Leadless pacemaker, electrode delivery assembly, and leadless pacemaker system

Abstract

The present invention provides a leadless pacemaker, an electrode delivery assembly, and a leadless pacemaker system. The leadless pacemaker comprises a pacemaker body, a signal line, and a distal electrode; the distal electrode is connected to the pacemaker body by means of the signal line; the distal electrode comprises a mating structure, the mating structure being used for detachably connecting to a docking structure of the electrode delivery assembly; and when the mating structure is connected to the docking structure, the distal electrode is configured to be implanted at a target site, delivered by the electrode delivery assembly. When the mating structure is connected to the docking structure, the distal electrode can be implanted at the target site, delivered by the electrode delivery assembly. After the distal electrode is implanted, the electrode delivery assembly can be removed by means of separating the docking structure from the mating structure. After implantation, when subjected to myocardial contraction, stress can be relieved by means of a signal line, thereby reducing or preventing fatigue fracturing, and improving safety and reliability for long-term use.

Description

Leadless pacemaker, electrode delivery assembly, and leadless pacemaker system TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a leadless pacemaker, an electrode delivery assembly, and a leadless pacemaker system. BACKGROUND

[0002] For more than half a century, artificial cardiac pacing has evolved from the initial simple electrical stimulation to restore the heartbeat to the current increasingly physiological pacing, which is inseparable from the updating of concepts, devices, and algorithms, and is also inseparable from the experience of clinicians improving implantation technology through practice. The current physiological pacing is increasingly directed to the self-conduction system below the pacing block site, maximally maintaining or correcting the electrical and mechanical synchronization of the heart below the block site, thereby reducing or improving heart failure. His bundle pacing is born in such a pursuit and applied in clinical practice. Although His bundle pacing is a relatively physiological pacing method, its long-term safety concerns limit its use in patients with all pacing indications, especially for some diseases with block sites below the His bundle or more distal, such as His bundle below block atrioventricular block and left bundle branch block, etc. His bundle pacing alone cannot achieve long-term stable low threshold pacing across the block site. In contrast, left bundle branch region pacing can more safely and more physiologically pace the conduction bundle across the block site.

[0003] On the other hand, leadless pacemakers can effectively avoid lead breakage, displacement, infection, and other complications associated with pacemaker pockets, such as pocket bleeding, infection, and ulceration. However, leadless pacemakers are generally fixed to the right ventricular wall by a fixation structure, and due to their fixed position and structure, they can only achieve pacing in the right ventricular apex or low septal region, and it is difficult to achieve physiological left bundle branch region pacing. SUMMARY

[0004] The present application aims to provide a leadless pacemaker, an electrode delivery assembly, and a leadless pacemaker system to solve the problem that existing leadless pacemakers are difficult to achieve physiological left bundle branch region pacing.

[0005] To solve the above technical problems, the present application provides a leadless pacemaker, which comprises a pacemaker body, a signal line, and a distal electrode.

[0006] The distal electrode is connected to the pacemaker body through the signal line.

[0007] The distal electrode comprises a mating structure configured to detachably connect with a docking structure of an electrode delivery assembly; when the mating structure is connected with the docking structure, the distal electrode is configured to be implanted into a target site under delivery of the electrode delivery assembly.

[0008] Optionally, the mating structure has a limiting cavity arranged at an angle with respect to an axial direction of the electrode delivery assembly, the limiting cavity being configured to accommodate the docking structure to limit an axial position of the docking structure.

[0009] Optionally, the limiting cavity extends in a circumferential direction or a helical direction and has an opening to allow the docking structure to rotate in the circumferential direction or move in the helical direction to disengage from the limiting cavity.

[0010] Optionally, the mating structure is helically coiled, and a gap between two adjacent turns is configured as the limiting cavity; or the mating structure comprises a first threaded hole or a first threaded stud, and a threaded groove of the first threaded hole or the first threaded stud is configured as the limiting cavity.

[0011] Optionally, the distal electrode has a sharp end distal to a connection end with the signal line; and / or the pacemaker body has a delivery cavity configured to movably pass through the electrode delivery assembly.

[0012] Optionally, the mating structure and the docking structure are connected by physical engagement.

[0013] To solve the above technical problems, the application further provides an electrode delivery assembly for delivering the leadless pacemaker as described above; the electrode delivery assembly comprises a delivery rod and a docking structure; when the docking structure is connected with the mating structure, the delivery rod is configured to move in an axial direction of the delivery rod to deliver the distal electrode to the target site.

[0014] Optionally, the docking structure is configured to rotate in a circumferential direction or move in a helical direction around an axis of the docking structure to separate from the mating structure.

