CN116510161B

CN116510161B - Catheter sheath for interventional therapy

Info

Publication number: CN116510161B
Application number: CN202310786507.3A
Authority: CN
Inventors: 阙诗昊; 徐军; 林林
Original assignee: Suzhou Huihe Medical Technology Co ltd; Shanghai Huihe Healthcare Technology Co Ltd
Current assignee: Suzhou Huihe Medical Technology Co ltd; Shanghai Huihe Healthcare Technology Co Ltd
Priority date: 2023-06-30
Filing date: 2023-06-30
Publication date: 2023-09-08
Anticipated expiration: 2043-06-30
Also published as: CN117018401A; CN116510161A

Abstract

The application relates to a catheter sheath for interventional therapy, which comprises a sheath tube, a mounting seat, a hemostatic valve assembly and a side branch assembly, wherein the sheath tube is internally provided with a first channel, the mounting seat is arranged at the proximal end of the sheath tube and is internally provided with a second channel, and the hemostatic valve assembly is arranged at the proximal end of the mounting seat; the first channel is communicated with the second channel; the side branch assembly comprises a conduit, a runner and a plurality of suction holes, wherein the conduit is internally provided with a third channel, one end of the conduit is arranged on the side wall of the mounting seat, the conduit sheath also comprises the runner which is arranged on the mounting seat and is communicated with the third channel, and the plurality of suction holes are arranged on the mounting seat; the runner is circumferentially surrounded along the mounting seat, a plurality of suction holes are respectively communicated with the runner and the second channel, and the suction holes are circumferentially distributed along the mounting seat.

Description

Catheter sheath for interventional therapy

Technical Field

The application belongs to the technical field of medical instruments, and particularly relates to a catheter sheath for interventional therapy.

Background

A catheter sheath is a medical device used for interventional medical procedures, typically for guiding medical devices, catheters or drugs into the human body during surgery or medical procedures. When using the catheter sheath, the physician leaves a small hole in the patient, and inserts the catheter sheath through the hole, and inserts the medical device or catheter to be used into the catheter sheath. Thus, the skin of the patient can be prevented from being repeatedly pierced in multiple operations, and the injury and pain to the patient are reduced. After the operation is finished, the catheter sheath can be easily removed without leaving any obvious trace.

For the catheter sheath used in the intravascular interventional operation, better sealing performance is needed to prevent the gas from entering the blood vessel during the operation to cause danger. However, in the operation process, the internal catheter is easy to deform due to careless operation in the pushing or withdrawing process of the catheter sheath, so that gas enters the sealed cavity of the catheter sheath from the gap, and the risk is caused. And also when the catheter sheath produces unavoidable air inflow, it is difficult to pump out the air at the proximal end of the catheter sheath using the suction intensity of the patient without damaging the operation, because the side branch assembly of the catheter sheath is not usually installed at the proximal end of the catheter sheath.

Disclosure of Invention

The application aims to solve the technical problem of providing a catheter sheath for interventional therapy, which can easily suck air at the tail end of the proximal end of the catheter sheath.

In order to achieve the above purpose, the application adopts the following technical scheme:

the application provides a catheter sheath for interventional therapy, which comprises a sheath tube, a mounting seat, a hemostatic valve assembly and a side branch assembly, wherein the sheath tube is internally provided with a first channel, the mounting seat is arranged at the proximal end of the sheath tube and is internally provided with a second channel, and the hemostatic valve assembly is arranged at the proximal end of the mounting seat; the first channel is communicated with the second channel; the side branch assembly comprises a conduit, a runner and a plurality of suction holes, wherein the conduit is internally provided with a third channel, one end of the conduit is arranged on the side wall of the mounting seat, the conduit sheath also comprises the runner which is arranged on the mounting seat and is communicated with the third channel, and the plurality of suction holes are arranged on the mounting seat; the runner is circumferentially surrounded along the mounting seat, a plurality of suction holes are respectively communicated with the runner and the second channel, and the suction holes are circumferentially distributed along the mounting seat.

Preferably, the longitudinal cross-sectional area of the flow passage is 1.5 times or less the cross-sectional area of the third passage.

