Sheath Assemblies and Interventional Sheath Kits

Abstract

The present invention provides a sheath tube assembly and an interventional surgery sheath tube kit, which relates to the field of medical devices. The sheath tube assembly includes a catheter sheath assembly and a bending adjustment assembly; the catheter sheath assembly includes an outer sheath tube, which is provided with a central guide wire cavity, a support guide wire cavity, a traction wire cavity and a super-selection guide wire cavity, and the distal end opening of the super-selection guide wire cavity is an outer sheath tube side opening; the bending adjustment assembly includes a guide head, a bending adjustment wire and a traction wire, and the guide head includes a fixed seat and an adjustable bend tube; the fixed seat is connected to the distal end of the outer sheath tube, and is provided with a central guide wire cavity, a support guide wire cavity and a traction wire cavity; the central tube cavity of the outer sheath tube, the fixed seat and the adjustable bend tube is connected in sequence to form a bending adjustment wire cavity; the distal end of the bending adjustment wire is connected to a support head; the traction wire passes through the traction wire cavity, and the distal end is fixed to the distal end of the adjustable bend tube. The interventional surgery sheath tube kit includes a guide guide wire, a support guide wire, a guiding catheter, a branch super-selection guide wire and the aforementioned sheath tube assembly. The present invention reduces the difficulty of accurately and quickly super-selecting a branch guide wire into a branch blood vessel.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a sheath tube assembly and an interventional surgery sheath tube kit. Background Art

[0002] Interventional therapy refers to the use of interventional diagnostic and therapeutic sheaths (such as guide catheters, delivery sheaths, guide sheaths, etc.) under the guidance of medical imaging equipment to establish a channel between the diseased part of the patient's body and the external operating end, so as to introduce various diagnostic and therapeutic instruments, drugs, implantable devices, etc. to the patient's diseased part, so as to avoid surgical operation and allow diagnostic and therapeutic instruments, drugs, implantable devices, etc. to reach the diseased part.

[0003] With the advancement of interventional treatment technology, endovascular repair has gradually become the main treatment method for aortic aneurysms or aortic dissections involving visceral arteries due to its characteristics of low trauma, fast postoperative recovery and low complications. The covered stent is delivered to the lesion site in the patient's aorta through an interventional diagnostic sheath, so as to isolate the aneurysm or dissection rupture with the covered stent to achieve the treatment purpose. However, in some cases, when the lesion site in the aorta is very close to the opening of the branch vessel of the aorta, or the lesion site extends to the junction of the branch vessel opening and the aorta or even extends to the branch vessel, the covered stent isolates the aortic aneurysm or dissection rupture while blocking the blood supply of the branch artery. At this time, in addition to implanting the aortic covered stent in the aorta, it is also necessary to open a window on the aortic covered stent and further implant a branch stent inside the branch vessel. When implanting the branch stent, it is necessary to perform guidewire superselection on the branch vessel and insert the branch stent along the guidewire to reconstruct the blood supply of the branch vessel.

[0004] In the prior art, imaging equipment is generally used to image the lesion site. Under the guidance of the imaging equipment, medical staff locate the opening of the branch blood vessel, introduce the sheath from the femoral artery or brachial artery to the aorta, and insert the guiding catheter with different head angles along the sheath, so that the catheter head is aligned with the angle of the opening of the branch blood vessel, insert the guide wire along the guiding catheter, select the guide wire into the branch blood vessel, withdraw the guiding catheter, retain the guide wire, and insert the branch stent along the guide wire. This method is not only difficult to locate, but also has large anatomical variations in the opening direction of the visceral artery. In the process of superselection of the guide wire, it is often necessary to replace the guiding catheter with different head angles. It is necessary to determine what angle of the guiding catheter should be used and how to operate it specifically, which requires high experience of medical equipment and medical staff.

[0005] In order to solve the problem that the angle of the guiding catheter is fixed and cannot be adjusted continuously, the prior art uses an adjustable curved sheath tube to cooperate with the operation to realize the continuous adjustment of the angle of the guiding catheter tip. However, the existing adjustable curved sheath tube is difficult to process, has a complex structure, and is expensive. In addition, the adjustable curved length of the adjustable curved sheath tube is fixed. If the adjustable curved length is too long, it may lead to the inability to adjust the expected angle. If the adjustable curved length is too short, during the process of superselecting the guidewire into the branch vessel opening, the sheath tube is suspended in the blood vessel, and the sheath tube may move or rotate with the guidewire, making it difficult to select the guidewire, or the guidewire may fall out of the branch vessel after being selected into the corresponding branch vessel, resulting in a long guidewire superselection time and complicated operation. In addition, the existing adjustable curved sheath tube can only perform superselection of a single branch vessel at a time, and cannot perform guidewire superselection on multiple visceral branch vessels at the same time. Summary of the invention

[0006] The object of the present invention is to provide a sheath assembly and an interventional surgery sheath kit to alleviate the above-mentioned technical problems existing in the prior art.

[0007] To achieve the above objectives, the embodiments of the present invention adopt the following technical solutions:

[0008] In a first aspect, an embodiment of the present invention provides a sheath assembly, including a catheter sheath assembly and a bending adjustment assembly.

