Sheath and core assembly and delivery instrument

Abstract

The application discloses a sheath core assembly and a delivery system, the sheath core assembly comprises a sheath core and a U-shaped anchor, the U-shaped anchor comprises an anchor body and a stent fixing rod, the anchor body is sleeved on the sheath core and is fixed relative to the sheath core, the anchor body comprises opposite distal end faces and proximal end faces and an outer peripheral surface which is arranged between the distal end faces and the proximal end faces, the distal end faces are larger than the proximal end faces, and the edges of the distal end faces and the proximal end faces are arc-shaped, and the outer peripheral surface is a smooth arc surface from the distal end faces to the proximal end faces; and the proximal end of the stent fixing rod is fixedly connected with the distal end face of the anchor body. The sheath core assembly and the delivery instrument comprising the sheath core assembly of the application are provided with the arc-shaped transition of the outer peripheral surface of the anchor body and the welding groove arranged on the arc-shaped transition surface, so that the distal end of the anchor body is free of steps, and the problems of difficult pushing and withdrawing caused by the steps of the welding area are solved.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to a sheath core assembly and delivery system. Background Technology

[0002] In recent years, interventional therapy has become a growing trend in the treatment of cardiovascular diseases. With the continuous development of interventional techniques, the advantages of using endovascular stent grafts (ECLs) to treat aortic aneurysms and aortic dissections have become increasingly prominent. An ECL is an artificial blood vessel adapted to the size of the blood vessel. It mainly consists of a lining and a supporting metal coil. The lining is generally made of polyester or e-PTFE membrane, and the metal coil is mainly woven from nickel-titanium alloy wire. When an ECL is delivered to the lesion site using a delivery device, the stent is first compressed into the sheath of the delivery device. Then, the blood vessel is punctured, and a guidewire is used to establish a track, guiding the delivery device to the designated location of the lesion. The stent is then released, unfolding and adhering tightly to the aneurysm wall. The lining of the stent isolates blood flow from the lesion site, eliminating the impact of blood flow on the aneurysm wall and re-establishing normal blood circulation. Finally, the guidewire and delivery device are withdrawn, thus achieving interventional treatment for aneurysms and aortic dissections.

[0003] Existing iliac bifurcation stent delivery devices, such as Figure 1 As shown, its sheath core assembly consists of a tip head 1, a bifurcated tube 2, a U-shaped anchor 3, and a stainless steel tube 4. See also... Figure 2 As shown, the U-shaped anchor 3 consists of a support fixing rod 3-2 and a welding area 3-1. The U-shaped anchor 3 is used to hook the near end of the support, allowing the support to be released later. The welding area 3-1 of the U-shaped anchor 3 is a separately set section of stainless steel pipe. After being welded and fixed to the stainless steel pipe 4 and the welding area 3-1 of the U-shaped anchor 3, a circumferential step m is formed at the far end of the welding area 3-1 and the stainless steel pipe 4, as shown in the figure. Figure 3 As shown, when the sheath core is withdrawn from the curved blood vessel a, the step m of the U-shaped anchor 3 may snag on the stent, causing stent displacement or making it difficult to withdraw due to snagging on the blood vessel wall. Summary of the Invention

[0004] Based on the above problems, the present invention proposes a sheath core assembly and a delivery system.

[0005] To achieve this objective, the present invention adopts the following technical solution:

[0006] This invention provides a sheath core assembly, including a sheath core and a U-shaped anchor. The U-shaped anchor includes an anchor body and a support fixing rod. The anchor body is sleeved on the sheath core and fixed relative to it. The anchor body includes a distal end face and a proximal end face, and an outer peripheral surface surrounding the distal end face and the proximal end face. The distal end face is larger than the proximal end face, and the edge contours of the distal end face and the proximal end face are arc-shaped. The outer peripheral surface is an arc surface that smoothly transitions from the distal end face to the proximal end face. The proximal end of the support fixing rod is fixedly connected to the distal end face of the anchor body.

[0007] In one embodiment, the distal end face and the proximal end face have the same end face shape.

[0008] In one embodiment, both the distal end face and the proximal end face of the anchor body are circular, making the anchor body approximately conical.

[0009] In one embodiment, a receiving groove penetrating the distal end face is recessed on the outer peripheral surface near the distal end of the anchor body. The receiving groove is located near the bracket fixing rod, so that the connecting arm of the bracket hooked on the bracket fixing rod can be placed in the receiving groove.

[0010] In one embodiment, the bracket fixing rod is provided with receiving grooves on both sides, so that the connecting arms connected to the hook part on both sides of the bracket can be respectively accommodated in the receiving grooves on both sides of the bracket fixing rod.

[0011] In one embodiment, the distal end face and the proximal end face of the anchor body are both elliptical surfaces, making the anchor body approximately elliptical cone-shaped.

[0012] In one embodiment, the bracket fixing rod is provided in two parts, and the two bracket fixing rods are radially opposite each other on the distal end face.

[0013] In one embodiment, a welding groove is recessed on the outer peripheral surface near the proximal end of the anchor body.

[0014] In one embodiment, multiple welding grooves are provided at circumferential intervals along the outer peripheral surface of the anchor body.

