Interventional sheath group, interventional device and sheath tube

Abstract

The utility model discloses an interventional sheath set, an interventional device and a sheathing canal, the interventional sheath set comprises an outer sheath and an inner sheath, and the outer sheath comprises an elastic sheathing canal extending in the axial direction of the outer sheath and a first passage defined by the elastic sheathing canal; a second passage extending in the axial direction of the inner sheath is arranged in the inner sheath, the outer sheath is arranged in the mode that when the inner sheath extends into the first passage, at least part of the elastic sheath tube expands and wraps the inner sheath extending into the first passage, and the second passage is communicated with the first passage; and when the inner sheath moves out of the first passage, the elastic sheath tube rebounds. The outer sheath comprises the elastic sheath tube, when the inner sheath intervenes into the first passage, the inner sheath enables the outer sheath to expand and wrap the surface of the inner sheath, the first passage is expanded, subsequent intervention of the interventional instrument is facilitated, after the interventional instrument reaches a designated position, the inner sheath is withdrawn, the elastic sheath tube rebounds and wraps the surface of the interventional instrument, and the interventional instrument is prevented from being damaged. The interventional diameter is reduced, and blood is prevented from flowing into the space between the elastic sheath tube and the interventional instrument to form thrombus.

Description

Technical Field

[0001] This application belongs to the technical field of medical devices, and particularly relates to an interventional sheath set, an interventional device, and a sheath tube. Background Art

[0002] In some scenarios, in vascular interventional surgery, it is necessary to first insert a catheter sheath to form a passage, and then insert interventional instruments through the passage in the catheter sheath. However, the radial dimensions of common interventional instruments are inconsistent. For example, the diameter of the head end is larger than that of the tail end. In order to deliver these interventional instruments, the diameter of the passage in the catheter sheath needs to be larger than the maximum diameter of the interventional instrument, resulting in a gap between the passage in the catheter sheath and the interventional instrument, which is likely to form thrombus in the passage, and causing a large outer diameter of the catheter sheath, which is likely to cause problems such as ischemia of the patient's lower limb artery during the intervention, and will exclude some patients with a small vascular diameter who have a treatment need. Summary of the Utility Model

[0003] The embodiments of this application provide an interventional sheath set, an interventional device, and a sheath tube, which can reduce the interventional diameter.

[0004] The embodiments of this application provide an interventional sheath set, including an outer sheath and an inner sheath. The outer sheath includes an elastic sheath tube extending along its axial direction and a first passage formed by enclosing the elastic sheath tube; a second passage extending along the axial direction of the inner sheath is provided in the inner sheath. The outer sheath is configured such that when the inner sheath extends into the first passage, at least part of the elastic sheath tube expands and wraps the inner sheath extending into the first passage, and the second passage communicates with the first passage; when the inner sheath is removed from the first passage, the elastic sheath tube rebounds.

[0005] According to the embodiment of the first aspect of this application, the outer sheath includes a natural state and an expanded state that can be mutually converted. When at least part of the inner sheath extends into the first passage, the outer sheath changes from the natural state to the expanded state, and at least part of the elastic sheath tube expands and wraps the inner sheath extending into the first passage; when the inner sheath is removed from the first passage, the elastic sheath tube rebounds and the outer sheath changes from the expanded state to the natural state.

[0006] According to the embodiment of the first aspect of this application, the expanded state includes a partially expanded state. In the partially expanded state, the inner sheath axially penetrates part of the first passage along the outer sheath, and part of the elastic sheath tube expands and wraps the inner sheath extending into the first passage.

[0007] According to the embodiment of the first aspect of this application, the expanded state includes a fully expanded state. In the fully expanded state, the inner sheath axially penetrates the entire first passage along the outer sheath, and the entire elastic sheath tube expands and wraps the inner sheath extending into the first passage.

[0008] According to the embodiment of the first aspect of this application, the radial dimension of the first passage in the natural state is smaller than the radial dimension of the outer surface of the inner sheath deviating from its central axis.

[0009] According to an embodiment of the first aspect of the present application, the elastic sheath tube includes: an elastic layer; a lubricating layer located on at least one of the inner and outer sides of the elastic layer, and the friction coefficient of the lubricating layer is less than that of the elastic layer.

[0010] According to an embodiment of the first aspect of the present application, the elastic layer is entirely composed of an elastic material, or a part of the elastic layer is composed of an elastic material and the other part is composed of a rigid material, or the elastic layer is formed by surrounding an elastic material mesh.

[0011] According to an embodiment of the first aspect of the present application, lubricating layers are provided on both the side of the elastic layer facing the first passage and the side facing away from the first passage.

[0012] According to an embodiment of the first aspect of the present application, the material of the elastic layer includes at least one of polydimethylsiloxane, polyurethane elastomer, and polyolefin elastomer, and the material of the lubricating layer includes at least one of polyacrylamide, polyvinylpyrrolidone, polyethylene glycol, and polyvinyl alcohol.

[0013] According to an embodiment of the first aspect of the present application, it further includes: an outer sheath base connected to the proximal end of the outer sheath, and a fourth passage axially penetrating through the outer sheath base and communicating with the first passage is provided in the outer sheath base; a fixing wing connected to the outer sheath base, and the fixing wing is located on the side of the outer sheath base facing away from the fourth passage.

[0014] According to an embodiment of the first aspect of the present application, it further includes: a balloon connected to the outer sheath base and located in the fourth passage, and the balloon encloses to form a third passage communicating with the first passage; an inflation tube connected to the balloon, and the inflation tube is used to inflate the balloon to reduce the radial dimension of the third passage or release the gas in the balloon to increase the radial dimension of the third passage.

[0015] According to an embodiment of the first aspect of the present application, the circumferential dimension of the outer sheath is greater than or equal to 9F and less than or equal to 24F.

[0016] According to an embodiment of the first aspect of the present application, the elasticity of the inner sheath is less than that of the outer sheath.

[0017] The second aspect of the present application provides an interventional device, including an interventional instrument and the interventional sheath set as above. The interventional instrument is detachably connected to the interventional sheath set. The interventional device includes a first state, a second state, and a third state; in the first state, the outer sheath is in a natural state; in the second state, at least part of the inner sheath extends into the first passage and causes the outer sheath to change from the natural state to a partially expanded state or a fully expanded state. In the partially expanded state, the inner sheath axially penetrates part of the first passage along the outer sheath, and part of the elastic sheath tube expands and wraps the inner sheath extending into the first passage; in the fully expanded state, the inner sheath axially penetrates the entire first passage along the outer sheath, and the entire elastic sheath tube expands and wraps the inner sheath extending into the first passage; in the third state, the interventional instrument extends into the second passage from the proximal end of the inner sheath and extends out of the second passage from the distal end of the inner sheath.

