Valve delivery system and methods of using the same

Abstract

The application provides a valve delivery system and a method thereof, the valve delivery system comprising a first housing, a sheath assembly, a bending control assembly, a second housing, a proximal end assembly, a hanger assembly and a distal end assembly, the sheath assembly and the bending control assembly are arranged in the first housing, a positioning member release pipe is movable along the axial direction of the first housing, the bending control assembly is capable of controlling the bending degree of the positioning member release pipe, a distal end release pipe of the distal end assembly and a proximal end release pipe of the proximal end assembly are arranged in the positioning member release pipe, the distal end release pipe is connected with a distal end hanger seat, the proximal end release pipe is connected with a proximal end hanger seat, a valve stent is loaded on the hanger assembly, the second housing is rotated to position the valve stent in the circumferential direction, and the proximal end assembly and the distal end assembly are controlled to axially deliver and release the valve stent. The valve delivery system of the application realizes the delivery and release of the valve stent through one access, improves the fault tolerance and accuracy of the release of the valve stent, and is convenient to operate.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a valve delivery system and its method of use. Background Technology

[0002] The aortic valve opens with the contraction of the left ventricle to pump blood into the aorta. If the aortic valve fails to close properly, blood can leak back from the aorta into the left ventricle as the left ventricle relaxes to fill with blood from the left atrium. This backflow is called regurgitation, and in severe cases, it can lead to heart failure and pulmonary effusion. Drug therapy is not very effective in slowing the progression of heart failure, and most treatments involve replacing the valve with an artificial one. Currently, there are few catheter-based devices available for treating aortic regurgitation. Most are designed via the femoral artery approach, with a modular design consisting of an ultra-long valve catheter, a guide sheath, and a delivery handle. This modular design is often disorganized, and the prosthetic valve is typically deployed simultaneously at both the proximal and distal ends, posing uncontrollable risks. Furthermore, once the distal end is deployed first, further adjustments are not possible. Summary of the Invention

[0003] In view of this, the purpose of the present invention is to provide a valve delivery system that can solve the problems existing in the prior art, realize the delivery and release of valve stents through a single access, improve the fault tolerance and release accuracy of valve stents, and has a simple structure and convenient operation.

[0004] This invention provides a valve delivery system, including a delivery device and a release device connected to each other. The release device is movable relative to the delivery device. The delivery device includes a first housing, a sheath assembly, and a bending control assembly. The sheath assembly and the bending control assembly are disposed within the first housing. A positioning release tube of the sheath assembly is used to accommodate a valve stent. The positioning release tube is movable along the axial direction of the first housing. The bending control assembly is used to bend the positioning release tube. The release device includes a second housing, a proximal assembly, an ear assembly, and a distal assembly. The second housing is connected to the first housing. The proximal assembly, the ear assembly, and the distal assembly are respectively disposed within the second housing. The distal release tube of the distal assembly, the proximal release tube of the proximal assembly, and the ear tube of the ear assembly are respectively disposed within the positioning release tube. The valve stent is respectively loaded at the distal end of the proximal assembly, the distal end of the ear assembly, and the distal end of the distal assembly.

[0005] In one embodiment, the sheath assembly includes a positioning knob and a positioning tube seat. The positioning release tube extends through the first housing and the second housing. The distal end of the positioning release tube is a larger diameter end, and the proximal end of the positioning release tube is fixedly connected to the positioning tube seat. The positioning tube seat is movably disposed within the first housing.

[0006] In one embodiment, the bending control assembly includes a bending control tube, a movable component, a bending control element, a bending control knob, and a bending control tube seat. The proximal end of the bending control tube is fixedly connected to the bending control tube seat, and the distal end of the bending control tube passes through the positioning element tube seat and is disposed within the positioning element release tube. The movable component is movably connected to the bending control tube seat. One end of the bending control element is connected to the movable component, and the other end of the bending control element is connected to the distal end of the bending control tube. The bending control knob is fixedly connected to the bending control tube seat.

[0007] In one embodiment, the proximal assembly includes a proximal tube seat, the distal end of the proximal release tube is a large-diameter variable end, the distal end of the proximal release tube is connected to the proximal end of the ear assembly, the proximal end of the proximal release tube is fixedly connected to the proximal tube seat, and the proximal tube seat is movable within the second housing along the axial direction of the second housing.

[0008] In one embodiment, the proximal assembly further includes a safety clamp, and the second housing has a through hole through which the safety clamp clamps the proximal tube seat, the safety clamp being used to limit the position of the proximal tube seat.

