CN109568793B - Leadless pacemaker and leadless pacing system - Google Patents
Leadless pacemaker and leadless pacing system Download PDFInfo
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- CN109568793B CN109568793B CN201811593169.7A CN201811593169A CN109568793B CN 109568793 B CN109568793 B CN 109568793B CN 201811593169 A CN201811593169 A CN 201811593169A CN 109568793 B CN109568793 B CN 109568793B
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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
- A61N1/362—Heart stimulators
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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
- A61N1/02—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
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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
- A61N1/37512—Pacemakers
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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
- A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
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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
- A61N1/02—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
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Abstract
The invention provides a leadless pacemaker and a leadless pacing system, wherein the leadless pacemaker is of an umbrella-shaped structural design and comprises a leadless pacing device positioned on an umbrella handle and a supporting device positioned on an umbrella cover, wherein the supporting device can fix the leadless pacing device at a specified position, thereby eliminating side effects caused by a traditional electrode lead, and meanwhile, compared with other leadless pacemakers used for a right ventricle (especially a right apex), the umbrella-shaped structure of the leadless pacemaker provided by the invention can be in contact with heart tissues more, has better fixation stability, and can be used for a right auricle close to a sinus node, thereby providing a more reasonable pacing sequence and reducing damage to the heart. The leadless pacing system of the present invention adopts the leadless pacemaker of the present invention and is provided with a special conveyer and a guide, so that the implantation of the leadless pacemaker is more convenient and accurate.
Description
Technical Field
The invention relates to the technical field, in particular to a leadless pacemaker and a leadless pacing system.
Background
The cardiac pacemaker system can treat irreversible cardiac pacing and conduction dysfunction heart diseases caused by various reasons, can effectively reduce the death risk of patients with severe bradycardia, and improves the life quality of the patients. Conventional cardiac pacemaker systems are wired systems that generally include a pacemaker (i.e., a pulse generator) and an electrode lead, through which electrical pulses are generated that are conducted by the electrode lead to electrodes in contact with the heart muscle, thereby stimulating the heart muscle and causing the heart to become excited and contracted. But it has the following drawbacks: (1) Because of the existence of the electrode lead, side effects such as electrode dislocation, lead fracture, heart perforation, venous thrombosis of a lead path and the like are easily caused, so that the normal work of a pacemaker is influenced, and the life health and the life quality of a patient are seriously endangered; (2) The electrode removal procedure is difficult and requires a large electrophysiological center and is performed by a skilled physician.
With the continuous development of molding processes, the connection mode between the pacemaker and the electrode of the current cardiac pacemaker system has been developed from a wired mode to a leadless mode, so that some defects of the traditional wired cardiac pacemaker system can be overcome. Most of the existing leadless pacemakers are implanted at the position of the apex of the right ventricle of a patient, and the implantation at the position is relatively easy, the fixation stability is good, and the leadless pacemakers are not easy to fall off. Normal cardiac pacing begins with the sinus node of the atrium, and automatically generated excitation is conducted to various parts of the heart along its conducting bundle (atrioventricular node-left and right bundle branches-purkinje fibers) to cause excitation and contraction of the whole heart, and heart physiological and pathophysiological studies prove that the conduction direction of the excitation originating from the right ventricular apex is contrary to the normal pacing sequence, i.e. the pacing is not physiological, which can lead to the asynchrony of ventricular contraction, long-term right ventricular apex pacing can lead to the reconstruction and electrical reconstruction of ventricular musculature, and finally damage cardiac function, and atrial fibrillation, heart failure and even increased death risk are easily initiated.
Accordingly, there is a need for further improvements to current leadless pacemakers to reduce damage to a patient's heart from the leadless pacemaker.
Disclosure of Invention
The invention aims to provide a leadless pacemaker and a leadless pacing system, which can eliminate side effects caused by electrode leads, and can also avoid being arranged at the position of the apex of the right ventricle of a patient, thereby reducing damage to the heart.
In order to achieve the above object, the present invention provides a leadless pacemaker, which has an umbrella-shaped structure and comprises a leadless pacing device and a supporting device, wherein the leadless pacing device is an umbrella handle of the umbrella-shaped structure, the supporting device is an umbrella cover of the umbrella-shaped structure, the head end of the supporting device is connected to the head end of the leadless pacing device, the supporting device extends towards the tail end of the leadless pacing device, the tail end of the supporting device can gather towards the leadless pacing device for recovery and release and spread away from the leadless pacing device, and the supporting device is used for setting the leadless pacing device at a designated position after the supporting device releases and spreads.
Optionally, a sensing electrode and a pacing electrode are arranged on the outer side of the supporting device, or the pacing electrode and the sensing electrode are arranged at the head end of the leadless pacing device; the sensing electrode is used for sensing bioelectric signals at the corresponding positions after the supporting device is released and unfolded, and the pacing electrode is used for transmitting pacing signals to the corresponding positions after the supporting device is released and unfolded.
Optionally, the support means comprises a canopy mesh and/or a plurality of ribs for forming the canopy.
Optionally, when the supporting device includes a plurality of ribs, the head ends of all the ribs are connected to the head end of the leadless pacing device, and the tail ends of all the ribs are uniformly distributed on the circumference of a circle after being released and unfolded, or all the ribs of the supporting device are axisymmetric with respect to the leadless pacing device after being released and unfolded.
Optionally, after all the ribs of the supporting device are released and unfolded, the diameter of the circle or the distance between any two tail ends of the ribs which are axisymmetric relative to the leadless pacing device is larger than the length of the designated position.
Optionally, a threading mechanism for passing through the traction wire is arranged on the tail end of the supporting device.
