An adjustable elbow, sheath and catheter
By designing an adjustable bendable tube and sheath structure with a triangular cross-section, the problems of difficulty in bending existing catheters in complex vascular channels and wasted space are solved. This achieves multi-directional bending and a compact sheath design, ensuring smooth delivery of implants and protection of blood vessels.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- MITRASSIST LIFESCIENCES LTD
- Filing Date
- 2023-10-10
- Publication Date
- 2026-06-05
AI Technical Summary
Existing adjustable bendable catheters bend within a plane, making them unable to pass through complex vascular channels. Furthermore, the circular lumen encapsulates irregularly shaped implants, resulting in wasted space and an increased outer diameter of the delivery system.
An adjustable bendable tube is designed, with a tubular body having a triangular cross-section. By setting reinforcing ribs and groove structures on the wall, it can bend in multiple directions, and a coating layer is set inside the sheath to enhance strength and protect blood vessels.
It enables multi-directional bending through complex vascular channels, reduces the outer diameter of the sheath, avoids wasting space, ensures smooth release and retrieval of the implant, and protects the blood vessels from scratches.
Smart Images

Figure CN117323541B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical technology, and more specifically, to an adjustable bend tube, sheath, and catheter. Background Technology
[0002] Catheters are common surgical instruments in interventional procedures. In minimally invasive interventional treatments via catheters, the catheter is typically inserted into the desired location, such as the heart or a specific blood vessel, first. Then, instruments or medications are inserted along the catheter's pathway to the target location for treatment. To achieve the desired device insertion, the catheter tip usually needs to be coaxial with the target location. In addition to pre-setting certain bends in the catheter based on the characteristics of the insertion site, especially at the distal end, navigation settings are used to make it easier for the distal end of the catheter to reach the intended location. Furthermore, the angle relative to the target location is beneficial for successful instrument or medication insertion.
[0003] In the prior art, there are also some adjustable bendable catheters to achieve the bending of the catheter. For example, the patent with publication number CN115317761A discloses an adjustable bendable catheter with a thiocyanate tube. In this solution, the thiocyanate tube can only bend in one plane. After the implant is loaded, it cannot smoothly pass through more complex blood vessel channels. In addition, the cross-sectional shape of the thiocyanate tube in this solution is circular. After encapsulating irregularly shaped implants, there is a cavity area, which leads to a large waste of space inside the sheath, thereby increasing the maximum outer diameter of the delivery system. Summary of the Invention
[0004] This application provides an adjustable bend tube, sheath, and catheter, which can be used for the delivery of irregularly shaped implants, avoids wasting internal space of the sheath, and effectively controls the outer diameter of the sheath to a minimum.
[0005] In a first aspect, embodiments of this application provide an adjustable bend tube, which includes a tubular body that can be bent in the axial direction. The tubular body has a first wall, a second wall, and a third wall that are interconnected in the circumferential direction. A cavity for accommodating the passage of a graft is formed between the first wall, the second wall, and the third wall. The planes containing the first wall, the second wall, and the third wall intersect each other.
[0006] In this design, the tubular body can be bent axially, giving the adjustable tube a certain degree of flexibility, allowing it to bend and deform to pass through complex vascular channels. The tubular body includes a first wall, a second wall, and a third wall, and the planes containing the first, second, and third walls intersect each other to form a lumen with a roughly triangular cross-section. The shape of the lumen is adapted to the cross-sectional shape of the implant to be encapsulated. By encapsulating the roughly triangular cross-section implant in the contracted state within the tubular body, compared to the circular lumen of existing adjustable tubes, this design reduces the waste of internal space and effectively controls the outer diameter of the sheath to a minimum.
[0007] In some embodiments, at least one of the first wall, the second wall, and the third wall is provided with a reinforcing rib, and the tubular body has a first end and a second end in the axial direction, with the reinforcing rib extending from the first end to the second end.
[0008] In the above technical solution, by providing reinforcing ribs on at least one of the first wall, the second wall, and the third wall, and the reinforcing ribs extending from the first end to the second end along the axial direction of the tubular body, the reinforcing ribs can support and strengthen the wall, thereby improving the compressive strength and / or bending strength of the tubular body and meeting the rigidity requirements of the tubular body itself.
[0009] In some embodiments, the first wall is provided with a first reinforcing rib, the second wall is provided with a second reinforcing rib, and the third wall is provided with a third reinforcing rib.
