Fixing device and ventricular auxiliary device

Abstract

The invention provides a fixing device and a ventricular assist device. The fixing device is used for fixing an interventional medical element and comprises a main body internally provided with a cavity; the flexible part is arranged in the cavity, and the medical element is arranged in the flexible part in a sliding mode; when the locking unit is switched to the first position, the flexible part is extruded to fix the medical element; and when the flexible part is switched to the second position, the extrusion on the flexible part is relieved, and the medical element is released. The invention further provides a ventricular assist device comprising the fixing device. According to the invention, the deformation quantity of the flexible part is controlled through the locking unit so as to lock or unlock the medical element, so that the operation difficulty of locking and unlocking the medical element is reduced, and the use safety of the instrument is improved. The locking unit cannot be separated from the fixing device in the using process, user operation is facilitated, and operation convenience and user experience are greatly improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a fixing device and a ventricular assist device. Background Art

[0002] In the prior art, the sheath position fixing device is composed of a front bolt, a front nut, a rear nut, a rear bolt, a chuck and a bacteria-blocking sleeve, etc. The bacteria-blocking sleeve is fixedly connected to the proximal end of the front nut and the distal end of the rear nut, and the chuck is used to clamp the sheath. When adjusting the extension state of the bacteria-blocking sleeve and the position of the sheath, it is necessary to rotate the front nut to release the lock of the chuck on the sheath. When only the front nut is rotated, the bacteria-blocking sleeve will twist with the rotation of the front nut, and cause the bacteria-blocking sleeve to twist on the sheath, causing damage to the bacteria-blocking sleeve; and when the front and rear bolts are rotated synchronously to avoid the torsion of the bacteria-blocking sleeve, many problems will occur, such as cumbersome operation, time-consuming adjustment process, and inconvenient operation. Furthermore, in this scheme, the bite area between the chuck and the sheath surface is relatively small, and whether the chuck can lock the sheath depends on whether the front bolt and the front nut are screwed into place, which is prone to misoperation problems and even problems of instrument damage to tissues in the body. In addition, there are also instruments in the prior art that use buttons, springs, locking pins and other structures to quickly lock or unlock the sheath, but the structural design of such instruments is complex and the cost is high. After the locking pin is removed, it will be separated from the instrument body, which is inconvenient to use and has a poor operating experience. In addition, the problem of misoperation has not been solved. Summary of the invention

[0003] In order to overcome at least one of the problems in the related art, a first aspect of the present invention provides a fixing device.

[0004] Wherein, the fixing device is used to fix the interventional medical element.

[0005] And comprises a main body, and a cavity is provided inside;

[0006] An extrusion unit is disposed in the cavity, and the medical element is slidably disposed inside the extrusion unit;

[0007] The locking unit, when switched to the first position, squeezes the squeezing unit to fix the medical element; when switched to the second position, releases the squeezing of the squeezing unit and releases the medical element.

[0008] In some optional embodiments, the extrusion unit includes a flexible part and a rigid part; the flexible part, the medical element is slidably disposed inside the flexible part; the rigid part, the rigid part is at least partially in contact with the flexible part; the locking unit squeezes the rigid part to evenly apply the load on the flexible part.

[0009] In some optional embodiments, the flexible member is elastic;

[0010] When the rigid part releases the pressure on the flexible part, the flexible part recovers its deformation to release the medical element.

[0011] In some optional embodiments, the cavity includes a first cavity extending axially and a second cavity extending radially, and the first cavity and the second cavity have an intersecting portion;

[0012] The flexible member is disposed in the first cavity, and the rigid member is disposed in the second cavity;

[0013] During the process of switching positions of the locking unit, the portion of the rigid member for accommodating the flexible member can move relative to the intersecting portion.

[0014] In some optional embodiments, the locking unit includes a cam, and the cam abuts against the pressing unit.

[0015] In some optional embodiments, the cam is provided with a limiting wheel, and the limiting wheel is provided with a first limiting portion;

[0016] The main body is provided with a second limiting portion;

[0017] The first limiting portion cooperates with the second limiting portion to limit the rotational travel of the cam.

[0018] In some optional embodiments, the limiting wheels include two, and are symmetrically arranged on the end faces at both ends of the cam.

[0019] In some optional embodiments, one of the first limiting portion and the second limiting portion is a limiting groove, and the other is a limiting protrusion.

[0020] In some optional embodiments, the locking unit further comprises a handle, one end of the handle is connected to the cam, and the other end of the handle is provided with a first positioning portion;

[0021] The main body is provided with a second positioning portion;

[0022] The first positioning portion cooperates with the second positioning portion to locate the position of the handle.