Optionally, the tail end of the supporting device is curled outwards or inwards to form a ring-shaped structure so as to form the threading mechanism, or holes are formed in the tail end of the supporting device so as to form the threading mechanism, or the tail end of the supporting device is curled outwards or inwards to form a hook-shaped structure so as to form the threading mechanism.
Optionally, a barb mechanism is provided on the outside of the support device, which when the support device is released and deployed penetrates the tissue at the corresponding location to define the location of the support device.
Optionally, the supporting device is made of elastic material.
The present invention also provides a leadless pacing system comprising:
a leadless pacemaker according to the present invention;
a conveyor connected to the tail end of the leadless pacing device of the leadless pacemaker for conveying the leadless pacemaker to a designated location; the method comprises the steps of,
and an introducer for transporting the conveyor to the specified location.
Optionally, the conveyor comprises a delivery sheath, a push rod, and a loading sheath; wherein, the head end of the loading sheath is loaded on the tube seat at the tail end of the delivery sheath and is used for loading the leadless pacemaker in a recovery state; the pushing rod is loaded in the loading sheath, and the head end of the pushing rod is connected with the tail end of the leadless pacing device.
Optionally, the rod body of the pushing rod is of a coiled spring structure.
Optionally, a threading mechanism is arranged on the tail end of the supporting device; the delivery device further includes a pull wire passing through the threading mechanism and extending from a head end of the delivery sheath to and out of a tail end of the loading sheath for pulling the leadless pacemaker to retrieve the leadless pacemaker into the loading sheath and releasing the leadless pacemaker for deployment after the leadless pacemaker is detached from the head end of the delivery sheath.
Compared with the prior art, the technical scheme provided by the invention has the following beneficial effects:
1. the leadless pacemaker disclosed by the invention is designed in an umbrella-shaped structure and comprises a leadless pacing device positioned on an umbrella handle and a supporting device positioned on an umbrella surface, wherein the supporting device comprises a plurality of umbrella ribs distributed on the umbrella surface, and can fix the leadless pacing device at a designated position, so that side effects caused by a traditional electrode lead are eliminated; meanwhile, the normal cardiac pacing sequence starts from the sinus node of an atrium, and the automatically generated excitation is conducted to various parts of the heart along the conduction beam (atrioventricular node, left and right bundle branches and Purkinje fibers) to cause the excitation and contraction of the whole heart, and the umbrella-shaped structure of the leadless pacemaker provided by the invention can enable the leadless pacemaker to be easily implanted at a designated position (such as the right auricle), namely, the implantation position of the leadless pacemaker is close to the sinus node, so that the pacing sequence of the leadless pacemaker is closer to natural pacing, and the pacing of the pacemaker is more physiological. In addition, the leadless pacemaker is implanted at a designated position by virtue of the umbrella-shaped structural supporting device, namely, the supporting device is more in contact with heart tissues, the fixation stability is better, and the leadless pacemaker can be further used at the position of the right auricle close to the sinus node, so that the pacing pulse emitted by the leadless pacemaker is closer to the normal cardiac pacing sequence, and therefore, the leadless pacemaker is more physiological, and damage to the heart is reduced.
2. The leadless pacing system adopts the leadless pacemaker of the invention and is provided with the special conveyer and the guide, thereby not only having the beneficial effects brought by the leadless pacemaker of the invention, but also enabling the implantation operation of the leadless pacemaker to be more convenient and more accurate.
Drawings
Fig. 1 is a schematic diagram of a leadless pacemaker according to one embodiment of the invention in a released deployed state;
fig. 2 is a schematic view of a leadless pacemaker according to another embodiment of the present invention in a released deployment state;
fig. 3 is a schematic diagram of the configuration of a leadless pacemaker and delivery device cooperation of a leadless pacing system according to one embodiment of the present invention;
fig. 4 is a schematic view of the configuration of the delivery sheath of the delivery device and the dilating sheath of the introducer of a leadless pacing system according to an embodiment of the present invention;
fig. 5 is a schematic structural view of the delivery sheath and loading sheath cooperation of a leadless pacing system according to an embodiment of the present invention;
fig. 6 is a schematic diagram of the use of a leadless pacing system according to an embodiment of the present invention;
wherein, the reference numerals are as follows:
1-leadless pacemaker; 11-leadless pacing device; 111-a head end of a leadless pacing device; 112-tail end of leadless pacing device; 1121-internal threads; 12-ribs of the supporting device; 121-the head end of the rib; 1221-threading mechanism; 122-the tail end of the rib; 123-barb mechanism;
20-pushing a rod; 200-pushing the head end of the rod; 21-drawing wire; 22-loading sheath; 220-the head end of the loading sheath; 23-a delivery sheath; 231-a sheath tube of a delivery sheath; 2310—the head end of the delivery sheath; 232-a hub at the tail end of the delivery sheath; 233-infusion tube of delivery sheath; 234-valve;
31-dilating sheath; 311-the head end of the dilating sheath; 312—a hub at the tail end of the dilating sheath;
40-heart; 41-inferior vena cava; 42-superior vena cava; 43-right ventricle; 44-right atrium; 441-right atrial appendage.
Detailed Description
The present invention will be described in detail with reference to the accompanying drawings, for the purpose of making the objects and features of the present invention more understandable, however, the present invention may be embodied in various forms and should not be construed as limited to the embodiments set forth herein. It is noted that the drawings are in a very simplified form and utilize non-precise ratios, and are intended to facilitate a convenient, clear, description of the embodiments of the invention. It should be further noted that, in the present invention, the "head end" of a certain component refers to the end that first enters the body when the component is implanted in the body, and correspondingly, the "tail end" of a certain component refers to the end that last enters the body when the component is implanted in the body or the end that is exposed outside the body.
