Reflux heart valve conveyor stable in operation and conveying system

Abstract

The utility model provides a stable-operation reflux heart valve conveyor and a stable-operation reflux heart valve conveying system, and belongs to the technical field of medical instruments. The conveyor comprises a conveyor handle, and the conveyor handle comprises a handle shell, a valve conveying pipe assembly connected with the handle shell and an outer sheath pipe assembly arranged in the handle shell. The conveyor handle comprises a valve control part and a valve release part, the valve conveying pipe assembly is connected to the valve release part, and the outer sheath pipe is connected to the valve control part. The conveyor handle further comprises a valve propelling structure arranged between the valve control part and the valve release part. The valve propelling structure comprises a valve propelling sleeve arranged in the handle shell in a sliding mode, and the valve propelling sleeve is used for enabling the valve releasing part to be close to or away from the valve control part. The valve pushing structure between the valve control part and the valve release part is used for driving the valve release part to be close to or away from the valve control part, and the pushing process is stable.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices for heart valve repair, and in particular to a regurgitant heart valve delivery device and delivery system with stable operation. Background Art

[0002] The heart consists of two chambers and two ventricles. The mitral valve, tricuspid valve, aortic valve and pulmonary valve separate the chambers and the heart from the outside. The four valves act as one-way valves, allowing blood in the heart to flow in a predetermined direction but not in the opposite direction.

[0003] The aortic valve connects the left ventricle and the aorta. When the left ventricle expands, the aortic valve is closed, and when the left ventricle contracts, the aortic valve is open. The oxygenated blood in the left ventricle is pumped into the aorta by the systolic pressure, and the oxygenated blood is delivered to all parts of the body through the aorta. Since the systolic pressure is high when the heart contracts, generally reaching 120 mmHg, and even as high as 150 mmHg in patients with hypertension, and the aortic valve is located in a special position, close to the mitral valve ring, for patients with aortic regurgitation, it is necessary to consider the fixation of the regurgitant valve and avoid affecting the normal operation of other valves.

[0004] Traditional aortic valve replacement is a method of establishing extracorporeal circulation by inserting a catheter into the aorta and right atrium through a midline incision in the chest. However, traditional surgical operations cause great damage to patients and take a long time to recover. Especially for elderly patients, it is difficult for them to bear the damage caused by traditional surgical operations. As transcatheter surgery has many advantages such as less trauma and faster recovery, more and more surgeries are being performed through transcatheter surgery. The research on aortic valve replacement has also gradually shifted from early surgical methods to transcatheter aortic valve replacement.

[0005] The regurgitant stent used in transcatheter aortic replacement is generally inserted into the sinus bottom of the native aortic valve through three positioning pieces before the regurgitant stent is released. After the regurgitant stent is completely released, the positioning piece and other parts of the regurgitant stent are used together to fix the regurgitant stent through the native aortic valve and the aortic wall. To explain a key step in conjunction with the delivery device, after the positioning piece is released, the centering (bending) component of the delivery device is used to control the rotation of the heart valve so that the positioning piece is aligned with the sinus bottom. At this time, the centering (bending) component needs to remain stationary, and the valve is driven to move toward the proximal end through the internal pipe system of the delivery device so that the positioning piece is inserted into the sinus bottom. This process requires high operational stability, so it is hoped that a regurgitant heart valve delivery device with stable operation can be provided to ensure the accuracy and stability of the operation. Utility Model Content

[0006] In view of the above-mentioned problems of the prior art, the main purpose of the present application is to provide a regurgitant heart valve delivery device and delivery system with stable operation, so that the positioning member can be placed into the sinus stably through the coordination of the structures.

[0007] To achieve the above-mentioned object and other related objects, the present application provides a regurgitant heart valve delivery device with stable operation in a first aspect, comprising a delivery device handle, wherein the delivery device handle comprises a handle housing, a valve delivery tube assembly connected to the handle housing, and an outer sheath tube assembly disposed in the handle housing; the delivery device handle comprises a valve control portion and a valve release portion, the valve delivery tube assembly is connected to the valve release portion, and the outer sheath tube is connected to the valve control portion;

[0008] The conveyor handle also includes a valve propulsion structure disposed between the valve control portion and the valve release portion; the valve propulsion structure includes a valve propulsion sleeve slidably disposed in the handle housing, and is used to move the valve release portion closer to or farther away from the valve control portion.

[0009] In one embodiment of the first aspect, the valve advancement structure also includes a valve advancement knob, the distal end of the valve advancement sleeve is provided with an advancement thread guide, the handle shell is provided with an advancement axial guide groove, the advancement thread guide is movably arranged in the advancement axial guide groove, and the advancement thread guide is threadedly connected to the valve advancement knob.

[0010] In an implementable embodiment of the first aspect, the handle housing comprises a first housing and a second housing that can move closer to and farther from each other, the valve control unit is located in the second housing, and the valve release unit is located in the first housing;

[0011] The advancing axial guide groove is arranged on the second shell, and the proximal end of the valve advancing sleeve is detachably connected to the first shell.

