A novel sheath and catheter sheath

Abstract

This utility model discloses a novel sheath, relating to the field of medical device technology. It includes an inner and outer tube body and a sheath. The tube body comprises an inner tube, a reinforcing layer, and an outer tube, sequentially arranged from the inside out. The outer tube includes multiple transition segments connected in series. From the distal end to the proximal end of the tube body, the hardness of the multiple transition segments increases sequentially. Each transition segment has a fusion-fitting portion at its end, where the fusion-fitting portions of any two adjacent transition segments interlock to form a transition zone. By providing fusion-fitting portions at the ends of the transition segments, any two adjacent transition segments can be fused together through the fusion-fitting portions, thereby balancing support and flexibility, ensuring smooth pushing of the sheath, and providing sufficient support to guide catheters or other vascular devices to the lesion area.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a novel sheath and catheter sheath. Background Technology

[0002] Minimally invasive interventional therapy has become a major treatment method for cardiovascular and cerebrovascular diseases after years of development. Currently, in interventional therapy, the catheter sheath typically consists of a three-layer structure: an inner sheath, an outer sheath, and a reinforcing layer between the inner and outer sheaths. The sheath body needs to provide sufficient support while also possessing good flexibility to navigate tortuous blood vessels.

[0003] In existing technologies, the outer sheath of a catheter sheath is generally composed of multiple segments with varying stiffness to provide support at the proximal end and flexibility at the distal end. However, in product implementation, existing technologies are prone to issues such as uneven transitions between segments and insufficient distal support. This can lead to problems like kinking and ellipticization of the lumen during delivery, and even uneven force transmission during pushing or pulling due to uneven sheath stiffness. Furthermore, the requirements for access systems in clinical practice are constantly increasing. An ideal access system requires good permeability, strong support, and a sufficiently large lumen. Given a fixed outer diameter, existing technologies cannot improve sheath performance by reducing the inner lumen size. Utility Model Content

[0004] To solve the above-mentioned technical problems, this utility model provides a novel sheath and catheter sheath, the specific technical solution of which is as follows:

[0005] A novel sheath includes an inner and outer tube body and a protective sleeve. The tube body includes an inner tube, a reinforcing layer, and an outer tube arranged sequentially from the inside to the outside. The outer tube includes multiple transition sections connected in series. From the distal end to the proximal end of the tube body, the hardness of the multiple transition sections increases sequentially. The ends of the transition sections are provided with interlocking welded portions, and the interlocking welded portions of any two adjacent transition sections interlock to form a transition zone.

[0006] Preferably, the interlocking weld portion is a bevel or a plurality of cutting grooves circumferentially opened around the end of the transition section.

[0007] Preferably:

[0008] The cutting groove is triangular, and the base of the triangle is parallel to the end face of the transition section. Multiple triangles are arranged in a ring to form a wedge-shaped ring fitting groove.

[0009] Alternatively, the cutting groove may be trapezoidal, with the base of the trapezoid parallel to the end face of the transition section, and multiple trapezoids arranged in a circular pattern to form a trapezoidal circular fitting groove;

[0010] Alternatively, the cutting groove may be an embedded type, which includes a rectangular fixing groove. The inner sidewall of the rectangular fixing groove is provided with a limiting block, and multiple embedded cutting grooves are arranged in a ring to form an embedded ring fitting groove.

[0011] Preferably, there are multiple transition zones extending from the distal end to the proximal end of the tube body. Each of the multiple transition zones is formed by the interlocking of a slanted cut, a wedge-shaped surrounding groove, a trapezoidal surrounding groove, and an embedded surrounding groove.

[0012] Preferably, there are 7 transition sections, extending from the distal end to the proximal end of the tube body, and the hardness of the 7 transition sections are 25D, 30D, 35D, 40D, 50D, 63D and 72D, respectively.

[0013] Preferably:

[0014] The transition zone between the transition segments with hardness of 25D and 30D is formed by beveled cut fitting;

[0015] The transition zone between the transition segments with hardness of 30D, 35D and 40D is formed by wedge-shaped surrounding fitting grooves;

[0016] The transition zone between the transition segments with hardnesses of 40D, 50D and 63D is formed by trapezoidal surrounding interlocking grooves;

[0017] The transition zone between the transition segments with hardness of 63D and 72D is formed by an embedded surrounding interlocking groove.

