Delivery device and delivery system for stepwise release of a control stent

Abstract

An embodiment of the present invention discloses a delivery device for controlling the step-by-step release of a stent, comprising: a sheath core assembly; an outer sheath tube, which is hollow and sleeved outside the sheath core assembly, and there is a delivery gap between the outer sheath tube and the sheath core assembly, and the distal end of the delivery gap is used to accommodate the contracted stent; a stent restraint assembly, which is used to make the released part of the stent not fully deployed to reduce the outer diameter when the stent is in a partially released state, and to make the stent fully deployed when the stent is in a fully released state. An embodiment of the present invention also provides a delivery system for controlling the step-by-step release of a stent. By adopting the present invention, it has the advantage of facilitating the adjustment of the position of the stent.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a delivery device and a delivery system for controlling the step-by-step release of a stent. Background Art

[0002] An aortic aneurysm refers to a local or diffuse abnormal dilation of the aortic wall, which compresses surrounding organs and causes symptoms. Aortic aneurysms can be mainly classified into true aortic aneurysms, false aortic aneurysms, and dissecting aortic aneurysms according to their structures. An aortic aneurysm causes an increase in the medial pressure of the blood vessel, so it expands progressively. If it develops for a long time, it will eventually rupture. The larger the aneurysm, the greater the possibility of rupture.

[0003] Thoracic endovascular aortic repair (TEVAR) has currently been used to treat various aortic dilative diseases such as aortic dissection, penetrating aortic ulcer, intramural hematoma of the aorta, thoracic aortic aneurysm, and false aneurysm. Since the first case of endovascular aneurysm repair (EVAR) was reported in the 1990s and used to treat abdominal aortic aneurysms, it has developed rapidly within just 20 years due to its advantages such as less trauma, short operation and hospitalization time, fast postoperative recovery, low perioperative mortality rate, and low complication rate.

[0004] TEVAR and EVAR often use expandable stents as treatment devices. In order to maintain good apposition with the blood vessel to be repaired, the diameter of the stent after release is generally about 10% larger than the diameter of the blood vessel. And since the fully released stent is in close contact with the blood vessel, even if the release position is inaccurate, it cannot be readjusted. This requires the operating personnel to have rich experience and spend a lot of time and energy accurately positioning the release angle of the stent before the stent is released, which takes a lot of time. Therefore, it is necessary for us to develop a delivery device and a delivery system for step-by-step release, which can facilitate the adjustment of the position of the stent. Summary of the Invention

[0005] The technical problem to be solved by the embodiments of the present invention is to provide a delivery device and a delivery system for controlling the step-by-step release of a stent, which can facilitate the adjustment of the position of the stent when the stent is in a partially released state, and is beneficial to saving time and energy.

[0006] To solve the above technical problem, the first aspect of the embodiments of the present invention provides a delivery device for controlling the step-by-step release of a stent, which is used to deliver and step-by-step release the stent, and includes:

[0007] A sheath-core assembly;

[0008] An outer sheath tube, which is hollow and sleeved outside the sheath-core assembly. There is a delivery gap between the outer sheath tube and the sheath-core assembly, and the distal end of the delivery gap is used to accommodate the shrunk stent;

[0009] A stent restraint assembly, which is used to make the released part of the stent not fully deployed to reduce the outer diameter when the stent is in a partially released state, and to make the stent fully deployed when the stent is in a fully released state.

[0010] In an embodiment of the first aspect of the present invention, the delivery device further includes a control handle, which is connected to the outer sheath tube, and the control handle controls the axial movement of the outer sheath tube relative to the sheath core assembly so that the contracted stent is in a partially released state or a fully released state.

[0011] In an embodiment of the first aspect of the present invention, the stent restraint assembly includes at least one control wire, the control wire enters from the proximal end of the delivery gap and extends to the distal end of the delivery gap, and the distal end of the control wire is used to circumferentially restrain the released part of the stent.

[0012] In an embodiment of the first aspect of the present invention, the stent restraint assembly further includes a pull ring, the pull ring is fixedly connected to the proximal end of the control wire, and a force is applied proximally through the pull ring to release the restraint of the control wire on the stent.

[0013] In an embodiment of the first aspect of the present invention, the delivery device further includes a first locking assembly, and the first locking assembly is used to lock the movement of the stent restraint assembly to prevent accidental release of the restraint of the control wire on the stent.

[0014] In an embodiment of the first aspect of the present invention, a sheath tube joint is fixedly connected to the outside of the outer sheath tube; the control handle includes:

[0015] A support body, inside which the sheath tube joint is provided. When an axial force is applied to the sheath tube joint, it moves axially in the support body to drive the outer sheath tube to move axially;

[0016] A fixed handle, which is installed on the outside of the distal end of the support body and is fixedly connected to the support body;

[0017] A sliding handle, which is installed on the outside of the support body. The sliding handle is arranged adjacent to the proximal end of the fixed handle, and the sliding handle is rotatable on the outside of the support body and drives the sheath tube joint to move axially.

[0018] In an embodiment of the first aspect of the present invention, a long hole extending axially is provided on the support body, a main body tooth block is sleeved on the outside of the support body, the sheath tube joint includes a joint main body and an abutting block, the joint main body includes a distal convex block, the abutting block and the distal convex block respectively abut against the proximal end and the distal end of the main body tooth block to limit the axial movement of the main body tooth block relative to the sheath tube joint. The inner side of the sliding handle is provided with an internal thread, the outside of the main body tooth block is provided with an external thread, and the internal thread meshes with the external thread. When the sliding handle rotates, the sheath tube joint is driven to move axially through the main body tooth block, the abutting block and the distal convex block, and then the outer sheath tube is driven to move axially.