[0012] In one possible implementation of the first aspect, the valve advancement structure further includes a connecting knob, and a connecting gear is provided at the proximal end of the valve advancement sleeve;

[0013] The first shell is provided with a threaded hole; the connecting knob is screwed and passes through the threaded hole and then is snap-fitted with the connecting gear.

[0014] In one embodiment of the first aspect, the valve delivery tube assembly includes an inner tube, a middle tube and an outer tube that are sequentially socketed, the proximal end of the regurgitant heart valve is constrained between the middle tube and the outer tube, and the distal end is constrained between the middle tube and the inner tube.

[0015] As a preferred embodiment, the inner tube member includes an inner tube and a front loading head sheath located at the distal end of the inner tube; the outer tube member includes an outer tube and a rear loading sheath located at the distal end of the outer tube; the middle tube member includes a middle tube, and from the distal end to the proximal end of the middle tube, the middle tube is provided with a first step groove, a valve bearing portion and a second step groove; the front loading head sheath cooperates with the first step groove to form a front loading bin, and the rear loading sheath cooperates with the second step groove to form a rear loading bin.

[0016] As a preferred solution, the valve delivery tube assembly further comprises a distal release structure connected to the inner tube, a valve fixing structure connected to the middle tube, and a proximal release structure connected to the outer tube;

[0017] The valve fixing structure is fixedly connected to the handle shell; the distal release structure is slidably connected to the handle shell, and is used to drive the inner tube to move axially along the handle shell; the proximal release structure is slidably connected to the handle shell, and is used to drive the outer tube to move axially along the handle shell.

[0018] As a preferred embodiment, the distal release structure includes an inner tube connector, an inner tube threaded guide member arranged on the inner tube connector and a distal release knob threadedly connected to the inner tube threaded guide member; the handle shell is provided with an inner tube movable guide groove, the inner tube connector is arranged in the handle shell, and the inner tube threaded guide member is movably arranged in the inner tube movable guide groove, and the inner tube member is connected to the inner tube connector.

[0019] As another preferred embodiment, the inner tube connector includes a hollow inner tube plug-in section and a first cylindrical fixing block, the outer circumference of the first cylindrical fixing block matches the inner circumference of the handle shell, and the inner tube member is plugged into the inner tube plug-in section.

[0020] As a preferred embodiment, the proximal release structure includes an outer tube connector, an outer tube threaded guide member arranged on the outer tube connector and a proximal release knob threadedly connected to the outer tube threaded guide member; the handle shell is provided with an outer tube movable guide groove, the outer tube connector is arranged in the handle shell, and the outer tube threaded guide member is movably arranged in the outer tube movable guide groove.

[0021] As a preferred embodiment, the valve fixing structure includes a middle tube connector fixed in the handle shell, the middle tube connector includes a hollow middle tube plug-in section and a third cylindrical fixing block, the outer circumference of the third cylindrical fixing block matches the inner circumference of the handle shell, and the middle tube is plugged into the middle tube plug-in section.

[0022] As another preferred solution, the third cylindrical fixing block is provided with at least one insertion hole, and the inner side of the handle housing is provided with a plug column that cooperates with the insertion hole.

[0023] As another preferred solution, the outer periphery of the middle pipe inserting section is provided with radial ribs, and one end of the rib (55) is connected to the third cylindrical fixing block.

[0024] A second aspect of the present application provides a regurgitant heart valve delivery system with stable operation, comprising a regurgitant heart valve and the above-mentioned streamlined evacuation regurgitant heart valve delivery device.

[0025] In one possible implementation of the second aspect, the free end of the positioning member is provided with a wire pulling composite ring, and the wire pulling hole is provided in the wire pulling composite ring; preferably, the material of the wire pulling composite ring is a developing material; and / or the wire pulling composite ring is a regular or irregular geometric shape.

[0026] The stable operation regurgitation heart valve delivery device and system provided by the present application has but is not limited to the following beneficial effects:

[0027] 1) The present application uses the valve propulsion structure between the valve control part and the valve release part to drive the valve release part to move closer to or away from the valve control part, and the propulsion process is stable.

[0028] 2) A propulsion thread guide is provided at the distal end of the valve propulsion sleeve. The thread guide is movably arranged in a propulsion axial guide groove located on the handle housing, and the propulsion thread guide is screwed to the valve propulsion knob. The screwed propulsion method makes the pushing process of driving the valve release part close to or away from the valve control part more stable.

[0029] 3) The proximal end of the valve pushing sleeve is detachably connected to the first shell to ensure that the valve control part and the valve release part maintain synchronous movement during connection and avoid relative rotation. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 Shown is a schematic diagram of the structure of the valve control part and the valve release part of the conveyor described in Example 1 of the present application in a separated state.

