CN115523244A

CN115523244A - Torque device of medical equipment and medical equipment system

Info

Publication number: CN115523244A
Application number: CN202110712430.6A
Authority: CN
Inventors: 吴楠; 程志军; 和好学; 孙江凯
Original assignee: Microport Sorin CRM Shanghai Co Ltd
Current assignee: Microport Sorin CRM Shanghai Co Ltd
Priority date: 2021-06-25
Filing date: 2021-06-25
Publication date: 2022-12-27
Also published as: WO2022267852A1

Abstract

The invention relates to a torque device of medical equipment and a medical equipment system; the medical equipment system comprises a medical equipment and a torque device; the torque device is fixedly connected with the tail end of the medical equipment; the torsion device comprises a torque input component and a torque output component which are connected; one of the torque input member and the torque output member is provided with main teeth; the main tooth has a first tooth face; when the torque input component and the torque output component are in meshing transmission through the first tooth surface, the torque input component can drive the torque output component to rotate along the first direction, so that the torque rotating along the first direction is output, and further, for example, a driving spiral component on a leadless pacemaker or an electrode lead can be driven to be screwed into or out of a target tissue, so that a torque transmission structure is simplified, and the stability and the reliability of torque transmission are improved.

Description

Torque device of medical equipment and medical equipment system

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a torque device of medical equipment and a medical equipment system.

Background

At present, a leadless pacemaker or an electrode lead mainly has two fixing modes of passive wing fixing and active spiral fixing, wherein the active spiral fixing mode has the advantages of wide selectable range of fixing positions and stable and reliable fixing, so that the application is more and more extensive. However, in the active screw fixation mode, the force for screwing forward into the heart tissue is determined by the torque transmitted from the leadless pacemaker or the electrode lead head end body to the active screw component, and if the screwing force is too large, the tissue perforation is easily caused, which causes serious consequences and even life danger. In addition, in the operation process, the leadless pacemaker or the electrode lead is required to be screwed out of the body for repositioning, and at the moment, a main body at the head end of the leadless pacemaker or the electrode lead is required to transmit a larger torque to the driving spiral component, so that the driving spiral component is ensured to be screwed out normally. However, there are some problems existing in the current twisting operation of the leadless pacemaker or the electrode lead, such as complex torque transmission structure, unstable torque transmission, low reliability, and incapability of adjusting the torque of screwing the leadless pacemaker or the electrode lead into or out of the body, which results in inconvenient operation.

Disclosure of Invention

The invention aims to provide a torque device of medical equipment and a medical equipment system, which can realize the twisting operation of a leadless pacemaker or an electrode lead through the torque device, simplify a torque transmission structure and improve the stability and reliability of torque transmission.

To achieve the above object, according to a first aspect of the present invention, there is provided a torque device of a medical apparatus, the medical apparatus being a leadless pacemaker or an electrode lead, the torque device comprising a torque input part and a torque output part connected; the torque input component is used for being fixedly connected with the tail end of the medical equipment;

one of the torque input member and the torque output member is provided with main teeth; the main tooth has a first tooth face;

the torque device is configured such that the torque input member is capable of driving the torque output member in a first direction when there is transmission between the torque input member and the torque output member via the first tooth engagement.

Optionally, the torque input member and the torque output member are coaxially disposed.

Optionally, the main tooth further has a second tooth flank disposed opposite the first tooth flank; an included angle between the second tooth surface and a tangent of the pitch circle at the node is larger than an included angle between the first tooth surface and a tangent of the pitch circle at the node;

the torque device is configured such that the torque input member is capable of driving the torque output member to rotate in a second direction when there is gearing between the torque input member and the torque output member via the second flank engagement; the second direction is opposite to the first direction.

Optionally, the other of the torque input member and the torque output member is provided with secondary teeth for meshing with the primary teeth.

Optionally, the secondary teeth are embedded with balls or are extruded from the primary teeth.

Optionally, the torque device further comprises a pretensioning means for adjusting the pressure of engagement between the torque input means and the torque output means.

Optionally, the torque input part and the torque output part are in end-face engagement transmission, and the pretensioning part is used for applying axial pressure to the torque output part and/or the torque output part, or the torque input part and the torque output part are in circumferential engagement transmission, and the pretensioning part is used for applying radial pressure to the torque input part and/or the torque output part.

Optionally, the pretensioning element is fixedly connected to the torque input element, and the relative position between the pretensioning element and the torque input element can be adjusted.

Optionally, the pretensioning member is screwed or snapped into connection with the torque input member.

Optionally, when the torque input component and the torque output component are in mesh transmission through the peripheral surfaces, the pre-tightening component and the torque input component are matched through a slope to apply radial pressure on the torque input component.

Optionally, the torque input member comprises a body connector and a first connector, and the torque output member comprises a second connector; 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 in inner engagement transmission with the second connecting piece; the first connecting piece is provided with a conical cavity, at least part of the pre-tightening component is of a cone structure, at least 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.

Optionally, when the torque input component and the torque output component are in meshing transmission through end faces, 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, and one end face of the transmission part is meshed with one end face of the second connecting piece; the connecting part penetrates through the second connecting part and is fixedly connected with the pre-tightening part.

Optionally, one of the pretensioning member, the torque input member and the torque output member is a flexible member, or both of the pretensioning member and the torque output member are flexible members.

Optionally, the pre-tightening component includes a first base and a second base, the first base is fixedly connected to the torque output component, the second base is fixedly connected to the torque input component, and the second base is configured to limit axial movement of the first base, or the pre-tightening component includes a second base, the second base is fixedly connected to the torque input component, and the second base is configured to limit axial movement of the torque input component.

Optionally, the torque device further comprises a fixation component for engaging with a target object to position the torque device at a target location;

the fixed component is fixedly connected with the torque output component, and the fixed component, the torque output component and the torque input component are coaxially arranged.