[0015] Optionally, the docking structure comprises a protrusion arranged on the delivery rod, the protrusion being configured to be engaged into the limiting cavity of the mating structure; or the docking structure comprises a second threaded stud or a second threaded hole to threadedly connect with the first threaded hole or the first threaded stud of the mating structure.

[0016] Optionally, a distal end of the delivery rod is a sharp end.

[0017] Optionally, the protrusion is arranged at a distal end of the delivery rod, and the protrusion and the delivery rod form an L-shaped connection structure; or the protrusion is arranged at a position away from the distal end of the delivery rod by a distance, and the protrusion and the delivery rod form a T-shaped connection structure.

[0018] To solve the above technical problems, the application further provides a leadless pacemaker system, which comprises the leadless pacemaker as described above, and further comprises the electrode delivery assembly as described above.

[0019] To sum up, in the leadless pacemaker, the electrode delivery assembly, and the leadless pacemaker system provided by the application, the leadless pacemaker comprises a pacemaker body, a signal line, and a distal electrode; the distal electrode is connected to the pacemaker body through the signal line; the distal electrode comprises a matching structure, which is used for detachably connecting to a docking structure of the electrode delivery assembly; when the matching structure is connected to the docking structure, the distal electrode is configured to be implanted into a target site under the delivery of the electrode delivery assembly.

[0020] In this way, based on the arrangement of the matching structure, the distal electrode can be connected to and separated from the docking structure, and when the matching structure is connected to the docking structure, the distal electrode can be implanted into the target site under the delivery of the electrode delivery assembly. Furthermore, after the distal electrode is implanted, the electrode delivery assembly can be removed by separating the docking structure from the matching structure. After being implanted, when being squeezed by myocardial contraction, the stress can be eliminated through the signal line, so that fatigue fracture can be reduced or avoided, and the safety and reliability of long-term use can be improved. BRIEF DESCRIPTION OF DRAWINGS

[0021] Those skilled in the art will understand that the provided drawings are for the purpose of better illustrating the application and do not constitute any limitation on the scope of the application. Among them:

[0022] Fig. 1 is a schematic diagram of a leadless pacemaker system according to an embodiment of the application.

[0023] Fig. 2 is a schematic diagram of an implantation scene of a leadless pacemaker according to an embodiment of the application.

[0024] Fig. 3 is a schematic diagram of a distal part of an exemplary leadless pacemaker according to an embodiment of the application.

[0025] Fig. 4 is a schematic diagram of an electrode delivery assembly according to an embodiment of the application.

[0026] Fig. 5 is a schematic diagram of a first exemplary docking structure and matching structure according to an embodiment of the application.

[0027] Fig. 6 is a schematic diagram of a second exemplary docking structure and matching structure according to an embodiment of the application.

[0028] Fig. 7 is a schematic view of a distal end portion of another exemplary leadless pacemaker according to embodiments of the present application.

[0029] Fig. 8 is a schematic view of a third exemplary docking structure and mating structure according to embodiments of the present application.

[0030] In the drawings: 01 - right ventricle; 02 - left ventricle; 03 - interventricular septum; 1 - pacemaker body; 10 - housing; 11 - connecting portion; 12 - fixing portion; 13 - ring electrode; 14 - circuit assembly; 15 - delivery lumen; 2 - signal wire; 3 - distal electrode; 31 - mating structure; 311 - gap; 312 - first threaded hole; 32 - sharp end; 4 - electrode delivery assembly; 41 - docking structure; 411 - protrusion; 412 - second threaded stud; 42 - delivery shaft; 421 - sharp end; 43 - handle. DETAILED DESCRIPTION

[0031] In order to make the objects, advantages and features of the present application clearer, the following further describes the present application in detail with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are very simplified and not drawn to scale, and are only used to facilitate and clarify the purpose of assisting the description of the embodiments of the present application. In addition, the structures shown in the drawings are often part of the actual structures. In particular, the emphasis shown in each drawing is different, and sometimes different scales are used.

