WO2019196851A1 - 心脏植入装置及起搏系统 - Google Patents

心脏植入装置及起搏系统 Download PDF

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Publication number
WO2019196851A1
WO2019196851A1 PCT/CN2019/081995 CN2019081995W WO2019196851A1 WO 2019196851 A1 WO2019196851 A1 WO 2019196851A1 CN 2019081995 W CN2019081995 W CN 2019081995W WO 2019196851 A1 WO2019196851 A1 WO 2019196851A1
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WO
WIPO (PCT)
Prior art keywords
implant device
pacemaker
cardiac
cardiac implant
support rods
Prior art date
Application number
PCT/CN2019/081995
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English (en)
French (fr)
Inventor
孙江凯
Original Assignee
创领心律管理医疗器械（上海）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
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 EP19784888.0A priority Critical patent/EP3777967A4/en
Priority to US17/046,718 priority patent/US11833358B2/en
Publication of WO2019196851A1 publication Critical patent/WO2019196851A1/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
    • A61N1/375—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
    • A61N1/362—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
    • A61N1/37205—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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • 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
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators

Definitions

  • the present invention relates to the field of cardiac medical device technology, and in particular to a cardiac implant device and a pacing system.
  • the wireless pacemaker has been gradually applied in clinical practice because of its ability to solve various complications of traditional wire pacemakers, and has broad application prospects.
  • a leadless pacemaker in the current surgery of a leadless pacemaker, a leadless pacemaker is mainly implanted in the ventricle, and the pacing is performed in the ventricular region.
  • the success rate of chronic extraction of a paceless pacemaker is about 91%. Due to the limited service life of the leadless pacemaker and the inability to remove 100%, it may result in multiple wires in the patient. The problem with the beater. Therefore, there is currently no relevant equipment, patents, literature, etc. to solve the problem of pacing atrial and low success rate of chronic extraction.
  • the device is easier to recycle and can improve the success rate of the leadless pacemaker, so it can promote the application of the wireless pacemaker and improve the patient experience.
  • an embodiment of the present invention provides a cardiac implant device including: a first connecting member; a proximal end of the first connecting member for connecting to a pacemaker; N support rods, each The proximal end of the support rod is connected to the distal end of the first connecting member, and at least one of the support rods is provided with a positioning portion for positioning when the pacemaker is implanted; The distal end of each of the support rods is in a free state and can be opened or closed; N is a natural number greater than or equal to 1.
  • the positioning portion is a needled structure or a barbed structure.
  • the positioning portion is disposed at a distal end or a middle portion of the support rod.
  • the N is greater than 1, and the proximal ends of the N support rods are evenly disposed over a portion of the circumference of the distal end of the first connector.
  • the partial circumferential extent covers at least half a circumference.
  • the N support bars are connected to the distal end of the first connector in a welded or crimped manner.
  • the cardiac implant device is made of a biocompatible metallic material and the N support rods are made of a biocompatible elastic metal material.
  • embodiments of the present invention also provide a cardiac cardiac pacing system, including the aforementioned cardiac implant device, and a pacemaker connected to the cardiac implant device.
  • the proximal end of the first connector of the cardiac implant device is coupled to the pacemaker via a second connector.
  • first connecting member and the second connecting member are both columnar structures, and the first connecting member and the second connecting member are capable of supporting connection.
  • the second connector is mated with the first connector in the form of an internal or external thread.
  • the end of the pacemaker that is not coupled to the cardiac implant device is provided with a pull hook.
  • the N support rods of the cardiac implant device are received in a positioning sheath prior to implantation of the cardiac pacing system.
  • the cardiac implant device can not only be better positioned in certain regions of the superior vena cava of the human body, so that the leadless pacemaker can be easily implanted in the superior vena cava.
  • a leadless pacemaker can pace a position near the atrium, ie a leadless pacemaker can initiate pacing from the atria, and the pacing signal is transmitted from the atria to the ventricle. This pacing sequence is close to the pacing of the patient during natural pacing. The sequence is to achieve physiological pacing.
  • the above-mentioned cardiac implant device has a simple structure, is easy to be positioned and recovered after being collected, and the wire-free pacemaker can realize convenient operation of implantation and recovery of the leadless pacemaker by means of the above-mentioned cardiac implant device. Further, the above-mentioned cardiac implant device is stably supported in the superior vena cava, so that the leadless pacemaker can be stably implanted at the target position; the setting of the N support rods can also achieve better adhesion, perception and rise. Stroke; thus facilitating the application of a wireless pacemaker and improving the patient experience.
  • FIG. 1 is a schematic view showing a stowed state of a cardiac implant device according to a first embodiment of the present invention
  • FIG. 2 is a schematic view showing an open state of a cardiac implant device according to a first embodiment of the present invention
  • FIG. 3 is a schematic structural view of a pacemaker that can be used in conjunction with the cardiac implant device of the first embodiment of the present invention
  • FIG. 4 is a schematic view showing the connection state of the first and second connecting members and the non-wire pacemaker according to the first embodiment of the present invention
  • Figure 5 is a schematic view showing the stowed state of the cardiac implant device according to the second embodiment of the present invention.
