WO2021121412A1 - 无导线起搏器及其尾端部件与头端部件 - Google Patents

无导线起搏器及其尾端部件与头端部件 Download PDF

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Publication number
WO2021121412A1
WO2021121412A1 PCT/CN2020/137797 CN2020137797W WO2021121412A1 WO 2021121412 A1 WO2021121412 A1 WO 2021121412A1 CN 2020137797 W CN2020137797 W CN 2020137797W WO 2021121412 A1 WO2021121412 A1 WO 2021121412A1
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WO
WIPO (PCT)
Prior art keywords
end part
leadless pacemaker
head end
connecting piece
tail end
Prior art date
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PCT/CN2020/137797
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English (en)
French (fr)
Inventor
孙江凯
杨莹
程志军
Original Assignee
创领心律管理医疗器械（上海）有限公司
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Application filed by 创领心律管理医疗器械（上海）有限公司 filed Critical 创领心律管理医疗器械（上海）有限公司
Priority to EP20903276.2A priority Critical patent/EP4079370A4/en
Priority to US17/786,748 priority patent/US20230050125A1/en
Publication of WO2021121412A1 publication Critical patent/WO2021121412A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37205—Microstimulators, e.g. implantable through a cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37512—Pacemakers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37518—Anchoring of the implants, e.g. fixation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3758—Packaging of the components within the casing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a leadless pacemaker and its tail end part and head end part.
  • cardiac pacemakers Since the advent of cardiac pacemakers in 1958, they have become the first-line treatment for bradyarrhythmias. After more than half a century of development and innovation, the implantation technology of cardiac pacemakers has evolved from the initial thoracic implantation of a single lead to pacing the ventricle, and gradually develops the implantation of 2 to 3 leads through the vein to provide atrioventricular physiological pacing. Pacing or even synchronized pacing of both ventricles. However, lead dislocation, thrombosis, tricuspid regurgitation, and infection and lead-related complications have not only affected the normal use of pacemakers, but also seriously endangered patients' health and quality of life.
  • the lead when the infection is related to the complications of the lead, the lead should be removed as soon as possible, but the removal of the lead has a certain degree of difficulty and risk. This work usually needs to be completed by a skilled doctor in a larger electrophysiology center. This is a resource The workload of use and doctors is relatively large.
  • the "wireless" pacemaker In order to overcome the above-mentioned problems caused by the use of wires, the "wireless" pacemaker has become a new development direction in the treatment of arrhythmia.
  • leadless pacemakers have a limited service life. For example, when the power supply runs out and/or the processing circuit needs to be updated, it is best to remove the entire pacemaker from the heart. However, for a long period of time after implantation of the leadless pacemaker (in the chronic period), due to the adhesion or wrapping of myocardial tissue, the leadless pacemaker cannot be taken out 100% during the chronic period of implantation.
  • the removal of the entire pacemaker is difficult and may damage the surrounding heart and/or blood vessel tissue, and in some cases the removal may even tear the myocardium
  • the tissue, especially in the chronic phase after implantation, is more difficult to remove because part or all of the pacemaker is wrapped by the tissue.
  • the purpose of the present invention is to provide a leadless pacemaker and its tail end part and head end part, which can realize the separation of the tail end part and the head end part more conveniently, thereby reducing the difficulty of taking out the leadless pacemaker.
  • the present invention provides a tail end part of a leadless pacemaker for use with the head end part of a leadless pacemaker.
  • the tail end part includes a first connector and Second connecting piece
  • the first connecting piece is used for detachably connecting with the head end part, while the second connecting piece is used for being non-detachably or detachably connected with the head end part to realize the tail end part Locking with the head end part; wherein: the first connection piece is not biodegradable, the second connection piece is biodegradable, or the second connection piece and the head end piece are through biodegradable Corresponding connectors are connected together.
  • the second connector is used for snap connection or pin connection with the head end part.
  • the second connector in the tail end part of the leadless pacemaker, includes a pin hole, and the pin hole is aligned with the pin hole of the head end part and used for biodegradable The positioning pin is inserted.
  • the second connector in the tail end part of the leadless pacemaker, includes a positioning slot, and the positioning slot is used to engage with a protruding engaging part of the head end part;
  • the second connecting member includes a protruding engaging member, the protruding engaging member is made of a biodegradable material, and the protruding engaging member is used to engage with the positioning slot of the head end member And is configured to begin to degrade when the leadless pacemaker is implanted in the body for a predetermined time.
  • the first connector is used for threaded connection, snap connection or interference fit connection with the head end part.
  • the first connector in the tail end part of the leadless pacemaker, includes a guide groove, and the guide groove is used to fit the guide post of the head end part; or, the first connector A connecting piece includes a guide post which is used to fit the guide groove of the head end part.
  • the guide groove has an internal thread, or the guide post has an external thread.
  • the first connector in the tail end part of the leadless pacemaker, includes a positioning slot, and the positioning slot is used to engage with a protruding engaging part of the head end part;
  • the first connecting member includes a protruding engaging member, and the protruding engaging member is used to engage with the positioning slot of the head end component.
  • the tail part includes a first part and a second part, the first part includes a main body part and a recessed part, and the second part sleeve Is arranged on the recessed portion; wherein: the second connecting piece is arranged on the second component, and the second connecting piece and/or the second component are biodegradable.
  • the outer diameter of the second part is consistent with the outer diameter of the main body part.
  • the present invention also provides a head-end part of a leadless pacemaker, which is used in conjunction with the tail part of a leadless pacemaker, and the head-end part includes a third connection. Pieces and the fourth connecting piece;
  • the third connecting piece is used for detachably connecting with the tail end part, while the fourth connecting piece is used for non-detachably or detachably connecting with the tail end part to realize the tail end part Locking with the head end part; wherein: the third connection piece is not biodegradable, the fourth connection piece is biodegradable, or the fourth connection piece and the tail end piece are through biodegradable Corresponding connectors are connected together.
  • the fourth connector is used for snap connection or pin connection with the tail end part.
  • the fourth connector includes a pin hole, and the pin hole is aligned with the pin hole of the tail end part and is used for biodegradable The positioning pin is inserted.
  • the fourth connector in the head end part of the leadless pacemaker, includes a positioning slot, and the positioning slot is used to engage with a protruding engaging part of the tail end part;
  • the fourth connecting member includes a protruding engaging member, the protruding engaging member is made of a biodegradable material, and the protruding engaging member is used to engage with the positioning slot of the tail end member And is configured to begin to degrade when the leadless pacemaker is implanted in the body for a predetermined time.
  • the third connector is used for threaded connection, snap connection or interference fit connection with the tail end part.
  • the third connecting member includes a guide groove, and the guide groove is used to fit the guide post of the tail end part; or, the first The three-connector includes a guide post, which is used to fit the guide groove of the tail end part.
  • the guide groove has an internal thread; or the guide post has an external thread.
  • the third connecting member includes a positioning slot, and the positioning card slot is used to engage with a protruding engaging member of the tail end member;
  • the third connecting member includes a protruding engaging member, and the protruding engaging member is used to engage with the positioning slot of the tail end component.
  • the present invention provides a leadless pacemaker, including:
  • the end part includes a first connecting piece and a second connecting piece
  • a head end member for fixing to a predetermined object including a third connecting member and a fourth connecting member;
  • the first connecting piece and the third connecting piece are detachably connected, while the second connecting piece and the fourth connecting piece are non-detachably or detachably connected, so as to realize the connection between the end part and the The locking between the head end parts; wherein: the first connection piece and the third connection piece are not biodegradable; the second connection piece and/or the fourth connection piece are biodegradable, or the first connection piece
  • the two connecting pieces are connected to the fourth connecting piece through a biodegradable corresponding connecting piece.
  • the first connector is threadedly connected with the third connector
  • the second connector is snap-connected with the fourth connector
  • One of the two connecting pieces and the fourth connecting piece includes a positioning slot
  • the other of the second connecting piece and the fourth connecting piece includes a protruding engagement piece
  • the positioning slot is ring-shaped Set up.
  • the second connector and the fourth connector respectively include pin holes, and the pin holes of the tail end member and the pin holes of the head end member Alignment;
  • the biodegradable corresponding connector includes a positioning pin, the positioning pin is inserted in the pin hole of the tail end part and the pin hole of the head end part, and the positioning pin is configured to The leadless pacemaker begins to degrade after being implanted in the body for a predetermined time.
  • the leadless pacemaker is designed into two parts, namely the tail end part and the head end part, and the two parts are implanted After entering the body, it can be separated, thereby facilitating the implantation, repositioning, removal and replacement of the leadless pacemaker.
  • the first connecting piece and the second connecting piece of the caudal end component are respectively mated and connected with the third connecting piece, that is, the fourth connecting piece of the head end component, so that the entire leadless pacemaker can be easily implanted In vivo, and facilitates repositioning at improper implant position.
  • part of the leadless pacemaker will be wrapped in tissue.
  • the second connector of the tail end member, the fourth connector of the head end member, or the corresponding connector for connecting the second connector and the fourth connector are biodegraded.
  • the first connector is operated Separating from the third connecting piece can realize the separation of the tail end part and the head end part.
  • a new leadless pacemaker is implanted in the space of the project.
  • Fig. 1 is an assembly diagram of a leadless pacemaker provided by the first embodiment of the present invention
  • FIG. 2 is a schematic structural diagram of a tail end part provided by Embodiment 1 of the present invention.
  • Fig. 3a is a schematic structural diagram of a head end component provided in the first embodiment of the present invention.
  • Figure 3b is an axial cross-sectional view of the head end component provided in the first embodiment of the present invention without the guide groove;
  • Fig. 3c is a schematic structural view of the head end part provided by the first embodiment of the present invention without the guide groove;
  • Figure 4 is an assembly diagram of the leadless pacemaker provided in the second embodiment of the present invention.
  • Figure 5a is a schematic structural diagram of a tail end part of the second embodiment of the present invention, wherein the tail end part is provided with a guide post;
  • Figure 5b is a schematic structural view of the tail end component provided in the second embodiment of the present invention without the guide post;
  • Fig. 6a is a schematic structural diagram of a head end part provided by a second embodiment of the present invention, wherein the head end part is provided with a guide groove;
  • Figure 6b is a schematic structural diagram of the head end part provided in the second embodiment of the present invention without the guide groove;
  • Figure 7a is a schematic diagram of the assembly of the leadless pacemaker provided in the third embodiment of the present invention.
  • Figure 7b is an axial cross-sectional view of the leadless pacemaker provided by the third embodiment of the present invention.
  • Fig. 8a is a schematic structural diagram of the first part of the tail end part according to the third embodiment of the present invention.
  • Fig. 8b is a schematic structural view of the second part of the tail end part according to the third embodiment of the present invention.
  • FIG. 8c is a schematic diagram of the first component provided in another preferred example of Embodiment 3 of the present invention.
  • Figure 9 is an axial cross-sectional view of the head end part provided by the third embodiment of the present invention.
  • Fig. 10 is a schematic diagram of removing the tail part in the chronic phase provided by an embodiment of the present invention.
  • proximal end and distal end refer to the relative orientation, relative position, and relative position of elements or actions relative to each other from the perspective of the doctor using the medical device.
  • proximal and distal are not restrictive, “proximal” and “head” usually refer to the end of the medical device that is close to the doctor during normal operation, while “distal” and “distal” “Caudal end” usually refers to the end that enters the patient's body first.
