Conveying system

Abstract

The invention provides a delivery system. The delivery system comprises a sheath tube, a sheath core and a sheath core connector, the sheath core is nested in an inner cavity of the sheath tube, and the sheath core comprises a sheath core main body tube and two reference wires which are symmetrical about the center of the sheath core; the sheath core connector is arranged on the sheath core in a sleeving mode and comprises a fixing part at the near end and a rotating part at the far end, the fixing part is fixedly arranged on the sheath core body tube, and the rotating part can rotate relative to the sheath core. According to the conveying system, before the valve prosthesis is loaded into the sheathing canal, the sheath core connector rotating part can be rotated to circumferentially adjust the valve prosthesis to the optimal position, it is ensured that after the valve prosthesis is conveyed to the designated position, the connection part of the valve prosthesis is aligned with connection of a native aortic valve, and the release accuracy is improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and specifically relates to a delivery system. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Transcatheter aortic valve replacement (TAVR) is a non-open-heart surgery used to treat severe aortic stenosis. A valve prosthesis is delivered into the heart through a catheter to replace the diseased aortic valve.

[0004] TAVR surgery is typically performed through the femoral artery. The surgeon makes a small incision in the patient's thigh and inserts a thin catheter through this incision. The catheter contains a valve prosthesis. When the catheter reaches the aortic valve, the valve prosthesis is released and unfolded, fixing itself to the aortic valve annulus, thereby replacing the diseased valve.

[0005] The human aortic valve consists of three leaflets. Behind each leaflet, the aortic wall bulges outward, forming the aortic sinus. Figure 1 As shown, two of the three aortic sinuses give rise to coronary arteries, namely the left coronary artery 11 and the right coronary artery 12. The left coronary sinus 13 connects to the left coronary artery 11, and the right coronary sinus 14 connects to the right coronary artery 12, hence named the left coronary sinus 13 and the right coronary sinus 14. The third one is the non-coronary sinus 15. There are commissures 16 between the leaflets of each coronary sinus. The commissure between the leaflet of the left coronary sinus 13 and the leaflet of the right coronary sinus 14 is defined as the first commissure 16a, the commissure between the leaflet of the left coronary sinus 13 and the leaflet of the non-coronary sinus 15 is defined as the second commissure 16b, and the commissure between the leaflet of the right coronary sinus 14 and the leaflet of the non-coronary sinus 15 is defined as the third commissure 16c.

[0006] Valve prostheses typically have three leaflets and corresponding commissures, each corresponding one-to-one with the commissure of the aortic valve. For example... Figure 2 As shown, when the commissure 26 of the valve prosthesis 200 is aligned with the commissure 16 of the native aortic valve 100, the left coronary sinus 13 and the right coronary sinus 14 are located in the stent-filled area of ​​the valve prosthesis 200, resulting in a low risk of coronary artery occlusion. Figure 3As shown, when the commissure 26 of the valve prosthesis 200 is close to the left coronary sinus 13 and the right coronary sinus 14, the junction 23 of the valve prosthesis 200 is located at approximately the same height as the coronary artery ostium, and the highest point of the skirt of the valve prosthesis 200 is on the same straight line as the junction 23. This can easily obstruct the coronary artery ostium, increasing the risk of coronary artery occlusion. Ideally, we want the commissure of the implanted valve prosthesis to be aligned with the commissure of the native aortic valve to avoid the valve prosthesis obstructing coronary blood flow.

[0007] When the commissure of the valve prosthesis is not aligned with the commissure of the native aortic valve, this condition is called commissural misalignment. Commissural misalignment is classified as mild (15.1°–30.0°), moderate (30.1°–45°), and severe (45.1°–60.0°) based on the deviation in angle from the native aortic valve commissure. The minimum deflection angle required for the delivery system to achieve commissural alignment is 30°. Severe commissural misalignment can cause the commissure of the valve prosthesis to obstruct the coronary artery ostium, potentially leading to coronary artery occlusion and ultimately, patient death.

[0008] As TAVR expands to younger, lower-risk patients with longer life expectancies, lifelong management of cardiovascular disease, including the need for future interventions for valvular dysfunction and coronary artery disease, becomes increasingly important. Unlike surgical aortic valve replacement (SAVR), which can actively align the commissure of the prosthetic valve leaflets with the commissure of the autologous aortic valve and away from the coronary ostium under exposed conditions, there is currently a lack of available devices or methods in the field of TAVR to achieve commissure alignment, limiting the application of TAVR. Summary of the Invention

[0009] Therefore, it is necessary to provide a delivery system that can adjust the circumferential position of the valve prosthesis relative to the native valve, so as to align the suture portion of the valve prosthesis with the suture of the native valve.

[0010] This invention provides a conveying system, comprising:

[0011] The sheath is used to house the valve prosthesis, which has multiple prosthesis connectors.

[0012] The sheath core is inserted into the inner cavity of the sheath tube and can move axially relative to the sheath tube. The sheath core includes a hollow sheath core main tube and two reference wires symmetrically distributed along the center of the sheath core main tube.

[0013] The sheath core connector is located on the sheath core. The sheath core connector includes a fixed part at the proximal end and a rotating part at the distal end. The fixed part and the rotating part are rotatably engaged. The fixed part is fixed on the distal side of the sheath core main tube. The rotating part can rotate relative to the sheath core main tube. Multiple rotating part connectors are provided on the outer circumferential surface of the rotating part. The multiple rotating part connectors are detachably connected to multiple valve prosthesis connectors in a one-to-one correspondence. After the valve prosthesis is connected to the rotating part but before it is fully loaded into the sheath, the rotating part can rotate circumferentially relative to the fixed part, thereby driving the valve prosthesis to rotate circumferentially to a predetermined position.

