Catheter assembly for controlling implant and method of manipulating same

Abstract

The invention provides a catheter assembly and a method of manipulating the same. The catheter assembly includes a handle housing, a catheter, an actuation element, and an actuation controller. The actuation controller includes a moving member, a release member coupled to the proximal end of the actuation element, and a locking device having a first position to lock the moving member and the release member, and a second position to release locking between the moving member and the release member. At the first position, a preset stroke is formed between the moving component and the releasing component; in the second position, one of the moving member and the release member is axially translatable relative to the other within a preset stroke. According to the catheter assembly and the corresponding control method thereof, the stress applied to the actuating element can be automatically released in the operation process, the huge risk that the actuating element is broken is effectively avoided, the operation steps are further simplified, and the effectiveness of an operation is greatly guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a catheter assembly for controlling an implant and a method for operating the same. Background Art

[0002] The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart. A normal and healthy mitral valve can control the blood flow from the left atrium to the left ventricle, while preventing the blood from flowing from the left ventricle to the left atrium. Under normal circumstances, when the left ventricle of the heart contracts, the edges of the two leaflets of the mitral valve are completely aligned, preventing the blood from regurgitating from the left ventricle to the left atrium. However, when the leaflets, chordae tendineae, annulus, etc. of the mitral valve are diseased, the two leaflets of the mitral valve will exhibit a poor alignment phenomenon. At this time, when the left ventricle of the heart contracts, the mitral valve will not be able to close completely, resulting in blood regurgitating from the left ventricle to the left atrium, thereby causing a series of pathological or physiological changes, known as "mitral regurgitation".

[0003] Edge-to-edge repair of the mitral valve is an effective method for treating mitral regurgitation. Specifically, the edges of the two leaflets of the mitral valve that cannot be normally aligned are fixed together by suture or clamping, etc., thereby reducing the leaflet gap, making the mitral valve orifice form a double-orifice structure, reducing the total area of the mitral valve orifice, and reducing or eliminating the regurgitation volume. For example, in the existing valve clip delivery devices, the bilateral jaws of the valve clip are usually controlled to open and close by the forward and backward movement of a control wire. However, considering that the control wire is a slender structure, there is a high risk of the control wire breaking due to overloading during the operation, ultimately leading to the failure of the operation. Summary of the Invention

[0004] The purpose of the present invention is to provide a catheter assembly for controlling an implant and a method for operating the same, which can automatically release the stress applied to the actuating element during the operation, not only effectively avoiding the huge risk of the actuating element breaking, but also further simplifying the operation steps and greatly ensuring the effectiveness of the operation.

[0005] To achieve the above purpose, in a first aspect, the present invention provides a catheter assembly for controlling an implant, the catheter assembly comprising:

[0006] A handle housing;

[0007] A catheter extending distally from the handle housing;

[0008] An actuating element extending through the catheter, the distal end of the actuating element being removably coupled to the implant; and

[0009] An actuating controller coupled to the handle housing, the actuating controller comprising:

[0010] A moving member;

[0011] A release member coupled to the proximal end of the actuating element; and

[0012] A locking device having a first position for locking the moving member and the release member, and a second position for releasing the lock between the moving member and the release member; in the first position, a preset stroke is formed between the moving member and the release member, and in the second position, one of the moving member and the release member can axially translate relative to the other within the preset stroke.

[0013] In a second aspect, the present invention further provides a method for manipulating a catheter assembly, the method comprising:

[0014] Positioning the locking device in the first position to lock the moving member and the release member; wherein, a preset stroke is formed between the moving member and the release member;

[0015] Applying a first acting force to the driver to drive the moving member to axially translate proximally relative to the handle housing, and the moving member transmits the axial pulling force to an implant through the release member and the actuating element coupled to the release member to actuate the implant to close;

[0016] Switching the locking device to the second position to release the lock between the moving member and the release member; wherein, the pulling force generated by the implant is transmitted to the release member through the actuating element, and further actuates the release member to axially translate distally relative to the moving member by a first stroke to release the stress on the actuating element; wherein, the first stroke is less than or equal to the preset stroke; and

[0017] Rotating the release member to generate a torsional force, and the torsional force is transmitted to the implant through the actuating element until the actuating element disengages to release the implant.

[0018] By forming a preset stroke between the moving member and the release member, the catheter assembly provided by the present invention enables the stress applied to the actuating element to be automatically released when the locking device is unlocked, without the need for the operator to manually manipulate the actuating controller again to release the stress on the actuating element, thereby effectively avoiding the risk of the actuating element breaking when operating on the actuating element with relatively large stress subsequently. That is, the catheter assembly and the corresponding manipulation method provided by the present invention not only effectively avoid the huge risk of the actuating element breaking, but also further simplify the operation steps, greatly ensuring the effectiveness of the surgery. Description of the Drawings

[0019] To more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the embodiments. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0020] Figure 1-2 Shows an overall schematic diagram of a catheter assembly in some embodiments.

