Prosthetic valve delivery device and system

Abstract

This invention relates to an artificial valve delivery device and system. The device includes a balloon catheter, a bend-controlled outer tube, and a proximal handle. The balloon catheter includes a balloon body, a first stop, and at least two alignment imaging elements. The first stop is located at the distal end of the balloon body and is used to limit the compression of the artificial valve. The alignment imaging elements are located on the first stop, and multiple alignment imaging elements are distributed circumferentially. At least some of the alignment imaging elements differ in at least one of axial length, shape, or circumferential position, for forming orientation identification features under fluoroscopic imaging. The proximal end of the balloon catheter is provided with an external marker including multiple circumferentially distributed alignment marks, which correspond to the alignment imaging elements. The bend-controlled outer tube is sleeved outside the balloon catheter and includes a bendable adjustment section. The proximal handle is connected to the proximal ends of the balloon catheter and the bend-controlled outer tube and includes a bending control mechanism and a position adjustment mechanism.

Description

Technical Field

[0001] This invention relates to the field of cardiac interventional medical device technology, and in particular to an artificial valve delivery device and system. Background Technology

[0002] Transcatheter aortic valve replacement (TAVR), a minimally invasive interventional technique for treating severe aortic stenosis, has seen improvements in ease of operation, clinical efficacy, and hemodynamic parameters thanks to continuous advancements in transcatheter heart valve (THV) design. However, current clinical practice of transcatheter aortic valve implantation (TAVI) still faces numerous technical challenges that limit the precision, safety, and long-term efficacy of the procedure.

[0003] Precise commissural alignment (CA) between the prosthetic valve leaflet commissure and the patient's native valve is one of the key technical challenges in TAVI surgery. In current techniques, valve alignment heavily relies on the surgeon's clinical experience and subjective judgment, lacking standardized procedures and precise positioning methods. Surgeons typically need to repeatedly adjust the delivery system position and rely on multi-view DSA imaging to infer the alignment status. This complex and time-consuming process not only increases surgical time and intraoperative risks, such as the incidence of complications like coronary artery obstruction and valve displacement, but also leads to significant differences in surgical outcomes between different surgeons, failing to meet the core requirements of precision medicine for "quantifiable, repeatable, and highly safe" treatment plans.

[0004] Furthermore, existing delivery systems have significant shortcomings in valve orientation adjustment and position fine-tuning. The valve positioning accuracy of traditional delivery systems is greatly affected by various factors such as the patient's vascular anatomy and the clarity of DSA imaging, making standardized operation difficult. During delivery, the surgeon cannot accurately determine the rotation direction of the delivery system within the body and the actual orientation of the valve, making it impossible to precisely control the valve's rotation angle inside the body through external manipulation. Moreover, when the valve's position deviates after deployment, current technology lacks effective position correction methods, often requiring either accepting the positional deviation or removing the valve again. This not only increases surgical risks but also affects the patient's treatment outcome and long-term prognosis.

[0005] Furthermore, existing delivery systems also have limitations in terms of visualization and positioning. Although some systems use visualization markers, these markers often only provide axial position information and cannot effectively indicate the circumferential rotation of the valve. Operators find it difficult to visually determine whether the delivery system has rotated into position, and the relative positional relationship between the prosthetic valve commissure and the native valve commissure, under DSA imaging. This lack of visual information increases the blindness of alignment operations, making it difficult to guarantee accuracy. Summary of the Invention

[0006] This invention discloses an artificial valve delivery device and system, aiming to solve the technical problems existing in the prior art. The invention adopts the following technical solution:

[0007] In a first aspect, embodiments of the present invention provide an artificial valve delivery device, including a balloon catheter, a bend-controlled outer tube, and a proximal handle;

[0008] The balloon catheter includes a balloon body, a first stop, and at least two alignment imaging elements. The first stop is located at the distal end of the balloon body and is used to limit the compression of the artificial valve. The alignment imaging elements are located on the first stop, and multiple alignment imaging elements are distributed circumferentially. At least some of the alignment imaging elements differ in at least one of the following: axial length, shape, or circumferential position, to form orientation identification features under fluoroscopic imaging to indicate the rotation direction of the delivery device. The proximal end of the balloon catheter is provided with an external marker, which includes multiple circumferentially distributed alignment markers, and the alignment markers correspond to the alignment imaging elements.

[0009] The control tube is axially movable and sleeved on the outside of the balloon catheter, and includes at least a bendable adjustment section;

[0010] The proximal handle is connected to the proximal end of the balloon catheter and the bend-controlled outer tube, and includes a bend control mechanism and a position adjustment mechanism. The bend control mechanism is used to control the bending of the bend-controlled section, and the position adjustment mechanism is used to adjust the axial position of the balloon catheter relative to the bend-controlled outer tube.

[0011] As a preferred technical solution, the first stop member includes, in sequence along the axial direction, a first limiting section, a first fixing section, and a connecting section;

[0012] The first limiting segment is located at the proximal end of the first stop and includes multiple first protrusions distributed circumferentially. The multiple first protrusions are used to circumferentially engage with the compressed artificial valve to achieve circumferential limiting.

[0013] The first fixed section is provided with an injection port for injecting adhesive material to fix the first stop to the balloon catheter.

[0014] The connecting section is located at the distal end of the first stop and is used for a sealed connection with the balloon body.

[0015] As a preferred technical solution, the alignment developing element includes at least two developing wires, which are disposed in the first fixed section and / or the first limiting section, and at least one developing wire has a circumferential positional correspondence with the first protrusion;

[0016] Multiple developing filaments are distributed circumferentially, and at least some of the developing filaments have different axial lengths to form orientation recognition features under fluoroscopic imaging; multiple developing filaments are distributed in a gradient along the axial direction to avoid projection overlap during fluoroscopic imaging.

[0017] As a preferred technical solution, the first fixing section and / or the first limiting section are provided with a developing wire groove, and the developing wire is inserted into the developing wire groove by interference fit and fixed by adhesive material;

[0018] The outer surface of the developing wire is covered with a protective film, which is fixedly connected to the first fixed section and / or the first limiting section.

[0019] As a preferred technical solution, the shape of the developing filament is configured as at least one of filament, geometric shape, number or letter;

[0020] Multiple developing wires are arranged at equal or unequal intervals along the circumference.

[0021] As a preferred technical solution, the first baffle is made of a non-transparent material;

[0022] The alignment developing element includes a developing protrusion that protrudes radially and is positioned between the first fixed section and the connecting section; the developing protrusion and the first stop form a perspective imaging contrast to achieve a dual developing feature.

[0023] As a preferred technical solution, the shape of the developing protrusion includes at least one of rectangle, semicircle, and notched polygon, and the edges of the developing protrusion are provided with rounded corner transitions.

[0024] As a preferred technical solution, there is an annular transition groove between the first fixed section and the connecting section, and the developing protrusion is disposed in the transition groove. The height of the developing protrusion is not higher than the maximum outer diameter of the first stop.

[0025] As a preferred technical solution, at least two developing protrusions are provided, and adjacent developing protrusions are arranged at equal or unequal intervals along the circumference.

[0026] As a preferred technical solution, the alignment developing element also includes a developing mark disposed on the first fixed section. The developing mark and the developing protrusion both form a perspective imaging contrast with the first stop to achieve dual developing features.

[0027] As a preferred technical solution, the developing marks and developing protrusions are staggered in the axial direction.

[0028] As a preferred technical solution, the first fixed section is provided with a developing point groove, and the developing mark is inserted into the developing point groove by interference fit and fixed by adhesive material; the shape of the developing mark is configured as at least one of geometric shape, number or letter.

[0029] As a preferred technical solution, a second stop is also included. The second stop is disposed on the inner tube of the balloon catheter or at the distal end of the control tube, and is used to axially cooperate with the first stop to bidirectionally limit the artificial valve in a compressed state through axial and circumferential restraint.

[0030] As a preferred technical solution, the second stop includes, in sequence along the axial direction, a second limiting section and a second fixing section;

[0031] The second limiting section is located at the far end of the second stop and includes multiple second protrusions distributed circumferentially. The second protrusions correspond one-to-one with the first protrusions axially and are used to circumferentially limit the artificial valve in the compressed state.

[0032] The second fixed section is used for fixed connection with the outer surface of the inner tube or the far end of the controlled-bend outer tube.

[0033] As a preferred technical solution, the second stop is also provided with an alignment developing element, and the alignment developing element on the second stop is arranged in a circumferential direction corresponding to or staggered with the alignment developing element on the first stop.

[0034] As a preferred technical solution, the first limiting segment has a conical structure, including a small-diameter end at the distal end and a large-diameter end at the proximal end. The small-diameter end is connected to the first fixing segment, and the large-diameter end is provided with an opening.

[0035] The cross-section of the first limiting segment is configured as a positive star-shaped polygon, and multiple corners of the positive star-shaped polygon are used to form a first protrusion. The first protrusion is also used to contact the balloon body in a compressed and folded state, and the gap between adjacent first protrusions is used to form a fluid channel for the balloon body inflation process.

[0036] As a preferred technical solution, the balloon catheter also includes an inner tube and an outer tube, with the gap between them configured as a fluid delivery chamber for the balloon body; the external identification device includes a three-way tailstock and a tag tube arranged sequentially along the axial direction at the proximal end of the balloon catheter;

[0037] The three-way tailstock includes a guidewire port, a balloon inflation port, and a marking section. The guidewire port is connected to the inner tube, and the balloon inflation port is connected to the fluid delivery chamber.

[0038] The label tube is provided with multiple alignment marks distributed circumferentially, and the alignment marks correspond to the circumferential positions of the alignment imaging elements; the balloon filling port or marking part of the three-way tail seat has a circumferential alignment relationship with at least one of the alignment marks.

[0039] In a second aspect, embodiments of the present invention provide an artificial valve delivery system, including an artificial valve delivery device as described in any of the preceding claims, and further including an artificial valve;

[0040] The artificial valve is loaded in a compressed state on the outside of the balloon body. The inflow end of the artificial valve is located near the first stop. The leaflet junction of the artificial valve has a circumferential positional correspondence with the alignment imaging element.

[0041] As a preferred technical solution, the inner tube of the balloon catheter is provided with multiple imaging points along the axial direction, and the multiple imaging points include at least:

[0042] The first imaging point is located at the proximal end of the first stop and is used to mark the distal boundary of the compression area of ​​the balloon body.

[0043] Multiple release prediction development points are set near the first development point and arranged sequentially along the axial direction, with a preset axial spacing relationship between adjacent release prediction development points;

[0044] The axial position of the release prediction imaging point is configured as follows: when the artificial valve expands from the compressed state to the released state, there is an axial position of the release prediction imaging point that corresponds to the position of the clip at the upper edge of the leaflet or the junction of the leaflet after the artificial valve expands. This is used to predict the height position of the artificial valve after release under fluoroscopic imaging.

[0045] One embodiment of the above invention has the following advantages or beneficial effects:

[0046] This invention provides an artificial valve delivery device, including a balloon catheter, a bend-controlled outer tube, and a proximal handle. The balloon catheter comprises a balloon body, a first stop, and alignment imaging elements. By setting multiple alignment imaging elements with different positions or shapes on the first stop, directional identification features can be formed under fluoroscopic imaging. By setting a corresponding external marker at the proximal end of the balloon catheter, the rotation direction is linked between the external and internal systems. During surgery, the surgeon does not need repeated fluoroscopic confirmation; they only need to observe the external marker to accurately determine the rotation angle of the delivery device within the body. This allows for precise control of the circumferential alignment between the artificial valve and the native valve, significantly reducing surgical difficulty, shortening surgical time, and minimizing patient radiation exposure.

[0047] Furthermore, the proximal end of the first stop is provided with a limiting section. The limiting section is provided with multiple circumferentially distributed protrusions, which can cooperate with the circumferential state of the compressed artificial valve to achieve reliable circumferential limiting and prevent the valve from rotating or displacing during delivery. The fluid channel formed between adjacent protrusions can ensure smooth fluid flow during the balloon inflation process and avoid the risk of balloon rupture caused by local pressure concentration.

[0048] Furthermore, the bend-controlled outer cannula includes a flexible bend-adjustable section, and the proximal handle includes a bend control mechanism and a position adjustment mechanism. The bend-adjustable section, in conjunction with the bend control mechanism of the proximal handle, allows the delivery device to flexibly adjust its bend angle and direction within the body to adapt to the vascular anatomy of different patients. The position adjustment mechanism allows for precise axial position adjustment of the balloon catheter relative to the bend-controlled outer cannula to ensure accurate placement of the artificial valve at the target implantation location. This dual adjustment mechanism further improves the maneuverability and adaptability of the delivery device, reducing the risk of complications such as valve misalignment and paravalvular leakage.

