Lumen stent system
By using a combination of sheath, push tube, inner core tube, first anchor, and second anchor in the luminal stent delivery device, the problem of inaccurate luminal stent release position in the prior art is solved, achieving precise release and secondary position adjustment in the diseased blood vessel, and reducing surgical risks.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- LIFETECH SCI (SHENZHEN) CO LTD
- Filing Date
- 2017-12-28
- Publication Date
- 2026-04-21
AI Technical Summary
Existing stent delivery devices cannot precisely control the release location, especially when the diseased vessel has multiple branches, making it difficult to meet clinical needs.
A delivery device comprising a sheath, a push tube, an inner core tube, a first anchor, and a second anchor is used to anchor the distal and proximal ends of the lumen support respectively through the first and second anchors. By using opposite axial forces, the support is stretched to less than 90% of its natural outer diameter before release, thereby achieving secondary position adjustment.
It enables precise control of the release position of the luminal stent, reducing surgical risks, especially in cases involving multiple branch vessels, allowing for precise adjustment of the release position.
Smart Images

Figure CN109984877B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of interventional medical devices, and in particular to a lumen stent system. Background Technology
[0002] Currently, in the field of interventional medicine, compressible stent interventional surgery has become the main method for treating vascular stenosis, aneurysm, and aortic dissection due to its minimally invasive nature, fewer complications, and good efficacy.
[0003] Lumen stents are generally made by compressing a stent and inserting it into a hollow catheter. The stent is then delivered to the lesion site through a puncture site in the lumen of the blood vessel under the guidance of digital imaging equipment. The stent is then released from the catheter by a certain method and unfolds by its own radial support force to adhere to the blood vessel wall, thereby achieving the purpose of treating or alleviating the disease.
[0004] In existing technologies, the metal structure of luminal stents is generally made of nickel-titanium alloy. After undergoing a certain heat treatment forming process, the stent has the ability to restore its own shape (self-expanding stent). Currently, the delivery device for this type of stent generally includes at least one outer sheath for compressing and inserting the stent into it; it also includes a push rod, which is pre-installed inside the outer sheath. The distal end face of the push rod is in close contact with the proximal end of the stent, used to "push" or "push out" the stent from the outer sheath, thereby releasing the stent.
[0005] The method for delivering and releasing self-expanding luminal stents using the aforementioned delivery device generally includes the following steps: 1. Delivering the pre-loaded compressed stent delivery system into the body under the guidance of a guidewire; 2. Positioning the stent at the lesion site using a contrast marker at the distal end of the stent; 3. Fixing the push rod, withdrawing the outer sheath, and releasing the stent. The stent expands due to its own resilience and adheres to the inner wall of the blood vessel to achieve the therapeutic purpose. This method of delivering and releasing luminal stents cannot adjust the stent's release position after sheath withdrawal. For luminal stents with shortening characteristics, they shorten from distal to proximal after release from the sheath, making it difficult to precisely control the stent's release position. Existing luminal stent delivery devices cannot perform secondary adjustments to the stent's position after release, thus failing to precisely control the stent's release position and failing to meet clinical application needs, especially when the lesion vessel to which the stent is released has multiple branches, requiring even more precise adjustment of the stent's release position. Summary of the Invention
[0006] Therefore, it is necessary to provide a lumen stent system that can precisely control the release position of the lumen stent.
[0007] A lumen stent system includes a lumen stent and a delivery device for delivering the lumen stent. The delivery device includes a sheath, a push tube, an inner core tube, a first anchor, and a second anchor. The push tube passes through the sheath, and the inner core tube passes through the push tube and extends out of the sheath. The first anchor is located at the distal end of the inner core tube, and the second anchor is at least partially located at the distal end of the push tube. The first anchor is used to connect with the distal end of the lumen stent to provide a first axial force to the lumen stent, and the second anchor is used to connect with the distal end of the push tube. The proximal end of the lumen stent is connected to provide a second axial force to the lumen stent, the first axial force being opposite in direction to the second axial force, thereby loading the lumen stent into the cavity formed by the inner core tube and the sheath tube; when the sheath tube moves axially along the inner core tube until the distal end of the sheath tube is flush with the distal end of the push tube, the distal end of the lumen stent remains connected to the first anchor, and the proximal end of the lumen stent remains connected to the second anchor, such that the outer diameter of the lumen stent is at least less than 90% of the outer diameter of the lumen stent in its natural state.
[0008] In the aforementioned luminal stent system, when the luminal stent is loaded into the delivery device, the distal end of the stent is anchored by a first anchor, and the proximal end is anchored by a second anchor. After the delivery device delivers the stent to the lesion site, when the sheath moves axially along the inner core until the distal end of the sheath is flush with the distal end of the push tube, the distal end of the stent remains connected to the first anchor, and the proximal end remains connected to the second anchor. When the luminal stent has shortening properties, it is stretched due to opposite axial forces acting on both ends, resulting in an outer diameter that is at least 90% smaller than its natural outer diameter, i.e., smaller than the inner diameter of the vessel at the lesion site. Therefore, the stent can still be moved axially for secondary position adjustment. Thus, this luminal stent system can precisely control the release position of the stent. Attached Figure Description
[0009] Figure 1 This is a schematic diagram of the lumen support system of Example 1 in the loaded state;
[0010] Figure 2 for Figure 1 The diagram shows the structural schematic of the lumen support system.
[0011] Figure 3 for Figure 1 A three-dimensional structural schematic diagram of the first anchoring element of the lumen support system shown;
[0012] Figure 4 for Figure 3 A schematic diagram of the planar structure of the first anchoring element shown;
[0013] Figure 5 for Figure 1 A schematic diagram of the structure of the second anchoring element in the lumen support system shown;
[0014] Figure 6 for Figure 1 The diagram shows the structure of the lumen stent system in the semi-released state.
[0015] Figure 7 for Figure 1 The diagram shows the structure of the lumen stent system in the fully released state.
[0016] Figure 8 A diagram showing the dimensional changes of a spirally braided S-shaped tubular support.
[0017] Figure 9 Dimensional variation diagram of a Z-shaped corrugated braided tubular support;
[0018] Figure 10 for Figure 1 The diagram shows the relationship between the length and outer diameter of the lumen stent in the lumen stent system.
[0019] Figure 11 This is a schematic diagram of the delivery device of the lumen support system in Example 2;
[0020] Figure 12 This is a schematic diagram of the lumen support system of Example 3 in the loaded state;
[0021] Figure 13 for Figure 12 A magnified view of a portion of the image;
[0022] Figure 14 This is a schematic diagram of the delivery device of the lumen support system in Example 4;
[0023] Figure 15 This is a schematic diagram of the lumen support system of Example 5 in the loaded state;
[0024] Figure 16 for Figure 15 The diagram shows the structure of the lumen stent system in the semi-released state.
[0025] Figure 17 for Figure 15 A schematic diagram showing the binding method of the second anchor of the lumen support system;
[0026] Figure 18 This is a schematic diagram of the structure of the second anchoring element of the lumen support system in Example 6. Detailed Implementation
[0027] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.
[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
[0029] In the field of interventional medical devices, "distal" is defined as the end furthest from the operator during surgery, and "proximal" is defined as the end closest to the operator during surgery. "Axial" refers to the direction parallel to the line connecting the center of the distal and proximal ends of the medical device, and "radial" refers to the direction perpendicular to the aforementioned axial direction.