[0018] According to an embodiment of the second aspect of the present application, the interventional device further includes a fourth state. In the fourth state, the inner sheath and the outer sheath are separated, at least part of the interventional instrument is located in the first passage, and at least part of the outer sheath rebounds and wraps around the surface of the interventional instrument.

[0019] According to an embodiment of the second aspect of the present application, it further includes: a guide wire, detachably connected to the interventional sheath set, and the guide wire is used to guide the interventional sheath set to a designated position; a dilator, detachably connected to the distal end of the inner sheath.

[0020] The third aspect of the present application provides a sheath tube, including an elastic sheath tube extending along its axis and a first passage formed by enclosing the elastic sheath tube. The sheath tube includes a natural state and an expanded state that can be converted into each other. In the expanded state, at least part of the elastic sheath tube expands and makes the radial dimension of the first passage larger; in the natural state, the elastic sheath tube rebounds and makes the radial dimension of the first passage smaller.

[0021] According to an embodiment of the third aspect of the present application, the expanded state includes a partially expanded state and a fully expanded state. In the partially expanded state, part of the elastic sheath tube expands and wraps the inner sheath extending into the first passage; in the fully expanded state, the inner sheath axially penetrates the entire first passage along the outer sheath, and the entire elastic sheath tube expands.

[0022] According to an embodiment of the third aspect of the present application, the elastic sheath tube includes: an elastic layer; a lubricating layer located on at least one side of the inner and outer sides of the elastic layer, and the friction coefficient of the lubricating layer is less than the friction coefficient of the elastic layer.

[0023] According to an embodiment of the third aspect of the present application, the elastic layer is entirely composed of an elastic material, or part of the elastic layer is composed of an elastic material and the other part is composed of a rigid material, or the elastic layer is formed by surrounding an elastic material mesh.

[0024] According to an embodiment of the third aspect of the present application, lubricating layers are provided on both the side of the elastic layer facing the first passage and the side facing away from the first passage.

[0025] According to an embodiment of the third aspect of the present application, the material of the elastic layer includes at least one of polydimethylsiloxane, polyurethane elastomer, and polyolefin elastomer, and the material of the lubricating layer includes at least one of polyacrylamide, polyvinylpyrrolidone, polyethylene glycol, and polyvinyl alcohol.

[0026] The introducer sheath set of the embodiments of the present application includes an outer sheath and an inner sheath. The outer sheath includes an elastic sheath tube extending along its axial direction and a first passage formed by enclosing the elastic sheath tube; a second passage extending along its axial direction is provided inside the inner sheath. The outer sheath is configured such that when the inner sheath extends into the first passage, at least a part of the elastic sheath tube expands and wraps the inner sheath extending into the first passage, and the second passage communicates with the first passage; when the inner sheath is removed from the first passage, the elastic sheath tube rebounds. By making the outer sheath include an elastic sheath tube, when the inner sheath intervenes into the first passage, the inner sheath causes the outer sheath to expand and wrap around the surface of the inner sheath, and the first passage is enlarged, facilitating the intervention of subsequent interventional instruments. After the interventional instrument reaches the designated position and the inner sheath is withdrawn, the elastic sheath tube rebounds and wraps around the surface of the interventional instrument, which not only reduces the intervention diameter but also prevents blood from flowing into the space between the elastic sheath tube and the interventional instrument to form thrombus. In addition, the introducer sheath set of the present application can also reduce the damage to blood vessels caused by long-term implantation and avoid ischemia of the lower extremities caused by the occupation of the sheath tube during the implantation process. Finally, the introducer sheath set provided by the present application has a simple structure and is convenient to operate. Description of the Drawings

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings required to be used in the embodiments of the present application. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without creative efforts.

[0028] Figure 1a It is a schematic structural diagram of the outer sheath in a natural state of the introducer sheath set in some embodiments of the present application;

[0029] Figure 1b It is a schematic structural diagram of the inner sheath of the introducer sheath set in some embodiments of the present application;

[0030] Figure 2a Showing an example of Figure 1a The longitudinal sectional structural diagram of the outer sheath in

[0031] Figure 2b Showing an example of Figure 1b The longitudinal sectional structural diagram of the inner sheath in

[0032] Figure 3 It is a schematic structural diagram of the introducer sheath set in some embodiments of the present application in another scenario;

[0033] Figure 4Shows an exemplary Figure 3 Schematic cross-sectional view of the access sheath set in Figure 3 under the A-A section;

[0034] Figure 5 Schematic structural view of an access sheath set in another scenario;

[0035] Figure 6 Shows an exemplary Figure 5 Schematic cross-sectional view of the access sheath set in Figure 5 under the B-B section;

[0036] Figure 7 Shows an exemplary Figure 4 Enlarged partial cross-sectional view of the access sheath set in Figure 4 in the C area;

[0037] Figure 8 Shows another exemplary Figure 4 Enlarged partial cross-sectional view of the access sheath set in Figure 4 in the C area;

[0038] Figure 9 Schematic longitudinal cross-sectional view of an exemplary outer sheath base and fixed wing;

[0039] Figure 10 Schematic longitudinal cross-sectional view of another exemplary outer sheath base and fixed wing;

[0040] Figure 11 Schematic structural view of an exemplary access device.

[0041] Reference numerals:

[0042] 10. Access sheath set; 20. Intervention instrument;

[0043] 100. Outer sheath; 110. Elastic sheath tube; 111. Elastic layer; 112. Lubricating layer; 120. First passage;

[0044] 200. Inner sheath; 210. Second passage;

[0045] 300. Outer sheath base; 310. Fourth passage;

[0046] 400. Fixed wing;

[0047] 500. Balloon; 510. Third passage;

[0048] 600. Inflation tube;

[0049] x. First direction. Detailed implementation manners

[0050] The features and exemplary embodiments of various aspects of the present application will be described in detail below. To make the objectives, technical solutions, and advantages of the present application more clear, the following further describes the present application in detail in conjunction with the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only intended to explain the present application, rather than limiting the present application. For those skilled in the art, the present application can be implemented without some of these specific details. The following description of the embodiments is only to provide a better understanding of the present application by showing examples of the present application.

[0051] It should be noted that, in this document, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or elements inherent to such process, method, article or device. Without further limitation, elements defined by the statement "comprising..." do not preclude the presence of additional identical elements in the process, method, article or device comprising the said elements.

[0052] The introductions of the access sheath set provided by the embodiments of the present application will be described below in conjunction with the accompanying drawings. It should be noted that in the accompanying drawings, the connection line along the proximal end and the distal end of the access sheath set extends, and the direction from the distal end to the proximal end is the first direction, denoted as x. In the accompanying drawings, for the convenience of drawing, the dimensions in the drawings are not necessarily in proportion to the actual dimensions.