  • FIG. 6 is a schematic view showing an open state of a cardiac implant device according to a second embodiment of the present invention.
  • Figure 7 is a schematic view showing the connection state of the cardiac implant device shown in Figure 6 and a leadless pacemaker;
  • Figure 8 is a schematic view showing the state of implantation of the cardiac implant device shown in Figure 6;
  • Figure 9 is a schematic view of the structure of the human heart.
  • FIGS. 10 and 11 are schematic views of implantation of a cardiac implant device according to an embodiment of the present invention.
  • Figure 12 is a schematic illustration of the recovery of a cardiac implant device in accordance with an embodiment of the present invention.
  • proximal and distal are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of a physician using the medical device, despite “near end” and “far” “End” is not limiting, but “proximal” generally refers to the end of the medical device that is near the physician during normal operation, while “distal” generally refers to the end that first enters the patient.
  • a first embodiment of the invention relates to a cardiac implant device 1, please refer to Figures 1 to 4, the cardiac implant device 1 comprising: a first connector 10; one end of the first connector 10 (here near The end can be used to connect to the pacemaker 2 (the pacemaker 2 is a non-wired pacemaker); the N support rods 11, the proximal end of the support rod 11 and the other end of the first connector 10 (here the distal end)
  • the at least one support rod 11 is provided with a positioning portion 111 for fixing the implant device in the superior vena cava, wherein each support rod 11 is provided with a positioning portion 111; a support rod
  • the distal end of the 11 is in a free state, and when the N support rods 11 are elastically yielded and brought closer to the axis of the first connecting member 10 when the gathering force is applied, when the gathering force is revoked, the respective support rods 11 are elastically restored and are away from the axis.
  • N is a natural number greater than or equal to 1.
  • the pacemaker 2 is preferably a leadless pacemaker.
  • the N-shaped support rods 11 are opened and positioned on the inner wall of the superior vena cava, thereby providing a stable support positioning force for the leadless pacemaker 2, and only need to be recovered when recycling is required.
  • the support rods 11 can be separated from the superior vena cava for successful recovery, and thus the cardiac implant device of the present embodiment allows the leadless pacemaker to have a very high take-up success rate.
  • the cardiac implant device of the present embodiment can implant a non-wire pacemaker in the superior vena cava, the atrial can be sensed and paced to achieve physiological pacing, which is beneficial to the application of the leadless pacemaker. To improve the patient experience.
  • the details of the implementation of the cardiac implant device of the present embodiment will be specifically described below. The following details are merely for facilitating understanding of the implementation details provided, and are not necessary for implementing the present solution.
  • the N support rods 11 serve to support the positioning of the wireless pacemaker 2, that is, the N support rods can support the weight of the entire leadless pacemaker 2, thereby enabling a post-implantation leadless pacemaker 2 does not shift.
  • the number N of the support bars 11 can be determined according to actual needs, and a plurality of, for example, four are generally selected. In this embodiment, the value of N is not specifically limited as long as the number of the support rods 11 can satisfy the implantation of the non-wire pacemaker 2 into the human vein.
  • the proximal ends of the N support rods are evenly disposed within a portion of the circumference of the distal end of the first connector 10, thereby enabling implantation of the cardiac implant device 1, the superior vena cava, and pacing
  • the force point of the device 2 is increased, so that the leadless pacemaker 2 can be more stably implanted at the target position (the superior vena cava).
  • the four support rods 11 are evenly distributed over a part of the circumference of the end portion of the first connecting member 10, so that the pacemaker 2 is stably implanted, and the superior vena cava is uniformly stressed as much as possible to avoid The vessel wall of the superior vena cava is damaged, ie the leadless pacemaker 2 can be safely implanted.
  • a portion of the circumference covers at least half of the circumference.
  • each of the four support rods 11 is fixed in a half circumference of the end surface of the cylindrical first connecting member 10.
  • the N support bars 11 may also be symmetrically distributed at the ends of the first connector 10.
  • the present embodiment does not specifically limit the connection position of the support rod 11 and the first connecting member 10 and the manner of its distribution.
  • the four support rods are welded or crimped to the other end of the first connector 10.
  • the manner of connection of the support rod 11 and the first connecting member 10 in the present embodiment is not specifically limited.
  • the cardiac implant device can also be fabricated by a 3D printing process as a whole, and the present embodiment does not specifically limit the processing technique of the cardiac implant device 1.
  • the support rod 11 includes a rod body 110, and the positioning portion 111 is disposed at a distal end or a middle portion of the rod body 110.
  • the rod body 110 and the positioning portion 111 are integrally formed.
  • the rod body 110 and the positioning portion 111 are integrally formed by using a nickel-titanium alloy, and the production process is simple and the cost is low.
  • the positioning portion 111 is disposed at a distal end of the rod body 110.