[0009] The catheter sheath assembly includes an outer sheath tube, which is provided with a central guidewire cavity extending axially, at least one supporting guidewire cavity, at least one traction wire cavity and at least one superselective guidewire cavity, and the distal openings of each superselective guidewire cavity respectively penetrate the distal outer peripheral surface of the outer sheath tube to form an outer sheath tube side opening.

[0010] The bending adjustment component includes a guide head, a bending adjustment wire and a traction wire with the same number as the super-selective guide wire cavity; wherein: the guide head includes a fixed seat and an adjustable bend tube fixed or integrally connected to the distal end of the fixed seat; the fixed seat is fixed or integrally connected to the distal end of the outer sheath tube; the fixed seat is provided with an axially penetrating central guide wire cavity, at least one supporting guide wire cavity and at least one traction wire cavity; the central guide wire cavity of the outer sheath tube, the central guide wire cavity of the fixed seat and the central tube cavity of the adjustable bend tube are connected in sequence to form a bending adjustment guide wire cavity; the supporting guide wire cavity of the outer sheath tube is connected to the supporting guide wire cavity of the fixed seat; the traction wire cavity of the outer sheath tube is connected to the traction wire cavity of the fixed seat. The bending adjustment wire passes through the bending adjustment guide wire cavity, and the distal end of the bending adjustment wire is connected to a support head, which can be retracted into the interior of the adjustable bend tube toward the proximal direction, or released to the outside of the adjustable bend tube toward the distal direction. In the released state, the support head expands radially along the adjustable bend tube to form a forked shape with the distal end opened. Each of the traction wires passes through the traction wire cavity of the fixing seat and the traction wire cavity of the outer sheath tube respectively, the proximal end of each of the traction wires is located outside the proximal end of the outer sheath tube, the distal end of each of the traction wires is fixedly connected to the distal end of the adjustable bend tube respectively, and the distal end of each of the traction wires corresponds one by one to the projection of each of the side openings of the outer sheath tube along the axial direction of the outer sheath tube on the plane where the same radial section of the outer sheath tube is located, and is on the same side of the radial section.

[0011] The sheath tube assembly provided in this embodiment can at least achieve the following beneficial effects:

[0012] (1) It can cooperate with the support guide wire to form a support and positioning for the outer sheath, preventing the outer sheath from tilting or moving during use, and ensuring that the side opening of the outer sheath will not move after it is aligned with the opening of the selected branch blood vessel, thereby improving the alignment accuracy;

[0013] (2) The branch super-selective guidewire is first positioned by the outer sheath opening when passing through the outer sheath opening, and then, with the cooperation of the guiding catheter, is positioned again by the support head of the bending wire to achieve double positioning. The space required for adjustment is small, and a wide range of angle adjustment can be completed. In addition, during the process, the angle of the adjustable bend can be adjusted at any time by the traction wire to achieve real-time fine-tuning. The adjustment can be adaptively adjusted in the cavity according to the opening direction of the visceral artery of different patients. In addition, the branch super-selective guidewire is supported by the bifurcation of the support head of the bending wire to prevent the branch super-selective guidewire from falling out of the branch blood vessel.

[0014] (3) The cavity structures inside the outer sheath and the guide head are separated from each other and do not interfere with each other, making full use of the space inside the sheath and avoiding the problem of multiple instruments entering and exiting the same cavity causing jamming, thereby improving the accuracy and safety of the operation;

[0015] (4) The sheath assembly provided in this embodiment has a simple overall structure, low processing cost, and convenient operation, which significantly reduces the difficulty of superselection of the branch guidewire.

[0016] For the specific usage of this embodiment, please refer to the description in the subsequent specific implementation method section.

[0017] Further:

[0018] In an optional technical solution of the present embodiment, the supporting guidewire cavity of the outer sheath tube and the supporting guidewire cavity of the fixed seat respectively include at least a first supporting guidewire cavity and a second supporting guidewire cavity, and the first supporting guidewire cavity and the second supporting guidewire cavity are arranged on both sides of the bending guidewire cavity along the radial direction of the outer sheath tube, the first supporting guidewire cavity of the outer sheath tube is correspondingly connected to the first supporting guidewire cavity of the fixed seat, and the second supporting guidewire cavity of the outer sheath tube is correspondingly connected to the second supporting guidewire cavity of the fixed seat.

[0019] In an optional technical solution of the present embodiment, the superselective guidewire cavity comprises a first superselective guidewire cavity and a second superselective guidewire cavity; the outer sheath tube side opening corresponding to the first superselective guidewire cavity and the outer sheath tube side opening corresponding to the second superselective guidewire cavity are arranged opposite to or alternately along the radial direction of the outer sheath tube.

[0020] In an optional technical solution of the present embodiment, a developing mark is provided at a position of the distal end of the outer sheath tube located at the proximal side and / or the distal side of each of the outer sheath tube side openings.

[0021] In an optional technical solution of the present embodiment, when the support head is in a released state outside the adjustable elbow, the support head is in a "Y" shape with a closed proximal end and an open distal end.

[0022] In an optional technical solution of the present embodiment, the proximal end of each traction wire is fixedly connected to a traction wire handle, and / or the proximal end of the bending adjustment wire is fixedly connected to a bending adjustment wire handle.