[0010] In the above technical solution, by providing a first reinforcing rib, a second reinforcing rib, and a third reinforcing rib on the first wall, the second wall, and the third wall respectively, each wall of the tubular body can be effectively supported by the reinforcing rib, ensuring that the compressive strength and / or bending strength of each wall of the tubular body are relatively uniform, which is conducive to the smooth release and retrieval of the subsequent implant.
[0011] In some embodiments, at least one of the first reinforcing rib, the second reinforcing rib, and the third reinforcing rib is disposed along its diagonal on the corresponding wall.
[0012] In some embodiments, the first reinforcing rib is arranged along the diagonal of the first wall, the second reinforcing rib is arranged along the diagonal of the second wall, and the third reinforcing rib is arranged along the diagonal of the third wall.
[0013] In the above technical solution, the first reinforcing rib, the second reinforcing rib, and the third reinforcing rib are all diagonally distributed on the corresponding wall. As reinforcement points, the reinforcing ribs are not easily deformed. When the tubular body is subjected to external force, it is beneficial to guide the tubular body to bend with the diagonal of the wall as the reference line.
[0014] In some embodiments, at the first end, the first reinforcing rib, the second reinforcing rib, and the third reinforcing rib are circumferentially staggered along the tubular body; at the second end, the first reinforcing rib, the second reinforcing rib, and the third reinforcing rib are circumferentially staggered along the tubular body.
[0015] In the above technical solution, the first, second and third reinforcing ribs are all circumferentially staggered at both ends on the tubular body, which enables the tubular body to undergo 360° bending deformation, thus realizing the function of non-directional and multi-directional bending deformation of the adjustable bend.
[0016] In some embodiments, a first cutting area is formed between the first reinforcing rib and the second reinforcing rib, a second cutting area is formed between the second reinforcing rib and the third reinforcing rib, and a third cutting area is formed between the third reinforcing rib and the first reinforcing rib. Each of the first cutting area, the second cutting area and the third cutting area is provided with a plurality of grooves arranged along the axial direction of the tubular body. The plurality of grooves are configured to allow the tubular body to be bent in its axial direction.
[0017] In the above technical solution, multiple grooves arranged along the axial direction of the tubular body are provided in the first cutting area, the second cutting area and the third cutting area. Each groove forms a clearance space for the axial deformation of the tubular body, so that the tubular body can bend in multiple directions. When the tubular body is subjected to external force, it can bend along the normal plane of the groove and bend in the axial direction with the diagonal of the wall as the reference line, thereby realizing the multi-directional bending function of the tubular body.
[0018] In some embodiments, the first wall, the second wall, and the third wall have equal lengths in the circumferential direction.
[0019] In some embodiments, a first transition portion is formed between the first wall and the second wall, a second transition portion is formed between the second wall and the third wall, and a third transition portion is formed between the third wall and the first wall.
[0020] In the above technical solution, the first transition section, the second transition section and the third transition section on the tubular body make the junction of any two adjacent walls of the tubular body smoother, avoid the sharp corners of the tubular body from scratching the blood vessels, and ensure the flexibility of the adjustable bend when the blood vessels pass through.
[0021] In some embodiments, one end of the tubular body is provided with a connecting claw for welding with the sheath.
[0022] In the above technical solution, a connecting claw is provided at one end of the tubular body. The connecting claw facilitates the welding and fixing between the adjustable bend and the sheath, ensuring the integrity of the sheath.
[0023] Secondly, embodiments of this application also provide a sheath tube, the sheath tube including a coating layer and the aforementioned adjustable bend tube, the coating layer covering at least the inner and / or outer sides of the tubular body.
[0024] In this embodiment, the covering layer includes an inner tube and an outer tube. The inner tube is located inside the tubular body, and the outer tube is located outside the tubular body. The inner and outer tubes enhance the strength of the adjustable bend and protect blood vessels, while the inner tube ensures that the implant within the sheath is not damaged.
[0025] In some embodiments, the sheath includes a tension member for adjusting the adjustable bend, one end of which is connected to the tubular body and the other end extends out of the sheath.
[0026] In the above technical solution, by setting up the traction component, one end of the pulling component is connected to the tubular body, and the other end extends out of the sheath tube and acts on the traction component, so that the tubular body can be actively bent, which is highly controllable.
[0027] Thirdly, embodiments of this application also provide a catheter, which includes the aforementioned sheath, with the sheath located at the distal end of the catheter.
[0028] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description
[0029] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.