[0014] In one embodiment, the proximal end of the fixing part is fixedly connected to the distal end of the two reference wires.

[0015] In one embodiment, the main tube contains two first cavities, and a reference wire passes through one of the first cavities.

[0016] In one embodiment, the sheath is further provided with two reinforcing wires symmetrical about the center of the sheath, and the plane formed by the two reinforcing wires is parallel to the plane formed by the two reference wires.

[0017] In one embodiment, the valve prosthesis includes valve leaflets and valve stent, with a connecting portion between the valve leaflets. The valve prosthesis is provided with a radiopaque marker, which is located at the junction of the connecting portion and the valve stent.

[0018] In one embodiment, the fixed part and the rotating part are rotated in a stepped hole fit or a ball lock shaft fit.

[0019] In one embodiment, the stepped hole recessed platform is provided with an elastic element.

[0020] In one embodiment, the delivery system further includes a limiting wire, and one or more receiving members are provided on the proximal side of the rotating portion of the sheath connector. The distal end of the limiting wire can be received in the receiving member, and when the limiting wire is received in the receiving member, the sheath connector is circumferentially locked.

[0021] In one embodiment, the sheath core further includes one or more second cavities, in which a limiting wire passes through and can move axially relative to the sheath core.

[0022] In one embodiment, it further includes:

[0023] The distal end of the sheath core is nested within the main sheath core tube.

[0024] A guide head is located on the distal end of the distal tube of the sheath core.

[0025] The beneficial effects of this application are as follows: Unlike existing technologies, the sheath core of this application is provided with two reference wires, which serve as reference planes for circumferential adjustment and ensure that the valve prosthesis will not shift due to insufficient tensile strength of the sheath core or erosion by blood flow during release. The sheath core connector of this application can, before the valve prosthesis is loaded into the sheath, adjust the valve prosthesis circumferentially to the optimal position by rotating the rotating part of the sheath core connector, based on the positional relationship between the aortic and coronary artery ostia and the reference plane determined by techniques such as angiography and CT scans. This ensures that after the valve prosthesis is delivered to the designated position, the commissure of the valve prosthesis is aligned with the commissure of the native aortic valve, improving release accuracy. Attached Figure Description

[0026] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0027] Figure 1 This is a schematic diagram showing the positional relationship between the coronary artery ostia and commissures of the native aortic valve;

[0028] Figure 2 A schematic diagram showing the alignment of the suture of the valve prosthesis with the suture of the native aortic valve (low risk of coronary artery blockage);

[0029] Figure 3 This is a schematic diagram showing the fusion of a valve prosthesis that fails to align with the native aortic valve (high risk of coronary artery blockage).

[0030] Figure 4 A schematic diagram of the three-dimensional structure of a valve prosthesis;

[0031] Figure 5 This is a top view of a valve prosthesis;

[0032] Figure 6 This is a schematic diagram of the conveying system according to the first embodiment of the present invention;

[0033] Figure 7 This is a schematic diagram of the sheath tube according to the first embodiment of the present invention;

[0034] Figure 8 This is a schematic diagram of the conveying system according to the first embodiment of the present invention;

[0035] Figure 9 This is a schematic diagram showing the positional relationship of the two reference wires within the polymer layer of the sheath core tube according to the first embodiment of the present invention.

[0036] Figure 10This is a schematic diagram showing the positional relationship between the two reference wires on the inner surface of the polymer layer of the sheath core tube in the first embodiment of the present invention;

[0037] Figure 11 This is an assembly diagram of the rotating part and the fixing part of the sheath core connector according to the first embodiment of the present invention;

[0038] Figure 12 This is a cross-sectional view of the sheath core body tube according to the first embodiment of the present invention;

[0039] Figure 13 This is a cross-sectional view of the sheath core connector and the sheath core body tube according to the first embodiment of the present invention;

[0040] Figure 14 This is a schematic diagram of the rotating part of the sheath core connector with angle markings according to the first embodiment of the present invention;

[0041] Figure 15 This is a schematic diagram illustrating the alignment of the connecting portion of the valve prosthesis with the aortic valve during the valve prosthesis implantation process according to the first embodiment of the present invention.

[0042] Figure 16 This is a schematic diagram showing the alignment of the plane formed by the reference wires and the first joint during the valve prosthesis implantation process according to the first embodiment of the present invention.

[0043] Figure 17 This is a schematic diagram showing the deflection angle between the plane formed by the reference wires and the first ligature during valve prosthesis implantation according to the first embodiment of the present invention.