  • the present invention is mainly to provide a leadless pacemaker, which includes a tail end part and a head end part; the tail end part includes a first connector and a second connector, and the head end part includes a third connector and a fourth connector;
  • the first connecting piece is used to detachably connect with the third connecting piece, while the second connecting piece is used to detachably or non-detachably connect with the fourth connecting piece to realize the tail
  • the locking between the end part and the head end part; and the first connection piece and the third connection piece are not biodegradable; at least one of the second connection piece and the fourth connection piece is biodegradable Degradable, or the second connecting piece and the fourth connecting piece are matedly connected through a biodegradable corresponding connecting piece.
  • the tail end part and the head end part are first assembled outside the body, and the two are fixedly connected together by four connectors, and then the delivery device is used to deliver the entire leadless pacemaker to the body .
  • the leadless pacemaker of the present invention is implanted in the body, it is mainly divided into the following two situations:
  • the first situation is: the position of the leadless pacemaker needs to be changed during the implantation process, or the leadless pacemaker needs to be taken out in the acute phase (such as within 6 months of implantation). At this time, the delivery device can be used to operate the entire wireless pacemaker.
  • Wire pacemakers can adjust the position of the leadless pacemaker or take it out as a whole by separating the head part from the myocardial tissue; in this case, one or both of the second connector and the fourth connector are biodegradable Or the biodegradable corresponding connector used to connect the second connector and the fourth connector has not yet begun to degrade, so the leadless pacemaker is in a fixed state, and the tail part and the head part will not be separated , So it is convenient to take out or adjust the leadless pacemaker as a whole;
  • the second situation is: postoperative chronic phase (such as 6 months after implantation), one or both of the second connector and the fourth connector are biodegradable or used to connect the second connector and the fourth connector
  • the biodegradable corresponding connecting parts of the parts begin to degrade, and the locking of the tail end part and the head end part is released over time, and the head end part can be fixed by the conveying device to keep the head end part stationary and reused
  • the conveying device operates the end part to separate the end part from the head end part. At this time, the end part can be taken out separately while the head end part remains in the heart; in this case, the conveying can be reused if necessary later.
  • the device implants the new tail part into the body and repositions and cooperates with the old head part, so as to realize the replacement of the leadless pacemaker, or the entire new leadless pacemaker can also be implanted in the body for replacement.
  • the above-mentioned operation can reduce the difficulty of taking out the leadless pacemaker, especially in the chronic phase, and can also reduce the damage to the surrounding heart and/or blood vessel tissues and improve the safety of the operation. It should be known that in the chronic phase, part or even the whole of the leadless pacemaker will be wrapped in tissue. If the whole leadless pacemaker needs to be taken out, it is very difficult and easy to damage the tissue. For this reason, only consider taking it out. The tail-end components and the smaller-volume head-end components are kept in the body, which will cause less damage to the tissues, and the parts that cannot be removed will not occupy a large space in the body, which is convenient for the subsequent implantation of new non-wireless cables. Pacemaker.
  • the difficulty of separating the tail end part and the head end part can be reduced, thereby reducing the difficulty of taking out the leadless pacemaker.
  • the unlocking process does not require excessive mechanical force, As a result, the damage to the surrounding heart and/or blood vessel tissues during the separation process is small, so the safety of removal is higher.
  • Fig. 1 is an assembly diagram of the leadless pacemaker provided in the first embodiment of the present invention.
  • an embodiment of the present invention provides a leadless pacemaker 100, which includes a tail end part 1 and a head end part 2. The two parts are assembled together by related connectors.
  • the end component 1 preferably includes various electronic components (for example, electronic components are configured in the dashed frame shown in FIG. 1), and the electronic components include, but are not limited to, a pulse generator, a power supply, a memory, a processor, and a sensing circuit. Wait.
  • the electronic components of the pacemaker are technologies well known to those skilled in the art, they will not be described in detail here.
  • the head part 2 is used for fixation with myocardial tissue, and the fixation method is not limited.
  • FIG. 2 is a schematic structural diagram of a tail end component provided in Embodiment 1 of the present invention
  • FIG. 3a is a schematic structural diagram of a head end component provided in Embodiment 1 of the present invention.
  • the end component 1 includes a first body 11, which is actually a shell, and the shell is used for accommodating various electronic components.
  • the head end part 2 includes a second body 21, which can be but is not limited to a housing; the head end part 2 also includes a fixing mechanism 22, which is arranged at the distal end of the second body 21 It is used for fixation with myocardial tissue, but the present invention does not impose special restrictions on the structure of the fixation mechanism 22.
  • the fixation mechanism 22 is not limited to the spiral structure shown in the figure, and may also be wing-shaped or other structures.
  • the end member 1 further includes a first connecting piece 12 and a second connecting piece 13 arranged on the first body 11.
  • the first connecting member 12 includes a guide post 121, which is arranged at the distal end of the first body 11, preferably at the center of the distal end; at the same time, the second connecting member 13 includes a protruding engaging member, which protrudes
  • the engaging member is preferably an elastic buckle 131, the elastic buckle 131 is disposed on the outer wall of the first body 11 and extends outward, and the extension direction is preferably perpendicular to the axis of the first body 11.
  • the head end member 2 further includes a third connecting member 23 and a fourth connecting member 24 arranged on the second body 21.
  • the second body 21 has an inner cavity 25 that opens toward the proximal end
  • the third connecting member 23 includes a guide groove 231 that is provided in the center of the bottom (ie, the distal end) of the inner cavity 25; and the fourth The connecting member 24 includes a positioning slot 241, and the positioning slot 241 is opened on the side wall of the inner cavity 25.
  • the elastic buckle 131 is elastically engaged with the positioning slot 241, and the guide post 121 is at the same time It is matched with the guide groove 231, such as an interference connection or a snap connection, so that the tail end part 1 and the head end part 2 are firmly locked.
  • the elastic buckle 131 is not limited to being provided on the outer wall of the first body 11, but can also be provided on the inner wall of the first body 11, for example, similar to the second body 21, a cavity is opened at the distal end of the first body 11, and An elastic buckle 131 is provided on the side wall of the cavity.
  • the positioning slot 241 is not limited to being provided on the side wall of the inner cavity 25 of the second body 21, and can also be similar to the first body 11 and the second body
  • An inwardly recessed positioning slot 241 is provided on the outer wall of 21, and the locking can be achieved by inserting the proximal end of the head end part 2 into the cavity. Therefore, the present invention does not limit the position of the elastic buckle 131 on the first body 11, and similarly does not limit the position of the positioning slot 241 on the second body 21.
  • the second connecting member 13 includes a positioning slot
  • the corresponding fourth connecting member includes a protruding engaging member
  • an elastic buckle 131 is provided on the second body 21
  • the positioning slot 241 is provided on the first body 11. Therefore, as long as one of the first body 11 and the second body 21 is provided with an elastic buckle 131, and the other is provided with a positioning slot 241 that cooperates with the elastic buckle 131, those skilled in the art can adapt the configuration.
  • the first connecting member 12 includes a guide groove 231
  • the third connecting member 23 includes a guide post 121.
  • the guide post 121 may be disposed on the second body 21, and the guide groove 231 is disposed on the second body 21.
  • One body 11 on. As long as one of the first body 11 and the second body 21 is provided with a guide post 121, and the other is provided with a guide groove 231 matched with the guide post 121.
  • the arrangement of the guide post 121 on the second body 21 is basically the same as the arrangement on the first body 11, the difference is that a guide post is provided at the proximal end of the second body 21, and a guide groove is also provided in the first body 11. remote.
  • the connecting force between the guide post 121 and the guide groove 231 needs to be greater than the weight of the tail end member 1, so that when the second connecting piece 13 and the fourth connecting piece 24 are biodegraded and lose their binding force, the guide post The 121 and the guide groove 231 can be separated only when subjected to an external force, so as to ensure the reliability of the connection.
  • the guide post 121 and the guide groove 231 form an electrical connection while mating, so that the end part 1 and the head end part 2 can realize the transmission of electric signals and energy.
  • the guide post 121 and the guide groove 231 may also be non-conductive, and the transmission of electrical signals and energy between the tail end part 1 and the head end part 2 can be realized by other means, for example, the elastic buckle 131 and the positioning slot 241 are engaged with each other.
  • the same effect can be achieved by directly forming electrical connections.
  • connecting electrodes are provided at positions corresponding to the inner cavity 25 and the first body 11, and the tail end member 1 and the head end member 2 are electrically connected through the connecting electrodes.
  • the elastic buckle 131 and the guide post 121 on the first body 11, and the positioning slot 241 and the guide groove 231 on the second body 21 are used as an illustration to further explain the structure and use of the leadless pacemaker 100
  • those skilled in the art should be able to modify the following description and apply it to the case where the elastic buckle 131 and the guide post 121 are provided on the second body 21, and the positioning slot 241 and the guide groove 231 are provided on the first body 11.
  • the elastic buckle 131 is disposed on the outer wall of the first body 11, at least one; preferably two and symmetrically distributed with respect to the axis of the first body 11. It should be known that the elastic buckle 131 can be elastically deformed, and it can shrink when subjected to an external force to separate or engage with the positioning slot 241 to achieve locking or unlocking. Therefore, the elastic buckle is convenient to use and has good connection reliability. .
  • the positioning slot 241 is provided on the inner cavity 25 of the second body 21, at least one; preferably two and symmetrically distributed about the axis of the second body 21.
  • the tail end part 1 and the head end part 2 can be locked.
  • the guide post 121 and the guide groove 231 it can further ensure that after the elastic buckle 131 is degraded, the tail end part 1 and the head end part 2 can be kept locked and the tail end part 1 will not loosen. There is a risk.
  • the elastic buckle 131 is made of a biodegradable material, so that it begins to degrade in the chronic phase after the operation, and after the degradation is completed, since the guide post 121 and the guide groove 231 are still in mating connection,
  • the end part 1 and the head end part 2 can be separated, and the end part 1 can be taken out; but before the elastic buckle 131 is degraded, Since the entire leadless pacemaker 100 is still in a fixed state, the leadless pacemaker 100 can be taken out or adjusted as a whole at this time.
  • the elastic buckle 131 includes a cylinder, the cylinder is more preferably a cylinder and is connected to the outer wall of the first body 11, and the top surface of the cylinder is preferably a circular arc surface.
  • the circular arc surface helps the elastic buckle 131 to receive a better force in the radial direction, so that it is better deformed in the radial direction, which facilitates the locking and unlocking of the elastic buckle 131, and at the same time, it will not move after being forced in the axial direction. High connection reliability.
  • one end of the positioning slot 241 is preferably provided with a guiding inclined surface 242.
  • the guiding inclined surface 242 is preferably an arc surface (for example, a circular arc surface) and is used for mating contact with the top surface of the elastic buckle 131, thereby reducing The resistance when the elastic buckle 131 is separated or combined with the positioning slot 241.
  • an axially extending guide groove 243 is provided on the end of the guide inclined surface 242 away from the positioning slot 241 for guiding the elastic buckle 131 into the positioning slot 241 along the guide groove 243, so that the assembly is more convenient and the assembly accuracy is more convenient. high.
  • only the guiding inclined surface 242 and the positioning slot 241 may be provided instead of the guiding groove 243.
  • the elastic buckle 131 is constructed as a biological material.
  • the degradable structure When the elastic buckle 131 is biodegraded, the locking of the elastic buckle 131 and the positioning slot 241 is released.
  • the pacemaker is mostly or completely wrapped by tissue, in order to ensure the reliability of use, it is still
  • the guide post 121 is matched with the guide groove 231 to ensure that the tail end member 1 will not loosen, and the doctor can separate the tail end member 1 from the head end member 2 by operating the tail end member 1 with the delivery device, and then separate the tail end member 1 from the head end member 2
  • the end piece 1 is taken out of the body while leaving the head end piece 2 fixed in the body.
