Wire-free pacemaker, electrode delivery assembly and wire-free pacemaker system

Abstract

The invention provides a lead-free pacemaker, an electrode conveying assembly and a lead-free pacemaker system. The lead-free pacemaker comprises a pacemaker body, a signal line and a far-end electrode, the far-end electrode is connected with the pacemaker body through the signal line; the far-end electrode comprises a matching structure, and the matching structure is used for being detachably connected with a butt joint structure of an electrode conveying assembly. When the matching structure is connected with the butt joint structure, the far-end electrode is configured to be implanted into a target part under conveying of the electrode conveying assembly. And when the matching structure is connected with the butt joint structure, the far-end electrode can be implanted into a target part under the conveying of the electrode conveying assembly. After implantation of the far-end electrode is completed, the electrode conveying assembly can be removed through separation of the butt joint structure and the matching structure. After implantation, stress can be eliminated through the signal line when myocardial contraction and extrusion are carried out, fatigue fracture is reduced or avoided, and safety and reliability of long-term use are improved.

Description

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 heart beat to the current increasingly physiological pacing. This is inseparable from the update of concepts, devices and algorithms, and is also inseparable from the experience of clinicians in practice and the continuous improvement of implantation technology. At present, the scope of 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, due to its generally high pacing threshold, the long-term safety concerns limit the use of His bundle pacing in all patients with pacing indications, especially for some diseases with block sites below the His bundle or more distal, such as His bundle below the atrioventricular block, 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, the leadless pacemaker can effectively avoid the lead breakage, displacement and infection of the traditional leaded pacemaker, and avoid the occurrence of complications such as pacemaker pocket bleeding, infection and ulceration related to the pacemaker pocket. However, the leadless pacemaker is generally fixed on the right ventricular wall by a fixed structure, and due to its fixed position and structure, it can only achieve pacing in the right ventricular apex or right ventricular low septal region, and it is difficult to achieve physiological left bundle branch region pacing function. SUMMARY

[0004] The purpose of the present application is 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.

[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. The distal electrode is connected to the pacemaker 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.

[0006] Optionally, the matching structure has a limiting cavity arranged at an angle with respect to the axial direction of the electrode delivery assembly, and the limiting cavity is configured to accommodate the docking structure to limit the axial position of the docking structure.

[0007] 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 a circumferential direction or move in a helical direction to disengage from the limiting cavity.

[0008] Optionally, the matching structure is helically wound, and the gap between two adjacent turns is configured as the limiting cavity; or the matching structure comprises a first threaded hole or a first threaded stud, and the thread groove of the first threaded hole or the first threaded stud is configured as the limiting cavity.

[0009] Optionally, the distal end of the electrode is a sharp end away from the end connected to the signal line; and / or the pacemaker body has a delivery cavity for movably passing through the electrode delivery assembly.

[0010] To solve the above technical problems, the present 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 to the matching structure, the delivery rod is configured to move in the axial direction of itself to deliver the distal end of the electrode to the target implantation site.

[0011] Optionally, the docking structure is configured to rotate in a circumferential direction or move in a helical direction around the axis of itself to separate from the matching structure.

[0012] Optionally, the docking structure comprises a protrusion arranged on the delivery rod, and the protrusion is configured to be clamped into the limiting cavity of the matching 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 matching structure.

[0013] Optionally, the distal end of the delivery rod is a sharp end.

[0014] To solve the above technical problems, the present application further provides a leadless pacemaker system comprising the leadless pacemaker as described above, and further comprising the electrode delivery assembly as described above.

[0015] In summary, in the leadless pacemaker, electrode delivery assembly, and leadless pacemaker system provided by the present invention, the leadless pacemaker includes a pacemaker body, a signal line, and a distal electrode; the distal electrode is connected to the pacemaker body via the signal line; the distal electrode includes a mating structure for detachably connecting with a docking structure of the electrode delivery assembly; when the mating structure is connected to the docking structure, the distal electrode is configured to be implanted at a target site under the delivery of the electrode delivery assembly.

[0016] This configuration, based on the mating structure, allows the distal electrode to connect and disconnect from the docking structure. When the mating and docking structures are connected, the distal electrode can be implanted into the target site under the delivery of the electrode delivery assembly. After implantation, the electrode delivery assembly can be removed by separating from the mating structure via the docking structure. Post-implantation, under myocardial contraction and compression, stress can be relieved via the signal lines, reducing or preventing fatigue fracture and improving the safety and reliability of long-term use. Attached Figure Description

[0017] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein: Figure 1 This is a schematic diagram of a leadless pacemaker system according to an embodiment of the present invention.