[0019] In an embodiment of the first aspect of the present invention, the sliding handle can slide axially on the supporting body, and a release button is embedded in the fixed handle. The release button extends a hook to one side of the sliding handle, and the hook hooks the sliding handle so that the sliding handle is arranged adjacent to the fixed handle and prevents the sliding handle from sliding in the axial direction.

[0020] In one embodiment of the first aspect of the present invention, the delivery device also includes a push rod, the distal end of which is located in the delivery gap. When the control handle controls the outer sheath tube to move axially proximally relative to the sheath core assembly, the push rod is used to resist the stent to prevent the stent from moving toward the proximal end of the delivery gap.

[0021] In an embodiment of the first aspect of the present invention, the conveying device further comprises a support tube, a distal end of the support tube is located in the conveying gap, and the push rod is located in the support tube.

[0022] In an embodiment of the first aspect of the present invention, the push rod is provided with a plurality of through holes in the axial direction, and the control wire enters from the proximal end of the through hole and passes out from the distal end of the through hole.

[0023] In an embodiment of the first aspect of the present invention, the delivery device also includes a pre-embedded guide wire, which enters from the proximal end of the delivery gap and extends to the distal end of the delivery gap, and the distal end of the pre-embedded guide wire is used to enter from the outside of the stent through the window on the stent to the inside of the stent, and the pre-embedded guide wire is used to guide the branch guide wire to pass through the window of the stent from the inside of the stent.

[0024] In an embodiment of the first aspect of the present invention, a second locking component is provided on the proximal side of the delivery device, and the second locking component can be used to lock the movement of the embedded guide wire.

[0025] A second aspect of the present invention provides a delivery system for controlling the step-by-step release of a stent, comprising a stent and a delivery device, wherein the stent comprises a tubular coating and an annular support frame; the delivery device comprises:

[0026] sheath core assembly;

[0027] An outer sheath tube, which is hollow and sleeved on the outside of the sheath core assembly, a delivery gap exists between the outer sheath tube and the sheath core assembly, and a distal end of the delivery gap accommodates the shrunk stent;

[0028] The stent restraining component prevents the stent in the released portion from being fully expanded to reduce the outer diameter when the stent is in a partially released state, and fully expands the stent when the stent is in a fully released state.

[0029] In an embodiment of the second aspect of the present invention, a connecting member is axially provided on the tubular film covering from the proximal end to the distal end, and at least two columns of the connecting members are circumferentially spaced apart.

[0030] In an embodiment of the second aspect of the present invention, when the stent is in a partially released state, the stent restraint assembly controls to bind at least two columns of the connecting members together so that the stent is not fully deployed in the circumferential direction, and when the stent is in a fully released state, the stent restraint assembly releases the restraint on the connecting members to fully deploy the stent.

[0031] In an embodiment of the second aspect of the present invention, a window is provided on the tubular film covering, and when the stent is in a partially released state, the window is located on the released part of the tubular film covering.

[0032] In an embodiment of the second aspect of the present invention, the stent restraint assembly includes at least one control wire, the control wire enters from the proximal end of the delivery gap and extends to the distal end of the delivery gap, and the distal end of the control wire circumferentially binds the released part of the stent.

[0033] In an embodiment of the second aspect of the present invention, the delivery device includes a control handle, which is connected to the outer sheath tube, and the control handle controls the outer sheath tube to axially move relative to the sheath core assembly so that the contracted stent is in a partially released state or a fully released state.

[0034] Implementing the embodiments of the present invention has the following beneficial effects:

[0035] Since the delivery device for controlling the step-by-step release of the stent includes a stent restraint assembly, the stent restraint assembly is used to make the released part of the stent not fully deployed to reduce the outer diameter when the stent is in a partially released state, and to fully deploy the stent when the stent is in a fully released state. Thus, since the released part of the stent is not fully deployed and the outer diameter is small, this part of the stent does not closely adhere to the blood vessel. Therefore, when the position of the stent during release is inaccurate, there is no resistance when the non-released part of the stent is fully deployed and closely adheres to the blood vessel. The delivery device can drive the stent to move relatively easily, and it is convenient to adjust the stent through the delivery device in this embodiment, which is beneficial to saving the time and energy of the operator. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0037] Figure 1 is a perspective view of a delivery device for controlling the step-by-step release of a stent according to an embodiment of the present invention;

[0038] Figure 2 is a cross-sectional view in one direction of a delivery device for controlling the stepwise release of a stent according to an embodiment of the present invention;

[0039] Figure 3 is a cross-sectional view in another direction of a delivery device for controlling the stepwise release of a stent according to an embodiment of the present invention;

[0040] Figure 4 is Figure 2 an enlarged view of the portion circled by A in

[0041] Figure 5 is Figure 2 an enlarged view of the portion circled by B in

[0042] Figure 6 is Figure 3 an enlarged view of the portion circled by D in

[0043] Figure 7 is Figure 2 an enlarged view of the portion circled by C in

[0044] Figure 8 is Figure 3 an enlarged view of the portion circled by E in

[0045] Figure 9 is a schematic view of a delivery device for controlling the stepwise release of a stent according to an embodiment of the present invention at an angle (the stent is in a partially released state);

[0046] Figure 10 is a schematic view of a delivery device for controlling the stepwise release of a stent according to an embodiment of the present invention at another angle (the stent is in a partially released state);

[0047] Figure 11 is a schematic view of a stent in a fully released state according to an embodiment of the present invention;

[0048] Reference numerals:

