Valve clamping system with linkage control

Abstract

The invention provides a valve clamping system. The valve clamping system comprises a first clamping piece, a second clamping piece, a catheter, a first actuating element, a second actuating element and a handle. A first actuation element is engaged to the first clip and extends proximally through the catheter, and a second actuation element is engaged to the second clip and extends proximally through the catheter. The handle includes a handle housing connected to the proximal end of the catheter, first and second actuation controllers connected to the first and second actuation elements, respectively, first and second linkage members coupled to the first and second actuation controllers, respectively, and an unlocking member. The two linkage components are matched with the unlocking component to complete linkage control and independent control of the first actuating controller and the second actuating controller. The valve clamping system can synchronously clamp two valve leaflets of a heart valve, clamping symmetry and clamping depth consistency are guaranteed, and the treatment effect of an operation is also guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a valve clamping system with linkage control. 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. Specifically, the mitral valve includes an anterior leaf and a posterior leaf. Under normal circumstances, when the left ventricle contracts, the edges of the anterior leaf and the posterior leaf are completely opposed to each other to prevent the blood from flowing from the left ventricle to the left atrium. However, when the mitral valve is diseased and the anterior leaf and the posterior leaf of the mitral valve do not oppose well, then when the left ventricle contracts, the mitral valve cannot be completely closed, resulting in blood refluxing from the left ventricle to the left atrium, thereby causing a series of pathophysiological changes, known as "mitral regurgitation".

[0003] The edge-to-edge repair of the mitral valve is an effective means for treating mitral regurgitation. Specifically, the edges of the anterior leaf and the posterior leaf of the mitral valve that cannot oppose normally are fixed by means such as suturing or clamping, so that the valve orifice of the mitral valve forms a double-orifice structure, thereby reducing the total area of the mitral valve orifice and reducing or eliminating the regurgitation volume. The traditional edge-to-edge repair of the mitral valve is performed under direct vision during surgery, usually requiring thoracotomy and establishing extracorporeal blood circulation, so the risk is relatively high.

[0004] With the progress of technology, various minimally invasive surgeries and interventional surgeries have become increasingly common. In such surgeries, the surgeon only needs to make a small operation window on the patient's body, and then use a delivery device to deliver the valve clamp to the diseased mitral valve and remotely control the valve clamp to hold the anterior leaf and the posterior leaf to reduce the regurgitation. In the existing delivery device, when controlling the two proximal components of the valve clamp, two joysticks are respectively connected to the two proximal components to individually control the anterior leaf and the posterior leaf. However, this individual control method not only fails to meet the needs of the surgeon, but also easily causes defects such as asymmetric clamping and inconsistent clamping depth of the anterior leaf and the posterior leaf, and ultimately may lead to the adverse consequence that the surgical effect is affected due to uneven forces on the anterior leaf and the posterior leaf after clamping. Summary of the Invention

[0005] The purpose of the present invention is to provide a valve clamping system that can synchronously clamp two leaflets of a heart valve, not only ensuring the symmetry of the clamping and the consistency of the clamping depth, but also ensuring the therapeutic effect of the surgery.

[0006] To achieve the above purpose, on the one hand, the present invention provides a valve clamping system, and the valve clamping system includes:

[0007] A valve clip applicator, comprising clamping arms and a first clip and a second clip that are movable relative to the clamping arms;

[0008] A catheter;

[0009] A first actuating element and a second actuating element, the first actuating element being removably engaged with the first clip, the first actuating element extending proximally through the catheter and being axially movable within the catheter; the second actuating element being removably engaged with the second clip, the second actuating element extending proximally through the catheter and being axially movable within the catheter; and

[0010] A handle, the handle comprising:

[0011] A handle housing connected to the proximal end of the catheter;

[0012] A first actuation controller and a second actuation controller, the first actuation controller being connected to the proximal end of the first actuating element, the second actuation controller being connected to the proximal end of the second actuating element;

[0013] A first linkage member and a second linkage member, the first linkage member being coupled to the first actuation controller, the second linkage member being coupled to the second actuation controller; and

[0014] An unlocking member connected to the first linkage member, the unlocking member being capable of shifting relative to the second linkage member under the action of an external force to switch between connecting the first actuation controller and the second actuation controller and releasing the connection, thereby controlling the synchronous movement or independent movement of the first actuating element and the second actuating element.

[0015] On the other hand, the present invention also provides a valve clamping system, the valve clamping system comprising:

[0016] A valve clip applicator, comprising clamping arms and a first clip and a second clip that are movable relative to the clamping arms;

[0017] A catheter;

[0018] A first actuating element and a second actuating element, the first actuating element being removably engaged with the first clip, the first actuating element extending proximally through the catheter and being axially movable within the catheter; the second actuating element being removably engaged with the second clip, the second actuating element extending proximally through the catheter and being axially movable within the catheter; and

[0019] A handle, the handle comprising:

[0020] A handle housing connected to the proximal end of the catheter;

[0021] A first actuation controller and a second actuation controller, the first actuation controller being connected to the proximal end of the first actuation element, and the second actuation controller being connected to the proximal end of the second actuation element; and

[0022] A first linkage member and a second linkage member, the first linkage member being coupled to the first actuation controller, and the second linkage member being coupled to the second actuation controller; the first linkage member and the second linkage member are capable of relatively rotating synchronously with respect to the handle housing to jointly control the first actuation controller and the second actuation controller to move synchronously proximally or distally, thereby driving the first actuation element and the second actuation element to move synchronously proximally or distally.

