WO2022253060A1

WO2022253060A1 - Leadless pacemaker, delivery device, and system

Info

Publication number: WO2022253060A1
Application number: PCT/CN2022/094835
Authority: WO
Inventors: 成诗伟; 邱丰伟
Original assignee: 创领心律管理医疗器械（上海）有限公司
Priority date: 2021-06-02
Filing date: 2022-05-25
Publication date: 2022-12-08
Also published as: CN115430054A

Abstract

A leadless pacemaker, a delivery device, and a system. The leadless pacemaker comprises a first housing (110), a second housing (120), a first unit (200) arranged in the first housing (110), and a second unit (300) and a pacemaker body (400) which are arranged in the second housing (120), wherein the second unit (300) is electrically connected to the pacemaker body (400) and the first unit (200); the first housing (110) is made of a biocompatible non-metallic material; and the second housing (120) comprises an enclosed housing made of a biocompatible metallic material. The leadless pacemaker, the delivery device and the system can ensure that the transmitted or received radio frequency signals will not be attenuated and shielded, can realize long-distance data interaction between the leadless pacemaker and an external control device, and can improve the convenience of follow-up after the patient has the leadless pacemaker implanted.

Description

Leadless pacemakers, delivery devices and systems

technical field

The invention relates to the technical field of medical devices, in particular to a leadless pacemaker, a delivery device and a system.

Background technique

Different from the traditional implantable cardiac leadless pacemaker implanted subcutaneously, the leadless pacemaker implanted in the heart cavity has the advantages of less trauma, no influence on the appearance, and avoiding complications related to electrode leads, and has been more and more popular. more and more widely used.

In order to perform pacing stimulation more safely and effectively, patients with implanted cardiac leadless pacemakers need to go to the hospital for follow-up visits regularly, and exchange data with the implantable cardiac leadless pacemaker through specific equipment provided by the manufacturer. The parameters of the leadless pacemaker can be adjusted to allow the leadless pacemaker to adapt to changes in the patient's physiology.

Traditional implantable pacemakers usually use a near-field coupling communication method for data interaction, and this communication method usually has a low carrier frequency, low data transmission rate, and short communication distance. However, since the data interaction between the leadless pacemaker implanted in the heart chamber and the external control device is usually non-invasive, that is, it is not connected through a wired method, this near-field coupling method is difficult to ensure the accuracy of signal transmission. sex. Moreover, since the leadless pacemaker is implanted in the patient's heart cavity, compared with the traditional lead pacemaker, the distance from the human body surface is longer, and the traditional near-field coupling communication basically cannot meet the needs of leadless pacing. The need for communication between the controller and the external control device.

In order to ensure the normal data interaction between the leadless pacemaker and the external control device, in the prior art, human body communication is usually used, that is, the human body is used as a transmission medium for signal transmission. However, this communication method has the following defects:

1. It is easily affected by noise, and the communication quality is difficult to guarantee.

2. When communication is established, the external control device needs a specific connection device to be connected to the surface of the human body, which is very inconvenient to operate.

There have also been attempts by those skilled in the art to apply radio frequency communication technology with high data transmission rate and long communication distance to leadless pacemakers. However, there are no relevant successful cases recorded in public information. This is because integrating RF communication into a leadless pacemaker is nearly impossible. The reasons are as follows:

1. The structure of the existing leadless pacemaker shields radio frequency signals: In order to ensure the safety of the leadless pacemaker, all electronic components of the leadless pacemaker must be enclosed in a metal titanium shell; and the airtight metal shell The body has a strong attenuation and shielding effect on radio frequency signals, so that the receiving device in the leadless pacemaker cannot receive the radio frequency signal sent by the external controller, and the radio frequency signal sent by the sending device in the leadless pacemaker cannot Outgoing metal titanium case.

2. It is very difficult to improve the structure of the existing leadless pacemaker: see FIG. 1 , which is a schematic structural diagram of one of the leadless pacemakers in the prior art. It can be seen from FIG. 1 that this kind of leadless pacemaker includes a pacemaker main body 11 and a ring-shaped bracket 12. In order to enable the leadless pacemaker body to have a better fixing effect, the first pacemaker The main body 11 is laterally attached to the outer wall of the ring bracket 12 .

