Conveying device
By designing a delivery device that includes a capsule, an inner sheath, and a sheath core, the problem of inaccurate implantation of artificial valves was solved, smooth blood flow and reduced paravalvular leakage were achieved, and implantation efficiency and positional stability were improved.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SHENZHEN LIFEVALVE MEDICAL SCI CO LTD
- Filing Date
- 2021-12-31
- Publication Date
- 2026-07-03
AI Technical Summary
In existing technologies, traditional implantation methods for artificial valves cannot ensure the precise positioning of the valve at the heart annulus, leading to problems such as poor blood flow and paravalvular leakage.
A delivery device was designed, comprising a covering body, an inner sheath, a sheath core mechanism, and an outer sheath. Through the design of the flow hole and the sliding engagement of the sheath core mechanism, the artificial valve maintains positional accuracy during implantation and allows blood flow after implantation, preventing paravalvular leakage.
This improved the implantation precision of artificial valves at the heart valve annulus, ensuring normal blood flow area and flow, reducing paravalvular leakage, and improving implantation efficiency and positional stability.
Smart Images

Figure CN116407353B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a delivery device and an electronic device including the delivery device. Background Technology
[0002] Heart valve disease has become one of the most common cardiovascular diseases. With the continuous development and improvement of interventional medical device technology, diseased valves such as the aortic valve, pulmonary valve, mitral valve, or tricuspid valve can be replaced by implanting artificial valves to achieve the goal of treatment. However, the traditional implantation method of artificial valves makes it difficult to implant them in the ideal position, thus affecting their efficiency and causing blood flow around the artificial valve (i.e., paravalvular leakage). Summary of the Invention
[0003] One of the technical problems solved by this invention is how to improve the positional accuracy of artificial valves after implantation.
[0004] A delivery device for delivering an artificial valve, the delivery device comprising:
[0005] The encapsulation body is tubular and used to encapsulate the artificial valve, and the encapsulation body has a flow hole that connects its internal cavity to the outside.
[0006] The inner sheath is slidable relative to the covering body; and
[0007] The sheath core mechanism is slidably inserted in the inner sheath and connected to the cover body. The sheath core mechanism is used for detachable connection with the artificial valve. During the release of the artificial valve from the inner sheath, fluid can flow out from inside the cover body through the flow hole.
[0008] In one embodiment, the covering is inserted inside the inner sheath and located between the sheath core mechanism and the inner sheath.
[0009] In one embodiment, the sheath core mechanism includes a traction assembly, a central sheath, and a mounting component. The central sheath passes through the inner sheath tube and is connected to the artificial valve. The mounting component is slidably connected to the central sheath and the inner sheath tube and is fixedly connected to the covering body. The traction assembly is connected to the mounting component.
[0010] In one embodiment, an outer sheath tube is also included, which is fixedly connected to the inner sheath tube. The traction assembly includes a guide and a traction line, the traction line being connected between the mounting member and the guide, and the guide being slidably connected to the outer sheath tube within a set stroke.
[0011] In one embodiment, the outer sheath has a large hole and a small hole that are interconnected. The diameter of the large hole is larger than the diameter of the small hole. The bottom wall of the large hole forms a stepped surface. The central sheath passes through the large hole and the small hole. The guide is slidably engaged with the large hole and can abut against the stepped surface to move synchronously with the outer sheath.
[0012] In one embodiment, the central sheath includes a core tube and an end cap, the end cap being connected to the distal end of the core tube and located outside the inner sheath tube, the proximal end of the end cap having a larger cross-sectional dimension than the inner sheath tube; the cross-sectional dimension of the end cap decreases from the proximal end to the distal end.
[0013] In one embodiment, the central sheath further includes a limiting member with a cross-sectional dimension larger than that of the core tube. The limiting member is accommodating within the inner sheath and includes a cylindrical segment and a tapered segment. The cross-sectional dimension of the cylindrical segment is larger than that of the tapered segment. The cylindrical segment connects the end and the tapered segment, and the tapered segment is connected to the core tube. The cross-sectional dimension of the tapered segment increases along the direction from the tapered segment to the cylindrical segment.
[0014] In one embodiment, the central sheath further includes a mounting base fixed to the core tube, the mounting base having a groove for fitting the artificial valve.