[0018] Figure 2 This is a schematic diagram of the implantation scenario of the leadless pacemaker according to an embodiment of the present invention.

[0019] Figure 3 This is a schematic diagram of a distal portion of an exemplary example of a leadless pacemaker according to an embodiment of the present invention.

[0020] Figure 4 This is a schematic diagram of the electrode delivery assembly according to an embodiment of the present invention.

[0021] Figure 5 This is a schematic diagram of the first exemplary example of the docking structure and mating structure in an embodiment of the present invention.

[0022] Figure 6 This is a schematic diagram of the second exemplary example of the docking structure and mating structure in an embodiment of the present invention.

[0023] Figure 7 This is a schematic diagram of the distal portion of another exemplary example of a leadless pacemaker according to an embodiment of the present invention.

[0024] Figure 8 This is a schematic diagram of the third exemplary example of the docking structure and mating structure in this invention.

[0025] In the attached image:

[0026] 01-Right ventricle; 02-Left ventricle; 03-Interventricular septum; 1-Pacemaker body; 10-Housing; 11-Connecting part; 12-Fixing part; 13-Ring electrode; 14-Circuit assembly; 15-Delivery chamber; 2-Signal line; 3-Distal electrode; 31-Matching structure; 311-Gap; 312-First screw hole; 32-Sharp end; 4-Electrode delivery assembly; 41-Matching structure; 411-Protrusion; 412-Second stud; 42-Delivery rod; 421-Sharp end; 43-Handle. Detailed Implementation

[0027] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0028] As used herein, the singular forms “a,” “an,” “one,” and “the” include plural objects; the term “or” is generally used to include the meaning of “and / or”; the term “a number” is generally used to include the meaning of “at least one”; and the term “at least two” is generally used to include the meaning of “two or more”. Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature; “one end” and “the other end,” and “proximal end” and “distal end” generally refer to two corresponding portions, which include not only the endpoints. The terms “proximal end” and “distal end” are defined herein in relation to a leadless pacemaker having a fixed end for attachment to the heart and a connecting end for connection to a pacemaker delivery device. The term “proximal end” refers to a position closer to the connecting end, and the term “distal end” refers to a position closer to the fixed end and therefore further away from the connecting end. Optionally, in applications involving manual or hand-operated techniques, the terms "proximal" and "distal" are defined herein in relation to the operator, such as a surgeon or clinician. The term "proximal" refers to a position closer to the operator, and the term "distal" refers to a position closer to the affected area and therefore further away from the operator. Furthermore, as used in this invention, terms such as "installed," "connected," "attached," and "set" of one element on another should be interpreted broadly, generally indicating only a connection, coupling, engagement, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element. This connection, coupling, engagement, or transmission should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located inside, outside, above, below, or to one side of another element, unless otherwise explicitly stated. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances. Additionally, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as shown in the figures, with upward or upper directions pointing towards the top of the corresponding figure, and downward or lower directions pointing towards the bottom of the corresponding figure.

[0029] The purpose of this invention is to provide a leadless pacemaker, an electrode delivery assembly, and a leadless pacemaker system to solve the problem that existing leadless pacemakers cannot achieve physiological left bundle branch pacing function. The following description refers to the accompanying drawings.

[0030] Please refer to Figures 1 to 3This invention provides a leadless pacemaker, comprising: a pacemaker body 1, a signal line 2, and a distal electrode 3; the distal electrode 3 is connected to the pacemaker body 1 via the signal line 2; the distal electrode 3 includes a mating structure 31, which is detachably connected 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 at a target site under the delivery of the electrode delivery assembly 4.

[0031] Please refer to Figure 4 and in conjunction with references Figure 1 This invention also provides an electrode delivery assembly 4 for delivering a leadless pacemaker as described above. The electrode delivery assembly 4 includes a delivery rod 42 and a docking structure 41. When the docking structure 41 is connected to the mating structure 31, the delivery rod 42 moves along its own axis to deliver the distal electrode 3 to the target implantation site. Preferably, the electrode delivery assembly 4 further includes a handle 43, with the delivery rod 42 extending proximally from within the body and connected to the handle 43, allowing the operator to manipulate the delivery rod 42 and the docking structure 41 by operating the proximal handle 43. Preferably, the delivery rod 42 has a certain degree of flexibility, for example, it can be a supporting wire to adapt to the curvature of the interventional path (such as a blood vessel). Furthermore, since the delivery rod 42 is flexible, its axis is not limited to being a straight line, but can be adjusted to follow the curvature. Even further, the axis of the delivery rod 42 is configured as the axis of the entire electrode delivery assembly 4.