[0031] Figure 2 Display as Figure 1 Cross-sectional view of .

[0032] Figure 3 Display as Figure 2 Enlarged view of part A in .

[0033] Figure 4 It shows a schematic cross-sectional view of the structure of the valve control part and the valve release part in a close state.

[0034] Figure 5 Display as Figure 4 Enlarged view of part B in the middle.

[0035] Figure 6 Shown is a state diagram of the heart valve (only the valve support is shown) described in the present application, wherein a1 is the initial state after the positioning member is released; a2 is the state in which the heart valve moves toward the proximal end and the positioning member opens to a certain angle when the positioning pull wire and the free end of the fixing member remain stationary; a3 is the state in which the heart valve self-expands and releases after adjusting the positional relationship between the inner tube, the outer tube and the middle tube.

[0036] Figure 7 Shown is a partial exploded view of the outer sheath assembly of the valve delivery tube assembly.

[0037] Figure 8 The diagram shows the structure of the conveyor with part of the handle shell cut away.

[0038] Fig. 9 Display as Figure 6 Magnified view of the proximal end of the conveyor.

[0039] Fig.10 Shown is a schematic diagram of the structure of the outer pipe connector.

[0040] Fig.11 Shown is a schematic diagram of the structure of the mid-tube connector.

[0041] Fig.12 Shown is a heart valve (only part of the valve stent is shown), in which the pull wire composite ring is triangular in shape.

[0042] Fig.13 Shown is a heart valve (only part of the valve support is shown) in which the pull wire composite ring is prismatic.

[0043] Fig.14 Shown is a heart valve (only part of the valve support is shown), in which the pull wire composite ring is circular.

[0044] Fig.15 Shown is a heart valve (only a portion of the valve stent is shown), in which the pull-wire composite ring is in the shape of a five-pointed star.

[0045] Description of Reference Numerals

[0046] 6 Conveyor handle

[0047] 40 Handle housing

[0048] 41 first handle housing

[0049] 42 Second handle housing

[0050] 611 Valve Control Unit

[0051] 612 Valve release unit

[0052] 1 Inner tube

[0053] 11 Front Loading Scabbard

[0054] 2 Middle pipe

[0055] 21 First step groove

[0056] 22 Valve bearing part

[0057] 23 Second step groove

[0058] 3 Outer tube

[0059] 31 Rear Loading Sheath

[0060] 5 Outer sheath

[0061] Distal release structure:

[0062] 600 Remote Release Knob

[0063] 402 Internal pipe connector

[0064] 81 Inner tube plug section

[0065] 82 first cylindrical fixing block

[0066] 84 Internal pipe thread guide

[0067] 414 First limit column

[0068] Proximal release structure

[0069] 405 External pipe connector

[0070] 500 Proximal Release Knob

[0071] 91 Outer tube plug section

[0072] 92 second cylindrical fixing block

[0073] 93 External pipe connection sealing cover

[0074] 94 External pipe thread guide

[0075] 95 Reinforcement

[0076] Valve fixation structure:

[0077] 403 Middle pipe connector

[0078] 51 Middle pipe joint

[0079] 52 third cylindrical fixing block

[0080] 53 Middle pipe connection sealing cover

[0081] 55 Rib

[0082] Regurgitant heart valves:

[0083] 10 Valve stent

[0084] 20 Positioning piece

[0085] 2001 Cable Compound Ring DETAILED DESCRIPTION

[0086] As described in the background art, the present application provides a regurgitant heart valve delivery device with stable operation to ensure the accuracy and stability of operation.

[0087] Explanation of terms in this application: "distal end" and "proximal end" are directional words, which are commonly used terms in the field of interventional medical devices, where "distal end" refers to the end of the delivery system away from the operator during surgery, and "proximal end" refers to the end of the delivery system close to the operator during surgery. "Axial" refers to the direction parallel to the line connecting the distal center and the proximal center of the delivery device; "radial" refers to the direction perpendicular to the above "axial". "Connecting end" in this application generally refers to the connection between one component and another component, and "free end" in this application generally refers to an end of a component that is in a free state and not connected to other components. "Distal end" refers to the end of the delivery system away from the apex during surgery, and "proximal end" refers to the end of the delivery system close to the apex during surgery. In addition, the regurgitant heart valve includes a valve stent and a valve (artificial valve or biological valve) connected to the valve stent. The regurgitant heart valve, valve body, valve and heart valve described in the embodiments of this application have the same meaning. In addition, the orientations or positional relationships indicated by "upper end", "lower end", "upper part", "lower part", "inside", "outside", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. In addition, the well-known technologies generally associated with heart valve repair are not described in detail, and those skilled in the art who are not described can understand them according to the conventional methods in the prior art. The following specific embodiments illustrate the implementation of the present application, and those familiar with this technology can easily understand other advantages and functions of the present application from the contents disclosed in this specification.

