WO2022267718A1 - Leadless pacemaker and active separation module thereof - Google Patents

Abstract

Disclosed are a leadless pacemaker (100) and an active separation module (20) thereof. The active separation module (20) comprises a release assembly (21) and a deformable member (22). The release assembly (21) is provided with an insertion hole (21a), and the deformable member (22) is connected to the release assembly (21). The deformable member (22) is used to change from a first state to a second state when energized, wherein when the deformable member (22) is in the first state, a connecting member (11) is limited in the insertion hole (21a) such that the active separation module (20) remains connected to a distal end module (10), and when the deformable member (22) is in the second state, the deformable member (22) releases the limiting of the connecting member (11) and the insertion hole (21a) such that the connecting member (11) can exit the insertion hole (21a), thereby disconnecting the active separation module (20) from the distal end module (10).

Description

Leadless pacemaker and its active isolation module

Cross References to Related Applications

This application claims the priority of the Chinese patent application with the application number 202110712122.3 and the title of the invention "leadless pacemaker and its active separation module" submitted to the China Patent Office on June 25, 2021, the entire contents of which are incorporated herein by reference In this application.

technical field

The present application relates to the technical field of leadless pacemakers, in particular to a leadless pacemaker and its active separation module.

technical background

At present, a leadless pacemaker generally includes a proximal end of the pacemaker, a package casing, a ring electrode, a battery, an electrical component, a distal end of the pacemaker, and a head electrode, etc., and is mainly used for implanting into a patient's ventricle for sensory pacing .

The distal end of the pacemaker contains fixing components, which are used to fix the pacemaker on the inner wall of the ventricle, and the proximal end of the pacemaker contains a captured structure, which is used to remove the pacemaker in whole or in part from the human body when needed. However, after a leadless pacemaker has been implanted for a period of time, the fixation components at the distal end adhere to the tissue, so it is difficult or even impossible to remove the pacemaker even if the proximal end of the pacemaker is captured. Remove the pacemaker in its entirety. In this case, if the leadless pacemaker is forcibly removed, it will cause severe trauma to the inner wall of the ventricle.

Contents of the invention

According to an exemplary embodiment of the present application, an active disengagement module and a leadless pacemaker including the active disengagement module are provided.

In one aspect, the present application provides an active disengagement module of a leadless pacemaker, the active disengagement module is used for detachable connection with the remote module of the leadless pacemaker, and the active disengagement module includes:

a release assembly having a socket that matches the connector of the remote module; and

a deformable part connected to the release assembly, the deformable part is used to change from the first state to the second state when electrified, wherein, when the deformable part is in the first state, the connecting part limited to the socket so that the active separation module remains connected to the remote module, and when the deformable member is in the second state, the deformable member releases the connection between the connecting member and the socket The position is limited, so that the connecting piece can withdraw from the socket, so as to disconnect the connection between the active separation module and the remote module.

In one of the embodiments, the deformable member comprises a shape memory alloy wire. Alternatively, the deformable member includes a spring member, and the material of the spring member is a shape memory alloy material.

In one embodiment, the shape memory alloy material is selected from nickel-titanium alloy, indium-titanium alloy, nickel-aluminum alloy and nickel-gallium alloy.

In one of the embodiments, the connector is detachably mated with the socket, the connector is provided with a matching portion, and the deformable member is provided with a limiting portion; when the deformable member is in In the first state, the limiting part cooperates with the matching part to restrict the connecting part from withdrawing from the insertion hole; when the deformable part is in the second state, the limiting part releases the Fitting of the matching portion, so that the connecting piece exits the insertion hole.

In one of the embodiments, the limiting portion includes a clamp, and the matching portion includes a groove matching with the clamp; when the deformable member is in the first state, the clamp engages In the groove, when the deformable element changes from the first state to the second state, the clamp moves away from the groove relative to the connecting element.

In one of the embodiments, the limiting portion includes a limiting pin, and the matching portion includes a pin hole; when the deformable member is in the first state, the limiting pin is inserted into the pin hole, When the deformable part changes from the first state to the second state, the limiting pin moves away from the pin hole relative to the connecting part.

In one of the embodiments, the connector is snap-connected to the jack, and the connector is provided with a buckle portion; when the deformable member changes from the first state to the second state, it can drive the The buckle part moves relative to the socket to release the buckle connection between the connector and the socket.

