Adjustable elbow for stent conveyor and stent conveyor

Abstract

The present invention discloses an adjustable bend for a stent conveyor and a stent conveyor, which belongs to the technical field of minimally invasive surgery and is designed to solve the problem that the turning angle of the existing stent conveyor is difficult to accurately control. The adjustable bend for the stent conveyor of the present invention comprises a bendable section, a transition connecting top rod, a rear tough multi-lumen tube and an adjustment handle connected in sequence, at least two traction wires are inserted in the bendable section, the head ends of all the traction wires are respectively fixedly connected to different positions of the front end inside the bendable section, and the tail ends of all the traction wires are respectively connected to the steering assembly on the adjustment handle after passing through different azimuth holes of the transition connecting top rod and the rear tough multi-lumen tube. The adjustable bend for the stent conveyor and the stent conveyor of the present invention can make the adjustable bend travel in a blood vessel with severe twisting and a small growth angle through the traction wire to adapt to the tortuosity of the human vascular system and realize the long-distance accurate delivery and operation of the coated stent.

Description

Technical Field

[0001] The present invention relates to the technical field of minimally invasive surgery, and in particular to an adjustable bend for a stent conveyor, a stent conveyor including the adjustable bend, and an ascending aorta covered stent and a conveying system component including the stent conveyor. Background Art

[0002] Aortic aneurysms located in the ascending aorta often involve the aortic sinus, causing deformation of the aortic valve ring and separation of the valve leaflets, leading to aortic valve insufficiency, and long-term effects leading to heart failure. According to the different distribution of aortic lesions, aortic dissection can be divided into the following three types according to the DeBakey system: Type I dissection originates from the ascending aorta, extends beyond the aortic arch to the descending aorta, and even the abdominal aorta. This type is the most common. Type II dissection originates from and is limited to the ascending aorta. DeBakey types I and II can be equated with Stanford type A.

[0003] Currently, aortic aneurysms can only be treated with open surgery, open-chest artificial blood vessel replacement, such as Bentall surgery (using polyester blood vessel replacement with artificial aortic valve and reimplanting the coronary artery into the polyester blood vessel), Wheat surgery, etc. Open surgery requires cardiac arrest and extracorporeal circulation, which is extremely traumatic and has high mortality and complication rates.

[0004] Due to the complex anatomical structure of the ascending aorta, with the heart, valves, and coronary arteries at the anterior proximal end and the supra-aortic branch arteries that supply blood to the brain and upper limbs at the posterior end, as well as the high blood pressure and rapid flow rate of the ascending aorta, large pulsation and deformation of the vascular wall, and the severity of ascending aortic dissection, it is difficult for the stent delivery device to accurately deliver the ascending aortic covered stent to the designated position, resulting in difficulty in applying intravascular minimally invasive technology to the treatment of the ascending aorta. Summary of the invention

[0005] One object of the present invention is to provide an adjustable elbow for a stent conveyor which can accurately adjust the turning direction and the turning angle.

[0006] Another object of the present invention is to provide a stent conveyor that can accurately deliver the ascending aorta covered stent to a designated position.

[0007] Another object of the present invention is to provide an ascending aorta covered stent and delivery system assembly that can perform minimally invasive surgery on ascending aortic dissection.

[0008] To achieve this object, on the one hand, the present invention adopts the following technical solutions:

[0009] An adjustable curved tube for a stent conveyor comprises a bendable section, a transition connection top rod, a rear tough multi-lumen tube and an adjustment handle which are connected in sequence, wherein at least two traction wires are passed through the bendable section, and the head ends of all the traction wires are respectively fixedly connected to different positions of the front end inside the bendable section, and the tail ends of all the traction wires respectively pass through different azimuth holes of the transition connection top rod and the rear tough multi-lumen tube and are connected to a steering assembly on the adjustment handle.

[0010] In particular, the steering assembly comprises a plurality of bending adjustment sliders, the end of each of the traction wires is fixedly connected to one of the bending adjustment sliders, and the bending adjustment sliders are configured to be able to retract or release the traction wires.

[0011] In particular, the adjustment handle includes an adjustable bending knob in the X-axis direction and an adjustable bending knob in the Y-axis direction, and a plurality of the bending adjustment sliders are respectively connected to the adjustable bending knob in the X-axis direction or the adjustable bending knob in the Y-axis direction.