Optionally, the fixing member is of a helical configuration.

Optionally, the torque device further comprises a second base fixedly connected with the torque input component, and the second base is used for loading drugs and/or connecting electrodes.

Optionally, the torque device further comprises a suppository and/or an electrode, the suppository is fixedly connected with the second base, and the electrode is fixedly connected with the second base.

In order to achieve the above object, according to a second aspect of the present invention, there is provided a medical device system comprising a medical device and any one of the torque devices, wherein a torque input part of the torque device is fixedly connected with a distal end of the medical device, and the medical device is a leadless pacemaker or an electrode lead.

In the torque device and the medical equipment system, the torque is output through the torque device, and when the torque is transmitted through the tooth surface meshing transmission, the torque transmission structure is simple, and the torque transmission is stable and reliable.

In the torque device and the medical equipment system, the torque device realizes torque transmission through the torque input part and the torque output part which are coaxially arranged, so that the torque transmission structure is further simplified, and the torque transmission is more stable and reliable.

In the torque device and medical equipment system, the main tooth further has a second tooth surface disposed opposite to the first tooth surface; the included angle between the second tooth surface and the tangent line of the pitch circle at the node is larger than that between the first tooth surface and the tangent line of the pitch circle at the node, so that when the torque input part and the torque output part are in meshing transmission through the second tooth surface, the torque input part can drive the torque output part to rotate along a second direction; the second direction is opposite to the first direction; by adopting the structure, the adjustment and control of the torque can be realized, and the operation of a leadless pacemaker or an electrode lead is more convenient. Specifically, the torque device rotates along the first direction under the condition that the torque limit value is not exceeded, so that the upper limit value of the torque transmitted by the torque device when the torque device rotates towards the first direction is limited, for a leadless pacemaker or an electrode lead, the tail end of the medical equipment can be screwed into target tissues such as cardiac muscle under the driving of the torque device, and the torque transmitted by the torque device to the tail end of the medical equipment does not exceed the limit value, so that the force for screwing the tail end of the medical equipment into the target tissues such as cardiac muscle is not too large, the risk of tissue perforation can be reduced, the safety and reliability of the operation can be improved, the operation difficulty can be reduced, and the torque transmitted by the torque transmission mode is more stable and easier to control, and the operation difficulty can be further reduced. Meanwhile, the torque device rotates towards the second direction under the condition that the torque limit value is exceeded, so that larger torque can be transmitted when the torque device is limited to rotate towards the second direction by different torques, further, for a leadless pacemaker or an electrode lead, the tail end of the medical equipment can unscrew target tissues such as cardiac muscle and the like, and the torque transmitted to the tail end of the medical equipment by the torque device is larger, so that the force of unscrewing the tail end of the medical equipment from the target tissues such as the cardiac muscle and the like is large enough, further, the tail end of the medical equipment can be ensured to unscrew the target tissues smoothly, the operation time is shortened, and the operation difficulty is reduced.

In the torque device and the medical equipment system, the engagement pressure between the torque input component and the torque output component can be adjusted and controlled through the pre-tightening component, the larger the engagement pressure is, the larger the friction force between the two components is, the larger the upper limit of the torque allowed to be transmitted is, and conversely, the smaller the engagement pressure is, the smaller the friction force between the two components is, the smaller the upper limit of the torque allowed to be transmitted is, so that the torque value transmitted between the torque input component and the torque output component can be adjusted and controlled through the pre-tightening component, and the torque adjustment is more flexible and convenient.

Drawings

The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:

FIG. 1 shows an exploded view of a torque device according to a first embodiment of the present invention;

fig. 2a, 2b and 2c are axial sectional views showing an assembly structure of a torque device according to a first embodiment of the present invention, respectively;

FIG. 3 shows an exploded view of a torque device according to a second embodiment of the present invention;

fig. 4 is an axial sectional view showing an assembling structure of a torque device according to a second embodiment of the invention;

fig. 5 is a perspective view showing an exploded structure of a torque device according to a second embodiment of the present invention;

fig. 6a, 6b and 6c show schematic views of circumferential engagement of a torque input member and a torque output member of a torque device according to a second embodiment of the present invention.

The reference numerals are explained below:

1-a torque input member; 11. 31-a first connector; 311-inner inclined plane; 32-a body connector; 101.

401-main teeth; 102-a first tooth surface; 103-a second tooth surface; theta 1-the angle between the first tooth surface and the tangent at the pitch circle node; theta 2-the angle between the second tooth surface and the tangent at the pitch circle node; 2-a torque output member; 21. 41-a second connector; 201. 301-secondary teeth; 22-a first base; 3-a stationary part; 4. 8-a pre-tightening component; 811-outer slope; 5-a second base; 6-suppository of medicine; 7-electrodes.

Detailed Description

The invention is described in further detail below with reference to the drawings and specific examples. The advantages and features of the present invention will become more apparent from the following description. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. As used in this specification, the term "tip" is generally the end of the medical device that first enters the body, and "head end" as opposed to "tip end" refers to the end of the medical device that is distal to the operator when it is activated. As used herein, the term "axial" generally refers to a direction parallel to the axis of a component, "radial" generally refers to a direction perpendicular to the axis of a component, and "circumferential" generally refers to a direction about the axis of a component. The terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, unless otherwise specified, "plurality" means two or more, and "several" means indefinite, such as one or more than one.