Referring to fig. 1, one embodiment of the present invention provides a leadless pacemaker having an umbrella-like structure comprising a leadless pacing device 11 and a retrievable and releasable support device. The leadless pacing device 11 is an umbrella handle of the umbrella structure, the supporting device comprises a plurality of ribs 12 for forming an umbrella surface of the umbrella structure, each rib 12 extends towards the tail end 112 of the leadless pacing device 11, the head end 122 of each rib 12 is connected to the head end 111 of the leadless pacing device 11, the tail end 121 of each rib 12 can gather towards the leadless pacing device 11 for recovery and release and deployment away from the leadless pacing device 11, and the supporting device is used for fixing the leadless pacing device 11 at a designated position (such as the right atrial appendage) on the heart after release and deployment.
In this embodiment, the number of the ribs 12 is 4-10, and the tail ends 122 of all the ribs 12 are uniformly distributed on the circumference of a circle when the supporting device is released and unfolded, so that the heart tissue at the installation position of the leadless pacemaker is uniformly stressed, unnecessary inclination of the leadless pacemaker is avoided, and the risk of penetration caused by overlarge stress of the heart tissue at a certain position is avoided; alternatively, in this embodiment, when the supporting device is released and deployed, all the ribs 12 are axisymmetric with respect to the leadless pacemaker device 11, that is, the head end 121 of each rib 12 of the supporting device of this embodiment starts from the head end 111 of the leadless pacemaker device 11, the leadless pacemaker device 11 is located at the "umbrella stem" position of the center surrounded by all the ribs 12, whether the leadless pacemaker 1 is in the recovery state or in the released and deployed state, the leadless pacemaker device 11 is located at the center of the space surrounded by all the ribs 12, thereby, the uniformity of the stress of the heart tissue at the installation position of the leadless pacemaker can be improved, so as to avoid unnecessary inclination of the leadless pacemaker, and avoid the risk of possible penetration due to excessive stress of the heart tissue at one side of the leadless pacemaker. The rib 12 may be a sheet structure or a wire structure, and has a thickness of 0.05 mm to 1 mm, so as to reduce the size and gravity thereof as much as possible on the premise of achieving excellent mechanical support performance, thereby reducing the burden on the heart. The material for manufacturing the rib 12 is preferably a high elastic material with excellent biocompatibility, for example, a memory metal material such as nickel-titanium alloy, so that the rib is as light as possible and has high elastic recovery performance, therefore, the rib 12 can be utilized to realize that the supporting device has elasticity on the whole, the rib can be recovered and released and unfolded relative to the wireless pacing device 11, and further, when the rib is released and unfolded, a heart space (for example, a right auricle) at a designated position can be unfolded, so that a better fixing effect is achieved on the wireless pacing device 11, a recovery mechanism and a release unfolding mechanism are prevented from being specially arranged on the supporting device, and the weight of the supporting device and the manufacturing cost of the supporting device are further reduced. When all the ribs 12 are completely released and unfolded, if the tail ends of all the ribs 12 are uniformly distributed on the circumference of a circle, the diameter of the circle should be larger than the length of the designated position (for example, the inner diameter of the right atrial appendage), and if all the ribs 12 are axisymmetric with respect to the leadless pacing device 11, the distance between any two tail ends 122 of the ribs 12 axisymmetric with respect to the leadless pacing device 11 should be larger than the length of the designated position (for example, the inner diameter of the right atrial appendage), so as to expand the space therein and squeeze the ribs 12 by muscle retraction force to realize fixation of the leadless pacemaker 1. Preferably, when all the ribs 12 are completely released and unfolded, if the tail ends of all the ribs 12 are uniformly distributed on the circumference of a circle, the diameter of the circle is 0.5 mm to 50 mm larger than the length of the designated position (for example, the inner diameter of the right atrial appendage), and if all the ribs 12 are axisymmetric with respect to the leadless pacing device 11, the distance between the tail ends 122 of any two of the ribs 12 axisymmetric with respect to the leadless pacing device 11 is 0.5 mm to 50 mm larger than the length of the designated position (for example, the inner diameter of the right atrial appendage), thereby expanding the right atrial appendage without damaging tissues and achieving a good fixing effect on the leadless pacing device 11.
Referring to fig. 2, in this embodiment, threading mechanisms 1221 for passing through traction wires (as shown in 21 of fig. 3) are disposed on the tail ends 122 of all the ribs 12 of the supporting device, the traction wires are used for pulling the ribs 12 by the threading mechanisms 1221 after being pulled, so that the tail ends of all the ribs 12 gather and recover toward the leadless pacing device 11, and releasing the gathered and recovered ribs 12 away from the leadless pacing device 11 after being loosened. The tail end 122 of the rib 12 in this embodiment is curled outwardly in a loop configuration to form the threading mechanism 1221. In other embodiments of the invention, the tail end 122 of the rib 12 may also be curled inwardly in a loop configuration to form the threading mechanism 1221, or holes may be punched in the tail end 122 of the rib 12 to form the threading mechanism 1221, or the tail end 122 of the rib 12 may be curled outwardly or inwardly in a hook configuration to form the threading mechanism 1221.
Referring to fig. 2, in the present embodiment, an internal thread 1121 is provided on the tail end 112 of the leadless pacing device 11 and cooperates with an external thread provided on the head end of the transporter (e.g., an external thread provided on the head end 200 of the pushing rod 20 in fig. 3), so that the head end of the transporter is connected to the tail end 112 of the leadless pacing device 11 to transport the leadless pacing device 11 to a designated position. In other embodiments of the present invention, the head end of the push rod 20 and the tail end 112 of the leadless pacing device 11 may be connected by a capture connection.