[0030] Figure 1 This is a schematic diagram of the adjustable bend provided in some embodiments of this application;
[0031] Figure 2 A top view of an adjustable bend provided for some embodiments of this application;
[0032] Figure 3 A side view of an adjustable bend provided for some embodiments of this application;
[0033] Figure 4 for Figure 1 Enlarged diagram of A in the middle;
[0034] Figure 5 Schematic diagrams of the catheter structure provided in some embodiments of this application;
[0035] Figure 6 A side view of a catheter provided for some embodiments of this application.
[0036] Icons: 10-Tubular body; 11-First wall; 12-Second wall; 13-Third wall; 14-First end; 15-Second end; 16-Lumen; 20-First reinforcing rib; 21-Second reinforcing rib; 22-Third reinforcing rib; 30-First cutting area; 31-Second cutting area; 32-Third cutting area; 33-Groove; 40-First transition section; 41-Second transition section; 42-Third transition section; 50-Connecting claw; 51-Body section; 52-Extending section; 53-Drill holes; 60-Flanged skeleton; 100-Adjustable bend; 200-Sheath; 201-Inner tube; 202-Outer tube; 300-Conduit. Detailed Implementation
[0037] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.
[0038] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.
[0039] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.
[0040] In the description of the embodiments of this application, it should be noted that the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this application is usually placed during use. It is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on this application. In addition, the terms "first," "second," "third," etc. are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.
[0041] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up" and "connected" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.
[0042] Example
[0043] In related technologies, the cross-sectional shape of adjustable bend tubes is generally circular. When an irregularly shaped implant is sealed in the adjustable bend tube, there is a cavity between the implant and the inner wall of the adjustable bend tube, resulting in a large waste of space inside the adjustable bend tube, which correspondingly increases the maximum outer diameter of the sheath.
[0044] Therefore, this application provides an adjustable bendable tube suitable for implants with a roughly triangular cross-section in the contracted state. In this embodiment, the adjustable bendable tube refers to an adjustable bendable skeleton tube located at the distal end of the catheter used to establish the interventional surgical channel. Please refer to... Figures 1 to 4 The adjustable bend 100 includes a tubular body 10 that can be bent in the axial direction. The tubular body 10 has a first wall 11, a second wall 12 and a third wall 13 that are interconnected in the circumferential direction. A cavity 16 for accommodating the passage of a graft is formed between the first wall 11, the second wall 12 and the third wall 13. The planes containing the first wall 11, the second wall 12 and the third wall 13 intersect each other.
[0045] In this design, the tubular body 10 can be bent axially, giving the adjustable bend tube 100 a certain degree of bending performance, allowing it to bend and deform to pass through complex vascular channels. The tubular body 10 includes a first wall 11, a second wall 12, and a third wall 13. The planes containing the first wall 11, the second wall 12, and the third wall 13 intersect each other to form a lumen 16 with a roughly triangular cross-section. The shape of the lumen 16 is adapted to the cross-sectional shape of the implant to be encapsulated. By encapsulating the roughly triangular cross-section implant in the contracted state within the tubular body 10, compared to the circular cross-section lumen 16 of the adjustable bend tube 100 in the prior art, the internal space waste of the lumen 16 is reduced, and the outer diameter of the sheath can be effectively controlled to a minimum.
[0046] In some embodiments, at least one of the first wall 11, the second wall 12, and the third wall 13 is provided with a reinforcing rib, and the tubular body 10 has a first end 14 and a second end 15 in the axial direction, with the reinforcing rib extending from the first end 14 to the second end 15. By providing a reinforcing rib on at least one of the first wall 11, the second wall 12, and the third wall 13, and with the reinforcing rib extending from the first end 14 to the second end 15 in the axial direction of the tubular body 10, the reinforcing rib can provide support and reinforcement for the corresponding wall on the tubular body 10, thereby improving the compressive strength and / or bending strength of the tubular body 10 and meeting the rigidity requirements of the tubular body 10 itself.
[0047] In some embodiments, the first wall 11 is provided with a first reinforcing rib 20, the second wall 12 is provided with a second reinforcing rib 21, and the third wall 13 is provided with a third reinforcing rib 22. By providing the first reinforcing rib 20, the second reinforcing rib 21, and the third reinforcing rib 22 on the first wall 11, the second wall 12, and the third wall 13 respectively, each wall of the tubular body 10 can be effectively supported by the reinforcing ribs, ensuring that the compressive strength and / or bending strength of each wall of the tubular body 10 are relatively uniform, which is conducive to the smooth release and retrieval of subsequent implants.