[0049] This invention also provides an artificial valve delivery system. Multiple imaging points with functionally spaced intervals are set on the inner tube, with one of these imaging points corresponding to the clip position at the upper edge of the leaflet or the leaflet junction of the released artificial valve. Before balloon inflation, the operator can observe the relative position of the target imaging point to the original coronary artery ostium via DSA, predicting in advance whether the implanted valve will obstruct the coronary artery or affect the space for subsequent interventional treatment. This eliminates the need for experience-based estimations or repeated trial releases, significantly reducing the risk of serious complications such as coronary artery obstruction. During valve release, by monitoring the overlap between the target imaging point and the annular plane, the axial position of the balloon catheter can be calibrated in real time, ensuring that the valve implantation height meets the precise requirements of neither obstructing the coronary artery too high nor causing paravalvular leakage too low, further improving the safety, precision, and predictability of the procedure. Attached Figure Description

[0050] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0051] Figure 1 This is a schematic diagram of the artificial valve delivery device disclosed in one embodiment of the present invention;

[0052] Figure 2 for Figure 1 A magnified view of a section at point A in the middle;

[0053] Figure 3 This is a cross-sectional view of the controlled-bend outer tube and balloon catheter disclosed in one embodiment of the present invention;

[0054] Figure 4 This is a cross-sectional view of the balloon body in a compressed state, as disclosed in one embodiment of the present invention;

[0055] Figure 5 This is a schematic diagram of the structure of the first stop disclosed in one embodiment of the present invention;

[0056] Figure 6 This is a front view of the first stop disclosed in one embodiment of the present invention;

[0057] Figure 7 This is a cross-sectional view of the first fixed segment disclosed in one embodiment of the present invention;

[0058] Figure 8 This is a cross-sectional view of a first fixed section equipped with a developing wire, as disclosed in one embodiment of the present invention.

[0059] Figure 9 This is a schematic diagram of the structure of the first stop disclosed in one embodiment of the present invention;

[0060] Figure 10 This is a schematic diagram of the structure of the first stop disclosed in one embodiment of the present invention;

[0061] Figure 11 This is a front view of the first stop disclosed in one embodiment of the present invention;

[0062] Figure 12 This is a cross-sectional view of the first limiting segment disclosed in one embodiment of the present invention;

[0063] Figure 13 This is a schematic diagram of the structure of the first limiting segment disclosed in one embodiment of the present invention;

[0064] Figure 14 This is a front view of the first stop disclosed in one embodiment of the present invention;

[0065] Figure 15 This is a schematic diagram of the structure of the first stop disclosed in one embodiment of the present invention;

[0066] Figure 16 This is a front view of the first stop disclosed in one embodiment of the present invention;

[0067] Figure 17 This is a schematic diagram of the structure of the first stop disclosed in one embodiment of the present invention;

[0068] Figure 18 This is a schematic diagram of the structure of the second stop disclosed in one embodiment of the present invention;

[0069] Figure 19 This is a schematic diagram of the cooperation between the first stop and the second stop disclosed in one embodiment of the present invention;

[0070] Figure 20 This is a schematic diagram of the structure of an external identification element disclosed in one embodiment of the present invention;

[0071] Figure 21 for Figure 20A side view of the external signage component;

[0072] Figure 22 for Figure 20 Another side view of the external signage component;

[0073] Figure 23 This is a schematic diagram of the structure of an external identification element disclosed in one embodiment of the present invention;

[0074] Figure 24 for Figure 23 A side view of the external signage component;

[0075] Figure 25 for Figure 23 Another side view of the external signage component;

[0076] Figure 26 This is a schematic diagram of the artificial valve delivery device disclosed in one embodiment of the present invention;

[0077] Figure 27 for Figure 26 A magnified view of a section at point B in the middle;

[0078] Figure 28 This is a schematic diagram of the proximal handle disclosed in one embodiment of the present invention;

[0079] Figure 29 This is a schematic diagram of the assembly position of the artificial valve disclosed in one embodiment of the present invention;

[0080] Figure 30 This is a schematic diagram of the assembled artificial valve disclosed in one embodiment of the present invention;

[0081] Figure 31 This is a schematic diagram illustrating the cooperation relationship between the artificial valve and the alignment imaging element in one embodiment of the present invention;

[0082] Figure 32 This is a schematic diagram illustrating the cooperation relationship between the artificial valve and the alignment imaging element in another embodiment of the present invention;

[0083] Figure 33 This is an anatomical and imaging schematic diagram of the right coronary sinus in a central position, as disclosed in one embodiment of the present invention;

[0084] Figure 34 This is an anatomical and imaging diagram of overlapping left and right coronary sinuses disclosed in one embodiment of the present invention.

[0085] Figure 35 This is a schematic diagram of the initial state of rotational alignment of the right coronary sinus in one embodiment of the present invention;

[0086] Figure 36This is a schematic diagram of the rotational alignment target state of the right coronary sinus centering disclosed in one embodiment of the present invention;

[0087] Figure 37 This is a schematic diagram of the rotational alignment of the overlapping left and right coronary sinuses disclosed in one embodiment of the present invention;

[0088] Figure 38 This is a schematic diagram of the initial state of rotational alignment of the right coronary sinus in one embodiment of the present invention;

[0089] Figure 39 This is a schematic diagram of the rotational alignment target state of the right coronary sinus centering disclosed in one embodiment of the present invention;

[0090] Figure 40 This is a schematic diagram of the rotational alignment of the overlapping left and right coronary sinuses disclosed in one embodiment of the present invention;

[0091] Figure 41 This is a schematic diagram of rotational alignment of three imaging wires corresponding to the right coronary sinus centering in one embodiment of the present invention;

[0092] Figure 42 This is a schematic diagram of the rotational alignment of the left and right coronary sinuses corresponding to the three imaging wires disclosed in one embodiment of the present invention;

[0093] Figure 43 This is a schematic diagram of an artificial valve after being released in a first compression posture, as disclosed in one embodiment of the present invention.

[0094] Figure 44 This is a schematic diagram of an artificial valve after being released in a second compression posture, as disclosed in one embodiment of the present invention.

[0095] Explanation of reference numerals in the attached figures:

[0096] Conical head 11, balloon body 12, outer tube 13, inner tube 14, first stop 15, first limiting section 15-1, first fixing section 15-2, connecting section 15-3, glue injection port 15-4, developing wire groove 15-5, second stop 16, second limiting section 16-1, second fixing section 16-2, developing wire 17-1, developing protrusion 17-2, developing mark 17-3, developing point 18, first developing point 18-1, second developing point 18-2, third developing point 18-3, and so on. Four imaging points 18-4, external identification element 19, three-way stopcock 19-1, guidewire port 19-1-1, balloon inflation port 19-1-2, identification part 19-1-3, label tube 19-2, alignment mark 19-2-1, control tube 21, bending knob 31, traction wire fixation element 32, control tube fixation element 33, fine adjustment knob 34, fine adjustment scale element 35, catheter locking knob 36, three-way stopcock 37, emptying tube 38, scale indicator window 39, artificial valve 4, ear clip 41. Detailed Implementation

[0097] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0098] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0099] In the description of this invention, unless otherwise specified, "front" specifically refers to the chest side of the human body, and "back" specifically refers to the back side of the human body; "left" and "right" are based on the DSA imaging view and specifically refer to the corresponding directions when viewed from the chest side to the back side.

[0100] Those skilled in the art will understand that, in order to achieve their respective functions and meet the requirements of surgical procedures, the specific shape, size, angle, etc., of each structure can be adaptively adjusted. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of the present invention.

[0101] refer to Figures 1-3To address the technical problems existing in the prior art, this invention provides an artificial valve delivery device, including a balloon catheter, a bend-controlled outer tube 21, and a proximal handle. The balloon catheter carries the compressed artificial valve 4 and releases it through the expansion of the balloon body 12. The balloon catheter is equipped with an alignment imaging element and an external marker 19 to indicate the rotation direction of the delivery device. The bend-controlled outer tube 21 is coaxially sleeved outside the balloon catheter to protect it and provide controllable bending functionality. The proximal handle is used to manipulate the balloon catheter and the bend-controlled outer tube 21 to achieve bending control and position adjustment.

[0102] In some embodiments, the balloon catheter includes an inner tube 14, an outer tube 13, a balloon body 12, a first stop 15, and at least two alignment imaging elements; the gap between the outer tube 13 and the inner tube is configured as a fluid delivery chamber for the balloon body 12; the balloon body 12 is disposed at the distal end of the outer tube 13, and the outer side of the balloon body 12 is used to assemble a compressed artificial valve 4, and the expansion of the balloon body 12 is used to drive the artificial valve 4 to expand and release; the inner tube 14 is used to pass through a guidewire; the first stop 15 is disposed at the distal end of the inner tube 14 to limit the compressed artificial valve 4; the alignment imaging elements are disposed on the first stop 15, and a plurality of alignment imaging elements are distributed circumferentially, and at least some of the alignment imaging elements are axially... The balloon catheter has at least one difference in shape or circumferential position to form a direction recognition feature under fluoroscopic imaging, indicating the rotation direction of the delivery device under fluoroscopic imaging; the proximal end of the balloon catheter is provided with an external marker 19, which includes a plurality of circumferentially distributed alignment markers 19-2-1, which correspond to the alignment imaging element; the bend control tube 21 is axially movable and sleeved on the outside of the balloon catheter, including at least a bendable adjustment section; the proximal handle is connected to the proximal end of the balloon catheter and the bend control tube 21, and includes a bend control mechanism and a position adjustment mechanism, the bend control mechanism is used to control the bend of the adjustment section, and the position adjustment mechanism is used to adjust the axial position of the balloon catheter relative to the bend control tube 21.

[0103] In some embodiments, at least a portion of the outer surface of the balloon catheter is coated with a hydrophilic coating. This hydrophilic coating can quickly form a lubricating hydration layer upon contact with bodily fluids such as blood or saline, thereby reducing the frictional resistance between the balloon catheter and the inner wall of the control tube 21, as well as between the balloon catheter and the vessel wall. This ensures that when the control tube 21 is in a bent state, the operator's rotation of the proximal handle can be smoothly transmitted to the distal balloon catheter and artificial valve 4, avoiding rotational jamming or angular deviation caused by frictional resistance. This ensures precise alignment of the imaging element with the native valve and reduces mechanical stimulation of the vascular endothelium during delivery.

[0104] In some embodiments, the artificial valve 4 is preferably an artificial aortic valve, the main structure of which includes a mesh-like valve support and leaflets that can be expanded by the balloon body 12. The artificial valve 4 has an inflow end and an outflow end. During assembly and delivery, the artificial valve 4 is loaded in a compressed state on the outside of the balloon body 12, with the inflow end located adjacent to the first stop 15. The leaflet junction of the artificial valve 4 has a circumferential positional correspondence with the alignment imaging element, so that the doctor can accurately control the circumferential positioning of the artificial valve 4 through the alignment imaging element and the external marker 19. In some embodiments, the leaflet junction of the artificial valve 4 has a clip 41 for connecting two adjacent leaflets. In this embodiment and the following embodiments, the positional correspondence between the alignment imaging element and / or the alignment marker 19-2-1 and the leaflet junction can be regarded as the positional correspondence between the alignment imaging element and / or the alignment marker 19-2-1 and the clip 41.

[0105] In this embodiment, the specific structural form and related specifications of the artificial valve 4 are no longer limited. Those skilled in the art can make adaptive selections or adjustments according to clinical application needs and the actual situation of patients.

[0106] like Figure 4 In some embodiments, the balloon body 12 is configured as an eight-wing folding structure in a compressed and folded state. The eight folding wings are folded and rolled around the inner tube 14 in the same direction in the circumferential direction. Compared with the traditional four-fold or six-fold design, the eight-wing folding structure can significantly reduce the outer diameter dimension during delivery and reduce the radial dimension by about 15%-20%, thereby reducing the risk of puncture and damage to the patient's blood vessel lumen and improving the passability of the delivery system in curved blood vessels.

[0107] In some embodiments, the balloon body 12 is preferably made of a high-strength, high-flexibility polymer material, such as polyethylene terephthalate (PET), nylon, or other medical-grade polymers, to ensure that the balloon body 12 has sufficient strength and stability during inflation and expansion, and to avoid rupture or over-expansion.

[0108] In this embodiment, the size parameters of the balloon body 12 after expansion are no longer specifically limited. The expansion diameter, expansion length and other specifications of the balloon body 12 should be adaptively selected according to the specifications of the artificial valve 4, the anatomical size of the patient's aortic valve annulus and the clinical application requirements. Those skilled in the art can adjust and optimize the size parameters of the balloon body 12 according to the actual clinical situation.

[0109] In some embodiments, the distal end of the balloon catheter is further provided with a conical head 11, which has a generally conical structure and good guiding performance, enabling the delivery device to be smoothly advanced in the blood vessel to reduce mechanical stimulation to the inner wall of the blood vessel.

[0110] In some embodiments, the outer side of the conical head 11 is connected to the first stop 15 and the distal end of the balloon body 12, respectively, preferably by an adhesive bonding process, to ensure that the connection has sufficient strength and sealing, and to prevent the balloon body 12 from falling off or leaking under the pressure during the inflation process.

[0111] In some embodiments, the distal outer surface of the inner tube 14 is fixedly connected to the first stop 15 and the conical head 11, and the guide wire can be inserted from the proximal end of the inner tube 14. The inner diameter of the inner tube 14 is larger than the diameter of the guide wire so that the guide wire can slide freely in the inner tube 14. Its inner diameter is preferably 0.035 inches, which matches the guide wire specifications commonly used in clinical practice.

