Drawings
The present specification will be further described by way of exemplary embodiments, which will be described in detail by way of the accompanying drawings. The embodiments are not limiting, in which like numerals represent like structures, wherein:
FIG. 1 is a schematic illustration of a delivery tube of a tissue gripping device according to some embodiments of the present application;
FIG. 2 is an exploded view of a delivery tube of a tissue gripping device in accordance with some embodiments of the present application;
FIG. 3 is an enlarged view of a portion of the connection of the stop shown in FIG. 2 with a spring tube, according to some embodiments of the present application;
FIG. 4 is a schematic view of a first tubular body according to some embodiments of the present application;
FIG. 5 is a schematic view of a first tubular body from another perspective, according to some embodiments of the present application;
FIG. 6 is a schematic illustration of a second tubular body according to some embodiments of the present application;
FIG. 7 is a schematic illustration of a valve repair device according to some embodiments of the application;
FIG. 8 is a schematic illustration of a delivery connector and tissue clamping device according to some embodiments of the present application;
FIG. 9 is a schematic illustration of a transport connector according to some embodiments of the application;
FIG. 10 is a schematic view of an open configuration of an outer clamp arm of a tissue clamping device, in accordance with some embodiments of the present application;
FIG. 11 is a schematic illustration of an exploded construction of a delivery tube control mechanism according to some embodiments of the present application;
FIG. 12 is a schematic view of a partial cross-sectional configuration of an outer arm control mechanism according to some embodiments of the application;
FIG. 13 is a schematic illustration of a sleeve according to some embodiments of the application;
Figure 14 is a schematic view of an exploded construction of a slider and protective sleeve according to some embodiments of the present application;
FIG. 15 is a schematic view of a partial cross-sectional configuration of an inner arm control mechanism according to some embodiments of the application;
FIG. 16 is a schematic view of a housing shown according to some embodiments of the application;
fig. 17 is a schematic diagram of a structure of a second control section according to some embodiments of the present application;
FIG. 18 is a schematic view of a second control and locking mechanism in a first view according to some embodiments of the application, and
Fig. 19 is a schematic view of a second control and locking mechanism in a second view according to some embodiments of the present application.
1000-Valve repair device; 100-delivery tube, 110-outer tube, 111-first tube body, 1110-notch, 1111-first fixation, 1112-second fixation, 112-second tube body, 120-inner core, 121-groove, 122-through hole, 130-traction mechanism, 131-traction wire, 132-spring tube, 133-blocking member, 140-delivery connector, 142-main body, 144-first connecting piece, 146-second connecting piece, 148-fixation strut, 150-connecting piece, 200-tissue clamping device, 210-inner clamping arm, 211-first inner clamping arm, 213-second inner clamping arm, 215-barb, 220-outer clamping arm, 221-first outer clamping arm, 223-second outer clamping arm, 230-first fixation, 240-support, 250-second fixation, 260-outer clamping plate, 261-first outer clamping plate, 263-second outer clamping plate, 300-control handle, 400-outer clamping arm control mechanism, 410-sleeve, 412-first sliding chute, 420-first control groove 421-connection groove, 421-second inner clamping arm, 215-outer clamping arm, 215-support, 220-outer clamping arm, 221-first outer clamping arm, 223-second outer clamping arm, 230-first outer clamping arm, 240-support, 250-second outer clamping arm, 260-outer clamping plate, 261-first outer clamping plate, 263-outer clamping arm, 400-outer clamping arm control mechanism, 410-sleeve, 420-first sliding chute, 420-first control groove 421-first control arm, 421-connecting groove 421-connecting rod, 460-35, locking arm, 35-inner clamping arm, 35-35, 35-locking mechanism, 35-outer clamping arm, 35-35, 35-outer clamping arm, 35, locking mechanism, 35-outer clamping arm, and 35-outer clamping mechanism Part 630-traction part, 635-thread traction block and 640-bending indicating device.
Detailed Description
The present application will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present application more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the application.
On the contrary, the application is intended to cover any alternatives, modifications, equivalents, and variations as may be included within the spirit and scope of the application as defined by the appended claims. Further, in the following detailed description of the present application, certain specific details are set forth in order to provide a better understanding of the present application. The present application will be fully understood by those skilled in the art without the details described herein.
Embodiments of the present application relate to a delivery tube for a tissue gripping device and valve repair apparatus. Valve repair devices may be used to repair heart valves (e.g., mitral valve, tricuspid valve, etc.) or other valves. The valve repair device includes a tissue gripping means. The tissue gripping device may be used to grip a valve to effect repair of the valve. The delivery tube may be used to secure and deliver a tissue gripping device. In some embodiments, the tissue gripping device may reach a predetermined location through a particular path. For example, the tissue gripping device may be delivered to the mitral valve via the femoral vein, inferior vena cava, right atrium, and left atrium to repair the mitral valve.
In some embodiments, the delivery tube of the tissue gripping devices disclosed herein may also find application in other types of interventional medical devices. For example, the delivery tube may also be applied to cardiac interventional devices, nervous system interventional devices, vascular interventional devices, artificial insemination devices, and the like. The interventional medical device including the delivery tube may be applied to valve repair surgery, heart stent surgery, puncture surgery, drug infusion surgery, vascular embolization surgery, artificial insemination surgery, and the like. In alternative embodiments, the delivery tube may be used in other medical devices or in other technical fields (e.g., instrumentation), etc.
