Torque device for medical device and medical device system

Abstract

The present application relates to a kind of medical equipment's torque device and medical equipment system;The medical equipment system includes medical equipment and torque device;The torque device is fixedly connected with the end of medical equipment;The torsion device includes connected torque input component and torque output component;One of the torque input component and torque output component is provided with main tooth;The main tooth has first tooth face;When the torque input component and torque output component are driven by first tooth face meshing transmission between, the torque input component can drive torque output component rotate along first direction, to output the torque that rotates along first direction, further can drive the leadless pacemaker or electrode lead, for example, active helical component is screwed into or screwed out target tissue, thereby simplifying torque transmission structure, promote the stability and reliability of torque transmission.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, in particular to a torque device of a medical device and a medical device system. BACKGROUND

[0002] Currently, there are two fixing methods for leadless pacemakers or electrode leads, namely passive wing fixing and active spiral fixing. The active spiral fixing method has the advantages of large selectable range of fixed position and stable and reliable fixation, and thus is applied more and more widely. However, for the active spiral fixing method, the force of rotating into the heart tissue is determined by the torque transmitted from the head end body of the leadless pacemaker or electrode lead to the active spiral component. If the rotating force is too large, tissue perforation is likely to occur, resulting in serious consequences, and even life-threatening. In addition, during the operation, it is sometimes necessary to rotate the leadless pacemaker or electrode lead out of the body for repositioning. At this time, it may be necessary to transmit a larger torque from the head end body of the leadless pacemaker or electrode lead to the active spiral component, so as to ensure that the active spiral component is normally rotated out. However, there are still some problems in the current twisting operation of the leadless pacemaker or electrode lead, such as complex torque transmission structure, unstable torque transmission, low reliability, inability to adjust the size of the torque of the leadless pacemaker or electrode lead rotating into and out of the body, and the like, which leads to inconvenient operation. SUMMARY

[0003] The purpose of the present application is to provide a torque device of a medical device and a medical device system, which can realize the twisting operation of the leadless pacemaker or electrode lead through the torque device, and simplify the torque transmission structure, and improve the stability and reliability of torque transmission.

[0004] To achieve the above-mentioned purpose, according to the first aspect of the present application, a torque device of a medical device is provided, the medical device being a leadless pacemaker or electrode lead, the torque device comprising a torque input component and a torque output component connected to each other; the torque input component is used for fixed connection with the tail end of the medical device;

[0005] One of the torque input component and the torque output component is provided with a main tooth; the main tooth has a first tooth surface;

[0006] The torque device is configured to drive the torque output component to rotate in a first direction when the torque input component and the torque output component are driven through the first tooth surface.

[0007] Optionally, the torque input component and the torque output component are coaxially arranged.

[0008] Optionally, the main tooth further has a second tooth surface arranged opposite to the first tooth surface; an included angle between the second tooth surface and a tangent line of the pitch circle at the node is greater than an included angle between the first tooth surface and the tangent line of the pitch circle at the node.

[0009] The torque device is configured such that when the torque input component and the torque output component are in mesh transmission through the second tooth surface, the torque input component can drive the torque output component to rotate in a second direction; the second direction is opposite to the first direction.

[0010] Optionally, the other of the torque input component and the torque output component is provided with a secondary tooth for meshing with the main tooth.

[0011] Optionally, the secondary tooth is embedded with a ball, or the secondary tooth is formed by extrusion of the main tooth.

[0012] Optionally, the torque device further comprises a pre-tightening component for adjusting the pressure of the meshing between the torque input component and the torque output component.

[0013] Optionally, the torque input component and the torque output component are in mesh transmission through an end surface, the pre-tightening component is used to apply axial pressure to the torque output component and / or the torque output component, or the torque input component and the torque output component are in mesh transmission through a peripheral surface, the pre-tightening component is used to apply radial pressure to the torque input component and / or the torque output component.

[0014] Optionally, the pre-tightening component is fixedly connected with the torque input component, and the relative position between the pre-tightening component and the torque input component can be adjusted.

[0015] Optionally, the pre-tightening component is screw-connected or snap-connected with the torque input component.

[0016] Optionally, when the torque input component and the torque output component are in mesh transmission through a peripheral surface, the pre-tightening component is matched with the torque input component through an inclined surface to apply radial pressure to the torque input component.

[0017] Optionally, the torque input component comprises a main body connector and a first connector, the torque output component comprises a second connector; the main body connector is fixedly connected with the first connector, the pre-tightening component is fixedly connected with the main body connector; the first connector is arranged inside the second connector and is in mesh transmission with the second connector; the first connector has a conical cavity, the pre-tightening component is at least partially a conical structure, at least a part of the conical structure is inserted into the conical cavity, and an outer wall of the conical structure is matched with an inner wall of the conical cavity.

[0018] Optionally, when the torque input component and the torque output component are in transmission through end face engagement, the torque input component comprises a first connecting piece, the torque output component comprises a second connecting piece, the first connecting piece comprises a transmission part and a connecting part, one end of the transmission part is in engagement with one end of the second connecting piece in end face, and the connecting part passes through the second connecting piece and is fixedly connected with the pre-tightening component.

[0019] Optionally, one of the pre-tightening component, the torque input component and the torque output component is a flexible component, or both of the pre-tightening component and the torque output component are flexible components.

[0020] Optionally, the pre-tightening component comprises a first base and a second base, the first base is fixedly connected with the torque output component, the second base is fixedly connected with the torque input component, and the second base is used for limiting axial movement of the first base, or the pre-tightening component comprises a second base, the second base is fixedly connected with the torque input component, and the second base is used for limiting axial movement of the torque input component.

[0021] Optionally, the torque device further comprises a fixing component, the fixing component is used for being combined with a target object to position the torque device at a target position.

[0022] The fixing component is fixedly connected with the torque output component, and the fixing component, the torque output component and the torque input component are coaxially arranged.

[0023] Optionally, the fixing component is a spiral structure.

[0024] Optionally, the torque device further comprises a second base, the second base is fixedly connected with the torque input component, and the second base is used for loading a drug and / or connecting an electrode.

[0025] Optionally, the torque device further comprises a drug plug and / or an electrode, the drug plug is fixedly connected with the second base, and the electrode is fixedly connected with the second base.

