CN115518296A

CN115518296A - Leadless pacemaker and active separation module thereof

Info

Publication number: CN115518296A
Application number: CN202110712122.3A
Authority: CN
Inventors: 吴楠; 程志军; 和好学
Original assignee: Microport Sorin CRM Shanghai Co Ltd
Current assignee: Microport Sorin CRM Shanghai Co Ltd
Priority date: 2021-06-25
Filing date: 2021-06-25
Publication date: 2022-12-27
Also published as: WO2022267718A1

Abstract

The invention relates to a leadless pacemaker and an active separation module thereof, wherein the active separation module comprises a release component and a deformable part, the release component is provided with a jack, the deformable part is connected with the release component, and the deformable part is used for changing from a first state to a second state when electrified, wherein when the deformable part is in the first state, a connecting part is limited in the jack so that the active separation module is kept connected with a remote module, and when the deformable part is in the second state, the deformable part releases the limitation of the connecting part and the jack so that the connecting part can exit the jack, thereby disconnecting the active separation module from the remote module. The leadless pacemaker and the active separation module thereof actively release the connection between the active separation module and the remote module by electrifying the deformable part so as to take out the active separation module, thereby reducing the adverse effect caused by the residual of the useless leadless pacemaker in the body.

Description

Leadless pacemaker and active separation module thereof

Technical Field

The invention relates to the technical field of leadless pacemakers, in particular to a leadless pacemaker and an active separation module thereof.

Background

At present, a leadless pacemaker generally comprises a pacemaker proximal end, a packaging shell, a ring electrode, a battery, an electrical component, a pacemaker distal end, a head electrode and the like, and is mainly implanted into a heart chamber of a patient for sensing and pacing.

Wherein the distal end of the pacemaker comprises a fixation assembly for fixing the pacemaker to the inner wall of the ventricle and the proximal end of the pacemaker comprises a capture structure for removing the pacemaker wholly or partially from the body when required. However, after the leadless pacemaker is implanted and used for a period of time, the fixing component at the far end of the leadless pacemaker is adhered with the tissue, so that when the pacemaker needs to be taken out, even if the pacemaker is captured at the near end, the pacemaker cannot be taken out integrally; if forcefully removed, it can cause severe trauma to the inner wall of the ventricle.

Disclosure of Invention

Based on this, it is necessary to provide an active detachment module capable of active release and a leadless pacemaker including the same, aiming at the problems that the pacemaker is difficult to take out and is easy to cause serious trauma.

In one aspect, the present invention provides an active detachment module of a leadless pacemaker, the active detachment module being adapted to detachably connect with a distal module of the leadless pacemaker, the active detachment module comprising:

a release assembly having a receptacle that mates with the connector of the remote module; and

the deformable piece, with the release subassembly is connected, the deformable piece is used for changing to the second state by first state when the circular telegram, wherein, works as when the deformable piece is in the first state, the connecting piece spacing in the jack so that the initiative separation module with far-end module keeps being connected, works as when the deformable piece is in the second state, the deformable piece relieves the connecting piece with the spacing of jack, so that the connecting piece can withdraw from the jack, thereby the disconnection the initiative separation module with the connection of far-end module.

In one embodiment, the deformable element comprises a shape memory alloy wire, or the deformable element comprises a spring member made of a shape memory alloy material.

In another aspect, the present invention provides a leadless pacemaker comprising a distal module and an active detachment module as described above.

In one embodiment, the connecting piece and the jack are detachably connected and matched in an inserting mode, a matching portion is arranged on the connecting piece, the deformable piece is provided with a limiting portion, when the deformable piece is in a first state, the limiting portion is matched with the matching portion to limit the connecting piece to exit the jack, and when the deformable piece is in a second state, the limiting portion is removed from being matched with the matching portion to enable the connecting piece to exit the jack.

In one embodiment, the limiting part comprises a clamp, the matching part comprises a groove matched with the clamp, when the deformable piece is in a first state, the clamp is clamped in the groove, and when the deformable piece is changed from the first state to a second state, the clamp moves away from the groove relative to the connecting piece.

