Valve conveying structure, artificial valve and valve conveying method

Abstract

The invention provides a valve conveying structure, an artificial valve and a valve conveying method.The valve conveying structure comprises a balloon tube cavity, a first restraining piece and a pushing base, a balloon is arranged on the surface of the proximal end of the balloon tube cavity, and the surface of the balloon tube cavity is suitable for being sleeved with the artificial valve; the surface of a balloon tube cavity is sleeved with the first restraining piece, the first restraining piece is suitable for being arranged at the proximal end of the artificial valve, and the proximal end of the first restraining piece at least wraps the distal end of the artificial valve so as to limit expansion of the artificial valve; the pushing base is arranged on the surface of the balloon tube cavity in a sleeving mode, is fixed to the first restraining piece and is configured to move towards the balloon under the action of external force so as to be suitable for pushing the artificial valve to move to the balloon; and after the artificial valve moves to the balloon, the first restraint part is configured to move away from the balloon under opposite force so as to drive the first restraint part to be separated from the artificial valve, so that the diameter of the artificial valve during conveying can be limited, and the artificial valve can conveniently pass through lower limb artery blood vessels of most patients.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve delivery structure, an artificial valve, and a valve delivery method. Background Art

[0002] Heart valve disease can be treated with medication or surgery. Heart valve disease surgeries are generally divided into three categories: traditional open-chest heart valve surgery, minimally invasive thoracoscopic heart valve surgery, and transcatheter aortic valve replacement (TAVR). Transcatheter valve therapy has a lower mortality rate than the other two types of surgery. For patients who are elderly, have poor physical conditions, or have other serious medical conditions, the risks of traditional open-chest heart valve surgery and minimally invasive thoracoscopic heart valve surgery are increased. In these cases, transcatheter aortic valve replacement (TAVR) is more appropriate and safer.

[0003] However, there is still an access size problem in existing TAVR surgeries. That is, in clinical surgery, when accessing through the femoral artery, a vascular sheath needs to be placed at the opening of the lower limb artery to protect the lower limb artery. However, the existing aortic valve regurgitation treatment devices, because the valve stents loaded inside are mostly equipped with positioning parts, the size of their delivery systems is also relatively large. The current size of the aortic valve delivery sheath is between 20F and 24F. In order to allow the delivery sheath to pass through, the inner diameter of the vascular sheath needs to be larger than the maximum outer diameter of the delivery sheath, making the outer diameter of the vascular sheath thicker and unable to pass through the lower limb arteries of most patients. If the vascular sheath cannot be placed for this reason, the treatment of the heart valve disease will consider a more damaging access method, which will increase complications and make the risk more uncontrollable. Summary of the Invention

[0004] Therefore, the technical problem to be solved by the present invention is that in the existing TAVR surgery, when accessing through the femoral artery, it is necessary to first insert a vascular sheath at the opening of the lower limb artery to protect the lower limb artery. However, the existing aortic valve regurgitation treatment devices, because the valve stents loaded inside are mostly equipped with positioning parts, the size of their delivery systems is also relatively large, resulting in the inability to pass through the lower limb arteries of most patients. If the vascular sheath cannot be placed for this reason, the treatment of heart valve disease will require a more damaging access method, which will increase complications and make the risks more uncontrollable.

[0005] To this end, the present invention provides a valve delivery structure for delivering an artificial valve, comprising:

[0006] A balloon lumen, the proximal end surface of which is provided with a balloon, and the surface of the balloon lumen is suitable for sheathing an artificial valve;

[0007] a first restraining member, sleeved on the surface of the balloon lumen and adapted to be arranged at the proximal end of the artificial valve, wherein the proximal end of the first restraining member at least wraps around the distal end of the artificial valve to limit the expansion of the artificial valve;

[0008] The pushing base is sleeved on the surface of the balloon lumen and fixed to the first restraint. It is configured to move toward the balloon under external force, so as to push the artificial valve to move to the balloon; and after the artificial valve moves to the balloon, it is configured to move in the direction away from the balloon under reverse force, so as to drive the first restraint to separate from the artificial valve.

[0009] Optionally, a protrusion is provided at the proximal end of the balloon lumen, and the artificial valve comprises a valve frame body and a positioning member, which are adapted to be arranged in series on the balloon lumen with the protrusion provided therebetween;

[0010] The protrusion is configured to expand the opening diameter of the proximal end of the positioning member when the positioning member is pushed by the pushing base to move toward the balloon end, and to limit the valve frame body.

[0011] Optionally, the first restraining member is a hollow columnar structure, which includes a grid-shaped skeleton and a coating covering the inner and outer layers of the grid-shaped skeleton; wherein,

[0012] Only the outer layer is provided with a plurality of pores, or both the inner and outer layers are provided with a plurality of pores, or only the outer layer at the proximal end is provided with a plurality of pores, and both the inner and outer layers at the distal end are provided with a plurality of pores.

[0013] Optionally, a protective structure is provided at the proximal end of the first restraint member, and the protective structure is arranged on the outer periphery or inner periphery or evenly on the inner and outer peripheries of the first restraint member.

[0014] Optionally, the first restraint may be foldable or expandable along its radial direction.

[0015] Optionally, the pushing base includes a receiving portion and a pushing portion that are connected to each other, one end of the pushing portion is trumpet-shaped and fixedly connected to the first restraining member, and can be folded or expanded along its radial direction.

[0016] Optionally, the cross section of at least the trumpet-shaped portion of the pushing portion is a five-pointed star or a ring with a gap.

[0017] Optionally, the valve delivery structure further comprises a second restraint fixedly connected to the balloon lumen; the proximal end of the second restraint is open and adapted to wrap at least the distal end portion of the artificial valve to limit the expansion of the artificial valve.

[0018] Optionally, the pushing base is configured to move toward the balloon under external force, so as to push the artificial valve to separate from the second restraint and move to the balloon; after the artificial valve moves to the balloon, it is configured to move away from the balloon under reverse force, so as to drive the first restraint to separate from the artificial valve.

[0019] Optionally, the valve delivery structure further includes a bending adjustment lumen, which is sleeved on the outside of the balloon lumen; the bending adjustment lumen is connected to the pushing base to advance or retract the pushing base.