[0018] Preferably, the volumes of the interlocking weld portions on any two adjacent transition sections are different.

[0019] This utility model also provides a catheter sheath, including a guidewire and a novel sheath tube as described in any of the above, wherein the guidewire is slidably disposed within the novel sheath tube.

[0020] The novel sheath provided by this utility model has a fitting and fusion joint at the end of the transition section, which allows any two adjacent transition sections to be fitted together and fused together, thereby balancing support and flexibility, ensuring that the sheath can be smoothly pushed, and providing sufficient support to guide the catheter or other vascular instruments to the lesion area. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 A front view of the novel sheath provided for an embodiment of this utility model;

[0023] Figure 2 A partial cross-sectional view of the novel sheath provided for an embodiment of this utility model;

[0024] Figure 3 A three-dimensional structural diagram of the transition section provided for an embodiment of this utility model;

[0025] Figure 4 A three-dimensional structural diagram of the transition zone formed by the oblique cut fitting provided for an embodiment of this utility model;

[0026] Figure 5 A three-dimensional structural schematic diagram of the wedge-shaped surrounding fitting groove provided for an embodiment of this utility model;

[0027] Figure 6 A three-dimensional structural diagram of the transition zone formed by the fitting of the wedge-shaped surrounding interlocking grooves, provided for an embodiment of this utility model;

[0028] Figure 7 A three-dimensional structural schematic diagram of the trapezoidal surrounding fitting groove provided for an embodiment of this utility model;

[0029] Figure 8 A three-dimensional structural diagram of the transition zone formed by the fitting of the trapezoidal surrounding interlocking grooves, provided for an embodiment of this utility model;

[0030] Figure 9 A three-dimensional structural schematic diagram of the embedded surrounding fitting groove provided for an embodiment of this utility model;

[0031] Figure 10 A three-dimensional structural diagram of the transition zone formed by the embedded surrounding interlocking groove provided in the embodiment of this utility model.

[0032] Figure Labels

[0033] 100 - Tube body; 200 - Sheath;

[0034] 10 - Outer tube; 20 - Inner tube; 30 - Reinforcing layer;

[0035] 1-Transition section; 11-Matching and welding part; 12-Transition zone; 13-Wedge-shaped surrounding meshing groove; 14-Trapezoidal surrounding meshing groove; 15-Rectangular fixing groove; 16-Limiting block; 17-Embedded surrounding meshing groove. Detailed Implementation

[0036] To enable those skilled in the art to better understand the technical solution of this utility model, the present utility model will be described in detail below with reference to the accompanying drawings. The description in this part is only exemplary and explanatory, and should not be used to limit the scope of protection of this utility model in any way.

[0037] It should be noted that similar labels 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.

[0038] It should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are only for the convenience of describing the present invention 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. Therefore, they should not be construed as limitations on the present invention. In addition, the terms "first," "second," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0039] Furthermore, terms such as "horizontal," "vertical," and "sag" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0040] In the description of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" 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 mechanical connection or an electrical 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 utility model based on the specific circumstances.

[0041] Please see Figures 1 to 10This embodiment provides a novel sheath tube, including an inner and outer tube body 100 and a sheath 200. The tube body 100 includes an inner tube 20, a reinforcing layer 30 and an outer tube 10 arranged sequentially from the inside to the outside. The outer tube 10 includes a plurality of transition sections 1 connected in series. From the distal end to the proximal end of the tube body 100, the hardness of the plurality of transition sections 1 increases sequentially. The end of the transition section 1 is provided with an interlocking weld portion 11. The interlocking weld portions 11 of any two adjacent transition sections 1 interlock with each other to form a transition zone 12.

[0042] The distal end of the tube 100 is the end furthest from the surgeon, and the proximal end is the end closest to the surgeon. The interlocking weld 11 at the end of the transition segment 1 can be a cutting groove of various shapes. When two adjacent transition segments 1 are interlocked, the two interlocking weld 11 can be embedded and fused together. Because the hardness of the two adjacent transition segments 1 is different, the hardness of the transition area 12 after interlocking and fusion is between the hardness of the two transition segments 1, forming a hardness transition range to avoid sudden changes in hardness. Furthermore, the two interlocking weld 11 can support each other, providing sufficient support. The design of the interlocking weld 11 at the end of the transition segment 1 enables a smooth transition between different segments of the tube 100, while also considering support and flexibility.