[0009] In one embodiment, the ear loop assembly includes an ear loop tube, a proximal ear loop seat, a distal ear loop seat, and an ear loop tube seat. One end of the ear loop tube is fixedly connected to the ear loop tube seat. The proximal ear loop seat is sleeved outside the ear loop tube, and the distal ear loop seat is sleeved outside the ear loop tube and fixedly connected to the ear loop tube; or the proximal ear loop seat is sleeved outside the ear loop tube and fixedly connected to the ear loop tube, and the distal ear loop seat is sleeved outside the ear loop tube.

[0010] In one embodiment, the positioning tube seat is fixedly connected to a first guide block, and the first housing is provided with a first guide groove that mates with the first guide block, the first guide groove being arranged along the axial direction of the first housing; and / or, the ear tube seat is also fixedly connected to a second guide block, and the second housing is also provided with a second guide groove corresponding to the second guide block, the second guide block and the second guide groove mate to make the ear tube seat radially fixed relative to the second housing; and / or, the moving member is fixedly connected to a third guide block, and the first housing is provided with a third guide groove that mates with the third guide block, the third guide groove being arranged along the length direction of the first housing.

[0011] In one embodiment, the distal assembly includes a distal tube seat and a distal knob. The proximal end of the distal release tube is fixedly connected to the distal end of the distal tube seat. The distal knob is threadedly connected to the distal tube seat. Rotating the distal knob can drive the distal tube seat to move the distal release tube axially to release the distal end of the valve stent.

[0012] In one embodiment, the distal release tube includes a tip, a connecting section, and an inner tube. The inner tube and the connecting section are respectively fixedly connected to the tip. The connecting section is arranged circumferentially around the inner tube. An accommodating area is formed between the connecting section and the inner tube. The end of the connecting section is spliced ​​with the positioning release tube.

[0013] In one embodiment, the distal end of the second housing is embedded in the proximal end of the first housing, and the valve delivery system further includes a locking knob for defining the relative positions of the first housing and the second housing.

[0014] The present invention also relates to a method of using the above-described valve delivery system, the method comprising:

[0015] The valve stent of the valve assembly is loaded into the valve delivery system through the loading system and inserted into the preset position.

[0016] Control the positioning knob to retract the positioning release tube to a preset distance and release the positioning element of the valve stent;

[0017] Control the bending knob, and the bending tube will drive the positioning component release tube to the release position, so that its axis is aligned;

[0018] Control the locking knob to push the entire release device further to the distal end; control the second housing to perform circumferential positioning, and push the entire release device further to the distal end again;

[0019] First release the proximal end of the valve stent; or first release the distal end of the valve stent.

[0020] Double-check that the valve stent release position meets the requirements;

[0021] Then release the distal end of the valve stent; or release the proximal end of the valve stent.

[0022] The valve delivery system of this invention integrates two separate structures, a delivery device and a release device, into one unit. The delivery device completes the delivery of the valve stent, catheter bending control, and valve alignment. The release device performs fine-tuning of the valve stent to achieve circumferential alignment, proximal release, and distal release. Valve stent release can be achieved through a single access, which is not only convenient and time-saving, but also reduces patient discomfort and improves error tolerance and release accuracy. The dual-hook structure, with one fixed and one movable, provides greater stability during valve loading, delivery, and release. By manipulating the proximal and distal components, fine-tuning of the valve stent can be performed before and during partial release, reducing the requirements for the surgeon's experience and skill level. This valve delivery system has a simple structure, reduces production costs, thereby reducing surgical expenses for patients and alleviating their financial burden. Attached Figure Description

[0023] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the valve delivery system of the present invention.

[0025] Figure 2 This is a top view of the valve delivery system of the present invention.

[0026] Figure 3 This is a perspective structural diagram of the valve delivery system of the present invention.

[0027] Figure 4 This is a partial structural diagram of the valve delivery system of the present invention with part of the second housing removed.

[0028] Figure 5 This is a partial cross-sectional view of the valve delivery system of the present invention.

[0029] Figure 6 This is a cross-sectional view of the safety clamp of the valve delivery system of the present invention.

[0030] Figure 7 yes Figure 3 A schematic diagram of the cross-sectional structure at point A in the middle.

[0031] Figure 8 This is a schematic diagram of the valve stent of the present invention.

[0032] Figure 9 This is a schematic diagram of the proximal ear mount of the present invention.

[0033] Figure 10 This is a schematic diagram of the release positioning component of the valve delivery system of the present invention.

[0034] Figure 11 This is a schematic diagram of the valve delivery system of the present invention during bending control.

[0035] Figure 12 This is a schematic diagram of the valve delivery system of the present invention during the alignment and adjustment of the valve stent.

[0036] Figure 13 This is a schematic diagram of the valve delivery system of the present invention for proximal release of the valve stent.

[0037] Figure 14This is a schematic diagram of the valve delivery system of the present invention for distal release of the valve stent.