[0023] In an optional technical solution of the present embodiment, each traction wire cavity of the fixing seat respectively includes a main cavity, a first branch cavity and a second branch cavity, the proximal end of the first branch cavity and the proximal end of the second branch cavity are both connected to the distal end of the main cavity, the proximal end of the main cavity passes through the proximal surface of the fixing seat, and the distal end of the first branch cavity and the distal end of the second branch cavity respectively pass through the distal surface or the distal outer peripheral surface of the fixing seat.

[0024] In an optional technical solution of the present embodiment, the catheter sheath assembly also includes an outer sheath handle fixedly connected to the proximal end of the outer sheath, and the outer sheath handle is internally provided with a central handle channel, a traction wire channel, support guide wire channels the same number as the support guide wire channels of the outer sheath and connected one-to-one, and branch handle channels the same number as the superselective guide wire cavities of the outer sheath and connected one-to-one; the central handle channel is connected to the bending guide wire cavity; the traction wire passes through the traction wire channel; the bending guide wire passes through the central handle channel.

[0025] Optionally, the proximal ends of the central handle channel, the traction wire channel and the branch handle channel are respectively provided with a sealing rubber pad and an end cover, the middle part of the end cover is provided with a through hole penetrating the end cover, the center of the sealing rubber pad is provided with a guide wire through hole that can be automatically closed, and the end cover is located on the proximal side of the sealing rubber pad; and / or, the catheter sheath assembly also includes a stress protection tube fixedly connected to the inside of the outer sheath tube handle and extending toward the distal end of the outer sheath tube, and the proximal end of the outer sheath tube is penetrated by and fixedly connected to the inner wall of the stress protection tube.

[0026] In the second aspect, an embodiment of the present invention provides an interventional surgery sheath kit, including a guide guidewire, a support guidewire, a guiding catheter, a branch super-selective guidewire and a sheath assembly as described in any of the aforementioned embodiments. Its specific usage refers to the detailed description in the specific implementation method section of this specification.

[0027] In particular, in the embodiments of the present invention, “and / or” indicates that the first feature before “and / or” and the second feature after “and / or” include the following specific setting methods: (1) only the first feature is set, and the second feature is not set; (2) only the second feature is set, and the first feature is not set; (3) the first feature and the second feature are set at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0029] Figure 1 A front view of the overall structure of the sheath tube assembly provided by an embodiment of the present invention;

[0030] Figure 2 A front cross-sectional view of the overall structure of a sheath tube assembly provided in an embodiment of the present invention (the traction wire is not shown);

[0031] Figure 3An exploded schematic diagram of the overall structure of a sheath tube assembly provided in an embodiment of the present invention (the traction wire is not shown);

[0032] Figure 4 for Figure 1 AA section view;

[0033] Figure 5 An axonometric view of an outer sheath handle in a sheath assembly provided in an embodiment of the present invention;

[0034] Figure 6 for Figure 2 A partial enlarged view of the distal structure of the middle and outer sheaths;

[0035] Figure 7 for Figure 6 BB section view;

[0036] Figure 8 A schematic diagram of a method of threading a traction wire inside a guide head in a sheath tube assembly provided in an embodiment of the present invention;

[0037] Fig. 9 for Figure 8 CC section view;

[0038] Fig.10 for Figure 8 DD section view;

[0039] Fig.11 Schematic diagram of the operation of the sheath tube assembly provided in an embodiment of the present invention Figure 1 ;

[0040] Fig.12 for Fig.11 A magnified view of the local structure;

[0041] Fig.13 Schematic diagram of the operation of the sheath tube assembly provided in an embodiment of the present invention Figure 2 ;

[0042] Fig.14 for Fig.13 A magnified view of the local structure;

[0043] Fig.15 Schematic diagram of the operation of the sheath tube assembly provided in an embodiment of the present invention Figure 3 ;

[0044] Fig.16 for Fig.15 A magnified view of the local structure;

[0045] Fig.17 Schematic diagram of the operation of the sheath tube assembly provided in an embodiment of the present invention Figure 4 ;

[0046] Fig.18 for Fig.17 A magnified view of the local structure.

[0047] Icons: 100-central guidewire cavity; 200-support guidewire cavity; 210-first support guidewire cavity; 220-second support guidewire cavity; 300-traction wire cavity; 310-first traction wire cavity; 320-second traction wire cavity; 301-main cavity; 302-first branch cavity; 303-second branch cavity; 400-super-selected guidewire cavity; 410-first super-selected guidewire cavity; 420-second super-selected guidewire cavity;

[0048] 1-catheter sheath assembly; 11-outer sheath; 110-outer sheath side opening; 111-development mark; 12-outer sheath handle; 121-center handle channel; 122-traction wire channel; 1221-first traction wire channel; 1222-second traction wire channel; 123-support guide wire channel; 124-branch handle channel; 125-sealing rubber pad; 126-end cover; 13-stress protection tube;

[0049] 2-bending assembly; 21-guide head; 211-fixed seat; 212-adjustable bending pipe; 22-bending wire; 221-support head; 23-bending wire handle; 24-traction wire; 241-first traction wire; 242-second traction wire; 25-traction wire handle;

