A medical device delivery sheath and delivery system for use in the human body

Abstract

The application relates to a medical instrument delivery sheath and a delivery system for use in a human body, the delivery sheath comprising an inner membrane, an outer membrane, a braided mesh and a traction mechanism, the traction mechanism comprising an anchor ring and a traction wire; the anchor ring comprises a first part and a second part, the wall thickness of the first part is greater than that of the second part, and the distance from the inner wall of the first part to the center of the anchor ring is less than that from the inner wall of the second part to the center of the anchor ring; the traction mechanism further comprises a positioning block arranged on the inner wall of the second part; the anchor ring is sleeved on the distal end of the braided mesh, the positioning block is inserted into the mesh hole of the braided mesh; and at the first part of the anchor ring, the braided mesh is formed with a avoiding part for exposing the inner wall of the first part. The application increases the bonding strength of the inner membrane, the outer membrane, the anchor ring and the braided mesh of the delivery sheath, can avoid the delamination of the inner and outer membranes, the blood leakage and the problem of the inner membrane being scratched and falling off, and can avoid the problem of the outer membrane being wrinkled.

Description

[0001] The present application is a divisional application of a patent application with the application date of September 8, 2022, the application number of 202211094720X, and the invention name of a medical instrument delivery sheath tube and delivery system for use in human body. TECHNICAL FIELD

[0002] The present application belongs to the technical field of medical instruments, and particularly relates to a medical instrument delivery sheath tube and delivery system for use in human body. BACKGROUND

[0003] Minimally invasive interventional surgery is increasingly favored by doctors and patients due to its smaller trauma. In minimally invasive surgery, a delivery sheath tube is used to establish a delivery channel from outside to inside (mainly to the lesion site), and an implantable instrument (such as a closure device, a valve, a stent, a balloon, a vascular plug, a filter, etc.) can be delivered to the lesion site or retrieved through the delivery channel. Through the delivery channel, drugs can also be input into the patient's body or body fluids in the patient's body can be guided out.

[0004] The adjustable bending delivery sheath tube is a sheath tube assembly applied in the process of interventional minimally invasive treatment surgery. The sheath tube can be bent within a certain angle range through the operation of the proximal handle. After the distal end of the sheath tube is bent, it can more quickly and reliably reach the target position of the lesion, reducing the operation time and the difficulty of the doctor's operation.

[0005] The existing adjustable bending delivery sheath tube is shown in the application publication No. CN114681127A. The delivery sheath tube includes a main body segment and a bending adjustment segment connected to the distal end of the main body segment. The bending adjustment segment is a multi-layer composite pipe body, which includes an inner film, an intermediate layer and an outer film successively sleeved and fused together from inside to outside. The inner film is preferably made of polytetrafluoroethylene to ensure that its inner wall is smooth, which is conducive to the passage of a guide wire or an implantable instrument. The intermediate layer is a woven mesh made of metal material, and the outer film is made of thermoplastic plastic. The delivery sheath tube further includes a traction mechanism, which includes an anchoring ring and a traction wire. The anchoring ring is sleeved on the distal end of the woven mesh, and the distal end of the traction wire is connected to the anchoring ring. The traction wire extends through the bending adjustment segment and the main body segment, and is connected to the bending adjustment mechanism on the handle, so that the operator can pull the bending adjustment mechanism at the proximal end to bend the bending adjustment segment connected to the anchoring ring in the traction direction.

[0006] However, since the inner membrane adopts extremely lubricated polytetrafluoroethylene, the inner membrane and the outer membrane are difficult to be firmly combined even after the melting treatment. Thus, when the bending section is stressed, the braided mesh can be caused to leak wires due to the extrusion of the material, and the surface of the delivery sheath can be caused to wrinkle. On one hand, the wire leakage and the wrinkle can intensify the delamination of the inner membrane and the outer membrane, bring the risk of blood leakage and the inner membrane being scratched and falling off, and the debris entering the patient's body; on the other hand, when the delivery sheath is used as an outer sheath in contact with a blood vessel, the wire leakage and the wrinkle can easily cause the blood vessel to be damaged when the delivery sheath is withdrawn; when the delivery sheath is used as an inner sheath in contact with an outer sheath, the wire leakage and the wrinkle can cause the resistance between the delivery sheath and the outer membrane sheath to be large or the delivery sheath to be stuck, thereby affecting the withdrawal of the delivery sheath, and if the delivery sheath is forcibly withdrawn, the blood vessel can also be easily damaged. SUMMARY

[0007] One of the technical problems to be solved by the present application is to provide a medical device delivery sheath, in which a braided mesh is firmly fixed with an anchor ring, and wire leakage and wrinkle are less likely to occur when the medical device delivery sheath is stressed and bent.