[0015] In one embodiment, the inner sheath includes a delivery section, a transition section, and a loading section. The loading section has a cross-sectional dimension greater than or equal to that of the delivery section and is used to accommodate an artificial valve. The transition section connects the delivery section and the loading section, and its cross-sectional dimension increases along the direction from the delivery section to the loading section.
[0016] In one embodiment, the cover includes a flow section for receiving the exposed portion of the artificial valve, and the flow orifice is formed on the flow section.
[0017] One technical advantage of an embodiment of the present invention is that by housing the artificial valve within a capsular body, a certain gap exists between the capsular body and the valve annulus when it is implanted. This prevents the artificial valve from anchoring to the valve annulus and ensures that the leaflets within the artificial valve can expand at a certain angle. Therefore, on the one hand, blood can flow through the gap between the capsular body and the valve annulus; on the other hand, under the impact of the blood, the leaflets within the artificial valve can expand at a certain angle, allowing blood to enter the artificial valve and flow out through the flow holes on the capsular body. This ensures a sufficiently large blood flow area and flow rate, preventing excessive pressure caused by a small or nonexistent flow area. This avoids displacement of the capsular body and the artificial valve under such pressure, ensuring that the artificial valve remains positioned at the implantation site, thereby improving the positional accuracy of the artificial valve after implantation. Attached Figure Description
[0018] Figure 1 This is a cross-sectional structural diagram of the delivery device introducing the artificial valve to the implantation site.
[0019] Figure 2 for Figure 1 A schematic diagram of the conveying device shown, in which the inner sheath is retracted to expose at least part of the flow hole of the covering body.
[0020] Figure 3 for Figure 1 A schematic diagram of the delivery device when the covering is retracted to expose part of the artificial valve;
[0021] Figure 4 for Figure 1 A schematic diagram of the planar structure of the first example cover in the conveying device shown;
[0022] Figure 5 for Figure 1 A schematic diagram of the planar structure of the second example covering body in the conveying device shown;
[0023] Figure 6 for Figure 1 A schematic diagram of the planar structure of the third type of covering body in the conveying device shown;
[0024] Figure 7 for Figure 1 A schematic diagram of the planar structure of the fourth type of covering body in the conveying device shown;
[0025] Figure 8 for Figure 1 A partial planar structural diagram of the fifth example of the covering body in the conveying device shown;
[0026] Figure 9 This is a schematic diagram of a delivery device that does not use a cover to implant an artificial valve into the valve annulus. Detailed Implementation
[0027] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the invention.
[0028] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.
[0029] See Figure 1 and Figure 4 According to one embodiment of the present invention, the delivery device 10 is used to implant an artificial valve 20 into the valve annulus 30 of a human heart. The artificial valve 20 includes a stent and leaflets. The stent is generally tubular, and there are multiple leaflets connected within the lumen of the stent. The stent has a certain degree of flexibility. When the stent contracts radially by a certain distance, the leaflets cannot swing relative to the stent, resulting in the inability to form a flow gap between the leaflets, thus preventing blood from flowing through the flow gap within the lumen of the stent. When the stent expands from a contracted state to a free state, the leaflets expand and can swing relative to the stent, thus forming a flow gap between the leaflets, ensuring that blood can flow through the flow gap within the lumen of the stent. The stent includes an exposed portion 21 and a covered portion 22 connected to each other. The covered portion 22 is covered with a membrane, so the covered portion 22 is a circumferentially closed structure, preventing blood within the lumen of the stent from flowing out of the stent through the covered portion 22. The exposed portion 21 is not covered by a membrane and has perforations, making it a circumferentially open structure. This allows blood within the stent lumen to flow out through these perforations. In short, blood cannot pass through the covered portion 22, but it can pass through the exposed portion 21. For ease of description, the ends of each component closer to the operator are referred to as proximal ends, and the ends farther from the operator are referred to as distal ends.