  • the connection structure of the lever body 110 and the positioning portion 111 and the processing technology and the position of the positioning portion on the rod body are not specifically limited in this embodiment.
  • the positioning portion 111 is used for positioning the cardiac implant device 1 on the inner wall of the superior vena cava and conveniently positioning and separating on the superior vena cava.
  • the superior vena cava can be the main part of the superior vena cava, and can also include the superior vena cava and the atrium.
  • the portion of the excessive region is not specifically limited in this embodiment.
  • the positioning portion 111 may be a portion on the support rod 11.
  • the positioning portion 111 may be an end portion of the support rod 11, or the positioning portion 111 may be a convex portion at the end of the support rod 11 at the support. After the rod 11 is opened, the positioning portion 111 can abut against and support the inner wall of the superior vena cava, thereby achieving support and fixation of the implanted pacemaker 2.
  • the positioning portion 111 is needle-shaped, and the needle-shaped positioning portion 111 can further penetrate the positioning to prevent the pacemaker 2 from moving during the heartbeat, so that the implanted pacemaker 2 can be provided better. Support and fixation.
  • the N support rods 11 can provide a supporting positioning force to the non-wire pacemaker 2 fixed to the cardiac implant device 1.
  • the positioning portion 111 is, for example, a conical needle-like structure, so that when the rod body 110 abuts against the inner wall of the superior vena cava, the inner wall of the superior vena cava can be pierced and positioned in the inner wall of the superior vena cava.
  • the length of the needle-like structure should be reliably positioned without causing perforation of the superior vena cava after puncture.
  • the shape and size of the needle-like structure in the present embodiment are not particularly limited.
  • Factors affecting the supporting positioning ability of the cardiac implant device 1 include the diameter and length of the rod body 110, the strength of the material, the processing process of the rod body 110, the number of the rod bodies, and the shape of the positioning portion 111, etc., and thus In the application, the cardiac implant device can be designed based on the aforementioned factors, and the present embodiment does not limit the specific structure of the support rod 11.
  • the first connecting member 10 of the cardiac implant device 1 and the pacemaker 2 are connected by a second connecting member, which can be realized by a screw connection.
  • the second connecting member can be fixedly disposed on the pacemaker 2 and can be used as a component of the pacemaker 2; or the second connecting member can be detachably connected to the pacemaker 2, for example, the second connecting member can be
  • the pacemaker 2 is connected by means of a screw connection, in which case the second connector can be used as either a component of the pacemaker 2 or as a separate device.
  • the second connecting member is connected to the first connecting member 10 in the form of an internal thread or an external thread.
  • This embodiment does not specifically limit the position of the thread on the second connecting member.
  • the embodiment has no particular limitation on the shape of the first connecting member 10 and the second connecting member, and is generally a columnar structure, and particularly a cylindrical structure is convenient for implantation into a blood vessel.
  • the implanting device is made of a biocompatible metal material.
  • the material of the first connecting member 10 can be MP35N, and the MP35N alloy is a non-magnetic nickel-cobalt-chromium-molybdenum alloy, which has a unique super high.
  • the support rod 11 can be made of a biocompatible elastic metal material, for example, made of nickel-titanium alloy.
  • the support rod 11 can also adopt other The biocompatible and super-elastic metal material is fabricated to avoid damage to the human body by the cardiac implant device. The above embodiments do not specifically limit the above materials.
  • the heart implant device 1 when the N support rods 11 are stowed by the contraction force, for example, the heart implant device 1 is housed in the contraction sheath tube (see FIG. 11), and has an umbrella-like or bundle-like structure, that is, The contraction sheath provides an external force to elastically deform the N support rods 11 to be stowed. At this time, it is convenient to feed the whole heart implant device 1 into the superior vena cava when the cardiac implant device 1 protrudes from the contraction sheath tube.
  • the contracting force applied by the contraction sheath to the N support rods 11 is revoked, and the N support rods 11 are automatically opened by their own elasticity, so that the positioning portions 111 of the N support rods 11 abut against the inner wall of the superior vena cava, thereby The cardiac implant device 1 is supported for positioning within the superior vena cava.
  • the N support rods 11 can be brought closer to the axial direction of the first connecting member 10 and stowed when the gathering force is received, so that the cardiac implant device 1 can be conveniently sent.
  • the folding force is cancelled, and the N support rods 11 can be automatically opened, so that there will be no
  • the lead pacemaker 2 is supported in the superior vena cava.
  • the leadless pacemaker 2 when it is required to take out the leadless pacemaker 2 chronically, it is only necessary to apply a gathering force to the N support rods 11, for example, by fitting the contraction sheath tube to the heart implant device 1, thereby applying a contraction to the N support rods 11.
  • the heart implant device 1 can be separated from the superior vena cava as a whole, and the cardiac implant device 1 can be stowed, and then the recovery of the leadless pacemaker 2 can be achieved. Since the cardiac implant device 1 is simple and easy to recover, and the cardiac implant device 1 is easily separated from the superior vena cava, the recovery success rate is high.