[0048] The reinforcing ribs can be arranged in various ways on the corresponding wall of the tubular body 10. For example, the reinforcing ribs can be arranged in a straight line, spiral, wavy or diagonal shape on the wall.
[0049] Optionally, at least one of the first reinforcing rib 20, the second reinforcing rib 21, and the third reinforcing rib 22 is provided along its diagonal on the corresponding wall.
[0050] In some embodiments, the first reinforcing rib 20 is arranged along the diagonal of the first wall 11, the second reinforcing rib 21 is arranged along the diagonal of the second wall 12, and the third reinforcing rib 22 is arranged along the diagonal of the third wall 13. By distributing the first reinforcing rib 20, the second reinforcing rib 21, and the third reinforcing rib 22 diagonally on their respective walls, the reinforcing ribs, as reinforcement points, are less prone to deformation. When the tubular body 10 is subjected to external force, it facilitates bending of the tubular body 10 with the diagonal of its respective wall as a reference line.
[0051] In some embodiments, at the first end 14, the first reinforcing rib 20, the second reinforcing rib 21, and the third reinforcing rib 22 are circumferentially staggered and distributed along the tubular body 10; at the second end 15, the first reinforcing rib 20, the second reinforcing rib 21, and the third reinforcing rib 22 are circumferentially staggered and distributed along the tubular body 10. By having both ends of the first reinforcing rib 20, the second reinforcing rib 21, and the third reinforcing rib 22 circumferentially staggered and distributed along the tubular body 10, the tubular body 10 can undergo 360° bending deformation, realizing the non-directional and multi-directional bending deformation function of the adjustable bend 100.
[0052] In some embodiments, a first cutting area 30 is formed between the first reinforcing rib 20 and the second reinforcing rib 21, a second cutting area 31 is formed between the second reinforcing rib 21 and the third reinforcing rib 22, and a third cutting area 32 is formed between the third reinforcing rib 22 and the first reinforcing rib 20. Each of the first cutting area 30, the second cutting area 31, and the third cutting area 32 is provided with a plurality of grooves 33 arranged axially along the tubular body 10. These grooves 33 are configured to allow the tubular body 10 to bend axially. By providing a plurality of grooves 33 arranged axially along the tubular body 10 in each of the first cutting area 30, the second cutting area 31, and the third cutting area 32, each groove 33 forms a clearance space for axial deformation of the tubular body 10, enabling the tubular body 10 to bend in multiple directions. Furthermore, when the tubular body 10 is subjected to external force, it can bend along the normal plane of the groove 33 and bend axially with the diagonal of its wall as the reference line, thereby achieving the multi-directional bending function of the tubular body 10.
[0053] The main material of the tubular body 10 is a metal tube, such as stainless steel tube, 304 stainless steel tube or nickel-titanium alloy tube.
[0054] In some embodiments, the first wall 11, the second wall 12, and the third wall 13 are of equal length in the circumferential direction, that is, the cross-sectional shape of the tubular body is an equilateral triangle. Of course, the lengths of the first wall 11, the second wall 12, and the third wall 13 in the circumferential direction may not be equal.
[0055] In some embodiments, a first transition portion 40 is formed between the first wall 11 and the second wall 12, a second transition portion 41 is formed between the second wall 12 and the third wall 13, and a third transition portion 42 is formed between the third wall 13 and the first wall 11. The provision of the first transition portion 40, the second transition portion 41, and the third transition portion 42 on the tubular body 10 makes the junction of any two adjacent walls of the tubular body 10 smoother, preventing sharp edges from the tubular body 10 from scratching blood vessels and ensuring the flexibility of the adjustable bend 100 when blood vessels pass through it.
[0056] In this embodiment, the first transition portion 40, the second transition portion 41, and the third transition portion 42 are arc-shaped.
[0057] In some embodiments, a connecting claw 50 is provided at one end of the tubular body 10, which is used for welding with the sheath. By providing a connecting claw 50 at one end of the tubular body 10, the connecting claw 50 facilitates the welding and fixing between the adjustable bend 100 and the sheath, ensuring the overall stability of the sheath.
[0058] The connecting claw 50 includes a body section 51 and an extension section 52. The body section 51 is connected to the end of the adjustable bend 100, and the extension section 52 includes a plurality of circumferentially arranged claw portions, one end of which is connected to the body section 51. In this embodiment, the number of claw portions is set to three. Both the body section 51 and the claw portions are provided with row holes 53, which can be used for solder accumulation, facilitating the subsequent welding of the adjustable bend 100 with the guide tube during assembly.