Therefore, how to provide a leadless pacemaker has increasingly become one of the technical problems to be solved urgently by those skilled in the art.

It should be noted that the information disclosed in the background technology section of the invention is only intended to deepen the understanding of the general background technology of the invention, and should not be regarded as an acknowledgment or in any form to imply that the information constitutes information already known to those skilled in the art. current technology.

Contents of the invention

The object of the present invention is to provide a leadless pacemaker, a delivery device and a system for the above-mentioned defects in the prior art, which can realize the leadless pacemaker while meeting the sealing requirements of the leadless pacemaker for electronic devices. Remote data exchange between the pacemaker and the external control device.

In order to achieve the above object, the present invention is achieved through the following technical solutions: a leadless pacemaker, comprising a first casing, a second casing, a first unit arranged in the first casing, and a first unit arranged in the second casing A second unit in the body and a pacemaker body; the second unit is electrically connected to the pacemaker body and the first unit respectively;

The first unit is configured to receive control information from an in vitro control device;

The second unit is configured to receive the control information and send the control information to the pacemaker body;

The pacemaker body is configured to control the operation of the leadless pacemaker according to the control information; and send the operation information of the leadless pacemaker to the second unit;

The second unit is further configured to send the operation information to the first unit, and the first unit is further configured to send the operation information to the in vitro control device;

Wherein, the first casing is made of biocompatible non-metallic material; the second casing includes a closed casing made of biocompatible metal material.

Optionally, a first signal transmission unit is further included, the first end of the first signal transmission unit is located in the first housing, and the second end of the first signal transmission unit is located in the second housing;

The first unit is connected to the first end of the first signal transmission unit, and the second unit is connected to the second end of the first signal transmission unit.

Optionally, it also includes a second signal transmission unit electrically connected to the pacemaker body, the first end of the second signal transmission unit is located in the second casing, and the first end of the second signal transmission unit is the two ends are located outside the second housing;

The second signal transmission unit is configured to transmit the physiological information of the subject to the pacemaker body.

Optionally, a third shell is also included, the third shell is made of biocompatible non-metallic material;

The second end of the second signal transmission unit outside the second housing extends into the third housing.

Optionally, a fixing unit is further included, the first end of the fixing unit is fixed on the outer wall of the third housing, and the second end is used to be fixed on the receptor.

Optionally, it also includes a battery unit electrically connected to the pacemaker body, the battery unit is arranged in the second casing, and the battery unit is used for powering the pacemaker body and/or the pacemaker body. The second unit is powered.

Optionally, the second signal transmission unit and the battery unit are respectively located at opposite ends of the pacemaker body.

Optionally, the battery unit is located between the pacemaker body and the second unit, and the outer wall of the battery unit has a groove;

The signal line connecting the pacemaker body and the second unit is located in the groove.

Optionally, the operating information includes physiological information of the recipient and implantation status information of the leadless pacemaker;

The pacemaker body is used to send the physiological information and the implantation status information to the second unit.

Optionally, the running information also includes battery information;

The pacemaker body also includes a battery performance detection module, the battery performance detection module is configured to monitor the operating state of the battery, obtain the battery information according to the operating state of the battery, and send the battery information to the Describe the second unit.

To achieve the above object, the present invention also provides a delivery device, which is used to deliver the leadless pacemaker as described in any one of the above;

The delivery device includes: a delivery handle assembly, a delivery rod assembly, and a head-end part matched with the first casing of the leadless pacemaker, and the head-end part is arranged at the distal end of the delivery rod assembly , the delivery handle assembly is arranged at the proximal end of the delivery rod assembly and connected to the head end part through the delivery rod assembly;

The delivery device is configured to advance the leadless pacemaker to a target location and, upon reaching the target location, to release the leadless pacemaker.

To achieve the above object, the present invention also provides a leadless pacing system, which includes the leadless pacemaker described in any one of the above and the above delivery device.

To achieve the above object, the present invention also provides a wireless communication system based on implantable medical electronic devices, the wireless communication system includes an implanted device in the body and an external control device;

Wherein, the implanted device in the body includes the leadless pacemaker described in any one of the above, and the external control device includes a wireless communication unit, and the wireless communication unit is used to communicate with the first unit of the leadless pacemaker. communication connection.

