WO2020043205A1 - 输送装置、心脏起搏装置及其固定结构 - Google Patents

输送装置、心脏起搏装置及其固定结构 Download PDF

Info

Publication number
WO2020043205A1
WO2020043205A1 PCT/CN2019/103839 CN2019103839W WO2020043205A1 WO 2020043205 A1 WO2020043205 A1 WO 2020043205A1 CN 2019103839 W CN2019103839 W CN 2019103839W WO 2020043205 A1 WO2020043205 A1 WO 2020043205A1
Authority
WO
WIPO (PCT)
Prior art keywords
driving member
inner cavity
fixing structure
sheath
housing
Prior art date
Application number
PCT/CN2019/103839
Other languages
English (en)
French (fr)
Inventor
程志军
杨莹
王励
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.)
Filing date
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 US17/271,870 priority Critical patent/US11896836B2/en
Priority to EP19854873.7A priority patent/EP3845270A4/en
Publication of WO2020043205A1 publication Critical patent/WO2020043205A1/zh

Links

Images

Classifications

    • 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
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/057—Anchoring means; Means for fixing the head inside the heart
    • 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
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/057—Anchoring means; Means for fixing the head inside the heart
    • A61N2001/058—Fixing tools

Definitions

  • the present invention relates to the technical field of medical instruments, and in particular, to a delivery device, a cardiac pacing device, and a fixing structure thereof.
  • pacemakers Since the introduction of pacemakers in 1958, it has become the first-line treatment for bradycardia. After more than half a century of development and innovation, the pacemaker has evolved from the initial open chest implantation of a single lead to pace the ventricle, and has gradually developed to intravenously implant 2 to 3 leads to provide atrioventricular physiological pacing or even double ventricles Pacing in sync.
  • lead dislocation, thrombosis, tricuspid regurgitation, and infection-related complications have not only affected the normal use of pacemakers, but also seriously endangered patients' health and quality of life. Among them, it is necessary to remove the lead as early as possible when it is infected with the complications related to the lead. However, the removal of the lead has certain difficulties and risks. This work usually needs to be completed by a large electrophysiology center and skilled doctors. The workload is large. In order to overcome these problems caused by the use of lead wires, "wireless" pacemakers have become the new development direction of the current arrhythmia treatment.
  • a leadless pacemaker includes a fixing mechanism separate from the pacemaker electrode and having a diameter equal to or smaller than the outer diameter of the pacemaker.
  • the fixing mechanism allows the pacemaker to be inserted into the tissue through 2 rotations to contact the tissue to fix the pacemaker. Stroke electrode.
  • Some leadless pacemakers also have a donut-shaped structure at the proximal end of the leadless pacemaker. When the leadless pacemaker's fixing mechanism fails, the donut-shaped pacemaker can stay in the pacemaker. In the right ventricle, prevent it from harming the patient after entering the blood circulation system.
  • the pacemaker When the leadless pacemaker is implanted in the heart, the pacemaker is delivered to the right ventricular apex using a delivery system, and the pacemaker is rotated so that the spiral structure at the distal end of the pacemaker is screwed into the right ventricular apex.
  • the atrium wall Because the atrium wall is thin, if the spiral structure is fixed to the thin-walled atrium, it will bring major risks such as insecure fixation and atrial perforation. Therefore, the existing leadless pacemaker can only be fixed at the right ventricular apex, so that the current leadless pacemaker can only achieve single-chamber pacing of the ventricle and cannot achieve dual-chamber pacing (DDD pacing mode).
  • DDD pacing mode dual-chamber pacing
  • the object of the present invention is to provide a delivery device, a cardiac pacing device and a fixing structure thereof, which are not only limited by the thickness of the tissue wall, but are convenient to fix, and can achieve pacing of the atrium or ventricle, that is, dual-chamber pacing.
  • This method is used to treat arrhythmia, and the structure is simple, and the pacing position can be recovered and readjusted.
  • a fixed structure includes:
  • a shell having a first inner cavity and a groove, the groove is radially opened on the outer surface of the shell and penetrates the first inner cavity;
  • a driving member the driving member is partially received in the first inner cavity, and one end of the driving member extends from a proximal end of the first inner cavity;
  • An elastic member is accommodated in the first inner cavity, and one end of the elastic member is connected to the driving member, and the other end extends to the outside of the driving member and extends into the recess. groove;
  • the driving member is cooperatively connected with the casing, and the driving member can drive the elastic member to move in the groove along the axial direction of the casing, so that the elastic member protrudes Or retract the groove.
  • the driving member has an external thread
  • an inner wall of the housing corresponding to the first inner cavity has an internal thread that cooperates with the external thread
  • the elastic member is configured to be able to communicate with the driving member. Make relative movements in the circumferential direction.
  • the fixed structure further includes:
  • a washer having a central hole, and the washer is sleeved on the distal end of the driving member through the central hole, for limiting the axial displacement of the elastic member.
  • an end of the driving member protruding from the first inner cavity is in a polygonal prism shape.
  • proximal end of the shell is polygonal.
  • the fixed structure further includes:
  • a first limiting portion, the first limiting portion is configured to limit a distance that the driving member moves in a distal direction of the housing; and / or,
  • a second limiting portion is used to limit the distance that the driving member moves in the proximal direction of the casing.
  • the first inner cavity is a T-shaped structure
  • the T-shaped structure has a top surface and a bottom surface opposite to each other, the top surface forms the first limiting portion, and the bottom surface forms the first Second limit department.
  • the driving member has a stopping portion located at a distal end of the driving member, the stopping portion has a first surface and a second surface opposite to each other, and the first surface of the stopping portion is used to resist Abutting the top surface of the first inner cavity, the second surface of the stop portion is used to abut the bottom surface of the first inner cavity.
  • the stop portion is in a cross shape or a T shape.
  • the fixing structure includes a plurality of the elastic members, and the plurality of the elastic members are arranged at intervals around the axis of the driving member.
  • the elastic member has a long shape and has a tip portion, and the tip portion is used to penetrate a predetermined object.
  • the groove is inclined toward the proximal end or the distal end of the casing.
  • the casing further has a second internal cavity, and the second internal cavity and the first internal cavity are disposed separately from each other in the axial direction of the casing.
  • a cardiac pacing device which includes the fixed structure according to any one of the foregoing, and a leadless pacemaker provided on the fixed structure.
  • the casing of the fixed structure further has a second internal cavity, which is separately provided from the first internal cavity in the axial direction of the casing;
  • the leadless pacemaker includes:
  • a control portion provided in the second inner cavity of the housing
  • each of the electrodes is connected to the control portion, each of the electrodes is disposed on the housing, and each of the electrodes is used to contact a predetermined object.
  • a delivery device for delivering the cardiac pacing device, which includes:
  • a retractable sheath the distal end of the retractable sheath for detachably connecting with the proximal end of the shell;
  • a driving sheath, a distal end of the driving sheath is used to be detachably connected with one end of the driving member protruding from the first inner cavity;
  • the driving sheath is movably inserted into the retracting sheath and cooperates with the retracting sheath to push the cardiac pacing device to a target position and drive the driving member relative to the Said shell movement.
  • the distal end of the retractable sheath has a first polygonal inner hole, and the first polygonal inner hole is used for cooperative connection with the proximal end of the housing in a polygonal prism shape; the drive The distal end of the sheath has a second polygonal inner hole, and the second polygonal inner hole is used for cooperative connection with an end of the driving member in a polygonal column shape protruding from the first inner cavity.
  • the delivery device, the cardiac pacing device and the fixing structure provided by the present invention have the following beneficial effects:
  • the present invention uses a conveying device to drive a driving member of a cardiac pacing device to move, and the driving member drives the elastic member to reciprocate in a groove of the housing, thereby realizing the elastic member to be retractable.
  • the tissue wall can be pierced to fix the cardiac pacing device at a target position in the body, and when one end of the elastic member is retracted into the groove, the cardiac pacing device can be recovered and the heart can be made by the delivery device.
  • the pacing device can be readjusted during the implantation process to facilitate the fixation of the cardiac pacing device at the optimal pacing point;
  • the present invention utilizes the threaded cooperation of the driving member and the casing to facilitate the conversion of the rotational movement of the two into an axial movement, thereby driving the elastic member to reciprocate in the groove, the structure is simple, and the operation is convenient;
  • the elastic member of the present invention is long and has a tip portion, which can directly penetrate into the tissue wall. There is basically no requirement on the thickness of the tissue wall, and the depth of penetration is adjusted by telescopic movement, which makes it more convenient to fix. Therefore, the leadless pacing device can be fixed in the ventricle or in the atrium, thereby achieving dual-chamber pacing and achieving atrioventricular synchronized physiological pacing.
  • FIG. 1 is a perspective view of a cardiac pacing device provided by an embodiment of the present invention.
  • FIG. 2 is an axial sectional view of the cardiac pacing device shown in FIG. 1;
  • FIG. 3 is a partial enlarged view of the cardiac pacing device shown in FIG. 2 in the area C;
  • FIG. 4 is a partial axial sectional view of a conveying device in an embodiment of the present invention.
  • FIG. 5 is an axial cross-sectional view of a delivery device connected to a cardiac pacing device according to an embodiment of the present invention
  • FIG. 6 is an axial cross-sectional view of a guide device in an embodiment of the present invention.
  • FIG. 7 is a schematic diagram of the delivery of the dilation sheath and the guide sheath from the femoral vein to the superior vena cava via the inferior vena cava and the right atrium in order according to an embodiment of the present invention