[0053] Combined with Figures 1a to 6 As can be seen, in order to solve the technical problems involved in the background art, the applicant proposes an access sheath set 10, which includes an outer sheath 100 and an inner sheath 200. The outer sheath 100 includes an elastic sheath tube 110 extending along its axial direction (the direction x in the figure) and a first passage 120 formed by enclosing the elastic sheath tube 110. A second passage 210 extending along its axial direction is provided inside the inner sheath 200. The outer sheath 100 is configured such that when the inner sheath 200 extends into the first passage 120, at least a part of the elastic sheath tube 110 expands and wraps the inner sheath 200 extending into the first passage 120, and the second passage 210 communicates with the first passage 120. When the inner sheath 200 is removed from the first passage 120, the elastic sheath tube 110 rebounds.

[0054] It should be noted that the axial direction of the outer sheath 100 can be understood as the direction in which the interventional instrument intervenes through the access sheath set 10, or it can be understood as the extension direction of the first passage in the outer sheath 100.

[0055] In some embodiments of the present application, when the inner sheath 200 extends into the first passage 120, the elastic sheath tube 110 opposite to the extending part of the inner sheath 200 expands and wraps the inner sheath 200 extending into the first passage 120. In some other embodiments of the present application, when the inner sheath 200 extends into the first passage 120, the elastic sheath tube 110 opposite to the extending part of the inner sheath 200 and the elastic sheath tube 110 connected to this part expand, and the elastic sheath tube 110 opposite to the extending part of the inner sheath 200 wraps the inner sheath 200 extending into the first passage 120.

[0056] In the present application, when the inner sheath 200 is removed from the first passage 120 of the outer sheath, the elastic sheath tube 110 rebounds, which means that when the inner sheath 200 is withdrawn from the first passage 120 of the outer sheath elastic sheath tube 110, the elastic sheath tube 110 rebounds to the state before expansion. In some of these embodiments, when the inner sheath 200 is completely withdrawn from the first passage 120 of the elastic sheath tube 110, the deformed elastic sheath tube 110 rebounds. Among them, the elastic sheath tube 110 can rebound to the state before expansion, or can rebound to a state between the state before expansion and the state after expansion. The present application does not make specific limitations on this. In some other embodiments, when the inner sheath 200 is partially withdrawn from the first passage 120 of the elastic sheath tube 110, after the inner sheath 200 is withdrawn, the deformed part of the elastic sheath tube 110 separated from the inner sheath 200 rebounds, and its rebounding form is the same as the rebounding method in the previous embodiment, which will not be elaborated here. In some other embodiments, when the inner sheath 200 is partially withdrawn from the first passage 120 of the elastic sheath tube 110, the elastic sheath tube 110 does not rebound, and when the inner sheath 200 is completely withdrawn from the first passage 120 of the outer sheath elastic sheath tube 110, the elastic sheath tube 110 rebounds, and its rebounding form is the same as the rebounding method in the previous embodiment, which will not be elaborated here.

[0057] In some embodiments of the present application, the outer sheath 100 includes a natural state and an expanded state that can be mutually converted. When at least a part of the inner sheath 200 extends into the first passage 120, the outer sheath 100 changes from the natural state to the expanded state, and at least a part of the elastic sheath tube 110 expands and wraps the inner sheath 200 extending into the first passage 120. When the inner sheath 200 is removed from the first passage 120, the elastic sheath tube 110 rebounds and causes the outer sheath 100 to change from the expanded state to the natural state. It can be understood that the rebounding state of the elastic sheath tube 110 can be a state that is completely consistent with the natural state, that is, it can be a state close to the natural state (for example, a certain state between the natural state and the expanded state). In addition, it is worth noting that when the intervention sheath group 10 is used in cooperation with the intervention instrument, the elastic sheath tube 110 has the ability to rebound to the natural state, but stops rebounding when rebounding to wrap the intervention instrument, which does not conflict with the description of the rebounding performance of the elastic sheath tube 110 described above.

[0058] In some embodiments of the present application, the outer sheath 100 and the inner sheath 200 in the intervention sheath set 10 are detachably connected. In the initial state, the outer sheath 100 and the inner sheath 200 are relatively separated. During use, the outer sheath 100 and the inner sheath 200 are assembled. In some other embodiments, in the initial state, the outer sheath 100 and the inner sheath 200 are in a pre-assembled state, that is, the distal end of the inner sheath 200 extends into the first passage 120. During use, the inner sheath 200 is further extended into the first passage 120.

[0059] It can be understood that when the inner sheath 200 extends into the outer sheath 100 in the present application, the outer sheath 100 wraps the inner sheath extending into the outer sheath. The present application does not specifically limit the cross-section of the outer sheath in its natural state, and any cross-section form of the outer sheath that can ensure the wrapping effect is within the protection scope of the present application, and the present application does not specifically limit this.

[0060] In some embodiments of the present application, the cross-sectional shapes of both the outer sheath 100 and the inner sheath 200 are axisymmetric figures. The outer sheath 100 has a central axis, and the extending direction of the central axis is the first direction x in the figure. Among them, the cross-sectional shapes of the outer sheath 100 and the inner sheath 200 can be circular or other axisymmetric shapes. When the inner sheath 200 extends into the first passage 120 along the first direction x, the central axis of the inner sheath 200 is coaxially arranged with the central axis of the outer sheath 100. The outer sheath 100 is a cylindrical structure, so it has two circumferential surfaces. The circumferential surface of the outer wall of the elastic sheath tube 110 is the outer circumferential surface, and the circumferential surface of the inner wall of the elastic sheath tube 110 is the inner circumferential surface. The axial direction of the outer sheath 100 refers to the direction in which the central axis extends, the circumferential direction refers to the circumferential direction of the outer periphery of the cylinder, the radial direction refers to the direction passing through the central axis in the radial plane, usually also refers to the straight line direction along the diameter or radius, or the straight line direction perpendicular to the central axis. The radial dimension generally refers to the radius or diameter of an axisymmetric part, and the circumferential dimension generally refers to the circumference of an axisymmetric part. Among them, since the first passage 120 is formed by enclosing the elastic sheath tube 110, the radial dimension of the first passage 120 is equal to the radial dimension of the inner circumferential surface of the elastic sheath tube 110. It can be understood that in the present application, the axial, circumferential, radial, and circumferential surfaces of other components can refer to the relevant descriptions of the outer sheath 100 above.