[0023] In some optional embodiments, one of the first positioning portion and the second positioning portion is a buckle, and the other is a slot.

[0024] In some optional embodiments, the first positioning portion is a buckle, and the second positioning portion is a slot;

[0025] The hardness of the handle is smaller than the hardness of the main body.

[0026] In some optional embodiments, at least one accommodating portion is provided on the side wall of the through hole of the rigid member;

[0027] In the process of the rigid member pressing the flexible member to fix the medical element, the receiving portion is used to receive at least a portion of the flexible member.

[0028] A second aspect of the present invention provides a ventricular assist device, comprising the fixing device described in any one of the first aspects; and the fixing device controls the position of an invasive medical element in the ventricular assist device.

[0029] The technical solution of the present invention has the following advantages or beneficial effects:

[0030] (1) In the present invention, the medical component can be fixed and released by controlling the load applied by the locking unit to the squeezing unit, thereby achieving the purpose of safely and reliably controlling the degree of freedom of the medical component. Furthermore, the user can achieve the purpose of controlling the medical component by simply observing and adjusting the position of the locking unit, which greatly improves the convenience of operation and reduces the possibility of misoperation.

[0031] (2) In the present invention, the medical element can be slidably arranged inside the flexible member, and the deformation of the flexible member is controlled by the locking unit to lock or unlock the medical element, thereby reducing the difficulty of locking and unlocking the medical element, avoiding problems such as twisting of the antibacterial sleeve and unreliable locking of the medical element. At the same time, the locking unit will not be separated from the fixing device during use, which is convenient for user operation, greatly improving the convenience of operation and user experience.

[0032] (3) The fixing device of the present invention also includes a rigid part, which is at least partially in contact with the flexible part. The load of the locking unit acts on the rigid part and is then transferred to the flexible part, so that the load acting on the flexible part is evenly distributed, and the load acting on the medical element is evenly distributed, thereby improving the locking effect.

[0033] (4) The cavity of the present invention includes a first cavity extending axially and a second cavity extending radially, and the first cavity and the second cavity have an intersecting portion; the flexible component is disposed in the first cavity, and the rigid component is disposed in the second cavity. Since there is an orthogonal relationship between the first cavity and the second cavity, when the locking unit drives the rigid component to move, the rigid component can quickly push the flexible component and squeeze the medical element, thereby effectively improving the operating efficiency of the device.

[0034] (5) A first limiting portion is provided on the cam of the present invention, and a second limiting portion is provided on the main body. The two limiting portions constrain the stroke of the cam, and the locking and unlocking states of the medical element are accurately controlled. Furthermore, a first positioning portion and a second positioning portion are provided on the end of the handle away from the cam and the main body, respectively, and in the locked state, the first positioning portion and the second positioning portion cooperate with each other to constrain the movement of the handle, thereby preventing the handle from rotating due to misoperation, so that the medical element is stably in the locked state. The material hardness of the handle is lower than the hardness of the rigid part and the main body; this arrangement can, on the one hand, allow the handle to be smoothly inserted into the slot, and on the other hand, can also increase the service life of the instrument, avoiding the problem of rapid wear of the handle and the main body during repeated clamping of the handle.

[0035] (6) In the present invention, at least one accommodating portion is provided on the side wall of the through hole of the rigid member. When the flexible member is compressed by the rigid member, the compressed portion can be fully accommodated by the accommodating portion, so that the pressure applied by the flexible member on the medical element is uniform, ensuring that the flexible member fully compresses and locks the medical element in the extrusion direction. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation of the present invention.

[0037] Figure 1 is a schematic diagram of the working state of the fixing device according to an embodiment of the present invention;

[0038] FIG. 2( a ) is a schematic diagram of a fixing device according to a first example of an embodiment of the present invention;

[0039] FIG2( b ) is a schematic diagram of a fixing device according to a second example of an embodiment of the present invention;

[0040] FIG2( c ) is a schematic diagram of a fixing device according to a third example of an embodiment of the present invention;

[0041] Figure 3 is a cross-sectional schematic diagram of an unlocked state of a fixing device according to an embodiment of the present invention;

[0042] Figure 4 is a cross-sectional schematic diagram of a locking state of a fixing device according to an embodiment of the present invention;

[0043] Figure 5 is a schematic diagram of the working principle of a locking unit according to an embodiment of the present invention;

[0044] Figure 6 is a partial cross-sectional schematic diagram of a fixing device in a released positioning state according to an embodiment of the present invention;

[0045] Figure 7 is a partial cross-sectional schematic diagram of a positioning state of a fixing device according to an embodiment of the present invention;