[0021] Figure 3 Shows a schematic structural diagram of the catheter.

[0022] Figure 4-5 Shows a state diagram of the locking device in the first position and the second position respectively.

[0023] Figure 6 Shows a schematic structural diagram of the implant.

[0024] Figure 7 Shows a schematic structural diagram of the actuating element.

[0025] Figure 8-9 Shows a schematic structural diagram of the first abutting surface and the second abutting surface.

[0026] Figure 10-11 Shows a schematic structural diagram of the annular sink and the annular boss.

[0027] Figure 12 Shows a schematic structural diagram in which the locking member can be radially inserted into the moving member and the releasing member.

[0028] Figure 13 Shows a schematic structural diagram of the moving member.

[0029] Figure 14 Shows a schematic structural diagram of the release tube.

[0030] Figure 15-17 Shows two embodiments of the locking device.

[0031] Figure 18-20 Shows a schematic structural diagram of the driver.

[0032] Figure 21 Shows a method flow chart of the control method of the catheter assembly.

[0033] Figure 22-24 Shows a schematic diagram of the scenario of the catheter assembly in multiple steps of the control method.

[0034] The following specific embodiments will further illustrate the present invention in conjunction with the above drawings. Specific Embodiments

[0035] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0036] In addition, the descriptions of the following embodiments refer to the attached drawings for illustrating specific embodiments in which the present invention can be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions in the attached drawings. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be construed as a limitation to the present invention.

[0037] It should be noted that, in order to more clearly describe the catheter assembly for controlling an implant and its manipulation method provided by the present invention, the defined terms "proximal end" and "distal end" in the description of the present invention are both conventional terms in the field of interventional medicine. Specifically, the "distal end" refers to the end far from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation; the direction of the rotation central axis of an object such as a cylinder or a tube is defined as the axial direction or the longitudinal axis; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius at the same time); the radial direction is the direction along the diameter or the radius. It should be noted that, regardless of the "end" in words such as "proximal end", "distal end", "one end", "the other end", "the first end", "the second end", "the initial end", "the terminal end", "both ends", "the free end", "the upper end", and "the lower end", it not only refers to the end point, the end point or the end face, but also includes the part that extends an axial distance and / or a radial distance on the element to which the end point, the end point or the end face belongs from the end point, the end point or the end face. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The conventional terms used in the description of the present invention are only for the purpose of describing specific embodiments and cannot be construed as a limitation to the present invention.

[0038] Please refer to Figure 1-2, the present invention provides a catheter assembly 800 for controlling an implant 200 to implant the implant 200 into human tissue, such as implanting it into the interior of the human heart through a transcatheter or transapical approach to treat heart diseases. Specifically, the catheter assembly 800 includes a handle housing 30, a catheter 40, an actuating element 50, and an actuation controller 70. The catheter 40 extends distally from the handle housing 30, and the actuation controller 70 is coupled to the handle housing 30, such as being coupled to the proximal end of the handle housing 30. The actuating element 50 has a proximal end and a distal end, and the actuating element 50 can extend through the catheter 40. Moreover, the proximal end of the actuating element 50 is coupled to the actuation controller 70, and the distal end of the actuating element 50 is removably coupled to the implant 200.

[0039] In some embodiments, as Figure 3 shown, the catheter 40 is configured as a multi-lumen catheter to reduce interference between multiple components extending through the catheter 40. Specifically, the multi-lumen catheter 40 is provided with a plurality of axially through hollow channels, including a central channel 400 at the central position and at least one peripheral channel 401 circumferentially spaced around the central channel 400.

[0040] In some embodiments, the actuating element 50 is an elongated shaft, such as an elongated control wire or control rod. The hollow channel 400 is for the elongated actuating element 50 to extend through, and the peripheral channels 401 are for other components to extend through respectively. Among them, the cross-sections of the central channel 400 and the peripheral channels 401 can be circular, square, or other irregular shapes, etc., and the arrangement of the peripheral channels 401 can be defined according to requirements. Preferably, the central channel 400 and the peripheral channels 401 are circular hollow channels.