Fig. 1 is a schematic structural view of a delivery tube of a tissue clamping device according to some embodiments of the present application, fig. 2 is an exploded schematic view of a delivery tube of a tissue clamping device according to some embodiments of the present application, fig. 3 is a partially enlarged view of a junction of a blocking member and a spring tube shown in fig. 2 according to some embodiments of the present application, fig. 4 is a schematic structural view of a first tube body according to some embodiments of the present application, fig. 5 is a schematic structural view of a first tube body according to another view angle shown in some embodiments of the present application, and fig. 6 is a schematic structural view of a second tube body according to some embodiments of the present application. The delivery tube of the tissue gripping device according to embodiments of the present application will be described in detail below with reference to FIGS. 1-6. It is noted that the following examples are only for explaining the present application and are not to be construed as limiting the present application.
As shown in fig. 1-6, the delivery tube 100 may include an outer tube 110, an inner core 120, and a traction mechanism 130. Wherein the outer tube 110 is sleeved outside the inner core 120. In some embodiments, the delivery tube 100 may also include a delivery connector 140. Delivery tube 100 may be removably coupled to the tissue gripping device by delivery connector 140. In some embodiments, the outer tube 110 may include a first tube 111 and a second tube 112. One end of the first tube 111 is connected to the tissue clamping device, and the other end of the first tube 111 is connected to the second tube 112. Specifically, the first tube 111 may be located at a front end of the delivery tube 100 (i.e., an end proximal to the tissue clamping device), and the second tube 112 may be located at a rear end of the delivery tube 100 (i.e., an end distal to the tissue clamping device), with the first tube 111 being connected end-to-end with the second tube 112. In some embodiments, as shown in fig. 2-3, the other end of the first tube 111 may be connected to the second tube 112 by a connector 150. In some alternative embodiments, the other end of the first tube 111 may also be directly connected to the second tube 112. In some embodiments, both ends of the first tube 111 may be provided with a first fixing portion 1111 and a second fixing portion 1112, respectively. The first fixing portion 1111 and the second fixing portion 1112 may be integrally formed with the first pipe body 111. The first pipe 111 and the conveying connector 140 may be connected (e.g. clamped) by the first fixing portion 1111, and the first pipe 111 may be connected (e.g. clamped) by the second fixing portion 1112 and the connector 150. In some embodiments, an end of the second tube 112 remote from the first tube 111 may be connected to a control handle. In some embodiments, one or more through holes 122 may be provided inside the inner core 120 for passage of control wires and/or control rods of the tissue clamping device. In some embodiments, the inner core 120 may be made of an elastic material (e.g., nylon, silicone, heat-shrinkable polyether block polyamide (Pebax), polytetrafluoroethylene (PTFE) material) to provide the inner core 120 with a certain elasticity so that the outer tube 110 can bend to bring the inner core 120 to bend.
In some embodiments, the traction mechanism 130 may be used to control the bending of the first tube 111. In some embodiments, the traction mechanism 130 may include a traction wire 131, with one end of the traction wire 131 being fixedly coupled to one end (e.g., a front end) of the first tube 111. For example, one end of the traction wire 131 may be fixedly connected to the first fixing portion 1111 of the first tube 111 or other portions by welding, gluing, clamping, or the like. In some alternative embodiments, one end of the pulling wire 131 may also be fixedly attached to the core 120. The other end of the pulling wire 131 may be connected to a delivery tube control mechanism that may control the bending of the first tube body 111 by pulling or releasing the pulling wire 131. In some embodiments, one side of the core 120 is provided with a groove 121 along its length, and the pulling wire 131 is disposed in the groove 121. The grooves 121 can limit the position of the traction wire 131, preventing the traction wire 131 from being inclined or wound between the outer tube 110 and the inner core 120, thereby ensuring precise control of the bending direction and the bending degree of the traction wire 131 to the first tube body 111. In some embodiments, the traction mechanism 130 may further include a spring tube 132, where the spring tube 132 is sleeved on a portion of the traction wire 131 corresponding to the second tube 112. When the delivery pipe control mechanism pulls the tightening traction wire 131, the traction wire 131 drives the first pipe body 111 to bend. Because the part of the traction wire 131 corresponding to the second pipe body 112 is sleeved with the spring pipe 132, the spring pipe 132 generates stress for preventing the second pipe body 112 from bending, so that the influence of the traction wire 131 on the second pipe body 112 can be reduced, and the traction wire 131 is mainly used for controlling the bending of the first pipe body 111. In some embodiments, spring tubes 132 of different spring rates may be provided, depending on the different bending requirements of the first tube 111 and the second tube 112. In some embodiments, the traction wire may comprise a steel wire rope, a nano wire, a glass rope, or the like, as the application is not limited in this regard.
