Adjustable bend sheath and prosthetic valve delivery system
By setting a first groove and a second groove on the adjustable bending sheath, the bending range can be increased and the stress reduced by using the traction wire. This solves the problems of limited bending range and laborious operation of existing adjustable bending sheaths, and improves the convenience and safety of operation.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- HANGZHOU VALGEN MEDTECH CO LTD
- Filing Date
- 2025-05-08
- Publication Date
- 2026-06-16
AI Technical Summary
Existing adjustable sheaths have limited bending range and require considerable effort to adjust, making it difficult to effectively and accurately deliver artificial heart valves to the target location.
An adjustable bending sheath is designed, including a handle, a sheath tube, and a traction wire. The sheath tube is provided with a first groove and a second groove that extend circumferentially at an axial interval. By pulling the traction wire, the first groove is compressed and the second groove is extended, which increases the bending amplitude and reduces the bending stress, thus realizing a labor-saving and convenient bending operation.
The increased bending range of the adjustable sheath improves the ease and safety of operation, reduces damage to vascular tissue, and adapts to different anatomical shapes of human blood vessels.
Smart Images
Figure CN224357710U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical devices, specifically to an adjustable curved sheath and artificial valve delivery system. Background Technology
[0002] Aortic valve disease is a common heart condition, including aortic stenosis and aortic regurgitation. In recent years, transcatheter aortic valve replacement has become an effective treatment for severe aortic stenosis.
[0003] Transcatheter aortic valve replacement (TAVR) establishes a minimally invasive interventional pathway through peripheral blood vessels, delivering a compressed artificial heart valve mounted on a delivery system to the diseased native aortic valve. The delivery system is then manipulated to expand the artificial heart valve, thereby replacing the diseased native aortic valve with the artificial heart valve.
[0004] Adjustable bending sheaths are an important component of the delivery system, used to manipulate or adjust the bending shape of the sheath to help deliver the artificial heart valve accurately to the target location. Existing adjustable bending sheaths often suffer from technical problems such as limited bending range and laborious adjustment. Summary of the Invention
[0005] In view of this, the present invention aims to provide an adjustable bending sheath that can increase the bending range while making operation easier.
[0006] The adjustable bending sheath provided by this utility model includes a handle, a sheath tube connected to and controlled by the handle, and a traction wire. The sheath tube includes at least one adjustable bending section, the adjustable bending section includes a metal cutting tube, the metal cutting tube includes a plurality of first grooves extending circumferentially at intervals along the axial direction, and a plurality of second grooves extending circumferentially at intervals along the axial direction. The first grooves and the second grooves are respectively located on opposite sides in the circumferential direction, and the length of the first groove extending circumferentially is greater than the length of the second groove extending circumferentially. The traction wire is disposed on the circumferential side where the first groove is located.
[0007] This utility model also provides an artificial valve delivery system, including the aforementioned adjustable curved sheath and a balloon dilation catheter movably inserted within the adjustable curved sheath; in the delivery state, the artificial valve is disposed on the balloon of the balloon dilation catheter in a compressed configuration; the balloon can be inflated to dilate the artificial valve.
[0008] The adjustable bending sheath and valve delivery system including the adjustable bending sheath provided by this utility model have several axially spaced, circumferentially extending first grooves and several axially spaced, circumferentially extending second grooves respectively opened on the circumferentially opposite sides of the metal cutting tube of the adjustable bending section. Pulling the traction wire can compress the first grooves, thereby bending the adjustable bending section toward the circumferential side where the first groove is located. At the same time, the second grooves can extend to the opposite side of the circumferential side where the first groove is located. This can increase the bending range of the adjustable bending section and reduce bending stress, making the bending operation labor-saving and convenient. Attached Figure Description
[0009] Figure 1A This is a schematic diagram of the adjustable curved sheath of this utility model;
[0010] Figure 1B yes Figure 1A Schematic diagram of the cross section at point AA;
[0011] Figure 2 This is a schematic diagram of the structure of a metal cutting tube with adjustable bends from one angle.
