Prosthetic stent, valve stent and delivery system
By designing a prosthesis stent with elastically deformable barbs and a flexible skirt, combined with a flexible delivery system, the problems of existing prostheses being difficult to bend and causing cardiac compression during delivery have been solved, achieving safer and more flexible delivery and implantation.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- SHANGHAI CONFLOW MEDTECH CO LTD
- Filing Date
- 2024-12-31
- Publication Date
- 2026-05-19
AI Technical Summary
Existing prosthetic stents are difficult to bend at small angles during delivery, requiring a large turning radius. Furthermore, the implant can compress the heart during release, affecting blood flow and cardiac structure. The existing skirt design may lead to paravalvular leakage and cardiac damage.
Design a prosthetic stent comprising a ring frame and barbs that are elastically deformable with tips that retract to protect from damage. Employ a flexible skirt and a bendable delivery system to reduce delivery difficulty and cardiac compression, and prevent paravalvular leakage.
This technology enables the feasibility of delivering prosthetic stents under small-angle bending, reducing pressure on the heart, improving the applicability and safety of the delivery system, and lowering the requirements on human anatomy.
Smart Images
Figure CN224251574U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, specifically to prosthetic stents, valve stents, and delivery systems. Background Technology
[0002] With technological advancements, the femoral approach is currently considered the safest and most stable method for valve products, with low mortality rates and low rates of intraoperative conversion to surgical valves. However, this also places higher demands on the products, requiring them to be smaller, shorter, have better delivery capabilities, and be adaptable to more physiological structures.
[0003] Currently, most mainstream products protect implants by adding a rigid metal tube to the outside of the implant. This means that the implant cannot bend at small angles during delivery and requires a very large turning radius. Moreover, during the implant release process, the implant needs to be completely pushed out of the metal tube for proper deployment. This means that the corresponding human body part needs to accommodate at least the length of the metal tube and the implant, which poses a great challenge to the human body structure.
[0004] Furthermore, to address the issue of paravalvular leakage after implantation, most implants currently incorporate a metal-supported skirt on the outer side to perfectly fit the original valve. However, this results in significant pressure from the implant on the heart, which, in turn, is further compressed by the skirt. This immense pressure can compress the aorta and pulmonary artery, affecting blood flow and blood pressure. Additionally, excessive pressure can affect nerves within the heart, particularly those near the His bundle, potentially leading to atrial flutter and premature beats. The existing skirt is immobile, inevitably forcing blood to flow only through the central valve. Utility Model Content
[0005] This invention provides a variety of prosthetic stents to address the shortcomings of existing technologies. This invention aims to solve, at least to a certain extent, one of the technical problems in existing technologies.
[0006] Another aspect of this invention provides a variety of valve stents.
[0007] Another aspect of this invention provides a variety of conveying systems.
[0008] The objective of this utility model is achieved through the following technical solution:
[0009] On the one hand, the present invention provides a prosthetic support, which includes an annular frame and barbs. The annular frame has a cavity extending through both ends thereon. The outer peripheral wall of the annular frame has a plurality of barbs. One end of the barb is connected to the annular frame and can be elastically deformed. The other end of the barb is a tip, which faces the same end face of the annular frame. At least a portion of the barb protrudes along the axial direction of the annular frame from the line connecting the two ends of the barb.
[0010] Compared with the prior art, when the prosthetic support provided by this utility model is housed in a tubular object, the inner wall of the tubular object can compress the protruding part of the barb, causing the root of the barb to deform elastically and the tip to retract inward. This can protect the tip, prevent it from being damaged, and maintain its sharpness.
[0011] In some embodiments, the barb includes a straight connecting segment and a barb tip; one end of the connecting segment is connected to the annular frame and is elastically deformable, the other end of the connecting segment is connected to one end of the barb tip, and the extension line of the connecting segment intersects or is not in plane with the axis of the annular frame; there is an angle between the barb tip and the connecting segment, and the end of the barb tip away from the connecting segment is a pointed tip; from the end of the barb tip near the connecting segment to the pointed tip, the barb tip gradually deviates from the annular frame.
[0012] The barb in this embodiment adopts a two-section structure design. The overall shape of the barb is roughly V-shaped. The structure of this barb only requires two bending of the metal wire. The bending method is also very simple and has the advantage of being easy to process, which is conducive to improving production efficiency and yield.
[0013] In some embodiments, the extension of the connecting segment intersects the axis of the annular frame.
[0014] This embodiment, by having the extension line of the connecting section intersect with the axis of the ring frame, helps to further reduce the bending difficulty of the barbs, thereby reducing processing costs and increasing production.
[0015] In some embodiments, the angle between the connecting segment and the axis of the annular frame is 45 to 80 degrees.
[0016] This embodiment makes the use and operation of prosthetic stents simpler.
[0017] In some embodiments, the barb includes a straight tip segment and a curved connecting segment. One end of the connecting segment is connected to the annular frame and is elastically deformable. The other end of the connecting segment is connected to one end of the tip segment. At least a portion of the connecting segment protrudes along the axial direction of the annular frame from the line connecting the two ends of the barb. The end of the tip segment away from the connecting segment is a pointed tip. From the end of the tip segment near the connecting segment to the pointed tip, the tip segment gradually deviates from the annular frame.