[0043] The novel sheath provided in this embodiment provides a fitting and welding part 11 at the end of the transition section 1, so that any two adjacent transition sections 1 can be fitted together by the fitting and welding part 11, thereby balancing support and flexibility, ensuring that the sheath can be smoothly pushed, and providing sufficient support to guide the catheter or other vascular instruments to the lesion area.

[0044] Further, please see Figure 3 The interlocking and fusion portion 11 has a beveled cut.

[0045] Please see Figure 5 , Figure 7 and Figure 9 The interlocking and welding part 11 can also be a plurality of cutting grooves circumferentially opened around the end of the transition section 1. The cutting grooves can be various shapes and structures such as triangles or trapezoids.

[0046] Further, please see Figure 5 The cutting groove is triangular, with the base of the triangle parallel to the end face of the transition section 1. Multiple triangles are arranged in a ring to form a wedge-shaped ring fitting groove 13. Specifically, multiple triangular cutting grooves are arranged in a ring to form a sawtooth fitting groove, which facilitates the fitting of two transition sections 1 and provides sufficient support.

[0047] Please see Figure 7The cutting groove can also be trapezoidal, with the base of the trapezoid parallel to the end face of the transition section 1. Multiple trapezoids are arranged in a ring to form a trapezoidal ring fitting groove 14. The trapezoidal fitting grooves are interlocked and fused together, which can provide stronger support than the triangular fitting groove.

[0048] Please see Figure 9 The cutting groove is an embedded type, which includes a rectangular fixing groove 15. The inner side wall of the rectangular fixing groove 15 is provided with a limiting block 16. Multiple embedded cutting grooves are arranged in a ring to form an embedded ring fitting groove 17. Specifically, the embedded cutting grooves on two adjacent transition sections 1 form a mortise and tenon structure, which can provide greater support after being interlocked.

[0049] Furthermore, there are multiple transition zones 12, extending from the distal end to the proximal end of the tube body 100. The multiple transition zones 12 are formed by the engagement of oblique cuts, wedge-shaped surrounding grooves 13, trapezoidal surrounding grooves 14, and embedded surrounding grooves 17.

[0050] Among them, the support force provided by the oblique cut, the wedge-shaped surrounding interlocking groove 13, the trapezoidal surrounding interlocking groove 14 and the embedded surrounding interlocking groove 17 increases in sequence. Therefore, the transition zone 12 between the transition sections 1 with greater hardness adopts an interlocking groove structure with greater support force.

[0051] Furthermore, there are 7 transition sections 1, extending from the distal end to the proximal end of the tube body 100. The hardness of the 7 transition sections 1 are 25D, 30D, 35D, 40D, 50D, 63D and 72D, respectively.

[0052] Furthermore:

[0053] The transition zone 12 between the transition segments 1 with hardness of 25D and 30D is formed by oblique cut fitting.

[0054] The transition zone 12 between the transition segments 1 with hardness of 30D, 35D and 40D is formed by wedge-shaped surrounding fitting grooves 13.

[0055] The transition zone 12 between the transition segments 1 with hardness of 40D, 50D and 63D is formed by trapezoidal surrounding interlocking grooves 14.

[0056] The transition zone 12 between the transition segments 1 with hardness of 63D and 72D is formed by an embedded surrounding interlocking groove 17.

[0057] Furthermore, the volume of the interlocking weld portion 11 on any two adjacent transition segments 1 is different.

[0058] The volume of the interlocking weld portion 11 on two adjacent transition sections 1 can determine the hardness of the transition zone 12. In order to achieve a smooth transition between each transition section 1 and make the hardness of the tube body 100 more uniform, the volume of the interlocking weld portion 11, i.e. the groove width and spacing of the cutting groove, can be adjusted according to the actual design, thereby adjusting the hardness of each weld section.

[0059] This embodiment also provides a catheter sheath, including a guidewire and a novel sheath tube as described in any of the above embodiments, wherein the guidewire is slidably disposed within the novel sheath tube.