[0112] In some embodiments, the inner tube 14 is preferably made of PI (polyimide) material, which has excellent corrosion resistance and flexibility to facilitate passage through tortuous blood vessels during delivery.

[0113] like Figure 2 , Figure 29 , Figure 30 In some embodiments, the inner tube 14 is provided with a plurality of imaging points 18 along the axial direction. The plurality of imaging points 18 are used to identify the compression area of ​​the artificial valve 4 on the balloon body 12 under fluoroscopic imaging, and / or to identify the relative position of the balloon body 12 and the original valve annulus.

[0114] In some embodiments, the inner tube 14 preferably has six imaging points 18, which are distributed sequentially along the axial direction. The most distal imaging point 18 is located proximally to the first stop 15, marking the distal boundary of the compression area of ​​the balloon body 12. This ensures the accurate positioning of the artificial valve 4 on the balloon body 12, preventing positional deviation after release due to compression offset. Several imaging points 18 in the middle region mark the relative position of the valve to the original valve annulus. The surgeon can observe the overlap between these imaging points 18 and the valve annulus using DSA to determine if the valve's axial position is appropriate, providing a visual basis for precise release. The closest imaging point 18 is located proximally to the balloon body 12, marking the proximal outer boundary of the balloon body 12. Observing this imaging point 18 during surgery ensures that the distal end of the control tube 21 is outside this imaging point 18 during balloon inflation, preventing it from obstructing the balloon body 12 and affecting balloon expansion and artificial valve release.

[0115] In some embodiments, the inner tube 14 is further provided with a second stop 16, which is arranged at the proximal end of the balloon body 12 and is used to axially cooperate with the first stop 15 to bidirectionally limit the artificial valve 4 in the compressed state. The first stop 15 can prevent the artificial valve 4 from shifting distally, and the second stop 16 can prevent the artificial valve 4 from shifting proximally. The cooperation of the two can also simultaneously limit the artificial valve 4 circumferentially, thereby effectively preventing the artificial valve 4 from shifting due to vascular friction and fluctuations in pushing force during delivery. Preferably, the inner tube 14 is provided with a contrast point 18 at the distal end near the second stop 16. This contrast point 18 and the contrast point 18 at the proximal end of the first stop 15 jointly mark the boundary of the compressed area of ​​the balloon body 12.

[0116] In some embodiments, three imaging points 18 are provided in the area between the first stop 15 and the second stop 16 to mark the relative position of the artificial valve 4 and the human native valve annulus in real time during delivery and release. The surgeon can observe the degree of overlap between these three imaging points 18 and the valve annulus through DSA to determine whether the axial position of the artificial valve 4 is appropriate, providing a visual basis for precise release.

[0117] like Figure 5 In some embodiments, the first stop 15 includes, in sequence along the axial direction, a first limiting section 15-1, a first fixing section 15-2, and a connecting section 15-3; wherein, the first limiting section 15-1 is disposed at the proximal end of the first stop 15 and includes a plurality of first protrusions distributed circumferentially, the plurality of first protrusions being used to engage circumferentially with the compressed artificial valve 4 to achieve circumferential limiting; the first fixing section 15-2 is provided with an injection port 15-4, the injection port 15-4 being used to inject adhesive material to fix the first stop 15 to the inner tube 14; the connecting section 15-3 is disposed at the distal end of the first stop 15 and is used to seal and connect with the balloon body 12.

[0118] In some embodiments, the first limiting segment 15-1 has a tapered structure, and its axial length and taper angle should ensure effective support and axial limitation for the inflow end of the artificial valve 4; the first limiting segment 15-1 has a large-diameter end and a small-diameter end, the small-diameter end of which is smoothly connected to the first fixing segment 15-2, and the large-diameter end forms an opening, the diameter of which should be slightly larger than the diameter of the inflow end of the artificial valve 4 under compression, so as to facilitate the assembly of the artificial valve 4 and to circumferentially limit it, preventing the artificial valve 4 from rotating and shifting due to vascular friction during delivery, and ensuring the initial positioning accuracy of the valve.

[0119] In some embodiments, the cross-section of the first limiting segment 15-1 is configured as a regular star-shaped polygon, preferably a regular hexagonal star or a regular octagonal star. The corners of the regular star-shaped polygon extend outward to form first protrusions. The number of first protrusions is preferably six or eight, and the specific number is adapted to the circumferential groove at the inflow end of the artificial valve 4. The circumferentially spaced first protrusions not only circumferentially limit the artificial valve 4, but the V-shaped gaps formed between adjacent first protrusions also constitute a fluid channel. This fluid channel ensures that when the balloon body 12 is inflated, the fluid can flow smoothly through the first baffle 15 to the distal region of the balloon body 12, avoiding uneven expansion of the balloon body 12 or excessive local pressure due to local fluid obstruction, thereby reducing the risk of balloon rupture and improving the radial force balance during the release process.

[0120] In some embodiments, the first fixing section 15-2 has a cylindrical structure, and its inner diameter is adapted to the outer diameter of the inner tube 14 to form a clearance fit or transition fit relationship. The first fixing section 15-2 is provided with an adhesive injection port 15-4. When multiple adhesive injection ports 15-4 are provided, they are evenly distributed circumferentially. Preferably, two adhesive injection ports 15-4 are provided, and the two are circumferentially spaced 180 degrees apart, so as to achieve uniform injection and distribution of adhesive, thereby forming an annular adhesive layer, ensuring that there is no relative displacement between the first stop 15 and the inner tube 14 during pushing and bending operations, and meeting the mechanical strength requirements of the delivery system. In some embodiments, the adhesive injection port 15-4 is firmly connected to the inner tube 14 by medical epoxy resin adhesive or other medical-grade adhesive materials. The shear strength of the adhesive material after curing is ≥15MPa to improve the bonding strength.

[0121] In some embodiments, the connecting segment 15-3 is disposed at the distal end of the first stop 15 for a sealed connection with the distal end of the balloon body 12. The outer diameter of the connecting segment 15-3 matches the inner diameter of the distal end of the balloon body 12. The connecting segment 15-3, the conical head 11, and the balloon body 12 are sealed together by means of thermofusion welding or bonding. The connecting segment 15-3 and the conical head 11 have a smooth transition to avoid forming sharp steps or edges, thereby reducing the risk of mechanical damage to the inner wall of the blood vessel. The axial length of the connecting segment 15-3 should ensure sufficient overlap area with the balloon body 12 to improve connection strength and sealing reliability, and prevent detachment or leakage under high pressure during balloon inflation. Specifically, this fixing method can structurally eliminate the risk of liquid leakage when the balloon body 12 is inflated, maintain the stability of the pressure inside the balloon during balloon release, ensure that the pressure fluctuation range is controlled within 5%, and avoid unstable balloon release effect due to sudden pressure drop.

[0122] like Figure 18In some embodiments, similar to the structure of the first stop 15, the second stop 16 includes a second limiting section 16-1 and a second fixing section 16-2 along the axial direction. The second limiting section 16-1 is disposed at the distal end of the second stop 16 and includes a plurality of second protrusions distributed circumferentially. The second protrusions correspond one-to-one with the first protrusions axially and are used to circumferentially limit the artificial valve 4 in a compressed state. The second fixing section 16-2 is used to fix and connect to the outer surface of the inner tube 14 or the distal end of the bending control outer tube 21.

[0123] In some embodiments, the structure of the second limiting segment 16-1 is the same as that of the first limiting segment 15-1, and the plurality of second protrusions correspond one-to-one with the plurality of first protrusions in the axial direction; preferably, the structure of the second fixing segment 16-2 is also the same as that of the first fixing segment 15-2, and the glue injection port 15-4 on the second fixing segment 16-2 and its connection method with the inner tube 14 are also the same as the specific arrangement in the first stop 15.

[0124] In some embodiments, the alignment developing element includes at least two developing wires 17-1, the developing wires 17-1 being disposed in the first fixed section 15-2 and / or the first limiting section 15-1, and at least one developing wire 17-1 having a circumferential positional correspondence with the first protrusion; multiple developing wires 17-1 are distributed circumferentially, and at least some of the developing wires 17-1 have different axial lengths to form orientation recognition features under fluoroscopic imaging; multiple developing wires 17-1 are distributed in a gradient along the axial direction to avoid projection overlap during fluoroscopic imaging.

[0125] like Figure 7 , Figure 8 In some embodiments, the first fixing segment 15-2 and / or the first limiting segment 15-1 are provided with a developing wire groove 15-5. The developing wire groove 15-5 extends axially along the first stop 15. The opening size of the developing wire groove 15-5 is slightly smaller than the size of the developing wire 17-1, so that the developing wire 17-1 is inserted into the developing wire groove 15-5 by interference fit. The interference should ensure that the developing wire 17-1 can be tightly embedded in the groove without loosening during assembly, while avoiding deformation or cracking of the first stop 15 due to excessive interference. After assembly, medical UV adhesive or other medical-grade adhesive material is applied to the opening of the developing wire groove 15-5. The developing wire 17-1 is reliably fixed to the first fixing segment 15-2 and / or the first limiting segment 15-1 by ultraviolet curing or chemical curing, ensuring that the developing wire 17-1 will not loosen or shift during bending, pushing and other operations.

[0126] In some embodiments, the outer surface of the imaging wire 17-1 is covered with a protective film, which is fixedly connected to the first fixing section 15-2 and / or the first limiting section 15-1. The protective film is preferably made of polytetrafluoroethylene (PTFE) and has a thickness of 0.05~0.1 mm. The protective film is bonded to the first fixing section 15-2 and / or the first limiting section 15-1 by hot-melt welding or medical adhesive, forming an encapsulated protection for the imaging wire 17-1. This protective film has a dual function: on the one hand, it can effectively shield the sharp edges of the imaging wire 17-1, preventing the imaging wire 17-1 from puncturing the balloon body 12 during balloon inflation and avoiding the risk of balloon rupture; on the other hand, it can also avoid affecting the DSA imaging effect of the imaging wire 17-1, thus balancing the needs of imaging and protection.

[0127] In some embodiments, the shape of the radiopaque filament 17-1 may be configured as at least one of filament, strip, geometric shape, number, or letter to enhance the recognizability of radiopaque features and adapt to more complex clinical scenarios; multiple radiopaque filaments 17-1 are arranged equidistantly or unequally spaced along the circumference. The radiopaque filament 17-1 is preferably made of platinum-iridium alloy.

[0128] In some embodiments, the developing wire 17-1 is configured as two wires. The two developing wires 17-1 can be arranged on the first fixed section 15-2, or on the first limiting section 15-1, or one wire can be arranged on the first fixed section 15-2 and the first limiting section 15-1 respectively. Alternatively, the second stop 16 is also provided with an aligning developing element, in which case one developing wire 17-1 is arranged on the first stop 15 and the second stop 16 respectively.

[0129] It should be noted that when both the first stop 15 and the second stop 16 are provided with a developing wire 17-1, the developing wire 17-1 on the first stop 15 can be arranged in the first fixed section 15-2 or the first limiting section 15-1, and the developing wire 17-1 on the second stop 16 can be arranged in the second fixed section 16-2 or the second limiting section 16-1. The shapes of the developing wires 17-1 provided on the first stop 15 and the second stop 16 can be the same or different.

[0130] refer to Figure 5 , Figure 6When both imaging wires 17-1 are positioned in the first fixed section 15-2, the two imaging wires 17-1 are arranged at 90° or 120° intervals circumferentially, and each can also correspond circumferentially to a protrusion of the first limiting section 15-1 to form a directional identification feature under fluoroscopic imaging. The axial lengths of the two imaging wires 17-1 are set to different dimensions; for example, one imaging wire 17-1 is 4 to 5 mm long, and the other is 2 to 3 mm long, or the length ratio between the two is 1.5:1 to 2:1. Through the length difference, the surgeon can quickly identify the directionality of the imaging wires 17-1 under fluoroscopic imaging, thereby determining the circumferential orientation of the first stop 15, providing a visual reference for precise positioning and release of the artificial valve 4. Preferably, the two imaging wires 17-1 are distributed in a gradient along the axial direction to avoid overlapping and occlusion during fluoroscopic projection, ensuring image clarity and recognizability.

[0131] When both imaging wires 17-1 are arranged in the first limiting section 15-1, the imaging wires 17-1 are also arranged at circumferential intervals of 90° or 120°, and each can also correspond circumferentially to a protrusion of the first limiting section 15-1. The two wires have different lengths and are distributed in a gradient in the axial direction. Optionally, both imaging wires 17-1 can be set on the outer surface of the first limiting section 15-1, or both can be set on its inner surface, or one can be set on the inner surface and the other on the outer surface. The specific arrangement can be selected according to different clinical operating habits and imaging needs to improve the applicability and effectiveness of the imaging wires 17-1 in practical applications.

[0132] like Figure 9 When the first limiting section 15-1 and the first fixing section 15-2 are each provided with a developing wire 17-1, they are arranged circumferentially at intervals. At this time, the lengths of the two developing wires 17-1 can be the same or different.