[0088] Please refer to the attached Figure 1-15 It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings in this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the restrictive conditions for the implementation of this application. Therefore, they have no substantive technical significance. Any modification of the structure, change in the proportion relationship or adjustment of the size should still fall within the scope of the technical content disclosed in this application without affecting the effects and purposes that can be achieved by this application.

[0089] Example 1

[0090] See also Figures 1 to 11 The present embodiment provides a regurgitant heart valve delivery device with stable operation, including a delivery device handle 6, wherein the delivery device handle 6 includes a handle housing 40, a valve delivery tube assembly connected to the handle housing 40, and an outer sheath tube assembly disposed in the handle housing 40. The delivery device handle 6 includes a valve control portion 611 and a valve release portion 612, wherein the valve delivery tube assembly is connected to the valve release portion 612, and the outer sheath tube 5 is connected to the valve control portion 611. The delivery device handle 6 also includes a valve propulsion structure disposed between the valve control portion 611 and the valve release portion 612, wherein the valve propulsion structure includes a valve propulsion sleeve 408 slidably disposed in the handle housing 40, and is used to move the valve release portion 612 close to or away from the valve control portion 611. Specifically, the valve release portion 612 is pushed as a whole to move toward the proximal end, so as to drive the valve release portion 612 as a whole to be delivered into the body, thereby delivering the heart valve to the sinus bottom of the aortic valve. That is, the valve propulsion structure between the valve control part 611 and the valve release part 612 is used to drive the valve release part 612 to approach or move away from the valve control part 611, so that the propulsion process is stable, and the action of pushing the valve into place is stable to avoid damaging tissues.

[0091] In a preferred embodiment, see Figure 1 , 3 and Figure 8 The valve advancement structure also includes a valve advancement knob 300, a advancement thread guide 420 is provided at the distal end of the valve advancement sleeve 408, and the handle housing 40 is provided with an advancement axial guide groove 401, and the advancement thread guide 420 is movably provided in the advancement axial guide groove, and the advancement thread guide 420 is screwed with the valve advancement knob 300. That is, the distal end of the valve advancement sleeve is provided with an advancement thread guide, the thread guide is movably provided in the advancement axial guide groove located in the handle housing, and the advancement thread guide is screwed with the valve advancement knob, and the screwed advancement method makes the pushing process of driving the valve release part close to or away from the valve control part more stable.

[0092] In a preferred embodiment, see Figure 3 and Figure 8 The handle housing includes a first housing 41 and a second housing 42 that can move closer to and farther from each other, the valve control unit 611 is located in the second housing 42, and the valve release unit 612 is located in the first housing. The propulsion axial guide groove is provided in the second housing 42, and the proximal end of the valve propulsion sleeve 408 is controllably connected to the first housing. The proximal end of the valve propulsion sleeve is controllably connected to the first housing to ensure that the valve control unit 611 and the valve release unit 612 maintain synchronous motion during connection and avoid relative rotation.

[0093] In one specific embodiment, see Figure 3 , 5 and 8, provide a specific controllable rotation connection mode between the proximal end of the valve pushing sleeve and the first shell, the valve pushing structure also includes a connecting knob 400, and a connecting gear 407 is provided at the proximal end of the valve pushing sleeve 408; the first shell is provided with a threaded hole. The connecting knob 400 is screwed and passed through the threaded hole to be snap-fitted and connected with the connecting gear 407. Specifically, a connecting gear 407 is provided at the proximal end of the valve pushing sleeve 408 to which the valve pushing knob 300 is adapted, and the handle shell 40 of the valve release part restricts the connecting gear 407 inside thereof to ensure the consistency of the axial movement of the valve control part 611 and the valve release part 612. Rotating the valve pushing knob 300 can drive the valve pushing sleeve 408 and the valve release part to move toward the distal end. After the conveyor delivers the heart valve at its distal end into the aorta, the stent needs to be rotated so that the locating member is axially upward and aligned with the sinus bottom of the native aortic valve. At this time, the connecting knob 400 should be rotated to disengage the connecting knob 400 from the connecting gear 407, and then the first handle shell 41 of the handle shell 40 of the valve release part 612 is rotated. After the locating member 20 is rotated to a suitable position, the connecting knob 400 is rotated in the opposite direction to insert the bolt of the connecting knob 400 between the adjacent teeth of the connecting gear 407, so that the valve control part 611 and the valve release part 612 maintain synchronous action and avoid relative rotation. In addition, refer to Fig. 9 An axial limiter 803 is also provided on the outer periphery of the second handle housing 42 and the first handle housing 41 to limit the axial movement of the valve advancing knob 300 .