[0061] In some of these embodiments, the outer sheath 100 includes a natural state and an expanded state that can be mutually converted. When at least a part of the inner sheath 200 extends into the first passage 120, the outer sheath 100 changes from the natural state to the expanded state, and at least a part of the elastic sheath tube 110 expands and wraps the inner sheath 200 extending into the first passage 120. When the inner sheath 200 is removed from the first passage 120, the elastic sheath tube 110 rebounds and makes the outer sheath 100 change from the expanded state to the natural state. Among them, Figure 1a 、 Figure 2a the outer sheath in

[0062] In some of these embodiments, in combination withFigure 3 and Figure 4 As can be seen, the expanded state includes a partially expanded state. In the partially expanded state, the inner sheath 200 axially penetrates through a part of the first passage 120 of the outer sheath 100, and a part of the elastic sheath tube 110 expands and wraps around the inner sheath 200 extending into the first passage 120. Among them, the expanded elastic sheath tube 110 can be the elastic sheath tube 110 corresponding to the inner sheath 200. Or, the expanded elastic sheath tube 110 can also be the elastic sheath tube 110 corresponding to the inner sheath 200 and the part of the elastic sheath tube 110 connected to this part. That is, the outer sheath 100 wrapped around the inner sheath 200 gradually transitions to other parts.

[0063] In some embodiments, in combination with Figure 5 and Figure 6 As can be seen, the expanded state also includes a fully expanded state. In the fully expanded state, the inner sheath 200 axially penetrates through the entire first passage 120 of the outer sheath 100, and the entire elastic sheath tube 110 expands and wraps around the inner sheath 200 extending into the first passage 120.

[0064] In some embodiments, the expanded state also includes another fully expanded state (not shown). In the fully expanded state, the inner sheath 200 axially penetrates through a part of the first passage 120 of the outer sheath 100, and the entire elastic sheath tube 110 expands and wraps around the inner sheath 200 extending into the first passage 120.

[0065] In some embodiments, Figure 5 and Figure 6 the inner sheath 200 in is completely inserted into the outer sheath 100 and extends out from the distal end of the first passage 120. In some implementation manners, the distal end of the elastic sheath tube 110 in the outer sheath 100 is a chamfered structure, so that the outer sheath 100 outside the inner sheath 200 wraps around the inner sheath 200, and the outer peripheral surface of the outer sheath 100 smoothly transitions to the outer peripheral surface of the inner sheath 200, reducing the intervention difficulty of the intervention sheath group 10.

[0066] For the convenience of drawing and description, the x - direction in the figure is a straight - line direction. However, in fact, both the outer sheath 100 and the inner sheath 200 have a certain bending performance, which is convenient for the outer sheath 100 and the inner sheath 200 to intervene in blood vessels. Therefore, the extending direction of the central axes of the outer sheath 100 and the inner sheath 200 can also extend in a curve.

[0067] It can be understood that in this application, the proximal end refers to the end facing the operator or physician, and the distal end refers to the end away from the operator or physician.

[0068] In some implementations, the elasticity of the inner sheath 200 is less than that of the outer sheath 100, so that the outer sheath 100 has a natural state and an expanded state, and the outer sheath 100 can be transformed from the natural state to the expanded state when expanded by an external force, and can rebound from the expanded state to the natural state without being acted upon by an external force. In addition, the rigidity of the inner sheath 200 is greater than that of the outer sheath 100, so that the inner sheath 200 has better support and can assist the interventional instrument to reach a specified position.

[0069] In some implementations, the distal end of the inner sheath 200 is a chamfered structure to reduce friction when the inner sheath 200 extends into the outer sheath 100, reduce the difficulty of assembling the outer sheath 100 and the inner sheath 200, and reduce the difficulty of operation.

[0070] In some implementations, the radial dimension of the first passage 120 in the natural state is smaller than the radial dimension of the outer surface of the inner sheath 200 away from its central axis. That is, the aperture of the first passage 120 in the natural state is smaller than the outer diameter of the inner sheath 200, so that the inner sheath 200 can expand the outer sheath 100 and change from the natural state to the expanded state when the first passage 120 is inserted.

[0071] The interventional sheath group 10 provided in this embodiment enables the outer sheath 100 to include a natural state and an expanded state. When the inner sheath 200 intervenes in the first passage 120, the inner sheath 200 expands the outer sheath 100 and changes from the natural state to the expanded state, and the first passage 120 is enlarged, which is convenient for the intervention of subsequent interventional instruments. After the interventional instrument reaches the designated position, the inner sheath 200 is withdrawn, and the elastic sheath tube 110 rebounds and wraps around the surface of the interventional instrument, which not only reduces the intervention diameter, but also prevents blood from flowing into the elastic sheath tube and the interventional instrument to form a thrombus. In addition, the inner sheath 200 does not need to be torn off after being withdrawn from the first passage 120, and can be re-interposed into the first passage 120 when necessary, so as to realize repeated intervention of the inner sheath 200. After describing the overall structure of the interventional sheath group, the implementation method of the outer sheath in the interventional sheath group is described below in conjunction with the accompanying drawings. Please refer to Figure 7 , Figure 7 An example is shown Figure 4 Schematic diagram of the local cross-sectional structure of the interventional sheath group in the C area.

[0072] Combination Figure 7 It can be seen that in some embodiments, the elastic sheath 110 includes an elastic layer 111 and a lubricating layer 112 , the lubricating layer 112 is located on at least one side of the elastic layer 111 , and the friction coefficient of the lubricating layer 112 is smaller than the friction coefficient of the elastic layer 111 .

[0073] It can be understood that both the elastic layer 111 and the lubricating layer 112 extend along the axial direction of the outer sheath 100 , and the lubricating layer 112 is located on a side of the elastic layer 111 facing the first passage 120 and at least one side away from the first passage 120 .

[0074] In some of these implementations, the elastic layer 111 is made of a highly elastic flexible material. The material of the elastic layer 111 includes at least one of polydimethylsiloxane (PDMS), polyurethane elastomer, and polyolefin elastomer. Such materials have the advantages of low viscosity, high elasticity, high temperature resistance, and chemical resistance. Such materials have relatively high temperature stability, and the molecular motion generated as the temperature rises will increase the elasticity of the material. The material of the lubricating layer 112 includes at least one of polyacrylamide (PAM), polyvinylpyrrolidone, polyethylene glycol, and polyvinyl alcohol. Such materials have good hydrophilic properties; at the same time, such materials also have good cell compatibility and blood compatibility.