[0026] To achieve the above object, according to a second aspect of the present application, a medical equipment system is provided, comprising a medical equipment and any one of the torque devices, a torque input component of the torque device is fixedly connected with an end of the medical equipment, and the medical equipment is a leadless pacemaker or an electrode lead.

[0027] In the above torque device and medical equipment system, the torque output is realized through the torque device, and when the torque transmission is realized through gear face engagement transmission, the torque transmission structure is simple, and the torque transmission is stable and reliable.

[0028] In the torque device and medical equipment system, the torque device realizes torque transmission through coaxially arranged torque input component and torque output component, further simplifies the torque transmission structure, and the torque transmission is more stable and reliable.

[0029] In the torque device and medical equipment system, the main tooth further has a second tooth surface arranged opposite to the first tooth surface; the included angle between the second tooth surface and the tangent of the pitch circle at the node is greater than the included angle between the first tooth surface and the tangent of the pitch circle at the node, so that when the torque input component and the torque output component are driven through the second tooth surface meshing transmission, the torque input component can drive the torque output component to rotate in the second direction; the second direction is opposite to the first direction; in this way, the torque adjustment and control can also be realized, and the operation of the leadless pacemaker or the electrode lead is more convenient. Specifically, the torque device rotates in the first direction without exceeding the torque limit value, thereby limiting the upper limit value of the torque transmitted by the torque device when the torque device rotates in the first direction. For the leadless pacemaker or the electrode lead, the tip of the medical equipment can be screwed into the target tissue such as myocardium under the drive of the torque device, and since the torque transmitted by the torque device to the tip of the medical equipment does not exceed the limit value, the force with which the tip of the medical equipment is screwed into the target tissue such as myocardium is not too large, thereby reducing the risk of tissue perforation, improving the safety and reliability of the operation, and reducing the difficulty of the operation. Moreover, the torque transmitted by this torque transmission mode is more stable and easier to control, and the difficulty of the operation can be further reduced. At the same time, the torque device rotates in the second direction when the torque exceeds the limit value, thereby limiting the torque that can be transmitted when the torque device rotates in the second direction. For the leadless pacemaker or the electrode lead, the tip of the medical equipment can be screwed out of the target tissue such as myocardium, and since the torque transmitted by the torque device to the tip of the medical equipment is larger, the force with which the tip of the medical equipment is screwed out of the target tissue such as myocardium is large enough, thereby ensuring that the tip of the medical equipment can be smoothly screwed out of the target tissue, thereby shortening the operation time and reducing the difficulty of the operation.

[0030] In the torque device and medical equipment system, the engagement pressure between the torque input component and the torque output component can be adjusted and controlled by the pre-tightening component. The greater the engagement pressure, the greater the friction between the two, and the greater the upper limit of the torque allowed to be transmitted. Conversely, the smaller the engagement pressure, the smaller the friction between the two, and the smaller the upper limit of the torque allowed to be transmitted. Therefore, the torque value transmitted between the torque input component and the torque output component can be adjusted and controlled by the pre-tightening component, making the torque adjustment more flexible and convenient. BRIEF DESCRIPTION OF DRAWINGS

[0031] The accompanying drawings are used to better understand the present application and do not constitute undue limitations on the present application. Among them:

[0032] Figure 1 An exploded view of the torque device of the first embodiment of the present application is shown;

[0033] Figure 2a Figure 2b and Figure 2c respectively show the axial cross-sectional view of the assembled structure of the torque device of the first embodiment of the present application;

[0034] Figure 3 An exploded view of the torque device of the second embodiment of the present application is shown;

[0035] Figure 4 An axial cross-sectional view of the assembled structure of the torque device of the second embodiment of the present application is shown;

[0036] Figure 5 A perspective view of the exploded structure of the torque device of the second embodiment of the present application is shown;

[0037] Figure 6a Figure 6b and Figure 6c respectively show the schematic view of the engagement of the torque input component and the torque output component of the torque device in the second embodiment of the present application.

[0038] The reference signs are explained as follows:

[0039] 1 - torque input component; 11, 31 - first connecting member; 311 - inner inclined surface; 32 - main connecting member; 101,

[0040] 401 - main tooth; 102 - first tooth surface; 103 - second tooth surface; θ1 - the included angle of the first tooth surface and the tangent at the node of the pitch circle; θ2 - the included angle of the second tooth surface and the tangent at the node of the pitch circle; 2 - torque output component; 21, 41 - second connecting member; 201, 301 - secondary tooth; 22 - first base; 3 - fixed component; 4, 8 - pre-tightening component; 811 - outer inclined surface; 5 - second base; 6 - plug; 7 - electrode. DETAILED DESCRIPTION

[0041] The present application will be further described below in conjunction with the drawings and specific embodiments. The advantages and features of the present application will be more apparent according to the following description. It should be noted that the drawings are all in a very simplified form and all use non-precise proportions, only for the purpose of facilitating and clarifying the purpose of assisting the description of the embodiments of the present application.

[0042] ​​As used in this specification, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise. As used in this specification, the term "distal" generally refers to the end of a medical device first entering the human body, and "proximal" is opposite to "distal", which refers to the end of a medical device far from the operator when the medical device is in action. As used in this specification, the term "axial" generally refers to the direction parallel to the axis of a component, "radial" generally refers to the direction perpendicular to the axis of a component, and "circumferential" generally refers to the direction around the axis of a component. The terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second", etc. can explicitly or implicitly include one or more of the features. In the description of the present application, unless otherwise specified, "a plurality of" means two or more, and "several" means an indefinite number, such as one or more than one.