[0094] In a preferred embodiment, the valve delivery tube assembly includes an inner tube, a middle tube, and an outer tube that are sequentially connected, and the proximal end of the regurgitant heart valve is bound between the middle tube and the outer tube, and the distal end is bound between the middle tube and the inner tube. Specifically, the proximal end of the regurgitant heart valve is bound between the middle tube and the outer tube, and the distal end is bound between the middle tube and the inner tube, and the connection end of the positioning member 20 is close to the proximal end of the regurgitant heart valve, and the free end is close to the distal end of the regurgitant heart valve. Specifically, refer to Figure 6 and Figure 7The inner tube member includes an inner tube 1 and a front loading head sheath 11 located at the distal end of the inner tube 1. The outer tube member includes an outer tube 3 and a rear loading sheath 31 located at the distal end of the outer tube 3. The middle tube member includes a middle tube 2. From the distal end to the proximal end of the middle tube 2, the middle tube 2 is provided with a first step groove 21, a valve bearing portion 22 and a second step groove 23. Among them, the front loading head sheath 11 cooperates with the first step groove 21 to form a front loading bin, and the rear loading sheath 31 cooperates with the second step groove 23 to form a rear loading bin. The regurgitant heart valve is in a compressed state, and the distal end of the heart valve is loaded in the front loading bin, and the proximal end of the heart valve is loaded in the rear loading bin. When the inner tube 1 and the middle tube 2, the middle tube 2 and the outer tube 3 are displaced, the heart valve can release self-expansion from the two loading bins. The release action as described above relies on the connection structure provided inside the conveyor handle 6. Specifically, the valve conveying tube assembly also includes a distal release structure connected to the inner tube, a valve fixing structure connected to the middle tube, and a proximal release structure connected to the outer tube. Among them, the middle tube is fixed relative to the handle housing, and the inner tube and the outer tube can be displaced relative to the middle tube, that is, the valve fixing structure is fixedly connected to the handle housing 40, the distal release structure is slidably connected to the handle housing 40, and is used to drive the inner tube to move along the axial direction of the handle housing 40, and the proximal release structure is slidably connected to the handle housing 40, and is used to drive the outer tube to move along the axial direction of the handle housing 40. As described above, the inner tube 1 can be moved away from the middle tube 2 to release the distal end of the heart valve in the front loading bin, and the outer tube 3 can be moved away from the middle tube 2 to release the proximal end of the heart valve in the rear loading bin. Specifically, specific examples of the distal release structure, the proximal release structure, and the valve fixing structure are given as follows:

[0095] B1, the distal release structure corresponds to Figure 1 The distal release knob 600 shown in the figure controls the movement of the distal release structure by rotating the distal release knob 600. Figure 1 , 8 9, the distal release structure includes an inner tube connector 402, an inner tube threaded guide 84 disposed on the inner tube connector 402, and a distal release knob 600 threadedly connected to the inner tube threaded guide 84. The handle housing 40 is provided with an inner tube movable guide groove, the inner tube connector 402 is disposed in the handle housing 40 (specifically in the first handle housing 41), and the inner tube threaded guide 84 is movably disposed in the inner tube movable guide groove, and the inner tube is connected to the inner tube connector 402.

[0096] Specifically, see Fig. 9The inner tube connector 402 includes a hollow inner tube plug-in section 81 and a first cylindrical fixing block 82. The outer circumference of the first cylindrical fixing block 82 matches the inner circumference of the handle housing 40, and the inner tube is plugged into the inner tube plug-in section 81. The setting of the first cylindrical fixing block 82 can make it fit with the handle housing 40 to increase the contact area between the two. When the cylindrical fixing block 82 moves axially along the handle housing 40, the movement is smoother and there will be no shaking, thereby improving the accuracy of valve control. The design of the inner tube plug-in section 81 can correspondingly extend the contact area and contact length between the inner tube connector 402 and the inner tube 1, improve the centrality of the inner tube 1, and reduce the risk of the valve not being released due to the bending or even bending of the inner tube 1 during the axial movement of the inner tube 1.

[0097] More specifically, see Fig. 9 , a threaded guide 84 is provided on the outer periphery of the first cylindrical fixing block 82, and the threaded guide 84 passes through the inner tube moving guide groove and is threadedly connected to the distal release knob 600. During use, the inner tube 1 is fixedly connected to the first cylindrical fixing block 82, and the distal release knob 600 is rotated to drive the inner tube 1 to move axially toward the distal end, and the distal end of the inner tube 1 is separated from the proximal end of the heart valve, releasing the proximal end of the heart valve. A reinforcing tube (not shown) is provided between the cylindrical fixing block 82 and the inner tube 1, and the reinforcing tube is fixedly connected to the inner tube 1 to prevent the cylindrical fixing block 82 from moving with the inner tube 1 and damaging the inner tube 1.

[0098] More specifically, see Fig. 9 A first limiting column 414 is provided in the handle housing 40, and is located at the distal end of the inner tube movement guide groove, and is used to limit the movement end point of the inner tube connector 402, that is, the first limiting column 414 is provided near the distal end of the inner tube connector 402, and the first limiting column 414 and the handle housing 40 jointly form a movement space of the inner tube connector 402, so as to ultimately limit the axial movement distance of the inner tube 1. That is, the inner tube movement guide groove and the first limiting column 414 jointly ensure the stability of the inner tube movement.