  • FIG. 8 is a schematic diagram of delivering a cardiac pacing device to a superior vena cava through a guide sheath according to an embodiment of the present invention
  • FIG. 9 is a schematic diagram of an elastic member extending out of a groove and penetrating a blood vessel wall of a superior vena cava in an embodiment of the present invention.
  • FIG. 10 is a schematic diagram of a single cardiac pacing device fixed to the superior vena cava in an embodiment of the present invention.
  • 10-heart pacing device 11-shell; 11a-first part; 11b-second part; 111-groove; 112-first lumen; 113-top surface; 114-bottom surface; 115-second lumen ; 12-driving member; 121-first end; 122-second end; stop portion-121; 13-elastic member; 131-third end; 132-fourth end; 14-first electrode; 15-section Two electrodes; 16-gasket;
  • the delivery device, the cardiac pacing device, and the fixing structure thereof provided by the present invention are described in further detail below with reference to FIGS. 1 to 10. It should be noted that the drawings are in a very simplified form and all use inaccurate proportions, which are only used to facilitate and clearly assist the description of the embodiments of the present invention.
  • proximal and distal are relative positions, positions, and directions of elements or actions relative to each other from the perspective of the physician using the medical device, although “proximal” and “distal” “End” is not restrictive, but “proximal” generally refers to the end of the medical device that is close to the doctor during normal operation, and “distal” usually refers to the end that first enters the patient.
  • proximal generally refers to the end of the medical device that is close to the doctor during normal operation
  • distal usually refers to the end that first enters the patient.
  • inside or “inside” refer to a direction near the axis of the drive member
  • outer or “outer” refer to a direction away from the axis of the drive member.
  • FIG. 1 is a perspective view of a cardiac pacing device according to an embodiment of the present invention
  • FIG. 2 is an axial sectional view of the cardiac pacing device shown in FIG. 1
  • FIG. 3 is a cardiac pacing device shown in FIG. 2 in a region C Partial enlarged view.
  • an embodiment of the present invention provides a cardiac pacing device 10 for pacing the atrium or ventricle to improve the arrhythmia problem.
  • the cardiac pacing device 10 specifically includes a fixed structure (not labeled) and a leadless pacemaker disposed on the fixed structure.
  • the fixing structure includes a housing 11, a driving member 12, and an elastic member 13.
  • the leadless pacemaker includes a control portion (not labeled) and at least two electrodes.
  • the control part includes a pulse generator, a communication module, a battery and a processor.
  • the pulse generator is used for generating a pacing pulse and transmitting the pacing pulse to the first electrode 14, and the first electrode 14 further transmits the pacing pulse to the myocardium to achieve contraction of the myocardium.
  • the communication module can establish a wireless connection with the outside world through wireless communication, thereby realizing data exchange.
  • the communication module may receive a command from an external program controller, the communication module sends the command to the processor, and the processor adjusts the pulse generator to adjust the pulse output by the pulse generator.
  • the processor is the core of the entire leadless pacemaker, and all data storage, output, and scheduling between modules are performed by it.
  • the second electrode 15 transmits an electrical signal of atrial or ventricular activity to the processor, and after processing and processing the electrical signal of atrial or ventricular activity, the processor adjusts the pulse generator to adjust the output pulse.
  • the battery is used for powering a pulse generator, a communication module, a processor, and the like, so as to ensure that the electronic components required for the operation of the cardiac pacemaker can work normally.
  • the two electrodes are a first electrode and a second electrode, respectively.
  • the control portion is connected to the electrode.
  • the first electrode can realize the function of pacing
  • the second electrode can realize the function of perception
  • each of the first electrode and the second electrode can be connected to a control part, and the first electrode and the second electrode are connected.
  • a loop is formed between the control section, the first electrode, and the second electrode to realize the pacing or sensing function of the heart by the leadless pacemaker.
  • the number of electrodes may also be multiple to achieve more functions of the leadless pacemaker.
  • the casing 11 is used to install and seal a leadless pacemaker.
  • the casing 11 is preferably a capsule structure, or may be a rectangular, oval, or polygonal structure.
  • the casing with a small space is the best choice.
  • a groove 111 is provided on an outer surface of the casing 11 in a radial direction, and the groove 111 penetrates the first inner cavity 112 in the casing 11.
  • the “radial opening” cannot be narrowly considered that the groove 111 can only be opened in a direction perpendicular to the axial direction of the casing, but should be broadly understood as the groove 111 is not in the axial direction of the casing 11 open.
  • the groove 111 forms an angle with the casing in the radial direction, the groove 111 at this time may be inclined toward the proximal end of the casing 11 (see FIG. 2), or may be inclined toward the distal end of the casing 11.
  • the driving member 12 is used for driving the elastic member 13 to move in the groove 11, and a part of the driving member 12 is received in the first inner cavity 112 of the housing 11, that is, the first end 121 of the driving member 12 extends to In the first lumen 112, the second end 122 extends from a proximal end of the first lumen 112 to be connected to a driving sheath 22 described below.
  • the driving member 12 also needs to be cooperatively connected with the casing 11 and capable of at least axial movement relative to the casing 11.
  • the mating connection means that the two components can be relatively stationary under the condition of no external force or exceeding a limited external force.
  • the driving member 12 performs an axial rotational movement with respect to the casing 11 to transform the rotational movement into an axial movement.
  • the elastic member 13 is accommodated in the first inner cavity 112 of the housing 11, and the third end 131 of the elastic member 13 is connected to the driving member 12, and the fourth end 132 faces the driving member 12.
  • the outer portion of the outer portion extends into the groove 111.
  • the elastic member 13 has an elastic deformation ability. Through good deformation ability, the elastic member 13 is reciprocated along the extending direction of the groove 111 under the driving of the driving member 12.
  • the elastic member 13 is preferably a long strip, and is preferably a sheet structure. More preferably, the fourth end 132 of the elastic member 13 has a tip portion, which can directly penetrate into a tissue wall (that is, a predetermined object).
  • the material of the elastic member 13 is preferably a highly elastic memory metal material.
  • the second end 122 of the driving member 12 is used for detachable connection with the driving sheath 22, and at the same time, the proximal end of the casing 11 is used for detachable connection with the retractable sheath 21, so that The cardiac pacing device 10 is delivered into the body by a delivery device 20 described below.
  • the first electrode 14 and the second electrode 15 are fixed on the casing 11, but may be part of the casing and the other part extends out of the casing 11 to contact the myocardium, or the whole of the casing.
  • the control part is used to realize pacing and sensory control of a pacemaker.
  • the second electrode 15 is used to transmit an electrical signal of the atrium or ventricle to the control portion, and the first electrode 14 is used to receive a pacing pulse signal generated by the control portion to pace the atrium or ventricle.
  • FIG. 4 is a partial axial sectional view of a conveying device in an embodiment of the present invention. As shown in FIG. 4, this embodiment also provides a conveying device 20.
  • the conveying device 20 includes a retracting sheath 21 and a driving sheath. 22.
  • the driving sheath 22 is used to insert the retractable sheath 21 and can move axially relative to the retractable sheath 21.
  • the distal end of the retractable sheath 21 is detachably connected to the proximal end of the housing 11, and the distal end of the drive sheath 22 is detachably connected to the second end 122 of the drive member 12. .
  • FIG. 5 is an axial cross-sectional view of a delivery device connected to a cardiac pacing device according to an embodiment of the present invention.
  • the cardiac pacing device 10 is assembled on the delivery device 20 (actually In the process, the cardiac pacing device 10 is located at the distal end of the delivery device 20), and keeps the retractable sheath 21 fixed (that is, the casing 11 connected to the retractable sheath 21 is fixed), and the drive sheath 22 is driven relative to the retractable sheath 21
  • the sheath 21 performs an axial movement (such as an axial rotational movement), so that the driving sheath 22 drives the driving member 12 to perform an axial movement relative to the casing 11, so that the elastic member 13 is entirely contained in the casing 11 (as shown in FIG. 5).
  • the driving member 12 moves upward, that is, moves toward the distal end of the casing 11).
  • FIG. 6 is an axial cross-sectional view of a guide device in an embodiment of the present invention. As shown in FIG. 6, this embodiment also provides a guide device 30 for establishing a delivery channel in the body in advance to facilitate the delivery device 20 A target position in the body is reached through the delivery channel.
  • the guiding device 30 includes an expansion sheath 31 and a guiding sheath 32.
  • the expansion sheath 31 is used to be inserted into the guide sheath 32 and movable within the guide sheath 32.
  • the expansion sheath 31 has an axial through hole for passing a guide wire.
  • the dilation sheath 31 and the guide sheath 32 are sequentially delivered from the femoral vein through the inferior vena cava A and the right atrium RA to the superior vena cava B position, and then the dilation sheath 31 is removed and the guide sheath is retained. 32 is in place. Thereafter, as shown in FIG. 8, the delivery device 20 connected to the cardiac pacing device 10 is loaded into the guide sheath 32 from the proximal end of the guide sheath 32, and the delivery device 20 is pushed until the distal end of the delivery device 20 reaches up The vena cava position B (that is, the pacemaker 10 reaches the superior vena cava position B). Further, as shown in FIG.
  • the retractable sheath 21 is kept fixed, and the driving sheath 22 is driven to move (compared to FIG. 5, in FIG. 9, the driving member 12 moves downward, that is, to the proximal end of the housing 11 Direction movement), so that the fourth end 132 of the elastic member 13 penetrates into the blood vessel wall of the superior vena cava, so that the second electrode 15 and the first electrode 14 are in contact with the inner wall of the superior vena cava B.
  • the pacing and perceived electrical parameters can be controlled by an external program. If the measured pacing and perceived electrical parameters are not ideal, the position of the cardiac pacing device 10 can be readjusted.
  • the driving member 12 moves upward in FIG. 9
  • the driving member 12 moves upward in FIG. 9