[0041] Furthermore, as Figure 4-5 shown, the actuation controller 70 includes a moving member 71, a release member 72, and a locking device 73. Among them, the release member 72 is coupled to the proximal end of the actuating element 50, such as being removably coupled or fixedly coupled to the proximal end of the actuating element 50. At the same time, the locking device 73 has a first position (see Figure 4 ) for locking the moving member 71 and the release member 72, and a second position (see Figure 5 ) for unlocking between the moving member 71 and the release member 72. In the first position, as Figure 4 shown, a preset stroke D is formed between the moving member 71 and the release member 72. In the second position, as Figure 5 shown, one of the moving member 71 and the release member 72 can axially translate relative to the other within the preset stroke D. For some applications, the range of the preset stroke D is 1 mm - 10 mm.

[0042] Please continue to refer to Figure 4-5As shown, in some embodiments, the pulling force F1 generated by the implant 200, such as the pulling force F1 generated by the implant 200 clamping the leaflet, can be transmitted to the release member 72 via the actuating element 50. In the Figure 4 first position shown, the pulling force F1 is restricted by the locking device 73 and cannot drive the release member 72 to move, but the release member 72 still has a tendency to move distally. However, when the locking device 73 is switched from the Figure 4 first position shown to the Figure 5 second position shown, the locking device 73 releases the restriction on the release member 72. Thus, in the second position, the pulling force F1 can actuate the release member 72 to axially translate distally relative to the moving member 71 by a first stroke S to release the stress on the actuating element 50 and avoid the risk of the actuating element 50 breaking due to subsequent operations. It can be understood that the first stroke S is less than or equal to the preset stroke D so that the present invention has sufficient preset stroke to ensure that the stress applied to the actuating element 50 can be completely released.

[0043] Specifically, as shown in Figure 6 , the implant 200 includes a valve clip 200a. The valve clip 200a is located outside the distal end of the catheter 40 and is removably coupled to the distal end of the actuating element 50. The actuation controller 70 controls the opening, closing, and release of the valve clip 200a through the actuating element 50. Specifically, please also refer to Figure 6-7 . The distal end of the actuating element 50 is provided with an internal thread 51 to be threadedly connected to the central shaft 210 with an external thread of the valve clip 200a. Among them, the axial movement of the actuating element 50 can drive the central shaft 210 of the valve clip 200a to axially move to control the opening and closing of at least two clamping arms 220 of the valve clip 200a. However, the rotation of the actuating element 50 is specifically a circumferential rotation, which can force its internal thread 51 to be threadedly released from the central shaft 210 of the valve clip 200a, thereby completing the release of the valve clip 200a from the catheter assembly 800 and finally completing the edge-to-edge repair of the leaflet by the valve clip 200a.

[0044] Based on the surgical characteristics of edge-to-edge repair, the valve clip 200a is specifically such that the clamping arms 220 generally need to provide a relatively large clamping force to clamp the leaflets, so as to prevent the implanted valve clip 200a from falling off due to the rhythmic beating of the heart and the leaflets not being tightly clamped. However, after the valve clip 200a is clamped, the operator needs to further rotate the release member 72 to drive the actuating element 50 coupled thereto to rotate, so as to screw the internal thread 51 of the actuating element 50 out of the central axis 210 of the valve clip 200a to complete the release of the valve clip 200a. In view of this, at this time, the actuating element 50 bears a relatively large tensile stress due to the relatively large clamping force of the valve clip 200a on the leaflets, that is, the actuating element 50 is tightly stretched. Then, during the process of the operator rotating the release member 72 to release the valve clip 200a, rotating the actuating element 50 with a relatively large tensile stress is extremely likely to cause the risk of fracture of the actuating element 50, ultimately leading to the failure of the operation, and may further cause great damage to the leaflets in severe cases.

[0045] Therefore, the present invention forms a preset stroke D between the moving member 71 and the release member 72, so that when the locking device 73 is unlocked, the stress applied to the actuating element 50 can be automatically released, and it is no longer necessary for the operator to manually operate the actuation controller 70 again to release the stress on the actuating element 50, so as to effectively avoid the risk of fracture of the actuating element 50 when operating the actuating element 50 with relatively large stress subsequently. Therefore, the catheter assembly 800 provided by the present invention not only effectively avoids the great risk of fracture of the actuating element 50, but also further simplifies the operation steps, greatly ensuring the effectiveness of the operation.

[0046] It should be particularly noted that, in some embodiments, at least a part of the release member 72 axially extends through the moving member 71. The locking device 73 can be radially inserted into the moving member 71 and the release member 72, or removed from at least one of the moving member 71 and the release member 72 to switch between a first position and a second position. In other embodiments, the release member 72 is provided at the proximal end of the moving member 71, and the locking device 73 can be locked or unlocked with the release member 72 and the moving member 71 by means of threads, buckles, etc. Of course, in other embodiments, the locking device 73 may not be an independent component, but mating parts respectively located on the release member 72 and the moving member 71, such as thread mating, buckle mating, and snap-fit mating, etc., which will not be elaborated herein.

