Interventional system for facilitating rotation

Abstract

The application discloses an intervention system convenient to rotate, which comprises an intervention delivery system and an artificial implant loaded on the intervention delivery system; the artificial implant is an aortic valve with a first mark; the intervention delivery system comprises a catheter assembly for delivering the artificial implant and a control handle for controlling the catheter assembly; the catheter assembly comprises an outer sheath, an inner shaft, and a balloon body; the inner shaft is rotatably arranged in the outer sheath and axially slidably matched with the outer sheath; the aortic valve is radially compressed and arranged on the outer periphery of the balloon body; the intervention delivery system is provided with a third mark; when the artificial implant is loaded on the intervention delivery system, the rotation range between the inner shaft and the outer sheath is adjusted through the first mark and the third mark to match the deviation information. The intervention system convenient to rotate can improve positioning accuracy and is convenient to operate.

Description

[0001] This application is a divisional application. The original application has the application number "202310621086.9", the application date is "May 30, 2023", and the invention title is "Intervention System for Easy Rotation". Technical Field

[0002] This application relates to the field of medical device technology, and in particular to an interventional system that is easy to rotate. Background Technology

[0003] Transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement (TAVR), involves inserting a catheter through the femoral artery to deliver an artificial heart valve to the aortic valve area, thereby restoring valve function. This procedure does not require open-chest surgery, resulting in minimal trauma and rapid recovery. It should be performed by experienced cardiologists and surgeons.

[0004] See Figures 1 to 2c Taking the aortic valve 100 as an example, the human aortic valve 100 consists of three leaflets 110. Adjacent leaflets 110 form commissures 120, namely commissures 120a, commissures 120b, and commissures 120c. Behind each leaflet 110, the aortic wall bulges outward, forming the aortic sinuses. Two of the three aortic sinuses give rise to coronary arteries, hence named the left coronary sinus (LCC) and right coronary sinus (RCC), while the third is the non-coronary sinus (NCC). The two coronary arteries are the left coronary artery 130 and the right coronary artery 140, with the left coronary artery 130 abbreviated as LCA and the right coronary artery 140 abbreviated as RCA.

[0005] Artificial aortic valves typically have three leaflets 220 and corresponding syndesms, each corresponding one-to-one with the syndesms 120 of the aortic valve 100. During the procedure, we aim to align the syndesms of the implanted artificial valve with the syndesms 120 of the native aortic valve to prevent the artificial leaflets 220 from obstructing coronary blood flow.

[0006] In existing technologies, to facilitate the delivery of artificial heart valves within the body, the artificial heart valve needs to be pre-compressed to a smaller diameter outside the body. Then, a delivery system is used to transport the artificial heart valve to the appropriate location within the body, followed by expansion and release. To achieve precise positioning, contrast agents can be placed at certain locations on the artificial heart valve, such as at the synapse 120. This allows the circumferential position of the artificial heart valve to be adjusted during implantation by rotating the valve (e.g., rotating the delivery system to rotate the valve as well), aligning the synapse of the artificial heart valve with the synapse 120 of the original valve.

[0007] However, this method of aligning artificial heart valves by rotating them has the following problems:

[0008] The sheath of the delivery system is usually quite long, and human blood vessels are often quite tortuous. The force of rotating the delivery system at the handle cannot be effectively transmitted to the distal artificial heart valve. Rotating a certain degree at the handle does not mean that the artificial heart valve can also rotate a corresponding degree. In addition to the excessive length of the sheath, it is also affected by the sheath's own resistance to kinking, etc. Therefore, the rotation effect is poor and difficult to control. Summary of the Invention

[0009] This invention provides an interventional system that is easy to rotate, solving the problems of easy displacement and poor positioning effect of artificial heart valves in the prior art.

[0010] An interventional system that is easy to rotate includes an interventional delivery system and an artificial implant mounted on the interventional delivery system;

[0011] The artificial implant is an aortic valve, including a stent and multiple leaflets connected to the stent, with a junction formed between adjacent leaflets, and the aortic valve is marked with a first identifier.

[0012] The interventional delivery system includes a catheter assembly for delivering the artificial implant, and a control handle for controlling the catheter assembly, the catheter assembly comprising:

[0013] The outer sheath, with its interior used to house the artificial implant;

[0014] The inner shaft is rotatably inserted inside the outer sheath and slides axially relative to the outer sheath.

[0015] An adapter, fixed to the inner shaft, is used for releasable connection to the artificial implant;

[0016] The interventional delivery system is equipped with a third identifier. When the artificial implant is loaded into the interventional delivery system, the rotation amplitude between the inner axis and the outer sheath is adjusted by the first identifier and the third identifier to match the deviation information. The deviation information is obtained by comparing the position information of each valve sinus in the native aortic valve with the reference information.

[0017] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0018] This application also provides an interventional system that is easy to rotate, including an interventional delivery system and an artificial implant loaded in the interventional delivery system;

[0019] The artificial implant is an aortic valve, including a stent and multiple leaflets connected to the stent, with a junction formed between adjacent leaflets, and the aortic valve is marked with a first identifier.

[0020] The interventional delivery system includes a catheter assembly for delivering the artificial implant, and a control handle for controlling the catheter assembly, the catheter assembly comprising:

[0021] The outer sheath, with its interior used to house the artificial implant;

[0022] The inner shaft passes through the outer sheath and slides axially relative to the outer sheath.

[0023] The adapter, rotatably mounted on the inner shaft, is used for releasable connection of the artificial implant.

[0024] A locking structure acts between the inner shaft and the adapter to maintain their relative circumferential position.

[0025] The interventional delivery system is equipped with a third identifier. When the artificial implant is loaded into the interventional delivery system, the rotation amplitude between the adapter and the inner shaft is adjusted by the first identifier and the third identifier to match the deviation information. The deviation information is obtained by comparing the position information of each valve sinus in the native aortic valve with the reference information.

[0026] Optionally, the stent is made of memory material and is released by self-expansion. The adapter is an installation head, and the installation head and the aortic valve stent are provided with mutually cooperating circumferential and axial limiting structures. The limiting structures include:

[0027] Connecting ear, fixedly connected to the bracket;

[0028] The positioning part includes a positioning groove and / or a positioning protrusion formed on the outer periphery of the mounting head and cooperating with the connecting ear.

[0029] Optionally, the connecting ear serves as the first identifier.

[0030] Optionally, the adapter is a balloon body that can deform under fluid action, with the aortic valve radially compressed and disposed on the periphery of the balloon body.

[0031] Optionally, a stop is provided inside or outside the balloon body to restrict the axial relative position of the aortic valve and the balloon body.

[0032] Optionally, the third identifier is configured on the stop.

[0033] Optionally, the intervention delivery system further includes:

[0034] An adjustment line is used to releasably secure the artificial implant to the balloon body. One end of the adjustment line can be kept fixed to the balloon body, and the other end can pass through the artificial implant and has a locking hole.

[0035] The locking wire has a relative locked state and an unlocked state. The proximal end of the locking wire is connected to the control handle. The distal end of the locking wire is inserted into each keyhole in the locked state to restrict the artificial implant. In the unlocked state, it is disengaged from each keyhole to release the artificial implant.

[0036] Optionally, at least one end of the bracket along its axial direction has an eyelet structure for the adjustment line to pass through, the eyelet structure serving as the first identifier; the adjustment line and / or the locking line serving as the third identifier. Optionally, the first identifier and the third identifier are each configured independently, serving as either an identifier symbol or a shape-recognizable component at its location.

[0037] Optionally, at least one of the first identifier and the third identifier is distributed circumferentially, with a span of at least 60 degrees.

[0038] Optionally, the third identifier has a reference position and identifier distribution areas located on both sides of the reference position in the circumferential direction, wherein the circumferential span of the identifier distribution areas is at least 120 degrees.

[0039] Optionally, the first identifier may specifically be at least one of the following:

[0040] a1. The junction of the leaflet and the support includes the fixing edge of the leaflet, and the midpoint of the fixing edge serves as the first identifier;

[0041] a2. Among the multiple petals, the splicing part of two adjacent petals on the support is the connecting part, and the connecting part serves as the first identifier.

[0042] a3. The aortic valve has an identification mark on its periphery, and the identification mark serves as the first identifier;

[0043] The third identifier is specifically at least one of the following:

[0044] b1. In the conduit assembly, one of the fittings has an identification mark on its outer periphery, and the identification mark serves as the third identifier;

[0045] b2. The outer surface of the control handle is marked with an identification symbol, which serves as the third identifier;

[0046] b3. At least a portion of the control handle is circumferentially fixed to the control handle as a whole and has a recognizable shape difference from the surrounding area, and this portion serves as the third identifier.