In some embodiments, one end of the spring tube 132 may be directly attached to the outer tube 110 (the second tube 112 or the connection between the first tube 111 and the second tube 112) or the inner core 120, and the attachment between the outer tube 110 or the inner core 120 and the spring tube 132 may serve as a limiting stop for the spring tube 132. In some embodiments, the traction mechanism 130 may further include a blocking member 133, where the blocking member 133 is sleeved on the traction wire 131 and fixedly disposed at the connection between the first tube 111 and the second tube 112, so as to form a blocking for the spring tube 132. In some embodiments, the blocking member 133 may be a cylindrical structure having a through hole (not shown in fig. 3) provided along a length direction thereof, through which the pulling wire 131 may pass and be movable in the through hole of the blocking member 133. One end of the spring tube 132 is abutted or fixedly connected with the blocking member 133, and the diameter of the spring tube 132 is larger than the through hole of the blocking member 133, so that the spring tube 132 cannot move relative to the blocking member 133. In some embodiments, the stop 133 may also function to limit the pulling wire 131 to prevent the pulling wire 131 from shifting relative to the groove 121. It should be noted that the stopper 133 is not limited to the cylindrical structure shown in fig. 2 and 3, as long as other structures that function to block the movement of the spring tube 132 in the length direction of the inner core can be regarded as the stopper 133 in the embodiment of the present specification.
In some embodiments, a connecting piece 150 is disposed at a connection portion between the first tube 111 and the second tube 112, and two ends of the connecting piece 150 are respectively connected (e.g. clamped, abutted, fixedly connected, etc.) with the second fixing portion 1112 of the first tube 111 and an end portion of the second tube 112. For example, the outer surface of the outer tube 110 may be provided with a polymer material layer (such as a heat-shrinkable polyether block polyamide (Pebax) material layer), and in the preparation process, the polymer material layers on the outer surfaces of the first tube 111, the connecting piece 150 and the second tube 112 are in a molten state at a high temperature, and after cooling, the first tube 111, the connecting piece 150 and the second tube 112 may be fixedly connected. In some embodiments, the barrier 133 may be affixed (e.g., welded, glued, etc.) to the connector 150. In some embodiments, the stop 133 may also be integrally formed with the connector 150. In some alternative embodiments, the barrier 133 may also be fixedly attached to the core 120.
In some embodiments, a plurality of notches 1110 are formed on one side of the first tube 111 along the length direction thereof, and the first tube 111 can be bent towards the opening direction of the plurality of notches 1110. By providing the plurality of notches 1110, the first tube 111 can be bent easily, and the first tube 111 can be bent in a specific direction. In the present embodiment, a plurality of notches 1110 are formed on one side of the first tube 111, so that the first tube 111 can be bent toward the opening direction of the notches. Specifically, one side of the plurality of notches 1110 in the opening direction may be the same as the side of the core 120 where the grooves 121 are provided. In other embodiments, the plurality of notches 1110 may be formed on different sides of the first tube 111 at intervals. In this case, the corresponding different sides of the inner core 120 may be provided with grooves, and the traction mechanism 130 may include a corresponding plurality of traction wires, so that the first tube 111 can be bent in different directions under the control of the different traction wires. In some embodiments, the first tube 111 may be integrally cut from stainless steel (e.g., 316 stainless steel) or shape memory alloy (e.g., nitinol) tubing.
In some embodiments, the apertures of the plurality of notches 1110 may be substantially the same, and each portion of the first tube 111 may have the same bending capability. The notch aperture is understood to be the distance between the two sides of the open end of the notch. In some embodiments, the apertures of the plurality of notches 1110 may not be exactly the same, such that each portion of the first tube 111 has a different bending capability. For example, when the force applied to the pulling wire 131 is constant, the larger the diameter of the notch 1110, the greater the degree of bending of the first tube 111, and the smaller the diameter of the notch 1110, the smaller the degree of bending of the first tube 111. In some embodiments, the aperture of the notch 1110 near one end of the first tube 111 that is adjacent to the tissue gripping device is smaller than the aperture of the notch 1110 near the other end of the first tube 111 (the end connected to the second tube 112). When the traction wire 131 is tightened, the traction wire 131 drives the first tube 111 to bend, and the bending degree of the first tube 111 at one end is smaller and the bending degree of the first tube 111 at the other end is relatively larger because the aperture of the notch 1110 of the first tube 111 near one end of the tissue clamping device is smaller. Such an arrangement may make it easier for the tissue gripping device to be aimed at a target area (e.g., a heart valve to be repaired).
In some embodiments, the second tube 112 may be a mesh braid structure. On the one hand, the mesh-like woven structure has better torque control performance, and when the control handle is rotated, the second tube 112 can transmit the torque of the control handle so as to drive the first tube 111 to rotate. On the other hand, the mesh-like woven structure has better extrusion resistance and bending resistance, and when the delivery tube 100 enters human tissues (such as blood vessels, atrial walls and the like), the second tube 112 formed by the mesh-like woven structure can bear extrusion of the human tissues, so that the second tube 112 maintains a normal shape. In addition, when the traction wire 131 is tightened, the traction wire 131 drives the outer tube 110 (the first tube body 111 and the second tube body 112) and the inner core 120 to bend, and the second tube body 112 has higher bending resistance so that the bending action of the traction wire 131 on the second tube body 112 is smaller, thereby enabling the traction wire 131 to better control the bending of the first tube body 111.