  • the axial direction can be synchronized by retracting and retracting the sheath 21 and the driving sheath 22 Move or rotate in the circumferential direction to adjust the position of the cardiac pacing device 10.
  • the same method as described above can be used to drive the fourth end 132 of the elastic member 13 to protrude from the groove 111 to pierce the blood vessel wall to complete pacing. Position adjustment.
  • the guiding sheath 32, the retracting sheath 21, and the driving sheath 22 are all withdrawn from the human body, that is, the implantation of the cardiac pacing device is finally completed.
  • the cardiac pacing device 10 can also be fixed at the junction of the superior vena cava and the right atrium by a similar method, or at the junction of the inferior vena cava or the inferior vena cava and the right atrium, but it is not limited to this, and can also be fixed. In other locations, dual-chamber pacing is achieved, and atrioventricular synchronized physiological pacing is achieved.
  • the present invention uses the delivery device 20 to drive the driving member 12 of the cardiac pacing device 10 to move, and the driving member 12 drives the elastic member 13 to reciprocate in the groove 111 of the housing 11, thereby realizing the elastic member 13 Telescopic, when the fourth end 132 of the elastic member 13 protrudes from the groove 111, the tissue wall can be penetrated to fix the cardiac pacing device 10 at a target position in the body, and when the fourth end 132 of the elastic member 13 is retracted With the recess 111, the recovery of the cardiac pacing device 10 can be realized, and the cardiac pacing device 10 can be readjusted during the implantation process by the delivery device 20, so that the cardiac pacing device 10 can be fixed at the optimal pacing. Beat the point.
  • first electrode 14 and the second electrode 15 are located at two ends of the casing 11 respectively, so that the casing has a simple structure and is easy to be formed during manufacture.
  • the first electrode 14 is located on the casing 11
  • the second electrode 15 is located at the distal end of the casing 11, but the present invention does not specifically limit the distribution position of the two electrodes.
  • the two electrodes may also be located at the casing 11. As long as it can contact the tissue wall, it can fulfill its corresponding function.
  • the second electrode 15 and the first electrode 14 are both disposed on the first portion 11a described below, but are respectively located at the distal end and the proximal end of the first portion 11a.
  • any one of the first electrode 14 and the second electrode 15 is preferably provided on the outer surface of the casing 11 in a ring shape, thereby increasing the contact area between the electrode and the tissue wall, and the use effect is better.
  • the fixing structure further includes at least one of a first limiting portion and a second limiting portion, and the first limiting portion is configured to restrict the driving member 12 from moving in a distal direction of the housing 11.
  • the second limiting portion is used to limit the distance that the driving member 12 moves toward the proximal end of the housing 11, so as to strictly control the size of the elastic member 13 protruding or retracting the groove. It should be understood that when the groove 111 is inclined toward the proximal end of the housing, the length of the elastic member 13 protruding from the groove 111 is restricted by the second limiting portion, and the retracting of the elastic member 13 by the first limiting portion is restricted. The length of the groove 111.
  • the driving member 12 can be restricted from moving between the first limiting portion and the second limiting portion.
  • the first inner cavity 112 of the housing 11 is preferably a blind hole, so that the first limiting portion is formed by a distal end portion of the first inner cavity 112.
  • the first inner cavity 112 is a T-shaped structure, thereby forming two spaces with different cross sections, and moving the driving member 12 in a space with a larger cross section, and passing through the top surface 113 of the space.
  • the first limiting portion is formed, and the bottom surface 114 opposite to the top surface 113 forms the second limiting portion.
  • the axial distance between the top surface 113 and the bottom surface 114 limits the moving distance of the driving member 12. .
  • a stopper 121 is formed on the driving member 12 (preferably provided on the first end of the driving member).
  • a lateral surface of the stopper 121 is used to abut against the bottom surface 114.
  • the other surface in the lateral direction is for abutting on the top surface 113.
  • the stop portion 121 is preferably a cross shape, but is not limited thereto.
  • the stop portion 121 may also have a T-shaped structure.
  • the housing 11 also has a second inner cavity 115 disposed in the axial direction, which may or may not pass through the first inner cavity 112.
  • the control portion is disposed in the second inner cavity 115.
  • the cross-section of the second inner cavity 115 needs to be smaller than that of the first inner cavity 112.
  • a cross section, and a cross section of another surface of the stop portion 121 for abutting against the top surface 113 is larger than the second inner cavity 115.
  • the first inner cavity 112 and the second inner cavity 115 are preferably arranged coaxially, and the second inner cavity 115 is preferably closed at the distal end.
  • the casing 11 includes a first portion 11a and a second portion 11b which are arranged axially, and the first portion 11a and the second portion 11b are preferably formed separately, and then may be connected together by welding, bonding, or the like. More preferably, the groove 111 is provided at a portion where the first portion 11a and the second portion 11b are connected, and the groove 111 is formed at the connection portion, for example, by laser cutting, or the first portion 11a and the second portion 11b are formed. After the portions 11b are connected, the groove 111 is directly formed, that is, a proximal end of the first portion 11a and a distal end of the second portion 11b are respectively provided with a gap, and the gaps of the two cooperate to define the groove 111. Wherein, the second internal cavity 115 is provided in the first portion 11a, a portion of the first internal cavity 112 is provided in the first portion 11a, and another portion is provided in the second portion 11b.
  • the driving member 12 and the housing 11 are preferably connected by a screw fit, which is convenient to convert the rotational movement of the thread into an axial movement, so as to drive the elastic member 13 to achieve a telescopic movement through the axial movement.
  • the driving member 12 has an external thread
  • the inner wall of the housing 11 corresponding to the first internal cavity 112 has an internal thread that cooperates with the external thread.
  • both the retractable sheath 21 and the housing 11 remain fixed.
  • the elastic member 13 is also configured to be capable of relative movement with the driving member 12 in the circumferential direction, that is, the elastic member 13 and the driving member 12 are circumferentially moved. The movements can be synchronized; or they can be out of synchronization.
  • the elastic member 13 can also remain stationary in the circumferential direction of the driving member 12.
  • the fixing structure 110 further includes a washer 16 fixed on the first end 121 of the driving member 12.
  • the washer 16 and the driving member 12 together limit the axial displacement of the elastic member 13 to prevent elasticity.
  • the member 13 moves in the axial direction relative to the driving member 12.
  • the elastic member 13 is housed in a locking groove formed by the spacer 16 and the stopper 121 and is configured to maintain relative axial staticness with the driving member 12 but can be moved in the circumferential direction to ensure The elastic member 13 can freely reciprocate in the groove 111.
  • the washer 16 is a ring-shaped body, and the first end 121 of the driving member 12 is inserted into a central hole of the washer 16 and is fixed to the washer 16.
  • the elastic members 13 are preferably multiple, such as two, three or more, and are arranged at intervals around the axis of the driving member 12.
  • a plurality of the elastic members 13 are configured to be movable in the circumferential direction relative to the driving member 12.
  • the plurality of elastic members 13 may be integrally disposed on a ring-shaped body and surround the body. The axis is arranged, and the body is sleeved on the driving member through the hole and is located between the washer 16 and the stop portion 121 and can rotate in the circumferential direction.
  • the elastic member 13 may also be in an inverted L shape, and is respectively pressed between the gasket 16 and the stop portion 121.
  • the number of the grooves 111 and the number of the elastic members 13 may be the same or inconsistent.
  • multiple elastic members 13 expand and contract in different grooves 111, or multiple adjacent elastic members 13 expand and contract in the same groove 111. It should be understood that a plurality of the grooves 111 are spaced apart from each other on the casing 11 to ensure the continuity of the casing 11.
  • the second end 122 of the driving member 12 is preferably connected with the driving sheath 22 by a form-locking fit.
  • the second end 122 of the driving member 12 is configured as a polygonal prism, and the inside of the driving sheath 22 is opened.
  • the second portion 11 b of the casing 11 is correspondingly configured as a polygonal prism, which is used to cooperate with the polygonal blind hole at the distal end of the retractable sheath 21 to achieve a fixed connection between the casing 11 and the retractable sheath 21.
  • the retracting sheath 21 is further provided with a through hole connected to the polygonal blind hole, and the driving sheath 22 is passed through the through hole.
  • the present invention is not limited to the mating connection between the driving member 12 and the housing 11 through screwing.
  • the connection can also be achieved by means of snaps, snaps, etc., as long as the housing 11 can be kept stationary and the driving member is driven. 12 can be moved axially relative to the housing 11.
  • the housing 11 and the retractable sheath 21, the driving member 12 and the driving sheath 22 are not limited to the connection of the polygonal prism and the polygonal inner hole, and other detachable connection methods are also applicable, such as threads, snaps , Buckle, etc., as long as these parts can be connected together, and then can be disconnected.
  • the expansion sheath 31, the guide sheath 32, the retractable sheath 21, the drive sheath 22, and the like are all preferably made of a polymer material.
  • the structure that restricts the moving range of the driving member 12 is not limited to the T-shaped first inner cavity, and may also be implemented by other methods, such as protrusions and card slots.
  • the groove 111 may be an arc-shaped groove, and at least a portion of the elastic member 13 received in the groove 111 is also arc-shaped.
  • the elastic member of the present invention is mainly a long thin sheet structure with a tip portion, which can be effectively penetrated into the tissue wall without being restricted by the thickness of the tissue wall, and can fix the cardiac pacing device at a target position.
  • the leadless pacing device can be fixed in the ventricle or in the atrium. Achieve dual-chamber pacing and achieve atrioventricular synchronized physiological pacing.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