[0008] Another technical problem to be solved by the present application is to provide a delivery system using the above medical device delivery sheath.

[0009] To achieve the above-mentioned purpose, the technical solution adopted by the present application is as follows:

[0010] In one aspect, the present application provides a medical device delivery sheath for use in a human body, comprising an inner membrane, an outer membrane, and a braided mesh located between the inner membrane and the outer membrane; the medical device delivery sheath further comprises a traction mechanism capable of bending a distal end of the medical device delivery sheath, the traction mechanism comprising an anchor ring located between the inner membrane and the outer membrane, and a traction wire fixedly connected with the anchor ring.

[0011] The anchor ring comprises a first portion and a second portion, the wall thickness of the first portion is greater than the wall thickness of the second portion, and the distance from the inner wall of the first portion to the center of the anchor ring is less than the distance from the inner wall of the second portion to the center of the anchor ring.

[0012] The traction mechanism further comprises a positioning block provided on the inner wall of the second portion and protruding toward the center of the anchor ring; the anchor ring is sleeved on the distal end of the braided mesh, the positioning block is inserted into the mesh hole of the braided mesh; and at the first portion of the anchor ring, the braided mesh is formed with an avoiding portion for exposing the inner wall of the first portion.

[0013] According to the technical scheme, the delivery sheath is not prone to delamination, blood leakage caused by delamination can be avoided, the delivery sheath is not prone to wire leakage, the risk of the debris formed by the inner membrane or the outer membrane being cut off from the delivery sheath entering the patient's body is reduced, and the delivery sheath is not prone to wrinkling, so that the withdrawal of the delivery sheath is not blocked or the blood vessel is not damaged during the withdrawal.

[0014] According to some specific and preferred embodiments, the positioning blocks are spaced along the circumferential direction of the second part, and one positioning block is inserted into one mesh, so that the relative fixation of the woven mesh and the anchor ring can be better achieved.

[0015] Further, the number of meshes of the woven mesh on the circumference of the positioning blocks is equal to the number of the positioning blocks.

[0016] Further, the side wall of the positioning block is in contact with the woven wire of the woven mesh.

[0017] According to some specific and preferred embodiments, the two side walls of the positioning block in the circumferential direction of the anchor ring are inclined inwardly from the bottom to the top of the positioning block or are concave inwardly to the inside of the positioning block.

[0018] According to some specific and preferred embodiments, the inner wall of the positioning block and the inner wall of the first part are located on the same cylindrical surface, and the thickness of the woven mesh is less than or equal to the thickness of the positioning block, so that the woven mesh can be prevented from protruding from the anchor ring, and the risk of the woven mesh cutting the inner membrane can be reduced.

[0019] According to some specific and preferred embodiments, the outer wall of the first part and the outer wall of the second part are located on the same cylindrical surface.

[0020] According to some specific and preferred embodiments, the wall thickness of the first part is 0.5-0.8 mm, and the wall thickness of the second part is 0.2-0.3 mm, so that the connection strength of the anchor ring and the traction wire can be ensured, the outer diameter of the delivery sheath can be reduced as much as possible, and the inner diameter of the delivery sheath can be increased.

[0021] According to some specific and preferred embodiments, one or more through grooves are formed on the second part and extend from the inside to the outside, and the one or more through grooves are located at the distal end and / or the proximal end of the positioning block, so that the strength of the heat fusion of the inner membrane and the outer membrane can be further improved.

[0022] According to some specific and preferred embodiments, the through groove is arc-shaped and extends along the circumferential direction of the second part.

[0023] According to some specific and preferred embodiments, two through holes are formed in the first portion along the axial direction, the traction wire passes through the two through holes in sequence, and both free ends of the traction wire extend to the proximal end of the medical device delivery sheath, so as to improve the connection strength between the traction wire and the anchoring ring, avoid the traction wire scratching the intima or the adventitia, and prevent the occurrence of the delivery sheath wire leakage.