[0032] In an exemplary embodiment, the pacemaker body 1 is generally cylindrical and includes a housing 10, a connecting portion 11, a fixing portion 12, a ring electrode 13, and a circuit assembly 14. The housing 10 is preferably a metal housing, such as a titanium housing or a titanium alloy housing. The circuit assembly 14 is housed inside the housing 10. The connecting portion 11 is located at the proximal end of the housing 10 and is used for detachable connection to a pacemaker delivery device (not shown) to enable implantation or retrieval of a leadless pacemaker. The fixing portion 12 is located at the distal end of the housing 10 and is used for fixation to human tissue (such as myocardial tissue). Please refer to the references. Figure 2 The fixing part 12 can be fixed, for example, to the apex of the right ventricle 01 or to the interventricular septum 03 between the right ventricle 01 and the left ventricle 02. Please refer to [reference needed]. Figure 3In some embodiments, the fixation part 12 may be configured as a spiral needle, which can be inserted into the myocardial tissue by rotation. In other embodiments, the fixation part 12 is also configured in other hook shapes to achieve connection and fixation with the myocardial tissue. Optionally, the fixation part 12 may also be electrically connected to the circuit assembly 14 for sensing and transmitting electrical signals. The ring electrode 13 is disposed circumferentially on the housing 10 and exposed to the implantation environment. The ring electrode 13 is also electrically connected to the circuit assembly 14 for sensing and transmitting electrical signals. Furthermore, the pacemaker body 1 also includes components known to those skilled in the art, such as a battery; their structure and principles will not be described in detail in this embodiment.

[0033] Please continue to refer to this. Figures 1 to 3 The signal line 2 is preferably a flexible cable, one end of which is connected to the pacemaker body 1 and further electrically connected to the circuit assembly 14. The other end of the signal line 2 is connected to the distal electrode 3, enabling electrical conduction. The distal electrode 3 is used to be implanted into a target site, such as the interventricular septum 03 between the right ventricle 01 and the left ventricle 02, under the delivery of the electrode delivery assembly 4. After implantation into 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, and the outer periphery is covered with an insulating layer. By using the flexible conductor in conjunction with the metallic distal electrode 3, the flexible conductor can withstand long-term bending stress, and the supporting steel wire can be cleverly designed as the electrode delivery assembly 4 to achieve easy linkage and separation with the distal electrode 3 (the specific structure of the electrode delivery assembly 4 and the distal electrode 3 will be further explained below). This can greatly reduce the outer diameter of the distal electrode 3, allowing the distal electrode 3 to easily penetrate and remain in the myocardial tissue.

[0034] like Figure 3 As shown, in an optional embodiment, before implantation of the leadless pacemaker (such as in its state at the time of manufacture or transportation), or during delivery of the leadless pacemaker (referring to the overall implantation process of the leadless pacemaker, not specifically the implantation process of the distal electrode 3), the signal line 2 can be coiled into a spiral shape, such as... Figure 3 As shown, this is to reduce or avoid undesirable situations such as tangling or twisting of the signal line 2 during transportation or implantation. Furthermore, it is untangled during the implantation of the distal electrode 3 and elongated under traction.

[0035] It should be noted that the fixation point 12 is generally fixed in the superficial region of the myocardium, for example, in the superficial region of the interventricular septum 03. The target site for implantation of the distal electrode 3 can be relatively deep into the interventricular septum 03 to the left bundle branch region, thereby allowing direct pacing and sensing of the left bundle branch region. Furthermore, after implantation of the distal electrode 3, the electrode delivery assembly 4 can be removed by separating it from the mating structure 31 via the docking structure 41. After implantation, when subjected to myocardial contraction and compression, stress can be relieved through the signal line 2, reducing or avoiding fatigue fracture and improving the safety and reliability of long-term use.

[0036] Optionally, the mating structure 31 has a limiting cavity, which is arranged at an angle to the axial direction of the electrode delivery assembly 4. The limiting cavity is used to accommodate the docking structure 41 to restrict the axial position of the docking structure 41. In some embodiments, the mating structure 31 and the docking structure 41 are preferably connected by physical engagement. Since the limiting cavity is arranged at an angle to the axial direction of the electrode delivery assembly 4, after the docking structure 41 is accommodated in the limiting cavity, the axial position of the docking structure 41 relative to the mating structure 31 is limited. When the electrode delivery assembly 4 moves along its own axial direction, it drives the distal electrode 3 to move along the axial direction as well.