In one embodiment, one end of the deformable member is connected to the release assembly, and the other end has a collar, and the collar is set on the buckle portion. When the deformable member is energized and deformed, The collar drives the buckle part to move so that the buckle part exits the insertion hole.

In one of the embodiments, the active separation module includes a packaging case, a battery and an electrical component, the battery and the electrical component are arranged in the packaging case, and the electrical component is used to connect the battery to the The deformable part is electrically connected, and the electrical component is connected with the signal of the external device. When the electrical component receives a release signal from the external device, the electrical component makes the deformable part energized.

In one of the embodiments, the release assembly further includes a first package, a second package and a mount; the first package is connected to the package housing, and the socket is opened in the first package ; the second package is connected to the first package; and the mounting seat is connected between the first package and the second package, and the deformable member is installed on the mounting seat .

In one embodiment, the second package is sealed and connected with a first electrical connector, and the deformable member is connected to an electrical component through the first electrical connector.

In another aspect, the present application provides a leadless pacemaker, which includes a remote module and the above-mentioned active separation module.

In one of the embodiments, the distal module is provided with a head electrode and a fixing assembly, the fixing assembly is used to fix the body and make the head electrode contact with the body, and the second package is sealed and connected with a first Two electrical connectors, one end of the second electrical connector is connected to the electrical component, and the other end extends out of the first package and is used for electrical contact with the head electrode.

The above-mentioned leadless pacemaker and its active separation module, the active separation module includes a release assembly and a deformable part, the release assembly is provided with a jack for detachably mating with the remote module of the leadless pacemaker, and the deformable part Connected with the release component, the deformable part can be deformed when energized to change from the first state to the second state, releasing the limit between the connecting part and the socket of the remote module, so that the active separation module can be released from the The distal module is detached for removal from the body. Therefore, the leadless pacemaker adopting the active separation module can actively release the connection between the active separation module and the remote module by energizing the deformable part when the leadless pacemaker is about to lose its function, so that the active The separation module is taken out to reduce the adverse effects caused by the useless leadless pacemaker remaining in the body. This active separation method is simple to operate and has a high success rate.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present application. Those skilled in the art can also obtain the drawings of other embodiments according to these drawings without creative work.

Fig. 1 is a schematic structural diagram of a leadless pacemaker according to an embodiment, wherein the active separation module and the remote module are in a state of being connected.

Fig. 2 is a schematic structural diagram of a leadless pacemaker according to an embodiment, wherein the active separation module and the remote module are in a state of separation.

Fig. 3 is a schematic diagram of the connection between the active separation module and the remote module when the deformable member is in the first state in the leadless pacemaker according to an embodiment.

FIG. 4 is a schematic diagram of the connection between the active separation module and the remote module when the deformable member is in the second state in the leadless pacemaker shown in FIG. 3 .

Fig. 5 is a schematic diagram of the connection between the active separation module and the remote module when the deformable member is in the first state in a leadless pacemaker according to another embodiment.

Fig. 6 is a schematic diagram of the connection between the active separation module and the remote module when the deformable member is in the second state in the leadless pacemaker shown in Fig. 5 .

Fig. 7 is a schematic diagram of the connection between the active separation module and the distal module when the deformable member is in the first state in a leadless pacemaker according to another embodiment, wherein one deformable member is removed.

Fig. 8 is a schematic diagram of the connection between the active separation module and the remote module when the deformable member is in the second state in the leadless pacemaker shown in Fig. 7 .

Fig. 9 is a schematic diagram of an exploded structure of a leadless pacemaker according to an embodiment, which schematically shows signal connections between external devices and electrical components.

Fig. 10 is a schematic structural diagram of a deformable part of an active separation module of a leadless pacemaker according to an embodiment.

Fig. 11 is a schematic diagram of another exploded structure of a leadless pacemaker according to an embodiment.

FIG. 12 is a partially enlarged schematic view of the leadless pacemaker shown in FIG. 11 .

detailed description

In order to make the above-mentioned purpose, features and advantages of the present application more obvious and understandable, the specific implementation manners of the present application will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the application. However, the present application can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

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

In this application, terms such as "installation", "connection", "connection" and "fixation" should be interpreted in a broad sense, for example, it can be a fixed connection or a detachable connection, unless otherwise clearly specified and limited. , or integrated; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise specified limit. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations.