[0018] In this embodiment, the connecting segment is roughly C-shaped. This shape of the connecting segment has good structural stability. When the tubular object compresses the connecting segment, the shape of the connecting segment is not easily changed. Instead, the connection between the connecting segment and the ring frame deforms. This helps to ensure that the tip can move closer to the center of the ring frame, thereby avoiding damage to the tip.
[0019] In some embodiments, the side of the connecting segment adjacent to the annular frame is concave, and the side of the connecting segment away from the annular frame is convex.
[0020] In this embodiment, during the process of housing the tubular object, the end of the tubular object can directly act on the convex surface of the connecting section, so that as the tip approaches the annular frame, the thorn segment only needs to deflect at a small angle, ensuring that the prosthesis stent can be more easily housed inside the tubular object.
[0021] In some embodiments, the extension of the spike segment intersects the axis of the annular frame.
[0022] The structural design of this embodiment facilitates the smooth insertion of the tip into human tissue, thereby achieving a firm fixation of the prosthesis.
[0023] In some embodiments, the angle between the spike segment and the axis of the annular frame is 10 to 25 degrees.
[0024] This embodiment maintains the angle between the tip and the axis of the ring frame within the range of 10 to 25 degrees, which facilitates the tip's easier penetration into human tissue.
[0025] In some embodiments, the ring frame is a perforated mesh structure.
[0026] In this embodiment, the ring frame is designed as a hollow mesh structure to achieve radial shrinkage, while also having relatively low processing difficulty.
[0027] In some embodiments, the annular frame is provided with multiple mesh holes to form a hollow mesh structure, with adjacent mesh holes having common nodes, and connecting segments connecting to the nodes.
[0028] This embodiment achieves a stable connection of the barbs by connecting the connecting segment to the node, and can reduce the impact of deformation of the connecting segment on the structure of the ring frame to a certain extent.
[0029] In some embodiments, the mesh is hexagonal in shape.
[0030] On the other hand, the present invention also provides a valve stent, which includes an artificial valve and the aforementioned prosthetic stent. The three artificial valves are arranged in a ring array within the cavity. The edges of the artificial valves are fixed to the ring frame, and the end face of the ring frame with the tip facing the end of the blood outflow is the blood outflow end.
[0031] Compared with existing technologies, this valve stent can effectively protect the tip, preventing damage and maintaining its sharpness.
[0032] In some embodiments, the valve stent further includes a flexible skirt connected to the prosthetic stent, the flexible skirt surrounding the outside of the prosthetic stent and adjacent to the blood outflow end of the prosthetic stent.
[0033] This embodiment employs a flexible skirt design without rigid support, enabling the product to be suitable for more physiological structures and a wider age range.
[0034] In some embodiments, the flexible skirt includes a plurality of pouches connected to the prosthesis stent, the plurality of pouches being distributed at equal intervals around the prosthesis stent, the blood outflow end of the pouch being provided with an opening, and the other end of the pouch being sealed.
[0035] In this embodiment, when the sac is subjected to blood flow, the opening is opened, the entire sac becomes congested and expands, and fills the gap between the annular frame and the heart, thereby preventing paravalvular leakage.
[0036] In some embodiments, the valve stent further includes sutures, and the annular frame has a plurality of suture holes through which the sutures pass and the artificial valve to fix the artificial valve to the annular frame.
[0037] In this embodiment, the artificial valve is connected to the annular frame via sutures, a connection method that offers the advantages of stability and reliability.
[0038] On the other hand, the present invention also provides a delivery system, which includes a catheter, a soft cannula, a traction member, and the aforementioned prosthetic stent. The catheter and the soft cannula are coaxial, the soft cannula is located at the distal end of the catheter and at least partially on the outside of the catheter, the traction member is located inside the catheter, one end of the traction member is connected to the soft cannula, and the other end of the traction member extends from the proximal end of the catheter. After the annular frame is contracted, it is placed inside the soft cannula and located outside the catheter. The inner diameter of the catheter is smaller than the outer diameter of the annular frame after contraction. The inner wall of the soft cannula compresses the connecting section to deform so that the tip tends to be parallel to or at a certain angle to the outside of the annular frame.
[0039] Compared to existing technologies, the prosthetic stent and flexible tubing in this delivery system possess a degree of flexibility, allowing the entire system to bend according to the physiological structure of the human body, significantly reducing the bending radius. Therefore, this delivery system is applicable to a wider range of physiological structures and age groups. Furthermore, the position of the prosthetic stent remains unchanged during its release within the body. This invention eliminates the need for pushing the prosthetic stent completely out of the metal tube; the corresponding human body part only needs to be long enough to accommodate the prosthetic stent, further reducing the requirements on the human physiological structure.
[0040] In some embodiments, the traction device includes a first retraction line and a second retraction line, one end of which is connected to a soft cannula, and the other end of which extends from the proximal end of the catheter.
[0041] In this embodiment, the traction component uses two retraction lines, which not only simplifies the operation but also helps reduce manufacturing costs.