[0030] See also Figure 2 , Figure 3 and Figure 4In some embodiments, the delivery device 10 includes a covering body 100, an inner sheath 200, a sheath core mechanism 300, and an outer sheath 400. The inner sheath 200 and the outer sheath 400 are fixedly connected, for example, by bonding, threading, or other fixed connection methods. The sheath core mechanism 300 passes through the inner sheath 200 and the outer sheath 400, and the sheath core mechanism 300 can slide relative to the inner sheath 200 and the outer sheath 400. The covering body 100 can be located inside the inner sheath 200, such that the covering body 100 is located in the space between the inner sheath 200 and the sheath core mechanism 300. The covering body 100 is fixedly connected to the sheath core mechanism 300 and can slide relative to the inner sheath 200. During delivery, the artificial valve 20 is housed within the covering body 100 and detachably connected to the sheath core mechanism 300. When the artificial valve 20 is fully released into the valve annulus 30, the artificial valve 20 will detach from the sheath core mechanism 300, and the delivery device 10 can then be withdrawn from the body. The covering body 100 has a tubular structure and multiple flow holes 101. The flow holes 101 can be evenly distributed along the circumference of the covering body 100. The flow holes 101 connect the inner cavity of the covering body 100 with the outside, allowing blood in the inner cavity of the covering body 100 to flow out through the flow holes 101 to the outside of the covering body 100. In other embodiments, the covering body 100 can be sleeved outside the inner sheath tube 200, that is, the covering body 100 is located outside the lumen of the inner sheath tube 200.
[0031] In some embodiments, the proximal portion of the outer sheath 400 may be located outside the body for the operator to grip. The outer sheath 400 includes a first sheath 410 and a second sheath 420, which are threadedly connected. The first sheath 410 is positioned near the proximal end of the outer sheath 400, and the second sheath 420 is positioned near the distal end of the outer sheath 400. A portion of the inner sheath 200 passes through the second sheath 420 and is fixedly connected to it. The second sheath 420 has a large hole 421 and a small hole 422. The large hole 421 has a reasonable length, and its diameter is larger than that of the small hole 422. The large hole 421 and the small hole 422 together form a stepped hole, such that the bottom wall surface of the large hole 421 forms the stepped surface 423 of the stepped hole.
[0032] See Figure 1 , Figure 2 and Figure 3In some embodiments, the inner sheath 200 includes a loading section 210, a transition section 220, and a delivery section 230. The loading section 210 has the largest cross-sectional dimension, and the delivery section 230 has the smallest cross-sectional dimension. Both the delivery section 230 and the loading section 210 can be columnar structures. The delivery section 230 is fixedly connected to the second sheath 420. The covering body 100 and the artificial valve 20 are housed within the loading section 210. The transition section 220 is connected between the delivery section 230 and the loading section 210. Along the direction from the delivery section 230 to the loading section 210, the cross-sectional dimension of the transition section 220 can gradually increase, making the transition section 220 approximately conical in shape.
[0033] In some embodiments, the sheath core mechanism 300 includes a traction assembly 310, a central sheath 320, and a mounting member 330. The central sheath 320 passes through the inner sheath tube 200 and is connected to the artificial valve 20. The mounting member 330 may be generally disc-shaped and housed within the loading section 210 of the inner sheath tube 200. The covering body 100 is fixed to the mounting member 330. The mounting member 330 can be slidably fitted onto the central sheath 320, allowing it to slide relative to the central sheath 320. The inner sheath tube 200 is slidably fitted onto the mounting member 330, allowing the mounting member 330 to also slide relative to the inner sheath tube 200. The cross-sectional dimension of the mounting member 330 may be larger than the inner diameter of the transition section 220, preventing the mounting member 330 from sliding from the loading section 210 into the transition section 220, thus ensuring that the transition section 220 limits the sliding stroke of the mounting member 330.
[0034] The traction assembly 310 includes a guide member 311 and a traction line 312. The guide member 311 can be approximately annular and slidably fitted onto the central sheath 320, meaning the guide member 311 can slide relative to the central sheath 320. The guide member 311 slidably engages with a large hole 421 on the second sheath tube 420, allowing the guide member 311 to slide within a set stroke range with the outer sheath tube 400. Clearly, the length of the large hole 421 is the sliding stroke of the guide member 311 relative to the second sheath tube 420; that is, the guide member 311 slides relative to the second sheath tube 420 within the range set by the large hole 421. When the guide member 311 slides to the end of the large hole 421 and abuts against the stepped surface 423, the guide member 311 stops sliding relative to the second sheath tube 420. Since the inner sheath tube 200 is fixed to the second sheath tube 420, the guide member 311, the inner sheath tube 200, and the outer sheath tube 400 can maintain synchronous movement. The traction line 312 is a flexible rope that can be bent and wound. The proximal end of the traction line 312 is fixedly connected to the guide member 311, and the distal end of the traction line 312 is fixedly connected to the mounting member 330.
