flange 21 is received in a reserved hole at the distal end of the housing 4 and welded and fixed; the insulating and sealing member 22 is received in the outer ring flange 21 and is penetrated by the internal part of the antenna 1; the insulating and sealing member 22 is insulated and sealedly connected to the outer ring flange 21 and the internal part of the antenna 1 respectively. With such a setting, insulation and sealing can be achieved in the simplest way. The material of the outer ring flange 21 needs to have weldable characteristics with the housing 4, that is, the materials are the same or close. In this embodiment, the outer ring flange 21 is welded and fixed and sealed with the end cap 41 of the housing 4. A reserved hole is provided in the middle of the end cap 41.

[0074] The insulating and sealing member 22 has two performance requirements, namely insulation and sealing. In some embodiments, the insulating and sealing member 22 is realized by the same part. For example, a glass sintered material is filled between the outer ring flange 21 and the internal part of the antenna 1 to directly form the insulating and sealing member 22. Specifically, please refer to Figure 8In other embodiments, the insulating seal 22 is realized by different parts. For example, optionally, the insulating seal 22 includes an insulator 221 and a brazing material 222. The outer ring flange 21 and the insulator 221 are connected, fixed and sealed by the brazing material 222. At the same time, the insulator 221 and the built-in part of the antenna 1 are connected, fixed and sealed by the brazing material 222. For details, please refer to Figure 9 .

[0075] Please refer to Figure 8 In an exemplary embodiment, the insulating seal 22 is a glass sintered product, that is, glass solder is filled between the built-in part of the antenna 1 and the outer ring flange 21, so that it can be both insulated and sealed.

[0076] Please refer to Figure 9 In another exemplary embodiment, the insulator 221 in the insulating seal 22 is a ceramic ring, and the brazing material 222 is a gold brazing material. The ceramic ring provides insulation, and the gold brazing material provides sealing. Specifically, the inner side of the ceramic ring is connected to the built-in part of the antenna 1 through the gold brazing material and achieves sealing, and the outer side of the ceramic ring is connected to the outer ring flange 21 through the gold brazing material and achieves sealing.

[0077] Therefore, the insulating seal 22 is a component formed by manufacturing the insulating seal structure 2 through a suitable process. Of course, the structure and material of the insulating seal 22 are not limited to the above-mentioned contents, as long as the above-mentioned sealing performance requirements can be met.

[0078] Please refer to Figure 3 In some embodiments, a groove 31 is provided on the outer surface of the insulating base 3 so that the external part of the antenna 1 is directly limited in the groove 31. The groove 31 can clamp the antenna 1 to a certain extent to prevent the antenna 1 from being separated from the groove 31. To increase the reliability of the connection, the external part of the antenna 1 is optionally further bonded and fixed in the groove 31 by glue. In a typical example, the external part of the antenna 1 is in a spiral shape. At this time, the end of the external part away from the internal part can be bent and clamped and fixed at the bayonet 32 of the groove 31, so that the end of the antenna 1 can be prevented from protruding and the antenna 1 can be further fixed.

[0079] Optionally, the shell 4 is formed by splicing the end cap 41, the shell top 42 and the shell bottom 43, but the fixing method between the three includes but is not limited to laser welding. In addition, the end cap 41 is located at the far end of the shell 4, and a reserved hole is provided in the middle of the end cap 41. The insulating sealing structure 2 is arranged in the reserved hole of the end cap 41 and fixed by welding. In this way, after the insulating sealing structure 2 and the end cap 41 are welded, a sealed shell with a leakage rate that meets the requirements of long-term implantation is formed, and the antenna 1 and the shell 4 are insulated and non-conductive.

[0080] On the other hand, a lead wire 6 can be connected to the inner surface of the housing 4 (see Figure 2 , Figures 10 - 11 for key points). The lead wire 6 is electrically connected to the electrical component 5 so that the housing 4 is grounded as the neutral point of the entire leadless cardiac pacemaker. Thus, the antenna is grounded by connecting the lead wire 6 to the housing 4, optimizing the reflection and scattering of electromagnetic waves, improving the signal reception quality, and reducing the electrostatic accumulation. Preferably, the lead wire 6 is pre-welded to the inner surface of the end cap 41, and the lead wire 6 is soldered to the circuit board 51.

[0081] In this embodiment, when the insulating base 3 is disposed at the distal end of the housing 4 and is fixedly connected to the end cap 41, a hollow outer column 7 can be sleeved outside the insulating base 3. Further, the external portion of the antenna 1 is accommodated between the hollow outer column 7 and the insulating base 3, and the hollow outer column 7 and the insulating base 3 are sealed with glue to relatively fix the insulating base 3 and the hollow outer column 7. For details, see Figure 15 . Further, a fixing portion 402 is disposed on the outer surface of the hollow outer column 7.