[0043] As background, due to the increasingly unsuitable position for passive fixation of leadless pacemakers or electrode leads, active helix fixation is increasingly used. However, for active helix fixation, the force of the active helix screwing into the target tissue is determined by the torque transmitted by the distal end of the medical device to the active helix component, and if the screwing force is too large, it is easy to cause tissue perforation, resulting in serious consequences, even life-threatening. In addition, sometimes during the operation, the medical device needs to be unscrewed from the body for repositioning, at which time a larger torque needs to be transmitted by the distal end of the medical device to the active helix component to ensure that the active helix component is smoothly unscrewed. Therefore, it is necessary to adjust and control the torque, but the current leadless pacemakers or electrode leads do not have the function of adjusting and controlling the torque, making the operation very inconvenient. Not only that, the torque transmission structure realized by the current leadless pacemakers or electrode leads is complex, and the torque transmission stability and reliability also need to be improved,

[0044] To this end, the present application provides a torque device, which is mainly arranged at the end of a leadless pacemaker or an electrode lead to transmit torque. The torque device of the present application comprises a torque input component and a torque output component connected to each other; the torque input component is used to be fixedly connected with the end of a medical device. One of the torque input component and the torque output component is provided with a main tooth; the main tooth has a first tooth surface; the torque device is configured to drive the torque output component to rotate in a first direction when the torque input component and the torque output component are driven through the first tooth surface. The first direction is usually the direction that enables the end of the medical device to be screwed into the target tissue. Such a torque device can simplify the torque transmission structure of the leadless pacemaker or the electrode lead, and at the same time make the torque transmission more stable and reliable.

[0045] In the preferred embodiment of the present application, the main tooth further has a second tooth surface arranged opposite to the first tooth surface; the included angle between the second tooth surface and the tangent of the pitch circle at the node is greater than the included angle between the first tooth surface and the tangent of the pitch circle at the node; the torque device is configured to enable the torque input component to drive the torque output component to rotate in a second direction when the torque input component and the torque output component are in mesh transmission through the second tooth surface; and the second direction is opposite to the first direction. In this way, the adjustment and control of the torque can be realized, and the operation of the leadless pacemaker or the electrode lead is more convenient. In more detail, when the torque transmitted between the torque input component and the torque output component is greater than a certain limit value, the torque input component and the torque output component cannot be in mesh transmission through the first tooth surface, at this time, the torque output component cannot be driven to rotate in the first direction by the torque input component, and when the torque transmitted between the torque input component and the torque output component does not exceed the limit value, the torque input component and the torque output component are in mesh transmission through the first tooth surface, so that the torque input component can drive the torque output component to rotate in the first direction. It can be understood that, after the torque input component is driven to rotate, if the torque transmitted between the torque input component and the torque output component is too large, the torque input component and the torque output component can rotate relative to each other, thereby cutting off the torque transmission path between the torque input component and the torque output component, so that the torque input component cannot transmit the torque to the torque output component, and the torque output component cannot rotate with the torque input component. Conversely, after the torque input component is driven to rotate, if the torque transmitted between the torque input component and the torque output component is small, the torque transmission path between the torque input component and the torque output component remains normal, so that the torque input component can normally transmit the torque to the torque output component, so that the torque output component can rotate with the torque input component. Here, it should be understood that, once the torque transmitted between the torque input component and the torque output component exceeds the torque limit value defined in the first direction, the torque device automatically cuts off the torque transmission path between the torque input component and the torque output component, so that the torque input component idles without causing the rotation of the torque output component. In this way, the torque size when the torque device rotates in the first direction can be limited, and the safety risk caused by too large torque can be avoided.

[0046] In addition, when the medical device tip needs to be rotated out of the myocardium, the torque device can increase the torque transmitted to the medical device tip, thereby limiting the force of the medical device tip rotating backward out of the myocardium, ensuring that the medical device tip can be smoothly rotated out of the tissue. Specifically, the torque device is also configured such that when the torque input component and the torque output component are driven by the second tooth surface meshing, the torque input component can drive the torque output component to rotate in a second direction; the second direction is opposite to the first direction. When the torque input component drives the torque output component to rotate in the second direction, the torque transmitted between the torque input component and the torque output component is greater than or equal to a certain limit, so that the torque transmitted between the torque input component and the torque output component can be greater. In this way, the torque device can be configured to have a greater torque when rotating in the second direction, facilitating related operations with a greater torque.

[0047] It should also be understood that the present application does not limit the specific orientation of the first direction and the second direction. For example, the first direction can be clockwise, and the second direction can be counterclockwise, or the first direction can be counterclockwise, and the second direction can be clockwise.

[0048] The present application also provides a medical device system comprising a medical device and a torque device, wherein the torque input component of the torque device is fixedly connected to the tip of the medical device, and the medical device is a leadless pacemaker or an electrode lead. Therefore, the torque device of the present application can transmit torque to the tip of the medical device, and in particular can adjust and control the size of the torque transmitted to the tip of the medical device. For example, when the medical device tip needs to be rotated into the myocardium, the torque device can limit the upper limit of the torque transmitted to the medical device tip, thereby limiting the force of the medical device tip rotating forward into the myocardium, reducing the risk of tissue perforation, thereby improving the safety and reliability of the operation, reducing the difficulty of the operation, and shortening the operation time.

[0049] <Embodiment I>

[0050] Please refer to Figure 1 The present embodiment provides a torque device comprising a torque input component 1 and a torque output component 2 connected together, and preferably further comprising a fixing component 3. The fixing component 3 is used to combine with a target object to position the torque device at a target position. The structure of the fixing component 3 includes but is not limited to a spiral structure. The fixing component 3 is fixedly connected to the torque output component 2 and is preferably coaxially arranged, and more preferably, the fixing component 3, the torque output component 2 and the torque input component 1 are coaxially arranged. Of course, in other embodiments, the torque output component 2 and the torque input component 1 can be arranged non-coaxially, such as parallelly or staggeredly.

[0051] The torque input component 1 comprises a first connecting member 11, the torque output component 2 comprises a second connecting member 21, the first connecting member 11 and the second connecting member 21 are engaged in transmission and preferably coaxially arranged. In this embodiment, one end surface of the first connecting member 11 is engaged with one end surface of the second connecting member 21 to achieve the transmission of the first connecting member 11 and the second connecting member 21 by end surface engagement.