[0035] In some embodiments, the central sheath 320 includes a core tube 321, an end 322, a limiting member 323, and a fixing base 324. The core tube 321 is relatively long, allowing it to pass through both the inner sheath 200 and the outer sheath 400. The proximal end of the core tube 321 can protrude from the outer sheath 400, enabling it to be connected to a control mechanism for controlling its movement. The limiting member 323 has a larger cross-sectional dimension than the core tube 321, and can be housed within the loading section 210 of the inner sheath 200. The limiting member 323 includes a cylindrical segment 323a and a tapered segment 323b. The cross-sectional dimensions of the cylindrical segment 323a are uniform and approximately equal to the inner diameter of the loading segment 210. The tapered segment 323b is connected to the distal end of the core tube 321, i.e., the tapered segment 323b connects the core tube 321 and the cylindrical segment 323a. The cross-sectional dimensions of the tapered segment 323b are non-uniformly arranged, and the cross-sectional dimensions of the tapered segment 323b can gradually increase along the direction from the tapered segment 323b to the cylindrical segment 323a. By setting the tapered segment 323b, when the limiting member 323 is inserted from the distal end of the loading segment 210 into the loading segment 210, the tapered segment 323b can play a guiding role, reducing the interference resistance of the limiting member 323 during the assembly process and preventing the distal end of the loading segment 210 from deforming under the action of interference resistance. At the same time, when the limiting member 323 is installed inside the loading section 210, the limiting member 323 can restrain the radial deformation of the loading section 210, and also prevent the far end of the loading section 210 from deforming.
[0036] The end cap 322 is always located outside the loading section 210. The end cap 322 is connected to the cylindrical section 323a of the limiting member 323. The cross-sectional dimension of the proximal end of the end cap 322 is greater than or equal to the cross-sectional dimension of the inner sheath 200, allowing the end cap 322 to abut against the distal end of the loading section 210, ensuring a seal between the end cap 322 and the distal port of the loading section 210. Since the limiting member 323 prevents deformation of the distal port of the loading section 210, this improves the sealing efficiency of the end cap 322. Along the proximal to distal end of the end cap 322, the cross-sectional dimension of the end cap 322 can gradually decrease, making the end cap 322 approximately conical. By setting the end cap 322 to a conical shape, during delivery, the end cap 322 can be thoroughly compressed to open the diseased leaflet within the heart valve annulus 30 that needs replacement, allowing the artificial valve 20 to be smoothly implanted into the annulus 30.
[0037] The fixation seat 324 is connected to the core tube 321 and located within the loading section 210 of the inner sheath tube 200. The fixation seat 324 may have a groove 324a, which the artificial valve 20 engages with. After the artificial valve 20 is implanted, the artificial valve 20 will disengage from the groove 324a, allowing the artificial valve 20 to detach from the entire delivery device 10, so that the delivery device 10 can be smoothly withdrawn from the body.
[0038] The working principle and operation procedure of the conveying device 10 are described below:
[0039] See Figure 1 The first step involves delivering the inner sheath 200 to the valve annulus 30, ensuring the artificial valve 20 is accurately positioned for implantation. At this point, the tip 322 is stationary and presses against the distal end of the loading section 210. The limiting member 323, the covering body 100, and the artificial valve 20 are all housed within the loading section 210. Simultaneously, the guide member 311 is located in the middle of the large hole 421 within the second sheath 420, meaning the guide member 311 maintains a certain distance from the stepped surface 423, ensuring that the guide member 311 can slide relative to the entire outer sheath 400.
[0040] See Figure 2 In the second step, with end 322 stationary to ensure its absolute position remains constant, the outer sheath 400 is pulled, causing it to move synchronously with the inner sheath 200. This causes the inner sheath 200 to gradually retract relative to the covering body 100, gradually exposing the inner sheath 200. When the guide 311 moves to abut against the stepped surface 423, some or all of the flow holes 101 on the covering body 100 are outside the inner sheath 200. At this point, there is a certain radial distance between the covering body 100 and the valve ring 30.