[0075] In some of these implementations, the elastic layer 111 is entirely composed of elastic materials. For example, the elastic layer 111 is a cylindrical elastomer. When the inner sheath 200 extends into the first passage 120, the elastic layer 111 expands uniformly in the circumferential direction. In some alternative implementations, a part of the elastic layer 111 is composed of elastic materials and another part is composed of rigid materials. For example, the elastic layer 111 includes a plurality of rigid columns arranged along the circumference, and each rigid column can extend along the axis. An elastomer is filled between adjacent rigid columns. When the inner sheath 200 extends into the first passage 120, the elastomer deforms, and the circumferential distance between adjacent rigid columns changes, thereby realizing the wrapping of the inner sheath. In some other alternative implementations, the elastic layer 111 is formed by surrounding an elastic material grid. When the inner sheath 200 extends into the first passage 120, the shape of the elastic material grid changes, thereby adjusting the circumferential dimension of the elastic layer. It can be understood that the above implementations only illustrate some structures of the elastic layer 111, and other structures that can realize the corresponding functions of the elastic sheath 110 are also within the protection scope of this application, and this application does not make specific limitations on this.

[0076] For the intervention sheath group 10 provided in this embodiment, the lubricating layer 112 located on the side of the elastic layer 111 away from the first passage 120 can reduce the friction between the outer wall of the elastic sheath 110 and the blood vessel wall and improve the intervention passability. The lubricating layer 112 located on the side of the elastic layer 111 facing the first passage 120 can reduce the friction between the inner wall of the elastic sheath 110 and the inner sheath 200 during the expansion process.

[0077] Figure 8 Showing another example of Figure 4 The schematic diagram of the partial cross-sectional structure of the intervention sheath group in the C area.

[0078] Combined with Figure 8 It can be known that in some of these embodiments, lubricating layers 112 are provided on both the side of the elastic layer 111 facing the first passage 120 and the side away from the first passage 120.

[0079] The introducer sheath set 10 provided in this embodiment is provided with lubricating layers 112 on both the side of the elastic layer 111 facing the first passage 120 and the side facing away from the first passage 120, which not only reduces the friction between the outer wall of the elastic sheath tube 110 and the blood vessel wall, improves the intervention passability, but also reduces the friction between the inner wall of the elastic sheath tube 110 and the inner sheath 200 during the expansion process.

[0080] In some other embodiments, the elastic sheath tube 110 is a cylindrical elastic body. When the outer sheath 100 changes from the natural state to the expanded state, the elastic sheath tube 110 can be uniformly deformed in the radial direction to achieve expansion, so that the radial dimension of the first passage 120 becomes larger. When the outer sheath 100 changes from the expanded state to the natural state, the elastic sheath tube 110 can be uniformly deformed in the radial direction to achieve rebound, so that the radial dimension of the first passage 120 becomes smaller. In some of these embodiments, the circumferential dimension of the outer sheath 100 is greater than or equal to 9F and less than or equal to 24F. It can also be understood that the maximum circumferential dimension of the outer sheath 100 during expansion is 24F, and the circumferential dimension of the outer sheath 100 is 9F when it rebounds without external force.

[0081] In this application, the introducer sheath set 10 can be compatible with sheath tubes and instruments of various specifications, has high compatibility, many optional solutions, and expands the scope of use.

[0082] Among them, F is a perimeter unit, 1F is equal to a perimeter of 1 mm, and the corresponding tube orifice diameter is approximately equal to 0.33 mm.

[0083] It can be understood that when the elastic sheath tube 110 expands, its radial dimension (diameter) will become larger, and then its circumferential dimension (perimeter) will also become larger; when the elastic sheath tube 110 rebounds without external force, its radial dimension (diameter) will become smaller, and then its circumferential dimension (perimeter) will also become smaller.

[0084] The introducer sheath set 10 provided in this embodiment satisfies the intervention requirements of most commonly used intervention instruments by making the maximum circumferential dimension of the outer sheath 100 24F. By making the minimum circumferential dimension of the outer sheath 100 9F, the intervention dimension of the outer sheath 100 is reduced, thereby reducing the intervention difficulty.

[0085] After describing the implementation manner of the outer sheath in the introducer sheath set, the implementation manner of the inner sheath in the introducer sheath set will be described below with reference to the drawings. Combining Figure 3 and Figure 4 it can be seen that in some of these embodiments, the axial length of the inner sheath 200 is greater than the axial length of the outer sheath 100. When the inner sheath 200 extends from the proximal end of the first passage 120 and axially passes through the outer sheath 100, it can finally extend out from the distal end of the first passage 120, so that subsequent intervention instruments can reach the designated position through the second passage 210.

[0086] The axial length of the outer sheath 100 refers to the distance from the proximal end to the distal end, that is, the distance from the left end to the right end of the outer sheath 100 after being straightened in the figure. The axial length of the inner sheath 200 is the same.

[0087] In some embodiments, the material of the inner sheath 200 includes at least one of polyethylene or polytetrafluoroethylene.

[0088] The interventional sheath set 10 provided in this embodiment makes the axial length of the inner sheath 200 greater than the axial length of the outer sheath 100, so that when the inner sheath 200 extends from the proximal end of the first passage 120 and passes through the outer sheath 100 along its axial direction, it can eventually extend from the distal end of the first passage 120 and expand the entirety of the proximal end to the distal end of the first passage 120. At the same time, since the elasticity of the inner sheath 200 is less than that of the outer sheath 100, the support of the inner sheath 200 is better than that of the outer sheath 100. After the inner sheath 200 completely passes through the outer sheath 100 and extends from the distal end of the first passage 120, the subsequent interventional instrument can directly reach the designated position with the help of the inner sheath 200 with better support.

[0089] In some embodiments, the inner sheath 200 is a tearable sheath or a femoral artery sheath. After the interventional device is inserted into the designated position, the tearable sheath can be withdrawn from the proximal end of the interventional sheath group 10, and can be detached from the outer sheath 100 and the interventional device after being torn in vitro. The tearable sheath is suitable for use in long-term support type interventional surgeries, in which case the interventional device can be a blood pumping catheter, etc. After the tearable sheath is withdrawn, the elastic sheath tube 110 rebounds and wraps around the surface of the blood pumping catheter, and the blood pumping catheter and the outer sheath 100 remain in the patient's blood vessels for a long time, and provide the patient with an auxiliary blood pumping function through the blood pumping catheter. The femoral artery sheath is suitable for use in short-term support type interventional surgeries, in which case the interventional device can be a valve prosthesis, etc. After the valve prosthesis is inserted into the designated position, the femoral artery sheath and the outer sheath 100 can be withdrawn, and the valve prosthesis can be left at the designated position.

[0090] Figure 9 A schematic diagram of a longitudinal cross-sectional structure of an exemplary outer sheath seat and a fixed wing is shown.