[0037] Preferably, the limiting cavity extends circumferentially or helically around the axis of the electrode delivery assembly 4 and has an opening to allow the docking structure 41 to rotate circumferentially or move helically and disengage from the limiting cavity. Alternatively, the docking structure 41 is configured to rotate circumferentially or move helically about its own axis to separate from the mating structure 31. Since the distal electrode 3 needs to be easily disengaged from the distal electrode 3 after implantation at the target site, and considering that the electrode delivery assembly 4 is an invasive component with limited operational capabilities, configuring the limiting cavity to extend circumferentially or helically allows the docking structure 41 to move circumferentially or helically within it, thereby disengaging from the opening of the limiting cavity, facilitating the actual operation of the electrode delivery assembly 4.

[0038] Please refer to Figures 3 to 6In an alternative example, the mating structure 31 is spirally coiled, with the gap 311 between adjacent turns configured as the limiting cavity. The mating structure 31 can be a spiral structure coiled around the axis of the electrode delivery assembly 4, forming a spring-like structure, and a certain gap 311 must exist between adjacent turns during coiling to allow the docking structure 41 to be inserted. Adapted, the docking structure 41 includes a protrusion 411 disposed on the delivery rod 42, the protrusion 411 being used to engage with the limiting cavity (i.e., gap 311) of the mating structure 31. Preferably, the axial width of the gap 311 is adapted to the outer contour dimension of the protrusion 411; for example, the gap 311 is slightly wider than the protrusion 411, allowing the protrusion 411 to engage with the gap 311. When the delivery rod 42 moves axially, the protrusion 411 can push against the mating structure 31, thereby causing the mating structure 31 to move axially as well. Furthermore, since the gap 311 is slightly wider than the protrusion 411, the protrusion 411 can move along the extension direction (i.e., the helical direction) of the gap 311. As the conveyor rod 42 moves helically around its own axis, the protrusion 411 can move along the gap 311 until it disengages from the mating structure 31 at the proximal end of the gap 311. Understandably, the helical movement of the conveyor rod 42 has both an outward and an inward direction. When the conveyor rod 42 moves in the outward direction, the protrusion 411 can gradually withdraw from the gap 311 until it separates. Conversely, when the conveyor rod 42 moves in the inward direction, the protrusion 411 can gradually screw into the distal end of the gap 311 from the proximal end of the exit. The inward and outward directions are specifically configured according to the different helical directions of the mating structure 31. For example... Figure 5 In the illustrated example, the helix direction of the mating structure 31 is left-handed. Therefore, when the conveying rod 42 is viewed from the proximal end to the distal end, the clockwise direction is the outward rotation direction, and the counterclockwise direction is the inward rotation direction. Conversely, in some embodiments, the helix direction of the mating structure 31 is right-handed. Therefore, when the conveying rod 42 is viewed from the proximal end to the distal end, the counterclockwise direction is the outward rotation direction, and the clockwise direction is the inward rotation direction.

[0039] like Figure 5 As shown, in one embodiment, the protrusion 411 can be disposed at the distal end of the conveying rod 42, thereby forming an L-shaped connection structure between the protrusion 411 and the conveying rod 42. Optionally, the protrusion 411 and the conveying rod 42 can be integrally formed, for example, by bending the distal end of the support wire to form the protrusion 411. Figure 6 As shown, in another embodiment, the protrusion 411 can be provided at a position on the conveying rod 42 near the far end, but at a certain distance from the far end, so that the protrusion 411 and the conveying rod 42 can form a T-shaped connection structure.

[0040] Optionally, the diameter of the central hole formed by the coiling of the mating structure 31 is adapted to the outer diameter of the delivery rod 42. This configuration further improves the reliability of the protrusion 411 engaging with the gap 311, ensuring reliable engagement between the mating structure 31 and the docking structure 41 when the protrusion 411 is engaged with the gap 311 and the delivery rod 42 is not rotating, reducing or avoiding undesirable detachment. Furthermore, the adaptation of the diameter of the central hole formed by the coiling of the mating structure 31 to the outer diameter of the delivery rod 42 can also reduce the outer contour size of the mating structure 31, thereby reducing the overall size of the distal electrode 3, which is beneficial for the implantation of the distal electrode 3 and also helps to reduce damage to the target tissue.