[0032] As used in the present disclosure, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise. The term "plurality" is generally employed in its sense including "at least one" unless the context clearly dictates otherwise. The term "at least two" is generally employed in its sense including "two or more" unless the context clearly dictates otherwise. In addition, the terms "first," "second," "third," etc. are used only to describe different instances and do not imply or suggest relative importance or imply a specific number of the technical features indicated. Thus, features qualified by "first," "second," "third," etc. can expressly or implicitly include one or at least two of the features. The terms "one end" and "the other end" and "proximal" and "distal" generally refer to two parts that correspond to each other and do not necessarily include end points. The terms "proximal" and "distal" are defined herein with respect to a leadless pacemaker having a fixation end for fixation to a heart and a connection end for connection to a pacemaker delivery device. The term "proximal" refers to a location closer to the connection end, and the term "distal" refers to a location closer to the fixation end and thus further away from the connection end. Alternatively, in a manual or hand-operated application scenario, the terms "proximal" and "distal" are defined herein with respect to a practitioner such as a surgeon or clinician. The term "proximal" refers to a location closer to the practitioner, and the term "distal" refers to a location closer to the site of treatment and thus further away from the practitioner. In addition, as used in the present disclosure, "mounted," "connected," "linked," one element "disposed" on another element should be construed broadly and generally means that there is a connection, coupling, engagement or transmission relationship between the two elements, and the two elements can be directly or indirectly connected, coupled, engaged or transmitted through an intermediate element, and cannot be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be in any orientation inside, outside, above, below or on one side of the other element, unless the context clearly dictates otherwise. For those skilled in the art, the specific meanings of the above terms in the present disclosure can be understood according to the specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the drawings, with the upward or upward direction being toward the top of the corresponding drawing, and the downward or downward direction being toward the bottom of the corresponding drawing.

[0033] The present disclosure aims to provide a leadless pacemaker, an electrode delivery assembly and a leadless pacemaker system to solve the problem that the existing leadless pacemaker is difficult to achieve physiological left bundle branch region pacing function. The following description is made with reference to the accompanying drawings.

[0034] Referring to FIGS. 1-3, an embodiment of the present application provides a leadless pacemaker, which comprises a pacemaker body 1, a signal line 2, and a distal electrode 3; the distal electrode 3 is connected to the pacemaker body 1 through the signal line 2; the distal electrode 3 comprises a mating structure 31, which is configured to detachably connect to a docking structure 41 of an electrode delivery assembly 4; when the mating structure 31 is connected to the docking structure 41, the distal electrode 3 is configured to be implanted into a target site under delivery of the electrode delivery assembly 4.

[0035] Referring to FIG. 4, and in combination with FIG. 1, an embodiment of the present application further provides an electrode delivery assembly 4, which is used to deliver the leadless pacemaker as described above; the electrode delivery assembly 4 comprises a delivery rod 42 and the docking structure 41; when the docking structure 41 is connected to the mating structure 31, the delivery rod 42 is configured to move along its own axis to deliver the distal electrode 3 to implant into a target site. Preferably, the electrode delivery assembly 4 further comprises a handle 43, and the delivery rod 42 extends out of the body from the proximal end to the outside and is connected to the handle 43, so that the operator can operate the delivery rod 42 and the docking structure 41 by operating the proximal handle 43. Preferably, the delivery rod 42 has a certain flexibility, for example, it can be a supporting steel wire, to adapt to the curve of the intervention path (such as a blood vessel). Further, since the delivery rod 42 is bendable, its axis is not limited to be a straight line, but can be adjusted to follow the curve. Further, the axis of the delivery rod 42 is configured to be the axis of the entire electrode delivery assembly 4.

[0036] In one exemplary embodiment, the pacemaker body 1 is generally cylindrical, which includes a housing 10, a connecting portion 11, a fixing portion 12, a ring electrode 13, and a circuit assembly 14, etc. The housing 10 is preferably a metal shell, such as a titanium shell or a titanium alloy shell. The circuit assembly 14 is accommodated in the interior of the housing 10. The connecting portion 11 is arranged at the proximal end of the housing 10, which is used to detachably connect with a pacemaker delivery device (not shown) to achieve the implantation or recovery of the leadless pacemaker. The fixing portion 12 is arranged at the distal end of the housing 10, which is used to be fixed on the human tissue (such as myocardial tissue). Please refer to FIG. 2, the fixing portion 12 can be fixed, for example, at the apex of the right ventricle 01 or the interventricular septum 03 between the right ventricle 01 and the left ventricle 02, etc. Please refer to FIG. 3, in some embodiments, the fixing portion 12 can be arranged as a spiral needle, which can be screwed into the myocardial tissue based on rotation. In other embodiments, the fixing portion 12 is also arranged in other hook shapes to achieve the connection and fixation with the myocardial tissue. Optionally, the fixing portion 12 can also be electrically connected with the circuit assembly 14 for sensing and transmitting electrical signals. The ring electrode 13 is arranged on the housing 10 along the circumference of the housing 10, which is exposed to the implantation environment. And the ring electrode 13 is electrically connected with the circuit assembly 14 for sensing and transmitting electrical signals. Further, the pacemaker body 1 also includes a battery and other components known to those skilled in the art, and the structure and principle of the present embodiment will not be described in detail.