[0047] Optionally, the control handle has a first posture in the working state, in which the third mark is vertically upward relative to the circumferential position of the intervention delivery system.

[0048] Optionally, the control handle is equipped with a drive mechanism to drive the inner shaft to rotate relative to the outer sheath.

[0049] Optionally, the locking structure is a locking nut that engages with the inner shaft thread, and the locking nut is positioned against the mounting head along the axial direction.

[0050] Optionally, the artificial implant is pre-installed in the outer sheath in a compressed state; the control handle includes a first handle and a second handle that are rotatably engaged, the proximal end of the outer sheath is connected to the first handle, the proximal end of the inner shaft is connected to the second handle, and a mark is provided between the first handle and the second handle to identify the rotation range of the artificial implant within the body as the inner shaft rotates.

[0051] Optionally, the artificial implant is pre-installed in the outer sheath in a compressed state; the control handle rotates to drive the inner shaft, and the rotation angle of the control handle is used to identify the extent of rotation of the artificial implant within the body along with the inner shaft, wherein the identification of the rotation angle of the control handle is at least one of the following:

[0052] C1. The outer periphery of the control handle is marked with a rotation angle symbol;

[0053] C2. An indicator ring is rotatably mounted on the outer periphery of the control handle, and the indicator ring provides visual, auditory or tactile cues when it rotates;

[0054] C3. A stabilizer is installed, and the control handle is rotated and positioned on the stabilizer. The stabilizer and the control handle are provided with a mark that cooperates to indicate the rotation range of the control handle.

[0055] The rotatable interventional system of this application has at least one of the following technical advantages:

[0056] 1. Improved positioning accuracy and easier operation;

[0057] 2. The relative posture of the artificial implant is pre-adjusted before implantation to achieve personalized customization and reduce the inconvenience of rotation and adjustment within the body;

[0058] 3. For deviations caused during implantation, internal adjustments can be made. Attached Figure Description

[0059] Figure 1 A schematic diagram of the aortic valve in the heart;

[0060] Figure 2a A schematic diagram of the aortic arch structure according to an embodiment provided in this application;

[0061] Figure 2b for Figure 2a Cross-sectional view of the middle aortic valve;

[0062] Figure 2c This is a schematic diagram of the structure of an artificial aortic valve;

[0063] Figure 3a This is a schematic diagram of the structure after the artificial implant has been released;

[0064] Figure 3b This is a schematic diagram of the interventional delivery system;

[0065] Figure 3c A flowchart of a method for placing an artificial implant in an interventional delivery system, as provided in this application;

[0066] Figure 4a A schematic diagram of the aortic valve structure obtained using MSCT or other equivalent imaging systems;

[0067] Figure 4b A schematic diagram of the structure of the image to be evaluated under normal conditions, with clock time as the circumferential scale and the distribution around the center point of the aortic valve.

[0068] Figure 4c This is a schematic diagram of the structure of the image to be evaluated under normal conditions in another embodiment, with clock time as the circumferential scale and additional distribution around the center point of the aortic valve.

[0069] Figure 4dA schematic diagram of the distribution of the aortic valve center point on the image to be evaluated under normal conditions, with angles as the circumferential scale.

[0070] Figure 4e This is a schematic diagram of the structure of the image to be evaluated under normal conditions in another embodiment, with the angle as the circumferential scale and the distribution around the center point of the aortic valve.

[0071] Figure 5a for Figure 4b A schematic diagram of the structure of the image to be evaluated deflected to the left by an angle α.

[0072] Figure 5b for Figure 4b A schematic diagram of the structure of the image to be evaluated deflected to the right by an angle β.

[0073] Figure 6a One embodiment provided in this application employs a pressure gripper for an artificial implant using a ball-expanding method;

[0074] Figure 6b A pressure gripper for use with self-expanding artificial implants;

[0075] Figure 6c A schematic diagram of a structure for installing an artificial implant into the mechanical channel of a gripper and initiating gripping;

[0076] Figure 7a The schematic diagram of the artificial implant after being gripped by the interventional delivery system is omitted.

[0077] Figure 7b for Figure 7a Enlarged view of A1;

[0078] Figure 7c for Figure 7a Schematic diagram of the structure before medium pressure gripping;

[0079] Figure 7d for Figure 7c Enlarged view of A2;

[0080] Figure 7e A schematic diagram of the structure used when a bracket is used to hold an artificial implant;

[0081] Figure 8 A schematic diagram of the structure of an interventional delivery system according to an embodiment provided in this application;

[0082] Figure 9 A schematic diagram of the structure of an interventional system that is easy to rotate, provided in this application;

[0083] Figure 10a This is a schematic diagram of the structure of a support in one embodiment;

[0084] Figure 10bThis is a schematic diagram of the structure of an artificial implant in one embodiment;

[0085] Figure 10c This is a schematic diagram of the structure of a support in one embodiment;

[0086] Figure 11a A schematic diagram showing the continuous distribution of marking lines on the catheter assembly;

[0087] Figure 11b This is a schematic diagram of the segmented distribution of marking lines on the catheter assembly.

[0088] Figure 11c A schematic diagram showing the continuous distribution of marking lines on the control handle;

[0089] Figure 11d A schematic diagram showing the continuous distribution of marking lines on the catheter assembly and control handle;

[0090] Figure 12a This is a schematic diagram of the artificial implant located on the periphery of the balloon in its expanded state.

[0091] Figure 12b A schematic diagram of a structure in which an artificial implant is placed on the periphery of a balloon and one end of an adjustment suture with a locking hole passes through the locking hole;

[0092] Figure 12c A schematic diagram illustrating the structure for preventing the locking wire from disengaging from the locking hole;

[0093] Figure 13 A schematic diagram of an artificial implant loaded within an interventional system;

[0094] Figure 14a A schematic diagram of a structure provided in this application for a rotation-friendly interventional system in which a third identifier is distributed around the distal end of the outer sheath;

[0095] Figure 14b A schematic diagram of the structure of a third identifier disposed on a control handle according to an embodiment provided in this application;

[0096] Figure 14c A schematic diagram of a balloon with a stopper provided inside a rotational interventional system provided in this application;

[0097] Figure 14d A schematic diagram of the structure of an interventional system that is easy to rotate, provided in another embodiment of this application;

[0098] Figure 14e A schematic diagram showing the structure in which the mounting head can be rotated and adjusted with the inner shaft;

[0099] Figure 14f A schematic diagram showing the structure in which the locking nut and the mounting head are positioned against each other.

[0100] Figure 14g A schematic diagram of the structure of an interventional delivery system according to another embodiment of this application;

[0101] Figure 15a A schematic diagram of the structure of an interventional delivery system according to an embodiment provided in this application;

[0102] Figure 15b A schematic diagram of the structure of an interventional delivery system according to another embodiment of this application;

[0103] Figure 15c A schematic diagram of the structure of an interventional delivery system according to another embodiment of this application;

[0104] Figure 15d A schematic diagram of the structure of an interventional delivery system according to another embodiment of this application;

[0105] Figure 15e A schematic diagram of the structure of an interventional delivery system according to another embodiment of this application;

[0106] Figure 15f Another embodiment of the intervention delivery system provided in this application includes a structural schematic diagram of a stabilizer;

[0107] Figure 16a A schematic diagram of the structure of an intervention delivery system including an interception device, provided for another embodiment of this application;

[0108] Figure 16b A schematic diagram of a deflection device intervening in the aortic arch and releasing a filter;

[0109] Figure 16c A cross-sectional view showing the delivery pipe fixed to the outside of the outer sheath, with the deflection device housed inside the delivery pipe;

[0110] Figure 17a A cross-sectional view showing that the deflection device is housed inside the outer sheath, and that the connecting shaft and inner shaft can move relative to the distal end of the outer sheath;

[0111] Figure 17b A cross-sectional view showing that the deflection device is housed inside the outer sheath, and that the outer sheath can move proximally relative to the inner axis;

[0112] Figure 17c for Figure 17b Structural diagram;

[0113] Figure 17d A cross-sectional view of the deflection device housed within the delivery pipe and exposed and releasable within the delivery pipe;

[0114] Figure 17e for Figure 17d A structural diagram.