一种输送装置、心脏起搏装置及其固定结构，所述固定结构包括壳体（11）、驱动件（12）和弹性件（13），所述壳体（11）具有第一内腔（112）和凹槽（111），所述驱动件（12）部分容置在第一内腔（112）中，且驱动件（12）的一端从第一内腔（112）的近端端部延伸出与驱动鞘（22）可分离式连接，所述弹性件（13）容置于第一内腔（112）中，且一端与驱动件（12）连接，另一端向驱动件（12）外部延伸并伸入凹槽（111），驱动件（12）与壳体（11）配合连接，并能够沿着壳体（11）的轴向驱动弹性件（13）在凹槽（111）内运动，使得弹性件（13）伸出或缩回凹槽（111），以此实现心脏起搏装置在体内的固定、回收和起搏位置的重调整，结构简单，操作方便，且不受组织壁厚度的限制，固定方便，因此，无导线起搏装置可以固定在心室，也可以固定在心房，由此实现双腔起搏，实现房室同步的生理性起搏。

Description

输送装置、心脏起搏装置及其固定结构 技术领域
本发明涉及医疗器械技术领域，特别涉及一种输送装置、心脏起搏装置及其固定结构。
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，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，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并由技术熟练的医生完成，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。
通常，无导线起搏器包括与起博电极分开的并且直径等于或小于起搏器外直径的固定机构，该固定机构允许起搏器经过2次旋转插入组织中，以与组织接触从而固定起搏电极。一些无导线起搏器中还具有一个圆环状的结构位于无导线起搏器的近端，当无导线起搏器的固定机构失效时，该圆环状的结构可以让起搏器停留在右心室中，防止其进入血液循环系统后对患者带来伤害。在上述无导线起搏器植入心脏时，使用递送系统将起搏器输送到右心室尖部，并旋转起搏器使位于起搏器远端的螺旋结构旋入到右心室尖部较厚实的心肌组织中。由于心房壁很薄，如果螺旋结构固定在壁薄的心房，则会带来固定不牢、心房穿孔等重大风险。因此，现有的无导线起搏器只能固定在右心室尖部，致使目前的无导线起搏器仅可实现心室单腔起搏，无法实现双腔起搏(DDD起搏模式)，故而，现有的无导线起搏器容易导致房室失去同步的非生理性起搏。
发明内容
有鉴于此，本发明的目的在于提供一种输送装置、心脏起搏装置及其固定结构，不仅不受组织壁厚度的限制，固定方便，可实现心房或心室的起搏，即实现双腔起搏，以此治疗心律失常问题，且结构简单，还可以回收和重新调整起搏位置。
根据本发明的一个方面，提供了一种固定结构，所述固定结构包括：
一壳体，所述壳体具有一第一内腔以及一凹槽，所述凹槽径向开设在所述壳体的外表面上并与所述第一内腔贯通；
一驱动件，所述驱动件部分容置于所述第一内腔中，且所述驱动件的一端从所述第一内腔的近端端部延伸出；以及，
一弹性件，所述弹性件容置于所述第一内腔中，且所述弹性件的一端与所述驱动件连接，另一端向所述驱动件的外部延伸，并伸入所述凹槽；
其中：所述驱动件与所述壳体配合连接，且所述驱动件能够沿着所述壳体的轴向驱动所述弹性件在所述凹槽内运动，以使所述弹性件伸出或缩回所述凹槽。
进一步的，所述驱动件具有外螺纹，所述第一内腔对应的所述壳体的内壁具有与所述外螺纹配合的内螺纹；且所述弹性件被配置为能够与所述驱动件在周向上作相对运动。
进一步的，所述固定结构还包括：
一垫片，所述垫片具有一中心孔，所述垫片通过所述中心孔套接在所述驱动件的远端，用于限制所述弹性件的轴向位移。
进一步的，所述驱动件伸出所述第一内腔的一端呈多棱柱形。
进一步的，所述壳体的近端呈多棱柱形。
进一步的，所述固定结构还包括：
一第一限位部，所述第一限位部用于限制所述驱动件向所述壳体的远端方向移动的距离；和/或，
一第二限位部，所述第二限位部用于限制所述驱动件向所述壳体的近端 方向移动的距离。
进一步的，所述第一内腔为T字形结构，所述T字形结构具有一顶面以及相对设置的一底面，所述顶面形成所述第一限位部，所述底面形成所述第二限位部。
进一步的，所述驱动件具有一止位部，位于所述驱动件的远端，所述止位部具有相对的第一表面和第二表面，所述止位部的第一表面用于抵靠所述第一内腔的顶面，所述止位部的第二表面用于抵靠所述第一内腔的底面。
进一步的，所述止位部呈十字形或T字形。
进一步的，所述固定结构包括多个所述弹性件，多个所述弹性件围绕所述驱动件的轴线间隔布置。
进一步的，所述弹性件呈长条状并具有一尖端部，所述尖端部用于刺入一预定对象。
进一步的，所述凹槽向所述壳体的近端或远端倾斜。
进一步的，所述壳体还具有第二内腔，所述第二内腔与所述第一内腔在所述壳体的轴向上分开设置。
根据本发明的另一个方面，提供了一种心脏起搏装置，其包括前述任意一项所述的固定结构，以及设置在固定结构上的无导线起搏器。
进一步的，所述固定结构的壳体还具有第二内腔，与所述第一内腔在所述壳体的轴向上分开设置；
所述无导线起搏器包括：
一控制部分，所述控制部分设置于所述壳体的第二内腔；以及
至少两个电极，每个所述电极与所述控制部分连接，每个所述电极设置在所述壳体上，且每个所述电极用于与预定对象接触。
根据本发明的又一个方面，提供了一种输送装置，用于输送所述的心脏起搏装置，其包括：
一收放鞘，所述收放鞘的远端用于与所述壳体的近端可分离式连接；以及，
一驱动鞘，所述驱动鞘的远端用于与所述驱动件伸出所述第一内腔的一 端可分离式连接；
其中：所述驱动鞘以可活动的方式插入所述收放鞘中，并与所述收放鞘相配合，将所述心脏起搏装置推送至目标位置，以及驱动所述驱动件相对于所述壳体运动。
进一步的，所述收放鞘的远端具有第一多边形内孔，所述第一多边形内孔用于与呈多棱柱形的所述壳体的近端配合连接；所述驱动鞘的远端具有第二多边形内孔，所述第二多边形内孔用于与呈多棱柱形的所述驱动件伸出所述第一内腔的一端配合连接。
与现有技术相比，本发明提供的输送装置、心脏起搏装置及其固定结构，具有如下有益效果：
第一、本发明利用输送装置驱动心脏起搏装置的驱动件运动，并通过驱动件驱动弹性件在壳体的凹槽内往复移动，从而实现弹性件的可伸缩，当弹性件的一端伸出凹槽时，可刺入组织壁从而实现心脏起搏装置在体内目标位置处的固定，且当弹性件的一端缩回凹槽时，可实现心脏起搏装置的回收，并通过输送装置使心脏起搏装置在植入过程中能够重新调整起搏位置，便于将心脏起搏装置固定在最佳起搏点；
第二、本发明利用驱动件与壳体的螺纹配合，方便将两者的旋转运动转化为轴向移动，从而驱动弹性件在凹槽内往复移动，结构简单，操作方便；
第三、本发明的弹性件为长条状并具有一个尖端部，可直接刺入组织壁，基本上对组织壁的厚度没有要求，且刺入的深度通过伸缩运动调节，固定更为方便，因此，无导线起搏装置可以固定在心室，也可以固定在心房，由此实现双腔起搏，实现房室同步的生理性起搏。
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是本发明一个实施例提供的心脏起搏装置的立体图；
图2是图1所示的心脏起搏装置的轴向剖面图；
图3是图2所示的心脏起搏装置于C区域的局部放大图；
图4是本发明一个实施例中输送装置的轴向剖视局部图；
图5是本发明一个实施例中输送装置与心脏起搏装置相连接时的轴向剖视图；
图6是本发明一个实施例中导引装置的轴向剖视图；
图7是本发明一个实施例中将扩张鞘和导引鞘从股静脉依次经下腔静脉和右心房递送到上腔静脉位置的示意图；
图8是本发明一个实施例中通过导引鞘将心脏起搏装置输送到达上腔静脉的示意图；
图9是本发明一个实施例中使弹性件伸出凹槽并刺入上腔静脉的血管壁的示意图；
图10是本发明一个实施例中心脏起搏装置单独固定在上腔静脉的示意图。
图中：
10-心脏起搏装置；11-壳体；11a-第一部分；11b-第二部分；111-凹槽；112-第一内腔；113-顶面；114-底面；115-第二内腔；12-驱动件；121-第一端；122-第二端；止位部-121；13-弹性件；131-第三端；132-第四端；14-第一电极；15-第二电极；16-垫片；
20-输送装置；21-收放鞘；22-驱动鞘；
30-导引装置；31-扩张鞘；32-导引鞘；