In one embodiment, the limiting portion comprises a limiting pin, the matching portion comprises a pin hole, when the deformable piece is in the first state, the limiting pin is inserted into the pin hole, and when the deformable piece is changed from the first state to the second state, the limiting pin moves away from the pin hole relative to the connecting piece.

In one embodiment, the connecting piece is connected with the jack in a buckling mode, a buckling part is arranged on the connecting piece, and when the deformable piece changes from the first state to the second state, the buckling part can be driven to move relative to the jack, so that the buckling connection between the connecting piece and the jack is released.

In one embodiment, one end of the deformable piece is connected with the release assembly, the other end of the deformable piece is provided with a sleeve ring, the sleeve ring is sleeved on the buckling part, and when the deformable piece is electrified and deformed, the sleeve ring drives the buckling part to move so that the buckling part is withdrawn from the jack.

In one embodiment, the active separation module includes a package housing, a battery and an electrical component, the battery and the electrical component are disposed in the package housing, the electrical component is used for electrically connecting the battery and the deformable member, the electrical component is in signal connection with an external device, and when the electrical component receives a release signal of the external device, the electrical component enables the deformable member to be electrified.

In one embodiment, the remote module is provided with a head electrode and a fixing component, the fixing component is used for being fixed on a body and enabling the head electrode to be in contact with the body, the second packaging part is connected with a second electric connecting piece in a sealing mode, one end of the second electric connecting piece is connected with the electric component, and the other end of the second electric connecting piece extends out of the first packaging part and is used for being in electric contact with the head electrode.

Above-mentioned leadless pacemaker and initiative separation module thereof, this initiative separation module includes release assembly and deformable spare, the release assembly be provided with the distal end module of leadless pacemaker realize detachable complex jack, deformable spare is connected with the release assembly, deformable spare can take place to warp when the circular telegram and change to the second state by first state, relieve spacing between the connecting piece of distal end module and the jack, like this alright from the distal end module separation with the module of initiatively separating to it is external to move out. Therefore, the leadless pacemaker adopting the active separation module can actively release the connection between the active separation module and the remote module in a mode of electrifying the deformable part when the leadless pacemaker is about to lose the action so as to take out the active separation module, thereby reducing the adverse effect caused by the residual useless leadless pacemaker in the body.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the prior art descriptions will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that drawings of other embodiments can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic diagram of a leadless pacemaker of an embodiment wherein an active detachment module is in communication with a remote module;

FIG. 2 is a schematic structural diagram of an embodiment of a leadless pacemaker wherein the active separation module is in a separated state from the remote module;

FIG. 3 is a schematic diagram illustrating the connection of the active release assembly to the distal module when the deformable member is in the first state, in accordance with one embodiment of the leadless pacemaker;

FIG. 4 is a schematic diagram of the connection of the active release assembly to the distal module in the leadless pacemaker of FIG. 3 with the deformable member in the second state;

fig. 5 is a schematic diagram of the connection of an active release assembly to a distal module in another embodiment of a leadless pacemaker with a deformable member in a first state;

FIG. 6 is a schematic diagram of the connection of the active release assembly to the distal module in the leadless pacemaker of FIG. 5 with the deformable member in the second state;

fig. 7 is a schematic diagram illustrating the connection of the active release assembly to the distal module when the deformable member is in the first state in yet another embodiment of the leadless pacemaker, wherein fig. 7 shows the connection of the active release assembly to the distal module with one deformable member removed for clarity;

FIG. 8 is a schematic diagram of the connection of the active release assembly to the distal module in the leadless pacemaker of FIG. 7 with the deformable member in the second state;

fig. 9 is an exploded schematic view of an embodiment of a leadless pacemaker, wherein the external device is schematically shown in signal connection with electrical components;

FIG. 10 is a schematic diagram of a deformable member of an active detachment module of an embodiment of a leadless pacemaker;

FIG. 11 is a schematic diagram of another exploded view of an embodiment of a leadless pacemaker;

fig. 12 is an enlarged view of a part of the disassembled leadless pacemaker device shown in fig. 11.