Further preferably, the longitudinal cross-sectional area of the flow passage is 0.2 times and more the cross-sectional area of the third passage.

Preferably, the total cross-sectional area of the orifices of the plurality of suction holes is 1.5 times and less than the cross-sectional area of the third channel.

Further preferably, the total cross-sectional area of the orifices of the plurality of suction holes is 0.2 times and more the cross-sectional area of the third passage.

Preferably, the aperture area of the suction hole close to the third passage among the plurality of suction holes is smaller than the aperture area of the suction hole far from the third passage.

According to some embodiments, the plurality of suction holes are circumferentially offset from each other and axially aligned with each other.

According to some embodiments, the plurality of suction holes are uniformly distributed in the circumferential direction.

According to some embodiments, one of the plurality of suction holes is located at a junction of the conduit and the mount.

According to some embodiments, each of the plurality of said suction holes is equal in cross-sectional area in its axial direction.

According to some embodiments, the number of the plurality of suction holes is 2-10.

Preferably, the hemostasis valve assembly includes a hemostasis valve, and the catheter sheath further includes a blocking portion formed on an inner wall of the mount and configured to contact the hemostasis valve to prevent the hemostasis valve from continuing to move distally with the instrument.

Further preferably, the distance between the blocking part and the hemostatic valve is 0.5-2 times the thickness of the hemostatic valve.

Still further, at least a portion of the suction aperture is located distally of the barrier.

Further, the surface of the blocking part is an arc surface.

According to some embodiments, the mounting seat comprises a body, a guide ring which is positioned in the body and is fixedly connected with the body or integrally formed with the body, the flow channel is formed between the body and the guide ring, a plurality of suction holes are formed on the guide ring, mounting holes communicated with the flow channel are formed in the side wall of the body, and the guide pipe is connected with the body through the mounting holes.

Further, the flow channel is a groove formed on the side wall of the guide ring and recessed inwards from the outer side wall of the guide ring, a plurality of suction holes are formed on the distal end face and the proximal end face of the guide ring respectively, and a blocking portion capable of contacting with the hemostatic valve to prevent the hemostatic valve from continuing to move along with the distal end of the instrument is formed on the inner wall of the guide ring at the proximal end.

Further, a blocking surface contacting the distal end surface of the guide ring is formed on the inner wall of the body with a gap between the blocking surface and the suction hole formed on the distal end surface of the guide ring.

According to other specific embodiments, the mounting seat comprises a body and a collar fixedly sleeved outside the body, the flow channel is formed on the side wall of the body and is a groove recessed from the outer side wall of the body to the interior of the body, the plurality of suction holes are formed on the side wall of the body, the side wall of the collar is provided with a mounting hole communicated with the flow channel, and the guide pipe is connected with the body through the mounting hole.

Further, the axial lines of the plurality of suction holes extend along the radial direction of the body; and/or a blocking portion capable of contacting the hemostatic valve to prevent the hemostatic valve from continuing to move distally with the instrument is formed on an inner side wall of the body at proximal ends of the plurality of suction holes.

According to some embodiments, the hemostasis valve assembly comprises hemostasis valves and the number of hemostasis valves is one.

According to some embodiments, the side branch assembly further comprises a three-way valve mounted on the other end of the conduit.

According to some embodiments, the material of the mounting base is transparent.

According to some embodiments, the catheter sheath further comprises a bending adjustment assembly disposed within the sheath, and a handle connected to the bending adjustment assembly and capable of controlling bending of the distal end of the sheath.

Due to the application of the technical scheme, compared with the prior art, the application has the following advantages:

according to the application, through the arrangement of the flow passage and the suction hole, when air is inadvertently introduced into the proximal end of the catheter sheath from the hemostatic valve assembly in the operation process, no matter what direction the side branch assembly points to, the air in the catheter sheath can be easily sucked out through the side branch assembly, so that the safety performance of the catheter sheath in the use process can be further improved, the risks of air blockage and the like caused by air entering into a blood vessel can be avoided, and the operation of doctors can be simpler.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for the description of the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a cross-sectional view of a catheter sheath of one embodiment;

FIG. 2 is an exploded view of one embodiment of the catheter sheath mount;

FIG. 3 is a cross-sectional view of an embodiment of an internal catheter without access to the catheter sheath;