[0015] In one embodiment, the anchor body has two symmetrical pull holes axially, which are opposite to the venting groove on the tip head in the sheath core assembly.

[0016] In one embodiment, the sheath core assembly further includes a connector sleeved on the distal end of the sheath core for connecting the sheath core and the tip head. The outer peripheral surface of the connector is recessed with a groove, through which the connector is relatively fixed to the sheath core and the tip head.

[0017] In one embodiment, the radial cross-section of the connector is polygonal, such that the outer peripheral surface of the connector includes multiple surfaces, and the groove is recessed on the outer peripheral surface of the connector.

[0018] In one embodiment, the radial cross-section of the connector is quadrilateral, such that the outer peripheral surface of the connector includes four surfaces, and the groove includes a first groove disposed on the surface and penetrating the distal end face and proximal end face of the connector, and / or includes a second groove recessed circumferentially along the outer peripheral surface of the connector.

[0019] In one embodiment, the groove includes a third groove recessed circumferentially along the outer peripheral surface of the connector, and a blocking portion is formed on the proximal and distal sides of the third groove. The radial cross-section of the blocking portion is quadrilateral, with two pairs of straight sides and two pairs of curved sides, such that two opposite surfaces of the blocking portion are curved surfaces, and the curved surfaces of the two blocking portions on the proximal and distal sides are staggered in orientation.

[0020] In one embodiment, the sheath core includes a first tube and a second tube sleeved within the first tube, the distal end of the second tube extending beyond the distal end face of the first tube, and the compliance of the second tube being superior to that of the first tube.

[0021] In one embodiment, the first tube is a cylindrical tube and the second tube is a spiral tube.

[0022] In one embodiment, the first tube includes a first segment sleeved outside the second tube and a second segment connected to the distal end of the first segment, the first segment having a cut.

[0023] In one embodiment, the cuts are spaced apart at multiple intervals along the axial direction of the first segment.

[0024] In one embodiment, the spacing between adjacent cuts on the first segment is equal from the proximal end to the distal end.

[0025] In one embodiment, the spacing between adjacent cuts on the first segment gradually decreases from the proximal end to the distal end of the first segment.

[0026] In one embodiment, the cut is a helical cut that extends helically along the axial direction of the first segment.

[0027] In one embodiment, the spacing between adjacent spiral cuts on the first segment gradually decreases from the proximal end to the distal end of the first segment.

[0028] In one embodiment, the length between the farthest and nearth cuts on the first segment is 5 to 200 mm.

[0029] Another technical solution adopted in this invention:

[0030] The present invention also provides a delivery device, including the sheath core assembly described above.

[0031] The sheath core assembly and delivery device including the sheath core assembly of the present invention, by setting an arc-shaped transition on the periphery of the anchor body and recessing a welding groove on the arc-shaped transition surface, not only eliminates the step at the distal end of the anchor body, solving the problem of difficult pushing and retracting caused by the step in the welding area, but also greatly improves the smoothness of the delivery device's retraction in blood vessels, especially curved blood vessels; and the weld point is built-in, avoiding damage to blood vessels caused by surface unevenness due to welding, further improving smoothness. Furthermore, in a further embodiment, it simultaneously solves the pushing, retracting, and breakage failure problems caused by existing bifurcated tubes, and also solves the pushing and retracting difficulties caused by the poor compliance of the distal end of the existing sheath core. Attached Figure Description

[0032] Figure 1 This is a partial schematic diagram of an existing sheath-core assembly;

[0033] Figure 2 for Figure 1 Enlarged schematic diagram of part A' in the diagram;

[0034] Figure 3 A schematic diagram of the U-shaped anchor step of the existing sheath core assembly attaching to the blood vessel wall;

[0035] Figure 4 for Figure 1 Enlarged schematic diagram of part B' in the diagram;

[0036] Figure 5 A schematic diagram showing the existing sheath core assembly with the tip head hidden;

[0037] Figure 6 This is a schematic diagram of the sheath core in a blood vessel in an existing sheath core assembly;

[0038] Figure 7 This is a schematic diagram of the sheath core assembly of the present invention;

[0039] Figure 8 for Figure 7 Enlarged diagram of part A in the diagram;

[0040] Figure 9This is a schematic diagram of another U-shaped anchor in the sheath core assembly of the present invention;

[0041] Figure 10 This is a schematic diagram of the sheath core assembly of the present invention after the tip head is hidden;

[0042] Figure 11 for Figure 10 Enlarged schematic diagram of part B in the diagram;

[0043] Figure 12 This is a schematic diagram of another connector in the sheath core assembly of the present invention;

[0044] Figure 13 This is a schematic diagram of the structure of another connector in the sheath core assembly of the present invention;

[0045] Figure 14 This is a schematic diagram of the structure of another connector in the sheath core assembly of the present invention;

[0046] Figure 15 for Figure 10 Enlarged schematic diagram of part C in the diagram;

[0047] Figure 16 This is a schematic diagram of a partial structure of the sheath core in the sheath core assembly of the present invention. Figure 1 ;

[0048] Figure 17 This is a schematic diagram of a partial structure of the sheath core in the sheath core assembly of the present invention. Figure 2 . Detailed Implementation

[0049] To make the objectives, technical solutions, and advantages of this invention clearer, exemplary embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of this disclosure are shown in the drawings, it should be understood that this disclosure can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of this disclosure and to fully convey the scope of this disclosure to those skilled in the art.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] Additionally, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body, or the delivery system that delivers the medical device, closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device or delivery system are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0054] Example 1

[0055] See Figure 7 In view of the problem that the circumferential steps of the U-shaped anchor in existing delivery devices can cause the stent to shift or become stuck on the blood vessel wall, making it difficult to remove. The present invention provides an exemplary sheath core assembly 100, so that a delivery device including the sheath core assembly 100 of this embodiment can be smoothly pushed and withdrawn in a blood vessel.