As background, active helical fixation is increasingly used as the locations where leadless pacemakers or electrode leads need or can be fixed are increasingly unsuitable for passive fixation. However, in the active screw fixation mode, the force for screwing forward into the target tissue is determined by the torque transmitted from the end of the medical device to the active screw component, and if the screwing force is too large, the tissue is easily perforated, which causes serious consequences and even life risks. In addition, sometimes the medical equipment needs to be unscrewed from the body for repositioning in the operation process, and at the moment, the tail end of the medical equipment needs to transmit larger torque to the driving spiral component, so that the driving spiral component is ensured to be unscrewed smoothly. Therefore, it is necessary to adjust and control the torque, but the current leadless pacemaker or electrode lead has no function of adjusting and controlling the torque, so that the operation is very inconvenient. Not only this, the torque transmission structure achieved by the current leadless pacemaker or electrode leads is complicated, and the torque transmission stability and reliability are also to be improved,

therefore, the invention provides a torque device which is mainly arranged at the tail end of a leadless pacemaker or an electrode lead to transmit torque. The torque device comprises a torque input component and a torque output component which are connected; the torque input component is used for being fixedly connected with the tail end of the medical equipment. Wherein one of the torque input member and the torque output member is provided with main teeth; the main tooth has a first tooth face; the torque device is configured such that the torque input member is capable of driving the torque output member in a first direction when there is drive between the torque input member and the torque output member via the first flank engagement. The first direction is generally a direction that enables the tip of the medical device to be screwed into the target tissue. The torque device can simplify the torque transmission structure of a leadless pacemaker or an electrode lead, and simultaneously make the torque transmission more stable and reliable.

In a preferred embodiment of the present invention, the main tooth further has a second tooth face disposed opposite to the first tooth face; the included angle between the second tooth surface and the tangent of the pitch circle at the node is larger than the included angle between the first tooth surface and the tangent of the pitch circle at the node; the torque device is configured such that the torque input member is capable of driving the torque output member to rotate in a second direction when there is gearing between the torque input member and the torque output member via the second flank engagement; the second direction is opposite to the first direction. By adopting the structure, the adjustment and control of the torque can be realized, and the operation of a leadless pacemaker or an electrode lead is more convenient. In more detail, when the torque transmitted between the torque input member and the torque output member is greater than a certain limit value, the torque input member and the torque output member cannot realize meshing transmission through the first tooth surface, and at this time, the torque output member cannot be driven to rotate in the first direction through the torque input member, and when the torque transmitted between the torque input member and the torque output member does not exceed the limit value, the torque input member and the torque output member can realize meshing transmission through the first tooth surface, so that the torque input member can drive the torque output member to rotate in the first direction. It will be appreciated that if the torque transmitted between the torque input member and the torque output member is too great after the torque input member is driven to rotate, the torque input member and the torque output member can rotate relative to each other, thereby cutting off the torque transmission path between the torque input member and the torque output member, so that the torque input member cannot transmit torque to the torque output member, and the torque output member cannot rotate with the torque input member. On the contrary, after the torque input component is driven to rotate, if the torque transmitted between the torque input component and the torque output component is smaller, the torque transmission path between the torque input component and the torque output component is kept normal, so that the torque input component can normally transmit the torque to the torque output component, and the torque output component can rotate along with the torque input component. It will be understood that the torque device is configured to limit the amount of torque applied to the torque device when the torque applied to the torque input member is in the first direction, and to avoid a safety risk due to too much torque, by automatically interrupting the torque transmission path between the torque input member and the torque output member to allow the torque input member to freewheel without causing rotation of the torque output member, once the torque transmitted between the torque input member and the torque output member exceeds a torque limit value defined in the first direction.

In addition, when the medical equipment tail end needs to be unscrewed from the cardiac muscle, the torque transmitted to the medical equipment tail end can be increased through the torque device, so that the force for unscrewing the medical equipment tail end from the cardiac muscle backwards is limited, and the medical equipment tail end can be smoothly unscrewed from the tissue. Specifically, the torque device is further configured such that the torque input member is capable of driving the torque output member to rotate in a second direction when the transmission between the torque input member and the torque output member is through the second gearing; the second direction is opposite to the first direction. When the torque input component drives the torque output component to rotate along the second direction, the torque transmitted between the torque input component and the torque output component is larger than or equal to a certain limit value, so that the torque transmitted between the torque input component and the torque output component can be larger, and the structure can limit the larger torque when the torque device rotates along the second direction, and is convenient to perform related operations with the larger torque.

It should also be understood that the present application is not limited to the particular orientation of the first and second directions. For example, the first direction may be clockwise and the second direction may be counterclockwise, or the first direction may be counterclockwise and the second direction may be clockwise.

The invention also provides a medical equipment system, which comprises medical equipment and a torque device, wherein a torque input part of the torque device is fixedly connected with the tail end of the medical equipment, and the medical equipment is a leadless pacemaker or an electrode lead. Therefore, the torque device of the invention can transmit torque to the medical equipment terminal, especially can adjust and control the torque transmitted to the medical equipment terminal, for example, when the medical equipment terminal needs to be screwed into the cardiac muscle, the upper limit of the torque transmitted to the medical equipment terminal can be limited through the torque device, so as to limit the force for screwing the medical equipment terminal into the cardiac muscle forwards, reduce the risk of tissue perforation, improve the safety and reliability of the operation, reduce the operation difficulty and shorten the operation time.

< first embodiment >

Referring to fig. 1, the present embodiment provides a torque device, which includes a torque input member 1 and a torque output member 2 connected to each other, and preferably further includes a fixed member 3. The stationary member 3 is adapted to engage a target object to position the torque device at a target location. The structure of the fixing member 3 includes, but is not limited to, a spiral structure. The fixed member 3 is fixedly connected with the torque output member 2 and is preferably coaxially arranged, and more preferably, the fixed member 3, the torque output member 2 and the torque input member 1 are coaxially arranged. Of course, in other embodiments, the torque output member 2 and the torque input member 1 may be non-coaxially disposed, such as in a parallel arrangement or in a staggered arrangement.