[0049] 100 - Sheath - core assembly; 110 - Inner sheath - core; 120 - Outer sheath - core tube; 130 - Guide head; 131 - Hollow channel; 140 - Stent fixing assembly; 142 - Positioning sleeve; 143 - Fixed anchor; 150 - Sheath - core tube fixing piece; 160 - Sheath - core fixing steel sleeve; 170 - Rear release screw cap; 200 - Outer sheath tube; 210 - Delivery gap; 220 - Sheath tube joint; 221 - Abutting block; 222 - Joint body; 223 - Distal bump; 300 - Control handle; 310 - Support body; 320 - Fixed handle; 321 - Unlocking button; 322 - Hook; 323 - Button support body; 324 - Positioning post; 330 - Sliding handle; 332 - Rotating cap; 333 - Inverted flange; 334 - Drag - reducing convex ring; 340 - Main body tooth block; 400 - Stent binding assembly; 410 - Control wire; 420 - Pull ring; 500 - First locking assembly; 510 - Pull - ring fixing piece; 520 - Near - release screw cap; 610 - Push rod; 620 - Support tube; 630 - Push - rod fixing piece; 640 - Tail - end fixing piece; 650 - Tail - end slideway piece; 670 - Luer connector; 680 - Outer cover; 710 - Pre - embedded guide wire; 720 - Second locking assembly; 721 - Wire fixing piece; 722 - Fixed convex ring; 723 - Flap; 800 - Stent; 810 - Tubular film covering; 811 - Window; 820 - Annular support frame; 830 - Connecting piece; 840 - Bare stent. Detailed implementation mode

[0050] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0051] The terms "including" and "having" and any variations thereof that appear in the specification, claims and drawings of this application are intended to cover non - exclusive inclusion. For example, a process, method, system, product or device that includes a series of steps or units is not limited to the listed steps or units, but optionally further includes steps or units not listed, or optionally further includes other steps or units inherent to these processes, methods, products or devices. In addition, the terms "first", "second", "third", etc. are used to distinguish different objects, rather than to describe a specific order.

[0052] For the sake of clear description, the end of the delivery device close to the operator is defined as the proximal end, and the end relatively far from the operator is defined as the distal end; the end of the stent close to the heart is defined as the proximal end, and the end relatively far from the heart is defined as the distal end. The proximal and distal ends of the delivery device and the stent are defined by different reference objects.

[0053] An embodiment of the present invention provides a delivery device for controlling the stepwise release of a stent, which is used to deliver and control the stepwise release of the stent. Here, the stent is loaded in the delivery device. When the stent is delivered to a suitable position in the blood vessel through the delivery device, the delivery device performs stepwise release of the stent. Specifically: First, release a part of the stent, and release a part of the stent 800 from the outer sheath of the delivery device (please refer to Figure 9 , Figure 10 ). Here, the part of the stent 800 released is on the proximal side of the stent 800, and the rest of the stent 800 is still in the delivery device. At the same time, one side of the released proximal stent 800 is still constrained by the delivery device. At this time, the stent 800 is in a partially released state (described later). The outer diameter of the stent in the partially released state is smaller than the blood vessel diameter, and the position of the stent 800 can be adjusted. When the adjustment is in place, the remaining part of the stent 800 is released later. At this time, the stent 800 is completely released (please refer to Figure 11 ). At this time, the stent 800 is in a completely released state. In addition, in other embodiments of the present invention, the number of times of stepwise releasing the stent is not limited to two, and can also be more times. Please refer to Figures 1 - 11 . The delivery device for controlling the stepwise release of the stent includes a sheath core assembly 100, an outer sheath 200, and a stent restraint assembly 400.

[0054] In this embodiment, please refer to Figures 2 - 4 , the sheath core assembly 100 includes an inner sheath core 110 and an outer sheath core tube 120. The outer sheath core tube 120 is hollow and sleeved on the inner sheath core 110, and the outer sheath core tube 120 can axially slide relative to the inner sheath core 110.

[0055] In this embodiment, the conveying device further includes a guiding head 130 and a stent fixing assembly 140. The guiding head 130 is conical, the distal end of the guiding head 130 is pointed, and a hollow channel 131 is formed axially along the center of the guiding head 130. The distal end of the inner sheath core 110 is fixedly connected to the proximal end of the guiding head 130, and the inner sheath core 110 is hollow and communicates with the hollow channel 131 of the guiding head 130. The stent fixing assembly 140 is arranged adjacent to the proximal end of the guiding head 130. The stent fixing assembly 140 includes a positioning sleeve 142 and a fixing anchor 143. The fixing anchor 143 is fixedly connected to the distal end of the outer sheath core tube 120. The fixing anchor 143 has a columnar structure, and a circle of uniformly spaced protrusions is circumferentially arranged on it for fixing the bare stent 840 at the proximal end of the stent 800, so as to position the proximal end of the stent 800, that is, the proximal end of the stent 800 is sleeved on the fixing anchor 143; the distal end of the positioning sleeve 142 is injection-molded and fixedly connected to the guiding head 130. The positioning sleeve 142 is hollow. The positioning sleeve 142 extends proximally to the fixing anchor 143 and partially sleeves on the fixing anchor 143. There is a limiting gap between the fixing anchor 143 and the inner wall of the positioning sleeve 142, and the proximal part of the stent 800 is located in this limiting gap.

[0056] In this embodiment, the outer sheath tube 200 is hollow and sleeved outside the sheath core assembly 100, specifically outside the outer sheath core tube 120. The outer sheath tube 200 can move axially relative to the outer sheath core tube 120. There is a conveying gap 210 between the outer sheath tube 200 and the sheath core assembly 100. Specifically, the conveying gap 210 is located between the outer sheath tube 200 and the outer sheath core tube 120. The conveying gap 210 here refers to the space between the inner wall of the outer sheath tube 200 and the outer wall of the outer sheath core tube 120. The entire fixing anchor 143 and the proximal part of the positioning sleeve 142 are located in the conveying gap 210. The distal end of the conveying gap 210 is used to accommodate the shrunk stent 800. Here, the stent 800 is forced to reduce its volume by an external force to be accommodated in the conveying gap 210. The bare stent 840 at the proximal end of the stent 800 is positioned on the protrusions of the fixing anchor 143, and the entire stent 800 is located in the conveying gap 210.