[0041] Given the restraining effect of the covering 100, which maintains a certain distance from the valve annulus 30, on the artificial valve 20, it can both prevent the artificial valve 20 from anchoring to the valve annulus 30 and ensure that the leaflets can expand at a certain angle. Therefore, on the one hand, blood can flow through the gap between the covering 100 and the valve annulus 30; on the other hand, under the impact of blood, the leaflets inside the artificial valve 20 can expand at a certain angle, allowing blood to enter the artificial valve 20 and flow out through the flow hole 101 on the flow portion 111 of the covering 100. In other words, there are two blood flow paths: one is the gap between the covering 100 and the valve annulus 30, and the other is the space inside the covering 100. This ensures that the blood has a sufficiently large flow area and flow rate, improves the smoothness of blood flow to ensure that it is as close as possible to the normal blood flow rate, and prevents the large pressure caused by the small flow area or the inability to flow at all. This avoids displacement of the covering 100 and the artificial valve 20 under the action of such large pressure, ensuring that the artificial valve 20 is always positioned in the implantation position. This improves the positional accuracy of the artificial valve 20 after implantation, enhances the sealing effect of the artificial valve 20 on the valve annulus 30, effectively eliminates the gap between the artificial valve 20 and the valve annulus 30, and prevents blood from flowing in the gap and forming "paravalvular leakage". On the other hand, it eliminates the process of repeatedly adjusting the implantation position of the artificial valve 20, reduces the implantation difficulty and improves the implantation efficiency of the artificial valve 20.
[0042] In fact, if the sheath 100 is not provided, after the inner sheath 200 retracts a small distance, the small portion of the artificial valve 20 exposed outside the inner sheath 200 will immediately expand to the position of the valve annulus 30, thereby blocking the entire valve annulus 30 to eliminate the gap between the valve annulus 30 and the artificial valve 20. At this time, the small portion of the artificial valve 20 that expands cannot cause the leaflets to expand, so blood cannot flow through the artificial valve 20. In addition, since there is no gap for blood flow between the valve annulus 30 and the artificial valve 20, blood cannot flow at all, resulting in a large pressure. Ultimately, under this pressure, the artificial valve 20 deviates from the correct implantation position, reducing the positional accuracy of the artificial valve 20 after implantation.
[0043] See Figure 3 In the third step, with end 322 remaining stationary, the outer sheath 400 is pulled further. The outer sheath 400 drives the guide 311 to move synchronously, causing the guide 311 to move the mounting component 330 relative to the core tube 321 via the traction wire 312. This, in turn, causes the mounting component 330 to retract relative to the encapsulation body 100 relative to the artificial valve 20. Therefore, the artificial valve 20 gradually protrudes from the encapsulation body 100, bringing it into contact with the valve annulus 30. Clearly, the outer sheath 400, inner sheath 200, guide 311, mounting component 330, and encapsulation body 100 move synchronously. At this point, the expansion of the inner leaflets of the artificial valve 20 further increases, thus increasing the blood flow through the artificial valve 20 and further eliminating the impact of blood flow obstruction on the implantation position accuracy.
[0044] In the fourth step, the end cap 322 remains stationary. When the capsule 100 completely detaches from the artificial valve 20, the artificial valve 20 is fully exposed, and the artificial valve 20 also detaches from the groove 324a within the fixation seat 324, thereby releasing the connection between the artificial valve 20 and the entire delivery device 10, ensuring that the artificial valve 20 is accurately anchored at the implantation site. After the capsule 100 completely detaches from the artificial valve 20, the capsule 100 can undergo radial contraction. Next, the core tube 321 is pulled, causing it to move relative to the outer sheath 400, inner sheath 200, mounting member 330, and capsular body 100. After the end 322 is withdrawn from the implanted artificial valve 20, the end 322 continues to move towards the distal end of the loading section 210 of the inner sheath 200. When the proximal end of the fixation seat 324 abuts against the distal end of the mounting member 330, the fixation seat 324 can drive the mounting member 330 to move proximally, so that the capsular body 100 moves with the core tube 321 and is completely contained within the loading section 210. At this point, the entire delivery device 10 can be completely withdrawn from the body. In other embodiments, after the capsular body 100 is completely detached from the artificial valve 20, it can radially contract to clamp onto the core tube 321, and the core tube 321 can move the capsular body 100 together.