The torque input part 1 comprises a first connecting piece 11, the torque output part 2 comprises a second connecting piece 21, and the first connecting piece 11 and the second connecting piece 21 are in meshing transmission and are preferably coaxially arranged. In this embodiment, an end surface of one end of the first connecting member 11 is engaged with an end surface of one end of the second connecting member 21, so that the first connecting member 11 and the second connecting member 21 are engaged and driven through the end surfaces.

Furthermore, the first connector 11 may be adapted for a fixed connection to the distal end of the medical device. For example, when the medical device is a leadless pacemaker, the first connector 11 is fixedly connected to a metal housing (e.g., a titanium housing) of the leadless pacemaker. For example, when the medical device is an electrode lead, the first connecting member 11 is fixedly connected to the distal end of the electrode lead. The first connector 11 and the distal end of the medical device may be fixedly connected by welding, bonding, screws, or fasteners, for example. Further, a connecting device may be provided to fix the first connecting member 11 to the end of the medical device, and the connecting device may circumferentially limit the first connecting member 11 to keep the first connecting member 11 and the end of the medical device relatively stationary, so that when the head end of the medical device is rotated, the first connecting member 11 may be driven to rotate. Therefore, the torque transmission can be realized by the engagement transmission of the end surfaces of the first connecting piece 11 and the second connecting piece 21, the structure of the torque transmission is simple, and the torque transmission is more stable and reliable.

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

When the number of main teeth 101 is multiple, the multiple main teeth 101 are distributed, preferably evenly distributed, in the circumferential direction on the end face of the first connecting piece 11. Further, in order to limit the magnitude of the torque, the angle θ 1 between the first tooth face 102 and the tangent of the pitch circle at the node point is smaller than or equal to the first angle. This application does not add the restriction to the size of first angle, first angle can carry out corresponding settlement according to actual demand can. Thus, a smaller torque limit is defined by the angle of inclination of the first tooth face 102 to ensure a smaller torque output when the torque device is rotated in the first direction. That is, when the first link 11 and the second link 21 are in meshing transmission via the first tooth surface 101, the first link 11 can drive the second link 21 to rotate, for example, in the clockwise direction. It will be appreciated that when the torque transmitted between the first and second connecting

members

11, 21 does not exceed the first limit value defined by the first flanks 102, the first and second connecting

members

11, 21 can be driven in normal mesh, and when the torque transmitted between the first and second connecting

members

11, 21 exceeds the first limit value defined by the first flanks 102, the first and second connecting

members

11, 21 cannot be driven in normal mesh, so that the second connecting member 21 does not rotate with the first connecting member 11.

Further, the main tooth 101 has a second tooth surface 103 disposed opposite to the first tooth surface 102, and an angle θ 2 between the second tooth surface 103 and a tangent line of the pitch circle at the pitch point is greater than or equal to a second angle, which is greater than the first angle. That is, the angle θ 2 between the second tooth surface 103 and the tangent of the pitch circle at the pitch point is larger than the angle θ 1 between the first tooth surface 102 and the tangent of the pitch circle at the pitch point. The size of this application to the second angle does not put the restriction, and the second angle also sets for according to actual need. Thus, the second tooth flank 103, which may be at a greater angle, defines a greater torque limit to ensure that the torque device is able to output a greater torque when rotating in the second direction. Therefore, when the first connecting member 11 and the second connecting member 21 are in meshing transmission via 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, which is greater than the first limit value.

Furthermore, the distal end of the medical device is provided with a fixing part 3, the fixing part 3 is preferably a spiral structure, and the fixing part 3 is fixedly connected with the second connecting piece 21. Optionally, the torque device includes a first base 22, and the first base 22 is fixedly connected with the second connecting member 21, and the fixed connection manner is not required, for example, a concave-convex fit connection, a pin connection welding or an adhesion is selected. Further, the first base 22 and the fixing member 3 are fixedly connected, for example, by welding, bonding, or other fixing means. The first base 22 and the second connecting member 21 may be assembled together after being formed separately, or may be formed integrally. Further, the fixing member 3 has a spiral structure, the first base 22 has a through axial groove, and a part of the spiral structure is fixed in the axial groove.

In practice, when the head end of the medical device is rotated clockwise, the first connecting piece 11 can be driven to rotate clockwise, for example, and when the second connecting piece 21 is in normal meshing transmission with the first connecting piece 11, the second connecting piece 21 and the fixing component 3 rotate clockwise along 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 smaller, so that the force for screwing the fixing component 3 into the target tissue is limited, and the risk of tissue perforation is reduced. Conversely, when the head end of the medical device is rotated counterclockwise, the first connecting part 11 can be driven to rotate counterclockwise, for example, and since the angle of the second tooth surface 103 is larger than the angle of the first tooth surface 102, a larger torque can be transmitted between the first connecting part 11 and the second connecting part 21, so as to ensure that the force when the fixing member 3 is withdrawn from the target tissue is sufficiently large.

Further, the second connecting member 21 has a plurality of secondary teeth 201, and the number of the secondary teeth 201 may be the same as or different from the number of the primary teeth 101. The secondary teeth 201 are used for meshing with the primary teeth 101 to achieve torque transmission and limitation. The number of secondary teeth 201 is not limited by the present application.

As shown in fig. 2a, the shape of the secondary teeth 201 may be different from the shape of the primary teeth 101, in which case the tooth profile of the secondary teeth 201 does not match the tooth profile of the primary teeth 101 when meshing. Or, as shown in fig. 2b, the shape of the secondary tooth 201 is matched with the shape of the main tooth 101, and at this time, the tooth shape of the secondary tooth 201 is completely matched with the tooth shape of the main tooth 101, so that the meshing strength is good, and the torque transmission reliability is good. Alternatively, as shown in fig. 2c, the sub-teeth 201 are embedded with balls to reduce friction and improve the engagement strength. In this embodiment, the secondary teeth 201 may be obtained in the machining process, or the secondary teeth 201 may be formed by using the deformation of the second connecting member 21 itself, that is, the primary teeth 101 are pressed on the second connecting member 21 to form the secondary teeth 201. Therefore, the present application does not limit the manner of obtaining the secondary teeth 201, and the secondary teeth 201 can be obtained during the machining process, or the secondary teeth 201 can be formed by pressing the primary teeth to the second connecting member 21.