[0133] Specifically, when the first stop 15 and the second stop 16 each have a radiopaque fiber 17-1, an axially symmetrical or asymmetrical radiopaque structure can be formed. This can provide directional indication for the rotation of the delivery device and the artificial valve 4 in the body from both the front and rear dimensions. By observing the relative positional changes of the two radiopaque fibers 17-1, the surgeon can more comprehensively and accurately determine the rotational state of the delivery device.

[0134] Specifically, the imaging wire 17-1 set on the first stop 15 can be located in the first fixed section 15-2 or the first limiting section 15-1, and the imaging wire 17-1 set on the second stop 16 can be located in the second fixed section 16-2 or the second limiting section 16-1; the circumferential positional relationship of the two imaging wires 17-1 can be configured to be circumferentially aligned, that is, the two imaging wires 17-1 are at an angle of 0° or 180° in the circumferential direction, so that the surgeon can observe the relative positional changes of the two imaging wires 17-1 through fluoroscopy and judge the torsion state or bending degree of the delivery system in the body; the shape and size of the two imaging wires 17-1 can be the same, or they can be set to different shapes or different lengths. The shape difference further enhances the direction recognition ability, so that the surgeon can accurately distinguish the positional state of the first stop 15 and the second stop 16, and ensure the axial positioning accuracy and circumferential alignment accuracy when the artificial valve 4 is released. In some embodiments, when the artificial valve 4 is pressed against the first stop 15 and the second stop 16, it is aligned with the two developing wires 17-1 at a preset angle. For example, the leaflet junction of the artificial valve 4 is aligned or intersected with the developing wires 17-1 on the first stop 15 and / or the second stop 16 in the axial / circumferential direction to ensure that the developing wires 17-1 can accurately reflect the position of the artificial valve 4.

[0135] In the above embodiment, only two imaging wires 17-1 are provided. By reducing the number of imaging wires 17-1, the risk of puncture to the balloon body 12 can be effectively reduced, and the assembly process can be simplified. It is especially suitable for application scenarios with low imaging accuracy requirements or high clinical operation proficiency. In addition, the configuration of two imaging wires 17-1 can significantly reduce manufacturing costs and quality control difficulties while ensuring basic direction indication function, and further improve the reliability and consistency of the product.

[0136] In some embodiments, the developing wires 17-1 are configured as three wires. The three developing wires 17-1 can be evenly arranged in the first fixed section 15-2, or evenly arranged in the first limiting section 15-1, or one or two developing wires can be arranged in the first fixed section 15-2 and the first limiting section 15-1 respectively. Alternatively, the second stop 16 is also provided with an aligning developing element, in which case one or two developing wires 17-1 are arranged in the first stop 15 and the second stop 16 respectively.

[0137] It should be noted that when both the first stop 15 and the second stop 16 are provided with developing wires 17-1, the developing wires 17-1 on the first stop 15 can be arranged in the first fixed section 15-2 or the first limiting section 15-1, and the developing wires 17-1 on the first limiting section 15-1 can be disposed on its inner surface or outer surface; the developing wires 17-1 on the second stop 16 can be arranged in the second fixed section 16-2 or the second limiting section 16-1, and the developing wires 17-1 on the second limiting section 16-1 can be disposed on its inner surface or outer surface; the shapes of the developing wires 17-1 disposed on the first stop 15 and the second stop 16 can be the same or different.

[0138] like Figure 10 , Figure 11 When all three developing wires 17-1 are arranged in the first fixed section 15-2, the three developing wires 17-1 are evenly distributed circumferentially, with the circumferential interval angle preferably being 120°, forming a symmetrical distribution pattern in the circumferential direction. The three developing wires 17-1 are preferably aligned circumferentially with the protrusions of the first limiting section 15-1. When the first limiting section 15-1 has six protrusions, the three developing wires 17-1 are aligned with the axial protrusions after being spaced one protrusion apart in the circumferential direction, ensuring that the imaging position of the developing wires 17-1 can accurately map the valve junction direction.

[0139] The axial lengths of the three developing wires 17-1 are preferably set to different sizes. The lengths of adjacent developing wires 17-1 can show a gradient decreasing or increasing relationship. For example, the developing wire 17-1 located in the middle is the longest or the largest in size, and the developing wires 17-1 on both sides of its circumference are set to 1 / 2 or 1 / 3 of its length, respectively. Through the difference in length, obvious directional identification features can be formed under fluoroscopic imaging.

[0140] The three developing wires 17-1 are distributed in a gradient along the axial direction. For example, the developing wire 17-1 in the middle is located in the middle of the first fixed section 15-2 along the axial direction, and the developing wires 17-1 on both sides are arranged adjacent to the first limiting section 15-1 and the connecting section 15-3, respectively, to avoid the overlap of the three developing wires 17-1 during DSA imaging and to ensure the clarity of the developing wires.

[0141] like Figure 12 , Figure 13When all three imaging wires 17-1 are arranged in the first limiting section 15-1, they are also uniformly spaced 120° apart circumferentially. Each imaging wire 17-1 corresponds to a protrusion in the axial direction, and the three imaging wires 17-1 are arranged in a gradient pattern with different lengths to avoid overlapping and obstruction during fluoroscopic projection. The three imaging wires 17-1 can be all set on the outer surface of the first limiting section 15-1 to obtain the best imaging contrast and clarity, or they can all be set on the inner surface, or a mixed arrangement can be used, that is, some imaging wires 17-1 are set on the outer surface and some are set on the inner surface, to meet the imaging requirements and structural strength requirements under different fluoroscopic angles. Since the first limiting section 15-1 usually has a conical or gradient geometry, this arrangement of imaging wires 17-1 can have a larger projection outline under DSA, which is convenient for the operator to operate and observe. Furthermore, since the first limiting segment 15-1 is closer to the original valve annulus, the imaging wire 17-1 at this location can more accurately reflect the relative position of the artificial valve 4 and the original valve annulus.

[0142] When one or two developing wires 17-1 are arranged in the first fixed section 15-2 and the first limiting section 15-1, the developing wires 17-1 are segmented in the axial direction, which can simultaneously identify the position of the fixed area and the limiting area of ​​the first stop 15. When one developing wire 17-1 is arranged in the first fixed section 15-2 and two developing wires 17-1 are arranged in the first limiting section 15-1, the two developing wires 17-1 arranged in the first limiting section 15-1 are spaced apart in the circumferential direction, forming a corresponding or staggered angular relationship with the developing wire 17-1 arranged in the first fixed section 15-2 in the circumferential direction; conversely, when two developing wires 17-1 are arranged in the first fixed section 15-2 and one developing wire 17-1 is arranged in the first limiting section 15-1, the two developing wires 17-1 arranged in the first fixed section 15-2 are also spaced apart in the circumferential direction, forming a composite positioning mark in the axial and circumferential directions with the single developing wire 17-1 on the first limiting section 15-1. This segmented arrangement provides the surgeon with richer positional information, making it easier to observe the attitude changes of different areas of the first barrier 15 simultaneously under DSA imaging.

[0143] like Figure 19When one or two developing wires 17-1 are arranged on the first baffle 15 and the second baffle 16 respectively, a symmetrical or asymmetrical developing system is formed. When one developing wire 17-1 is arranged on the first baffle 15 and two developing wires 17-1 are arranged on the second baffle 16, or when two developing wires 17-1 are arranged on the first baffle 15 and one developing wire 17-1 is arranged on the second baffle 16, different combinations of developing wires 17-1 in different numbers and positions can be used to differentiate the front and rear ends of the delivery system. The developing wires 17-1 on the first baffle 15 can be selected to be arranged on the first fixed section 15-2 or the first limiting section 15-1, and the developing wires 17-1 on the second baffle 16 can be selected to be arranged on the second fixed section 16-2 or the second limiting section 16-1. The circumferential position of each developing wire 17-1 can be flexibly configured according to clinical needs. Multiple imaging wires 17-1 can establish a circumferential alignment or a specific angular interval positional relationship, enabling the surgeon to comprehensively judge the overall posture, degree of torsion and bending state of the delivery system in the body by observing the relative position and morphological changes of the imaging wires 17-1 in the fluoroscopic image, thereby achieving precise control and real-time monitoring of the artificial valve 4 release process.

[0144] In some embodiments, regardless of whether the three developing wires 17-1 are respectively disposed in the first fixed section 15-2, the first limiting section 15-1, or the combination of the first stop 15 and the second stop 16, the three developing wires 17-1 can also be uniformly distributed. The circumferential spacing angle of the three developing wires 17-1 can be differentiated according to the actual morphological characteristics of the human natural valve or the artificial valve 4, rather than using a uniform 120° spacing. For example, when the artificial valve 4 has a three-leaf structure and the leaflet size varies, the three developing wires 17-1 can establish a correspondence with the junction position or center position of each leaflet, and the circumferential distribution of the developing wires 17-1 can be adjusted to match the actual angle of the leaflet junction. Through this non-uniformly distributed structure, the imaging wire 17-1 can accurately reflect the true orientation of the artificial valve 4 in the circumferential direction and the relative positional relationship of each leaflet. This allows the surgeon to intuitively judge the alignment relationship between the artificial valve 4 and anatomical landmarks such as the natural valve ring or coronary artery opening under fluoroscopic imaging. In addition, the axial length and shape of the imaging wire 17-1 can be customized according to the imaging needs of different leaflet areas to achieve key identification of specific leaflets or key anatomical areas. This provides more targeted visual guidance for the precise positioning and release of the artificial valve 4, improving the success rate of the surgery and the implantation effect.

[0145] In the above configuration of three imaging wires 17-1, by increasing the number of imaging wires 17-1 to three, richer positional information and directional indication features can be presented under DSA imaging, significantly improving the surgeon's accuracy in recognizing the posture of the delivery device and the precision of operation; the gradient length configuration and circumferential uniform distribution of the three imaging wires 17-1 ensure that clear and non-overlapping imaging images can be obtained under different fluoroscopic angles, providing reliable visual guidance for the implantation of artificial valve 4 under complex anatomical structures.

[0146] refer to Figures 14-17 In some embodiments, the first stop 15 is made of a radiopaque material, such as medical silicone or PEBAX material with 25%~30% barium sulfate powder added, to ensure clear imaging under DSA. The surgeon can preliminarily determine the axial positioning state of the first stop 15 by the relative imaging position of the first limiting segment 15-1 and the original valve annulus, providing a basic reference for subsequent rotational alignment. Further, in this embodiment, the imaging wire 17-1 is omitted, and the alignment imaging element is configured as a imaging protrusion 17-2. The imaging protrusion 17-2 protrudes radially and is disposed in the annular transition groove between the first fixing segment 15-2 and the connecting segment 15-3. The imaging protrusion 17-2 can form a fluoroscopic imaging contrast with the first stop 15 to achieve dual imaging characteristics.

[0147] In some embodiments, the material composition of the imaging protrusion 17-2 and the first baffle 15 exhibits a contrast difference: the first baffle 15 is made of a radiopaque material containing barium sulfate powder, while the imaging protrusion 17-2 can be made of a material with a higher degree of radiopaqueness, such as medical silicone or PEBAX material with a higher proportion of barium sulfate powder or other high-density contrast agents. This results in the imaging protrusion 17-2 exhibiting a stronger imaging signal under DSA imaging, creating a significant brightness contrast with the background imaging of the first baffle 15. This contrast design further enhances the visualization effect of the imaging protrusion 17-2, enabling surgeons to clearly identify the position and morphological changes of the imaging protrusion 17-2 even in complex anatomical environments, providing reliable imaging guidance for the precise positioning and release of the artificial valve 4.

[0148] In some embodiments, the developing protrusion 17-2 and the first stop 15 are configured as an integrated structure, which avoids the risk of loosening. During repeated bending and pushing, the developing feature remains stable, avoiding alignment errors caused by the displacement of the developing element, thereby improving the reliability of developing. In addition, since there are no other assembly or gluing processes, there are no problems such as the developing wire 17-1 falling off or glue overflowing, thus further reducing production complexity and assembly error risks.

[0149] In some embodiments, the height of the developing protrusion 17-2 is not higher than the maximum outer diameter of the first stop 15, and its structure can be configured as a three-dimensional rectangle or semi-circle, such as... Figure 14 , Figure 15 , or a notched polygon, such as Figure 16 , Figure 17 Furthermore, the edges of the imaging protrusions 17-2 are rounded to avoid damaging the balloon body 12, the artificial valve 4, or tissue structures.

[0150] refer to Figure 16 and Figure 17 A notched polygon refers to a polygon with recesses or cut-off portions on one or more sides, forming a non-complete, closed polygonal outline. This notched structure can create unique asymmetrical imaging features under fluoroscopic imaging, giving the imaging protrusion 17-2 a clear directional indication. By observing the orientation and positional changes of the notch, the surgeon can quickly identify the circumferential posture of the imaging protrusion 17-2, and thus determine the rotation angle of the first stop 15 relative to the anatomical landmark. The geometry of the notched polygon can also be customized according to clinical needs, such as being configured as a notched triangle, notched rectangle, or notched trapezoid, to adapt to different imaging angles and imaging accuracy requirements, improving the accuracy and reliability of directional judgment.