As shown in FIG. 1 and FIG. 2 , a leadless pacemaker 100 according to an embodiment of the present application includes at least two modules. For ease of understanding, the distal part of the leadless pacemaker 100 is referred to as "remote module 10" , other parts that are connected to the distal module 10 and need to be separated and removed when the leadless pacemaker 100 does not work are called "active separation module 20". In this embodiment, the active separation module 20 can be released from the distal module 10 and finally moved out of the body. In this way, when the leadless pacemaker 100 does not work, it will not remain in the body and cause adverse effects.

As shown in FIGS. 1 and 2 , the leadless pacemaker 100 further includes a captured structure 30 connected to the proximal end of the active isolation module 20 (the end away from the distal module 10 ). The captured structure 30 is used to be captured by corresponding instruments for subsequent operations. For example, when the deformable member 22 is energized and enters the second state, that is, when the limit between the connecting member 11 and the socket 21a is released, the active separation module 20 is separated from the distal module 10 by pulling the captured structure 30 and finally moved out of the body . The connection between the captured structure 30 and the active separation module 20 may be one or more of welding, bonding, screw connection, pin connection and snap connection, which is not limited here.

As shown in conjunction with FIG. 2 and FIG. 3 , the active separation module 20 includes a release assembly 21 and a deformable member 22 . The deformable member 22 is connected with the release assembly 21 .

The release assembly 21 has an insertion hole 21 a matching with the connecting piece 11 of the remote module 10 . The deformable part 22 is used to change from the first state to the second state when the power is turned on, wherein, when the deformable part 22 is in the first state, the connecting part 11 is limited to the socket 21a so that the active separation module 20 and the remote module 10 remains connected, when the deformable member 22 is in the second state, the deformable member 22 releases the limit of the connecting member 11 and the socket 21a, so that the connecting member 11 can withdraw from the socket 21a, thereby disconnecting the active separation module 20 from the socket 21a. Connection of the remote module 10.

This active release method only needs to control the power supply of the deformable member 22 to separate the active separation module 20 from the distal module 10 , and the separation operation will not be affected by the connection between the distal module 10 and the human body. Therefore, even if the distal module 10 maintains a stable connection with the human body and is difficult to separate, the active separation module 20 in the embodiment of the present application can also be effectively separated from the distal module 10, and there will be no damage to the distal module 10 during the separation process. Excessive traction can cause adverse effects. Therefore, this active separation method is easy to operate and has a high success rate.

The deformable part 22 includes a shape memory alloy wire, that is to say, the deformable part 22 includes a wire member made of a shape memory alloy material. For example, nickel-titanium alloy wire has the advantages of superelasticity, shape memory characteristics, good biocompatibility, and corrosion resistance. The deformable part 22 is made of nickel-titanium alloy wire, which can meet the requirements of the release component in the active separation module 20. 21 and the release of the distal module 10 are required, and at the same time, its good biocompatibility can reduce negative effects.

As a memory metal, shape memory alloys can undergo plastic deformation in a certain temperature range, and can restore their original macroscopic shape in another temperature range. Therefore, the deformable member 22 made of this special metal material can realize heat shrinkage and deformation by means of energization, thereby forming the first state and the second state.

The shape memory alloy material is selected from nickel-titanium alloys, indium-titanium alloys, nickel-aluminum alloys, nickel-gallium alloys, and similar materials. For example, nickel-titanium alloys have various grades according to different element ratios, such as NiTi-1, NiTi-2, NiTi-3, NiTi-SS, NiTi-YY, TiNiCU, TiNiNb, etc., and their thermal deformation temperature ranges are different. Among them, the heat shrinkage temperature of nickel-titanium alloy NiTi-1 is 20°C-40°C, and the heat shrinkage temperature of NiTi-YY is 33°C±3°C, both of which meet the conditions of deformation in the human body.

In some other embodiments, the deformable member 22 includes a spring member, and the material of the spring member is a shape memory alloy material. The spring member is made of a shape memory alloy material to obtain a greater amount of deformation, so that the deformable member 22 can obtain a greater deformation when an electric current of the same size and duration is applied, so that the deformable member 22 can be more deformed. Efficiently change from the first state to the second state, so as to speed up the separation efficiency of the active separation module 20 and the remote module 10, and shorten the time of the whole operation.