Compared with the prior art, the leadless pacemaker, delivery device and system provided by the present invention have the following beneficial effects:

The leadless pacemaker provided by the present invention includes a first housing, a second housing, a first unit disposed in the first housing, a second unit and a pacemaker body disposed in the second housing; The second unit is electrically connected to the pacemaker body and the first unit respectively. The first housing is made of a biocompatible non-metallic material; the second housing includes a closed housing made of a biocompatible metallic material. With such a configuration, the leadless pacemaker provided by the present invention has the function of radio frequency communication, and the first unit is located in the first housing to ensure that the transmitted or received radio frequency signal will not be attenuated and shielded by the second housing, thus realizing the leadless pacemaker Perform remote data interaction with the external control device; further, the second unit and the pacemaker body are located in the second housing, which can prevent the second unit and the pacemaker body from being affected by implantation. Physiological impact and erosion of the body, and at the same time, damage to the organ tissue of the implanted recipient by the second unit and the pacemaker body is reduced. Therefore, the leadless pacemaker provided by the present invention has the advantages of high data transmission rate and long communication distance, and can improve the convenience of follow-up visits after the implantation of the leadless pacemaker.

Description of drawings

FIG. 1 is a schematic structural view of one of the leadless pacemakers in the prior art;

Fig. 2 is a schematic structural diagram of a leadless pacemaker provided by an embodiment of the present invention;

Fig. 3 is one of the structural schematic diagrams of the second unit in Fig. 2;

Fig. 4 is one of the schematic diagrams of the battery unit in Fig. 2;

Fig. 5 is a structural schematic diagram of the pacemaker body in Fig. 2;

FIG. 6 is a schematic structural diagram of a transmission device provided by an embodiment of the present invention;

Wherein, the reference signs are explained as follows:

11-pacemaker main body, 12-ring bracket;

110-first housing, 120-second housing, 130-third housing, 200-first unit, 300-second unit, 400-pacemaker body, 500-first signal transmission unit, 600- The second signal transmission unit, 700-fixed unit, 800-battery unit;

310-matching network module, 320-radio frequency signal receiving module, 330-radio frequency signal sending module;

410-data processing unit, 420-intracavity electrocardiographic perception processing module, 430-myocardial contact evaluation module, 440-pacing voltage generation module, 450-battery performance detection module;

910-head end part, 920-delivery rod assembly, 930-delivery handle assembly.

Detailed ways

In order to make the purpose, advantages and features of the present invention clearer, the leadless pacemaker, delivery device and system proposed by the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that all the drawings are in a very simplified form and use imprecise scales, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present invention. It should be understood that the drawings in the specification do not necessarily show the specific structure of the invention to scale, and that the illustrative features used to illustrate some principles of the invention in the drawings in the specification are also drawn in a somewhat simplified manner. The specific design features of the invention disclosed herein, including, for example, specific dimensions, orientations, locations and shapes will be determined in part by the particular intended application and use environment. Also, in the embodiments described below, the same reference numerals may be used in common between different drawings to denote the same parts or parts having the same functions, and repeated descriptions thereof will be omitted. In this specification, similar reference numerals and letters are used to refer to similar items, therefore, once an item is defined in one figure, it does not require further discussion in subsequent figures.

The terms "proximal" and "distal" refer to the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of a physician using the medical device, although "proximal" and "distal" are not limiting However, "proximal" generally refers to the end of the medical device that is closest to the physician during normal operation, and "distal" generally refers to the end that enters the patient first.

Due to the long-term commitment to the research and development of wireless pacemakers, the inventors of the present invention have finally found through continuous in-depth research and a lot of practice that by improving the structure of the existing leadless pacemakers, the described Leadless pacemakers have radiofrequency capabilities.

In order to realize the above ideas, the present invention provides a leadless pacemaker, a delivery device and a system. The leadless pacemaker includes a first housing, a second housing, a first unit disposed in the first housing, and The second unit and the pacemaker body are arranged in the second casing; the second unit is electrically connected with the pacemaker body and the first unit. The leadless pacemaker proposed by the present invention has the advantages of high data transmission rate and long communication distance, and can improve the convenience of follow-up visits after patients are implanted with the leadless pacemaker. A leadless pacemaker proposed by the present invention will be described in detail below.