[0038] Figure 15 This is a schematic diagram of the process by which the positioning device release tube and the distal release tube of the valve delivery system of the present invention return to their initial state.

[0039] Figure 16 This is a schematic diagram of the valve delivery system of the present invention after the positioning release tube and the distal release tube have been restored to their initial state and combined.

[0040] Reference numerals: Through hole - 101; Reception area - 102; Display window - 103; First housing - 11; Sheath assembly - 12; Positioning member release tube - 121; Positioning member knob - 122; Positioning member tube seat - 123; First sealing cap - 124; Bending control assembly - 13; Bending control tube - 131; Moving part - 132; Bending control part - 133; Bending control knob - 134; Bending control tube seat - 135; Second sealing cap - 136; Second housing - 14; Proximal assembly - 15; Proximal release tube - 151; Proximal tube seat - 152; First plane - 1521; Second plane - 1 522; Safety clamp-153; Ear loop assembly-16; Ear loop tube-161; Proximal ear loop seat-162; First ear loop groove-1621; Distal ear loop seat-163; Ear loop tube seat-164; Ear loop sealing cap-165; Second guide block-166; Distal assembly-17; Distal release tube-171; Tip-1711; Connecting section-1712; Inner tube-1713; Distal tube seat-172; Distal knob-173; Locking knob-18; Valve stent-20; Stent body-21; Positioning element-22; Proximal ear loop-23; Distal ear loop-24.

[0041] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0042] The specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings. Obviously, the described embodiments are merely some, not all, of the embodiments of the present invention. Based on the description of the present invention, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of the present invention.

[0043] In the description of this invention, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0044] The terms “upper,” “lower,” “left,” “right,” “front,” “back,” “top,” “bottom,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of the invention is in use. They are only for the convenience of description and simplification, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0045] The terms “first,” “second,” “third,” etc., are used merely to distinguish elements with similar properties, not to indicate or imply relative importance or a specific order.

[0046] The terms “include,” “comprising,” or any other variation thereof are intended to cover non-exclusive inclusion, which includes not only the elements listed but also other elements not expressly listed.

[0047] As described herein, when referring to the first housing, second housing, positioning release tube, proximal release tube, distal release tube, bend control tube, positioning tube seat, bend control tube seat, proximal seat, ear seat, distal seat, etc., "proximal" refers to the side of the positioning release tube located in the extended state or the side located closer to the end operated by the user. Correspondingly, "distal" refers to the side of the positioning release tube located away from the extended state or the side located away from the end operated by the user.

[0048] like Figures 1 to 9As shown, the valve delivery system includes a delivery device and a release device connected to each other. The release device is movable relative to the delivery device. The delivery device includes a first housing 11, a sheath assembly 12, and a bending control assembly 13. The sheath assembly 12 and the bending control assembly 13 are disposed within the first housing 11. The positioning release tube 121 of the sheath assembly 12 is used to accommodate the valve stent 20. The positioning release tube 121 is movable along the axial direction of the first housing 11. The bending control assembly 13 can control the curvature of the positioning release tube 121. The release device includes a second housing 14, a proximal assembly 15, an ear assembly 16, and a distal assembly 17. The second housing 14 is connected to the first housing. 11. The proximal assembly 15, the ear-mount assembly 16, and the distal assembly 17 are respectively disposed within the second housing 14. The distal release tube 171 of the distal assembly 17, the proximal release tube 151 of the proximal assembly 15, and the ear-mount assembly 16 are respectively disposed within the positioning member release tube 121. The distal release tube 171 is connected to the distal ear-mount seat 163 of the ear-mount assembly 16, and the proximal release tube 151 is connected to the proximal ear-mount seat 162 of the ear-mount assembly 16. The valve stent 20 is mounted on the ear-mount assembly 16. Rotating the second housing 14 can circumferentially position the valve stent 20. Manipulating the proximal assembly 15 and the distal assembly 17 can axially deliver and release the valve stent 20. In this embodiment, the first housing 11 and the second housing 14 are assembled in upper and lower halves, respectively, and fixed by pin holes and screws. The assembled first housing 11 and second housing 14 are preferably tubular hollow structures, with the inner diameter of the first housing 11 being larger than the inner diameter of the second housing 14. The distal end of the second housing 14 is embedded in the proximal end of the first housing 11, and the second housing 14 can move axially and rotate circumferentially relative to the first housing 11. The valve delivery system also includes a locking knob 18, one end of which is connected to the first housing 11, and the other end of which is used to fix the second housing. The locking knob 18 is used to fix the relative position of the second housing 14 and the first housing 11 to avoid accidental operation. The first housing 11 and the second housing 14 can be fixed in the following ways: the locking knob 18 can fix the second housing 14 by abutting against it, that is, by limiting the movement of the second housing 14 through friction; or the second housing 14 is provided with a groove, and the locking knob 18 is inserted into the groove to fix the relative position of the first housing 11 and the second housing 14. Therefore, the method of fixing the first housing 11 and the second housing 14 is not limited here.