[0044] Figure 18 This is a schematic diagram showing the positional relationship between the sheath core connector and the sheath core body tube according to the second embodiment of the present invention;

[0045] Figure 19 This is a cross-sectional view of the sheath core connector and the sheath core body tube along the AA direction according to the second embodiment of the present invention;

[0046] Figure 20 This is the tightening stud of the second embodiment of the present invention;

[0047] Figure 21 The fixing part of the sheath core connector according to the second embodiment of the present invention;

[0048] Figure 22 The rotating part of the sheath core connector according to the second embodiment of the present invention;

[0049] Figure 23 This is an assembly diagram of the sheath core connector according to the second embodiment of the present invention;

[0050] Figure 24 This is a schematic diagram of the conveying system according to the third embodiment of the present invention;

[0051] Figure 25 This is a schematic diagram of the near-end face of the rotating part of the sheath core connector according to the third embodiment of the present invention;

[0052] Figure 26 This is a cross-sectional view of the sheath core body tube according to the third embodiment of the present invention;

[0053] Figure 27 This is a schematic diagram of the split sheath loading section according to the fourth embodiment of the present invention;

[0054] Figure 28 This is a schematic diagram of the split sheath delivery section according to the fourth embodiment of the present invention;

[0055] Figure 29 This is a schematic diagram of the split sheath support section according to the fourth embodiment of the present invention;

[0056] Figure 30 This is a schematic diagram of the first polymer layer wrapping the main body of the split sheath support section and the variable diameter section of the support section in the fourth embodiment of the present invention.

[0057] Figure 31 for Figure 30 A magnified view of a portion of the image;

[0058] Figure 32 This is a schematic diagram of the variable diameter portion of the split sheath support section wrapped with the second polymer layer according to the fourth embodiment of the present invention.

[0059] Figure 33 for Figure 32 A magnified view of a portion of the image;

[0060] Figure 34 This is a schematic diagram of the sheath core connector and rotating ring according to the fourth embodiment of the present invention;

[0061] Figure 35 This is a schematic diagram showing the positional relationship between the sheath core connector, the rotating ring, and the sheath core main tube according to the fourth embodiment of the present invention.

[0062] Figure 36 This is a cross-sectional view of the sheath core body tube according to the fourth embodiment of the present invention;

[0063] The markings in the attached diagram are as follows:

[0064] 100. Native aortic valve;

[0065] 11. Left coronary artery; 12. Right coronary artery; 13. Left coronary sinus; 14. Right coronary sinus; 15. Non-coronary sinus; 16. Combination; 16a. First combination; 16b. Second combination; 16c. Third combination;

[0066] 200. Valve prosthesis;

[0067] 21. Valve stent; 22. Prosthesis connector; 23. Joint; 24. Leaflet; 25. Skirt; 26. Commissure;

[0068] 300. Conveying system;

[0069] 31. Sheath;

[0070] 310. Polymer material layer; 311. Sheath loading section; 312. Sheath conveying section;

[0071] 32. Sheath core connector;

[0072] 321. Fixing part; 3211. Fixing part through hole; 322. Rotating part; 3221. Rotating part connector; 3222. Positioning hole; 3223. Recess; 323. Elastic element; 324. Locking ball; 325. Tightening stud; 326. Angle mark;

[0073] 33. Sheath core;

[0074] 33a. Sheath core main tube; 33b. Sheath core distal tube; 331. Reference wire; 331a. Reference wire a; 331b. Reference wire b; 332. Limiting wire; 333. Control wire; 3331. Control wire distal portion; 330. Polymer layer of sheath core main tube; 3301. First cavity; 3302. Second cavity; 3303. Third cavity; 3304. Tube;

[0075] 34. Guide head;

[0076] 35. Split-type sheath;

[0077] 351. Loading section; 3511. Variable diameter section of loading section; 3512. Main body of loading section; 352. Conveying section; 3521. Protrusion of conveying section; 3522. Main body of conveying section; 353. Supporting section; 3531. Variable diameter section of supporting section; 3532. Main body of supporting section; 3501. First polymer layer; 3502. Second polymer layer;

[0078] 36. Rotating ring;

[0079] 361. Inclined groove. Detailed Implementation

[0080] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0081] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0082] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0083] 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 invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0084] In the field of interventional medical devices, "distal" is defined as the end furthest from the operator during surgery, and "proximal" is defined as the end closest to the operator during surgery. "Axial" refers to the direction parallel to the line connecting the distal and proximal centers of the medical device, "radial" refers to the direction perpendicular to the aforementioned axial direction, and "circumferential" refers to the direction surrounding the line connecting the distal and proximal centers of the medical device.

[0085] First Embodiment

[0086] The following explanation uses the aortic valve as an example. It should be noted that this delivery system 300 is also suitable for replacing other types of valves. For example... Figure 4-5 As shown, the valve prosthesis 200 for aortic valve replacement includes a valve stent 21, leaflets 24, and a skirt 25. Three leaflets 24 are provided, corresponding to the three leaflets of the original aortic valve, and the leaflets 24 are connected by a connecting portion 26. The valve stent 21 is provided with prosthesis connectors 22, the number of which corresponds to the number of rotating connectors 3221 (see reference). Figure 11 The number is the same. The prosthesis connector 22 is used to cooperate with the rotating connector 3221 when the valve prosthesis 200 is loaded into the sheath 31, so that the valve prosthesis 200 is received in the sheath 31 (see...). Figure 6 The leaflets 24 are fixed to the valve stent 21 by stitching. A connecting portion 23 is provided at the junction of the leaflets 24 and the valve stent 21. In this embodiment, the connecting portion 23 is defined as the part where the connecting portion 26 connects to the valve stent 21. When there are three leaflets 24, there are also three corresponding connecting portions 23. The spaces between the connecting portions 23 are the cutout positions of the valve stent 21.

[0087] like Figure 6 As shown, a delivery system 300 according to an embodiment of the present invention includes: a sheath 31, a sheath core connector 32, and a sheath core 33.

[0088] In this embodiment, as Figure 7 As shown, the sheath 31 includes a sheath loading section 311 and a sheath delivery section 312, which are fixed together by an outer polymer material layer 310. The sheath loading section 311 is used to accommodate the valve prosthesis 100.