[0012] In particular, the steering assembly includes four bending adjustment sliders, two of which are connected to the adjustable bending knobs in the X-axis direction, and the other two of which are connected to the adjustable bending knobs in the Y-axis direction.

[0013] In particular, two of the bending adjustment sliders are provided with left-handed external threads, and the other two bending adjustment sliders are provided with right-handed external threads, and the X-axis adjustable bending knob and the Y-axis adjustable bending knob are both provided with left-handed and right-handed internal threads.

[0014] In particular, the steering assembly includes meshing spur gears and racks, the end of each traction wire is fixedly connected to one of the racks, and the spur gear is configured to drive the rack to move when it rotates.

[0015] In particular, the steering assembly comprises two spur gears and four racks, and two of the racks are respectively meshed with one of the spur gears from opposite sides.

[0016] In particular, the steering assembly further comprises two rotating hand wheels, each of which is connected to one of the spur gears, and the rotating hand wheels are configured to drive the spur gears to rotate.

[0017] On the other hand, the present invention adopts the following technical solutions:

[0018] A stent delivery device comprises an outer sheath tube and a single-lumen inner tube, and also comprises the above-mentioned adjustable bend tube for the stent delivery device, wherein the adjustable bend tube is sleeved on the outer side of the single-lumen inner tube and penetrated on the inner side of the outer sheath tube.

[0019] On the other hand, the present invention adopts the following technical solution:

[0020] An ascending aorta covered stent and delivery system component includes a covered stent and the above-mentioned stent delivery device. When the covered stent is in a folded state, it is at least partially sleeved on the outside of the adjustable bend and penetrated on the inside of the outer sheath.

[0021] The adjustable bend for the stent delivery device of the present invention comprises a bendable section, a transition connection top rod, a rear tough multi-lumen tube and an adjustment handle which are connected in sequence. The adjustable bend can be advanced in a blood vessel with severe twisting and a small growth angle through a traction wire to adapt to the tortuosity of the human vascular system, thereby realizing long-distance delivery and operation of the coated stent, solving the problem that ascending aortic dissection is not suitable for minimally invasive surgery, reducing the mortality rate and complication rate during surgery, and shortening the required hospitalization and postoperative monitoring time. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a structural schematic diagram of the ascending aorta covered stent and delivery system assembly provided by a specific embodiment of the present invention;

[0023] Figure 2 is a schematic structural diagram of a stent conveyor provided in a specific embodiment of the present invention;

[0024] Figure 3 is a schematic diagram of the internal structure of a stent conveyor provided in a specific embodiment of the present invention;

[0025] Figure 4 is a structural schematic diagram of an end portion of a stent conveyor provided in a specific embodiment of the present invention;

[0026] Figure 5 It is a structural schematic diagram of an adjustable elbow provided in a specific embodiment of the present invention;

[0027] Figure 6 It is a structural schematic diagram of a transition connection top rod provided in a specific embodiment of the present invention;

[0028] Figure 7 is a schematic diagram of another preferred structure of a steering assembly provided in a specific embodiment of the present invention;

[0029] Figures 8 to 12 They are schematic diagrams of the process of delivering the coated stent by the stent conveyor.

[0030] In the figure:

[0031] 100. Stent delivery device; 110. Outer sheath; 120. Adjustable bend tube; 121. Bendable section; 122. Post-tough multi-lumen tube; 123. Traction wire; 124. Bending slider; 125. Transition connection push rod; 130. Single-lumen middle tube; 150. Flexible TIP head; 172. X-axis adjustable bending knob; 173. Y-axis adjustable bending knob; 200. Covered stent; 210. Proximal bare crown stent; 220. Distal covered stent; 401. Hand wheel; 402. Spur gear; 403. Rack; 1251. Azimuth hole. DETAILED DESCRIPTION

[0032] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0033] Embodiment 1

[0034] This embodiment discloses an adjustable elbow for a stent delivery device, a stent delivery device, an ascending aorta stent graft, and a delivery system assembly. Figure 1 As shown, the ascending aorta stent graft and delivery system assembly includes a stent graft 200 and a stent delivery device 100. Figures 2 to 4 As shown, the stent delivery device includes an outer sheath tube 110, a single-lumen inner tube 130 and an adjustable curved tube 120, wherein the adjustable curved tube 120 is sleeved on the outer side of the single-lumen inner tube 130 and penetrates the inner side of the outer sheath tube 110. When the stent graft 200 is in a collapsed state, it is at least partially sleeved on the outer side of the adjustable curved tube 120 and penetrates the inner side of the outer sheath tube 110.