[0050] 3-support guidewire; 31-first support guidewire; 32-second support guidewire; 4-guiding catheter; 5-branch superselective guidewire; 6-balloon catheter. DETAILED DESCRIPTION

[0051] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0052] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0053] It should be noted that like reference numerals and letters denote similar items in the drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0054] In the description of the present invention, it should be noted that:

[0055] Unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0056] The orientation or position relationship indicated by the terms "proximal", "distal", "front end", "rear end", "radial", "inner", "outer", etc. is based on the orientation or position relationship shown in the drawings, or is the orientation or position relationship in which the product of the invention is usually placed when used. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0057] The terms “first”, “second”, etc. are only used for distinguishing descriptions and do not indicate the total number or relative position in time and / or space, and cannot be understood as indicating or implying relative importance.

[0058] In the following, some embodiments of the present invention are described in detail with reference to the accompanying drawings, with the end of the medical device close to the operator during surgery being the proximal end of the medical device and the end of the medical device entering the patient's blood vessel being the distal end of the medical device (the front end of the medical device is the distal end, and the rear end of the medical device is the proximal end). In the absence of conflict, the features of the following embodiments and the optional embodiments in the embodiments can be combined with each other.

[0059] Embodiment 1

[0060] This embodiment provides a sheath tube assembly, referring to Figures 1 to 10 The sheath assembly includes a catheter sheath assembly 1 and a bending adjustment assembly 2. Specifically, the catheter sheath assembly 1 includes an outer sheath 11, and the outer sheath 11 is provided with a central guidewire cavity 100 extending along the axial direction, at least one supporting guidewire cavity 200, at least one traction wire cavity 300 and at least one super-selected guidewire cavity 400, and the distal openings of each super-selected guidewire cavity 400 respectively penetrate the distal outer peripheral surface of the outer sheath 11 to form an outer sheath side opening 110.

[0061] The bending adjustment component 2 includes a guide head 21, a bending adjustment wire 22 and the same number of traction wires 24 as the super-selective guide wire cavity 400; wherein: the guide head 21 includes a fixed seat 211 and an adjustable bend tube 212 fixed or integrally connected to the distal end of the fixed seat 211; the fixed seat 211 is fixed or integrally connected to the distal end of the outer sheath tube 11; the fixed seat 211 is provided with an axially through central guide wire cavity 100, at least one supporting guide wire cavity 200 and at least one traction wire cavity 300; the central guide wire cavity 100 of the outer sheath tube 11, the central guide wire cavity 100 of the fixed seat 211 and the central tube cavity of the adjustable bend tube 212 are connected in sequence to form a bending adjustment guide wire cavity; the supporting guide wire cavity 200 of the outer sheath tube 11 is connected to the supporting guide wire cavity 200 of the fixed seat 211; the traction wire cavity 300 of the outer sheath tube 11 is connected to the traction wire cavity 300 of the fixed seat 211. The bending adjustment wire 22 passes through the aforementioned bending adjustment guide wire cavity, and the distal end of the bending adjustment wire 22 is connected to a support head 221, which can be retracted into the interior of the adjustable curved tube 212 toward the proximal direction, or released to the outside of the adjustable curved tube 212 toward the distal direction. In the released state, the support head 221 expands radially along the adjustable curved tube 212 to form a forked shape with the distal end opened. Each traction wire 24 passes through the traction wire cavity 300 of the fixed seat 211 and the traction wire cavity 300 of the outer sheath tube 11 respectively, and the proximal end of each traction wire 24 is located outside the proximal end of the outer sheath tube 11, and the distal end of each traction wire 24 is fixedly connected to the distal end of the adjustable curved tube 212, and the distal end of each traction wire 24 corresponds to each outer sheath tube side opening 110 along the axial direction of the outer sheath tube. The projection on the plane where the same radial section of the outer sheath tube is located is on the same side of the radial section.