[0052] In addition, the first connecting member 11 can be used for fixed connection with the end of the medical device. For example, when the medical device is a leadless pacemaker, the first connecting member 11 is fixedly connected with the metal shell (such as titanium shell) of the leadless pacemaker. For example, when the medical device is an electrode lead, the first connecting member 11 is fixedly connected with the end of the electrode lead. The present application does not limit the fixed connection mode of the first connecting member 11 and the end of the medical device, for example, the connection mode can be welding, bonding, screwing, buckling, etc. Further, a connecting device can be provided to fix the first connecting member 11 on the end of the medical device, and the connecting device can circumferentially limit the first connecting member 11, so that the first connecting member 11 and the end of the medical device remain relatively stationary. Therefore, when the head end of the medical device is rotated, the first connecting member 11 can be driven to rotate. Therefore, the present application can achieve torque transmission through the end surface engagement transmission of the first connecting member 11 and the second connecting member 21. This torque transmission structure is simple, and the torque transmission is more stable and reliable.

[0053] Further, the first connecting member 11 comprises a plurality of main teeth 101, the number of main teeth 101 can be one or more than one, and the main teeth 101 have a first tooth surface 102. When the torque input component 1 and the torque output component 2 are engaged in transmission through the first tooth surface 102, the torque input component 1 can drive the torque output component 2 to rotate in the first direction.

[0054] When the number of the main teeth 101 is plural, the plural main teeth 101 are distributed along the circumference of the end surface of the first connecting member 11, preferably uniformly. Further, in order to limit the size of the torque, the angle θ1 between the first tooth surface 102 and the tangent of the pitch circle at the node is less than or equal to a first angle. The present application does not limit the size of the first angle, and the first angle can be set according to actual needs. Therefore, the inclination angle of the first tooth surface 102 limits a smaller torque limit value, so as to ensure that the torque device has a smaller torque output when rotating in the first direction. That is, when the first connecting member 11 and the second connecting member 21 are meshed and transmitted by the first tooth surface 101, the first connecting member 11 can drive the second connecting member 21 to rotate, for example, in the clockwise direction. It should be understood that when the torque transmitted between the first connecting member 11 and the second connecting member 21 does not exceed the first limit value limited by the first tooth surface 102, the first connecting member 11 and the second connecting member 21 can be normally meshed and transmitted, and when the torque transmitted between the first connecting member 11 and the second connecting member 21 exceeds the first limit value limited by the first tooth surface 102, the first connecting member 11 and the second connecting member 21 cannot be normally meshed and transmitted, so that the second connecting member 21 cannot rotate with the first connecting member 11.

[0055] Further, the main tooth 101 also has a second tooth surface 103 opposite to the first tooth surface 102, and the angle θ2 between the second tooth surface 103 and the tangent of the pitch circle at the node is greater than or equal to a second angle, and the second angle is greater than the first angle. That is, the angle θ2 between the second tooth surface 103 and the tangent of the pitch circle at the node is greater than the angle θ1 between the first tooth surface 102 and the tangent of the pitch circle at the node. The present application does not limit the size of the second angle, and the second angle is also set according to actual needs. Therefore, the second tooth surface 103 with a larger angle can limit a larger torque limit value, so as to ensure that the torque device can output a larger torque when rotating in the second direction. Therefore, when the first connecting member 11 and the second connecting member 21 are meshed and transmitted by the second tooth surface 103, the first connecting member 11 can drive the second connecting member 21 to rotate, for example, in the counterclockwise direction, and the torque transmitted between the first connecting member 11 and the second connecting member 21 is greater than or equal to a second limit value, and the second limit value is greater than the first limit value.

[0056] Further, the end of the medical device is provided with a fixing component 3, which is preferably a spiral structure, and the fixing component 3 is fixedly connected with the second connecting piece 21. Optionally, the torque device comprises a first base 22, which is fixedly connected with the second connecting piece 21 in a manner without any requirement, such as a concave-convex matching connection, a pin connection, welding or bonding and the like. Further, the first base 22 is fixedly connected with the fixing component 3, such as welding or bonding and the like. The first base 22 and the second connecting piece 21 can be assembled together after being formed in a separate manner, or be integrally formed. Further, the fixing component 3 is a spiral structure, and the first base 22 has an axial slot, and a part of the spiral structure is fixed in the axial slot.

[0057] In actual operation, when the head end of the medical device is rotated clockwise, the first connecting piece 11 can be driven to rotate clockwise, and when the second connecting piece 21 and the first connecting piece 11 are normally engaged and transmitted, the second connecting piece 21 and the fixing component 3 rotate clockwise with the first connecting piece 11, so that the fixing component 3 is screwed into the target tissue, and due to the limitation of the first tooth surface 102, the torque transmitted between the first connecting piece 11 and the second connecting piece 21 is small, thereby limiting the force of the fixing component 3 screwed into the target tissue, and reducing the risk of tissue perforation. Conversely, when the head end of the medical device is rotated counterclockwise, the first connecting piece 11 can be driven to rotate counterclockwise, and due to the fact that the angle of the second tooth surface 103 is greater than that of the first tooth surface 102, a greater torque can be transmitted between the first connecting piece 11 and the second connecting piece 21, so as to ensure that the force when the fixing component 3 exits the target tissue is large enough.

[0058] Further, the second connecting piece 21 has a plurality of secondary teeth 201, and the number of the secondary teeth 201 can be the same as or different from that of the primary teeth 101. The secondary teeth 201 are used to engage with the primary teeth 101 to achieve torque transmission and limitation. The number of the secondary teeth 201 is not limited in the present application.

[0059] As shown in Figure 2a , the shape of the secondary teeth 201 can be different from that of the primary teeth 101, and at this time, when engaged, the tooth shape of the secondary teeth 201 does not match the tooth shape of the primary teeth 101. Alternatively, as shown in Figure 2b , the shape of the secondary teeth 201 matches the shape of the primary teeth 101, and at this time, the tooth shape of the secondary teeth 201 completely matches the tooth shape of the primary teeth 101, the engagement strength is good, and the torque transmission reliability is good. Alternatively, as shown in Figure 2cAs shown, the secondary teeth 201 are embedded with balls to reduce friction and increase meshing strength. In this embodiment, the secondary teeth 201 can be obtained in the machining process or formed by deforming the second connecting member 21, i.e. the primary teeth 101 extrude the secondary teeth 201 on the second connecting member 21. Therefore, the application does not limit the way of obtaining the secondary teeth 201, which can be obtained in the machining process or formed by extruding the second connecting member 21 with the primary teeth.