[0047] Furthermore, in some embodiments, as Figure 8 shown, the moving member 71 includes a first abutting surface 710, and the release member 72 includes a second abutting surface 720. As in Figure 8At the first position shown, an axial gap with a preset stroke D is formed between the first abutting surface 710 and the second abutting surface 720. For some applications, the first abutting surface 710 is located on the distal side of the second abutting surface 720. After the locking device 73 is switched from the first position to the second position, the release member 72 can axially translate distally relative to the moving member 71 to reduce at least part of the gap, so as to release all the stress on the actuating element 50. It can be understood that when the second abutting surface 720 has not yet abutted against the first abutting surface 710 or just abutted against the first abutting surface 710, all the stress of the actuating element 50 has been completely released.

[0048] Preferably, as Figure 9 shown, at least part of the release member 72 axially extends through the moving member 71. Specifically, the moving member 71 has a first axially through cavity 711, and the release member 72 coaxially extends through the first cavity 711. In order to visualize the preset stroke D so that the operator can visually observe the relative movement between the first abutting surface 710 and the second abutting surface 720, wherein the first abutting surface 710 is provided at the proximal opening of the first cavity 711, and the second abutting surface 720 is continuously exposed outside the proximal end of the moving member 71.

[0049] Of course, in other embodiments, the first abutting surface 710 and the second abutting surface 720 can also be respectively arranged at other positions of the moving member 71 and the corresponding positions on the release member 72, such as positions that are not visible to the operator, etc., as long as a gap for the release member 72 to axially translate distally by the preset stroke D can be formed between the two.

[0050] Further, in some other embodiments, please also refer to Figure 10-11 shown, the release member 72 includes a release tube 721 and a release knob 722. Among them, the release knob 722 is sleeved outside the release tube 721, such as fixedly sleeved outside the proximal end of the release tube 721. In addition, anti-slip patterns are provided on the circumferential direction of the release knob 722 to facilitate the operator to hold. Further, as Figure 11 shown, the moving member 71 is recessed inwardly from its proximal end by the preset stroke D to form an axially extending annular groove 713, and the release knob 722 axially extends from its distal end surface by the preset stroke D to form an annular boss 723 with a reduced outer diameter, so as to form the preset stroke D between the moving member 71 and the release member 72. The outer diameter of the annular boss 723 is adapted to the inner diameter of the annular groove 713, so that after the locking device 73 is switched from the first position to the second position, the annular boss 723 can be driven by the release member 72 to axially translate distally by a first stroke S in the annular groove 713 until at least part of it or even completely accommodated in the annular groove 713.

[0051] Preferably, please continue to refer toFigure 10 , at least a part of the release member 72 axially extends through the moving member 71. The moving member 71 has a first axially through channel 711, and the release member 72 extends coaxially through the first channel 711. At the same time, in order to visualize the preset stroke D, an annular groove 713 is formed at the proximal opening of the first channel 711, and the diameter of the annular groove 713 is larger than the diameter of the first channel 711 to prevent the annular boss 723 from entering the first channel 711.

[0052] Further preferably, please also refer to Figure 12-17 as shown, the locking device 73 can be radially inserted into the moving member 71 and the release member 72. Specifically, as Figure 12-14 shown, the moving member 71 further has a second radially extending channel 712, and the second channel 712 communicates with the first channel 711. At the same time, the release member 72 is specifically a release tube 721 having a third radially extending channel 724, and the third channel 724 can communicate with the second channel 712 of the moving member 71. Among them, the locking device 73 can be radially inserted into the second channel 712 and the third channel 724 in sequence. In some embodiments, the second channel 712 radially penetrates the moving member 71, the third channel 724 radially penetrates the release tube 721, and the outer diameter of the distal end of the locking device 73 can be adapted to the inner diameters of the second channel 712 and the third channel 724 for the locking device 73 to radially pass through.

[0053] It can be understood that the first abutting surface 710 and the second abutting surface 720 are continuously positioned adjacent to the proximal side of the second channel 712 and the third channel 724, please see Figure 9 . Or, the annular groove 713 and the annular boss 723 are continuously positioned adjacent to the proximal side of the second channel 712 and the third channel 724, please see Figure 12 . Thus, when the operator manually manipulates the locking device 73 to switch the locking device 73 from the first position to the second position, the visual line of the operator can instantaneously move to the first stroke S between the release member 72 and the moving member 71, and the humanized effect is better.