[0037] Please continue to refer to FIGS. 1-3, the signal line 2 is preferably a flexible cable, one end of which is connected with the pacemaker body 1 and further electrically connected with the circuit assembly 14. The other end of the signal line 2 is connected with the distal electrode 3 and realizes electrical conduction. The distal electrode 3 is used to be implanted at the target site under the delivery of the electrode delivery assembly 4, such as the interventricular septum 03 between the right ventricle 01 and the left ventricle 02. After being implanted at the target site, the distal electrode 3 is used to transmit sensing signals and / or pacing signals. In one embodiment, the inner layer of the signal line 2 is a flexible conductor, which is coated with an insulating layer. By using the flexible conductor to cooperate with the metal distal electrode 3, the flexible conductor can withstand long-term bending stress, and by cleverly designing the supporting steel wire as the electrode delivery assembly 4, the flexible conductor can easily realize the linkage and separation action with the distal electrode 3 (which will be further described below in combination with the specific structure of the electrode delivery assembly 4 and the distal electrode 3), which can greatly reduce the outer diameter of the distal electrode 3, so that the distal electrode 3 can easily penetrate and stay in the myocardial tissue.

[0038] As shown in Fig. 3, in an alternative embodiment, the signal wire 2 can be coiled into a spiral shape, as shown in Fig. 3, before the leadless pacemaker is implanted (e.g. in a factory or during transportation) or during the delivery of the leadless pacemaker (referring to the whole process of implanting the leadless pacemaker, not specifically the process of implanting the distal electrode 3), so as to reduce or avoid the signal wire 2 from being scattered or entangled during transportation or implantation. Then the signal wire 2 is uncoiled during the implantation of the distal electrode 3 and is elongated by traction.

[0039] It should be noted that the position fixed by the fixing portion 12 is generally in the superficial region of the myocardium, for example, it can be fixed in the superficial region of the interventricular septum 03. The target site where the distal electrode 3 is implanted can be relatively deep into the left bundle branch region of the interventricular septum 03, so that the left bundle branch region can be directly paced and sensed. Then the electrode delivery assembly 4 can be removed by separating the docking structure 41 from the matching structure 31 after the distal electrode 3 is implanted. After implantation, the stress can be relieved by the signal wire 2 when it is squeezed by the myocardial contraction, so as to reduce or avoid fatigue fracture and improve the safety and reliability of long-term use.

[0040] Optionally, the matching structure 31 has a limiting cavity, which is arranged at an angle with the axial direction of the electrode delivery assembly 4, and is used for accommodating the docking structure 41 to limit the axial position of the docking structure 41. In some embodiments, the matching structure 31 and the docking structure 41 are preferably connected by physical engagement. Since the limiting cavity is arranged at an angle with the axial direction of the electrode delivery assembly 4, the axial position of the docking structure 41 relative to the matching structure 31 is limited after the docking structure 41 is accommodated in the limiting cavity, and the distal electrode 3 moves axially along with the electrode delivery assembly 4 when the electrode delivery assembly 4 moves along the axial direction.

[0041] Preferably, the limiting cavity extends circumferentially or spirally around the axis of the electrode delivery assembly 4 and has an opening to allow the docking structure 41 to rotate circumferentially or move spirally to separate from the limiting cavity. Adapted, the docking structure 41 is configured to rotate circumferentially or move spirally around its own axis to separate from the matching structure 31. Since the distal electrode 3 needs to be easily separated from the electrode delivery assembly 4 after being implanted into the target site, the electrode delivery assembly 4 has limited operations due to its invasive nature. By configuring the limiting cavity to extend circumferentially or spirally, the docking structure 41 can move circumferentially or spirally in the limiting cavity and then separate from the opening of the limiting cavity, which facilitates the actual operation of the electrode delivery assembly 4.