A-下腔静脉；RA-右心房；B-上腔静脉。
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1～10对本发明提出的输送装置、心脏起搏装置及其固定结构作进一步详细说明。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”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。术语“内”或“内部”是指靠近驱动件的轴线的方向，“外”或“外部”是指远离驱动件的轴线的方向。
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。
图1是本发明一个实施例提供的心脏起搏装置的立体图，图2是图1所示的心脏起搏装置的轴向剖面图，图3是图2所示的心脏起搏装置于C区域的局部放大图。如图1至图3所示，本发明实施例提供一种心脏起搏装置10，用于起搏心房或心室，以改善心律失常问题。
所述心脏起搏装置10具体包括固定结构(未标示)以及设置于固定结构上的无导线起搏器。所述固定结构包括壳体11、驱动件12和弹性件13。所述无导线起搏器包括控制部分(未标示)和至少两个电极。
所述控制部分包括脉冲发生器、通讯模块、电池和处理器等。所述脉冲发生器用于产生起搏脉冲并将起搏脉冲传递至第一电极14，所述第一电极14进一步将起搏脉冲传递至心肌，实现心肌的收缩。所述通讯模块可通过无线通信的方式建立与外界的无线连接，从而实现数据的交换。在一些实施例中，通讯模块可接收到外界程控仪传来的命令，通讯模块将该命令发送给处理器，处理器对脉冲发生器进行调节，调整脉冲发生器输出的脉冲。所述处理器是整个无导线起搏器的核心，所有数据存储、输出、各模块之间的调度都由其来完成。所述第二电极15将心房或心室活动的电信号传递给所述处理器，所述处理器将心房或心室活动的电信号运算处理后，对脉冲发生器进行调节，调整输出的脉冲。所述电池用于为脉冲发生器、通讯模块、处理器等供电，以确保心脏起搏器运行所需的电子部件能够正常工作。
本实施方式中，两个电极分别为第一电极和第二电极。所述控制部分与 所述电极连接。第一电极可以实现起搏的功能，第二电极可以实现感知的功能，所述第一电极和第二电极各自可与控制部分连接，所述第一电极和所述第二电极连接。在无导线起搏器工作时，所述控制部分、所述第一电极和所述第二电极之间形成回路，以实现无导线起搏器对心脏的起搏或感知功能。在其它实施例中，电极的数量也可以为多个，以实现无导线起搏器的更多功能。为了简明起见，在以下描述中假设电极为两个，分别是第一电极14和第二电极15，本领域技术人员应当能够修改以下描述，在细节上作适当修改后将所述描述用于二个以上电极的情况。
所述壳体11用于安装并密封无导线起搏器，其优选为胶囊结构，或者还可以是长方形、椭圆形、多棱柱等结构，主要以占用空间小的壳体作为最佳选择。其中，所述壳体11的外表面上沿径向开设有凹槽111，所述凹槽111与壳体11内的第一内腔112贯通。这里的“径向开设”不能狭义认为所述凹槽111只能沿垂直于壳体轴向的方向开设，而应广义的理解为所述凹槽111不是沿所述壳体11的轴向方向开设。倘若所述凹槽111与壳体径向呈一夹角，此时的凹槽111可以是向壳体11的近端倾斜(参阅图2)，也可以是向壳体11的远端倾斜。
所述驱动件12用于驱动弹性件13在凹槽11内运动，其一部分容置于所述壳体11的第一内腔112中，即所述驱动件12的第一端121延伸至所述第一内腔112中，第二端122从第一内腔112的近端端部延伸出，以与下述的驱动鞘22连接。除此之外，所述驱动件12还需要与壳体11配合连接，并能够相对于所述壳体11至少做轴向运动。这里，所述配合连接是指，在没有外力或没有超过限定外力的条件下，两个部件能实现相对静止。在较佳的情况下，所述驱动件12相对于所述壳体11做轴向的旋转运动，以通过旋转运动转化为轴向的移动。
所述弹性件13容置于所述壳体11的第一内腔112中，且所述弹性件13的第三端131与所述驱动件12连接，第四端132向所述驱动件12的外部延伸并伸入所述凹槽111。当所述驱动件12相对于所述壳体11做轴向运动时，同步带动所述弹性件13在所述凹槽111内运动，从而使所述弹性件13的第 四端132伸出所述凹槽111，进而刺入一组织壁，从而将心脏起搏装置10固定在体内的一目标位置处，当然，若做相反的运动，则可使所述弹性件13的第四端132脱离组织壁而重新缩回凹槽111，便于回收和重新定位心脏起搏装置10。本发明中，所述弹性件13具有弹性变形能力，通过良好的形变能力，所述弹性件13在驱动件12的驱动下沿着凹槽111的延伸方向做往复运动。所述弹性件13优选为长条状，且较佳地为薄片结构，更优选，所述弹性件13的第四端132具有一个尖端部，能够直接刺入组织壁(即预定对象)。所述弹性件13的材料优选为高弹性记忆金属材料。
本发明中，所述驱动件12的第二端122用于与驱动鞘22可分离式连接，与此同时，所述壳体11的近端用于与收放鞘21可分离式连接，从而通过下述的输送装置20将心脏起搏装置10输送至体内。
进而为了使电极能够接触心肌，所述第一电极14和第二电极15固定在壳体11上，但可以是一部分在壳体内，另一部分伸出壳体11与心肌接触，或者是整个在壳体外，以此确保电极能够接触心肌。所述控制部分用于实现心脏起搏器的起搏和感知控制。所述第二电极15用于将心房或心室的电信号传送至所述控制部分，所述第一电极14用于接收所述控制部分产生的起搏脉冲信号以起搏心房或心室。
图4是本发明一个实施例中输送装置的轴向剖视局部图，如图4所示，本实施例还提供了一种输送装置20，所述输送装置20包括收放鞘21和驱动鞘22，所述驱动鞘22用于插入所述收放鞘21，并可相对于所述收放鞘21做轴向运动。实际使用时，所述收放鞘21的远端与所述壳体11的近端可分离式连接，所述驱动鞘22的远端与所述驱动件12的第二端122可分离式连接。
图5是本发明一个实施例中输送装置与心脏起搏装置相连接时的轴向剖视图，如图5所示，在植入之前，先将心脏起搏装置10组装到输送装置20上(实际过程中，心脏起搏装置10位于输送装置20的远端)，并保持收放鞘21固定不动(即与收放鞘21连接的壳体11固定不动)，驱动驱动鞘22相对于收放鞘21做轴向运动(如轴向旋转运动)，使驱动鞘22带动驱动件12相对于壳体11做轴向运动，从而使弹性件13全部收入在壳体11中(在图5所 示的角度下，驱动件12向上运动，即向壳体11的远端方向移动)。
图6是本发明一个实施例中导引装置的轴向剖视图，如图6所示，本实施例还提供了一种导引装置30，用于事先在体内建立输送通道，以便于输送装置20通过该输送通道到达体内目标位置。
所述导引装置30包括扩张鞘31和导引鞘32。所述扩张鞘31用于插入所述导引鞘32中，并可在导引鞘32内活动，所述扩张鞘31具有用于穿设导引导丝的轴向通孔。
具体的，如图7所示，将扩张鞘31和导引鞘32从股静脉依次经下腔静脉A和右心房RA递送到上腔静脉B位置，然后，撤去扩张鞘31并保留导引鞘32在原位。之后，如图8所示，自导引鞘32的近端，将连接心脏起搏装置10的输送装置20装载进入导引鞘32，进而，推送输送装置20直至输送装置20的远端到达上腔静脉B位置(即心脏起搏装置10到达上腔静脉B位置)。进一步，如图9所示，保持收放鞘21固定不动，驱动驱动鞘22运动(相对于图5而言，在图9中，驱动件12向下运动，即向壳体11的近端方向移动)，使弹性件13的第四端132刺入上腔静脉的血管壁，使第二电极15和第一电极14与上腔静脉B的内壁接触。之后，便可以通过外部程序控制测试起搏和感知电学参数，如果测试得到的起搏和感知电学参数不理想，则可以重新调整心脏起搏装置10的位置。在重新调整心脏起搏装置10的位置时，具体保持收放鞘21固定不动，而反方向驱动驱动鞘22运动(图9中，驱动件12向上运动)，使弹性件13的第四端132脱离血管壁，并进而缩回到凹槽111内，随后，通过输送装置20重新调整心脏起搏装置10在上腔静脉B的位置，如可以通过收放鞘21和驱动鞘22同步轴向移动或周向转动，调整心脏起搏装置10的位置。通过一次或多次的调整后，确认起搏、感知电学参数满足要求时，可采用上述同样的方法，驱动弹性件13的第四端132伸出凹槽111刺入血管壁，从而完成起搏位置的调整。最后，如图10所示，将导引鞘32、收放鞘21和驱动鞘22全部撤出人体，即最终完成心脏起搏装置的植入。同理，也可采用类似的方法将心脏起搏装置10固定在上腔静脉与右心房交界处，或固定在下腔静脉或下腔静脉与右心房的交界处，但不限于此，还可固定在其 他位置，实现双腔起搏，实现房室同步的生理性起搏。