[0046] Figure 8 is an axonometric schematic diagram of another locking unit according to an embodiment of the present invention;

[0047] Fig. 9 is a schematic side view of a rigid member according to an embodiment of the present invention;

[0048] Fig.10 It is a schematic diagram of the working state of the fixing device in the prior art before adjustment;

[0049] Fig.11 It is a schematic diagram of the working state of the fixing device after adjustment in the prior art. DETAILED DESCRIPTION

[0050] The following is a description of exemplary embodiments of the present invention in conjunction with the accompanying drawings, including various details of the embodiments of the present invention to facilitate understanding, which should be considered as merely exemplary. Therefore, it should be recognized by those of ordinary skill in the art that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present invention. Similarly, for clarity and conciseness, the description of well-known functions and structures is omitted in the following description.

[0051] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The singular forms of "a", "said" and "the" used in this application and the appended claims are also intended to include plural forms unless the context clearly indicates other meanings. It should also be understood that the term "and / or" used herein refers to and includes any or all possible combinations of one or more associated listed items.

[0052] It should be understood that although the terms first, second, third, etc. may be used in the present application to describe various information, these information should not be limited to these terms. These terms are only used to distinguish the same type of information from each other. For example, without departing from the scope of the present application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Depending on the context, the word "if" as used herein may be interpreted as "at the time of" or "when" or "in response to determining".

[0053] like Fig.10 and 11In the prior art shown, the sheath 1001 is inserted into the interior of the fixing device, and can move relative to the fixing device, or be locked by the fixing device. The fixing device includes a front bolt 1003, a front nut 1004, a rear nut 1005, a rear bolt 1006, a chuck 1009 and a bacterial barrier sleeve 1101. The suture pad 1002 is fixed on the sheath seat 1008, and each of the two wings of the suture pad is provided with a suture hole, and the suture hole is used to pass the suture thread to fix the suture pad on the skin. The sheath seat 1008 is fixed on the front bolt 1003. The bacterial barrier sleeve is arranged between the front nut and the rear nut, and is interference-fitted by a fixing ring 1100 located at the proximal end of the front nut and the distal end of the rear nut. The bacterial barrier sleeve is used to block bacteria, viruses, etc. when the sheath 1001 moves, so as to ensure the safety of the medical process. As Fig.10 As shown, it shows a cross-sectional schematic diagram of the sheath being locked. In this state, the front bolt, the front nut, and the rear bolt, the rear nut are connected by threads 1007 and 1102, respectively. Chucks 1009 are placed inside the front nut and the rear nut, respectively. When locking the sheath, the front nut and / or the rear bolt rotate clockwise, and the bottom surfaces of the front bolt and the rear bolt push the chuck to move deeper into the nut until the conical surface of the chuck hits the conical surface inside the nut. Because there are several gaps on the chuck. When the chuck is pushed forward, the gap will gradually tighten, causing the chuck to deform and close, and clamp the sheath in the chuck to achieve the purpose of locking the sheath. As shown Fig.11As shown, it shows a cross-sectional schematic diagram of unlocking the sheath and adjusting its position relative to the suture pad and adjusting the length of the antibacterial sleeve. For example, during operation, the rear bolt and the rear nut are not adjusted, the locking state of the proximal sheath is maintained, and only the front nut is loosened counterclockwise to release the squeezing effect on the chuck, so that it returns to the initial state and releases the sheath, thereby adjusting the position of the sheath, and at the same time, the antibacterial sleeve can be stretched or contracted while adjusting the position of the suture pad. After the adjustment is completed, the front nut is tightened clockwise to lock the position of the sheath. Since the fixing ring and the antibacterial sleeve are fixedly connected, when only the front nut is turned and the rear nut is fixed, the antibacterial sleeve will be twisted synchronously with the front nut, and then the antibacterial sleeve will be twisted on the sheath, which is easy to cause the antibacterial sleeve to break or tear. For this reason, in order to prevent the antibacterial sleeve from twisting, the prior art needs to unlock the rear bolt counterclockwise, and rotate the rear nut in the opposite direction until the antibacterial sleeve no longer twists, and finally tighten the rear bolt clockwise. However, this operation is complicated, time-consuming, and the operator's experience is not good. Furthermore, since the engagement area between the chuck and the sheath surface is relatively small, and whether the chuck can lock the sheath depends on whether the front bolt and the front nut are screwed into place, if the front bolt and the front nut are not completely screwed into place, the chuck and the sheath will loosen, and the parts connected to the sheath in the body may be relatively displaced, causing damage to human tissue and posing a safety hazard. Of course, there is also a press-to-unlock method in the prior art, but the pressing mechanism extends out of the surface of the fixing device, which is prone to misoperation; in addition, the device is provided with springs, locking pins and other structures to quickly lock or unlock the sheath, but such devices have complex structural designs and high costs, or cannot be operated with one hand, or the locking pin will be separated from the device body after removal, which is inconvenient to use and has a poor operating experience.