One embodiment of the present invention provides a leadless pacemaker. Referring to FIG. 2, FIG. 2 is a schematic structural diagram of the leadless pacemaker provided by this embodiment. It can be seen from FIG. 2 that the leadless pacemaker provided by this embodiment includes a first housing 110, a second housing 120, a first unit 200 disposed in the first housing 110, and a first unit 200 disposed in the second The second unit 300 and the pacemaker body 400 inside the casing 120 ; the second unit 300 is electrically connected with the pacemaker body 400 and the first unit 200 .

Specifically, the first unit 200 is configured to receive control information of an in vitro control device; the second unit 300 is configured to receive the control information and send the control information to the Pacemaker body 400; the pacemaker body 400 is configured to control the operation of the leadless pacemaker according to the control information; and send the operation information of the leadless pacemaker to the The second unit 300; the second unit 300 is also configured to send the operation information to the first unit 200, and the first unit 200 is also configured to send the operation information to the External control device.

Wherein, the first casing 110 is made of biocompatible non-metallic material; the second casing 120 includes a closed casing made of biocompatible metal material. Wherein, the biocompatible non-metallic materials include but not limited to bioglass, bioceramics, biocement, and bioglass ceramics. With such a configuration, the first housing 110 can not only ensure that the first unit 200 remains insulated from the outside, but also, the biocompatible non-metallic material is easy to be sterilized at high temperature, and has good chemical stability in the human body, tissue Good compatibility and high compressive strength; further, the first housing 110 can avoid direct contact between the first unit 200 and the blood and/or organ tissue of the implanted recipient, avoiding the first A unit 200 is protected from impact and erosion by blood and/or organ tissue of the implanted recipient. Furthermore, the first housing 110 can cooperate with an external delivery device (such as a delivery handle) to deliver the leadless pacemaker to a target position; the first unit 200 is set on the In the first casing 110 , under the condition of ensuring stable signal transmission, the overall volume of the lead pacemaker is not increased, and the available space can be effectively used. The biocompatible metal materials include but are not limited to pure metals such as titanium, tantalum, niobium and zirconium, medical stainless steel, cobalt-based alloys, titanium-based alloys and other alloys. With such a configuration, the second casing 120 has good corrosion resistance, which can prevent the second unit 300 and the pacemaker body 400 from losing their functions due to external influences and prolong their service life.

It can be seen that the first unit 200 of the leadless pacemaker provided by the present invention includes, but is not limited to, an antenna capable of receiving and transmitting radio frequency signals. The radio frequency signal will not be attenuated and shielded, and the remote data interaction between the leadless pacemaker and the external control device can be realized; further, the second unit 300 and the pacemaker body 400 are located in the second housing 120, the second housing 120 can prevent the second unit 300 and the pacemaker body 400 from being affected and eroded by the blood and/or organ tissue of the implanted recipient, and also reduce the second The damage of the unit 300 and the pacemaker body 400 to the organ tissue of the implanted recipient. Therefore, the leadless pacemaker provided by the present invention can prevent the radio frequency signal from being shielded and attenuated by the metal casing, and realize the radio frequency communication function of the leadless pacemaker.

To sum up, the leadless pacemaker provided by the present invention has the advantages of high data transmission rate and long communication distance, and can improve the convenience of follow-up visits after the implantation of the leadless pacemaker.

Preferably, in one implementation manner, refer to FIG. 3 , which is a schematic structural diagram of the second unit. It can be seen from FIG. 3 that the second unit 300 includes a matching network module 310 , and a radio frequency signal receiving module 320 and a radio frequency signal sending module 330 electrically connected to the matching network module 310 .

Specifically, the radio frequency signal receiving module 320 is configured to convert the control information from radio frequency signals into low frequency signals; the radio frequency signal sending module 330 is configured to convert the operating information from low frequency signals to RF signal. Wherein, the second unit 300 is electrically connected to the pacemaker body 400 and the first unit 200, including: the radio frequency signal receiving module 320 and the radio frequency signal sending module 330 are both connected to the pacemaker The main body 400 is electrically connected; the matching network module 310 is electrically connected to the first unit 200 .