[0042] This utility model also provides another delivery system, which includes a catheter, a soft cannula, and the aforementioned prosthetic stent. The soft cannula is inserted inside the catheter, with both ends of the soft cannula extending to the outside of the catheter. The annular frame is placed inside the soft cannula after it contracts. The annular frame is located outside the catheter and near the distal end of the catheter. The inner diameter of the catheter is smaller than the outer diameter of the annular frame after it contracts. The inner wall of the soft cannula compresses and deforms the connecting section so that the tip tends to be parallel to or at a certain angle to the outside of the annular frame.
[0043] Compared to existing technologies, the prosthetic stent and flexible cannula in this delivery system possess a degree of flexibility, allowing the entire system to bend according to the physiological structure of the human body, significantly reducing the bending radius. Therefore, this delivery system is applicable to a wider range of physiological structures and age groups. Furthermore, the position of the prosthetic stent remains unchanged during its release within the body. This invention eliminates the need for pushing the stent completely out of the metal tube; the corresponding human body part only needs to be long enough to accommodate the stent, further reducing the requirements on the human physiological structure. In addition, the flexible cannula in this delivery system directly passes through both ends of the catheter; assembly is simpler as it is merely inserted into the catheter.
[0044] In some embodiments, the prosthetic stent in the aforementioned delivery system is replaced by the aforementioned valve stent. Attached Figure Description
[0045] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0046] Figure 1 This is a three-dimensional view of the prosthetic stent in Embodiment 1 of this utility model.
[0047] Figure 2 This is a front view of the prosthetic stent in Embodiment 1 of this utility model.
[0048] Figure 3yes Figure 2 A magnified view of a portion of point A in the middle.
[0049] Figure 4 This is a top view of the prosthetic stent in Embodiment 1 of this utility model.
[0050] Figure 5 This is a partial schematic diagram of the connection segment and the axis of the ring frame in Embodiment 1 of this utility model when the included angle is an obtuse angle.
[0051] Figure 6 This is a three-dimensional view of the prosthetic stent in Embodiment 2 of this utility model.
[0052] Figure 7 This is a front view of the prosthetic stent in Embodiment 2 of this utility model.
[0053] Figure 8a yes Figure 7 A magnified view of a portion of point B in the middle.
[0054] Figure 8b yes Figure 8a A schematic diagram showing the barbs rotated 80 degrees clockwise.
[0055] Figure 9 This is a schematic diagram of the connection segment and the ring frame in Embodiment 3 of this utility model.
[0056] Figure 10 This is a perspective view of the valve stent in Embodiment 4 of this utility model.
[0057] Figure 11 This is a front view of the conveying system in Embodiment 7 of this utility model.
[0058] Figure 12 yes Figure 11 A schematic diagram showing the retraction of the flexible sleeve a certain distance.
[0059] Figure 13 This is a perspective view of the flexible sleeve in Embodiment 7 of this utility model.
[0060] Figure 14 This is a schematic diagram of the assembled catheter, soft sleeve, and traction component in Embodiment 7 of this utility model.
[0061] Figure 15 This is a partial schematic diagram of the prosthetic stent housed inside the soft sleeve in Embodiment 1 of this utility model.
[0062] Figure 16 This is a partial schematic diagram of the prosthetic stent housed inside the soft sleeve in Embodiment 2 of this utility model.
[0063] Figure 17This is a partial schematic diagram of the prosthetic stent housed inside the soft sleeve in Embodiment 3 of this utility model.
[0064] Figure 18 This is a cross-sectional view of the conveying system in Embodiment 8 of this utility model.
[0065] Figure 19 This is a perspective view of the valve stent in Embodiment 6 of this utility model.
[0066] The annotations in the attached figures are explained as follows:
[0067] In the diagram: 1. Annular frame; 11. Mesh; 12. Node; 13. Threading hole; 2. Barb; 21. Connecting section; 211. Convex surface; 212. Concave surface; 22. Spike tip; 3. Artificial valve; 4. Catheter; 5. Soft cannula; 6. Traction element; 61. First retraction line; 62. Second retraction line; 7. Axis of the annular frame; 8. Flexible skirt; 81. Pocket; 811. Opening; 100. Prosthetic stent; 200. Valve stent; 300. Delivery system. Detailed Implementation
[0068] The embodiments of this application will be further described in detail below with reference to the accompanying drawings and examples. The detailed description of the following embodiments and the accompanying drawings are used to illustrate the principles of this application by way of example, but should not be used to limit the scope of this application. This application can be implemented in many different forms and is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.
[0069] These embodiments are provided to make the application thorough and complete, and to fully express the scope of the application to those skilled in the art. It should be noted that, unless otherwise specifically stated, the relative arrangement of components and steps, material composition, numerical expressions, and values illustrated in these embodiments should be interpreted as merely exemplary and not as limiting.
[0070] It should be noted that, in the description of this application, unless otherwise stated, "a plurality of" means two or more; the terms "upper," "lower," "left," "right," "inner," and "outer," etc., indicating orientation or positional relationship, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.