[0024] Further, the connecting surface between the two through holes at the distal end is in the shape of a circular arc, and the diameter is 2-6 times the diameter of the traction wire, so as to effectively avoid the strength reduction of the traction wire due to bending, while ensuring that the anchoring ring is approximately single-point stressed when the traction wire pulls the anchoring ring, so as to improve the bending performance of the delivery sheath, effectively reduce the bending radius and bending angle of the delivery sheath, and improve the efficiency of the delivery system to reach the target position.

[0025] Further, the distal end of the first portion is provided with a groove recessed towards the proximal end, and the through hole is located on the groove bottom surface; the distal end surface of the anchoring ring is flush with the distal end of the traction wire, or the distal end of the traction wire is located between the distal end surface and the proximal end surface of the anchoring ring and close to the distal end surface of the anchoring ring.

[0026] According to some specific and preferred embodiments, the first portion, the second portion, and the positioning block are integrally formed by cutting processing.

[0027] According to some specific and preferred embodiments, the first portion is 2-4 and uniformly distributed along the circumferential direction of the anchoring ring, and the first portion and the second portion are spaced apart.

[0028] According to some specific and preferred embodiments, the intima and the adventitia are fixedly connected by heat melting.

[0029] According to some specific and preferred embodiments, the material of the intima is polytetrafluoroethylene, the material of the adventitia is one or more of nylon, block polyether amide, polycarbonate, polyamide, and polyurethane, the braided mesh is braided by stainless steel wires, and the material of the anchoring ring is one or more of stainless steel, tungsten, platinum-iridium, and tantalum.

[0030] According to some specific and preferred embodiments, the medical device delivery sheath comprises a main body segment, a transition segment, a bendable segment, and a tip segment connected in sequence from the proximal end to the distal end, wherein the hardness of the main body segment is greater than the hardness of the transition segment, which is greater than the hardness of the bendable segment; the anchoring ring is arranged on the tip segment and located at the junction of the tip segment and the bendable segment.

[0031] The second aspect of the present application provides a delivery system, which comprises the medical instrument delivery sheath, a bending handle mounted at the proximal end of the medical instrument delivery sheath, and a bending mechanism arranged on the bending handle, and the proximal end of the traction wire is fixedly connected with the bending mechanism.

[0032] Thanks to the above technical solution, the present application has the following advantages compared with the prior art:

[0033] The present application improves the bending performance of the delivery sheath, reduces the bending radius and bending angle, and improves the efficiency of the delivery sheath reaching the target position by improving the structure of the anchoring ring and the cooperation mode of the anchoring ring and the woven mesh, and increasing the bonding strength of the inner membrane, the outer membrane, the anchoring ring and the woven mesh of the delivery sheath. Moreover, the structure of the present application can avoid the delamination of the inner and outer membranes, blood leakage, and the problem of the inner membrane being torn off and the debris entering the patient's body, and can also avoid the problem of the outer membrane being wrinkled, affecting the withdrawal of the delivery sheath and causing damage to the blood vessel wall. BRIEF DESCRIPTION OF DRAWINGS

[0034] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0035] Figure 1 The structure schematic diagram of the delivery system of the present application in the embodiment when not bending (the bending handle is a cross-sectional view);

[0036] Figure 2 The structure schematic diagram of the delivery system of the present application after bending;

[0037] Figure 3 The cross-sectional view of the medical instrument delivery sheath of the present application in the embodiment;

[0038] Figure 4 The cooperation structure schematic diagram of the anchoring ring and the woven mesh of one embodiment of the present application;

[0039] Figure 5 The perspective view of the anchoring ring of one embodiment of the present application;

[0040] Figure 6 The front view of the anchoring ring of one embodiment of the present application;

[0041] Figure 7 The top view of the anchoring ring of one embodiment of the present application;

[0042] Figure 8A side view of an anchor ring of one embodiment of the present application;

[0043] Figure 9 A perspective view of an anchor ring of another embodiment of the present application;

[0044] Figure 10 A front view of an anchor ring of another embodiment of the present application;

[0045] Figure 11 A top view of an anchor ring of another embodiment of the present application;

[0046] Figure 12 A side view of an anchor ring of another embodiment of the present application;

[0047] Figure 13 A perspective view of an anchor ring of another embodiment of the present application;

[0048] Figure 14 A top view of an anchor ring of another embodiment of the present application;

[0049] Figure 15 A schematic view of the cooperation structure of an anchor ring and a partial braided mesh of another embodiment of the present application;

[0050] Figure 16 A schematic view of the cooperation structure of an anchor ring and a traction wire;