[0020] Optionally, the valve delivery structure also includes a third restraint member, which is filamentous and has one end in a ring shape, and the ring-shaped end of the third restraint member is suitable for being sleeved around the artificial valve to limit its expansion; the ring-shaped end of the third restraint member is configured to have an adjustable inner diameter to control the release of the artificial valve.

[0021] Optionally, the valve delivery structure further comprises a guidewire lumen, which is passed through the interior of the balloon lumen and has a TIP head at its proximal end.

[0022] Optionally, the first restraint member is made of a flexible material or a built-in metal frame, and the second restraint member is made of a flexible material.

[0023] An artificial valve, used for delivery by the valve delivery structure described above, comprising:

[0024] Valve frame body;

[0025] A positioning member, adapted to be sleeved on the outer peripheral side of the valve frame body;

[0026] a connecting wire connected between the valve frame body and the positioning member;

[0027] The valve frame body and the positioning element are adapted to be arranged in series on the surface of the balloon lumen; or

[0028] The valve frame body and the end portions of the positioning member that are close to each other are overlapped and arranged on the surface of the balloon lumen.

[0029] Optionally, a buffer structure is provided at the proximal end of the positioning member, and the buffer structure is a biogenic material and a polymer material coated on the proximal end of the positioning member.

[0030] Optionally, a plurality of guide rails with limiting tracks are provided on the positioning member or the flap frame body. The limiting tracks are arranged along the pushing direction of the positioning member or the flap frame body and are suitable for slidingly placing the end of the connecting wire therein.

[0031] Optionally, a slot structure is provided at the distal end of the positioning member, and the slot structure is suitable for being engaged with a groove on the pushing base.

[0032] A valve delivery method, using the valve delivery structure described above to deliver the artificial valve described above, the method comprising:

[0033] In vitro valve assembly: The valve frame is pressed and gripped on the balloon or the balloon lumen, and the positioning piece is wrapped and restrained to the proximal end of the push base with a first restraint. The valve frame and the positioning piece are placed in series or with their ends partially overlapped and loaded on the balloon lumen or the balloon, with the positioning piece located at the distal end of the valve frame. The assembly is completed and the air is confirmed to be empty.

[0034] Prosthetic valve placement: Puncture the patient's artery, insert a vascular sheath through the main approach, insert a pigtail catheter through the auxiliary approach to locate the lesion and use it for angiography, insert a guidewire into the vascular sheath, and perform transvalvular valve placement;

[0035] The artificial valve is pushed along the guide wire along with the valve delivery structure into the vascular sheath blood sealing valve. The vascular sheath is retained in the main access and fixed, and is pushed along the main access to the proximal end of the vascular sheath.

[0036] In vivo assembly of the artificial valve: pushing the push base to move the positioning member from the distal end of the valve frame body to the proximal end until the valve frame body and the positioning member gradually change from a series state or a partially overlapping state at the ends to a parallel state, and the valve frame body and the positioning member are wrapped in a parallel state within the first restraint member, and the pushing base is continued to be pushed to assemble the artificial valve in the parallel state onto the balloon to complete the in vivo assembly; or

[0037] Under the push of the pushing base, the positioning member is wrapped in the first restraining member, the valve frame body is located on the balloon, and the positioning member is located at the distal end of the balloon. The pushing base is further pushed to push the positioning member from the distal end of the valve frame body to the proximal end. The valve frame body and the positioning member are gradually transformed from a series or end-part overlapping state to a parallel state to complete the in vivo assembly;

[0038] Release the positioning member: withdraw the push base, the first restraint member then withdraws, and the positioning member gradually opens. Observe the anatomy of the sinus and the position of the positioning member with the help of angiography and ultrasound imaging, and rotate the balloon lumen in the bending state to achieve sinus alignment.

[0039] Balloon dilation: After the positioning piece enters the sinus floor, it is concentrically sheathed with the valve frame. The valve frame is released, and the first restraining piece is confirmed to be completely withdrawn, with no overlap with the artificial valve. Then, balloon dilation is performed to anchor the native valve leaflets between the valve frame and the positioning piece. At this point, the positioning piece and the valve frame are both in a fully expanded state, completing aortic valve replacement for regurgitation cases.

[0040] System retrieval: After the prosthetic valve is released normally, the valve delivery structure is withdrawn.

[0041] Optionally:

[0042] The in vitro assembly of the valve can be replaced by: pressing the valve frame body onto the balloon or the balloon lumen, wrapping the positioning piece with the first restraining piece and the second restraining piece and restraining it to the proximal end of the pushing base, placing the valve frame body and the positioning piece in series or with their ends partially overlapping and loading them onto the balloon lumen or the balloon, with the positioning piece located at the distal end of the valve frame body, completing the assembly, and confirming that the valve is empty.

[0043] The in vivo assembly of the artificial valve can be replaced by: pushing the pushing base to move the positioning member from the distal end of the valve frame body to the proximal end until the valve frame body and the positioning member gradually change from a series state or a partially overlapping state of the ends to a parallel state and gradually slide out of the second restraint member, and the valve frame body and the positioning member are in a parallel state and wrapped in the first restraint member, and continue to push the pushing base to assemble the artificial valve in the parallel state onto the balloon to complete the in vivo assembly; or

[0044] Under the push of the pushing base, the positioning part gradually slides out of the second restraint part and is covered by the first restraint part. The valve frame body is located on the balloon, and the positioning part is located at the distal end of the balloon. Continue to push the pushing base to push the positioning part from the distal end of the valve frame body to the proximal end. The valve frame body and the positioning part gradually change from a series or partially overlapping state at the ends to a parallel state to complete the in vivo assembly.

[0045] Optionally:

[0046] The in vitro assembly of the valve can be replaced as follows: the positioning member is wrapped and fixed on the balloon lumen by the first restraining member and the third restraining member, and the valve frame body is pressed and gripped on the balloon or the balloon lumen;

[0047] The in-vivo assembly of the artificial valve can be replaced as follows: the balloon lumen with the artificial valve enters the lower limb artery through the vascular sheath, and at the abdominal aorta, the third restraint is released until the positioning part is V-shaped or trumpet-shaped, and the first restraint moves forward, covering the distal end of the positioning part to the position from the middle section to the proximal end section of the positioning part, and the third restraint is withdrawn from the vascular sheath, and the first restraint continues to be pushed forward, successively wrapping the valve frame body and the positioning part, and at the same time pushing the base to push the valve frame body onto the balloon.