[0060] Further preferably, the torque device further comprises a pre-tightening component 4 for adjusting the meshing pressure between the first connecting member 11 and the second connecting member 21. The greater the meshing pressure, the greater the friction between the first connecting member 11 and the second connecting member 21, and the greater the upper limit of the torque allowed to be transmitted, and vice versa. Therefore, the pre-tightening component 4 can further adjust and control the size of the torque transmitted between the first connecting member 11 and the second connecting member 21, making the torque adjustment more flexible and convenient.

[0061] In this embodiment, the first connecting member 11 and the second connecting member 21 are meshed and transmitted by the end face, i.e. the direction of extrusion of the first connecting member 11 and the second connecting member 21 is substantially axial, and the pre-tightening component 4 is used to apply axial pressure to the first connecting member 11 and / or the second connecting member 21. Further, the pre-tightening component 4 is fixedly connected with the first connecting member 11 and used to apply axial pressure to the second connecting member 21, and the relative position between the pre-tightening component 4 and the first connecting member 11 can be adjusted to adjust the pressure between the second connecting member 21 and the first connecting member 11. The application does not particularly limit the connection mode between the pre-tightening component 4 and the first connecting member 11, which includes but is not limited to threaded connection, and can also be snap connection or other suitable connection mode. Optionally, the pre-tightening component 4 has an internal thread, the first connecting member 11 has an external thread, and the internal thread of the pre-tightening component 4 is threadedly connected with the external thread of the first connecting member 11, which facilitates moving the pre-tightening component 4 left and right to adjust the upper limit of the torque allowed to be transmitted between the first connecting member 11 and the second connecting member 21.

[0062] In addition, during the rotation of the first connecting member 11, the extrusion of the primary teeth 101 of the first connecting member 11 on the second connecting member 21 will cause the second connecting member 21 to move slightly away from the first connecting member 11. In order to compensate for this displacement, the second connecting member 21 is preferably a flexible component. The "flexible component" is a deformable body relative to a rigid component, which can produce a certain deformation under external force, and such deformation is generally recoverable.

[0063] Reference Figure 2aThe first connecting member 11 and the pre-tightening member 4 can be integrated as a whole A, and the second connecting member 21, the first base 22 and the fixing member 3 can be integrated as a whole B. The whole A can rotate relative to the whole B in the circumferential direction, but there is no axial movement or only a small amount of axial movement. However, if the second connecting member 21 is flexible, the whole B has almost no axial movement relative to the whole A. Of course, in other embodiments, the second connecting member 21 can also be a rigid member, and at this time the pre-tightening member 4 is a flexible member, allowing the second connecting member 21 to have a slight axial movement, but at the same time limiting the axial movement of the second connecting member 21 through the pre-tightening member 4, so as to ensure that the first connecting member 11 and the second connecting member 21 are in a meshing state of mutual extrusion. The "rigid member" is a non-deformable body relative to the flexible member, which cannot be deformed under external force. It should be understood that the insertion of the fixing member 3 into the target tissue mainly depends on the rotation of the fixing member 3, rather than the axial movement, so the whole B only needs to have a small amount of axial movement, or can have no axial movement.

[0064] In other embodiments, one of the second connecting member 21 and the pre-tightening member 4 is a flexible member, and the other is a rigid member, or both are flexible members.

[0065] Further, the pre-tightening member 4 can be a nut structure or a sheet structure or other suitable structure. Preferably, the pre-tightening member 4 is a non-metallic sheet to reduce the weight of the parts. Therefore, by the fixed connection of the pre-tightening member 4 and the first connecting member 11, the initial deformation amount of the second connecting member 21 can be directly determined to determine the upper limit of the torque allowed to be transmitted between the first connecting member 11 and the second connecting member 21. Optionally, the first connecting member 11 is configured as a T-shaped structure and includes a transmission part and a connecting part, one end surface of the transmission part is engaged with one end surface of the second connecting member 21, and the connecting part passes through the second connecting member 21 and is threadedly connected with the pre-tightening member 4. Further, the pre-tightening member 4 can have an internal thread, and the connecting part has an external thread.

[0066] In other embodiments, the pre-tightening member 4 can also include the first base 22 and the second base 5, or only include the second base 5. Among them, the second base 5 is fixedly connected with the first connecting member 11, such as that the connecting part of the first connecting member 11 has an internal thread, the second base 5 has an external thread, and the internal thread of the first connecting member 11 is connected with the external thread of the second base 5. Therefore, the axial movement of the first base 22 can be limited by the contact of the second base 5 with the first base 22, and finally the initial deformation amount of the second connecting member 21 is limited, or in the case of removing the first base 22, the axial movement of the second connecting member 21 is limited by the direct contact of the second base 5 with the second connecting member 21, so as to determine the initial deformation amount of the second connecting member 21, and further determine the upper limit of the torque allowed to be transmitted between the first connecting member 11 and the second connecting member 21, and ensure that the two are in an extrusion state. At this time, the pre-tightening member 4 can be omitted.

[0067] Further, the second base 5 can be used to load medicine and / or connect with electrodes. In this embodiment, the torque device further comprises a medicine plug 6, which is fixedly connected with the second base 5. The medicine plug 6 can be filled with medicine. The type of medicine is not limited in this application. The medicine plug 6 can deliver medicine to the target tissue. The torque device can further comprise an electrode 7, which is fixedly connected with the second base 5. The electrode 7 can sense electrocardio signals or deliver electric stimulation signals to the target tissue. The electrode 7 can be connected with the electrical part of the medical device through a lead, such as the electrical component of a leadless pacemaker or the lead of an electrode lead.

[0068] <Embodiment Two>

[0069] Please refer to Figure 3 and Figure 4 , this embodiment provides a torque device, which comprises a torque input component 1 and a torque output component 2 connected with each other, and preferably further comprises a fixing component 3. The fixing component 3 is used to combine with the target object to position the torque device at the target position. The structure of the fixing component 3 comprises but is not limited to a spiral structure. In this embodiment, the fixing component 3 is fixedly connected with the torque output component 2 and coaxially arranged, and preferably the fixing component 3, the torque output component 2 and the torque input component 1 are coaxially arranged. Of course, in other embodiments, the torque output component 2 and the torque input component 1 can also be arranged non-coaxially, such as parallelly or staggeredly.