[0041] Please refer to Figure 7 and Figure 8 In other embodiments, the mating structure 31 includes a first threaded hole 312 or a first stud (not shown), the threaded groove of which is configured as the limiting cavity. Correspondingly, the mating structure 41 includes a second stud 412 or a second threaded hole (not shown) for threaded connection with the first threaded hole 312 or the first stud of the mating structure 31. Figure 8 In the illustrated embodiment, the first threaded hole 312 has an internal thread, and the second stud 412 has a matching external thread, so that the second stud 412 can be screwed into the first threaded hole 312 to form a threaded connection. Furthermore, the axis of the second stud 412 coincides with the axis of the conveying rod 42. The axis of the first threaded hole 312, which is also the axis of the entire distal electrode 3, also coincides with the axis of the conveying rod 42.

[0042] After the second stud 412 is threadedly connected to the first threaded hole 312, their relative axial positions are defined. When the conveying rod 42 moves axially, the threaded connection between the second stud 412 and the first threaded hole 312 drives the mating structure 31 to move axially as well. When the conveying rod 42 moves helically around its own axis, the second stud 412 can move along the thread of the first threaded hole 312 until it disengages from the mating structure 31 from the opening near the end of the first threaded hole 312.

[0043] Furthermore, in some embodiments, the end of the distal electrode 3 furthest from the connection with the signal line 2 is a sharp end 32. Figures 3 to 6 In the illustrated embodiment, the pointed end 32 may, for example, be formed at the distal end of the helically wound mating structure 31. Figure 7 and Figure 8 In the illustrated embodiment, the outer contour of the entire distal electrode 3 generally forms a shape that gradually tapers towards the distal end, for example, a cone shape, with the distal end forming a sharp end 32. The sharp end 32 of the distal electrode 3 facilitates the implantation of the distal electrode 3.

[0044] Please refer to Figure 6Optionally, the distal end of the delivery rod 42 is a pointed end 421. The pointed end 421 of the delivery rod 42 also facilitates the implantation of the distal electrode 3. In some embodiments, the distal electrode 3 may have a channel through which the delivery rod 42 passes, for example... Figure 6 The central hole is formed by the coiling of the mating structure 31 shown. After the distal electrode 3 is assembled and connected 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 contact the target tissue before the distal electrode 3, and at this time the sharp end 421 can open the implantation channel first.

[0045] It needs to be explained that, Figures 3 to 6 ,as well as Figure 7 and Figure 8 Two exemplary examples of the mating structure 31 and the docking structure 41 are shown respectively. However, the mating structure 31 and the docking structure 41 are not limited to the examples disclosed above. In other embodiments, the mating structure 31 may be cylindrical, and the limiting cavity may be formed circumferentially on the cylindrical sidewall of the mating structure 31 and have an opening. In this case, the docking structure 41 may also be adapted to have a protrusion 411 and engage with the limiting cavity, so that the mating structure 31 moves with the axial movement of the conveying rod 42. Furthermore, the docking structure 41 can also disengage from the limiting cavity by rotating circumferentially with the conveying rod 42.

[0046] Please continue to refer to this. Figure 1 Preferably, the pacemaker body 1 has a delivery cavity 15 for the electrode delivery assembly 4 to be movably inserted through. In one embodiment, the delivery cavity 15 may be a through cavity formed in the pacemaker body 1, preferably formed along the axis of the pacemaker body 1. In another embodiment, the delivery cavity 15 may be a slot formed on the surface of the housing 10 of the pacemaker body 1, i.e., the delivery cavity 15 may be a non-closed slot. The delivery cavity 15 is preferably formed along an axis parallel to the pacemaker body 1. The arrangement of the delivery cavity 15 ensures that the electrode delivery assembly 4 does not exceed the cross-sectional area of ​​the pacemaker body 1 when passing through it, reducing or avoiding obstruction to the implantation process of the pacemaker body 1 and reducing or avoiding impact on the overall implantation passability of the leadless pacemaker.

[0047] This invention also provides a leadless pacemaker system, which includes the leadless pacemaker described above and the electrode delivery assembly 4 described above. The following is an illustrative description of how to use the leadless pacemaker system provided in this embodiment.

[0048] Step S1: Before implantation, first connect the docking structure 41 to the mating structure 31. For example, the protrusion 411 can be screwed into the spiral gap 311 of the mating structure 31 along the screwing direction.