[0049] The valve delivery system of this invention integrates two separate structures, a delivery device and a release device, into one unit. The delivery device completes the delivery of the valve stent 20, catheter bending control, and valve alignment. The release device fine-tunes the valve stent 20 to achieve circumferential alignment, proximal release, and distal release. The valve stent 20 can be released through a single access, which is not only convenient and time-saving, reducing patient discomfort, but also improves error tolerance and release accuracy. The dual-hook structure, with one fixed and one movable, provides higher stability for valve loading, delivery, and release. By operating the proximal component 15 and the distal component 17, fine-tuning of the valve stent 20 can be performed before and during partial release, reducing the requirements for the surgeon's experience and skill level. This valve delivery system has a simple structure, reduces production costs, thereby reducing surgical expenses for patients and alleviating their economic burden.

[0050] like Figure 8 As shown, the valve stent 20 includes a stent body 21, a positioning element 22, a proximal loop 23, a distal loop 24, and a prosthetic valve. The stent body 21 has a mesh-like structure. The positioning element 22 is provided on the stent body 21. The proximal loop 23 is placed at one end of the stent body 21, and the distal loop 24 is connected to the other end of the stent body 21. The prosthetic valve is connected to the stent body 21. The valve stent 20 is made of shape memory alloy material, such as nickel-titanium alloy. When not restrained, the valve stent 20 can automatically deploy and has a certain radial support force.

[0051] like Figure 2 and Figure 3As shown, the sheath assembly 12 includes a positioning knob 122 and a positioning tube seat 123. The positioning release tube 121 passes through the first housing 11 and the second housing 14. The distal end of the positioning release tube 121 is the larger diameter end, while the remaining sections are of constant diameter. The sections of the positioning release tube 121 that require bending can bend automatically. The positioning release tube 121 is the outermost covering tube that encloses the valve stent 20 in its compressed state. The positioning release tube 121 can be made of, but is not limited to, an outer Pebax tube + a metal braided middle layer. The inner layer is composed of +PTFE. The proximal end of the positioning release tube 121 is fixedly connected to the positioning tube seat 123, which can be sealed and fixed by means of glue or welding. The positioning tube seat 123 is movably disposed in the first housing 11. The positioning knob 122 is threadedly connected to the positioning tube seat 123. Rotating the positioning knob 122 can drive the positioning tube seat 123 to move the positioning release tube 121 along the axial direction of the first housing 11, thus realizing the forward and backward movement of the positioning release tube 121. In this embodiment, the threaded connection between the positioning knob 122 and the positioning tube seat 123 can be a single-start thread, a double-start thread, or a multi-start thread. Using a multi-start thread can increase the axial movement speed of the positioning release tube 121. Therefore, the thread of the threaded connection between the positioning knob 122 and the positioning tube seat 123 can be selected according to the requirements.

[0052] like Figure 3 As shown, the positioning element tube seat 123 is fixedly connected to a first guide block. The first housing 11 is provided with a first guide groove that cooperates with the first guide block. The first guide groove is arranged along the axial direction of the first housing 11. When the positioning element tube seat 123 moves, the first guide block and the first guide groove cooperate to radially limit the positioning element tube seat 123, preventing the positioning element tube seat 123 and the positioning element release tube 121 from rotating circumferentially during movement. The positioning element release tube 121 is mainly used to restrain the valve stent 20 and its positioning element 22. By rotating the positioning element knob 122 clockwise, the positioning element 22 of the valve stent 20 is automatically released as the positioning element 22 is released and retracted (i.e., the positioning element release tube 121 moves axially towards the proximal end).