[0035] The target lesion vessel sometimes grows at an abnormally twisted angle, so the stent delivery device 100 needs to use an adjustable bending function during the delivery of the coated stent 200, such as Figure 5 and Figure 6 As shown, the adjustable curved tube for the stent delivery device includes a bendable section 121, a transition connecting rod 125, a rear tough multi-lumen tube 122 and an adjustment handle connected in sequence, at least two traction wires 123 are inserted in the bendable section 121, the head ends of all the traction wires 123 are respectively fixedly connected to different positions of the front end of the inner part of the bendable section 121, and the tail ends of all the traction wires 123 respectively pass through different azimuth holes 1251 of the transition connecting rod 125 and the rear tough multi-lumen tube 122 and are connected to the steering assembly on the adjustment handle. The end of the single-lumen inner tube 130 and the end of the outer sheath tube 110 are respectively connected to the adjustment handle.

[0036] There are preferably four traction wires 123, and four circular azimuth holes 1251 are symmetrically arranged in the transition connecting top rod 125. The bendable section 121 is preferably laser-engraved from a metal tube and can be bent radially; the bendable section 121 can also be a multi-lumen tube with a front section hardness less than a rear section hardness. The built-in traction wire 123 can avoid cutting the inner wall of the blood vessel and is safer to use.

[0037] The stent delivery device 100 of the ascending aorta covered stent and delivery system assembly can deliver the covered stent 200 used to isolate the target diseased blood vessel to a designated location, perform ascending aorta intraluminal isolation, and treat ascending aortic dissection or aneurysm, and is particularly suitable for treating type A aortic dissection and ascending aortic aneurysm, solving the problem that ascending aortic dissection is not suitable for minimally invasive surgery, reducing the mortality rate and complication rate during surgery, and shortening the required hospitalization and postoperative monitoring time. The outer sheath 110 has sufficient axial and radial support and compliance, and the adjustable bend 120 can travel in a severely twisted blood vessel with a small growth angle to adapt to the tortuosity of the human vascular system, and realize the long-distance delivery and operation of the covered stent 200.

[0038] The specific structure of the steering assembly is not limited, as long as the bendable section 121 can be pulled to turn by the corresponding traction wire 123. Preferably, the steering assembly includes a plurality of bending adjustment sliders 124, and the end of each traction wire 123 is fixedly connected to a bending adjustment slider 124. The traction wire 123 can be retracted or released by rotating or moving the bending adjustment slider 124, thereby pulling the bendable section 121 to turn in the corresponding direction.

[0039] On the basis of the above structure, the adjustment handle includes an X-axis direction adjustable bending knob 172 and a Y-axis direction adjustable bending knob 173, and a plurality of bending adjustment sliders 124 are respectively connected to the X-axis direction adjustable bending knob 172 or the Y-axis direction adjustable bending knob 173. The X / Y axis direction uses the cross section of the blood vessel as a reference plane, and a vertical coordinate system is formed within the reference plane.

[0040] The steering assembly preferably includes four bending adjustment sliders 124, and the tail of each traction wire 123 is connected to a bending adjustment slider 124. Two bending adjustment sliders 124 are connected to the X-axis direction adjustable bending knob 172, and the other two bending adjustment sliders 124 are connected to the Y-axis direction adjustable bending knob 173. The bending adjustment slider 124 is driven to rotate or move by turning the X-axis direction adjustable bending knob 172 or the Y-axis direction adjustable bending knob 173.

[0041] Preferably, the X-axis adjustable bending knob 172 and the Y-axis adjustable bending knob 173 are both provided with left-handed and right-handed internal threads. Among the four bending sliders 124, two bending sliders 124 are provided with left-handed external threads, which are respectively connected to the X-axis adjustable bending knob 172 and the Y-axis adjustable bending knob 173; the other two bending sliders 124 are provided with right-handed external threads, which are respectively connected to the X-axis adjustable bending knob 172 and the Y-axis adjustable bending knob 173. When the X-axis adjustable bending knob 172 (or the Y-axis adjustable bending knob 173) is rotated clockwise or counterclockwise, one bending slider 124 can be driven to rotate or move, thereby pulling the corresponding traction wire 123 to retract and retract, realizing any bending direction and angle of the bendable section 121, so that the proximal bare crown stent 210 can turn within a range of 360°.