[0057] In order to prevent the released part of the stent 800 from fully expanding when the stent 800 is in a partially released state, resulting in the released part of the stent 800 clinging to the blood vessel, leading to inaccurate release of the stent 800 and inability to readjust the position of the stent 800. In this embodiment, please refer to Figures 1 - 3 、 Figure 8, the stent restraint assembly 400 is used to prevent the released part of the stent 800 from fully expanding when the stent 800 is in a partially released state, so as to reduce the outer diameter of the released part of the stent 800. Here, the released part of the stent 800 refers to the part of the stent 800 that is not restricted by the outer sheath 200, that is, the exposed part of the stent 800. Here, the ratio of the outer diameter of the released part of the stent 800 when it is not fully expanded to the outer diameter of the released part of the stent 800 when it is fully expanded is less than or equal to 90%. Thus, since the released part of the stent 800 is not fully expanded and has a smaller outer diameter, this part of the stent 800 will not be in close contact with the blood vessel. Therefore, when the position of the stent 800 during release is inaccurate, for example, when the circumferential alignment of the stent 800 is inaccurate, for example, when the position of the window 811 (please refer to Figure 10 ) on the stent 800 is inaccurate, there is no resistance when the non-released part of the stent 800 is fully expanded and in close contact with the blood vessel. The delivery device can drive the stent 800 to move relatively easily, such as rotation or axial movement, so as to facilitate the adjustment of the position of the stent 800, such as adjusting the circumferential alignment of the stent 800. When the adjustment of the stent 800 is in place, the outer sheath 200 can be operated to move proximally along the axis, so as to fully release the stent 800. At this time, the stent 800 is fully expanded and in close contact with the blood vessel. Thus, it is convenient to adjust the stent 800 through the delivery device in this embodiment, which is beneficial to saving the time and energy of the operator. In this embodiment, the stent restraint device can cause the released part of the stent 800 to fully expand after the adjustment of the stent 800 is in place, or it can also cause the stent 800 to fully expand when the stent 800 is in a fully released state. In addition, in other embodiments of the present invention, when the axial position of the stent is inaccurate, the operator can also adjust the position of the stent by operating the delivery device.

[0058] Please continue to refer to Figures 1 - 3 , Figure 8 , in this embodiment, the stent restraint assembly 400 includes at least one control wire 410. Here, the number of control wires 410 can be one, two or more. The material of the control wire 410 can be selected from stainless steel wires. The control wire 410 enters from the proximal end of the delivery gap 210 and extends to the distal end of the delivery gap 210. Please refer to Figure 11, the stent 800 includes a tubular membrane 810 and an annular support frame 820. Axially arranged on the tubular membrane 810 from the proximal end to the distal end are connecting members 830. At least two columns of the connecting members 830 are circumferentially spaced apart. Preferably, the proximal end of the connecting member 830 is located at the proximal end of the tubular membrane 810, and the distal end of the connecting member 830 is located in the middle of the tubular membrane 810. At least one window 811 is provided on the tubular membrane 810, and the window 811 is located between the proximal end and the middle of the tubular membrane 810. When the stent 800 is in a partially released state, at this time the membrane starts to be released from the proximal end to the distal end, but generally does not exceed the middle position of the membrane. At this time, the window 811 will be located on the released part of the stent 800. The control wire 410 binds at least two columns of the connecting members 830 together so that the stent 800 is not fully expanded circumferentially, thereby reducing the outer diameter of the released part of the stent 800. Specifically, the outer diameter of the released part of the stent 800 is smaller than the blood vessel diameter, which is beneficial to adjusting the position of the stent 800, such as adjusting the window 811 to face the branch blood vessel. Preferably, the circumferential length between the two columns of connecting members 830 bound by the control wire 410 can reduce the outer diameter of the released part of the stent 800 by more than 10%, that is, the ratio of the outer diameter of the released part of the stent 800 when not expanded to the outer diameter of the released part of the stent 800 when fully expanded is less than or equal to 90%.

[0059] In this embodiment, the stent binding assembly 400 further includes a pull ring 420. The pull ring 420 is fixedly connected to the proximal end of the control wire 410, which is convenient for the operation of the control wire 410 during the operation. Specifically, the staff can release the binding of the control wire 410 on the stent 800 by applying a force proximally through the pull ring 420, thereby completing the release of the bound part of the stent 800.

[0060] To increase the safety of the instrument use, in this embodiment, the delivery device further includes a first locking assembly 500, and the first locking assembly 500 is used to lock the movement of the stent restraint assembly 400 to prevent accidental release of the restraint of the control wire 410 on the stent 800. In this embodiment, the first locking assembly 500 is used to lock the movement of the pull ring 420 to prevent accidental release of the restraint of the control wire 410 on the stent 800. Additionally, in other embodiments of the present invention, the first locking assembly may also be used to lock the movement of the control wire to prevent accidental release of the restraint of the control wire on the stent. In this embodiment, the first locking assembly 500 includes a pull ring fixing member 510 and a proximal release cap 520. The pull ring fixing member 510 is threadedly connected to the proximal end of the tail end slide member 650 (described later). The pull ring fixing member 510 is provided with a through hole for positioning the pull ring 420 and a first groove for cooperating with the proximal release cap 520. The proximal release cap 520 is rotatably installed at the proximal end of the pull ring fixing member 510. The distal end of the inner side of the proximal release cap 520 is provided with an L-shaped protrusion. The long arm of the L-shaped protrusion extends circumferentially, and the short arm of the L-shaped protrusion extends axially towards the distal end from one end of the long arm. The L-shaped protrusion encloses a second groove. The distal end of the pull ring 420 is provided with an outwardly extending second protrusion. After the pull ring 420 is inserted into the through hole and fixed, the proximal release cap 520 is rotated to make the second protrusion enter the second groove, thereby locking the pull ring 420 in this position. At this time, the pull ring 420 cannot drive the control wire 410 to move in the proximal direction, preventing accidental release of the restraint on the stent 800. When the proximal release cap 520 is rotated to make the second protrusion come out of the second groove, the pull ring 420 can be operated to drive the control wire 410 to move in the proximal direction, and the restraint on the stent 800 can be released.