[0053] like Figures 1 to 3 as well as Figure 7As shown, the bending control assembly 13 includes a bending control tube 131, a movable component 132, a bending control component 133, a bending control knob 134, and a bending control tube seat 135. The proximal end of the bending control tube 131 is fixedly connected to the bending control tube seat 135 and sealed and fixed by means of glue or welding. The bending control tube 131 is composed of, but is not limited to, an outer Pebax tube + a metal braided middle layer + a PTFE inner layer + a bending control metal wire. The entire length of the bending control tube 131 is a tube of equal diameter. The distal end of the bending control tube 131 passes through the positioning component tube seat 123 and is set inside the positioning component release tube 121. The movable part 132 is threadedly connected to the bending control tube seat 135. One end of the bending control part 133 is connected to the movable part 132, and the other end of the bending control part 133 is connected to the distal end of the bending control tube 131. The bending control part 133 is also known as the bending control thread. The bending control knob 134 is fixedly connected to the bending control tube seat 135. Rotating the bending control knob 134 causes the movable part 132 to move, thereby driving the tightening and loosening of the bending control part 133 to control the bending degree of the bending control tube 131 and the positioning release tube 121. The large end of the bending control tube seat 135 is a square anti-rotation flange, which is embedded in the first housing. Within the slot of 11, the axial width of the slot can restrict the axial movement of the bending control tube seat 135 relative to the first housing 11. The bending control tube seat 135 includes a first screw section and a first cylindrical section fixedly connected. The first cylindrical section passes through the bending control knob 134 and is fixedly connected to the bending control knob 134. The first screw section is threadedly connected to the moving member 132. When the bending control knob 134 is rotated, the moving member 132 moves along the axial direction of the first screw section. Since the bending control wire is connected between the moving member 132 and the bending control tube 131, the movement of the moving member 132 can... The control wire can be tightened and loosened to achieve the bending of the control tube 131. The control tube 131 is set inside the positioning member release tube 121, so the curvature of the positioning member release tube 121 is consistent with the curvature of the control tube 131. In particular, a third guide block is fixedly connected to the moving member 132. The first housing 11 is provided with a third guide groove that cooperates with the third guide block. The third guide groove is set along the length direction of the first housing 11. The third guide block is set inside the third guide groove. Therefore, the moving member 132 can only make axial displacement when it moves.

[0054] like Figure 2 As shown, the first housing 11 is provided with a display window 103, and the moving part 132 is provided with a position indicator point. The position indicator point is set in correspondence with the display window 103. When the operator uses the valve delivery system to operate, he / she can observe the bending state in the display window 103 of the first housing 11, so as to improve the bending efficiency and bending accuracy of the bending control tube 131.

[0055] like Figure 3As shown, the sheath assembly 12 also includes a first sealing cap 124, a first sealing element, and a first venting pipe. The control tube 131 and the positioning tube seat 123 are radially sealed by the first sealing cap 124. The first sealing element is disposed between the positioning tube seat 123 and the first sealing cap 124. The first sealing element is preferably a rubber ring or a silicone ring, etc. The first venting pipe is used to vent the air in the sheath assembly 12.

[0056] Preferably, the bending control assembly 13 further includes a second sealing cap 136, a second sealing element, and a second venting pipe. The tail end of the bending control tube seat 135 passes through the proximal release tube 151 and is sealed by the second sealing cap 136 and the second sealing element. The second sealing element is disposed between the bending control tube seat 135 and the second sealing cap 136. The second sealing element is preferably a rubber ring or a silicone ring, etc. The second venting pipe is used to vent the air in the bending control assembly 13.

[0057] like Figure 3 As shown, the proximal assembly 15 includes a proximal tube seat 152, and the distal end of the proximal release tube 151 is a large-diameter reducing end. The distal end of the proximal release tube 151 is close to the proximal end of the lug assembly 16. The proximal end of the proximal release tube 151 is fixedly connected to the proximal tube seat 152 and sealed by means of glue or welding. The proximal release tube 151 may be composed of, but is not limited to, an outer Pebax tube + a metal braided middle layer + a PTFE inner layer. The distal end of the proximal release tube 151 is a large-diameter reducing end, while the remaining sections are of equal diameter. The proximal tube seat 152 can move within the second housing 14 along the axial direction of the second housing 14. In this embodiment, the large end of the proximal tube seat 152 is a square anti-rotation flange, which is embedded in the second housing 14, so that the proximal assembly 15 can only move axially a short distance relative to the second housing 14 to release the proximal end of the valve stent 20.

[0058] like Figure 1 , Figure 2 and Figure 5 As shown, the proximal assembly 15 also includes a safety clamp 153. The second housing 14 is provided with a through hole 101. The safety clamp 153 passes through the through hole 101 to clamp the proximal tube seat 152. The safety clamp 153 is used to limit the proximal tube seat 152.

[0059] like Figure 3 and Figure 7As shown, the ear loop assembly 16 includes an ear loop tube 161, a proximal ear loop seat 162, a distal ear loop seat 163, and an ear loop tube seat 164. One end of the ear loop tube 161 is fixedly connected to the ear loop tube seat 164. The proximal ear loop seat 162 is sleeved on the ear loop tube 161 and can move axially to finely adjust the position of the valve stent 20. The distal ear loop seat 163 is sleeved on the ear loop tube 161 and fixedly connected to the ear loop tube 161. It can be sealed and fixed by means of adhesive or welding. The ear loop tube 161 is preferably a conventional PI tube or nickel-titanium tube. In this embodiment, to prevent the proximal release tube 151 from rotating radially on its own, a first plane 1521 and a second plane 1522 are provided in the inner hole of the proximal tube seat 152, which is fixedly connected to the proximal release tube 151. The proximal ear seat 162 is provided with a third plane and a fourth plane. The third plane is corresponding to the first plane 1521, and the fourth plane is corresponding to the second plane 1522. The main function of the proximal assembly 15 is to drive the proximal tube seat 152 to move axially so as to drive the proximal release tube 151 to move proximally. After the proximal ear seat 162 fully exposes the valve stent 20 of the proximal release tube 151, the proximal end of the valve stent 20 can be automatically released.