  • the cardiac implant device 1 of the present embodiment can not only facilitate the convenient and reliable implantation of the wireless pacemaker 2 in the superior vena cava, but also realize the atrial perception and pacing function of the leadless pacemaker 2, and in the chronic When recycling, the recycling success rate is higher, which is beneficial to promote the application of the wireless pacemaker 2.
  • a second embodiment of the present invention relates to a cardiac implant device, and the present embodiment specifically provides an alternative structure of the positioning portion 111 of the cardiac implant device 1.
  • the positioning portion 111 has a barbed structure.
  • the sharp end of the barbed structure provides an upward support force to the leadless pacemaker 2 after obliquely penetrating the inner wall of the superior vena cava.
  • the gathering force acts on the support rod 11
  • the barbed positioning portion 111 can be smoothly retracted and separated from the superior vena cava without affecting the removal of the cardiac implant device.
  • the present embodiment does not specifically limit the shape, size, and the like of the barb structure.
  • the present embodiment adopts the barbed positioning portion 111, so that the cardiac implant device 1 can be more reliably supported and positioned in the inner wall of the superior vena cava, thereby enabling the implantation of the leadless pacemaker 2.
  • the position is more stable.
  • FIG. 9 shows the right atrium 30, the right ventricle 31, the superior vena cava 32, and the inferior vena cava 33 of the heart.
  • FIG. 8 shows the structural diagram of the cardiac implant device of the present embodiment shown in Fig. 8 implanted in the superior vena cava.
  • the support rod 11 is fixed in the half circumference of the circular end surface of the first connecting member 10
  • the non-wire pacemaker 2 is implanted into the superior vena cava 32
  • the non-wire pacemaker 2 is on the N support rods.
  • the abutment of 11 abuts against the inner wall of the superior vena cava 32, thereby facilitating the senseless pacemaker perception and pacing of the atria.
  • the present embodiment makes the positioning of the leadless pacemaker more stable and reliable.
  • Embodiments of the present invention also provide a cardiac cardiac pacing system comprising the aforementioned implant device, and a pacemaker coupled thereto.
  • the support rod of the implant device is received in the positioning sheath prior to implantation; the other end of the pacemaker (here the proximal end, ie the end not connected to the cardiac implant device)
  • the part is provided with a hook which is a connection position for taking out the sheath lasso when the cardiac implant device is being recovered.
  • the procedure for implanting the leadless pacemaker 2 is as follows:
  • the operator first penetrates the guiding sheath 40 through the femoral vein and the inferior vena cava 33, and then the contraction sheath 41 into which the cardiac implant device 1 and the leadless pacemaker 2 are loaded and
  • the positioning sheath 42 is slowly fed into the SVC32 position of the patient through the guiding sheath 40, and is moved under X-ray, and the sheath tube 41 is rotated and contracted to determine the implantation position of the non-wire pacemaker 2, and the position is confirmed repeatedly.
  • the contraction sheath 41 is slowly withdrawn until the cardiac implant device 1 is fully popped and released, and the cardiac implant device 1 fixes the leadless pacemaker 2 to the SVC wall.
  • FIG. 8 for the structure after implantation.
  • the chronic removal procedure for the leadless pacemaker 2 is as follows:
  • the operator first penetrates the guiding sheath 40 through the femoral vein and the inferior vena cava 33, and then slowly introduces the contraction sheath tube 41 and the removal sheath tube 43 through the guiding sheath 40 under X-ray. Slowly move to the position of the leadless pacemaker 2, slowly extend out the sheath tube 43 and take out the lasso 44 in the front section of the sheath tube 43 to fix the noose 44 on the hook of the leadless pacemaker 2, and fix it.
  • the contraction sheath tube 41 is gradually pushed to the position of the cardiac implant device 1, and after the sheath tube 43 is pulled out, the contraction sheath tube 41 is gradually pushed inwardly, and the cardiac implant device 1 is recovered. Inside the contraction sheath 41, the removal sheath 43 and the contraction sheath 41 are slowly removed, and finally the guide sheath 40 is removed.