In some embodiments, the outer surface of the outer tube 110 (first tube 111 and second tube 112) may be provided with a layer of thermoplastic material. For example, the thermoplastic material may include polyether block polyamide (PEPAX), polyurethane, polyamide, polyimide, polyethylene, polypropylene, polytetrafluoroethylene, and the like, or any combination thereof. Preferably, the outer surface of the outer tube 110 is provided with a layer of heat-shrinkable polyether block polyamide material, so that blood contact with the tubing can be effectively reduced. In addition, the thermoplastic material has higher stability and fatigue resistance at low temperature and good rebound and elastic recovery properties, and can improve the accuracy of the conveying pipe 100 in the bending adjustment process. In some embodiments, to further reduce the friction of the outer tube 110 with the body, the outer surface of the outer tube 110 may also be provided with a hydrophilic coating. In some embodiments, the material of the hydrophilic coating may include polyacrylic acid, silica, polysiloxane, siloxane, urethane, or the like, or any combination thereof.
The delivery tube 100 of the tissue clamping device described in the embodiments of the present application has both the functions of delivering the tissue clamping device and bending adjustment, so that the corresponding medical device (such as a valve repair device) can be more convenient to operate. It should be noted that the above description of the delivery tube 100 is for illustrative purposes only and is not intended to limit the present application. It will be understood by those skilled in the art that various modifications and changes in form and detail of the delivery tube 100 described above may be made without departing from the principles of the delivery tube 100 in accordance with embodiments of the present application. For example, the outer tube 110 may not be limited to the first tube 111 and the second tube 112 described above. In some embodiments, the outer tube 110 may further include a third tube, a fourth tube, etc., to accommodate surgery at different parts of the human body by controlling the bending of the first tube 111, the third tube, and/or the fourth tube.
Fig. 7 is a schematic structural view of a valve repair device according to some embodiments of the present application, fig. 8 is a schematic structural view of a delivery connector and a tissue clamping device according to some embodiments of the present application, fig. 9 is a schematic structural view of a delivery connector according to some embodiments of the present application, and fig. 10 is a schematic structural view of an outer clamp arm of a tissue clamping device according to some embodiments of the present application in an expanded state. As shown in fig. 7-10, the valve repair device 1000 may include a tissue clamping device 200 and a control handle 300. The tissue clamping device 200 may include an outer clamp arm 220 and an inner clamp arm 210, and the control handle 300 may include an outer clamp arm control mechanism 400 and an inner clamp arm control mechanism 500, respectively. The outer clip arm control mechanism 400 can be used to control the opening and closing of the outer clip arm 220 of the tissue gripping device 200, and the inner clip arm control mechanism 500 can be used to control the opening and closing of the inner clip arm 210 relative to the outer clip arm 220, such that the control handle 300 can be used to control the opening and closing of the outer clip arm 220 and the inner clip arm 210 to enable a valve (e.g., a mitral valve) to be gripped between the outer clip arm 220 and the inner clip arm 210.
In some embodiments, valve repair apparatus 1000 includes delivery tube 100 of tissue gripping device 200, and tissue gripping device 200 is coupled to control handle 300 via delivery tube 100. In some embodiments, control handle 300 is capable of delivering tissue gripping device 200 to the valve to be repaired via delivery tube 100. For example, control handle 300 can deliver tissue gripping device 200 to the mitral valve via delivery tube 100 via the femoral vein, inferior vena cava, right atrium, and left atrium. In some embodiments, the control handle 300 can include a delivery tube control mechanism 600, the delivery tube control mechanism 600 being operable to control bending of the first tube body 111 of the delivery tube 100. For more details regarding the delivery tube 100 and the first tube 111, reference may be made to other embodiments of the present application (e.g., the embodiments shown in fig. 1-5) and their associated descriptions. For more details regarding the delivery tube control mechanism 600, reference may be made to other embodiments of the present application (such as the embodiment shown in FIG. 11) and their associated description.
In some embodiments, the valve repair device 1000 may further include a support tube (not shown). In the valve repair process, the support tube can be delivered into the body first. For example, during mitral valve repair, the support tube may be delivered to the left atrium via the femoral vein, inferior vena cava, or right atrium first. On this basis, the control handle 300 may be used to deliver the tissue clamping device 200 through a support tube to a valve to be repaired (e.g., a mitral valve). Specifically, control handle 300 may deliver tissue gripping device 200 through delivery tube 100 such that tissue gripping device 200 and first tube 111 protrude from the forward end of the support tube, and control handle 300 (e.g., delivery tube control mechanism 600) may then control bending of first tube 111 such that tissue gripping device 200 is directed toward the valve to be repaired. If the tissue clamping device 200 cannot reach the valve to be repaired, the control handle 300 can control the first tube 111 to further extend out of the support tube, and the bending degree of the support tube and/or the first tube 111 can be adjusted in the process of controlling the first tube 111 to further extend out, so that the tissue clamping device 200 moves towards the valve to be repaired. In some embodiments, the aperture of the notch 1110 of the first tube 111 near one end of the tissue gripping device 200 may be smaller than the aperture of the notch 1110 near the other end of the first tube 111, such that the front end of the first tube 111 extending out of the support tube is curved to a lesser extent than the rear end, to facilitate better control of delivery of the tissue gripping device 200 to the valve to be repaired.