[0151] In some embodiments, at least two developing protrusions 17-2 are provided, and adjacent developing protrusions 17-2 are arranged at equal or unequal intervals along the circumference. Optionally, the number of developing protrusions 17-2 can be set to two or three. When two are provided, it is more suitable for scenarios with moderate developing resolution requirements. This structure makes assembly simpler and reduces the risk of contact with the inner wall of the balloon body 12. When three are provided, it is more suitable for scenarios with high-precision alignment requirements. The projection features formed by multiple developing protrusions 17-2 are richer, and the rotation direction is more accurately determined.

[0152] When two imaging protrusions 17-2 are configured, they are distributed circumferentially at intervals. The circumferential interval angle can be set to an asymmetrical distribution of 90° or 120° to avoid overlapping projections under DSA, or it can be set to a symmetrical distribution of adjacent protrusions at 180°. The two imaging protrusions 17-2 can adopt the same or different geometric shapes. For example, one imaging protrusion 17-2 can be configured as a rectangular structure, and the other as a semi-circular or notched polygonal structure. The difference in shape creates a clear directional identification feature under fluoroscopic imaging. The radial height of the two imaging protrusions 17-2 can also be set to different sizes, presenting a height gradient change, to avoid overlapping and occlusion during fluoroscopic projection, ensuring image clarity and recognizability. The surgeon can quickly determine the circumferential orientation of the first stop 15 by observing the relative position and morphological differences of the two imaging protrusions 17-2, thereby achieving precise control over the release direction of the artificial valve 4.

[0153] like Figure 33Taking the central view of the right coronary sinus as an example, in actual operation, the surgeon first pushes the delivery device to the target position under DSA fluoroscopy. When the first stop 15 reaches the aortic valve annulus plane, the two contrasting protrusions 17-2 form a contrasting image with the background contrast of the first stop 15. In the initial state, the two contrasting protrusions 17-2 are located on the right side of the guidewire. When the delivery device is rotated, the projection angles of the two contrasting protrusions 17-2 will change synchronously. By observing the relative positional changes of the two contrasting protrusions 17-2 with the guidewire and the original valve sinus projection, the surgeon can accurately determine the direction and angle of rotation.

[0154] When three developmental protrusions 17-2 are configured, they are evenly distributed circumferentially, with a preferred circumferential interval of 120°, forming a symmetrical distribution pattern. The three developmental protrusions 17-2 can adopt the same geometric shape and size to present a uniform developmental pattern under fluoroscopic imaging, facilitating the surgeon to establish a stable visual reference system. The three developmental protrusions 17-2 can also adopt different geometric shapes or radial height combinations, such as a combination of a rectangle, a semicircle, and a notched polygon, or three identical shapes with gradually decreasing heights. This differentiated configuration of shape or size further enhances the ability to identify directions and the accuracy of rotation angle judgment. The circumferential distribution of the three imaging protrusions 17-2 can also be non-uniformly spaced, and can be differentiated according to the actual morphological characteristics of the human natural valve or the artificial valve 4. For example, they can be asymmetrically distributed at intervals of 80°, 100° and 180°, so that the position of the imaging protrusions 17-2 corresponds to the valve leaflet junction or the valve leaflet center, thereby accurately reflecting the true orientation of the artificial valve 4 in the circumferential direction.

[0155] like Figure 34 Taking the overlapping view of the left and right coronary sinuses as an example, in actual operation, the surgeon pushes the delivery system to the aortic valve annulus plane under DSA fluoroscopy. The three imaging protrusions 17-2 appear as a symmetrical pattern of "tripartite circles" under fluoroscopic imaging. When the delivery device is rotated, the projection interval of the three imaging protrusions 17-2 always remains at 120°, but the whole rotates around the guidewire. The surgeon can judge whether the rotation is in place by the "position of the imaging protrusion 17-2 closest to the right coronary sinus projection". Compared with the design of two imaging protrusions 17-2, the judgment accuracy can be improved by 30% to 50%. It is particularly suitable for clinical scenarios with complex anatomical structures or requiring high-precision alignment, and significantly improves the success rate and safety of artificial valve implantation.

[0156] In some embodiments, only one developing protrusion 17-2 is provided. In this case, the aligning developing element also includes a developing mark 17-3 provided on the first fixed section 15-2. The developing mark 17-3 and the developing protrusion 17-2 both form a perspective imaging contrast with the first stop 15 to achieve dual developing features and improve imaging clarity.

[0157] In this embodiment, by arranging the imaging protrusion 17-2 and the imaging mark 17-3 at different axial positions of the first stop 15, a composite imaging pattern with axial segments can be formed under fluoroscopic imaging. The imaging protrusion 17-2 is located in the transition groove between the first fixed section 15-2 and the connecting section 15-3, protruding radially, while the imaging mark 17-3 is located on the surface of the first fixed section 15-2. The two are spatially staggered. Since both the imaging protrusion 17-2 and the imaging mark 17-3 are made of radiopaque or highly radiopaque materials, they form a significant imaging contrast with the radiopaque substrate of the first stop 15. Under DSA imaging, the surgeon can simultaneously observe the positional relationship and relative changes of the two imaging features, thereby more accurately determining the circumferential orientation and rotational state of the first stop 15.

[0158] In some embodiments, the first fixed section 15-2 is provided with a developing point groove, and the developing mark 17-3 is inserted into the developing point groove by interference fit and fixed by adhesive material to ensure that the developing mark 17-3 does not fall off or shift when subjected to pushing force, bending stress and blood flow impact during the transport process.

[0159] In some embodiments, the shape of the imaging marker 17-3 is configured as at least one of geometric shapes, numbers, or letters, and the specific shape can be selected according to clinical imaging needs and orientation recognition requirements. For example, the imaging marker 17-3 can be configured as regular geometric shapes such as triangles, circles, squares, and trapezoids, or as asymmetrical symbols such as the letters L, R, N, or the numbers 1, 2, 3. By using an asymmetrical shape, a clear directional indication feature can be formed under fluoroscopic imaging, enabling the surgeon to quickly identify the orientation of the imaging marker 17-3 and thus determine the rotation angle of the first stop 15. Regardless of the shape of the imaging marker 17-3, its volume or area density must meet the requirements of DSA imaging. Preferably, the diameter or maximum size of the imaging marker 17-3 is not less than 0.5 mm, and the area is not less than 1 mm². 2 This ensures that sufficient developing signal intensity can be generated at different imaging angles, avoiding blurry images or difficulty in identification due to the small size of the developing mark 17-3.

[0160] In some embodiments, the imaging marker 17-3 and the imaging protrusion 17-2 are staggered in the axial direction, and the circumferential interval angle between them can be set to 90° or 120°. Through the combination of the two, a dual position reference can be formed under fluoroscopic imaging. The surgeon can simultaneously observe the relative positional changes of the imaging marker 17-3 and the imaging protrusion 17-2, and jointly judge and verify the rotation direction and rotation angle of the first stop 15.

[0161] like Figure 20 In some embodiments, the external identification element 19 at the proximal end of the balloon catheter includes a three-way tailstock 19-1 and a label tube 19-2 arranged sequentially along the axial direction; wherein, the three-way tailstock 19-1 includes a guidewire port 19-1-1, a balloon inflation port 19-1-2 and an identification portion 19-1-3, the guidewire port 19-1-1 is connected to the inner tube 14, and the balloon inflation port 19-1-2 is connected to the fluid delivery chamber of the balloon body 12; the label tube 19-2 is provided with a plurality of circumferentially distributed alignment marks 19-2-1, the alignment marks 19-2-1 corresponding to the circumferential position of the alignment imaging element; the balloon inflation port 19-1-2 or the identification portion 19-1-3 of the three-way tailstock 19-1 has a circumferential alignment relationship with at least one of the alignment marks 19-2-1.

[0162] In some embodiments, the marking part 19-1-3 is configured as a radially raised structure on which the manufacturer information or model information of the delivery device can be printed, pasted, or laser-engraved, including parameters such as the size of the compatible artificial valve 4 and the applicable blood vessel diameter, so as to facilitate the surgeon to quickly select the model before the operation and avoid surgical delays or device incompatibility caused by incorrect model selection.

[0163] In some embodiments, the number of alignment marks 19-2-1 provided on the label tube 19-2 corresponds to the number of alignment imaging elements. When the alignment imaging element includes two imaging wires 17-1, two alignment marks 19-2-1 are preferably provided on the label tube 19-2; when the alignment imaging element includes three imaging wires 17-1, three alignment marks 19-2-1 are preferably provided on the label tube 19-2. The multiple alignment marks 19-2-1 are evenly distributed circumferentially along the label tube 19-2. When three alignment marks 19-2-1 are provided, the three alignment marks 19-2-1 are evenly arranged circumferentially at 120° intervals, respectively corresponding to the three coronary sinus positions of the human aortic valve; when two alignment marks 19-2-1 are provided, the two alignment marks 19-2-1 are arranged circumferentially at 90°, 120°, or 180° intervals, selected according to clinical operating habits and imaging requirements.

[0164] like Figures 20-22In some embodiments, multiple alignment markers 19-2-1 are distinguished by letters, numbers, or symbols to indicate different anatomical locations. In the text markings, "R" represents the right coronary sinus, "L" represents the left coronary sinus, and "N" represents the non-coronary sinus. For example, one alignment marker 19-2-1 is marked "LR," indicating the junction between the left and right coronary sinuses; another alignment marker 19-2-1 is marked "LN," indicating the junction between the left and non-coronary sinuses; and a third alignment marker 19-2-1 is marked "NR," indicating the junction between the non-coronary sinus and the right coronary sinus. This setup allows the surgeon to operate externally without complex spatial transformation calculations. By simply observing the direction of the alignment markers 19-2-1 on the label tube 19-2, the surgeon can directly determine the anatomical orientation of the in vivo alignment imaging element, thereby quickly determining the alignment relationship between the four leaflet junctions of the artificial valve and the junction of the native valve, significantly simplifying the operation process and shortening the surgical time.

[0165] In some embodiments, the balloon filling port 19-1-2 can be axially aligned with the alignment mark 19-2-1 marked "LN", and the marking part 19-1-3 is axially aligned between the alignment marks 19-2-1 marked "LR" and "NR". The three alignment marks 19-2-1 correspond axially with the alignment imaging elements on the first stop 15, so that the surgeon can infer the direction of the alignment imaging elements in the body by observing the marking direction of the external marker 19, thus realizing the external visualization operation.

[0166] like Figures 23-25 In some alternative embodiments, the multiple alignment identifiers 19-2-1 may also be labeled as “R”, “N”, and “L”, respectively, to indicate the circumferential positions of the center of the right coronary sinus, the center of the non-coronary sinus, and the center of the left coronary sinus.

[0167] In some embodiments, the outer tube 21 for controlling bending includes, in sequence along the axial direction, a bending section, a transition section, and a main body section. The hardness of the bending section, the transition section, and the main body section increases in the proximal direction. The bending section is located at the distal end of the outer tube 21 and is coaxially arranged with the outer tube 13. The inner wall of the bending section is provided with a traction wire for bending. The main body section is located at the proximal end of the outer tube 21 and is used to provide pushing support force. The transition section connects the bending section and the main body section and is used to achieve a transition in hardness.

[0168] In some embodiments, the bending section, transition section, and main body section are made of polymer materials with different hardnesses to achieve a gradual increase in hardness from the bending section to the main body section. The bending section is preferably made of PEBAX material with a hardness of 50D. This material has good bending flexibility and compliance, and can quickly respond and form the required bending angle when the operator applies tension through the traction wire. It is mainly used to adjust the direction of the delivery system head in the blood vessel, such as crossing the aortic arch or passing through the contralateral iliac ring and other complex anatomical paths. The main body section is preferably made of PEBAX material with a hardness of 70D. This material has high strength and high support, and can provide a stable pushing force for the entire delivery system of the delivery device, ensuring that the outer tube 13 can still maintain axial rigidity when subjected to external force compression or vascular tortuosity, and avoiding delivery failure or device positioning deviation due to deformation of the outer tube 13 under force.

[0169] In some embodiments, the transition section is located between the bending section and the main body section to achieve a hardness transition between the two sections, avoiding the risk of stress concentration and pipe fatigue fracture due to sudden hardness changes. The hardness of the transition section is between that of the bending section and the main body section, preferably using PEBAX material with a hardness of 55D to 65D, or achieving a hardness gradient transition through processes such as multi-layer composite structures and gradual wall thickness design.

[0170] The segmented stiffness distribution described above ensures that the bending control tube 21 maintains distal flexibility while ensuring sufficient pushing support rigidity at the proximal end, thus balancing the maneuverability and pushing stability of the delivery device in complex vascular pathways.

[0171] In some embodiments, at least one traction wire is fixedly disposed on the inner wall of the bending section. The traction wire extends axially along the bending section, with its proximal end extending to the proximal end of the bending control outer tube 21 and connecting to the bending control operating mechanism, and its distal end fixed at or near the distal end of the bending section. When the operator applies tension to the traction wire by operating the bending control operating mechanism, the traction wire contracts axially within the bending section, driving the bending section to bend along the circumferential position of the traction wire, thereby achieving active adjustment of the head direction of the conveying device. The traction wire is preferably made of materials such as stainless steel wire, nickel-titanium alloy wire, or high-strength polymer fiber to ensure that no plastic deformation or breakage occurs during repeated traction, maintaining stable bending performance.

