Adjusting device and adjusting system

Abstract

The invention relates to an adjusting device and an adjusting system, and the adjusting device comprises an adjusting member which has a radial expansion state and a radial contraction state; in the radial unfolding state, the adjusting component is provided with an axial penetrating channel, and the channel is provided with an inflow opening and an outflow opening. The adjusting sleeve is movably arranged on the adjusting component in a sleeving mode and located on the side where the outflow opening is located, and the adjusting sleeve can axially move relative to the adjusting component to adjust the radial unfolding size of the adjusting component at the outflow opening so as to adjust the size of the outflow opening; and the push rod assembly is connected with the adjusting sleeve and used for enabling the adjusting sleeve to axially move relative to the adjusting component. According to the adjusting device, in the operation process, under the condition that the blood pressure parameter of a patient is within the range value allowed by the operation, the size of the outflow opening can be adjusted to be the minimum, difference adjustment can be conducted according to the physical conditions of different patients, the applicability of clinical operation is improved, and the application range is wide.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an adjustment device and an adjustment system. Background Art

[0002] The information provided in this section is only background information related to the present disclosure, and it is not necessarily prior art.

[0003] Acute heart failure (AHF) refers to a clinical syndrome caused by acute onset or exacerbation of left ventricular dysfunction, resulting in reduced myocardial contractility, increased cardiac load, sudden decrease in acute cardiac output, increased pulmonary circulation pressure, increased peripheral vascular resistance, causing pulmonary congestion and presenting acute pulmonary congestion, pulmonary edema, and may be accompanied by tissue and organ hypoperfusion and cardiogenic shock. The conditions of acute heart failure caused by the sudden deterioration of chronic heart failure symptoms usually include dyspnea, leg swelling and fatigue, fluid retention, etc. Among them, patients with fluid retention symptoms usually receive intravenous diuretic treatment, and during the treatment of acute heart failure, the occurrence of diuretic resistance is a common clinical problem.

[0004] Generally, in the face of the problem of diuretic resistance, some researchers have tried to change the blood flow in the infrarenal vena cava through an adjustment device to increase renal perfusion, reduce preload of the heart and afterload of the kidney, increase renal blood flow, urine output and sodium excretion, thereby improving diuretic responsiveness. After such an adjustment device is implanted into the blood vessel, by accelerating the blood flow passing through the adjustment device, the blood flow at the branch of the renal vein in the inferior vena cava is accelerated, achieving the effect of renal vein decompression, thereby reducing the afterload of the kidney, increasing renal blood flow, increasing urine output, increasing sodium excretion, and improving diuretic responsiveness.

[0005] During the clinical treatment process, after such an adjustment device reaches the target position and is opened, it will cause a certain degree of obstruction to the blood flow, thereby causing changes in the patient's blood pressure parameters. Different patients have different tolerance ranges for blood pressure. When the blood pressure exceeds the patient's tolerance range for blood pressure, it will cause varying degrees of damage to the patient's body. Summary of the Invention

[0006] Based on this, it is necessary to provide an adjustment device with a wide range of applications.

[0007] Furthermore, an adjustment system with a wide range of applications is also provided.

[0008] An adjusting device includes: an adjusting member having a radially expanded state and a radially contracted state; in the radially expanded state, the adjusting member has an axially penetrating channel with an inflow opening and an outflow opening; an adjusting sleeve movably sleeved on the adjusting member and located on the side where the outflow opening is located, and the adjusting sleeve can axially move relative to the adjusting member to adjust the radially expanded dimension of the adjusting member at the outflow opening, thereby adjusting the size of the outflow opening; and a push rod assembly connected to the adjusting sleeve for axially moving the adjusting sleeve relative to the adjusting member.

[0009] In one embodiment, the push rod assembly includes a first push rod and a second push rod movably penetrating through the first push rod; when the outflow opening is located at the proximal end of the adjusting member, the first push rod is connected to the proximal end of the adjusting member, and the distal end of the second push rod extends into the adjusting member and is connected to the adjusting sleeve; or, the second push rod is connected to the proximal end of the adjusting member, and the first push rod is connected to the adjusting sleeve; when the outflow opening is located at the distal end of the adjusting member, the first push rod is connected to the proximal end of the adjusting member, and the distal end of the second push rod extends into the adjusting member and is connected to the adjusting sleeve.