In some embodiments, as shown in fig. 8-10, tissue clamping device 200 may include an inner clamping arm 210, an outer clamping arm 220, a first securing member 230, a support 240, a second securing member 250, and an outer clamping plate 260. Wherein the inner clip arm 210 may include a first inner clip arm 211 and a second inner clip arm 213, the outer clip arm 220 may include a first outer clip arm 221 and a second outer clip arm 223, and the outer clip 260 may include a first outer clip plate 261 and a second outer clip plate 263. One side of the supporting part 240 is sequentially bendable to the first outer clamping arm 221 and the first outer clamping plate 261, and the other side of the supporting part 240 is sequentially bendable to the second outer clamping arm 223 and the second outer clamping plate 263. The first outer clip arm 221 and the second outer clip arm 223 can be folded relative to the support portion 240, and the first outer clip arm 221 and the second outer clip arm 223 can also be folded away from the support portion 240 to be opened relative to each other. The tissue clamping device 200 shown in fig. 8 is in a state in which the first outer arm 221 and the second outer arm 223 are relatively closed, and the tissue clamping device 200 shown in fig. 10 is in a state in which the first outer arm 221 and the second outer arm 223 are relatively opened up to 180 °. The angle at which the first outer clip arm 221 and the second outer clip arm 223 are relatively open may be any angle, such as 10 °,40 °, 90 °, 120 °, 180 °, 270 °, 350 °, 360 °, etc. In some embodiments, the outer clip arms 220, the support 240, and the outer clip 260 may be an integrally formed structure. For example, the outer clip arms 220, the support 240 and the outer clip 260 may be an integrally formed structure of a shape memory alloy tube that is cut and heat set. In some embodiments, as shown in fig. 8, one end (upper end shown) of the supporting portion 240 is connected (e.g., fixedly connected) to the second fixing member 250, and one end (lower end shown) of the first outer clamping plate 261 and one end (lower end shown) of the second outer clamping plate 263 are connected (e.g., fixedly connected) to the first fixing member 230, respectively. With this arrangement, the first fixing member 230 can move relative to the support portion 240 as the first fixing member 230 moves relative to the second fixing member 250. When the first fixing member 230 is far away from the supporting portion 240, the first outer clamping plate 261 and the second outer clamping plate 263 can pull the first outer clamping arm 221 and the second outer clamping arm 223 to open relatively under the driving of the first fixing member 230. In the embodiment shown in fig. 8-10, the outer clamp arm control mechanism 400 is capable of controlling the opening and closing of the outer clamp arm 220 of the tissue clamping device 200 via the control lever 440. Specifically, one end (lower end as viewed in fig. 8) of the control rod 440 may have a screw structure by which the control rod 440 can be detachably coupled with the first fixing member 230. The outer clamping arm control mechanism 400 may control the first fixing member 230 to move relative to the second fixing member 250 by pushing and pulling the control rod 440, thereby controlling the outer clamping arm 220 of the tissue clamping device 200 to open and close.
In some embodiments, the first inner clamp arm 211 may be disposed on the first outer clamp arm 221 and the second inner clamp arm 213 may be disposed on the second outer clamp arm 223, the first inner clamp arm 211 and the second inner clamp arm 213 being capable of opening and closing relative to the first outer clamp arm 221 and the second outer clamp arm 223, respectively, and enabling tissue to be clamped between the first inner clamp arm 211 and the first outer clamp arm 221 and between the second inner clamp arm 213 and the second outer clamp arm 223. In some embodiments, the inner clip arms 210 may be barb clips. For example, the movable end of the inner clip arm 210 may be provided with barbs 215. In some embodiments, the inner clip arm 210 and the outer clip arm 220 may be connected by a bent portion (e.g., an S-bar bent structure) that may have a pre-formed spring-back force so that the inner clip arm 210 can abut against the outer clip arm 220 in a natural state. In some embodiments, the inner clamp arm control mechanism 500 may control the opening and closing of the inner clamp arm 210 relative to the outer clamp arm 220 via a control cable (not shown). For example, the control wires may be connected to the movable ends of the inner clamp arms 210. When the inner arm control mechanism 500 pulls the control wire, the inner arm 210 can be opened relative to the outer arm 220 under the pulling force of the control wire, and when the control wire is released, the inner arm 210 can be closed with the outer arm 220 under the pre-formed resilience force of the bending part. In some embodiments, the control wires may include steel wires, nanowires, glass ropes, or the like, as the application is not limited in this regard.
In some embodiments, delivery tube 100 may be removably coupled to tissue gripping device 200 via delivery connector 140. For example, the first fastening portion 1111 of the first tube 111 may be removably coupled (e.g., snapped, threaded) to the tissue clamping device 200 via the delivery connector 140. The transfer link 140 is provided with through holes through which the control rod 440 and the control wire pass, respectively. In the embodiment shown in fig. 8 and 9, the delivery connector 140 may include a body 142, a first connector tab 144, and a second connector tab 146. Wherein the connection of the first and second connection pieces 144 and 146 with the body 142 may have a pre-formed resilient force that enables the first and second connection pieces 144 and 146 to be automatically opened in a natural state. The middle parts of the first connecting piece 144 and the second connecting piece 146 can be further provided with a fixed supporting rod 148, the fixed supporting rod 148 is perpendicular to the first connecting piece 144 and the second connecting piece 146 respectively, and one suspended end of the fixed supporting rod 840 is provided with a through hole for the control rod 440 to pass through. When the delivery connector 140 is connected to the second fixing member 250 of the tissue clamping device 200, the first connecting piece 144 and the second connecting piece 146 are relatively folded and respectively clamped with the protruding blocks on the second fixing member 250. At this time, the control rod 440 may pass through the through holes of the fixing struts 148 connected to the first connecting pieces 144 and the second connecting pieces 146, and the control rod 440 will limit the opening of the first connecting pieces 144 and the second connecting pieces 146. When it is desired to disengage the delivery connector 140 from the tissue clamping device 200, the control rod 440 can be disconnected from the tissue clamping device 200 (e.g., the first securing member 230) and the control rod 440 can be withdrawn such that the control rod 440 is disengaged from the through-holes in the securing struts 148 associated with the first connecting tab 144 and the second connecting tab 146, such that the first connecting tab 144 and the second connecting tab 146 automatically expand and disengage from the tabs on the second securing member 250. In some embodiments, the delivery connector 140 may be an integrally formed structure of a shape memory alloy tubing that is cut and heat set. In some embodiments, tissue gripping device 200 may be in other alternative configurations.