In some embodiments, the connector 11 is detachably mated with the insertion hole 21a, the connector 11 is provided with a matching portion, and the deformable member 22 is provided with a limiting portion. When the deformable part 22 is in the first state, the limiting part cooperates with the matching part to restrict the connecting part 11 from exiting the socket 21a; when the deformable part 22 is in the second state, the limiting part releases the cooperation with the matching part , so that the connector 11 can exit the socket 21a.

It should be noted that the limiting portion and the matching portion have various structures to meet the functional requirements of the above-mentioned deformable member 22 in the first state and the second state.

In some embodiments, as shown in FIG. 3 and FIG. 4 , the limiting part includes a limiting pin 221 , the fitting part includes a pin hole 11 a, and the limiting pin 221 fits into the pin hole 11 a.

As shown in FIG. 3, when the deformable member 22 is in the first state, the limit pin 221 is inserted into the pin hole 11a, so that the connecting member 11 cannot withdraw from the insertion hole 21a, that is, the connecting member 11 is limited to the insertion hole 21a, and the active The separation module 20 is kept connected with the remote module 10 . As shown in FIG. 4, when the deformable member 22 changes from the first state to the second state, the limit pin 221 moves away from the pin hole 11a relative to the connecting member 11, and then the limit pin 221 releases the limit on the connecting member 11. , so that the connecting piece 11 can move relative to the release assembly 21 and withdraw from the socket 21a, so as to realize the release of the active separation module 20 from the distal module 10, so that the active separation module 20 can be removed from the body later, reducing the useless residual leadless pacemaker 100 cause adverse effects in the body.

In some other embodiments, as shown in FIG. 5 and FIG. 6 , the limiting part includes a clamp 222 , and the matching part includes a groove 11 b matching with the clamp 222 . In some embodiments, the connecting piece 11 is column-shaped, and the groove 11 is defined on a peripheral side of the connecting piece 11 .

When the deformable part 22 is energized and deformed, the clamp 222 located on the deformable part 22 moves relative to the connecting part 11 to change the mating state with the groove 11b, thereby changing the contact between the deformable part 22 and the connecting part 11 in the first state and the second state. the role played.

As shown in FIG. 5 , when the deformable member 22 is in the first state, the clamp 222 is engaged with the groove 11b. Hole 21a exits. As shown in FIG. 6, when the deformable member 22 changes from the first state to the second state, the clamp 222 moves relative to the connecting member 11 and leaves the groove 11b, so as to release the restriction on the connecting member 11, so that the connecting member 11 It can withdraw from the jack 21a, and then realize the release of the active isolation module 20 from the distal module 10, so that the active isolation module 20 can be removed from the body later, and the adverse effects caused by the useless leadless pacemaker 100 remaining in the body can be reduced.

It should be noted that the structures of the deformable member 22 and the connecting member 11 are not limited to the above-mentioned situation. In some other embodiments, as shown in FIG. 7 and FIG. 8 , the connector 11 is snap-connected with the socket 21a. In order to facilitate the observation of the engaging structure of the connecting member 11 and the insertion hole 21a, the deformable member 22 on one side is omitted in FIGS. 7 and 8 .

In this embodiment, the connecting part 11 is provided with a buckle part 11c, and when the deformable part 22 changes from the first state to the second state, the buckle part 11c can be driven to move relative to the insertion hole 21a and release the connection part 11 from the insertion hole. Snap connection to hole 21a.

When the deformable member 22 is in the first state, as shown in FIG. 7 , the buckle portion 11 c is kept in a buckled connection with the insertion hole 21 a, and at this time, the release assembly 21 is kept connected with the distal module 10 . When the deformable member 22 is energized and deformed, the deformable member 22 gradually enters the second state from the first state, as shown in FIG. The part 11c generates traction, so that the buckle part 11c moves to the position where it can withdraw from the socket 21a. At this time, the connection between the release assembly 21 and the remote module 10 is released, and then the active separation module 20 can be operated to release from the remote module 10. separated and eventually removed from the body.

Further, one end of the deformable member 22 is connected to the release assembly 21, and the other end has a collar 223, and the collar 223 is sleeved on the buckle part 11c. When the deformable part 22 is energized and deformed, the collar 223 drives the buckle part 11c Moved so that the catch portion 11c can exit the insertion hole 21a.