[0012] Figure 3A This is a schematic diagram of the structure of a metal cutting tube with adjustable bends from another perspective;
[0013] Figure 3B yes Figure 3A A magnified view of a portion of point 3-1 in the diagram;
[0014] Figure 3C yes Figure 3A A magnified view of a portion of point 3-2 in the middle;
[0015] Figure 4A This is a structural schematic diagram of the first adjustable bending segment from another perspective;
[0016] Figure 4B yes Figure 4A Schematic diagram of the cross section at point BB;
[0017] Figure 4C yes Figure 4A Cross-sectional view at point CC;
[0018] Figure 5A This is a schematic diagram showing the complete first groove of a metal-cut tube in its flattened state;
[0019] Figure 5B This is a schematic diagram showing the complete second groove of the metal-cut tube in its flattened state;
[0020] Figure 6 It is a schematic diagram showing the bending of the first and second bending sections;
[0021] Figure 7A This is a schematic diagram of the structure of the first adjustable bend in another embodiment;
[0022] Figure 7B This is a schematic diagram showing the complete first groove of the metal cut tube in a flattened state in another embodiment;
[0023] Figure 7C This is a schematic diagram showing the complete second groove of the metal cutting tube in a flattened state in another embodiment;
[0024] Figure 8 This is a schematic diagram of the artificial valve delivery system of this utility model;
[0025] Figure 9 This is a schematic diagram showing the usage status of an artificial valve delivery system. Detailed Implementation
[0026] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model. Furthermore, the embodiments described below can be combined with each other as long as there is no contradiction or conflict, and the same or similar concepts or processes may not be repeated in some embodiments.
[0027] First, it should be noted that in this article, "proximal end" refers to the end of the device or component closer to the operator, and "distal end" refers to the end of the device or component farther from the operator. "Axial direction" refers to the direction that coincides with or is parallel to the central axis of the device or component. "Radial direction" refers to the direction that is perpendicular or approximately perpendicular to the axial direction and along the radius or diameter of the device or component. "Circumferential direction" refers to the direction around the axial direction.
[0028] It is worth noting that the terms such as the indicated orientation or positional relationship are only for the convenience of describing this utility model and simplifying the description, and do 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, and therefore should not be construed as a limitation on this utility model.
[0029] Please see Figures 1A to 2An embodiment of this utility model provides an adjustable bending sheath 1000, including a handle 100, a sheath tube 300, and a traction wire 500. The proximal end (not shown) of the sheath tube 300 is connected to the handle 100. The distal section 30 of the sheath tube 300 includes at least one adjustable bending section 31. The main body section 60 of the sheath tube 300 is located between the distal section 30 and the handle 100. The distal end of the traction wire 500 is fixedly connected to the distal end of the sheath tube 300, and the proximal end is connected to a control mechanism (not shown) within the handle 100. The remaining portion is movably inserted within the sheath tube 300. The handle 100 can manipulate the sheath tube 300 and the traction wire 500. For example, translating or / and rotating the handle 100 controls the translation or / and twisting of the sheath tube 300. Actuating the control mechanism within the handle 100 can pull or release the traction wire 500, i.e., control the adjustable bending section 31 of the sheath tube 100 to bend or straighten.
[0030] Each section of the sheath 300, whether the distal section 30 or the main section 60, includes a polymer inner membrane layer 32, a metal layer, and a polymer outer membrane layer 36 stacked from the inside out. The polymer outer membrane layer 36 fuses the layers together. The polymer inner membrane layer 32 is preferably made of PTFE, which has a lubricating effect. The metal layer can be made of stainless steel, nickel-titanium alloy, etc., and the polymer outer membrane layer 36 can be made of PEBAX, nylon, etc. The metal layer corresponding to the adjustable bend section 31 or the distal section 30 is a metal cut tube 34, or in other words, the adjustable bend section 31 or the distal section 30 includes a metal cut tube 34. The metal layer corresponding to the main section 60 can be a metal wire braided mesh tube (not shown in the figure).