[0054] Furthermore, the locking device 73 can be a non-removable pin 73a as Figure 15-16 shown, or a removable pin 73b as Figure 17 shown. Among them, as Figure 15 shown, the base 731 of the non-removable pin 73a is fixedly connected to the outer wall of the moving member 71, and the connecting rod 733 of the non-removable pin 73a can move relative to the base 731 to insert into or remove from the third channel 724 of the release member 72, so as to switch the non-removable pin 73a between the first position and the second position. As Figure 17As shown, the removal pin 73b can be inserted into the second cavity 712 of the moving member 71 and the third cavity 724 of the release member 72 under the manipulation of the operator to lock the two, or removed from the second cavity 712 and the third cavity 724 to release the lock between the two. Among them, the removal pin 73b can be frictionally engaged into the second cavity 712 and the third cavity 724 to ensure that the mutual lock can be maintained at all times without applying force.

[0055] In the embodiment as Figure 15-16 shown, the non-removable pin 73a is a component structure composed of multiple elements. Specifically, the non-removable pin 73a includes a base 731, a lifting knob 732, a connecting rod 733, and an elastic member 734. Among them, the base 731 is arranged around the second cavity 712 of the moving member 71 to be fixedly coupled to the moving member 71, for example, threadedly connected to the internal thread in the second cavity 712 through an external thread and fixed by gluing. One end of the connecting rod 733 extends through the base 731 to connect to the lifting knob 732 located on the base 731; the other end of the connecting rod 733 extends through the second cavity 712 of the moving member 71 and enters the third cavity 724 of the release member 72. At this time, the outer diameter of the end of the other end of the connecting rod 733 is adapted to the inner diameter of the third cavity 724, so that the end of the other end of the connecting rod 733 can be frictionally engaged into the third cavity 724. Preferably, the cross-section of the third cavity 724 is circular. In addition, the elastic member 734 is sleeved outside the connecting rod 733 and compressed between the base 731 and the connecting rod 733. Among them, the elastic member 734 is always in a compressed state to ensure that the lifting knob 732 is always tightly attached to the base 731 under the elastic force of the elastic member 734 to avoid shaking.

[0056] Specifically, the lifting knob 732 includes a cylindrical holding portion 7321 and a limiting boss 7322 protruding from the holding portion 7321. Among them, anti-slip patterns are provided on the circumferential surface of the cylindrical holding portion 7321 to facilitate the operator's holding. Correspondingly, a limiting groove 7311 is formed by recessing a part of the upper surface of the base 731 downward, and the limiting boss 7322 can be circumferentially limited in the limiting groove 7311. When the lifting knob 732 is lifted upward, the limiting boss 7322 can be disengaged from the circumferential limit of the limiting groove 7311. At the same time, the movement of the lifting knob 732 can further drive the connecting rod 733 to compress the elastic member 734 upward and make the end of the other end of the connecting rod 733 disengage from the third cavity 724 of the release member 72, thereby releasing the lock on the release member 72. After the lock is released, by rotating the lifting knob 732, the limiting boss 7322 is made to abut against the upper surface of other parts of the base 731, such as the upper surface 7312, so as to maintain the state of the lock being released, which is convenient for the operator to operate the release valve clip 200a subsequently.

[0057] Of course, in some embodiments, refer to Figure 18-20 , the actuation controller 70 further includes a driver 74, and the moving member 71 is axially translated relative to the handle housing 30 by the driver 74. Wherein, the driver 74 includes a driving wheel 741 and an internally threaded member 742 which are sleeved with each other. By circumferentially rotating the driving wheel 741 relative to the handle housing 30, the moving member 71 threadedly connected to the internally threaded member 742 can be axially translated.

[0058] To avoid the risk of over-driving the driver 74 and causing the distal valve clip 200a to over-clamp the leaflets, further, the driver 74 further includes a constant-force gear 743 disposed between the driving wheel 741 and the internally threaded member 742. Wherein, the internally threaded member 742 is rotatably connected to the handle housing 30 and is in threaded engagement with the moving member 71. A constant-force gear 743 is fixedly sleeved outside the internally threaded member 742, and the driving wheel 741 is sleeved outside the constant-force gear 743 and is in ratchet-pawl cooperation with the constant-force gear 743. In some embodiments, the circumferential internal thread 7420 of the internally threaded member 742 is threadedly connected to the circumferential external thread 714 of the moving member 71 (see Figure 13 and 19 ), while, the moving member 71 can only be axially translated relative to the handle housing 30 under the circumferential restriction between the limiting portion 715 (see Figure 13 ) of the moving member 71 and the limiting portion (not shown in the figure) of the handle housing 30.

