Lumen stent
Patent Information
- Application Number
- CN202111677226.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-12-31
- Publication Date
- 2026-08-21
- Estimated Expiration
- 2041-12-31
AI Technical Summary
上述支架植入至目标位置后,输送器自近端向远端方向后撤的过程中,输送器的某些部件(例如,Tip头)可能会钩挂住分支支架,使得分支支架带动主体支架短缩
[0021]本发明的管腔支架,在输送器自近端向远端方向后撤的过程中,即使该分支支架的自由端被输送器钩挂住并向近端方向拉动时,该自由端也能相对于主体支架活动,且自由端通过连接件与锚定部连接,故输送器钩挂分支支架的力沿连接件传递到锚定能力更强的锚定部上,而不会因直接作用于主体覆膜或主体波圈而导致主体支架短缩或移位。
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Figure CN116407371B_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of medical device technology, and specifically relates to a lumen stent. Background Technology
[0002] Minimally invasive interventional procedures are currently available for treating vascular diseases. These methods are minimally invasive, highly safe, and highly effective, thus gaining acceptance from both doctors and patients and becoming an important treatment option for vascular diseases. Interventional treatment involves implanting a vascular stent into the diseased segment of the blood vessel using a delivery system. The implanted stent can expand to support the narrowed or occluded segment of the vessel or seal any ruptures in the blood vessel, reducing elastic recoil and remodeling of the vessel, maintaining unobstructed blood flow, and preventing restenosis.
[0003] For endovascular treatment of aortic aneurysms or dissections involving branch arteries, bridging stenting techniques have become the current trend in treating aortic dissections or aortic aneurysms involving branch arteries due to their advantages such as low postoperative endoleak, good stent integrity, and continuous blood supply to the branch arteries during implantation. Bridging stenting techniques can be divided into branch stenting and external bridging stenting techniques based on the positional relationship of the bridging stent relative to the main stent. Among these, branch stenting techniques are easier to assemble and have relatively lower surgical difficulty, making them a current research focus.
[0004] Existing branch stents are fixed to the inner wall of the main stent membrane using sutures. For example, sutures run from one end of the branch stent to the other to ensure that the entire branch stent is tightly attached to the inner wall of the main stent membrane. After the stent is implanted at the target location, during the retraction of the delivery device from proximal to distal, certain components of the delivery device (e.g., the tip) may snag on the branch stent, causing the branch stent to shorten the main stent. Summary of the Invention
[0005] This invention provides a luminal stent, the purpose of which is to reduce the degree to which the branch stent causes shortening of the main stent. This objective is achieved through the following means:
[0006] This invention proposes a lumen stent, comprising:
[0007] A tubular main support, the main support including an anchoring part;
[0008] A branch support is disposed within the cavity of the main support, and the branch support includes a free end that is movable relative to the main support;
[0009] Connectors, which connect the free end of the branch bracket to the anchoring part respectively.
[0010] In one embodiment, the main support includes a membrane and a plurality of axially spaced main waverings connected to the membrane, the anchoring part includes bare waverings and / or anchor spikes, and the radial support force of the bare waverings is greater than the radial support force of the main waverings.
[0011] In one embodiment, the free end of the branch support is located at the proximal end of the branch support, and the anchoring portion is located at the proximal end of the main support; or, the free end of the branch support is located at the distal end of the branch support, and the anchoring portion is located at the distal end of the main support.
[0012] In one embodiment, the connector includes a straight or curved support rod, one end of which is connected to the anchoring part and the other end of which is connected to the free end of the branch bracket.
[0013] In one embodiment, the connector includes an elastic segment, the two ends of which are respectively connected to the anchoring part and the free end of the branch bracket; the elastic segment includes one or more of a helical spring structure, a planar folding structure, and an elastomer component.
[0014] In one embodiment, the planar folding structure includes a sawtooth wave, the sawtooth wave including sawtooths inclined toward the anchor or toward the branch support.
[0015] In one embodiment, the connector includes a helical segment that extends helically around the axis of the main support and at least partially conforms to the inner surface of the main support, and is movable relative to the inner surface of the main support.
[0016] In one embodiment, the helical segment includes a helical structure formed by one or more helical loops of a helical spring structure, a planar folded structure, or an elastomer member.
[0017] In one embodiment, the connector is fixedly or movably connected to the anchoring portion, and the connector is fixedly or movably connected to the free end of the branch bracket.
[0018] In one embodiment, the lumen support includes two connectors, which are respectively disposed on both sides of the branch support.
[0019] In one embodiment, the lumen support further includes an intermediate component movably connected to the anchor and connected to at least one connector.
[0020] In one embodiment, the lumen support includes a first connector and a second connector, the second connector being closer to the axis of the main support than the first connector, and the stiffness of the second connector being less than the stiffness of the first connector.
[0021] In the process of the lumen stent of the present invention, even when the free end of the branch stent is hooked by the conveyor and pulled in the proximal direction during the retraction of the conveyor from the proximal end to the distal end, the free end can still move relative to the main stent. Moreover, the free end is connected to the anchoring part through the connector. Therefore, the force of the conveyor hooking the branch stent is transmitted along the connector to the anchoring part with stronger anchoring ability, and the main stent will not shorten or shift due to direct action on the main body film or the main body corrugated coil. Attached Figure Description
[0022] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Wherein:
[0023] Figure 1 This is a schematic diagram of the structure of a lumen support according to an embodiment of the present invention;
[0024] Figure 2 This is a top view of the attachment segment in one embodiment of the present invention;
[0025] Figure 3 This is a front view of the attachment segment in one embodiment of the present invention;
[0026] Figure 4 for Figure 2 A schematic diagram of the planar development of a pair of main wave loops in the middle attachment section;
[0027] Figure 5 This is a planar unfolded schematic diagram of a pair of main wave loops of the attachment segment in another embodiment of the present invention;
[0028] Figure 6 This is a schematic diagram of the branch support structure in one embodiment of the present invention;
[0029] Figure 7 for Figure 6 Side view of the transition section of the middle branch support;
[0030] Figure 8 This is a front view of the attachment segment in another embodiment of the present invention;
[0031] Figure 9 for Figure 8 A schematic diagram of the planar development of a pair of main wave loops in the middle attachment section;
[0032] Figure 10This is a planar unfolded schematic diagram of a pair of main wave loops of the attachment segment in another embodiment of the present invention;
[0033] Figure 11 This is a schematic diagram of the branch support structure in another embodiment of the present invention;
[0034] Figure 12 This is a schematic diagram of the keel structure of the branch support in another embodiment of the present invention;
[0035] Figure 13 This is a schematic diagram of the structure of the elastic element in one embodiment of the present invention;
[0036] Figure 14 This is a schematic diagram of the elastic element in another embodiment of the present invention;
[0037] Figure 15 This is a schematic diagram of the structure of a lumen support according to an embodiment of the present invention;
[0038] Figure 16 This is a schematic diagram of the structure of a lumen support according to another embodiment of the present invention;
[0039] Figure 17 for Figure 16 Schematic diagram of the middle connector;
[0040] Figure 18a , Figure 18b This is a schematic diagram of the structure of a connector according to another embodiment of the present invention;
[0041] Figure 19 This is a schematic diagram of the connector structure in another embodiment of the present invention;
[0042] Figure 20 This is a schematic diagram of a connector with an intermediate component in one embodiment of the present invention;
[0043] Figure 21 This is a schematic diagram of a connector with an intermediate component in another embodiment of the present invention;
[0044] Figure 22 This is a schematic diagram of a connector with a helical segment in one embodiment of the present invention;
[0045] Figure 23 This is a schematic diagram of a connector with a helical segment in another embodiment of the present invention. Detailed Implementation
[0046] Exemplary embodiments of the present invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. These embodiments are provided so that this invention will be thorough and complete, and will fully convey the inventive concept to those skilled in the art.