[0048] The present invention provides a valve delivery structure, an artificial valve, and a valve delivery method, which have the following advantages:

[0049] 1. The present invention provides a valve delivery structure, comprising a balloon lumen, a first restraint and a pushing base, wherein a balloon is provided on the proximal surface of the balloon lumen, and the surface of the balloon lumen is suitable for sheathing an artificial valve; the first restraint is sheathed on the surface of the balloon lumen and is suitable for being arranged at the proximal end of the artificial valve, and the proximal end of the first restraint at least wraps around the distal end of the artificial valve to limit the expansion of the artificial valve; the pushing base is sheathed on the surface of the balloon lumen and fixed to the first restraint, and is configured to move toward the balloon under external force, so as to be suitable for pushing the artificial valve to move to the balloon; and after the artificial valve moves to the balloon, it is configured to move in the direction away from the balloon under reverse force, so as to drive the first restraint to separate from the artificial valve.

[0050] In this valve delivery structure, during delivery of the artificial valve, the proximal end of the first restraint wraps around at least the distal end of the artificial valve to limit expansion. The push base is moved toward the balloon by an external force, thereby pushing the artificial valve to the balloon. After the artificial valve reaches the balloon, the push base is configured to be moved away from the balloon by a reverse force, thereby separating the first restraint from the artificial valve. This restricts the diameter of the artificial valve during delivery, facilitating passage through the lower limb arteries of most patients.

[0051] 2. The present invention provides a valve delivery structure, which also includes a second restraint member fixedly connected to the balloon lumen; the proximal end of the second restraint member is open and suitable for wrapping at least the distal end portion of the artificial valve to limit the expansion of the artificial valve.

[0052] The valve delivery structure of this structure is provided with a second restraining member. When the valve frame body is pressed and gripped on the balloon or the proximal end of the balloon, the second restraining member is used to wrap the positioning member to restrain the positioning member.

[0053] 3. The present invention provides an artificial valve, comprising a valve frame body, a positioning member and a connecting wire, wherein a buffer structure is provided at the proximal end of the positioning member.

[0054] The valve delivery structure of this structure is provided with a buffer structure at the proximal end of the positioning member. The buffer structure is a biogenic material and a polymer material coated on the proximal end of the positioning member to avoid damaging the blood vessel wall when passing through the aortic arch.

[0055] 4. The present invention provides an artificial valve, wherein the distal end of the positioning member is provided with a slot structure, and the slot structure is suitable for being engaged with the groove on the pushing base.

[0056] The valve delivery structure of this structure is provided with a slot structure at the distal end of the positioning member suitable for engaging with the groove on the pushing base to prevent the positioning member from rotating and kinking. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0058] Figure 1 Schematic diagram of an artificial valve provided in an embodiment of the present invention Figure 1 ;

[0059] Figure 2 Schematic diagram of an artificial valve provided in an embodiment of the present invention Figure 2 ;

[0060] Figure 3 A schematic structural diagram of a positioning member provided in an embodiment of the present invention (with a slot structure attached);

[0061] Figure 4 Schematic diagram of the structure of the positioning member provided in an embodiment of the present invention (positioning member without a slot structure);

[0062] Figure 5 A perspective view of a first restraining member provided in an embodiment of the present invention;

[0063] Figure 6 A front view of a first restraining member provided in an embodiment of the present invention;

[0064] Figure 7 The first restraint provided in the embodiment of the present invention is unfolded Figure 1 ;

[0065] Figure 8 The first restraint provided in the embodiment of the present invention is unfolded Figure 2 ;

[0066] Figure 9 The first restraint provided in the embodiment of the present invention is unfolded Figure 3 ;

[0067] Figure 10 A top view of a pushing base provided in an embodiment of the present invention (five-pointed star);

[0068] Figure 11 A left view of a push base provided in an embodiment of the present invention (five-pointed star);

[0069] Figure 12 A top view of a pushing base (ring-shaped with a gap) provided in an embodiment of the present invention;

[0070] Figure 13 This is a left side view of the pushing base provided in an embodiment of the present invention (annular with a gap);

[0071] Figure 14 This is a schematic diagram of the pre-assembly of the valve delivery structure provided in an embodiment of the present invention (non-overlapping state);

[0072] Figure 15 This is a schematic diagram of the pre-assembly of the valve delivery structure provided in an embodiment of the present invention (overlapping state);

[0073] Figure 16 This is a schematic diagram of the pre-assembly of the valve delivery structure provided in an embodiment of the present invention (assembled state);

[0074] Figure 17 This is a schematic diagram of a pre-adjusted bend of a valve delivery structure provided in an embodiment of the present invention;

[0075] Figure 18 A schematic diagram of positioning of a positioning member provided in an embodiment of the present invention;

[0076] Figure 19 This is a schematic diagram of the final state of an artificial valve provided in an embodiment of the present invention;

[0077] Figure 20 Schematic diagrams of four forms of protrusions on the balloon lumen provided in embodiments of the present invention;

[0078] Figure 21 This is a schematic structural diagram of a protective structure provided in an embodiment of the present invention being inside an outer sheath tube;

[0079] Figure 22 Schematic diagrams of three structures of the protection structure provided in the embodiments of the present invention.

[0080] Description of reference numerals:

[0081] 1. Artificial valve;

[0082] 2. Valve frame body;

[0083] 3. Positioning parts; 3-1. Slot structure; 3-2. Buffer structure,

[0084] 4. Guide rail, 4-1, limit rail;

[0085] 5. Connecting wire;

[0086] 6. Second restraint;

[0087] 7. Pushing base; 7-1. Receiving part; 7-2. Pushing part;

[0088] 8. First restraint; 8-1. Aperture; 8-2. Connecting portion; 8-3. Protective structure;

[0089] 10. Guidewire lumen;

[0090] 11. Balloon lumen; 11-1. Bump;

[0091] 12. Adjust the tube cavity;

[0092] 13. Balloon;

[0093] 14. TIP head;

[0094] 15. Autologous valve leaflets;

[0095] 16. Outer sheath. DETAILED DESCRIPTION

[0096] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0097] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance. In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0098] In this embodiment, for the convenience of description, the end close to the heart is set as the proximal end, and the end far from the heart is set as the distal end.