[0023] The valve clamping system provided by the present invention realizes the joint control and independent control of the first actuation controller and the second actuation controller through the cooperation of two linkage members and an unlocking member, so as to jointly control the first clip and the second clip to simultaneously clamp two leaflets of the heart valve. This joint control method of the present invention not only facilitates the operation of the valve clipper by the operator, but also can realize the synchronous and symmetric clamping of two leaflets of the heart valve, so as to ensure that the clamping depths after clamping are basically the same, and the surgical effect is effectively improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required to be used in the embodiments will be briefly introduced below. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0025] Figure 1 Shows a schematic diagram of the valve clamping system in the joint control state in the first embodiment, and the valve clipper is in a state where the first clip and the second clip are closed relative to the forceps arms.

[0026] Figure 2 Shows Figure 1 A schematic diagram of the state where the first clip and the second clip are deployed relative to the forceps arms under joint control in [[ ]].

[0027] Figure 3 Shows Figure 2 A schematic diagram of the structure of the valve clamping system in [[ ]] after closing the upper housing.

[0028] Figure 4 Shows Figure 2 A schematic diagram of the structure of the handle in [[ ]].

[0029] Figure 5 Shows Figure 4Schematic diagram of the structure of the first linkage component or the second linkage component.

[0030] Figure 6 Shown Figure 4 Schematic diagram of the seal design of the middle handle.

[0031] Figure 7 Shown Figure 4 Schematic diagram of the structure of the first control handle.

[0032] Figure 8 A three-dimensional schematic diagram showing a first method of releasing the linkage control in the first embodiment.

[0033] Figure 9 A structural diagram of the second method of releasing the linkage control in the first embodiment is shown.

[0034] Figure 10 Shown Figure 9 Schematic diagram of the structure after removing the upper shell.

[0035] Figure 11 Shown Figure 9 A three-dimensional sectional view of the unlocking member being pulled up to release the linkage control.

[0036] Figure 12 Shown Figure 11 Schematic diagram of the structure of the unlocked component.

[0037] Figure 13 Shown Figure 12 Schematic diagram of the structure of the middle knob.

[0038] Figure 14 Shown Figure 11 Schematic diagram of the structure of the upper and middle shell.

[0039] Figure 15 Shown Figure 12 Schematic diagram of the structure of the connecting rod.

[0040] Figure 16 Shown Figure 11 A three-dimensional cross-sectional view of the connection between the middle unlocking member and the upper shell.

[0041] Figure 17 Shown Figure 16 Side cross-sectional view of .

[0042] Figure 18 Shown Figure 10 Another structural schematic diagram of the first control handle.

[0043] Figure 19 A schematic structural diagram showing the first actuation controller and the second actuation controller being aligned in parallel is shown.

[0044] Figure 20 The structural schematic diagram of the catheter is shown.

[0045] Figure 21 The schematic diagram shows the valve clamping system in the linkage control state in the second embodiment, and the valve clipper is in the state where the first clip and the second clip are closed relative to the clamping arms.

[0046] Figure 22 It shows Figure 21 The schematic diagram of the state where the first clip and the second clip in [] are deployed relative to the clamping arms under the linkage control.

[0047] Figure 23 The structural schematic diagram of the handle in the second embodiment is shown.

[0048] Figure 24 It shows Figure 23 The structural schematic diagrams of the first actuation controller and the second actuation controller in [].

[0049] Figure 25 It shows Figure 23 Another structural schematic diagrams of the first actuation controller and the second actuation controller in [].

[0050] The following specific embodiments will further illustrate the present invention in conjunction with the above-mentioned drawings. Specific Embodiments

[0051] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the 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 of 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 shall fall within the scope of protection of the present invention.

[0052] 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 references to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer illustration 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.

[0053] It should be noted that, in order to more clearly describe the valve clamping system with linkage control provided by the present invention, the defined terms "proximal end" and "distal end" described in the specification of the present invention are both common 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 at the same time perpendicular to the cross-sectional radius); 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 is not limited to the end head, 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 head, the end point, or the end face belongs from the end head, 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 common terms used in the specification of the present invention are only for the purpose of describing specific embodiments and should not be construed as a limitation of the present invention.

[0054] In the first embodiment of the present invention, please refer to Figure 1 and Figure 2 as shown, a valve clamping system 100 with linkage control includes a valve clamp 20, a catheter 30, a first actuating element 40, a second actuating element 50, and a handle 60. Specifically, the valve clamp 20 includes clamp arms 21 and a first clip 22 and a second clip 23 that can move relative to the clamp arms 21. The first actuating element 40 is removably engaged with the first clip 22, the first actuating element 40 extends proximally through the catheter 30, and can axially move relative to the catheter 30. The second actuating element 50 is removably engaged with the second clip 23, the second actuating element 50 extends proximally through the catheter 30, and can axially move relative to the catheter 30. Further, the handle 60 includes a handle housing 61, a first actuating controller 62, a second actuating controller 63, and a linkage member 64. The handle housing 61 is connected to the proximal end of the catheter 30, the first actuating controller 62 is connected to the proximal end of the first actuating element 40, and the second actuating controller 63 is connected to the proximal end of the second actuating element 50. The linkage member 64 is movably coupled between the first actuating controller 62 and the second actuating controller 63, for example, rotatably disposed between the first actuating controller 62 and the second actuating controller 63. Among them, the linkage member 64 can move relative to the handle housing 61 to synchronously move the first actuating controller 62 and the second actuating controller 63 relative to the linkage member 64 in a linkage manner.

[0055] Under the action of an external force, the linkage member 63 can be decoupled from the first actuation controller 62 and / or the second actuation controller 63 to cut off the linkage control between the first actuation controller 62 and the second actuation controller 63 and switch to independent control between them. While the valve clamping system 100 of the present invention realizes the linkage control of the first clip 22 and the second clip 23, it can also realize the independent control of the first clip 22 or the second clip 23, thereby enabling the operator to perform diverse and selectable manipulations on the valve clamp 20 and meeting the diverse needs of the operator.