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Abstract

本发明涉及心律医疗设备技术领域，公开了一种心脏植入装置和起搏系统。本发明中，该心脏植入装置，包括：第一连接件；所述第一连接件的一端用于与起搏器相连；N个支撑杆，支撑杆的近端与所述第一连接件的另一端相连接，支撑杆上设置有定位部，用于植入时的固定，远端处于自由状态，可以张开或收拢；以及公开了包含以上植入装置和起搏器的起搏系统。采用本发明，能够将无导线起搏器植入人体上腔静脉内，使其对心房进行感知和起搏，并且使得无导线起搏器更易于回收，提高无导线起搏器慢性取出成功率，从而有利于推动无导线起搏器的应用，改善患者使用体验。

Description

心脏植入装置及起搏系统 技术领域
本发明涉及心律医疗设备技术领域，特别涉及一种心脏植入装置和起搏系统。
背景技术
随着技术的发展，无导线起搏器由于能够解决传统导线起搏器的多种并发症问题，正逐渐在临床得到应用，并具有广阔的应用前景。
发明人发现现有技术中至少存在如下问题：目前的无导线起搏器的手术中，无导线起搏器主要被植入在心室中，在心室区域进行感知起搏。据相关文献报道，无导线起搏器的慢性取出成功率约为91％，由于无导线起搏器的使用寿命有限，且无法100％取出，可能由此导致患者体内同时存在多个无导线起搏器的问题。因此，目前尚无相关器械及专利、文献等解决起搏心房以及慢性取出成功率低的问题。
发明内容
本发明的目的在于提供一种心脏植入装置和心脏起搏系统，能够将无导线起搏器植入在人体上腔静脉内，使其对心房进行感知和起搏，并且使得无导线起搏器更易于回收，能够提高无导线起搏器慢性取出成功率，从而有利于推动无导线起搏器的应用，提高患者使用体验。
为解决上述技术问题，本发明的实施方式提供了一种心脏植入装置，包括：第一连接件；所述第一连接件的近端用于与起搏器相连；N个支撑杆，每个所述支撑杆的近端与所述第一连接件的远端相连接，至少一个所述支撑杆上设置有定位部，所述定位部用于所述起搏器植入时的定位；每个所述支撑杆的远端处于自由状态，可以张开或收拢；N为大于或者等于1的自然数。
在另一实施方式中，所述定位部为针刺状结构或者倒钩状结构。
在另一实施方式中，所述定位部设置在所述支撑杆的远端或中部。
在另一实施方式中，所述N大于1，所述N个支撑杆的近端在所述第一 连接件远端端部的部分圆周范围内均匀设置。
在另一实施方式中，所述部分圆周范围覆盖至少半个圆周。
在另一实施方式中，所述N个支撑杆与所述第一连接件的远端以焊接或压接的方式连接。
在另一实施方式中，所述心脏植入装置由生物相容性金属材料制成，所述N个支撑杆由生物相容性弹性金属材料制成。
另为解决上述技术问题，本发明的实施方式还提供了一种心脏心脏起搏系统，包括前述心脏植入装置，以及与所述心脏植入装置连接的起搏器。
在另一实施方式中，所述心脏植入装置的第一连接件的近端与所述起搏器通过一第二连接件相连。
在另一实施方式中，所述第一连接件和所述第二连接件均为柱状结构，且所述第一连接件和所述第二连接件能够配套连接。
在另一实施方式中，所述第二连接件以内螺纹或外螺纹的形式与所述第一连接件配套连接。
在另一实施方式中，所述起搏器的未与所述心脏植入装置连接的端部设置有拉钩。
在另一实施方式中，所述心脏起搏系统植入前，所述心脏植入装置的所述N个支撑杆容纳在一定位鞘管中。
本发明相对于现有技术而言，所述心脏植入装置不仅可以更好的定位在人体上腔静脉内某些区域，使得无导线起搏器较容易地植入在上腔静脉内，实现无导线起搏器能够起搏心房附近的位置，即无导线起搏器能够由心房开始起搏，进而起搏信号由心房传送至心室，这个起搏顺序接近于患者自然起搏时的起搏顺序，实现生理性起搏。上述心脏植入装置结构简单，易于定位和收拢后回收，无导线起搏器借助于上述心脏植入装置，可以实现无导线起搏器的植入与回收的便利操作。进一步地，上述心脏植入装置在上腔静脉内支撑稳定，使得无导线起搏器能够稳定地植入在目标位置处；N个支撑杆的设置也能实现较好的贴壁、感知和起搏；从而有利于推动无导线起搏器的应用，改善患者使用体验。
附图说明
一个或多个实施例通过与之对应的附图进行示例性说明，这些示例性说明并不构成对实施例的限定，附图中具有相同参考数字标号的元件表示为相同/类似的元件，除非有特别申明，附图中的图示不构成比例限制。
图1是根据本发明第一实施方式的心脏植入装置的收起状态示意图；
图2是根据本发明第一实施方式的心脏植入装置的张开状态示意图；
图3是可与本发明第一实施方式的心脏植入装置配合使用的起搏器的结构示意图；
图4是根据本发明第一实施方式的第一、第二连接件与无导线起搏器的连接状态示意图；