[0070] The torque input component 1 comprises a first connecting piece 31 and a main connecting piece 32, and the torque output component 2 comprises a second connecting piece 41, the first connecting piece 31 and the second connecting piece 41 engage in transmission and are preferably coaxially arranged. In this embodiment, the first connecting piece 31 and the second connecting piece 41 engage in transmission through the peripheral surface, and preferably the outer peripheral surface of the first connecting piece 31 engages with the inner peripheral surface of the second connecting piece 41. The main connecting piece 32 is fixedly connected with the first connecting piece 31 and is further used to be fixedly connected with the tip of the medical device. The way of fixing the main connecting piece 32 with the tip of the medical device is not limited in this application, for example, the welding, bonding, screwing, buckling and other connecting ways described in the above embodiment one can be referred to. Similarly, a connecting device can be provided to fix the main connecting piece 32 on the tip of the medical device, and the connecting device can limit the main connecting piece 32 in the circumferential direction to keep the main connecting piece 32 and the tip of the medical device relatively stationary, so that when the head of the medical device is rotated, the main connecting piece 32 and the first connecting piece 31 can be driven to rotate. And the first connecting piece 31 and the second connecting piece 41 engage in transmission through the peripheral surface, thereby realizing the transmission of torque. This torque transmission structure is also simple, and the torque transmission is also stable.

[0071] Further, the second connecting member 41 comprises a plurality of main teeth 401, the number of the main teeth 401 can be one or more than one, and the main teeth 401 have a first tooth surface (not labeled). When the first tooth surface of the main teeth 401 is engaged to transmit the torque between the torque input member 1 and the torque output member 2, the torque input member 1 can drive the torque output member 2 to rotate in the first direction.

[0072] When the number of the main teeth 401 is more than one, the plurality of main teeth 401 are distributed along the circumference of the second connecting member 41, preferably uniformly. Further, in order to limit the size of the torque, the first tooth surface of the main teeth 401 in this embodiment is the same as that in the first embodiment, and will not be described in detail. Therefore, a smaller torque upper limit is determined by the first tooth surface with a small angle, so as to ensure that the torque device has a smaller torque when rotating in the first direction. Therefore, when the first tooth surface of the main teeth 401 is engaged to transmit the torque between the first connecting member 31 and the second connecting member 41, the first connecting member 31 can drive the second connecting member 41 to rotate, for example, in the clockwise direction. Similarly, when the torque transmitted between the first connecting member 31 and the second connecting member 41 does not exceed the first limit value defined by the first tooth surface, the first connecting member 31 and the second connecting member 41 can be normally engaged to transmit the torque. Once the torque transmitted between the first connecting member 31 and the second connecting member 41 exceeds the first limit value defined by the first tooth surface, the first connecting member 31 and the second connecting member 41 cannot be normally engaged to transmit the torque, so that the second connecting member 41 cannot rotate with the first connecting member 31, i.e., the first connecting member 31 and the main connecting member 32 are idling.

[0073] Similarly to the first embodiment, the main teeth 401 also have a second tooth surface (not labeled) arranged opposite to the first tooth surface, and the second tooth surface of the main teeth 401 in this embodiment is the same as that in the first embodiment, and will not be described in detail. That is, the included angle between the second tooth surface and the tangent of the pitch circle at the node is greater than the included angle between the first tooth surface and the tangent of the pitch circle at the node. Therefore, a larger torque upper limit can be determined by the second tooth surface with a larger angle, so as to ensure that the torque device has a larger output torque when rotating in the second direction. Therefore, when the second tooth surface of the main teeth 401 is engaged to transmit the torque between the first connecting member 31 and the second connecting member 41, the first connecting member 31 can drive the second connecting member 41 to rotate, for example, in the counterclockwise direction, and the torque transmitted between the first connecting member 31 and the second connecting member 41 is greater than or equal to the second limit value.

[0074] Furthermore, the fixing component 3 is preferably a spiral structure, and the fixing component 3 is fixedly connected to the second connecting component 41. In actual operation, when the head end of the medical device is rotated clockwise, the main connecting component 32 and the first connecting component 31 can be driven to rotate clockwise, for example. When the second connecting component 41 and the first connecting component 31 are normally engaged, the second connecting component 41 and the fixing component 3 rotate clockwise with the first connecting component 31, causing the fixing component 3 to screw into the target tissue. Due to the limitation of the first tooth surface of the main tooth 401, the torque transmitted between the first connecting component 31 and the second connecting component 41 is relatively small, thereby limiting the force of the fixing component 3 screwing into the target tissue and reducing the risk of tissue perforation. Conversely, when the head end of the medical device is rotated counterclockwise, for example, the main connecting component 32 and the first connecting component 31 can be driven to rotate counterclockwise. Since the angle of the second tooth surface of the main tooth 401 is greater than the angle of the first tooth surface, a larger torque can be transmitted between the first connecting component 31 and the second connecting component 41 to ensure that the force when the fixing component 3 exits the target tissue is large enough.

[0075] In this embodiment, the first connector 31 has a plurality of auxiliary teeth 301, the number of which may be the same as or different from the number of main teeth 401. The auxiliary teeth 301 are used to mesh with the main teeth 401 to achieve torque transmission and limitation. This application does not limit the number of auxiliary teeth 301.

[0076] like Figure 6a As shown, the shape of the auxiliary tooth 301 may be different from the shape of the main tooth 401. In this case, during meshing, the tooth profile of the auxiliary tooth 301 does not match the tooth profile of the main tooth 401. Or, as... Figure 6b As shown, the shape of the auxiliary tooth 301 matches the shape of the main tooth 401. At this point, the tooth profile of the auxiliary tooth 301 perfectly matches the tooth profile of the main tooth 401, resulting in good meshing strength and reliable torque transmission. Alternatively, as... Figure 6c As shown, the secondary tooth 301 is embedded with balls to reduce friction and improve meshing strength. In this embodiment, the secondary tooth 301 can be obtained during processing, or it can be formed by the deformation of the first connecting member 31 itself, that is, the main tooth 401 is pressed onto the first connecting member 31 to form the secondary tooth 301. Therefore, this application does not limit the method of obtaining the secondary tooth 301. The secondary tooth 301 can be obtained during processing, or it can be formed by the pressing of the main tooth 401 onto the first connecting member 31.