[0056] It can be understood that the movement of the linkage member 64 relative to the handle housing 61 can be generated by applying an external force to the first actuation controller 62 or the second actuation controller 63, or by directly applying an external force to the linkage member 64. For specific details, reference can be made to the subsequent description.

[0057] For some applications, the first actuation element 40 and the second actuation element 50 are respectively control wires or control lines. One free end of the first actuation element 40 passes through the first clip 22 and then folds back proximally to extend through the catheter 30, and the two free ends of the first actuation element 40 are connected to the first actuation controller 62. One free end of the second actuation element 50 passes through the second clip 23 and then folds back proximally to extend through the catheter 30, and the two free ends of the second actuation element 50 are connected to the second actuation controller 63. Thus, the operator can respectively release one free end of the first actuation element 40 and the second actuation element 50 and pull the other free end to complete the removal and detachment of the first actuation element 40 at the first clip 22 and the removal and detachment of the second actuation element 50 at the second clip 23.

[0058] In some other applications, the valve clipper 20 is located outside the distal end of the catheter 30 and removably engaged with a drive rod. The drive rod can extend through the catheter 30 and is connected to a third actuator control of the handle 60. The proximal third actuator control is manipulated to drive the drive rod relative to the catheter 30, thereby actuating the opening and closing of the distal clamp arms 21 and the disengagement of the valve clipper 20 from the drive rod. Specifically, the clamp arms 21 are a pair of relatively openable and closable clamp arms, including a first clamp arm 211 and a second clamp arm 212 hingedly connected to the first clamp arm 211. The first clip 22 and the second clip 23 are each elastic sheet-like structures. Driven by the first actuator control 62, the first actuator element 40 can move axially relative to the catheter 30 and actuate the first clip 22 relative to the first clamp arm 211 to switch between a position closer to the first clamp arm 211 and a position farther away from the first clamp arm 211, thereby switching the first clip 22 between a clamping state for clamping the heart valve and a deployed state for disengaging the heart valve. The second actuating element 50 can move axially relative to the catheter 30 under the drive of the second actuating controller 63, and actuate the second clamp 23 to move relative to the second clamp arm 212 to switch between close to the second clamp arm 212 and away from the second clamp arm 212, thereby completing the switching of the second clamp 23 between the clamping state of clamping the heart valve and the expanded state of detaching from the heart valve.

[0059] In the first embodiment, the present invention utilizes the movement of the linkage member 64 to synchronously drive the first and second actuation controllers 62 and 63, thereby controlling the first and second clips 22 and 23 to simultaneously clamp both leaflets of the heart valve. This linkage control not only facilitates operator control of the valve clipper 20 but also enables synchronized and symmetrical clamping of the two leaflets of the heart valve, ensuring substantially consistent clamping depths after clipping, effectively improving surgical outcomes.

[0060] In some embodiments, the linkage member 64 is rotatably disposed within the handle housing 61, for example, rotatably disposed within the handle housing 61 and respectively coupled to at least the distal portion of the first actuation controller 62 and at least the distal portion of the second actuation controller 63. Meanwhile, the proximal ends of the first actuation controller 62 and the proximal ends of the second actuation controller 63 extend through the handle housing 61 and are respectively exposed outside the handle housing 61.

[0061] Specifically, see Figure 4, the linkage member 64 includes a first linkage member 641 and a second linkage member 642 that are coupled to each other. The first linkage member 641 is rotationally coupled to the first actuation controller 62, and the second linkage member 642 is rotationally coupled to the second actuation controller 63. For some applications, both the first linkage member 641 and the second linkage member 642 can rotate relative to the handle housing 61. Wherein, the handle housing 61 has a first radial center line Z1 and a second radial center line Z2 that extend radially and are parallel to each other. The first linkage member 641 rotates around the first radial center line Z1, for example, rotates within the handle housing 61, and the second linkage member 642 rotates around the second radial center line Z2, for example, rotates within the handle housing 61.

[0062] It can be understood that, please refer to Figure 3 and Figure 4 As shown, the handle housing 61 has an upper housing 611 and a lower housing 612 that cooperate with each other. The upper housing 611 and the lower housing 612 can be connected to each other to define an internal cavity. Wherein, a first positioning shaft 6121 and a second positioning shaft 6122 that extend upward from bottom are provided at the proximal end of the internal cavity of the lower housing 612 for positioning the first linkage member 641 and the second linkage member 642 respectively. The first positioning shaft 6121 and the second positioning shaft 6122 extend along the radial direction of the handle housing 61 and are arranged in parallel. At this time, the center line of the first positioning shaft 6121 can be set as the first radial center line Z1, and the center line of the second positioning shaft 6122 can be set as the second radial center line Z2.

[0063] In particular, the first linkage member 641 and the second linkage member 642 are meshing gears. As Figure 5 shown, among them, the meshing teeth on the circumference of the gear can be set as a standard tooth profile, such as a straight tooth, or can also be set as a non-standard tooth profile, such as a bevel tooth and a helical tooth. The present invention preferably uses a standard cylindrical straight gear, and all gear parameters are designed according to standard values to ensure good meshing and transmission performance. At the same time, at least the distal part of the first actuation controller 62 and at least the distal part of the second actuation controller 63 are provided with racks. The present invention preferably uses this coupling method of gear and rack to realize the linkage control of the valve clamping system 100, so as to achieve the technical effects of high transmission accuracy and greatly ensuring the synchronism of the linkage control. For example, please refer to Figure 1 and Figure 2 shown, under the drive control of the gear and rack, the first linkage member 641 and the second linkage member 642 will be driven to rotate in opposite directions, while the first actuation controller 62 and the second actuation controller 63 are synchronously driven to move proximally or distally in synchronization.