[0051] Wherein, 1, a delivery sheath; 2, a bending handle; 11, an inner membrane; 12, a braided mesh; 13, an anchor ring; 14, an outer membrane; 15, a traction wire; 131, a first part; 132, a second part; 133, a positioning block; 134, a groove; 135, a through hole; 136, a connecting surface; 137, a through slot; 1331, a side wall. DETAILED DESCRIPTION

[0052] Hereinafter, only certain exemplary embodiments are simply described. As those skilled in the art can recognize, the described embodiments can be modified in various different ways without departing from the spirit or scope of the embodiments of the present application. Therefore, the drawings and the description are considered to be exemplary in nature rather than limiting.

[0053] In the description of the present application, it should be understood that the distal end refers to the end of the instrument or component far from the operator, the proximal end refers to the end of the instrument or component close to the operator; the axial direction refers to the direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction around the axial direction; the inner and outer positions are defined relative to the center of the instrument or component, wherein the inner position is close to the center of the instrument or component, and the outer position is far from the center of the instrument or component. The above orientation words are only for the convenience of describing the embodiments of the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the embodiments of the present application.

[0054] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second" can explicitly or implicitly include one or more of the features. In the description of the embodiments of the present application, the meaning of "multiple" is two or more, unless otherwise explicitly specified and limited.

[0055] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting", "fixing" and the like should be understood in a broad sense, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0056] The following disclosure provides many different embodiments or examples for implementing different structures of the embodiments of the present application. In order to simplify the disclosure of the embodiments of the present application, the components and settings of specific examples are described below. Of course, they are only examples, and the purpose is not to limit the embodiments of the present application. In addition, the embodiments of the present application can repeatedly refer to numbers and / or letters in different examples. Such repetition is for the purpose of simplification and clarity, and does not itself indicate the relationship between the various embodiments and / or settings discussed.

[0057] The embodiments of the present application will be described in detail below with reference to the accompanying drawings.

[0058] The inner membrane 11, the braided mesh 12, the anchor ring 13 and the outer membrane 14 in the delivery sheath tube 1 for the medical instrument delivery system in the human body are inconsistent in material, so that the existing delivery sheath tube 1 cannot completely fuse the inner membrane 11 and the outer membrane 14, and thus the anchor ring 13 and the braided mesh 12 cannot be firmly fixed with the outer membrane 14 and the inner membrane 11 as a whole, so that when the delivery sheath tube 1 is bent under force, the anchor ring 13 and the braided mesh 12 are prone to relative displacement, and then the inner membrane 11 and the outer membrane 14 are prone to delamination, the sheath tube is prone to damage, leakage and wrinkling, and then blood leakage, sheath tube withdrawal and blood vessel wall damage problems are caused. In order to solve the above problems, the embodiment provides a medical instrument delivery system for use in the human body.

[0059] As Figure 1 and Figure 2 described, the delivery system includes a medical instrument delivery sheath tube 1, a bending handle 2 mounted at the proximal end of the medical instrument delivery sheath tube 1, a bending mechanism provided on the bending handle 2, and a proximal end of a pulling wire 15 of the medical instrument delivery sheath tube 1 fixedly connected with the bending mechanism. The specific structure of the bending handle 2 and the bending mechanism is not the improvement point of the present application, and the existing structure in the prior art can be adopted, so the structure of the two is not described in detail here. The connection mode of the pulling wire 15 and the bending mechanism can adopt conventional winding and other fixing modes, and will not be described in detail here.

[0060] As Figures 1 to 3 shown, the medical instrument delivery sheath tube 1 includes a main body section, a transition section, a bendable section and a tip section connected in sequence from the proximal end to the distal end, wherein the hardness of the main body section is greater than the hardness of the transition section, the hardness of the transition section is greater than the hardness of the bendable section, and the hardness of the tip section is adjusted according to different use conditions. The lengths of the main body section, the transition section, the bendable section and the tip section are set according to different requirements, for example, the length of the main body section is 1020mm, the length of the transition section is 40mm, the length of the bendable section is 30mm, and the length of the tip section is 7mm. The hardness difference of each section of the delivery sheath tube 1 can be adjusted in the existing manner in the prior art, for example, different hardness materials are used for each section, or the density of the braided mesh 12 is changed.