Those skilled in the art can understand that the matching network module 310 is used to make the electrical characteristics of the second unit 300 and the external control device consistent to form an RF matching network, so as to minimize the loss and distortion of radio signal transmission. The same electrical characteristics are also called impedance matching, including that the internal resistance of the signal source (external control device) is equal in size and phase to the characteristic impedance of the connected transmission line, and/or the characteristic impedance of the transmission line is the same as the connected load (second unit) impedances are equal in magnitude and in phase. Further, the radio frequency signal receiving module 320 and the radio frequency signal sending module 330 are only exemplary descriptions of preferred embodiments, rather than limitations of the present invention. In other embodiments, the radio frequency signal receiving module 320 The RF signal transmitting module 330 may also be an integrated RF signal transmitting and receiving module, which is not limited in the present invention.

Preferably, in one of the implementation manners, referring to FIG. 2, it can be seen from FIG. 2 that the leadless pacemaker provided in this embodiment further includes a first signal transmission unit 500, and the first signal transmission unit 500 One end of the first signal transmission unit 500 is located in the first housing 110 , and the other end of the first signal transmission unit 500 is located in the second housing 120 . The first unit 200 is connected to one end of the first signal transmission unit 500 , and the matching network module 310 is connected to the other end of the first signal transmission unit 500 . With such a configuration, the first signal transmission unit 500 can ensure smooth electrical signals between the first unit 200 and the second unit 300, specifically, the first signal transmission unit 500 is a feed-through element.

Preferably, in one of the implementation manners, the leadless pacemaker provided by the present invention further includes a second signal transmission unit 600 electrically connected to the pacemaker body 400, and the second signal transmission unit One end of the 600 is located inside the second housing 120 , and the other end of the second signal transmission unit 600 is located outside the second housing 120 . Specifically, the second signal transmission unit 600 is configured to transmit the physiological information of the subject to the pacemaker body 400 . So configured, as the internal circuit components and external circuits of the second housing 120 (not shown in the figure, they are arranged at the front end of the leadless pacemaker, the external circuits include but not limited to physiological parameter sensors, pacemaker pacing sensor) can enable the pacemaker body inside the second housing 120 to transmit electrical signals with external circuits, so that the pacemaker body 400 can sense and/or pace the implanted The receiver, specifically, the second signal transmission unit 600 is a feedthrough element.

Preferably, in one of the implementation manners, a third housing 130 is further included, and the third housing 130 is made of biocompatible non-metallic material. The other end of the second signal transmission unit 600 outside the second housing 120 extends into the third housing 130 . With such a configuration, the third housing 130 can not only protect the second signal transmission unit 600, so that the leadless pacemaker can meet the requirements of increased contact tightness with implanted recipients (such as myocardium); and In one of the preferred implementation manners, the third housing 130 can also serve as the base of the fixing unit 700 . Specifically, as mentioned above, the biocompatible non-metallic materials include but are not limited to bioglass, bioceramics, biocement, and bioglass ceramics, etc., which will not be repeated here.

Preferably, as a preferred embodiment, continue to refer to FIG. 2 , along the length direction of the leadless pacemaker, the first casing 110 , the second casing 120 and the third casing 130 centerlines are on the same straight line. Preferably, the connection between the first housing 110 and the second housing 120 is a hermetic connection, that is, the first signal transmission unit 500 is completely enclosed by the first housing 110 and the second housing. Body 120 is airtightly covered; similarly, the connection between the second housing 120 and the third housing 130 is also airtight connection, that is, the second signal transmission unit 600 is completely covered by the second housing 120 and the third casing 130 are airtightly covered. Such a configuration can prevent the first signal transmission unit 500 and the second signal transmission unit 600 from being interfered by the outside world, thereby ensuring signal transmission quality. Further, the first casing 110, the second casing 120 and the third casing 130 are all cylinders with the same outer diameter, and are configured in such a way that the shape of the leadless pacemaker is similar to a capsule The structure not only facilitates the transportation and implantation of the transmission device, but also greatly reduces its external size, reduces the contact area with the implanted receptor, and can accurately approach the lesion, thereby improving the therapeutic effect.