[0010] In one embodiment, the adjusting member includes: a frame having a radially expanded state and a radially contracted state, the frame having axially opposite first and second ends, the inflow opening being located at the first end and the outflow opening being located at the second end; and a flow blocking film surrounding a partial side wall of the frame to form the channel, and the flow blocking film can radially expand or contract along with the frame.

[0011] In one embodiment, the frame includes a first constricting member, a second constricting member, a first connecting portion, a second connecting portion, and an expanding portion with two ends respectively connected to the first connecting portion and the second connecting portion. One end of the first connecting portion away from the expanding portion is connected to the first constricting member, and one end of the second connecting portion away from the expanding portion is connected to the second constricting member. The outflow opening is located at the first connecting portion, and the inflow opening is located at the second connecting portion; the flow blocking film surrounds the expanding portion, and the adjusting sleeve is movably sleeved on the first connecting portion.

[0012] In one embodiment, the first connecting portion includes a plurality of first connecting rods extending axially. One end of each first connecting rod is connected to the expanding portion, and the other end is connected to the first constricting member; and, the plurality of first connecting rods all penetrate through the adjusting sleeve, and the adjusting sleeve can axially move along the first connecting rods to adjust the size of the outflow opening.

[0013] In one embodiment, the adjusting sleeve includes an inner ring and an outer ring sleeved on the inner ring. A plurality of receiving grooves are provided on the inner side wall of the outer ring and are circumferentially spaced apart. The receiving grooves axially penetrate through the proximal end face and the distal end face of the outer ring. The inner ring is connected to the inner wall of the outer ring, and a plurality of through holes are formed at circumferential intervals in cooperation with each receiving groove. A plurality of the first connecting rods correspondingly penetrate through the plurality of through holes.

[0014] In one embodiment, the proximal end face of the inner ring and the inner side wall of the outer ring cooperate to form a stepped portion. When the outflow opening is located at the proximal end of the adjusting member, the distal end of the second push rod extends into the outer ring and is connected to the stepped portion; when the outflow opening is located at the distal end of the adjusting member, the distal end of the second push rod extends into the outer ring and is connected to the stepped portion; or, the end face of one end of the outer ring and the outer wall of the inner ring cooperate to form a stepped portion, and the first push rod is sleeved on the inner ring and is connected to the stepped portion.

[0015] In one embodiment, the adjusting device further includes: an end connector and an inner tube. The end connector is connected to the end of the adjusting member away from the push rod assembly. The inner tube movably penetrates through the push rod assembly, the adjusting sleeve, and the adjusting member, and the distal end of the inner tube is connected to the end connector.

[0016] In one embodiment, the end connector is a developing member and has a through hole axially penetrating therethrough. The end connector includes: a head and a tail connected to the proximal end of the head. The radial dimension of the head is greater than the radial dimension of the tail. The end of the adjusting member away from the push rod assembly is sleeved on the tail and is fixedly connected to the tail. The inner tube penetrates into the through hole and is connected to the side wall of the through hole.

[0017] An adjusting system includes: an outer sheath tube, an operating handle, and the adjusting device as described above. The proximal end of the outer sheath tube and the proximal end of the push rod assembly are both connected to the operating handle, and the push rod assembly movably penetrates through the outer sheath tube. The adjusting member and the adjusting sleeve are movably received in the lumen of the outer sheath tube. The operating handle is used to control the axial movement of the push rod assembly to drive the adjusting sleeve to axially move relative to the adjusting member.

[0018] In the regulating device provided by the embodiment of the present invention, the regulating sleeve can be movably sleeved on the side where the outflow opening of the regulating member is located, and the regulating sleeve and the regulating member can be relatively displaced in the axial direction through the arranged push rod assembly to adjust the radial expansion size of the regulating member at the outflow opening, thereby adjusting the size of the outflow opening. The regulating device arranged in this way can adjust the size of the outflow opening to the minimum while ensuring that the patient's blood pressure parameters are within the range allowed by the operation during the operation, which is conducive to differential adjustment according to the physical conditions of different patients, improves the applicability of clinical operations, and has a wide range of applications.