由此可见，本发明利用输送装置20驱动心脏起搏装置10的驱动件12运动，并通过驱动件12驱动弹性件13在壳体11的凹槽111内往复移动，从而实现弹性件13的可伸缩，当弹性件13的第四端132伸出凹槽111时，可刺入组织壁从而实现心脏起搏装置10在体内目标位置处的固定，且当弹性件13的第四端132缩回凹槽111时，可实现心脏起搏装置10的回收，并通过输送装置20使心脏起搏装置10在植入过程中能够重新调整起搏位置，便于将心脏起搏装置10固定在最佳起搏点。
进一步，所述第一电极14和第二电极15分别位于所述壳体11的两端，这样壳体结构简单，制作时容易加工成型，例如所述第一电极14位于所述壳体11的近端，所述第二电极15位于所述壳体11的远端，但本发明对该两个电极的分布位置不作具体的限定，根据实际治疗需要，该两个电极也可以位于壳体11的同一端，只要能够接触组织壁，起到其对应的功能便可。本发明实施例中，所述第二电极15和第一电极14均设于下述的第一部分11a，但分别位于第一部分11a的远端和近端。
更进一步，所述第一电极14和第二电极15中的任意一个优选环状设置于所述壳体11的外表面上，从而增大电极与组织壁接触的面积，使用效果更好。
进一步，所述固定结构还包括第一限位部和第二限位部中的至少一个，所述第一限位部用于限制所述驱动件12向所述壳体11的远端方向移动的距离，所述第二限位部用于限制所述驱动件12向所述壳体11的近端方向移动的距离，从而严格控制弹性件13伸出凹槽或缩回凹槽的尺寸。应理解的，当凹槽111向壳体的近端倾斜时，通过所述第二限位部限制弹性件13伸出凹槽111的长度，通过第一限位部限制弹性件13缩回凹槽111的长度。而当凹槽111向壳体的远端倾斜时，通过所述第二限位部限制弹性件13缩回凹槽111的长度，通过第一限位部限制弹性件13伸出凹槽111的长度。因此，可限制驱动件12在第一限位部和第二限位部之间移动。
进一步，所述壳体11的第一内腔112优选为盲孔，以通过所述第一内腔 112的远端端部形成所述第一限位部。较佳地，所述第一内腔112为T字形结构，以此形成两个横截面不同的空间，并使驱动件12在横截面较大的空间内运动，并通过该空间的顶面113形成所述第一限位部，与顶面113相对的底面114形成所述第二限位部，所述顶面113与底面114之间的轴向距离便限制了驱动件12的运动的距离。
相对应的，所述驱动件12上形成有止位部121(优选设置在驱动件的第一端上)，该止位部121在横向上的一表面用于抵靠在底面114上，在横向上的另一表面用于抵靠在顶面113上。所述止位部121优选为十字形，但不限于此，所述止位部121也可以是T字形结构。
所述壳体11还具有轴向设置的第二内腔115，与所述第一内腔112相贯通或不贯通均可。所述控制部分设置于所述第二内腔115。当所述第二内腔115与所述第一内腔112相贯通时，为了形成所述第一限位部，所述第二内腔115的横截面需小于所述第一内腔112的横截面，且所述止位部121用于与顶面113抵靠的另一表面的横截面大于所述第二内腔115。所述第一内腔112与第二内腔115优选同轴布置，且所述第二内腔115优选远端封闭。
进一步，所述壳体11包括轴向布置的第一部分11a和第二部分11b，所述第一部分11a和第二部分11b优选分体成型，之后，可通过焊接、粘结等方式连接在一起，更优选，在第一部分11a和第二部分11b相连接的部位设置有所述凹槽111，例如通过激光切割在所述连接部位处形成所述凹槽111，或者，在第一部分11a和第二部分11b相连接后，直接形成所述凹槽111，即，第一部分11a的近端和第二部分11b的远端各自设有缺口，两者的缺口相配合限定形成所述凹槽111。其中，所述第二内腔115设置在所述第一部分11a，所述第一内腔112的一部分设置在所述第一部分11a，另一部分设置在所述第二部分11b。
进一步，所述驱动件12与壳体11优选通过螺纹配合连接，便于将螺纹的旋转运动转换为轴向移动，从而通过轴向移动驱动弹性件13实现伸缩运动。具体来说，所述驱动件12具有外螺纹，所述第一内腔112对应的壳体11的内壁具有与所述外螺纹配合的内螺纹，当驱动鞘22受外力作轴向旋转运动时， 通过其与驱动件12的第二端122的配合，带动驱动件12相对于壳体11做轴向旋转运动，两者的旋转运动便通过螺纹配合转化为相对的轴向运动。在做轴向旋转运动时，应知晓的是，收放鞘21和壳体11均保持固定不动。此外，当驱动件12做轴向旋转运动时，所述弹性件13亦被配置为能够与驱动件12在周向上作相对运动，即所述弹性件13与所述驱动件12在周向上的运动能够同步；也能够不同步，例如，当所述驱动件12做轴向旋转运动时，所述弹性件13也可以在所述驱动件12的周向上保持静止。
进一步，所述固定结构110还包括固定在驱动件12之第一端121上的垫片16，所述垫片16与所述驱动件12一起限制所述弹性件13的轴向位移，防止弹性件13相对于驱动件12在轴向上移动。具体的，所述弹性件13容置在垫片16与止位部121所形成的卡槽中，并被配置为与所述驱动件12保持轴向相对静止，但可周向活动，以确保弹性件13能够在凹槽111中自由地往复。所述垫片16为一环状体，所述驱动件12的第一端121穿设在所述垫片16的中心孔内并与垫片16固定。
所述弹性件13优选为多个，如2个、3个或以上，并围绕驱动件12的轴线间隔布置。倘若驱动件12能够轴向旋转，则多个所述弹性件13被配置为能够相对于驱动件12在周向上活动，多个弹性件13可以整体设置在一个环状本体上，并围绕本体的轴线布置，该本体优选通过孔套接在驱动件并位于垫片16与止位部121之间，且可周向转动。在其他实施例中，所述弹性件13也可成倒L形，分别抵压在垫片16和止位部121之间。
所述凹槽111与弹性件13的数量一致或不一致均可，例如多个弹性件13在不同的凹槽111内伸缩，或多个相邻弹性件13在同一个凹槽111内伸缩。应理解的是，多个所述凹槽111在壳体11上间隔分布，以确保壳体11的连贯性。
本发明实施例中，所述驱动件12的第二端122优选与驱动鞘22通过形锁配合连接，如驱动件12的第二端122构造成多棱柱，而所述驱动鞘22的内部开设有远端开口的多边形内孔，多边形内孔与多棱柱配合。因此，本发明实施例中，所述驱动件12的第二端122为多棱柱结构，在异于第二端122 和第一端121的区域设有外螺纹。
所述壳体11的第二部分11b相应被构造成多棱柱，用于与收放鞘21远端的多边形盲孔配合，实现壳体11与收放鞘21的固定连接。所述收放鞘21还设有与多边形盲孔连接的贯通孔，所述驱动鞘22穿设在所述贯通孔中。
然而，本发明不限于通过螺纹配合实现驱动件12与壳体11的配合连接，例如还可通过弹扣、卡扣等方式实现连接，只要能够在保持壳体11静止不动，且驱动驱动件12相对于壳体11做轴向移动即可。另外，壳体11与收放鞘21，驱动件12与驱动鞘22，均不限于多棱柱与多边形内孔配合的方式实现连接，其他可分离式连接的方式也可适用，例如螺纹、弹扣、卡扣等方式，只要能够将这些部件二二连接在一起，之后又能解除连接便可。此外，扩张鞘31、导引鞘32、收放鞘21、驱动鞘22等，均优选为高分子材料。另外，限制驱动件12移动范围的结构不限于T字形的第一内腔，也可通过其他方式实现，如凸起与卡槽等。再则，所述凹槽111可以是弧形槽，所述弹性件13至少容置在所述凹槽111内的部分亦呈弧形。
综上，根据本发明实施例提供的技术方案，较佳地通过螺旋运动驱动驱动件相对于外壳做轴向旋转运动，这样的结构简单，操作方便。此外，本发明的弹性件主要为长条薄片且带有尖端部的结构，可以不受组织壁厚度的限制，能够有效的刺入组织壁，将心脏起搏装置固定在目标位置。并且通过弹性件的伸缩运动，便于调整弹性件的刺入深度，以便于适应不同的固定要求，固定更为灵活，因此，无导线起搏装置可以固定在心室，也可以固定在心房，由此实现双腔起搏，实现房室同步的生理性起搏。
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 (17)