It is further preferred that the torque device further comprises a pretensioning element 4, wherein the pretensioning element 4 is used to adjust the pressure of the engagement between the first connection element 11 and the second connection element 21. The larger the engaging pressure is, the larger the friction force between the first connecting piece 11 and the second connecting piece 21 is, the larger the upper limit of the torque allowed to be transmitted is, whereas the smaller the engaging pressure is, the smaller the friction force between the first connecting piece 11 and the second connecting piece 21 is, the smaller the upper limit of the torque allowed to be transmitted is, so that the magnitude of the torque transmitted between the first connecting piece 11 and the second connecting piece 21 can be further adjusted and controlled by the pre-tightening part 4, and the torque adjustment is more flexible and convenient.

In this embodiment, the first connecting part 11 and the second connecting part 21 are driven by end face engagement, i.e. the direction in which the first connecting part 11 and the second connecting part 21 are pressed against each other is substantially axial, and the pretensioning element 4 is used to apply axial pressure to the first connecting part 11 and/or the second connecting part 21. Further, the pre-tightening part 4 is fixedly connected with the first connecting piece 11 and is used for applying axial pressure to the second connecting piece 21, and the relative position between the pre-tightening part 4 and the first connecting piece 11 can be adjusted, so that the pressure between the second connecting piece 21 and the first connecting piece 11 can be adjusted. The connection between the pretensioning element 4 and the first connection member 11 is not particularly limited in this application, and includes, but is not limited to, a threaded connection, a snap connection or other suitable connection. Optionally, the pre-tightening element 4 has an internal thread, the first connecting piece 11 has an external thread, and the internal thread of the pre-tightening element 4 is in threaded connection with the external thread of the first connecting piece 11, so that the pre-tightening element 4 can be moved left and right to adjust the upper limit of torque allowed to be transmitted between the first connecting piece 11 and the second connecting piece 21.

In addition, in view of the fact that the second connecting member 21 is slightly moved away from the first connecting member 11 due to the pressing of the main teeth 101 of the first connecting member 11 against the second connecting member 21 during the rotation of the first connecting member 11, it is preferable that the second connecting member 21 is a flexible member in order to compensate for the displacement. A "flexible member" is a deformable body as opposed to a rigid member that is capable of some deformation under an external force, and such deformation is generally recoverable.

Referring to fig. 2a, the first connecting part 11 and the pretensioning element 4 can be considered as a whole a, and the second connecting part 21, the first base 22 and the securing element 3 as a whole B, which is rotatable circumferentially relative to the whole B, but with no or only a small amount of axial movement. But if the second connector 21 is flexible, the entity B will have almost no axial movement with respect to the entity a. Of course, in other embodiments, the second connecting member 21 may be a rigid member, and in this case, the pre-tightening unit 4 is a flexible member, which allows a slight axial movement of the second connecting member 21, but at the same time limits the axial movement of the second connecting member 21 by the pre-tightening unit 4, so as to ensure a mutual pressing engagement between the first connecting member 11 and the second connecting member 21. A "rigid member" is an undeformable body relative to a flexible member that is undeformable under an external force. It will be appreciated that insertion of the fixation element 3 into the target tissue relies primarily on rotation of the fixation element 3, rather than axial movement, so that the whole B may or may not require only a slight axial movement.

In other embodiments, one of the second connector 21 and the pretensioning element 4 is a flexible element, the other is a rigid element, or both are flexible elements.

Further, the pre-tightening element 4 may be a nut structure or a sheet structure or other suitable structures. Preferably, the pretensioning element 4 is a non-metallic sheet to reduce the weight of the part. Therefore, by the fixed connection of the prestressing element 4 to the first connecting part 11, the initial deformation of the second connecting part 21 can be determined directly and the upper limit of the torque which can be transmitted between the first connecting part 11 and the second connecting part 21 can be determined. Optionally, the first connecting member 11 is configured as a T-shaped structure and includes a transmission portion and a connecting portion, an end face of the transmission portion is engaged with an end face of the second connecting member 21, and the connecting portion passes through the second connecting member 21 and is in threaded connection with the pretensioning member 4. Further, the pretensioning element 4 may have an internal thread and the connection portion may have an external thread.

In other embodiments, the pretensioning element 4 may also comprise the first base 22 and the second base 5, or only the second base 5. The second base 5 is fixedly connected to the first connecting member 11, for example, the connecting portion 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 to 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 connector 21 is limited, or in the case of canceling the first base 22, the axial movement of the second connector 21 is limited by the direct contact of the second base 5 with the second connector 21, so as to determine the initial deformation amount of the second connector 21, and thus the upper limit of the torque allowed to be transmitted between the first connector 11 and the second connector 21, and ensure that both are in a pressed state. In this case, the biasing member 4 may be omitted.

Further, the second base 5 may be used to carry a drug and/or to interface with an electrode. In this embodiment, the torque device further comprises a suppository 6, and the suppository 6 is fixedly connected with the second base 5. The suppository 6 can be filled with medicine. The application does not limit the type of the drug. The peg 6 may deliver a drug to a target tissue. The torque device may further comprise an electrode 7, the electrode 7 being fixedly connected to the second base 5. The electrodes 7 may sense cardiac electrical signals or deliver electrical stimulation signals to the target tissue. The electrodes 7 may be connected by leads to electrical parts of the medical device, such as to electrical components of a leadless pacemaker or to leads of electrode leads.