FIG. 4 is a cross-sectional view of an embodiment of an inner catheter after entering a catheter sheath;

FIG. 5 is a perspective view of an embodiment catheter sheath without a hemostatic valve assembly mounted thereto;

FIG. 6 is a side view of an embodiment catheter sheath without a hemostatic valve assembly mounted thereto;

FIG. 7 is an enlarged view of a portion of FIG. 1;

FIG. 8 is an enlarged view of a portion of FIG. 4;

FIG. 9 is a cross-sectional view of a baffle ring;

FIG. 10 is a perspective view of a baffle ring;

FIG. 11 is a partial side view of a mount of a second embodiment;

FIG. 12 is a partial side view of a mount of a third embodiment;

fig. 13 is a partial cross-sectional view (first cross-section) of a mount of a fourth embodiment;

fig. 14 is a partial exploded view of a mount of a fourth embodiment;

fig. 15 is a partial cross-sectional view (second cross-section, wherein the first cross-section and the second cross-section intersect) of a mount of a fourth embodiment;

FIG. 16 is a cross-sectional view of the fourth embodiment of the inner catheter after entering the catheter sheath;

fig. 17 is a cross-sectional view of the catheter sheath of the fifth embodiment;

wherein, 1, sheath tube; 2. a mounting base; 3. a hemostatic valve assembly; 4. a side branch assembly; 11. a first channel; 21. a second channel; 22. a mounting hole; 23. a flow passage; 24. a suction hole; 25. a body; 26. a guide ring; 27. a blocking portion; 28. a blocking surface; 29. a collar; 31. a hemostatic valve; 32. an end cap; 41. a conduit; 42. a three-way valve; 43. and a third channel.

Detailed Description

Hereinafter, only certain exemplary embodiments are briefly described. As will be recognized by those of skill in the pertinent art, the described embodiments may be modified in numerous different ways without departing from the spirit or scope of the embodiments of the present application. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

In the description of the present application, it is to be understood that distal refers to the end of the instrument or component that is distal to the operator and proximal refers to the end of the instrument or component that is proximal to the operator; axial refers to a direction parallel to the central line of the distal and proximal ends of the instrument or component, radial refers to a direction perpendicular to the axial direction, and circumferential or circumferential refers to a direction around the axial direction; the inner and outer are positions defined relative to the distance of the center of the instrument or component, wherein the inner is a position near the center of the instrument or component and the outer is a position away from the center of the instrument or component. The above description of orientation words is merely for convenience in describing embodiments of the present application and for simplicity of description, and does not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting embodiments of the present application.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the embodiments of the present application, the meaning of "plurality" is two or more, unless explicitly defined otherwise.

In the present application, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. It will be understood by those skilled in the art that the terms described above are meant specifically in embodiments of the present application, such as when the sheath 1 is attached to the mount 2, the two require a relative seal to prevent blood within the sheath 1 from seeping out of the gap between the sheath 1 and the mount 2.

The following disclosure provides many different implementations, or examples, for implementing different configurations of embodiments of the application. In order to simplify the disclosure of embodiments of the present application, components and arrangements of specific examples are described below. Of course, they are merely examples and are not intended to limit embodiments of the present application. Furthermore, embodiments of the present application may repeat reference numerals and/or letters in the various examples, which are for the purpose of brevity and clarity, and which do not themselves indicate the relationship between the various embodiments and/or arrangements discussed.

Embodiments of the present application will be described in detail below with reference to the accompanying drawings.

Fig. 1-17 illustrate various exemplary embodiments of the catheter sheaths of the present application that may be adapted for use in endovascular interventions. The catheter sheath comprises a sheath tube 1, a mounting seat 2, a hemostatic valve assembly 3 and a lateral branch assembly 4.

The interior of the sheath 1 has a first passageway 11 extending through the distal and proximal ends of the sheath 1, the first passageway 11 being for passage of medical instruments or internal catheters. The mounting seat 2 is mounted on the proximal end of the sheath tube 1 in a sealing manner, a second channel 21 penetrating through the distal end and the proximal end of the mounting seat 2 is formed in the mounting seat 2, the mounting seat 2 is fixedly connected with the sheath tube 1, and the first channel 11 and the second channel 21 are communicated to provide a channel for a medical instrument or an internal catheter to pass through. The material of mount pad 2 is transparent material, makes things convenient for the doctor to observe whether there is air to get into mount pad 2.