[0045] See Figure 1 In some embodiments, the cover 100 includes a receiving section 110, a necking section 120, and a connecting section 130, both of which can be columnar structures. The necking section 120 connects the receiving section 110 and the connecting section 130. The cross-sectional dimension of the receiving section 110 is larger than that of the connecting section 130. Along the direction from the connecting section 130 to the receiving section 110, the cross-sectional dimension of the necking section 120 increases, making the receiving section 110 conical. When the cover 100 is housed within the inner sheath 200, the shape of the cover 100 can be well adapted to the shape of the inner sheath 200, allowing the connecting section 130 to be housed within the conveying section 230, the necking section 120 to be housed within the transition section 220, and the receiving section 110 to be housed within the loading section 210.
[0046] The capsule 100 can have a certain degree of flexibility, allowing it to elastically compress in a direction perpendicular to its own axis; in simpler terms, the capsule 100 can undergo radial elastic compression. When the capsule 100 undergoes radial elastic compression, it allows the capsule 100, which encapsulates the artificial valve 20, to be smoothly inserted into the inner sheath 200. When the inner sheath 200 delivers the artificial valve 20 to the implantation site and the capsule 100 protrudes from the inner sheath 200, the capsule 100 will radially expand and return to its natural state, as the inner sheath 200 removes its constraint. At this time, the radial dimension of the capsule 100 increases, also causing the artificial valve 20 to undergo a certain degree of radial expansion. This allows the leaflets within the artificial valve 20 to expand at a larger angle under the impact of blood flow, thus increasing the blood flow through the artificial valve 20, reducing the impact of blood flow pressure on the artificial valve 20, and improving the post-implantation positioning accuracy.
[0047] See Figure 2 , Figure 3 and Figure 4In some embodiments, the receiving section 110 includes a flow portion 111 and a covering portion 112 connected to each other. The flow portion 111 is used to receive the exposed portion 21 of the artificial valve 20, and the covering portion 112 is used to receive the covered portion 22 of the artificial valve 20. When the receiving section 110 is received within the inner sheath 200, the covering portion 112 is closer to the distal port of the inner sheath 200 than the flow portion 111. A flow hole 101 is formed on the flow portion 111. The flow holes 101 can be evenly distributed along the axial direction of the flow portion 111. The shape of the flow holes 101 can be square, rhomboid, circular, or elliptical, etc. The flow holes 101 connect the inner cavity of the flow portion 111 to the outside. With the artificial valve 20 still contained within the cover body 100 at the implantation site, when the inner sheath 200 retracts a certain distance to expose the flow portion 111 of the cover body 100, blood entering the artificial valve 20 will flow out through the flow hole 101 of the flow portion 111 to the outside of the cover body 100. This effectively ensures that blood flows through the gap between the cover body 100 and the valve annulus 30, while also ensuring that blood enters the artificial valve 20 and flows out through the flow portion 111. This guarantees that the blood flow rate during implantation of the artificial valve 20 is close to the normal blood flow rate, preventing the pressure caused by poor blood flow from affecting the accuracy of the implantation position. Of course, when the retracted inner sheath 200 has not yet exposed the flow portion 111 of the cover body 100, blood can only flow within the gap between the cover body 100 and the valve annulus 30. Compared to the situation where the cover body 100 is not present and blood flow is completely blocked 111, the blood flow pressure will be significantly reduced. However, the short time required for the inner sheath 200 to retract to expose the flow portion 111 means that the blood flow pressure does not have enough time to affect the implantation position of the artificial valve 20.
[0048] See Figure 4 In some embodiments, the flow section 111 includes a first braided thread 141 and a second braided thread 142, meaning the flow section 111 is formed using the first braided thread 141 and the second braided thread 142 through a braiding process. There are multiple first braided threads 141 and multiple second braided threads 142. The first braided threads 141 are arranged at intervals along a first direction, and the second braided threads 142 are arranged at intervals along a second direction different from the first direction, such that the first braided threads 141 and the second braided threads 142 are intersecting each other and forming the flow hole 101. Furthermore, the first braided threads 141 and the second braided threads 142 can move relative to each other at the intersections, meaning they are not fixedly connected at the intersections. This gives the entire flow section 111 good flexibility and generates a large radial elastic compression. In other embodiments, the first braided threads 141 and the second braided threads 142 are fixedly connected at the intersections, or the first braided threads 141 and the second braided threads 142 are fixedly connected at some intersections, but can move relative to each other at some intersections.