[0059] In some embodiments, the tubular body 10 is provided with a flared skeleton 60 at the end opposite to the connecting claw 50, and the flared skeleton 60 can play a role in assisting valve retrieval.
[0060] This application also provides a sheath tube; please refer to [link / reference]. Figure 5 and Figure 6 The sheath 200 includes a coating layer and an adjustable bend 100, the coating layer covering at least the inner and / or outer sides of the tubular body 10.
[0061] In this embodiment, the coating layer consists of two layers, including an inner tube 201 and an outer tube 202. The inner tube 201 is located inside the tubular body 10, and the outer tube 202 is located outside the tubular body 10. The inner tube 201 and outer tube 202 on the tubular body 10 enhance the strength of the adjustable bend tube 100 and protect human blood vessels, while the inner tube 201 ensures that the implant within the sheath 200 is not damaged.
[0062] The inner tube 201 and the outer tube 202 can be made of polymer materials. The material of the inner tube 201 is such as PTFE, and the material of the outer tube 202 is such as PTFE, Pebax, or TSPU. The inner tube 201, the adjustable bend tube 100, and the outer tube 202 are fused together.
[0063] In some embodiments, the sheath 200 includes a traction member for adjusting the adjustable bend 100, one end of which is connected to the tubular body 10 and the other end extends out of the sheath. By providing the traction member, and with one end of the traction member connected to the tubular body 10, active bending of the tubular body 10 can be achieved simply by applying the traction member, making the bending of the adjustable bend 100 highly controllable.
[0064] The pulling component can be a pull wire, and the number of pull wires can be one or more, depending on the actual situation.
[0065] This application also provides a catheter; please refer to [link / reference]. Figure 5 The catheter 300 includes the aforementioned sheath 200, which is located at the distal end of the catheter 300.
[0066] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.
[0067] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.
Claims
1. An adjustable bend, characterized in that, include: A tubular body that can be bent in the axial direction, the tubular body having a first wall, a second wall and a third wall that are interconnected in the circumferential direction, forming a cavity between the first wall, the second wall and the third wall to allow the passage of a graft, the planes containing the first wall, the second wall and the third wall intersecting each other; The tubular body has a first end and a second end in the axial direction, and a reinforcing rib extends from the first end to the second end; the first wall is provided with a first reinforcing rib, the second wall is provided with a second reinforcing rib, and the third wall is provided with a third reinforcing rib; The first reinforcing rib is arranged along the diagonal of the first wall, the second reinforcing rib is arranged along the diagonal of the second wall, and the third reinforcing rib is arranged along the diagonal of the third wall; at the first end, the first reinforcing rib, the second reinforcing rib, and the third reinforcing rib are staggered circumferentially distributed along the tubular body; at the second end, the first reinforcing rib, the second reinforcing rib, and the third reinforcing rib are staggered circumferentially distributed along the tubular body.
2. The adjustable bend according to claim 1, characterized in that, A first cutting area is formed between the first reinforcing rib and the second reinforcing rib, a second cutting area is formed between the second reinforcing rib and the third reinforcing rib, and a third cutting area is formed between the third reinforcing rib and the first reinforcing rib. Each of the first cutting area, the second cutting area and the third cutting area is provided with a plurality of grooves arranged along the axial direction of the tubular body. The plurality of grooves are configured to allow the tubular body to be bent in its axial direction.
3. The adjustable bend according to claim 1, characterized in that, The first wall, the second wall, and the third wall have equal lengths in the circumferential direction.
4. The adjustable bend according to claim 1, characterized in that, A first transition portion is formed between the first wall and the second wall, a second transition portion is formed between the second wall and the third wall, and a third transition portion is formed between the third wall and the first wall.
5. The adjustable bend according to claim 1, characterized in that, One end of the tubular body is provided with a connecting claw, which is used to weld with the sheath.
6. A sheath, characterized in that, Includes a coating layer and an adjustable bend according to any one of claims 1-5, wherein the coating layer covers at least the inner and / or outer sides of the tubular body.
7. The sheath according to claim 6, characterized in that, The sheath includes a tension member for adjusting the adjustable bend, one end of which is connected to the tubular body and the other end extends out of the sheath.
8. A catheter, characterized in that, Includes a sheath as described in claim 6 or 7, wherein the sheath is located at the distal end of the catheter.