In this embodiment, the leadless pacing device 11 is used for sensing bioelectric signals (i.e., cardiac electric signals) and sending pacing signals, the outer layer is a cylindrical sealed housing, and the housing contains electronic components required for the operation of the leadless pacing device 11, such as a control component for sensing cardiac electric signals, generating pulse pacing signals, and controlling therapy delivery, and other functions of the leadless pacing device 11, a battery component for providing electric power to the control component, a memory, etc., which may be a register, etc., for storing data and related parameters, etc., and a leadless communication electronic component for bidirectional leadless communication with external devices (such as a programmer used by a clinician or other user in a medical facility, a home monitor or a handheld device located in a patient's home, etc.), which may be used for setting and acquiring parameters in the leadless pacing device 11 (including parameters characterizing the operating state of the leadless pacemaker 1, parameters of the patient's heart sensed by the leadless pacemaker 1, etc.).
It is contemplated that the outer sealed housing of the leadless pacing device 11 may be a cylinder, cuboid, prism, or other generally cylindrical structure, with sides that may be straight or curved, so long as it is capable of pacing and is reduced in size to be movable via a sheath of a transvenous delivery device to achieve intracardiac implantation, and the present invention encompasses these aspects. At this time, the shape of the rib 12 may be adjusted to be changed in accordance with the shape of the outer sealed housing of the leadless pacing device 11. In order to enhance the overall gas and water tightness of the leadless pacemaker 1, the support means and the outer sealed housing of the leadless pacing device 11 are preferably integrally formed.
Preferably, referring to fig. 2, at least a part of the supporting device is provided with a barb mechanism 123 on the outer side of the rib 12, wherein the barb direction of the barb mechanism 123 is opposite to the direction from the beginning to the end of the rib 12, on one hand, when all the ribs 12 are released and unfolded, the barb mechanism 123 can passively interact with the heart tissue at the designated position (for example, firmly prick into the atrial wall) so as to enhance the fixing reliability of the leadless pacemaker 1, and on the other hand, the leadless pacemaker 1 can be conveniently pulled out without damaging the tissue when being recovered. It is further preferred that the number of barb mechanisms on each rib 12 does not exceed 1, such that the total number of barb mechanisms 123 is less than or equal to the total number of ribs 12, to simultaneously compromise the enhancement of the fixation reliability of the leadless pacemaker 1 and the reduction of the heart wall burden. The barb mechanism 123 and the rib 12 are integrally formed to reduce manufacturing costs.
The leadless pacemaker 1 is configured to sense bioelectric signals (in this embodiment cardiac electrical signals, such as intracardiac electrograms EGMs) through sensing electrodes (not shown) and deliver pacing pulses to cardiac tissue in contact therewith via pacing electrodes. Wherein the sensing electrode may be disposed on the outside of at least one of the ribs 12 of the support device and the pacing electrode may be disposed on the outside of at least another of the ribs 12 of the support device. On one hand, the sensing electrode and the pacing electrode are used for contacting the tissues of the heart and pacing and sensing the heart after the supporting device is released and unfolded, and on the other hand, the sensing electrode and the pacing electrode are positioned on different umbrella ribs, so that the condition that signal interference exists between the sensing electrode and the pacing electrode can be avoided. In other embodiments of the present invention, the pacing and sensing electrodes may also be both disposed on the head end 111 of the leadless pacing device 11, the sensing and pacing electrodes being configured to contact and pace and sense tissue of the heart after the support device is released and deployed, and the pacing and sensing electrodes being shielded from protection by the support device when the support device is in the retracted state and being exposed to contact tissue of the heart by the support device when the support device is in the fully released and deployed state when both electrodes are disposed on the head end 111 of the leadless pacing device 11.
In the above embodiment, the supporting means is formed by a plurality of ribs 12, but the technical solution of the present invention is not limited thereto, as long as the supporting means can perform recovery and release deployment like an umbrella cover with respect to the wireless pacing device 11 and can have more contact surfaces with heart tissue. In other embodiments of the present invention, the supporting device may be a canopy net capable of presenting a canopy after being released and unfolded, or a canopy structure formed by combining a canopy net and ribs as required, for example, in a manner that a whole canopy net is connected to the head end of the wireless pacing device, and at least a plurality of ribs are connected to the tail end of the canopy net; for another example, a plurality of ribs are connected at the head end of the wireless pacing device, and a whole umbrella surface net is connected at the tail ends of all ribs; also for example, a plurality of ribs are connected to the head end of the wireless pacing device, the ribs are different in length, and a plurality of small pieces of canopy mesh are connected to the tail end of a shorter rib so that the tail end is aligned with the tail end of a longer rib; for example, the plurality of ribs have a structure as shown in fig. 1, and a canopy net is provided between some or all of the adjacent ribs. Wherein the mechanical properties of the support device with the canopy mesh are better than those of a support device consisting of ribs only, enabling a more secure fixation of the wireless pacing device 11. It should be noted that, when the supporting device is mainly made of elastic materials, the self elasticity can be utilized to realize recovery and release and expansion relative to the wireless pacing device 11, so that more contact surfaces can be provided with heart tissues at the designated positions when the wireless pacing device 11 is released and expanded, and the heart spaces at the designated positions are expanded, so that a better fixing effect is achieved on the wireless pacing device 11; when the supporting device is not made of elastic materials, a recovery mechanism for recovering the supporting device and a release unfolding mechanism for realizing release unfolding of the supporting device are specially arranged on the supporting device, so that the supporting device can be recovered and released and unfolded as an umbrella cover relative to the wireless pacing device 11 as a whole, and when the supporting device is released and unfolded, more contact surfaces with heart tissues at the designated positions can be formed, and the heart spaces at the designated positions are unfolded, so that a better fixing effect on the wireless pacing device 11 is achieved.