[0071] Furthermore, the terms "first," "second," and similar terms used in this application do not indicate any order, quantity, or importance, but are merely used to distinguish different parts. "Vertical" is not strictly vertical, but within the permissible margin of error. "Parallel" is not strictly parallel, but within the permissible margin of error. Terms such as "including" or "contains" mean that the element preceding the word encompasses the element listed after it, and do not exclude the possibility of encompassing other elements as well.
[0072] It should also be noted that, in the description of this application, unless otherwise expressly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this application depending on the specific circumstances. When a specific device is described as being located between a first device and a second device, an intermediary device may or may not be present between the specific device and the first or second device.
[0073] All terms used in this application have the same meaning as understood by one of ordinary skill in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be interpreted as having meanings consistent with their meanings in the context of the relevant art, and not as idealized or highly formalized, unless expressly defined herein.
[0074] Techniques, methods, and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, they should be considered part of the specification.
[0075] See Figures 1-4 As shown, this utility model provides a prosthetic support 100, which includes an annular frame 1 and barbs 2. The annular frame 1 has cavities extending through both ends of it, and a plurality of barbs 2 are provided on the outer peripheral wall of the annular frame 1. One end of the barb 2 is connected to the annular frame 1 and is elastically deformable, and the other end of the barb 2 is a pointed tip facing the same end face of the annular frame 1. At least a portion of the barb 2 protrudes along the axial direction of the annular frame 1 beyond the line connecting the two ends of the barb 2.
[0076] See Figures 15 to 17 As shown, when the prosthetic support 100 provided by this utility model is housed inside the tubular object, the inner wall of the tubular object can compress the protruding part of the barb 2, causing the root of the barb 2 to deform elastically and the tip to retract inward, thus protecting the tip, preventing damage to the tip, and maintaining the sharpness of the tip.
[0077] Example 1
[0078] See Figures 1-5 As shown, this embodiment provides a prosthetic scaffold 100, which includes an annular frame 1 and barbs 2.
[0079] The annular frame 1 has a cavity running through both ends. The annular frame 1 is cylindrical. The axis 7 of the annular frame 1 mentioned in this article is the axis of rotation of the cylinder. The annular frame 1 can contract along its own radial direction. The outer peripheral wall of the annular frame 1 is provided with multiple barbs 2. Figure 1 and Figure 2 The annular frame 1 shown is in its fully extended state. After contracting along its own radial direction, the annular frame 1 becomes a contracted state, in which it has a smaller outer diameter. When the annular frame 1 is not radially constrained, or under certain specific conditions, the annular frame 1 can spring back from the contracted state to the extended state.
[0080] The barb 2 includes a straight connecting segment 21 and a barb tip 22. The barb 2 can be formed by bending a metal wire. In this embodiment, the metal wire is divided into the aforementioned connecting segment 21 and barb tip 22 by the bending line. One end of the connecting segment 21 is connected to the annular frame 1 and can be elastically deformed. The other end of the connecting segment 21 is connected to one end of the barb tip 22. The extension line of the connecting segment 21 intersects or is not parallel to the axis of the annular frame 1. In other words, the connecting segment 21 is not parallel to the axis of the annular frame 1. The barb tip 22 and the connecting segment 21 have an angle, making the overall structure of the barb 2 V-shaped. The end of the barb tip 22 away from the connecting segment 21 is the tip, which faces the same end face of the annular frame 1. From the end of the barb tip 22 near the connecting segment 21 to the tip, the barb tip 22 gradually deviates from the annular frame 1.
[0081] In this embodiment, the extension line of the tip segment 22 intersects the axis of the annular frame 1. This structural design facilitates the tip to smoothly penetrate human tissue, thereby achieving a firm fixation of the prosthesis scaffold 100.
[0082] In this embodiment, when the annular frame 1 is fully extended, the angle β between the spike segment 22 and the axis of the annular frame 1 is an acute angle. In a preferred embodiment, the value of β is 10 to 25 degrees. See also Figure 6 As shown, during transportation, the prosthetic stent 100 is housed in the soft sleeve 5. Under the action of the soft sleeve 5, the end of the connecting segment 21 connected to the annular frame 1 undergoes elastic deformation, and the end of the connecting segment 21 away from the annular frame 1 moves towards the axis of the annular frame 1. Since the included angle between the connecting segment 21 and the spike segment 22 does not change, the included angle between the spike segment 22 and the axis of the annular frame 1 will change. Figure 15This is a partial schematic diagram of the prosthetic stent 100 in this embodiment being housed inside the tubular object. As shown in the figure, there is a gap between the tip of the prosthetic stent 100 and the inner wall of the soft sleeve 5 during transportation. This can protect the tip, prevent damage to the tip, and maintain the sharpness of the tip.
[0083] To facilitate manufacturing, the extension line of the connecting segment 21 intersects the axis of the annular frame 1; in other words, the connecting segment 21 and the axis of the annular frame 1 are coplanar. In this embodiment, the prosthetic support 100 can be made by cutting a metal tube. After cutting, the annular frame 1 in its unfolded state and the metal wire used to prepare the barbs 2 are obtained. After cutting, the annular frame 1 and the barbs 2 are connected together. The barbs 2 are then obtained by bending the metal wire twice. Alternatively, the prosthetic support 100 in this embodiment can also be made from a metal sheet. Regardless of whether the prosthetic support 100 is made of a metal tube or a metal sheet, ensuring that the extension line of the connecting segment 21 intersects the axis of the annular frame 1 helps reduce the difficulty of bending the barbs 2.