[0030] Example 1
[0031] Please see Figure 1 One embodiment of the lumen stent system 100 includes a lumen stent 110 and a delivery device 120 for delivering the lumen stent 110. The lumen stent 110 is loaded into the delivery device 120 and then delivered to the lesion site in the human body.
[0032] Please see Figure 2 The lumen stent 110 includes a stent body 112 and multiple bare wave coils 114 disposed at the proximal and distal ends of the stent body 112. The stent body 112 is a lumen structure. In its natural state (without any external force), the outer diameter of the lumen stent 110 is R0 (nominal outer diameter), and its length is L0 (nominal length). Here, R0 refers to the outer diameter of the stent body 112, and L0 refers to the sum of the lengths of the bare wave coils 114 at the proximal and distal ends of the stent body 110.
[0033] The number of bare wave loops 114 at the near end and the number of bare wave loops 114 at the far end are equal, and there are at least two bare wave loops 114 at the near end and at least two bare wave loops 114 at the far end.
[0034] When there are two bare wave coils 114 at the proximal end and two at the distal end, the two bare wave coils 114 at the proximal end are symmetrically arranged with the horizontal axis of the support body 112 as the axis of symmetry, and the two bare wave coils 114 at the distal end are symmetrically arranged. When there are more than two bare wave coils 114 at both the proximal end and the distal end, preferably, the multiple bare wave coils 114 at the proximal end are evenly distributed along the circumference of the support body 112, and the multiple bare wave coils 114 at the distal end are also evenly distributed along the circumference of the support body 112. It can be understood that the wire diameter of the bare wave coil 114 at the proximal end can be equal to or unequal to the wire diameter of the bare wave coil 114 at the distal end.
[0035] The lumen support 110 is a self-expanding lumen support. The lumen support 110 has a shortening capability. In the loaded state (the state in which the lumen support 110 is loaded in the conveying device 120), the length of the lumen support 110 is L1 and the outer diameter is R1.
[0036] The shortening performance refers to the characteristic that when the luminal stent 110 is loaded into the delivery device 120, the luminal stent 110 is stretched axially, and when the luminal stent 110 is released, its length is shortened due to radial expansion. After the luminal stent 110 is delivered to the lesion site by the delivery device 120, the luminal stent 110 is released, and its length after complete release is less than L1.
[0037] The support body 112 has a braided structure. Specifically, the support body 112 can be a tubular structure formed by S-shaped corrugations woven along the axial direction of nickel-titanium alloy wire or other materials, or it can be a tubular structure formed by Z-shaped corrugations woven from nickel-titanium alloy wire or other materials.
[0038] Please refer to it again. Figure 1 The conveying device 120 includes a sheath 121, a push tube 122, an inner core tube 123, a first anchoring element 124, and a second anchoring element 125. The sheath 121, push tube 122, and inner core tube 123 are all hollow tubes. The push tube 122 passes through the sheath 121, and the inner core tube 123 passes through the push tube 122 and extends out of the sheath 121. The sheath 121, push tube 122, and inner core tube 123 are coaxial. The sheath 121 can slide axially along the inner core tube 123, and the push tube 122 can slide axially along the inner core tube 123.
[0039] The first anchor 124 is disposed at the distal end of the inner core tube 123, and is used to anchor the distal end of the lumen stent 110. The second anchor 125 is disposed at the distal end of the push tube 122, and is used to anchor the proximal end of the lumen stent 110. When the sheath 121 slides axially along the inner core tube 123 to the distal end of the inner core tube 123, and the distal end of the sheath 121 is further away from the operator during the operation than the distal end of the first anchor 124, the inner core tube 123 and the sheath 121 form an annular cavity for accommodating the lumen stent 110.
[0040] More preferably, the delivery device 120 further includes a guide head 126. The guide head 126 is a hollow conical head. The inner core tube 123 is fixedly connected to the guide head 126, and the inner cavity of the inner core tube 123 communicates with the inner cavity of the guide head 126. The inner cavities of the inner core tube 123 and the guide head 126 are used to accommodate and pass a guide wire (not shown) so that the delivery device 120 delivers the lumen stent 110 to the lesion site of the human body under the traction of the guide wire. The proximal end face of the guide head 126 is fixedly connected to the distal end of the inner core tube 123 by welding or gluing, and the diameter of the proximal end face of the guide head 126 is larger than the outer diameter of the inner core tube 123.
[0041] Please see Figure 3 The first anchoring element 124 includes a fixing sleeve, multiple connecting rods 1244 and multiple anchoring rods 1246.
[0042] The fixing sleeve includes a first assembly 1242 and a second assembly 1243. Both the first assembly 1242 and the second assembly 1243 are hollow cylinders. The diameter of the cavity of the first assembly 1242 is equal to the diameter of the cavity of the second assembly 1243, and both cavities have a diameter larger than the outer diameter of the inner core tube 123. The bottom radius of the first assembly 1242 is larger than the bottom radius of the second assembly 1243. The bottom surfaces of the first assembly 1242 and the second assembly 1243 are fixedly connected, allowing communication between the cavities of the first assembly 1242 and the second assembly 1243. This enables the fixing sleeve to be fitted onto the inner core tube 123, with the first assembly 1242 located at the distal end and the second assembly 1243 located at the proximal end. The fixing sleeve is made of stainless steel or polymer material. It can be fixedly fitted onto the inner core tube 123 by welding, bonding, or other methods.
[0043] It is understood that in other embodiments, the fixing sleeve may also be a hollow cylindrical structure.
[0044] The number of connecting rods 1244 is at least 2. Figure 3 The first anchoring member 124 shown has six connecting rods 1244. The connecting rods 1244 are arc-shaped. One end of the connecting rod 1244 is located on the side of the first assembly 1242, so that the multiple connecting rods 1244 are distributed at intervals along the circumference of the fixing sleeve.
[0045] The number of anchor rods 1246 is equal to the number of connecting rods 1244. The number of anchor rods 1246 is at least 2. Figure 3 The first anchoring member 124 shown has six anchoring rods 1246. It can be understood that the number of connecting rods 1244 and anchoring rods 1246 matches the number of bare corrugated coils 114 at the distal end of the lumen support 110. The anchoring rods 1246 are straight rods. One end of the anchoring rod 1246 is connected to the end of the connecting rod 1244 away from the first assembly 1242, and the other end of the anchoring rod 1246 extends axially along the inner core tube 123 towards its distal end and is suspended. Each anchoring rod 1246 is parallel to the inner core tube 123, and the multiple anchoring rods 1246 are arranged at circumferential intervals along the fixing sleeve. The diameter of the circumscribed circle of the multiple anchoring rods 1246 is smaller than the inner diameter of the sheath tube 121. Furthermore, each anchoring rod 1246 forms an opening with the outer surface of the inner core tube 123, the width of which is smaller than the wire diameter of the bare corrugated coil 114 at the distal end of the lumen support 110. The width of the opening refers to the vertical distance from the anchor rod 1246 to the outer surface of the inner core tube 123.