Detailed Description

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

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

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

Referring to fig. 1 and 2, a leadless pacemaker 100 of an embodiment of the present invention includes at least two modules, and for ease of understanding, a distal portion of the leadless pacemaker is referred to as a "distal module 10", and other portions connected to the distal module 10 that need to be separated and removed when the leadless pacemaker 100 is not in operation are referred to as "active separation modules 20". In this embodiment, active detachment module 20 may be released from remote module 10 and eventually removed from the body, so that it does not remain entirely in the body and adversely affect it when leadless pacemaker 100 is not functioning. For example, as shown in fig. 1 and 2, leadless pacemaker 100 includes a captured structure 30, with capture structure 30 coupled to the proximal end of active isolation module 20 (the end farther from distal module 10), and capture structure 30 for capture by a corresponding instrument for subsequent operation. For example, when deformable member 22 is energized into the second state, i.e., the spacing between connecting member 11 and receptacle 21a is released, active detachment module 20 is detached from distal module 10 and eventually removed from the body by pulling on captured structure 30.

The specific connection between the captured structure 30 and the active separation module 20 may be one or more of welding, bonding, screwing, pinning, and snapping, and is not limited herein.

As shown in fig. 2 and 3, the active separation module 20 includes a release assembly 21 and a deformable member 22.

The release member 21 has a receptacle 21a for mating with the connector 11 of the remote module 10, and the deformable member 22 is connected to the release member 21. In this embodiment, the deformable element 22 is configured to change from a first state to a second state when powered on, wherein when the deformable element 22 is in the first state, the connecting element 11 is limited by the insertion hole 21a so that the active separation module 20 and the remote module 10 are kept connected, and when the deformable element 22 is in the second state, the deformable element 22 releases the limitation of the connecting element 11 and the insertion hole 21a so that the connecting element 11 can exit the insertion hole 21a, thereby disconnecting the active separation module 20 and the remote module 10.

Since the active separation module 20 can be separated from the remote module 10 only by controlling the energization of the deformable member 22 through the active release, the separation operation is not affected by the connection between the remote module 10 and the body, and therefore, even if the remote module 10 and the body are stably connected and difficult to separate, the active separation module 20 in the embodiment of the present invention can be effectively separated from the remote module 10, and the separation process does not generate excessive traction force on the remote module 10 to cause adverse effects. Therefore, the active separation mode is simple to operate and high in success rate.

The deformable member 22 includes shape memory alloy wires, that is, the deformable member 22 includes filamentous members made of shape memory alloy material, for example, nitinol wires have the advantages of super elasticity, shape memory property, good biocompatibility and corrosion resistance, and the deformable member 22 made of nitinol wires can meet the releasing requirement of the releasing assembly 21 and the distal module 10 in the active separation module 20, and meanwhile, the good biocompatibility can reduce negative effects.

The shape memory alloy as memory metal can produce plastic deformation in certain temperature range and restore original macro shape in other temperature range. Thus, the deformable member 22 made of such a special metal material can be deformed by heat contraction by energization to form the first state and the second state.

Shape memory alloy materials include nickel titanium alloys, indium titanium alloys, nickel aluminum alloys, nickel gallium alloys, and the like. For example, nickel-titanium alloy has various grades according to different element mixture ratios, such as NiTi-1, niTi-2, niTi-3, niTi-SS, niTi-YY, tiNiCu, tiNiNb and the like, and the respective thermal deformation temperature ranges are different, wherein the thermal shrinkage temperature of the nickel-titanium alloy NiTi-1 is 20-40 ℃, the thermal shrinkage temperature of the NiTi-YY is 33 +/-3 ℃, and the condition of deformation in a human body is just met, so the nickel-titanium alloy is preferable.