[0019] The adjustment system provided in an embodiment of the present invention adopts the above-mentioned adjustment device, so that during the operation, the adjustment system can adjust the size of the outflow opening to the minimum while ensuring that the patient's blood pressure parameters are within the range allowed by the operation. This is conducive to differential adjustments based on the physical conditions of different patients, improves the applicability of clinical operations, and has a wide range of applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0021] in:

[0022] Figure 1 It is a structural schematic diagram of a regulating system in one embodiment of the present invention;

[0023] Figure 2 It is a front view of an adjusting device in one embodiment of the present invention;

[0024] Figure 3 For along Figure 2 Sectional view after cutting along the center section line AA;

[0025] Figure 4 It is a schematic diagram of the structure of the regulating device in one embodiment of the present invention when the inflow opening is in the maximum state;

[0026] Figure 5 It is a schematic diagram of the structure of the regulating device in one embodiment of the present invention when the inflow opening is in the smallest state;

[0027] Figure 6 It is a structural schematic diagram of an adjusting device in another embodiment of the present invention;

[0028] Figure 7 is an expanded view of a flow-blocking film in one embodiment of the present invention;

[0029] Figure 8 Schematic structural diagram of a frame in an embodiment of the present invention;

[0030] Figure 9 Schematic structural diagram of an adjusting device in another embodiment of the present invention;

[0031] Figure 10 Schematic structural diagram of an adjusting device in another embodiment of the present invention;

[0032] Figure 11 Schematic structural diagram of an adjusting sleeve from a first perspective in an embodiment of the present invention;

[0033] Figure 12 Schematic structural diagram of an adjusting sleeve from a second perspective in an embodiment of the present invention;

[0034] Figure 13 Schematic structural diagram of a distal connector in an embodiment of the present invention. Detailed implementation manners

[0035] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with 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. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0036] In the description of the embodiments of the present invention, it should be noted that terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the embodiments of the present invention. In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0037] In the description of the embodiments of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "installed", "connected", "connected" should be understood in a broad sense. For example, it can be a fixed connection, a replaceable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium. It can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific situations.

[0038] In the field of interventional medical devices, generally, the end of a medical device implanted into the human body or animal body that is closer to the operator is called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined based on this principle. The "axial direction" generally refers to the length direction of the medical device when it is being delivered, and the "radial direction" generally refers to the direction of the medical device that is not parallel to its "axial direction", and the "axial direction" and "radial direction" of any component of the medical device are defined based on this principle. The "circumferential direction" refers to the circumferential direction, that is, the direction around the axis of the lumen structure or cylinder.

[0039] Please refer to Figure 1 , an embodiment of the present invention relates to an adjustment system 100 for adjusting the blood flow velocity in blood vessels, thereby triggering a series of hemodynamic effects to achieve a therapeutic purpose. In this embodiment, the adjustment system 100 is mainly used for interventional treatment operations, and by adjusting the blood flow in the inferior vena cava, the problem of diuretic resistance during the treatment of acute heart failure is solved.

[0040] In one embodiment, the adjustment system 100 includes: an outer sheath 1, an operating handle 2, and an adjustment device 3. Among them, the outer sheath 1 is used to establish a delivery channel with the human blood vessel so as to send the adjustment device 3 to the target position. The proximal end of the outer sheath 1 is connected to the distal end of the operating handle 2. The adjustment device 3 is movably inserted through the outer sheath 1, and its proximal end is connected to the operating handle 2 or can be movably extended from the operating handle 2. During delivery, the adjustment device 3 is received in the lumen of the outer sheath 1. After reaching the target position, the distal end of the adjustment device 3 can be released from the distal end of the outer sheath 1 by operating the handle 2 or directly pushing the adjustment device 3 to adjust the blood flow velocity at the target position.

[0041] It should be noted that in this embodiment, the target position is the upstream of the blood flow near the renal vein branch of the inferior vena cava. By the adjustment device 3, the blood flow velocity at the renal vein branch is increased, and according to Bernoulli's principle, the pressure in the renal vein blood vessel can be reduced to achieve the therapeutic purpose.

[0042] Please refer to Figure 2 and Figure 3, in one embodiment, the adjusting device 3 includes: an adjusting member 31, an adjusting sleeve 32, and a push rod assembly 33. Specifically, the adjusting member 31 has a radially expanded state and a radially contracted state. In the radially expanded state of the adjusting member 31, it has an axially penetrating channel 30, and the channel 30 has an inflow opening 301 and an outflow opening 302. The adjusting sleeve 32 is movably sleeved on the adjusting member 31 and is located on the side where the outflow opening 302 is located. The adjusting sleeve 32 can axially move relative to the adjusting member 31 to adjust the radially expanded dimension of the adjusting member 31, thereby adjusting the size of the outflow opening 302 and increasing the fluid flow rate through the channel 30. The push rod assembly 33 is connected to the adjusting sleeve 32. The push rod assembly 33 is used to axially move the adjusting sleeve 32 relative to the adjusting member 31 to adjust the size of the outflow opening 302 of the adjusting member 31, achieving the effect of adjusting the flow rate.