[0056] For details, see Figure 7 The sheath core assembly 100 of this embodiment includes a sheath core 10 and a U-shaped anchor 20 sleeved on and fixed relative to the sheath core 10. Additionally, the sheath core assembly 100 may also include a tip head 40 covering the distal end of the sheath core 10. The structure of the sheath core 10 in this embodiment can refer to existing technology; for example, it can be a stainless steel tube. Preferably, a new sheath core structure can also be proposed. A specific implementation of the new sheath core structure can be found in Embodiment 3 below. This embodiment mainly focuses on a detailed description of the structure of the U-shaped anchor 20 in the sheath core assembly 100.

[0057] Combination Figure 7 and Figure 8 As shown, unlike existing designs, the U-shaped anchor 20 in this embodiment includes an anchor body 21 and a support fixing rod 22. The anchor body 21 has an axially oriented through-hole 20a, through which it is sleeved onto the sheath core 10 and fixed relative to it. The anchor body 21 includes opposing distal end faces 21a and proximal end faces 21b, and an outer peripheral surface 21c surrounding the distal end face 21a and proximal end face 21b. The distal end face 21a is larger than the proximal end face 21b, and the edge contours of both faces are arc-shaped, resulting in the outer peripheral surface 21c being a smoothly transitioning arc surface from the distal end face 21a to the proximal end face 21b. In this embodiment, the proximal end of the anchor body 21 has no step. Preferably, in order to ensure a smooth transition of the outer peripheral surface, the end face shapes of the distal end face 21a and the proximal end face 21b are the same. This arrangement ensures that there are no sharp edges on the outer peripheral surface 21c formed by the distal end face 21a and the proximal end face 21b, thus ensuring the smoothness of pushing and retracting.

[0058] The proximal end of the bracket fixing rod 22 is fixedly connected to the distal end face 21a of the anchor body 21. The bracket fixing rod 22 is used to hook the bare corrugated ring of the bracket. After the pull line is fixed on the U-shaped anchor 20, the bracket can be brought into the sheath tube together to complete the assembly. In addition, the U-shaped anchor 20 also serves to release the bracket at the rear.

[0059] Reference Figure 8 In one embodiment of the anchor body 21, both the distal end face 21a and the proximal end face 21b of the anchor body 21 are circular, making the anchor body 21 approximately conical. Here, "approximately conical" means that the proximal end face 21b of the anchor body 21 is as close as possible to the outer periphery of the sheath core 10, which is fixed to it, so that the proximal end of the anchor body 21 is stepless. Preferably, the edge at the connection between the distal end face 21a and the outer peripheral surface 21c of the anchor body 21 is rounded to improve smoothness.

[0060] Continue to refer to Figure 8 In the case where the anchor body 21 is approximately conical, preferably, a receiving groove 23 penetrating the distal end face 21a is recessed on the outer peripheral surface 21c near the distal end of the anchor body 21. The receiving groove 23 is located near the support fixing rod 22, so that the connecting arm of the support hooked on the support fixing rod 22 can be placed in the receiving groove 23. Because the space between the outer wall of the U-shaped anchor 20 and the inner wall of the sheath is limited, the receiving groove 23 serves to expand the receiving space between the sheath and the U-shaped anchor 20, so that the bare wave of the support can be accommodated by the sheath, avoiding the phenomenon that the bare wave of the support will bulge after being hooked on the support fixing rod 22, making it difficult to install into the sheath or damaging the sheath when the support is installed. In addition, the receiving groove 23 also serves to fix the bare wave of the support by placing it in it, preventing the bare wave from shaking and damaging the sheath when the support is installed. Preferably, since the bracket fixing rod 22 is fixed to the distal end face 21a of the anchor body 21, after the bracket is hooked onto the bracket fixing rod 22, the connecting arm of the bracket, i.e., the bare corrugated section of the bracket, is inclined relative to its center. Therefore, the depth of the receiving groove 23 in this embodiment can gradually increase from near to far, so that the distal end of the receiving groove 23 is inclined towards its center, in order to better conform to the compressed shape of the bare corrugated section of the bracket, allowing the connecting arm of the bracket to be completely placed within the receiving groove 23. This avoids wear on the bracket caused by friction between the anchor body 21 and the connecting arm of the bracket, and makes the release process easier.