Preferably, in one of the implementation manners, referring to FIG. 2 , the leadless pacemaker further includes a fixing unit 700, one end of the fixing unit 700 is fixed on the outer wall of the third housing 130, And the other end of the fixing unit 700 is used to be fixed on the receptor. Configured in this way, the fixing unit 700 can fix the leadless pacemaker to the implant recipient (such as the myocardium), so that the front end of the leadless pacemaker can be in close contact with the myocardium. Further, the third housing 130 serves as the base of the fixing unit 700, which is more convenient for tightly fixing the fixing unit 700 and the leadless pacemaker together.

Preferably, in one of the implementation manners, the leadless pacemaker further includes a battery unit 800 electrically connected to the pacemaker body 400 , and the battery unit 800 is arranged in the second casing 120 Inside, the battery unit 800 is used for powering the pacemaker body 400 and/or the second unit 300 . Further, the second signal transmission unit 600 and the battery unit 800 are respectively located at opposite ends of the pacemaker body 400 . Such a configuration makes the various functional components of the leadless pacemaker more compact and reasonable, and further reduces the external size of the leadless pacemaker.

Preferably, in one of the implementation manners, see FIG. 4 , which is a schematic diagram of one battery unit of the leadless pacemaker provided by the present invention. 2 and 4, it can be seen that the battery unit 800 is located between the leadless pacemaker body 400 and the second unit 300, and the outer wall of the battery unit 800 has a groove; The signal lines of the pacemaker body 400 and the second unit 300 are located in the groove. Different from the traditional cylindrical battery, the battery unit 800 of this embodiment has a groove. Such configuration further enables the signal line between the second unit 300 and the pacemaker body 400 to make full use of the space, not only The wiring is reasonable and easy to implement, and the space is rationally utilized to reduce the volume of the leadless pacemaker.

In one of the exemplary embodiments, the leadless pacemaker is a cardiac leadless pacemaker, and the implanted recipient includes a cardiac chamber of a patient. Referring to FIG. 5 , FIG. 5 is a structural schematic diagram of the pacemaker body of the leadless pacemaker. It can be seen from FIG. 5 that the pacemaker body 400 includes: a data processing unit 410, an intracavity electrocardiographic sensing processing module 420 electrically connected to the data processing unit 410, a myocardial contact evaluation module 430, and a pacing voltage generating module. Module 440.

Specifically, the intracavity electrocardiographic sensing processing module 420 is configured to detect the patient's electrocardiographic activity, and obtain the patient's physiological information according to the patient's electrocardiographic activity information. The myocardial contact evaluation module 430 is configured to monitor the contact state between the leadless pacemaker and the myocardium, and obtain information about the implantation state of the leadless pacemaker. The data processing unit 410 is configured to generate pacing control according to the control information, the physiological information and the implantation status information. The pacing voltage generation module 440 is configured to generate a pulse stimulation voltage according to the pacing control; the pulse stimulation voltage is sent out of the second casing 120 through the second signal transmission unit 600 .

Wherein, the second unit 300 is electrically connected to the pacemaker body 400 , including: the data processing unit 410 of the pacemaker body 400 is connected to the second unit 300 . Further, the pacemaker body 400 is electrically connected to the second signal transmission unit 600, including the intracavity electrocardiographic sensing processing module 420 and the pacing voltage generation module 440 and the second signal transmission unit 600 electrical connection.

Preferably, in one of the implementation manners, the operation information includes physiological information of the recipient and implantation status information of the leadless pacemaker. Specifically, the pacemaker body 400 is configured to send the physiological information and the implantation status information to the second unit 300 . Further, the second unit 300 sends the physiological information and the implantation status information to an in vitro control device via the first unit 200 . With such a configuration, the external control device can be informed of the real-time working state of the leadless pacemaker and the physiological state of the patient in time, so as to adjust the control information so that the leadless pacemaker can adapt to the physiological changes of the patient, Safer and more effective pacing stimulation.

Preferably, in one of the implementation manners, the running information also includes battery information. The pacemaker body also includes a battery performance detection module 450, the battery performance detection module 450 is configured to monitor the battery operating state, obtain the battery information according to the battery operating state, and send the battery information to to the pacemaker body (in this embodiment, the data processing unit 410). With such a configuration, an alarm message will be issued before the battery power is exhausted, so as to deal with it in time. Obviously, in other implementation manners, the battery information also includes battery life, health status, etc., which will not be repeated here.