[0049] Step S2: Connect the pacemaker delivery device to the connection part 11 of the pacemaker body 1, and then deliver the leadless pacemaker to the area of ​​the right ventricle 01 near the interventricular septum 03. Push the handle 43 to make the delivery rod 42 move axially toward the distal end. Through the docking structure 41, the distal electrode 3 is driven into the interventricular septum 03, for example, the left bundle branch region.

[0050] Step S3: At this point, electrical parameters can be measured. If the electrical parameters do not meet the requirements, the device can be pushed to a deeper position or withdrawn from the interventricular septum 03 and re-inserted at another position to measure the electrical parameters until the ideal electrical parameters are measured.

[0051] Step S4: Rotate the handle 43 in the outward direction to make the delivery rod 42 move axially in a spiral motion towards the proximal end, separating the docking structure 41 from the mating structure 31. Then, remove the delivery rod 42, leaving the distal electrode 3 in the implantation position. Next, screw the pacemaker body 1 onto the myocardium through the fixing part 12 to complete the implantation of the leadless pacemaker. Finally, separate the pacemaker delivery device from the connection part 11 of the pacemaker body 1, remove the pacemaker delivery device and the electrode delivery assembly 4, and complete the implantation of the leadless pacemaker.

[0052] In summary, the leadless pacemaker, electrode delivery assembly, and leadless pacemaker system provided by this invention include a pacemaker body, a signal line, and a distal electrode. The distal electrode is connected to the pacemaker body via the signal line. The distal electrode includes a mating structure for detachably connecting to a docking structure of the electrode delivery assembly. When the mating structure is connected to the docking structure, the distal electrode is configured to be implanted at a target site under the delivery of the electrode delivery assembly. With this configuration, based on the mating structure, the distal electrode can be connected and disconnected from the docking structure. When the mating structure is connected to the docking structure, the distal electrode can be implanted at the target site under the delivery of the electrode delivery assembly. After implantation, the electrode delivery assembly can be removed by separating the docking structure from the mating structure. After implantation, under myocardial contraction and compression, stress can be relieved through the signal line, reducing or avoiding fatigue fracture and improving the safety and reliability of long-term use.

[0053] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A leadless pacemaker, characterized in that, include: Pacemaker body, signal lines, and distal electrodes; The distal electrode is connected to the pacemaker body via the signal line; The distal electrode includes a mating structure for detachably connecting to a docking structure of the electrode delivery assembly; when the mating 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.

2. The leadless pacemaker according to claim 1, characterized in that, The mating structure has a limiting cavity, which is arranged at an angle to the axis of the electrode delivery assembly. The limiting cavity is used to accommodate the docking structure to limit the axial position of the docking structure.

3. The leadless pacemaker according to claim 2, characterized in that, The limiting cavity extends circumferentially or spirally and has an opening to allow the docking structure to rotate circumferentially or move spirally to disengage from the limiting cavity.

4. The leadless pacemaker according to claim 2, characterized in that, The mating structure is spirally coiled, and the gap between two adjacent turns is configured as the limiting cavity; or, the mating structure includes a first screw hole or a first stud, and the thread groove of the first screw hole or the first stud is configured as the limiting cavity.

5. The leadless pacemaker according to claim 1, characterized in that, The distal electrode has a sharp end away from the end connected to the signal line; and / or, the pacemaker body has a delivery cavity for the electrode delivery assembly to be movably inserted.

6. An electrode delivery assembly, characterized in that, For delivering a leadless pacemaker according to any one of claims 1 to 5; the electrode delivery assembly includes a delivery rod and a docking structure; when the docking structure is connected to the mating structure, the delivery rod is used to move along its own axis to deliver the distal electrode to the target implantation site.

7. The electrode delivery assembly according to claim 6, characterized in that, The docking structure is configured to rotate circumferentially or move in a spiral motion around its own axis in order to separate from the mating structure.

8. The electrode delivery assembly according to claim 7, characterized in that, The docking structure includes a protrusion disposed on the conveying rod, the protrusion being used to engage with the limiting cavity of the mating structure; or, the docking structure includes a second stud or a second threaded hole for threaded connection with the first threaded hole or the first stud of the mating structure.

9. The electrode delivery assembly according to claim 6, characterized in that, The distal end of the conveyor rod is a sharp point.

10. A leadless pacemaker system, characterized in that, The device includes a leadless pacemaker according to any one of claims 1 to 5, and further includes an electrode delivery assembly according to any one of claims 6 to 9.

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