[0064] To ensure the smoothness of the sliding of the first actuation controller 62 and the second actuation controller 63 at the handle housing 61, in some embodiments, as Figure 6As shown, the first actuation controller 62 includes a first fixed rod 621 and a first control handle 622 slidably sleeved on the first fixed rod 621. The second actuation controller 63 includes a second fixed rod 631 and a second control handle 632 slidably sleeved on the second fixed rod 631. Further, a first seal 623 is provided between the first control handle 622 and the first fixed rod 621, and a second seal 633 is provided between the second control handle 632 and the second fixed rod 631 to ensure the sealing performance of the first actuation controller 62 and the second actuation controller 63. For example, at least one sealing ring can be circumferentially surrounded around the proximal end of the first fixed rod 621 to close the radial gap between the first fixed rod 621 and the first control handle 622, and at least one sealing ring can be circumferentially surrounded around the proximal end of the second fixed rod 631 to seal the radial gap between the second fixed rod 631 and the second control handle 632.

[0065] In some embodiments, after the proximal end of the first actuation element 40 extends through the catheter 30 and the handle housing 61 (including the sealing valve and PI tube etc. located within the handle housing 61), it further extends through the first fixed rod 621 to be connected to the inside of the first control handle 622, thereby ensuring reliable sealing of the handle 60 during the operation. After the proximal end of the second actuation element 50 extends through the catheter 30 and the handle housing 61 (including the sealing valve and PI tube etc. located within the handle housing 61), it further extends through the second fixed rod 631 to be connected to the inside of the second control handle 632, thereby further ensuring reliable sealing of the handle 60 during the operation.

[0066] In view of the fact that the specific structures of the first actuation controller 62 and the second actuation controller 63 are the same, the following takes the specific structure of the first actuation controller 62 as an example for detailed description. Among them, a first proximal rib position is provided in the internal cavity of the upper housing 611, and second proximal rib positions are symmetrically provided in the internal cavity of the lower housing 612, and after being connected to each other, a first chute of the handle housing 61 is formed. The first fixed rod 621 is fixedly arranged at the distal end of the first chute, the distal end of the first control handle 622 is sleeved outside the first fixed rod 621, and the proximal end extends out of the handle housing 61 for an operator to operate. Under the action of an external force, the first control handle 622 can slide in the first chute in a direction away from or close to the first fixed rod 621.

[0067] Please refer to Figure 7As shown, the first control handle 622 includes a first gripping portion 6221 and a first sliding rod 6222 protruding from the distal end of the first gripping portion 6221. The first gripping portion 6221 is always positioned outside the handle housing 61, and at least the distal portion of the first sliding rod 6222 is sleeved outside the first fixing rod 621. By operating the first control handle 622, the first sliding rod 6222 is actuated to slide proximally or distally relative to the first fixing rod 621, so as to switch back and forth between extending out of the handle housing 61 and retracting into the handle housing 61. Specifically, anti-slip patterns are circumferentially provided on the first gripping portion 6221 to facilitate the operator's gripping. The first sliding rod 6222 is generally in a hollow rod-shaped structure, and a first rack 620 having a plurality of engaging teeth is axially arranged and extended along the side end of the first sliding rod 6222 for engaging with the engaging teeth of the first linkage member 641.

[0068] In some embodiments of the present invention, the disconnection of the linkage control is completed by applying the actuating force of the operator to the first actuating controller 62 and / or the second actuating controller 63. As Figure 7 - 8 shown, the first actuating controller 62 can be rotationally actuated relative to the handle housing 61 to disengage from the coupling of the first linkage member 641, such as engagement; and / or, the second actuating controller 63 can be rotationally actuated relative to the handle housing 61 to disengage from the coupling of the second linkage member 641, such as engagement. This simple switching scheme without the need for an additional switching knob not only makes the overall structure of the handle 60 extremely simple, but also is more conducive to convenient operation.

[0069] To ensure the smoothness and stability of the gear and rack when meshing again, only the first actuating controller 62 is rotationally actuated to disengage it from the engagement with the first linkage member 641. However, the first linkage member 641 and the second linkage member 642 are still in an engaged state. Then, when the second actuating controller 63 is pulled proximally alone, the first linkage member 641 can idle under the drive of the second linkage member 642 to maintain the engaged state. And when it is necessary to switch back to the linkage control again, the first linkage member 641 only needs to be engaged with the first actuating controller 62 again, thereby increasing the controllability of the operation.

[0070] Specifically, in order to ensure that the first actuating controller 62 can smoothly rotate out of the engagement with the first linkage member 641, a tooth-shaped feature that penetrates up and down is provided between each engaging tooth of the first rack 620 on the first actuating controller 62. In the linkage control state of the valve clamping system 100, the first rack 620 and the first linkage member 641 are in an engaged state. When the first actuating controller 62 is controlled to rotate counterclockwise by 90 degrees alone, the first actuating controller 62 can disengage from the engagement with the first linkage member 641, so as to switch to the independent control of the first actuating controller 62 and the second actuating controller 63.

[0071] Certainly, in some other embodiments of the present invention, as Figure 9 - 11 shown, the handle 60 further includes an unlocking member 65, and the unlocking member 65 is connected to the first linkage member 641 or the second linkage member 642. The unlocking member 65 can be displaced radially along the handle housing 61 under the action of an external force, such as being displaced radially along the first radial center line Z1 or the second radial center line Z2. At this time, the operator can drive the first linkage member 641 or the second linkage member 642 to synchronously displace radially by pulling or pushing the unlocking member 65, so as to switch between disengaging from and re-engaging with the first actuation controller 62 or the second actuation controller 63, thereby completing the mutual switching between the linkage control state and the independent control state. The following will take the unlocking member 65 being connected to the first linkage member 641 as an example for illustration.