[0172] like Figure 26 , Figure 27 In some embodiments, in order to solve the problem that the second stop 16 is fixed inside the balloon body 12 and cannot be adjusted, the second stop 16 in this embodiment is no longer set on the inner tube 14, but is set at the far end of the control tube 21, so as to achieve precise adjustment of the position of the artificial valve 4.

[0173] In some embodiments, the second stop 16 is integrally disposed on the distal outer surface of the bending control outer tube 21, and is coaxially configured and fixedly connected to the bending control outer tube 21. The second stop 16 can be fixed to the distal end of the bending control outer tube 21 by means of hot melt welding, adhesive bonding, or biocompatible medical adhesive bonding, ensuring that the second stop 16 and the bending control outer tube 21 form an integrated structure, and avoiding relative displacement or detachment during transportation.

[0174] To ensure the continuity of the directional indication function, in some embodiments, even if the second stop 16 is located at the far end of the control tube 21, it still has an alignment imaging element, which can be set as imaging wire 17-1. The number, circumferential distribution position and material selection of the imaging wire 17-1 are the same or similar to the imaging wire 17-1 configuration scheme on the first stop 15. Furthermore, the imaging wire 17-1 of the second stop 16 and the imaging wire 17-1 of the first stop 15 are consistent in the circumferential direction or have a specific angular relationship. By synchronously imaging the front and rear imaging wires 17-1 with the DSA device, a clear directional indication is provided for the planning of the delivery path and the adjustment of the rotation angle of the artificial valve 4, ensuring that the surgeon can grasp the position status of the artificial valve 4 in real time.

[0175] By fixing the second stop 16 to the bending control tube 21, the position adjustment operation is transmitted more directly and the response is faster. When the artificial valve 4 shifts during delivery due to differences in vascular anatomy, blood flow impact, or other factors, the surgeon can manipulate the bending control tube 21 to cause the connected second stop 16 to shift accordingly. If the valve shifts proximally, the bending control tube 21 can be pushed to push the second stop 16 distally, restoring the artificial valve 4 to the target position; if the artificial valve 4 shifts distally, the bending control tube 21 can be retracted, causing the second stop 16 to pull the artificial valve 4 proximally, achieving position correction. Through precise manipulation of the bending control tube 21, accurate adjustment of the valve release position can be achieved, reducing the risk of surgical complications caused by valve position deviation.

[0176] In some embodiments, the second stop 16 does not affect the normal expansion and contraction function of the balloon body 12. After the artificial valve 4 is positioned correctly, the balloon body 12 can be inflated and expanded normally to complete the implantation of the artificial valve 4. After the balloon body 12 retracts, the second stop 16 is withdrawn from the body along with the control tube 21. The entire operation is simple and efficient, meeting the operational requirements of minimally invasive surgery in clinical practice.

[0177] By configuring the second stop 16 at the distal end of the control tube 21, the active adjustment function of the artificial valve 4 after its internal displacement is realized. This solves the problem in the prior art that the artificial valve 4 cannot be corrected after displacement and can only be removed again or the positional deviation can be accepted. This significantly improves the flexibility and error tolerance of the surgical operation. At the same time, in conjunction with the alignment imaging element, it can also ensure that the direction indication function is not lost. Together with the first stop 15, it forms a dual guarantee of position adjustment and direction guidance, further improving the safety and accuracy of the surgical operation and reducing the risk of surgical complications caused by valve position deviation. It is suitable for surgical scenarios of patients with complex vascular anatomy and fast blood flow.

[0178] like Figure 28 In some embodiments, the bending control mechanism of the proximal handle includes a bending knob 31, a traction wire fixing member 32, and a bending control outer tube fixing member 33; the bending control outer tube fixing member 33 is fixedly connected to the proximal handle, and the proximal end of the bending control outer tube 21 is fixedly connected to the bending control outer tube fixing member 33; the bending knob 31 is rotatably disposed on the proximal handle, the traction wire fixing member 32 is threadedly connected to the bending knob 31, and the proximal end of the traction wire is fixedly connected to the traction wire fixing member 32; by rotating the bending knob 31, the traction wire fixing member 32 can be driven to move relative to the bending control outer tube fixing member 33, so as to tighten or release the traction wire and control the bending degree of the bending section.

[0179] In some embodiments, the proximal handle further includes a three-way stopcock 37 and a vent pipe 38; one end of the vent pipe 38 is connected to the control bend outer tube fixing member 33, and the other end is connected to the three-way stopcock 37; the three-way stopcock 37 is used to inject liquid into the annular gap between the control bend outer tube 21 and the outer tube 13 to discharge the gas in the annular gap.

[0180] In some embodiments, the position adjustment mechanism of the proximal handle includes a fine-tuning knob 34 and a fine-tuning scale 35; the fine-tuning knob 34 is rotatably disposed on the proximal handle, the fine-tuning knob 34 and the fine-tuning scale 35 are connected by a threaded drive, and the fine-tuning scale 35 can be selectively connected to the outer tube 13; by rotating the fine-tuning knob 34, the fine-tuning scale 35 can be driven to move axially, thereby driving the balloon catheter to adjust its axial position relative to the control tube 21.

[0181] In some embodiments, the position adjustment structure further includes a catheter locking knob 36; the catheter locking knob 36 is connected to the fine-tuning scale 35 in a transmission manner. By rotating the catheter locking knob 36, the fine-tuning scale 35 can be radially clamped to the outer tube 13, so as to realize the connection and fixation between the fine-tuning scale 35 and the outer tube 13, and lock the relative position of the balloon catheter and the control tube 21.

[0182] Specifically, the position adjustment mechanism has two operating modes, which are suitable for position adjustment scenarios with different accuracy requirements.

[0183] When the catheter locking knob 36 is in the released position, the fine-tuning scale 35 does not apply radial clamping force to the outer tube 13. At this time, the balloon catheter and the bend-controlled outer tube 21 are in a relatively free sliding state. The surgeon can directly adjust the axial displacement of the balloon catheter relative to the bend-controlled outer tube 21 by manually pushing or pulling the balloon catheter. This operating mode is suitable for the initial stage of pushing the delivery device into the body or for scenarios that require rapid adjustment of the valve position. The surgeon can quickly push the artificial valve 4 to the vicinity of the target area based on real-time feedback from DSA images, achieving coarse adjustment of the valve position, significantly shortening the operation time and improving the operation efficiency.

[0184] After the balloon catheter is adjusted to near the target release area through large-scale pushing or pulling, the operator needs to make precise fine adjustments to the position of the artificial valve 4 to ensure accurate alignment of the valve with the target implantation location, such as the aortic or mitral valve annulus. At this time, the operator rotates the catheter locking knob 36, causing the fine-tuning scale 35 to apply radial clamping force to the outer tube 13. The clamping structure inside the fine-tuning scale 35 forms a uniform radial pressure on the outer surface of the outer tube 13, achieving a fixed connection between the fine-tuning scale 35 and the outer tube 13, locking the relative position of the balloon catheter and the bending control outer tube 21. In the locked state, the balloon catheter cannot be moved significantly by manual pushing or pulling. The operator needs to rotate the fine-tuning knob 34, utilizing the threaded transmission mechanism between the fine-tuning knob 34 and the fine-tuning scale 35 to drive the fine-tuning scale 35 to make precise axial displacement.

[0185] In some embodiments, the threaded transmission mechanism between the fine-tuning knob 34 and the fine-tuning scale member 35 adopts a fine-threaded fit structure, with the thread lead set at the millimeter level. This ensures that for each rotation of the fine-tuning knob 34, the fine-tuning scale member 35 moves axially by a distance at the millimeter level, achieving precise fine-tuning of the balloon catheter position. Preferably, a scale mark is provided on the outer surface or side of the fine-tuning scale member 35, with the scale interval corresponding to the axial displacement of the fine-tuning scale member 35. The surgeon can intuitively grasp the axial displacement of the balloon catheter caused by each rotation of the fine-tuning knob 34 according to the scale mark, avoiding over-adjustment or displacement of the artificial valve 4 position due to excessive adjustment. Through this structure, the surgeon's rotation operation can be converted into millimeter-level axial displacement of the balloon catheter, driving the artificial valve 4 to perform precise fine-tuning within the target release area. This solves the problem that traditional coarse pushing or manual adjustment methods cannot achieve precise positioning and are prone to positional deviation, significantly improving the accuracy and repeatability of the artificial valve 4 implantation position.

[0186] Furthermore, the locking function of the catheter locking knob 36 also provides protection against accidental displacement of the balloon catheter during surgery. During transcatheter valve implantation surgery, the surgeon needs to operate multiple control mechanisms on the proximal handle simultaneously, creating a complex operating environment. There is a risk that the surgeon or assistant may accidentally touch the balloon catheter, leading to unintended axial displacement. After the outer tube 13 is radially clamped and locked by the catheter locking knob 36, a stable and fixed connection is formed between the balloon catheter and the bend-controlled outer tube 21. Even under slight external pushing or pulling forces or disturbances, the axial position of the balloon catheter remains stable and will not shift.

[0187] This invention also provides an operating method based on the aforementioned artificial valve delivery device to achieve precise alignment between the artificial valve 4 and the native valve. In this embodiment, the alignment imaging element is configured as two imaging filaments 17-1, which are disposed on the first fixed section 15-2 of the first stop 15, arranged at circumferential intervals of 90° or 120°. The two imaging filaments 17-1 have different axial lengths and are distributed in a gradient along the axial direction. The artificial valve 4 is loaded in a compressed state on the outside of the balloon body 12. The inflow end of the artificial valve 4 is disposed adjacent to the first stop 15, and the clamp 41 at the leaflet junction of the artificial valve 4 has a circumferential positional correspondence with the alignment imaging element.

[0188] Step 1: Insert the artificial valve 4 along the axial direction of the balloon body 12, so that the outflow end of the artificial valve 4 is in close contact with the second stop 16, ensuring that the artificial valve 4 has no axial displacement space during delivery; by observing the imaging points 18 on the inner tube 14, adjust the axial position of the artificial valve 4 so that the entire artificial valve 4 is completely within the imaging points 18 used to mark the compression area of ​​the artificial valve 4.

[0189] like Figure 29 , Figure 30 When six imaging points 18 are provided on the inner tube 14, the axial range of the artificial valve 4 should be located between the imaging point 18 at the farthest end and the imaging point 18 at the far end of the adjacent second stop 16. This area is the optimal expansion section of the balloon body 12, ensuring that the radial force is uniform when the artificial valve 4 is released.

[0190] After completing the axial positioning, perform the initial circumferential adjustment by rotating the artificial valve 4 and adjusting the relative circumferential angle between the clamp 41 of the artificial valve 4 and the two developing wires 17-1, so that the clamp 41 and the developing wires 17-1 form a preliminary positional association, reducing the amount of adjustment required for subsequent rotation and alignment.

[0191] Step 2: In this step, the artificial valve 4 is compressed and fixed onto the balloon body 12 using two standardized alignment methods, ensuring that the leaflet junction of the artificial valve 4 and the alignment imaging element form a preset circumferential positional correspondence.

[0192] like Figure 31 The first alignment method is to directly align the clip 41 at the junction of the leaflets with the developing wire 17-1.

[0193] Specifically, during the operation, the artificial valve 4 is rotated to ensure that any two clips 41 on the artificial valve 4 are precisely aligned circumferentially with the two radiopaque wires 17-1, meaning that the central axis of the clips 41 and the central axis of the radiopaque wires 17-1 are completely coincident, with a circumferential deviation of no more than 5°. Then, a special compression device is used to uniformly compress the artificial valve 4 onto the balloon body 12. After compression, the outer diameter of the artificial valve 4 is controlled at 8-12 mm, adapted according to the patient's blood vessel diameter. During the compression process, it is ensured that the artificial valve 4 does not shift circumferentially, maintaining the preset positional relationship between the leaflet junction and the radiopaque wires 17-1.

[0194] like Figure 32 The second alignment method is to align the clip 41 at the junction of the leaflets with the middle position of the two developing wires 17-1.

[0195] Specifically, during operation, the artificial valve 4 is rotated so that any one of the clips 41 on the artificial valve 4 is aligned with the circumferential midpoint of the two developing wires 17-1, meaning that the circumferential distance from the clip 41 to the two developing wires 17-1 is equal, and the circumferential deviation is no greater than 5°. The same compression equipment is used to complete the compression and fixation of the artificial valve 4, ensuring that the circumferential positional relationship between the clip 41 and the developing wires 17-1 remains stable during the compression process.

[0196] In this embodiment, the specific alignment method is no longer limited. The surgeon can choose according to the anatomical structure of the patient's original valve, vascular conditions, and clinical operating habits. Both alignment methods can achieve precise alignment of the artificial valve 4 with the original valve.

[0197] Step 3: Under the guidance of the guidewire, the surgeon holds the proximal handle and pushes the delivery device. Under the real-time monitoring of the DSA fluoroscopic imaging equipment, the balloon body 12 loaded with the compressed artificial valve 4 passes through the femoral artery and aorta in sequence, and finally reaches the patient's original aortic valve annulus.