[0061] Preferred, such as Figure 8As shown, since the single wave of the bracket is usually V-shaped, it actually has two connecting arms. Therefore, both sides of the bracket fixing rod 22 are provided with receiving grooves 23, so that the connecting arms connected to the hook part on both sides of the bracket can be respectively accommodated in the receiving grooves 23 on both sides of the bracket fixing rod 22. Furthermore, there are two bracket fixing rods 22, and the two bracket fixing rods 22 are radially opposite each other at their distal end faces 21a. It is understood that when there are two bracket fixing rods 22, each bracket fixing rod 22 is provided with receiving grooves 23 on both sides. It should be noted that in other embodiments, the number of bracket fixing rods 22 can be set according to actual needs, and the number and arrangement of the receiving grooves 23 on the sides of the bracket fixing rods 22 can be improved as needed and are not limited thereto.

[0062] Reference Figure 9 In another embodiment of the anchor body 21, the anchor body 21 has a through hole 20a in the axial direction. The anchor body 21 is sleeved onto the sheath core 10 through the through hole 20a and is fixed relative to the sheath core 10. The distal end face 21a and the proximal end face 21b of the anchor body 21 are both elliptical surfaces, making the anchor body 21 approximately elliptical cone-shaped. Here, "approximately elliptical cone-shaped" means that the proximal end face 21b of the anchor body 21 is as close as possible to the outer periphery of the sheath core 10 to which it is fixed, so that there is no step at the proximal end of the anchor body 21. The approximately elliptical cone-shaped anchor body 21 provides a large gap between the outer periphery of the anchor body 21 and the sheath tube during installation. This gap allows the connecting arm of the bracket hooked on the bracket fixing rod 22 to pass through without the need for an additional receiving groove 23. This simplifies the structure and greatly reduces the difficulty and cost of machining. Preferably, the edge of the connection between the distal end face 21a and the outer peripheral face 21c of the anchor body 21 is rounded to improve smoothness.

[0063] Furthermore, such as Figure 9 As shown, in order to minimize the volume of the U-shaped anchor 20 while achieving its basic function and improve the smoothness of pushing, when the anchor body 21 is set in an approximately elliptical cone shape, the two support fixing rods 22 are respectively fixed to the edges of the two long axes on the far end face of the anchor body 21. After the through hole 20a is set in the axial direction of the anchor body 21, a larger connection position will be reserved on both sides of the long axis, so that the U-shaped anchor 20 can be made smaller and smoother when retracting.

[0064] Existing such as Figure 1 and Figure 2 As shown, the U-shaped anchor 3 is a machined metal part, and the sheath core 4 is a stainless steel metal part. To achieve relative fixation between the U-shaped anchor 3 and the sheath core 4, existing technology requires an additional welding zone 3-1 to weld and fix the U-shaped anchor and the sheath core. Regarding this, refer to... Figure 8 and Figure 9In this embodiment, a welding groove 24 is recessed on the arc-shaped outer peripheral surface 21c near the proximal end of the anchor body 21. After the anchor body 21 is fitted onto the sheath core 10 through the perforation 20a, the anchor body 21 and the sheath core 10 are welded and fixed through the welding groove 24. This method eliminates the need for an additional welding area, avoiding the steps and increased length caused by setting a welding area. At the same time, the setting of the welding groove 24 in this embodiment makes the weld point internal and not on the surface of the U-shaped anchor 20, avoiding damage to blood vessels due to surface unevenness caused by welding.

[0065] For example, multiple welding grooves 24 are arranged circumferentially along the arc-shaped outer peripheral surface 21c of the anchor body 21. In this embodiment, "multiple" refers to two or more. To ensure the connection effect, the welding grooves 24 are arranged circumferentially along the outer peripheral surface 21c of the anchor body 21. Furthermore, four welding grooves 24 are arranged at equal intervals circumferentially.

[0066] Reference Figure 7 and Figure 8 As shown, in other embodiments, the anchor body 21 is also provided with two symmetrical pull wire holes 25 in the axial direction. The pull wire holes 25 are used for passing the pull wire of the pull bracket into the sheath tube. Furthermore, the pull wire holes 25 are opposite to the vent groove 41 on the tip head 40 in the sheath core assembly 100. The pull wire holes 25 and the vent groove 41 of the tip head 40 are on the same side, which facilitates the pull wire to pass straight through the tip head 40.

[0067] In this embodiment, the sheath core assembly 100 is designed with an arc-shaped transition around the anchor body and a welding groove recessed on the arc-shaped transition surface. This not only eliminates the step at the distal end of the anchor body, solving the problem of difficulty in pushing and retracting caused by the step in the welding area, but also greatly improves the smoothness of the delivery device's retraction in blood vessels, especially curved blood vessels. Furthermore, the weld point is built-in, avoiding damage to blood vessels caused by uneven surface due to welding, further improving smoothness.

[0068] Example 2

[0069] Reference Figure 7 and Figure 10This embodiment, based on Embodiment 1, further proposes a sheath core assembly 100. The sheath core assembly 100 of this embodiment includes a sheath core 10, a U-shaped anchor 20 sleeved on and fixed relative to the sheath core 10, and a connector 30 sleeved at the distal end of the sheath core 10 for connecting the sheath core 10 and the tip head 40. Additionally, the sheath core assembly 100 may also include a tip head 40 covering the distal end of the sheath core 10. The structure of the sheath core 10 in this embodiment can refer to existing technology; for example, it can be a stainless steel tube. Preferably, a new sheath core structure can also be proposed. The specific implementation of the new sheath core structure can be referred to Embodiment 3 below. The specific structure of the U-shaped anchor 20 is referred to in Embodiment 1 above and will not be repeated here. This embodiment mainly describes in detail the structure of the connector 30 sleeved at the distal end of the sheath core 10 for connecting the sheath core 10 and the tip head 40.