[0089] In this embodiment, the sheath core 33 is nested within the inner cavity of the sheath tube 31 and can move axially relative to the sheath tube 31, such as... Figure 8-10 As shown, two reference wires 331 are symmetrically distributed along the center of the sheath core 33. The two reference wires 331 can be disposed in the polymer layer 330 of the sheath core main tube, or on the inner or outer surface of the polymer layer 330 of the sheath core main tube.

[0090] Furthermore, the two reference wires 331, symmetrically distributed along the center of the sheath core 33, can improve the axial compressive and tensile strength of the conveying system 300, preventing the conveying system 300 from kinking during long-distance movement. At the same time, since the two reference wires 331 are symmetrically distributed along the center of the sheath core 33, the conveying system 300 is less likely to bend in the plane parallel to the plane containing the two reference wires 331, and easier to bend in the plane perpendicular to the plane containing the two reference wires 331, thus taking into account the compressive strength, tensile strength, and flexibility of the conveying system 300.

[0091] Furthermore, two reinforcing wires symmetrically arranged along the center of the sheath 31 can be provided in the sheath 31. The plane formed by the two reinforcing wires is parallel to the plane formed by the two reference wires mentioned above, thereby enhancing the compressive strength of the valve prosthesis 200 upon insertion into the sheath and the delivery system 300 in the axial direction. This also improves the certainty of the plane formed by the two reference wires 331 after the delivery system 300 passes through the aortic arch and bends.

[0092] In this embodiment, the sheath core main tube 33a includes a hollow lumen 3304. The lumen 3304 can be located at the center of the sheath core main tube 33a or at a non-central position. The position of the lumen 3304 does not affect the circumferential position of the valve prosthesis 100 release. The lumen 3304 is through which the distal sheath core tube 33b passes. A guide head 34 is provided at the distal end of the inner catheter 35. The guide head 34 is fixedly connected to the distal sheath core tube 33b. The fixing method includes, but is not limited to, welding, adhesive bonding, interference fit, etc. A guide wire can be passed through the distal sheath core tube 33b and the guide head 34. The guide head 34 can reach the predetermined position for valve prosthesis implantation along the guide wire.

[0093] During assembly and subsequent processing, the distal end tube 33b of the sheath core is fixed in the cavity 3304 of the main tube 33a of the sheath core by heat fusion. After heat fusion, the distal end tube 33b of the sheath core cannot move axially relative to the main tube 33a of the sheath core in the cavity 3304 of the main tube 33a, but can move axially relative to the sheath tube 31 together with the sheath core 33.

[0094] In this embodiment, the delivery system 300 also includes a handle (not shown), which the operator can control to move the sheath 31 and the sheath core 33 axially, thereby loading / releasing the valve prosthesis 100. Specifically, during loading, the operator controls the handle to move the sheath core 33 axially proximally relative to the sheath 31, and the valve prosthesis 100 is housed in the sheath 31; when the delivery system 300 reaches the predetermined position, the operator controls the handle to move the sheath 31 axially proximally relative to the sheath core 33, and the valve prosthesis 100 is released from the sheath 31.

[0095] The sheath connector 32 includes a fixing part 321 and a rotating part 322, which are rotatably engaged. Specifically, threaded engagement, stepped hole engagement, or other methods can be used. In this embodiment, for example... Figure 11 As shown, the sheath core connector 32 has a through hole at its center, through which the distal end tube 33b of the sheath core can pass. Furthermore, the stepped hole can be either cylindrical or conical, as long as the rotating part 322 cannot move radially or axially relative to the fixed part 321, but can rotate circumferentially. In this embodiment, a cylindrical stepped hole is used as an example for explanation.

[0096] A rotating part connector 3221 is provided on the outer peripheral surface of the rotating part 322, which can cooperate with the prosthesis connector 12 of the valve prosthesis. The rotating part 322 can rotate circumferentially relative to the fixed part 321, thereby driving the valve prosthesis 100 to rotate circumferentially to a predetermined position. The fixed part 321 is divided into two parts with different outer diameters. The distal end of the fixed part 321 is divided into a larger outer diameter part. The proximal end of the fixed part 321 is divided into a smaller outer diameter part. The proximal part of the fixed part 321 is inserted into the distal side of the lumen 3304 of the sheath core body tube 33a and is fixedly connected to the sheath core body tube 33a as a whole.

[0097] To further improve the firmness of the connection between the fixation part 321 and the sheath core body tube 33a, and to improve the stability of the valve prosthesis 200 during insertion and release, the proximal part of the fixation part 321 can be fixedly connected to the distal ends of the two reference wires 331 of the sheath core 33.

[0098] Furthermore, the plane containing the two reference wires 331 can serve as a reference plane for the circumferential rotation of the rotating part 322 relative to the fixed part 321. Simultaneously, the symmetrical arrangement of the two reference wires 331 along the center of the sheath core tube 33a ensures that the valve prosthesis 100 will not be deviated during release due to insufficient tensile strength of the sheath core 33 or impact from blood flow, thus improving the accuracy of valve prosthesis 100 release.