[0031] Combination Figure 1A , Figure 2 , Figures 4A to 4C and Figure 6In this embodiment, the distal section 30 of the sheath 300 is provided with two adjustable bends 31, which can be referred to as the first adjustable bend 311 and the second adjustable bend 313 for ease of distinction and description. The first adjustable bend 311 is located distal to the second adjustable bend 313, that is, the first adjustable bend 311 is closer to the distal end of the sheath 300. It is understood that this embodiment is only an example with two adjustable bends 31. In some other embodiments, the sheath may be provided with only one adjustable bend, while in other embodiments, the sheath may be provided with three or even more adjustable bends. In this embodiment, regardless of whether it is the first adjustable bend 311 or the second adjustable bend 313, the metal cutting tube 34 corresponding to each adjustable bend 31 includes several first grooves 341 that are spaced apart along the axial direction and extend circumferentially, and several second grooves 343 that are spaced apart along the axial direction and extend circumferentially. The first grooves 341 and the second grooves 343 are located on opposite sides of the metal cutting tube 34 in the circumferential direction, and the length of the first groove 341 extending circumferentially is greater than the length of the second groove 343 extending circumferentially, or in other words, the angle α of the central angle occupied by the first groove 341 is greater than the angle β of the central angle occupied by the second groove 343; the traction wire 500 is located on the circumferential side where the first groove 341 with the dominant circumferential extension length is located.
[0032] contrast Figure 2 and Figure 6 Pulling the traction wire 500 can compress each of the first grooves 341, gradually reducing the groove width of each of the first grooves 341 corresponding to its circumferential center (which can be called the middle section), until the corresponding groove walls of the middle section of each of the first grooves 341 abut against each other, thereby causing the adjustable bending section 31 to bend towards the circumferential side where the first groove 341 is located; at the same time, each of the second grooves 343 can extend on the opposite side of the circumferential side where the first groove 341 is located, i.e., the bending back side, gradually increasing the groove width of each of the second grooves 343 corresponding to its circumferential center (which can be called the middle section), thereby increasing the bending amplitude of the adjustable bending section 31 and reducing bending stress, making the bending operation labor-saving and convenient. Furthermore, the opening of the second groove 343 also improves the overall flexibility of the metal cutting tube 34, making the adjustable bend 31 more adaptable to bending in the tortuous human blood vessels and more passable; and, at the moment when the traction wire 500 releases the pull on the metal cutting tube 34 and the adjustable bend 31, because each second groove 343 reduces the bending stress, the metal cutting tube 34 and the adjustable bend 31 can relatively gently recover to a straight state, thereby avoiding the adjustable bend 31 from instantaneous violent bouncing and damaging the blood vessel tissue.
[0033] Furthermore, such as Figures 3A to 3CAs shown, the first grooves 341 and second grooves 343 are staggered in the axial direction. That is, when viewed from the axial direction, a second groove 343 is located between two adjacent first grooves 341, and a first groove 341 is located between two adjacent second grooves 343. While ensuring that the circumferential extension length of the first groove 341 is dominant, the first grooves 341 and second grooves 343 can be spaced apart or partially overlap in the circumferential direction. In this embodiment, for example... Figure 4A As shown, the first groove 341 and the second groove 343 partially overlap in the circumferential direction. Specifically, the portion of the second groove 343, including its end 346, extends circumferentially into the solid between the two adjacent first grooves 341. This arrangement, compared to a circumferentially spaced arrangement, is beneficial in improving the overall flexibility and deformability of the metal cutting tube 34. Of course, both the first groove 341 and the second groove 343 should extend appropriately in the circumferential direction. To balance the strength and flexibility of the metal cutting tube 34, preferably, as shown... Figure 4B As shown, the central angle α corresponding to the first groove 341 ranges from 180° to 300°, meaning the first groove 341 occupies 1 / 2 to 5 / 6 of the circumference of the metal cutting tube 34; Figure 4C As shown, the central angle β corresponding to the second groove ranges from 60° to 180°, meaning that the second groove 343 occupies 1 / 6 to 1 / 2 of the circumference of the metal cutting tube 34.