[0047] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.
[0048] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.
[0049] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.
[0050] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end from which blood flows out, and "proximal" refers to the end from which blood flows in. For example, after stent implantation, blood flows from the proximal end of the stent toward the distal end; "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.
[0051] The "wave loop" in this invention is a closed ring structure, also known as a waveform ring, which can be woven or cut from a metallic elastic material or a polymer material. This metallic elastic material includes known materials used in implanted medical devices or combinations of various biocompatible materials, such as alloys of two or more single metals selected from cobalt, chromium, nickel, titanium, magnesium, and iron, as well as 316L stainless steel, nickel-titanium-tantalum alloys, or other biocompatible metallic elastic materials. The wave loop has radial expansion capability, allowing it to radially contract under external force and recover its initial shape and maintain it after the external force is removed, either by self-expansion or mechanical expansion (e.g., balloon inflation). Thus, after implantation into a lumen, its radial support force allows it to adhere tightly to the inner wall of the lumen. The waveform of the wave loop is unrestricted and includes Z-shaped waves, M-shaped waves, V-shaped waves, sine waves, etc. The wave loop includes multiple peaks (also known as proximal apexes), multiple troughs (also known as distal apexes), and wave rods connecting adjacent peaks and troughs. A wave is formed by a vertex (near or far) and two wave rods connected to that vertex.
[0052] In this invention, "wave number" refers to the number of wave crests or troughs, and the number of wave crests and troughs is the same within the same wave cycle. "Wave height" in this invention refers to the vertical distance between a wave crest and the line connecting two adjacent wave troughs.
[0053] Regarding the shortest axial distance between adjacent waveform units as referred to in this invention, we will take two axially adjacent waveform units, waveform unit A and waveform unit B, as an example for explanation. Waveform unit A is located near the end of waveform unit B. The shortest axial distance that waveform unit A needs to move to abut against waveform unit B is the shortest axial distance.
[0054] Example 1
[0055] like Figures 1-3 As shown, the lumen stent 100 in this embodiment includes a main stent 1 and a branch stent 2.
[0056] The main support 1 is a tubular structure with openings at both ends, including a main wave coil 11 and a main membrane 12. Multiple main wave coils 11 are arranged axially and connected by the tubular main membrane 12.
[0057] The main support 1 includes at least one attachment segment 13, which is tubular, and the branch support 2 is disposed within the cavity of the attachment segment 13. In this embodiment, within the attachment segment 13, the main corrugated coil 11 is disposed on the outer side of the main covering membrane 12 to enhance the friction between the attachment segment 13 and the inner wall of the cavity, which helps to prevent the main support 1 from shifting or shortening relative to the cavity. In other embodiments, the main corrugated coil 11 may be disposed on the inner side of the main covering membrane 12, or the main covering membrane 12 may be disposed on both the inner and outer sides of the main corrugated coil 11.
[0058] In this embodiment, in order to better fit the inner wall of the lumen, the cross-sectional shape of the attachment segment 13 is generally circular. In other embodiments, the cross-sectional shape of the attachment segment 13 can be elliptical or any other suitable shape.
[0059] Reference Figure 4 In this embodiment, the attachment segment 13 includes a first region 14 and a second region 16 connected to the first region 14 in the circumferential direction. The first region 14 includes a plurality of axially arranged first waveform units 15. The second region 16 includes a plurality of axially arranged second waveform units 17. Both the first waveform units 15 and the second waveform units 17 are part of the main waveform loop 11. In this embodiment, the first region 14 includes two axially arranged first waveform units 15, namely a proximal first waveform unit 15a closer to the proximal end and a distal first waveform unit 15b closer to the distal end. The second region 16 also includes two second waveform units 17, namely a proximal second waveform unit 17a closer to the proximal end and a distal second waveform unit 17b closer to the distal end.
[0060] The first waveform unit 15 includes multiple high waves with roughly the same height. The second waveform unit 17 includes multiple low waves with roughly the same height. The ratio of the wave height of the first waveform unit 15 to the wave height of the second waveform unit 17 is 1.2 to 1.8.
[0061] The proximal first waveform unit 15a includes a first proximal trough 151 and a first proximal peak 153, and the distal first waveform unit 15b includes a first distal trough 152 and a first distal peak 154. The proximal second waveform unit 17a includes a second proximal trough 171 and a second proximal peak 173, and the distal second waveform unit 17b includes a second distal trough 172 and a second distal peak 174.
[0062] The first waveform unit 15a at the proximal end and the first waveform unit 15b at the distal end are out of phase, that is, the first proximal valley 151 and the first distal peak 154 are opposite (close to each other), and the first proximal peak 153 and the first distal valley 152 are separated (far from each other). At least one line connecting the first proximal valley 151 and the first distal peak 154 is approximately parallel to the axis of the main support 1.
[0063] The proximal second waveform unit 17a and the distal second waveform unit 17b are out of phase, that is, the second proximal trough 171 is opposite to the second distal peak 174, and the second proximal peak 173 is separate from the second distal trough 172. At least one line connecting the second proximal trough 171 and the second distal peak 174 is approximately parallel to the axis of the main support 1. Alternatively, the proximal second waveform unit 17a and the distal second waveform unit 17b have a phase difference, that is, the second proximal trough 171 is opposite to the second distal peak 174, and the line connecting any second proximal trough 171 and the second distal peak 174 forms an angle with the axis of the main support 1.
[0064] Reference Figure 4 In this embodiment, the first proximal valley 151 and the second proximal valley 171 are approximately located in the same radial plane, and the first distal valley 152 and the second distal valley 172 are also approximately located in the same radial plane.
[0065] Reference Figure 5 In other embodiments, the first proximal peak 153 and the second proximal peak 173 are approximately located in the same radial plane, and the first distal trough 152 and the second distal trough 172 are also approximately located in the same radial plane. This arrangement helps to increase the axial distance between adjacent second waveform units 17, making the second region 16 more flexible. When the second region 16 is implanted onto the lesser curve of the aortic arch (i.e., the side with a greater degree of curvature and a smaller radius of curvature), it can better conform to the curvature of the lesser curve, thereby increasing the friction between the main stent 1 and the inner wall of the lumen and further preventing shortening; in addition, Figure 5 Both the proximal first waveform unit 15 and the distal first waveform unit 15b can be manufactured using the same mold (or tooling), and the proximal second waveform unit 17a and the distal second waveform unit 17b can also be manufactured using the same mold (or tooling), thus making the manufacturing process simpler and more efficient.
[0066] In this embodiment, the shortest axial distance (also known as axial spacing) between two adjacent first waveform units 15 is less than the shortest axial distance between two adjacent second waveform units 17. For example, the shortest axial distance between adjacent first waveform units 15 is 0 to 2 mm. In other embodiments, the first region 14 includes two or more first waveform units 15, and the second region 16 includes two or more second waveform units 17, then the shortest axial distance between any two adjacent first waveform units 15 is less than the shortest axial distance between any two adjacent second waveform units 17.