[0043] In this embodiment, a part of the push rod assembly 33 is connected to the adjusting sleeve 32, and another part is connected to the adjusting member 31. The push rod assembly 33 is mainly used to drive the adjusting member 31 and the adjusting sleeve 32 to axially move, so that the adjusting member 31 and the adjusting sleeve 32 can extend or retract into the lumen of the outer sheath tube 1, and can axially move the adjusting sleeve 32 relative to the adjusting member 31 to adjust the size of the outflow opening 302 of the adjusting member 31.

[0044] Specifically, the push rod assembly 33 includes a first push rod 331 and a second push rod 332 that is movably inserted through the first push rod 331. In this embodiment, the inflow opening 301 is a proximal opening, and the outflow opening 302 is a distal opening. At this time, the adjusting sleeve 32 is sleeved on the distal end of the adjusting member 31. The distal end of the first push rod 331 is connected to the proximal end of the adjusting member 31, and the proximal end is connected to the distal end of the operating handle 2. The first push rod 331 is movably inserted through the outer sheath tube 1 and is used to drive the adjusting member 31 to axially move, so that the adjusting member 31 can be accommodated in the lumen of the outer sheath tube 1 during transportation and can be released from the distal end of the outer sheath tube 1 after reaching the target position. The distal end of the second push rod 332 extends out of the first push rod 331 and extends into the adjusting member 31 and is connected to the adjusting sleeve 32. The proximal end of the second push rod 332 is connected to the distal end of the operating handle 2. The second push rod 332 is used to drive the adjusting sleeve 32 to axially move and can axially move the adjusting sleeve 32 relative to the adjusting member 31 to adjust the radially expanded dimension of the distal end of the adjusting member 31, thereby adjusting the radially expanded degree of the outflow opening 302 and realizing the adjustability of the outflow opening 302.

[0045] It should be noted that during the transportation process, the adjusting sleeve 32 is located at the distal end of the adjusting member 31. After the adjusting device 3 reaches the target position, by pushing the first push rod 331 distally, the adjusting member 31 is gradually released from the distal end of the outer sheath tube 1. After the adjusting member 31 is completely released, the outflow opening 302 is in the maximum state (such asFigure 4 As shown, since the adjustment member 31 implanted in the anatomical structure of the human body lumen will cause a certain obstruction to blood flow, and the outflow opening 302 is set to be in the maximum state after the adjustment member 31 is released, the impact on blood pressure caused by the adjustment member 31 after release can be reduced, making it easier for the patient to accept the implantation of the adjustment member 31 and facilitating the continuation of the blood flow regulation surgery. Then, the second push rod 332 can be driven proximally to move the adjustment sleeve 32 relative to the adjustment member 31 toward the proximal side, thereby gradually reducing the radial dimension of the outflow opening 302 (as Figure 5 shown, the figure shows the state where the outflow opening 302 is in the minimum state). Since the faster the blood flow, the more obvious the decompression effect on the renal vein, therefore, by gradually reducing the radial dimension of the outflow opening 302, on the premise of ensuring that the patient's blood pressure is within the normal range, the radial dimension of the outflow opening 302 can be adjusted to the minimum, thereby improving the treatment effect.

[0046] It can be understood that in this embodiment, the adjustment device 3 is delivered to the target position along the blood flow direction. At this time, the inflow opening 301 is the proximal opening, the outflow opening 302 is the distal opening, and the adjustment sleeve 32 is sleeved on the distal side of the adjustment member 31. In other embodiments, the adjustment device 3 can also be delivered to the target position against the blood flow direction. At this time, the inflow opening 301 is the distal opening, the outflow opening 302 is the proximal opening, and the adjustment sleeve 32 is sleeved on the proximal side of the adjustment member 31.