[0046] Please refer to the following: Figure 4 The connecting rod 1244 is an arc-shaped rod, and the anchoring rod 1246 is a straight rod, so that the first anchoring element 124 forms an arc-shaped transition from the distal end to the proximal end. It can be understood that the connecting rod 1244 can be an arc-shaped rod with a circular, rectangular, or square cross-section. The anchoring rod 1246 can be a straight rod with a circular, rectangular, or square cross-section. Both the connecting rod 1244 and the anchoring rod 1246 are made of nickel-titanium alloy or flexible polymer material, so that in the loaded state, the connecting rod 1244 and the anchoring rod 1246 are compressed within the cavity formed by the inner core tube 123 and the sheath tube 121 through deformation. This facilitates the use of a smaller outer diameter sheath tube 121 to deliver the luminal stent 110 to blood vessels with smaller outer diameter lesions.
[0047] It is understood that in other embodiments, the connecting rod 1244 can be omitted, and the anchoring rod 1246 can be directly connected to the fixing sleeve. For example, one end of the anchoring rod 1246 is fixedly connected to the distal end face of the first assembly 1242; or, one end of the anchoring rod 1246 is connected to the side of the first assembly 1242.
[0048] In the loaded state, the bare wave ring 114 at the distal end of the lumen support 110 is hooked onto the end of the anchor rod 1246 away from the connecting rod 1244, and the first anchor 124 provides a first axial force to the lumen support 110.
[0049] Please see Figure 5The second anchoring element 125 includes a clamping member 1252 and at least two hooks. The clamping member 1252 is a hollow cylindrical structure. The clamping member 1252 is sleeved on the inner core tube 123, and the clamping member 1252 and the inner core tube 123 are movably connected. The proximal end of the clamping member 1252 is fixedly connected to the distal end of the push tube 122, so that when the push tube 122 slides along the axial direction of the inner core tube 123, it can drive the second anchoring element 125 to slide along the axial direction of the inner core tube 123. The hooks include a connecting section 1254 and a hook section 1256 connected to one end of the connecting section 1254. The end of the connecting section 1254 away from the hook section 1256 is fixedly connected to the distal end of the clamping member 1252, and the end of the hook section 1256 away from the connecting section 1254 is a free end. The hook section 1256 is elastic. In its natural state (without any external force), the connecting section 1254 and the hook section 1256 are connected at a certain angle, so that the extension direction of the end of the hook section 1256 away from the connecting section 1254 is at a certain angle to the axis of the inner core tube 123. This allows the hook section 1256 to hook onto the bare bellows 114 near the proximal end of the lumen support 110, thus providing a second axial force to the lumen support 110. Furthermore, due to the elasticity of the hook section 1256, under the action of external force, the angle between the extension direction of the end of the hook section 1256 away from the connecting section 1254 and the axis of the inner core tube 123 gradually changes until the extension direction of the end of the hook section 1256 away from the connecting section 1254 is at 0° to the axis of the inner core tube 123. This causes the hook connection between the bare bellows 114 near the proximal end of the lumen support 110 and the hook section 1256 to disappear, releasing the proximal end of the lumen support 110.
[0050] In this embodiment, the connecting section 1254 is parallel to the axis of the inner core tube 123, and the extension direction of the end of the hook section 1256 away from the connecting section 1254 is at 90° to the axial direction of the inner core tube 123. This allows the hook section 1256 to be reliably hooked and connected to the bare wave ring 114 at the proximal end of the lumen support 110 in the anchored state, thereby ensuring that the proximal end of the lumen support 110 remains in the anchored state before the secondary position adjustment is performed after the sheath tube 121 is withdrawn.
[0051] It is understood that in other embodiments, the connecting segment 1254 is parallel to the axis of the inner core tube 123, and the extension direction of the end of the hook segment 1256 away from the connecting segment 1254 is not necessarily 90° with the axial direction of the inner core tube 123. As long as the bare wave ring 114 at the proximal end of the lumen support 110 can be hooked and connected with the hook segment 1256 in the anchored state, and the hook segment 1256 can be deformed under the action of external force to release the hook connection between the bare wave ring 114 of the lumen support 110 and the hook segment 1256, it is acceptable.
[0052] In this embodiment, all components of the second anchor 125 are located at the far end of the push tube 122.
[0053] Please refer to it again. Figure 1 The lumen support 110 is subjected to axial stretching and radial compression, and the bare wave ring 114 at the distal end of the lumen support 110 is hooked to the end of the suspended end of the anchor rod 1246 of the first anchor 124. The bare wave ring 114 at the proximal end of the lumen support 110 is hooked to the hook 1256 of the second anchor 125. When the sheath 121 moves axially along the inner core tube 123 to the point where the distal end of the sheath 121 is closer to the guide head 126 than the distal end of the anchor rod 1246, the lumen support 110 is bound in the annular cavity formed between the inner core tube 123 and the sheath 121, thereby loading the lumen support 110 into the conveying device 120.
[0054] Under the traction of the guidewire, after the delivery device 120 delivers the luminal stent 110 to the lesion site in the human body, the sheath 121 slides axially proximally along the inner core tube 123, exposing the distal end of the anchor rod 1246. Due to the shortening capability of the luminal stent 110, the distal end of the luminal stent 110 will axially contract proximally, causing the bare wave coil 114 at the distal end of the luminal stent 110 to slide proximally along the anchor rod 1246 from the end of the anchor rod 1246. When the bare wave coil 114 is hooked by the connecting rod 1244, the sliding stops, and the shortening of the luminal stent 110 also stops. At this time, the bare wave coil 114 at the distal end of the luminal stent 110 is still hooked and connected to the first anchor 124, that is, the distal end of the luminal stent 110 is still in a state of being anchored by the first anchor 124. The sheath 121 continues to slide axially along the inner core tube 123 towards the proximal end. When the sheath 121 slides to the point where the distal end of the sheath 121 is flush with or exposed at the distal end of the push tube 122, the hook of the second anchor 125 is not subjected to external force, and the hook section 1256 of the hook remains hooked to the bare wave ring 114 at the proximal end of the lumen support 110. That is, at this time, the bare wave coil 114 at the distal end of the lumen stent 110 is still hooked and connected to the first anchor 124, which provides a first axial force to the lumen stent 110; the bare wave coil 114 at the proximal end of the lumen stent 110 is still hooked and connected to the second anchor 125, which provides a second axial force to the lumen stent 110. The direction of the first axial force provided by the first anchor 124 to the lumen stent 110 is opposite to the direction of the second axial force provided by the second anchor 125 to the lumen stent 110, so that the proximal and distal ends of the lumen stent 110 remain in a restrained state, such as... Figure 6As shown. At this point, the luminal stent 110 is not fully released; this state is defined as the semi-released state. In this semi-released state, the length of the luminal stent 110 is L2, and the outer diameter of the luminal stent 110 is R2. L2 is less than L1, and R2 is greater than R1. When the anchoring effect of the first anchor 124 and the second anchor 125 is released, the luminal stent 110 is fully released. In the fully released state, the length of the luminal stent 110 is L3, and the outer diameter is R3. In the fully released state, the luminal stent 110 is fully deployed, adhering to the vessel wall at the lesion site, and the luminal stent 110 is fixed at the lesion site, and its position cannot be adjusted.