[0099] Also, see Fig. 9 An inner tube emptying tube 401 is provided at the proximal end of the inner tube connector 402, which is used to inject physiological saline to exhaust the air in the inner tube. Specifically, a through hole is provided in the middle of the inner tube connector 402, and the distal end of the inner tube emptying tube 401 passes through the through hole and is connected with the inner tube 1 inside the cylindrical fixing block 82. When operating the conveyor, physiological saline or the like is injected into the inner tube emptying tube 401 to exhaust the air in the inner tube. For example, the inner tube emptying tube 401 is connected to a Luer connector, through which it can be connected to an external syringe or other injection device.

[0100] B2, the proximal release structure corresponds to Figure 1The proximal release knob 500 is shown, and the movement of the proximal release structure is controlled by rotating the proximal release knob 500. Figure 1 , 8 10, specifically, the proximal release structure includes an outer tube connector 405, an outer tube threaded guide 94 disposed on the outer tube connector 405, and a proximal release knob 500 threadedly connected to the outer tube threaded guide 94. The handle housing 40 is provided with an outer tube moving guide groove, the outer tube connector is disposed in the handle housing 40, and the outer tube threaded guide can be movably disposed in the outer tube moving guide groove.

[0101] Specifically, the proximal release structure is substantially the same as the distal release structure, the outer tube connector 405 comprises a hollow outer tube plug-in section 91 and a second cylindrical fixing block 92, the outer periphery of the second cylindrical fixing block 92 matches the inner periphery of the handle housing 40, the outer tube is plugged into the outer tube plug-in section 91, and the outer periphery of the second cylindrical fixing block 92 is provided with an outer tube threaded guide 94, which passes through the outer tube moving guide groove and is threadedly connected with the proximal release knob 500. The second cylindrical fixing block 92 is provided so that it can fit with the handle housing 40 to increase the contact area between the two. When the second cylindrical fixing block 92 moves axially along the handle housing 40, the movement is more stable and there is no shaking, thereby improving the accuracy of valve control. The design of the outer tube plug-in section 91 can correspondingly extend the contact area and contact length between the outer tube connector 405 and the outer tube 3, improve the centrality of the outer tube 3, and reduce the risk that the valve cannot be released due to the bending or even bending of the inner tube during the axial movement of the outer tube 31.

[0102] See also Fig.10 The outer tube plug section 91 is provided with a reinforcing rib 95 on the outside. The reinforcing rib 95 gradually increases in radial direction from the distal end to the proximal end until it is connected to the inner side wall of the second cylindrical fixing block 92. More specifically, see Fig.10 The outer tube connector 405 also includes an outer tube connection sealing cover 93. The outer tube plug-in section 91 and the outer tube connection sealing cover 93 are respectively connected to the distal end and the proximal end of the second cylindrical fixing block 92. The outer tube connection sealing cover 93 plays a good sealing role.

[0103] It is worth noting that the proximal release structure and the distal release structure are basically the same, and their specific structures can be referenced to each other.

[0104] B3, valve fixing structure package corresponds to Figure 1 The proximal release structure of the first sleeve 700 shown in the figure always remains relatively stationary with the handle housing 40 to accurately control the delivery and release position of the valve. Figure 8 , 9And 11, the valve fixing structure includes a middle tube connector 403 fixed in the handle shell 40. During the process of conveying the valve, the middle tube connector 403 always remains relatively still with the handle shell 40. The middle tube connector 403 includes a hollow middle tube plug-in section 51 and a third cylindrical fixing block 52. The outer periphery of the third cylindrical fixing block 52 matches the inner periphery of the handle shell 40, thereby increasing the contact area with the handle shell 40 and improving the stability of the conveyor. The middle tube is plugged into the middle tube plug-in section 51.

[0105] More specifically, see Fig.11 The middle tube connector 403 also includes a middle tube connection sealing cover 53. The middle tube plug-in section 51 and the middle tube connection sealing cover 53 are respectively connected to the distal end and the proximal end of the third cylindrical fixing block 52. The middle tube connection sealing cover 53 plays a good sealing role.

[0106] As Fig. 9 As shown, the middle tube plug section 51 has a certain length, which can correspondingly extend the contact area and contact length between the middle tube connector 403 and the middle tube 2, and keep the position of the middle tube 2 relative to the handle housing 40 (first handle housing 41) unique and stable, so the following structural settings are made to facilitate stability:

[0107] Specifically, see Fig.11 The third cylindrical fixing block 52 is provided with at least one insertion hole 54, and the inner side of the handle shell 40 is provided with a plug that cooperates with the insertion hole 54. The plug is inserted into the insertion hole 54 to limit the axial position of the middle tube connector 403 to maintain relative stillness with the handle shell 40.