[0099] Example 1

[0100] This embodiment provides an artificial valve, such as Figures 1 to 4 As shown, it includes a valve frame body 2, a positioning member 3 and a connecting wire 5. The positioning member 3 is suitable for being sleeved on the outer peripheral side of the valve frame body 2. The connecting wire 5 is connected between the valve frame body 2 and the positioning member 3. The valve frame body 2 and the positioning member 3 are suitable for being arranged in series on the surface of the balloon lumen 11; or the end portions of the valve frame body 2 and the positioning member 3 that are close to each other are overlapped and arranged on the surface of the balloon lumen 11.

[0101] In this embodiment, the valve body is made of cobalt-chromium alloy or other implantable metal, and the positioning member 3 is a medical memory metal material. In the illustrated embodiment, the positioning member 3 has a dumbbell structure, with a slot structure 3-1 added to the distal end to accommodate the grooves of the delivery system's outer tube push base 7 and other structures to prevent rotation and kinking. The valve frame body 2 is connected in series with the positioning member 3 via a connecting wire 5 and is pressed and gripped within the balloon lumen 11. The proximal end of the positioning member 3 is coated with a buffer structure 3-2 composed of a biomaterial and a polymer material to prevent damage to the vascular wall during passage through the aortic arch. The positioning member 3 is designed as a dumbbell structure with slightly flared upper and lower ports, making it easier for the positioning member 3 to wrap around the periphery of the valve frame body 2 under the action of the push base 7, completing the in vivo assembly of the valve frame and positioning member 3.

[0102] In this embodiment, a plurality of flexible or rigid guide rails 4 are arranged along the pushing direction of the valve frame main body 2 or the positioning member 3. The guide rails 4 are long strip-shaped structures such as long oval or rectangular, and a limiting track 4-1 is left in the middle to facilitate the sliding of the connecting wire 5; the guide rails 4 can not only realize the directional sliding function of the positioning member 3 but also effectively prevent circumferential rotation. The valve frame main body 2 and the positioning member 3 can be optionally set up specifically for the guide rails 4.

[0103] The connecting wire 5 is made of polymer material thread and is used to connect the valve frame body 2 and the positioning member 3. In the illustrated embodiment, the connection method is a movable connection structure; in some embodiments, the connection method can also be a fixed connection.

[0104] Example 2

[0105] This embodiment provides a valve delivery structure for delivering the artificial valve 1 in embodiment 1, such as Figures 5 to 19 As shown, the valve delivery structure includes a balloon lumen 11, a first restraint 8, a second restraint 6, a pushing base 7, a guidewire lumen 10, a balloon lumen 11, a bending adjustment lumen 12 and a balloon 13. The guidewire lumen 10 is arranged inside the balloon lumen 11, and a TIP head 14 is provided at its proximal end.

[0106] In this embodiment, a balloon 13 is provided on the proximal surface of the balloon lumen 11, and the surface of the balloon lumen 11 is suitable for sleeved with the artificial valve 1 in Example 1; the first restraint 8 is sleeved on the surface of the balloon lumen 11 and is suitable for being arranged at the proximal end of the artificial valve 1, and the proximal end of the first restraint 8 at least wraps the distal end part of the artificial valve 1 to limit the expansion of the artificial valve 1; the pushing base 7 is sleeved on the surface of the balloon lumen 11 and is fixed to the first restraint 8, and is configured to move toward the balloon 13 under external force, so as to be suitable for pushing the artificial valve 1 to move to the balloon 13; and after the artificial valve 1 moves to the balloon 13, it is configured to move in the direction away from the balloon 13 under reverse force, so as to drive the first restraint 8 to separate from the artificial valve 1.

[0107] Specific as Figures 5 to 8 as well as Figure 14 As shown, the first restraint 8 is composed of a braided tube, a tearable sheath, an expandable snake bone tube at the head end or an expandable metal stent, so that it can open to a certain angle. A pore 8-1 is set on the first restraint 8. The distal end of the first restraint 8 is integrally connected to the push base 7, which can be connected by welding or fusion. As the proximal restraint structure of the valve delivery structure, it effectively restrains the opening angle of the positioning member 3 during the delivery process to prevent the outer surface of the positioning member 3 from being exposed during the delivery process and damaging the blood vessel. At the same time, the reserved pore 8-1 can serve as a buffer to reduce the impact of blood flow on the first restraint 8 and ensure that the first restraint 8 can be recovered. Figures 7 to 9 Three schematic diagrams of the internal structure of first restraining member 8 are shown. In each configuration, the inner wall of first restraining member 8 is provided with a mesh-like groove structure adapted for blood flow. These grooves are arranged in the direction of blood flow and, in conjunction with pores 8-1, reduce the impact of blood flow on first restraining member 8. A connecting portion 8-2 is provided at the distal end of first restraining member 8 for connection to pushing base 7.

[0108] like Figure 21 and Figure 22 As shown, the proximal end of the first restraint member 8 is provided with a protective structure 8-3, and the protective structure 8-3 is arranged on the outer periphery or inner periphery or evenly arranged on the inner and outer peripheries of the first restraint member 8 (as shown in FIG. Figure 22 The three structures shown), Figure 21 This is the state where the protective structure 8-3 is compressed into the outer sheath 16. The protective structure 8-3 is provided to prevent the artificial valve 1 from withdrawing due to excessive resistance when entering the sheath, and to prevent damage to blood vessels during transportation.

[0109] In this embodiment, the second restraining member 6 is fixedly connected to the balloon lumen 11; the proximal end of the second restraining member 6 is open and adapted to wrap around at least the distal end of the prosthetic valve 1 to limit expansion of the prosthetic valve 1. Specifically, in the illustrated embodiment, the second restraining member 6 is located at the proximal end of the balloon 13 and is made of a polymer material. It covers the outer periphery of the balloon lumen 11 and is used to restrain the positioning member 3 and the valve body, or only the positioning member 3, which are sequentially connected in series in the balloon lumen during delivery. The proximal end of the second restraining member 6 does not cover the balloon 13, while the distal end is fused or adhered to the balloon lumen 11.

[0110] In this embodiment, the pushing base 7 includes a receiving portion 7-1 and a pushing portion 7-2 connected to each other. One end of the pushing portion 7-2 is trumpet-shaped and fixedly connected to the first restraining member 8. The cross section of at least the trumpet-shaped portion of the pushing portion 7-2 is a five-pointed star or a ring with a notch.