In some embodiments, control handle 300 includes an outer clip arm control mechanism 400 and an inner clip arm control mechanism 500. The outer arm control mechanism 400 is used to control movement of the outer arm 220 of the tissue clamping device 200 and the inner arm control mechanism 500 is used to control movement of the inner arm 210 of the tissue clamping device 200. In some embodiments, the control handle 300 may further include a delivery tube control mechanism 600, the delivery tube control mechanism 600 being operable to control bending of the first tube 111.
Fig. 11 is a schematic exploded view of a duct control mechanism according to some embodiments of the present application. In some embodiments, as shown in fig. 11, the conveying pipe control mechanism 600 may include a screw 610, a rotating part 620 and a traction part 630, wherein the screw 610 and the traction part 630 are in threaded connection, the rotating part 620 can drive the screw 610 to rotate so as to drive the traction part 630 to move, and the movement of the traction part 630 can control the first pipe 111 to bend. In some embodiments, the traction portion 630 may include a traction wire 131 and a threaded traction block 635, where one end (e.g., a tail end) of the traction wire 131 is connected to the threaded traction block 635, and the other end (e.g., a front end) is fixedly connected to the front end of the first tube 111, and an internal thread is formed inside the screw 610, and the threaded traction block 635 is movably disposed inside the screw 610 and is matched with the internal thread of the screw 610. When the rotating portion 620 drives the screw 610 to rotate, the screw 610 drives the threaded traction block 635 to move in the length direction in the screw 610, so as to achieve traction or loosening of the traction wire 131, and further control the bending of the first tube 111. Specifically, the traction wire 131 pulls the first tube 111 to close the plurality of notches 1110 on the first tube 111, so that the first tube 111 is bent. When the screw drag block 635 stops moving, the first tube 111 may maintain a bent state. When the thread drawing block 635 releases the drawing wire 131, the first tube 111 may be bent to a reduced degree by its own elastic force until the natural state is restored (e.g., maintained in a cylindrical shape).
In some embodiments, as shown in fig. 11, the delivery tube control mechanism 600 may include a bend indicating device 640. The bending indicating device 640 may be used to indicate the degree of bending of the first tube 111. In some embodiments, the bending indicating device 640 may include an indicating block that may be engaged with the external thread of the screw 610 and move as the screw 610 rotates, and the bending degree of the first tube 111 may be reflected by the moving position of the indicating block. In some embodiments, the moving positions of the indication blocks may correspond to the bending angles of the first tube 111 one by one. The correspondence between the two can be determined through experiments. In some embodiments, the bending indicating device 640 may further include an indication mark, which may be disposed on the housing (e.g., a transparent housing covering the outside of the indicating block) to intuitively reflect the bending degree (e.g., bending angle) of the first tube 111 corresponding to the movement of the indicating block to a specific position.
Fig. 12 is a schematic view of a partial cross-sectional structure of an outer arm control mechanism according to some embodiments of the present application, fig. 13 is a schematic view of a sleeve according to some embodiments of the present application, and fig. 14 is an exploded schematic view of a sliding portion and a protective sheath according to some embodiments of the present application. In some embodiments, as shown in fig. 12-14, the outer arm control mechanism 400 may include a sleeve 410, a first control portion 420 and a sliding portion 430, where the sliding portion 430 is disposed in the sleeve 410, and the first control portion 420 can rotate to drive the sliding portion 430 to move along the length direction of the sleeve 410 in the sleeve 410 to control the outer arm 220 to open or close. If the end of the control handle 300 adjacent the tissue clamping device 200 is defined as the front end and the opposite end of the control handle 300 is the rear end, movement of the sliding portion 430 forward within the cannula 410 can be used to control the opening of the outer clamp arms 220 (e.g., the first outer clamp arm 221 and the second outer clamp arm 223 are relatively open), and movement of the sliding portion 430 rearward can be used to control the closing of the outer clamp arms 220.
In some embodiments, the sleeve 410 may be provided with one or more interlayers, the sliding portion 430 is disposed in the interlayer of the sleeve 410, and the first control portion 420 can drive the sliding portion 430 to move along the length direction of the sleeve 410 in the sleeve 410. For example, the sleeve 410 may have a hollow cylindrical shape, which may be formed by connecting two semi-cylindrical shells, the sliding portion 430 has a cylindrical shape, and the sliding portion 430 may be engaged between the two semi-cylindrical shells of the sleeve 410.