[0067] Because the shortest axial distance between two adjacent first waveform units 15 in the first region 14 is less than the shortest axial distance between adjacent second waveform units 17, and the wave height of the first waveform unit 15 is greater than the wave height of the second waveform unit 17, when shortened by external force, the first region 14 can shorten axially by less than the second region 16. Furthermore, in this embodiment, the axial lengths of the first region 14 and the second region 16 are the same, therefore, the axial shortening rate of the first region 14 is less than that of the second region 16. The axial shortening rate refers to the ratio of the axial shortening length to the axial length in the naturally unfolded state when subjected to an axial pressure F (e.g., 1N ≤ F ≤ 2N) until it can no longer shorten. The axial shortening rate of the first region 14 and the second region 16 can be measured by the following method: In the naturally unfolded state, the length of the region to be tested (the first region 14 or the second region 16) is a, and the diameter is d. The attachment segment 13 is fitted into an inner tube with a diameter of 0.9d (e.g., a relatively smooth inner tube). Axial pressure (e.g., 1N to 2N) is applied uniformly to both ends of the region to be tested. Once there is a position in the region to be tested where it can no longer be shortened, the axial pressure is stopped, and the axial length of the region to be tested is measured as b. The axial shortening rate of the region to be tested is (ab) ÷ a × 100%.
[0068] It should be noted that the shortest axial distance between adjacent first waveform units 15 should be appropriate. An excessively long shortest axial distance makes the axial shortening ratio of the first region 14 too large, while an excessively short shortest axial distance makes it easy for the relative peaks and troughs on adjacent first waveform units 15 to stack together when the first waveform unit 15 extends to both ends due to radial compression. This increases the difficulty of assembling the lumen support 100 and increases the assembly force.
[0069] The surface of the attachment segment 13 is provided with a window 131, which is located on the main cover 12 at a position without a corrugation. For example, a recessed segment 18 can be formed on the surface of the main support 1, and the attachment segment 13 is provided with a slope 132 connected to the recessed segment 18. The slope 132 is formed by a part of the main cover 12, and the window 131 can be provided on the slope 132. The recessed segment 18 can provide a larger extension space for the bridging stent (not shown) at the connection between the bridging stent and the main support 1 during implantation, making it less likely for the bridging stent to become occluded during and after implantation.
[0070] The branch stent 2 is disposed within the lumen of the attachment section 13, and the inner cavity of the branch stent 2 is connected to the window 131 to ensure that the implanted bridging stent can be smoothly inserted into the branch stent 2 through the window 131. In other embodiments, the window of the main stent 1 may be omitted, the inner cavity of the branch stent 2 is connected to the inner cavity of the main stent 1, and the bridging stent can enter the main stent 1 from the distal end of the main stent 1 and be inserted into the branch stent 2.
[0071] Reference Figure 6 The branch support 2 includes branch wave coils 21 and branch cladding 22, with multiple branch wave coils 21 connected by the branch cladding 22. The branch support 2 includes two branch tubes 23 and a transition section 24. The distal end of the transition section 24 is connected to window 131 (see reference). Figure 1 The two branch tubes 23 are sealed together, with their distal ends connected to the proximal end of the transition section 24. The proximal end of the branch tube 23 is a free end and faces the proximal end of the main stent 1. The branch tube 23 and the transition section 24 can be an integral structure, formed by multiple branch coils 21 spaced apart and covered with a membrane on their inner and / or outer sides. In its naturally extended state, the axis of the branch tube 23 is approximately parallel to the axis of the main stent 1, which reduces the difficulty of bridging stent implantation and does not significantly affect blood flow within the lumen of the main stent 1. In other embodiments, the angle between the axial direction of the branch tube 23 and the axial direction of the main stent 1 can be any other angle within the range of 0° to 15°. Furthermore, the number of branch tubes 23 is not limited; there can be one or more, depending on the number and location of the bridging stents to be inserted. Therefore, it can meet the needs of emergency surgery in clinical use, avoiding the need for long waiting times due to custom-made stents and missing the optimal treatment opportunity. In addition, the branch cover 22 on the branch support 2 can also be formed by splicing multiple covers together through stitching, bonding and other methods.
[0072] Please refer to the following at the same time Figure 7The transition section 24 includes an arc-shaped sheet 241 and a relatively flat base 242. The arc-shaped sheet 241 and the base 242 together form a tubular structure with a roughly crescent-shaped cross-section. The arc-shaped sheet 241 is positioned closer to the inner wall of the attachment section 13 than the base 242, so that the transition section 24 fits better with the inner wall of the attachment section 13. Furthermore, the transition section 24 includes a small-diameter end and a large-diameter end. The small-diameter end is connected to the distal end of the branch pipe 23, and the large-diameter end is connected to the window 131. The radial dimension of the small-diameter end matches the radial dimension of the branch pipe 23, and the radial dimension of the large-diameter end matches the dimension of the window 131, thereby achieving a sealed connection between the small-diameter end and the branch pipe 23, and a sealed connection between the transition section 24 and the window 131. The transition section 24 can be connected to the window 131 and the branch pipe 23 by means of stitching, bonding, etc. A first annular support member may also be provided at the edge of the large-diameter end of the transition section 24 or the edge of the window 131 to maintain the stability of the shape of the window 131.
[0073] The shape of the window 131 in this invention is not limited and can be circular, elliptical, crescent-shaped, or any other arbitrary shape. The radial dimension of the window 131 is larger than the radial dimension (e.g., diameter) of the branch tube 23, thereby facilitating the implantation of the bridging stent. In other embodiments, multiple windows 131 and multiple branch stents 2 can be provided on the surface of the main stent 1. The multiple windows 131 are spaced apart along the axial direction of the main stent 1, thereby allowing the specific fixing position of the main stent 1 to be adjusted according to the structure of the arterial blood vessels, thereby enabling the reconstruction of blood supply to multiple branch vessels. It is understood that in this embodiment, the branch tube 23 of the branch stent 2 is closer to the proximal end of the main stent 1 than the transition section 24. In other embodiments, the branch tube 23 of the branch stent 2 may also be closer to the distal end of the main stent 1 than the transition section 24. Alternatively, when multiple branch stents 2 are provided, in the case of multiple branch stents 2, the branch tube 23 of some branch stents 2 is closer to the proximal end of the main stent 1, while the main body of another portion of the branch stents 2 is closer to the distal end of the main stent 1.
[0074] Please refer to the following at the same time Figures 1-3 In this embodiment, the branch support 2 is connected to the first region 14, and the distance from the branch support 2 to the first region 14 is less than the distance from the branch support 2 to the second region 16. Since the branch support 2 is connected to the first region 14, which has a low axial shortening rate, even if the branch support 2 is hooked by the conveyor and causes the main support 1 to deform, the first region 14 connected to the branch support 2 can still greatly reduce the shortening rate of the main support 1.