[0084] In this embodiment, the included angle α between the connecting segment 21 and the axis of the annular frame 1 can theoretically be any angle between 0 and 180 degrees, excluding 0 and 180 degrees. For example... Figure 5 As shown in the figure, the angle α between the connecting segment 21 and the axis of the ring frame 1 is an obtuse angle, approximately 145 degrees, and the angle β between the spike segment 22 and the axis of the ring frame 1 is approximately 60 degrees.
[0085] In a preferred embodiment, when the annular frame 1 is fully extended, the angle α between the connecting segment 21 and the axis of the annular frame 1 is 45 to 80 degrees. Figure 3 As shown, the connecting segment 21 forms an inclined upper surface. During the process of putting the soft sleeve 5 on the outside of the prosthesis stent 100, the annular frame 1 is first contracted, and then the soft sleeve 5 is placed above the prosthesis stent 100. Next, the soft sleeve 5 is pulled down. When the lower edge of the soft sleeve 5 contacts the upper surface of the connecting segment 21, the soft sleeve 5 will force the root of the connecting segment 21 to deform elastically. The 45-80 degree angle between the connecting segment 21 and the axis of the annular frame 1 makes the process of putting the soft sleeve 5 on the outside of the prosthesis stent 100 simpler.
[0086] In this embodiment, the annular frame 1 has a hollow mesh structure. This hollow mesh structure allows the annular frame 1 to contract radially, while also facilitating manufacturing. For example... Figure 1As shown, in a specific implementation, the annular frame 1 has multiple mesh holes 11 to form a hollow mesh structure. Adjacent mesh holes 11 share a common node 12, and the connecting segment 21 is connected to the node 12. By connecting the connecting segment 21 to the node 12, a stable connection of the barbs 2 can be achieved, and the impact of deformation of the connecting segment 21 on the structure of the annular frame 1 can be reduced to a certain extent. In this embodiment, the shape of the mesh hole 11 is a regular hexagon; however, the shape of the mesh hole 11 can also be rhomboid.
[0087] Example 2
[0088] See Figures 6-8a As shown, this embodiment provides another type of prosthetic support 100, which includes an annular frame 1 and barbs 2. The annular frame 1 in this embodiment has the same structure as the annular frame 1 in embodiment 1. The main difference between this embodiment and embodiment 1 is the structure of the barbs 2.
[0089] See Figure 8a As shown, in this embodiment, the barb 2 includes a straight tip segment 22 and a curved connecting segment 21. One end of the connecting segment 21 is connected to the annular frame 1 and can be elastically deformed. The other end of the connecting segment 21 is connected to one end of the tip segment 22. At least a portion of the connecting segment 21 protrudes along the axial direction of the annular frame 1 from the line connecting the two ends of the barb 2. The end of the tip segment 22 away from the connecting segment 21 is a pointed tip. From the end of the tip segment 22 near the connecting segment 21 to the pointed tip, the tip segment 22 gradually deviates from the annular frame 1.
[0090] In this embodiment, the bending area of the barb 2 is mainly concentrated in the connecting section 21. The connecting section 21 is roughly C-shaped. This shape of the connecting section 21 has good structural stability. When the tubular object presses the connecting section 21, the overall shape of the connecting section 21 is not easily changed. Instead, the connection between the connecting section 21 and the ring frame 1 is deformed. This helps to ensure that the tip can move towards the center of the ring frame 1, thereby avoiding damage to the tip.
[0091] In this embodiment, the extension line of the tip segment 22 intersects the axis of the annular frame 1. This structural design facilitates the tip to smoothly penetrate human tissue, thereby achieving a firm fixation of the prosthesis scaffold 100. It also allows the extension line of the tip segment 22 to roughly coincide with the root of the barb 2.
[0092] In this embodiment, when the annular frame 1 is fully extended, the angle β between the spike segment 22 and the axis of the annular frame 1 is 30 to 60 degrees. See also Figure 6As shown, during transportation, the prosthetic stent 100 is housed in the soft sleeve 5. Under the action of the soft sleeve 5, the end of the connecting section 21 connected to the annular frame 1 undergoes elastic deformation, and the end of the spike section 22 away from the annular frame 1 moves towards the axis of the annular frame 1. Figure 16 This is a partial schematic diagram of the prosthetic stent 100 in this embodiment being housed inside the tubular object. As shown in the figure, there is a gap between the tip of the prosthetic stent 100 and the inner wall of the soft sleeve 5 during transportation. This can protect the tip, prevent damage to the tip, and maintain the sharpness of the tip.
[0093] For ease of assembly, see Figure 8a As shown, the side of the connecting segment 21 adjacent to the annular frame 1 is concave 212, and the side of the connecting segment 21 away from the annular frame 1 is convex 211. During the process of the prosthesis scaffold 1 being housed into the tubular object, the end of the tubular object can directly act on the convex surface 211 of the connecting segment 21, so that as the tip approaches the annular frame 1, the spike segment 22 only needs to deflect at a small angle, ensuring that the prosthesis scaffold 1 can be more easily housed inside the tubular object.