[0070] Among them, combined Figure 1 and Figure 4 The background section mentions that the sheath core assembly of existing conveyors also includes a bifurcated tube 2, which is used to connect and fix the tip head 1 and the stainless steel tube 4. The structure of the existing bifurcated tube 2 is as follows: Figure 4 As shown, the bifurcation tube 2 has a welding area 2-1 and a fixing area 2-2. The two functional areas are located at different positions on the bifurcation tube 2, resulting in a relatively long overall length L1. Furthermore, because the bifurcation tube 2 is embedded in the tip head 1, the area of ​​the tip head 1 with higher rigidity, L2, is also relatively long, thus reducing the compliance of the tip head 1 and affecting the advancement and retraction of the punctured tissue in the blood vessel by the sheath core 4. Additionally, during the injection molding of the tip head 1, the bifurcation tube 2 is affected by the injection pressure (pressure direction as shown in the diagram). Figure 4 The direction indicated by the middle arrow will cause the fixed area 2-2 to deform or even break in the direction of the arrow, reducing the connection strength and potentially leading to connection failure.

[0071] In view of this, a new connection scheme is provided in the sheath core assembly of this embodiment to further solve the problem of fracture failure.

[0072] Combination Figure 7 , Figure 10 and Figure 11As shown, the connector 30 for connecting the sheath core 10 and the tip head 40 in this embodiment is a solid metal part. For example, it is made of stainless steel. The connector 30 has an axial hole 31, through which it is sleeved onto the distal end of the sheath core 10 and fixed relative to it. A groove is recessed on the outer circumferential surface of the connector 30, which allows for relative fixation between the connector 30, the sheath core 10, and the tip head 40. This groove serves two purposes: firstly, it reduces the thickness at the groove, facilitating welding between the connector 30 and the sheath core 10; secondly, during the injection molding process of the tip head 40, the injection adhesive can enter the groove, achieving connection between the tip head 40 and the connector 30 while simultaneously providing axial and circumferential positioning.

[0073] For example, the radial cross-section of the connector 30 is polygonal, such that the outer peripheral surface of the connector 30 includes multiple surfaces, and grooves are recessed on the outer peripheral surface of the connector 30. This arrangement can further enhance the connection while improving axial and circumferential limiting. The grooves can be provided on one surface or on multiple surfaces, or multiple grooves can be provided on one surface; the specific arrangement depends on the situation. It should also be noted that the radial cross-section of the connector 30 can also be other shapes, not limited to polygons. For example, it can be circular, in which case the connector 30 can be a columnar body, with grooves recessed on the surface of the columnar body.

[0074] Reference Figure 11 As shown, in one embodiment, the radial cross-section of the connector 30 is quadrilateral, such that the outer peripheral surface of the connector 30 includes four surfaces. Preferably, for ease of processing, the connector 30 is a cuboid or cube, and the circumferential surface of the cuboid or cube is provided with a groove. Exemplarily, each outer peripheral surface of the cuboid or cube is provided with a first groove 32 penetrating the distal end face and the proximal end face of the connector 30, thereby forming a strip-shaped groove on each outer peripheral surface. The bottom of the strip-shaped groove is welded to the sheath core 10 to achieve relative fixation between the connector 30 and the sheath core 10.

[0075] Reference Figure 12 As shown, in another embodiment, the radial cross-section of the connector 30 is quadrilateral, such that the outer peripheral surface of the connector 30 includes four surfaces. Preferably, for ease of processing, the connector 30 is a cuboid or cube, and the circumferential surface of the cuboid or cube is provided with a second groove 33 that does not penetrate the distal end face and proximal end face of the connector 30. Exemplarily, the second groove 33 is an annular groove surrounding the outer peripheral surface of the cuboid or cube, and the bottom of the annular groove is welded to the sheath core 10 to achieve relative fixation between the connector 30 and the sheath core 10.

[0076] Reference Figure 13As shown, in another embodiment, the radial cross-section of the connector 30 is quadrilateral, so that the outer peripheral surface of the connector 30 includes four surfaces. Preferably, for ease of processing, the connector 30 is a cuboid or cube, and the circumferential surface of the cuboid or cube is provided with a groove. For example, each outer peripheral surface of the cuboid or cube is provided with a first groove 32 that penetrates the distal end face and the proximal end face of the connector 30, thereby forming a strip-shaped groove on each outer peripheral surface. At the same time, the circumferential surface of the cuboid or cube is provided with a second groove 33 that does not penetrate the distal end face and the proximal end face of the connector 30. The second groove 33 is arranged in annular shape, and the annular groove penetrates the strip-shaped groove. The connector 30 and the sheath core 10 are relatively fixed by welding the bottom of the groove to the sheath core 10.