[0115] The annotations in the figure are explained as follows:

[0116] 1000. Interventional system;

[0117] 100. Aortic valve; 101. Pulmonary valve; 102. Mitral valve; 103. Aortic arch; 110. Leaflet; 120. Commissure; 120a. Commissure; 120b. Commissure; 120c. Commissure; 130. Left coronary artery; 140. Right coronary artery;

[0118] 200. Artificial implant; 210. Scaffold; 220. Leaflet; 230. Commissure; 230a. Commissure; 230b. Commissure; 230c. Commissure; 240. Eyelet; 251. Fixation edge; 260. Connecting ear;

[0119] 300. Pressure gripper; 310. Housing; 311. Mechanical channel; 320. Force-applying block; 330. Second mark; 340. Bracket;

[0120] 400. Intervention delivery system; 401. Identification line; 410. Catheter assembly; 420. Balloon body; 421. Adjustment line; 422. Locking hole; 423. Locking wire; 424. Stop; 430. Outer sheath; 431. Delivery tube; 440. Inner shaft; 450. Mounting head; 451. Positioning part; 460. Control handle; 461. First handle; 462. Second handle; 470. Offset device; 480. Locking nut; 482. Identification ring; 483. Stabilizer;

[0121] 500, Deflection device; 510, Pull wire; 520, Mesh cover; 521, Support frame; 522, Filter screen; 530, Connecting shaft; 524, Handle. Detailed Implementation

[0122] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0123] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.

[0124] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0125] In this application, the terms “comprising” and “having”, and any variations thereof, are intended to cover non-exclusive inclusion, for example, a system, product, or device that includes a series of units is not necessarily limited to those units that are explicitly listed, but may include other units that are not explicitly listed or that are inherent to such products or devices.

[0126] refer to Figure 1 and Figure 3a To address the alignment issues of existing artificial heart valves, this application provides an artificial implant 200 that can be placed not only in the aortic valve 100, but also, after adaptive adjustment, in the mitral valve 102, pulmonary valve 101, etc. The following embodiment is based on placement in the aortic valve 100. Like existing artificial aortic heart valves, the artificial implant 200 has a connecting portion 230 corresponding to the connecting portion 120 of the aortic valve 100, namely connecting portion 230a, connecting portion 230b, and connecting portion 230c.

[0127] refer to Figures 3b-3c This application provides a method for configuring an artificial implant 200 in an interventional delivery system 400, wherein the artificial implant 200 is an artificial aortic valve, comprising:

[0128] S100. Obtain the image to be evaluated, which contains at least the location information of each valve sinus in the native aortic valve.

[0129] In step S100, there are various ways to obtain the image to be evaluated. The relationships between the left coronary sinus (LCC), right coronary sinus (RCC), and non-coronary sinus (NCC) differ between different evaluation images. For example, the sectional structure of the native aortic valve is a horizontal mirror image of images obtained by multi-slice computed tomography (MSCT) or any other equivalent imaging system. For ease of understanding, the following embodiment describes obtaining the evaluation image using multi-slice computed tomography (MSCT). In this embodiment, the image to be evaluated can be obtained in advance for the current patient. For example, the image to be evaluated can be an image perpendicular to the plane of the native aortic valve annulus, in which the positional information of each aortic valve sinus can be determined.

[0130] S200. Compare the position information with the reference information to obtain the deviation information;

[0131] In this embodiment, reference information can be predetermined, which can be obtained by analyzing reference images. Reference images can be obtained by analyzing images of a specified population, such as people over 65 years of age, or people with valvular heart disease, etc. Images of most people perpendicular to the plane of the native aortic valve annulus can be selected, and the positional information of each valve sinus can be determined based on these images. This positional information is then used as the reference information. Specific methods can be found in existing technologies and will not be elaborated further.

[0132] Because the positions of the valve sinuses in the native aortic valve of each individual are different and not completely consistent, in order to achieve precise positioning of the artificial implant 200, it is necessary to first measure the deviation between the actual valve sinus position information of the current patient and the baseline information, so as to obtain the deviation information in advance.

[0133] S300, Determine the first relative position between the artificial implant 200 and the interventional delivery system 400 based on the deviation information;

[0134] In step S300, the aforementioned deviation information can be used to make adjustments before the intervention. Specifically, the interventional operator can determine the first relative position between the artificial implant 200 and the interventional delivery system 400 based on the deviation information. The position information of the artificial implant 200 assembled according to the first relative position can match the position information in the native aortic valve after the intervention. For example, the synaptic portion 230 of the artificial implant 200 and the synaptic portion 120 in the native aortic valve can be matched one-to-one.

[0135] S400, the artificial implant 200 is loaded into the interventional delivery system 400 according to the first relative position.

[0136] In this embodiment, when the artificial implant 200 is installed in the interventional delivery system 400, the interventional operator can adjust the circumferential position of the artificial implant 200 in advance according to the deviation information. After the artificial implant 200 is released, the safety hazards caused by the leaflets of the artificial implant 200 obstructing the coronary sinus are avoided.

[0137] Using the above method, the artificial implant can be pre-loaded externally according to the location information of each valvular sinus in the patient's native aortic valve. This ensures that when the artificial implant is delivered and released into the body, its suture point is perfectly aligned with the suture point of the native aortic valve, thereby improving hemodynamics and reducing risks. Furthermore, it eliminates the need for in-body rotation of the artificial implant, preventing the risk of thrombus dislodgement due to rotation.

[0138] refer to Figures 4a to 5bThis is a schematic diagram of the image to be evaluated. The viewing angle of the image is perpendicular to the plane of the aortic valve annulus, avoiding positional deviations in the information of each valve sinus due to angle issues. The positional information at least determines the actual rotation angle of the right coronary sinus relative to the center point of the aortic valve in the image to be evaluated; the reference information at least determines the reference rotation angle of the right coronary sinus relative to the center point of the aortic valve; and the deviation information is the deviation between the actual rotation angle and the reference rotation angle. The rotation angle is the direction of the right coronary sinus relative to the center point of the aortic valve. Specifically, the positioning line can be determined first. Ideally, a horizontal line is first drawn as the baseline (L2 in the figure). Then, a midline is drawn at the midpoint of the right coronary sinus (RCC) (the midline is L1 in the figure, and this midline can be directly opposite the commissure 120b opposite the right coronary sinus RCC). The center point of the aortic valve is the intersection of L1 and L2. The angle between L1 and L2 is the so-called rotation angle. As can be seen from the figure, the angle between L1 and L2 is approximately 90 degrees, which is the actual situation for most individuals.

[0139] However, some individuals may have deviations, resulting in angular deviations of the coronary sinuses relative to the ideal state. The angle between the midline (L1) and the baseline (L2) may be greater than or less than 90 degrees. To facilitate reading the specific angle, a circumferential scale distributed around the center of the aortic valve is added to the image under evaluation during comparison. (A circle encompassing all aortic sinuses is drawn on the image under evaluation, centered on the aortic valve center; the circumferential scale is set on this circle.) The circumferential scale can completely encircle the entire circumference or only halfway. There are various ways to represent the circumferential scale. For example, using a clock face, the angle between every two adjacent large divisions is 30 degrees, and the angle between every small division is 6 degrees. The operator can read the value based on the specific distance between the divisions. Similarly, the angle can also be read directly. Figure 4d and 4e In the game, the angle between any two adjacent large squares is 10 degrees, and the angle between adjacent large squares and small squares is 5 degrees.

[0140] Considering that the actual circumferential position needs to be compared with the reference information, the circumferential scale also includes a first scale indicating the reference rotation angle. The specific position of the first scale can be set according to the requirements. This application does not make any special requirements. For example, the first scale in the figure can be represented as "12". For the actual rotation angle, the second scale (i.e., the angle between the actual position pointed to by "L2" and L1) is obtained. Similarly, when reading by angle, the first scale can be represented as "90°". The specific settings can be flexibly set according to actual needs. The deviation between the second scale and the first scale is the deviation information.

[0141] refer to Figure 5a The original aortic valve is deflected to the left, L1 points to 11 o'clock. At this time, the angle α between 11 o'clock and the first scale (pointing to 12 o'clock) is 30 degrees, that is, the deviation information is 30 degrees. Similarly, as Figure 5b In the process, the native aortic valve is deflected to the right, and the angle β between L1 and the first scale is 36 degrees, i.e., the deviation information is 36°. Therefore, the artificial implant 200 can be adaptively rotated according to the actual deflection information to determine the first relative position between the artificial implant 200 and the interventional delivery system 400.

[0142] To facilitate loading and adjustment of the circumferential position of the artificial implant 200, this application also provides a loading device with a second identifier. The artificial implant 200 has a first identifier. During loading, the artificial implant 200 is first registered to the loading device. During the registration process, the circumferential relative position of the first identifier and the second identifier is adjusted until it is adapted to the deviation information. Then, the loading device is used to load the artificial implant 200 into the interventional delivery system 400.

[0143] When there is no information deviation, the first and second markers remain relatively fixed in their original circumferential positions. However, when there is a deviation between the actual position information of each valve sinus in the native aortic valve and the reference information, they rotate relative to each other from their original positions until they adapt to the deviation information. The loading device can compress the implant 200. During the compression process, the circumferential relative positions of the first and second markers remain unchanged, so that the implant 200 is loaded into the interventional delivery system 400 in this posture.