  • the new end member 1 can be re-implanted in the body and can optionally be repositioned and matched with the head end member 2 left in the body, but it is usually difficult to accurately position the old head end member 2 ( Because it is wrapped in tissue), in this case, a new leadless pacemaker 100 can be optionally implanted in the body for overall replacement.
  • the elastic buckle 131 is made of a biodegradable material.
  • the elastic buckle 131 is configured to begin to degrade after the leadless pacemaker 100 is implanted in the body for a predetermined period of time.
  • the leadless pacemaker enters the chronic phase about 6 weeks after implantation in the body, so the elastic buckle 131 is preferably configured to begin to degrade 6 weeks after the leadless pacemaker 100 is implanted in the body, and the degradation is complete.
  • the elastic buckle 131 is completely degraded, that is, when the elastic buckle 131 completely loses its physical properties, at this time, the elastic buckle 131 does not have the function of restricting the positioning slot 241 at all.
  • the degradation time depends on a number of factors, including the molecular weight, crystallinity, hydrophilicity, volume, surface area and environmental factors of the materials used, etc.
  • the specific start and complete degradation time can be determined by those skilled in the art according to their needs. select.
  • the biodegradable material is selected from medical polymer materials, including but not limited to polylactic acid (PLA), polylactic acid (PLLA) or polylactic acid (PDLA), or PLGA (ie L- Random copolymer of lactide and glycolide) or PDLGA (that is, random copolymer of DL-lactide and glycolide).
  • PLA polylactic acid
  • PLLA polylactic acid
  • PDLA polylactic acid
  • PLGA ie L- Random copolymer of lactide and glycolide
  • PDLGA random copolymer of DL-lactide and glycolide
  • the distal end of the second body 21 is also connected with pacing electrodes and/or sensing electrodes.
  • the fixing mechanism 22 may surround the electrode so that the electrode is in the central channel of the spiral structure.
  • the spiral structure is part of the electrode.
  • one or both of the first body 11 and the second body 21 can be provided with a ring of ring electrodes on the outer surface for sensing the myocardial tissue.
  • the proximal end of the first body 11 is preferably provided with a fifth connecting piece 14. As shown in FIG. 2, the fifth connecting piece 14 is used to detachably connect with the shrink sheath in the delivery device to facilitate the passage of the shrink sheath. Operate the tail part and the entire leadless pacemaker.
  • the connection mode of the fifth connecting member 14 and the shrinkable sheath is not limited, for example, a threaded connection or a snap connection can be selected to facilitate quick disassembly and assembly.
  • the guide post and the guide groove can be eliminated.
  • the guide post 121 and the guide groove 231 can be eliminated.
  • at least two sets of elastic buckles can be optionally provided on the first body 11.
  • Each group of elastic buckles includes two symmetrically distributed elastic buckles. Therefore, at least four elastic buckles are distributed on the first body 11 at intervals around the axis, and one group of elastic buckles is configured to be biodegradable, and the other group is configured to be biodegradable.
  • the elastic buckle is not biodegradable.
  • two sets of elastic buckles can be used to lock the tail end part 1 and the head end part 2.
  • one set of elastic buckles degrades, and the other set of elastic buckles keeps the end part 1 and the head end
  • the connection between the end parts 2 needs to be taken out, it is only necessary to fix the head end part 2 by the conveying device, and operate the end part 1 to separate the end part 1 and the head end part 2.
  • the first connecting member and the second connecting member are both elastic buckles, and the third connecting member and the fourth connecting member are both positioning slots; in some embodiments, the first The connecting piece is an elastic buckle, the second connecting piece is a positioning slot, the third connecting piece is a positioning slot, and the fourth connecting piece is an elastic buckle; in some embodiments, the first connecting piece is a positioning slot, and the first connecting piece is a positioning slot.
  • the second connecting piece is an elastic buckle, the third connecting piece is an elastic buckle, and the fourth connecting piece is a positioning slot.
  • first connecting piece and the second connecting piece may both be elastic buckles, or both may be positioning slots, or one of them is an elastic buckle and the other is a positioning slot; similarly, the third connecting piece and the fourth connecting piece
  • the parts can be all elastic buckles, or all locating slots, or one of them is an elastic buckle and the other is a locating slot.
  • the proximal end surface 26 of the second body 21 of the head end member 2 constitutes a limiting portion for positioning the positioning sheath 400 in the delivery device.
  • the proximal end surface 26 is used to abut against the distal end of the positioning sheath 400, thereby limiting the position where the positioning pin tube 400 is advanced distally, so that the positioning sheath 400 only covers the tail end part.
  • the head end part is kept fixed.
  • the outer diameter of the second body 21 of the head end part 2 is larger than the inner diameter of the positioning sheath 400.
  • the structure of the leadless pacemaker 200 provided in this embodiment is basically the same as that of the first embodiment, and only the differences will be described below.
  • Fig. 4 is an assembly diagram of the leadless pacemaker provided in the second embodiment of the present invention.
  • the embodiment of the present invention provides a leadless pacemaker 200, which includes a tail end part 3 and a head end part 4.
  • the two are detachably snap-connected through the first connecting piece 32 and the third connecting piece 42, while the second connecting piece and the fourth connecting piece are matedly connected through a biodegradable corresponding connecting piece.
  • the first The second connecting piece and the fourth connecting piece are connected by a pin.
  • the end member 3 includes a first body 31, and a first connecting piece 32 and a second connecting piece arranged on the first body 31.
  • the first connecting member 32 includes a protruding engaging member, such as a positioning block 321 (that is, a rigid buckle, which is not easily deformed when subjected to force), and the positioning block 321 is provided on the first body 31 on the outer wall and extend outwards, the extension direction is preferably perpendicular to the axis of the first body 31;
  • the second connector includes a pin hole 34, the pin hole 34 is used to align with the pin hole 44 of the head end part , And for inserting positioning pins, and the pin holes 34 are radially penetratingly provided on the outer wall of the first body 31.
  • the head end part 4 includes a second body 41, and a third connecting piece 42 and a fourth connecting piece arranged on the second body 41.
  • the third connecting member 42 includes a positioning slot 421 which is provided on the outer wall of the second body 41 and penetrates radially.
  • the positioning slot 421 also extends along the circumferential direction of the second body 41 so as to It can be locked with the positioning block 321 in the circumferential direction, and at the same time, one end of the positioning slot 421 is opened in the axial direction, so that the positioning block 321 enters the positioning slot 421 through the opening; at the same time, the fourth connecting member includes a pin hole 44, The pin hole 44 is radially penetratingly provided on the outer wall of the second body 41, and the pin hole 44 is used for aligning with the pin hole 34 of the tail end component, and is used for the positioning pin to be inserted.
  • the biodegradable corresponding connector includes a positioning pin for inserting the pin hole 34 of the tail end part 3 and the pin hole 44 of the head end part 4 to lock the tail end part 3 and the head end part 4.
  • the positioning pin is made of a biodegradable material, and the positioning pin is configured to begin to degrade after the leadless pacemaker is implanted in the body for a predetermined time.
  • the distal end of the tail end member 3 is inserted into the inner cavity 25 of the proximal end of the head end member 4, and the positioning block 321 is inserted into the positioning card slot 421 along the opening of the positioning card slot 421 during the insertion process. And rotate the positioning block 321 into the arc-shaped groove of the positioning card slot 421 and lock it. In this way, the displacement of the head end part 4 and the tail end part 3 when rotating in the first direction can be restricted, and then the positioning pin will be inserted.
  • Pin connection is realized in the pin holes 34 and 44 of the tail end part 3 and the head end part 4, so that the displacement of the head end part 4 and the tail end part 3 when rotating in the second direction is restricted by the positioning pin, the first direction and the second direction
  • the direction is a pair of opposite directions. Therefore, by means of the snap connection and the pin connection, the tail end part 3 and the head end part 4 are firmly locked and cannot be separated. The tail end part 3 and the head end part 4 can be separated unless the positioning pin is degraded.
  • the pin holes 34 and 44 are also preferably two each and are symmetrically distributed on the corresponding body.
  • the number of positioning pins is also preferably two.
  • the present invention does not require the number of pin holes, positioning pins, and positioning blocks.
  • the positions of the pin holes 34 and the positioning blocks 321 on the first body 31, and the pin holes 44 and the positioning slots 421 on the second body 41 are not required.
  • the position of is not required, as long as the positioning block 321 does not interfere with the positioning pin when the positioning pin is inserted.
  • the shape of the positioning slot 421 includes but is not limited to an L shape.
  • the molding method of the positioning pin is not required, and it can be injection molded or machined.
  • the positioning slot 421 may be provided on the first body 31 and the positioning block 321 may be provided on the second body 41.
  • the arrangement of the positioning slot 421 on the first body 31 is basically the same as that of the second body 41, and the arrangement of the positioning block 321 on the second body 41 is basically the same as that of the first body 31. It is the same and will not be described in detail here.
  • a guide post 35 is provided at the distal end of the first body 31; at the same time, as shown in Fig. 6a, a guide groove 45 is formed at the bottom of the inner cavity 25 of the second body 41, and the guide post 35 is inserted into the guide The groove 45 forms a mating connection.
  • a guide post is provided at the proximal end of the second body 41, and a guide groove is provided at the distal end of the first body 31 to form a mating connection.
  • the guide post and the guide groove can be eliminated, and the connection can be realized only by the connection of the positioning block 321 and the positioning card slot 421, as shown in FIGS. 5b and 6b.
  • the connection between the guide post 35 and the guide slot 45 or the connection between the positioning block 321 and the positioning slot 421 can be conductive.
  • the tail end part 3 and the head end part 4 are not the same when the leadless pacemaker 200 is operated. Separate. Furthermore, when it is necessary to change the position of the leadless pacemaker 200 or take out the leadless pacemaker 200 in the acute phase, just rotate the leadless pacemaker 200 and wait for the fixing mechanism 22 at the distal end of the head end component 4 to separate from the myocardial tissue. , You can readjust the implant position of the leadless pacemaker or take it out as a whole.
  • the positioning pins are constructed as biodegradable When the positioning pin is completely degraded, the locking of the positioning pin can be released.
  • the positioning block and the positioning card slot are still connected It is snapped to ensure that the tail end part 3 will not fall off, and the doctor can separate the tail end part 3 from the head end part 4 by rotating the tail end part 3 with the conveying device, and then take the tail end part 3 out of the body while keeping the head.
  • the end piece 4 is fixed in the body.
  • the positioning pins are not required, but only the engagement between the positioning block 321 and the positioning card slot 421 is used.
  • the connection is such that the end part 3 and the head end part 4 are connected. Of course, it is better to re-implant the entire new leadless pacemaker.
  • the structure of the leadless pacemaker 300 provided in this embodiment is basically the same as that of the first embodiment, and only the differences will be described below.
  • Figure 7a is a schematic diagram of the assembly of the leadless pacemaker provided in the third embodiment of the present invention
  • Figure 7b is an axial cross-sectional view of the leadless pacemaker provided in the third embodiment of the present invention
  • Figure 8a is provided by the third embodiment of the present invention
  • Fig. 8b is a schematic diagram of the structure of the second part of the end part provided by the third embodiment of the present invention
  • Fig. 8c is a schematic view of the first part provided by another preferred example of the third embodiment of the present invention Schematic diagram
  • FIG. 9 is an axial cross-sectional view of the head end part provided by the third embodiment of the present invention.