[0062] Combine the following Figures 11 to 18 The use of the sheath assembly provided in this embodiment is introduced as follows: when in use, it is combined with the guide wire, the support wire 3, the guiding catheter 4, and the branch super-selective guide wire 5 into a kit for use. Fig.11 and Fig.12 As shown, first, the bending wire 22 is not inserted into the bending wire cavity; the guide wire is inserted into the aorta to the lesion site through percutaneous puncture, and the guide wire passes through the bending wire cavity of the outer sheath tube 11 and the guide head 21, and is lowered into the outer sheath tube 11 along the guide wire; the support guide wire 3 is inserted into the patient's body through the support guide wire cavity 200 of the outer sheath tube 11 and the fixing seat 211, so that the distal end of the support guide wire 3 is supported in the anchorable area in the blood vessel cavity to form a supporting force for the outer sheath tube 11; as shown in FIG. Fig.13 and Fig.14As shown, then, withdraw the guide wire and insert the bending wire 22 into the bending wire cavity; move the outer sheath 11 axially and rotate circumferentially to align the outer sheath side opening 110 with the selected branch blood vessel entrance; insert the branch super-selective guide wire 5 along the proximal entrance of the super-selective guide wire cavity 400 on the outer sheath 11, and when the distal end of the branch super-selective guide wire 5 is exposed to a certain length, pull back the traction wire 24 on the corresponding side to make the distal end of the adjustable bend tube 212 of the guide head 21 return a certain angle, and then adjust the bending wire 22 so that the support head 221 at its distal end is released outside the adjustable bend tube 212, and the support head 221 is moved along the adjustable The radial expansion of the curved tube 212 is a forked shape with its distal end opened, and its forked portion supports the above-mentioned branch super-selective guide wire 5; thereafter, the guiding catheter 4 is lowered along the above-mentioned branch super-selective guide wire 5, and the distal return angle of the adjustable curved tube 212 is further adjusted by adjusting the traction wire 24, and the length of the guiding catheter 4 extending to the outside of the outer sheath side opening 110 is further adjusted by adjusting the bending adjustment wire 22, thereby adjusting the relative position and relative angle of the guiding catheter 4 to the branch blood vessel opening again, and after the position is adjusted, the branch super-selective guide wire 5 is operated to super-select the branch super-selective guide wire 5 into the selected branch blood vessel; Fig.17 and Fig.18 As shown, a balloon catheter 6 or other treatment device can be further inserted along the branch super-selective guide wire 5; when there are multiple branch blood vessels and multiple corresponding super-selective guide wire cavities 400 and traction wires 24, for example Fig.15 and Fig.16 As shown, the above method can be repeated to insert branch super-selective guidewires 5 into other branch blood vessels.

[0063] The sheath tube assembly provided in this embodiment can at least achieve the following beneficial effects:

[0064] (1) It can cooperate with the support guide wire 3 to form a support and positioning for the outer sheath tube 11, so as to prevent the outer sheath tube 11 from tilting or moving during use, and ensure that the outer sheath tube side opening 110 will not move after being aligned with the opening of the selected branch blood vessel, thereby improving the alignment accuracy;

[0065] (2) The branch super-selective guide wire 5 is positioned for the first time by the outer sheath tube side opening 110 when passing through the outer sheath tube side opening 110, and then, with the cooperation of the guiding catheter 4, is positioned for the second time by the support head 221 of the adjustable bend wire 22, thereby realizing double positioning. The space required for adjustment is small, and a larger range of angle adjustment can be completed. Moreover, during the process, the angle of the adjustable bend tube 212 can be adjusted at any time by the traction wire 24 to realize real-time fine adjustment. The adjustment can be adaptively adjusted within the cavity according to the opening direction of the visceral artery of different patients. Moreover, the branch super-selective guide wire 5 is supported by the bifurcation of the support head 221 of the adjustable bend wire 22, thereby preventing the branch super-selective guide wire 5 from coming out of the branch blood vessel.

[0066] (3) The cavity structures in the outer sheath tube 11 and the guide head 21 are separated from each other and do not interfere with each other, which fully utilizes the space inside the sheath and avoids the problem of multiple instruments entering and exiting the same cavity and causing jamming, thereby improving the accuracy and safety of operation;

[0067] (4) The sheath assembly provided in this embodiment has a simple overall structure, low processing cost, and convenient operation, which significantly reduces the difficulty of superselection of the branch guidewire.

[0068] In order to further improve the supporting stability of the outer sheath 11 during use and make the outer sheath side opening 110 more accurately position the branch super-selective guidewire 5, in the optional technical scheme of the present embodiment, the supporting guidewire cavity 200 of the outer sheath 11 and the supporting guidewire cavity 200 of the fixed seat 211 respectively include at least a first supporting guidewire cavity 210 and a second supporting guidewire cavity 220, and the first supporting guidewire cavity 210 and the second supporting guidewire cavity 220 are arranged on both sides of the bending guidewire cavity along the radial direction of the outer sheath 11, and the first supporting guidewire cavity 210 of the outer sheath 11 is correspondingly connected to the first supporting guidewire cavity 210 of the fixed seat 211, and the second supporting guidewire cavity 220 of the outer sheath 11 is correspondingly connected to the second supporting guidewire cavity 220 of the fixed seat 211. When in use, the first support guide wire 31 can be used to pass through the first support guide wire cavity 210 of the outer sheath tube 11 and the first support guide wire cavity 210 of the fixing seat 211 in sequence, and the distal end is supported in the first anchorable area in the blood vessel cavity. After the second support guide wire 32 is used to pass through the second support guide wire cavity 220 of the outer sheath tube 11 and the second support guide wire cavity 220 of the fixing seat 211 in sequence, the distal end is supported in the second anchorable area in the blood vessel cavity. The specific support method includes but is not limited to pre-bending the distal end of the support guide wire 3 so that the support guide wire 3 automatically bends back and supports in the anchorable area after passing through, so as to reduce damage to the inner wall of the patient's blood vessel. Of course, this is only an example of the specific number of support guide wires 3 and their support guide wire cavities 200 provided in this application, and it is not intended to limit it. In other optional embodiments of the present application, the number of support guide wires 3 and their support guide wire cavities 200 can also be a corresponding group, or three or more groups, and the distal end of the support guide wire 3 may not be pre-bent. When in use, an external force is used to cause it to deform to achieve the anchoring function.