图5是根据本发明第二实施方式的心脏植入装置的收起状态示意图；
图6是根据本发明第二实施方式的心脏植入装置的张开状态示意图；
图7是图6所示的心脏植入装置与无导线起搏器的连接状态示意图；
图8是图6所示的心脏植入装置的植入状态示意图；
图9是人体心脏结构示意图；
图10和图11是根据本发明实施方式的心脏植入装置的植入示意图；
图12是根据本发明实施方式的心脏植入装置的回收示意图。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将结合附图对本发明的各实施方式进行详细的阐述。然而，本领域的普通技术人员可以理解，在本发明各实施方式中，为了使读者更好地理解本申请而提出了许多技术细节。但是，即使没有这些技术细节和基于以下各实施方式的种种变化和修改，也可以实现本申请所要求保护的技术方案。
在本申请文件中，“近端”和“远端”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”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”通常是指首先进入患者体内的一端。
本发明的第一实施方式涉及一种心脏植入装置1，请参阅图1至图4，该心脏植入装置1包括：第一连接件10；第一连接件10的一端(在此为近端)可用于与起搏器2相连(起搏器2为无导线起搏器)；N个支撑杆11，支撑杆11的近端与第一连接件10的另一端(在此为远端)相连接，至少一个支撑杆11上设置有定位部111，用于将植入装置植入时固定在上腔静脉内，在此，每个支撑杆11上均设置有定位部111；支撑杆11的远端处于自由状态，当N个支撑杆11在被施加收拢力时将弹性屈服并向第一连接件10的轴线靠拢，在收拢力被撤销时，各支撑杆11弹性恢复后远离轴线，N为大于或者等于1的自然数。其中，起搏器2优选为无导线起搏器。本实施方式的心脏植入装置在自然状态下，N个支撑杆11张开且定位在上腔静脉内壁，从而为无导线起搏器2提供稳定的支撑定位力，当需要回收时，只需要向各支撑杆11施加收拢力，即可将各支撑杆11与上腔静脉分离，实现成功回收，因此本实施方式的心脏植入装置使得无导线起搏器具有非常高的取出成功率。由于本实施方式的心脏植入装置可将无导线起搏器植入在上腔静脉内，从而可对心房进行感知和起搏，实现生理性起搏，有利于推动无导线起搏器的应用，提高患者使用体验。下面对本实施方式的心脏植入装置的实现细节进行具体的说明，以下内容仅为方便理解提供的实现细节，并非实施本方案的必须。
在实施方式中，N个支撑杆11起到支撑定位无导线起搏器2的作用，即N个支撑杆可以支撑整个无导线起搏器2的重量，从而使得植入后无导线起搏器2不会发生位移。在不同实施方式中，支撑杆11的数量N可以根据实际需要确定，一般选取多个，例如4个。本实施方式对于N的取值不做具体限制，只要支撑杆11的数量能够满足将无导线起搏器2植入人体静脉内即可。
当N大于1时，N个支撑杆的近端在第一连接件10远端端部的部分圆周范围内均匀设置，由此能够使得心脏植入装置1植入后，上腔静脉以及起搏器2受力点增多，使得无导线起搏器2能够更稳定地植入在目标位置(上腔静脉)。在本实施方式中，4个支撑杆11均匀分布在第一连接件10端部的部分圆周范围，这样，起搏器2在稳定植入的同时，上腔静脉尽可能地受力均 匀，避免上腔静脉的血管壁受到损坏，即使得无导线起搏器2能够安全植入。本实施例中，部分圆周范围覆盖至少半个圆周。这样，N个支撑杆11之间的两两支撑杆11的端部相对距离较大，以尽可能地避免影响上腔静脉内的血液流通，使得心脏植入装置1和起搏器2植入后，上腔静脉中的血流正常。请参阅图5，4个支撑杆11的一端均固定在圆柱状第一连接件10端面的半圆周内。在一些例子中，N个支撑杆11还可以对称地分布在第一连接件10的端部。本实施方式对于支撑杆11与第一连接件10的连接位置及其分布方式均不作具体限制。在实施方式中，4个支撑杆与第一连接件10的另一端焊接或压接连接。本实施方式对于支撑杆11以及第一连接件10的连接方式不作具体限制。在一个例子中，心脏植入装置整体还可以采用3D打印工艺制作，本实施方式对于心脏植入装置1的加工工艺不作具体限制。
支撑杆11包括与杆本体110，定位部111设置在杆本体110的远端或中部。本实施方式中，杆本体110与定位部111为一体成型结构，例如，杆本体110以及定位部111均采用镍钛合金一体成型制成，生产工艺简单、成本低。定位部111设置在杆本体110的远端。本实施方式对于杆本体110以及定位部111的连接结构以及加工工艺以及定位部在杆本体上的位置均不做具体限制。