The hemostatic valve assembly 3 comprises a hemostatic valve 31 and an end cover 32, wherein the end cover 32 is positioned at the proximal end of the hemostatic valve 31, the hemostatic valve 31 is pressed at the proximal end of the mounting seat 2 through the end cover 32 to realize the fixed connection of the end cover 32, the hemostatic valve 31 and the mounting seat 2, and the hemostatic valve 31 is blocked on the second channel 21 of the mounting seat 2 to realize the sealing of the second channel 21, prevent external air from entering the catheter sheath and prevent blood leakage in the catheter sheath.

According to one embodiment, the number of hemostatic valves 31 may be one or more. When the number of hemostasis valves 31 is a plurality of, a plurality of hemostasis valves 31 are along the axial distribution of mount pad 2 in order to realize the multilayer seal to mount pad 2 to can improve the leakproofness of catheter sheath, but a plurality of hemostasis valves 31 can lead to catheter sheath structure comparatively complicated, and the equipment degree of difficulty is high and catheter sheath overall length is longer. Preferably, by describing the structural design of the flow channel 23 and the suction hole 24 in detail below, when air is inadvertently introduced into the mounting seat 2, the air in the mounting seat 2 can be conveniently sucked out through the side branch assembly 4, so that the number of the hemostatic valves 31 in the present application can be only one. Compared with the arrangement of a plurality of hemostatic valves 31, the hemostatic valve 31 is only arranged one, so that the structure of the catheter sheath can be simplified, the assembly of the catheter sheath is simple, and the whole length of the catheter sheath is shortened. According to one embodiment, the hemostatic valve 31 adopts the hemostatic valve in CN115337521a, and the hemostatic valve with the structure can better ensure the tightness of the catheter sheath, so that the surgical risk caused by the entry of external air is further reduced.

The side branch assembly 4 comprises a guide pipe 41 and a three-way valve 42, and the side wall of the mounting seat 2 is provided with a mounting hole 22. The inside of the conduit 41 is provided with a third channel 43 penetrating through two ends of the conduit 41, one end of the conduit 41 is fixedly connected with the side wall of the mounting seat 2 through the mounting hole 22 on the mounting seat 2, and the three-way valve 42 is fixedly arranged on the other end of the conduit 41. The third passage 43 of the catheter 41 is communicable with the second passage 21 of the mount 2, and when the three-way valve 42 is connected to the medical cylinder and the medical cylinder is operated, air in the mount 2 can be sucked out through the second passage 21 and the third passage 43.

The catheter sheath further comprises a flow channel 23 provided on the mount 2, and a plurality of suction holes 24 provided on the mount 2. The flow passage 23 is an annular flow passage that surrounds the mount 2 in one turn in the circumferential direction, and a plurality of suction holes 24 are distributed in the circumferential direction of the mount 2. Each suction hole 24 of the plurality of suction holes 24 communicates with the flow passage 23 and the second passage 21 of the mount 2, respectively, and the flow passage 23 communicates with the third passage 43 of the duct 41, thereby realizing that the second passage 21 of the mount 2 communicates with the third passage 43 of the duct 41. By providing the flow channel 23 and the plurality of suction holes 24, it is possible to solve the problem that when the connection position of the duct 41 and the mount 2 is located below the mount 2 (i.e., the duct 41 is directed downward) and the air in the mount 2 is located above the mount 2, the air is accumulated above the mount 2 and is difficult to suck through the duct 41.

The arrangement of the flow path 23 and the suction hole 24 may be varied, and several arrangements of the flow path 23 and the suction hole 24 will be described in detail below.