[0069] In addition, for patients who need to superselect multiple branched blood vessels at the same time and insert branched guidewires into branched stents or therapeutic devices, the operation of repeatedly withdrawing the sheath is not conducive to the rapid completion of the operation and is not conducive to the patient's postoperative recovery. In contrast, in the optional technical solution of the present embodiment, the superselected guidewire cavity 400 includes a first superselected guidewire cavity 410 and a second superselected guidewire cavity 420; the outer sheath tube side opening 110 corresponding to the first superselected guidewire cavity 410 and the outer sheath tube side opening 110 corresponding to the second superselected guidewire cavity 420 are arranged radially opposite to or staggered with each other along the outer sheath tube 11 to adapt to the branched blood vessel openings at different positions. That is, two or more superselected guidewire cavities 400 are set inside the outer sheath tube 11, so as to superselect branched superselected guidewires 5 into different branched blood vessels successively through different superselected guidewire cavities 400 and corresponding outer sheath tube side openings 110, so as to improve the operation efficiency as much as possible.

[0070] In order to facilitate the operation of the operator and further improve the positioning accuracy, in the optional technical solution of this embodiment, the distal end of the outer sheath 11 is provided with a developing mark 111 at the proximal side and / or distal side of each outer sheath side opening 110, and the developing mark 111 is used to mark the specific position of each outer sheath side opening 110 to ensure that the outer sheath side opening 110 is facing the selected branch blood vessel opening as much as possible. For the developing mark 111, it is optional but not limited to a mark in a ring, semicircle or circle shape, which can be but not limited to protruding on the surface of the outer sheath 11, and can be made of non-radiopaque metal materials such as platinum, iridium, tantalum, gold, stainless steel, etc., and fixed to the outer sheath 11 by forging or bonding. In addition to the developing mark 111 being provided on the outside of the outer sheath 11, the distal head of the bending wire 22 can also be partially or completely developed, and the developing method includes but is not limited to inlaying gold or inlaying developing metal.

[0071] As for the specific structure of the adjustable bend wire 22, in the optional technical solution of the present embodiment, its support head 221 is in a released state outside the adjustable bend tube 212 and presents a "Y"-shaped bifurcated structure with the proximal end closed and the distal end open. It can also be formed as a clamping structure with three or more branches, or other structures with bifurcated parts that can support the guiding catheter 4 or the branch super-selective guide wire 5.

[0072] To facilitate operation, in the optional technical scheme of the present embodiment, the proximal end of each traction wire 24 is fixedly connected to a traction wire handle 25, and / or the proximal end of the bending adjustment wire 22 is fixedly connected to a bending adjustment wire handle 23. When the bending adjustment wire handle 23 is provided, a printed or silk-screen indicator mark may be provided on the bending adjustment wire handle 23. In addition, a marking line is also provided on the outer surface of the outer sheath tube 11 to cooperate with each other to help the doctor determine the relative position and bending angle of the bending adjustment wire 22 and the outer sheath tube side opening 110.

[0073] In addition, in the present embodiment, the number of traction wires 24 is the same as the number of superselective guidewire cavities 400 and the outer sheath side openings 110. In the optional technical scheme of the present embodiment, each traction wire cavity 300 of the fixed seat 211 respectively includes its own main cavity 301, first branch cavity 302 and second branch cavity 303. The proximal end of the first branch cavity 302 and the proximal end of the second branch cavity 303 are both connected to the distal end of the main cavity 301. The proximal end of the main cavity 301 passes through the proximal surface of the fixed seat 211, and the distal end of the first branch cavity 302 and the distal end of the second branch cavity 303 respectively pass through the distal surface or the distal outer peripheral surface of the fixed seat 211. The distal end of each traction wire 24 is fixedly connected to one side of the distal end of the adjustable bend tube 212, and the other end passes through a branch cavity of the first branch cavity 302 and the second branch cavity 303 of the fixed seat 211 toward the direction of the fixed seat 211, which is close to the distal end of the traction wire 24, continues to pass through the main cavity 301, and then passes through the traction wire cavity 300 of the outer sheath tube 11 to pass through the proximal side of the outer sheath tube 11. For example, a first super-selected guide wire cavity 410, a second super-selected guide wire cavity 420, a first traction wire 241, and a second traction wire 242 are provided. The projection of the distal end of the first traction wire 241 and the outer sheath tube side opening 110 corresponding to the first super-selected guide wire cavity 410 on the plane where the same radial section of the outer sheath tube 11 is located along the axial direction of the outer sheath tube 11 is on the same side of the radial section. By pulling the first traction wire 241 in the proximal direction, the distal end of the adjustable curved tube 212 can be adjusted to bend toward the outer sheath tube side opening 110 corresponding to the first super-selected guide wire cavity 410; the projection of the distal end of the second traction wire 242 and the outer sheath tube side opening 110 corresponding to the second super-selected guide wire cavity 420 along the axial direction of the outer sheath tube 11 on the plane where the same radial section of the outer sheath tube 11 is located is on the same side of the radial section. By pulling the second traction wire 242 in the proximal direction, the distal end of the adjustable curved tube 212 can be adjusted to bend toward the outer sheath tube side opening 110 corresponding to the second super-selected guide wire cavity 420. Corresponding to the first traction wire 241 and the second traction wire 242 , a first traction wire cavity 310 and a second traction wire cavity 320 are respectively provided on the outer sheath 11 and the fixing seat 211 of the guide head 21 , and a first traction wire channel 1221 and a second traction wire channel 1222 are respectively provided on the outer sheath handle 12 .