定位部111用于将心脏植入装置1定位在上腔静脉内壁，并方便在上腔静脉上定位和分离，上腔静脉既可以是上腔静脉的主体部分，也可以包括上腔静脉与心房过度区的部分，本实施方式对此不作具体限制。其中，定位部111可以是支撑杆11上的一个部分，例如定位部111可以是支撑杆11的端部，或者，定位部111可以是位于支撑杆11的端部的一凸起部，在支撑杆11张开后，定位部111能够抵靠、撑住上腔静脉的内壁，从而实现对于植入的起搏器2的支撑与固定。
优选的，定位部111为针刺状，针刺状的定位部111可以进一步刺入定位，防止在心脏跳动过程中起搏器2发生移动，从而可以提供植入的起搏器2更好的支撑与固定作用。当针刺状结构的定位部111刺入上腔静脉内壁后，N个支撑杆11能够对固定在心脏植入装置1上的无导线起搏器2提供支撑定位力。具体地，定位部111例如采用圆锥形针刺状结构，从而可以在杆本体110 抵靠在上腔静脉内壁时，刺破上腔静脉内壁，并定位在上腔静脉内壁内。其中，针刺状结构的长度应在刺入后不引起上腔静脉穿孔的情况下实现可靠定位，本实施方式对于针刺状结构的形状以及尺寸等均不作具体限制。
对心脏植入装置1的支撑定位能力产生影响的因素包括：杆本体110的直径、长度、材料的强度、杆本体110的处理工艺、杆本体的数量以及定位部111的形状等，因此在实际应用中，可以基于前述因素对心脏植入装置进行设计，本实施方式对于支撑杆11的具体结构不做限制。
请参阅图3所示的无导线起搏器2的结构示意图以及图4所示的心脏植入装置1与无导线起搏器2配合使用的结构示意图。其中，心脏植入装置1的第一连接件10与起搏器2通过第二连接件相连，可以采用螺纹连接的方式实现。其中，第二连接件可以固定设置在起搏器2上，并可作为起搏器2的一个部件；或者，第二连接件可与起搏器2可拆卸连接，例如，第二连接件可通过螺纹连接的方式与起搏器2连接，此时，第二连接件既可作为起搏器2的一个部件，也可作为一个独立的装置。具体的，第二连接件以内螺纹或外螺纹的形式与第一连接件10连接。本实施方式对于第二连接件上的螺纹位置不作具体限制。本实施方式对于第一连接件10和第二连接件的形状不作具体限制，一般为柱状结构，特别是圆柱状结构便于植入血管内。
本实施方式中，植入装置由生物相容性金属材料制成，例如，第一连接件10的材质可以采用MP35N，MP35N合金是一种无磁的镍钴铬钼合金，具有独特的超高抗拉强度、良好的延展性、韧性以及极佳的抗腐蚀性；支撑杆11可以由生物相容性弹性金属材料制成，例如采用镍钛合金制成，当然，支撑杆11还可以采用其他生物相容性佳、超弹性的金属材料制作，从而避免心脏植入装置对人体造成损害，本实施方式对以上材料不作具体限制。
本实施方式中，N个支撑杆11在收拢力的作用下收起时，例如心脏植入装置1被收纳于收缩鞘管(请参看图11)内时呈类似伞状或者束状结构，即收缩鞘管提供了外力使得N个支撑杆11发生弹性形变从而被收起，此时，便于将心脏植入装置1整体送入上腔静脉内，当心脏植入装置1从收缩鞘管伸出时，收缩鞘管对N个支撑杆11施加的收拢力被撤销，N个支撑杆11依靠 自身弹性自动张开，使得N个支撑杆11的定位部111抵靠上腔静脉的内壁，从而使得心脏植入装置1支撑定位在上腔静脉内。
本发明实施方式相对于现有技术而言，在受到收拢力时，N个支撑杆11能够向第一连接件10的轴线方向靠拢并收起，从而使得心脏植入装置1能够方便地被送入上腔静脉内，从而将无导线起搏器2送入到位，并且在无导线起搏器2送入到位时，撤销该收拢力，则N个支撑杆11能够自动张开，从而将无导线起搏器2支撑定位在上腔静脉内。通过本实施方式的植入装置的结构，使得无导线起搏器2的植入非常方便。并且，在需要慢性取出无导线起搏器2时，只需要向N个支撑杆11施加收拢力，例如通过将收缩鞘管套在心脏植入装置1上，从而向N个支撑杆11施加收拢力，心脏植入装置1整体与上腔静脉即可分离，心脏植入装置1即可被收起，然后即可实现无导线起搏器2的回收。由于心脏植入装置1回收操作简单、容易，且心脏植入装置1与上腔静脉易分离，所以回收成功率很高。因此，本实施方式的心脏植入装置1不仅能够将无导线起搏器2方便、可靠地植入在上腔静脉内，实现无导线起搏器2对心房感知和起搏功能，而且在慢性回收时，回收成功率更高，从而有利于推动无导线起搏器2的应用。
本发明的第二实施方式涉及一种心脏植入装置，本实施方式具体提供了一种心脏植入装置1的定位部111的替代结构。
请参阅图6、图7，本实施方式中，定位部111为倒钩状结构。倒钩状结构的尖锐端在斜向下刺入上腔静脉内壁后，能够对无导线起搏器2提供向上的支撑力。而当收拢力作用在支撑杆11上时，倒钩状定位部111可以顺利回退，并与上腔静脉分离，不会影响心脏植入装置的取出。本实施方式对于倒钩状结构的形状以及尺寸等均不做具体限制。