[0075] In this embodiment, the branch stent 2 is fitted to the inner wall of the first region 14, and the tangent areas of the branch stent 2 and the first region 14 are sutured together and fixed. For example, there is a tangent line extending approximately axially between the branch tube 23 and the inner wall of the first region 14. The tangent points of the branch tube 23 and the inner wall of the first region 14 (i.e., along the tangent line) are sutured to fix the branch tube 23 and the first region 14, so that multiple fixing points are formed on the tangent line between the branch tube 23 and the inner wall of the first region 14. Fixing points are provided on both the proximal port (i.e., the free end 20a of the branch stent 2) and the distal port of the branch tube 23. A second annular support can be provided on the free end 20a of the branch stent 2 to ensure that the shape of the branch stent 2 does not change significantly under the impact of blood flow or when it is hooked by the delivery device, effectively preventing the branch stent 2 from shortening. Furthermore, the side of the transition segment 24 that fits against the first region 14 (i.e., the arc-shaped sheet 241) can be connected to the first region 14 via sutures to ensure better fit between the transition segment 24 and the inner wall of the first region 14, and to minimize the gap between the transition segment 24 and the first region 14, preventing blood from accumulating in the gap and causing thrombosis. In other embodiments, the transition segment 24 is connected to the window 131 at one end and to the branch tube 23 at the other end; other areas may not be fixed to the first region 14. Additionally, in other embodiments, the branch support 2 can be fixed to the first region 14 by bonding or other methods.
[0076] Please refer to the following at the same time Figure 1 , Figure 4 The length and position of the branch tube 23 affect performance. In this embodiment, the ratio of the length of the branch tube 23 to the wave height of the first waveform unit 15 can be 0.5 to 2.2. The proximal port of the branch tube 23 and the wave crest of the proximal first waveform unit 15a are approximately located on the same radial plane, or the proximal port of the branch tube 23 is located between the first proximal wave crest 153 and the first distal wave trough 152. The purpose of this arrangement is to position the branch tube 23 in the first region 14 where it is supported by the first waveform unit 15, thereby making it more difficult for the branch support 2 to shorten the main support 1.
[0077] Example 2
[0078] Reference Figure 8 , Figure 9 This embodiment is largely the same as the lumen support 100 in Embodiment 1, except for the structure of the first waveform unit 35 and the second waveform unit 37 in the attachment segment 13, and the connection method between the branch support 2 and the first region 14.
[0079] like Figure 9As shown, both the first waveform unit 35 and the second waveform unit 37 are part of the main waveform loop 11. In this embodiment, the first region 14 includes two axially arranged first waveform units 35, namely a proximal first waveform unit 35a closer to the proximal end and a distal first waveform unit 35b closer to the distal end. The second region 16 also includes two second waveform units 37, namely a proximal second waveform unit 37a closer to the proximal end and a distal second waveform unit 37b closer to the distal end.
[0080] The proximal first waveform unit 35a and the distal first waveform unit 35b are out of phase. The proximal second waveform unit 37a and the distal second waveform unit 37b are out of phase; or, there is a phase difference between the proximal second waveform unit 37a and the distal second waveform unit 37b. The wave height of the first waveform unit 35a is greater than the wave height of the second waveform unit 37b. The proximal first waveform unit 35a includes multiple first proximal peaks 353 and multiple first proximal valleys 351, which are generally located in the same radial plane. Similarly, the distal first waveform unit 35b includes multiple first distal peaks 354 and multiple first distal valleys 352, which are generally located in the same radial plane. The proximal second waveform unit 37a includes multiple second proximal peaks 373, which are generally located in the same radial plane, and multiple second proximal valleys 371, which are located in different radial planes. The distal second waveform unit 37b includes a plurality of second distal troughs 372 generally located in the same radial plane, and a plurality of second distal peaks 374 located in different radial planes. The second proximal troughs 371 that are closer to the first region 14 circumferentially are closer to the proximal end of the main support 1 axially, and / or, the second distal peaks 374 that are closer to the first region 14 circumferentially are closer to the distal end of the main support 1 axially. For example, in this embodiment, in the proximal second waveform unit 37a, the second proximal peaks 373 are all closer to the distal end than the first proximal peaks 353, the second proximal troughs 371 are all closer to the proximal end than the first proximal troughs 351, and the second proximal troughs 371 that are farther from the proximal first waveform unit 35a are offset more proximally relative to the first proximal troughs 351. Figure 9As shown, the line connecting the second proximal troughs 371 forms an angle α with the radial plane, where 0 < α ≤ 20°. In other embodiments, the line connecting the second proximal troughs 371 may not be straight; for example, it may be stepped. In the distal second waveform unit 37b, the second distal troughs 372 are all closer to the proximal end than the first distal troughs 352, and the second distal peaks 374 are all closer to the distal end than the first proximal peaks 353. Furthermore, the distance a second distal peak 374 is further from the distal first waveform unit 35b is greater relative to the first distal peak 354. For example, the line connecting the second distal peaks 374 forms an angle β with the radial plane, where 0 < β ≤ 20°. In other embodiments, the line connecting the second distal peaks 374 may not be straight; for example, it may be stepped. Since the second proximal trough 371 is distributed on different radial planes and the second distal peak 374 is distributed on different radial planes, when the second waveform unit 37 is radially compressed, the second proximal trough 371 and the second distal peak 374 will not accumulate on the same radial plane. This reduces the radial compression size and assembly difficulty of the luminal stent 100 while ensuring the same radial force. In addition, when the second waveform unit 37 is implanted into the lesser curve of the aortic arch, it can better fit the curvature of the lesser curve, thereby increasing the friction between the main stent 1 and the inner wall of the lumen and further preventing shortening.
[0081] In this embodiment, the shortest axial distance (also known as axial spacing) between two adjacent first waveform units 35 is less than the shortest axial distance between two adjacent second waveform units 37. For example, the shortest axial distance between adjacent first waveform units 35 is 0-2 mm. In other embodiments, the first region 14 includes two or more first waveform units 35, and the second region 16 includes two or more second waveform units 37, then the shortest axial distance between any two adjacent first waveform units 35 is less than the shortest axial distance between any two adjacent second waveform units 37.
[0082] Because the shortest axial distance between two adjacent first waveform units 35 in the first region 14 is less than the shortest axial distance between adjacent second waveform units 37, and the wave height of the first waveform unit 35 is greater than the wave height of the second waveform unit 37, when shortened by external force, the amount of axial shortening of the first region 14 is less than that of the second region 16. Therefore, the axial shortening rate of the first region 14 is less than that of the second region 16. Even if the main support 1 is driven by the branch support 2, the first region 14 can still greatly reduce the shortening degree of the main support 1.
[0083] Reference Figure 8In this embodiment, the branch tube 23 can also be connected to the first region 14 by suturing. For example, there is a generally axially extending tangent between the branch tube 23 and the inner wall of the first region 14. The suture can be run from the distal end of the branch tube 23 along the tangent towards the proximal end (or from the proximal end to the distal end), and the suture ends near the proximal end of the branch tube 23. This results in the branch tube 23 having a fixed segment sutured and fixed to the first region 14 and located at the distal end, and a movable segment (at least including the free end 20a of the branch stent 2) that can move relative to the main stent 1 and located at the proximal end. The ratio of the length of the movable segment to the length of the fixed end is 0.1 to 1, to ensure that the movable segment can move relatively flexibly relative to the main stent 1, and to avoid the instability of the branch tube 23 under the impact of blood flow. For the transition segment 24, the side of the transition segment 24 that fits against the first region 14 (i.e., the arc-shaped sheet 241) can be connected to the first region 14 by sutures, so that the transition segment 24 fits better against the inner wall of the first region 14, and the gap between the transition segment 24 and the first region 14 can be minimized to prevent blood from pooling in the gap and causing thrombosis. In other embodiments, the transition segment 24 has only one end and window 131 (see reference). Figure 1 One end is connected to the first region 14, and the other end is connected to the branch pipe body 23. Other areas may not be fixed to the first region 14. In addition, in other embodiments, the fixed connection between the branch bracket 2 and the first region 14 can also be by bonding, etc.