[0034] In addition, combined Figures 3A to 4A The width (or simply groove width) W1 of the first groove 341 can be greater than or equal to the width (or simply groove width) W2 of the second groove 343. Preferably, the width W1 of the first groove 341 is greater than the width W2 of the second groove 343, so that the metal cutting tube 34 can be bent more easily toward the circumferential side of the first groove 341. More specifically, the size range of the width W1 of the first groove 341 can be 0.1mm-1.5mm, and the size range of the width W2 of the second groove 343 can be 0.05mm-1.0mm. It can be understood that the more first grooves 341 are opened within a certain length, the smaller the distance S between two adjacent first grooves 341, which is more beneficial to increasing the bending range of the metal cutting tube 34 and the adjustable bending section 31. At the same time, in this embodiment, the distance S between two adjacent first grooves 341 is set to be greater than 1 / 3 of the width W1 of the first groove 341, so as to adequately ensure the strength of the metal cutting tube 34.
[0035] like Figure 2 , Figure 3A , Figure 6As shown, in order to adapt to different anatomical shapes or different curvatures of human blood vessels, the density of the first groove 341 on the first adjustable bend 311 can be set to be higher than the density of the first groove 341 on the second adjustable bend 313, and the density of the second groove 343 on the first adjustable bend 311 can be set to be higher than the density of the second groove 343 on the second adjustable bend 313. As a result, the bendable radius of the first adjustable bend 311 is smaller than the bendable radius of the second adjustable bend 313, that is, the bending amplitude or curvature of the first adjustable bend 311 is greater than the bending amplitude or curvature of the second adjustable bend 313.
[0036] Understandably, the width of each first groove 341 on the first adjustable bend 311 can be equal, and the spacing between any two adjacent first grooves 341 can also be equal; the width of each first groove 341 on the second adjustable bend 313 can be equal, and the spacing between any two adjacent first grooves 341 can also be equal, but the width of the first groove 341 on the first adjustable bend 311 can be greater than the width of the first groove 341 on the second adjustable bend 313, and the spacing between any two adjacent first grooves 341 on the first adjustable bend 311 can be less than the spacing between any two adjacent first grooves 341 on the second adjustable bend 313. Over a predetermined length of equal length, the number of first grooves 341 on the first adjustable bend 311 is greater than the number of first grooves 341 on the second adjustable bend 313.
[0037] Similarly, the widths of the second grooves 343 on the first adjustable bend 311 can be equal, and the spacing between any two adjacent second grooves 343 can also be equal; the widths of the second grooves 343 on the second adjustable bend 313 can also be equal, and the spacing between any two adjacent second grooves 343 can also be equal, but the width of the second grooves 343 on the first adjustable bend 311 can be greater than the width of the second grooves 343 on the second adjustable bend 313, and the spacing between any two adjacent second grooves 343 on the first adjustable bend 311 can be less than the spacing between any two adjacent second grooves 343 on the second adjustable bend 313. Over a predetermined length of equal length, the number of second grooves 343 on the first adjustable bend 311 is greater than the number of second grooves 343 on the second adjustable bend 313.
[0038] Combined with reference Figure 9 The first adjustable bend segment 311 and the second adjustable bend segment 313 work together to form a bend shape that is compatible with the aortic arch and the ascending aorta. The second adjustable bend segment 313 adapts to the bend shape of the aortic arch, and the first adjustable bend segment 311 can bend within the ascending aorta to its distal end and be coaxial with the aortic valve annulus.