In summary, the leadless pacemaker of the invention is designed in an umbrella-shaped structure, and comprises a leadless pacing device positioned on an umbrella handle and a supporting device positioned on an umbrella cover, wherein the supporting device can fix the leadless pacing device at a specified position, thereby eliminating side effects caused by the traditional electrode leads; meanwhile, because normal cardiac pacing starts from the sinus node of an atrium, automatically generated excitation is conducted to various parts of the heart along a conducting bundle (atrioventricular node-left and right bundle branch-purkinje fiber) to cause excitation and contraction of the whole heart, and the pacing sequence of the leadless pacemaker positioned at the apex of the ventricle is contrary to the normal pacing sequence, compared with the leadless pacemaker used for the right ventricle, particularly the leadless pacemaker of the right apex, the leadless pacemaker provided by the invention can be implanted to the right auricle of the heart close to the sinus node, so that the released pacing pulse starts to be conducted from the sinus node, is closer to the normal pacing sequence, and is more physiological, and thus reduces the damage to the heart; in addition, the umbrella-shaped structure of the leadless pacemaker provided by the invention can be more in contact with heart tissue, has better fixation stability, and can be used for the position of the right auricle close to the sinus node, thereby providing a more reasonable pacing sequence and reducing damage to the heart.
Referring to fig. 1 to 6, an embodiment of the present invention further provides a leadless pacing system, including: the leadless pacemaker 1, delivery apparatus and introducer of the present invention. The conveyer and the guide are matched for use, and the leadless pacemaker 1 is conveyed to a designated position of the heart, such as the right atrial appendage, which is close to the sinus node, and the like for fixation during operation. And in the implantation process of the leadless pacemaker 1, the guide device can guide the conveyor to enter the patient and reach a proper position, and the conveyor can send the leadless pacemaker 1 into the patient and adjust the position of the leadless pacemaker 1, so that an operator can conveniently find the optimal pacing position of the leadless pacemaker 1, and the pacing effect of the leadless pacemaker 1 is improved.
The specific structure of the leadless pacemaker 1 of the leadless pacing system of the present embodiment may be referred to above.
Referring to fig. 3 to 5, in the present embodiment, the conveyor includes a push rod 20, a traction wire 21, a loading sheath 22, and a delivery sheath 23. The tail end 112 of the leadless pacing device 11 is provided with an internal thread 1121, and the head end 200 of the pushing rod 20 is provided with an external thread, which cooperates with the internal thread 1121 of the tail end 112 of the leadless pacing device 11, so that the head end of the pushing rod 20 is connected with the tail end 112 of the leadless pacing device 11. Preferably, the shaft portion of the push rod 200 employs a coiled spring structure that enhances the bending properties of the push rod 20, facilitating the passage of the push rod 200 through complex endocardial tissue structures. In other embodiments of the present invention, the head end of the push rod 20 and the tail end 112 of the leadless pacing device 11 may be connected by a capture connection. The loading sheath 22 is used for loading the leadless pacemaker 1 in a recovery state, as shown in fig. 5, the head end 220 of the loading sheath 22 loaded with the pushing rod 20 and the leadless pacemaker 1 in the recovery state is loaded on the tube seat 232 at the tail end of the delivery sheath 23, the loading sheath 22 and the pushing rod 20 are all on the same axis, the pushing rod 20 can push the leadless pacemaker 1 to move axially along the sheath axis of the loading sheath 20 into the sheath tube 231 of the delivery sheath 23, and further the leadless pacemaker 1 is separated from the head end of the delivery sheath 23 to be released and spread to the designated position. Obviously, the length of the pushing rod 20 should be greater than the total length of the delivery sheath 23 and the loading sheath 22 together.
At least a part of the tail end 122 of the umbrella rib 12 of the supporting device is provided with a threading mechanism 1221, the traction wire 21 passes through the threading mechanism 1221 and is long enough to be longer than the length of the delivery sheath 23, and can extend from the head end 2310 of the delivery sheath 23 to the tail end of the loading sheath 22 and extend out from the tail end of the loading sheath 22, so that an operator can recover the leadless pacemaker 1 into the sheath of the loading sheath 22 through the traction action of the traction wire 21 in the process of implanting the leadless pacemaker 1, and when the leadless pacemaker 1 is conveyed to a designated position through the sheath of the delivery sheath 23, the traction wire 21 can enable the umbrella rib 12 to be completely released and unfolded and can also be partially exposed outside the sheath of the loading sheath 22, and therefore, after the leadless pacemaker 1 is successfully paced and reliably fixed, the operator can cut off the traction wire 21 at the tail end of the loading sheath 22 to take out all the traction wire 21. Furthermore, the structural design of the rib 12 with the threading mechanism 1221 also facilitates the removal operation of the leadless pacemaker 1 after a period of use in the patient. In this embodiment, the tail end 122 of each rib 12 of the supporting device is curled outwards or inwards to form a ring structure to form the threading mechanism 1221, so that on one hand, the tail end 122 of the rib 12 is smooth, friction when the leadless pacemaker 1 moves in each sheath can be reduced to the greatest extent, damage to the rib 12 and the inner wall of the sheath can be avoided, cardiac tissue cannot be damaged after the rib is completely released and unfolded, and on the other hand, stress of the leadless pacemaker 1 can be uniform when the leadless pacemaker 1 is pulled, so that the axis of the leadless pacemaker 1 coincides with the axis of the sheath, and transportation and retrieval of the leadless pacemaker 1 are facilitated. In other embodiments of the invention, the threading mechanism 1221 may also be formed by punching holes in the trailing end 122 of the respective rib 12. It should be noted that, in other embodiments of the present invention, the threading mechanism 1221 having a hole structure or a ring structure may be formed on the tail end of the rib by any other suitable manufacturing method, and of course, the threading mechanism 1221 is not limited to the hole structure or the ring structure, but may also have a hook structure, for example, formed by curling the tail end of the rib outwards or inwards.