[0054] In order to overcome at least one of the many problems in the related art, the first aspect of the present invention provides a fixing device. It includes a main body, a cavity is provided inside; a squeezing unit is arranged in the cavity, and the medical element can be slidably arranged inside the squeezing unit; a locking unit, when it switches to the first position, squeezes the squeezing unit to fix the medical element; when it switches to the second position, the squeezing of the squeezing unit is released and the medical element is released. In some embodiments, the squeezing unit can be a flexible part or a rigid part, or a combination of a flexible part and a rigid part, or a combination of a flexible part and a flexible part, or a combination of flexible parts with different elastic coefficients. If it is only a rigid part, the part where the cavity and the rigid part contact the medical element and / or the part where there is a possibility of contact needs to have a smooth contour to avoid the problem of stress concentration caused by excessive local pressure on the medical element.

[0055] like Figure 1In the illustrated embodiment, the system structure of the fixing device in the working state is divided into two parts with AA as the boundary, wherein the left side is the in-vivo part and the right side is the in-vitro part, and the fixing device is located in the in-vitro part in the working state. The distal end of the fixing device shown is connected to the proximal end of the interventional sheath, and the proximal end of the fixing device is connected to the antibacterial sleeve 1101. The distal end of the suture pad is provided with an interventional sleeve 102, and the medical element is arranged inside the system and passes through the interventional sheath, the suture pad, the fixing device and the antibacterial sleeve 1101, the rear nut 1005, the rear bolt 1006 and other components in sequence. Among them, the medical element includes a sheath tube 1001, as shown in FIG. Figure 1 As shown, the suture pad 1002 is arranged on the interventional sheath, and the antibacterial sleeve is arranged between the fixing device and the rear nut. The fixing device is used to lock or unlock the medical element. When the relative position of the medical element needs to be adjusted, the locking effect of the medical element can be unlocked by the fixing device, and then the fixing device can be moved. At this time, the antibacterial sleeve is stretched or compressed and deformed with the movement of the fixing device. When the set target position is reached, the position of the medical element can be adjusted again. When the adjustment process is completed, the suture pad is fixed on the skin to achieve local fixation of the medical system. The sheath 1001 is also provided with a mark 101 to facilitate the operator to confirm and adjust the position of the sheath. As shown Figure 1 As shown, the fixing device is used to lock the distal end of the sheath tube, and the rear nut and rear bolt are used to lock the proximal end of the sheath tube. After the rear bolt and rear nut lock the proximal end of the sheath tube, the position is no longer adjusted. Figure 3 As shown, the fixing device 103 includes a main body, and a cavity is provided inside the main body to accommodate the corresponding element. The flexible member 203 is provided in the cavity, and the medical element can be slidably provided inside the flexible member. When the medical element is not locked, it can slide inside the flexible member; when locked, the relative position between the flexible member and the medical element is fixed. In some embodiments, a through hole is provided inside the flexible member, and there is a clearance fit or transition fit between the through hole and the medical element. In order to achieve the purpose of locking or unlocking the position of the medical element, a locking unit 104 is further provided, which can switch between a first position and a second position. As shown Figure 1 As shown, the locking unit 104 can rotate from the vertical direction to the horizontal direction, or vice versa. The locking unit is connected to the main body. Figure 4As shown, the locking unit can be switched between the first position and the second position by one hand through the handle. When the locking unit is switched to the first position, the handle 201 is in a horizontal state, which will squeeze the flexible member and force the flexible member to tightly rest on the outer surface of the medical element to fix the medical element. It should be noted that the horizontal state refers to the state in which the handle 201 is parallel or approximately parallel to the axis of the fixing device. Figure 3 As shown, when the locking unit is switched to the second position, the handle 201 is in a vertical state, and the squeezing effect on the flexible member is released. At this time, the flexible member will gradually recover its deformation, and the pressure acting on the medical element will be eliminated, thereby releasing the medical element. In the second position, the medical element can be operated and freely slid inside the flexible member to adjust the relative position between the medical element and the suture pad. In some optional embodiments, the flexible member is elastic; if the rigid member releases the squeezing of the flexible member, the flexible member recovers its deformation to release the medical element. When in use, the locking element is first switched to the second position, and the operator can hold the fixing device and push it to the distal end. Since the proximal end of the medical element is fixed by the rear nut and the rear bolt, the fixing device will move relative to the medical element. At the same time, the antibacterial sleeve is also stretched with the movement of the fixing device until the intervention sheath enters the human body. After the position adjustment is completed, the suture pad can be bound to the skin with sutures, and the positions of the intervention sheath and the suture pad are fixed. Finally, hold the fixing device still, withdraw the sheath to the proximal end, and withdraw the distal mark 101 of the sheath into the interventional sheath to complete the sheath adjustment. Finally, switch the locking unit to the first position to lock the medical element. In some embodiments, in order to enhance the friction between the flexible member and the medical element in the locked state, and to facilitate the production of the flexible member and reduce the manufacturing cost, the flexible member is made of silicone. In some embodiments, in order to enhance the protection of the medical element by the flexible member and prevent the medical element from being damaged during the locking process, the flexible member adopts a ring structure. In some other embodiments, a clamping portion 301 is also provided on the main body to connect with the sheath seat. It can be seen from the above description that in this embodiment, the medical element is wrapped by the flexible member, and the deformation of the flexible member is controlled by the locking unit to lock or unlock the medical element, thereby reducing the difficulty of locking and unlocking the medical element, and avoiding many problems such as twisting of the antibacterial sleeve and unreliable locking of the medical element. At the same time, the locking unit will not be separated from the fixing device during use, which is convenient for user operation and greatly improves the convenience of operation and user experience.