It should be noted that, in the embodiment in which the connector 11 is snap-connected to the socket 21a, the deformable member 22 does not need to be provided with a collar 223, as long as the deformable member 22 is energized and deformed, a pushing or pulling force is formed to make the buckle The portion 11c may be moved relative to the insertion hole 21a until it can withdraw from the insertion hole 21a.

As shown in FIG. 9 , in some embodiments, the active separation module 20 includes a packaging case 23 , a battery 24 and an electrical component 25 .

The battery 24 and the electrical component 25 are disposed in the package casing 23 , and the electrical component 25 is used to electrically connect the battery 24 and the deformable member 22 . The electrical component 25 is connected with the external device 200 for signal. When the electrical component 25 receives the release signal of the external device 200, the electrical component 25 makes the deformable part 22 energized and changes from the first state to the second state, so that the connecting part 11 and the plug The limit between the holes 21 a is released, so that the active separation module 20 is separated from the distal module 10 .

In this embodiment, when it is necessary to release the connection between the active separation module 20 and the remote module 10, the battery 24 carried by the leadless pacemaker 100 can be used to provide power, and the electrical component 25 can be connected to the external device 200 in a signal manner , the power-on control of the deformable part 22 is extremely convenient, and the safety performance is good.

In some embodiments, when the power of the battery 24 is about to run out, in order to avoid adverse effects caused by the entire leadless pacemaker 100 remaining in the body, the electric energy of the battery 24 can be delivered to the deformable member 22 through the electrical component 25 , That is to realize that the battery 24 supplies current to the deformable member 22, so that the deformable member 22 is deformed, and finally the deformable member 22 enters the second state from the first state to release the connection between the remote module 10 and the active separation module 20, thereby It is adapted to the requirement that the active separation module 20 leaves the remote module 10 .

Continuing to refer to FIG. 9, in some embodiments, the electrical assembly 25 includes a first input terminal 251 and a second input terminal 252, and the first input terminal 251 and the second input terminal 252 are respectively connected to the positive and negative poles of the battery 24 , to realize the electrical connection between the electrical component 25 and the battery 24 .

10, the electrical assembly 25 includes a first output terminal 253 and a second output terminal 254, the deformable member 22 has a first connection end 201 and a second connection end 202, the first output terminal 253 and the second output terminal 254 respectively connected to the first connection end 201 and the second connection end 202, so that the electrical component 25 can control the electrical path between the battery 24 and the deformable member 22, and then when the active separation module 20 needs to be released from the remote module 10 , the electrical component 25 connects the electrical path between the battery 24 and the deformable member 22 after receiving the signal from the external device 200 , so that the battery 24 outputs current to the deformable member 22 . In this way, the deformable member 22 deforms after being energized and changes from the first state to the second state, and finally completes the release of the active separation module 20 from the distal module 10, so that the active separation module 20 can be removed from the body later to avoid remaining in the body and causing adverse effects.

It should be noted that one, or two or more deformable members 22 may be provided, and the number of deformable members 22 may be configured according to actual needs. In some embodiments, the release assembly 21 and the distal module 10 have two sets of jacks 21a and connectors 11 that are arranged in one-to-one correspondence, and the active separation module 20 is provided with two deformable members 22 and two deformable members 22 They are arranged corresponding to the two sockets 21a, so that the two deformable parts 22 can be used to adaptively release the limit of the corresponding connecting piece 11 and the socket 21a. Of course, a synchronous structure can also be provided on one deformable member 22, so that one deformable member 22 can meet the requirement of releasing the two sets of correspondingly arranged connecting members 11 and the insertion holes 21a. The number of the jacks 21a of the release assembly 21 and the number of the connecting pieces 11 of the remote module 10 are not limited here.

As shown in FIG. 11 , the release assembly 21 includes a first package 211 , a mount 212 and a second package 213 .

The first package 211 is connected to the package housing 23, the socket 21a is opened in the first package 211, the second package 213 is connected to the first package 211, and the mounting base 212 is connected to the first package 211 and the second package. Between the parts 213, the deformable part 22 is installed on the mounting base 212, so that the deformable part 22 located on the mounting base 212 is packaged and fixed by the first package 211 and the second package 213, which is convenient for overall assembly as an accessory and improves manufacturing efficiency.