Specifically, the pacemaker body 400 is further configured to send the battery information to the second unit 300 . Further, the second unit 300 sends the battery information to the external control device via the first unit 200 . With such a configuration, the external control device can be informed of the battery health status of the leadless pacemaker in time, so that corresponding countermeasures can be taken in time, so that the leadless pacemaker can operate normally.

To sum up, in the leadless pacemaker provided by the present invention, the first unit 200 is located in the first casing 110 to ensure that the transmitted or received radio frequency signal will not be attenuated and shielded by the second casing 120, realizing the leadless pacemaker. Remote data exchange between the pacemaker and the external control device; further, the second unit 300 and the pacemaker body 400 are located in the second housing 120, which can avoid the second unit 300 and the pacemaker The pacemaker body 400 is protected from the physiological impact and erosion of the implant recipient, and at the same time reduces the damage of the second unit 300 and the pacemaker body 400 to the organ tissue of the implant recipient. Therefore, the leadless pacemaker provided by the present invention has the advantages of high data transmission rate and long communication distance, and can improve the convenience of follow-up visits after the implantation of the leadless pacemaker.

Another embodiment of the present invention also provides a delivery device, which is used for delivering the leadless pacemaker described in any one of the above-mentioned embodiments. Specifically, referring to FIG. 6, FIG. 6 is a schematic structural diagram of a transmission device provided by an embodiment of the present invention. It can be seen from FIG. 6 that the delivery device includes: a delivery handle assembly 930, a delivery rod assembly 920, and a head end part 910 that cooperates with the first housing 110 of the leadless pacemaker. The component 910 is arranged at the far end of the delivery rod assembly 920, and the delivery handle assembly 930 is arranged at the proximal end of the delivery rod assembly 920 and connected to the head end part 910 through the delivery rod assembly 920; The delivery device is configured to advance the leadless pacemaker to a target location, and upon reaching the target location, release the leadless pacemaker.

In summary, the leadless pacemaker provided by the present invention can be implanted into the patient's right ventricle via the femoral vein using the delivery device shown in FIG. 6 . Wherein the head end part 910 of the delivery device is connected with the first casing 110 of the leadless pacemaker, and then the leadless pacemaker is delivered into the body. Obviously, any delivery device in the prior art that can play the above role can deliver the leadless pacemaker proposed by the present invention, and the present invention does not make any limitation thereto; further, the leadless pacemaker proposed by the present invention The device is not limited to be transported by the transport device, but can also be installed in other ways, which is not limited in the present invention.

Another embodiment of the present invention also provides a leadless pacing system, which includes the leadless pacemaker described in any one of the above and the above delivery device.

Since the leadless pacing system provided by the present invention belongs to the same inventive concept as the leadless pacemaker provided by the present invention, it has at least the same beneficial effect, which will not be repeated here.

Another embodiment of the present invention provides a wireless communication system based on implantable medical electronic devices, the wireless communication system includes an internal implant device and an external control device; wherein the internal implant device includes any of the above-mentioned In the leadless pacemaker described in the embodiment, the external control device includes a wireless communication unit, and the wireless communication unit is used for communicating with the first unit of the leadless pacemaker.

In summary, the leadless pacemaker proposed by the present invention has the first unit 200 disposed in the first housing 110 , the second unit 300 and the pacemaker body 400 disposed in the second housing 120 ; The second unit 300 is electrically connected to the pacemaker body 400 and the first unit 200 . With such a configuration, the wireless communication system with the leadless pacemaker proposed by the present invention can overcome the low carrier frequency, low data transmission rate, short communication distance and poor communication quality of human body communication in the prior art. It can ensure that the transmitted or received radio frequency signal will not be attenuated and shielded, thus realizing the long-distance data interaction between the leadless pacemaker and the external control device, and improving the follow-up safety of patients after implantation of the leadless pacemaker Convenience.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present invention, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

In the description of this specification, descriptions referring to the terms "one embodiment", "some embodiments", "example", "specific examples", or "some examples" mean that specific features described in connection with the embodiment or example , structure, material or characteristic is included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the described specific features, structures, materials or characteristics may be combined in any suitable manner in any one or more embodiments or examples. In addition, those skilled in the art can combine and combine different embodiments or examples and features of different embodiments or examples described in this specification without conflicting with each other.