[0099] like Figure 12 As shown, in this embodiment, two reference wires 331 are disposed in the polymer layer 330 of the sheath core main tube, which includes two symmetrically distributed first cavities 3301. Compared to disposing the two reference wires 331 on the outside or inside of the polymer layer 330, disposing the two reference wires 331 in the polymer layer 330 of the sheath core main tube is easier to process and more reliable, and will not contact the distal end tube 33b of the sheath core or the sheath tube 31, thus improving the smoothness of the insertion process. Specifically, during the processing, the distal ends of the two reference wires 331 can be fixed to the proximal part of the fixing part 321 firstly, and the cavity 3304 can be partially enlarged. Then, the two reference wires 331 are sequentially inserted into the first cavity 3301, and finally the fixing part 321 is embedded into the enlarged cavity 3304. It should be noted that by partially enlarging the cavity 3304, the fixing part 321 can be easily inserted into the cavity 3304 after fixing the two reference wires.

[0100] After the fixing part 321 is inserted into the cavity 3304, it cannot move axially, radially, or rotate circumferentially relative to the sheath core 33. The distal end of the sheath core main tube 33a abuts against the proximal end face of the rotating part 322, and the distal end of the fixing part 321 abuts against the stepped surface of the stepped hole of the rotating part 322. Under the combined action of the sheath core main tube 33a and the fixing part 321, the rotating part 322 cannot move axially or radially relative to the fixing part 321, but it can rotate circumferentially.

[0101] In this embodiment, as Figure 13 As shown, an elastic element 323 is provided between the distal portion of the fixing part 321 and the stepped recessed surface of the rotating part 322. The elastic element 323 can be an elastic element that easily recovers after deformation, such as a silicone ring or an elastic metal sheet. Specifically, before the fixing part 321 is inserted into the cavity 3304, the elastic element 323 is compressed and deformed by pressing the rotating part 322 and the fixing part 321. When the fixing part 31 is inserted into the cavity 3304, the external force acting on the elastic element 323 disappears, and the elastic element 323 recovers its deformation. The restoring force of the elastic element 323 acts simultaneously on the distal portion of the fixing part 321 and the rotating part 322. Since the distance between the distal portion of the fixing part 321 and the distal surface of the sheath core tube 33a is fixed, under the action of the elastic member 323, the axial force of the rotating part 322 being squeezed by the distal portion of the fixing part 31 and the distal surface of the sheath core tube 33a increases, thereby increasing the torque required for the circumferential movement of the rotating part 32 and reducing the probability of the rotating part 322 rotating circumferentially and causing inaccurate positioning when the valve prosthesis 100 is loaded into the sheath tube 31.

[0102] like Figure 14 As shown, optionally, the delivery system 300 may also be provided with an angle mark 326, which may be provided on the outer surface of the sheath core 31, the outer surface of the inner catheter 35, the outer surface of the fixing part 321 of the sheath core connector 32, the outer surface of the rotating part 322 of the sheath core connector 32, etc. In this embodiment, the angle mark 326 is provided on the outer surface of the rotating part 322 of the sheath core connector 32.

[0103] In this embodiment, the valve prosthesis 100 may encounter various situations during implantation, and the following describes some of the possible situations.

[0104] like Figure 15As shown, before the valve prosthesis 100 is inserted into the sheath, the patient's original valve leaflets, coronary artery ostia, and aortic arch vessels are evaluated using techniques such as CT (Computed Tomography) and ultrasound. The aortic root is reconstructed in three dimensions using the relevant data, and a 3D model of the aorta is printed. Because the two reference wires 331 are symmetrically distributed along the center of the sheath core 33, the delivery system 300 is less likely to bend in a plane parallel to the two reference wires 331, but more likely to bend in a plane perpendicular to the two reference wires 331. Therefore, the plane formed by the two reference wires 331 is fixed after the delivery system 300 passes through the aortic arch vessels. By analyzing the positional distribution of the delivery system 300 through the 3D model of the aorta, the optimal circumferential distribution direction for valve prosthesis 100 release is determined.

[0105] like Figure 16 As shown, reference wire 331a is defined as the reference wire with a relatively low height after the delivery system 300 passes through the aortic arch vessels, and reference wire 331b is defined as the reference wire with a relatively high height after the delivery system 300 passes through the aortic arch vessels. If, according to CT evaluation, the delivery system 300 is located at the aortic valve, the plane formed by reference wires 331a and 331b is aligned with the first suture 26a. Then, before the valve prosthesis 100 is fully loaded into the sheath 31, the rotating part 322 is rotated so that the suture 16 of one of the valve prostheses 100 is aligned with the reference wire 331a, and then the valve prosthesis 100 is loaded.

[0106] During the loading of the valve prosthesis 100 into the sheath 31, it is only subjected to axial force and does not rotate circumferentially. During delivery, because the sheath loading section 311 and the sheath delivery section 312 are designed as a single unit, the valve prosthesis 100 is housed within the sheath 31, and the valve prosthesis 100 cannot rotate circumferentially after loading is completed. When the valve prosthesis 100 is delivered to the native aortic valve 200, the valve prosthesis 100 is released, and the circumferential positioning of the valve prosthesis 100 is the same as the intended design, and the syndesm 16 of the valve prosthesis 100 can be aligned with the syndesm 26 of the native aortic valve 200.

[0107] like Figure 17 As shown, if the delivery system 300 is located at the aortic valve according to CT evaluation, the angle between the plane formed by the reference wires 331a and 331b and the first syndesm 26a is α (viewed from the distal end to the proximal end of the delivery system 300). Before the valve prosthesis 100 is fully loaded into the sheath 31, the rotating part 322 is first rotated so that the syndesm 16 of one of the valve prostheses 100 is aligned with the reference wire 331a. Then, rotating counterclockwise by an angle α ensures that after implantation, one syndesm 16 of the valve prosthesis 100 is aligned with the syndesm 26a of the native aortic valve 200.