[0042] Please refer to FIG. 3 to FIG. 6, in an alternative exemplary embodiment, the mating structure 31 is helically coiled, and the gap 311 between adjacent turns is configured as the limiting cavity. The mating structure 31 can be a helical structure coiled around the axis of the electrode delivery assembly 4, forming a spring-like configuration, and a certain gap 311 between adjacent turns is required when coiling, for the insertion of the docking structure 41. Adapted, the docking structure 41 includes a protrusion 411 provided on the delivery rod 42, which is used to be clamped into the limiting cavity (i.e. the gap 311) of the mating structure 31. Preferably, the axial width of the gap 311 is adapted to the outer contour size of the protrusion 411, for example, the gap 311 is slightly wider than the protrusion 411, so that the protrusion 411 can be clamped into the gap 311. When the delivery rod 42 moves axially, the protrusion 411 can push the mating structure 31, thereby driving the mating structure 31 to move axially. Further, since the gap 311 is slightly wider than the protrusion 411, the protrusion 411 can move along the extension direction of the gap 311 (i.e. the helical direction). When the delivery rod 42 moves helically around its own axis, the protrusion 411 can move along the gap 311 until it is separated from the mating structure 31 at the proximal outlet of the gap 311. It can be understood that the helical movement of the delivery rod 42 has a direction of unwinding and a direction of winding. When the delivery rod 42 moves along the direction of unwinding, the protrusion 411 can gradually exit from the gap 311 until it is separated. Conversely, when the delivery rod 42 moves along the direction of winding, the protrusion 411 can gradually rotate from the proximal outlet of the gap 311 to the distal end of the gap 311. The direction of winding and the direction of unwinding are configured according to the different helical directions of the mating structure 31. For example, in the exemplary embodiment shown in FIG. 5, the helical direction of the mating structure 31 is left-handed, and when the delivery rod 42 is observed from the proximal end to the distal end, the clockwise direction is the direction of unwinding, and the counterclockwise direction is the direction of winding. Conversely, in other embodiments, the helical direction of the mating structure 31 is right-handed, and when the delivery rod 42 is observed from the proximal end to the distal end, the counterclockwise direction is the direction of unwinding, and the clockwise direction is the direction of winding.

[0043] As shown in FIG. 5, in one embodiment, the protrusion 411 can be provided at the distal end of the delivery rod 42, so that the protrusion 411 and the delivery rod 42 can form an L-shaped connection structure. Alternatively, the protrusion 411 and the delivery rod 42 can be integrally formed, for example, the distal end of the supporting steel wire can be bent to form the protrusion 411. As shown in FIG. 6, in another embodiment, the protrusion 411 can be provided at a position close to the distal end of the delivery rod 42, but separated from the distal end by a certain distance, so that the protrusion 411 and the delivery rod 42 can form a T-shaped connection structure.

[0044] Optionally, the diameter of the central hole formed by the coiled structure 31 is adapted to the outer diameter of the delivery rod 42. With this configuration, the reliability of the protrusion 411 being engaged into the gap 311 can be further improved, so that the reliable engagement of the coiled structure 31 and the abutting structure 41 can be ensured after the protrusion 411 is engaged into the gap 311 and the delivery rod 42 is not rotated, and the undesired disengagement can be reduced or avoided. Further, the diameter of the central hole formed by the coiled structure 31 being adapted to the outer diameter of the delivery rod 42 can also reduce the outer profile of the coiled structure 31, so that the size of the whole distal electrode 3 can be reduced, which is beneficial to the implantation of the distal electrode 3 and also beneficial to reduce the damage to the target tissue.

[0045] Please refer to FIG. 7 and FIG. 8, in some other embodiments, the coiled structure 31 comprises a first screw hole 312 or a first screw post (not shown), and the thread groove of the first screw hole 312 or the first screw post is configured as the limiting cavity. Correspondingly, the abutting structure 41 comprises a second screw post 412 or a second screw hole (not shown) to be threadedly engaged with the first screw hole 312 or the first screw post of the coiled structure 31. In the embodiment shown in FIG. 8, the first screw hole 312 has an internal thread, and the second screw post 412 has an external thread adapted thereto, so that the second screw post 412 can be screwed into the first screw hole 312 to form a threaded connection. Further, the axis of the second screw post 412 coincides with the axis of the delivery rod 42. The axis of the first screw hole 312, i.e. the axis of the whole distal electrode 3, also coincides with the axis of the delivery rod 42.

[0046] After the threaded connection of the second screw post 412 and the first screw hole 312, the relative axial positions of the two are defined. When the delivery rod 42 moves axially, the coiled structure 31 can be driven to move axially by the threaded connection of the second screw post 412 and the first screw hole 312. When the delivery rod 42 moves helically around its own axis, the second screw post 412 can move along the thread of the first screw hole 312 until it is disengaged from the coiled structure 31 from the opening at the proximal end of the first screw hole 312.

[0047] Further, in some embodiments, the distal electrode 3 has a sharp end 32 distal to the end connected with the signal line 2. In the embodiments shown in FIG. 3 to FIG. 6, the sharp end 32 can be formed at the distal end of the coiled structure 31, for example. In the embodiments shown in FIG. 7 and FIG. 8, the outer profile of the whole distal electrode 3 is generally formed in a shape gradually reducing towards the distal end, such as a conical shape, and the distal end thereof forms the sharp end 32. The provision of the sharp end 32 of the distal electrode 3 is beneficial to the implantation of the distal electrode 3.