[0056] In some optional embodiments, the fixing device further comprises a rigid part, which is arranged in the cavity and at least partially contacts the flexible part. The load of the locking unit acts on the rigid part and is then transferred to the flexible part, so that the load acting on the flexible part is evenly distributed, and then the load acting on the medical element is evenly distributed, thereby improving the locking effect and not damaging the medical element. The rigid part can be a pressing block structure, such as a tile-shaped, cylindrical, elliptical cylindrical, prism-shaped, cube-shaped and cuboid-shaped, etc. The rigid part can also be an annular structure, such as a circular ring-shaped, etc. The shape description of the rigid part here is only an example and does not constitute a limitation on the protection scope of the present invention. Preferably, the inner surface of the rigid part is in surface contact with the outer surface of the flexible part, and the contact surface is as large as possible, so that the load of the locking unit acts on the flexible part as evenly as possible. The locking unit fixes or releases the medical element by controlling the rigid part. Since the locking unit repeatedly switches positions between the first position and the second position, it will continuously squeeze and wear the flexible part, reducing its service life and reliability of use. In particular, when the locking unit directly acts on the flexible part, its service life and reliability will be significantly reduced. Furthermore, in the embodiment without the rigid part, the contact surface between the locking unit and the extrusion unit is small, resulting in uneven distribution of the extrusion load on the surface of the medical component, resulting in poor locking effect. Figure 3 and 4 In the illustrated embodiment, a rigid part 204 is added to solve this problem. The rigid part is arranged in the cavity of the main body and between the locking unit and the flexible part. Preferably, a through hole is provided in the rigid part to accommodate the flexible part. This arrangement can increase the contact area between the inner wall of the rigid part and the outer wall of the flexible part, reduce the pressure on the contact surface between the rigid part and the flexible part, thereby improving the service life of the flexible part and the safety of the fixing device. When it is necessary to lock the medical element, the load of the locking unit acts on the rigid part and then is transferred to the flexible part to achieve the purpose of locking the medical element. The problem of the load of the locking unit acting directly on the flexible part is effectively avoided. Furthermore, the wear resistance of the rigid part is better than that of the flexible part, and the rigid part can withstand the repeated extrusion of the locking unit.