[0047] Please refer to Figures 2 to 4 , in one embodiment, the adjustment member 31 includes a frame 311 and a flow blocking membrane 312. The frame 311 has a radially expanded state and a radially contracted state. In this embodiment, the frame 311 has self-expanding properties, enabling the frame 311 to automatically return to the radially expanded state after being released from the lumen of the outer sheath tube 1. The flow blocking membrane 312 is connected to the side wall of the frame 311 and can expand or contract radially with the frame 311. The flow blocking membrane 312 surrounds the side wall of the frame 311 to form a channel 30.

[0048] It should be noted that in this embodiment, the frame 311 also has a certain flexibility for easy bending during delivery. The flow blocking membrane 312 is arranged on the outer side wall of the frame 311 and is fixedly connected to the frame 311 by suture or other fixing means. The flow blocking membrane 312 is made of a flexible material, for example, made of nylon material. Therefore, the arranged flow blocking membrane 312 will not significantly reduce the overall flexibility of the frame 311, ensuring the bending ability of the adjustment device 3 and facilitating the delivery of the adjustment device 3.

[0049] Please refer to Figure 6, in another embodiment, the flow blocking membrane 312 is disposed within the frame 311. When the frame 311 radially contracts, it can constrain the flow blocking membrane 312, which helps to prevent the flow blocking membrane 312 from accumulating on the outer periphery of the frame 311, thereby reducing the resistance of the flow blocking membrane 312 to the sheath insertion of the frame 311. This facilitates the retraction of the adjusting member 31 into the sheath after adjusting the renal vein blood flow pressure, and reduces the operational difficulty of the surgery.

[0050] In one embodiment, a plurality of corners 3121 are provided at the proximal end of the flow blocking membrane 312, and the plurality of corners 3121 are fixedly connected to the frame 311. When the frame 311 radially contracts, the flow blocking membrane 312 located within the frame 311 is squeezed by the frame 311 and contracts. There are V-shaped notches or U-shaped notches between adjacent corners 3121, and the V-shaped notches or U-shaped notches correspond to the mesh holes of the frame 311. Therefore, the situation where the flow blocking membrane 3121 at the mesh hole position bulges out of the outer wall of the contracted frame 311 due to wrinkling during contraction is avoided, thereby reducing the sheath insertion resistance of the frame 311. Moreover, the V-shaped notches or U-shaped notches between adjacent corners 3121 are also the gaps between adjacent corners 3121, making the radial dimension of the proximal end of the radially contracted frame 311 smaller, further reducing the sheath insertion resistance of the adjusting member 31.

[0051] It should be noted that the flow blocking membrane 312 may be provided with corners 3121 only at the proximal end, or may be provided with corners 3121 at the distal end, or may be provided with corners 3121 at both the proximal and distal ends.

[0052] Please refer to Figure 6 and Figure 7 , in one embodiment, the flow blocking membrane 312 is formed by joining the two waistlines of a trapezoidal thin film body. The two waistlines form a tubular structure through fixing means such as suturing to allow blood flow through. The inflow opening 301 is the proximal opening of the flow blocking membrane 312, and the outflow opening 302 is the distal opening of the flow blocking membrane 312. It should be noted that the radial dimension of the inflow opening 301 should be as large as possible to allow more blood flow to enter the channel 30.

[0053] In this embodiment, the flow blocking membrane 312 is fixedly connected to the frame 311 by suturing. The specific suturing route is not described here in detail, as long as the fixed connection between the flow blocking membrane 312 and the frame 311 can be achieved.

[0054] Please refer to Figure 8, in one embodiment, the frame 311 includes a first connecting portion 3111, a second connecting portion 3112, an expansion portion 3113, a first constricting member 3114, and a second constricting member 3115. Among them, both ends of the expansion portion 3113 are respectively connected to the first connecting portion 3111 and the second connecting portion 3112. One end of the first connecting portion 3111 far from the expansion portion 3113 is connected to the first constricting member 3114, and one end of the second connecting portion 3112 far from the expansion portion 3113 is connected to the second constricting member 3115, so that the frame 311 forms a grid structure with smaller ends and a larger middle.

[0055] The expansion portion 3113 includes a plurality of circumferentially connected polygonal structures. In this embodiment, the polygonal structure is a hexagon and includes two first main rods 31131, two second main rods 31132, and two intermediate rods 31133. The intermediate rods 31133 extend axially, and the two intermediate rods 31133 are circumferentially spaced. Both ends of each intermediate rod 31133 are respectively connected to a first main rod 31131 and a second main rod 31121. Moreover, the ends of the two first main rods 31131 far from the intermediate rods 31133 are connected to form a first connection point 31134, and the ends of the two second main rods 31132 far from the intermediate rods 31133 are connected to form a second connection point 31135.