[0077] Reference Figure 14 As shown, in one embodiment where the radial cross-section of the connector 30 is not quadrilateral, a third groove 34 is circumferentially recessed on the outer peripheral surface of the connector 30. This third groove 34 does not penetrate the distal and proximal ends of the connector 30, thus forming blocking portions 30b on both the proximal and distal sides of the third groove 34. The radial cross-section of the blocking portion 30b is quadrilateral, with two pairs of straight sides and two pairs of curved sides, making two opposite faces of the blocking portion 30b curved surfaces. The curved surfaces of the two blocking portions 30b located on the proximal and distal sides are staggered in orientation. The staggered arrangement of the blocking portions 30b further enhances the strength of both circumferential and axial limiting.

[0078] In this embodiment, the welding area and the circumferential fixing area of ​​the connector 30 are designed in the same groove, such as... Figure 11 and Figure 4 In comparison, the overall length L3 of the connector 30 in this embodiment is significantly smaller than the length L4 of the existing branch pipe, thus reducing the overall length. Figure 7 As shown, after being embedded in the tip head 40, the length L4 of the area with higher hardness in the tip head 40 is shorter, resulting in better conformability. Simultaneously, the overall structure of the connector 30 is more stable, preventing deformation due to the injection molding of the tip head 40, and making the connection with the tip head 40 more reliable. The sheath core assembly 100 of this embodiment not only solves the problem of difficult retraction caused by the steps in the welding area, but also addresses the problems of pushing, retraction, and breakage failure caused by existing bifurcated tubes.

[0079] Example 3

[0080] Reference Figure 7 and Figure 10This embodiment, based on Embodiment 1, further proposes a sheath core assembly 100. The sheath core assembly 100 of this embodiment includes a sheath core 10 and a U-shaped anchor 20 sleeved on and fixed relative to the sheath core 10. Additionally, the sheath core assembly 100 may also include a tip head 40 covering the distal end of the sheath core 10. The specific structure of the U-shaped anchor 20 in this embodiment is the same as described in Embodiment 1 above, and will not be repeated here. This embodiment mainly describes in detail the structure of the sheath core in the sheath core assembly 100.

[0081] Among them, see Figure 1 and Figure 6 As shown in the background section, the existing sheath core assembly includes a sheath core 4, which is usually made of stainless steel tube. This results in the distal end of the sheath core 4 being relatively hard and having poor compliance. It cannot bend or recover in time to conform to the shape of the blood vessel a. The blood vessel a and the sheath core 4 form a resistance zone a1, which makes it difficult to push or retract the sheath core.

[0082] In view of this, a new sheath core structure is adopted in the sheath core assembly 100 of this embodiment to further solve the problem of difficulty in pushing and retracting caused by the hardness of the distal end of the sheath core.

[0083] Specifically, in combination Figure 7 , Figure 10 and Figure 15 As shown, the sheath core 10 in this embodiment includes a first tube 11 and a second tube 12 sleeved within the first tube 11. The distal end of the second tube 12 extends beyond the distal end face of the first tube 11. The compliance of the second tube 12 is better than that of the first tube 11. A U-shaped anchor 20 is sleeved on the second tube 12 and fixed relative to it. In this embodiment, the more compliant second tube 12 is sleeved on the first tube 11 and extends beyond its distal end, thereby improving the hardness of the distal end of the sheath core 10. This enhances the compliance of the distal end of the sheath core 10 and solves the problem of difficulty in pushing and retracting caused by the hardness of the distal end of the sheath core 10.

[0084] For example, see Figure 15 The first tube 11 is a cylindrical tube, preferably a stainless steel tube, and the second tube 12 is a spiral tube, similar to the spiral structure of a spring. The stainless steel tube covers the outer wall of the spiral tube, and the distal end of the spiral tube extends beyond the distal end of the stainless steel tube. The compliance of the spiral tube is better than that of the stainless steel tube, ensuring the flexibility of the proximal end of the sheath core 10 while ensuring the rigidity of the distal end, thus ensuring that the sheath core 10 body has sufficient pushing force.

[0085] Because the spiral tube and the stainless steel tube are connected by a sleeve, a gap exists between them. During the manufacturing process, there is usually a final cleaning process. During this cleaning, the cleaning fluid enters the gap and also rinses it. Therefore, referring to... Figure 16 and Figure 17 As shown, the first tube 11 in this embodiment includes a first segment 11a sleeved outside the second tube 12 and a second segment 11b connected to the distal end of the first segment 11a. The first segment 11a has a cut 11a1. Through the cut 11a1, the stainless steel tube and the spiral tube can be thoroughly rinsed, and the rinsing liquid can flow out from the cut after the cleaning process, avoiding the cleaning liquid from remaining in the gap. At the same time, the hardness of the sleeved section of the first tube 11 and the second tube 12 is transitioned to avoid excessive local hardness, so that the sheath core 10 has better conformability. It should be noted that the distal end of the first segment 11a is closed, so that there is a closed section at the end. The distal ends of the first tube 11 and the second tube 12 can be welded through this closed section.