[0061] As Figure 3As shown, the medical instrument delivery sheath tube 1 comprises an inner membrane 11, an outer membrane 14, and a braided mesh 12 between the inner membrane 11 and the outer membrane 14, according to the division from inside to outside. The medical instrument delivery sheath tube 1 further comprises a traction mechanism capable of driving the distal end of the medical instrument delivery sheath tube 1 (i.e. the above-mentioned bendable section) to bend. The traction mechanism comprises an anchor ring 13 and a traction wire 15 fixedly connected with the anchor ring 13. Specifically, the anchor ring 13 is fixedly arranged between the inner membrane 11 and the outer membrane 14 of the tip section and located at the junction of the tip section and the bendable section. The distal end of the traction wire 15 is fixedly connected with the anchor ring 13, and the proximal end is fixedly connected with the bending mechanism of the bending handle 2, so that the traction wire 15 can be driven to move by operating the bending mechanism on the bending handle 2, thereby pulling the anchor ring 13 to change the angle of the bendable section of the delivery sheath tube 1.

[0062] The three different structures of the anchor ring 13 of the present application will be described in detail below. Figures 4 to 15

[0063] The anchor ring 13 in the present application comprises a first part 131 and a second part 132, the wall thickness of the first part 131 is the same in the circumferential direction and the axial direction, and the wall thickness of the second part 132 is the same in the circumferential direction and the axial direction. The wall thickness of the first part 131 is greater than that of the second part 132, and the distance from the inner wall of the first part 131 to the center of the anchor ring 13 is less than the distance from the inner wall of the second part 132 to the center of the anchor ring 13; so that the inside of the anchor ring 13 forms opposite convex parts and opposite concave parts. The inner wall of the second part 132 of the anchor ring 13 is formed with a positioning block 133 protruding towards the center of the anchor ring 13. As shown, the anchor ring 13 is sleeved on the distal end of the braided mesh 12, and the positioning block 133 is inserted into the mesh hole of the braided mesh 12; and at the first part 131 of the anchor ring 13, the braided mesh 12 is formed with a avoiding part which exposes the inner wall of the first part 131. That is, when the anchor ring 13 is sleeved on the braided mesh 12, the braided mesh 12 is pulled away to form an avoiding part for the first part 131, so that the braided mesh 12 is only embedded in the second part 132 of the anchor ring 13 and fixed by the positioning block 133, thereby reducing the relative movement of the braided mesh 12 and the anchor ring 13 when the anchor ring 13 is stressed. Figure 4

[0064] ​​The anchor ring 13 and the woven mesh 12 are matched according to the above structure, on the one hand, when the inner membrane 11 and the outer membrane 14 are hot fused, the outer membrane 14 can melt and enter the second part 132 of the anchor ring 13 and cover the inner surface of the woven mesh 12, so that the woven mesh 12 and the inner membrane 11 form a thin layer, which can make the woven mesh 12 and the inner membrane 11 more firmly combined; on the other hand, the structure of the anchor ring 13 and the positioning block 133 fixes the relative position of the woven mesh 12 and the anchor ring 13, reduces the amplitude of relative movement, and can reduce the inner diameter of the delivery sheath 1. Therefore, the delivery sheath 1 of the present application is not prone to delamination, which can effectively avoid blood leakage caused by delamination, the delivery sheath 1 of the present application is also not prone to wire leakage, thereby avoiding the risk of the inner membrane 11 or the outer membrane 14 being scratched and falling off to form debris into the patient's body, and the delivery sheath 1 of the present application is also not prone to wrinkling, thereby avoiding the delivery sheath 1 being blocked or causing blood vessel damage when retracting; and the structure of the anchor ring 13 of the present application makes the overall weight of the anchor ring 13 smaller, thereby reducing the operation resistance of the delivery sheath 1.

[0065] As shown in Figure 4 and Figure 16 , the traction wire 15 in the present application is fixedly connected with the anchor ring 13 through the first part 131. Specifically, as shown in Figures 4 to 15 , the distal end of the first part 131 of the anchor ring 13 is provided with a groove 134 recessed toward the proximal end, and two through holes 135 are provided on the first part 131 at the position of the groove bottom surface of the groove 134 and penetrate along the axial direction. As shown in Figure 16 , one traction wire 15 passes through the two through holes 135 in turn and is folded, the traction wire 15 extends along the axial direction of the delivery sheath 1 after being folded, and both free ends extend to the proximal end of the medical device delivery sheath 1 and are fixedly connected with the bending mechanism of the bending handle 2. The distal end of the anchor ring 13 is flush with the distal end of the traction wire 15, or the distal end of the traction wire 15 is located between the distal end and the proximal end of the anchor ring 13 and close to the distal end of the anchor ring 13, thereby avoiding the traction wire 15 protruding from the anchor ring 13, and as far as possible to improve the firmness of the connection between the anchor ring 13 and the traction wire 15, so that the delivery sheath 1 can be used more safely during the operation.