[0056] In one embodiment, the first connecting portion 3111 includes a plurality of first connecting rods 31111 circumferentially spaced apart. One end of the first connecting rod 31111 is connected to the first constricting member 3111, and the other end is connected to the first connection point 31134. The second connecting portion 3112 also includes a plurality of second connecting rods 31121 circumferentially spaced apart. One end of the second connecting rod 31121 is connected to the second connection point 31135, and the other end is connected to the second constricting member 3115.

[0057] In this embodiment, the adjusting device 3 is delivered to the target position against the blood flow direction. The first connecting portion 3111 is located at the distal end, and the second connecting portion 3112 is located at the proximal end. The first connecting rods 31111 are longer than the second connecting rods 31121. The adjusting sleeve 32 is movably sleeved on the first connecting rods 31111 so that the adjusting sleeve 32 has a longer movement stroke, making the opening adjustment range of the first connecting portion 3111 wider. Moreover, a plurality of first connecting rods 31111 all pass through the adjusting sleeve 32 to guide the axial movement of the adjusting sleeve 32, which is beneficial for the adjusting sleeve 32 to adjust the radial expansion degree of the first connecting portion 3111.

[0058] In one embodiment, in the natural state, the two intermediate rods 31133 are not parallel, and the circumferential distance between the ends of the two intermediate rods 31133 close to the first main rod 31131 is smaller than the circumferential distance between the ends of the two intermediate rods 31133 close to the second main rod 31132, so that in the natural state, the radial dimension of the inflow opening 301 is larger than the radial dimension of the outflow opening 302. Thus, after being implanted into the blood vessel, the blood flow velocity can be quickly adjusted.

[0059] In one embodiment, in the natural state, from the end of the intermediate rod 31133 connected to the second main rod 31131 to the first constriction member 3114, the radial dimension of the frame 311 gradually decreases, so that when the adjusting sleeve 32 is in different positions, the radial dimension of the outflow opening 302 is different, thereby broadening the range of changes in the radial openings of the outflow opening 302 and the inflow opening, and thus being able to be applicable to more patients with different tolerances to blood pressure changes.

[0060] Please refer to Figures 8 to 10 , in another embodiment, the adjusting device 3 is delivered to the target position against the blood flow direction. In this state, the first connecting portion 3111 is located at the proximal end and the second connecting portion 3112 is located at the distal end. In this way, the structure of the adjusting member 31 can remain unchanged, and by setting the cooperation mode of the push rod assembly 33 with the adjusting member 31 and the adjusting sleeve 32, it can be realized that when the adjusting device 3 is delivered to the target position against the blood flow direction, the blood flow velocity can also be adjusted.

[0061] As Figure 9 shown, at this time, the distal end of the first push rod 331 is connected to the proximal end of the adjusting member 31, the second push rod 332 passes through the lumen of the first push rod 331, and its distal end extends into the adjusting member 31 and is connected to the proximal end of the adjusting sleeve 32; or, as Figure 10 shown, the distal end of the first push rod 331 is connected to the adjusting sleeve 32, and the adjusting member 31 can be movably received in the lumen of the first push rod 331. The second push rod 332 passes through the lumen of the first push rod 331, and the distal end of the second push rod 332 is connected to the proximal end of the adjusting member 31. By driving the second push rod 332 to move proximally relative to the first push rod 331, on the one hand, the adjusting member 31 can be completely received in the lumen of the first push rod 331 for delivering or retracting the adjusting member 31, and on the other hand, the adjusting member 31 can be partially received in the lumen of the first push rod 331 to adjust the size of the outflow opening 302. At this time, the outer sheath tube 1 can be omitted, and the first push rod 311 plays the role of delivery.

[0062] Please refer to Figure 4 , Figure 11 and Figure 12, in one embodiment, the adjusting sleeve 32 includes an inner ring 321 and an outer ring 322 sleeved on the inner ring 321. Specifically, a plurality of circumferentially spaced-apart receiving grooves 3221 are provided on the inner side wall of the outer ring 322, and the receiving grooves 3221 axially penetrate through the proximal end face and the distal end face of the outer ring 322. The inner ring 321 is connected to the inner wall of the outer ring 322, and a plurality of through holes 323 that are circumferentially spaced apart are formed in cooperation with each receiving groove 3221. In this embodiment, the number of the through holes 323 is the same as the number of the first connecting rods 31111, and the first connecting rods 31111 respectively pass through the through holes 323 in a one-to-one correspondence.