[0108] In addition, to facilitate observation of the circumferential positional relationship between the commissure portion 16 of the valve prosthesis 200 and the commissure 26 of the native aortic valve 100 after the valve prosthesis 200 is implanted into the human body, at least one imaging marker is provided on the valve prosthesis 200.

[0109] Furthermore, three imaging markers can be set near the junction 23. Since the junction 23 is the part where the connecting part 26 connects to the valve stent 21, after the valve prosthesis 200 is implanted into the human body, the position and height of the valve prosthesis junction 23 relative to the coronary artery ostium can be determined by determining the location of the imaging points.

[0110] It should be noted that the presence or absence of contrast markers does not affect the adjustment of the circumferential position of the valve prosthesis 200 relative to the native aortic valve 100 by the delivery system 300. The contrast markers are only used to better confirm whether the position of the valve prosthesis 200 after implantation in the human body meets expectations. Even without contrast markers, materials or contrast solutions with other contrasting functions can be used instead.

[0111] Second Embodiment

[0112] like Figure 18-23 As shown, the difference between this embodiment and the first embodiment lies in that the rotational engagement between the fixing part 321 and the rotating part 322 is a ball-lock shaft engagement. In this embodiment, the rotating part 322 is sleeved on the fixing part 321. The outer peripheral surface of the fixing part 321 is provided with a plurality of fixing part through holes 3211, and the inner wall of the rotating part 322 is provided with a plurality of recesses 3223. The locking ball 324 is located in the fixing part 321, and the tightening stud 325 is threadedly engaged with the fixing part 321. The locking ball 324 abuts against the recesses 3223 through the fixing part through holes 3211. Specifically, when the circumferential angle of the rotating part 322 is adjusted, the tightening stud 325 is tightened. The tightening stud 325 moves axially towards its proximal end, pushing the locking ball 324 radially through the fixing part through holes 3211 and abutting against the recesses 3223, thus completing the circumferential locking of the rotating part 322. The rotating part no longer rotates circumferentially during the loading and release of the valve prosthesis 100, thus improving the accuracy of release.

[0113] Furthermore, when the locking ball 324 moves radially through the through hole 3211 of the fixing part and abuts against the recess 3223, the axial locking of the rotating part 322 is also completed, and the rotating part cannot move axially.

[0114] Third Embodiment

[0115] like Figure 24-25As shown, the difference between this embodiment and the first embodiment lies in that circumferential locking / unlocking is achieved by providing a receiving member in the rotating part 322. Specifically, a plurality of positioning holes 3222 are circumferentially spaced on the proximal end face of the rotating part 322, and a limiting wire 332 can be inserted into each positioning hole 3222. The circumferential locking / unlocking of the sheath core connector 32 is achieved by the limiting wire 332. Similarly, the circumferential locking / unlocking of the sheath core connector 300 can also be controlled by providing one positioning hole 322 and multiple limiting wires 332. Furthermore, in the scheme of providing one positioning hole 3222 and multiple limiting wires 332, the embodiment of the present invention limits the number of limiting wires 332 to a range that does not affect the passage of the delivery system 300 through large curved sections such as the aortic arch. Since the limiting wire 332 is in a free state after processing, the arrangement of multiple limiting wires 332 will not significantly affect the bending ability of the delivery system 300, nor will it affect the passage of the delivery system 300 through large bends such as the aortic arch. In this embodiment, it is described with twelve positioning holes 3222 evenly spaced circumferentially on the proximal end face of the rotating part 322 and one limiting wire 332.

[0116] In addition, the proximal part of the limiting wire 332 is connected to the handle. The operator controls the axial movement of the limiting wire 332 through the handle, so that the limiting wire 332 is inserted into / out of the positioning hole 3222, thereby realizing the circumferential locking / unlocking of the sheath core connector 32.

[0117] Among them, since the near end of the rotating part 322 of the sheath core connector is provided with twelve positioning holes 3222 at equal intervals in the circumference, and the angle between adjacent positioning holes 3222 and the center of the circle is 30°, that is, the angle interval between rotations of the sheath core connector is at least 30°, which meets the minimum angle requirement for connection and alignment.

[0118] In this embodiment, as Figure 26 As shown, the polymer layer 330 of the sheath core tube contains three cavities. The first cavity 3301 is symmetrically distributed along the center of the sheath core 33. Two reference wires 331 are inserted into the symmetrically distributed first cavity 3301, and the limiting wire 332 is inserted into the asymmetrically distributed second cavity 3302.

[0119] Furthermore, during assembly and processing, the limiting wire 332 can be coated with a high-melting-point, non-adhesive polymer film such as PTFE (Polytetrafluoroethylene) before being threaded into the second cavity 3302. The two reference wires 331 are directly threaded into the first cavity 3301. After the sheath core 33 is heat-fused, the gap in the first cavity 3301 decreases, and the two reference wires 331 are fixed in the first cavity 3301 and cannot move axially. However, the limiting wire 332, due to the PTFE film coating, is not affected during heat fusion and remains in a free state in the second cavity 3302 after heat fusion, allowing axial movement and realizing the function of controlling the circumferential locking / unlocking of the sheath core connector 32.