[0059] Preferably, the constant-force gear 743 is provided with a one-way tooth-shaped feature 7430. Correspondingly, a one-way limiting feature 7410 is provided on the inner wall of the driving wheel 741, and the one-way tooth-shaped feature 7430 and the one-way limiting feature 7410 form a ratchet-pawl cooperation. Then, when the driving wheel 741 rotates circumferentially in the positive direction relative to the handle housing 30 and the driving force of the driving wheel 741 on the constant-force gear 743 is less than a preset force value, the driving wheel 741 drives the constant-force gear 743 and the internally threaded member 742 to rotate circumferentially in the positive direction synchronously, and further drives the moving member 71 to axially translate proximally relative to the handle housing 30 until the valve clip 200a clamps the leaflets. At this time, if the driving wheel 741 continues to rotate circumferentially in the positive direction, the driving force of the driving wheel 741 on the constant-force gear 743 will be greater than or equal to the preset force value, and the driving wheel 741 will only be able to rotate independently relative to the constant-force gear 743, that is, rotate independently and slip, thereby preventing the valve clip 200a from over-clamping the leaflets and damaging the leaflets, and at the same time, avoiding the risk of the actuating element 50 breaking or being damaged due to excessive tension. Of course, when the driving wheel 741 rotates circumferentially in the opposite direction, the driving wheel 741 drives the constant-force gear 743 and the internally threaded member 742 to rotate circumferentially in the reverse direction synchronously, and further drives the moving member 71 to axially translate distally relative to the handle housing 30 so that the valve clip 200a opens to release the leaflets.

[0060] Please refer to simultaneouslyFigure 21-24 As shown, the present invention also provides a method for manipulating a catheter assembly 800. The following describes in detail the method for manipulating the catheter assembly 800 by taking the implant 200 as a valve clip 200a to clamp the valve leaflet and release the valve clip 200a. Figure 21 As shown, the control method includes the following steps:

[0061] First, if Figure 22 , the locking device 73 is positioned at the first position to lock the moving member 71 and the releasing member 72; wherein a preset stroke D is formed between the moving member 71 and the releasing member 72. Preferably, in the initial state, the locking device 73 is at the first position to lock the moving member 71 and the releasing member 72.

[0062] Then, when the implant 200 is specifically the valve clip 200a, Figure 22 After the leaflet is captured, a first force is applied to the driver 74, specifically, the driving wheel 741 is rotated in the forward direction to drive the moving member 71 to translate axially toward the proximal end relative to the handle housing 30 until it moves to the position shown in FIG. Figure 23 As a result, the moving member 71 can transmit the axial pulling force to the implant 200, specifically to at least two sides of the clamp arms 220 of the valve clip 200a, via the release member 72 and the actuating element 50 coupled to the release member 72, so as to actuate the implant 200, specifically at least two sides of the clamp arms 220 of the valve clip 200a to close. At this time, if the driving wheel 741 continues to rotate forward, the driving wheel 741 will slip in place, and can no longer continue to apply pulling force to the actuating element 50 through the fixed force gear 743 and the internal threaded member 742.

[0063] Of course, in other embodiments, the first force includes at least one of torsional force, axial tension, rotational force, and spiral propulsion force, and is not limited to torsional force of forward and reverse rotation.

[0064] Then, if Figure 24 As shown, the locking device 73 is switched to the second position to release the lock between the moving member 71 and the release member 72. The traction force generated by the implant 200, specifically the valve clip 200a, can be transmitted to the release member 72 via the actuating element 50, thereby actuating the release member 72 to translate the first stroke S toward the distal end relative to the moving member 71 to release the stress on the actuating element 50. The first stroke S is less than or equal to the preset stroke D.

[0065] Specifically, the step of axially translating the actuation release member 72 relative to the moving member 71 by a first stroke S towards the distal end may include: axially translating the actuation release member 72 relative to the moving member 71 by the first stroke S towards the distal end, thereby forcing at least a part of the annular boss 723 of the release member 72 to be received in the annular sink 713 of the moving member 71 to reduce at least a part of the preset stroke D; or axially translating the actuation release member 72 relative to the moving member 71 by the first stroke S towards the distal end, thereby forcing the second abutting surface 720 of the release member 72 to move towards the first abutting surface 710 of the moving member 71 to reduce at least a part of the preset stroke D. Preferably, the first stroke S is equal to the preset stroke D so that when the second abutting surface 720 just abuts against the first abutting surface 710, or the annular boss 723 is just completely received in the annular sink 713, the stress on the actuating element 50 can be completely released.

[0066] In some embodiments, the manipulation method further includes: inserting the locking device 73 into the second channel 712 of the moving member 71 and the third channel 724 of the release member 72 to position the locking device 73 at the first position; and pulling up the locking device 73 to remove the locking device 73 from at least one of the second channel 712 and the third channel 724 to switch the locking device 73 to the second position.