[0144] Furthermore, the interventional delivery system 400 is equipped with a third identifier, and the compatibility between the interventional delivery system 400 and the loading device is determined based on the third identifier and the second identifier. This ensures that the circumferential relative positions and deviation information of the first and third identifiers are aligned. The loading device and the second identifier can serve as intermediate references during the assembly process. Finally, during the interventional surgery, the circumferential relationship between the artificial implant 200 and the interventional delivery system 400 still needs to be monitored.

[0145] The loading device can use existing auxiliary tooling to radially compress the artificial implant 200, so that the compressed artificial implant 200 can be connected with the intervention delivery system 400, and the loading device can be removed after assembly.

[0146] refer to Figures 6a to 7e In one embodiment, the loading device can be a gripper 300, which includes:

[0147] Multiple force-applying blocks 320 are movably connected to each other and surround the defined mechanical channel 311. The multiple force-applying blocks 320 can relatively converge and separate, and correspondingly extend and retract the mechanical channel 311.

[0148] Multiple force-applying blocks 320 are driven directly or are housed in a housing 310 that is fitted with a clearance mechanical channel 311. The housing 310 is equipped with a drive mechanism that is linked to the force-applying blocks 320.

[0149] The second identifier 330 is disposed on the housing 310 or the force-applying block 320 around the mechanical channel 311.

[0150] The specific distribution of the second identifier 330 can be as shown in the circumferential scale above (the figure uses numbers 1 to 12, similar to those on a clock, to represent the circumferential position).

[0151] To facilitate delivery within the body, the artificial implant 200 needs to be radially compressed using a gripper 300 before surgery to obtain a smaller radial size. After compression, it is loaded into the interventional delivery system 400 and delivered to the treatment site in a compressed state. Finally, it expands to the functional size at the desired location.

[0152] Before the implant 200 enters the mechanical channel 311, the multiple force-applying blocks 320 are in a relatively separated state. After the implant 200 enters the mechanical channel 311, the multiple force-applying blocks 320 gradually switch from separation to convergence. During this process, the multiple force-applying blocks 320 will shrink the mechanical channel, and the inner wall of the mechanical channel 311 will compress the implant 200, thus uniformly reducing the size of the implant 200.

[0153] The gripper 300 has a front and a back (see reference). Figure 6c (The front is X1, the back is X2), and it has a bottom surface that matches the supporting platform (e.g. Figure 6a The F in the middle, and the top surface opposite the bottom surface. The two ends of the mechanical channel 311 are respectively open on the front and back of the gripper 300.

[0154] To reduce the deviation of the artificial implant 200 relative to the interventional delivery system 400 during loading, the circumferential position of the interventional delivery system 400 and the loading device remains unchanged during the compression process. Preferably, in this application, the third mark of the interventional delivery system 400 and the first mark of the loading device are always aligned in the compressed state.

[0155] Furthermore, the implant 200 can be gripped or compressed multiple times under the driving force of the gripper 300 as needed. During the process of loading the implant 200 into the interventional delivery system 400 using the gripper 300, the interventional delivery system 400 may experience circumferential torsion, or the implant 200 itself may exhibit uneven deformation; these factors can all lead to assembly misalignment. For example, if the actual intention is to place the first marker of the implant 200 (in...) Figure 7b and Figure 7dSpecifically, the circumferential angle between the first mark (p) and the mark (12 o'clock position) in the gripper 300 remains at W2. However, after the gripping is completed (the force application block 320 is in relative separation), the angle between the first mark and the 12 o'clock position is W1. Therefore, the entire intervening conveyor system 400 needs to be rotated clockwise to adapt to the angle and compensate for the assembly offset caused by the gripping process.

[0156] Of course, to compensate for the assembly offset, a bracket 340 can be configured on the gripper 300. The bracket 340 is located on one side of the mechanical channel 311 axial direction. It can support the artificial implant 200 or the intervention delivery system 400 during the assembly process, so that the artificial implant 200 always tends to the axis of the mechanical channel 311 when it deforms and contracts, thereby reducing the assembly offset.

[0157] When no assembly device is used or the assembly device does not have a second mark, the artificial implant 200 has a first mark and the intervention delivery system 400 has a third mark. During loading, it is only necessary to adjust the circumferential relative position of the first mark and the third mark until they are adapted to the deviation information.

[0158] refer to Figure 8 The interventional delivery system 400 includes a catheter assembly 410 for delivering the implant 200 and a control handle 460 for controlling the catheter assembly 410. At least one of the control handle 460 and the catheter assembly 410 bears a third identifier. To configure the actual surgical scenario, the control handle 460 has a first orientation in its working state. This first orientation primarily refers to the circumferential orientation of the control handle 460 during surgery. For example, if the control handle 460 has a viewing window or operating knob facing upwards during use, then during loading, the distal portion of the catheter assembly 410 is positioned in the first orientation by the control handle 460. Of course, to avoid torsional stress, the control handle 460 can also be positioned precisely in the first orientation. The distal portion of the catheter assembly 410 can be used to connect to or accommodate the implant 200. In this state, in conjunction with the loading instrument, the expected in-body orientation of the implant 200 can be determined during surgery solely through the external control handle 460.

[0159] Based on the above, the assembly offset of included angle W1 and included angle W2 can be calibrated after assembly. For example, artificial implant 200 is a radially deformable structure with relative expansion and compression states.

[0160] In the expanded state or partially expanded state (partial expansion is understood as at least a portion in the axial direction not reaching the expected maximum radial dimension), the artificial implant 200 is registered to the loading device according to the relative position, and the loading device is used to apply a driving force to the artificial implant 200 to switch the artificial implant 200 to a compressed state and load it into the interventional delivery system 400.

[0161] While the loading device is under driving force, there may be torsional stress between the implant 200 and the interventional delivery system 400. This torsional stress should be released before calibration. For example, the driving force of the loading device can be released, and the implant 200, catheter assembly 410, and control handle 460 can be relaxed in the circumferential direction.

[0162] The current circumferential relative position between the artificial implant 200 and the loading device is the second relative position. The second relative position is adjusted to the first relative position in order to adjust the circumferential relative position between the artificial implant 200 and the catheter assembly 410, i.e., to perform pre-intervention calibration.

[0163] One embodiment of this application provides a method for delivering an artificial implant 200, comprising:

[0164] The artificial implant 200 is loaded into the interventional delivery system 400 according to the methods of the embodiments described above in this application;

[0165] Maintain the circumferential relative position between the artificial implant 200 and the interventional delivery system 400, and deliver the artificial implant 200 to the predetermined position;

[0166] Release 200 artificial implants.

[0167] During delivery and release, it is necessary to maintain the circumferential positional relationship between the artificial implant 200 and the control handle 460. Even if the artificial implant 200 rotates around its own axis and changes the circumferential positional relationship, the amount of change can be known at least through the markings on the control handle to match the deviation information. Similarly, during release, it is necessary to maintain the control handle 460 in the first posture. Even if the posture of the control handle 460 changes, the amount of change can be known at least to match the deviation information.

[0168] refer to Figures 9-10c To address the issue of pre-calibrating the artificial implant 200 before intervention, this application provides an easily rotatable interventional system 1000, including an interventional delivery system 400 and an artificial implant 200 mounted in the interventional delivery system 400, wherein... Figure 9 The artificial implant 200 in the diagram is only meant to indicate its location in the interventional delivery system 400, and is generally encased in external tubing after loading.

[0169] The artificial implant 200 is an aortic valve, including a stent 210 and multiple leaflets 220 connected to the stent 210. Specifically, there are three leaflets 220. The aortic valve is marked with a first identifier. The interventional delivery system 400 is marked with a third identifier. The third identifier is used to adjust the circumferential relative position between the first identifier and the third identifier to match the deviation information when the artificial implant 200 is loaded into the interventional delivery system 400. The deviation information can be obtained based on the method described above, for example, by comparing the position information of each valve sinus in the native aortic valve with the reference information.

[0170] The interventional delivery system 400 includes a catheter assembly 410 for delivering an artificial implant 200, and a control handle 460 for controlling the catheter assembly 410. The interventional delivery system 400 has opposing distal and proximal ends, with the control handle 460 located at the proximal end and the catheter assembly 410 located at the distal end. For ease of understanding, please refer to... Figure 9 The X and Y directions are defined, with the X direction representing the distal end and the Y direction representing the proximal end.