[0060] In another preferred embodiment, the proximal ear mount 162 is sleeved outside the ear mount tube 161 and fixedly connected to the ear mount tube 161. It can be sealed and fixed by means of adhesive or welding. The distal ear mount 163 is sleeved outside the ear mount tube 161. The distal ear mount 163 can move axially to finely adjust the position of the valve stent 20.

[0061] In this embodiment, the proximal ear mount 162 is preferably a columnar hollow structure, such as... Figure 9 As shown, the proximal auricle seat 162 is provided with multiple first auricle grooves 1621, each first auricle groove 1621 being axially arranged around the axis of the proximal auricle seat 162. When the valve stent 20 is compressed, the proximal auricle 23 of the valve stent 20 is disposed within the first auricle groove 1621. The distal auricle seat 163 is preferably a cylindrical hollow structure, and the distal auricle seat 163 is provided with multiple second auricle grooves, the second auricle grooves being axially arranged around the axis of the distal auricle seat 163, such as... Figures 7 to 9 As shown, when the valve stent 20 is compressed, the distal awl 24 of the valve is placed in the second awl groove, and then the proximal release tube 151 and the distal release tube 171 are inserted to complete the loading of both ends of the valve stent 20. The number and size of the first awl groove 1621 are configured according to the number and size of the proximal awl 23 of the valve stent 20, and the number and size of the second awl groove are configured according to the number and size of the distal awl 24 of the valve stent 20. Therefore, the number and size of the first awl groove 1621 and the second awl groove can be the same or different, and can be selected according to actual needs.

[0062] like Figure 3As shown, the ear-hook assembly 16 also includes an ear-hook sealing cap 165, which is fixedly connected to the end of the ear-hook tube seat 164 away from the proximal assembly 15. The second housing 14 is provided with a connecting groove, and the proximal end of the ear-hook tube seat 164 and the ear-hook sealing tube are disposed in the connecting groove, so that the ear-hook tube seat 164 is axially fixed relative to the second housing 14. The ear-hook tube seat 164 serves as the mandrel carrier to which the valve stent 20 is attached when compressed. Therefore, the ear-hook tube seat 164 is also fixedly connected with a second guide block 166. The second housing 14 is also provided with a second guide groove corresponding to the second guide block 166. The second guide block 166 cooperates with the second guide groove to radially fix the ear-hook tube seat 164 relative to the second housing 14, so as to ensure the stability of the position of the valve stent 20 during delivery and release.

[0063] like Figure 3 and Figure 7 As shown, the distal assembly 17 includes a distal tube seat 172 and a distal knob 173. The proximal end of the distal release tube 171 is fixedly connected to the distal end of the distal tube seat 172 by means of bonding or welding. The distal knob 173 is threadedly connected to the distal tube seat 172. Rotating the distal knob 173 can drive the distal tube seat 172 to move the distal release tube 171 axially to release the distal end of the valve stent 20. The tail end of the distal tube seat 172 is provided with a Luer head, which is directly connected to the syringe to complete the emptying. In this embodiment, the distal release tube 171 can be a metal tube such as nickel-titanium or stainless steel. The distal release tube 171 includes a tip 1711, a connecting section 1712, and an inner tube 1713. The tip 1711 can preferably be a tip head. The inner tube 1713 and the connecting section 1712 are respectively fixedly connected to the tip 1711. The connecting section 1712 is arranged circumferentially around the inner tube 1713. A receiving area 102 is formed between the connecting section 1712 and the inner tube 1713. The distal ear seat 163 is disposed in the receiving area 102. The end of the connecting section 1712 is spliced ​​with the positioning release tube 121. Rotating the distal knob 173 causes the distal release tube 171 to move axially to the distal end. After the distal ear seat 163 is fully exposed in the distal release tube 171, the distal end of the valve stent 20 can be automatically released.

[0064] Preferably, the threaded connection between the distal knob 173 and the distal tube seat 172 can be a single-start thread, a double-start thread, or a multi-start thread. Using a multi-start thread can increase the axial movement speed of the distal release tube 171. Therefore, the thread of the threaded connection between the distal knob 173 and the distal tube seat 172 can be selected according to the requirements.