  • the third embodiment of the present invention provides a leadless pacemaker 300, which includes a tail end part 5 and a head end part 6, both of which are clamped by a second connector and a fourth connector 63.
  • Buckle connection and at the same time threaded connection with the third connecting piece 62 through the first connecting piece, one of the second connecting piece and the fourth connecting piece 63 includes a positioning slot, the second connecting piece and the The other of the fourth connecting members 63 includes a protruding engaging member, and the positioning slot is arranged in a ring shape.
  • the end member 5 includes a first member 510 and a second member 520.
  • the first member 510 includes a first body 511
  • the first body 511 includes a main body portion 511a and is disposed far away from the main body portion 511a.
  • the outer diameter of the main body part 511a is larger than the outer diameter of the recessed part 511b
  • the second part 520 is directly sleeved on the recessed part 511b; at the same time, the second part 520 is a sleeve structure with two open ends.
  • the outer diameter of the member 520 preferably coincides with the diameter of the main body portion 511a.
  • first connector is provided on the first component 510
  • second connector is provided on the second component 520.
  • first connecting member is a guide post 512
  • guide post 512 has an external thread and is disposed at the distal end of the recessed portion 511b; meanwhile, the second connecting member is an undercut 522.
  • the second component 520 includes a third body 521.
  • the undercut 522 is disposed on the outer wall of the third body 521 and extends outward.
  • the shape of the undercut 522 is not limited, including but not limited to Triangularity, trapezoid, etc. Further, there are at least two undercuts 522 and are preferably distributed symmetrically.
  • the head end part 6 further includes a second body 61, and a third connecting member 62 and a fourth connecting member 63 provided on the second body 61.
  • the third connecting member 62 includes a guide groove 621 threadedly engaged with the guide post 512, and preferably the guide groove 621 is electrically connected to the guide post 512.
  • the fourth connecting member 63 includes a positioning groove 631 engaged with the undercut 522.
  • the positioning groove 631 is a circular groove and is opened on the side wall of the inner cavity 64 at the proximal end.
  • a guide groove is provided at the center of the bottom of the inner cavity 64 621.
  • the second component 520 is first sleeved on the recess of the first component 510, both of which include but are not limited to bonding, welding, hot-melt connection or interference fit, etc., and then The head end part 6 is rotated and sleeved on the second part 520, so that the guide post 512 and the guide groove 621 are screwed and locked, and at the same time, the undercut 522 on the second part 520 is gradually clamped into the positioning card on the head end part 6 The groove is locked until the end part 5 and the head end part 6 are locked finally.
  • the undercut 522 can be separately degraded, but the second part 520 is not degradable; or, both the undercut 522 and the second part 520 are degradable, that is, the second part 520 and the undercut 522 are made of biodegradable materials.
  • the undercut 522 and the second part 520 can be integrally formed so that the whole part can be degraded.
  • the positioning slot can be provided on the second part 520 of the tail end part 5; correspondingly, an undercut is provided on the side wall of the inner cavity 64 of the head end part 6 so as to be in contact with the second part 520 of the end part 5.
  • the positioning slot on the component 520 matches.
  • one or both of the second component 520 and the undercut are degradable.
  • the second component 520 is degradable, it means that the positioning slot is degraded.
  • the undercut loses its position, thereby realizing the unlocking of the second connecting member and the fourth connecting member 63.
  • the undercut 522 and/or the second The component 520 is configured as a biodegradable structure.
  • the undercut lock can be released.
  • the pacemaker is mostly or completely wrapped by tissue, it is necessary to ensure The reliability of use still ensures that the end part 5 will not fall off through the threaded fit of the guide post and the guide groove, and as long as the doctor rotates the end part 5 by the delivery device, the end part 5 and the head end part 6 can be connected. After separating, the tail end member 5 is taken out from the body, and the head end member 6 is retained and fixed in the body.
  • the first component 510 may be integrally formed, or may be assembled from two parts. As shown in FIG. 8c, the first component 510 is assembled from two sub-components, namely the first sub-component 510a and the second sub-component 510b.
  • the second sub-component 510b preferably includes a first part S1 and a second part S2, and the outer diameter of the first part S1 is smaller than the outer diameter of the second part S2.
  • the fixed connection method is preferably threaded connection, snap connection, etc., with good sealing performance, and finally the first component 510 shown in FIG. 8c can be obtained. .
  • a part of the first part S1 is exposed to the outside of the first sub-member 510a to form a recessed portion, and the recessed portion is used to cover the second member 520 so that the second member 520 is firmly clamped on the first sub-member 510a and the first sub-member 510a.
  • the outer diameter of the second part S2 is consistent with the outer diameter of the first sub-component 510a, and the outer diameter of the second component 520 is consistent with the outer diameter of the first sub-component 510a.
  • the second connector on the tail end member and the fourth connector on the head end member are in addition to snap connection and pin connection.
  • rivet connection is also possible, and there is no limitation on the conduction mode between the tail end part and the head end part.
  • the leadless pacemaker provided by the embodiments of the present invention, either the second connector in the tail end part may be degraded, or the fourth connector in the head end part may be degraded, or the second connector in the tail end part may be degraded.
  • Both the two connecting pieces and the fourth connecting piece of the head end part can be degraded, or the second connecting piece and the fourth connecting piece are matedly connected by a biodegradable corresponding connecting piece.
  • the present invention does not show the protruding engaging parts on the head end part, such as elastic buckles, positioning blocks or undercuts, those skilled in the art should know how to attach the head end part on the basis of the disclosure of this application.
  • These protruding engaging elements are provided on the upper part, and these protruding engaging elements are biodegradable, so that the locking of the protruding engaging elements and the positioning slot on the tail end part is released.
  • the doctor can insert the guide wire through the inferior vena cava, then pass the guide wire into the guiding sheath and deliver it to the heart (such as the ventricle or atrium), and then remove the guide wire;
  • the positioning sheath 400 and the shrinking sheath 500 of the loaded and fixed leadless pacemaker (the shrink sheath 500 is connected to the fifth connector 14 at the proximal end of the leadless pacemaker) are sent through the guiding sheath together.
  • the surgeon operates the positioning sheath 400 with the aid of the imaging device under X-rays, so that the positioning sheath 400 is positioned in a suitable position (the suitable position can be determined by the doctor); then, when positioning the sheath 400 After confirming the position, and operating the shrinking sheath 500 to screw the fixing mechanism 22 of the head end part 2 into the myocardial tissue to achieve fixation; finally, removing the shrinking sheath, positioning sheath and guiding sheath and other delivery devices to complete Implantation of leadless pacemakers.
  • the doctor first inserts the guide wire, passes the implanted guide wire into the guide sheath, then removes the guide wire, and then passes the positioning sheath 400 through the guide Introduce the sheath tube into the heart, and then move the positioning sheath (with the help of X-ray) to the position of the leadless pacemaker, and slowly move the contraction sheath 500 through the positioning sheath and connect with the fifth leadless pacemaker.
  • the connector 14 is connected, and when the leadless pacemaker is fixed, the positioning sheath 400 is moved forward, the leadless pacemaker is slowly retracted into the positioning sheath 400, and then the entire leadless pacing is rotated The helical structure is separated from the myocardial tissue to achieve detachment; finally, the delivery devices such as the contraction sheath, positioning sheath and guiding sheath are removed to complete the recovery of the leadless pacemaker.
  • the doctor when it is necessary to remove or replace the leadless pacemaker in the chronic phase, the doctor also inserts the guide wire first, inserts the guide wire through the implanted guide wire into the guide sheath, then removes the guide wire, and then passes the positioning sheath through the guide. Introduce the sheath tube into the heart, and move the positioning sheath (by X-ray) to the position of the leadless pacemaker, and then insert the shrink sheath 500 into the positioning sheath 400 and connect it to the fifth connection piece of the tail end part 1.
  • the head end part 4 is kept stationary by the positioning sheath 400, and the sheath 500 is rotated and contracted to make The tail end part 1 is rotated and separated from the head end part 2, and finally the tail end part 1 is evacuated from the human body together with the positioning sheath 400.
  • the tail end component includes a first connector and a second connector
  • the head end component includes a third connector and a fourth connector.
  • the first connecting piece is used to detachably connect with the third connecting piece
  • the second connecting piece is used to detachably or non-detachably connect with the fourth connecting piece to realize the Locking between the tail end part and the head end part
  • the first connecting piece and the third connecting piece are not biodegradable
  • the four connectors can ensure that the tail end part and the head end part are firmly combined to facilitate the overall removal or adjustment of the pacemaker. After the connector is degraded, the tail end can be easily removed. ⁇ End parts.