To sum up, the above-mentioned embodiments have described in detail the different configurations of the leadless pacemaker, the delivery device and the system. Of course, the above-mentioned description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. The invention includes but is not limited to the configurations listed in the above implementation. Those skilled in the art can draw inferences based on the content of the above embodiments. Any changes and modifications made by those of ordinary skill in the field of the invention based on the above disclosures belong to the claims. protection scope of the book.

Claims

A leadless pacemaker, characterized by comprising a first housing, a second housing, a first unit disposed in the first housing, a second unit disposed in the second housing, and a pacemaker body; The second unit is electrically connected to the pacemaker body and the first unit respectively;

The first unit is configured to receive control information from an in vitro control device;

The second unit is configured to receive the control information and send the control information to the pacemaker body;

The pacemaker body is configured to control the operation of the leadless pacemaker according to the control information, and send the operation information of the leadless pacemaker to the second unit;

The second unit is further configured to send the operation information to the first unit, and the first unit is further configured to send the operation information to the in vitro control device;

Wherein, the first casing is made of biocompatible non-metallic material; the second casing includes a closed casing made of biocompatible metal material.
The leadless pacemaker according to claim 1, further comprising a first signal transmission unit, the first end of the first signal transmission unit is located in the first housing, and the first signal transmission the second end of the unit is located within the second housing;

The first unit is connected to the first end of the first signal transmission unit, and the second unit is connected to the second end of the first signal transmission unit.
The leadless pacemaker according to claim 1, further comprising a second signal transmission unit electrically connected to the pacemaker body, the first end of the second signal transmission unit is located at the first Inside the second housing, the second end of the second signal transmission unit is located outside the second housing;

The second signal transmission unit is configured to transmit the physiological information of the subject to the pacemaker body.
The leadless pacemaker according to claim 3, further comprising a third casing, the third casing is made of biocompatible non-metallic material;

The second end of the second signal transmission unit outside the second housing extends into the third housing.
The leadless pacemaker according to claim 4, further comprising a fixing unit, the first end of the fixing unit is fixed on the outer wall of the third housing, and the second end is used to be fixed on on the receptor.
The leadless pacemaker according to claim 3, further comprising a battery unit electrically connected to the pacemaker body, the battery unit is arranged in the second casing, and the battery unit is used for for supplying power to the pacemaker body and/or the second unit.
The leadless pacemaker according to claim 6, wherein the second signal transmission unit and the battery unit are located at two opposite ends of the pacemaker body.
The leadless pacemaker according to claim 6, wherein the battery unit is located between the pacemaker body and the second unit, and the outer wall of the battery unit has a groove;

The signal line connecting the pacemaker body and the second unit is located in the groove.
The leadless pacemaker according to claim 1, wherein the operating information includes physiological information of the recipient and implantation status information of the leadless pacemaker;

The pacemaker body is used to send the physiological information and the implantation status information to the second unit.
The leadless pacemaker according to claim 1, wherein the running information further includes battery information;

The pacemaker body also includes a battery performance detection module, the battery performance detection module is configured to monitor the operating state of the battery, obtain the battery information according to the operating state of the battery, and send the battery information to the Second unit.
A delivery device, characterized in that the delivery device is used to deliver the leadless pacemaker according to any one of claims 1-10;

The delivery device includes: a delivery handle assembly, a delivery rod assembly, and a head-end part matched with the first casing of the leadless pacemaker, and the head-end part is arranged at the distal end of the delivery rod assembly , the delivery handle assembly is arranged at the proximal end of the delivery rod assembly and connected to the head end part through the delivery rod assembly;

The delivery device is configured to advance the leadless pacemaker to a target location and, upon reaching the target location, to release the leadless pacemaker.
A leadless pacing system, comprising the leadless pacemaker according to any one of claims 1-10 and the delivery device according to claim 11.
A wireless communication system based on an implantable medical electronic device, characterized in that it includes an internal implant device and an external control device;

Wherein, the implanted device in the body includes the leadless pacemaker according to any one of claims 1 to 10, and the external control device includes a wireless communication unit for communicating with the leadless pacemaker. The first unit communication connection of the device.