[0084] In this embodiment, by setting a branch support 2 with a movable free end 20a, even if the free end 20a of the branch support 2 is hooked by the conveyor and pulled towards the near end during the process of the conveyor retracting from the near end to the far end, the free end 20a can still move relative to the main support 1. Therefore, the force of the branch support 2 driving the main support 1 to move towards the far end can be weakened to a certain extent, thereby reducing the risk of the branch support 2 causing the main support 1 to shorten.
[0085] The location of the branch bracket 2 and the position of the fixing point between the branch bracket 2 and the first region 14 also affect the anti-shortening performance. In this embodiment, the free end 20a of the branch bracket 2 is approximately flush with the first proximal wave crest 353, or the free end 20a of the branch bracket 2 is located between the first proximal wave crest 353 and the first proximal wave trough 351; and the nearest fixing point between the branch bracket 2 and the first region 14 is located between the first proximal wave crest 353 and the first proximal wave trough 351. In this embodiment, even if the branch bracket 2 drives the main bracket 1 to move to the distal end, it will only drive the area near the proximal first waveform unit 35a to move to the distal end. Since the shortest axial distance between the proximal first waveform unit 35a and the distal first waveform unit 35b is small, the shortening degree of the main bracket 1 is greatly reduced.
[0086] Example 3
[0087] Reference Figure 10 , Figure 11 This embodiment is largely the same as the lumen support 100 in Embodiments 1 and 2, except for the structure of the first waveform unit 45, the second waveform unit 47 and the branch support 2, as well as the connection method between the branch support 2 and the first region 14.
[0088] Reference Figure 10 The first proximal peak 453 of the proximal first waveform unit 45a and the second distal peak 473 of the proximal second waveform unit 47a are approximately located in the same radial plane. The first proximal trough 451 of the proximal first waveform unit 45a and the second proximal trough 471 of the proximal second waveform unit 47a are approximately located in the same radial plane. The first distal peak 454 of the distal first waveform unit 45b and the second distal peak 474 of the distal second waveform unit 47b are approximately located in the same radial plane. The first distal trough 452 of the distal first waveform unit 45b and the second distal trough 472 of the distal second waveform unit 47b are approximately located in the same radial plane. That is, the wave height of the first waveform unit 45 is approximately equal to the wave height of the second waveform unit 47. In addition, the proximal first waveform unit 45a and the distal first waveform unit 45b are out of phase. The proximal second waveform unit 47a and the distal second waveform unit 47b are in phase, that is, the line connecting the second proximal trough 471 and the second distal trough 472 is approximately parallel to the axis of the main support 1, and the line connecting the second proximal peak 473 and the second distal peak 474 is approximately parallel to the axis of the main support 1. In other embodiments, a phase difference may exist between the proximal second waveform unit 47a and the distal second waveform unit 47b.
[0089] In this embodiment, the shortest axial distance (also known as axial spacing) between two adjacent first waveform units 45 is less than the shortest axial distance between two adjacent second waveform units 47. For example, the shortest axial distance between adjacent first waveform units 45 is 1 to 2 millimeters. In other embodiments, the first region 14 includes two or more first waveform units 45, and the second region 16 includes two or more second waveform units 47, then the shortest axial distance between any two adjacent first waveform units 45 is less than the shortest axial distance between any two adjacent second waveform units 47.
[0090] Since the shortest axial distance between two adjacent first waveform units 45 in the first region 14 is less than the shortest axial distance between adjacent second waveform units 47, and the wave height of the first waveform unit 45 is approximately equal to the wave height of the second waveform unit 47, when shortened by external force, the amount of axial shortening of the first region 14 is less than that of the second region 16. Therefore, the axial shortening rate of the first region 14 is less than that of the second region 16. Even if the main support 1 is driven by the branch support 2, the first region 14 can greatly reduce the shortening degree of the main support 1. In addition, in this embodiment, the wave height of the first waveform unit 45 is approximately equal to the wave height of the second waveform unit 47. Compared with the high and low wave design, the hollow membrane region of the attachment segment 13 in this embodiment (i.e., the region where the main body film 12 is not covered on the waveform unit) is more uniform and round in the circumferential direction, and is less likely to cause a large accumulation of film on one side when bent.
[0091] Reference Figure 11 In this embodiment, the branch tube 23 of the branch support 2 is further provided with a straight or curved keel 25. The keel 25 can be a rigid or flexible structure, and can be made of an alloy of two or more single metals selected from cobalt, chromium, nickel, titanium, magnesium, and iron, as well as 316L stainless steel, nickel-titanium-tantalum alloy, or other biocompatible elastic metallic materials. The keel 25 connects the nearest branch coil 21 and the farthest branch coil 21, which can prevent the branch support 2 from shortening to a certain extent. In other embodiments, the keel 25 can also extend to the transition section 24 of the branch support 2.
[0092] Reference Figure 12 In other embodiments, the keel 25 is disposed on the outer surface of the branch support 2, and the branch support 2 is connected to the main support 1 through the keel 25. Since the keel 25 is connected to the main support 1, it can also prevent the main support 1 from shortening to a certain extent. The proximal end of the keel 25 can extend beyond the proximal port of the branch support 2 to improve the anti-shortage performance. Furthermore, the proximal end of the keel 25 can extend further proximal and abut against the bare wave coil 11a, which can more effectively prevent the shortening of the branch support 2 and the main support 1. In other embodiments, the proximal end of the keel 25 can also be located between the proximal port of the branch support 2 and the bare wave coil 11a, without abutting against the bare wave coil 11a.
[0093] Example 4
[0094] Reference Figure 13 This embodiment is largely the same as the lumen support 100 in embodiments 1-3, except that one or more elastic elements 56 are provided between adjacent first waveform units 55. The elastic elements 56 can be integrally woven or cut with the first waveform units 55, or they can be connected to the first waveform units 55 by means of bonding, welding, etc.
[0095] Figure 13 The first waveform unit 55 and the second waveform unit 57 shown are substantially the same as those in Embodiment 1. The elastic element 56 includes a spring segment, one end of which is connected to the trough of the proximal first waveform unit 55a, and the other end is connected to the peak of the distal first waveform unit 55b, with the peak and trough being opposite to each other.
[0096] Figure 14 The first waveform unit 55 and the second waveform unit 57 shown are substantially the same as those in Embodiment 1, except that adjacent first waveform units 55 have the same phase. The elastic element 56 is a metal wire made of a biocompatible metallic elastic material, and the metal wire includes at least one wave, with waveforms including Z-shaped, M-shaped, V-shaped, and sinusoidal shapes. One end of the elastic element 56 is connected to the wave rod of the proximal first waveform unit 55a, and the other end is connected to the wave rod of the distal first waveform unit 55b.