[0091] After describing the implementation of the inner sheath in the interventional sheath set, the implementation of other components in the interventional sheath set will be described below in conjunction with the accompanying drawings. Figures 1a to 6 and Figure 9 It can be seen that in some optional embodiments, the interventional sheath assembly 10 further includes an outer sheath seat 300 and a fixed wing 400, the outer sheath seat 300 is connected to the proximal end of the outer sheath 100, and the outer sheath seat 300 is provided with a fourth passage 310 that penetrates along its axial direction and communicates with the first passage 120. The fixed wing 400 is connected to the outer sheath seat 300, and the fixed wing 400 is located on the side of the outer sheath seat 300 away from the fourth passage 310.

[0092] In some alternative embodiments, in the direction of the connection from the distal end to the proximal end, the radial dimension of the outer sheath seat 300 gradually increases and then remains unchanged, that is, the outer contour of the outer sheath seat 300 is a combination of a cone and a cylinder. The proximal end of the outer sheath 100 at least wraps part of the outer peripheral surface of the outer sheath seat 300, and the outer sheath 100 and the outer sheath seat 300 are hermetically connected by processes such as bonding.

[0093] For the intervention sheath set 10 provided in this embodiment, after the outer sheath 100 intervenes, at least part of the outer sheath seat 300 and the fixing wing 400 are located outside the blood vessel, and the outer sheath 100 can be prevented from shifting in the blood vessel by fixing the fixing wing 400 on the patient's skin.

[0094] Figure 10 The longitudinal sectional structural schematic diagram of another example of the outer sheath seat and the fixing wing is shown.

[0095] Combined with Figure 10 As can be seen, in some alternative embodiments, the intervention sheath set 10 further includes a balloon 500 and an inflation tube 600. The balloon 500 is connected to the outer sheath seat 300 and is located in the fourth passage 310. The balloon 500 encloses to form a third passage 510 communicating with the first passage 120. The inflation tube 600 is communicated with the balloon 500. The inflation tube 600 is used to inflate the balloon 500 to make the radial dimension of the third passage 510 smaller or deflate the gas in the balloon 500 to make the radial dimension of the third passage 510 larger. When the inner sheath 200 extends into the first passage 120 from the third passage 510, the inflation tube 600 can be used to inflate the balloon 500 to make the radial dimension of the third passage 510 smaller and wrap around the outer peripheral surface of the inner sheath 200 to achieve the function of fixing the inner sheath 200. When the intervention instrument extends into the first passage 120 from the third passage 510, the inflation tube 600 can be used to inflate the balloon 500 to make the radial dimension of the third passage 510 smaller and wrap around the outer peripheral surface of the intervention instrument to achieve the function of fixing the inner sheath 200. When the intervention instrument is a blood pumping catheter, the blood pumping motor in the blood pumping catheter intervenes in the blood vessel after passing through the third passage 510 and the first passage 120, and the blood pumping sheath tube in the blood pumping catheter is also connected to the proximal end of the blood pumping motor and extends into the first passage 120 from the third passage 510. The inflation tube 600 can be used to inflate the balloon 500 to make the radial dimension of the third passage 510 smaller and wrap around the outer peripheral surface of the blood pumping sheath tube to achieve the function of fixing the blood pumping sheath tube.

[0096] In some alternative embodiments, in the first direction x, the balloon 500 only occupies a part of the fourth passage 310, and the axial length of the balloon 500 is less than the axial length of the fourth passage 310.

[0097] In some alternative embodiments, in the first direction x, the balloon 500 extends from the proximal end to the distal end of the fourth passage 310, and the axial length of the balloon 500 is equal to the axial length of the fourth passage 310.

[0098] In some alternative embodiments, the balloon 500 is attached to and disposed around the inner wall surface of the outer sheath base 300 on the side facing the fourth passage 310. Since the outer sheath base 300 is made of a rigid material, the radial dimension of the fourth passage 310 is fixed. Therefore, when the balloon 500 is inflated through the inflation tube 600, due to the support of the inner wall surface of the outer sheath base 300, the balloon 500 can only expand towards the side of the third passage 510, causing the radial dimension of the third passage 510 to become smaller.

[0099] In the interventional sheath set 10 provided in this embodiment, during a long-term support type of interventional operation, after the inner sheath 200 is withdrawn and the elastic sheath tube 110 rebounds and wraps around the outer peripheral surface of the blood pumping catheter, the balloon 500 can be inflated through the inflation tube 600 to reduce the radial dimension of the third passage 510 until the balloon 500 also wraps around the outer peripheral surface of the blood pumping catheter, achieving the fixation of the blood pumping catheter, preventing the blood pumping catheter from shifting, and thus reducing the operation of repeatedly positioning the interventional instruments in the radiation environment, and reducing the surgical difficulty and radiation risk. If it is necessary to withdraw the blood pumping catheter, only need to deflate the balloon 500 through the inflation tube 600, then the balloon 500 can release the blood pumping catheter, and then the inner sheath 200 can be re-inserted to achieve the expansion purpose and form a passage, facilitating the withdrawal of the blood pumping catheter.

[0100] Please refer to Figure 11 , Figure 11 which shows a schematic structural diagram of an exemplary interventional device.

[0101] In addition, as Figure 11 shown, the present application also provides an interventional device, including an interventional instrument 20 and the interventional sheath set 10 shown in any of the above embodiments. Hereinafter, one of the interventional devices will be described as an example.

[0102] In some embodiments of the present application, the intervention sheath set 10 is detachably connected to the intervention device 20. Among them, the intervention device includes a first state, a second state, and a third state. In the first state, the intervention device 20 is separated from the intervention sheath set 10, the outer sheath 100 is in a natural state, and the inner sheath 200 does not extend into the first passage 120. In the second state, at least a part of the inner sheath 200 extends into the first passage 120 and causes the outer sheath 100 to change from the natural state to a partially expanded state or a fully expanded state. In the partially expanded state, the inner sheath 200 axially penetrates a part of the first passage 120 along the outer sheath 100, and a part of the elastic sheath tube 110 expands and wraps the inner sheath 200 extending into the first passage 120. In the fully expanded state, the inner sheath 200 axially penetrates the entire first passage 120 along the outer sheath 100, and the entire elastic sheath tube 110 expands and wraps the inner sheath 200 extending into the first passage 120. In the third state, the outer sheath 100 is in an expanded state, at least a part of the outer sheath 100 is sleeved outside the inner sheath 200, and the distal end of the intervention device 20 extends into the second passage 210 from the proximal end of the inner sheath 200 and extends out of the second passage 210 from the distal end of the inner sheath 200.