In other embodiments, the deformable member 22 comprises a spring member made of a shape memory alloy material. The elastic member made of the shape memory alloy material is used for obtaining larger deformation, so that when current with the same size and the same duration is introduced, the deformable part 22 can obtain larger deformation, the deformable part 22 can be more efficiently changed from the first state to the second state, the separation efficiency of the active separation module 20 and the far-end module 10 is improved, and the whole operation time is shortened.

In some embodiments, the connecting member 11 is detachably fitted to the insertion hole 21a by insertion, the connecting member 11 is provided with a fitting portion, the deformable member 22 is provided with a stopper portion, the stopper portion is fitted to the fitting portion to restrict the connecting member 11 from exiting the insertion hole 21a when the deformable member 22 is in the first state, and the stopper portion is released from fitting with the fitting portion to allow the connecting member 11 to exit the insertion hole 21a when the deformable member 22 is in the second state.

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

For example, as shown in fig. 3 and 4, the limiting portion includes a limiting pin 221, the matching portion includes a pin hole 11a, and the limiting pin 221 is matched with the pin hole 11 a.

As shown in fig. 3, when the deformable member 22 is in the first state, the limiting pin 221 is inserted into the pin hole 11a, so that the connecting member 11 cannot be withdrawn from the insertion hole 21a, i.e. the connecting member 11 is limited to the insertion hole 21a, and the active separation module 20 and the remote module 10 are kept connected. As shown in fig. 4, when the deformable member 22 changes from the first state to the second state, the limiting pin 221 moves away from the pin hole 11a relative to the connecting member 11, and then the limiting pin 221 releases the limitation on the connecting member 11, so that the connecting member 11 can move relative to the releasing assembly 21 to exit from the insertion hole 21a, thereby releasing the active separation module 20 from the distal module 10, so as to subsequently move the active separation module 20 out of the body, and reduce the adverse effect caused by the useless leadless pacemaker 100 remaining in the body.

In other embodiments, as shown in fig. 5 and 6, the limiting portion includes a clamp 222, and the engaging portion includes a groove 11b that engages with the clamp 222. In some embodiments, the connecting member 11 has a cylindrical shape, and the groove 11 is opened on the circumferential side of the connecting member 11.

When the deformable member 22 is deformed by electricity, the clamp 222 on the deformable member 22 moves relative to the connecting member 11 to change the state of engagement with the groove 11b, thereby changing the effect of the deformable member 22 on the connecting member 11 in the first state and the second state.

Specifically, as shown in fig. 5, when the deformable element 22 is in the first state, the clamp 222 is clamped in the groove 11b, and at this time, the connecting element 11 cannot be withdrawn from the insertion hole 21a under the limit of the fit between the clamp 222 and the groove 11b. 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 away from the groove 11b to release the position of the connecting member 11, so that the connecting member 11 can be withdrawn from the insertion hole 21a, and thus the active separation module 20 is released from the remote module 10, so that the active separation module 20 can be moved out of the body later, and the unwanted effect caused by the useless leadless pacemaker 100 remaining in the body is reduced.

It should be noted that the structures of the deformable element 22 and the connecting element 11 are not limited to the above, for example, in some other embodiments, as shown in fig. 7 and 8, the connecting element 11 is snap-connected with the insertion hole 21a, and for convenience of viewing the snap-connection structure between the connecting element 11 and the insertion hole 21a, the deformable element 22 on one side is omitted in fig. 7 and 8.

In this embodiment, the connecting member 11 is provided with a locking portion 11c, and when the deformable member 22 changes from the first state to the second state, the locking portion 11c is driven to move relative to the insertion hole 21a, and the locking connection between the connecting member 11 and the insertion hole 21a is released.

Specifically, when the deformable member 22 is in the first state, as shown in fig. 7, the snap portion 11c remains in snap connection with the insertion hole 21a, and at this time, the release member 21 remains connected with the remote module 10. When the deformable element 22 is electrically deformed, the deformable element 22 gradually enters the second state from the first state, and as shown in fig. 8, as the deformable element 22 is electrically deformed to be in the second state, the deformable element 22 generates a traction force on the latching portion 11c, so that the latching portion 11c moves to a position where it can be withdrawn from the insertion hole 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 separate from the remote module 10 and finally move out of the body.