[0074] In an optional technical solution of the present embodiment, the catheter sheath assembly 1 also includes an outer sheath handle 12 fixedly connected to the proximal end of the outer sheath 11, and the outer sheath handle 12 is provided with a central handle channel 121, a traction wire channel 122, support guide wire channels 123 which are the same in number as the support guide wire channels 123 of the outer sheath 11 and are connected one-to-one, and branch handle channels 124 which are the same in number as the superselective guide wire cavities 400 of the outer sheath 11 and are connected one-to-one; the central handle channel 121 is connected to the bending guide wire cavity; the traction wire 24 passes through the traction wire channel 122; the bending guide wire passes through the central handle channel 121.

[0075] Optionally, a sealing pad 125 and an end cover 126 are respectively provided inside the proximal ends of the central handle channel 121, the traction wire channel 122 and the branch handle channel 124. A through hole is provided in the middle of the end cover 126. A guide wire through hole that can be automatically closed is provided in the center of the sealing pad 125. The end cover 126 is located on the proximal side of the sealing pad 125. The sealing pad 125 and the end cover 126 can be viewed as a hemostatic valve structure. In addition to providing a developing mark 111 on the outer sheath 11, a mark can also be provided on the hemostatic valve structure at the proximal end of the central handle channel 121 to help doctors evaluate the angle of the side hole in the circumferential direction from in vitro.

[0076] And / or, the catheter sheath assembly 1 also includes a stress protection tube 13 fixedly connected to the inside of the outer sheath handle 12 and extending toward the distal end of the outer sheath 11. The proximal end of the outer sheath 11 is passed through and fixedly connected to the inner wall of the stress protection tube 13. By providing the stress protection tube 13, the proximal end of the outer sheath 11 can be protected to avoid stress fracture at the connection between the proximal end of the outer sheath 11 and the outer sheath handle 12 during use, thereby improving the service life of the sheath assembly.

[0077] In addition, other optional structures of this embodiment are described as follows:

[0078] The specific structure of the outer sheath tube 11 can be a single-layer tube or a double-layer or multi-layer composite tube. For example, the outer sheath tube 11 is a multi-layer composite tube structure. The composite tube structure can be made of inner and outer polymer conduits of different materials and a middle metal mesh reinforced composite tube. For example but not limited to, the inner layer is a PTFE tube, the middle is a woven mesh layer woven from stainless steel flat wire, and the outer layer is a nylon extruded tube. The three-layer structure is formed by high-temperature melt bonding.

[0079] The bending wire 22 may be made of, but not limited to, nickel-titanium alloy, and its distal end may be bent and heat-formed, but not limited to.

[0080] The guide head 21 and the stress protection tube 13 may be formed by extrusion molding of polymer materials but are not limited to it.

[0081] Embodiment 2

[0082] This embodiment provides an interventional surgery sheath kit, which includes a guide guidewire, a support guidewire 3, a guiding catheter 4, a branch super-selective guidewire 5 and a sheath assembly provided by any optional implementation in Embodiment 1. The specific usage thereof can be obtained by referring to Embodiment 1.

[0083] Finally, it should be noted that the above embodiments and their optional implementation modes in this specification are only used to illustrate the technical solutions of the present invention, rather than to limit them. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned optional implementation modes, or replace some or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. In addition, it is emphasized again that the features of the embodiments in this specification and the optional implementation modes in the embodiments can be combined with each other without conflict.

Claims

1. A sheath tube assembly, characterized in that: It comprises a catheter sheath component (1) and a bending adjustment component (2); The catheter sheath assembly (1) comprises an outer sheath tube (11), wherein the outer sheath tube (11) is provided with a central guidewire cavity (100) extending along the axial direction, at least one supporting guidewire cavity (200), at least one traction wire cavity (300) and at least one super-selective guidewire cavity (400), wherein the distal end openings of each of the super-selective guidewire cavities (400) respectively penetrate the distal outer peripheral surface of the outer sheath tube (11) to form an outer sheath tube side opening (110); The bending adjustment component (2) comprises: The guide head (21) comprises a fixing seat (211) and an adjustable curved tube (212) fixed or integrally connected to the distal end of the fixing seat (211); the fixing seat (211) is fixed or integrally connected to the distal end of the outer sheath tube (11); the fixing seat (211) is provided with an axially penetrating central guidewire cavity (100), at least one supporting guidewire cavity (200) and at least one traction wire cavity (300); the central guidewire cavity (100) of the outer sheath tube (11), the central guidewire cavity (100) of the fixing seat (211) and the central tube cavity of the adjustable curved tube (212) are connected in sequence to form an adjustable curved guidewire cavity; the supporting guidewire cavity (200) of the outer sheath tube (11) is connected to the supporting guidewire cavity (200) of the fixing seat (211); the traction wire cavity (300) of the outer sheath tube (11) is connected to the traction wire cavity (300) of the fixing seat (211); a bending adjustment wire (22), the bending adjustment wire (22) passing through the bending adjustment guide wire cavity, the distal end of the bending adjustment wire (22) being connected to a support head (221), the support head (221) being capable of being retracted into the interior of the adjustable bending tube (212) in a proximal direction, or being released to the exterior of the adjustable bending tube (212) in a distal direction, and in a released state, the support head (221) is expanded radially along the adjustable bending tube (212) to be in a forked shape with the distal end opened; and the same number of traction wires (24) as the super-selective guide wire cavity (400), each of the traction wires (24) respectively passing through the traction wire cavity (300) of the fixing seat (211) and the traction wire cavity (300) of the outer sheath tube (11), the proximal end of each of the traction wires (24) being located outside the proximal end of the outer sheath tube (11), the distal end of each of the traction wires (24) being respectively fixedly connected to the distal end of the adjustable curved tube (212), and the distal end of each of the traction wires (24) being located on the same side of the radial cross section along the axial direction of the outer sheath tube in correspondence with the projection of each of the outer sheath tube side openings (110) on the plane where the same radial cross section of the outer sheath tube is located.