[0103] In some other embodiments, in the first state, the inner sheath 200 and the outer sheath 100 are pre-assembled. In some alternative embodiments, the intervention device further includes a fourth state. In the fourth state, the inner sheath 200 is removed from the first passage 120, at least a part of the intervention device is located in the first passage 120, and at least a part of the outer sheath 100 rebounds and wraps around the surface of the intervention device. The radial dimension of the intervention device located in the first passage 120 is smaller than the radial dimension of the distal end of the intervention device.

[0104] In some embodiments of the present application, the inner sheath 200 is removed from the first passage, and the inner sheath 200 is separated from the outer sheath 100.

[0105] In some other embodiments of the present application, the inner sheath 200 is partially removed from the first passage, and a part of the inner sheath 200 remains in the first passage.

[0106] For example, the intervention device 20 is a blood pumping catheter. In the fourth state, the motor in the blood pumping catheter passes through the first passage 120, the sheath tube of the blood pumping catheter extends into the first passage 120, and the elastic sheath tube 110 wraps around the outer periphery of the sheath tube.

[0107] In some alternative embodiments, the intervention device further includes a guide wire (not shown) and a dilator (not shown). The guide wire is detachably connected to the intervention sheath set 10 and is used to guide the intervention sheath set 10 to a designated position; the dilator is detachably connected to the distal end of the inner sheath 200.

[0108] Among them, before use, the interventional device is in the first state, and then the guide wire preferentially intervenes into the blood vessel. The user connects the dilator to the distal end of the inner sheath 200 outside the body, and inserts the combined dilator and inner sheath 200 into the outer sheath 100 through the first passage 120 to change the outer sheath 100 from the natural state to a partially expanded state or a fully expanded state. At this time, the interventional device is in the second state. Then, the combined dilator and interventional sheath group 10 are inserted into the blood vessel along the guide wire until the specified position, and then the dilator is withdrawn. Then, the interventional instrument is inserted into the blood vessel through the second passage 210 and the guide wire until the specified position. At this time, the interventional device is in the third state.

[0109] Finally, the interventional instrument 20 can be withdrawn from the blood vessel together with the interventional sheath group 10. This usage scenario is suitable for short-term support type interventional surgeries. At this time, the interventional instrument 20 can be a valve delivery device. After the valve prosthesis in the valve delivery device is inserted into the specified position, the valve delivery device and the interventional sheath group 10 can be completely withdrawn from the blood vessel.

[0110] In addition, after the third state, the inner sheath 200 can also be withdrawn from the blood vessel first. Since the interventional instrument 20 is located inside the interventional sheath group 10, when the outer sheath 100 rebounds, it will wrap around the surface of the interventional instrument. At this time, the interventional device is in the fourth state. This usage scenario is suitable for long-term support type interventional surgeries. At this time, the interventional instrument 20 can be a blood pumping catheter, etc. After the inner sheath 200 is withdrawn, the elastic sheath tube 110 rebounds and wraps around the surface of the blood pumping catheter. The blood pumping catheter and the outer sheath 100 remain in the patient's blood vessel for a long time and provide an auxiliary blood pumping function for the patient through the blood pumping catheter.

[0111] In some alternative embodiments, the interventional device further includes a variable diameter sheath (not shown). In long-term support type interventional surgeries, after the inner sheath 200 is withdrawn, the variable diameter sheath is inserted into the blood vessel from the outer sheath seat 300 and the outer sheath 100 to the specified position to achieve a hemostatic function.

[0112] It can be understood that the interventional device can produce the same technical effects as the interventional sheath group, and will not be elaborated here.

[0113] In addition, the present application also provides a method for using an interventional device, which is applied to the interventional device. Hereinafter, taking one of the interventional devices as an example, the method includes the following steps:

[0114] Step S01: Insert the guide wire into the blood vessel.

[0115] Step S02: The dilator penetrates into the second passage of the inner sheath, connects the dilator to the distal end of the inner sheath 200, and then inserts the connected dilator and inner sheath 200 into the first passage 120 to expand at least part of the elastic sheath tube 110 and wrap it around the outer surface of the inner sheath 200 extending into the first passage 120.

[0116] Step S03: Insert the combined dilator, inner sheath 200, and outer sheath 100 into the blood vessel along the guide wire.

[0117] Step S04: Withdraw the dilator and leave the outer sheath 100 and inner sheath 200 in the blood vessel.

[0118] Step S05: Insert the interventional device into the blood vessel through the passage inside the inner sheath 200.

[0119] Among them, in step S02, at least a part of the inner sheath 200 needs to extend from the distal end of the first passage 120 so that the entire outer sheath 100 is squeezed and expanded.

[0120] In some alternative embodiments, after step S05, the usage method further includes:

[0121] Step S06: Withdraw the inner sheath 200, leave the interventional device and the outer sheath 100 in the blood vessel, and the elastic sheath tube 110 rebounds and wraps around the surface of the interventional device in the second passage.

[0122] Step S07: Inflate the balloon 500 to fixedly connect the interventional device and the inner sheath 200 through the balloon 500 and the outer sheath seat 300.

[0123] Among them, this usage method is suitable for application in long-term support type interventional surgeries. At this time, the interventional device can be a blood pumping catheter, etc. After the tearable sheath is withdrawn, the elastic sheath tube 110 rebounds and wraps around the surface of the blood pumping catheter. The blood pumping catheter and the outer sheath 100 remain in the patient's blood vessel for a long time, and provide an auxiliary blood pumping function for the patient through the blood pumping catheter.

[0124] In some alternative embodiments, after step S05, the usage method further includes:

[0125] Step S061: Deliver the components inside the interventional device to the designated position;

[0126] Step S062: Withdraw the interventional device and leave the components inside the interventional device at the designated position;

[0127] Step S063: Withdraw the inner sheath 200 and the outer sheath 100.

[0128] Among them, this usage method is suitable for application in short-term support type interventional surgeries. At this time, the interventional device can be a valve delivery device. After the valve prosthesis inside the valve delivery device is inserted into the designated position, after withdrawing the valve delivery device, both the femoral artery sheath and the outer sheath 100 can be withdrawn, and the valve prosthesis is left at the designated position.

[0129] In addition, the present application also provides a sheath tube, which includes an elastic sheath tube extending along its axial direction and a first passage formed by enclosing the elastic sheath tube. The sheath tube can be in a natural state and an expanded state that can be converted into each other. In the expanded state, at least part of the elastic sheath tube expands and makes the radial dimension of the first passage larger; in the natural state, the elastic sheath tube rebounds and makes the radial dimension of the first passage smaller.

[0130] It can be understood that the sheath tube in the present application can be any one of the foregoing intervention sheath groups.

[0131] Among them, the expansion of the elastic sheath tube can be achieved by inserting another sheath tube into the first passage to expand it, or by inserting other intervention instruments into the first passage to expand it.