[0072] Please refer to Figure 11 and Figure 12 shown, the unlocking member 65 includes a knob 651, a connecting rod 652, an elastic member 653 and a limiting member 654. One end of the connecting rod 652 extends through the handle housing 61 (specifically, the upper housing 611) to be connected to the knob 651 located outside the handle housing 61, and the other end is rotatably connected to the first linkage member 641 through the limiting member 654. The elastic member 653 is sleeved outside the connecting rod 652 and is compressed between the inner surface of the handle housing 61 (specifically, the inner surface of the upper housing 611) and the connecting rod 652 / the first linkage member 641.

[0073] Specifically, as Figure 13 - 14 shown, the knob 651 includes a cylindrical holding portion 6511 and a limiting boss 6512 protruding from the holding portion 6511. Among them, anti-slip patterns are provided on the circumferential surface of the cylindrical holding portion 6511 to facilitate the operator's holding. Correspondingly, the upper housing 611 is provided with a limiting portion 6110 that cooperates with the knob 651. The limiting portion 6110 is generally cylindrical and protrudes from the outer surface of the upper housing 611. A limiting groove 6111 is recessed downward from the upper surface of the limiting portion 6110, and the limiting boss 6512 can be circumferentially limited within the limiting groove 6111. Pull the knob 651 along the direction of the first radial center line Z1 to disengage from the circumferential limitation of the limiting groove 6111.

[0074] As Figure 15 - 16As shown, the connecting rod 652 is generally in the shape of an elongated rod structure. One end of the connecting rod 652 has a pin hole for fixed connection with the knob 651. A first skirt 6521 and a second skirt 6522 are circumferentially protruded at the other end of the connecting rod 652. Among them, the first skirt 6521 is used to abut against the elastic member 653, and the second skirt 6522 is used to abut against the first linkage member 641. The first skirt 6521 and the second skirt 6522 are spaced apart on the circumferential side wall of the connecting rod 652 away from the knob 651, and the first skirt 6521 is positioned between the second skirt 6522 and the knob 651.

[0075] After the unlocking member 65 is assembled to the first linkage member 641, the end of the connecting rod 652 away from the knob 651 will be connected to the first linkage member 641 to complete coaxial assembly with the first linkage member 641. Specifically, after the connecting rod 652 passes through the central channel of the first linkage member 641, the connecting rod 652 is radially limited to the first linkage member 641 along the first radial center line Z1 by using the second skirt 6522 and the limiting member 654. At this time, the second skirt 6522 and the limiting member 654 will respectively abut against the two radial sides of the first linkage member 641 to prevent radial displacement. That is, under the restriction of the second skirt 6522 and the limiting member 654, the connecting rod 652 and the first linkage member 641 will not have radial displacement relative to each other, but can rotate relative to each other around the first radial center line Z1. It should be noted that the radial direction here refers to the direction along the first radial center line Z1. For some applications, an external thread 6523 is circumferentially provided at the end of the connecting rod 652 away from the knob 651, and the limiting member 654 is designed as a nut with an internal thread. The unlocking member 65 uses the thread fit of the external thread and the internal thread to realize the fixation of the limiting member 654 to the connecting rod 652 at the end of the first linkage member 641.

[0076] At the same time, the other end of the connecting rod 652 extends through the through hole of the upper housing 611 along the first radial center line Z1 to penetrate out of the external through the internal hollow cavity, and is fixedly connected to the knob 651 outside the upper housing sixty-one one by a pin. Among them, the through hole is communicated with the limiting groove 6111. And, the knob 651 will be circumferentially limited to the upper housing 611 by the limiting groove 6111.

[0077] In addition, an elastic member 653 is sleeved outside the connecting rod 652 to achieve coaxial assembly with the connecting rod 652. One end of the elastic member 653 abuts against the side of the first skirt 6521 away from the second skirt 6522, and the other end abuts against the inner surface of the upper housing 611. Among them, the elastic member 653 is always in a pre-compressed state to ensure that the knob 651 is always tightly attached to the limiting portion 6110 under the elastic force of the elastic member 653 to avoid shaking. Of course, in other embodiments, the connecting rod 652 does not include the first skirt 6521, and the elastic member 653 realizes its elastic connection by abutting one end against the second skirt 6522 or the first linkage member 641 and the other end against the inner surface of the upper housing 611.

[0078] To ensure that when the unlocking member 65 is radially pulled, the first linkage member 641 can still maintain meshing with the second linkage member 642 while disengaging from the first actuation controller 62, the dimension of the first linkage member 641 on the first radial center line Z1 can be designed to be smaller than the dimension of the second linkage member 642 on the second radial center line Z2. Specifically, as Figure 17 shown, the dimension (i.e., tooth thickness) of the first linkage member 641 on the first radial center line Z1 is defined as h1, and the dimension (i.e., tooth thickness) of the second linkage member 642 on the second radial center line Z2 is defined as h2. Inevitably, h2 > h1. In addition, the height at which the first linkage member 641 meshes with the first actuation controller 62 is defined as h, and the height of the limiting boss 6512 of the knob 651 is defined as H. To ensure that after the unlocking member 65 is radially pulled, the limiting boss 6512 of the knob 651 can rotate and abut against the upper surface of the limiting portion 6110 to achieve stable positioning. During this stable positioning period, to ensure that the first linkage member 641 completely disengages from the first actuation controller 62 but still maintains complete meshing with the second linkage member 642, inevitably, H > h, h2 > H.