[0086] Preferably, multiple cuts 11a1 are spaced apart along the axial direction of the first segment 11a. These multiple axial cuts 11a1 allow for thorough cleaning of the entire sleeve segment, while simultaneously achieving a gradual transition in hardness. In one embodiment, the spacing between adjacent cuts 11a1 on the first segment 11a is equal from the proximal end to the distal end. In another embodiment, the spacing between adjacent cuts 11a1 on the first segment 11a gradually decreases from the proximal end to the distal end, resulting in a gradual increase in the size of adjacent cuts 11a1 from the proximal end to the distal end. This leads to a better transition in hardness from the proximal end to the distal end and better compliance towards the distal end.

[0087] Continue to refer to Figure 16 and Figure 17 In other embodiments, to facilitate processing while simultaneously cleaning the gaps within the entire socket segment, the cut 11a1 is a helical cut, extending helically along the axial direction of the first segment 11a. Preferably, as one implementation, the spacing W between adjacent cuts 11a1 on the first segment 11a is equal from the proximal end to the distal end. As another implementation, the spacing W between adjacent cuts 11a1 on the first segment 11a gradually decreases from the proximal end to the distal end, resulting in a gradual increase in the size of adjacent cuts 11a1 from the proximal end to the distal end, improving the transition from the proximal end to the distal end and enhancing flexibility towards the distal end.

[0088] During the socketing process, it is preferable to refer to... Figure 16 As shown, in this embodiment, the length L5 between the farthest and nearest cuts 11a1 on the first segment 11a is 5 to 200 mm. This length and orientation ensure the conformity of the transition segment as much as possible, while ensuring the rigidity of other segments of the sheath core 10, so that the sheath core 10 body has sufficient pushability.

[0089] This embodiment employs a design combining a spiral tube and a stainless steel tube for the sheath core 10. The stainless steel tube covers the outer wall of the spiral tube, with the distal end being the spiral tube and the proximal end being the stainless steel tube structure. The distal end of the stainless steel tube has a slit, forming a closed section for welding and fixing to the spiral tube, and sealing the slit. The slit ensures a smooth and uniform transition between the spiral tube and the stainless steel tube, maintaining the flexibility of the distal end of the sheath core 10 while ensuring the rigidity of the proximal end, thus guaranteeing sufficient pushing capability for the sheath core 10 body. The sheath core assembly 100 of this embodiment not only solves the problem of difficult retraction caused by the steps in the welding area but also addresses the pushing and retraction difficulties caused by the poor compliance of the distal end of the existing sheath core 10.

[0090] Example 4

[0091] Reference Figure 7 , Figure 10 and Figure 15 This embodiment, based on embodiments 1 and 2, further proposes a sheath core assembly 100. The sheath core assembly 100 of this embodiment includes a sheath core 10, a U-shaped anchor 20 sleeved on and fixed relative to the sheath core 10, and a connector 30 sleeved at the distal end of the sheath core 10 for connecting the sheath core 10 and a tip head 40. Additionally, the sheath core assembly 100 may also include a tip head 40 covering the distal end of the sheath core 10. The specific structure of the U-shaped anchor 20 in this embodiment is the same as in embodiment 1, and will not be repeated here. The specific structure of the connector 30 in this embodiment is the same as in embodiment 2, and will not be repeated here. The specific structure of the sheath core 10 in this embodiment is the same as in embodiment 3, and will not be repeated here.

[0092] This embodiment combines a spiral tube and a stainless steel tube in the design of the sheath core 10. The stainless steel tube covers the outer wall of the spiral tube, with the distal end being the spiral tube and the proximal end being the stainless steel tube structure. The distal end of the stainless steel tube has a slit, forming a closed section for welding and fixing to the spiral tube and sealing the slit. The slit ensures a smooth and uniform transition between the spiral tube and the stainless steel tube, maintaining the flexibility of the distal end of the sheath core 10 while ensuring the rigidity of the proximal end, thus guaranteeing sufficient pushing capability for the sheath core 10 body. The sheath core assembly 100 of this embodiment not only solves the problem of difficult retraction caused by the steps in the welding area, but also addresses the pushing, retraction, and breakage failure problems caused by existing bifurcated tubes, and solves the pushing and retraction difficulties caused by the poor compliance of the distal end of the existing sheath core 10.

[0093] Example 5

[0094] This embodiment proposes a conveying device, which includes any one of the sheath core assembly 100 in Embodiments 1 to 4 above.

[0095] The sheath core assembly and delivery device including the sheath core assembly of the present invention, by setting an arc-shaped transition on the periphery of the anchor body and recessing a welding groove on the arc-shaped transition surface, not only eliminates the step at the distal end of the anchor body, solving the problem of difficult pushing and retracting caused by the step in the welding area, but also greatly improves the smoothness of the delivery device's retraction in blood vessels, especially curved blood vessels; and the weld point is built-in, avoiding damage to blood vessels caused by surface unevenness due to welding, further improving smoothness. Furthermore, in a further embodiment, it simultaneously solves the pushing, retracting, and breakage failure problems caused by existing bifurcated tubes, and also solves the pushing and retracting difficulties caused by the poor compliance of the distal end of the existing sheath core.

[0096] 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.