[0061] To control the step-by-step release of the stent 800, in this embodiment, please refer to Figure 1 , Figure 2 , Figure 5 , Figure 6 , the delivery device includes a control handle 300. The control handle 300 is connected to the outer sheath tube 200. The control handle 300 is used to control the axial movement of the outer sheath tube 200 relative to the sheath core assembly 100, specifically used to control the axial movement of the outer sheath tube 200 relative to the outer sheath core tube 120. In the Figure 1 schematic diagram, the left-right direction is the axial direction. Thus, by controlling the axial movement of the outer sheath tube 200 with the control handle 300, the stent 800 located in the delivery gap 210 after contraction is in a partially released state or a fully released state. Here, the partially released state means that the proximal part of the stent 800 is released, and the released part of the stent 800 is no longer restricted by the outer sheath tube 200, which is the state for adjusting the position of the stent 800. Please refer to Figure 9 , Figure 10, the fully released state means that the outer sheath 200 no longer restricts the entire stent 800, that is, there is no outer sheath 200 outside the stent 800 at this time. Please refer to Figure 11 .

[0062] To adjust the axial position of the outer sheath 200, in this embodiment, please continue to refer to Figure 1 , Figure 2 , Figure 5 , Figure 6 , the outer sheath 200 is fixedly connected to the sheath joint 220. In this embodiment, the proximal outer side of the outer sheath 200 is fixedly connected to the sheath joint 220. When the sheath joint 220 moves axially, the sheath joint 220 will drive the outer sheath 200 to move axially. The control handle 300 includes a support body 310, a fixed handle 320 and a sliding handle 330. The support body 310 is hollow inside and the sheath joint 220 is provided inside. When an axial force is applied to the sheath joint 220, the sheath joint 220 moves axially in the support body 310 to drive the outer sheath 200 to move axially. The fixed handle 320 is installed on the outer side of the distal end of the support body 310 and the two are fixedly connected. The sliding handle 330 is installed on the outer side of the support body 310. The sliding handle 330 is arranged adjacent to the proximal end of the fixed handle 320. The sliding handle 330 is rotatable on the outer side of the support body 310 and drives the sheath joint 220 to move axially, that is, the rotation of the sliding handle 330 is converted into the axial movement of the sheath joint 220.

[0063] Specifically, a long hole extending axially (not shown in the figure) is provided on the support body 310. A main body tooth block 340 is sleeved on the outer side of the support body 310. The sheath joint 220 includes a joint main body 222 and an abutting block 221. The joint main body 222 includes a distal end convex block 223. A hole is provided on the joint main body 222. The abutting block 221 is partially located in the hole. The abutting block 221 and the distal end convex block 223 respectively abut against the proximal end and the distal end of the main body tooth block to limit the axial movement of the main body tooth block 340 relative to the sheath joint 220, that is, the main body tooth block 340 is axially located between the abutting block 221 and the distal end convex block 223. The inner side of the sliding handle 330 is provided with an internal thread, and the outer side of the main body tooth block 340 is provided with an external thread. The internal thread meshes with the external thread. When the sliding handle 330 rotates, the sheath joint 220 is driven to move axially through the main body tooth block 340, the abutting block 221 and the distal end convex block 223, and then the outer sheath 200 is driven to move axially, so that the stent 800 can be in a partially released state or a fully released state.

[0064] In this embodiment, the sliding handle 330 can also slide axially on the support body 310, that is, the sliding handle 330 can slide axially relative to the fixed handle 320. In order to maintain the axial position of the sliding handle 330 and further enhance the safety of the operation, in this embodiment, a release lock button 321 is embedded in the fixed handle 320. The release lock button 321 extends a catch 322 towards the sliding handle 330. A button support 323 is provided below the release lock button 321. The button support 323 is fixed on the support body 310. Positioning posts 324 are respectively provided between the release lock button 321 and the button support 323. A driving spring is sleeved on the two positioning posts 324. The driving spring is located between the release lock button 321 and the button support 323 to drive the catch 322 into place. The catch 322 hooks the sliding handle 330 so that the sliding handle 330 is arranged adjacent to the fixed handle 320 and prevents the sliding handle 330 from sliding axially. Specifically, the sliding handle 330 includes a rotating cover 332. The rotating cover 332 is arranged at the distal end of the sliding handle 330. The rotating cover 332 has an inward flanging 333. The catch 322 can extend into and engage with the inward flanging 333. One side of the inward flanging 333 that engages the catch 322 can be regarded as an annular positioning groove, that is, the catch 322 is located in the positioning groove, which limits the axial position of the catch 322 and allows the sliding handle 330 to rotate relative to the fixed handle 320. In this embodiment, two concentric drag reduction convex rings 334 are provided on the rotating cover 332. The drag reduction convex rings 334 are located on the distal side wall of the rotating cover 332. Through the drag reduction convex rings 334, the contact between the fixed handle 320 and the sliding handle 330 changes from surface contact to line contact, greatly reducing the contact area between the two, reducing the resistance during their relative movement, and making the release process smoother and more accurate.