< example two >

Referring to fig. 3 and 4, the present embodiment provides a torque device, which includes a torque input member 1 and a torque output member 2 connected to each other, and preferably further includes a fixing member 3. The stationary member 3 is adapted to engage a target object to position the torque device at a target location. The structure of the fixing member 3 includes, but is not limited to, a spiral structure. In the present embodiment, the fixing member 3 is fixedly connected to the torque output member 2 and coaxially disposed, and preferably, the fixing member 3, the torque output member 2 and the torque input member 1 are coaxially disposed. Of course, in other embodiments, the torque output member 2 and the torque input member 1 may be non-coaxially disposed, such as in a parallel arrangement or in a staggered arrangement.

The torque input part 1 comprises a first connecting piece 31 and a main body connecting piece 32, the torque output part 2 comprises a second connecting piece 41, and the first connecting piece 31 and the second connecting piece 41 are in meshing transmission and are preferably coaxially arranged. In this embodiment, the first connecting member 31 and the second connecting member 41 are driven by circumferential engagement, and preferably, the outer circumferential surface of the first connecting member 31 is engaged with the inner circumferential surface of the second connecting member 41. Wherein the body connector 32 is fixedly connected with the first connector 31 and is also used for fixedly connecting with the end of the medical device. The fixing connection manner of the main body connector 32 and the end of the medical device is not limited in the present application, for example, the connection manner of welding, bonding, screws, and buckles described in the first embodiment can be referred to. Similarly, a connecting device may be provided to fix the main body connector 32 to the end of the medical device, and the connecting device may circumferentially limit the main body connector 32 to keep the main body connector 32 and the end of the medical device relatively stationary, so that the main body connector 32 and the first connector 31 may be driven to rotate when the head end of the medical device is rotated. And the first connecting piece 31 and the second connecting piece 41 are in meshed transmission on the peripheral surfaces, so that the torque transmission is realized, the torque transmission structure is simple, and the torque transmission is stable.

Further, the second connecting member 41 includes a plurality of main teeth 401, the number of the main teeth 401 may be one or more than one, and the main teeth 401 have a first tooth surface (not labeled). When the torque input member 1 and the torque output member 2 are in mesh transmission with each other via the first tooth surface of the main tooth 401, the torque input member 1 is enabled to drive the torque output member 2 to rotate in the first direction.

When the number of the main teeth 401 is plural, the plural main teeth 401 are distributed in the circumferential direction on the circumferential surface of the second connecting member 41, and are preferably uniformly distributed. Further, in order to limit the magnitude of the torque, the first tooth surface of the main tooth 401 of the present embodiment is implemented in the same manner as in the first embodiment, and will not be described in detail. Therefore, a lower torque upper limit is determined by the first flank with a small angle to ensure that the torque device has a lower torque when rotating in the first direction. Therefore, when the first coupling member 31 and the second coupling member 41 are driven by the first tooth surface of the main tooth 401 in a meshing manner, the first coupling member 31 can drive the second coupling member 41 to rotate, for example, in a 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 in normal meshing transmission, and 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 in normal meshing transmission, so that the second connecting member 41 cannot rotate along with the first connecting member 31, namely, the first connecting member 31 and the body connecting member 32 are in idle rotation.

The main tooth 401 further has a second tooth surface (not labeled) opposite to the first tooth surface, which is the same as the first embodiment, and the second tooth surface of the main tooth 401 of the present embodiment is implemented in the same manner as the first embodiment, and will not be described in detail. That is, the angle between the second tooth flank and the tangent of the pitch circle at the node point is larger than the angle between the first tooth flank and the tangent of the pitch circle at the node point. Thus, a larger upper torque limit may be determined by a larger angle of the second flank to ensure a larger output torque when the torque device is rotated in the second direction. Therefore, when the first connecting piece 31 and the second connecting piece 41 are in meshing transmission through the second tooth surface of the main tooth 401, the first connecting piece 31 can drive the second connecting piece 41 to rotate in a counterclockwise direction for example, and the torque transmitted between the first connecting piece 31 and the second connecting piece 41 is greater than or equal to the second limit value.

Further, the fixing part 3 is preferably a spiral structure, and the fixing part 3 is fixedly connected with the second connecting piece 41. In practice, when the head end of the medical device rotates clockwise, the main body connecting piece 32 and the first connecting piece 31 can be driven to rotate clockwise, for example, and when the second connecting piece 41 and the first connecting piece 31 are in normal meshing transmission, the second connecting piece 41 and the fixing component 3 rotate clockwise along with the first connecting piece 31, so that the fixing component 3 is screwed into the target tissue, and the torque transmitted between the first connecting piece 31 and the second connecting piece 41 is smaller due to the limitation of the first tooth surface of the main tooth 401, so that the force for screwing the fixing component 3 into the target tissue is limited, and the risk of tissue perforation is reduced. In contrast, when the head end of the medical device is rotated counterclockwise, for example, the body link 32 and the first link 31 may be driven to rotate counterclockwise, and since the angle of the second tooth surface of the main tooth 401 is larger than that of the first tooth surface, a larger torque can be transmitted between the first link 31 and the second link 41 to ensure that the force when the fixing member 3 exits the target tissue is sufficiently large.

In this embodiment, the first connecting member 31 has a plurality of secondary teeth 301, and the number of the secondary teeth 301 is the same as or different from the number of the primary teeth 401. The secondary teeth 301 are used to mesh with the primary teeth 401 to effect torque transfer and limiting. The number of secondary teeth 301 is not limited by the present application.