The mount 212 provides a mounting point for the deformable member 22 . For example, as shown in FIG. 12, a mounting column 212a is formed on the mounting base 212, and an installation hole 22a is formed at one end of the deformable member 22. The cooperation between the mounting column 212a and the mounting hole 22a (see FIG. 8 ) makes it deformable The component 22 is stably connected with the mounting base 212 .

In some embodiments, the mount 212 can be welded or snap-fitted to the first package 211 or the second package 213, and the mount 212 is in the space enclosed by the first package 211 and the second package 213 The installation method is not limited here.

The mounting seat 212 can be made of biocompatible insulating material, such as polyetheretherketone.

The second package 213 is sealed and connected with the first electrical connector 26, specifically, the second package 213 is sealed with the inner wall of the package housing 23, and the first electrical connector 26 is sealed and connected to the second package 213, In order to make the packaging case 23 in a sealed state, the battery 24 and the electrical components 25 located in the packaging case 23 are protected.

As shown in FIG. 12 , the deformable member 22 is connected to the electrical component 25 through the first electrical connection member 26 . One end 261 of the first electrical connector 26 is connected to the electrical component 25 , and the other end 262 of the first electrical connector 26 is connected to the deformable member 22 , so as to realize the electrical connection between the deformable member 22 and the electrical component 25 .

In the embodiment where the active separation module 20 is provided with two deformable parts 22, the first electrical connecting part 26 includes four guide wires, so as to connect the electrical component 25 and the two deformable parts 22 respectively by using four guide wires, wherein Two guide wires are used to connect one of the two deformable parts 22 , and the other two guide wires are used to connect the other deformable part 22 . In this way, after the four guide wires are correspondingly connected to the two deformable parts 22, the electrical connections between the deformable parts 22 and the electrical components 25 can be realized respectively.

The first package 211 includes vent holes (not shown in the figure) to allow air, saline and blood to enter the space formed by the first package 211 and the second package 213, thereby preventing the deformable member 22 from being energized. The heat cannot be released and the temperature is too high.

It should be noted that the guide wire, the deformable member 22 and the connection between them can be insulated and protected to prevent electric energy from being released into the liquid between the first package 211 and the second package 213, thereby improving the utilization rate of electric energy , while also avoiding short circuits. The way of insulation protection includes but not limited to coating parylene coating. The remaining positions in the space formed by the first package 211 and the second package 213 can also be provided with insulation protection before packaging.

In some embodiments, as shown in FIG. 12 , the distal module 10 is provided with a head electrode 12 and a fixation component 13 , and the fixation component 13 is used to fix the body and make the head electrode 12 contact with the body. The fixation component 13 can be a helical fixer or a fixation structure with anchors, as long as it can be stably fixed to the body, the structure of the fixation component 13 is not limited here.

The second package 213 is sealed and connected with a second electrical connector 27, one end 271 of the second electrical connector 27 is connected to the electrical assembly 25, and the other end 272 of the second electrical connector 27 protrudes outside the first package 211 And used for electrical contact with the head electrode 12 (refer to FIG. 2). Wherein, the contact mode between the second electrical connector 27 and the head electrode 12 can be selected from different contact modes such as end surface contact, conical surface contact or spherical surface contact, as long as the two can realize electrical contact, and there is no limitation here. .

It should be noted that the first electrical connector 26 and the second electrical connector 27 can be feedthroughs, and the feedthroughs here refer to electrical feedthroughs. As an electrical connector, the feedthroughs include a guide wire, an insulating Part and the outer metal part, in order to facilitate sealing installation, feedthrough is used for communication connection, and has a certain anti-interference ability.

The first electrical connector 26 and the second electrical connector 27 can be installed in the manner shown in FIG. The electrical connector 27 is passed through the first through hole and the second through hole and sealed. The sealing structure may be a sealing ring or a sealant, which is not limited here.

It should be noted that the installation method of the first electrical connector 26 and the second electrical connector 27 on the second package 213 is not limited to the installation method shown in FIG. 12 , in some embodiments, the first electrical connector 26 When the feedthrough is adopted with the second electrical connector 27, their guide wires can be completely separated, or all can be packaged together to form an integral feedthrough. Feedthrough can be purchased off-the-shelf components, such as the electrical feedthrough products of Pfeiffer Vacuum in Germany, or it can be sealed and installed with wires, insulating materials, and conductive materials, which are not limited here.