[0065] In this embodiment, please refer to Figures 1 - 3 、 Figure 7The conveying device also includes a push rod 610 and a support tube 620, wherein the support tube 620 is located between the outer sheath tube 200 and the outer sheath core tube 120, that is, the support tube 620 is at least partially located in the conveying gap 210, and the support tube 620 serves to increase support; the push rod 610 is located between the support tube 620 and the outer sheath core tube 120, and the distal end of the push rod 610 is located in the conveying gap 210. When the control handle 300 controls the outer sheath tube 200 to move axially toward the proximal end relative to the sheath core assembly 100, the distal end of the push rod 610 is used to resist the stent 800 to prevent the stent 800 from moving toward the proximal end of the conveying gap 210, and the push rod 610 also serves as a support. In addition, in this embodiment, the push rod 610 is provided with a plurality of through holes in the axial direction, and the through holes can be used to control the passage of the control wire 410 and the embedded guide wire 710 (mentioned later), specifically, the control wire 410 and the embedded guide wire 710 enter from the proximal end of the through hole and pass out from the distal end of the through hole.

[0066] In this embodiment, the delivery device further includes a push rod fixing member 630 and a tail end fixing member 640. The push rod fixing member 630 is fixedly connected to the push rod 610 and the proximal end of the support tube 620. The distal end of the push rod fixing member 630 is located inside the proximal end of the support body 310, and the distal end of the push rod fixing member 630 is fixedly connected to the proximal end of the support body 310. The tail end fixing member 640 is sleeved on the outside of the proximal end of the support body 310, and the distal end of the tail end fixing member 640 is fixedly connected to the proximal end of the support body 310. In addition, the push rod fixing member 630 extends an interface, which is connected to one end of the TPU hose, and the other end of the TPU hose is connected to a three-way valve.

[0067] In this embodiment, the proximal end of the tail end fixing member 640 is fixedly connected to the tail end slide member 650, the distal end of the tail end slide member 650 is located inside the tail end fixing member 640, a sheath core tube fixing member 150 is provided inside the tail end slide member 650, the sheath core tube fixing member 150 is located approximately in the middle of the tail end slide member 650, and the sheath core tube fixing member 150 is fixedly connected to the outer side of the proximal end of the outer sheath core tube 120. An outer cover 680 is provided near the proximal end of the tail end slide member 650, and the outer cover 680 is sleeved on the tail end slide member 650.

[0068] In this example, see Figures 1 - 3 , Figure 7 , Figure 8, on one side of the proximal end of the tail slide member 650, there is a sheath core fixing steel sleeve 160 and a rear release rotary cap 170. The sheath core fixing steel sleeve 160 is located within the tail slide member 650. The sheath core fixing steel sleeve 160 is fixedly connected to the inner sheath core 110 and is located outside the inner sheath core 110. The rear release rotary cap 170 is located outside one side of the proximal end of the tail slide member 650. The rear release rotary cap 170 is fixedly connected to the sheath core fixing steel sleeve 160. On one side of the proximal end of the tail slide member 650, there is an axially extending long hole. The rear release rotary cap 170 can drive the sheath core fixing steel sleeve 160 to move axially within the range of the long hole, thereby controlling the rear release of the stent 800. In this embodiment, the proximal end of the tail slide member 650 is fixedly connected to the distal end of the pull ring fixing member 510. In this embodiment, the proximal end of the inner sheath core 110 is fixedly connected to the Luer connector 670.

[0069] Generally speaking, there are many branched blood vessels connected to the arterial blood vessels of the human body. When repairing the arterial blood vessels with the stent 800, sometimes it is necessary to repair the branched blood vessels synchronously. At this time, the branched stent needs to enter the branched blood vessels through the stent 800 to repair the branched blood vessels. In order to simply deliver the branched stent into the branched blood vessels, in this embodiment, please refer to Figure 2 , Figure 3 and Figure 7 , the delivery device further includes a pre-embedded guide wire 710. The pre-embedded guide wire 710 enters from the proximal end of the delivery gap 210 and extends to the distal end of the delivery gap 210. The distal end of the pre-embedded guide wire 710 is used to enter the inner side of the stent 800 from the outside of the stent 800 through the window 811 on the stent 800. The pre-embedded guide wire 710 is used to guide the branched guide wire to penetrate out of the window 811 of the stent 800 from the inner side. At this time, the connection between the pre-embedded guide wire 710 and the branched guide wire can be released. Thereafter, since the window 811 faces the branched blood vessel, the user continues to push the branched guide wire, and the branched guide wire can enter the branched blood vessel. Thereafter, the branched stent can be guided to the branched blood vessel through the branched guide wire. Additionally, in this embodiment, the distal end of the pre-embedded guide wire passes through the push rod.

[0070] In this embodiment, a second locking assembly 720 is provided at the proximal end of the delivery device. Specifically, the second locking assembly 720 is disposed on the tail end slide member 650 and can be used to lock the movement of the pre-embedded guide wire 710. Specifically, the tail end fixing member 640 includes a hollow tail slideway that communicates with the delivery gap 210, and the pre-embedded guide wire 710 enters the tail slideway; the second locking assembly 720 includes a wire fixing member 721, a fixing collar 722 fixed on the tail slideway, and a retaining piece 723 fixed in the tail end slide member. The pre-embedded guide wire 710 enters through the gap between the retaining piece 723 and the wire fixing member 721. The wire fixing member 721 and the fixing collar 722 can be movably connected by threads. When the wire fixing member 721 presses the pre-embedded guide wire 710 against the retaining piece 723, the movement of the pre-embedded guide wire 710 is locked to prevent the guide pre-embedded guide wire 710 from being pulled to an inappropriate position due to a mistake.