  1. 一种固定结构，其特征在于，所述固定结构包括：
    一壳体，所述壳体具有一第一内腔以及一凹槽，所述凹槽径向开设在所述壳体的外表面上并与所述第一内腔贯通；
    一驱动件，所述驱动件部分容置于所述第一内腔中，且所述驱动件的一端从所述第一内腔的近端端部延伸出；以及，
    一弹性件，所述弹性件容置于所述第一内腔中，且所述弹性件的一端与所述驱动件连接，另一端向所述驱动件的外部延伸，并伸入所述凹槽；
    其中：所述驱动件与所述壳体配合连接，且所述驱动件能够沿着所述壳体的轴向驱动所述弹性件在所述凹槽内运动，以使所述弹性件伸出或缩回所述凹槽。
  2. 根据权利要求1所述的固定结构，其特征在于，所述驱动件具有外螺纹，所述第一内腔对应的所述壳体的内壁具有与所述外螺纹配合的内螺纹；且所述弹性件被配置为能够与所述驱动件在周向上作相对运动。
  3. 根据权利要求2所述的固定结构，其特征在于，所述固定结构还包括：
    一垫片，所述垫片具有一中心孔，所述垫片通过所述中心孔套接在所述驱动件的远端，用于限制所述弹性件的轴向位移。
  4. 根据权利要求1或2所述的固定结构，其特征在于，所述驱动件伸出所述第一内腔的一端呈多棱柱形。
  5. 根据权利要求1或2所述的固定结构，其特征在于，所述壳体的近端呈多棱柱形。
  6. 根据权利要求1或2所述的固定结构，其特征在于，所述固定结构还包括：
    一第一限位部，所述第一限位部用于限制所述驱动件向所述壳体的远端方向移动的距离；和/或，
    一第二限位部，所述第二限位部用于限制所述驱动件向所述壳体的近端方向移动的距离。
  7. 根据权利要求6所述的固定结构，其特征在于，所述第一内腔为T字形结构，所述T字形结构具有一顶面以及相对设置的一底面，所述顶面形成所述第一限位部，所述底面形成所述第二限位部。
  8. 根据权利要求7所述的固定结构，其特征在于，所述驱动件具有一止位部，位于所述驱动件的远端，所述止位部具有相对的第一表面和第二表面，所述止位部的第一表面用于抵靠所述第一内腔的顶面，所述止位部的第二表面用于抵靠所述第一内腔的底面。
  9. 根据权利要求8所述的固定结构，其特征在于，所述止位部呈十字形或T字形。
  10. 根据权利要求1或2所述的固定结构，其特征在于，所述固定结构包括多个所述弹性件，多个所述弹性件围绕所述驱动件的轴线间隔布置。
  11. 根据权利要求1或2所述的固定结构，其特征在于，所述弹性件呈长条状并具有一尖端部，所述尖端部用于刺入一预定对象。
  12. 根据权利要求1或2所述的固定结构，其特征在于，所述凹槽向所述壳体的近端或远端倾斜。
  13. 根据权利要求1或2所述的固定结构，其特征在于，所述壳体还具有第二内腔，所述第二内腔与所述第一内腔在所述壳体的轴向上分开设置。
  14. 一种心脏起搏装置，其特征在于，包括:
    如权利要求1至12中任意一项所述的固定结构；以及，
    一无导线起搏器，设置在所述固定结构上。
  15. 根据权利要求14所述的心脏起搏装置，其特征在于，所述固定结构的壳体还具有第二内腔，与所述第一内腔在所述壳体的轴向上分开设置；
    所述无导线起搏器包括：
    一控制部分，所述控制部分设置于所述壳体的第二内腔；以及
    至少两个电极，每个所述电极与所述控制部分连接，每个所述电极设置在所述壳体上，且每个所述电极用于与预定对象接触。
  16. 一种输送装置，用于输送如权利要求14或15所述的心脏起搏装置，其特征在于，所述输送装置包括：
    一收放鞘，所述收放鞘的远端用于与所述壳体的近端可分离式连接；以及，
    一驱动鞘，所述驱动鞘的远端用于与所述驱动件伸出所述第一内腔的一端可分离式连接；
    其中：所述驱动鞘以可活动的方式插入所述收放鞘中，并与所述收放鞘相配合，将所述心脏起搏装置推送至目标位置，以及驱动所述驱动件相对于所述壳体运动。
  17. 如权利要求16所述的输送装置，其特征在于，所述收放鞘的远端具有第一多边形内孔，所述第一多边形内孔用于与呈多棱柱形的所述壳体的近端配合连接；所述驱动鞘的远端具有第二多边形内孔，所述第二多边形内孔用于与呈多棱柱形的所述驱动件伸出所述第一内腔的一端配合连接。
PCT/CN2019/103839 2018-08-31 2019-08-30 输送装置、心脏起搏装置及其固定结构 WO2020043205A1 (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US17/271,870 US11896836B2 (en) 2018-08-31 2019-08-30 Conveying device, cardiac pacing device, and fixing structure thereof
EP19854873.7A EP3845270A4 (en) 2018-08-31 2019-08-30 CONVEYING DEVICE, PACEMAKER DEVICE AND MOUNTING STRUCTURE THEREFOR