[0082] It should be noted that the fixing portion 402 can be set as an antenna and has the function of an antenna. In this way, the antenna is wound around the outer surface of the hollow outer column 7, and the hollow outer column 7 is used to limit and fix part of the antenna, and there is no need to provide the insulating base 3 inside the hollow outer column 7.

[0083] For easy understanding, the manufacturing method of the leadless cardiac pacemaker in this embodiment will be exemplarily described below through Steps 1 to 4.

[0084] Step 1: Fabricate the insulating and sealing structure 2 on the antenna 1, and there are two processing methods;

[0085] The first processing method is: as Figure 4 shown, directly fabricate the insulating and sealing structure 2 on the antenna wire 11, then shape the antenna wire 11 to obtain the Figure 5 shown spiral-shaped external portion, and then assemble the external portion with the insulating base 3;

[0086] The second processing method is: first shape the antenna wire 11, assemble it with the insulating base 3, and then fabricate the insulating and sealing structure 2 on the shaped antenna wire 11.

[0087] Those skilled in the art should understand that the processing and assembly methods of the antenna 1, the insulating base 3, and the insulating and sealing structure 2 are not limited to the above situations, but the sequence of processing can be adjusted according to the structure of the antenna 1 (such as material, thickness) and the structure of the insulating base 3 (such as material). The present application does not limit this.

[0088] In addition, when manufacturing the antenna 1, the antenna 1 can be directly formed through a mold or related equipment, or the antenna 1 can be directly formed by using the groove 31 on the insulating base 3, and specifically, it can be adjusted according to actual needs.

[0089] Thus, after step 1, the Figure 6 and Figure 7 shown assembled structure of the antenna 1, the insulating base 3, and the insulating seal structure 2 is obtained.

[0090] Step 2: As shown in Figure 10 and Figure 11 , the outer ring flange 21 of the insulating seal structure 2 is hermetically welded to the end cover 41 on the housing 4. The final required sealing performance is: when tested with a helium mass spectrometer leak detector, the leak rate is lower than 5×10 - 9 ATM·CC / SEC.

[0091] After step 2, a distal external antenna structure is formed.

[0092] Step 3: As shown in Figure 12 , the distal external antenna structure and the battery 52 obtained in the above steps are soldered to the circuit board 51 including the low-energy Bluetooth module 53. After this step, a shell-less communication system is formed.

[0093] Optionally, solder is coated at the contact between the pins of the battery 52 and the reserved plug holes on the circuit board 51 for soldering connection. Similarly, solder is coated at the contact between the internal part of the antenna 1 and the reserved plug holes on the circuit board 51 for soldering connection.

[0094] Step 4: The top 42 and bottom 43 of the housing are docked with the end cover 41 of the shell-less communication system and then hermetically welded. The final required sealing performance is: when tested with a helium mass spectrometer leak detector, the leak rate is lower than 5×10 -9 ATM·CC / SEC. For details of this part, please refer to Figure 13 and Figure 14 .

[0095] Another reference Figure 15 In the leadless cardiac pacemaker provided in the first embodiment of the present application, since the insulating base 3 is arranged at the distal end of the housing 4, the internal space of the hollow outer column 7 can be used to arrange the insulating base 3 and the antenna 1, without the need for a major transformation of the existing leadless pacemaker, reducing the development cost.

[0096] Finally, it should also be noted that the antenna 1 and the insulating base 3 may have various forms. For example, the antenna 1 and the insulating base 3 can also be arranged on the side surface of the housing 4 instead of the distal end of the housing 4. In addition, the antenna 1 may have various forms. Besides the spiral shape, it can also be a log-periodic antenna, a grid antenna, a serpentine antenna, etc., or an array antenna composed of multiple antennas of a certain type above.

[0097]

Embodiment 2

[0098] Please refer to Figures 16 to 18 , the leadless cardiac pacemaker provided in the second embodiment of the present application is basically the same as the leadless cardiac pacemaker provided in the first embodiment. The same parts will not be described again. The following only describes the differences.

[0099] Among them, as Figures 16 to 18 shown, in the leadless cardiac pacemaker provided in the second embodiment, the antenna 8 is in the shape of an array frame, and the insulating base 9 is directly sleeved on the outer surface of the distal end of the housing 4, and the outer surface of the proximal end of the housing 4 is exposed. At this time, the fixing part (not shown) can be arranged on the outer surface of the proximal end of the housing 4.

[0100] Then, for antennas and insulating bases with other shapes and positions, the arrangement methods are similar to those in the above embodiments and will not be elaborated.