As shown in fig. 6a, the shape of the secondary teeth 301 may be different from the shape of the primary teeth 401, in which case the tooth profile of the secondary teeth 301 does not match the tooth profile of the primary teeth 401 when engaged. Alternatively, as shown in fig. 6b, the shape of the secondary teeth 301 matches the shape of the primary teeth 401, and at this time, the tooth profile of the secondary teeth 301 completely matches the tooth profile of the primary teeth 401, so that the engagement strength is good and the torque transmission reliability is good. Alternatively, as shown in fig. 6c, the auxiliary teeth 301 are embedded with balls to reduce friction and improve the engagement strength. In this embodiment, the secondary teeth 301 may be obtained in the machining process, or the secondary teeth 301 may be formed by deforming the first connecting member 31 itself, that is, the primary teeth 401 are extruded on the first connecting member 31 to form the secondary teeth 301. Therefore, the present application does not limit the manner of obtaining the secondary teeth 301, and the secondary teeth 301 may be obtained during the machining process, or the secondary teeth 301 may be formed by pressing the primary teeth 401 against the first connecting member 31.

In addition, the present embodiment may eliminate or retain the first base 22. In addition, the torque device of the present embodiment further includes a preloading member 8, and the preloading member 8 is used for adjusting the pressure of engagement between the first connecting member 31 and the second connecting member 41. The larger the engaging pressure is, the larger the friction force between the first connecting piece 31 and the second connecting piece 41 is, the larger the upper limit of the torque allowed to be transmitted is, whereas the smaller the engaging pressure is, the smaller the friction force between the first connecting piece 31 and the second connecting piece 41 is, the smaller the upper limit of the torque allowed to be transmitted is, so that the magnitude of the torque transmitted between the first connecting piece 31 and the second connecting piece 41 can be further adjusted and controlled by the pre-tightening part 8, and the torque adjustment is more flexible and convenient. In this embodiment, the first connecting member 31 and the second connecting member 41 are driven by circumferential engagement, that is, the direction in which the first connecting member 31 and the second connecting member 41 are pressed against each other is substantially radial, and the pre-tightening member 8 is used to apply radial pressure to the first connecting member 31 and/or the second connecting member 41.

Further, the pre-tightening part 8 is fixedly connected with the main body connecting piece 32 and is used for applying radial pressure to the first connecting piece 31, and the relative position between the pre-tightening part 8 and the main body connecting piece 32 can be adjusted, so that the pressure between the second connecting piece 41 and the first connecting piece 31 can be adjusted. The connection between the pretensioning device 8 and the body connector 32 is not particularly limited in this application, and includes, but is not limited to, a threaded connection or a snap connection or other suitable connection. Further, the pre-tightening part 8 is provided with an internal thread, the main body connecting part 32 is provided with an external thread, and the two are in threaded connection, so that the pre-tightening part 8 can be moved left and right to adjust the upper limit of the torque allowed to be transmitted between the torque input part 1 and the torque output part 2.

In view of the fact that the pressing of the first connecting member 31 by the main teeth 401 of the second connecting member 41 during the rotation of the first connecting member 31 causes the first connecting member 31 to move slightly away from the second connecting member 41, it is preferable that the first connecting member 31 is a flexible member in order to compensate for this displacement. A "flexible member" is a deformable body as opposed to a rigid member that is capable of some deformation under an external force, and such deformation is generally recoverable. Similarly to the embodiment, the body connecting part 32, the first connecting part 31 and the pretensioning element 8 can be formed as a whole a, and the second connecting part 41 and the securing element 3 can be formed as a whole B, which can be rotated circumferentially relative to the whole a, but without axial movement or with only a small amount of axial movement. But if the first connection 31 is flexible, the entity B is hardly axially movable with respect to the entity a. Of course, in other embodiments, the first connecting member 31 may be a rigid member, and in this case, the pre-tightening unit 8 may be a flexible member, which allows a slight axial movement of the first connecting member 31, but at the same time limits the axial movement of the first connecting member 31 through the pre-tightening unit 8, so as to ensure a mutual pressing engagement state between the first connecting member 31 and the second connecting member 41. A "rigid member" is an undeformable body relative to a flexible member that is undeformable under an external force. It will be appreciated that insertion of the fixation element 3 into the target tissue relies primarily on rotation of the fixation element 3, rather than axial movement, so that the whole B may or may not require only a slight axial movement.

In other embodiments, one of the first connector 31 and the pretensioning element 8 is a flexible element, the other is a rigid element, or both are flexible elements.

Further, when the torque input component 1 and the torque output component 2 are in meshing transmission through the peripheral surfaces, the pre-tightening component 8 is matched with the torque input component 1 through an inclined surface so as to apply radial pressure on the torque input component 1. In one embodiment, the first connector 31 has an inner inclined surface 311, and the pretensioning element 8 has an outer inclined surface 811, wherein the outer inclined surface 811 is adapted to cooperate with the inner inclined surface 311 to exert a radial pressure on the first connector 31. Furthermore, the first connecting member 31 has a tapered cavity (not labeled), at least a portion of the pretensioning member 8 is a cone structure, at least a portion of the cone structure is inserted into the tapered cavity, and an outer wall of the cone structure is matched with an inner wall of the tapered cavity, so that the axial movement of the first connecting member 31 is limited by the matching of the inclined surfaces.

In another embodiment, the pretensioning device 8 can also comprise a second base 5, wherein the second base 5 is fixedly connected with the main body connecting member 32, for example, the main body connecting member 32 is configured in a T-shaped structure and comprises a positioning portion and a connecting portion, wherein the positioning portion is fixedly connected with the first connecting member 31, and the connecting portion penetrates through the first connecting member 31 and is fixedly connected with the second base 5. The connection portion of the body connection member 32 has an internal thread, the second base 5 has an external thread, and the internal thread of the body connection member 32 is connected with the external thread of the second base 5. Therefore, the axial movement of the first link 31 can be restricted by the contact of the second base 5 with the first link 31, so that the initial deformation amount of the first link 31 can also be restricted, thereby restricting the upper limit of the torque that is allowed to be transmitted between the first link 31 and the second link 41. Further, the second base 5 may be used to carry a drug and/or to interface with an electrode.