[0060] Explanation of the principle:

[0061] The fitting and welding portion 11 at the end of the transition section 1 can be a cut groove of various shapes. When two adjacent transition sections 1 are fitted together, the two fitting and welding portions 11 can be embedded and fused together. Since the hardness of the two adjacent transition sections 1 is different, the hardness of the transition area 12 after embedding and welding is between the hardness of the two transition sections 1, forming a hardness transition range to avoid sudden changes in hardness. Furthermore, the two embedded and welding portions 11 can support each other, providing sufficient support force. The design of the fitting and welding portion 11 at the end of the transition section 1 enables a smooth transition between different segments of the tube body 100, while taking into account both support and flexibility.

[0062] It should be noted that, in this document, the terms “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0063] This article uses specific examples to illustrate the principles and implementation methods of this utility model. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this utility model. The above are only preferred embodiments of this utility model. It should be noted that due to the limitations of textual expression, while there are objectively infinite specific structures, those skilled in the art can make several improvements, modifications, or changes without departing from the principles of this utility model, and can also combine the above technical features in an appropriate manner. These improvements, modifications, changes, or combinations, or the direct application of the concept and technical solution of the utility model to other occasions without modification, should all be considered within the protection scope of this utility model.

Claims

1. A novel sheath characterized in that, The tube includes an inner and outer sleeve (100) and a sheath (200). The tube (100) includes an inner tube (20), a reinforcing layer (30) and an outer tube (10) arranged sequentially from the inside to the outside. The outer tube (10) includes multiple transition sections (1) connected in series. From the far end to the near end of the tube (100), the hardness of the multiple transition sections (1) increases sequentially. The end of the transition section (1) is provided with a fusion joint (11). The fusion joints (11) of any two adjacent transition sections (1) are interlocked to form a transition zone (12).

2. The novel sheath of claim 1, wherein, The interlocking weld (11) is a bevel or a plurality of cutting grooves that are circumferentially opened around the end of the transition section (1).

3. The novel sheath according to claim 2, characterized in that: The cutting groove is triangular, and the base of the triangle is parallel to the end face of the transition section (1). Multiple triangles are arranged in a ring to form a wedge-shaped ring fitting groove (13). Alternatively, the cutting groove may be trapezoidal, with the base of the trapezoid parallel to the end face of the transition section (1), and multiple trapezoids arranged in a ring to form a trapezoidal ring fitting groove (14); Alternatively, the cutting groove may be an embedded type, which includes a rectangular fixing groove (15), and the inner sidewall of the rectangular fixing groove (15) is provided with a limiting block (16). Multiple embedded cutting grooves are arranged in a ring to form an embedded ring fitting groove (17).

4. The novel sheath of claim 3, wherein, The number of transition zones (12) is multiple, extending from the distal end to the proximal end of the tube body (100). The multiple transition zones (12) are formed by the interlocking of oblique cuts, wedge-shaped surrounding interlocking grooves (13), trapezoidal surrounding interlocking grooves (14) and embedded surrounding interlocking grooves (17).

5. The novel sheath of claim 4, wherein, The number of transition sections (1) is 7, extending from the distal end to the proximal end of the tube body (100), and the hardness of the 7 transition sections (1) are 25D, 30D, 35D, 40D, 50D, 63D and 72D respectively.

6. The novel sheath according to claim 5, characterized in that: The transition zone (12) between the transition segments (1) with hardness of 25D and 30D is formed by oblique cut fitting; The transition zone (12) between the transition segments (1) with hardness of 30D, 35D and 40D is formed by wedge-shaped surrounding fitting grooves (13); The transition zone (12) between the transition segments (1) with hardness of 40D, 50D and 63D is formed by trapezoidal surrounding fitting grooves (14); The transition zone (12) between the transition segments (1) with hardness of 63D and 72D is formed by an embedded surrounding groove (17).

7. The novel sheath according to any one of claims 1 to 6, characterized in that, The volumes of the interlocking weld portion (11) on any two adjacent transition sections (1) are different.

8. A catheter sheath characterized by, It includes a guidewire and a novel sheath as described in any one of claims 1 to 7, wherein the guidewire is slidably disposed within the novel sheath.

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