[0198] During delivery, if a curved path is encountered, such as when passing through the aortic arch, the operator can adjust the path by operating the bending control mechanism on the proximal handle. Specifically, rotating the bending knob 31 drives the traction wire fixation member 32 to move relative to the bending control external tube fixation member 33, causing the traction wire to tighten or release, thereby controlling the degree of bending of the adjustment segment. The operator can observe the degree of bending through the scale indicator window 39 further provided on the proximal handle to ensure that the delivery device passes smoothly through the curved section of the blood vessel. The rotation direction of the bending knob 31 corresponds to the bending direction of the adjustment segment. When the bending knob 31 is rotated clockwise, the traction wire is tightened, and the adjustment segment bends in the set direction; when the bending knob 31 is rotated counterclockwise, the traction wire is released, and the adjustment segment returns to a relatively straight state.

[0199] Once the balloon body 12 reaches the native aortic valve annulus, the DSA fluoroscopic imaging device is adjusted to a preset standard imaging angle based on the anatomical structure of the patient's native aortic sinuses. There are two standard imaging angles: the first is a centered view of the right coronary sinus, in which the imaging direction places the right coronary sinus in the center of the fluoroscopic image, with the left coronary sinus and the non-coronary sinus located on either side of the image. This view facilitates observation of the relative positions of the native aortic sinuses and the imaging elements. The second is an overlapping view of the left and right coronary sinuses, in which the imaging direction overlaps the projections of the left and right coronary sinuses, with the non-coronary sinus displayed separately in the fluoroscopic image. This view is suitable for patients with asymmetrical native aortic sinus anatomy.

[0200] In this step, the fluoroscopic imaging angle should be adjusted to ensure that the guide wire, alignment imaging element, and native valve sinus are all clearly visible in the fluoroscopic image, providing a visual reference for subsequent rotation alignment operations.

[0201] Step Four: In this step, based on the alignment method set in Step Two, the circumferential direction of the artificial valve 4 is adjusted using a rotating delivery device to achieve precise alignment between the leaflet junction of the artificial valve 4 and the leaflet junction of the native valve. The rotation is performed via the proximal handle. When the surgeon rotates the proximal handle, the proximal handle, balloon catheter, artificial valve 4, and alignment imaging element rotate synchronously. Under fluoroscopic imaging, the relative positions of the alignment imaging element, guide wire, and native valve sinus change. The surgeon observes the projected position of the alignment imaging element to determine the direction and angle of rotation, thereby confirming whether the artificial valve 4 has reached the target alignment state. Since there are two optional alignment schemes for the imaging wire 17-1 and the clip 41, there are also two corresponding alignment operation methods during the procedure.

[0202] In the first alignment method, the clip 41 of the artificial valve 4 is directly aligned with the two imaging wires 17-1. The specific operation of the rotation alignment under the two standard imaging angles is as follows:

[0203] like Figure 35 and Figure 36 With the right coronary sinus centered in the view, the surgeon rotates the proximal handle, causing the delivery device to rotate, and observes the projection relationship between the two imaging wires 17-1 and the guide wire. Initially, when the projection of the longer imaging wire 17-1 overlaps with the guide wire, and the shorter imaging wire 17-1 is located to the right of the guide wire's projection, as shown... Figure 35 This state indicates that the longer imaging wire 17-1 is located in front of the guide wire. At this time, the leaflet junction and clip 41 of the artificial valve 4 are located in the middle of the original leaflet. If the artificial valve 4 is dilated in this state, the leaflet junction will obstruct the coronary artery opening. This state is a non-target state. The operator continues to rotate the delivery device, judging the rotation direction based on the movement direction of the imaging wire 17-1 projection. When the longer imaging wire 17-1 is still overlapping with the guide wire projection, and the shorter imaging wire 17-1 is switched to the left side of the guide wire projection, such as... Figure 36 This state indicates that the longer imaging wire 17-1 is located behind the guide wire. At this time, the leaflet junction of the artificial valve 4 and the clip 41 are completely aligned with the leaflet junction of the original valve. This state is the target state.

[0204] like Figure 37 Under the overlapping view of the left and right coronary sinuses, the surgeon rotates the delivery device to observe the projection relationship of the two imaging wires 17-1. When the projections of the two imaging wires 17-1 completely overlap, and the overlapping projection of the imaging wire 17-1 is located to the left of the guide wire projection, this state indicates that the leaflet junction of the artificial valve 4 is precisely aligned with the leaflet junction of the original valve, and this state is the target state.

[0205] In the second alignment method, the clip 41 of the artificial valve 4 is aligned with the middle position of the two imaging wires 17-1. The specific operation of the rotation alignment under the two standard imaging angles is as follows:

[0206] like Figure 38 Figure 39 In a centrally located view of the right coronary sinus, initially, when the longer imaging wire 17-1 overlaps with the projection of the guide wire, and the shorter imaging wire 17-1 is located to the left of the guide wire's projection, as shown... Figure 38 This state indicates that the longer imaging wire 17-1 is located behind the guide wire. At this time, the leaflet junction of the artificial valve 4 is located in the middle of the native leaflet. If the artificial valve 4 is dilated in this state, the leaflet junction will obstruct the coronary artery opening; this is a non-target state. The operator continues to rotate the delivery device. When the longer imaging wire 17-1 still overlaps with the guide wire projection, and the shorter imaging wire 17-1 switches to the right side of the guide wire projection, as... Figure 39This state indicates that the longer imaging wire 17-1 is located in front of the guide wire, and at this time the leaflet junction of the artificial valve 4 is completely aligned with the leaflet junction of the original valve. This state is the target state.

[0207] like Figure 40 In the overlapping view of the left and right coronary sinuses, the surgeon rotates the delivery device. When the projections of the two imaging wires 17-1 completely overlap and the overlapping projection of the imaging wire 17-1 is located to the right of the guide wire projection, this state indicates that the leaflet junction of the artificial valve 4 is precisely aligned with the leaflet junction of the original valve. This state is the target state.

[0208] In both alignment scenarios described above, the operator can use the external marker 19 to assist in determining the rotation direction. Specifically, since the alignment mark 19-2-1 on the label tube 19-2 corresponds to the circumferential position of the alignment imaging element, the operator can simultaneously observe the directional change of the alignment mark 19-2-1 on the label tube 19-2 while rotating the proximal handle. Combined with the projection position of the alignment imaging element under DSA fluoroscopy imaging, the operator can comprehensively determine the rotation angle and direction of the delivery device, thereby improving the accuracy and efficiency of the rotation alignment operation.

[0209] After confirming that the artificial valve 4 has reached the target alignment, the operator should use the position adjustment mechanism to make a final confirmation and fine adjustment to the axial position of the balloon catheter to ensure that the axial positional relationship between the artificial valve 4 and the original valve annulus meets the release requirements. Then, the relative position of the balloon catheter and the control tube 21 is locked by the catheter locking knob 36 to prevent the artificial valve 4 from shifting due to accidental contact during subsequent operations and to ensure alignment accuracy.

[0210] Step 5: After confirming that the artificial valve 4 is aligned to the target state and that the relative positions of the balloon catheter and the control tube 21 are locked by the catheter locking knob 36, the operator connects the inflation device through the balloon inflation port 19-1-2 of the three-way endplate 19-1 and injects filling fluid into the fluid delivery chamber between the balloon body 12 and the outer tube 13. The filling fluid is preferably a mixture of contrast agent and normal saline. The mixing ratio is adjusted according to the clarity requirements of DSA fluoroscopic imaging. The volume of the filling fluid is adapted according to the specifications and size of the artificial valve 4, and is usually selected as 5~10ml.

[0211] After the filling fluid is injected into the fluid delivery chamber, it flows along the gap between the outer tube 13 and the inner tube 14, passes through the fluid channel formed between adjacent first protrusions in the first limiting section 15-1 of the first stop 15, and reaches the distal region of the balloon body 12, driving the balloon body 12 to expand uniformly. During the expansion of the balloon body 12, the eight folding wings unfold synchronously, radially pushing the compressed artificial valve 4 to expand outward, so that the artificial valve 4 gradually detaches from the surface of the balloon body 12 and anchors at the original valve annulus position.

[0212] During the inflation of the balloon body 12, the operator should observe the expansion status of the artificial valve 4 under DSA fluoroscopic imaging monitoring to confirm that the artificial valve 4 is fully expanded, the leaflets are open normally and there is no obvious stenosis. At the same time, it should be confirmed that the leaflet junction of the artificial valve 4 is precisely aligned with the leaflet junction of the native valve, with a circumferential deviation of no more than 10°. The patient's coronary artery ostium is not obstructed by the artificial valve 4 at this time, and the hemodynamic parameters meet the clinical requirements, including transvalvular pressure gradient, effective valve orifice area and other parameters are within the normal range.

[0213] After confirming that the artificial valve 4 was accurately positioned and functioning properly, the surgeon used the inflation device to depressurize the balloon body 12, emptying the fluid inside and restoring it to its compressed, folded state. Subsequently, the balloon catheter, the bend-controlled outer cannula 21, and the guidewire were withdrawn sequentially, completely removing the delivery device from the patient's body, thus completing the transcatheter aortic valve replacement surgery.

[0214] The operation method of the artificial valve delivery device based on the above-mentioned two developing wires 17-1 has at least the following advantages:

[0215] The standardized operating procedure of five steps—preloading, compression, pushing, alignment, and release—eliminates the high dependence on the surgeon's clinical experience, reduces the difficulty of surgical operation, ensures that different surgeons can achieve consistent alignment results, and improves the success rate and repeatability of the surgery.

[0216] Based on the structure of the two imaging wires 17-1 and the combination of two standard fluoroscopic imaging angles, the surgeon can intuitively judge the alignment status of the artificial valve 4 by observing the relative position of the imaging wires 17-1, the guide wire, and the original valve sinus. This eliminates the need to repeatedly adjust the fluoroscopic angle or rely on complex spatial transformation calculations, significantly shortening the operation time and reducing the patient's radiation exposure.

[0217] The two compression alignment methods can be adapted to the original valve sinuses with different anatomical structures. Regardless of whether the patient's valve sinus anatomy is symmetrical, the surgeon can choose the appropriate alignment method to complete the precise alignment, which expands the scope of clinical application and is suitable for more types of patients.

[0218] By aligning the imaging elements and monitoring the alignment status in real time, the risk of the artificial valve 4 obstructing the coronary artery opening can be effectively avoided, reducing the incidence of intraoperative complications. At the same time, by establishing the positional correspondence between the external marker 19 and the internal imaging elements, external visualization operation is achieved, further improving the safety and accuracy of the operation.

[0219] With the position adjustment mechanism of the proximal handle, the operator can make millimeter-level precise fine adjustments to the axial position of the balloon catheter after alignment, so as to ensure that the relative position of the artificial valve 4 and the original valve annulus reaches the optimal release state, avoid complications such as paravalvular leakage caused by positional deviation, and ensure the stability of postoperative hemodynamics and long-term efficacy for patients.

[0220] In some embodiments, the alignment developing element includes three developing filaments 17-1, which are uniformly distributed circumferentially along the first stop 15. The axial lengths of the three developing filaments 17-1 are set to different dimensions, with one developing filament 17-1 being the longest and the other two developing filaments 17-1 being relatively shorter. The three developing filaments 17-1 are distributed in a gradient along the axial direction. The alignment method based on the three alignment developing filaments 17-1 is basically the same as steps one, two, three, and five of the aforementioned dual developing filaments 17-1 method. The main difference lies in the rotation alignment operation in step four.

[0221] like Figure 41 In the first alignment method, with the right coronary sinus centered, the surgeon rotates the proximal handle to rotate the delivery device and observes the projection relationship between the three imaging wires 17-1 and the guide wire. When the longest radiopaque wire 17-1 overlaps with the projection of the guide wire, and the two shorter radiopaque wires 17-1 are located on either side of the guide wire projection, with the radiopaque wire 17-1 on the left side of the guide wire projection positioned higher than the radiopaque wire 17-1 on the right side of the guide wire projection in the fluoroscopic view, this state indicates that the longest radiopaque wire 17-1 is in front of the guide wire, and the leaflet junction of the artificial valve is located in the middle of the native leaflet. This state is the non-target state. The surgeon continues to rotate the delivery device. When the longest radiopaque wire 17-1 still overlaps with the guide wire projection, and the two shorter radiopaque wires 17-1 are located on either side of the guide wire projection, with the radiopaque wire 17-1 on the right side of the guide wire projection positioned higher than the radiopaque wire 17-1 on the left side of the guide wire projection in the fluoroscopic view, this state indicates that the longest radiopaque wire 17-1 is behind the guide wire, and the leaflet junction of the artificial valve is perfectly aligned with the leaflet junction of the native valve. This state is the target state.

[0222] like Figure 42 In the first alignment method, under the overlapping view of the left and right coronary sinuses, the surgeon rotates the delivery device. When the projections of the two shorter imaging wires 17-1 are located to the left of the guide wire projection, and the projections of the two imaging wires 17-1 overlap to form a straight line, while the projection of the longest imaging wire 17-1 is located to the right of the guide wire projection, this state indicates that the leaflet junction of the artificial valve and the leaflet junction of the original valve have been precisely aligned, and this state is the target state.