[0120] Fourth embodiment

[0121] like Figure 27-33 As shown, the difference between this embodiment and the first embodiment is that a split-type sheath 35 is used. The split-type sheath 35 consists of a loading section 351, a conveying section 352, and a support section 353 from the distal end to the proximal end.

[0122] Among them, such as Figure 27-29 As shown, the loading section 351 includes a variable diameter section 3511 and a main body section 3512. The main body section 3512 contains two layers of polymer material, with a hyaluronic acid tube in between to provide axial support. The conveying section 352 includes a conveying section protrusion 3521 and a main body section 3522. The main body section 3522 contains two layers of polymer material, with a braided mesh tube in between to provide axial support. The variable diameter section 3511 and the conveying section protrusion 3521 are contour-fitted, and the conveying section 352 is assembled with the loading section 351 by passing through. The support section 353 is cut from a variable diameter metal tube and includes a variable diameter section 3531 and a main body section 3532. The main body section 3532 has a hollow design, and it is fitted onto the main body section 3522, while the variable diameter section 3531 is fitted onto the variable diameter section 3511.

[0123] like Figures 30-33As shown, the first polymer layer 3501 is located outside the main body of the delivery section 3522, wrapping the main body of the support section 3532 and part of the variable diameter section 3531 of the support section. The first polymer layer 3501 is fixedly connected to the main body of the delivery section 3522. Furthermore, to prevent the variable diameter section 3531 of the support section from directly contacting and damaging the blood vessel, the second polymer layer 3502 is integrated with the outer polymer layer of the loading section 351, and covers the remaining portion of the variable diameter section 3531 of the support section not covered by the first polymer layer 3501. It should be noted that after the first polymer layer 3501 is fixedly connected to the main body of the delivery section 3522, the delivery section 352 cannot move axially relative to the loading section 351, but the loading section 351 can still rotate circumferentially relative to the delivery section 352. The arrangement of the second polymer layer 3502 does not affect the circumferential rotation of the loading section 351.

[0124] Specifically, the above structural design can be achieved using the following processing steps:

[0125] The first step involves heat-melting a layer of polymer material onto the outside of the support section 3532, since the main body 3532 has a hollow design. This allows the molten polymer material to flow into the support section 353 through the hollow portion, eventually contacting the conveying section 3522. This polymer material layer formed after melting and cooling is defined as the first polymer layer 3501. (The text repeats itself here.) Figures 30-31 As shown, the support section 353 and the conveying section 352 are fixedly connected by the first polymer layer 3501, forming a single unit. The first polymer layer 3501 encapsulates the main body of the support section 352 and part of the variable diameter section 3531 of the support section.

[0126] The second step involves covering the outer portion of the variable-diameter section 3531 that is not enclosed by the first polymer layer 3501 with a layer of polymer material. This newly added polymer material layer is defined as the second polymer layer 3502. For example... Figures 32-33 As shown, the second polymer layer 3502 and the outer polymer layer of the loading section 351 are integrated through melting and cooling, and the second polymer layer 3502 covers the portion of the support section variable diameter portion 3531 that is not covered by the first polymer layer 3501. Before covering the second polymer layer 3502, a PTFE film or a PTFE coating is applied to the support section variable diameter portion 3531 and the first polymer layer 3501 to prevent the second polymer layer 3502 from adhering to the support section variable diameter portion 3531 and the first polymer layer 3501. Through the above design, the loading section 351 can rotate circumferentially but cannot move axially relative to the conveying section 352 and the support section 353.

[0127] Alternatively, the loading section 351 and the support section 353 can be processed into one piece. The loading section 351 is axially limited by the inner polymer layer of the loading section 351 and the protrusion 3521 of the conveying section. After the loading section 351 and the support section 353 are processed into one piece, they can rotate circumferentially relative to the conveying section 352, but cannot move axially.

[0128] In this embodiment, as Figures 34-35 As shown, the sheath core connector 32 also includes a rotating ring 36, which is sleeved on the protruding part of the fixed part 321 relative to the near end face of the rotating part 322. The outer peripheral surface of the rotating ring 36 is provided with a slanted groove 361. The rotating ring 36 is fixedly connected to the near end face of the rotating part 322, and the rotating ring 36 can rotate circumferentially relative to the fixed part 321 of the sheath core connector.

[0129] In this embodiment, a control wire 333 is also included, with its distal end 3331 inserted into the inclined groove 361 of the rotating ring. Specifically, the distal end 3331 of the control wire can be configured as a bent metal wire, a bent metal wire with a spherical head, or the like, as long as the configuration allows the distal end of the control wire to be inserted into and move within the inclined groove 361. The operator controls the axial movement of the control wire 333 via a handle, causing the distal end 3331 of the control wire to move within the inclined groove 361.

[0130] Furthermore, the length and angle of the inclined groove 361 on the outer circumference of the rotating ring 36 can be set in various ways, as long as the rotation angle of the rotating ring is not less than 30° when the distal part 3331 of the control wire moves in the inclined groove 361.

[0131] Specifically, when the control wire 333 moves axially towards the distal end, the rotating ring 36 rotates counterclockwise (viewed from proximal to distal) under the compressive stress of the distal end 3331 of the control wire via the inclined groove 361. This causes the rotating part 322, which is fixed to the rotating ring 36, to rotate counterclockwise, and in turn, causes the valve prosthesis 100, which is anchored by the rotating part connector 3221 of the rotating part 32, to rotate. Since the valve prosthesis 100 is subjected to radial loading stress on the split sheath loading section 361 after being inserted into the split sheath loading section 361, the counterclockwise rotation of the valve prosthesis 100 will cause the split sheath loading section 361 to rotate counterclockwise. Similarly, when the control wire 333 moves axially towards the proximal end, the rotating ring 36 rotates clockwise, causing the rotating part 322 to rotate clockwise, thereby causing the valve prosthesis 100 and the split sheath loading section 361 to rotate clockwise.