[0063] By forming the through holes 323 in a manner of cooperating the inner ring 321 and the outer ring 322, a plurality of first connecting rods 31111 are respectively circumferentially restricted in the plurality of through holes 323, so that the connection between the adjusting sleeve 32 and the adjusting member 31 is more reliable, and the adjusting sleeve 32 can smoothly slide along the plurality of first connecting rods 31111 to smoothly adjust the size of the outflow opening 302.

[0064] In this embodiment, the distal end of the inner ring 321 is flush with the distal end of the outer ring 322, and a stepped portion 3211 is formed on the inner side wall of the outer ring 322 at the proximal end of the inner ring 321. The distal end of the second push rod 332 extends into the outer ring 332 and is connected to the stepped portion 3211, so that the connection area between the second push rod 332 and the adjusting sleeve 32 can be increased, which is beneficial to improving the stability and reliability of the connection between the second push rod 332 and the adjusting sleeve 32. It should be noted that, in this state, the second push rod 332 can also extend into the outer ring 332 and be fixedly connected to the inner side wall of the outer ring 332.

[0065] In one embodiment, the end face of the outer ring 322 can cooperate with the outer side wall of the inner ring 321 to form a stepped portion 3211, the second push rod 332 is sleeved on the part of the inner ring 321 protruding from the outer ring 322, and is connected to the stepped portion 3211 through an adhesive. It should be noted that, in this state, the second push rod 332 can also be only sleeved and fixed on the part of the inner ring 321 protruding from the outer ring 322 without being connected to the stepped portion 3211. Please refer to Figure 5 and Figure 13 , in one embodiment, the adjusting device 3 further includes an end connector 34 and an inner tube 35. The end connector 34 is connected to one end of the distal end of the adjusting member 31 away from the push rod assembly 33. Specifically, the end connector 34 is connected to one end of the first converging member 3114 away from the first connecting rod 31111. A through hole 340 that axially penetrates is formed in the end connector 34. The inner tube 35 is movably passed through the second push rod 332, the adjusting sleeve 32 and the adjusting member 31. The distal end of the inner tube 35 is connected to the end connector 34, and the proximal end is connected to the operating handle 2.

[0066] The inner tube 35 is a hollow tube body with openings at both ends. It should be noted that the setting of the inner tube 35, on the one hand, enables the guide wire to pass through the adjusting member 31 and the end connecting member 34 more smoothly; on the other hand, it can provide a supporting force for the adjusting member 31, so that when the second push rod 332 drives the adjusting sleeve 32 to move axially, the adjusting member 31 will not bend and deform, which is beneficial to the axial movement of the adjusting sleeve 32, thereby improving the smoothness of the adjustment operation; on the other hand, when the inner tube 35 moves distally, the adjusting member 31 is axially stretched, and the adjusting member 31 can be switched from the radially expanded state to the radially contracted state, reducing the sheath insertion resistance of the adjusting member 31, which is beneficial to the sheath insertion and retraction of the adjusting member 31 and reduces the difficulty of clinical operation.

[0067] In one embodiment, the end connecting member 34 is a radiopaque member. The end connecting member 34 includes a head 341 and a tail 342 connected to the proximal end of the head 341. The head 341 is generally hemispherical, and the radial dimension of the proximal end of the head 341 is larger than the radial dimension of the tail 342. The distal end of the adjusting member 31 is sleeved on the tail 342 and fixedly connected thereto. The distal end of the inner tube 35 penetrates into the through hole 340 and is connected to its inner side wall, which is beneficial to improving the connection reliability between the inner tube 35 and the end connecting member 34.

[0068] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0069] The above-disclosed are only the preferred embodiments of the present invention. Of course, the scope 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. An adjusting device, characterized in that, Comprising: A regulating member having a radially expanded state and a radially contracted state; In the radially expanded state, the regulating member has an axially penetrating channel with an inflow opening and an outflow opening; A regulating sleeve movably sleeved on the regulating member and located on the side where the outflow opening is located. The regulating sleeve can axially move relative to the regulating member to adjust the radially expanded dimension of the regulating member at the outflow opening, thereby adjusting the size of the outflow opening; And, A push rod assembly connected to the regulating sleeve for axially moving the regulating sleeve relative to the regulating member.