[0077] Further, the first base 22 can be cancelled or reserved in the present embodiment. In addition, the torque device of the present embodiment further comprises a pre-tightening component 8 for adjusting the engagement pressure between the first connecting member 31 and the second connecting member 41. The greater the engagement pressure, the greater the friction between the first connecting member 31 and the second connecting member 41, and the greater the upper limit of the torque allowed to be transmitted. Conversely, the smaller the engagement pressure, the smaller the friction between the first connecting member 31 and the second connecting member 41, and the smaller the upper limit of the torque allowed to be transmitted. Thus, the torque allowed to be transmitted between the first connecting member 31 and the second connecting member 41 can be further adjusted and controlled by the pre-tightening component 8, making the torque adjustment more flexible and convenient. In the present embodiment, the first connecting member 31 and the second connecting member 41 are engaged in transmission through the peripheral surface, i.e. the direction of mutual extrusion of the first connecting member 31 and the second connecting member 41 is substantially radial. Thus, the pre-tightening component 8 is used to apply radial pressure to the first connecting member 31 and / or the second connecting member 41.

[0078] Further, the pre-tightening component 8 is fixedly connected with the main body connecting member 32 and is used to apply radial pressure to the first connecting member 31. The relative position between the pre-tightening component 8 and the main body connecting member 32 can be adjusted, thereby adjusting the pressure between the second connecting member 41 and the first connecting member 31. The present application does not particularly limit the connection mode between the pre-tightening component 8 and the main body connecting member 32, which includes but is not limited to threaded connection or buckle connection or other suitable connection modes. Further, the pre-tightening component 8 has an internal thread, and the main body connecting member 32 has an external thread. The two are threadedly connected, facilitating left and right movement of the pre-tightening component 8 to adjust the upper limit of the torque allowed to be transmitted between the torque input component 1 and the torque output component 2.

[0079] In view of the slight displacement of the first connecting member 31 away from the second connecting member 41 due to the pressing of the main tooth 401 of the second connecting member 41 on the first connecting member 31 during the rotation of the first connecting member 31, the first connecting member 31 is preferably a flexible member to compensate for the displacement. The "flexible member" is a deformable body relative to a rigid member, which can be deformed under external force and the deformation is generally recoverable. Similar to the first embodiment, the main body connecting member 32, the first connecting member 31 and the pre-tightening member 8 can be regarded as an entirety A, and the second connecting member 41 and the fixing member 3 can be regarded as an entirety B, the entirety B can rotate relative to the entirety A in the circumferential direction but has no axial movement or only a small amount of axial movement. However, if the first connecting member 31 is flexible, the entirety B has almost no axial movement relative to the entirety A. Of course, in other embodiments, the first connecting member 31 can also be a rigid member, and the pre-tightening member 8 is a flexible member, allowing the first connecting member 31 to have a slight axial movement, but at the same time limiting the axial movement of the first connecting member 31 through the pre-tightening member 8 to ensure the meshing state of the mutual pressing between the first connecting member 31 and the second connecting member 41. The "rigid member" is a non-deformable body relative to the flexible member, which cannot be deformed under external force. It should be understood that the insertion of the fixing member 3 into the target tissue mainly depends on the rotation of the fixing member 3 rather than the axial movement, so the entirety B only needs to have a slight axial movement or can have no axial movement.

[0080] In other embodiments, one of the first connecting member 31 and the pre-tightening member 8 is a flexible member, and the other is a rigid member, or both are flexible members.

[0081] Further, when the torque input member 1 and the torque output member 2 are transmitted through the meshing of the circumferential surfaces, the pre-tightening member 8 cooperates with the torque input member 1 through the inclined surface to apply radial pressure to the torque input member 1. In an embodiment, the first connecting member 31 has an inner inclined surface 311, and the pre-tightening member 8 has an outer inclined surface 811, which is used to cooperate with the inner inclined surface 311 to apply radial pressure to the first connecting member 31. Further, the first connecting member 31 has a conical cavity (not labeled), and at least a part of the pre-tightening member 8 is a conical structure, at least a part of the conical structure is inserted into the conical cavity, and the outer wall of the conical structure cooperates with the inner wall of the conical cavity, so as to limit the axial movement of the first connecting member 31 through the cooperation of the inclined surfaces.

[0082] In another embodiment, the pre-tightening component 8 can also include a second base 5, which is fixedly connected with the main body connector 32. For example, the main body connector 32 is configured as a T-shaped structure and includes a positioning portion and a connecting portion. The positioning portion is fixedly connected with the first connector 31, and the connecting portion is fixedly connected with the second base 5 through the first connector 31. The connecting portion of the main body connector 32 has an internal thread, and the second base 5 has an external thread. The internal thread of the main body connector 32 is connected with the external thread of the second base 5. Therefore, the axial movement of the first connector 31 can be limited by the contact between the second base 5 and the first connector 31, so that the initial deformation of the first connector 31 can also be limited, and the upper limit of the torque allowed to be transmitted between the first connector 31 and the second connector 41 is also limited. Further, the second base 5 can be used to load drugs and / or be connected with electrodes.

[0083] In this embodiment, the torque device also includes a drug plug 6, which is fixedly connected with the second base 5. The drug plug 6 can be filled with drugs. The type of drugs is not limited in the present application. The drug plug 6 can deliver drugs to the target tissue. The torque device of this embodiment can also include an electrode 7, which is fixedly connected with the second base 5. The electrode 7 can sense electrocardio signals or deliver electrical stimulation signals to the target tissue. The electrode 7 can be connected with the electrical part of the medical device through a lead, such as being connected with the electrical component of a leadless pacemaker or being connected with the lead of an electrode lead.

[0084] It should be understood that the present application does not limit the way of fixedly connecting between the components, which can be one or more of welding, bonding, threaded connection, pin connection and buckle connection. It should also be understood that the same parts of Embodiment Two as Embodiment One can not be described in detail, but the same parts can be specifically referred to Embodiment One.