[0094] See Figure 8b As shown, in some embodiments, the side of the connecting segment 21 adjacent to the annular frame 1 is a convex surface 211, and the side of the connecting segment 21 away from the annular frame 1 is a concave surface 212. In this case, the angle between the spike segment 21 and the axis of the annular frame 1 is an obtuse angle. In these embodiments, the barbs 2... Figure 8b Rotate to the position shown Figure 16 The position shown requires a larger rotation angle, which slightly increases the difficulty of retracting the prosthesis 100 into the soft sleeve 5, but the purpose of this utility model can still be achieved.
[0095] Example 3
[0096] See Figure 9 As shown, this embodiment provides another type of prosthetic support 100, which includes an annular frame 1 and barbs 2. The annular frame 1 in this embodiment has the same structure as the annular frame 1 in Embodiment 1. The main difference between this embodiment and Embodiment 1 lies in the structure of the barbs 2. See also... Figure 9 As shown, in this embodiment, the barb 2 has an arc-shaped structure. From the end of the barb 2 near the annular frame 1 to the tip, the barb 2 gradually deviates from the annular frame 1.
[0097] Figure 17This is a partial schematic diagram of the prosthetic support 100 of this embodiment being housed inside the tubular object. As shown in the figure, the outermost edge of the barb 2 is tangent to the inner wall of the tubular object. During transportation, there is also a gap between the tip of the prosthetic support 100 and the inner wall of the soft sleeve 5, which can protect the tip, prevent the tip from being damaged, and maintain the sharpness of the tip.
[0098] Example 4
[0099] See Figure 10 As shown, this embodiment provides a valve stent 200, which includes an artificial valve 3 and a prosthetic stent 100 as in embodiment 1. The three artificial valves 3 are arranged in a ring array within the cavity. The edges of the artificial valves 3 are fixed to the ring frame 1, and the end face of the ring frame 1 with the tip facing the end of the blood flow. Special attention needs to be paid to the installation direction when installing the artificial valves 3.
[0100] In practice, the artificial valve 3 can be connected to the annular frame 1 via sutures, a connection method that offers the advantages of stability and reliability. The annular frame 1 has three suture holes 13, through which sutures are inserted to secure the artificial valve 3 to the annular frame 1.
[0101] Example 5
[0102] This embodiment provides another type of valve stent 200. The valve stent 200 in this embodiment differs from the valve stent 200 in embodiment 4 only in the structure of the prosthetic stent 100. This embodiment can be obtained by replacing the prosthetic stent 100 used in embodiment 4 with the prosthetic stent 100 in embodiment 2 or 3.
[0103] Example 6
[0104] See Figure 19 As shown, the difference between this embodiment and embodiment 4 is that a flexible skirt connected to the prosthesis stent is added to the valve stent 200 in this embodiment. The flexible skirt surrounds the outside of the prosthesis stent and is close to the blood outflow end of the prosthesis stent.
[0105] In practice, the flexible skirt consists of multiple pockets connected to the prosthesis stent. These pockets are equidistantly distributed around the prosthesis stent and interconnected. Each pocket has an opening at the blood outflow end, away from the prosthesis stent, while the other end is sealed. The flexible skirt can be made of a biocompatible membrane material, which is formed by suturing it to the annular frame. Figure 19 The fold pattern shown.
[0106] This embodiment employs a flexible skirt design, enabling the valve stent 200 to be suitable for a wider range of physiological structures and older age groups. In this embodiment, when subjected to blood flow impact, the opening of the sac expands, causing the entire sac to swell and fill the gap between the annular frame and the heart, thereby preventing paravalvular leakage. Furthermore, the flexible skirt allows some antegrade blood flow to pass through, while expanding upon retrograde blood flow impact to block it, significantly increasing blood flow capacity and greatly extending valve lifespan. Therefore, the structural design of this embodiment greatly reduces the requirements of the valve stent on human physiological structures, expanding the applicable population, and also taking into account the avoidance of corresponding secondary hazards.
[0107] Example 7
[0108] See Figures 11 to 14 As shown, this embodiment provides a delivery system 300 for delivering the aforementioned prosthetic stent 100. The delivery system 300 includes a catheter 4, a soft cannula 5, a traction member 6, and the aforementioned prosthetic stent 100. The catheter 4 and the soft cannula 5 are coaxial. The soft cannula 5 is located at the distal end of the catheter 4 and at least partially outside the catheter 4. The traction member 6 is located inside the catheter 4. One end of the traction member 6 is connected to the soft cannula 5, and the other end of the traction member 6 extends from the proximal end of the catheter 4. After the annular frame 1 is contracted, it is placed inside the soft cannula 5 and located outside the catheter 4. The inner diameter of the catheter 4 is smaller than the outer diameter of the annular frame 1 after contraction. The inner wall of the soft cannula 5 compresses the connecting section 21 to deform so that the tip moves toward the axis of the annular frame 1.