[0066] Further, the connecting surface 136 between the two through holes 135 at the distal end is in the form of a circular arc protruding toward the distal end, and the diameter of the circular arc is 2-6 times the diameter of the traction wire 15, thereby effectively avoiding the reduction of the strength of the traction wire 15 due to bending, while as far as possible to ensure that the anchor ring 13 is approximately single-point stressed when the traction wire 15 pulls the anchor ring 13, thereby improving the bending performance of the delivery sheath 1, and can effectively reduce the bending radius and bending angle of the delivery sheath 1, and improve the efficiency of the delivery system to reach the target position.

[0067] The number of the first part 131 and the second part 132 in the present application is adjusted according to actual needs. For example, when the delivery sheath 1 only needs to realize one-way bending, the number of the first part 131 and the second part 132 is one; when the delivery sheath 1 needs to realize two-way bending, the number of the first part 131 and the second part 132 is two; for example, the number of the first part 131 and the second part 132 can be three or four, so that the delivery sheath 1 can be bent in more directions. When the number of the first part 131 and the second part 132 is two or more, the first part 131 is evenly distributed along the circumferential direction of the anchor ring 13, and the first part 131 and the second part 132 are spaced apart.

[0068] As shown in Figures 4 to 15 , the number of the first part 131 and the second part 132 is two, and the two first parts 131 and the two second parts 132 are symmetrically arranged. Preferably, the area of the first part 131 on the anchor ring 13 is as small as possible, so that the connection strength of the anchor ring 13 and the pull wire 15 is ensured, and more outer membrane 14 can be melted into the second part 132 of the anchor ring 13 to realize better fusion with the inner membrane 11.

[0069] As shown in Figures 4 to 15 , the positioning block 133 is a plurality of, the plurality of positioning blocks 133 are spaced apart along the circumferential direction of the second part 132, and one positioning block 133 is inserted into one mesh of the woven mesh 12. Preferably, the number of mesh holes of the woven mesh 12 on one circle of the circumferential direction of the plurality of positioning blocks 133 is equal to the number of the positioning blocks 133, so that one positioning block 133 is inserted into each mesh hole on one circle of the woven mesh 12, so that the relative position of the woven mesh 12 and the anchor ring 13 can be better fixed. When the second part 132 is symmetrically arranged as two, the woven mesh 12 is evenly divided into two halves to be fixed in the two second parts 132, and the total number of the positioning blocks 133 in the two second parts 132 is equal to the number of the mesh holes on one circle of the woven mesh 12.

[0070] Preferably, the side wall 1331 of the positioning block 133 is in contact with the woven wire of the woven mesh 12, that is, the size of the positioning block 133 is set so that the positioning block 133 is just clamped in the mesh hole of the woven mesh 12, so that the woven mesh 12 can be better fixed.

[0071] As shown in Figures 4 to 12 , the two side walls 1331 of the positioning block 133 in the circumferential direction of the anchor ring 13 are inclined surfaces inclined inward from the bottom to the top of the positioning block 133. As shown in Figures 13 to 15As shown, the two side walls 1331 of the positioning block 133 in the circumferential direction of the anchoring ring 13 are arc surfaces recessed towards the inside of the positioning block 133.

[0072] The number and size of the positioning block 133 in the present application are adjusted according to different models of the delivery sheath 1 and different weaving densities of the woven mesh 12.

[0073] As Figures 9 to 12 For the anchoring ring 13 which is a specific and preferred embodiment of the present application, one or more through grooves 137 are provided on the second part 132 of the anchoring ring 13 and extend through the inside and outside of the second part 132. The through grooves 137 are located at the distal end and / or the proximal end of the positioning block 133. The through grooves 137 are arc-shaped and extend along the circumferential direction of the second part 132. The provision of the through grooves 137 makes it easier and more for the outer membrane 14 to enter the anchoring ring 13 when the inner membrane 11 and the outer membrane 14 are heat-fused, so that the delivery sheath 1 can be better heat-fused into a whole, and the provision of the through grooves 137 can further reduce the weight of the anchoring ring 13.