[0132] Furthermore, the control wire 333 serves both to adjust the circumferential position of the valve prosthesis 200 and to provide circumferential locking. During the assembly of the valve prosthesis 200, the operator controls the control wire 333 to remain axially stationary via a handle, preventing any circumferential position deviation of the valve prosthesis 200 during assembly. Before implantation, the optimal circumferential position of the valve prosthesis 200 relative to the plane containing the two reference wires 331 can be adjusted using the control wire 333. After implantation, if it is observed that the commissure 16 of the valve prosthesis 200 is not well aligned with the commissure 26 of the native aortic valve 100, the circumferential position of the valve prosthesis 200 can be adjusted by controlling the axial movement of the control wire 333.

[0133] In this embodiment, the timing of adjusting the circumferential position of the valve prosthesis 200 relative to the sheath core 33 via the control wire 333 can be either before the valve prosthesis 200 is implanted into the human body (i.e., when the valve prosthesis 200 is at least partially loaded into the split sheath 35) or after the valve prosthesis 200 is implanted into the human body (i.e., when the valve prosthesis 200 is at least partially released from the split sheath 35). The method for adjusting the circumferential position before the valve prosthesis 200 is implanted is the same as that in the first embodiment of this specification. In this case, the control wire 333 is only used to maintain the stability of the circumferential position of the valve prosthesis 200 during assembly and for small-angle adjustments after implantation. In the method for adjusting the circumferential position after the valve prosthesis 200 is implanted into the human body, the reference wire 331 is not necessary; the control wire 333 ensures that the valve prosthesis 200 can be adjusted to the required circumferential position even after implantation. Furthermore, since this embodiment does not involve the overall rotation of the delivery system 300, and the rotation is limited to the loading section 351, the probability of thrombosis caused by the overall rotation of the delivery system 300 is greatly reduced. At the same time, the control wire 333 is located inside the split sheath 35, does not directly contact the blood vessel wall, and avoids the problem of force transmission failure due to an excessively long bending path.

[0134] In this embodiment, as Figure 36 As shown, the polymer layer 330 of the sheath core tube contains a third cavity 3303, and the control wire 333 is nested in the third cavity 3303. The control wire 333 can move axially in the third cavity 3303. For specific assembly and processing, please refer to the assembly and processing process of the limiting wire 332 in the third embodiment.

[0135] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0136] The above embodiments merely illustrate several implementation methods of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A conveying system, characterized in that, include: A sheath for receiving a valve prosthesis, which has multiple prosthesis connectors. The sheath core is inserted into the inner cavity of the sheath tube. The sheath core includes a hollow sheath core main tube and two reference wires symmetrically distributed along the center of the sheath core main tube. A sheath core connector is disposed on the sheath core. The sheath core connector includes a fixed part at a proximal end and a rotating part at a distal end. The fixed part and the rotating part are rotatably engaged. The fixed part is fixed to the distal end of the sheath core main tube. The rotating part can rotate relative to the sheath core main tube. The outer circumferential surface of the rotating part is provided with a plurality of rotating part connectors. The plurality of rotating part connectors are detachably connected to a plurality of valve prosthesis connectors in a one-to-one correspondence. After the valve prosthesis is connected to the rotating part but before it is fully loaded into the sheath tube, the rotating part can rotate circumferentially relative to the fixed part, thereby driving the valve prosthesis to rotate circumferentially to a predetermined position.

2. The conveying system as described in claim 1, characterized in that, The proximal end of the fixing part is fixedly connected to the distal end of the two reference wires.

3. The conveying system as described in claim 1, characterized in that, The sheath core tube contains two first cavities, and a reference wire is inserted into one of the first cavities.

4. The conveying system as described in claim 1, characterized in that, The sheath also has two reinforcing wires symmetrically arranged along the center of the sheath, and the plane formed by the two reinforcing wires is parallel to the plane formed by the two reference wires.

5. The conveying system as described in claim 1, characterized in that, The valve prosthesis includes leaflets and a valve support, with a connecting portion between the leaflets. The valve prosthesis is provided with a radiopaque marker, which is located at the junction of the connecting portion and the valve support.

6. The conveying system as described in claim 1, characterized in that, The fixed part and the rotating part are rotated in a stepped hole fit or a ball lock shaft fit.

7. The conveying system as described in claim 6, characterized in that, The stepped hole recessed platform is equipped with an elastic element.

8. The conveying system as described in claim 1, characterized in that, The conveying system also includes a limiting wire, and one or more receiving members are provided on the proximal side of the rotating part of the sheath core connector. The distal end of the limiting wire can be received in the receiving member. When the limiting wire is received in the receiving member, the sheath core connector is circumferentially locked.

9. The conveying system as described in claim 8, characterized in that, The sheath core also includes one or more second cavities, and the limiting wire passes through the second cavity, and the limiting wire can move axially relative to the sheath core in the second cavity.

10. The conveying system as described in claims 1-9, characterized in that, Also includes: The distal end tube of the sheath core is nested within the main body tube of the sheath core; A guide head is located on the distal end of the distal tube of the sheath core.

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