[0057] In some optional embodiments, the cavity includes a first cavity extending axially and a second cavity extending radially, and there is an intersection between the first cavity and the second cavity; the flexible member is disposed in the first cavity, and the rigid member is disposed in the second cavity; during the position switching process of the locking unit, the portion of the rigid member used to accommodate the flexible member can move relative to the intersection. Figure 3 and 4In the embodiment shown, a through hole extending in the axial direction can be provided on the main body to form the first cavity, and a second hole can be provided in the radial direction to form the second cavity. In order to facilitate processing and manufacturing, the first cavity can be provided with a circular hole, and an interference fit between the first cavity and the flexible member can be provided to prevent the flexible member from moving relative to the main body during the process of adjusting the position of the medical element relative to the suture pad. The second cavity is a blind hole, and the blind hole can be a circular hole, a square hole, etc. Preferably, the second cavity is a square hole to increase the volume of the rigid member in the main body, thereby increasing the inner wall surface area of ​​the through hole on the rigid member that accommodates the flexible member, increasing the contact area between the flexible member and the rigid member, thereby reducing the pressure between the contact surface of the flexible member and the rigid member, and making the pressure act evenly on the flexible member, thereby improving the locking effect. The second cavity and the rigid member are transitionally matched or clearance matched so that the rigid member can slide freely in the second cavity. Advantageously, the wall surface of the second cavity can be used as a guide element during the sliding process of the rigid member so that the rigid member can slide stably in the main body. Furthermore, there is an intersection between the first cavity and the second cavity, and the portion of the rigid part used to accommodate the flexible part can move relative to the intersection, so that the flexible part can move with the rigid part in the second cavity during the process of locking or unlocking the medical element. From the above description, it can be seen that the two ends of the flexible part are located in the first cavity, and their positions are constrained by the first cavity, while the middle part can move between the first cavity and the second cavity to deform. The constrained two ends effectively define the position of the flexible part and can provide elastic force for the flexible part to restore deformation. Due to the orthogonal relationship between the first cavity and the second cavity, when the locking unit drives the rigid part to move, the rigid part can quickly push the flexible part and squeeze the medical element, effectively improving the operating efficiency of the instrument.

[0058] In some optional embodiments, the locking unit includes a cam, and the cam abuts against the rigid part to drive the rigid part to move. In practice, the locking unit can be implemented in a variety of ways, including but not limited to using a crank slider mechanism, a gear rack mechanism, a worm gear mechanism, etc. to push the rigid part to move. In a preferred embodiment, a cam is used, in which the cam is easy to operate, has a simple structure, and has a high transmission efficiency. It can quickly push the rigid part to squeeze the flexible part, or release the squeezing of the rigid part, thereby improving the efficiency of the surgical operation. Figure 3 and 4The main body is provided with a pin 202 for fixing the cam 400, and the cam can be driven to rotate around the pin. In the unlocked state, the handle 201 rotates in the vertical direction and maintains the vertical state, at which time the rigid part is tangent to the base circle of the cam, the flexible part is not compressed, and the medical element can move. It should be noted that the vertical direction refers to the direction in which the handle 201 is perpendicular or approximately perpendicular to the axis of the fixing device. In the locked state, the handle 201 is rotated and pressed down along the first direction, and the first direction can be clockwise or counterclockwise, and the direction of rotation is closely related to the structural design of the cam. Whether rotating clockwise or counterclockwise, the purpose is to push the flexible part to squeeze the medical element and deform it during the rotation of the cam. Specifically, the rigid part is tangent to the cam and moves and squeezes the flexible part as the cam rotates, so that the flexible part is bent in the cavity of the main body. Preferably, in order to avoid excessive squeezing of the medical element by the flexible part, the movement stroke of the rigid part can be constrained by the size matching between the rigid part and the second cavity. When the bottom surface of the rigid part contacts the bottom surface of the second cavity, the medical component and the flexible part can be prevented from being further squeezed. The cam is connected to the handle 201, and the handle can be set in various forms to facilitate the rotation of the cam; and the installation position can also be flexibly selected. Figure 2(a) , 2(b) As shown in FIG. 2( c ), the handle may be configured in a T-shaped or anchor-shaped manner, and the assembly position may be located at the center of the body or offset to one side; it should be noted that this is only an example and is not intended to limit the scope of protection. Figure 5 As shown in , whether the medical component can be locked by the flexible part is related to the downward pressing distance of the rigid part, and the end surface of the rigid part is tangent to the cam, so it is mainly determined by the relative displacement s of the cam. Figure 5 As shown, the cam moves along the theoretical profile 402 with the center of the base circle 401 as the rotation center. In the initial state, the handle is 90 degrees upward, and the angle before and after the handle rotates is recorded as α. When it is rotated clockwise so that α=90°, the farthest end of the cam is located below the theoretical profile. The relative displacement s is the displacement of the tangent horizontal line before and after the rotation. As the angle α reaches a right angle, the relative displacement s reaches a peak value, so that the rigid part completely compresses the flexible part. It can be understood that the maximum value of the relative displacement s is also related to the distance d between the center of the base circle and the center of the offset circle 403. The larger the distance d, the deeper the flexible part is pressed down when the relative displacement s reaches the maximum value. In some embodiments of the present invention, the value range of α is 30°-150°, the maximum value of s is between 0.5-5mm, and the distance d is between 0.5-5mm. The base circle diameter is between 1-10mm, and the offset circle diameter is between 0.5-6mm. The cam below the cam handle can be a centering cam (such as Figure 8 shown), or eccentric cam, etc.