[0049] For example, for the same first braided thread 141, at one portion of its intersections, the first braided thread 141 is located inside the second braided thread 142, and at another portion of its intersections, it is located outside the second braided thread 142. Clearly, when located inside, the first braided thread 141 is closer to the inner cavity of the flow portion 111; when located outside, the second braided thread 142 is closer to the inner cavity of the flow portion 111. Similarly, at one portion of its intersections, the first braided thread 141 is located inside the second braided thread 142, and at another portion, it is located outside the second braided thread 142. Furthermore, all the first braided threads 141 at their intersections may be located inside or outside the second braided thread 142. In other embodiments, the covering portion 112 is also made of the first braided thread 141 and the second braided thread 142, meaning the entire receiving portion is woven from the first braided thread 141 and the second braided thread 142.
[0050] See Figure 6 In some embodiments, the flow section 111 is integrally formed and includes multiple intersecting grid lines 143, with the gaps between the grid lines 143 forming flow holes 101, and two grid lines 143 are fixedly connected at their intersections. To fabricate the flow section 111, a tubular preform can first be formed by winding a thin sheet, and then the tubular preform can be processed using a laser cutting process to form the flow holes 101. Obviously, the ribs retained on the tubular preform that are not removed will form the grid lines 143. At this point, the tubular preform with the flow holes 101 will ultimately form the flow section 111. In other embodiments, the covering section 112 is also made using intersecting grid lines 143, meaning the entire receiving section 110 is integrally formed using intersecting grid lines 143.
[0051] See Figure 7In some embodiments, the cover 100 includes a first mounting ring 151, a second mounting ring 152, and a connecting rod 153. There is one first mounting ring 151 and one second mounting ring 152, which are spaced apart along the length of the connecting rod 153. The diameter of the first mounting ring 151 is smaller than the diameter of the second mounting ring 152. When the cover 100 is housed within the inner sheath 200, the second mounting ring 152 is positioned closer to the distal end of the inner sheath 200 relative to the first mounting ring 151. There are multiple connecting rods 153, which are spaced apart circumferentially along the cover 100. One end (proximal end) of each connecting rod 153 is connected to the first mounting ring 151, and the other end (distal end) of each connecting rod 153 is connected to the second mounting ring 152. The gap between two adjacent connecting rods 153 forms a flow hole 101. To fabricate the cover 100, a first mounting ring 151 and a second mounting ring 152 can be provided first, and then the two ends of a plurality of connecting rods 153 can be fixed to the first mounting ring 151 and the second mounting ring 152 by welding. The cover 100 of this embodiment may not have radial elastic compression function, making it easier to insert the cover 100 containing the artificial valve 20 into the inner sheath 200.
[0052] See Figure 8 In some embodiments, the flow section 111 includes multiple corrugated coils 144, each corrugated coil 144 being generally wave-shaped, thus having multiple raised crests and recessed troughs, with the crests and troughs arranged alternately along the circumference of the corrugated coil 144. Adjacent corrugated coils 144 are interlocked; specifically, for two adjacent corrugated coils 144, the crest of one corrugated coil 144 is attached to the trough of the other corrugated coil 144, thus forming flow holes 101 between the corrugated coils 144. The interlocked crests and troughs do not form a fixed connection. The flow section 111 in this embodiment also has good flexibility and generates a large radial elastic compression. In other embodiments, the covering section 112 has the same structure as the flow section 111, that is, the covering section 112 is also formed using interlocked corrugated coils 144, so that the entire receiving section 110 is formed using interlocked corrugated coils 144.
[0053] In some embodiments, see Figure 4 For example, the covering portion 112 has a mesh 102 that connects the inner cavity of the covering portion 112 to the outside. The diameter of the mesh 102 is smaller than the diameter of the flow hole 101. By setting the mesh 102 with a smaller diameter, the inner surface of the covering portion 112 can be made smoother, thereby reducing the friction between the covering portion 112 and the artificial valve 20. This facilitates the removal of the artificial valve 20 from the covering portion 112 during retraction, improving retraction efficiency and preventing damage to the covering portion 112 and the artificial valve 20 during retraction. (See also...) Figure 5 For example, the covering part 112 is a circumferentially closed structure, so that no mesh 102 is opened on the covering part 112, which can further reduce the friction between the covering part 112 and the artificial valve 20 during the retraction process.