[0065] Instructions for using the valve delivery system:

[0066] The valve stent 20 of the valve assembly is loaded into the valve delivery system using a loading system (not shown), and after all tubing is emptied, it is introduced into the preset position.

[0067] Delivery and release processes: such as Figure 10 As shown, rotate the positioning knob 122 clockwise to retract the positioning release tube 121 to a preset distance (the retraction distance should not affect the bending control effect), and release the positioning element 22 of the valve stent 20;

[0068] like Figure 11 As shown, rotating the bending control knob 134 clockwise causes the bending control tube 131 to drive the positioning component release tube 121 to bend or reverse until the valve stent 20 and the original valve annulus are aligned.

[0069] like Figure 12 As shown, loosen the locking knob 18 and push the entire release device (including the second housing 14, the distal assembly 17, the lug assembly 16, and the proximal assembly 15) about 1 cm to the distal end; rotate the entire second housing 14 for circumferential positioning, and use DSA imaging to observe the position of each positioning element 22 to ensure that each positioning element 22 is aligned with the original structure.

[0070] Push the entire release device further to the distal end until the distal end of the positioning piece 22 lightly touches the bottom of the sinus, then tighten the locking knob 18 to ensure that the second housing 14 is fixed in place.

[0071] Remove safety clamp 153 to prevent proximal valve seat 152 from shifting backward, thereby triggering accidental release of the proximal valve. Figure 13 As shown, the proximal cannula seat 152 is pulled to the limit in the proximal direction, and the proximal cannula seat 162 is fully exposed in the proximal release cannula 151 to release the proximal end of the valve stent 20.

[0072] The position of the valve stent 20 is confirmed again by DSA imaging to ensure that it meets the requirements. If adjustment is needed, the locking knob 18 can be loosened, and the axial and radial positions of the entire release device can be finely adjusted by controlling the second housing 14. Finally, the locking knob 18 is locked.

[0073] like Figure 14 As shown, rotating the distal knob 173 clockwise pushes the distal release tube 171 toward the distal end, and the distal ear mount 163 is fully exposed in the distal release tube 171 to release the distal end of the valve stent 20.

[0074] Withdrawal process: such as Figure 15 As shown, push the proximal tube seat 152 to the limit and insert the safety clamp 153. Rotate the distal knob 173 counterclockwise to the limit, and the proximal tube seat 152 and proximal release tube 151 return to their initial positions. Loosen the locking knob 18, pull the second housing 14 axially to the limit, tighten the locking knob 18, and the release device returns to its initial position. Rotate the bending control knob 134 counterclockwise to release the bending control for safe withdrawal. Figure 16As shown, rotate the positioning knob 122 counterclockwise so that the distal end of the positioning release tube 121 contacts and fits the end face of the connecting section 1712 of the distal release tube 171; at this time, the entire valve delivery system can be removed.

[0075] In another preferred embodiment, the release order of the distal and proximal ends of the valve stent 20 can be changed, i.e., the distal end of the valve stent 20 is released first, followed by the proximal end. However, this release order requires the surgeon to accurately confirm the position of the valve stent 20 before releasing the distal end, because the state of the valve stent 20 cannot be fine-tuned again after the distal end is released. This requires a certain level of experience and skill from the surgeon. The specific release process is as follows:

[0076] Rotate the positioning knob 122 clockwise to retract the positioning release tube 121 to a preset distance (the retraction distance should not affect the bending control effect). During this process, the positioning element 22 of the valve stent 20 is released.

[0077] Rotate the bending control knob 134 clockwise, and the bending control tube 131 will drive the positioning component release tube 121 to bend or reverse until the valve stent 20 is aligned with the original valve annulus axis.

[0078] Loosen the locking knob 18 and push the entire release device (including the second housing 14, the distal component 17, the lug component 16, and the proximal component 15) about 1 cm to the distal end; rotate the entire second housing 14 for circumferential positioning, and use DSA imaging to observe the position of each positioning component 22 to ensure that each positioning component 22 is aligned with the original structure.

[0079] Push the entire release device further to the distal end until the distal end of the positioning piece 22 lightly touches the bottom of the sinus, then tighten the locking knob 18 to ensure that the second housing 14 is fixed in place;

[0080] Rotate the distal knob 173 clockwise to push the distal release tube 171 distally, so that the distal ear bracket 163 is fully exposed in the distal release tube 171 to release the distal ear 24 of the valve stent 20.

[0081] Remove the safety clamp 153 (to prevent the proximal seat 152 from moving backward and triggering the accidental release of the proximal lug 23 of the valve stent 20), pull the proximal seat 152 towards the proximal end to limit its movement, and fully expose the proximal lug seat 162 to the proximal release tube 151 to release the proximal lug 23 of the valve stent 20.