[0097] This embodiment incorporates an elastic element 56, which possesses a certain degree of elasticity in the axial direction. Please also refer to... Figure 1 When the branch support 2 applies a force to the first region 14 to move distally, the elasticity of the elastic element 56 can provide a certain degree of buffering, thus effectively preventing the main support 1 from shortening regardless of the structure of the first waveform unit 55. In addition, when the attachment section 13 is in a radially compressed state, the elastic element 56 can prevent the opposing peaks and troughs on adjacent first waveform units 55 from stacking together.
[0098] Example 5
[0099] Reference Figure 15 This embodiment is largely the same as the lumen support 100 in embodiments 1-4, except that the lumen support 100 in this embodiment also includes a connector 19, and the main support 1 includes an anchoring part 10.
[0100] In this embodiment, the anchoring part 10 is located at the proximal end of the main support 1. When the lumen stent 100 is implanted into the human lumen, the anchoring part 10 forms an anchor with the inner wall of the human lumen, which can prevent the main support 1 from shifting during the operation and in the long term to a certain extent.
[0101] In this embodiment, the anchoring part 10 includes one or more bare wave rings 11a disposed near the main body support 1. The bare wave rings 11a are fixedly connected to the near end of the main body covering film 12, and at least part of the bare wave rings 11a are exposed, that is, the main body covering film 12 only partially covers the bare wave rings 11a or does not cover the bare wave rings 11a.
[0102] In other embodiments, the anchoring portion 10 may further include one or more anchor spikes (not shown) disposed on the bare waveband 11a. For example, multiple wave crests of the bare waveband 11a have anchor spike posts extending proximally, and the anchor spike posts are provided with anchor spikes integrally formed with the anchor spike posts. The anchor spikes extend outward from the anchor spike posts they are located on and point towards the distal end. After the lumen stent 100 is implanted into the human lumen, the anchor spikes can form a reliable fixed connection between the proximal end of the main stent 1 and the inner wall of the human lumen, further improving the anchoring force between the anchoring portion 10 and the inner wall of the human lumen. It is understood that in other embodiments, the bare waveband 11a may be omitted from the anchoring portion 10, and the anchor spikes in the anchoring portion 10 may be directly connected to the proximal edge of the main stent 1, which can also achieve the anchoring effect.
[0103] In this embodiment, the radial support force of the bare waveguide 11a is greater than that of the main waveguide 11. For example, the ratio of the radial support force of a single bare waveguide 11a to that of a single main waveguide 11 ranges from 1.1 to 2. The radial support forces of the bare waveguide 11a and the main waveguide 11 can be adjusted by adjusting parameters such as the material, wire diameter, wave angle, wave height, and wave number of the bare waveguide 11a and the main waveguide 11. For example, when other parameters of the bare waveguide 11a and the main waveguide 11 are the same, the material stiffness of the bare waveguide 11a can be made greater than the stiffness of the material used in the main waveguide 11, thereby making the radial support force of the bare waveguide 11a greater than that of the main waveguide 11; when the bare waveguide 11a and the main waveguide 11 are made of the same material, other waveform parameters can be kept the same, while the wire diameter of the bare waveguide 11a can be made greater than that of the main waveguide 11, thereby making the radial support force of the bare waveguide 11a greater than that of the main waveguide 11.
[0104] Since the bare wave coil 11a is at least partially exposed and has a large radial support force, it can have better anchoring ability after the lumen stent 100 is implanted into the human lumen, thus better resisting axial relative displacement.
[0105] In this embodiment, the free end 20a of the branch tube 23 is movable relative to the main stent 1. For example, there is a generally axially extending tangent between the branch tube 23 and the inner wall of the main stent 1. The suture can be run from the distal end of the branch tube 23 along the tangent towards the proximal end (or from the proximal end to the distal end), and the suture ends near the proximal end of the branch tube 23. This results in the branch tube 23 having a fixed segment that is sutured and fixed to the main stent 1 and located at the distal end, and a movable segment (at least including the free end 20a of the branch stent 2) that is movable relative to the main stent 1 and located at the proximal end. The ratio of the length of the movable segment to the length of the fixed end is 0.1 to 1, which ensures that the movable segment can move relatively flexibly relative to the main stent 1, and also avoids the instability of the branch tube 23 under the impact of blood flow. For the transition segment 24, the side of the transition segment 24 that fits against the main support 1 can be connected to the main support 1 via sutures. This allows for better fit between the transition segment 24 and the inner wall of the main support 1, and minimizes the gap between the transition segment 24 and the main support 1, preventing blood from pooling in the gap and causing thrombosis. In other embodiments, the transition segment 24 has only one end and window 131 (see reference). Figure 1 One end is connected to the main support 1, and the other end is connected to the branch pipe body 23. Other areas may not be fixed to the main support 1. In addition, in other embodiments, the fixed connection between the branch support 2 and the main support 1 can also be by bonding, heat fusion, etc.
[0106] The free end 20a of the aforementioned branch pipe body 23 is connected to the anchoring part 10 via a connector 19. In this embodiment, the connector 19 includes a support rod, one end of which is connected to the anchoring part 10 (e.g., the bare corrugated coil 11a of the anchoring part 10), and the other end is connected to the free end 20a of the branch support. For example, one end of the support rod is fixedly connected to the anchoring part 10 by welding, bonding, hot melting, sewing, or wrapping, and the other end of the support rod can be fixedly connected to one or more of the branch corrugated coil 21 at the nearest end of the branch pipe body 23, the branch covering membrane 22 at the free end 20a, and the second annular support member.
[0107] The support rod can be made of biocompatible polymer materials, metal materials, etc., with a diameter of 0.05mm to 0.3mm. The specific shape of the support rod is not required and can be straight and / or curved.
[0108] In this embodiment, the support rod is integrally attached to the surface of the main support 1, and the support rod is movable relative to the main film 12. The support rod allows at least a portion of the branch support 2 (e.g., the free end 20a of the branch support 2) to move relative to the main support 1 under external force, deforming within a certain range. After the external force is removed, it can roughly return to its initial position. During the process of the conveyor retracting from the proximal end to the distal end, even when the free end 20a of the branch support 2 is hooked by the conveyor and pulled towards the proximal end, the free end 20a can still move relative to the main support 1. The free end 20a is connected to the anchoring part 10 through the connector 19. Therefore, the force of the conveyor hooking the branch support 2 is transmitted along the connector 19 to the anchoring part 10, which has a stronger anchoring capacity, without causing the main support 1 to shorten or shift due to direct action on the main film 12. When the force of the conveyor hooking is removed, the free end 20a of the branch support 2 can return to its initial position.
[0109] In other embodiments, the support rod may be movably connected to the anchoring portion 10 and / or the free end 20a. For example, a movable connecting portion may be provided at the end of the support rod, which includes a collar and / or a winding portion (e.g., the winding portion includes a spirally wound filament). This movable connecting portion is movably connected to the anchoring portion 10 and / or the free end 20a, allowing the support rod to move relative to the anchoring portion 10 and / or the free end 20a in the longitudinal or circumferential direction. The advantage of this arrangement is that when the lumen stent 100 is under radial compression or when the lumen stent 100 is subjected to blood impact, the distance between the free ends 20a of the main stent 1 and the branch stent 2 may change. Since the movably connected support rod can move to a certain extent in its longitudinal direction, the support rod is prevented from restricting the change in the distance between the main stent 1 and the branch stent 2, thereby preventing damage to the main stent 1 or the branch stent 2 due to pulling during radial compression or blood impact. Furthermore, the movable connection between the support rod and the anchoring part 10 and / or the free end 20a allows the free end 20a to move more flexibly relative to the main body support 1. When the free end 20a bends to a certain extent, the conveyor can detach from the free end 20a.