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Abstract

一种无导线起搏器（100、200、300）及其尾端部件（1、3、5）与头端部件（2、4、6），尾端部件（1、3、5）包括第一连接件（12、32）和第二连接件（13），头端部件（2、4、6）包括第三连接件（23、42、62）和第四连接件（24、63）；所述第一连接件（12、32）用于与所述第三连接件（23、42、62）可拆卸地连接，同时所述第二连接件（13）用于与所述第四连接件（24、63）可拆卸地或不可拆卸地连接，以实现所述尾端部件（1、3、5）和所述头端部件（2、4、6）间的锁定；并且所述第一连接件（12、32）和所述第三连接件（23、42、62）均不可生物降解；所述第二连接件（13）和所述第四连接件（24、63）中的至少一个可生物降解，或者所述第二连接件（13）与所述第四连接件（24、63）通过可生物降解的对应连接件配合连接。如此，在连接件降解之前，通过四个连接件可确保尾端部件（1、3、5）和头端部件（2、4、6）牢固地结合，方便整体取出或调整起搏器（100、200、300），而在连接件将降解后，又可较为容易地取出尾端部件（1、3、5）。

Description

无导线起搏器及其尾端部件与头端部件 技术领域
本发明涉及医疗器械技术领域，特别涉及一种无导线起搏器及其尾端部件与头端部件。
背景技术
心脏起搏器自1958年问世以来，已成为缓慢性心律失常疾病的一线治疗手段。历经半个多世纪的发展与创新，心脏起搏器的植入技术由最初开胸植入单根导线起搏心室，逐步发展为经静脉植入2～3根导线以提供房室生理性起搏甚至双心室同步起搏。但是，导线脱位、血栓形成、三尖瓣反流以及感染与导线相关的并发症，这些问题一直以来不仅影响起搏器的正常使用，而且严重危害患者的生命健康与生活质量。其中，当感染与导线相关的并发症时，需尽早将导线拔除，但导线拔除具有一定的难度和风险，此工作通常需要在较大的电生理中心中由技术熟练的医生完成，这对于资源使用和医生的工作量均较大。为了克服因导线的使用而产生的上述这些问题，“无导线”的心脏起搏器成为目前心律失常治疗的新发展方向。
但是，无导线起搏器的使用寿命有限，例如当电源耗尽和/或处理电路需要更新时，最好从心脏移除整个起搏器。然而，在无导线起搏器植入后较长一段时间内(慢性期内)，由于心肌组织的黏连或包裹，导致无导线起搏器在植入的慢性期内无法100％取出。或者在无导线起搏器从心脏的心肌组织移除的过程中，整个起搏器的移除较为困难并且可能损坏周围的心脏和/或血管组织，在有些情况下移除甚至可能撕裂心肌组织，尤其在植入后进入慢性期，由于起搏器一部分或全部被组织包裹，如需要取出更困难。
发明内容
本发明的目的在于提供一种无导线起搏器及其尾端部件与头端部件，可较为方便地实现尾端部件和头端部件的分离，从而降低无导线起搏器的取出难度。
为实现上述目的或其它相关目的，本发明提供一种无导线起搏器的尾端部件，用于与无导线起搏器的头端部件配合使用，所述尾端部件包括第一连接件和第二连接件；
所述第一连接件用于与所述头端部件可拆卸地连接，同时所述第二连接件用于与所述头端部件不可拆卸地或可拆卸地连接，以实现所述尾端部件与所述头端部件间的锁定；其中：所述第一连接件不可生物降解，所述第二连接件可生物降解，或者所述第二连接件与所述头端部件通过可生物降解的对应连接件配合连接。
可选的，在所述无导线起搏器的尾端部件中，所述第二连接件用于与所述头端部件卡扣连接或销连接。
可选的，在所述无导线起搏器的尾端部件中，所述第二连接件包括销孔，所述销孔与所述头端部件的销孔对位，并用于供可生物降解的定位销插设。
可选的，在所述无导线起搏器的尾端部件中，所述第二连接件包括定位卡槽，所述定位卡槽用于与头端部件的凸出卡合件相卡合；或者，所述第二连接件包括凸出卡合件，所述凸出卡合件由生物可降解材料制成，且所述凸出卡合件用于与头端部件的定位卡槽相卡合，并被配置为当无导线起搏器植入体内预定时间以后开始降解。
可选的，在所述无导线起搏器的尾端部件中，所述第一连接件用于与所述头端部件螺纹连接、卡扣连接或过盈配合连接。
可选的，在所述无导线起搏器的尾端部件中，所述第一连接件包括导槽，所述导槽用于与头端部件的导柱相适配；或者，所述第一连接件包括导柱，所述导柱用于与头端部件的导槽相适配。
可选的，在所述无导线起搏器的尾端部件中，所述导槽具有内螺纹，或者所述导柱具有外螺纹。
可选的，在所述无导线起搏器的尾端部件中，所述第一连接件包括定位卡槽，所述定位卡槽用于与头端部件的凸出卡合件相卡合；或者所述第一连接件包括凸出卡合件，所述凸出卡合件用于与头端部件的定位卡槽相卡合。
可选的，在所述无导线起搏器的尾端部件中，所述尾端部件包括第一部 件和第二部件，所述第一部件包括主体部和凹陷部，所述第二部件套设在所述凹陷部上；其中：所述第二连接件设置于所述第二部件上，且所述第二连接件和/或第二部件可生物降解。
可选的，在所述无导线起搏器的尾端部件中，所述第二部件的外径与所述主体部的外径一致。
为实现上述目的或其它相关目的，本发明还提供一种无导线起搏器的头端部件，用于与无导线起搏器的尾端部件相配合使用，所述头端部件包括第三连接件和第四连接件；
所述第三连接件用于与所述尾端部件可拆卸地连接，同时所述第四连接件用于与所述尾端部件不可拆卸地或可拆卸地连接，以实现所述尾端部件与所述头端部件间的锁定；其中：所述第三连接件不可生物降解，所述第四连接件可生物降解，或者所述第四连接件与所述尾端部件通过可生物降解的对应连接件配合连接。
可选的，在所述无导线起搏器的头端部件中，所述第四连接件用于与所述尾端部件卡扣连接或销连接。
可选的，在所述无导线起搏器的头端部件中，所述第四连接件包括销孔，所述销孔与所述尾端部件的销孔对位，并用于供可生物降解的定位销插设。
可选的，在所述无导线起搏器的头端部件中，所述第四连接件包括定位卡槽，所述定位卡槽用于与尾端部件的凸出卡合件相卡合；或者，所述第四连接件包括凸出卡合件，所述凸出卡合件由生物可降解材料制成，且所述凸出卡合件用于与尾端部件的定位卡槽相卡合，并被配置为当无导线起搏器植入体内预定时间以后开始降解。
可选的，在所述无导线起搏器的头端部件中，所述第三连接件用于与所述尾端部件螺纹连接、卡扣连接或过盈配合连接。
可选的，在所述无导线起搏器的头端部件中，所述第三连接件包括导槽，所述导槽用于与尾端部件的导柱相适配；或者，所述第三连接件包括导柱，所述导柱用于与尾端部件的导槽相适配。
可选的，在所述无导线起搏器的头端部件中，所述导槽具有内螺纹；或 者所述导柱具有外螺纹。
可选的，在所述无导线起搏器的头端部件中，所述第三连接件包括定位卡槽，所述定位卡槽用于与尾端部件的凸出卡合件相卡合；或者所述第三连接件包括凸出卡合件，所述凸出卡合件用于与尾端部件的定位卡槽相卡合。
进一步的，为实现上述目的或其它相关目的，本发明又提供一种无导线起搏器，包括：
尾端部件，包括第一连接件和第二连接件；以及
头端部件，用于固定于预定对象，所述头端部件包括第三连接件和第四连接件；
所述第一连接件与所述第三连接件可拆卸地连接，同时所述第二连接件与所述第四连接件不可拆卸地或可拆卸地连接，以实现所述尾端部件与所述头端部件间的锁定；其中：所述第一连接件和所述第三连接件不可生物降解；所述第二连接件和/或所述第四连接件可生物降解，或者所述第二连接件与所述第四连接件通过可生物降解的对应连接件配合连接。
可选的，在所述无导线起搏器中，所述第一连接件与所述第三连接件螺纹连接，所述第二连接件与所述第四连接件卡扣连接，所述第二连接件和所述第四连接件中的一个包括定位卡槽，所述第二连接件和所述第四连接件中的另一个包括凸出卡合件，所述定位卡槽呈环状设置。
可选的，在所述无导线起搏器中，所述第二连接件与所述第四连接件分别包括销孔，且所述尾端部件的销孔与所述头端部件的销孔对位；所述可生物降解的对应连接件包括定位销，所述定位销插设于所述尾端部件的销孔与所述头端部件的销孔，且所述定位销被配置为当无导线起搏器植入体内预定时间以后开始降解。
在本发明提供的无导线起搏器及其尾端部件与头端部件中，通过将无导线起搏器设计成两个部分，即尾端部件和头端部件，且该两个部件在植入体内以后能够分离，进而便于实现无导线起搏器的植入、再定位、取出和更换。例如在植入过程中，尾端部件的第一连接件及第二连接件分别与头端部件的第三连接件即第四连接件配合连接，可方便地将整个无导线起搏器植入体内， 且便于植入位置不当时进行再定位。而经过一段时间后的慢性期，无导线起搏器的部分会被组织包裹，若需要整个取出无导线起搏器，难度很大，而且也容易损伤组织。而此时尾端部件的第二连接件、头端部件的第四连接件或用于连接第二连接件和第四连接件的对应连接件被生物降解，如此，通过操作将第一连接件与第三连接件分离，即可实现尾端部件与头端部件的分离。由此，可以实现更换新的尾端部件，或考虑取出尾端部件而保留体积较小的头端部件在体内，这样无法取出的部分在体内不会占用较大的空间，便于后续有更多的空间植入新的无导线起搏器。
附图说明
附图用于更好地理解本发明，不构成对本发明的不当限定。其中：
图1是本发明实施例一提供的无导线起搏器的装配图；
图2是本发明实施例一提供的尾端部件的结构示意图；
图3a是本发明实施例一提供的头端部件的结构示意图；
图3b是本发明实施例一提供的头端部件取消了导槽的轴向剖面图；
图3c是本发明实施例一提供的头端部件取消了导引槽的结构示意图；
图4是本发明实施例二提供的无导线起搏器的装配图；
图5a是本发明实施例二的尾端部件的结构示意图，其中尾端部件设置有导柱；
图5b是本发明实施例二提供的尾端部件取消了导柱的结构示意图；
图6a是本发明实施例二提供的头端部件的结构示意图，其中头端部件设置有导槽；
图6b是本发明实施例二提供的头端部件取消了导槽的结构示意图；
图7a是本发明实施例三提供的无导线起搏器的装配示意图；
图7b是本发明实施例三提供的无导线起搏器的轴向剖面图；
图8a是本发明实施例三提供的尾端部件之第一部件的结构示意图；
图8b是本发明实施例三提供的尾端部件之第二部件的结构示意图；
图8c是本发明实施例三另一优选示例提供的第一部件的示意图；
图9是本发明实施例三提供的头端部件的轴向剖面图；
图10是本发明实施例提供的在慢性期取出尾端部件的示意图。
图中：
100、200、300-无导线起搏器；
1、3、5-尾端部件；
11、31、511-第一本体；
511a-主体部；511b-凹陷部；
12、32-第一连接件；
121、35、512-导柱；
13-第二连接件；
131-弹性扣；
14-第五连接件；
321-定位块；
34、44-销孔；
2、4、6-头端部件；
21、41、61-第二本体；
22-固定机构；
23、42、62-第三连接件；
231、45、621-导槽；
24、63-第四连接件；
241、421、631-定位卡槽；
242-导向斜面；
243-导引槽；
25、64-内腔；
26-近端端面；
510-第一部件；
510a-第一子件；510b-第二子件；S1-第一部分；S2-第二部分；
520-第二部件；521-第三本体；522-倒扣；
400-定位鞘管；
500-收缩鞘管。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
在本文中，术语“近端”和“远端”；以及“头端”和“尾端”是从使用该医疗器械的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”和“远端”并非是限制性的，但是“近端”、“头端”通常指该医疗设备在正常操作过程中靠近医生的一端，而“远端”、“尾端”通常是指首先进入患者体内的一端。