[0108] More specifically, see Fig.11 The outer periphery of the middle pipe inserting section 51 is provided with a radial rib 55, and one end of the rib 55 is connected to the third cylindrical fixing block 52. The radial rib 55 plays a role of further fixing.

[0109] Example 2

[0110] See also Figure 6 and 1215, a precisely positioned regurgitant heart valve delivery system, comprising a regurgitant heart valve and a regurgitant heart valve delivery device, wherein the regurgitant heart valve comprises a valve stent 10 and a valve connected to the valve stent, and the valve stent 10 comprises a plurality of positioning members 20. Specifically, a pull-wire composite ring 2001 is provided at the free end of the positioning member 20, and the pull-wire hole is provided in the pull-wire composite ring 2001. Preferably, the material of the pull-wire composite ring 2001 is a developing material. Specifically, a mark "marker" (the mark is radiopaque) is provided at the distal end of the conventional positioning member. Although the setting of the "marker" facilitates the positioning implantation of the stent to a certain extent, there is a risk of the "marker" falling off. If the "marker" falls off and enters other organs with the blood flow, this will seriously affect the safety of the user. The pull-wire composite ring 2001 of this embodiment cancels the "marker" installation hole, but sets the pull-wire composite ring 2001 itself to have a developing function, thereby increasing the safety of the user. An X-ray-proof marking layer may be provided on the surface of the connecting plate of the wire drawing composite ring 2001 or a high-density metal plating layer may be added to the surface of the connecting plate, so that the wire drawing composite ring 2001 can be more clearly seen under X-rays.

[0111] Preferably, the pull wire compound ring 2001 is a regular or irregular geometric shape, that is, the outer contour of the connecting plate of the pull wire compound ring 2001 can be set to one or more of a gourd shape, a triangle, a circle, a diamond shape or a cat's paw shape. The pull wire compound ring 2001 has a specific shape, which is convenient for operators to quickly identify the pull wire compound ring 2001, thereby replacing the mark "marker".

[0112] The method of using the above-mentioned delivery device is briefly described as follows: 1) compress and load the regurgitant heart valve to the distal end of the delivery device and fix it with corresponding components; 2) deliver the delivery device from the left femoral artery against the blood flow to the descending aorta, pass through the aortic arch, and enter the ascending aorta; 3) control the rotation of the valve release part 612 by connecting the knob 400, cooperate with the external imaging device, drive the heart valve to rotate so that the positioning member 20 is aligned with the sinus bottom; 4) after entering the ascending aorta, adjust the center adjustment knob 200 to adjust the heart valve to the central axis of the ascending aorta, Ensure the centering of the heart valve; (wherein step 3) and step 4) can be performed in reverse order or alternately); 5) control the valve release part 612 to approach the valve control part 611, rotate the valve advancement knob 300 to drive the valve release part 612 to be transported into the body as a whole, the positioning part 20 captures the native valve leaflet, the positioning part enters the sinus, and the valve is placed at the aortic valve to replace the native valve; 7) rotate the distal release knob 600 to release the distal end of the heart valve; 8) rotate the proximal release knob 500 to release the proximal end of the heart valve; 9) exit the conveyor.

[0113] The above description of the embodiments is to facilitate those of ordinary skill in the art to understand and apply the present application. It is obvious that those familiar with the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without having to pay creative labor. Therefore, the present application is not limited to the embodiments herein, and improvements and modifications made by those skilled in the art based on the contents disclosed in the present application without departing from the scope and spirit of the present application are within the scope of the present application.

Claims

1. A regurgitant heart valve delivery device with stable operation, comprising a delivery device handle (6), wherein the delivery device handle (6) comprises a handle housing (40), a valve delivery tube assembly connected to the handle housing (40), and an outer sheath tube assembly disposed in the handle housing (40); It is characterized in that The conveyor handle (6) comprises a valve control part (611) and a valve release part (612), the valve conveying tube assembly is connected to the valve release part (612), and the outer sheath tube (5) is connected to the valve control part (611); The conveyor handle (6) also includes a valve propulsion structure disposed between the valve control portion (611) and the valve release portion (612); the valve propulsion structure includes a valve propulsion sleeve (408) slidably disposed in the handle housing (40) and used to move the valve release portion (612) closer to or farther away from the valve control portion (611).

2. The regurgitant heart valve delivery device according to claim 1, characterized in that: The valve advancement structure also includes a valve advancement knob (300), a advancement thread guide (420) is provided at the distal end of the valve advancement sleeve (408), the handle housing (40) is provided with an advancement axial guide groove (401), the advancement thread guide (420) is movably arranged in the advancement axial guide groove, and the advancement thread guide (420) is threadedly connected to the valve advancement knob (300).