[0048] Please refer to Fig. 6, optionally, the distal end of the delivery rod 42 is a sharp end 421. The provision of the sharp end 421 of the delivery rod 42 can also facilitate the implantation of the distal electrode 3. In some embodiments, the distal electrode 3 can have a passage for the delivery rod 42 to pass through, for example, the central hole formed by the coiling of the mating structure 31 shown in Fig. 6. After the distal electrode 3 is assembled with the electrode delivery assembly 4, the distal end of the delivery rod 42 can protrude from the distal electrode 3, so that when the distal electrode 3 is implanted, the delivery rod 42 can be in contact with the target tissue before the distal electrode 3, at which time the sharp end 421 can first open the implantation channel.

[0049] It should be noted that Figs. 3 to 6, and Figs. 7 and 8 respectively show two exemplary embodiments of the mating structure 31 and the docking structure 41, but the mating structure 31 and the docking structure 41 are not limited to the above exemplary embodiments disclosed. In other embodiments, for example, the mating structure 31 can be in the form of a cylinder, and the limiting cavity can be circumferentially formed on the cylindrical side wall of the mating structure 31 and have an opening, at which time the docking structure 41 can also be adapted to be provided with the protrusion 411 and be clamped into the limiting cavity, so that the mating structure 31 moves with the axial movement of the delivery rod 42. Further, the docking structure 41 can also be separated from the limiting cavity by circumferential rotation of the delivery rod 42.

[0050] Please continue to refer to Fig. 1, preferably, the pacemaker body 1 has a delivery cavity 15 for movably passing through the electrode delivery assembly 4. In one embodiment, the delivery cavity 15 can be a through cavity formed through the pacemaker body 1, and the delivery cavity 15 is preferably formed along the axis of the pacemaker body 1. In another embodiment, the delivery cavity 15 can be a slot cavity formed on the surface of the housing 10 of the pacemaker body 1, i.e. the delivery cavity 15 can be a non-closed slot. The delivery cavity 15 is preferably formed along the axis parallel to the pacemaker body 1. The provision of the delivery cavity 15 allows the electrode delivery assembly 4 to pass through the pacemaker body 1 without exceeding the cross-sectional range of the pacemaker body 1, reducing or avoiding the hindering effect on the implantation process of the pacemaker body 1, and reducing or avoiding the impact on the passability of the entire leadless pacemaker implantation.

[0051] The embodiment of the present application also provides a leadless pacemaker system, which comprises the leadless pacemaker as described above, and the electrode delivery assembly 4 as described above. The use method of the leadless pacemaker system provided by the embodiment is exemplarily described below.

[0052] Step S1: Before implantation, the docking structure 41 is first connected with the mating structure 31. For example, the protrusion 411 can be screwed into the helical gap 311 of the mating structure 31 in the screwing direction.

[0053] Step S2: after the connection of the pacing device and the connection part 11 of the pacing body 1, and then the leadless pacing device is delivered to the right ventricle 01 near the interventricular septum 03, the handle 43 is pushed to move the delivery rod 42 axially to the distal end, and the distal electrode 3 is driven to penetrate into the interventricular septum 03, for example, the left bundle branch area, through the docking structure 41.

[0054] Step S3: at this time, the electrical parameters can be measured, if the electrical parameters do not meet the requirements, the delivery can be continued to a deeper position or withdrawn from the interventricular septum 03 and other positions are searched for re-penetration and measurement of electrical parameters until the ideal electrical parameters are measured.

[0055] Step S4: the handle 43 is rotated in the unwinding direction to make the delivery rod 42 axially spiral to the proximal end, so that the docking structure 41 is separated from the matching structure 31, and then the delivery rod 42 is withdrawn, leaving the distal electrode 3 in the implanted position, and then the pacing body 1 is screwed onto the myocardium through the fixing part 12, and the entire leadless pacing device implantation is completed. Finally, the connection part 11 of the pacing device and the pacing body 1 is separated, the pacing device and the electrode delivery assembly 4 are removed, and the leadless pacing device implantation is completed.

[0056] In summary, in the leadless pacing device, the electrode delivery assembly and the leadless pacing system provided by the application, the leadless pacing device comprises a pacing body, a signal line and a distal electrode; the distal electrode is connected to the pacing body through the signal line; the distal electrode comprises a matching structure for detachable connection with a docking structure of an electrode delivery assembly; when the matching structure is connected with the docking structure, the distal electrode is configured to be implanted in a target site under the delivery of the electrode delivery assembly. In this way, based on the arrangement of the matching structure, the distal electrode can be connected and separated with the docking structure, and when the matching structure is connected with the docking structure, the distal electrode can be implanted in the target site under the delivery of the electrode delivery assembly. After the distal electrode is implanted, the electrode delivery assembly can be removed by separating the docking structure from the matching structure. After implantation, when subjected to the extrusion of myocardial contraction, the stress can be relieved through the signal line, fatigue fracture can be reduced or avoided, and the safety and reliability of long-term use are improved.