Preferably, the head end 2310 of the sheath 231 of the delivery sheath 23 is in a bent configuration, and the bent angle of the bent configuration is a fixed angle (for example, 45 °) or an adjustable angle (for example, 0-180 ° -adjustable), so as to adapt to the spatial structure inside the heart, which is beneficial for reducing the difficulty of entering the head end 2310 of the delivery sheath 23 into the heart.
Preferably, the head end 2310 of the sheath 231 of the delivery sheath 23 is provided with a visualization ring (not shown) that identifies the position of the sheath 231 under an imaging device during surgery. The tube seat 232 at the tail end of the delivery sheath 23 is also connected with an infusion tube 233, and a valve 234 is further arranged at one end of the infusion tube 233 away from the tube seat 232 at the tail end of the delivery sheath 23, the infusion tube 233 can be used for delivering the required liquid into the patient, and the valve 234 is used for controlling the liquid flow in the infusion tube 233 and for closing the infusion tube 233 when the infusion tube 233 is not in use.
In this embodiment, the introducer comprises an expanding sheath 31 and a guide wire (not shown), and when the leadless pacemaker 1 needs to be implanted, the head end of the guide wire may be fixed at the designated position (for example, the right atrial appendage) by a puncture technique, then the expanding sheath 31 is placed in the delivery sheath 23, and the sheath of the expanding sheath 31 is sleeved on the guide wire, so that the expanding sheath 31 moves along the guide wire to guide the delivery sheath 23 to the designated position. In this embodiment, the head end 311 of the dilating sheath 31 is in a tapered transition structure, after the sheath tube of the dilating sheath 31 is assembled in the sheath tube 231 of the delivering sheath 23, the head end 311 of the dilating sheath 31 can extend out of the head end 2310 of the sheath tube 231 of the delivering sheath 23, the socket at the tail end of the sheath tube of the dilating sheath 31 abuts against the socket 232 at the tail end of the delivering sheath 23 and can be further fixed together by screwing or catching, and the sheath tube 231 of the delivering sheath 23 can move along the axial direction of the sheath tube of the dilating sheath 31, so that the dilating sheath 31 can dilate the size of a blood vessel in the intravascular advancing process of a patient, and the sheath tube 231 of the delivering sheath 23 can smoothly enter the blood vessel. The leadless pacing system of the present embodiment further includes the external device for communication connection with the leadless pacemaker 1, and sets and acquires parameters in the leadless pacemaker 1.
It should be noted that each end of each component of the embodiment of the present invention is not limited to the shape shown in fig. 1 to 5, but may be any other suitable shape. For example, the leading and trailing ends of the leadless pacing device 11, the leading end of the delivery sheath 23, the leading end of the expansion sheath 31 may also be rounded, hemispherical, conical or polyhedral, etc.
The embodiment also provides a use method of the leadless pacing system, which comprises the following steps:
s1, placing the expanding sheath 31 in the delivery sheath 23, and delivering the delivery sheath 23 into a blood vessel along a guide wire;
s2, withdrawing the expanding sheath 31 and the guide wire, and keeping the delivery sheath 23 in place;
s3, the leadless pacemaker 1 is accommodated into the loading sheath 22 through the pushing rod 20 and matched with the traction wire 21, and the loading sheath 22 is connected to the tube seat 232 at the tail end of the delivery sheath 23;
s4, pushing the leadless pacemaker 1 through the pushing rod 20 from the loading sheath 22 into the delivery sheath 23 until the designated position, and enabling the leadless pacemaker 1 to be released and unfolded and fixed on the designated position;
and S5, taking out other components except the leadless pacemaker 1.
Referring to fig. 1 to 6, in step S1, before formally implanting the leadless pacemaker 1, first, a head end of a guide wire (not shown) is penetrated from a femoral vein (not shown) through a inferior vena cava 41 to a designated position (for example, on myocardium of right auricle 441 of right atrium 44) in a heart 40 of a patient by a puncture technique; then, the expanding sheath 31 is sleeved in the sheath tube 231 of the delivery sheath 23 until the head end 311 of the expanding sheath 31 penetrates out of the head end 2310 of the delivery sheath 23, the tube seat at the tail end of the expanding sheath 31 is propped against the tube seat 232 at the tail end of the delivery sheath 23, and the expanding sheath 31 and the delivery sheath 23 are fixed together through a mechanism on the tube seats of the two sheath tubes; next, the dilating sheath 31 is over the guidewire and the dilating sheath 31 is moved along the guidewire to deliver the dilating sheath 31, the delivery sheath 23 from the femoral vein through the inferior vena cava 41 to the position shown in fig. 5.
With continued reference to fig. 1-6, in step S2, the connection between the delivery sheath 23 and the hub of the dilating sheath 31 is loosened, and the dilating sheath 31 and guidewire are removed and the delivery sheath 23 is left in place.