[0109] The inner diameter of the flexible sleeve 5 is slightly larger than the outer diameter of the annular frame 1 after contraction. At the same time, half of the inner diameter of the flexible sleeve 5 is less than the distance from the outermost end of the connecting section 21 to the axis of the annular frame 1 when the annular frame 1 is contracted and the connecting section 21 is not deformed. The aforementioned flexible sleeve 5 has good flexibility, but the diameter of the flexible sleeve 5 cannot be expanded. After deformation, the flexible sleeve 5 can be housed inside the conduit 4, and the flexible sleeve 5 can bend as the conduit 4 bends.
[0110] In this embodiment, the traction element 6 includes a first retraction line 61 and a second retraction line 62. One end of the first retraction line 61 and the second retraction line 62 are connected to the flexible sheath 5, and the other ends of the first retraction line 61 and the second retraction line 62 extend from the proximal end of the conduit 4. During use, the flexible sheath 5 can be controlled by pulling the first retraction line 61 and the second retraction line 62, which not only simplifies the operation but also helps reduce manufacturing costs. In some embodiments, the traction element 6 may also use the same material and structure as the flexible sheath 5.
[0111] It is worth noting that when the prosthetic stent 100 in this embodiment is replaced with a valve stent 200, the delivery system can also be used to deliver the aforementioned valve stent 200.
[0112] During the process of delivering the prosthesis stent 100 or valve stent 200 into the body, the state of the delivery system 300 is as follows: Figure 11 As shown, during this process, the soft cannula 5 can bend along with the catheter 4. After the prosthesis stent 100 or valve stent 200 is delivered to the target position, the traction device 6 is pulled to retract the soft cannula 5 into the catheter 4. During this process, the prosthesis stent 100 or valve stent 200 is gradually released from the soft cannula 5. After the prosthesis stent 100 or valve stent 200 is freed from the restraint of the soft cannula 5, the annular frame 1 expands from the contracted state to the unfolded state. At the same time, the connecting section 21 of the barb 2 rebounds, causing the tip section 22 to expand outward and pierce into the human tissue. This achieves the fixation of the prosthesis stent 100 or valve stent 200. Finally, the catheter 4, soft cannula 5 and traction device 6 are withdrawn from the body.
[0113] Example 8
[0114] See Figure 18 As shown, this embodiment provides another delivery system 300, which includes a catheter 4, a soft cannula 5, and the aforementioned prosthetic stent 100 (or valve stent 200). The soft cannula 5 is inserted into the catheter 4, with both ends of the soft cannula 5 extending to the outside of the catheter 4. The annular frame 1 is retracted and placed inside the soft cannula 5. The annular frame 1 is located outside the catheter 4 and near the distal end of the catheter 4. The inner diameter of the catheter 4 is smaller than the outer diameter of the annular frame 1 after retraction. The inner wall of the soft cannula 5 compresses the connecting section 21 to deform so that the tip tends to be parallel to or at a certain angle to the outside of the annular frame 1.
[0115] In this embodiment, after the prosthetic stent 100 or valve stent 200 is delivered to the target position, the proximal end of the soft cannula 5 is pulled, causing the distal end of the soft cannula 5 to be retracted into the catheter 4. During this process, the prosthetic stent 100 or valve stent 200 is gradually released from the soft cannula 5. After the prosthetic stent 100 or valve stent 200 is freed from the restraint of the soft cannula 5, the annular frame 1 expands from the contracted state to the unfolded state. At the same time, the connecting section 21 of the barb 2 rebounds, causing the tip section 22 to expand outward and pierce into the human tissue. This achieves the fixation of the prosthetic stent 100 or valve stent 200. Finally, the catheter 4 and soft cannula 5 are withdrawn from the body.
[0116] Compared with Example 7, in Example 8, the soft sleeve 5 in the delivery system directly penetrates both ends of the conduit 4. The assembly of the soft sleeve 5 can be completed simply by inserting it into the conduit, making the assembly process simpler.
[0117] In Examples 7 and 8, the prosthetic stent 100 (or valve stent 200) and the soft sheath 5 both have a certain degree of flexibility, allowing the delivery system 300 to bend according to the physiological structure of the human body, greatly reducing the bending radius. Therefore, the delivery system 300 can be applied to more physiological structures and age groups. Moreover, during the release of the prosthetic stent 100 (or valve stent 200) into the body, the position of the prosthetic stent 100 (or valve stent 200) remains unchanged. Compared with the prior art, this invention does not require pushing the prosthetic stent 100 (or valve stent 200) completely out of the metal tube. The corresponding human body part only needs to have a length sufficient to accommodate the prosthetic stent 100 (or valve stent 200), further reducing the requirements on the human physiological structure.
[0118] The embodiments of this application have now been described in detail. To avoid obscuring the concept of this application, some details known in the art have not been described. Those skilled in the art can fully understand how to implement the technical solutions disclosed herein based on the above description.
[0119] While specific embodiments of this application have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of this application. Those skilled in the art should understand that modifications can be made to the above embodiments or equivalent substitutions can be made to some technical features without departing from the scope and spirit of this application. In particular, as long as there is no structural conflict, the various technical features mentioned in the embodiments can be combined in any manner.