[0074] As Figures 4 to 16 As shown, the inner wall of the positioning block 133 and the inner wall of the first part 131 are located on the same cylindrical surface, the thickness of the woven mesh 12 is less than or equal to the thickness of the positioning block 133, and the outer wall of the first part 131 and the outer wall of the second part 132 are located on the same cylindrical surface; so as to as far as possible ensure the smoothness of the inner and outer walls of the anchoring ring 13 and avoid damage to the inner membrane 11 and the outer membrane 14.

[0075] In the present application, the material of the inner membrane 11 is polytetrafluoroethylene, the material of the outer membrane 14 is one or more of nylon, block polyether amide, polycarbonate, polyamide, and polyurethane, the woven mesh 12 is woven from stainless steel wire, and the material of the anchoring ring 13 is one or more of stainless steel, tungsten, platinum-iridium, and tantalum. The first part 131, the second part 132, and the positioning block 133 are integrally formed by cutting processing on a ring body. The inner membrane 11 and the outer membrane 14 are heat-fused to fix and connect the inner membrane 11, the woven mesh 12, the anchoring ring 13, and the outer membrane 14 into a whole.

[0076] In the present application, the wall thickness of the first part 131 is 0.5-0.8 mm, and the wall thickness of the second part 132 is 0.2-0.3 mm. The inner diameter and the outer diameter of the medical device delivery sheath 1 are designed according to different requirements, and the inner and outer diameters can adopt the conventional inner and outer diameters in the art.

[0077] The application improves the combination strength of the inner membrane 11, the outer membrane 14, the anchoring ring 13 and the braided mesh 12 of the delivery sheath 1, improves the bending performance of the delivery sheath 1, reduces the bending radius and the bending angle, and improves the efficiency of the delivery sheath 1 to reach the target position. Moreover, the structure of the application can avoid the delamination of the inner and outer membranes 14, the blood leakage, the tearing and falling of the inner membrane 11, the debris entering the patient's body, the wrinkling of the outer membrane 14, the influence on the withdrawal of the delivery sheath 1, and the damage to the blood vessel wall.

[0078] The above examples are only for illustrating the technical concept and characteristics of the application, and the purpose is to enable those skilled in the art to understand the content of the application and to implement it, and cannot limit the protection scope of the application. Any equivalent changes made in accordance with the spirit and essence of the application.

Claims

1. A medical instrument delivery sheath for use in a human body, comprising an inner membrane (11), an outer membrane (14), and a braided mesh (12) between the inner membrane (11) and the outer membrane (14); the medical instrument delivery sheath (1) further comprises a traction mechanism capable of bending a distal end of the medical instrument delivery sheath (1), the traction mechanism comprising an anchor ring (13) between the inner membrane (11) and the outer membrane (14), and a traction wire (15) fixedly connected with the anchor ring (13); characterized in that: the anchor ring (13) comprises a first portion (131) and a second portion (132), a wall thickness of the first portion (131) is greater than a wall thickness of the second portion (132), and a distance from an inner wall of the first portion (131) to a center of the anchor ring (13) is less than a distance from an inner wall of the second portion (132) to the center of the anchor ring (13); the traction mechanism further comprises a positioning block (133) provided on the inner wall of the second portion (132) and protruding toward the center of the anchor ring (13); the anchor ring (13) is sleeved on a distal end of the braided mesh (12), the positioning block (133) is inserted into a mesh hole of the braided mesh (12), and at the first portion (131) of the anchor ring (13), the braided mesh (12) is formed with a avoiding portion exposing the inner wall of the first portion (131); the first portion (131) and the second portion (132) are each one in number. When the anchor ring (13) is sleeved on the braided mesh (12), the braided mesh (12) is pulled apart to form an avoiding portion for the first portion (131), so that the braided mesh (12) is embedded only in the second portion (132) of the anchor ring (13) and is fixed by the positioning block (133). When the inner membrane (11) and the outer membrane (14) are heat fused, the outer membrane (14) can be melted and enter the second portion (132) of the anchor ring (13) and cover the inner surface of the braided mesh (12), so that a layer of thin material is formed between the braided mesh (12) and the inner membrane (11). Inner and outer walls of the anchor ring (13) are smooth. An outer wall of the first portion (131) and an outer wall of the second portion (132) are located on the same cylindrical surface.