[0111] Specific as Figures 10 to 13As shown, the push base 7 is circumferentially symmetrical or asymmetrical, and can be a foldable or expandable structure. When the valve holder 2 is pressed against the balloon 13, the push base 7 expands, pushing the positioning member 3 through the protective cover at the distal end of the balloon 13 and onto the balloon 13. A hole is provided at the bottom, through which the second restraining member 6 passes. Grooves and other structures are provided around the circumference, allowing it to contract when passing through the vascular sheath. During the in vivo assembly phase, the push base 7 gradually moves proximally to push the positioning member 3 out of the second restraining member 6 and onto the valve holder 2, subsequently pushing the prosthetic valve 1 onto the balloon 13. In this embodiment, the push base 7 is configured to move toward the balloon 13 in response to an external force, thereby pushing the prosthetic valve 1 away from the second restraining member 6 and onto the balloon 13. After the prosthetic valve 1 reaches the balloon 13, it is configured to move away from the balloon 13 in response to a reverse force, thereby driving the first restraining member 8 to separate from the prosthetic valve 1.

[0112] like Figures 14 to 19 As shown, the bend adjustment lumen 12 is sleeved outside the balloon lumen 11 and connected to the push base 7 to advance or retract the push base 7. The bend adjustment lumen 12 can also be used to adjust the curvature of the valve delivery structure. This is a prior art technology, so the principle will not be elaborated here.

[0113] By setting the second restraint 6 and the first restraint 8, the second restraint 6 and the first restraint 8 wrap the positioning member 3 to improve clinical safety, effectively reduce the stimulation of the system tension on the blood vessel wall, and avoid the contact between the exposed valve frame and the blood vessel wall during the transportation process including the arch. In addition, the first restraint 8 is provided with a pore 8-1 to reduce the impact of blood flow on the first restraint 8, conform to hemodynamics, reduce vascular complications, shorten the surgical recovery period, and improve the patient's postoperative quality of life.

[0114] Furthermore, the valve delivery structure also includes a third restraint member, which is in the form of a thread and one end of which is in a ring shape. The ring-shaped end of the third restraint member is suitable for being mounted on the side of the artificial valve 1 to limit its expansion; the ring-shaped end of the third restraint member is configured to have an adjustable inner diameter to control the release of the artificial valve 1.

[0115] The third restraining member is composed of metal or polymer material, and its annular portion has a variable diameter. It secures the positioning member 3 to the balloon lumen 11 or balloon 13, similar to a snare. As an alternative to the second restraining member 6, it is used to restrain the positioning member 3 during delivery, preventing it from opening and damaging the blood vessel. During assembly, the diameter of the third restraining member can be adjusted to slightly open the distal end of the positioning member 3 to complete assembly. The third restraining member is then used to restrain the assembled artificial valve 1. As an alternative to the second restraining member 6, it is an optional structure, not a required structure. In some embodiments, only the first restraining member 8 can wrap around the positioning member 3, without the need for a third restraining member to wrap around the positioning member 3.

[0116] In this embodiment, the balloon lumen 11 is located in the outer layer of the guidewire lumen 10 and is fixed in position with the guidewire lumen 10. The balloon 13 at the distal end of the tip is filled with diluted contrast agent to expand the valve frame body 2. The soft capsule cavity of the valve is fixed to the proximal end of the inner tube of the balloon 13. During the transportation process, the capsule cavity wraps the positioning piece 3, and the handle can be operated to control the circumferential rotation of the balloon lumen 11 and the guidewire lumen 10, driving the rotation of the implant positioning piece 3, as well as the filling and decompression of the balloon 13.

[0117] In this embodiment, a protrusion 11-1 is provided at the end of the balloon lumen 11 near the balloon 13. The artificial valve 1 includes a valve frame body 2 and a positioning member 3. When the two are arranged in series on the balloon lumen 11, the protrusion 11-1 is provided between the two.

[0118] The protrusion 11-1 is configured to expand the opening diameter of the proximal end of the positioning member 3 when the positioning member 3 is pushed by the pushing base 7 to move toward the balloon 13 end, so as to facilitate the proximal end of the positioning member 3 to be sleeved on the surface of the valve frame body 2, and the protrusion 11-1 can also limit the valve frame body 2 to prevent it from moving backward.

[0119] like Figure 20 Four forms of the protrusion 11-1 are shown. Of course, these are just examples of several common forms of the protrusion 11-1. In some other embodiments, the protrusion 11-1 can also be set to other shapes, which can expand the opening diameter of the proximal end of the positioning member 3 when the positioning member 3 is pushed by the pushing base 7 to move toward the end of the balloon 13.

[0120] In this embodiment, the first restraining member 8 is a hollow columnar structure, which includes a grid-like skeleton and a coating covering the inner and outer layers of the grid-like skeleton; wherein,

[0121] Only the outer layer is provided with a plurality of pores 8-1, or both the inner and outer layers are provided with a plurality of pores 8-1, or only the outer layer at the proximal end is provided with a plurality of pores 8-1, and both the inner and outer layers at the distal end are provided with a plurality of pores 8-1.

[0122] Furthermore, when only the outer coating has a plurality of pores 8-1, the function of the pores 8-1 is to increase the flexibility of the coating material and enable the first restraining member 8 to fold evenly. When both the inner and outer coatings have a plurality of pores 8-1, the function of the pores 8-1 is to increase the flexibility of the coating material and enable the first restraining member 8 to fold evenly; and to reduce the impact of blood flow on the first restraining member 8, thereby conforming to hemodynamics and reducing vascular complications.

[0123] When only the outer layer of the proximal end is provided with a plurality of pores 8-1, and both the inner and outer layers of the distal end are provided with a plurality of pores 8-1, only the outer layer of the proximal end is provided with a plurality of pores 8-1 to improve the flexibility of the coating material, so that the first restraint 8 is evenly folded, and both the inner and outer layers of the distal end are provided with a plurality of pores 8-1 to reduce the impact of blood flow on the first restraint 8, conform to hemodynamics, and reduce vascular complications.

[0124] Among them, the first restraint member 8 and the first restraint member 8 can be folded along their radial directions and can be folded or expanded along their respective radial directions. The first restraint member 8 can be expanded radially, which makes it easier to complete the pre-assembly of the positioning member 3 and the valve frame body 2.