Further, one end of the deformable element 22 is connected to the releasing component 21, and the other end has a collar 223, the collar 223 is sleeved on the fastening portion 11c, when the deformable element 22 is deformed by electricity, the collar 223 drives the fastening portion 11c to move so that the fastening portion 11c can exit from the insertion hole 21a.

In the embodiment in which the connector 11 is snap-fitted to the insertion hole 21a, the collar 223 does not need to be provided on the deformable member 22, and the deformable member 22 may be deformed by applying a pushing force or a pulling force so that the snap-fit portion 11c moves relative to the insertion hole 21a to be able to be withdrawn from the insertion hole 21a.

As shown in connection with fig. 9, in some embodiments, active separation module 20 includes an enclosure housing 23, a battery 24, and an electrical assembly 25.

The battery 24 and the electrical component 25 are disposed in the package housing 23, and the electrical component 25 is used for electrically connecting the battery 24 and the deformable member 22. Specifically, the electrical component 25 is in signal connection with the external device 200, and when the electrical component 25 receives a release signal of the external device 200, the electrical component 25 energizes the deformable member 22 to change from the first state to the second state, so that the connection member 11 and the jack 21a are released from the limit, so as to actively separate the module 20 from the remote 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 supply power, and the deformable member 22 can be controlled by the signal connection between the electrical component 25 and the external device 200, which is very convenient and safe.

In one embodiment, for example, when the battery 24 is exhausted quickly, in order to avoid the adverse effect caused by the whole leadless pacemaker 100 remaining in the body, the electrical component 25 may be used to transmit the electrical energy of the battery 24 to the deformable member 22, that is, the battery 24 supplies current to the deformable member 22, so that the deformable member 22 deforms, and finally the deformable member 22 enters the second state from the first state, so as to release the connection between the remote module 10 and the active separation module 20, thereby adapting to the need for the active separation module 20 to leave the remote module 10.

With continued reference 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 electrode and the negative electrode of the battery 24, so as to electrically connect the electrical assembly 25 and the battery 24.

Referring to fig. 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 are respectively connected to the first connection end 201 and the second connection end 202, so that the electrical assembly 25 can control the electrical paths 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 assembly 25 receives a signal from the external device 200, and then the electrical paths between the battery 24 and the deformable member 22 are conducted, so that the battery 24 outputs current to the deformable member 22, and thus the deformable member 22 deforms after being powered, and changes from the first state to the second state, and finally the active separation module 20 is released from the remote module 10, so that the active separation module 20 is subsequently removed from the body, and adverse effects caused by remaining in the body are avoided.

It should be noted that the number of the deformable members 22 may be one, or may also be 2 or more than 2, and specifically, the number of the deformable members 22 may be configured according to actual needs. For example, in some embodiments, the release element 21 and the remote module 10 have 2 sets of insertion holes 21a and connection elements 11 arranged in one-to-one correspondence, and 2 deformable elements 22,2 are arranged in the active separation module 20 and respectively correspond to the 2 insertion holes 21a, so as to respectively and adaptively release the position limitation of the corresponding connection elements 11 and insertion holes 21a by using the 2 deformable elements 22. Of course, in this embodiment, a synchronizing structure may be provided for 1 deformable element 22, so that the requirement of releasing the limit of the connector 11 and the insertion hole 21a provided correspondingly to 2 sets can be satisfied by 1 deformable element 22. The number of the insertion holes 21a of the release member 21 and the number of the connection members 11 of the remote module 10 are not limited thereto.

As shown in connection with fig. 11, the release assembly 21 includes a first enclosure 211, a mount 212, and a second enclosure 213.

The first package member 211 is connected to the package housing 23, the insertion hole 21a is opened in the first package member 211, the second package member 213 is connected to the first package member 211, the mounting seat 212 is connected between the first package member 211 and the second package member 213, and the deformable member 22 is mounted on the mounting seat 212, so that the deformable member 22 on the mounting seat 212 is packaged and fixed by the first package member 211 and the second package member 213, thereby facilitating assembly as an assembly and improving manufacturing efficiency.