[0042] Based on the above structure, the outer sheath 110 preferably includes a three-layer structure arranged from the inside to the outside, the inner layer is made of a PTFE material with a smooth surface, the middle layer is made of a metal wire or a braided mesh, and the outer layer is made of PEBAX, PU or PTFE material. It has good compliance and has sufficient support, bending resistance and smooth inner and outer surfaces in both radial and axial directions.

[0043] Embodiment 2

[0044] This embodiment discloses an adjustable elbow for a stent conveyor, and its main structure is the same as that of the first embodiment. Figure 7 As shown, the steering assembly includes meshing spur gears 402 and racks 403, the end of each traction wire 123 is fixedly connected to a rack 403, and the spur gear 402 is configured to drive the rack 403 to move when it rotates.

[0045] The specific number of spur gears 402 and racks 403 is not limited and can be determined according to the specific number of traction wires 123. Preferably, the steering assembly includes two spur gears 402 and four racks 403, and two racks 403 are respectively meshed with one spur gear 402 from opposite sides.

[0046] Based on the above structure, the steering assembly also includes two rotating handwheels 401, each rotating handwheel 401 is connected to a spur gear 402, and the rotating handwheel 401 is configured to drive the spur gear 402 to rotate, thereby driving the rack 403 to move, and pulling the softer section of the multi-lumen tube head end to bend through the traction wire 123.

[0047] The method of using the ascending aorta stent graft and delivery system assembly is as follows:

[0048] Step 1: Build a channel, such as Figure 8 and Fig. 9As shown, the flexible TIP head 150 is pushed along the blood vessel until it reaches the set position. Considering that the stent delivery device 100 made of a four-layer structure is relatively hard, the outer sheath 110 can be removed first at a position with a large turn, and the stent graft 200 can be delivered to the target lesion position using the adjustable bend 120.

[0049] Step 2: After the stent graft 200 reaches the target lesion location, Fig.10 and Fig.11 As shown, the outer sheath 110 is removed to expose the semi-expanded coated stent 200; the single-lumen inner tube and the single-lumen middle tube 130 are pushed forward as a whole to expose the proximal bare crown stent 210.

[0050] Step 3, withdraw the single-lumen inner tube and the single-lumen middle tube 130 until the chronic dilator is aligned with the proximal bare crown stent 210; after adjusting the release angle, withdraw the single-lumen inner tube alone to allow the chronic dilator to expand radially, and the constrained proximal bare crown stent 210 gradually expands with the expansion of the chronic dilator.

[0051] Step 4: During the process of expanding the chronic expander, the angle of the proximal bare crown stent 210 is adjusted until the proximal bare crown stent 210 fits the inner wall of the target diseased blood vessel. That is, during the process of releasing the proximal bare crown stent 210, the angle of the proximal bare crown stent 210 can be adjusted at any time as needed.

[0052] Step 5: Fig.12 As shown, first remove the draw wire to completely release the distal coated stent 220; then push the single-lumen inner tube forward alone to slowly shrink the chronic dilator until the chronic dilator is completely separated from the proximal bare crown stent 210, completing the release and angle adjustment of the proximal bare crown stent 210.

[0053] In the method of use, the distal end covered stent 220 and the proximal end bare crown stent 210 are released successively. By setting the adjustable elbow 120 and the chronic dilator, the proximal end bare crown stent 210 can adjust the release angle while being slowly released, ensuring that the proximal end bare crown stent 210 can be more accurately anchored at the target position, even if the target position is extremely limited, thereby achieving minimally invasive surgery in the ascending aorta diseased blood vessels with extremely complex physiological and anatomical structures and extremely high criticality.

[0054] In the prior art, when the covered stent is released, its proximal end is released first, and the distal end is contracted. At this time, the covered stent is like a "pocket", which is prone to form a "storm" effect, causing the impact of blood flow on the covered stent to become greater. In severe cases, the proximal end of the covered stent is easily displaced, and even stimulates the inner wall of the blood vessel to cause dissection rupture, making the covered stent unsuitable for the current ascending aorta with an abnormally complex physiological and anatomical structure.