[0039] More specifically, for ease of describing the shape of the first groove 341, assume that the wall of the metal cutting tube 34 on the side away from the first groove 341 is cut axially and the metal cutting tube 34 is flattened. Please refer to... Figure 5AIn this embodiment, the first groove 341 is generally elongated, i.e., a slender rectangle, and the width of the middle section of the first groove 341 is basically the same as that of the grooves in other parts; in other embodiments, such as Figure 7A and Figure 7B As shown, the first groove 341 can also be crescent-shaped, with the width of the middle section of the first groove 341 being greater than the width of other parts, which is beneficial for further increasing the bending range of the adjustable bending section 31. It is understood that in other embodiments, the first groove 341 can also be spindle-shaped, similarly satisfying the requirement that the width of the middle section of the first groove 341 is greater than the width of other parts. It is worth noting that regardless of the shape of the first groove 341, a smooth transition can be provided between the end 342 of the first groove 341 and the solid metal cutting tube 34, such as by rounding corners or setting an arc, to reduce stress concentration at the end 342 and prevent cracks from easily forming at the end 342.
[0040] To facilitate the description of the shape of the second groove 343, it is assumed that the wall of the metal cutting tube 34 on the side away from the second groove 343 is cut axially and the metal cutting tube 34 is flattened. Please refer to... Figure 5B and Figure 7C The second groove 343 can be generally spindle-shaped, with an enlarged portion 344 in the middle section. The width of the enlarged portion 344 is greater than the width of other parts of the second groove 343, making the middle section of the second groove 343 easier to extend. It is understood that in other embodiments, the second groove 343 can also be crescent-shaped, elongated, etc. It is worth noting that regardless of the shape of the second groove 343, a smooth transition can be provided between the end 346 of the second groove 343 and the solid metal cutting tube 34, such as by rounding corners or setting an arc, to reduce stress concentration at the end 346 and prevent cracks from easily forming at the end 346.
[0041] Combination Figure 2 , Figure 5A and Figure 5BAs shown, in this embodiment, the distal end of the metal cutting tube 34 has two through holes 348 for the traction wire 500 to pass through. These two through holes 348 are symmetrical about the central axis of the metal cutting tube 34 and are located on opposite sides of the circumferential direction in the middle section of the second groove 343. A traction wire 500 is folded in half, and its two ends are passed through the two through holes 348 respectively from the radially outer side to the radially inner side of the metal cutting tube 34. Then, the traction wire 500 extends axially towards the proximal end of the metal cutting tube 34 along the radially inner side, achieving symmetrical traction of the two wires. It is understood that in other embodiments, the distal end of the traction wire 500 can also be fixedly connected to the distal end of the metal cutting tube 34 by means of, for example, welding or bonding. The material of the traction wire 500 is preferably stainless steel wire with sufficient strength. It is worth noting that setting the traction wire 500 to extend axially along the radial inner side of the metal cutting tube 34 helps to reduce the welding thickness of the polymer outer film layer 36, thereby reducing the outer diameter of the entire sheath 300. Furthermore, the traction wire 500 is subject to multiple constraints from the inner film layer 32, the metal layer such as the metal cutting tube 34, and the polymer outer film layer 36, making it less likely to be pulled off and preventing the traction wire 500 from protruding outward from the sheath 300.
[0042] Please see Figure 8 The present invention also provides an artificial valve delivery system 2000, including the adjustable curved sheath 1000 and a balloon dilation catheter 3000 that is movably inserted into the adjustable curved sheath 1000.
[0043] During the process of delivering the artificial valve from outside the body to the heart valve to be replaced, the artificial valve delivery system 2000 is in the delivery state. The artificial valve 600 is disposed in a compression configuration on the balloon (not shown) of the balloon dilation catheter 300. The balloon can be inflated by liquid to expand the artificial valve 600, so that the artificial valve 600 is positioned at the corresponding heart valve and replaces the heart valve to perform its function.