[0125] The valve delivery structure in this embodiment differs from the loading requirements of self-expanding stents. The positioning element 3 has a low radial force, allowing delivery while the positioning element 3 is in a compressed, gripped state. Combined with the balloon 13 to expand the valve, the valve's bending performance is fully utilized. The structure and materials are simpler, requiring no auxiliary equipment, making manufacturing easier and more cost-effective for mass production. Compared to traditional methods, the positioning and release procedures are more convenient and stable.

[0126] Example 3

[0127] This embodiment provides a valve delivery method, which uses the valve delivery structure of Example 2 to deliver the artificial valve 1 of Example 1. The method includes:

[0128] Valve assembly in vitro: The valve frame body 2 is pressed and gripped on the balloon 13 or the balloon lumen 11. The positioning member 3 is wrapped and restrained to the proximal end of the pushing base 7 with the first restraining member 8. The valve frame body 2 and the positioning member 3 are placed in series or with their ends partially overlapped and loaded on the balloon lumen 11 or the balloon 13. The positioning member 3 is located at the distal end of the valve frame body 2. The assembly is completed and the air is confirmed to be empty.

[0129] Prosthetic valve placement 1: Puncture the patient's artery, insert a vascular sheath through the main approach, insert a pigtail catheter through the auxiliary approach to locate the lesion and use it for angiography, insert a guidewire into the vascular sheath, and perform transvalvular valve placement;

[0130] The artificial valve 1 is pushed along the guide wire along the valve delivery structure into the vascular sheath blood sealing valve. The vascular sheath is retained in the main access and fixed, and is pushed along the main access to the proximal end of the vascular sheath.

[0131] In vivo assembly of the artificial valve: push the pushing base 7 to move the positioning member 3 from the distal end of the valve frame body 2 to the proximal end until the valve frame body 2 and the positioning member 3 gradually change from a series state or a partially overlapping state at the ends to a parallel state, and the valve frame body 2 and the positioning member 3 are wrapped in the first restraint member 8 in a parallel state, and continue to push the pushing base 7 to assemble the artificial valve 1 in the parallel state onto the balloon 13 to complete the in vivo assembly; or

[0132] Under the push of the push base 7, the positioning member 3 is enclosed within the first restraining member 8. The valve frame 2 is positioned above the balloon 13, and the positioning member 3 is located at the distal end of the balloon 13. Further pushing of the push base 7 propels the positioning member 3 from the distal end of the valve frame 2 to the proximal end. The valve frame 2 and positioning member 3 gradually transition from a series or partially overlapping state to a parallel state, completing in vivo assembly. While the valve frame 2 is enclosed within the balloon 13, a protective shield is placed at the distal end of the balloon 13 to prevent the valve frame 2 from retreating due to resistance during transport and to prevent the positioning member 3 from damaging the balloon 13.

[0133] Release the positioning member 3: withdraw the pushing base 7, and then withdraw the first restraining member 8, and gradually open the positioning member 3. Observe the relationship between the anatomy of the sinus and the position of the positioning member 3 with the help of angiography and ultrasound imaging, and rotate the balloon lumen 11 in the bending state to achieve sinus alignment;

[0134] Balloon 13 expansion: After the positioning member 3 enters the sinus floor, the positioning member 3 and the valve frame body 2 are concentrically arranged. The valve frame body 2 is released, and it is confirmed that the first restraining member 8 is completely withdrawn and there is no overlap with the artificial valve 1. Then the balloon 13 is expanded to anchor the native valve leaflets 15 between the valve frame body 2 and the positioning member 3. At this time, the positioning member 3 and the valve frame body 2 are both in a fully expanded state, completing the aortic valve replacement for regurgitation cases.

[0135] System recovery: After the artificial valve 1 is released normally, the valve delivery structure is withdrawn.

[0136] Alternatively, the valve can be assembled in vitro as follows: the valve frame body 2 is pressed and gripped onto the balloon 13 or the balloon lumen 11. The positioning member 3 is wrapped and secured to the proximal end of the push base 7 using the first and second restraining members 8 and 6. The valve frame body 2 and the positioning member 3 are then loaded onto the balloon lumen 11 or the balloon 13 in series or with their ends partially overlapping. The positioning member 3 is positioned at the distal end of the valve frame body 2. Assembly is completed and the balloon is confirmed empty. Similarly, when the valve frame body 2 is wrapped around the balloon 13, a protective cover is placed at the distal end of the balloon 13 to ensure that the valve frame body 2 does not retreat due to resistance during delivery, preventing the positioning member 3 from damaging the balloon 13.

[0137] The in vivo assembly of the artificial valve can be replaced by: pushing the pushing base 7 to move the positioning member 3 from the distal end of the valve frame main body 2 to the proximal end until the valve frame main body 2 and the positioning member 3 are gradually transformed from a series state or a partially overlapping state at the ends to a parallel state and gradually slide out the second restraining member 6, and the valve frame main body 2 and the positioning member 3 are in a parallel state and wrapped in the first restraining member 8, and the pushing base 7 is continued to be pushed to assemble the artificial valve 1 in the parallel state onto the balloon 13 to complete the in vivo assembly; or

[0138] Under the push of the pushing base 7, the positioning member 3 gradually slides out of the second restraint member 6 and is covered by the first restraint member 8. The valve frame body 2 is located on the balloon 13, and the positioning member 3 is located at the distal end of the balloon 13. Continue to push the pushing base 7 to push the positioning member 3 from the distal end of the valve frame body 2 to the proximal end. The valve frame body 2 and the positioning member 3 are gradually transformed from a series or partially overlapping end state to a parallel state to complete the in vivo assembly.

[0139] Alternatively, the valve can be assembled in vitro using the following method: the positioning member 3 is wrapped and fixed to the balloon lumen 11 by the first and third restraining members 8, and the valve frame body 2 is pressed and gripped on the balloon 13 or the balloon lumen 11. Similarly, when the valve frame body 2 is wrapped around the balloon 13, a protective cover is provided at the distal end of the balloon 13 to ensure that the valve frame body 2 does not retreat due to resistance during delivery, preventing the positioning member 3 from damaging the balloon 13.