Like the first embodiment, the torque device of this embodiment further includes a suppository 6, and the suppository 6 can be fixedly connected with the second base 5. The suppository 6 can be filled with medicine. The application does not limit the type of the drug. The peg 6 may deliver a drug to a target tissue. The torque device of the present embodiment may further include an electrode 7, and the electrode 7 may be fixedly connected to the second base 5. The electrodes 7 may sense cardiac electrical signals or deliver electrical stimulation signals to the target tissue. The electrodes 7 may be connected by leads to electrical parts of the medical device, such as to electrical components of a leadless pacemaker or to leads of electrode leads.

It should be understood that the present application is not limited to any fixed connection between the components, and may be one or more of welding, gluing, screwing, pinning, and snapping. It should also be understood that the same parts of the second embodiment as the first embodiment may not be described in detail, but the same parts may be referred to in particular in the first embodiment.

In addition, the application has no particular limitation on the implementation mode of the pretensioning element, and includes but is not limited to the disclosure of the above preferred embodiment. In addition, the present application does not require the magnitude of the first limit value and the second limit value, for example, the first limit value may be determined based on the force that the helical structure of the medical device tip can withstand to rotate into the myocardium without causing tissue perforation, and the second limit value may be determined based on the force that the helical structure of the medical device tip can rotate out of the myocardium without failure.

It should be understood that the above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any way and in any way, and that the inventive innovations, while originating from the field of cardiac pacing and pacing technology, will be appreciated by those skilled in the art that the torque device of the present invention may also be applied to spinal cord electrical stimulation or other site electrical stimulation technology.

It should be noted that, for a person skilled in the art, several modifications and additions can be made without departing from the method of the invention, which should also be considered as a protection scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any equivalent changes, modifications and evolutions of the above embodiments according to the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A torque device of a medical device, wherein the medical device is a leadless pacemaker or an electrode lead, and is characterized in that the torque device comprises a torque input part and a torque output part which are connected; the torque input component is used for being fixedly connected with the tail end of the medical equipment;

the torque device is configured such that the torque input member is capable of driving the torque output member in a first direction when there is drive between the torque input member and the torque output member via the first flank engagement.

2. The medical device torque apparatus of claim 1, wherein the torque input member and the torque output member are coaxially disposed.

3. The torque device of a medical apparatus according to claim 1, wherein the main tooth further has a second tooth flank disposed opposite the first tooth flank; the included angle between the second tooth surface and the tangent of the pitch circle at the node is larger than the included angle between the first tooth surface and the tangent of the pitch circle at the node;

4. The torque device of a medical apparatus according to claim 1, wherein the other of the torque input member and the torque output member is provided with secondary teeth for meshing with the primary teeth.

5. The torque device of a medical apparatus according to claim 4, wherein the secondary teeth are embedded with balls or are extruded from the primary teeth.

6. The torque device of a medical apparatus of claim 1, further comprising a pretensioning member for adjusting a pressure of engagement between the torque input member and the torque output member.

7. The torque device of a medical apparatus according to claim 6, wherein the torque input part and the torque output part are in end-face engagement transmission, and the pretensioning part is configured to apply axial pressure to the torque output part and/or the torque output part, or wherein the torque input part and the torque output part are in circumferential engagement transmission, and the pretensioning part is configured to apply radial pressure to the torque input part and/or the torque output part.

8. The torque device of the medical apparatus according to claim 7, wherein the pretensioning member is fixedly connected to the torque input member, and a relative position between the pretensioning member and the torque input member is adjustable.

9. The torque device of the medical apparatus according to claim 7, wherein the pretensioning member is in ramped engagement with the torque input member to apply radial pressure to the torque input member when the torque input member and the torque output member are in circumferential engagement for transmission.

10. The medical device torque apparatus of claim 9, wherein the torque input member includes a body connector and a first connector, and the torque output member includes a second connector; 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 in inner engagement transmission with the second connecting piece; the first connecting piece is provided with a conical cavity, at least part of the pre-tightening component is of a cone structure, at least 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 a medical apparatus according to claim 7, wherein when the torque input member and the torque output member are driven by end surface engagement, the torque input member includes a first connecting member, the torque output member includes a second connecting member, the first connecting member includes a transmission portion and a connecting portion, and an end surface of the transmission portion is engaged with an end surface of the second connecting member; the connecting part penetrates through the second connecting part and is fixedly connected with the pre-tightening part.

12. The medical device torque apparatus of claim 6, wherein one of the pretensioning member, the torque input member and the torque output member is a flexible member, or both the pretensioning member and the torque output member are flexible members.

13. The torque device of a medical apparatus according to claim 8, wherein the pretensioning member comprises a first base and a second base, the first base is fixedly connected with the torque output member, the second base is fixedly connected with the torque input member, the second base is used for limiting the axial movement of the first base, or the pretensioning member comprises a second base, the second base is fixedly connected with the torque input member, and the second base is used for limiting the axial movement of the torque input member.

14. The torque device of a medical apparatus according to claim 1 or 2, further comprising a fixation member for engaging with a target object to position the torque device at a target location;

15. The medical device torque apparatus according to claim 14, wherein the fixing member is a helical structure.

16. The torque device of a medical apparatus according to claim 1 or 2, further comprising a second base fixedly connected to the torque input member, the second base being adapted to carry a drug and/or to connect an electrode.

17. The torque device of a medical apparatus according to claim 16, further comprising a cartridge and/or an electrode, the cartridge being fixedly connected to the second base and the electrode being fixedly connected to the second base.

18. A medical device system comprising a medical device and a torque device of the medical device of any of claims 1-17, the torque input member of the torque device being fixedly connected to a distal end of the medical device, the medical device being a leadless pacemaker or an electrode lead.