[0132] In some alternative embodiments, the expanded state includes a partially expanded state and a fully expanded state. In the partially expanded state, part of the elastic sheath tube expands and wraps the inner sheath inserted into the first passage; in the fully expanded state, the inner sheath axially penetrates the entire first passage along the outer sheath, and the entire elastic sheath tube expands.

[0133] In some alternative embodiments, the elastic sheath tube includes: an elastic layer; a lubricating layer located on at least one of the inner and outer sides of the elastic layer, and the friction coefficient of the lubricating layer is less than that of the elastic layer.

[0134] In some alternative embodiments, the elastic layer is entirely composed of an elastic material, or part of the elastic layer is composed of an elastic material and the other part is composed of a rigid material, or the elastic layer is formed by surrounding an elastic material grid.

[0135] In some alternative embodiments, lubricating layers are provided on both the side of the elastic layer facing the first passage and the side facing away from the first passage.

[0136] As described above, the above is only the specific implementation manner of the present application. Those skilled in the art can clearly understand that for the convenience and brevity of description, the specific working processes of the systems, modules, and units described above can refer to the corresponding processes in the foregoing method embodiments and will not be elaborated herein. It should be understood that the protection scope of the present application is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present application can easily think of various equivalent modifications or substitutions, and these modifications or substitutions should all be covered within the protection scope of the present application.

Claims

1. An interventional sheath set, characterized in that: include: The outer sheath comprises an elastic sheath tube extending along its axial direction and a first passage formed by the elastic sheath tube; An inner sheath is provided with a second passage extending along its axial direction, and the outer sheath is configured so that when the inner sheath extends into the first passage, at least a portion of the elastic sheath tube expands and wraps the inner sheath extending into the first passage, and the second passage is connected to the first passage; when the inner sheath moves out of the first passage, the elastic sheath tube rebounds.

2. The interventional sheath set according to claim 1, characterized in that: The outer sheath includes a natural state and an expanded state that can be converted into each other. When at least a portion of the inner sheath extends into the first passage, the outer sheath is transformed from the natural state to the expanded state, and at least a portion of the elastic sheath tube expands and wraps the inner sheath extending into the first passage; when the inner sheath moves out of the first passage, the elastic sheath tube rebounds and transforms the outer sheath from the expanded state to the natural state.

3. The interventional sheath set according to claim 2, characterized in that: The expanded state includes a partially expanded state, in which the inner sheath penetrates a portion of the first passage along the axial direction of the outer sheath, and a portion of the elastic sheath tube expands and wraps the inner sheath extending into the first passage.

4. The interventional sheath set according to claim 2, characterized in that: The expanded state includes a fully expanded state, in which the inner sheath penetrates the entire first passage along the axial direction of the outer sheath, and the entire elastic sheath tube expands and wraps the inner sheath extending into the first passage.

5. The interventional sheath set according to claim 2, characterized in that: The radial dimension of the first passage in the natural state is smaller than the radial dimension of the outer surface of the inner sheath away from the central axis thereof.

6. The interventional sheath set according to claim 1, characterized in that: The elastic sheath comprises: Elastic layer; The lubricating layer is located on at least one of the inner and outer sides of the elastic layer, and the friction coefficient of the lubricating layer is smaller than the friction coefficient of the elastic layer.

7. The interventional sheath set according to claim 6, characterized in that: The elastic layer is entirely composed of elastic material, or a part of the elastic layer is composed of elastic material and the other part is composed of rigid material, or the elastic layer is formed by a mesh of elastic material surrounding it.

8. The interventional sheath set according to claim 6, characterized in that: A lubricating layer is provided on both the side of the elastic layer facing the first passage and the side facing away from the first passage.

9. The interventional sheath set according to claim 6, characterized in that: The material of the elastic layer includes at least one of polydimethylsiloxane, polyurethane elastomer, and polyolefin elastomer, and the material of the lubricating layer includes at least one of polyacrylamide, polyvinyl pyrrolidone, polyethylene glycol, and polyvinyl alcohol.

10. The interventional sheath set according to claim 1, characterized in that: Also includes: An outer sheath seat connected to the proximal end of the outer sheath, wherein the outer sheath seat is provided with a fourth passage penetrating along the axial direction thereof and communicating with the first passage; The fixing wing is connected to the outer sheath seat, and the fixing wing is located at a side of the outer sheath seat away from the fourth passage.

11. The interventional sheath set according to claim 10, characterized in that: Also includes: A balloon connected to the outer sheath seat and located in the fourth passage, wherein the balloon encloses a third passage communicating with the first passage; An inflation tube is connected to the balloon and is used to inflate the balloon to reduce the radial dimension of the third passage or to release the gas in the balloon to increase the radial dimension of the third passage.

12. The interventional sheath set according to claim 1, characterized in that: The circumferential dimension of the outer sheath is greater than or equal to 9F and less than or equal to 24F.

13. The interventional sheath set according to claim 1, characterized in that: The elasticity of the inner sheath is less than that of the outer sheath.

14. An interventional device, characterized in that: The invention comprises an interventional instrument and an interventional sheath set according to any one of claims 1 to 13, wherein the interventional instrument is detachably connected to the interventional sheath set, and the interventional device comprises a first state, a second state and a third state; In the first state, the outer sheath is in a natural state; In the second state, at least part of the inner sheath extends into the first passage and changes the outer sheath from the natural state to a partially expanded state or a fully expanded state. In the partially expanded state, the inner sheath passes through part of the first passage along the axial direction of the outer sheath, and part of the elastic sheath tube expands and wraps the inner sheath extending into the first passage; in the fully expanded state, the inner sheath passes through the entire first passage along the axial direction of the outer sheath, and the entire elastic sheath tube expands and wraps the inner sheath extending into the first passage; In the third state, the interventional instrument extends from the proximal end of the inner sheath into the second passage and extends from the distal end of the inner sheath out of the second passage.

15. The interventional device according to claim 14, characterized in that: The interventional device further comprises a fourth state, in which the inner sheath is removed from the first passage, at least a portion of the interventional instrument is located in the first passage, and at least a portion of the outer sheath rebounds and wraps around the surface of the interventional instrument.

16. The interventional device according to claim 14, characterized in that Also includes: A guide wire, detachably connected to the interventional sheath assembly, and used to guide the interventional sheath assembly to a designated position; The dilator is detachably connected to the distal end of the inner sheath.

17. A sheath tube, characterized in that: It includes an elastic sheath extending along its axial direction and a first passage formed by the elastic sheath, the sheath includes a natural state and an expanded state that can be converted into each other, in the expanded state, at least part of the elastic sheath expands and makes the radial size of the first passage larger; in the natural state, the elastic sheath rebounds and makes the radial size of the first passage smaller.

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