[0057] It should be noted that the above several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the application, and does not limit the scope of the application in any way. Any modification or modification of the application by a person skilled in the art based on the above disclosure is within the protection scope of the application.

Claims

1. A leadless pacemaker, characterized by, The pacing device comprises: a pacing device body, a signal wire, and a distal electrode; the distal electrode is connected with the pacing device body through the signal wire; the distal electrode comprises a mating structure configured to detachably connect with a docking structure of an electrode delivery assembly; when the mating structure is connected with the docking structure, the distal electrode is configured to be implanted into a target site under delivery of the electrode delivery assembly.

2. The leadless pacemaker of claim 1, wherein, the mating structure has a limiting cavity arranged at an angle with respect to an axial direction of the electrode delivery assembly, the limiting cavity is configured to accommodate the docking structure to limit an axial position of the docking structure.

3. The leadless pacemaker of claim 2, wherein, the limiting cavity extends in a circumferential direction or a helical direction and has an opening to allow the docking structure to rotate in a circumferential direction or move in a helical direction to disengage from the limiting cavity.

4. The leadless pacemaker of claim 2, wherein, the mating structure is helically wound, and a gap between two adjacent turns is configured as the limiting cavity.

5. The leadless pacemaker of claim 2, wherein, the mating structure comprises a first threaded hole or a first threaded stud, and a thread groove of the first threaded hole or the first threaded stud is configured as the limiting cavity.

6. The leadless pacemaker of claim 1, wherein, the distal electrode has a sharp end away from a connection end with the signal wire.

7. The leadless pacemaker of claim 1, wherein, the pacing device body has a delivery cavity configured to movably pass through the electrode delivery assembly.

8. The leadless pacemaker of claim 1, wherein, the mating structure and the docking structure are connected through physical engagement.

9. An electrode delivery assembly comprising: The electrode delivery assembly for delivering the leadless pacing device according to any one of claims 1-8 comprises a delivery rod and a docking structure; when the docking structure is connected with the mating structure, the delivery rod is configured to move in an axial direction of the delivery rod to deliver the distal electrode to the target site.

10. The electrode delivery assembly of claim 9, wherein, the docking structure is configured to rotate in a circumferential direction or move in a helical direction around an axial line of the docking structure to separate from the mating structure.

11. The electrode delivery assembly of claim 10, wherein, the docking structure comprises a protrusion arranged on the delivery rod, and the protrusion is configured to be engaged into the limiting cavity of the mating structure.

12. The electrode delivery assembly of claim 10, wherein, the docking structure comprises a second threaded stud or a second threaded hole configured to threadedly connect with the first threaded hole or the first threaded stud of the mating structure.

13. The electrode delivery assembly of claim 9, wherein, a distal end of the delivery rod is a sharp end.

14. The electrode delivery assembly of claim 11, wherein, the protrusion is arranged at a distal end of the delivery rod, and the protrusion and the delivery rod form an L-shaped connection structure; or the protrusion is arranged at a position away from the distal end of the delivery rod by a distance, and the protrusion and the delivery rod form a T-shaped connection structure.