[0055] In order to ensure that the stent 110 is securely placed against the blood vessel wall at the lesion site, the outer diameter R3 of the stent 110 when it is fully released at the lesion site is 90% of the outer diameter of the stent 110 in its natural state, i.e., the nominal outer diameter R0, i.e., R3 = 0.9R0.
[0056] In the semi-released state, the outer diameter of the luminal stent 110 is R2. In order to ensure that the outer diameter of the luminal stent 110 in the semi-released state is smaller than the inner diameter of the blood vessel at the lesion site, R2 is at least less than 90% of the outer diameter of the luminal stent 110 in the natural state, that is, R2 is at least less than 0.9R0. At this time, the luminal stent 110 has not yet adhered to the blood vessel wall, and the position of the luminal stent 110 at the lesion site can still be adjusted axially to accurately position the luminal stent 110. After the luminal stent 110 is adjusted to the appropriate position, the inner core tube 123 slides proximally while the push tube 122 and the second anchor 125 remain stationary, causing relative movement between the inner core tube 123 and the push tube 122. The sliding of the inner core tube 123 proximally causes the first anchor 124 to slide proximally, resulting in relative movement between the anchor rod 1246 of the first anchor 124 and the bare wave coil 114 at the distal end of the luminal stent 110. This causes the bare wave coil 114 at the distal end of the luminal stent 110 to separate from the anchor rod 1246, releasing the restraint of the bare wave coil 114 at the distal end of the luminal stent 110 and releasing the distal end of the luminal stent 110, allowing the distal end of the luminal stent 110 to adhere to the vessel wall at the corresponding location. Then, the push tube 122 is axially displaced proximally along the inner core tube 123. This axial displacement exerts a force on the hook segment 1256 of the hook element, causing the extension direction of the end of the hook segment 1256 furthest from the connecting segment 1254 to gradually change to 0° with the axis of the inner core tube 123. This releases the hook connection between the hook segment 1256 and the bare wave coil 114 proximal to the luminal stent 110, separating the bare wave coil 114 from the second anchor 125. The proximal end of the luminal stent 110 is released, and the proximal end of the luminal stent 110 adheres to the vessel wall at the corresponding location, resulting in complete release and adhesion of the luminal stent 110 to the vessel wall. The states of the distal and proximal ends of the luminal stent 110 after release are as follows: Figure 7As shown.
[0057] In the aforementioned luminal stent system 100, when the luminal stent 110 is loaded into the delivery device 120, the distal end of the luminal stent 110 is anchored by the first anchor 124, and the proximal end of the luminal stent 110 is anchored by the second anchor 125. After the delivery device 120 delivers the luminal stent 110 to the lesion site, when the sheath 121 moves axially along the inner core tube 123 until the distal end of the sheath 121 is flush with the distal end of the push tube 122, the distal end of the luminal stent 110 remains connected to the first anchor 124, and the proximal end of the luminal stent 110 is anchored to the second anchor 125. The second anchor 125 maintains the connection. When the lumen stent 110 has shortening properties, the two ends of the lumen stent 110 are stretched by opposite first and second axial forces, so that the outer diameter of the lumen stent 110 is at least 90% of the outer diameter of the lumen stent 110 in its natural state, that is, smaller than the inner diameter of the blood vessel at the lesion site. Therefore, the lumen stent 110 can still be moved axially for secondary position adjustment, and the release position of the lumen stent 110 with shortening properties can be precisely controlled.
[0058] The aforementioned luminal stent system 100 provides good positioning for the luminal stent 110 with shortening properties, meeting clinical application needs and reducing surgical risks. It is particularly suitable for situations where the lesion vessel to which the luminal stent 110 is deployed has multiple branch vessels, requiring more precise adjustment of the stent's deployment position.
[0059] It is understood that the lumen stent 110 in the aforementioned lumen stent system 100 can be various types of lumen stents with shortening properties. For example, the stent body 112 of the lumen stent 110 can be a lumen structure formed by S-shaped corrugations woven along the axial thread or a lumen structure formed by Z-shaped corrugations woven. The stent body 112 can be an integral braided structure or a segmented braided structure.
[0060] In one embodiment, when the support body 112 is a tubular structure formed by S-shaped corrugations woven along the axial thread, please refer to the following: Figure 8 When the length of the lumen support 110 changes, the unfolded length S of the helix of the support body 112 remains unchanged. When the outer diameter of the lumen support 110 is R1, the unfolded circumference of the lumen support 110 in this state is πR1 (i.e., the circumference of the bottom surface of the cylindrical cavity enclosed by the lumen support 110 in this state); when the outer diameter of the lumen support 110 is R2, the unfolded circumference of the lumen support 110 in this state is πR2, and the length change of the lumen support 110 is L1-L2. Based on the relationship between the loading length L1 and the length L2 in the partially released state of the lumen stent 110, the relationship between the loading length L1 and the length L3 after the lumen stent 110 is fully released can be derived. When the lumen stent 110 has a segmented spiral braided structure along the axial direction, the total length change of the lumen stent 110 is the sum of the length changes of each segment, which is n(L1-L3).
[0061] In another embodiment, when the stent body 112 has a Z-shaped corrugated braided structure, after the lumen stent 110 changes from a loaded state to a semi-released state from the sheath 121, the length of one Z-shaped corrugated annular structure changes to L1-L2. Please refer to... Figure 9 When the lumen stent 110 comprises n Z-shaped corrugated annular structures of equal height, the length variation of the lumen stent 110 is n(L1-L2). When the lumen stent 110 comprises n Z-shaped corrugated annular structures of unequal height, the overall variation in length of the lumen stent 110 is the sum of the variation lengths of each Z-shaped corrugated annular structure, and the length variation of each Z-shaped corrugated annular structure is... At this point, the length variation range of the lumen stent 110 is related to the length of the Z-shaped wave, and the length of the lumen stent 110 deformed from the loading length L1 to the fully released state can be calculated.
[0062] Please see Figure 10 When the lumen support 110 is axially stretched and radially compressed while being loaded in the conveying device 120, its length L1 is at its maximum and its outer diameter R1 is at its minimum. When the lumen support 110 is completely released from the sheath 121, the first anchor 124, and the second anchor 125, i.e., when the lumen support 110 is in a fully released state, its length L3 is at its minimum and its outer diameter R3 is at its maximum. During the transition from the loaded state to the semi-released state, the relationship between the length and outer diameter of the lumen support 110 changes along... Figure 8 The curve L1-L2 = μ(R1-R2) shown changes and tends to stabilize. The slope of the straight line connecting point A (R1,L1) and point B (R2,L2) is μ. μ is less than 0, and the absolute value of μ is less than 1.
[0063] While the luminal stent 110 is still anchored by the first anchor 124 and the second anchor 125, a secondary positioning is performed to ensure that the luminal stent 110 can move within the blood vessel. In this semi-restrained state, the stent R2 of the luminal stent 110 is less than or equal to 0.8 times R3, i.e., R2 ≤ 0.8 × R3. R2 is further preferably R3 = (0.6 ~ 0.8) × R3.