In this embodiment, the mounting 212 provides a mounting point for the deformable member 22. For example, as shown in fig. 12, a mounting post 212a is formed on the mounting seat 212, a mounting hole 22a is formed at one end of the deformable member 22, and the mounting post 212a is engaged with the mounting hole 22a (see fig. 8), so that the deformable member 22 is stably connected with the mounting seat 212.

In some embodiments, the mounting base 212 may be welded or snapped to the first package 211 or the second package 213, and the mounting manner of the mounting base 212 in the space enclosed by the first package 211 and the second package 213 is not limited herein.

The mounting base 212 may be made of an insulating material having biocompatibility, such as polyetheretherketone.

The second encapsulating member 213 is hermetically connected with the first electrical connector 26, specifically, the second encapsulating member 213 is hermetically sealed with the inner wall of the encapsulating housing 23, and the first electrical connector 26 is hermetically connected with the second encapsulating member 213, so that the encapsulating housing 23 is in a sealed state to protect the battery 24 and the electrical component 25 in the encapsulating housing 23.

As shown in connection with fig. 12, the deformable element 22 is connected to the electrical assembly 25 by means of a first electrical connector 26. One end 261 of the first electrical connector 26 is connected with the electrical component 25, and the other end 262 of the first electrical connector 26 is connected with the deformable member 22, so that the deformable member 22 is electrically connected with the electrical component 25.

In the embodiment in which the active separation module 20 is provided with 2 deformable members 22, the first electrical connection 26 comprises 4 wires, so as to connect the electrical component 25 and the 2 deformable members 22 respectively, with 4 wires, in particular 2 wires for connecting one of the 2 deformable members 22 and 2 wires for connecting the other deformable member 22. Thus, after the 4 guide wires are correspondingly connected with the 2 deformable parts 22, the deformable parts 22 and the electrical components 25 can be electrically connected respectively.

The first sealing member 211 includes a vent (not shown) to allow air, saline, blood, etc. to enter a space formed between the first sealing member 211 and the second sealing member 213, thereby preventing the deformable member 22 from being heated too high due to heat not being released when the deformable member is in the power-on state.

It should be noted that in this embodiment, the conducting wire, the deformable member 22 and the connection portion of the two can be insulated and protected to prevent the electric energy from being released into the liquid between the first packaging member 211 and the second packaging member 213, so as to improve the utilization rate of the electric energy and avoid short circuit. The manner of insulation protection includes, but is not limited to, applying a parylene coating. The remaining locations in the space formed by the first and

second encapsulants

211 and 213 may also be protected from insulation prior to encapsulation.

In some embodiments, as shown in connection with fig. 12, the distal module 10 is provided with a head electrode 12 and a fixation assembly 13, the fixation assembly 13 being used to be fixed to the body and bring the head electrode 12 into contact with the body. The fixing member 13 may be a spiral fixing member, or may be a fixing structure having an anchor, as long as it can be stably fixed to the body, and the structure of the fixing member 13 is not limited herein.

The second package 213 is hermetically connected with a second electrical connector 27, one end 271 of the second electrical connector 27 is connected with the electrical component 25, and the other end 272 of the second electrical connector 27 extends out of the first package 211 and is used for electrically contacting with the head electrode 12 (see fig. 2). The contact manner between the second electrical connector 27 and the head electrode 12 may be different contact manners, such as end surface contact, tapered surface contact, or spherical surface contact, as long as the two are in electrical contact, and is not limited herein.

It should be noted that the first electrical connector 26 and the second electrical connector 27 may be feedthroughs, where feedthroughs refer to electrical feedthroughs, which are electrical connectors that include a wire, an insulating portion, and an outer metal portion to facilitate a sealed installation, and which are used for communication connections and have a certain interference resistance.