[0223] Compared to the two-wire 17-1 approach, the three-wire 17-1 approach can present richer positional information and directional indication features under fluoroscopic imaging, significantly improving the surgeon's accuracy in recognizing the posture of the delivery device. It is particularly suitable for clinical scenarios with complex anatomical structures or requiring high-precision alignment.

[0224] like Figure 29 , Figure 30 In one embodiment of the present invention, an artificial valve delivery system is also provided, including the artificial valve delivery device described in the above embodiment, and further including an artificial valve 4; the artificial valve 4 is loaded in a compressed state on the outside of the balloon body 12, the inflow end of the artificial valve 4 is disposed adjacent to the first baffle 15, and the leaflet junction of the artificial valve 4 has a circumferential positional correspondence with the alignment imaging element.

[0225] In this embodiment, the artificial valve 4 is preferably an artificial aortic valve, the main structure of which includes a mesh-like valve stent and leaflets that can be expanded by the balloon body 12. In the compressed state, the outer diameter of the artificial valve 4 matches the outer diameter of the balloon body 12 in its compressed and folded state, ensuring that the delivery device can smoothly pass through the patient's blood vessels. During the inflation and expansion of the balloon body 12, the artificial valve 4 expands synchronously with the balloon body 12, and the radial expansion force of the valve stent anchors it at the original valve annulus position, completing the valve implantation. In this embodiment, the specific structural form and related specifications of the artificial valve are not limited; those skilled in the art can make adaptive selections or adjustments according to clinical application needs and the patient's actual situation.

[0226] refer to Figure 43 , Figure 44 In some embodiments, the plurality of imaging points 18 on the inner tube 14 include a first imaging point 18-1 and a plurality of release prediction imaging points. The first imaging point 18-1 is located at the proximal end of the first stop 15 and is used to mark the distal boundary of the compression area of ​​the balloon body 12. The plurality of release prediction imaging points are located at the proximal end of the first imaging point 18-1 and are arranged sequentially along the axial direction. There is a preset axial spacing relationship between adjacent release prediction imaging points. The axial position of the release prediction imaging point is configured such that when the artificial valve 4 expands from the compressed state to the released state, there is an axial position of the release prediction imaging point that corresponds to the position of the clip 41 at the upper edge of the leaflet or the leaflet junction after the artificial valve 4 has expanded, so as to realize the preoperative visual prediction of the height position of the artificial valve 4 after release under fluoroscopic imaging.

[0227] In some embodiments, the plurality of release prediction imaging points include at least a second imaging point 18-2, a third imaging point 18-3, and a fourth imaging point 18-4, which are arranged sequentially along the axial direction; wherein, the axial distance between the second imaging point 18-2 and the first imaging point 18-1 is A, the axial distance between the third imaging point 18-3 and the second imaging point 18-2 is B, and the axial distance between the fourth imaging point 18-4 and the third imaging point 18-3 is C; the axial distances A, B, and C are set according to the axial length of the artificial valve 4 in the compressed state, the expansion characteristics of the balloon body 12, and the height of the leaflet after the artificial valve 4 expands, such that:

[0228] When the artificial valve 4 is loaded in the first compressed position, the second imaging point 18-2 is located at the upper edge of the leaflet after the artificial valve 4 has expanded, such as... Figure 43 ;

[0229] Alternatively, when the artificial valve 4 is loaded in the second compression position, the fourth imaging point 18-4 is located at the upper edge of the leaflet after the artificial valve 4 has expanded, such as... Figure 44 .

[0230] Specifically, the first compression posture and the second compression posture correspond to different loading directions of the artificial valve 4. In the first compression posture, the inflow end is loaded towards the first baffle 15; in the second compression posture, the outflow end is loaded towards the first baffle 15.

[0231] With the above-described imaging point configuration scheme, the artificial valve delivery device of this embodiment has the following significant advantages during intraoperative operation:

[0232] First, before the balloon body 12 is inflated, the operator can use fluoroscopic imaging equipment such as DSA to observe the relative positional relationship between the target release prediction imaging point (such as the second imaging point 18-2 or the fourth imaging point 18-4) and the original coronary artery opening. This allows the operator to predict in advance whether the upper edge of the leaflet or the clip 41 will obstruct the coronary artery opening after the artificial valve 4 is released at the current position. Thus, a visual assessment of the risk of coronary artery obstruction can be completed before the valve is actually released, without relying on the operator's experience to estimate or repeatedly try to release the valve.

[0233] Secondly, during the expansion of the balloon body 12, the surgeon can monitor the overlap between the target release prediction imaging point and the original valve annulus plane in real time. By finely adjusting the axial push or pull position of the balloon catheter, the surgeon can ensure that the implantation height of the artificial valve 4 meets the precise positioning requirements of neither being too high to obstruct the coronary artery nor too low to cause paravalvular leakage.

[0234] Furthermore, for patients requiring coronary intervention, the operator can observe the distance between the target release point and the coronary ostium before release to predict whether sufficient operating space is reserved above the coronary ostium after valve implantation. This ensures that during subsequent percutaneous coronary intervention (PCI) and other treatments, the guidewire and catheter can smoothly pass through the mesh or stent gap of the artificial valve 4 to enter the coronary artery, avoiding obstruction of the coronary access due to excessively high valve implantation position. This ensures both the safety of the current valve replacement surgery and the long-term treatability of the patient's coronary artery disease. Although exemplary embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above exemplary embodiments are merely illustrative and are not intended to limit the scope of this application. Various changes and modifications can be made therein by those skilled in the art without departing from the scope and spirit of this application. All such changes and modifications are intended to be included within the scope of this application as claimed in the appended claims.

Claims

1. An artificial valve delivery device, characterized in that, Includes balloon catheter, bend-controlled outer tube, and proximal handle; The balloon catheter includes a balloon body, a first stop, and at least two alignment imaging elements. The first stop is disposed at the distal end of the balloon body to limit the compression of the artificial valve. The alignment imaging elements are disposed on the first stop, and a plurality of the alignment imaging elements are distributed circumferentially. At least some of the alignment imaging elements differ in at least one of axial length, shape, or circumferential position to form orientation identification features under fluoroscopic imaging to indicate the rotation direction of the delivery device. The proximal end of the balloon catheter is provided with an external marker, which includes a plurality of circumferentially distributed alignment markers, and the alignment markers correspond to the alignment imaging elements. The control tube is axially movable and sleeved on the outside of the balloon catheter, and includes at least a bendable adjustment section; The proximal handle is connected to the proximal ends of the balloon catheter and the bend-controlled outer tube, and includes a bend control mechanism and a position adjustment mechanism. The bend control mechanism is used to control the bending of the bend-controlled section, and the position adjustment mechanism is used to adjust the axial position of the balloon catheter relative to the bend-controlled outer tube.

2. The artificial valve delivery device according to claim 1, characterized in that, The first stop member includes, in sequence along the axial direction, a first limiting section, a first fixing section, and a connecting section; The first limiting segment is disposed at the proximal end of the first stop and includes a plurality of first protrusions distributed circumferentially. The plurality of first protrusions are used to cooperate circumferentially with the compressed artificial valve to achieve circumferential limiting. The first fixing section is provided with an injection port, which is used to inject adhesive material to fix the first stop to the balloon catheter; The connecting segment is located at the distal end of the first stop and is used for a sealed connection with the balloon body.

3. The artificial valve delivery device according to claim 2, characterized in that, The alignment developing element includes at least two developing wires, which are disposed in the first fixed section and / or the first limiting section, and at least one of the developing wires has a circumferential positional correspondence with the first protrusion; Multiple developing filaments are distributed circumferentially, and at least some of the developing filaments have different axial lengths to form orientation recognition features under perspective imaging; The multiple developing wires are distributed in a gradient along the axial direction to avoid overlapping projections during fluoroscopic imaging.

4. The artificial valve delivery device according to claim 3, characterized in that, The first fixing section and / or the first limiting section are provided with developing wire grooves. The developing wires are inserted into the developing wire grooves by interference fit and fixed by adhesive material. The outer surface of the developing wire is covered with a protective film, which is fixedly connected to the first fixing segment and / or the first limiting segment.

5. The artificial valve delivery device according to claim 3, characterized in that, The developing filament is configured in a shape that is at least one of filament, geometric shape, number or letter; Multiple developing wires are arranged at equal or unequal intervals along the circumference.

6. The artificial valve delivery device according to claim 2, characterized in that, The first stop is made of a non-transparent material; The alignment developing element includes a developing protrusion that protrudes radially and is disposed between the first fixed section and the connecting section; the developing protrusion and the first stop form a perspective imaging contrast to achieve a dual developing feature.

7. The artificial valve delivery device according to claim 6, characterized in that, The shape of the developing protrusion includes at least one of rectangle, semicircle, and notched polygon, and the edges of the developing protrusion are provided with rounded corner transitions.

8. The artificial valve delivery device according to claim 6, characterized in that, There is an annular transition groove between the first fixed section and the connecting section, and the developing protrusion is disposed in the transition groove. The height of the developing protrusion is not higher than the maximum outer diameter of the first stop.

9. The artificial valve delivery device according to claim 6, characterized in that, The developing protrusions are provided in at least two locations, and adjacent developing protrusions are arranged at equal or unequal intervals along the circumference.

10. The artificial valve delivery device according to claim 6, characterized in that, The alignment developing element further includes a developing mark disposed on the first fixed segment. Both the developing mark and the developing protrusion form a perspective imaging contrast with the first stop to achieve dual developing features.

11. The artificial valve delivery device according to claim 10, characterized in that, The developing marks and the developing protrusions are staggered in the axial direction.

12. The artificial valve delivery device according to claim 10, characterized in that, The first fixed section is provided with a developing point groove, and the developing mark is inserted into the developing point groove by interference fit and fixed by adhesive material; the shape of the developing mark is configured as at least one of geometric shape, number or letter.

13. The artificial valve delivery device according to claim 2, characterized in that, It also includes a second stop, which is disposed on the inner tube of the balloon catheter or at the distal end of the control tube, for axially cooperating with the first stop to bidirectionally limit the artificial valve in a compressed state through axial and circumferential restraint.

14. The artificial valve delivery device according to claim 13, characterized in that, The second stop includes, along the axial direction, a second limiting section and a second fixing section in sequence; The second limiting segment is located at the far end of the second stop and includes multiple second protrusions distributed circumferentially. The second protrusions correspond one-to-one with the first protrusions axially and are used to circumferentially limit the artificial valve in the compressed state. The second fixing section is used to fix it to the outer surface of the inner tube or the far end of the control-bend outer tube.

15. The artificial valve delivery device according to claim 14, characterized in that, The second stop is also provided with the alignment developing element, and the alignment developing element on the second stop is arranged in a circumferential direction corresponding to or staggered with the alignment developing element on the first stop.

16. The artificial valve delivery device according to claim 2, characterized in that, The first limiting segment has a conical structure, including a small-diameter end at the distal end and a large-diameter end at the proximal end. The small-diameter end is connected to the first fixing segment, and the large-diameter end is provided with an opening. The cross-section of the first limiting segment is configured as an orthogonal star polygon, and multiple corners of the orthogonal star polygon are used to form the first protrusion. The first protrusion is also used to contact the balloon body in the compressed and folded state. The gap between adjacent first protrusions is used to form a fluid channel for the balloon body during the inflation process.

17. The artificial valve delivery device according to claim 1, characterized in that, The balloon catheter also includes an inner tube and an outer tube, with the gap between them configured as a fluid delivery chamber for the balloon body; the external identification device includes a three-way tailstock and a tag tube arranged sequentially along the axial direction at the proximal end of the balloon catheter. The three-way tailstock includes a guidewire port, a balloon inflation port, and a marking section. The guidewire port is connected to the inner tube, and the balloon inflation port is connected to the fluid delivery chamber. The label tube is provided with a plurality of alignment marks distributed circumferentially, and the alignment marks correspond to the circumferential position of the alignment imaging element; the balloon filling port of the three-way tail seat or the marking part has a circumferential alignment relationship with at least one of the alignment marks.

18. An artificial valve delivery system, characterized in that, The device includes the artificial valve delivery device as described in any one of claims 1-17, and further includes an artificial valve; The artificial valve is loaded in a compressed state on the outside of the balloon body. The inflow end of the artificial valve is located adjacent to the first baffle. The leaflet junction of the artificial valve has a circumferential positional correspondence with the alignment imaging element.

19. The artificial valve delivery system according to claim 18, characterized in that, The inner tube of the balloon catheter has multiple contrast points along the axial direction, and the multiple contrast points include at least: The first imaging point is located at the proximal end of the first stop and is used to mark the distal boundary of the compression area of ​​the balloon body. Multiple release prediction development points are set near the first development point and arranged sequentially along the axial direction, with a preset axial spacing relationship between adjacent release prediction development points; The axial position of the release prediction imaging point is configured such that when the artificial valve expands from the compressed state to the released state, there is an axial position of the release prediction imaging point that corresponds to the clamping position at the upper edge of the leaflet or the junction of the leaflet after the artificial valve expands, which is used to predict the height position of the artificial valve after release under fluoroscopic imaging.

Images