Fig. 1 to 10 show a flow channel 23 and a suction opening 24 in a first embodiment, wherein the mount 2 comprises a body 25 and a deflector ring 26. As shown in fig. 1 to 8, the body 25 has a cavity penetrating the distal end and the proximal end, the sidewall of the body 25 is provided with a mounting hole 22 for mounting a catheter 41, the guide ring 26 is located in the cavity inside the body 25 and fixedly connected with the body 25 or integrally formed, the axis of the guide ring 26 coincides with the axis of the body 25, and the cavity inside the body 25 and the inner hole of the guide ring 26 together form the second channel 21. The guide ring 26 may be fixed to the body 25 by an adhesive, or may be fixed to the body 25 by an interference fit.

As shown in fig. 9 and 10, the flow passage 23 is a groove formed on a side wall of the deflector ring 26 and recessed inward from an outer side wall of the deflector ring 26. A plurality of suction holes 24 spaced apart from each other are formed on the distal end face and the proximal end face of the deflector ring 26, respectively, and the plurality of suction holes 24 are located near the outer periphery of the deflector ring 26, i.e., the plurality of suction holes 24 are located at the top of the side wall of the flow channel 23, the axis line of each suction hole 24 is parallel to the axis line of the deflector ring 26, and the cross-sectional area of each suction hole 24 in the axial direction thereof is equal. The plurality of aspiration holes 24 on the proximal face are circumferentially offset from one another, axially aligned with one another, and evenly distributed circumferentially. The plurality of suction holes 24 on the distal end face are circumferentially offset from each other, axially aligned with each other, and uniformly distributed in the circumferential direction. One of the plurality of suction holes 24 on the proximal face and one of the plurality of suction holes 24 on the distal face are each located at the junction of the catheter 41 and the mount 2 (i.e., at the mounting hole 22). The number and the shape and the size of the plurality of suction holes 24 on the proximal surface and the plurality of suction holes 24 on the distal surface are the same and are arranged in a one-to-one correspondence.

When the body 25 and the guide ring 26 are assembled, the annular flow channel 23 is located between the inner wall of the body 25 and the outer wall of the guide ring 26, and the mounting hole 22 is located at the position of the flow channel 23, that is, the mounting hole 22 is aligned with the flow channel 23 in the axial direction. The plurality of suction holes 24 are distributed in the circumferential direction of the flow channel 23, so that the original suction hole 24 is changed into a plurality of small suction holes 24 distributed at different positions in the circumferential direction of the mounting seat 2, and therefore no matter which direction the mounting hole 22 is positioned at the upper, lower, left and right of the mounting seat 2 in the operation process, no matter which position of the air in the mounting seat 2 is positioned in the mounting seat 2, even if the air is positioned at the upper position in the mounting seat 2, the air can be easily sucked out from the mounting seat 2 through the matching of the plurality of suction holes 24 and the annular flow channel 23, and the suction efficiency is greatly improved.

Preferably, the longitudinal cross-sectional area of the flow passage 23 is 1.5 times or less, 0.2 times or more the cross-sectional area of the third passage 43. The longitudinal cross-sectional area of the flow channel 23 is calculated by: one plane is intersected with the flow channel 23 to obtain a half of the total area of a plane pattern, wherein the axial line of the mounting seat 2 is positioned in the plane, and the flow channel 23 is in a ring shape surrounding the circumference of the mounting seat 2, so that the plane pattern intersected with the flow channel 23 is two, and the longitudinal sectional area of the flow channel 23 is calculated according to one plane. In this embodiment, since the longitudinal section of the flow path 23 is two approximate rectangles, the longitudinal section of the flow path 23 is the length a multiplied by the width b as shown in fig. 9. Of course, it will be appreciated by those skilled in the art that the longitudinal cross-sectional area of the flow channel 23 need not be rectangular, as long as any other shape is possible that enables communication with the suction aperture 24 and the third channel 43. The cross-sectional area of the third passage 43 is the area of the pattern obtained by intersecting the third passage 43 with a plane perpendicular to the axis of the conduit 41, and for a circular conduit 41, the cross-section of the third passage 43 is a circle.

Preferably, the total cross-sectional area of the orifices of the plurality of suction holes 24 is 1.5 times and less, 0.2 times and more the cross-sectional area of the third passage 43. Wherein the total area of the apertures of the plurality of suction holes 24 is calculated as the area of the aperture close to the second channel 21. In this embodiment, the total cross-sectional area of the orifices of the plurality of suction holes 24 is the total cross-sectional area of the plurality of suction holes 24 formed on the distal end face of the baffle ring 26, i.e., the total cross-sectional area of the orifices of the plurality of suction holes 24 is the total area of the four black solid areas shown in fig. 6.