[0055] The ascending aorta covered stent and delivery system assembly can release the distal end covered stent 220 and the proximal end bare crown stent 210 in steps and successively; after the outer sheath 110 is removed, the distal end covered stent 220 restrained by a soft membrane or binding wire with a diameter of 10mm-15mm is half-released, which enhances flexibility and reduces the "storm" effect, further improving the safety and feasibility of minimally invasive surgery.

[0056] Note that the above are only preferred embodiments of the present invention and the technical principles used. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and that various obvious changes, readjustments and substitutions can be made by those skilled in the art without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in more detail through the above embodiments, the present invention is not limited to the above embodiments, and may include more other equivalent embodiments without departing from the concept of the present invention, and the scope of the present invention is determined by the scope of the appended claims.

Claims

1. An adjustable elbow for a stent conveyor, characterized in that: It comprises a bendable section (121), a transition connecting rod (125), a rear tough multi-lumen tube (122) and an adjustment handle which are connected in sequence, wherein at least two traction wires (123) are inserted into the bendable section (121), the head ends of all the traction wires (123) are respectively fixedly connected to different positions of the front end of the bendable section (121), and the tail ends of all the traction wires (123) respectively pass through holes (1251) in different orientations of the transition connecting rod (125) and the rear tough multi-lumen tube (122) and are then connected to a steering assembly on the adjustment handle; The steering assembly comprises a plurality of bending adjustment sliders (124), the end of each of the traction wires (123) being fixedly connected to one of the bending adjustment sliders (124), and the bending adjustment sliders (124) being configured to be able to retract or release the traction wires (123); Alternatively, the steering assembly comprises meshing spur gears (402) and racks (403), the end of each traction wire (123) is fixedly connected to one of the racks (403), and the spur gear (402) is configured to drive the rack (403) to move when it rotates.

2. The adjustable elbow for a stent conveyor according to claim 1, characterized in that: The adjustment handle comprises an adjustable bending knob (172) in the X-axis direction and an adjustable bending knob (173) in the Y-axis direction, and a plurality of the bending adjustment sliders (124) are respectively connected to the adjustable bending knob (172) in the X-axis direction or the adjustable bending knob (173) in the Y-axis direction.

3. The adjustable elbow for a stent conveyor according to claim 2, characterized in that: The steering assembly comprises four bending adjustment sliders (124), two of the bending adjustment sliders (124) are connected to the X-axis direction adjustable bending knob (172), and the other two of the bending adjustment sliders (124) are connected to the Y-axis direction adjustable bending knob (173).

4. The adjustable elbow for a stent conveyor according to claim 3, characterized in that: Two of the bending adjustment sliders (124) are provided with left-handed external threads, and the other two bending adjustment sliders (124) are provided with right-handed external threads, and the X-axis direction adjustable bending knob (172) and the Y-axis direction adjustable bending knob (173) are both provided with left-handed and right-handed internal threads.

5. The adjustable elbow for a stent conveyor according to claim 1, characterized in that: The steering assembly comprises two spur gears (402) and four racks (403), and the two racks (403) are respectively meshed with one of the spur gears (402) from opposite sides.

6. The adjustable elbow for a stent conveyor according to claim 5, characterized in that: The steering assembly further comprises two rotating hand wheels (401), each of the rotating hand wheels (401) being connected to one of the spur gears (402), and the rotating hand wheels (401) being configured to drive the spur gears (402) to rotate.

7. A stent delivery device, comprising an outer sheath tube (110) and a single-lumen inner tube (130), characterized in that: It also comprises an adjustable bend tube (120) for a stent delivery device as claimed in any one of claims 1 to 6, wherein the adjustable bend tube (120) is sleeved on the outside of the single-lumen middle tube (130) and penetrates the inside of the outer sheath tube (110).

8. An ascending aorta stent graft and delivery system assembly, comprising a stent graft (200), characterized in that: It also comprises the stent delivery device (100) as claimed in claim 7, wherein the coated stent (200) is at least partially sleeved on the outside of the adjustable bend tube (120) and penetrates the inside of the outer sheath tube (110) when the stent graft (200) is in a folded state.

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