The technical features of the above embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be It is considered to be within the range described in this specification.

The above examples only express several implementation modes of the present application, and the description thereof is relatively specific and detailed, but should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the scope of protection of the patent application should be based on the appended claims.

Claims (14)

1. An active disengagement module of a leadless pacemaker, the active disengagement module is used for detachable connection with the remote module of the leadless pacemaker, the active disengagement module includes:

   a release assembly having a socket that matches the connector of the remote module; and

   a deformable part connected to the release assembly, the deformable part is used to change from the first state to the second state when electrified, wherein, when the deformable part is in the first state, the connecting part limited to the socket so that the active separation module remains connected to the remote module, and when the deformable member is in the second state, the deformable member releases the connection between the connecting member and the socket The position is limited, so that the connecting piece can withdraw from the socket, so as to disconnect the connection between the active separation module and the remote module.
2. The active separation module of claim 1, wherein the deformable member comprises a shape memory alloy wire.
3. The active separation module according to claim 1, wherein the deformable member comprises a spring member, and the material of the spring member is a shape memory alloy material.
4. The active separation module according to claim 3, wherein the shape memory alloy material is selected from nickel-titanium alloy, indium-titanium alloy, nickel-aluminum alloy and nickel-gallium alloy.
5. The active separation module according to claim 1, wherein the connector is detachably plugged and fitted with the jack, the connector is provided with a matching portion, and the deformable member is provided with a limiting portion;

   When the deformable member is in the first state, the limiting portion cooperates with the matching portion to restrict the connecting member from exiting the insertion hole; when the deformable member is in the second state In the state, the limiting part releases the cooperation with the matching part, so that the connecting part withdraws from the insertion hole.
6. The active separation module according to claim 5, wherein the limiting part comprises a clamp, and the matching part comprises a groove matched with the clamp; when the deformable part is in the first state When the clamp is engaged with the groove, when the deformable member changes from the first state to the second state, the clamp moves away from the groove relative to the connecting member .
7. The active separation module according to claim 5, wherein the limiting part comprises a limiting pin, and the matching part comprises a pin hole; when the deformable member is in the first state, the limiting pin Inserted in the pin hole, when the deformable part changes from the first state to the second state, the limiting pin moves away from the pin hole relative to the connecting part.
8. The active separation module according to claim 1, wherein the connecting piece is buckled connected with the jack, and the connecting piece is provided with a buckle portion; the deformable piece changes from the first state to In the second state, the locking part can be driven to move relative to the insertion hole, so as to release the locking connection between the connecting member and the insertion hole.
9. The active separation module according to claim 8, wherein one end of the deformable member is connected to the release assembly, and the other end has a collar, and the collar is sleeved on the buckle part; when the deformable member When the deformation member is energized and deformed, the collar drives the buckle part to move so that the buckle part exits the insertion hole.
10. The active separation module according to any one of claims 1-9, further comprising a packaging case, a battery and an electrical component, the battery and the electrical component are arranged in the packaging case, and the electrical component is used For electrically connecting the battery to the deformable member, the electrical component is signal-connected to an external device, and when the electrical component receives a release signal from the external device, the electrical component energizes the deformable member .
11. The active separation module according to claim 1, wherein the release assembly further comprises:

    a first package, the first package is connected to the package housing, and the socket is opened in the first package;

    a second package connected to the first package; and

    An installation seat, the installation seat is connected between the first package and the second package, and the deformable part is installed on the installation seat.
12. The active separation module according to claim 11, wherein the second package is sealed and connected with a first electrical connector, and the deformable member is connected to an electrical component through the first electrical connector.
13. A leadless pacemaker, comprising a remote module and the active isolation module according to any one of claims 1-12.
14. The leadless pacemaker according to claim 13, wherein the distal module is provided with a head electrode and a fixing assembly, and the fixing assembly is used to fix the body and make the head electrode contact with the body; The second package is sealed and connected with a second electrical connector, one end of the second electrical connector is connected to the electrical component, and the other end protrudes from the first package and is used to electrically connect to the head electrode. sexual contact.

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