[0101] To sum up, in the leadless cardiac pacemaker provided in the present application, it includes: a housing 4, an insulating base 3, an antenna 1, an insulating sealing structure 2, and an electrical component 5; the insulating base 3 is arranged on the outer surface of the housing 4; the antenna 1 includes an external part and an internal part connected to each other; the external part is limited on the outer surface of the insulating base 3; the internal part extends through the insulating sealing structure 2 in the insulating base 3 and then enters the housing 4 to be electrically connected to the electrical component 5; the insulating sealing structure 2 is arranged at the distal end of the housing 4 and is hermetically connected to the distal end of the housing 4 and the internal part respectively; the electrical component 5 is accommodated in the housing 4 and includes a Bluetooth module 53, and the Bluetooth module 53 is used to send and receive wireless signals through the antenna 1. With such a configuration, based on the setting of the insulating base 3, the soft antenna 1 can maintain the stability and consistency of its shape. Additionally, based on the setting of the insulating sealing structure 2, it can ensure that there is no electrical conduction between the housing 4 and the antenna 1, and at the same time, it can seal the housing 4, solving the internal and external sealing problems caused by the external antenna. Thus, the present application can realize the application of low-power Bluetooth communication on the leadless cardiac pacemaker. Compared with the leadless pacemaker using radio frequency communication, it has a greater transmission distance, faster transmission efficiency, smaller volume size, better compatibility and scalability, and better security.

[0102] In addition, compared with radio frequency communication, the wire-free cardiac pacemaker of the present application has a greater transmission distance, faster transmission efficiency, smaller volume, better compatibility and scalability, and better security. Additionally, compared with radio frequency communication, since a part of the antenna in the present application (i.e., the external part) is arranged outside the housing, the space vacated by the antenna in the housing can be left for the battery in the electrical components. Since the entire working cycle of the pacemaker relies on the battery, the end of the battery power consumption means that the pacemaker cannot work. Therefore, with the same housing size, an increase in the battery volume extends the life of the pacemaker.

[0103] It should be noted that the above-mentioned several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application in any way. Any changes and modifications made by those of ordinary skill in the art of the present application based on the above disclosure belong to the protection scope of the present application.

Claims

1. A leadless cardiac pacemaker, characterized in that, Comprising: A housing, an insulating base, an antenna, an insulating sealing structure, and an electrical component; The insulating base is disposed on the outer surface of the housing; The antenna includes an external part and an internal part connected to each other; the external part is limited on the outer surface of the insulating base; The internal part extends within the insulating base, passes through the insulating sealing structure, and then enters the housing to be electrically connected to the electrical component; The insulating sealing structure is disposed at the distal end of the housing and is hermetically connected to the distal end of the housing and the internal part of the antenna respectively; The electrical component is accommodated within the housing and includes a Bluetooth module for transmitting and receiving wireless signals through the antenna.

2. The leadless cardiac pacemaker according to claim 1, characterized in that, A groove is provided on the outer surface of the insulating base, and the external part is limited within the groove.

3. The leadless cardiac pacemaker according to claim 2, characterized in that, The insulating base is disposed at the distal end of the housing and is connected to the end cap of the housing, or the insulating base is sleeved on the outer surface of the distal end of the housing, and the outer surface of the proximal end of the housing is exposed.

4. The leadless cardiac pacemaker according to claim 3, wherein, When the insulating base is disposed at the distal end of the housing and is connected to the end cap of the housing, a hollow outer column is sleeved outside the insulating base, the external part is accommodated between the hollow outer column and the insulating base, and the hollow outer column and the insulating base are potted with glue. A fixing part is provided on the outer surface of the hollow outer column for fixing to a target tissue.

5. The leadless cardiac pacemaker according to claim 1, characterized in that, The insulating sealing structure includes an outer ring flange and an insulating seal; the outer ring flange is accommodated in a reserved hole at the distal end of the housing and is welded and fixed; the insulating seal is accommodated within the outer ring flange and is passed through by the internal part; the insulating seal is hermetically and insulatingly connected to the outer ring flange and the internal part respectively.

6. The leadless cardiac pacemaker according to claim 5, characterized in that, A glass sintered material is filled between the outer ring flange and the internal part to form the insulating seal.

7. The leadless cardiac pacemaker according to claim 5, wherein The insulating seal includes an insulator and a brazing filler metal; the outer ring flange and the insulator are connected and fixed and sealed through the brazing filler metal; the insulator and the internal part are connected and fixed and sealed through the brazing filler metal.

8. The leadless cardiac pacemaker according to claim 1, wherein, A lead is connected to the inner surface of the housing and is electrically connected to the electrical component so that the housing is grounded as a neutral point.

9. The leadless cardiac pacemaker according to claim 8, wherein, The housing is formed by splicing an end cap, a housing top, and a housing bottom; the end cap is located at the distal end of the housing; the end cap is provided with a reserved hole; the insulating sealing structure is disposed in the reserved hole and is welded and fixed; the lead is pre-welded to the inner surface of the end cap.

10. The leadless cardiac pacemaker according to claim 1, characterized in that, The electrical component further includes a circuit board and a battery. The Bluetooth module is integrated on the circuit board. The battery is electrically connected to the circuit board, and the antenna is electrically connected to the circuit board.

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