[0071] An embodiment of the present invention also provides a delivery system for controlling the stepwise release of a stent. Please refer to Figures 1 - 4 , Figures 9 - 11 , the delivery system for controlling the stepwise release of the stent includes a stent 800 and a delivery device. The stent 800 includes a tubular film 810 and an annular support frame 820. The delivery device includes a sheath core assembly 100, an outer sheath 200, and a stent restraint assembly 400. The outer sheath 200 is hollow and sleeved outside the sheath core assembly 100. There is a delivery gap 210 between the outer sheath 200 and the sheath core assembly 100. The distal end of the delivery gap 210 accommodates the contracted stent 800; when the stent 800 is in a partially released state, the stent restraint assembly 400 causes the released part of the stent 800 not to fully expand to reduce the outer diameter, and when the stent 800 is in a fully released state, it causes the stent 800 to fully expand.

[0072] In this embodiment, on the tubular film 810, connection members 830 are axially arranged from the proximal end to the distal end. The connection members 830 are circumferentially spaced and arranged in at least two columns. The connection members 830 are flexible connection rings. One column can be provided with 1 - 6 connection members, preferably 3 - 5. Multiple axially arranged connection members in a column can prevent the stent from shortening when using the delivery device restraint assembly. When the stent 800 is in a partially released state, the stent restraint assembly 400 controls to bind at least two columns of the connection members 830 together so that the stent 800 is not fully expanded circumferentially. When the stent 800 is in a fully released state, the stent restraint assembly 400 releases the restraint on the connection members 830 to cause the stent 800 to fully expand.

[0073] The tubular film covering 810 is provided with a window, and when the stent 800 is in a partially released state, the window 811 is located on the tubular film covering of the released part. The specific structure of the stent 800 in this embodiment has been described in detail in the prior application CN201711483955.7 of the applicant, and the disclosure information of this document is incorporated into this application by reference herein.

[0074] In this embodiment, the stent restraint assembly 400 includes at least one control wire 410. The control wire 410 enters from the proximal end of the delivery gap 210 and extends to the distal end of the delivery gap 210. The distal end of the control wire 410 circumferentially restrains the released part of the stent 800. Specifically, the control wire 410 restrains at least two rows of the connecting members 830 together so that the stent 800 is not fully unfolded circumferentially.

[0075] In addition, the delivery device further includes a control handle 300. The control handle 300 is connected to the outer sheath 200. The control handle 300 controls the axial movement of the outer sheath 200 relative to the sheath core assembly 100 so that the contracted stent 800 is in a partially released state or a fully released state. The delivery device has been described in detail above in this embodiment, and will not be elaborated here.

[0076] It should be noted that each embodiment in this specification is described in a progressive manner. The key point of each embodiment is to illustrate the differences from other embodiments. The same or similar parts among the embodiments can be referred to each other. For the device embodiments, since they are basically similar to the method embodiments, the description is relatively simple, and the relevant parts can refer to the partial description of the method embodiments.

[0077] What is disclosed above are only the preferred embodiments of the present invention. Of course, the scope of the rights of the present invention cannot be limited thereby. Therefore, equivalent changes made according to the claims of the present invention still fall within the scope covered by the present invention.

Claims

1. A delivery device for controlling the stepwise release of a stent, which is used to deliver and stepwise release the stent, characterized in that, Comprising: A sheath-core assembly; An outer sheath tube, which is hollow and sleeved outside the sheath-core assembly, and there is a conveying gap between the outer sheath tube and the sheath-core assembly, and the distal end of the conveying gap is used to accommodate the contracted stent; A stent restraint assembly, which is used to make the released part of the stent not fully expanded to reduce the outer diameter when the stent is in a partially released state, and to make the stent fully expanded when the stent is in a fully released state; The stent restraint assembly further includes a pull ring and a control wire, the pull ring is fixedly connected to the proximal end of the control wire, and the pull ring is applied with a force towards the proximal end to release the restraint of the control wire on the stent; The delivery device further includes a first locking assembly, the first locking assembly includes a pull-ring fixing member and a proximal release cap, the pull-ring fixing member is provided with a through hole for positioning the pull ring and a first groove for cooperating with the proximal release cap, the proximal release cap is rotatably installed at the proximal end of the pull-ring fixing member, the distal end of the inner side of the proximal release cap is provided with an L-shaped protrusion, the long arm of the L-shaped protrusion extends circumferentially, and the short arm of the L-shaped protrusion extends axially towards the distal end from one end of the long arm, the L-shaped protrusion encloses a second groove, and the distal end of the pull ring is provided with a second protrusion extending outwards. After the pull ring is inserted into the through hole and fixed, the proximal release cap is rotated to make the second protrusion enter the second groove, thereby locking the position of the pull ring. At this time, the pull ring cannot drive the control wire to move towards the proximal direction, preventing the restraint on the stent from being released due to mistakes. When the proximal release cap is rotated to make the second protrusion come out of the second groove, the pull ring is operated to drive the control wire to move towards the proximal direction to release the restraint on the stent.

2. The delivery device for stepwise releasing a control bracket according to claim 1, wherein, The delivery device includes a control handle, which is connected to the outer sheath tube, and the control handle controls the outer sheath tube to move axially relative to the sheath-core assembly so that the contracted stent is in a partially released state or a fully released state.

3. The delivery device for stepwise releasing the control bracket according to claim 2, wherein, The control wire enters from the proximal end of the conveying gap and extends to the distal end of the conveying gap, and the distal end of the control wire is used to circumferentially restrain the released part of the stent.

4. The delivery device for controlling the stepwise release of the support bracket according to any one of claims 2-3, characterized in that, The outer sheath tube is fixedly connected with a sheath tube joint on the outside; the control handle includes: A support main body, inside which there is the sheath tube joint, and when an axial force is applied to the sheath tube joint, it moves axially in the support main body to drive the outer sheath tube to move axially; A fixed handle, which is installed on the outside of the distal end of the support main body and is fixedly connected to the support main body; A sliding handle, which is installed on the outside of the support main body, the sliding handle is arranged adjacent to the proximal end of the fixed handle, and the sliding handle is rotatable on the outside of the support main body and drives the sheath tube joint to move axially.