2. The adjusting device according to claim 1, wherein The push rod assembly includes a first push rod and a second push rod movably passing through the first push rod; When the outflow opening is located at the proximal end of the regulating member, the first push rod is connected to the proximal end of the regulating member, and the distal end of the second push rod extends into the regulating member and is connected to the regulating sleeve; or, the second push rod is connected to the proximal end of the regulating member, and the first push rod is connected to the regulating sleeve; When the outflow opening is located at the distal end of the regulating member, the first push rod is connected to the proximal end of the regulating member, and the distal end of the second push rod extends into the regulating member and is connected to the regulating sleeve.

3. The adjusting device according to claim 1, characterized in that The regulating member includes: A frame having a radially expanded state and a radially contracted state. The frame has axially opposite first and second ends. The inflow opening is located at the first end, and the outflow opening is located at the second end; and, A blocking film forming the channel around a partial side wall of the frame, and the blocking film can radially expand or contract along with the frame.

4. The adjusting device according to claim 3, characterized in that The frame includes a first constricting member, a second constricting member, a first connecting portion, a second connecting portion, and a dilation portion with two ends respectively connected to the first connecting portion and the second connecting portion. One end of the first connecting portion away from the dilation portion is connected to the first constricting member, and one end of the second connecting portion away from the dilation portion is connected to the second constricting member. The outflow opening is located at the first connecting portion, and the inflow opening is located at the second connecting portion; the blocking film surrounds the dilation portion, and the regulating sleeve is movably sleeved on the first connecting portion.

5. The adjusting device according to claim 4, characterized in that, The first connecting portion includes a plurality of axially extending first connecting rods. One end of each first connecting rod is connected to the dilation portion, and the other end is connected to the first constricting member; and, the plurality of first connecting rods all pass through the regulating sleeve, and the regulating sleeve can axially move along the first connecting rods to adjust the size of the outflow opening.

6. The adjusting device according to claim 5, characterized in that, The regulating sleeve includes an inner ring and an outer ring sleeved on the inner ring. A plurality of circumferentially spaced-apart accommodating grooves are provided on the inner side wall of the outer ring. The accommodating grooves axially penetrate the proximal end face and the distal end face of the outer ring. The inner ring is connected to the inner wall of the outer ring and cooperates with each accommodating groove to form a plurality of perforations circumferentially spaced apart. The plurality of first connecting rods correspondingly pass through the plurality of perforations.

7. The adjusting device according to claim 6, characterized in that, The proximal end face of the inner ring cooperates with the inner side wall of the outer ring to form a stepped portion. When the outflow opening is located at the proximal end of the adjusting member, the distal end of the second push rod extends into the outer ring and is connected to the stepped portion; when the outflow opening is located at the distal end of the adjusting member, the distal end of the second push rod extends into the outer ring and is connected to the stepped portion; Alternatively, the end face of one end of the outer ring cooperates with the outer wall of the inner ring to form a stepped portion, and the first push rod is sleeved on the inner ring and connected to the stepped portion.

8. The adjusting device according to claim 1, characterized in that The adjusting device further includes: an end connector and an inner tube. The end connector is connected to the end of the adjusting member away from the push rod assembly. The inner tube is movably inserted through the push rod assembly, the adjusting sleeve and the adjusting member, and the distal end of the inner tube is connected to the end connector.

9. The adjusting device according to claim 8, characterized in that The end connector is a developer and has an axially penetrating through hole. The end connector includes: a head and a tail connected to the proximal end of the head. The radial dimension of the head is larger than the radial dimension of the tail. The end of the adjusting member away from the push rod assembly is sleeved on the tail and fixedly connected to the tail. The inner tube penetrates into the through hole and is connected to the side wall of the through hole.

10. An adjustment system, characterized in that, Comprising: An outer sheath tube, an operating handle and an adjusting device according to any one of claims 1-9. The proximal end of the outer sheath tube and the proximal end of the push rod assembly are both connected to the operating handle, and the push rod assembly is movably inserted through the outer sheath tube. The adjusting member and the adjusting sleeve are movably received in the lumen of the outer sheath tube. The operating handle is used to control the axial movement of the push rod assembly to drive the adjusting sleeve to axially move relative to the adjusting member.

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