With continued reference to fig. 1-6, in step S3, first, the head end 200 of the push rod 20 is connected to the tail end 112 of the leadless pacing device 11, and the traction wire 21 is threaded onto the threading mechanism 1221 on the tail end 122 of the rib 12 of the supporting device; then, the leadless pacemaker 1 is accommodated in the sheath tube of the loading sheath 22 to be in a recovery state by the pushing action of the pushing rod 20 and the pulling action of the pulling wire 21; next, the head end 220 of the loading sheath 22 containing the leadless pacemaker 1 and pusher rod 20, and the traction wire 21 is loaded onto the hub 232 at the tail end of the delivery sheath 23, at which time the loading sheath 22 is preferably disposed outside the patient's body in its entire structure to minimize parts entering the body, thereby simplifying the subsequent withdrawal of unnecessary parts.
With continued reference to fig. 1 to 6, in step S4, the operator pushes the leadless pacemaker 1 along the sheath tube of the loading sheath 22 into the sheath tube 231 of the delivery sheath 23 through the push rod 20 until the leadless pacemaker 1 is released and expanded by being separated from the head end 2310 of the delivery sheath 23, so that the sensing electrode and the pacing electrode on the leadless pacemaker 1 are in contact with the inner wall of the right atrial appendage (i.e., the designated position), at this time, the pacing and sensing electrical parameters of the leadless pacemaker 1 can be set and tested through external devices such as an external doctor programmer in wireless communication connection with the leadless pacemaker 1, if the pacing and sensing electrical parameters are not ideal due to the poor pacing sensing point position, the pulling wire 21 can be pulled and the push rod 20 is retracted to retract the leadless pacemaker 1 into the delivery sheath 23, then the position of the head end 2310 of the delivery sheath 23 is adjusted by the operation such as rotation of the delivery sheath 23, the position of the leadless pacemaker 1 is released and expanded again through the push rod 20, so that the pacing and sensing and expanding of the leadless pacemaker 1 are performed again, and the pacing and sensing electrical parameters are reliably obtained by the external device such as to obtain the optimal pacing and sensing electrical parameters of the leadless pacemaker 1 by the pacing and the pacing device.
With continued reference to fig. 1 to 6, in step S5, the traction wire 21 is first cut and removed, then the connection between the push rod 20 and the leadless pacemaker 1 is disconnected, and then the push rod 20 and the delivery sheath 23 are moved out of the human body together, thereby completing the implantation of the leadless pacemaker 1 at a designated position such as the right atrial appendage.
Similarly, the operator may implant the leadless pacemaker 1 in the right auricle position through the superior vena cava 42 in the above-described embodiment, or implant the leadless pacemaker 1 in the left atrium position through the venous system around the heart 40 in the above-described embodiment, and the present invention is intended to include this embodiment.
In addition, the leadless pacemaker 1 of the leadless pacemaker system of the embodiment can be combined with other leadless pacemakers in the heart in a wired or leadless manner to realize real leadless double-chamber and triple-chamber pacing, so that the advanced technology of the leadless pacemaker can benefit more patients.
It should be appreciated that, since the threading mechanism 1221 is provided on the rib 12 of the present embodiment, when the patient needs to take out the leadless pacemaker 1 after using it for a while, it is possible to take out the leadless pacemaker 1 by minimally invasive surgery, specifically, the leadless pacemaker 1 in the fully released and deployed state can be recovered to the recovered state by threading the traction wire 21 again by threading the traction wire 21 on the threading mechanism 1221, and thus the leadless pacemaker 1 can be conveniently taken out again by pushing the rod 20, the delivery sheath 23, and the like.
In the leadless pacemaker system of the above embodiment, the supporting means is formed by the plurality of ribs 12, but the technical solution of the present invention is not limited thereto, as long as the supporting means can perform recovery and release deployment like an umbrella surface with respect to the wireless pacemaker device 11 and can have more contact surfaces with heart tissue, the structure of the conveyor and introducer of the leadless pacemaker system of the various other embodiments thus obtained may not be changed in any way, and the usage method of the leadless pacemaker system of these embodiments is also described in the above examples. Specifically, in the leadless pacemaker system of some other embodiments of the present invention, the structure of the supporting device may be a canopy net capable of presenting a canopy after being released and unfolded, or a canopy structure formed by combining a canopy net and ribs as required, for example, a whole canopy net is connected to the head end of the wireless pacemaker device, and at least a plurality of ribs are connected to the tail end of the canopy net; for another example, a plurality of ribs are connected at the head end of the wireless pacing device, and a whole umbrella surface net is connected at the tail ends of all ribs; also for example, a plurality of ribs are connected to the head end of the wireless pacing device, the ribs are different in length, and a plurality of small pieces of canopy mesh are connected to the tail end of a shorter rib so that the tail end is aligned with the tail end of a longer rib; for example, the plurality of ribs have a structure as shown in fig. 1, and a canopy net is provided between some or all of the adjacent ribs. Wherein the mechanical properties of the support device with the canopy mesh are better than those of a support device consisting of ribs only, enabling a more secure fixation of the wireless pacing device 11.
In summary, the leadless pacemaker system of the invention comprises the leadless pacemaker with umbrella-shaped structure, the conveyor for conveying the leadless pacemaker to the designated position, and the like, and in the implantation process of the leadless pacemaker, the operator can adjust the position of the leadless pacemaker through the conveyor, so that the operator can conveniently find the optimal pacing position, thereby improving the pacing effect of the leadless pacemaker and eliminating the side effect caused by the traditional electrode lead; and because normal cardiac pacing starts from the sinus node of the atrium, the automatically generated excitation is conducted to each part of the heart along the conducting bundle (atrioventricular node, left and right bundle branches and purkinje fibers) to cause the excitation and contraction of the whole heart, and the pacing sequence of the leadless pacemaker positioned at the apex of the ventricle is contrary to the normal pacing sequence, compared with the leadless pacemaker used for the right ventricle, particularly the leadless pacemaker of the right ventricle, the leadless pacing system provided by the invention can be implanted at the right auricle of the heart close to the sinus node because the leadless pacemaker is in an umbrella-shaped structure, the issued pacing pulse is closer to the normal pacing sequence, and is more physiological, so that the damage to the heart can be reduced, and the leadless pacemaker is reliably fixed and more stable because of the characteristics of the structure of the right auricle and the umbrella-shaped structure of the leadless pacemaker.