[0064] Preferably, to facilitate secondary positioning of the lumen support 110, the length of the anchor rod 1246 is L1-L2, where L1-L2 = μ(R1-R2). It should be noted that in this embodiment, the end face of the anchor rod 1246 connected to the connecting rod 1244 is coplanar with the distal end face of the first assembly 1242. The length of the anchor rod 1246 refers to the distance from the free end of the anchor rod 1246 to the distal end face of the first assembly 1242. In other embodiments, when the connecting rod 1244 is omitted and one end of the anchor rod 1246 is located on the distal end face of the first assembly 1242, or when the connecting rod 1244 is omitted and one end of the anchor rod 1246 is connected to the side of the first assembly 1242, the distance of the anchor rod 1246 refers to the distance from the free end of the anchor rod 1246 to the distal end face of the first assembly 1242.
[0065] Please refer to it again. Figure 2 Preferably, a first developing unit is provided on the lumen support 110. The first developing unit is located at the distal end of the support body 112. The first developing unit includes at least one first developing mark 116. When there are multiple first developing marks 116, the multiple first developing marks 116 are spaced apart on the support body 112 circumferentially. When the sheath tube 121 slides axially along the inner core tube 123 towards the proximal end until the distal end of the anchor rod 1246 is exposed, the bare wave ring 114 at the distal end of the lumen support 110 slides from the end of the anchor rod 1246 towards the proximal end. When the sliding stops and the bare wave ring 114 is hooked by the connecting rod 1244, the first developing mark 116 and the solid sleeve of the first anchor 124 are opposite each other in the radial direction. The provision of the first developing unit is beneficial for confirming the position of the lumen support 110 in the semi-released state, and is beneficial for reasonably adjusting the position of the lumen support 110 to accurately position the lumen support 110.
[0066] More preferably, the luminal stent 110 is further provided with a second imaging unit. The first imaging unit and the second imaging unit are spaced apart axially, and the second imaging unit is closer to the proximal end of the luminal stent 110 than the first imaging unit. The second imaging unit includes at least one second imaging mark 118. When there are multiple second imaging marks 118, the multiple second imaging marks 118 are spaced apart circumferentially on the luminal stent 110. The second imaging unit is set to mark the final release position of the luminal stent 110. During the secondary positioning of the luminal stent 110, the position of the second imaging unit of the luminal stent 110 is aligned with the target lesion position in the blood vessel, and then the distal end of the luminal stent 110 is released.
[0067] Please refer to it again. Figure 10When the lumen stent 110 changes from a semi-released state to a fully released state, the length change of the lumen stent 110 is D = L2 - L3, L2 - L3 = γ*(R2 - R3), where γ is the slope of the straight line connecting point B (R2, L2) and point C (R3, L3), γ is less than 0, and the absolute value of γ is less than 1. When the sheath 121 slides axially along the inner core tube 123 towards the proximal end, causing the constraint of the sheath 121 on the distal end of the stent 110 to disappear, the peak height of the bare wave loop 114 at the distal end of the stent 110 will also be shortened to a certain extent. In order to include the shortening rate of the peak height of the bare wave loop 114 at the distal end of the stent 110 when the length of the stent 110 changes from L1 to L3 in the overall system of the stent 110, D is multiplied by a coefficient δ, that is, D=L2-L3=γ*(R2-R3)*δ, where δ is the shortening rate of the peak height of the bare wave loop at the distal end of the stent 110, that is, the ratio of the peak height of the bare wave loop when the stent 110 is in the half-release state minus the peak height of the bare wave loop when the stent 110 is in the fully released state to the peak height of the bare wave loop when the stent 110 is in the half-release state.
[0068] Example 2
[0069] Please see Figure 11 The lumen stent system of Example 2 includes a lumen stent ( Figure 11 (Not shown) and a delivery device 220 for delivering the lumen support.
[0070] The structure of the lumen stent is the same as that of the lumen stent 110 in Example 1, and will not be described again here.
[0071] The conveying device 220 includes a sheath 221, a push tube 222, an inner core tube 223, a first anchor 224, a second anchor 225, and a guide head 226. The structures of the sheath 221, push tube 222, inner core tube 223, first anchor 224, and guide head 226 are the same as those of the conveying device 120 in Embodiment 1, and will not be described again here. Unlike the conveying device 120, the conveying device 220 also includes an outer core tube 227, and the structure of the second anchor 225 is different from that of the second anchor 125.
[0072] A push tube 222 passes through a sheath 221, and an inner core tube 223 passes through the push tube 222 and extends out of the sheath 221. The sheath 221, push tube 222, inner core tube 223, and outer core tube 227 are coaxial. The sheath 221 can slide axially along the inner core tube 223. The distal end of the inner core tube 223 is fixedly connected to a guide head 226. The outer core tube 227 is sleeved on the inner core tube 223, and the push tube 222 is sleeved on the end of the outer core tube 227 furthest from the inner core tube 223. The outer core tube 227 can slide axially along the inner core tube 223.
[0073] The structure of the second anchor 225 is substantially the same as that of the first anchor 124. The second anchor 225 includes a clamping sleeve 2252, multiple connectors 2254, and multiple anchoring portions 2256. The clamping sleeve 2252 is fitted onto the outer core tube 227 to fix the second anchor 225 to the outer core tube 227. Furthermore, each anchoring portion 2256 forms an opening between itself and the outer surface of the outer core tube 227, the width of which is smaller than the wire diameter of the bare corrugated coil at the distal end of the tube support. The width of this opening refers to the vertical distance from the anchoring portion 2256 to the outer surface of the outer core tube 227. The second anchor 225 is disposed on the outer core tube 227, with the clamping sleeve 2252 located at the distal end and the anchoring portions 2256 located at the proximal end; that is, the clamping sleeve 2252 is further away from the push tube 222 than the anchoring portions 2256, thus positioning the second anchor 225 at the distal end of the push tube 222. The opening formed between each anchoring part 2256 and the outer surface of the outer core tube 227 faces the push tube 222. In this embodiment, all components of the second anchoring member 225 are located at the distal end of the push tube 222.
[0074] When the lumen stent is loaded into the conveying device 220, the bare corrugated ring at the distal end of the lumen stent is hooked to the end of the anchor rod of the first anchor 224, and the bare corrugated ring at the proximal end of the lumen stent is hooked to the connector 2254 of the second anchor 225. When the sheath 221 moves axially proximally relative to the inner core tube 223, the bare corrugated ring at the distal end of the lumen stent shortens proximally, the outer diameter of the lumen stent changes from the loading outer diameter R1 to R2, and the length of the lumen stent changes from the loading length L1 to L2. At this time, the bare wave coil at the distal end of the stent is still hooked to the first anchor 224, and the bare wave coil at the proximal end of the stent is still hooked to the second anchor 225. The secondary release position adjustment of the stent can be achieved by adjusting the overall axial position of the delivery device 220. After the stent moves to the designated position, the inner core tube 223 is moved proximally, causing relative movement between the stent and the inner core tube 223. After the hook connection between the distal end of the stent and the first anchor 224 is separated, the distal end of the stent adheres to the vessel wall. Then, the outer core tube 227 slides along the inner core tube 223 to the distal end, thereby separating the bare wave coil at the proximal end of the stent from the second anchor 225. After the proximal end of the stent separates from the second anchor 225 on the outer core tube 227, it adheres to the vessel wall, achieving complete release of the stent.