2. The medical device delivery sheath for use in the human body of claim 1, wherein: An inner wall of the positioning block (133) and an inner wall of the first portion (131) are located on the same cylindrical surface, and a thickness of the braided mesh (12) is less than or equal to a thickness of the positioning block (133).

3. The medical device delivery sheath for use in the human body of claim 1, wherein: A side wall (1331) of the positioning block (133) is in contact with a braided wire of the braided mesh (12).

4. The medical device delivery sheath for use in the human body of claim 1, wherein: The positioning block (133) is a plurality of blocks spaced apart along a circumferential direction of the second portion (132), and one positioning block (133) is inserted into one mesh hole.

5. The medical device delivery sheath for use in the human body of claim 1, wherein: ​ ​ ​ 6. The medical device delivery sheath for use in the human body of claim 1, wherein: ​ 7. A medical device delivery sheath for use in the human body according to claim 6, characterized in that: The number of meshes of the braided mesh (12) on a circle of the circumference where the positioning blocks (133) are located is equal to the number of the positioning blocks (133).

8. The medical device delivery sheath for use in the human body of claim 1, wherein: The two side walls (1331) of the positioning block (133) on both sides in the circumferential direction of the anchoring ring (13) are inclined inwardly from the bottom to the top of the positioning block (133) or are concave inwardly to the inside of the positioning block (133).

9. The medical device delivery sheath for use in the human body of claim 1, wherein: The wall thickness of the first part (131) is 0.5-0.8 mm, and the wall thickness of the second part (132) is 0.2-0.3 mm.

10. The medical device delivery sheath for use in the human body of claim 1, wherein: One or more through grooves (137) are formed on the second part (132) and extend through the inside and outside of the second part (132), and the one or more through grooves (137) are located at the distal end and / or the proximal end of the positioning block (133); the through groove (137) is arc-shaped and extends along the circumferential direction of the second part (132).

11. The medical device delivery sheath for use in the human body of claim 1, wherein: Two through holes (135) are formed on the first part (131) and extend axially, the pulling wire (15) passes through the two through holes (135) in sequence, and the two free ends of the pulling wire (15) extend to the proximal end of the medical device delivery sheath (1).

12. The medical device delivery sheath for use in the human body of claim 11, wherein: The connecting surface (136) between the two through holes (135) at the distal end is circular arc-shaped, and the diameter is 2-6 times the diameter of the pulling wire (15).

13. The medical device delivery sheath for use in the human body of claim 11, wherein: The distal end of the first part (131) is provided with a recess (134) recessed toward the proximal end, and the through hole (135) is located on the groove bottom surface of the recess (134); the distal end surface of the anchoring ring (13) is flush with the distal end of the pulling wire (15), or the distal end of the pulling wire (15) is located between the distal end surface and the proximal end surface of the anchoring ring (13) and close to the distal end surface of the anchoring ring (13).

14. The medical device delivery sheath for use in the human body of claim 1, wherein: The first part (131), the second part (132), and the positioning block (133) are integrally formed by cutting.

15. The medical device delivery sheath for use in the human body according to any of claims 1 to 14, characterized in that: The inner membrane (11) and the outer membrane (14) are fixedly connected by heat melting.

16. The medical device delivery sheath for use in the human body according to any of claims 1 to 14, characterized in that: The material of the inner membrane (11) is polytetrafluoroethylene, the material of the outer membrane (14) is one or more of nylon, block polyether amide, polycarbonate, polyamide, and polyurethane, the braided mesh (12) is made of stainless steel wire, and the material of the anchoring ring (13) is one or more of stainless steel, tungsten, platinum-iridium, and tantalum.

17. The medical device delivery sheath for use in the human body according to any of claims 1 to 14, characterized in that: The medical device delivery sheath (1) comprises a main body segment, a transition segment, a bendable segment, and a tip segment connected in sequence from the proximal end to the distal end, wherein the hardness of the main body segment is greater than the hardness of the transition segment, which is greater than the hardness of the bendable segment; the anchoring ring (13) is arranged on the tip segment and located at the junction of the tip segment and the bendable segment.

18. A delivery system characterized by: The delivery system comprises the medical instrument delivery sheath (1) as claimed in any one of claims 1 to 17, a bending handle (2) mounted at the proximal end of the medical instrument delivery sheath (1), a bending mechanism is arranged on the bending handle (2), and the proximal end of the traction wire (15) is fixedly connected with the bending mechanism.

Images