[0097] 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 sheath-core assembly, characterized in that, The assembly includes a sheath core and a U-shaped anchor. The U-shaped anchor includes an anchor body and a support fixing rod. The anchor body is sleeved on the sheath core and fixed relative to it. The anchor body includes opposing distal and proximal end faces, and an outer peripheral surface surrounding the distal and proximal end faces. The distal end face is larger than the proximal end face, and the edge contours of both the distal and proximal end faces are arc-shaped. The outer peripheral surface is an arc surface that smoothly transitions from the distal end face to the proximal end face. The proximal end of the support fixing rod is fixedly connected to the distal end face of the anchor body. The sheath core assembly also includes a connector sleeved on the distal end of the sheath core for connecting the sheath core and the tip head. The connector has an axial hole, through which it is sleeved onto the distal end of the sheath core and fixed relative to the sheath core. A groove is recessed on the outer circumferential surface of the connector, which allows for relative fixation between the connector, the sheath core, and the tip. The radial cross-section of the connector is polygonal, resulting in multiple surfaces on its outer circumferential surface. The groove is recessed on the outer circumferential surface, and the welding area and circumferential fixing area of ​​the connector are located within the same groove. The groove facilitates welding between the connector and the sheath core, and simultaneously connects the tip to the connector while providing axial and circumferential positioning.

2. The sheath-core assembly according to claim 1, characterized in that, The distal end face and the proximal end face have the same shape.

3. The sheath-core assembly according to claim 2, characterized in that, Both the distal end face and the proximal end face of the anchor body are circular, making the anchor body approximately conical in shape.

4. The sheath-core assembly according to claim 3, characterized in that, A receiving groove is recessed on the outer peripheral surface near the far end of the anchor body, penetrating the far end face. The receiving groove is located near the bracket fixing rod, so that the connecting arm of the bracket hooked on the bracket fixing rod can be placed in the receiving groove.

5. The sheath-core assembly according to claim 4, characterized in that, The bracket fixing rod is provided with receiving grooves on both sides, so that the connecting arms connected to the hook part on both sides of the bracket can be respectively accommodated in the receiving grooves on both sides of the bracket fixing rod.

6. The sheath-core assembly according to claim 2, characterized in that, Both the distal end face and the proximal end face of the anchor body are elliptical surfaces, making the anchor body approximately elliptical cone-shaped.

7. The sheath-core assembly according to claim 1, characterized in that, The bracket fixing rod is provided in two parts, and the two bracket fixing rods are radially opposite each other on the distal end face.

8. The sheath-core assembly according to claim 1, characterized in that, A welding groove is recessed on the outer peripheral surface near the proximal end of the anchor body.

9. The sheath-core assembly according to claim 8, characterized in that, Multiple welding grooves are provided at intervals along the outer circumferential surface of the anchor body.

10. The sheath-core assembly according to claim 1, characterized in that, The anchor body is provided with two symmetrical pull holes in the axial direction, and the pull holes are opposite to the venting groove on the tip head in the sheath core assembly.

11. The sheath-core assembly according to claim 1, characterized in that, The radial cross-section of the connector is quadrilateral, such that the outer peripheral surface of the connector includes four surfaces. The groove includes a first groove disposed on the surface and penetrating the distal end face and proximal end face of the connector, and / or includes a second groove recessed circumferentially along the outer peripheral surface of the connector.

12. The sheath-core assembly according to claim 1, characterized in that, The groove includes a third groove recessed circumferentially along the outer peripheral surface of the connector. A blocking portion is formed on the proximal and distal sides of the third groove. The radial cross-section of the blocking portion is quadrilateral, with two pairs of straight sides and two pairs of curved sides, such that two opposite surfaces of the blocking portion are curved surfaces. The curved surfaces of the two blocking portions on the proximal and distal sides are staggered in orientation.

13. The sheath-core assembly according to any one of claims 1 to 10, characterized in that, The sheath core includes a first tube and a second tube sleeved inside the first tube. The distal end of the second tube extends beyond the distal end face of the first tube, and the compliance of the second tube is better than that of the first tube.

14. The sheath-core assembly according to claim 13, characterized in that, The first tube is a cylindrical tube, and the second tube is a spiral tube.

15. The sheath-core assembly according to claim 13, characterized in that, The first tube includes a first segment sleeved outside the second tube and a second segment connected to the distal end of the first segment, and the first segment has a cut.

16. The sheath-core assembly according to claim 15, characterized in that, The cuts are spaced out at intervals along the axial direction of the first segment.

17. The sheath-core assembly according to claim 16, characterized in that, The intervals between adjacent incisions on the first segment are equal, from the proximal end to the distal end.

18. The sheath-core assembly according to claim 16, characterized in that, The spacing between adjacent incisions on the first segment gradually decreases from the proximal end to the distal end.

19. The sheath-core assembly according to claim 15, characterized in that, The cut is a spiral cut, which extends spirally along the axial direction of the first segment.

20. The sheath-core assembly according to claim 19, characterized in that, The spacing between adjacent spiral cuts on the first segment gradually decreases from the proximal end to the distal end.

21. The sheath-core assembly according to claim 16 or 19, characterized in that, The length between the farthest and nearth incisions on the first segment is 5 to 200 mm.

22. A conveying device, characterized in that, Includes the sheath core assembly as described in any one of claims 1 to 21.

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