[0171] At least one of the control handle 460 and the conduit assembly 410 has a third identifier; the first and third identifiers are independently configured and are respectively identification symbols or shape-identifiable components at their locations. The identification symbols can be printed, etched, or otherwise made on the basis of the original components, and the shape-identifiable components can be components with features such as protrusions, corners, and cavities at specific locations, which facilitates the use of their circumferential position as a reference or for identifying changes.

[0172] At least one of the first and third markers is distributed circumferentially, with a span of at least 60 degrees. When the circumferential positions of the interventional delivery system 400 and the artificial implant 200 change, the measurement can be accurate within a range of at least 60 degrees. Alternatively, they can be distributed circumferentially in all 360 degrees. The distribution accuracy, i.e., the corresponding angular resolution, can be 1 to 5 degrees.

[0173] For example, the third marker has a reference position and marker distribution areas located on both sides of the reference position in the circumferential direction, and the circumferential span of the marker distribution areas is at least 120 degrees; even when the deviation information is 0, it is not required that the first marker and the connecting part 230 be strictly aligned, they can be aligned with each other or have a predetermined angle. As long as the predetermined angle is known or measurable, it can be converted into deviation information.

[0174] For example, the third identifier is distributed on the scale around the outer periphery of the catheter assembly 410. Among the multiple leaflets 220, the splicing part of two adjacent leaflets on the support 210 is the connecting part 230. When the deviation information is 0, the connecting part 230 is aligned with the third identifier reference position as the first identifier. For another example, the support 210 is also provided with an eyelet 240 that is 60 degrees circumferentially offset from the connecting part 230. If the eyelet 240 is used as the first identifier, it is understood to have a predetermined angle of 60 degrees with the third identifier reference position, but it does not affect the circumferential registration process and identification.

[0175] Furthermore, the first identifier specifically refers to at least one of the following methods:

[0176] a1. The support 210 is a radially deformable tubular structure with an axial direction. At least one end of the support 210 in the axial direction has a grid node or eyelet 240 structure, and the grid node or eyelet 240 structure at the end serves as a first identifier.

[0177] a2. The joint between the leaflet 220 and the support 210 includes the fixing edge 251 of the leaflet 220, with the midpoint of the fixing edge 251 serving as the first identifier.

[0178] a3. The stent 210 has an axial positioning structure that matches the intervention delivery system 400, and the axial positioning structure serves as the first identifier.

[0179] a4. Among the multiple leaflets 220, the splicing part of two adjacent leaflets 220 on the support is the connecting part 230, and the connecting part 230 serves as the first identifier.

[0180] a5. The aortic valve has a circumferential marking, which serves as the primary identifier.

[0181] refer to Figures 11a-11d The control handle 460 has a first posture in the working state. In the first posture, the third mark is vertically upward relative to the circumferential position of the intervention conveying system. Specifically, the third mark is at least one of the following:

[0182] b1. In the conduit assembly 410, one of the fittings has an identification mark on its outer periphery, which serves as a third identifier.

[0183] b2. The outer surface of the control handle is marked with identification symbols, which serve as a third identifier;

[0184] b3. At least a portion of the control handle is circumferentially fixed to the control handle as a whole and has a recognizable shape difference from the surrounding area, and this portion serves as a third identifier.

[0185] The identification symbols in b1 and b2 can be of various types, such as identification line 401, which is continuously or segmentally arranged on the catheter assembly 410 and / or control handle 460 from the distal end to the proximal end.

[0186] The artificial implant 200 can be released by balloon expansion or self-expansion. The way the artificial implant 200 is matched with the catheter assembly 410 and the stent material of the artificial implant 200 can be adjusted accordingly in different release methods.

[0187] refer to Figures 12a-13 When using a balloon dilation method, the catheter assembly 410 includes:

[0188] The outer sheath 430 is used to house the artificial implant 200. The outer surface of the outer sheath 430 from the proximal end to the distal end is marked with an identification mark, which serves as a third identifier.

[0189] The inner shaft 440 is inserted inside the outer sheath tube 430 and is axially slidingly fitted relative to the outer sheath tube 430.

[0190] The balloon body 420 is connected to the distal portion of the inner shaft 440, and the artificial implant 200 is radially compressed and disposed on the periphery of the balloon body 420.

[0191] During release, the outer sheath 430 slides proximally to expose the artificial implant 200, and then fluid is injected into the balloon body 420 via the control handle 460 to inflate it, thereby causing the artificial implant 200 to expand radially and be released.

[0192] To maintain the axial positional relationship between the implant 200 and the balloon body 420 during delivery and release, the interventional delivery system 400 further includes:

[0193] An adjustment line 421 is used to releasably fix the artificial implant 200 to the balloon body 420. One end of the adjustment line 421 can be kept fixed to the balloon body 420, and the other end can pass through the artificial implant 200 and has a locking hole 422.

[0194] The locking wire 423 has a relative locked state and an unlocked state. In the locked state, the locking wire 423 is inserted into each keyhole 422 to restrict the artificial implant 200. In the unlocked state, the locking wire 423 is disengaged from each keyhole 422 to release the artificial implant 200.

[0195] For ease of description, the artificial implant 200 has a distal end and a proximal end.

[0196] The balloon 420 is made of an elastic material and is located at the distal end of the interventional delivery system 400. It is flexible and allows the artificial implant 200 placed on it to reach the lesion site. The balloon 420 can also be inflated with air / liquid to expand itself and drive the artificial implant 200 to switch to an inflated state. Of course, after deflating, the balloon 420 switches to a contracted state.

[0197] The outer sheath 430 is a hollow tubular tube that is slidably mounted on the interventional delivery system 400 and slides along the axial direction of the balloon body 420, thereby changing the constraint state on the artificial implant 200. When the outer sheath 430 is on the periphery of the balloon body 420, it can constrain the artificial implant 200 inside it and limit the expansion of the artificial implant 200. When the outer sheath 430 slides relative to the balloon body 420 and completely exits the expansion path of the artificial implant 200, the artificial implant 200 is exposed, allowing the artificial implant 200 to expand.

[0198] The adjustment line 421 is used to limit the misalignment between the artificial implant 200 and the balloon body 420 during operation (especially in the axial direction of the balloon body 420). Misalignment between the two may affect the three-dimensional shape of the artificial implant 200 after it enters the inflated state, and may even pose a safety hazard. The adjustment line 421 releasably fixes the artificial implant 200 to the balloon body 420, which can be understood as avoiding axial misalignment as much as possible without affecting the release of the artificial implant 200.

[0199] In this embodiment, the first identifier is the eyelet 240 structure on the bracket 210 through which the adjustment line 421 passes. The eyelet 240 structure can both be fixedly engaged with the intervention delivery system 400 and serve as the first identifier, avoiding the problem of not being able to accurately identify the first identifier after compression. In the locked state, after the eyelet 240 structure passes through the end of the corresponding adjustment line 421 with the locking hole 422, it engages with the locking line 423.

[0200] The adjustment line 421, with one end having a locking hole 422, passes through the eyelet 240 structure. The locking line 423 then restricts the eyelet 240 structure from detaching from it, preventing the adjustment line 421 from separating from the implant 200. This is primarily because when the implant 200 slides on the balloon body 420, it is ultimately restricted from further sliding at the locking hole 422. This restricts the axial sliding of the implant 200 relative to the balloon body 420 under compression / inflation conditions. Alternatively, the eyelet 240 structure could pass through the locking hole 422, and the locking line 423 could then restrict its detachment from the adjustment line 421.

[0201] refer to Figures 14a-14c One embodiment of this application provides an interventional system 1000 that is easy to rotate, including an interventional delivery system 400 and an artificial implant 200 loaded in the interventional delivery system 400;

[0202] The artificial implant 200 is an aortic valve, including a stent 210 and multiple leaflets 220 connected to the stent 210, with a junction 230 formed between adjacent leaflets 220, and the aortic valve is marked with a first identifier.

[0203] The interventional delivery system 400 includes a catheter assembly 410 for delivering an artificial implant 200, and a control handle 460 for controlling the catheter assembly 410. The catheter assembly 410 includes:

[0204] The outer sheath 430 has an internal structure for housing the artificial implant 200.

[0205] The inner shaft 440 is rotatably inserted inside the outer sheath 430 and slides axially relative to the outer sheath.

[0206] Adapter, fixed to the inner shaft 440, for releasable connection of artificial implant 200;

[0207] The interventional delivery system 400 is equipped with a third identifier. When the artificial implant 200 is loaded into the interventional delivery system 400, the rotation amplitude between the inner shaft 440 and the outer sheath 430 is adjusted by the first identifier and the third identifier to match the deviation information. The deviation information is obtained by comparing the position information of each valve sinus in the native aortic valve with the reference information.