[0067] Finally, rotate the release member 72 to generate a torsional force, which can be transmitted to the implant 200, specifically the valve clip 200a, via the actuating element 50 until the actuating element 50 disengages to release the implant 200, specifically the valve clip 200a. Specifically, circumferentially rotate the release knob 722 of the release member 72 to control the threaded removal of the actuating element 50 from the valve clip 200a until the two are completely disengaged.

[0068] The manipulation method of the catheter assembly 800 provided by the present invention can ensure that after the locking device 73 is released, the stress applied to the actuating element 50 is automatically released, and it is no longer necessary for the operator to manually manipulate the actuation controller 70 again to release the stress on the actuating element 50, thereby effectively avoiding the risk of breakage of the actuating element 50 when operating on the actuating element 50 with a large stress subsequently. That is, the manipulation method provided by the present invention not only effectively avoids the huge risk of breakage of the actuating element 50, but also further simplifies the operation steps, greatly ensuring the effectiveness of the surgery.

[0069] It can be understood that in order to accelerate the disengagement of the actuating element 50 from the implant 200, in some embodiments, see Figure 15 and Figure 17As shown, the actuation controller 70 further includes a buffer member 75. The release member 72 can drive the actuating element 50 to accelerate away from the coupling with the implant 200 under the elastic restoring force of the buffer member 75. Therefore, the further manipulation method further includes: the release member 72 can drive the actuating element 50 to accelerate away from the coupling with the implant 200 under the elastic restoring force of the buffer member 75.

[0070] It should be specifically noted that, in order to ensure that after the implant 200, specifically the valve clip 200a, is clamped, the defect of accidental opening and closing of the valve clip 200a is avoided. In a further embodiment, the catheter assembly 800 further includes a lock and an elongate locking element (not shown in the figure). Among them, the lock is coupled to the handle housing 30, and the elongate locking element is used to connect the implant 200 at the distal end and the lock at the proximal end. Specifically, after the implant 200, specifically the valve clip 200a, is actuated to complete closing, the further manipulation method further includes: applying a second acting force to the lock and transmitting it to the implant 200 through the elongate locking element, specifically to the locking mechanism 230 of the valve clip 200a (see Figure 6 ), so as to lock the implant 200, specifically the valve clip 200a, to avoid accidental opening and closing. At this time, the implant 200, specifically the valve clip 200a, has been locked, thus avoiding the subsequent manipulation of the actuation controller 70 from affecting the opening and closing of the implant 200, specifically the valve clip 200a. Preferably, the second acting force is the release of the axial pulling force.

[0071] It can be understood that the catheter assembly 800 can be applied to mitral valve repair to use the valve clip 200a to clamp the anterior leaf and posterior leaf of the mitral valve to avoid mitral regurgitation. Of course, it can also be applied to tricuspid valve repair to use the valve clip 200a to clamp any two adjacent leaflets among the anterior leaf, posterior leaf, and septal leaf of the tricuspid valve to avoid tricuspid regurgitation. Further, the catheter assembly 800 can be more applied to other minimally invasive cardiac interventional therapies or non-cardiac minimally invasive interventional therapies other than valve clips to achieve applications in similar scenarios, which will not be elaborated here.

[0072] The above are the implementation manners of the embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art in the technical field, without departing from the principle of the embodiments of the present invention, several improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present invention. The above are the implementation manners of the embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art in the technical field, without departing from the principle of the embodiments of the present invention, several improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present invention.

Claims

1. A catheter assembly for controlling an implant, characterized in that: include: Handle housing; a catheter extending distally from the handle housing; an actuation element extending through the catheter, a distal end of the actuation element being removably coupled to the implant; as well as an actuation controller coupled to the handle housing, the actuation controller comprising: Mobile components; a release member coupled to a proximal end of the actuation element; and A locking device, wherein the locking device has a first position for locking the movable member and the release member, and a second position for releasing the lock between the movable member and the release member; in the first position, a preset stroke is formed between the movable member and the release member, and in the second position, one of the movable member and the release member can be axially translated relative to the other within the preset stroke.

2. The catheter assembly according to claim 1, characterized in that The preset stroke ranges from 1 mm to 10 mm.

3. The catheter assembly according to any one of claims 1 to 2, characterized in that: The traction force generated by the implant is transmitted to the release member via the actuating element; In the second position, the pulling force can actuate the release member to translate axially toward the distal end by a first stroke relative to the moving member to release the stress on the actuating element; wherein the first stroke is less than or equal to the preset stroke.

4. The catheter assembly according to any one of claims 1 to 3, characterized in that: The moving member includes a first abutting surface, and the releasing member includes a second abutting surface; in the first position, the first abutting surface and the second abutting surface are axially spaced to form a gap having the preset stroke.