15. A leadless pacemaker system, characterized by The pacing device comprises: a pacing device body, a signal wire, and a distal electrode; the distal electrode is connected with the pacing device body through the signal wire; the distal electrode comprises a mating structure configured to detachably connect with a docking structure of an electrode delivery assembly; when the mating structure is connected with the docking structure, the distal electrode is configured to be implanted into a target site under delivery of the electrode delivery assembly. the mating structure has a limiting cavity arranged at an angle with respect to an axial direction of the electrode delivery assembly, the limiting cavity is configured to accommodate the docking structure to limit an axial position of the docking structure. the limiting cavity extends in a circumferential direction or a helical direction and has an opening to allow the docking structure to rotate in a circumferential direction or move in a helical direction to disengage from the limiting cavity. the mating structure is helically wound, and a gap between two adjacent turns is configured as the limiting cavity. the mating structure comprises a first threaded hole or a first threaded stud, and a thread groove of the first threaded hole or the first threaded stud is configured as the limiting cavity. the distal electrode has a sharp end away from a connection end with the signal wire. the pacing device body has a delivery cavity configured to movably pass through the electrode delivery assembly. the mating structure and the docking structure are connected through physical engagement. The electrode delivery assembly for delivering the leadless pacing device according to any one of claims 1-8 comprises a delivery rod and a docking structure; when the docking structure is connected with the mating structure, the delivery rod is configured to move in an axial direction of the delivery rod to deliver the distal electrode to the target site. the docking structure is configured to rotate in a circumferential direction or move in a helical direction around an axial line of the docking structure to separate from the mating structure. the docking structure comprises a protrusion arranged on the delivery rod, and the protrusion is configured to be engaged into the limiting cavity of the mating structure. the docking structure comprises a second threaded stud or a second threaded hole configured to threadedly connect with the first threaded hole or the first threaded stud of the mating structure. a distal end of the delivery rod is a sharp end. the protrusion is arranged at a distal end of the delivery rod, and the protrusion and the delivery rod form an L-shaped connection structure; or the protrusion is arranged at a position away from the distal end of the delivery rod by a distance, and the protrusion and the delivery rod form a T-shaped connection structure. The pacing device comprises: a pacing device body, a signal wire, and a distal electrode; the distal electrode is connected with the pacing device body through the signal wire; the distal electrode comprises a mating structure configured to detachably connect with a docking structure of an electrode delivery assembly; when the mating structure is connected with the docking structure, the distal electrode is configured to be implanted into a target site under delivery of the electrode delivery assembly. the mating structure has a limiting cavity arranged at an angle with respect to an axial direction of the electrode delivery assembly, the limiting cavity is configured to accommodate the docking structure to limit an axial position of the docking structure. the limiting cavity extends in a circumferential direction or a helical direction and has an opening to allow the docking structure to rotate in a circumferential direction or move in a helical direction to disengage from the limiting cavity. the mating structure is helically wound, and a gap between two adjacent turns is configured as the limiting cavity. the mating structure comprises a first threaded hole or a first threaded stud, and a thread groove of the first threaded hole or the first threaded stud is configured as the limiting cavity. the distal electrode has a sharp end away from a connection end with the signal wire. the pacing device body has a delivery cavity configured to movably pass through the electrode delivery assembly. the mating structure and the docking structure are connected through physical engagement. The electrode delivery assembly for delivering the leadless pacing device according to any one of claims 1-8 comprises a delivery rod and a docking structure; when the docking structure is connected with the mating structure, the delivery rod is configured to move in an axial direction of the delivery rod to deliver the distal electrode to the target site. the docking structure is configured to rotate in a circumferential direction or move in a helical direction around an axial line of the docking structure to separate from the mating structure. the docking structure comprises a protrusion arranged on the delivery rod, and the protrusion is configured to be engaged into the limiting cavity of the mating structure. the docking structure comprises a second threaded stud or a second threaded hole configured to threadedly connect with the first threaded hole or the first threaded stud of the mating structure. a distal end of the delivery rod is a sharp end. the protrusion is arranged at a distal end of the delivery rod, and the protrusion and the delivery rod form an L-shaped connection structure; or the protrusion is arranged at a position away from the distal end of the delivery rod by a distance, and the protrusion and the delivery rod form a T-shaped connection structure. The pacing device comprises: a pacing device body, a signal wire, and a distal electrode; the distal electrode is connected with the pacing device body through the signal wire; the distal electrode comprises a mating structure configured to detachably connect with a docking structure of an electrode delivery assembly; when the mating structure is connected with the docking structure, the distal electrode is configured to be implanted into a target site under delivery of the electrode delivery assembly. the mating structure has a limiting cavity arranged at an angle with respect to an axial direction of the electrode delivery assembly, the limiting cavity is configured to accommodate the docking structure to limit an axial position of the docking structure. the limiting cavity extends in a circumferential direction or a helical direction and has an opening to allow the docking structure to rotate in a circumferential direction or move in a helical direction to disengage from the limiting cavity. the mating structure is helically wound, and a gap between two adjacent turns is configured as the limiting cavity. the mating structure comprises a first threaded hole or a first threaded stud, and a thread groove of the first threaded hole or the first threaded stud is configured as the limiting cavity. the distal electrode has a sharp end away from a connection end with the signal wire. the pacing device body has a delivery cavity configured to movably pass through the electrode delivery assembly. the mating structure and the docking structure are connected through physical engagement. The electrode delivery assembly for delivering the leadless pacing device according to any one of claims 1-8 comprises a delivery rod and a docking structure; when the docking structure is connected with the mating structure, the delivery rod is configured to move in an axial direction of the delivery rod to deliver the distal electrode to the target site. the docking structure is configured to rotate in a circumferential direction or move in a helical direction around an axial line of the docking structure to separate from the mating structure. the docking structure comprises a protrusion arranged on the delivery rod, and the protrusion is configured to be engaged into the limiting cavity of the mating structure. the docking structure comprises a second threaded stud or a second threaded hole configured to threadedly connect with

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