[0208] When the stent 210 uses a memory material and is released via self-expansion, the adapter is the mounting head 450. The mounting head 450 and the aortic valve stent 210 are provided with mutually cooperating circumferential and axial limiting structures. The limiting structures include:

[0209] Connecting ear 260 is fixedly connected to bracket 210;

[0210] The positioning part 451 has a positioning groove and / or positioning protrusion formed on the outer periphery of the mounting head 450 and cooperating with the connecting ear 260. In this embodiment, the connecting ear 260 serves as a first identifier.

[0211] The positioning part 451 cooperates with the connecting ear 260, which serves as an axial positioning structure. The shape of the connecting ear 260 is not strictly limited. For example, it is located at the proximal end of the artificial implant 200 and can generally be T-shaped, L-shaped, or ring-shaped. The positioning part 451 can adopt a positioning groove that receives a T-shaped or L-shaped shape, or a positioning protrusion that snaps into a ring shape. The positioning part is at least partially radially open. During loading, the connecting ear 260 abuts against the mounting head 450 through the open part. After abutting, they are axially limited. The shape of the connecting ear 260 itself can adopt existing technology. Of course, this application also provides an improved solution.

[0212] In some embodiments, the implant 200 can also be connected to the mounting head 450 via a wired connection. The structural gaps or holes of the implant 200 itself can serve as connecting ears 260. One end of the pull wire is controlled by the control handle 460, and the other end passes through the connecting ear 260 and is locked to the mounting head 450. When released, the lock on the pull wire is released, and the pull wire is pulled away from the connecting ear 260, which allows the implant to detach from the mounting head.

[0213] After loading and during delivery, the outer sheath 430 encloses the artificial implant 200 and the mating part with the mounting head 450 to prevent the connecting ear 260 from dislodging. When released, the outer sheath 430 moves and exposes the connecting ear 260, allowing the connecting ear to move radially outward (with at least a component of radial outward movement) to release the axial restriction between it and the positioning part 451.

[0214] After the artificial implant 200 is loaded, it is also circumferentially limited to the positioning part 451. For example, the connecting ear 260 is restricted by the positioning groove and cannot rotate, or it is bound to the mounting head 450 by the pull line. When performing circumferential registration according to the deviation information, the circumferential positional relationship between the mounting head 450 and the outer sheath tube 430 or the control handle 460 can also be referred to.

[0215] When the stent 210 is deployed using a balloon expansion method, the adapter is a balloon body 420 that can deform under fluid action, with the aortic valve radially compressed and positioned around the periphery of the balloon body 420. A stop 424 is also provided inside or outside the balloon body 420 to restrict the axial relative position of the aortic valve and the balloon body 420. The stop 424 also compensates for the height difference between the balloon body 420 and the stent 210, preventing the stent 210 tip from puncturing the blood vessel wall. The stop 424 can be a perforated mesh structure or multiple arms spaced circumferentially to support the inner wall of the balloon body 420. A third marker can be positioned on the stop 424.

[0216] In one embodiment, the intervention delivery system 400 further includes:

[0217] An adjustment line 421 is used to releasably fix the artificial implant 200 to the balloon body 420. One end of the adjustment line 421 can be kept fixed to the balloon body 420, and the other end can pass through the artificial implant 200 and has a locking hole 422.

[0218] The locking wire 423 has a locked state and an unlocked state. The proximal end of the locking wire 423 is connected to the control handle 460. The distal end of the locking wire 423, in the locked state, passes through each locking hole 422 to restrain the artificial implant 200. In the unlocked state, it disengages from each locking hole 422 to release the artificial implant 200. At least one axial end of the support 210 has an eyelet 240 structure for the adjustment wire 421 to pass through, which serves as a first identifier; the adjustment wire 421 and / or the locking wire 423 serve as a third identifier. Of course, the first identifier can also adopt the structure described above.

[0219] In this embodiment, the artificial implant 200 can be driven to change its circumferential relative position with the intervention delivery system 400 by rotating the inner shaft 440. If there is a clear circumferential assembly relationship between the artificial implant 200 and the mounting head 450 (i.e., the inner shaft 440) and the two move synchronously in the circumferential direction, the first mark can be set on the artificial implant 200, the mounting head 450 or the inner shaft 440, and the third mark can be configured on the control handle 460 or distributed around the distal end of the outer sheath 430.

[0220] To facilitate locking and control the rotation range of the inner shaft 440, a drive mechanism is provided inside the control handle 460 to drive the inner shaft 440 to rotate relative to the outer sheath 430. The drive mechanism can be configured according to requirements; for example, a threaded drive can be used, specifically achieving self-locking after rotation through the shape and material of the thread.

[0221] refer to Figures 14d to 14f This application also provides an interventional system 1000 that is easy to rotate, including an interventional delivery system 400 and an artificial implant 200 loaded in the interventional delivery system 400;

[0222] The artificial implant 200 is an aortic valve, including a stent 210 and multiple leaflets 220 connected to the stent 210, with a junction 230 formed between adjacent leaflets 220, and the aortic valve is marked with a first identifier.

[0223] The interventional delivery system 400 includes a catheter assembly 410 for delivering an artificial implant 200, and a control handle 460 for controlling the catheter assembly 410. The catheter assembly 410 includes:

[0224] The outer sheath 430 has an internal structure for housing the artificial implant 200.

[0225] The inner shaft 440 is inserted inside the outer sheath tube 430 and is axially slidingly fitted relative to the outer sheath tube 430.

[0226] The adapter, rotatably mounted on the inner shaft 440, is used for releasable connection of the artificial implant 200.

[0227] The locking structure acts between the inner shaft 440 and the adapter to maintain their relative circumferential position.

[0228] The interventional delivery system 400 is equipped with a third identifier. When the artificial implant 200 is loaded into the interventional delivery system 400, the rotation range between the adapter and the inner shaft 440 is adjusted by the first and third identifiers to match the deviation information. The deviation information is obtained by comparing the position information of each valve sinus in the native aortic valve with the reference information. The release method of the artificial implant 200 and the adapter in this embodiment can adopt the above scheme. Specifically, when the adapter is the mounting head 450, the artificial implant 200 is connected to the mounting head 450 and can rotate with the mounting head 450 relative to the inner shaft 440. The first identifier can be set on either the artificial implant 200 or the mounting head 450. A circumferential scale is provided on the outer periphery of the distal end of the outer sheath 430 as the third identifier.

[0229] The locking structure can be locked after the mounting head 450 is rotated to a suitable angle. For example, it can be a locking nut 480 that mates with the inner shaft 440, and the locking nut 480 is positioned axially against the mounting head 450. Of course, to provide greater friction and tightening force, the locking nut 480 can be equipped with washers and spring washers. When it is necessary to adjust the angle of the implant 200, the locking nut 480 is rotated away from the mounting head 450, so that the mounting head 450 can rotate relative to the inner shaft 440, and circumferential adjustment is made according to the deviation information and the circumferential scale on the outer sheath 430. After the adjustment is completed, the locking nut 480 is rotated back towards the mounting head 450 until it is positioned against it.

[0230] refer to Figure 14g In another embodiment, the interventional delivery system 400 includes a catheter assembly 410 for delivering the artificial implant 200, and a control handle 460 for controlling the catheter assembly 410, the catheter assembly 410 including:

[0231] The outer sheath 430 has an internal structure for housing the artificial implant 200.

[0232] The inner shaft 440 is inserted inside the outer sheath tube 430 and is axially slidingly fitted relative to the outer sheath tube 430.

[0233] Mounting head 450, fixed to inner shaft 440, is used for releasable connection of implant 200. Mounting head 450 has a rotation locking structure that engages with implant 200 and allows implant 200 to change and maintain its circumferential relative position with mounting head 450, wherein the magnitude of the change in circumferential relative position is at least able to match the deviation information.

[0234] In this embodiment, in order to facilitate angle calibration, a circumferential scale is provided on the outer periphery of the mounting head 450 as a third mark. When the artificial implant 200 is rotated to a suitable angle, the rotation locking structure clamps and fixes the artificial implant 200.

[0235] During self-expansion release, to facilitate control of the release process and retrieval operation, the implant 200 can be released via a wire-controlled method and pre-connected to the interventional delivery system 400 via a pull cord 510. During pre-connection, i.e., pre-installation, the implant 200 can be entirely compressed and wrapped within the outer sheath 430, or, although the pull cord 510 has been threaded, the implant 200 may be located outside the outer sheath 430 or only partially contained within it.

[0236] refer to Figure 15a The artificial implant 200 is pre-loaded onto the interventional delivery system 400. In one embodiment, the interventional delivery system 400 includes a catheter assembly 410 for delivering the artificial implant 200 and a control handle 460 for controlling the catheter assembly 410. The catheter assembly 410 includes:

[0237] The outer sheath 430 is used internally to accommodate the artificial implant 200 during interventional delivery;

[0238] The inner shaft 440 is rotatably inserted inside the outer sheath 430 and is axially slidingly fitted relative to the outer sheath 430. The rotation range between the inner shaft 440 and the outer sheath 430 is at least able to match the deviation information.