[0110] Example 6
[0111] Please refer to Figure 1617. This embodiment is largely the same as the lumen support 100 in Embodiment 5, except that the connector 19 in this embodiment is elastic and includes an elastic segment 192 and connecting segments (hereinafter referred to as the first connecting segment 191 and the second connecting segment 193) located at both ends of the elastic segment 192. The first connecting segment 191 is connected to the main support 1, and the second connecting segment 193 is connected to the branch support 2. On the same longitudinal section, the angle between the extension direction of the connector 19 and the outer surface of the branch support 2 ranges from 0 to 60°, that is, the angle between the force direction of the connector 19 and the outer surface of the branch support 2 ranges from 0 to 60°.
[0112] The elastic segment 192 includes one or more of a helical spring structure, an elastomer component, and a planar folding structure. The helical spring structure includes one or more of a tension spring, a progressive spring, and a linear spring. The elastomer component includes a component made of an inherently elastic material, such as an elastic rope made of an elastic polymer material, an elastic wire or rod made of a hyperelastic metallic material (such as a nickel-titanium alloy), etc. The planar folding structure can extend or shorten along its length, including one or more of a Z-shaped wave, an M-shaped wave, a V-shaped wave, and a sine wave. As shown in Figure 18, to further reduce the radial compression dimension of the lumen support 100, the planar folding structure includes a sawtooth wave 192a, which includes one or more sawtooths 1921 inclined toward the anchoring portion 10 or toward the free end 20a of the branch support 2. This sawtooth wave 192a can be folded to a certain extent in the transverse direction (the direction perpendicular to the length direction), thereby reducing the radial compression dimension of the lumen support 100.
[0113] In this embodiment, when both the main support 1 and the branch support 2 are in their naturally extended state, the elastic segment 192 of the connector 19 is in a stretched state. This provides a certain tension to the branch support 2 through the connector 19, ensuring the branch support 2 is tightly against the inner wall of the main support 1. Simultaneously, it provides the branch support 2 with a certain amount of space to move relative to the main support 1, thus preventing the branch support 2 from shaking under the impact of blood flow and affecting normal blood flow. It is understood that in other embodiments, when both the main support 1 and the branch support 2 are in their naturally extended state, the connector 19 can also be in a naturally relaxed state.
[0114] In this embodiment, the first connecting segment 191 and the second connecting segment 193 of the connector 19 can respectively connect to the branch wave coil 21 of the anchoring part 10 and the branch coating 22 at the free end 20a of the branch bracket 2 (see reference). Figure 6 One or more connections to the second annular support member. For example, the connector 19 is connected to the branch wave coil 21 or the second annular support member to prevent damage to the branch membrane 22 under the tension of the connector 19, thus avoiding internal leakage.
[0115] It is understood that in other embodiments, the connector 19 may also be provided with only one connecting segment, in which case the other end of the elastic segment 192 is directly connected to the branch bracket 2 or the main bracket 1.
[0116] Specifically, the connector 19 can be made of single or multiple strands of nickel-titanium wire or stainless steel wire spiral, etc. In order to ensure that the connector 19 can fully extend when subjected to appropriate tensile force, and can return to its original state and maintain a certain stability after the force is released, the stiffness coefficient K of the elastic segment 192 of the connector 19 is in the range of 0 < K < 100 N / M.
[0117] The first connecting segment 191 of the connector 19 can be positioned closer to the anchoring part 10 than the second connecting segment 193 (i.e., the angle between the force direction of the connector 19 and the outer surface of the branch stent 2 is greater than 0 degrees), so that the branch stent 2 is always positioned towards the anchoring part 10 under the tension of the connector 19, thereby making the branch stent 2 sufficiently close to the inner surface of the main stent 1, thereby reducing or eliminating the gap between the main stent 1 and the branch stent 2, and thus minimizing the impact of the branch stent 2 on the blood flow in the main stent 1 and reducing the formation of thrombi.
[0118] In other embodiments, the first connecting segment 191 and the second connecting segment 193 may be omitted, and the two ends of the elastic segment 192 are respectively connected to the anchoring part 10 and the free end 20a of the branch bracket 2.
[0119] The connector in this embodiment is elastic, allowing the free end 20a of the branch stent 2 to move more flexibly relative to the main stent 1. Even when the free end 20a of the branch stent 2 is hooked by the delivery device and pulled proximally, the free end 20a can bend relatively easily. When bent to a certain extent, the delivery device can detach from the free end 20a. Furthermore, when the lumen stent 100 is in a radially compressed state or when the lumen stent 100 is subjected to blood impact, the elastic connector can adapt to changes in the distance between the free ends 20a of the main stent 1 and the branch stent 2, preventing damage to the main stent 1 or the branch stent 2 due to excessive pulling during radial compression or blood impact.
[0120] Example 7
[0121] Please refer to Figure 19This embodiment is largely the same as the lumen stent 100 in Embodiment 6, except that the lumen stent 100 in this embodiment includes a first connector 19a and a second connector 19b. For example, the first connector 19a connects to the first side of the branch stent 2 (the side facing the inner wall of the main stent 1 and close to the inner wall of the main stent 1), and the second connector 19b connects to the second side of the branch stent 2 (the side facing the central axis of the main stent 1 and close to the central axis of the main stent 1). The first connector 19a and the second connector 19b respectively connect the first side and the second side of the branch stent 2, making the force on the branch stent 2 more balanced and further improving the stability of the branch stent 2. In addition, the stiffness of the first connector 19a and the second connector 19b can be different. For example, if the conveyor can more easily hook onto the second side, the stiffness (e.g., axial stiffness, i.e., the ability to resist deformation along the length direction) of the second connector 19b connected to the second side can be less than the stiffness of the first connector 19a connected to the first side. Conversely, if the conveyor can more easily hook onto the first side, the stiffness of the first connector 19a connected to the first side can be less than the stiffness of the second connector 19b connected to the second side. This arrangement allows for more flexible movement of the free end 20a of the branch support 2. In other embodiments, both connectors 19 can be located on the first side or both on the second side. In other embodiments, more than two connectors 19 can also be provided.