[0140] The in-body assembly of the artificial valve can be replaced as follows: the balloon lumen 11 carries the artificial valve 1 through the vascular sheath into the lower limb artery. At the abdominal aorta, the third restraint is released to the positioning member 3 in a V-shape or trumpet shape. The first restraint 8 moves forward and is covered from the distal end of the positioning member 3 to the position from the middle section to the proximal end section of the positioning member 3. The third restraint is withdrawn from the vascular sheath and continues to push the first restraint 8, successively wrapping the valve frame body 2 and the positioning member 3 while pushing the base 7 to push the valve frame body 2 onto the balloon 13.

[0141] In this embodiment, the above-mentioned step of inserting the artificial valve 1 also includes system withdrawal: if the anatomical morphology is not suitable, the valve delivery structure needs to be withdrawn. If the first restraint 8 is not assembled in the descending main, the system can be withdrawn; if the assembly is completed, the access condition needs to be evaluated; if the arch is passed after assembly and the positioning member 3 is released, the bend needs to be loosened and the first restraint 8 is used to recover the artificial valve 1, the access condition is evaluated, and the valve is withdrawn from the body along the vascular sheath.

[0142] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A valve delivery structure for delivering an artificial valve (1), characterized in that: include: A balloon lumen (11) is provided with a balloon (13) on its distal end surface, and the surface of the balloon lumen (11) is suitable for sheathing an artificial valve (1); A first restraining member (8) is sleeved on the surface of the balloon lumen (11) and is suitable for being arranged at the distal end of the artificial valve (1), wherein the proximal end of the first restraining member (8) at least wraps around the distal end portion of the artificial valve (1) to limit the expansion of the artificial valve (1); The pushing base (7) is sleeved on the surface of the balloon lumen (11) and fixed to the first restraining member (8). The pushing base (7) is configured to move toward the balloon (13) under an external force, so as to be suitable for pushing the artificial valve (1) to move to the balloon (13); and after the artificial valve (1) moves to the balloon (13), the pushing base is configured to move in a direction away from the balloon (13) under a reverse force, so as to drive the first restraining member (8) to separate from the artificial valve (1).

2. The valve delivery structure according to claim 1, characterized in that: The end of the balloon lumen (11) near the balloon (13) is provided with a protrusion (11-1), and the artificial valve (1) comprises a valve frame body (2) and a positioning member (3), both of which are adapted to be arranged in series on the balloon lumen (11) with the protrusion (11-1) arranged between the two. The protrusion (11-1) is configured to expand the opening diameter of the proximal end of the positioning member (3) when the positioning member (3) is pushed by the pushing base (7) to move toward the end of the balloon (13), and to limit the position of the valve frame body (2).

3. The valve delivery structure according to claim 1 or 2, characterized in that: The first restraining member (8) is a columnar structure with a hollow interior, comprising a grid-like skeleton and a coating covering the inner and outer layers of the grid-like skeleton; wherein, Only the outer layer is provided with a plurality of pores (8-1), or both the inner and outer layers are provided with a plurality of pores (8-1), or only the outer layer at the proximal end is provided with a plurality of pores (8-1), and both the inner and outer layers at the distal end are provided with a plurality of pores (8-1).

4. The valve delivery structure according to claim 3, characterized in that: A protective structure (8-3) is provided at the proximal end of the first restraining member (8), and the protective structure (8-3) is arranged on the outer periphery or inner periphery of the first restraining member (8), or is evenly arranged on the inner and outer peripheries.

5. The valve delivery structure according to claim 3, characterized in that: The first restraining member (8) can be folded or expanded along its radial direction; The first restraining member (8) comprises a braided tube, a tearable sheath, a snake-bone tube with an expandable head end, or an expandable metal stent.

6. The valve delivery structure according to any one of claims 1 to 4, characterized in that: The pushing base (7) comprises a receiving portion (7-1) and a pushing portion (7-2) connected to each other. One end of the pushing portion (7-2) is trumpet-shaped and fixedly connected to the first restraining member (8). The pushing base (7) can be folded or expanded along its radial direction.

7. The valve delivery structure according to claim 6, characterized in that: The pushing portion (7-2) is at least in the shape of a trumpet, and the cross section of the portion is in the shape of a five-pointed star or a ring with a gap.

8. The valve delivery structure according to any one of claims 1 to 7, characterized in that: It also includes a second restraining member (6) fixedly connected to the balloon lumen (11); the proximal end of the second restraining member (6) is open and suitable for wrapping at least the distal end of the artificial valve (1) to limit the expansion of the artificial valve (1).

9. The valve delivery structure according to claim 8, characterized in that: The pushing base (7) is configured to be moved toward the balloon (13) by an external force, so as to be suitable for pushing the artificial valve (1) to separate from the second restraining member (6) and move to the balloon (13); after the artificial valve (1) moves to the balloon (13), it is configured to be moved in a direction away from the balloon (13) by an opposite force, so as to drive the first restraining member (8) to separate from the artificial valve (1).

10. The valve delivery structure according to claim 1 or 8, characterized in that: It also includes a bending adjustment lumen (12) which is sleeved on the outside of the balloon lumen (11); the bending adjustment lumen (12) is connected to the pushing base (7) to advance or retract the pushing base (7).

11. The valve delivery structure according to any one of claims 1 to 7, characterized in that: It also includes a third restraining member, which is in the form of a thread and one end of which is arranged in a ring shape, and the ring-shaped end of the third restraining member is suitable for being sleeved on the circumference of the artificial valve (1) to limit its expansion; One annular end of the third restraint is configured to have an adjustable inner diameter to control the release of the artificial valve (1).

12. The valve delivery structure according to claim 8, characterized in that: The first restraining member (8) is made of a flexible material or a built-in metal frame, and the second restraining member (6) is made of a flexible material.

13. An artificial valve, used for delivery by the valve delivery structure according to any one of claims 1 to 12, characterized in that: Prosthetic valves include: Valve frame body (2); A positioning member (3) adapted to be sleeved on the outer peripheral side of the valve frame body (2); A connecting wire (5) connected between the flap frame body (2) and the positioning member (3); The valve frame body (2) and the positioning member (3) are adapted to be arranged in series on the surface of the balloon lumen (11); or The end portions of the valve frame body (2) and the positioning member (3) that are close to each other are overlapped and arranged on the surface of the balloon lumen (11).