[0085] In addition, the present application does not particularly limit the implementation of the pre-tightening component, including but not limited to the disclosure of the preferred embodiments described above. In addition, the present application does not particularly require the size of the first limit value and the second limit value, for example, the first limit value can be determined according to the force that the helical structure at the end of the medical device can withstand when screwed into the myocardium without causing tissue perforation, and the second limit value can be determined according to the force required for the helical structure at the end of the medical device to smoothly rotate out of the myocardium.

[0086] It should be understood that the above description is only for the preferred embodiments of the present application, and is not a limitation on the form and substance of the present application. Although the innovation of the present application comes from the field of cardiac pacing and its pacing technology, it can be understood by those skilled in the art that the torque device of the present application can also be applied to spinal cord stimulation or other parts of electrical stimulation technology.

[0087] It should be noted that, for those skilled in the art, several improvements and supplements can also be made without departing from the method of the present application, and these improvements and supplements should also be considered as the protection scope of the present application. For those skilled in the art, some changes, modifications and equivalent changes made by using the disclosed technical content without departing from the spirit and scope of the present application are equivalent embodiments of the present application; meanwhile, any equivalent changes, modifications and evolution made to the above embodiments according to the essential technology of the present application are still within the scope of the technical solutions of the present application.

Claims

1. A torque device for a medical device, the medical device being a leadless pacemaker or an electrode lead, characterized in that, The torque device comprises a torque input component and a torque output component connected with each other; the torque input component is used to be fixedly connected with the tip of the medical device; the torque output component is also fixedly connected with a fixing component, which is used to be combined with the target object to position the torque device at the target position; The torque input component comprises a first connecting member; the torque output component comprises a second connecting member, the first connecting member and the second connecting member are engaged in transmission; the first connecting member is used to be fixedly connected with the tip of the leadless pacemaker or the electrode lead; The torque device further comprises a second base, which is fixedly connected with the first connecting member, and the second base is used to load drugs and / or connect electrodes; One of the torque input component and the torque output component is provided with a main tooth; the main tooth has a first tooth surface and a second tooth surface which is oppositely arranged with the first tooth surface; the first tooth surface defines a first limit value of torque, and the second tooth surface defines a second limit value of torque, the first limit value being smaller than the second limit value; The torque device is configured to drive the torque output component to rotate in a first direction to perform the implantation operation of the medical device when the torque input component and the torque output component are engaged in transmission through the first tooth surface; When the torque transmitted between the torque input component and the torque output component exceeds the first limit value, the path of torque transmission between the torque input component and the torque output component is cut off, so that the torque input component idles without causing the rotation of the torque output component; The torque device is configured to drive the torque output component to rotate in a second direction to perform the extraction operation of the medical device when the torque input component and the torque output component are engaged in transmission through the second tooth surface; the second direction is opposite to the first direction.

2. The torque device of claim 1, wherein, The torque input component and the torque output component are coaxially arranged.

3. The torque device of claim 1, wherein, The included angle between the second tooth surface and the tangent of the node of the pitch circle is larger than the included angle between the first tooth surface and the tangent of the node of the pitch circle.

4. The torque device of claim 1, wherein, The other one of the torque input component and the torque output component is provided with a secondary tooth, which is used to be engaged with the main tooth.

5. The torque device of claim 4, wherein, The secondary tooth is embedded with a ball, or the secondary tooth is formed by extrusion of the main tooth.

6. The torque device of claim 1, wherein A pre-tightening component is further included, which is used to adjust the pressure of engagement between the torque input component and the torque output component.

7. The torque device of claim 6, wherein, When the torque input component and the torque output component are engaged in transmission through the end surface, the pre-tightening component is used to apply axial pressure to the torque output component and / or the torque output component, or when the torque input component and the torque output component are engaged in transmission through the peripheral surface, the pre-tightening component is used to apply radial pressure to the torque input component and / or the torque output component.

8. The torque device of claim 7, wherein, The pre-tightening component is fixedly connected with the torque input component, and the relative position between the pre-tightening component and the torque input component can be adjusted.

9. The torque device of claim 7, wherein, When the torque input component and the torque output component are driven by peripheral surface engagement, the pre-tightening component is matched with the torque input component by an inclined surface to exert radial pressure on the torque input component.

10. The torque device of claim 9, wherein, The torque input component further comprises a main body connecting piece; the main body connecting piece is fixedly connected with the first connecting piece, and the pre-tightening component is fixedly connected with the main body connecting piece; the first connecting piece is arranged inside the second connecting piece and is driven by internal engagement with the second connecting piece; the first connecting piece has a conical cavity, the pre-tightening component is at least partially in the form of a cone structure, at least a part of the cone structure is inserted into the conical cavity, and the outer wall of the cone structure is matched with the inner wall of the conical cavity.

11. The torque device of claim 7, wherein, When the torque input component and the torque output component are driven by end surface engagement, the first connecting piece comprises a driving part and a connecting part, one end surface of the driving part is engaged with one end surface of the second connecting piece; the connecting part passes through the second connecting piece and is fixedly connected with the pre-tightening component.

12. The torque device of claim 6, wherein, One of the pre-tightening component, the torque input component and the torque output component is a flexible component, or both the pre-tightening component and the torque output component are flexible components.

13. The torque device of claim 8, wherein, The pre-tightening component comprises a first base and a second base, the first base is fixedly connected with the second connecting piece, and the second base is used to limit the axial movement of the first base, or the pre-tightening component comprises a second base, and the second base is used to limit the axial movement of the torque input component.

14. The torque device of claim 1 or 2, wherein, The fixed component, the torque output component and the torque input component are coaxially arranged.

15. The torque device of claim 14, wherein, The fixed component is in the form of a spiral structure.

16. The torque device of claim 1 or 2, wherein, Further comprising a medicine plug and / or an electrode, the medicine plug is fixedly connected with the second base, and the electrode is fixedly connected with the second base.

17. A medical device system, characterized by The medical device and the torque device of the medical device according to any one of claims 1-16, the torque input component of the torque device is fixedly connected with the tip of the medical device, and the medical device is a leadless pacemaker or an electrode lead.

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