[0059] In some optional embodiments, the cam is provided with a limiting wheel, and the limiting wheel is provided with a first limiting part; the main body is provided with a second limiting part; the first limiting part and the second limiting part cooperate to limit the rotation stroke of the cam. In some optional embodiments, the limiting wheel includes two, and is symmetrically arranged on the end faces of both sides of the cam. In some optional embodiments, one of the first limiting part and the second limiting part is a limiting groove, and the other is a limiting protrusion. In order to facilitate the control of the stroke of the cam, so that it works within the effective stroke range and avoids the operator's misoperation, it is a design that needs to be focused on. To this end, in one embodiment of the present invention, the problem is solved by respectively providing a first limiting part on the cam and a second limiting part on the main body. In order to facilitate processing and manufacturing, in one embodiment, a limiting wheel 503 is provided on one side surface of the cam and a first limiting part is processed on the limiting wheel. Correspondingly, the first limiting part can be a limiting groove, and the second limiting part 504 is a limiting protrusion. Among them, the limiting groove can be a superior arc groove or a inferior arc groove, which can be flexibly adjusted according to the stroke design requirements. Furthermore, in order to ensure the effectiveness and service life of the limit, the height of the limit protrusion is equal to the depth of the limit wheel groove, or equal to half of it. Figure 6 and 7 As shown, when the handle is in a vertical state, the end surface of one end of the limit groove abuts against the limit protrusion to prevent the handle from further rotating; when the handle gradually rotates from the vertical state to the horizontal position and reaches the limit downward position of the rigid member, the end surface of the other end of the limit groove abuts against the limit protrusion to prevent the cam from further moving. It should be noted that the vertical state refers to the state in which the handle 201 is perpendicular or approximately perpendicular to the axis of the fixing device.

[0060] In some optional embodiments, one end of the handle of the locking unit is connected to the cam, and the other end is provided with a first positioning portion; a second positioning portion is provided on the main body; and the first positioning portion cooperates with the second positioning portion to locate the position of the handle. In some optional embodiments, one of the first positioning portion and the second positioning portion is a buckle, and the other is a slot. In some optional embodiments, the first positioning portion is a buckle, and the second positioning portion is a slot; the hardness of the handle is less than the hardness of the main body. When the fixing device is in the locked state, a corresponding safety mechanism needs to be provided to avoid safety problems caused by user's misoperation. Figures 6 to 7In the illustrated embodiment, a first positioning portion and a second positioning portion are respectively provided on the end of the handle away from the cam and the main body; and in the locked state, the first positioning portion and the second positioning portion cooperate with each other to restrict the movement of the handle, thereby preventing the handle from rotating due to misoperation, so that the medical element is stably in the locked state. Exemplarily, the first positioning portion is a buckle 501, and the second positioning portion is a slot 502. In the locked state, the buckle on the handle and the slot on the main body are engaged. Figure 8 As shown, it shows the design details of the cam, handle, etc. in an example. The handle is provided with a buckle 501 and a reinforcing rib 601; the cam 400 is a centering cam, and limit wheels 503 are provided on both sides of the cam. Furthermore, the structure of the handle can be T-shaped, straight-shaped, anchor-shaped, arched, spherical, etc. The buckle can be a cylindrical structure or a semi-cylindrical structure, etc. The reinforcing rib is an oblique triangle to ensure that the handle has sufficient strength and does not bend. The cam can be set as an offset cam, and its base circle axis is not colinear with the axis of the limiting wheel; the limiting wheel is a minor arc cylinder or a major arc cylinder, and the angle range of the removed limiting groove is the same as that of the limiting wheel. Figure 5 The range of the α angle is consistent. Furthermore, the depth of the slot 502 is greater than the thickness of the buckle portion on the handle. At this time, when the buckle cooperates with the slot, the portion of the handle corresponding to the slot is completely located in the slot, thereby effectively preventing the user from easily lifting the handle and avoiding misoperation. As mentioned above, when the buckle cooperates with the slot, the limiting protrusion and the limiting groove are also in contact, so that the handle cannot be further rotated along the axial direction. Preferably, the hardness of the material of the handle is lower than the hardness of the rigid part and the main body; on the one hand, this setting can make the handle smoothly inserted into the slot, and on the other hand, it can also increase the service life of the instrument and avoid the problem of rapid wear of the handle and the main body during repeated clamping of the handle.