[0239] Mounting head 450, fixed to inner shaft 440;

[0240] The artificial implant 200 is releasably connected to the mounting head 450 via a pull wire 510, and at least a portion of the pre-installed artificial implant 200 is located outside the outer sheath 430.

[0241] The circumferential position of the artificial implant 200 and the mounting head 450 is relatively fixed, and at least part of it is located outside the outer sheath 430 after pre-installation. Therefore, the circumferential position of the artificial implant 200 can be adjusted directly by rotating the inner shaft through the drive control handle 460. A third mark can be configured on the outer periphery of the distal end of the outer sheath 430.

[0242] refer to Figure 15b The interventional delivery system 400 includes a catheter assembly 410 for delivering an artificial implant 200, and a control handle 460 for controlling the catheter assembly 410. The catheter assembly 410 includes:

[0243] The outer sheath 430 is used internally to accommodate the artificial implant 200 during interventional delivery;

[0244] The inner shaft 440 is inserted inside the outer sheath tube 430 and is axially slidingly fitted relative to the outer sheath tube 430.

[0245] Mounting head 450 is rotatably mounted on inner shaft 440 for releasable connection of artificial implant 200, and the rotation range between mounting head 450 and inner shaft 440 is at least able to match the deviation information;

[0246] A locking structure acts between the inner shaft 440 and the mounting head 450 to maintain their relative circumferential position.

[0247] The artificial implant 200 is releasably connected to the mounting head 450 via a pull wire 510, and at least a portion of the pre-installed artificial implant 200 is located outside the outer sheath 430.

[0248] In this embodiment, the artificial implant 200 is adjusted by rotating the mounting head 450 relative to the inner shaft 440, and the locking structure described above can also be used in conjunction with it.

[0249] In the above embodiments, the artificial implant 200 is pre-adjusted during loading to match the deviation information. During the operation, the on-site imaging equipment is also used to observe the posture of the artificial implant 200 in the body and its registration with the native tissue in real time.

[0250] In some cases, it is still necessary to adjust the circumferential posture of the artificial implant 200 within the body. In this case, the artificial implant 200 is driven by the overall rotation of the control handle 460 or the rotation of the inner shaft 440. Therefore, the following embodiments provide some specific solutions.

[0251] Referring to 15c, the interventional delivery system 400 of this embodiment includes a catheter assembly 410 for delivering an artificial implant 200, and a control handle 460 for controlling the catheter assembly 410. The catheter assembly 410 includes:

[0252] The outer sheath 430 has an internal structure for housing the artificial implant 200.

[0253] The inner shaft 440 is inserted inside the outer sheath tube 430 and is axially slidingly fitted relative to the outer sheath tube 430.

[0254] Mounting head 450, fixed to inner shaft 440;

[0255] The artificial implant 200 is releasably connected to the mounting head 450, and the artificial implant 200 is pre-loaded in a compressed state within the outer sheath 430;

[0256] When adjusting using the rotating inner shaft 440, the control handle 460 includes a first handle 461 and a second handle 462 that are rotated together (or a circumferentially rotating drive component, etc.). The proximal end of the outer sheath 430 is connected to the first handle 461, and the proximal end of the inner shaft 440 is connected to the second handle 462. A mark is provided between the first handle 461 and the second handle 462 to identify the rotation range of the artificial implant 200 in the body with the inner shaft 440.

[0257] The movement of the second handle 462 relative to the first handle 461 can drive the inner shaft 440 to rotate, adjusting the posture of the artificial implant 200 within the body. A locking mechanism can be provided between the first handle 461 and the second handle 462 to maintain their relative circumferential position.

[0258] If adjusting using the rotary control handle 460 itself, refer to... Figures 15d to 15f The interventional delivery system 400 includes a catheter assembly 410 for delivering an artificial implant 200, and a control handle 460 for controlling the catheter assembly 410. The catheter assembly 410 includes:

[0259] The outer sheath 430 has an internal structure for housing the artificial implant 200.

[0260] The inner shaft 440 is inserted inside the outer sheath tube 430 and is axially slidingly fitted relative to the outer sheath tube 430.

[0261] Mounting head 450, fixed to inner shaft 440;

[0262] The artificial implant 200 is releasably connected to the mounting head 450, and the artificial implant 200 is pre-loaded in a compressed state within the outer sheath 430;

[0263] The control handle 460 rotates to drive the inner shaft 440 to rotate, and the rotation angle of the control handle 460 is used to identify the rotation range of the artificial implant 200 within the body along with the inner shaft 440. The identification of the rotation angle of the control handle 460 is achieved in at least one of the following ways:

[0264] C1. The outer periphery of the control handle 460 has a rotation angle indicator;

[0265] C2. An indicator ring 482 is rotatably mounted on the outer periphery of the control handle 460, and the indicator ring 482 provides visual, auditory or tactile cues when it rotates.

[0266] C3. A stabilizer 483 is installed on the stabilizer 483, and a control handle 460 is rotated and positioned on the stabilizer 483. There are markings between the stabilizer 483 and the control handle 460 to indicate the rotation range of the control handle 460.

[0267] Considering that the artificial implant 200 may come into contact with the blood vessel wall and rub against it during circumferential rotation calibration after deployment, which may cause the thrombus to detach, and the detached thrombus may move along the blood flow direction of the aorta and enter the left subclavian artery, left common carotid artery and ascending aorta on the aortic arch 103, thus causing safety problems, some of the following embodiments are also equipped with an interception device.

[0268] refer to Figures 16a-16c The interventional delivery system 400 includes a catheter assembly 410 for delivering the artificial implant 200, and a control handle 460 for controlling the catheter assembly 410. The interventional delivery system 400 also includes an interception device that, upon release in the body, can filter and capture thrombi or drain thrombi to the inferior vena cava to prevent them from ascending into the brain. The interception device can be a filter for capturing thrombi or a deflector 500 for guiding the flow of thrombi.

[0269] The catheter assembly 410 includes:

[0270] The outer sheath 430 has an internal structure for housing the artificial implant 200.

[0271] The inner shaft 440 is inserted inside the outer sheath tube 430 and is axially slidingly fitted relative to the outer sheath tube 430.

[0272] Taking the deflection device 500 as an example, the deflection device 500 includes:

[0273] The mesh cover 520 has a deformable support frame 521 and a filter 522 installed in the support frame 521;

[0274] A connecting shaft 530 connects the support frame 521 and the control handle 460. The connecting shaft 530 may be configured independently of the inner shaft 440 or may be part of the same component.

[0275] The support frame 521 includes a deformable annular frame, the edge of the filter screen 522 is fixed to the annular frame, the annular frame has a handle 524 and is connected to the connecting shaft 530 through the handle 524.

[0276] The delivery channels for the deflection device 500 and the artificial implant 200 can be configured with independent tubing or utilize a multi-lumen tubing structure. For example, when the tubing is configured independently, the interventional delivery system 400 also includes a delivery tube 431 fixed to the outside of the outer sheath 430. The deflection device 500 is housed in the delivery tube 431 and can be exposed and released in the delivery tube 431 by driving the control handle 460; the artificial implant 200 is located inside the outer sheath 430.

[0277] For ease of understanding, in the cross-sectional views of the inner shaft 440, outer sheath 430, connecting shaft 530, and conveying pipe 431 involved in the following embodiments, the fixed connections are represented by solid lines, and the relatively movable connections are represented by dashed lines.

[0278] The inner shaft 440 can move distally relative to the outer sheath 430 under the drive of the control handle 460 to expose and release the artificial implant 200, and the connecting shaft can move distally relative to the delivery tube 431 under the drive of the control handle 460 to expose and release the mesh cover 520.

[0279] The released mesh 520 is positioned at the aortic arch, and the filter 522 can prevent thrombi from entering the artery above the aortic arch, thus avoiding the aforementioned safety hazards. After the artificial implant 200 is released, the deflection device 500 can be retrieved.

[0280] The filter can be a tubular or branched structure that can capture thrombi. The thrombi will be intercepted by the filter under the action of blood flow. After the artificial implant 200 is released, the filter carrying the thrombi will be recovered.

[0281] refer to Figure 17a In another embodiment, the outer sheath 430 is a multi-lumen tube, the inner shaft 440 extends through one of the lumens, and the deflection device 500 is housed in the other lumen.