Claims
1. A prosthetic scaffold, comprising an annular frame and barbs, wherein the annular frame has a cavity extending through both ends thereto, and the outer peripheral wall of the annular frame has a plurality of the barbs, characterized in that: One end of the barb is connected to the annular frame and is elastically deformable. The other end of the barb is a pointed tip, which faces the same end face of the annular frame. At least a portion of the barb protrudes along the axial direction of the annular frame from the line connecting the two ends of the barb.
2. The prosthetic stent according to claim 1, characterized in that: The barb includes a straight connecting segment and a barb tip; one end of the connecting segment is connected to the annular frame and is elastically deformable, the other end of the connecting segment is connected to one end of the barb tip, and the extension line of the connecting segment intersects or is not in plane with the axis of the annular frame; there is an angle between the barb tip and the connecting segment, and the end of the barb tip away from the connecting segment is a pointed tip; from the end of the barb tip near the connecting segment to the pointed tip, the barb tip gradually deviates from the annular frame.
3. The prosthetic stent according to claim 2, characterized in that: The extension line of the connecting segment intersects the axis of the annular frame.
4. The prosthetic stent according to claim 3, characterized in that: The angle between the connecting section and the axis of the annular frame is 45 to 80 degrees.
5. The prosthetic stent according to claim 1, characterized in that: The barb includes a straight tip and a curved connecting section. One end of the connecting section is connected to the annular frame and is elastically deformable. The other end of the connecting section is connected to one end of the tip. At least a portion of the connecting section protrudes along the axial direction of the annular frame from the line connecting the two ends of the barb. The end of the tip away from the connecting section is a pointed tip. From one end of the spiked segment near the connecting segment to the tip, the spiked segment gradually deviates from the annular frame.
6. The prosthetic stent according to claim 5, characterized in that: The side of the connecting segment adjacent to the annular frame is concave, and the side of the connecting segment away from the annular frame is convex.
7. The prosthetic stent according to any one of claims 2 to 6, characterized in that: The extension line of the spiked segment intersects the axis of the annular frame.
8. The prosthetic stent according to claim 7, characterized in that: The angle between the spiked segment and the axis of the annular frame is 10 to 25 degrees.
9. The prosthetic stent according to claim 2, characterized in that: The ring frame has a hollowed-out mesh structure.
10. The prosthetic stent according to claim 9, characterized in that: The annular frame has multiple mesh holes to form the hollow mesh structure. Adjacent mesh holes have common nodes, and the connecting segment is connected to the nodes.
11. The prosthetic stent according to claim 10, characterized in that: The mesh is hexagonal in shape.
12. A valve stent, characterized in that: Includes an artificial valve and a prosthetic stent as described in any one of claims 1 to 11, wherein three of the artificial valves are arranged in a ring array within the cavity, the edges of the artificial valves are fixed to the ring frame, and the end face of the ring frame facing the tip is the outflow end of blood.
13. The valve stent according to claim 12, characterized in that: It also includes a flexible skirt connected to the prosthesis stent, the flexible skirt surrounding the outside of the prosthesis stent and adjacent to the blood outflow end of the prosthesis stent.
14. The valve stent according to claim 13, characterized in that: The flexible skirt includes multiple pouches connected to the prosthesis stent. The multiple pouches are distributed at equal intervals around the prosthesis stent. The blood outflow end of each pouch is provided with an opening, and the other end of the pouch is sealed.
15. The valve stent according to any one of claims 12 to 14, characterized in that: It also includes sutures, and the annular frame is provided with multiple suture holes. The sutures are inserted into the suture holes and the artificial valve to fix the artificial valve to the annular frame.
16. A conveying system, characterized in that: The device includes a catheter, a soft cannula, a traction element, and a prosthetic stent as described in any one of claims 1 to 11. The catheter and the soft cannula are coaxial, the soft cannula is located at the distal end of the catheter and at least partially outside the catheter, the traction element is located inside the catheter, one end of the traction element is connected to the soft cannula, and the other end of the traction element extends from the proximal end of the catheter. The annular frame, after contraction, is placed inside the soft cannula and located outside the catheter. The inner diameter of the catheter is smaller than the outer diameter of the annular frame after contraction. The inner wall of the soft cannula compresses the connecting segment to deform so that the tip tends to be parallel to or at a certain angle to the outer side of the annular frame.
17. The conveying system according to claim 16, characterized in that: The traction device includes a first retraction line and a second retraction line, one end of the first retraction line and the second retraction line being connected to the soft cannula, and the other end of the first retraction line and the second retraction line extending from the proximal end of the catheter.
18. A conveying system, characterized in that: The device includes a catheter, a soft cannula, and a prosthetic stent as described in any one of claims 1 to 11. The soft cannula is inserted inside the catheter, with both ends of the soft cannula extending to the outside of the catheter. The annular frame is retracted and placed inside the soft cannula. The annular frame is located outside the catheter and near the distal end of the catheter. The inner diameter of the catheter is smaller than the outer diameter of the annular frame after retraction. The inner wall of the soft cannula compresses the connecting section to deform so that the tip tends to be parallel to or at a certain angle to the outside of the annular frame.
19. The conveying system according to any one of claims 16 to 18, characterized in that: The prosthetic stent is replaced by the valve stent according to any one of claims 12 to 15.