[0044] Taking aortic valve replacement surgery as an example, combined with Figure 9 and Figure 1 to Figure 2The artificial valve delivery system 2000, carrying the artificial valve 600, is delivered along the guidewire to the vicinity of the aortic arch. The handle 100 pulls the traction wire 500, causing the adjustable bend 31 of the sheath 300 to bend, facilitating the passage of the artificial valve delivery system 2000 through the aortic arch. Delivery of the artificial valve delivery system 2000 continues, bringing the artificial valve 600, mounted on the balloon dilation catheter 300, closer to the aortic valve. Then, the adjustable bend 31 of the sheath 300 is further bent, making... The first adjustable segment 311 and the second adjustable segment 313 work together to form a curved shape that adapts to the aortic arch and the ascending aorta. The second adjustable segment 313 adapts to the curved shape of the aortic arch. The first adjustable segment 311 bends within the ascending aorta until its distal end is coaxial with the aortic valve annulus. After confirming the correct position of the artificial valve 600 using imaging equipment such as DSA and ultrasound, the balloon is inflated to expand the artificial valve 600, thus completing the implantation of the artificial valve 600.
[0045] The above description is only a preferred embodiment of the present utility model. The protection scope of the present utility model is not limited to the embodiments listed above. Any simple changes or equivalent substitutions of the technical solutions that can be obviously obtained by those skilled in the art within the technical scope disclosed in the present utility model shall fall within the protection scope of the present utility model.
Claims
1. An adjustable bending sheath, comprising a handle, a sheath tube connected to and controlled by the handle, and a traction wire, the sheath tube comprising at least one adjustable bending section, characterized in that, The adjustable bend includes a metal cutting tube, which includes several first grooves that are spaced apart along the axial direction and extend circumferentially, and several second grooves that are spaced apart along the axial direction and extend circumferentially. The first grooves and the second grooves are located on opposite sides in the circumferential direction, and the length of the first groove extending circumferentially is greater than the length of the second groove extending circumferentially. The traction wire is located on one circumferential side of the first groove.
2. The adjustable curved sheath as described in claim 1, characterized in that, The first groove and the second groove are staggered in the axial direction, and / or the first groove and the second groove partially overlap in the circumferential direction.
3. The adjustable curved sheath as described in claim 2, characterized in that, The width of the first slot is greater than the width of the second slot.
4. The adjustable curved sheath as described in claim 3, characterized in that, In the flattened state, the first groove is generally elongated, crescent-shaped, or spindle-shaped, and / or the second groove is generally elongated, crescent-shaped, or spindle-shaped.
5. The adjustable curved sheath as described in claim 4, characterized in that, The end of the first groove smoothly transitions to the body of the metal cutting tube, and / or the end of the second groove smoothly transitions to the body of the metal cutting tube.
6. The adjustable curved sheath as described in claim 1, characterized in that, The central angle corresponding to the first groove ranges from 180° to 300°; the central angle corresponding to the second groove ranges from 60° to 180°.
7. The adjustable curved sheath as described in claim 1, characterized in that, The distance between two adjacent first slots is greater than 1 / 3 of the width of the first slot.
8. The adjustable curved sheath as described in claim 1, characterized in that, The traction wire extends axially along the radial inner side of the metal cutting tube.
9. The adjustable curved sheath as described in claim 1, characterized in that, An enlarged section is provided in the middle section of the second groove, and the width of the enlarged section is greater than the width of other parts of the second groove.
10. The adjustable bending sheath as described in any one of claims 1-9, characterized in that, The at least one adjustable bend includes a first adjustable bend and a second adjustable bend. The first adjustable bend is located far from the second adjustable bend. The density of the first groove on the first adjustable bend is higher than the density of the first groove on the second adjustable bend, and the density of the second groove on the first adjustable bend is higher than the density of the second groove on the second adjustable bend, so that the bendable radius of the first adjustable bend is smaller than the bendable radius of the second adjustable bend.
11. An artificial valve delivery system, characterized in that, Includes an adjustable curved sheath as described in any one of claims 1-10, and a balloon dilation catheter movably inserted within the adjustable curved sheath; in the delivery state, the artificial valve is disposed on the balloon of the balloon dilation catheter in a compressible configuration; the balloon is inflatable to dilate the artificial valve.