5. The catheter assembly according to claim 4, characterized in that The first abutting surface is located at the distal side of the second abutting surface. In the second position, the releasing member can be axially translated toward the distal end relative to the moving member to reduce at least part of the gap.

6. The catheter assembly according to claim 5, characterized in that The movable member has an axially penetrating first cavity, the release member coaxially extends through the first cavity, the first abutting surface is disposed at the proximal opening of the first cavity, and the second abutting surface is continuously exposed outside the proximal end of the movable member.

7. The catheter assembly according to any one of claims 1 to 3, characterized in that: The release member includes a release tube and a release knob, and the release knob is sleeved on the outside of the release tube; the movable member is recessed inward from its proximal end by the preset stroke to form an axially extending annular groove, and the release knob is axially extended from its distal end surface by the preset stroke to form an annular boss with a reduced outer diameter, and the outer diameter of the annular boss is adapted to the inner diameter of the annular groove.

8. The catheter assembly according to claim 7, characterized in that The movable member has an axially penetrating first cavity, and the release tube coaxially extends and penetrates the first cavity; the annular groove is formed at the proximal opening of the first cavity, and the diameter of the annular groove is greater than the diameter of the first cavity.

9. The catheter assembly according to claim 6 or 8, characterized in that: The movable member also has a second cavity extending radially, the second cavity is communicated with the first cavity, the release member / the release tube has a third cavity extending radially, the third cavity can be communicated with the second cavity, and the locking device can be radially inserted into the second cavity and the third cavity; wherein, the first abutting surface / the annular groove and the second abutting surface / the annular boss are continuously positioned adjacent to the proximal side of the second cavity and the third cavity.

10. The catheter assembly according to claim 9, characterized in that The locking device is a removal pin or a non-removable pin; the base of the non-removable pin is fixedly connected to the outer wall of the movable member, and the connecting rod of the non-removable pin can move relative to the base to be inserted into the third cavity or removed from the third cavity; the removal pin can move between frictionally engaging into the second cavity and the third cavity, and being removed from the second cavity and the third cavity.

11. The catheter assembly according to any one of claims 1 to 10, characterized in that: The actuation controller further comprises a driver, which comprises a driving wheel and an internal threaded member which are sleeved with each other. The driving wheel is actuated to rotate circumferentially relative to the handle housing, so as to drive the movable member threadedly connected to the internal threaded member to translate axially.

12. A method for controlling a catheter assembly, characterized in that: The method comprises: Positioning the locking device in a first position to lock the moving member and the releasing member; wherein a preset stroke is formed between the moving member and the releasing member; Applying a first force to the driver to drive the moving member to translate axially toward the proximal end relative to the handle housing, and the moving member transmits the axial pulling force to an implant via the release member and an actuating element coupled to the release member to actuate the implant to close; Switching the locking device to a second position to release the lock between the moving member and the releasing member; wherein the pulling force generated by the implant is transmitted to the releasing member via the actuating element, thereby actuating the releasing member to translate axially toward the distal end by a first stroke relative to the moving member to release the stress on the actuating element; wherein the first stroke is less than or equal to the preset stroke; and The release member is rotated to generate a torsional force which is transmitted to the implant via the actuation element until the actuation element disengages to release the implant.

13. The control method according to claim 12, characterized in that: The step of actuating the release member to move axially to the distal end relative to the moving member for a first stroke comprises: Actuating the release member to translate axially toward the distal end by a first stroke relative to the movable member, thereby forcing the annular boss of the release member to be at least partially accommodated in the annular recess of the movable member, so as to reduce at least part of the preset stroke; or The release member is actuated to move axially distally relative to the movable member by a first stroke, thereby forcing the second abutting surface of the release member to move toward the first abutting surface of the movable member, so as to reduce at least part of the preset stroke.

14. The control method according to claim 13, characterized in that: The method further includes: when the annular boss is completely accommodated in the annular recess, or the second abutting surface abuts against the first abutting surface, the stress on the actuating element has been completely released.

15. The control method according to any one of claims 12 to 14, characterized in that: After actuating the implant to close, the method further includes applying a second force to the locker and transmitting it to the locking mechanism of the implant via the elongated locking element to lock the implant.

16. The control method according to any one of claims 12 to 14, characterized in that: The method further includes: the release member drives the actuating element to accelerate the separation from the coupling with the implant under the elastic restoring force of the buffer member.

17. The control method according to any one of claims 12 to 14, characterized in that: The method comprises: inserting the locking device into the second lumen of the moving member and the third lumen of the releasing member to position the locking device in the first position; and The locking device is lifted to remove the locking device from at least one of the second cavity and the third cavity, so as to switch the locking device to the second position.

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