[0075] In the aforementioned luminal stent system, when the luminal stent is loaded into the delivery device 220, the distal end of the luminal stent is anchored by the first anchor 224, and the proximal end of the luminal stent is anchored by the second anchor 225. After the delivery device 220 delivers the luminal stent to the lesion site, when the sheath 221 moves axially along the inner core tube 223 until the distal end of the sheath 221 is flush with the distal end of the push tube 222, the distal end of the luminal stent remains connected to the first anchor 224, and the proximal end of the luminal stent remains connected to the second anchor 225. When the luminal stent has shortening properties, it is stretched due to the opposite first and second axial forces acting on both ends of the luminal stent, making the outer diameter of the luminal stent less than 90% of its nominal outer diameter in its natural state, i.e., less than the inner diameter of the blood vessel at the lesion site. Therefore, the luminal stent can still be moved axially for secondary position adjustment, and the release position of the luminal stent with shortening rate can be precisely controlled.
[0076] Example 3
[0077] Please see Figure 12 The lumen stent system 300 of Embodiment 3 includes a lumen stent 310 and a delivery device 320 for delivering the lumen stent.
[0078] The lumen stent system 300 of Example 3 is substantially the same as the lumen stent system 100 of Example 1. The lumen stent system 300 includes a sheath ( Figure 12 (Not shown), push tube 322, inner core tube 323, first anchor 324, second anchor 325, and guide head 326. The lumen support system 300 differs from the lumen support system 100 in that the second anchor 325 is different from the second anchor 125, and the push tube 322 is different from the push tube 122. Furthermore, a locking device 327 is provided at the proximal end of the delivery device 320. The locking device 327 can be provided on a handle at the proximal end of the delivery device 320, and the handle is connected to the inner core tube 323.
[0079] The second anchor 325 is at least one pull wire. One end of the pull wire is tied to the proximal end of the lumen support 310 by a slip knot, and the other end of the pull wire is fixed to the proximal end of the conveying device 320.
[0080] Please refer to the following: Figure 13 The push tube 322 has a double-cavity structure. The push tube 322 has a first cavity 3222 and a second cavity 3224. Both the first cavity 3222 and the second cavity 3224 are annular cavities. It can be understood that, in addition to the first cavity 3222 and the second cavity 3224, the push tube 322 also has a cavity in its middle section to allow the inner core tube 323 to pass through it.
[0081] One end of the pull wire is fixedly connected to the locking device 327, and the other end of the pull wire passes through the first cavity 3222 of the push tube 322 and is hooked to the bare wave coil near the end of the lumen support 310, and passes through the second cavity 3224 to be movably connected to the locking device 327. The bare wave coil at the distal end of the lumen support 310 is hooked to the first anchor 324. When the sheath slides axially along the inner core tube 323 towards the proximal end until the distal end face of the sheath is flush with or exposed to the distal end face of the push tube 322, the bare wave ring at the distal end of the lumen support 310 is hooked and connected to the first anchor 324. The bare wave ring at the proximal end of the lumen support 310 is still bound by the pull wire. By adjusting the overall position of the lumen support system 300, the second imaging unit of the lumen support 310 is aligned with the designated release position. Then, by retracting the inner core tube 323, the bare wave ring at the distal end of the lumen support 310 is separated from the first anchor 324. Then, the end of the locking device 327 that is movably connected to the pull wire is opened and retracted to separate the bare wave ring at the proximal end of the lumen support 310 from the pull wire, thereby achieving complete release of the lumen support 310.
[0082] In this embodiment, a portion of the second anchor 325 is located at the distal end of the push tube 322, and the other portion passes through the first cavity 3222 and / or the second cavity 3224 of the push tube 322.
[0083] In the aforementioned luminal stent system 300, when the luminal stent 310 is loaded into the delivery device 320, the distal end of the luminal stent 310 is anchored by the first anchor 324, and the proximal end of the luminal stent 310 is anchored by the second anchor 325. After the delivery device 320 delivers the luminal stent 310 to the lesion site, when the sheath moves axially along the inner core tube 323 until the distal end of the sheath is flush with the distal end of the push tube 322, the distal end of the luminal stent 310 remains connected to the first anchor 324, and the proximal end of the luminal stent 310 remains connected to the second anchor 325. The anchor 325 maintains the connection. When the lumen stent 310 has shortening properties, the two ends of the lumen stent 310 are stretched due to the opposite first axial force and second axial force, respectively. This makes the outer diameter of the lumen stent 310 less than 90% of the outer diameter (nominal outer diameter) of the lumen stent in its natural state, that is, less than the inner diameter of the blood vessel at the lesion site. Therefore, the lumen stent 310 can still be moved axially for secondary position adjustment, and the release position of the lumen stent 310 with shortening properties can be precisely controlled.
[0084] It is understood that in another embodiment, one of the first cavity 3222 and the second cavity 3224 may be omitted, and the other end of the pull wire passes through one cavity (not the central cavity) of the push tube 322 and is hooked to the bare wave coil near the end of the tube support 310, and then passes through the same cavity to be movably connected to the locking device 327.
[0085] Example 4
[0086] Please see Figure 14 The lumen stent system of Example 4 includes a lumen stent ( Figure 14 (Not shown) and a delivery device 420 for delivering the lumen support.
[0087] The lumen stent system of Example 4 is basically the same as the lumen stent system 300 of Example 3. The delivery device 420 includes a sheath 421 and a push tube ( Figure 14 (Not shown), inner core tube 423, first anchor 424, second anchor (not shown) and guide head 426.
[0088] The difference lies in that the inner core tube 423 of the lumen stent system in this embodiment is a stepped tubular structure, including a first branch tube 4232 with a smaller diameter and a second branch tube 4234 with a larger diameter. The distal end of the second branch tube 4234 is fixedly connected to the proximal end of the first branch tube 4232. The end of the first branch tube 4232 away from the second branch tube 4234 is fixedly connected to the guide head 426, and the first anchor 424 is disposed at the distal end of the first branch tube 4232.
[0089] In the aforementioned luminal stent system, when the luminal stent is loaded into the delivery device 420, the distal end of the luminal stent is anchored by the first anchor 424, and the proximal end of the luminal stent is anchored by the second anchor. After the delivery device 420 delivers the luminal stent to the lesion site, when the sheath 421 moves axially along the inner core tube 423 until the distal end of the sheath 421 is flush with the distal end of the push tube, the distal end of the luminal stent remains connected to the first anchor 424, and the proximal end of the luminal stent remains connected to the second anchor. When the luminal stent has shortening properties, it is stretched due to the opposite axial forces acting on both ends of the luminal stent, so that the outer diameter of the luminal stent is less than 90% of the outer diameter (nominal outer diameter) of the luminal stent in its natural state, that is, less than the inner diameter of the blood vessel at the lesion site. Therefore, the luminal stent can still be moved axially for secondary position adjustment, and the release position of the luminal stent with shortening properties can be precisely controlled.