[0054] See Figure 4 , Figure 5 and Figure 6 In some embodiments, in its natural state, the diameter of the covering portion 112 can gradually increase along the direction from the flow portion 111 to the covering portion 112, making the covering portion 112 approximately conical in shape, thereby making the radial dimension of the covering portion 112 larger than the radial dimension of the inner sheath 200. During the release of the artificial valve 20, when the inner sheath 200 is retracted and the covering portion 112 is fully exposed, the covering portion 112 expands to its natural state, making the radial dimension of the covering portion 112 larger than the radial dimension of the inner sheath 200. This results in a larger radial expansion of the artificial valve 20, ensuring a greater degree of expansion between the leaflets, allowing subsequent blood to flow through the artificial valve 20 at a larger flow rate and out through the flow hole 101, further reducing the pressure generated by the blood and improving the implantation accuracy of the artificial valve 20.
[0055] 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.
[0056] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, 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 delivery device for delivering a prosthetic valve, the delivery device comprising: The conveying device includes: The encapsulation body is tubular and used to encapsulate the artificial valve. The encapsulation body has a flow hole that connects its inner cavity to the outside, and the encapsulation body can slide relative to the artificial valve to release the artificial valve. The inner sheath is slidable relative to the covering body; and The sheath core mechanism is slidably inserted in the inner sheath and connected to the cover body. The sheath core mechanism is used for detachable connection with the artificial valve. During the process of the artificial valve being released from the inner sheath, the fluid flowing into the artificial valve can flow out through the flow hole from inside the cover body covering the artificial valve.
2. The delivery device of claim 1, wherein, The covering body is inserted inside the inner sheath tube and is located between the sheath core mechanism and the inner sheath tube.
3. The delivery device of claim 1, wherein, The sheath-core mechanism includes a traction assembly, a central sheath, and an mounting component. The central sheath passes through the inner sheath tube and is connected to the artificial valve. The mounting component is slidably connected to the central sheath and the inner sheath tube and is fixedly connected to the covering body. The traction assembly is connected to the mounting component.
4. The delivery device of claim 3, wherein, It also includes an outer sheath tube fixedly connected to the inner sheath tube. The traction assembly includes a guide and a traction line. The traction line is connected between the mounting member and the guide. The guide is slidably connected to the outer sheath tube within a set stroke.
5. The delivery device of claim 4, wherein, The outer sheath has a large hole and a small hole that are interconnected. The diameter of the large hole is larger than the diameter of the small hole. The bottom wall of the large hole forms a stepped surface. The central sheath passes through the large hole and the small hole. The guide is slidably engaged with the large hole and can abut against the stepped surface to move synchronously with the outer sheath.
6. The delivery device of claim 3, wherein, The central sheath includes a core tube and an end cap, the end cap being connected to the distal end of the core tube and located outside the inner sheath tube, the cross-sectional dimension of the proximal end of the end cap being greater than or equal to the cross-sectional dimension of the inner sheath tube; the cross-sectional dimension of the end cap decreases from the proximal end to the distal end.
7. The delivery device of claim 6, wherein, The central sheath further includes a limiting member with a cross-sectional dimension larger than that of the core tube. The limiting member is accommodated within the inner sheath and includes a cylindrical segment and a tapered segment. The cross-sectional dimension of the cylindrical segment is larger than that of the tapered segment. The cylindrical segment connects the end and the tapered segment. The tapered segment is connected to the core tube. The cross-sectional dimension of the tapered segment increases along the direction from the tapered segment to the cylindrical segment.
8. The delivery device of claim 6, wherein, The central sheath also includes a fixing seat fixed to the core tube, and the fixing seat has a groove for fitting the artificial valve.
9. The delivery device of claim 1, wherein, The inner sheath includes a delivery section, a transition section, and a loading section. The loading section has a larger cross-sectional dimension than the delivery section and is used to accommodate the artificial valve. The transition section connects the delivery section and the loading section, and its cross-sectional dimension increases along the direction from the delivery section to the loading section.
10. The delivery device of any of claims 1-9, wherein, The covering includes a flow section for receiving the exposed portion of the artificial valve, and the flow hole is formed on the flow section.