In some embodiments, referring to fig. 12-13, the sleeve 410 may be externally threaded on the outer circumferential surface, the first control portion 420 may be internally threaded on the inner circumferential surface, and the sleeve 410 may be threadably coupled to the first control portion 420. The sleeve 410 may be provided with a first sliding groove 412 along a length direction, and the sliding part 430 is connected with the first control part 420 through the first sliding groove 412. Specifically, the sliding portion 430 may include a protruding connection block 429, and the inner circumferential surface of the first control portion 420 may include a connection groove 421, where the connection block 429 may extend from the first sliding groove 412 and may be engaged with the connection groove 421, so that the sliding portion 430 may be driven to move along the first sliding groove 412 when the first control portion 420 rotates. In the embodiment of the present application, the sleeve 410 may include two first sliding grooves 412 respectively disposed on two sides of the sleeve 410, and two protruding connecting blocks 429 are correspondingly disposed on the sliding portion 430, so that the stability of the sliding portion 430 driven by the first control portion 420 can be ensured. In some alternative embodiments, the number of the first sliding grooves 412 may be one, three, five, or the like.
In some embodiments, the first control part 420 may have an annular outer contour, and a rubber layer may be provided on a surface of the outer contour. When the operator controls the outer arm 220 by rotating the first control portion 420, the rubber layer can increase the friction between the first control portion 420 and the palm or fingers, so that the operator can precisely control. In other embodiments, the outer surface of the first control portion 420 may be made of hard material such as plastic, metal, etc. without providing a rubber layer, and the surface may be provided with anti-skid patterns to increase the surface friction.
In some embodiments, as shown in fig. 12-14, the outer clip arm control mechanism 400 may include a control lever 440, a fixing block 460 and a protective sleeve 470, and the sliding portion 430 may control the outer clip arm 220 to open and close by the control lever 440, and the rear end of the control lever 440 is fixedly connected with the fixing block 460. Specifically, the fixing block 460 may have a cylindrical shape, and the cross-sectional diameter thereof may be larger than that of the control rod 440, and the control rod 440 may be inserted into the fixing block 460 and fixedly coupled with the fixing block 460 by means of gluing, welding, interference connection, or the like. The protective sheath 470 may be detachably coupled with the sliding part 430 by a screw thread, and the protective sheath 470 can restrict the relative movement of the fixing block 460 and the sliding part 430 when the protective sheath 470 is coupled with the sliding part 430. In some embodiments, the control rod 440 may be made of a memory alloy (such as nitinol), so that the control rod 440 has better tensile and compressive properties and better bending properties, and the outer clamp arm control mechanism 400 can also effectively control the opening and closing of the outer clamp arm 220 through the control rod 440 when the delivery tube 100 is bent.
In some embodiments, when the tissue clamping device 200 is clamped, the control rod 440 needs to be separated from the tissue clamping device 200 and withdrawn from the control handle 300 (e.g., completely withdrawn or withdrawn a distance). As shown in fig. 12-14, the protective sleeve 470 is detachably coupled to the sliding portion 430 by threads. When it is desired to disengage the control lever 440, the operator may rotate the protective sheath 470 to disengage from the sliding portion 430, then the operator may rotate the securing block 460 (i.e., rotate the control lever 440) to disengage the control lever 440 from the tissue clamping device, and then the operator may pull the securing block 460 to withdraw the control lever 440 from the control handle 300.
Fig. 15 is a schematic view of a partial cross-sectional structure of an inner arm control mechanism according to some embodiments of the present application, fig. 16 is a schematic view of a housing according to some embodiments of the present application, fig. 17 is a schematic view of a second control portion according to some embodiments of the present application, fig. 18 is a schematic view of a second control portion and a locking mechanism according to some embodiments of the present application in a first view, and fig. 19 is a schematic view of a second control portion and a locking mechanism according to some embodiments of the present application in a second view. In some embodiments, as shown in fig. 15-19, the inner arm control mechanism 500 may include a housing 510 and a second control portion 520, where the housing 510 is provided with a second chute 511, and the second control portion 520 passes through the second chute 511 and is capable of moving along the second chute 511 to control the opening and closing of the inner arm 210 relative to the outer arm 220.
In some embodiments, as shown in fig. 17, the second control part 520 may include an L-shaped guide pipe 521 and an end cap 523, and one end of the guide pipe 521 may pass through the second sliding groove 511 and be detachably connected with the end cap 523. In operation, the second control portion 520 can be slid within the second chute 511 by pushing and pulling the guide tube 521 at the end cap, the L-shaped guide tube 521 being more convenient for the operator to control. In this embodiment, the second control portion 520 may be drivingly connected to the inner clip arm 210 by a control cable. In a specific embodiment, the control wire may pass through a through hole in the movable end of the inner clamping arm 210, and both ends of the control wire may be fixed at the end cap 523. When it is necessary to separate the tissue clamping device 200 from the control handle 300, the end cap 523 and the catheter 521 may be separated, and then the fixation of the two ends of the control wire may be released and the control wire may be pulled out, thereby separating the control handle 300 from the inner clip arm 210. In some embodiments, releasing the fixation of the ends of the control wire may include releasing the clamping of the ends of the control wire to the end caps, releasing the knots formed at the ends of the control wire, shearing the control wire, and the like. In some embodiments, the control wire may not be completely withdrawn from the control handle 300, but rather the control wire may be disengaged from the inner clamp arm 210.