2. The sheath tube assembly according to claim 1, characterized in that: The supporting guidewire cavity (200) of the outer sheath tube (11) and the supporting guidewire cavity (200) of the fixing seat (211) respectively comprise at least a first supporting guidewire cavity (210) and a second supporting guidewire cavity (220); the first supporting guidewire cavity (210) and the second supporting guidewire cavity (220) are arranged on both sides of the bending guidewire cavity along the radial direction of the outer sheath tube (11); the first supporting guidewire cavity (210) of the outer sheath tube (11) is correspondingly communicated with the first supporting guidewire cavity (210) of the fixing seat (211); and the second supporting guidewire cavity (220) of the outer sheath tube (11) is correspondingly communicated with the second supporting guidewire cavity (220) of the fixing seat (211).

3. The sheath tube assembly according to claim 1, characterized in that: The super-selective guidewire cavity (400) comprises a first super-selective guidewire cavity (410) and a second super-selective guidewire cavity (420); an outer sheath tube side opening (110) corresponding to the first super-selective guidewire cavity (410) and an outer sheath tube side opening (110) corresponding to the second super-selective guidewire cavity (420) are arranged opposite to or staggered with each other along the radial direction of the outer sheath tube (11).

4. The sheath tube assembly according to claim 1, characterized in that: A developing mark (111) is provided at a location of the distal end of the outer sheath tube (11) located on the proximal side and / or the distal side of each outer sheath tube side opening (110).

5. The sheath tube assembly according to claim 1, characterized in that: When the support head (221) is in a released state outside the adjustable curved pipe (212), the support head (221) is in a "Y" shape with a closed proximal end and an open distal end.

6. The sheath tube assembly according to claim 1, characterized in that: The proximal end of each traction wire (24) is fixedly connected to a traction wire handle (25), and / or the proximal end of the bending adjustment wire (22) is fixedly connected to a bending adjustment wire handle (23).

7. The sheath tube assembly according to claim 1, characterized in that: Each traction wire cavity (300) of the fixing seat (211) comprises a main cavity (301), a first branch cavity (302) and a second branch cavity (303), respectively; the proximal end of the first branch cavity (302) and the proximal end of the second branch cavity (303) are both connected to the distal end of the main cavity (301); the proximal end of the main cavity (301) passes through the proximal surface of the fixing seat (211), and the distal end of the first branch cavity (302) and the distal end of the second branch cavity (303) respectively pass through the distal surface or the distal peripheral surface of the fixing seat (211).

8. The sheath tube assembly according to claim 1, characterized in that: The catheter sheath assembly (1) further comprises an outer sheath handle (12) fixedly connected to the proximal end of the outer sheath (11), wherein the outer sheath handle (12) is provided with a central handle channel (121), a traction wire channel (122), the same number of support guide wire channels (123) as the support guide wire channels (123) of the outer sheath (11) and connected one-to-one, and branch handle channels (124) the same number as the superselective guide wire cavities (400) of the outer sheath (11) and connected one-to-one; The central handle channel (121) is in communication with the bending guide wire cavity; the traction wire (24) passes through the traction wire channel (122); and the bending guide wire passes through the central handle channel (121).

9. The sheath tube assembly according to claim 8, characterized in that: The proximal ends of the central handle channel (121), the traction wire channel (122) and the branch handle channel (124) are respectively provided with a sealing rubber pad (125) and an end cover (126); a through hole penetrating the end cover (126) is provided in the middle of the end cover (126); a guide wire through hole that can be automatically closed is provided in the center of the sealing rubber pad (125); and the end cover (126) is located on the proximal side of the sealing rubber pad (125); And / or, the catheter sheath assembly (1) further comprises a stress protection tube (13) fixedly connected to the inside of the outer sheath tube handle (12) and extending toward the distal end of the outer sheath tube (11), and the proximal end of the outer sheath tube (11) is penetrated by and fixedly connected to the inner wall of the stress protection tube (13).

10. An interventional surgery sheath kit, characterized in that: It comprises a guide guidewire, a support guidewire (3), a guiding catheter (4), a branch super-selective guidewire (5) and a sheath assembly according to any one of claims 1 to 9.

Images