如在本说明书和所附权利要求中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“多个”通常是以包括“两个”或“两个以上”的含义而进行使用的，除非内容另外明确指出外。
本发明主要在于提供一种无导线起搏器，包括尾端部件和头端部件；尾端部件包括第一连接件和第二连接件，头端部件包括第三连接件和第四连接件；所述第一连接件用于与所述第三连接件可拆卸地连接，同时所述第二连接件用于与所述第四连接件可拆卸地或不可拆卸地连接，以实现所述尾端部件和所述头端部件间的锁定；并且所述第一连接件和所述第三连接件均不可生物降解；所述第二连接件和所述第四连接件中的至少一个可生物降解，或者所述第二连接件与所述第四连接件通过可生物降解的对应连接件配合连接。
于是植入无导线起搏器之前，首先在体外组装尾端部件和头端部件，使两者通过四个连接件固定连接在一起，进而再利用输送装置将整个无导线起 搏器递送至体内。本发明的无导线起搏器植入体内后，主要分以下两种情况：
第一种情况是：植入过程中需要改变无导线起搏器的位置，或急性期(如植入6个月内)需要取出无导线起搏器，此时，可利用输送装置操作整个无导线起搏器，使头端部件脱离心肌组织，即可调整无导线起搏器的位置或将其整个取出；此情况下，第二连接件和第四连接件中可生物降解的一个或两个，或者用于连接第二连接件和第四连接件的可生物降解的对应连接件还没有开始降解，因此无导线起搏器整个为固定状态，尾端部件和头端部件不会发生分离，这样便于整体取出或调整无导线起搏器；
第二种情况是：术后慢性期(如植入6个月后)，第二连接件和第四连接件中可生物降解的一个或两个或者用于连接第二连接件和第四连接件的可生物降解的对应连接件开始降解，且随着时间推移解除对尾端部件和头端部件的锁定，可利用输送装置固定住头端部件，使头端部件保持不动，进而再利用输送装置操作尾端部件，使尾端部件与头端部件分离，此时，可单独将尾端部件取出而头端部件保留在心内；在这种情况下，后续若有需要，可再次利用输送装置将新的尾端部件植入体内并与旧的头端部件重新定位配合，从而实现无导线起搏器的更换，或者也可将整个新的无导线起搏器植入体内进行更换。
上述这样操作，可降低无导线起搏器的取出难度，尤其是慢性期的取出难度，同时还能够减小对周围的心脏和/或血管组织造成的损伤，提高手术操作的安全性。应知晓的是，在慢性期，无导线起搏器的一部分甚至于整个会被组织包裹，若需要整个取出无导线起搏器，难度很大，而且也容易损伤组织，为此，只考虑取出尾端部件而保留体积较小的头端部件在体内，对组织的损伤较小，无法取出的部分在体内不会占用较大的空间，便于后续有更多的空间植入新的无导线起搏器。而且在慢性期，通过连接件的降解，可以降低尾端部件和头端部件的分离难度，进而降低无导线起搏器的取出难度，同时也因为解锁过程中无需借助过大的机械作用力，使得分离过程中对周围的心脏和/或血管组织造成的损伤小，故取出的安全性更高。
接下来结合图以及具体的实施例对本发明的无导线起搏器及其尾端部件 与头端部件作进一步的说明。
实施例一
图1为本发明实施例一提供的无导线起搏器的装配图，如图1所示，本发明实施例提供一种无导线起搏器100，包括尾端部件1和头端部件2，该两个部件通过相关的连接件组装在一起。实际应用时，尾端部件1优选包括各种电子部件(例如在图1所示的虚线框内配置电子部件)，电子部件包括但不限于脉冲发生器、电源、存储器、处理器、感测电路等。此处，由于起搏器的电子部件为本领域技术人员习知的技术，故而，此处不再详细叙述。另外头端部件2用于与心肌组织固定，固定方式不作限定。
图2为本发明实施例一提供的尾端部件的结构示意图，图3a为本发明实施例一提供的头端部件的结构示意图。如图2所示，尾端部件1包括第一本体11，第一本体11实际为一壳体，壳体内用于容置各种电子部件。如图3a所示，头端部件2包括第二本体21，第二本体21可以但不限于为壳体；头端部件2还包括固定机构22，固定机构22设置于第二本体21的远端并用于与心肌组织固定，但本发明对固定机构22的结构不作特别的限制，例如固定机构22不限于图示的螺旋结构，还可以为翼状或其它结构。
继续参阅图2，尾端部件1还包括设置在第一本体11上的第一连接件12和第二连接件13。本实施例中，第一连接件12包括导柱121，导柱121设置在第一本体11的远端，优选为远端的中心；同时第二连接件13包括凸出卡合件，凸出卡合件优选为弹性扣131，弹性扣131设置在第一本体11的外壁上并向外延伸，延伸方向优选与第一本体11的轴线垂直。
继续参阅图3a，头端部件2还包括设置在第二本体21上的第三连接件23和第四连接件24。本实施例中，第二本体21具有朝向近端开口的内腔25，第三连接件23包括导槽231，导槽231设置在内腔25的底部(即远端)的中心；同时第四连接件24包括定位卡槽241，定位卡槽241开设在内腔25的侧壁上。
结合图1，实际组装时，尾端部件1的远端插入头端部件2位于近端的内腔25中，且插入过程中，弹性扣131与定位卡槽241弹性卡合，同时导柱121 与导槽231实现配合，如过盈连接或卡扣连接，从而将尾端部件1和头端部件2牢固地锁紧。但是，弹性扣131不限于设置在第一本体11的外壁上，还可以设置在第一本体11的内壁上，例如类似于第二本体21，在第一本体11的远端开设空腔，且在空腔的侧壁上设置弹性扣131，同理，定位卡槽241也不限于设置在第二本体21之内腔25的侧壁上，还可以类似于第一本体11，在第二本体21的外壁上设置向内凹陷的定位卡槽241，进而只要将头端部件2的近端插入所述空腔即可实现锁定。因此，本发明对弹性扣131在第一本体11上的位置不作限定，同理对定位卡槽241在第二本体21上的位置也不作限定。另外，在一替代性实施例中，还可以是第二连接件13包括定位卡槽，而相对应的第四连接件包括凸出卡合件，例如弹性扣131设置在第二本体21上，而定位卡槽241设置在第一本体11上。因此，只要在第一本体11和第二本体21中的一个设置弹性扣131，而另一个设置与弹性扣131配合的定位卡槽241即可，本领域技术人员可进行适应性地配置。
在一替代性实施例中，第一连接件12包括导槽231，第三连接件23包括导柱121，具体的，导柱121可设置在第二本体21上，而导槽231设置在第一本体11上。只要在第一本体11和第二本体21中的一个设置导柱121，另一个设置与导柱121相配合的导槽231即可。导柱121在第二本体21上的设置方式与其在第一本体11上的设置方式基本相同，区别在于在第二本体21的近端设置导柱，同时导槽也设置在第一本体11的远端。需要说明的，导柱121与导槽231之间的连接力需大于尾端部件1的重量，使得当第二连接件13与第四连接件24在被生物降解而失去束缚力后，导柱121与导槽231之间只有在受到外力作用时才能分离，从而确保连接的可靠性。
在一些实施例中，导柱121和导槽231在配合的同时还形成电连接，从而使尾端部件1和头端部件2之间能够实现电信号和能量的传递。但是，导柱121和导槽231也可不导电，而通过其它方式使尾端部件1和头端部件2之间实现电信号和能量的传递，例如弹性扣131和定位卡槽241在卡合的同时直接形成电连接亦能达到同样的效果，又如通过在内腔25和第一本体11相对应的位置设置连接电极，尾端部件1和头端部件2通过连接电极实现电 连接。
接下去以第一本体11上的弹性扣131和导柱121，以及第二本体21上的定位卡槽241与导槽231作为示意对无导线起搏器100的结构以及使用方式作进一步的说明，但本领域技术人员应当能够修改以下描述，将其应用于弹性扣131和导柱121设置于第二本体21上，以及定位卡槽241与导槽231设置于第一本体11上的情况。
继续参阅图2，在本实施例中，弹性扣131凸起设置于第一本体11的外壁上，至少为一个；优选为两个且关于第一本体11的轴线对称分布。应知晓的是，弹性扣131能够弹性变形，其在受到外力作用时能够收缩而与定位卡槽241相分离或卡合，以实现锁定或解锁，因此弹性扣使用方便，且连接可靠性也好。同时继续参阅图3a，定位卡槽241设置在第二本体21的内腔25上，至少为一个；优选为两个且关于第二本体21的轴线对称分布。因此，通过弹性扣131与定位卡槽241的配合，即可实现尾端部件1和头端部件2的锁定。与此同时借助于导柱121与导槽231的配合，还能够进一步确保弹性扣131在降解后，尾端部件1和头端部件2还能保持锁紧而不至于尾端部件1松脱而出现风险。优选的，本实施例中，弹性扣131由生物可降解材料制成，使其在术后的慢性期开始降解，且降解完成之后，由于导柱121与导槽231仍然为配合连接，因此在慢性期取出时，只要对尾端部件1和头端部件2施加相反方向的力，即可分离尾端部件1和头端部件2，将尾端部件1取出；但是在弹性扣131降解之前，由于整个无导线起搏器100仍然为固定状态，因此此时可整体取出或调整无导线起搏器100。
进一步的，弹性扣131包括柱体，柱体更优选为圆柱体并连接第一本体11的外壁，且柱体的顶面优选为圆弧面。圆弧面有助于弹性扣131在径向上能够更好的受力，从而在径向上更好的形变，这样方便弹性扣131锁紧和解锁，同时在轴向上受力后也不会移位，连接可靠性高。
参阅图3a，本实施例中，定位卡槽241的一端优选设置了导向斜面242，导向斜面242优选为弧面(例如圆弧面)并用于与弹性扣131的顶面配合接触，以此降低弹性扣131与定位卡槽241分离或结合时的阻力。优选的，导 向斜面242远离定位卡槽241的一端还设置了轴向延伸的导引槽243，用于引导弹性扣131沿着导引槽243插入定位卡槽241，这样装配更方便，装配精度高。但是在其他实施例中，如图3c所示，也可仅设置导向斜面242和定位卡槽241，而取消导引槽243。
因此，本实施例中，通过弹性扣131与定位卡槽241的弹性卡合，可以保证操作整个无导线起搏器100时，尾端部件1和头端部件2不会脱离。进而当需要改变无导线起搏器100的位置，或在急性期取出无导线起搏器100时，只要旋转无导线起搏器100，待头端部件2远端的固定机构22脱离心肌组织后，即可重新调整无导线起搏器的植入位置或将其整体取出。并且在慢性期，由于无导线起搏器100大部分被组织包裹或完全包裹，使得无导线起搏器100的取出难度较大，此时，为了降低取出难度，弹性扣131被构造成可生物降解的结构，当弹性扣131被生物降解时，即解除弹性扣131与定位卡槽241的锁定，此时，虽然起搏器大部分或完全被组织包裹，但为了确保使用的可靠性，仍然通过导柱121与导槽231的配合来保证尾端部件1不会松脱，进而医生只要利用输送装置操作尾端部件1，即可将尾端部件1与头端部件2分离，进而将尾端部件1从体内取出而保留头端部件2在体内固定。后续若有需要，可以将新的尾端部件1重新植入体内并可选择与留在体内的头端部件2重新定位配合，但是通常情况下已很难精确定位到旧的头端部件2(因为被组织包裹)，在这种情况下，可选择将新的无导线起搏器100植入体内进行整体更换。