[0122] Reference Figure 20In other embodiments, an intermediate member 194 is provided between the first connector 19a and the second connector 19b. The intermediate member 194 connects the proximal ends of the first connector 19a and the second connector 19b respectively, and is connected to the bare wave coil 11a. In this embodiment, the intermediate member 194 is movably connected to the trough of the bare wave coil 11a. For example, the intermediate member 194 is arc-shaped and movably connected to the bare wave coil 11a (such as the trough of the bare wave coil 11a) by means of hook connection or winding connection; or, the intermediate member 194 includes a limiting member 1941 (such as an elastic long strip filament or rod), the limiting member 1941 is provided with at least one sliding connector 1942 (such as a ring or tube), the sliding connector 1942 is sleeved on the wave rod of the bare wave coil 11a, and can slide along the length direction of the wave rod of the bare wave coil 11a, the limiting member 194... 1. For limiting the sliding range of the sliding connector 1942, for example, the long strip-shaped limiting member 1941 is provided with sliding connectors 1942 at both ends, and the two sliding connectors 1942 are respectively connected to the proximal ends of the two connectors 19; or, one end of the long strip-shaped limiting member 1941 is fixedly connected to the bare wave coil 11a, and the other end is provided with a sliding connector 1942, wherein the proximal end of the first connector 19a is connected to the sliding connector 1942, and the proximal end of the second connector 19b is connected to the limiting member 1941 or the bare wave coil 11a. The function of the intermediate component 194 slidingly connected to the bare wave coil 11a is that when one side of the branch support 2 containing one of the connectors is hooked by the conveyor, the intermediate component 194 can move relative to the anchoring part 10, thereby adapting to changes in the distance between the proximal end of the connector and the anchoring part 10 to a certain extent. This allows the proximal port 20a of the branch support 2 to move more flexibly relative to the main support 1. After the conveyor detaches from the branch support 2, the intermediate component 194 can drive the connector to return to its initial position. In other embodiments, the intermediate component 194 can also be fixedly connected to the trough of the bare wave coil 11a.
[0123] Example 8
[0124] This embodiment is largely the same as embodiment 5, except that, see [link / reference] Figure 22 The connector 19 includes a spiral segment 195, which extends spirally around the central axis of the main support 1. The spiral segment 195 is at least partially attached to the inner surface of the main support 1 and can move relative to the inner surface of the main support 1. For example, the connector 19 is only connected to the anchoring part 10 and the branch support 2 at both ends, and the remaining area, including the spiral segment 195, is only attached to (or abutted against) the inner surface of the main support 1, without any connection point between it and the main support 1.
[0125] The aforementioned helical segment 195 may extend spirally around the central axis of the main support 1 one or more times. In other embodiments, the helical segment 195 may also extend spirally around the central axis of the main support 1 less than one time. Since the helical segment 195 itself is helical, and the helical structure itself has elastic recovery capability (i.e., the ability to deform under external force and return to its original shape after the external force is removed), the material used to make the helical segment 195 does not need to have excellent elasticity. Various types of biocompatible materials can be used, such as polymer materials or metallic materials. (Refer to...) Figure 23 To further enhance the elasticity of the helical segment 195, the helical segment 195 also includes a helical structure formed by helical winding of one or more of the following: a helical spring structure, a planar folding structure, and an elastomer component. For example, the helical spring structure includes one or more of the following: a tension spring, a progressive spring, and a linear spring. The helical segment 195 includes a helical structure formed by helical winding of one or more of the aforementioned springs. The elastomer component includes a component made of a material that is inherently elastic. For example, the helical segment 195 includes a helical structure formed by helical winding of an elastic rope made of an elastic polymer material, an elastic filament made of a super-elastic metallic material (such as a nickel-titanium alloy), or an elastic rod. The planar folding structure includes one or more of the following: a Z-shaped wave, an M-shaped wave, a V-shaped wave, and a sine wave. The planar folding structure of this embodiment can be radially compressed and has radial expansion capability. It can achieve radial contraction under the action of external force and self-expand or recover to its initial shape and maintain its initial shape after the external force is removed. The helical segment 195 includes a helical structure formed by helical winding of the aforementioned planar folding structure.
[0126] The helical segment 195 of this embodiment has elastic recovery capability, allowing the free end 20a of the branch stent 2 to move more flexibly relative to the main stent 1. Furthermore, when the lumen stent 100 is under radial compression or when it is subjected to blood impact, the connector with the helical segment 195 can adapt to changes in the distance between the free ends 20a of the main stent 1 and the branch stent 2, preventing damage to the main stent 1 or branch stent 2 due to excessive stretching during radial compression or blood impact. Moreover, since the helical segment 195 at least partially conforms to the inner surface of the main stent 1, it increases the wall adhesion, displacement resistance, and shortening resistance of the main stent 1 in the area where the helical segment 195 is located.
[0127] Furthermore, the connectors in embodiments 5-8 above can also be made of biodegradable materials, such as biodegradable polyesters and / or biodegradable polyanhydrides, or biodegradable metallic materials such as magnesium-based, iron-based, and zinc-based alloys. The advantage of this design is that it avoids problems such as restenosis and late-stage thrombosis in blood vessels, thus improving biocompatibility.
[0128] As will be understood by those skilled in the art, in embodiments 5-8 described above, the anchoring portion 10 is located at the proximal end of the main support 1, and the free end 20a of the branch support 2 is located at the proximal end of the branch support 2. In other embodiments, the anchoring portion 10 may be located at the distal end of the main support 1, and the free end 20a of the branch support 2 may be located at the distal end of the branch support 2. This invention does not limit the specific positions of the anchoring portion 10 and the free end 20a of the branch support 2, as long as the technical effects of this invention can be achieved.
[0129] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.
Claims
1. A lumen stent, characterized in that, include: A tubular main support, the main support including an anchoring part; A branch support is disposed within the cavity of the main support, and the branch support includes a free end that is movable relative to the main support; Connectors, which respectively connect the free end of the branch bracket to the anchoring part; The free end of the branch support is located at the proximal end of the branch support, and the anchoring portion is located at the proximal end of the main support; or, the free end of the branch support is located at the distal end of the branch support, and the anchoring portion is located at the distal end of the main support.
2. The lumen stent according to claim 1, characterized in that, The main support includes a membrane and a plurality of axially spaced main wave rings connected to the membrane. The anchoring part includes bare wave rings and / or anchor spikes. The radial support force of the bare wave rings is greater than the radial support force of the main wave rings.
3. The lumen stent according to any one of claims 1 to 2, characterized in that, The connector includes a straight or curved support rod, one end of which is connected to the anchoring part, and the other end is connected to the free end of the branch bracket.
4. The lumen stent according to any one of claims 1 to 2, characterized in that, The connector includes an elastic section, the two ends of which are respectively connected to the anchoring part and the free end of the branch bracket; the elastic section includes one or more of the following: a helical spring structure, a planar folding structure, and an elastomer component.
5. The lumen stent according to claim 4, characterized in that, The planar folding structure includes a sawtooth wave, which includes sawtooths that are inclined toward the anchor or toward the branch support.
6. The lumen stent according to any one of claims 1 to 2, characterized in that, The connector includes a helical segment that extends spirally around the axis of the main support and at least partially fits the inner surface of the main support, and is movable relative to the inner surface of the main support.
7. The lumen stent according to claim 6, characterized in that, The helical segment includes a helical structure formed by one or more helical windings of a helical spring structure, a planar folded structure, or an elastomer component.
8. The lumen stent according to any one of claims 1 to 2, characterized in that, The connector is fixedly or movably connected to the anchoring part, and the connector is fixedly or movably connected to the free end of the branch bracket.
9. The lumen stent according to any one of claims 1 to 2, characterized in that, The lumen support includes two connectors, which are respectively located on both sides of the branch support.
10. The lumen stent according to claim 9, characterized in that, The lumen support also includes an intermediate component, which is movably connected to the anchoring component and is connected to at least one connecting component.
11. The lumen stent according to claim 9, characterized in that, The lumen support includes a first connector and a second connector. The second connector is closer to the axis of the main support than the first connector, and the stiffness of the second connector is less than that of the first connector.
Citation Information
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