[0061] In some optional embodiments, at least one accommodating portion is provided on the side wall of the through hole of the rigid member; when the rigid member squeezes the flexible member to fix the medical element, the accommodating portion is used to accommodate at least part of the flexible member. Fig. 9 As shown, the rigid member 204 is provided with a through hole extending axially therethrough to accommodate the flexible member 203. The through hole may be a circular hole or an elliptical hole, etc. It is understandable that during the compression of the flexible member, the flexible member will shrink and deform. If the deformed flexible member cannot be evenly accommodated, the pressure on the medical element will be uneven, thereby failing to stably lock the medical element. To this end, in some embodiments of the present invention, some accommodating portions 701 are provided on the side walls of the through hole to solve this problem. For example, Fig. 9As shown, the accommodating portion is a groove provided on the through hole. Preferably, the groove is arranged in the horizontal direction. It is understandable that when the flexible member is compressed by the rigid member in the vertical direction, it is bound to expand in the horizontal direction. At this time, the accommodating portion can be fully utilized to accommodate the flexible member expanding in the horizontal direction, so that the flexible member can fully compress and lock the medical element in the vertical direction.

[0062] The second aspect of the present invention provides a ventricular assist device, which comprises the fixing device described in any one of the first aspects; and the fixing device controls the position of an invasive medical element in the ventricular assist device. Figure 1 As shown, the fixing device is integrated into the ventricular assist device, and the invasive medical element extends along the axis of the ventricular assist device and is located inside the ventricular assist device. The fixing device is used to lock and unlock the medical element, thereby achieving control over its position.

[0063] The above specific implementation methods do not constitute a limitation on the scope of protection of the present invention. After considering the specification and practicing the technical solutions disclosed in this application, those skilled in the art will easily think of other implementation methods of the present disclosure. This application is intended to cover any modification, use or adaptive changes of the present disclosure, which follow the general principles of the present disclosure and include common knowledge or customary technical means in the technical field that are not disclosed in the present disclosure. The description and examples are regarded as exemplary only, and the true scope and spirit of the present disclosure are indicated by the following claims.

[0064] It should be understood that the present disclosure is not limited to the exact structures that have been described above and shown in the drawings, and that various modifications and changes may be made without departing from the scope thereof. The scope of the present disclosure is limited only by the appended claims.

Claims

1. A fixing device for fixing an invasive medical element, Features: It comprises a main body, and a cavity is provided inside; An extrusion unit is disposed in the cavity, and the medical element is slidably disposed inside the extrusion unit; The locking unit, when switched to the first position, squeezes the squeezing unit to fix the medical element; when switched to the second position, releases the squeezing of the squeezing unit and releases the medical element.

2. The fixing device according to claim 1, It is characterized in that The extrusion unit includes a flexible part and a rigid part; The flexible member, the medical element is slidably disposed inside the flexible member; the rigid member, the rigid member at least partially in contact with the flexible member; The locking unit squeezes the rigid member to evenly apply the load to the flexible member.

3. The fixing device according to claim 2, It is characterized in that The flexible member is elastic; When the rigid part releases the pressure on the flexible part, the flexible part recovers its deformation to release the medical element.

4. The fixing device according to claim 2, It is characterized in that The cavity comprises a first cavity extending axially and a second cavity extending radially, and the first cavity and the second cavity have an intersecting portion; The flexible member is disposed in the first cavity, and the rigid member is disposed in the second cavity; During the process of switching positions of the locking unit, the portion of the rigid member for accommodating the flexible member can move relative to the intersecting portion.

5. The fixing device according to claim 1, It is characterized in that The locking unit comprises a cam, and the cam abuts against the pressing unit.

6. The fixing device according to claim 5, It is characterized in that The cam is provided with a limiting wheel, and the limiting wheel is provided with a first limiting portion; The main body is provided with a second limiting portion; The first limiting portion cooperates with the second limiting portion to limit the rotational travel of the cam.

7. The fixing device according to claim 6, It is characterized in that The limiting wheels include two, which are symmetrically arranged on the end surfaces at both ends of the cam.

8. The fixing device according to claim 6, It is characterized in that One of the first limiting portion and the second limiting portion is a limiting groove, and the other is a limiting protrusion.

9. The fixing device according to claim 5, It is characterized in that The locking unit further comprises a handle, one end of which is connected to the cam, and the other end of which is provided with a first positioning portion; The main body is provided with a second positioning portion; The first positioning portion cooperates with the second positioning portion to locate the position of the handle.

10. The fixing device according to claim 9, It is characterized in that One of the first positioning portion and the second positioning portion is a buckle, and the other is a slot.

11. A ventricular assist device, It is characterized in that include: A fixation device as described in any one of claims 1-10; wherein, the fixation device controls the position of an invasive medical element within the ventricular assist device.

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