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201811011695.8 2018-08-31
CN201811011695.8A CN110870948B (zh) 2018-08-31 2018-08-31 输送装置、心脏起搏装置及其固定结构

Publications (1)

Publication Number Publication Date
WO2020043205A1 true WO2020043205A1 (zh) 2020-03-05

Family

ID=69643447

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2019/103839 WO2020043205A1 (zh) 2018-08-31 2019-08-30 输送装置、心脏起搏装置及其固定结构

Country Status (4)

Country Link
US (1) US11896836B2 (zh)
EP (1) EP3845270A4 (zh)
CN (1) CN110870948B (zh)
WO (1) WO2020043205A1 (zh)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103328040A (zh) * 2010-12-20 2013-09-25 内诺斯蒂姆股份有限公司 具有径向固定机构的无导线起搏器
CN105536137A (zh) * 2016-03-10 2016-05-04 陈泗林 带固定装置的心脏起搏导线
CN106362288A (zh) * 2016-09-14 2017-02-01 郭成军 心脏植入物及其固定方法
US20180104449A1 (en) * 2016-10-14 2018-04-19 Pacesetter, Inc . Catheter-based system for delivery and retrieval of a leadless pacemaker
US20180133465A1 (en) * 2015-10-15 2018-05-17 Pacesetter, Inc. Fixation sleeve equipped leadless pulse generator
CN108310652A (zh) * 2018-04-10 2018-07-24 创领心律管理医疗器械（上海）有限公司 心脏植入装置及起搏系统

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5179962A (en) * 1991-06-20 1993-01-19 Possis Medical, Inc. Cardiac lead with retractible fixators
US5314462A (en) * 1992-05-27 1994-05-24 Cardiac Pacemakers, Inc. Positive fixation device
US8489189B2 (en) * 2004-10-29 2013-07-16 Medtronic, Inc. Expandable fixation mechanism
US20090082828A1 (en) * 2007-09-20 2009-03-26 Alan Ostroff Leadless Cardiac Pacemaker with Secondary Fixation Capability
JP5269268B2 (ja) * 2010-03-31 2013-08-21 エス・ホー・エル・グループ・アクチボラゲット フィードバック信号伝達手段を備えた薬剤送達装置
US8532790B2 (en) * 2010-04-13 2013-09-10 Medtronic, Inc. Slidable fixation device for securing a medical implant
US10112045B2 (en) * 2010-12-29 2018-10-30 Medtronic, Inc. Implantable medical device fixation
JP7071350B2 (ja) * 2016-10-27 2022-05-18 コンフォーマル・メディカル・インコーポレイテッド 左心耳を排除するためのデバイスおよび方法
CN107233665A (zh) * 2017-08-01 2017-10-10 郭成军 心腔内植入物及其固定方法
CN107583187B (zh) * 2017-09-25 2020-04-10 创领心律管理医疗器械（上海）有限公司 无导线起搏器系统及其使用方法

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103328040A (zh) * 2010-12-20 2013-09-25 内诺斯蒂姆股份有限公司 具有径向固定机构的无导线起搏器
US20180133465A1 (en) * 2015-10-15 2018-05-17 Pacesetter, Inc. Fixation sleeve equipped leadless pulse generator
CN105536137A (zh) * 2016-03-10 2016-05-04 陈泗林 带固定装置的心脏起搏导线
CN106362288A (zh) * 2016-09-14 2017-02-01 郭成军 心脏植入物及其固定方法
US20180104449A1 (en) * 2016-10-14 2018-04-19 Pacesetter, Inc . Catheter-based system for delivery and retrieval of a leadless pacemaker
CN108310652A (zh) * 2018-04-10 2018-07-24 创领心律管理医疗器械（上海）有限公司 心脏植入装置及起搏系统

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3845270A4 *

Also Published As

Publication number Publication date
US20210260386A1 (en) 2021-08-26
EP3845270A4 (en) 2022-03-02
US11896836B2 (en) 2024-02-13
CN110870948A (zh) 2020-03-10
CN110870948B (zh) 2021-11-05
EP3845270A1 (en) 2021-07-07

Similar Documents

Publication Publication Date Title
US10391319B2 (en) Trans septal implantable medical device
US20230083368A1 (en) Subcutaneous device for monitoring and/or providing therapies
US9597514B2 (en) Epicardial heart rhythm management devices, systems and methods
US8989873B2 (en) Intravascular medical device with advancable electrode
US9878151B2 (en) Multi-piece dual-chamber leadless intra-cardiac medical device and method of implanting same
US7212871B1 (en) Epicardial and myocardial leads for implanting in the heart by thoracotomy or port access surgeries with detachable electrode tip
US20150088155A1 (en) Mechanical configurations for a multi-site leadless pacemaker
US10639483B2 (en) Subcutaneous device
US11103710B2 (en) Systems, methods, and devices for treating bradyarrhythmias, tachyarrhythmias and heart failure
WO2020200222A1 (zh) 医疗装置及其医疗设备的固定机构
US11179571B2 (en) Subcutaneous device for monitoring and/or providing therapies
WO2021121412A1 (zh) 无导线起搏器及其尾端部件与头端部件
US11975189B1 (en) Transcoronary sinus pacing of posteroseptal left ventricular base
US11717674B2 (en) Subcutaneous device for use with remote device
WO2020043205A1 (zh) 输送装置、心脏起搏装置及其固定结构
CN216456543U (zh) 一种无导线左束支起搏器
WO2007075732A2 (en) Multifunctional temporary intra or extra-cardia pacemaker without fluoroscopy guidance for operation
US10569093B1 (en) Injectable subcutaneous device
US20240099662A1 (en) Clip design for a subcutaneous device
US20220160253A1 (en) Antennas for a subcutaneous device

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 19854873

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2019854873

Country of ref document: EP

Effective date: 20210331