[0282] The release can be performed in the following ways:

[0283] Driven by the control handle 460, the inner shaft 440 can move distally relative to the outer sheath 430 to expose and release the artificial implant 200; the connecting shaft 530, driven by the control handle 460, can move distally relative to the outer sheath 430 to expose and release the mesh cover 520; the release can also be performed in the following manner:

[0284] refer to Figures 17b-17c Driven by the control handle 460, the outer sheath 430 can move proximally relative to the inner shaft 440 to expose and release the implant 200 and the mesh cover 520. The cavity sidewall of the receiving deflection device 500 is pre-opened, the connecting shaft 530 is completely inside the cavity, while the mesh cover 520 connected to the connecting shaft 530 is outside the cavity. When the outer sheath 430 moves proximally, the implant 200 and the mesh cover 520 can be smoothly released. Of course, whether the connecting shaft 530 can move distally relative to the outer sheath 430 under the drive of the control handle 460 can be adaptively selected according to requirements.

[0285] refer to Figures 17d to 17eIn another embodiment, the outer sheath 430 is a multi-lumen tube, with the inner shaft 440 extending through one lumen. A delivery tube 431 is slidably disposed within another lumen. The deflection device 500 is housed within the delivery tube 431 and can be exposed and released from the delivery tube 431 by the drive of the control handle 460. The delivery tube 431 is longer than the outer sheath 430 at its distal end, meaning that part of the delivery tube 431 is exposed within the outer sheath 430, while the mesh cover 520 is located outside the delivery tube 431. In this embodiment, to facilitate the smooth release of the implant 200, the outer sheath 430 can move proximally relative to the inner shaft 440 under the drive of the control handle 460, or the inner shaft 440 can move distally under the drive of the control handle 460.

[0286] The technical features of the embodiments described above can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0287] The embodiments described above are merely examples of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.

Claims

1. An easy-to-rotate interventional system, characterized in that, The intervention delivery system and the artificial implant loaded in the intervention delivery system; The artificial implant is aortic valve, including a stent and a plurality of leaflets connected to the stent, and a commissure formed between adjacent leaflets, the aortic valve has a first mark; The intervention delivery system includes a catheter assembly for delivering the artificial implant, and a control handle for controlling the catheter assembly, the catheter assembly includes: An outer sheath, inside for receiving the artificial implant; An inner shaft, rotatingly arranged in the outer sheath and axially slidingly fitted relative to the outer sheath; A balloon body, which can be deformed under the action of fluid, the aortic valve is radially compressed and arranged on the outer periphery of the balloon body; The intervention delivery system is provided with a third mark, when the artificial implant is loaded in the intervention delivery system, the rotation amplitude between the inner shaft and the outer sheath is adjusted by the first mark and the third mark to match the deviation information, the deviation information is obtained by comparing the position information of each sinus of the native aortic valve with the reference information; The intervention system further includes a loading device with a second mark, the artificial implant is first registered to the loading device during loading, the circumferential relative position of the first mark and the second mark is adjusted during the registration process until it is adapted to the deviation information, and then the artificial implant is loaded in the intervention delivery system by using the loading device; The loading device is a pressing holder, the pressing holder includes a plurality of force blocks, each force block is movably connected to each other and surrounds a mechanical channel, the plurality of force blocks can relatively gather and separate, and correspondingly receive and release the mechanical channel, the pressing holder is provided with a bracket for supporting the artificial implant or the intervention delivery system, the bracket is located on one side of the mechanical channel in the axial direction, and the circumferential position of the intervention delivery system and the loading device remains unchanged during the loading and compression process of the artificial implant.

2. The interventional system of claim 1, wherein, The inner or outer part of the balloon body is further provided with a stopper, the stopper limits the axial relative position of the aortic valve and the balloon body, and the third mark is arranged on the stopper.

3. The intervention system according to claim 1, wherein The plurality of force blocks adopt a direct driving mode or are integrally provided with a shell avoiding the mechanical channel, and the shell is provided with a driving mechanism connected with the force blocks; The second mark is arranged on the shell or the force blocks around the mechanical channel.

4. The interventional system of claim 1, wherein, The second mark is a circumferential scale, and the circumferential scale includes a first scale indicating a reference rotation angle.

5. The interventional system of claim 4, wherein, During the loading and compression process of the artificial implant, the third mark of the intervention delivery system and the first scale of the loading device are always aligned in the compression state.

6. An intervention system for easy rotation, characterized in that The intervention delivery system and the artificial implant loaded in the intervention delivery system; The artificial implant is aortic valve, including a stent and a plurality of leaflets connected to the stent, and a commissure formed between adjacent leaflets, the aortic valve has a first mark; The intervention delivery system includes a catheter assembly for delivering the artificial implant, and a control handle for controlling the catheter assembly, the catheter assembly includes: an outer sheath, inside which the artificial implant is accommodated; an inner shaft, which is rotatably arranged in the outer sheath and axially slidably fitted relative to the outer sheath; an adapter, which is mounted on the inner shaft and is used for releasably connecting the artificial implant; the stent is made of a memory material and is released by self-expansion, the adapter is a mounting head, and a circumferential and axial limiting structure that cooperates with the stent of the aortic valve is arranged between the mounting head and the stent, and the limiting structure comprises: a connecting lug, which is fixedly connected to the stent; a positioning part, which is a positioning groove and / or a positioning protrusion arranged on the outer periphery of the mounting head and cooperates with the connecting lug; the interventional delivery system is provided with a third mark, and when the artificial implant is loaded in the interventional delivery system, the rotation amplitude between the inner shaft and the outer sheath is adjusted by the first mark and the third mark to match the deviation information, which is obtained by comparing the position information of each sinus of the native aortic valve with the reference information; the interventional system further comprises a loading device with a second mark, and the artificial implant is first registered to the loading device during loading, and the circumferential relative position of the first mark and the second mark is adjusted during the registration process until it is adapted to the deviation information, and then the artificial implant is loaded in the interventional delivery system by using the loading device; the loading device is a pressing holder, which comprises a plurality of force applying blocks, each of which is movably connected to each other and surrounds a mechanical channel, and the plurality of force applying blocks can relatively gather and separate, and correspondingly receive and release the mechanical channel, and the pressing holder is provided with a bracket for supporting the artificial implant or the interventional delivery system, and the bracket is located on one side of the mechanical channel in the axial direction, and the circumferential position of the interventional delivery system and the loading device remains unchanged during the loading and compression process of the artificial implant.

7. The interventional system of claim 6, wherein, the artificial implant is releasably connected between the mounting head and the pull wire, the connecting lug is a structural gap or a hole site of the artificial implant itself, and one end of the pull wire is controlled by the control handle and the other end cooperates with the connecting lug; the artificial implant is preloaded in the outer sheath in a compressed state, or at least a part of the artificial implant after preloading is outside the outer sheath.

8. The interventional system according to claim 6, characterized in that the adapter is fixed to the inner shaft, or the adapter is rotatably mounted on the inner shaft, and the interventional system further comprises a locking structure, which acts between the inner shaft and the adapter to keep the relative circumferential position of the two.

9. The interventional system of claim 8, wherein, the locking structure is a locking nut that cooperates with the inner shaft in a threaded manner, and the locking nut is positioned against the mounting head in the axial direction.

10. The interventional system of any one of claims 1 to 9, wherein, at least one of the first mark and the third mark is distributed in the circumferential direction, and the span is at least 60 degrees; the third mark has a reference position and a mark distribution area located on both sides of the reference position in the circumferential direction, and the circumferential span of the mark distribution area is at least 120 degrees.

11. The interventional system of claim 10, wherein, the third mark is distributed around the distal end of the outer sheath.

12. The interventional system of any one of claims 1 to 9, wherein, The control handle drives the inner shaft to rotate by rotating itself, and the rotation angle of the control handle itself is used to identify the rotation range of the artificial implant in the body with the inner shaft, and the identification of the rotation angle of the control handle itself is at least one of the following ways: C2. A mark ring is installed on the outer periphery of the control handle, and the mark ring provides visual, audible or tactile cues when it rotates; C3. A stabilizer is provided, and the control handle is installed on the stabilizer and positioned to rotate, and the stabilizer and the control handle are provided with marks that cooperate with each other to indicate the rotation range of the control handle.

13. The interventional system of any one of claims 1 to 9, wherein, The control handle has a first posture in a working state, in which the artificial implant is loaded, and the third mark is vertically upward relative to the circumferential position of the interventional delivery system.

14. The interventional system of any one of claims 1 to 9, wherein, When loading the artificial implant into the interventional delivery system, a driving force is applied to the artificial implant, the artificial implant is switched to a compressed state, and then the driving force is released, so that the artificial implant, the catheter assembly and the control handle are in a relaxed state in the circumferential direction and are calibrated.

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