[0079] Then, when it is necessary to switch the valve clamping system 100 from the linkage control state to the individual control state, the knob 651 can be pulled in the direction away from the upper housing 611 along the first radial center line Z1 in the manner as Figure 11 shown. Under this pulling force, the limiting boss 6512 will be disengaged from the restriction of the limiting groove 6111. Moreover, the first linkage member 641 will also be pulled up along the first radial center line Z1 under the drive of the connecting rod 652 to disengage from meshing with the first actuation controller 62, but still maintain meshing with the second linkage member 642. At this time, the first actuation controller 62 and the second actuation controller 63 are disengaged from meshing and enter the independent control state. Finally, by rotating the knob 651, the limiting boss 6512 can be abutted against the upper surface of the limiting portion 6110 to keep the valve clamping system 100 in the individual control state to facilitate subsequent operation by the operator.

[0080] In particular, to avoid jamming during the pushing process due to the tooth-shaped notches of the rack, for some applications, a tooth-shaped feature 6200 with a closed bottom is provided between each meshing tooth of the first rack 620 of the first control handle 622, and a tooth-shaped feature with a closed bottom is also provided between each meshing tooth of the second rack of the second control handle 632, so as to retain the smooth surface of the bottom surfaces of the first sliding rod 6222 and the second sliding rod 6222. Then, during the process of pushing the first actuating controller 62 and the second actuating controller 63, the design of the tooth-shaped feature with a closed bottom ensures the smoothness and smooth operation of the mating surfaces of the first control handle 622 and the second control handle 632 with the handle housing 61, thereby avoiding jamming.

[0081] It can be understood that, for some applications, the first actuating controller 62 and the second actuating controller 63 are angularly aligned, such as being aligned in a V-shape as shown in Figure 4 and located on both sides of the linkage member 64. At this time, the first actuating controller 62 and the second actuating controller 63 will be arranged on opposite sides of the central axis of the handle housing 61. This dispersed arrangement method is not affected by the layout method of the actuating controllers, which not only makes the structural space more flexible, but also does not interfere with each other, and will not cause accidental touch due to confusion. For other applications, the first actuating controller 62 and the second actuating controller 63 are parallelly aligned. Specifically, as shown in Figure 19 the first actuating controller 62 and the second actuating controller 63 will be arranged on the same side of the central axis of the handle housing 61 and arranged side by side in parallel. At this time, in order to avoid the defect of accidental touch and confusion during operation by the operator, one of the first actuating controller 62 and the second actuating controller 63 is provided with a tactile mark or a visual mark for distinguishing the two actuating controllers. Among them, the tactile mark can be, for example, at least one protrusion 66 provided on the first holding portion 6221 or the second holding portion of the second actuating controller 63, or the holding portions of the first actuating controller 62 and the second actuating controller 63 can be set to different shapes. The visual mark can be, for example, setting the first actuating controller 62 and the second actuating controller 63 to different colors, or setting one with scale marks and the other without scale marks.

[0082] In the present invention, in the initial state, the valve clamping system 100 is in a linkage control state. In this state, the first linkage member 641 that can rotate relative to the connecting rod 652 is in an engaged state with the second linkage member 642 and the first actuation controller 62, and the knob 651 is circumferentially limited by the limiting groove 6111 to the upper housing 611, that is, locked to the upper housing 611 to prevent accidental touch. At this time, pulling the first actuation controller 62 or the second actuation controller 63 proximally or pushing them distally can achieve the synchronous actuation of the first actuation element 30 and the second actuation element 40, so as to link and control the synchronous movement of the first clamping piece 22 and the second clamping piece 23 of the valve clamp 20 relative to the clamping arm 21 respectively.

[0083] However, when it is necessary to switch the valve clamping system 100 from the linkage control state to the individual control state, pull and rotate the knob 651 to abut the limiting boss 6512 of the knob 651 against the upper surface of the limiting portion 6110 of the upper housing 611 to keep the valve clamping system 100 in the individual control state. At this time, the first linkage member 641 disengages from the engagement with the first actuation controller 62, but still remains in engagement with the second linkage member 642. The first actuation controller 62 is unlocked by the first linkage member 641 and enters the individual control state, while the second actuation controller 63 still remains in the engaged state with the first linkage member 641 and the second linkage member and enters the individual control state, and the movements of the two do not affect each other. Pulling the first actuation controller 62 and the second actuation controller 63 proximally or pushing them distally can achieve the individual actuation of the first actuation element 30 and the second actuation element 40, so as to achieve the individual control of the first clamping piece 22 and the second clamping piece 23 of the valve clamp 20.

[0084] It should be particularly noted that, in some embodiments, as Figure 20 shown, the catheter 30 is arranged as a multi-lumen catheter to reduce the mutual interference between components. Specifically, the multi-lumen catheter is provided with a plurality of through hollow channels, including a central channel 300 at the central position and at least one peripheral channel 301 circumferentially spaced around the central channel 300. The hollow channel 300 is used for the driving rod connected to the clamping arm 21 of the valve clamp 20 to extend through, and the peripheral channels 301 are respectively used for the first actuation element 30, the second actuation element 40, and other components to extend through. Among them, the cross-sections of the central channel 300 and the peripheral channels 301 can be circular, square, or other irregular shapes, etc., and the arrangement of the peripheral channels 301 can be defined according to requirements. In this embodiment, the central channel 300 and the peripheral channels 301 are preferably circular hollow channels.

[0085] In the second embodiment of the present invention, please refer to Figure 21 - 22As shown in the figure, the present invention provides a valve clamping system 100 with linkage control, including a valve clamp 20, a catheter 30, a first actuating element 40, a second actuating element 50, and a handle 60. Specifically, the valve clamp 20 includes clamping arms 21 and a first clip 22 and a second clip 23 that can move relative to the clamping arms 21. The first actuating element 40 is removably engaged with the first clip 22, extends proximally through the catheter 30, and can axially move relative to the catheter 30. The second actuating element 50 is removably engaged with the second clip 23, extends proximally through the catheter 30, and can axially move relative to the catheter 30.