[0082] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the appended claims.

Claims

1. A valve delivery system, characterized in that, It includes a delivery device and a release device connected to each other, the release device being movable relative to the delivery device; The delivery device includes a first housing, a sheath assembly, and a bending control assembly. The sheath assembly and the bending control assembly are disposed within the first housing. The positioning release tube of the sheath assembly is used to accommodate a valve stent. The positioning release tube is movable along the axial direction of the first housing. The bending control assembly is used to bend the positioning release tube. The sheath assembly includes a positioning knob and a positioning tube seat. The positioning tube is disposed through the first housing and the second housing. The distal end of the positioning tube is a large-diameter end with a variable diameter. The proximal end of the positioning tube is fixedly connected to the positioning tube seat. The positioning tube seat is movably disposed within the first housing. The bending control assembly includes a bending control tube, a movable component, a bending control element, a bending control knob, and a bending control tube seat. The proximal end of the bending control tube is fixedly connected to the bending control tube seat, and the distal end of the bending control tube passes through the positioning element tube seat and is disposed in the positioning element release tube. The movable component is movably connected to the bending control tube seat. One end of the bending control element is connected to the movable component, and the other end of the bending control element is connected to the distal end of the bending control tube. The bending control knob is fixedly connected to the bending control tube seat. The release device includes a second housing, a proximal assembly, an ear loop assembly, and a distal assembly. The second housing is connected to the first housing. The proximal assembly, the ear loop assembly, and the distal assembly are respectively disposed within the second housing. The distal release tube of the distal assembly, the proximal release tube of the proximal assembly, and the ear loop tube of the ear loop assembly are respectively disposed within the positioning member release tube. The valve stent is loaded at the distal end of the proximal assembly, the distal end of the ear loop assembly, and the distal end of the distal assembly. The proximal assembly includes a proximal tube seat, the distal end of the proximal release tube is connected to the proximal end of the ear assembly, the proximal end of the proximal release tube is fixedly connected to the proximal tube seat, and the proximal tube seat is movable within the second housing along the axial direction of the second housing.

2. The valve delivery system as described in claim 1, characterized in that, The distal end of the proximal release tube is the larger diameter end.

3. The valve delivery system as described in claim 1, characterized in that, The proximal assembly also includes a safety clamp. The second housing has a through hole, through which the safety clamp passes to hold the proximal tube seat. The safety clamp is used to limit the position of the proximal tube seat.

4. The valve delivery system as described in claim 1, characterized in that, The ear-hook assembly includes an ear-hook tube, a proximal ear-hook seat, a distal ear-hook seat, and an ear-hook tube seat. One end of the ear-hook tube is fixedly connected to the ear-hook tube seat. The proximal ear-hook seat is sleeved outside the ear-hook tube, and the distal ear-hook seat is sleeved outside the ear-hook tube and fixedly connected to the ear-hook tube. Alternatively, the proximal ear hook seat may be sleeved outside the ear hook tube and fixedly connected to the ear hook tube, and the distal ear hook seat may be sleeved outside the ear hook tube.

5. The valve delivery system as described in claim 4, characterized in that, The positioning component tube seat is fixedly connected to a first guide block, and the first housing is provided with a first guide groove that cooperates with the first guide block. The first guide groove is arranged along the axial direction of the first housing. And / or, the ear-hanging tube seat is also fixedly connected to a second guide block, and the second housing is also provided with a second guide groove corresponding to the second guide block. The second guide block and the second guide groove cooperate to make the ear-hanging tube seat radially fixed relative to the second housing. And / or, a third guide block is fixedly connected to the moving part, and the first housing is provided with a third guide groove that cooperates with the third guide block, and the third guide groove is arranged along the length direction of the first housing.

6. The valve delivery system as described in claim 4, characterized in that, The distal assembly includes a distal tube seat and a distal knob. The proximal end of the distal release tube is fixedly connected to the distal end of the distal tube seat. The distal knob is threadedly connected to the distal tube seat. Rotating the distal knob can drive the distal tube seat to move the distal release tube axially to release the distal end of the valve stent.

7. The valve delivery system as described in claim 6, characterized in that, The distal release tube includes a tip, a connecting section, and an inner tube. The inner tube and the connecting section are fixedly connected to the tip. The connecting section is arranged circumferentially around the inner tube. An accommodating area is formed between the connecting section and the inner tube. The end of the connecting section is spliced ​​with the positioning release tube.

8. The valve delivery system according to any one of claims 1 to 7, characterized in that, The distal end of the second housing is fitted into the proximal end of the first housing, and the valve delivery system further includes a locking knob for defining the relative positions of the first housing and the second housing.

Images