The first electrical connector 26 and the second electrical connector 27 may be mounted in the manner shown in fig. 12, that is, the second package 213 is provided with a first through hole and a second through hole, the first electrical connector 26 and the second electrical connector 27 are inserted through the first through hole and the second through hole and are sealed, and the sealed structure may be a sealing ring or a sealant, which is not limited herein.

It should be noted that the mounting manner of the first electrical connector 26 and the second electrical connector 27 on the second package member 213 is not limited to the mounting manner shown in fig. 12, and in some embodiments, when the first electrical connector 26 and the second electrical connector 27 adopt a feedthrough, the wires of them may be all separated, or may be all packaged together to form an integral feedthrough. The feedthrough may be an off-the-shelf component, such as a Pfeiffer Vacuum electrical feedthrough, or may be a sealed assembly of wires, insulating materials, and conductive materials, without limitation.

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

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

Claims

1. An active detachment module of a leadless pacemaker, wherein the active detachment module is adapted to detachably connect to a distal module of the leadless pacemaker, the active detachment module comprising:

the deformable piece, with the release subassembly is connected, the deformable piece is used for changing to the second state by first state when the circular telegram, wherein, works as when the deformable piece is in the first state, the connecting piece spacing in the jack is so that the initiative separation module with distal end module keeps connecting, works as when the deformable piece is in the second state, the deformable piece is relieved the connecting piece with the spacing of jack, so that the connecting piece can withdraw from the jack, thereby the disconnection the initiative separation module with the connection of distal end module.

2. The active separation module of claim 1, wherein the deformable member comprises a shape memory alloy wire or a spring member made of a shape memory alloy material.

3. A leadless pacemaker comprising a remote module and an active separation module according to claim 1 or 2.

4. The leadless pacemaker of claim 3, wherein said connector detachably engages with said receptacle, said connector is provided with an engaging portion, said deformable member is provided with a position-limiting portion, said position-limiting portion engages with said engaging portion when said deformable member is in the first state to limit said connector from exiting said receptacle, and said position-limiting portion disengages from said engaging portion when said deformable member is in the second state to allow said connector to exit said receptacle.

5. The leadless pacemaker of claim 4, wherein the limiting portion comprises a clamp, the engaging portion comprises a groove for engaging with the clamp, the clamp engages with the groove when the deformable member is in the first state, and the clamp moves away from the groove relative to the connecting member when the deformable member changes from the first state to the second state.

6. The leadless pacemaker of claim 4, wherein the retention portion comprises a retention pin and the engagement portion comprises a pin hole, wherein the retention pin is inserted into the pin hole when the deformable member is in the first state, and wherein the retention pin moves away from the pin hole relative to the connector when the deformable member changes from the first state to the second state.

7. The leadless pacemaker of claim 3, wherein the connector is snap-fitted to the receptacle, and the connector is provided with a snap-fit portion, such that when the deformable member changes from the first state to the second state, the snap-fit portion is urged to move relative to the receptacle, thereby releasing the snap-fit connection between the connector and the receptacle.

8. The leadless pacemaker of claim 7, wherein one end of the deformable member is connected to the release element, and the other end of the deformable member has a collar, the collar is sleeved on the latching portion, and when the deformable member is deformed by power-on, the collar drives the latching portion to move so that the latching portion exits the insertion hole.

9. The leadless pacemaker of claim of any of claims 3-8, wherein said active detachment module comprises an encapsulating housing, a battery and an electrical component, said battery and said electrical component disposed within said encapsulating housing, said electrical component for electrically connecting said battery to said deformable member, said electrical component in signal communication with an external device, said electrical component energizing said deformable member when said electrical component receives a release signal from the external device.

10. The leadless pacemaker of claim 9, wherein the distal module is provided with a head electrode and a fixation assembly for fixation to and contacting the head electrode with a body, the second package has a second electrical connector hermetically connected thereto, one end of the second electrical connector is connected to the electrical assembly, and the other end of the second electrical connector protrudes out of the first package and is for electrical contact with the head electrode.