[0086] Further, the handle 60 includes a handle housing 61, a first actuating controller 62, a second actuating controller 63, and a linkage member 64. The handle housing 61 is connected to the proximal end of the catheter 30 and has a central axis X that is axially aligned with the catheter 30. The first actuating controller 62 is connected to the proximal end of the first actuating element 40, the second actuating controller 63 is connected to the proximal end of the second actuating element 50, and the linkage member 64 connects the first actuating controller 62 and the second actuating controller 63. Among them, the first actuating controller 62 has a first axis X1 that intersects the central axis X, and the second actuating controller 63 has a second axis X2 that intersects the central axis X. The linkage member 64 can link and control the first actuating controller 62 to move relative to the handle housing 61 along the first axis X1, and the second actuating controller 63 to move relative to the handle housing 61 along the second axis X2.

[0087] In some embodiments, the included angle between the central axis X and the first axis X1 / second axis X2 ranges from 0 to 90 degrees, and the preferred angle is 15 degrees.

[0088] In the second embodiment, the present invention configures the first actuating controller 62 and the second actuating controller 63 to be angled so that there is no interference between them. At the same time, the linkage member 64 is used to link and control the first actuating controller 62 and the second actuating controller 63, so as to link and control the first clip 22 and the second clip 23 to simultaneously clamp two leaflets of the heart valve, which not only meets the diverse needs of the operator, but also ensures that the clamping depth after clamping can be basically the same, thereby ensuring the surgical effect.

[0089] To avoid the defect of being prone to confusion and accidental touch when located on the same side of the handle housing 61, in some embodiments, the first axis X1 and the second axis X2 are symmetrically arranged on both sides of the central axis X. Further, to ensure that the first actuating controller 62 and the second actuating controller 63 are left-right symmetric, the extension line of the first axis X1 intersects the extension line of the second axis X2 at point A on the central axis X (see Figure 21 ).

[0090] Specifically, the linkage member 64 includes a first end 640a and a second end 640b. The first end 640a is movably connected to the first actuation controller 62, and the second end 640a is movably connected to the second actuation controller 63. The linkage member 64 is used to control the first actuation controller 62 to move proximally or distally relative to the first end 640a along the first axis X1, and the second actuation controller 63 to move proximally or distally relative to the second end 640a along the second axis X2.

[0091] In some embodiments, as Figure 23 As shown, the linkage member 64 includes a first linkage member 641 and a second linkage member 642 that are meshed with each other. The first linkage member 641 is meshed with at least the distal portion of the first actuation controller 62, and the second linkage member 642 is meshed with at least the distal portion of the second actuation controller 63. To ensure symmetrical meshing, the first linkage member 641 and the second linkage member 642 are meshed on the central axis X. The side of the first linkage member 641 away from the second actuation controller 63 is defined as the first end 640a, and the side of the second linkage member 642 away from the first actuation controller 62 is defined as the second end 640b, for achieving meshing connection. Since the above meshing structure and transmission method are consistent with those of the first embodiment, they are not repeated here.

[0092] Of course, in some embodiments of the present invention, such as Figure 24 As shown, the first actuation controller 62 includes a first fixing rod 621 and a first control handle 622. The first control handle 622 is slidably mounted on the first fixing rod 621 along the first axis X1. The second actuation controller 63 includes a second fixing rod 631 and a second control handle 632. The second control handle 632 is slidably mounted on the second fixing rod 631 along the second axis X2. It will be understood that since the detailed structures of the various components of the valve clipping system 100, as well as the connection relationships and motion relationships between the components, have been described in the first embodiment, they will not be repeated here.

[0093] Of course, in other embodiments of the present invention, such as Figure 25As shown, the first actuation controller 62 only includes the first control handle 622 and does not include the first fixed rod 621. The second actuation controller 63 only includes the second control handle 632 and does not include the second fixed rod 631. Specifically, at the proximal end of the handle housing 61, a first guide groove 610a extending along the first axis X1 and a second guide groove 610b extending along the second axis X2 are formed to respectively allow the distal ends of the first control handle 622 and the second control handle 632 to slide therein. For example, a first proximal rib position can be provided in the inner cavity of the upper housing 611, and a second proximal rib position can be symmetrically provided in the inner cavity of the lower housing 612. After being connected to each other, the first guide groove 610a and the second guide groove 610b of the handle housing 61 are formed. Among them, the first axis X1 can be the central axis of the first guide groove 610a, and the second axis X2 can be the central axis of the second guide groove 610b. The first actuation controller 62 can axially move or rotate along the first axis X1 within the first guide groove 610a, and the second actuation controller 63 can axially move or rotate along the second axis X2 within the second guide groove 610b. It can be understood that since the detailed structures of other components of the valve clamping system 100, the connection relationships and movement relationships between components have been described in the first embodiment, they will not be elaborated here.

[0094] It can be understood that the valve clamping system 100 can be applied to mitral valve repair to use the valve clamp 20 to clamp the anterior leaf and the posterior leaf of the mitral valve, so as to avoid mitral regurgitation. Of course, the valve clamping system 100 can also be applied to tricuspid valve repair to use the valve clamp 20 to clamp any two adjacent leaflets among the anterior leaf, the posterior leaf, and the septal leaf of the tricuspid valve, so as to avoid tricuspid regurgitation.

[0095] The above are the implementation manners of the embodiments of the present invention. It should be noted that for those of ordinary skill in the art, 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 noted that for those of ordinary skill in the art, 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 valve clamping system, characterized in that, Comprising: A valve clip applicator, including forceps arms and a first clip and a second clip that can move relative to the forceps arms; A catheter; A first actuating element and a second actuating element, the first actuating element being removably engaged with the first clip, the first actuating element extending proximally through the catheter and being axially movable within the catheter; The second actuating element is removably engaged with the second clip, the second actuating element extending proximally through the catheter and being axially movable within the catheter; And A handle, the handle including: A handle housing connected to the proximal end of the catheter; A first actuation controller and a second actuation controller, the first actuation controller being connected to the proximal end of the first actuating element, the second actuation controller being connected to the proximal end of the second actuating element; A first linkage member and a second linkage member, the first linkage member being coupled to the first actuation controller, the second linkage member being coupled to the second actuation controller; and An unlocking member connected to the first linkage member, the unlocking member being capable of shifting relative to the second linkage member under the action of an external force to switch between connecting the first actuation controller and the second actuation controller and releasing the connection, thereby controlling the synchronous movement or independent movement of the first actuating element and the second actuating element.