It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
Claims (10)
1. The leadless pacemaker is characterized by being of an umbrella-shaped structure and comprises a leadless pacing device and a supporting device, wherein the leadless pacing device is an umbrella handle of the umbrella-shaped structure, the supporting device is an umbrella cover of the umbrella-shaped structure, the head end of the supporting device is connected to the head end of the leadless pacing device, the supporting device extends towards the tail end of the leadless pacing device, the tail end of the supporting device can gather towards the leadless pacing device for recovery and is far away from the leadless pacing device for release and expansion, the supporting device can set the leadless pacing device at a designated position after release and expansion, and the leadless pacemaker is in the center of a space surrounded by the supporting device in a recovery state and in a release and expansion state;
Wherein the supporting device comprises a canopy mesh and/or a plurality of ribs for forming the canopy; the outer side of the supporting device is provided with a sensing electrode and a pacing electrode, the sensing electrode is used for sensing bioelectric signals at corresponding positions after the supporting device is released and unfolded, and the pacing electrode is used for transmitting pacing signals to the corresponding positions after the supporting device is released and unfolded;
and the tail end of the supporting device is provided with a threading mechanism for penetrating a traction wire, the traction wire is used for pulling the tail end of the supporting device through the threading mechanism after being subjected to a pulling action, so that the tail ends of all the supporting devices are gathered and recovered towards the leadless pacing device, and the tail end of the gathered and recovered supporting device is released and unfolded away from the leadless pacing device after being subjected to a loosening action.
2. The leadless pacemaker of claim 1 wherein when the support device comprises a plurality of ribs, the head ends of all ribs are connected to the head end of the leadless pacing device, and the tail ends of all ribs are evenly distributed on the circumference of a circle after release deployment, or wherein all ribs of the support device are axisymmetric with respect to the leadless pacing device after release deployment.
3. The leadless pacemaker of claim 2 wherein a diameter of the circle or a spacing between any two tails of the ribs that are axisymmetric about the leadless pacing device after release deployment of all of the ribs of the support device is greater than a dimension of the designated location.
4. The leadless pacemaker of claim 1 wherein the tail end of the support device is curled outwardly or inwardly in a loop configuration to form the threading mechanism, or wherein a hole is punched in the tail end of the support device to form the threading mechanism, or wherein the tail end of the support device is curled outwardly or inwardly in a hook configuration to form the threading mechanism.
5. The leadless pacemaker of claim 1 wherein a barb mechanism is provided on an outer side of the support device that pierces tissue at a corresponding location when the support device is released for deployment to define the position of the support device.
6. The leadless pacemaker of claim 1 wherein the support device is fabricated from an elastic material.
7. A leadless pacing system comprising:
The leadless pacemaker of any one of claims 1-6;
a conveyor connected to the tail end of the leadless pacing device of the leadless pacemaker for conveying the leadless pacemaker to a designated location; the method comprises the steps of,
and an introducer for transporting the conveyor to the specified location.
8. The leadless pacing system of claim 7, wherein the transporter comprises a delivery sheath, a push rod, and a loading sheath; wherein, the head end of the loading sheath is loaded on the tube seat at the tail end of the delivery sheath and is used for loading the leadless pacemaker in a recovery state; the pushing rod is loaded in the loading sheath, and the head end of the pushing rod is connected with the tail end of the leadless pacing device.
9. The leadless pacing system of claim 8 wherein the shaft body of the push rod is a coiled spring structure.
10. The leadless pacing system of claim 8 or 9 wherein a threading mechanism is provided on the trailing end of the support device; the delivery device further includes a pull wire passing through the threading mechanism and extending from a head end of the delivery sheath to and out of a tail end of the loading sheath for pulling the leadless pacemaker to retrieve the leadless pacemaker into the loading sheath and releasing the leadless pacemaker for deployment after the leadless pacemaker is detached from the head end of the delivery sheath.
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| CN110393854A (en) * | 2019-07-20 | 2019-11-01 | 霍勇 | A kind of pacing electrode wire component being fixed in left ventricle automatically |
| CN110665122B (en) * | 2019-09-26 | 2021-11-26 | 创领心律管理医疗器械（上海）有限公司 | Leadless pacemaker, head end component, tail end component and delivery device thereof |
| CN111939476A (en) * | 2020-08-25 | 2020-11-17 | 哈尔滨医科大学 | Using method of leadless double-cavity pacemaker system implanted in coronary sinus |
| CN112274777A (en) * | 2020-11-03 | 2021-01-29 | 复旦大学附属中山医院 | Leadless pacing system for realizing left bundle branch pacing at ventricular septum left ventricle side |
| EP4046682A1 (en) * | 2021-02-23 | 2022-08-24 | BIOTRONIK SE & Co. KG | Implantable medical device comprising an anchoring device for anchoring on intracardiac tissue |
| CN114246565A (en) * | 2022-01-14 | 2022-03-29 | 首都医科大学附属北京天坛医院 | A human detection first aid device for postural hypotension |
| CN117339108B (en) * | 2023-12-04 | 2024-02-13 | 山东瑞安泰医疗技术有限公司 | Leadless cardiac pacemaker system capable of reducing pacing threshold |
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