本实施方式与第一实施方式相比，采用倒钩状定位部111，从而使得心脏植入装置1能够更可靠地支撑定位在上腔静脉内壁内，进而使得无导线起搏器2的植入位置更稳定。
请参阅图9所示的人体心脏结构示意图，图9示出了心脏的右心房30、右心室31、上腔静脉32以及下腔静脉33等。请参阅图8所示的本实施方式 的心脏植入装置植入在上腔静脉内的结构示意图。其中，由于支撑杆11固定在第一连接件10的圆形端面的半圆周内，所以在无导线起搏器2植入上腔静脉32内时，无导线起搏器2在N个支撑杆11的抵靠作用下抵靠在上腔静脉32的内壁上，从而有利于无导线起搏器感知和起搏心房。
本实施方式与第一实施方式相比，使得无导线起搏器的定位更稳定、可靠。
本发明的实施方式还提供了一种心脏心脏起搏系统，包括前述植入装置，以及与其连接的起搏器。在另一实施方式中，的植入装置的支撑杆在植入前被容纳在定位鞘管中；起搏器的另一端(在此为近端，也即未与心脏植入装置连接的端部)设置有拉钩，在心脏植入装置在回收时，该拉钩为取出鞘管套索的连接位置。
接下来，对以上实施方式的心脏植入装置1的植入方法以及回收方法进行举例说明如下：
无导线起搏器2的植入步骤如下：
请参阅图10、图11，术者先通过股静脉、下腔静脉33穿入导引鞘管40，再将装入了心脏植入装置1以及无导线起搏器2的收缩鞘管41和定位鞘管42通过导引鞘管40缓缓送入到患者的SVC32位置，在X光下移动、旋转收缩鞘管41来确定无导线起搏器2的植入位置，反复确认位置无误后缓缓撤回收缩鞘管41直至心脏植入装置1完全弹开、释放，心脏植入装置1将无导线起搏器2固定在SVC壁上，植入后的结构请继续参阅图8。
无导线起搏器2的慢性取出步骤如下：
请参阅图12，术者先通过股静脉、下腔静脉33穿入导引鞘管40，再将收缩鞘管41和取出鞘管43通过导引鞘管40缓缓送入，在X光下缓缓移动至无导线起搏器2的位置，缓缓伸出取出鞘管43和取出鞘管43前段的套索44，将套索44固定在无导线起搏器2的拉钩上，固定住无导线起搏器2后，缓缓推动收缩鞘管41到达心脏植入装置1的位置后，一边拉取出鞘管43，一边缓缓向内推收缩鞘管41，将心脏植入装置1回收至收缩鞘管41内，再缓缓移出取出鞘管43和收缩鞘管41，最后移出导引鞘管40。
应当理解，以上植入步骤以及慢性取出步骤仅是举例说明而不应当以此为限。
本领域的普通技术人员可以理解，上述各实施方式是实现本发明的具体实施例，而在实际应用中，可以在形式上和细节上对其作各种改变，而不偏离本发明的精神和范围。

Claims (13)

  1. 一种心脏植入装置，其特征在于，包括：
    第一连接件；所述第一连接件的近端用于与起搏器相连；
    N个支撑杆，每个所述支撑杆的近端与所述第一连接件的远端相连接，至少一个所述支撑杆上设置有定位部，所述定位部用于所述起搏器植入时的定位；每个所述支撑杆的远端处于自由状态，可以张开或收拢；N为大于或者等于1的自然数。
  2. 根据权利要求1所述的心脏植入装置，其特征在于，所述定位部为针刺状结构或者倒钩状结构。
  3. 根据权利要求1所述的心脏植入装置，其特征在于，所述定位部设置在所述支撑杆的远端或中部。
  4. 根据权利要求1所述的心脏植入装置，其特征在于，所述N大于1，所述N个支撑杆的近端在所述第一连接件远端端部的部分圆周范围内均匀设置。
  5. 根据权利要求4所述的心脏植入装置，其特征在于，所述部分圆周范围覆盖至少半个圆周。
  6. 根据权利要求1所述的心脏植入装置，其特征在于，所述N个支撑杆与所述第一连接件的远端以焊接或压接的方式连接。
  7. 根据权利要求6所述的心脏植入装置，其特征在于，所述心脏植入装置由生物相容性金属材料制成，所述N个支撑杆由生物相容性弹性金属材料制成。
  8. 一种心脏起搏系统，其特征在于，包括如权利要求1-7中任一项所述的心脏植入装置，以及与所述心脏植入装置连接的起搏器。
  9. 根据权利要求8所述的心脏起搏系统，其特征在于，所述心脏植入装置的第一连接件的近端与所述起搏器通过一第二连接件相连。
  10. 根据权利要求9所述的心脏起搏系统，其特征在于，所述第一连接件和所述第二连接件均为柱状结构，且所述第一连接件和所述第二连接件能 够配套连接。
  11. 根据权利要求10所述的心脏起搏系统，其特征在于，所述第二连接件以内螺纹或外螺纹的形式与所述第一连接件配套连接。
  12. 根据权利要求8所述的心脏起搏系统，其特征在于，所述起搏器的未与所述心脏植入装置连接的端部设置有拉钩。
  13. 根据权利要求8所述的心脏起搏系统，其特征在于，所述心脏起搏系统植入前，所述心脏植入装置的所述N个支撑杆容纳在一定位鞘管中。
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