3. The regurgitant heart valve delivery device according to claim 2, characterized in that: The handle housing comprises a first housing (41) and a second housing (42) which can move closer to and farther from each other, the valve control unit (611) is located in the second housing (42), and the valve release unit (612) is located in the first housing; The propulsion axial guide groove is arranged on the second shell (42), and the proximal end of the valve propulsion sleeve (408) is controllably rotatably connected to the first shell.

4. The regurgitant heart valve delivery device according to claim 3, characterized in that: The valve propulsion structure further comprises a connecting knob (400), and a connecting gear (407) is provided at the proximal end of the valve propulsion sleeve (408); The first shell is provided with a threaded hole; the connecting knob (400) is screwed and passed through the threaded hole to be snap-fitted and connected with the connecting gear (407).

5. The regurgitant heart valve delivery device according to any one of claims 1 to 2 or 4, characterized in that: The valve delivery tube assembly comprises an inner tube, a middle tube and an outer tube which are sleeved in sequence. The proximal end of the regurgitant heart valve is bound between the middle tube and the outer tube, and the distal end is bound between the middle tube and the inner tube.

6. The regurgitant heart valve delivery device according to claim 5, characterized in that: The inner tube member comprises an inner tube (1) and a front loading head sheath (11) located at the distal end of the inner tube (1); the outer tube member comprises an outer tube (3) and a rear loading sheath (31) located at the distal end of the outer tube (3); the middle tube member comprises a middle tube (2), and from the distal end to the proximal end of the middle tube (2), the middle tube (2) is provided with a first stepped groove (21), a valve bearing portion (22) and a second stepped groove (23); the front loading head sheath (11) cooperates with the first stepped groove (21) to form a front loading bin, and the rear loading sheath (31) cooperates with the second stepped groove (23) to form a rear loading bin; And / or, the valve delivery tube assembly further comprises a distal release structure connected to the inner tube, a valve fixing structure connected to the middle tube, and a proximal release structure connected to the outer tube; The valve fixing structure is fixedly connected to the handle shell (40); the distal release structure is slidably connected to the handle shell (40) and is used to drive the inner tube to move axially along the handle shell (40); the proximal release structure is slidably connected to the handle shell (40) and is used to drive the outer tube to move axially along the handle shell (40).

7. The regurgitant heart valve delivery device according to claim 6, characterized in that: The distal release structure comprises an inner tube connector (402), an inner tube threaded guide (84) disposed on the inner tube connector (402), and a distal release knob (600) threadedly connected to the inner tube threaded guide (84); the handle housing (40) is provided with an inner tube movable guide groove, the inner tube connector (402) is disposed in the handle housing (40), and the inner tube threaded guide (84) is movably disposed in the inner tube movable guide groove, and the inner tube member is connected to the inner tube connector (402); And / or, the proximal release structure comprises an outer tube connector, an outer tube threaded guide member disposed on the outer tube connector, and a proximal release knob (500) threadedly connected to the outer tube threaded guide member; the handle housing (40) is provided with an outer tube movable guide groove, the outer tube connector is disposed in the handle housing (40), and the outer tube threaded guide member is movably disposed in the outer tube movable guide groove; And / or, the valve fixing structure includes a middle tube connector (403) fixed in the handle shell (40), the middle tube connector (403) includes a hollow middle tube plug-in section (51) and a third cylindrical fixing block (52), the outer periphery of the third cylindrical fixing block (52) matches the inner periphery of the handle shell (40), and the middle tube is plugged into the middle tube plug-in section (51).

8. The regurgitant heart valve delivery device according to claim 7, characterized in that: The inner tube connector (402) comprises a hollow inner tube plug-in section (81) and a first cylindrical fixing block (82), the outer circumference of the first cylindrical fixing block (82) matches the inner circumference of the handle housing (40), and the inner tube member is plugged into the inner tube plug-in section (81); And / or, a first limiting column (414) is provided in the handle housing (40), located at the far end of the inner tube movement guide groove, and is used to limit the movement end point of the inner tube connector (402); And / or, the third cylindrical fixing block (52) is provided with at least one insertion hole (54), and the inner side of the handle housing (40) is provided with a plug column that matches the insertion hole (54); And / or, a radial rib (55) is provided on the outer periphery of the middle tube inserting section (51), and one end of the rib (55) is connected to the third cylindrical fixing block (52).

9. A regurgitant heart valve delivery system with stable operation, characterized in that: It comprises a regurgitant heart valve and a regurgitant heart valve delivery device as claimed in any one of claims 1 to 8; the regurgitant heart valve comprises a valve support (10) and a valve connected to the valve support, and the valve support (10) comprises a plurality of positioning members (20).

10. The heart valve delivery system according to claim 9, characterized in that: A wire-pulling composite ring (2001) is provided at the free end of the positioning member (20); the material of the wire-pulling composite ring (2001) is a developing material; and / or the wire-pulling composite ring (2001) is a regular or irregular geometric shape.

11. The heart valve delivery system according to claim 10, characterized in that: The wire pulling composite ring (2001) is provided with a wire pulling hole.

Images