为此，弹性扣131由生物可降解材料制成，在本实施例中弹性扣131被配置为当无导线起搏器100植入体内预定时间以后开始降解。一般情况下，无导线起搏器植入体内大约6周以后进入慢性期，故而弹性扣131较佳地被配置为当无导线起搏器100植入体内后的6周开始降解，降解完成时间大约一年。当弹性扣131完全降解后，也就是弹性扣131完全失去物理特性的时候，此时，弹性扣131完全不具备约束定位卡槽241的作用。在此，降解时间取决于多项因素，包括所用材料的分子量、结晶度、亲水性、各部件的体积、表面积以及环境因素等，具体开始降解和完成降解的时间可由本领域技 术人员根据需要选择。本发明实施例中，生物可降解材料选自医用高分子材料，包括但不限于聚乳酸(PLA)、左旋聚乳酸(PLLA)或右旋聚乳酸(PDLA)，还可以是PLGA(即L-丙交酯与乙交酯的无规共聚物)或者PDLGA(即DL-丙交酯与乙交酯的无规共聚物)，当然本领域技术人员还可根据实际选用其它类型的生物可降解材料，本发明对生物可降解材料不作特别的限定。
本实施例中，第二本体21的远端还连接有起搏电极和/或感知电极。在一实施例中，固定机构22可以围绕电极，使得电极在螺旋结构的中心通道内。在替代实施例中，螺旋结构是电极的一部分。此外，第一本体11和第二本体21中的一个或二个的外表面上可设置一圈环电极，用于对心肌组织进行感知。另外，第一本体11的近端优选设置有第五连接件14，如图2所示，第五连接件14用于与输送装置中的收缩鞘管可分离地连接，以方便通过收缩鞘管操作尾端部件以及整个无导线起搏器。但对于第五连接件14与收缩鞘管的连接方式不作限定，例如可选择螺纹连接或卡扣连接等可方便快速拆装的连接。
进一步在一替代性实施例中，还可取消导柱和导槽。如图3b所示，例如当弹性扣131与定位卡槽241本身能够形成电连接的时候，可取消导柱121和导槽231，此时，可选在第一本体11上设置至少两组弹性扣，每组弹性扣包括对称分布的两个弹性扣，因此，至少四个弹性扣在第一本体11上围绕轴线间隔分布，并且其中一组弹性扣被配置为可生物降解，而另一组弹性扣不可生物降解。于是，在非慢性期，可通过两组弹性扣实现尾端部件1和头端部件2的锁定，而进入慢性期后，一组弹性扣降解，另一组弹性扣保持尾端部件1和头端部件2间的连接，需要取出时，亦只需要通过输送装置固定头端部件2，而操作尾端部件1，使尾端部件1与头端部件2分离即可。在这种情况下，在一些实施例中，第一连接件和第二连接件均为弹性扣，而第三连接件和第四连接件均为定位卡槽；在一些实施例中，第一连接件为弹性扣，第二连接件为定位卡槽，同时第三连接件为定位卡槽，而第四连接件为弹性扣；在一些实施例中，第一连接件为定位卡槽，第二连接件为弹性扣，同时第三连接件为弹性扣，而第四连接件为定位卡槽。显然，第一连接件和第二连接件可以均为弹性扣，也可以均为定位卡槽，或者其中一个为弹性扣，另 一个为定位卡槽；同理，第三连接件和第四连接件可以均为弹性扣，也可以均为定位卡槽，或者其中一个为弹性扣，另一个为定位卡槽。
进一步的，参阅图3a，并结合图10，头端部件2的第二本体21的近端端面26构成限位部，该限位部用于定位输送装置中的定位鞘管400。本实施例中，近端端面26用于与定位鞘管400的远端抵靠，从而限定定位销管400向远端推进的位置，以此使定位鞘管400仅包覆尾端部件而能够在分离尾端部件与头端部件时，使头端部件保持固定不动。优选的，头端部件2的第二本体21的外径大于定位鞘管400的内径。
实施例二
本实施例中提供的无导线起搏器200的结构与实施例一基本相同，以下仅针对不同点进行描述。
图4是本发明实施例二提供的无导线起搏器的装配图，如图4所示，本发明实施例提供一种无导线起搏器200，包括尾端部件3和头端部件4，两者通过第一连接件32和第三连接件42可拆卸地卡扣连接，同时所述第二连接件与所述第四连接件通过可生物降解的对应连接件配合连接，具体的，第二连接件和第四连接件通过销连接。
如图5a所示，尾端部件3包括第一本体31，以及设置在第一本体31上的第一连接件32和第二连接件。本实施例中，第一连接件32包括凸出卡合件，所述凸出卡合件如为定位块321(即刚性扣，在受力时不易变形)，定位块321设置在第一本体31的外壁上并向外延伸，延伸方向优选与第一本体31的轴线垂直；同时第二连接件包括销孔34，所述销孔34用于与所述头端部件的销孔44对位，并用于供定位销插设，销孔34径向贯通地设置在第一本体31的外壁上。
如图6a所示，头端部件4包括第二本体41，以及设置在第二本体41上的第三连接件42和第四连接件。本实施例中，第三连接件42包括定位卡槽421，定位卡槽421设置在第二本体41的外壁上且径向贯通，定位卡槽421还沿第二本体41的周向延伸，以便能够与定位块321在周向上卡合锁紧，同 时定位卡槽421在轴向上的一端开口，以便于定位块321通过该开口进入定位卡槽421；同时第四连接件包括销孔44，销孔44径向贯通地设置在第二本体41的外壁上，所述销孔44用于与所述尾端部件的销孔34对位，并用于供定位销插设。
可生物降解的对应连接件包括定位销，该定位销用以插入尾端部件3的销孔34和头端部件4的销孔44，以锁定尾端部件3和头端部件4。较佳的，定位销由生物可降解材料制成，且所述定位销被配置为当无导线起搏器植入体内预定时间以后开始降解。
结合图4，实际组装时，尾端部件3的远端插入头端部件4位于近端的内腔25中，且插入过程中定位块321沿着定位卡槽421的开口插入定位卡槽421，并旋转将定位块321卡入定位卡槽421的弧形槽中锁紧，这样做即可限制头端部件4和尾端部件3在朝第一方向旋转时的位移，之后再将定位销插入尾端部件3和头端部件4的销孔34及44中实现销连接，从而通过定位销限制头端部件4和尾端部件3在朝第二方向旋转时的位移，第一方向和第二方向为一对反方向。因此，借助于卡扣连接和销连接，使尾端部件3和头端部件4牢固地锁紧，不可分离，除非定位销降解才可分离尾端部件3和头端部件4。
本实施例中，定位块321至少为一个，优选为两个并关于第一本体31的轴线对称分布在第一本体31上。另外，销孔34及44也优选各为两个并对称分布在对应的本体上，当然定位销也优选为两个。但是，本发明对销孔、定位销及定位块的数量不作要求，对销孔34与定位块321在第一本体31上的位置，以及销孔44与定位卡槽421在第二本体41上的位置不作要求，只要插入定位销时，定位块321不会干涉定位销便可。且定位卡槽421的形状包括但不限于L形，另外定位销的成型方式不作要求，可以注塑成型，也可是机加工成型。
在一替代性实施例中，定位卡槽421可设置在第一本体31上，而定位块321设置在第二本体41上。定位卡槽421在第一本体31上的设置方式与其在第二本体41上的设置方式基本相同，同时定位块321在第二本体41上的设置方式与其在第一本体31上的设置方式基本相同，此处不再详细赘述。
继续参阅图5a，在一实施例中，第一本体31的远端设置导柱35；同时如图6a所示，第二本体41的内腔25的底部形成导槽45，导柱35插入导槽45形成配合连接。当然，也可作替换性的设置，即在第二本体41的近端设置导柱，而第一本体31的远端设置导槽来形成配合连接。此外也可取消导柱和导槽，仅通过定位块321与定位卡槽421的连接实现连接，即如图5b和图6b所示。较佳的，导柱35与导槽45的连接，或定位块321与定位卡槽421的连接能够导电。
在本实施例中，通过定位块321与定位卡槽421的卡合，以及定位销与销孔的连接，可以保证操作无导线起搏器200时，尾端部件3和头端部件4不会分离。进而当需要改变无导线起搏器200的位置，或在急性期取出无导线起搏器200时，只要旋转无导线起搏器200，待头端部件4远端的固定机构22脱离心肌组织后，即可重新调整无导线起搏器的植入位置或将其整体取出。并且在慢性期，由于无导线起搏器200大部分被组织包裹或完全包裹，使得无导线起搏器200的取出难度较大，此时，为了降低取出难度，定位销被构造成可生物降解的结构，当定位销完全降解时，即可解除定位销的锁定，此时，虽然起搏器大部分或完全被组织包裹，但为了确保使用的可靠性，仍然通过定位块与定位卡槽的卡合来保证尾端部件3不会脱落，进而医生只要利用输送装置旋转尾端部件3，即可将尾端部件3与头端部件4分离，进而将尾端部件3从体内取出而保留头端部件4在体内固定。可以理解的，由于定位销的降解，若使用新的尾端部件3与旧的头端部件4重新定位配合，则不需使用定位销，而仅利用定位块321与定位卡槽421的卡合连接来使得尾端部件3与头端部件4相连接。当然较佳的，可以将整个新的无导线起搏器重新植入体内。
实施例三
本实施例中提供的无导线起搏器300的结构与实施例一基本相同，以下仅针对不同点进行描述。
图7a是本发明实施例三提供的无导线起搏器的装配示意图，图7b是本 发明实施例三提供的无导线起搏器的轴向剖面图，图8a是本发明实施例三提供的尾端部件之第一部件的结构示意图，图8b是本发明实施例三提供的尾端部件之第二部件的结构示意图，图8c是本发明实施例三另一优选示例提供的第一部件的示意图，图9是本发明实施例三提供的头端部件的轴向剖面图。
如图7a～图9所示，本发明实施例三提供一种无导线起搏器300，包括尾端部件5和头端部件6，两者既通过第二连接件与第四连接件63卡扣连接，又同时通过第一连接件与第三连接件62螺纹连接，所述第二连接件和所述第四连接件63中的一个包括定位卡槽，所述第二连接件和所述第四连接件63中的另一个包括凸出卡合件，所述定位卡槽呈环状设置。以实现第一连接件与第三连接件62螺纹连接时，对凸出卡合件与定位卡槽的周向限制的解耦。
如图8a和图8b所示，尾端部件5包括第一部件510和第二部件520，第一部件510包括第一本体511，第一本体511包括主体部511a和设置于主体部511a之远端的凹陷部511b，主体部511a的外径大于凹陷部511b的外径，而第二部件520直接套接在凹陷部511b上；同时第二部件520为两端开口的套筒结构，第二部件520的外径优选与主体部511a的直径一致。并且在第一部件510上设置第一连接件，在第二部件520上设置第二连接件。本实施例中，所述第一连接件为导柱512，导柱512具有外螺纹并设置在凹陷部511b的远端；同时所述第二连接件为倒扣522。
如图8b所示，并结合图7b，第二部件520包括第三本体521，倒扣522设置在第三本体521的外壁上并向外延伸，倒扣522的形状不限定，包括但不限于三角性、梯形等。进一步的，倒扣522至少为两个并优选对称分布。
如图9所示，头端部件6还包括第二本体61，以及设置在第二本体61上的第三连接件62和第四连接件63。本实施例中，第三连接件62包括与导柱512螺纹配合的导槽621，优选导槽621与导柱512电连接。第四连接件63包括与倒扣522卡合的定位卡槽631，定位卡槽631为环形槽并开设在位于近端的内腔64的侧壁上，同时内腔64的底部中心设置导槽621。
结合图7b，实际组装时，先将第二部件520套接在第一部件510的凹陷部上，两者包括但不限于粘接、焊接、热熔连接或过盈配合等，之后，再将 头端部件6旋转套接在第二部件520上，使得导柱512与导槽621螺纹配合锁紧，与此同时第二部件520上的倒扣522逐渐卡入头端部件6上的定位卡槽，直至锁紧，最终实现尾端部件5和头端部件6的锁定。
本发明实施例中，倒扣522可以单独降解，但第二部件520不可降解；或者，倒扣522与第二部件520均可降解，即第二部件520和倒扣522均由生物可降解材料制成，且倒扣522与第二部件520可一体成型，使整个部件可降解。在其它的一些示范例中，定位卡槽可设置于尾端部件5的第二部件520上；相对应的，倒扣设置于头端部件6的内腔64之侧壁上，以与第二部件520上的定位卡槽相适配。可选的，第二部件520与倒扣中的一个或两个可降解。当第二部件520可降解时，即相当于定位卡槽被降解，此时倒扣即失去了限位，从而实现了第二连接件与第四连接件63的解除锁定。