5. The delivery device for stepwise releasing the control bracket according to claim 4, characterized in that, The support main body is provided with a long hole extending axially, the outside of the support main body is sleeved with a main body tooth block, the sheath tube joint includes a joint main body and an abutting block, the joint main body includes a distal convex block, the abutting block and the distal convex block respectively abut against the proximal end and the distal end of the main body tooth block to limit the axial movement of the main body tooth block relative to the sheath tube joint, the inner side of the sliding handle is provided with an internal thread, the outside of the main body tooth block is provided with an external thread, and the internal thread meshes with the external thread. When the sliding handle rotates, the sheath tube joint is driven to move axially through the main body tooth block, the abutting block and the distal convex block, and further drives the outer sheath tube to move axially.

6. The delivery device for stepwise releasing the control bracket according to claim 4, wherein, The sliding handle can slide axially on the supporting body, and a release button is embedded on the fixed handle. The release button extends a hook to one side of the sliding handle. The hook hooks the sliding handle so that the sliding handle is arranged close to the fixed handle and prevents the sliding handle from sliding in the axial direction.

7. The delivery device for controlling the stepwise release of the support bracket according to claim 3, wherein, The delivery device also includes a push rod, the distal end of which is located in the delivery gap. When the control handle controls the outer sheath tube to move axially proximally relative to the sheath core assembly, the push rod is used to resist the stent to prevent the stent from moving proximally to the delivery gap.

8. The delivery device for stepwise releasing the control bracket according to claim 7, wherein, The conveying device further comprises a supporting tube, the distal end of which is located in the conveying gap, and the push rod is located in the supporting tube.

9. The delivery device for stepwise releasing the control bracket according to claim 7, wherein, The push rod is provided with a plurality of through holes in the axial direction, and the control wire enters from the proximal end of the through hole and passes out from the distal end of the through hole.

10. The delivery device for controlling the stepwise release of the support bracket according to any one of claims 2-3, characterized in that The delivery device also includes a pre-embedded guide wire, which enters from the proximal end of the delivery gap and extends to the distal end of the delivery gap. The distal end of the pre-embedded guide wire is used to enter from the outside of the stent through the window on the stent to the inside of the stent. The pre-embedded guide wire is used to guide the branch guide wire to pass through the window of the stent from the inside of the stent.

11. The delivery device for controlling the stepwise release of the support bracket according to claim 10, characterized in that, A second locking assembly is provided on the proximal side of the delivery device, and the second locking assembly can be used to lock the movement of the embedded guide wire.

12. A delivery system for controlling the stepwise release of a stent, characterized in that, The invention comprises a stent and a conveying device, wherein the stent comprises a tubular covering and an annular support frame; the conveying device comprises: sheath core assembly; An outer sheath tube, which is hollow and sleeved on the outside of the sheath core assembly, a delivery gap exists between the outer sheath tube and the sheath core assembly, and a distal end of the delivery gap accommodates the shrunk stent; A stent restraint assembly, which causes the stent in the released portion to be not fully expanded to reduce the outer diameter when the stent is in a partially released state, and causes the stent to be fully expanded when the stent is in a fully released state; The stent restraint assembly further comprises a pull ring and a control wire, wherein the pull ring is fixedly connected to the proximal end of the control wire, and force is applied to the proximal end through the pull ring to release the restraint of the control wire on the stent; The conveying device also includes a first locking assembly, wherein the first locking assembly includes a pull ring fixing member and a near-release rotary cover, the pull ring fixing member is provided with a through hole for positioning the pull ring and a first groove cooperating with the near-release rotary cover, the near-release rotary cover is rotatably installed at the proximal end of the pull ring fixing member, an L-shaped protrusion is provided at the distal end of the inner side of the near-release rotary cover, the long arm of the L-shaped protrusion extends in the circumferential direction, and the short arm of the L-shaped protrusion extends axially from one end of the long arm toward the distal end, the L-shaped protrusion surrounds a second groove, and the distal end of the pull ring is provided with a second protrusion extending outwardly, when the pull ring is inserted into the through hole and fixed, the near-release rotary cover is rotated to make the second protrusion enter the second groove, thereby locking the position of the pull ring, at this time the pull ring cannot drive the control wire to move in the proximal direction, to prevent the bracket from being released due to error, when the near-release rotary cover is rotated to make the second protrusion come out of the second groove, the pull ring is operated to drive the control wire to move in the proximal direction, thereby releasing the bracket.

13. The conveying system according to claim 12, wherein Connectors are axially arranged on the tubular covering from the proximal end to the distal end, and the connectors are circumferentially spaced apart in at least two rows.

14. The conveying system according to claim 13, wherein, When the stent is in a partially released state, the stent binding assembly controls to bind at least two columns of the connecting members together so that the stent is not fully deployed circumferentially. When the stent is in a fully released state, the stent binding assembly releases the binding of the connecting members to fully deploy the stent.

15. The conveying system according to any one of claims 12 - 14, characterized in that, A window is provided on the tubular film. When the stent is in a partially released state, the window is located on the tubular film of the released portion.

16. The conveying system according to any one of claims 12-14, characterized in that, The stent binding assembly includes at least one control wire. The control wire enters from the proximal end of the delivery gap and extends to the distal end of the delivery gap. The distal end of the control wire circumferentially binds the released portion of the stent.

17. The conveying system according to any one of claims 12-14, characterized in that, The delivery device includes a control handle, which is connected to the outer sheath tube. The control handle controls the axial movement of the outer sheath tube relative to the sheath core assembly so that the contracted stent is in a partially released state or a fully released state.

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