[0090] Furthermore, when the lumen stent is compressed and in the loaded state, one side of the bare wavering at the distal end of the lumen stent is located between the anchor rod of the first anchor 424 and the inner core tube 423, and the other side is located between the inner core tube 423 and the sheath tube 421 stent. The bare wavering at the proximal end of the lumen stent is anchored by a pull wire. Therefore, the width of the gap between the first anchor 424 and the inner core tube 423 must be greater than the wire diameter of the compressed bare wavering so that the gap can accommodate the compressed bare wavering. When the inner diameter of the inner core tube 423 is large, the vertical distance (radial width between the two) from the anchor rod of the first anchor 424 to the inner core tube 423 needs to be increased accordingly so that the gap between the first anchor 424 and the inner core tube 423 is sufficient to accommodate the compressed bare wavering. Thus, the inner diameter of the sheath tube 421 needs to be increased accordingly so that the other side of the bare wavering of the lumen stent can be accommodated in the gap between the sheath tube 421 and the inner core tube 423. Therefore, the outer diameter of the sheath 421 required for loading the lumen support can be reduced by reducing the outer diameter of the inner core tube 423 at the radially opposite point of the first anchor 424. Since only the outer diameter of the inner core tube 423 at the radially opposite point of the first anchor 424 is reduced, the inner core tube 423 has a stepped tubular structure, which ensures that the inner core tube 423 still maintains sufficient mechanical strength, so that the overall stability of the conveying device 420 is not affected in any way.
[0091] Preferably, in order to further reduce the outer diameter of the sheath 421, the outer diameter of the second branch pipe 4234 is set to be equal to the outer diameter of the circumcircle of the first anchor 424.
[0092] It is understood that the inner cavities of the first branch pipe 4232 and the second branch pipe 4234 are connected and coaxial. In another embodiment, the first branch pipe 4232 and the second branch pipe 4234 can be an integral structure, as long as the diameters of the first branch pipe 4232 and the second branch pipe 4234 are different to form a stepped structure.
[0093] Example 5
[0094] Please see Figure 15 The lumen stent system 500 of Embodiment 5 includes a lumen stent 510 and a delivery device 520 for delivering the lumen stent.
[0095] The lumen stent system 500 of Example 5 is basically the same as the lumen stent system 300 of Example 3. The lumen stent system 500 includes a sheath ( Figure 15 (Not shown), push tube 522, inner core tube 523 (inner core tube 523 is represented by a straight line), first anchor 524, second anchor 525, and guide head 526. The difference is that the push tube 522 has a single cavity structure, that is, in addition to the central cavity, it contains only an annular cavity 5222 surrounding the central cavity, and the second anchor 525 is different from the second anchor 425.
[0096] The second anchoring element 525 is a binding structure formed by binding with a pull wire. One end of the binding wire is fixed to the handle near the end of the conveying device 520, and the other end of the binding wire passes through the annular cavity 5222 of the push tube 522. The proximal end of the lumen support 510 is bound to the loading outer diameter R1 by tying a slip knot and then passes out from the annular cavity 5222 of the push tube 522. When the lumen support 510 is in the loading state, the binding wire 510 and the lumen support 510 are compressed together in the gap between the sheath and the inner core tube 523.
[0097] When the sheath slides axially along the inner core tube 523 until the first anchoring element 524 is exposed, the lumen support 510 shortens, and the bare corrugated ring at the distal end of the lumen support 510 slides along the anchoring rod to the connecting rod and hooks onto the connecting rod. The distal end of the lumen support 510 is fixed in relative position to the delivery device 520, the sheath is completely retracted, and the proximal end of the lumen support 510 expands into the binding cavity of the binding thread, as... Figure 16 As shown. After aligning the second imaging unit of the luminal stent 510 with the designated release position by adjusting the position of the delivery device 520, the inner core tube 523 is withdrawn to separate the distal end of the luminal stent 510 from the inner core tube 523. After the distal end of the luminal stent 510 is freed from its restraints, it expands and adheres to the vessel wall. Then, pulling the suture fixed to one end of the handle can open the slipknot binding the luminal stent 510, thereby releasing the restraints on the proximal end of the luminal stent 510 and achieving complete release of the luminal stent 510.
[0098] The binding method of slipknot is as follows Figure 17 As shown, point 55 is the end of the pull cord fixed to the handle, and point 56 is the end of the pull cord used to tie a slip knot. Starting from point 55, the pull cord forms a loop A. At point 57, it wraps around the support once, forming a new loop B. This new loop B passes through the previously formed loop A. The pull cord returns to point 58 and then wraps around the support in the opposite direction once, forming another new loop C. Loop C passes through loop B, and this cycle repeats, forming a binding cord that secures the proximal end of the lumen stent 510. When the proximal end 56 of the pull cord is pulled, the nested loops formed by the pull cord will unravel sequentially until the binding cord completely releases the lumen stent 510.
[0099] In this embodiment, a portion of the second anchor 525 is located at the far end of the push tube 522, and the other portion passes through the annular cavity 5222 of the push tube 522.
[0100] In the aforementioned luminal stent system 500, when the luminal stent 510 is loaded into the delivery device 520, the distal end of the luminal stent 510 is anchored by a first anchor 524, and the proximal end of the luminal stent 510 is anchored by a second anchor 525. After the delivery device 520 delivers the luminal stent 510 to the lesion site, when the sheath moves axially along the inner core tube 523 until the distal end of the sheath is flush with the distal end of the push tube 522, the distal end of the luminal stent 510 remains connected to the first anchor 524, and the proximal end of the luminal stent 510 remains connected to the second anchor 525. The connection of component 525 is maintained. When the lumen stent 510 has shortening properties, the two ends of the lumen stent 510 are stretched by opposite first and second axial forces, so that the outer diameter of the lumen stent 510 is less than 90% of the outer diameter (nominal outer diameter) of the lumen stent in its natural state, that is, less than the inner diameter of the blood vessel at the lesion site. Therefore, the lumen stent 510 can still be moved axially to make secondary position adjustments, and the release position of the lumen stent 510 with shortening properties can be precisely controlled.
[0101] Example 6
[0102] The lumen stent system of Embodiment 6 includes a lumen stent and a delivery device for transporting the lumen stent. This lumen stent system is substantially the same as the lumen stent system 100 of Embodiment 1, except that the second anchoring element of Embodiment 6 is different from the second anchoring element 125 of Embodiment 1.
[0103] Please see Figure 18 The second anchoring element 625 includes a clamping member 6252 and at least two hooks 6254. The clamping member 6252 has the same structure and arrangement as the clamping member 1252. The difference is that the hooks 6254 are straight rods in their natural state, with one end connected to the clamping member 6252 and the other end being a free end. The hooks 6254 are elastic and can return to their natural state without being subjected to external force. The free end of the hook 6254 is passed through the bare corrugated ring at the proximal end of the lumen support, and the free end of the hook 6254 is bent towards the proximal end and housed in the cavity formed by the sheath and the inner core tube. Due to the binding effect of the sheath, the free end of the hook 6254 is fixed in the cavity formed by the sheath and the inner core tube, thereby anchoring the bare corrugated ring at the proximal end of the lumen support and causing the proximal end of the lumen support to receive a second axial force.
[0104] When the sheath is slid axially along the inner core tube to the free end where the hook is not exposed, the exposed corrugated ring at the proximal end of the stent is in a restrained state. After the entire stent system is moved and repositioned, the distal end of the stent is released in the same way as in Example 1, and the sheath is slid axially along the inner core tube to the free end where the hook is exposed. The restraining force on the hook disappears, and the hook returns to its elastic deformation to a straight rod shape, thereby releasing the proximal end of the stent. At this point, the stent is completely released.
[0105] In this embodiment, all components of the second anchor 625 are located at the far end of the push tube 222.