因此，本实施例中，通过倒扣522与定位卡槽631的卡合，以及导柱512与导槽321的螺纹配合，可以保证操作无导线起搏器300时，尾端部件5和头端部件6不会分离。进而当需要改变无导线起搏器300的位置，或在急性期取出无导线起搏器300时，只要旋转无导线起搏器300，待头端部件6远端的固定机构脱离心肌组织后，即可重新调整无导线起搏器的植入位置或将其整体取出。并且在慢性期，由于无导线起搏器300大部分被组织包裹或完全包裹，使得无导线起搏器300的取出难度较大，此时，为了降低取出难度，倒扣522和/或第二部件520被构造成可生物降解的结构，当倒扣522或第二部件520完全降解时，即可解除倒扣的锁定，此时，虽然起搏器大部分或完全被组织包裹，但为了确保使用的可靠性，仍然通过导柱与导槽的螺纹配合来保证尾端部件5不会掉落，进而只要医生利用输送装置旋转尾端部件5，即可将尾端部件5与头端部件6分离，进而将尾端部件5从体内取出而保留头端部件6在体内固定。
进一步的，第一部件510可以一体成型，也可以由两个零件组装而成。如图8c所示，第一部件510由两个子件装配而成，分别是第一子件510a和第二子件510b。第二子件510b优选包括第一部分S1和第二部分S2，第一部分S1的外径小于第二部分S2的外径。实际装配时，将第一部分S1插入第一子 件510a并与之固定连接，固定连接的方式优选为螺纹连接、卡扣连接等，密封性好，最终可得到图8c所示的第一部件510。其中，第一部分S1的一部分暴露在第一子件510a的外部而形成凹陷部，此凹陷部用于套设第二部件520，使第二部件520被牢固卡死在第一子件510a和第二子件510b之间。其中优选的，第二部分S2的外径与第一子件510a的外径一致，且第二部件520的外径与第一子件510a的外径一致。
本发明较佳实施例如上所述，但并不局限于上述实施例所公开的范围，例如尾端部件上的第二连接件与头端部件上的第四连接件除了卡扣连接、销连接以外，还可铆钉连接等，此外对于尾端部件与头端部件之间的导电方式也不作限定。另外本发明实施例提供的无导线起搏器中，既可以是尾端部件中的第二连接件降解，也可以是头端部件中的第四连接件降解，还可以是尾端部件的第二连接件以及头端部件的第四连接件均可降解，或者第二连接件与第四连接件通过可生物降解的对应连接件配合连接。并且本发明虽然未图示头端部件上的凸出卡合件，例如弹性扣、定位块或倒扣，但本领域技术人员在本申请文件公开内容的基础上，应当知晓如何在头端部件上设置这些凸出卡合件，且这些凸出卡合件可生物降解，从而解除凸出卡合件与尾端部件上的定位卡槽的锁定。
最后，结合图10，并以实施例一中的无导线起搏器100的操作过程作为示意，对本发明实施例提出的无导线起搏器(100、200以及300)的操作方式作更进一步的说明。
如图10所示，植入过程中，医生可通过下腔静脉穿入导丝，再通过导丝穿入导引鞘管并递送至心内(如心室或心房)，撤去导丝；接着，将装载并固定好的无导线起搏器(收缩鞘管500和无导线起搏器之近端的第五连接件14连接)的定位鞘管400和收缩鞘管500一起通过导引鞘管送入到心内，此过程中，术者在X光下借助显影设备操作定位鞘管400，使定位鞘管400定位在合适位置(该合适位置可由医生自行确定)；然后，当定位鞘管400的位置确定后，且操作收缩鞘管500使头端部件2的固定机构22旋入心肌组织而实现固定；最后，撤去收缩鞘管、定位鞘管和导引鞘管等输送器件，即可完成 无导线起搏器的植入。
进一步的，当需要取出或调整无导线起搏器的位置时，医生先穿入导丝，通过植入的导丝穿入导引鞘管，然后撤去导丝，再将定位鞘管400通过导引鞘管送入心内，再将定位鞘管(借助X光)移动至无导线起搏器的位置，将收缩鞘管500通过定位鞘管缓缓移动并与无导线起搏器的第五连接件14连接，进而在无导线起搏器被固定住的情况下，向前移动定位鞘管400，将无导线起搏器缓缓收回到定位鞘管400内，然后旋转整个无导线起搏器，使螺旋结构脱离心肌组织而实现脱离；最后撤去收缩鞘管、定位鞘管和导引鞘管等输送器件，即完成无导线起搏器的回收。
进一步，当慢性期需要取出或更换无导线起搏器时，医生亦通过先穿入导丝，通过植入的导丝穿入导引鞘管，然后撤去导丝，再将定位鞘管通过导引鞘管送入心内，并将定位鞘管(借助X光)移动至无导线起搏器的位置，再将收缩鞘管500插入定位鞘管400并与尾端部件1的第五连接件14连接，进而在无导线起搏器被固定住的情况下，向前移动定位鞘管，将无导线起搏器的尾端部件收回到定位鞘管内(此时，通过头端部件2的近端端面26来限位定位销管400，使定位鞘管400仅推进到头端部件的近端)，之后，然后通过定位鞘管400保持头端部件4不动，并旋转收缩鞘管500，使尾端部件1旋转与头端部件2分离，最后随同定位鞘管400将尾端部件1一起撤离人体即可。
综上，在本发明提供的无导线起搏器及其尾端部件与头端部件中，尾端部件包括第一连接件和第二连接件，头端部件包括第三连接件和第四连接件；所述第一连接件用于与所述第三连接件可拆卸地连接，同时所述第二连接件用于与所述第四连接件可拆卸地或不可拆卸地连接，以实现所述尾端部件和所述头端部件间的锁定；并且所述第一连接件和所述第三连接件均不可生物降解；所述第二连接件和所述第四连接件中的至少一个可生物降解，或者所述第二连接件与所述第四连接件通过可生物降解的对应连接件配合连接。如此，在连接件降解之前，通过四个连接件可确保尾端部件和头端部件牢固地结合，方便整体取出或调整起搏器，而在连接件将降解后，又可较为容易地 取出尾端部件。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。

Claims (21)

  1. 一种无导线起搏器的尾端部件，用于与无导线起搏器的头端部件配合使用，其特征在于，所述尾端部件包括第一连接件和第二连接件；
    所述第一连接件用于与所述头端部件可拆卸地连接，同时所述第二连接件用于与所述头端部件不可拆卸地或可拆卸地连接，以实现所述尾端部件与所述头端部件间的锁定；其中：所述第一连接件不可生物降解，所述第二连接件可生物降解，或者所述第二连接件与所述头端部件通过可生物降解的对应连接件配合连接。
  2. 根据权利要求1所述的无导线起搏器的尾端部件，其特征在于，所述第二连接件用于与所述头端部件卡扣连接或销连接。
  3. 根据权利要求2所述的无导线起搏器的尾端部件，其特征在于，所述第二连接件包括销孔，所述销孔与所述头端部件的销孔对位，并用于供可生物降解的定位销插设。
  4. 根据权利要求2所述的无导线起搏器的尾端部件，其特征在于，所述第二连接件包括定位卡槽，所述定位卡槽用于与头端部件的凸出卡合件相卡合；或者，所述第二连接件包括凸出卡合件，所述凸出卡合件由生物可降解材料制成，且所述凸出卡合件用于与头端部件的定位卡槽相卡合，并被配置为当无导线起搏器植入体内预定时间以后开始降解。
  5. 根据权利要求1所述的无导线起搏器的尾端部件，其特征在于，所述第一连接件用于与所述头端部件螺纹连接、卡扣连接或过盈配合连接。
  6. 根据权利要求5所述的无导线起搏器的尾端部件，其特征在于，所述第一连接件包括导槽，所述导槽用于与头端部件的导柱相适配；或者，所述第一连接件包括导柱，所述导柱用于与头端部件的导槽相适配。
  7. 根据权利要求6所述的无导线起搏器的尾端部件，其特征在于，所述导槽具有内螺纹，或者所述导柱具有外螺纹。
  8. 根据权利要求5所述的无导线起搏器的尾端部件，其特征在于，所述第一连接件包括定位卡槽，所述定位卡槽用于与头端部件的凸出卡合件相卡 合；或者所述第一连接件包括凸出卡合件，所述凸出卡合件用于与头端部件的定位卡槽相卡合。
  9. 根据权利要求1所述的无导线起搏器的尾端部件，其特征在于，所述尾端部件包括第一部件和第二部件，所述第一部件包括主体部和凹陷部，所述第二部件套设在所述凹陷部上；其中：所述第二连接件设置于所述第二部件上，且所述第二连接件和/或第二部件可生物降解。
  10. 根据权利要求9所述的无导线起搏器的尾端部件，其特征在于，所述第二部件的外径与所述主体部的外径一致。
  11. 一种无导线起搏器的头端部件，用于与无导线起搏器的尾端部件相配合使用，其特征在于，所述头端部件包括第三连接件和第四连接件；
    所述第三连接件用于与所述尾端部件可拆卸地连接，同时所述第四连接件用于与所述尾端部件不可拆卸地或可拆卸地连接，以实现所述尾端部件与所述头端部件间的锁定；其中：所述第三连接件不可生物降解，所述第四连接件可生物降解，或者所述第四连接件与所述尾端部件通过可生物降解的对应连接件配合连接。
  12. 根据权利要求11所述的无导线起搏器的头端部件，其特征在于，所述第四连接件用于与所述尾端部件卡扣连接或销连接。
  13. 根据权利要求12所述的无导线起搏器的头端部件，其特征在于，所述第四连接件包括销孔，所述销孔与所述尾端部件的销孔对位，并用于供可生物降解的定位销插设。
  14. 根据权利要求12所述的无导线起搏器的头端部件，其特征在于，所述第四连接件包括定位卡槽，所述定位卡槽用于与尾端部件的凸出卡合件相卡合；或者，所述第四连接件包括凸出卡合件，所述凸出卡合件由生物可降解材料制成，且所述凸出卡合件用于与尾端部件的定位卡槽相卡合，并被配置为当无导线起搏器植入体内预定时间以后开始降解。
  15. 根据权利要求11所述的无导线起搏器的头端部件，其特征在于，所述第三连接件用于与所述尾端部件螺纹连接、卡扣连接或过盈配合连接。
  16. 根据权利要求15所述的无导线起搏器的头端部件，其特征在于，所 述第三连接件包括导槽，所述导槽用于与尾端部件的导柱相适配；或者，所述第三连接件包括导柱，所述导柱用于与尾端部件的导槽相适配。
  17. 根据权利要求16所述的无导线起搏器的尾端部件，其特征在于，所述导槽具有内螺纹；或者所述导柱具有外螺纹。
  18. 根据权利要求15所述的无导线起搏器的头端部件，其特征在于，所述第三连接件包括定位卡槽，所述定位卡槽用于与尾端部件的凸出卡合件相卡合；或者所述第三连接件包括凸出卡合件，所述凸出卡合件用于与尾端部件的定位卡槽相卡合。
  19. 一种无导线起搏器，其特征在于，包括：
    尾端部件，包括第一连接件和第二连接件；以及
    头端部件，用于固定于预定对象，所述头端部件包括第三连接件和第四连接件；
    所述第一连接件与所述第三连接件可拆卸地连接，同时所述第二连接件与所述第四连接件不可拆卸地或可拆卸地连接，以实现所述尾端部件与所述头端部件间的锁定；其中：所述第一连接件和所述第三连接件不可生物降解；所述第二连接件和/或所述第四连接件可生物降解，或者所述第二连接件与所述第四连接件通过可生物降解的对应连接件配合连接。
  20. 根据权利要求19所述的无导线起搏器，其特征在于，所述第一连接件与所述第三连接件螺纹连接，所述第二连接件与所述第四连接件卡扣连接，所述第二连接件和所述第四连接件中的一个包括定位卡槽，所述第二连接件和所述第四连接件中的另一个包括凸出卡合件，所述定位卡槽呈环状设置。
  21. 根据权利要求19所述的无导线起搏器，其特征在于，所述第二连接件与所述第四连接件分别包括销孔，且所述尾端部件的销孔与所述头端部件的销孔对位；所述可生物降解的对应连接件包括定位销，所述定位销插设于所述尾端部件的销孔与所述头端部件的销孔，且所述定位销被配置为当无导线起搏器植入体内预定时间以后开始降解。
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