2. The valve clamping system according to claim 1, wherein The unlocking member is capable of driving the first linkage member to shift relative to the second linkage member to drive the first linkage member to switch between being coupled to the first actuation controller and releasing the coupling with the first actuation controller, and the first linkage member and the second linkage member always remain coupled.

3. The valve clamping system according to claim 2, characterized in that, The unlocking member drives the first linkage member to shift to drive the first linkage member to disengage from the coupling of the first actuation controller and continue to remain coupled to the second linkage member.

4. The valve clamping system according to claim 3, wherein The handle housing has a first radial center line and a second radial center line that extend radially and are parallel to each other. The unlocking member can shift along the first radial center line, and the dimension of the first linkage member on the first radial center line is smaller than the dimension of the second linkage member on the second radial center line.

5. The valve clamping system according to any one of claims 1-4, characterized in that, The unlocking member includes a knob, a connecting rod, an elastic member, and a limiting member; one end of the connecting rod extends through the handle housing to connect to the knob located outside the handle housing, and the other end of the connecting rod is rotatably connected to the first linkage member through the limiting member; the elastic member is sleeved outside the connecting rod and is compressed between the inner surface of the handle housing and the connecting rod / the first linkage member.

6. The valve clamping system according to claim 5, wherein The first linkage member has a central channel. The other end of the connecting rod is circumferentially convex with a first skirt and a second skirt. The first skirt is positioned between the second skirt and the knob; one end of the elastic member abuts against the first skirt; the other end of the connecting rod passes through the central channel and is connected to the limiting member, and the second skirt and the limiting member abut against both sides of the first linkage member to rotatably connect the other end of the connecting rod to the first linkage member circumferentially.

7. The valve clamping system according to any one of claims 1-6, characterized in that, The first linkage member and the second linkage member are gears meshing with each other, and at least the distal end portion of the first actuation controller and at least the distal end portion of the second actuation controller are both provided with racks.

8. A valve clamping system, characterized in that, include: A valve clipper comprising a clamp arm and a first clamp and a second clamp movable relative to the clamp arm; catheter; a first actuating element and a second actuating element, the first actuating element being removably coupled to the first clip, the first actuating element extending proximally through the catheter and being axially movable within the catheter; The second actuating element is removably coupled to the second clip, the second actuating element extending proximally through the catheter and being axially movable within the catheter; as well as A handle, comprising: a handle housing connected to the proximal end of the catheter; a first actuation controller and a second actuation controller, the first actuation controller being connected to a proximal end of the first actuation element, and the second actuation controller being connected to a proximal end of the second actuation element; and A first linkage member and a second linkage member, the first linkage member is coupled to the first actuation controller, and the second linkage member is coupled to the second actuation controller; the first linkage member and the second linkage member can rotate synchronously relative to the handle housing to linkage control the first actuation controller and the second actuation controller to move synchronously toward the proximal end or the distal end, thereby driving the first actuation element and the second actuation element to move synchronously toward the proximal end or the distal end.

9. The valve clamping system according to claim 8, wherein The first actuation element and the second actuation element extend in parallel through the conduit and, after being angularly separated at positions adjacent to the first actuation controller and the second actuation controller, each extend angularly through the first actuation controller and the second actuation controller.

10. The valve clamping system according to claim 9, wherein The first actuation element and the second actuation element are each separated by an angle of 15 degrees and extend through the first actuation controller and the second actuation controller.

11. The valve clamping system according to any one of claims 8-10, characterized in that, The first actuation controller includes a first control handle, and the second actuation controller includes a second control handle; the first control handle includes a first grip and a first sliding rod extending from the distal end of the first grip, the first grip is located outside the handle housing, and at least the distal end of the first sliding rod is slidably disposed in the handle housing; the second control handle includes a second grip and a second sliding rod extending from the distal end of the second grip, the second grip is located outside the handle housing, and at least the distal end of the second sliding rod is slidably disposed in the handle housing; the first linkage member is coupled to the first sliding rod, and the second linkage member is coupled to the second sliding rod.

12. The valve clamping system according to claim 11, wherein, The first actuation controller also includes a first fixed rod located in the handle housing, and the second actuation controller also includes a second fixed rod located in the handle housing. The first sliding rod is slidably mounted outside the first fixed rod, and the second sliding rod is slidably mounted outside the second fixed rod.

13. The valve clamping system according to claim 11, wherein A first rack is formed by extending along a side end of the first sliding rod, and a second rack is formed by extending along a side end of the second sliding rod; the first linkage member and the second linkage member are gears that mesh with each other.

14. The valve clamping system according to claim 13, wherein A tooth-shaped feature with a closed bottom is provided between each meshing tooth of the first rack, and a tooth-shaped feature with a closed bottom is provided between each meshing tooth of the second rack; or A tooth-shaped feature with an upper and lower through-hole is provided between each meshing tooth of the first rack, and the first actuation controller can be rotationally actuated relative to the handle housing to force the first rack to disengage from the first linkage member; and / or, a tooth-shaped feature with an upper and lower through-hole is provided between each meshing tooth of the second rack, and the second actuation controller can be rotationally actuated relative to the handle housing to force the second rack to disengage from the second linkage member.

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