[0106] In the aforementioned luminal stent system, when the luminal stent is loaded into the delivery device, the distal end of the luminal stent is anchored by a first anchor and the proximal end is anchored by a second anchor. After the delivery device delivers the luminal stent to the lesion site, when the sheath moves axially along the inner core tube until the distal end of the sheath is flush with the distal end of the push tube, the distal end of the luminal stent remains connected to the first anchor and the proximal end remains connected to the second anchor. When the luminal stent has shortening properties, it is stretched due to the opposite first and second axial forces acting on both ends of the luminal stent, resulting in the outer diameter of the luminal stent being less than 90% of its nominal outer diameter in its natural state, i.e., less than the inner diameter of the blood vessel at the lesion site. Therefore, the luminal stent can still be moved axially for secondary position adjustment, enabling precise control of the release position of the luminal stent with shortening properties.
[0107] The luminal stent systems of Embodiments 1 to 6 described above all include a luminal stent and a delivery device for delivering the luminal stent. The delivery device includes a sheath, a push tube, an inner core tube, a first anchor, and a second anchor. The push tube passes through the sheath, the inner core tube passes through the push tube and extends out of the sheath, the first anchor is located at the distal end of the inner core tube, and the second anchor is at least partially located at the distal end of the push tube. The first anchor is used to connect to the distal end of the lumen stent to provide a first axial force to the lumen stent, and the second anchor is used to connect to the proximal end of the lumen stent to provide a second axial force to the lumen stent. The first axial force and the second axial force are in opposite directions, thereby allowing the lumen stent to be loaded in the cavity formed by the inner core tube and the sheath tube. When the sheath tube moves axially along the inner core tube until the distal end of the sheath tube is flush with the distal end of the push tube, the distal end of the lumen stent remains connected to the first anchor, and the proximal end of the lumen stent remains connected to the second anchor, so that the outer diameter of the lumen stent is at least 90% less than the outer diameter of the lumen stent in its natural state.
[0108] It should be noted that "at least partially located at the distal end of the push tube" means that the second anchor is either entirely located at the distal end of the push tube or only partially located at the distal end of the push tube. Specifically, "entirely located at the distal end of the push tube" means that the second anchor is completely situated at the distal end of the push tube and connected to the distal end of the push tube; or, the second anchor is completely situated at the distal end of the push tube but not connected to the distal end of the push tube. "Only partially located at the distal end of the push tube" means that a portion of the second anchor is located at the distal end of the push tube, and this portion may or may not be connected to the distal end of the push tube. For example, when the second anchor is a pull wire, the portion of the pull wire anchored to the bare corrugated coil near the proximal end of the lumen support is located near the proximal end of the push tube, while the other portion of the pull wire passes through the push tube, meaning the other portion of the pull wire is connected to the push tube.
[0109] 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.
[0110] 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 lumen stent system, comprising a lumen stent and a delivery device for delivering the lumen stent, the delivery device comprising a sheath, a push tube, an inner core tube, a first anchor and a second anchor, the push tube passing through the sheath, the inner core tube passing through the push tube and extending out of the sheath, the first anchor disposed at the distal end of the inner core tube, and the second anchor at least partially disposed at the distal end of the push tube, characterized in that, The first anchoring element includes at least two anchoring rods. One end of each anchoring rod is connected to the inner core tube, and the other end extends axially along the inner core tube toward the distal end of the inner core tube and is suspended. The suspended end of each anchoring rod is hooked to the distal end of the lumen support to provide a first axial force to the lumen support. The second anchor is used to connect to the proximal end of the lumen stent to provide a second axial force to the lumen stent, the first axial force being opposite in direction to the second axial force, thereby loading the lumen stent into the cavity formed by the inner core tube and the sheath tube; When the sheath moves axially along the inner core tube until the distal end of the sheath is flush with the distal end of the push tube, the distal end of the lumen stent remains connected to the end of the anchor rod of the first anchor member away from the suspended end, and the proximal end of the lumen stent remains connected to the second anchor member, so that the outer diameter of the lumen stent is at least less than 90% of the outer diameter of the lumen stent in its natural state, so that the lumen stent does not adhere to the blood vessel wall and the position of the lumen stent can be adjusted axially.
2. The lumen support system according to claim 1, characterized in that, The first anchoring component further includes a fixing sleeve, which is sleeved on the inner core tube, and the end of the anchoring rod away from the suspended end is disposed on the fixing sleeve so that the anchoring rod is connected to the inner core tube.
3. The lumen stent system according to claim 1, characterized in that, When the lumen stent is housed within the cavity formed by the inner core tube and the sheath, the outer diameter of the lumen stent is R1; when the sheath moves axially along the inner core tube until its distal end is flush with the distal end of the push tube, the outer diameter of the lumen stent is R2, the loading length of the lumen stent is L1, and the length of the lumen stent in the semi-released state is L2. L1, L2, R1, and R2 satisfy the following relationship: L1-L2=μ(R1-R2), where μ is a constant less than 0 and whose absolute value is less than 1.
4. The lumen support system according to claim 3, characterized in that, When the stent is fully released, the length of the stent is L3, the outer diameter of the stent is R3, and L2, L3, R2, and R3 satisfy the following relationship: L2-L3=γ*(R2-R3), where γ is a constant less than 0 and whose absolute value is less than 1.
5. The lumen support system according to claim 4, characterized in that, R2 is less than or equal to 0.8R3.
6. The lumen support system according to claim 5, characterized in that, The R2 = (0.6~0.8) × R3.
7. The lumen support system according to claim 1, characterized in that, The lumen support is provided with a first developing unit, which includes at least one first developing mark; when there are multiple first developing marks, the multiple first developing marks are arranged circumferentially on the lumen support.
8. The lumen support system according to claim 7, characterized in that, The lumen support is further provided with a second developing unit, and the first developing unit and the second developing unit are spaced apart in the axial direction; the second developing unit includes at least one second developing mark; when there are multiple second developing marks, the multiple second developing marks are spaced apart in the circumferential direction on the lumen support.
9. The lumen support system according to claim 1, characterized in that, The second anchoring element includes a clamp and at least two hooks. The clamp is sleeved on the inner core tube and the proximal end of the clamp is connected to the distal end of the push tube. One end of each hook is disposed on the clamp and the other end is a free end. Each hook is elastic.
10. The lumen stent system according to claim 1, characterized in that, The conveying device further includes an outer core tube that passes through the push tube and is sleeved on the inner core tube. The second anchoring member includes a clamping sleeve and at least two anchoring parts. The clamping sleeve is sleeved on the outer core tube. One end of each anchoring part is disposed on the clamping sleeve, and the other end is a free end. The anchoring part is closer to the far end of the push tube than the clamping sleeve.
11. The lumen support system according to claim 1, characterized in that, The inner core tube is a stepped tubular structure, including a first branch tube with a smaller diameter and a second branch tube with a larger diameter. The distal end of the second branch tube is connected to the proximal end of the first branch tube, and the first anchor is disposed at the distal end of the first branch tube.
12. The lumen support system according to claim 1, characterized in that, The second anchor is at least one pull wire, one end of which passes through the push tube and is tied to the proximal end of the lumen support by a slip knot, and the other end of which is fixed to the proximal end of the conveying device.
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