In some embodiments, as shown in fig. 16, the second chute 511 may be provided in an elongated shape. The inner clip arm 210 may be in a collapsed state when the end cap 523 of the second control part 520 (or the portion of the guide tube 521 extending out of the second chute) moves to the rear end (the end remote from the tissue clamping device) of the second chute 511. In some alternative embodiments, the second runner 511 may be provided with an L-shaped profile. Specifically, a section of channel may be formed at the rear end of the second chute 511 along a direction at an angle (e.g., perpendicular) to the second chute 511. When the end cap 523 of the second control part 520 (or the portion of the guide pipe 521 extending out of the second sliding groove) moves to the rear end of the second sliding groove 511, the second control part 520 may be pushed and pulled laterally so that the portion of the guide pipe 521 extending out of the second sliding groove is caught in the passage, and thus the inner clip arm 210 may be kept in a folded state so as not to be erroneously operated during the operation.
In this embodiment, the two sides of the housing 510 may be respectively provided with a second sliding groove 511, and the second control part 520 includes a first sub-control part for controlling the first inner clamping arm 211 and a second sub-control part for controlling the second inner clamping arm 213. The first sub-control portion and the second sub-control portion may correspond to separate control wires, respectively. In some embodiments, the second control portion 520 may be configured to be linked or transferred as needed to accurately control the inner clamp arm 210 as needed for an experiment or procedure. For example, during a mitral valve repair procedure, the first inner clamping arm 211 may be controlled to clamp one side of the mitral valve before the second inner clamping arm 213 is controlled to clamp the other side of the mitral valve. For another example, the second control part 520 may control the first inner clip arm 211 and the second inner clip arm 213 to clip the mitral valve at the same time.
In some embodiments, one end of the housing 510 may be connected (or integrally formed) with the cannula 410, and the central axes of the housing 510 and cannula 410 coincide, making the control handle 300 more compact and easier to maneuver. For example, the housing 510 may be disposed at an end of the cannula 410 proximate to the tissue clamping device 200, and the first control portion 420 may be configured to be in a maximum open state of the outer clip arms 220 when abutting the rear end of the housing 510. In some alternative embodiments, housing 510 may also be provided at an end of cannula 410 remote from tissue gripping device 200.
In some embodiments, as shown in fig. 15-19, the inner clip arm control mechanism 500 may include a locking mechanism 530, the locking mechanism 530 including a resilient member 531, a locking button 533, and a locking stop 535. The second control portion 520 may also include a toothed connection 537. The locking button 533 is used to control the locking stopper 535 to move against the elastic force of the elastic member 531 to release the restriction of the locking stopper 535 to the tooth-shaped connection 537.
As shown in fig. 15-19, in this embodiment, the locking mechanism 530 includes a set of oppositely disposed locking stops 535, and the first and second sub-control portions may each include a corresponding toothed connection 537. In particular, the tooth connection 537 may be connected to or integrally formed with the conduit 521 of the first or second sub-control. A set of oppositely disposed locking stoppers 535 may be used to restrict movement of the first sub-control part and the second sub-control part, respectively, under the elastic force of the elastic member 531. For example, the locking stopper 535 corresponding to the first sub-control part may be locked into the tooth-shaped connection part 537 corresponding to the first sub-control part by the elastic force of the elastic member 531. The locking stopper 535 corresponding to the second sub-control part may be locked into the tooth-shaped connection part 537 corresponding to the second sub-control part by the elastic force of the elastic member 531. The elastic member 531 may be two springs in this embodiment. The locking button 533 may include two locking stoppers 535 connected to the two locking stoppers, respectively. The locking button 533 may be exposed from the housing 510. Taking the operation of the first sub-control portion as an example, when the locking button 533 corresponding to the first sub-control portion is pressed, the locking button 533 drives the locking stop 535 to overcome the elastic force of the elastic member 531 and separate from the tooth-shaped connection portion 537, and the operator can push and pull the first sub-control portion (such as the conduit 521 of the first sub-control portion) to slide in the second chute 511 to control the first inner clamping arm 211 to open or close. When the operator releases the locking button 533, the locking stopper 535 may be re-inserted into the tooth-shaped connection 537 under the elastic force of the elastic member 531, so as to limit the movement of the tooth-shaped connection 537 (i.e., the movement of the catheter 521). The operation of the second sub-control section is similar to that of the first sub-control section and will not be repeated here.
In some embodiments, since two lock buttons 533 are provided, a mark may be added to the lock buttons 533 for easy recognition by an operator. The label may be "left", "right", "L", "R", or arrow, etc.
The embodiment of the specification has the beneficial effects that the delivery pipe has the functions of delivering the tissue clamping device and bending, so that corresponding medical equipment (such as valve repair equipment) is more convenient to operate, (2) the delivery pipe can be rapidly and accurately bent, (3) the space required by the delivery pipe in the bending process can be effectively reduced through the cooperation of the traction mechanism and the first pipe body, and therefore the device is suitable for various operations, (4) the outer clamping arm and/or the inner clamping arm of the tissue clamping device can be rapidly and accurately controlled, and (5) the valve repair operation is more convenient, and the repair efficiency and success rate are higher. It should be noted that, the advantages that may be generated by different embodiments may be different, and in different embodiments, the advantages that may be generated may be any one or a combination of several of the above, or any other possible advantages that may be obtained.
The foregoing description of the preferred embodiments of the application is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the application.