14. The artificial valve according to claim 13, characterized in that A buffer structure (3-2) is provided at the proximal end of the positioning member (3); The buffer structure (3-2) is a biological source material and a polymer material coated on the proximal end of the positioning member (3).

15. The artificial valve according to claim 13 or 14, characterized in that: The positioning member (3) or the flap frame body (2) is provided with a plurality of guide rails (4) having limiting rails (4-1), and the limiting rails (4-1) are arranged along the pushing direction of the positioning member (3) or the flap frame body (2) and are suitable for slidingly placing the end of the connecting wire (5) therein.

16. The artificial valve according to any one of claims 13 to 15, characterized in that: The distal end of the positioning member (3) is provided with a slot structure (3-1), and the slot structure (3-1) is suitable for being engaged with a groove on the pushing base (7).

17. A valve delivery method, using the valve delivery structure according to any one of claims 1 to 12, for delivering the artificial valve according to any one of claims 13 to 16, characterized in that: The method includes: In vitro assembly of the valve: the valve frame body (2) is pressed and gripped on the balloon (13) or the balloon lumen (11), the positioning member (3) is wrapped and restrained to the proximal end of the pushing base (7) with the first restraining member (8), the valve frame body (2) and the positioning member (3) are connected in series or partially overlapped at the ends and loaded on the balloon lumen (11) or the balloon (13), the positioning member (3) is located at the distal end of the valve frame body (2), the assembly is completed, and the emptying is confirmed; Insertion of artificial valve (1): Puncture the patient's artery, insert the vascular sheath through the main approach, insert the pigtail catheter through the auxiliary approach to locate the lesion and use it for angiography, insert the guide wire into the vascular sheath, and perform transvalvular valve insertion; The artificial valve (1) is pushed along the guide wire along the valve delivery structure into the vascular sheath blood sealing valve, the vascular sheath is retained in the main access and fixed, and is pushed along the main access to the proximal end of the vascular sheath; In vivo assembly of the artificial valve: pushing the push base (7) to move the positioning member (3) from the distal end of the valve frame body (2) to the proximal end until the valve frame body (2) and the positioning member (3) are gradually transformed from a series state or a partially overlapping state at the ends to a parallel state, and the valve frame body (2) and the positioning member (3) are wrapped in a parallel state within the first restraining member (8), and the pushing base (7) is continued to be pushed to assemble the artificial valve (1) in the parallel state onto the balloon (13) to complete the in vivo assembly; or Under the pushing of the pushing base (7), the positioning member (3) is covered in the first restraining member (8), the valve frame body (2) is located on the balloon (13), and the positioning member (3) is located at the distal end of the balloon (13). The pushing base (7) is continuously pushed to push the positioning member (3) from the distal end of the valve frame body (2) to the proximal end. The valve frame body (2) and the positioning member (3) are gradually transformed from a series connection or a partially overlapping end state to a parallel connection to complete the in vivo assembly; Release the positioning member (3): withdraw the pushing base (7), and then withdraw the first restraining member (8), and gradually open the positioning member (3). According to the relationship between the anatomy of the sinus and the position of the positioning member (3) assisted by angiography and ultrasound imaging, the sinus alignment is achieved by rotating the balloon lumen (11) in the bending state; Balloon (13) expansion: After the positioning member (3) enters the sinus floor, the positioning member (3) and the valve frame body (2) are concentrically arranged, the valve frame body (2) is released, and it is confirmed that the first restraining member (8) is completely withdrawn and there is no overlap with the artificial valve (1). Then, the balloon (13) is expanded to anchor the autologous valve leaflet (15) between the valve frame body (2) and the positioning member (3). At this time, the positioning member (3) and the valve frame body (2) are both in a fully expanded state, thereby achieving aortic valve replacement in cases of regurgitation; System retrieval: After the artificial valve (1) is released normally, the valve delivery structure is withdrawn.

18. The valve delivery method according to claim 17, wherein: The in vitro assembly of the valve can be replaced as follows: the valve frame body (2) is pressed and gripped on the balloon (13) or the balloon lumen (11), the positioning member (3) is wrapped and restrained on the proximal end of the pushing base (7) with the first restraining member (8) and the second restraining member (6), the valve frame body (2) and the positioning member (3) are connected in series or partially overlapped at the ends and loaded on the balloon lumen (11) or the balloon (13), the positioning member (3) is located at the distal end of the valve frame body (2), the assembly is completed, and the emptying is confirmed; The in vivo assembly of the artificial valve can be replaced by: pushing the push base (7) to move the positioning member (3) from the distal end of the valve frame body (2) to the proximal end until the valve frame body (2) and the positioning member (3) gradually change from a series or end portion overlapping state to a parallel state and gradually slide out of the second restraining member (6), and the valve frame body (2) and the positioning member (3) are in a parallel state and wrapped in the first restraining member (8), and the pushing base (7) is continued to be pushed to assemble the artificial valve (1) in the parallel state onto the balloon (13) to complete the in vivo assembly; or Under the push of the pushing base (7), the positioning member (3) gradually slides out of the second restraining member (6) and is covered by the first restraining member (8). The valve frame body (2) is located on the balloon (13), and the positioning member (3) is located at the distal end of the balloon (13). The pushing base (7) is continued to be pushed to push the positioning member (3) from the distal end of the valve frame body (2) to the proximal end. The valve frame body (2) and the positioning member (3) are gradually transformed from a series or partially overlapping state at the ends to a parallel state to complete the in vivo assembly.

19. The valve delivery method according to claim 17, wherein: The in vitro assembly of the valve can be replaced as follows: the positioning member (3) is wrapped and fixed on the balloon lumen (11) by the first restraining member (8) and the third restraining member, and the valve frame body (2) is pressed and gripped on the balloon (13) or the balloon lumen (11); The artificial valve in vivo assembly can be replaced as follows: the balloon lumen (11) carries the artificial valve (1) through the vascular sheath into the lower limb artery, at the abdominal aorta, the third restraint is released to the positioning member (3) in a V-shape or trumpet shape, the first restraint (8) advances, and is covered from the distal end of the positioning member (3) to the position from the middle section to the proximal end section of the positioning member (3), the third restraint is withdrawn from the vascular sheath, and the first restraint continues to be pushed forward, successively wrapping the valve frame body (2) and the positioning member (3) and simultaneously pushing the base (7) to push the valve frame body (2) onto the balloon (13).

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