Preferably, the aperture area of the suction holes 24 of the plurality of suction holes 24 close to the third channel 43 is smaller than the aperture area of the suction holes 24 distant from the third channel 43, because the larger the suction holes 24, the larger the water flow at the large suction holes 24 during suction, and the easier it is to suck air out together with the water flow, and thus the design can further make it easier for the air located on the opposite side of the third channel 43 to be sucked out.

Preferably, the number of the suction holes 24 is 2 to 10. In this embodiment, the number of the suction holes 24 formed in the distal end surface of the deflector ring 26 is 2 to 10, and the number of the suction holes 24 formed in the proximal end surface of the deflector ring 26 is 2 to 10. For example, the number of the suction holes 24 may be 4 as shown in fig. 6 or 6 as shown in fig. 11.

Those skilled in the art will appreciate that the shape of the suction hole 24 is not strictly limited, and may be, for example, a pit as shown in fig. 6 or an elongated shape as shown in fig. 12.

By controlling the longitudinal cross-sectional area of the flow channel 23 and the total cross-sectional area of the openings of the plurality of suction holes 24, the suction holes 24 which are farthest from the inlet of the third channel 43 can also have a good suction effect during suction. By adjusting the number and shape of the suction holes 24, the suction range can be improved.

As shown in fig. 9 and 10, the inner side wall of the guide ring 26 is cylindrical, the distal end face of the guide ring 26 is a cambered surface extending from the distal end to the proximal end in an inward inclined manner, the proximal end face of the guide ring 26 is a cambered surface extending from the proximal end to the distal end in an inward inclined manner, the proximal end face of the guide ring 26 and the inner side wall of the guide ring 26 are in smooth transition, and the guide ring 26 is in an arch bridge shape which arches inwards as a whole.

As shown in fig. 4 and 8, a blocking portion 27 capable of contacting with the hemostatic valve 31 to prevent the hemostatic valve 31 from continuing to move distally with the instrument is formed on the proximal surface of the guide ring 26 and/or on the inner side wall of the guide ring 26, and smooth transition between the proximal surface of the guide ring 26 and the side wall ensures that the blocking portion 27 is an arc surface so as to avoid damage to the hemostatic valve 31 caused by the blocking portion 27. When the instrument enters the interior of the catheter sheath, the hemostatic valve 31 is pushed distally, and the pushed portion of the hemostatic valve 31 is forced to be folded inwards by the blocking portion 27 on the guide ring 26, so that the hemostatic valve 31 cannot leak out due to continuous distal movement, and a complete circle of hemostatic valve 31 is wrapped around the instrument.

In order to better improve the limit of the blocking part 27 on the hemostatic valve 31 and improve the sealing performance of the hemostatic valve 31, the distance between the blocking part 27 and the hemostatic valve 31 is 0.5-2 times the thickness of the hemostatic valve 31.

Further, as shown in fig. 4 and 8, a blocking surface 28 contacting the distal end surface of the deflector ring 26 is formed on the inner wall of the body 25, the blocking surface 28 extends in a direction perpendicular to the axis of the body 25, and a gap is provided between the blocking surface 28 and the suction hole 24 formed on the distal end surface of the deflector ring 26, so that when air is present inside the mount 2, the air can be easily sucked out through the duct 41. The distal face of the deflector ring 26 is positioned to facilitate aspiration, and water and air flow from the gap into the aspiration orifice 24. In this embodiment, the distal end surface of the deflector ring 26 must be provided with a plurality of suction holes 24, and the proximal end surface of the deflector ring 26 may or may not be provided with suction holes 24.

Fig. 13 to 16 show a flow channel 23 and a suction opening 24 in a further embodiment, wherein the mounting seat 2 comprises a body 25 and an annular collar 29, the collar 29 being fixedly arranged outside the body 25 and being arranged in a sealing manner opposite the body 25. The body 25 is internally formed with a second passage 21, and the flow passage 23 is formed on a side wall of the body 25 and is a groove recessed from an outer side wall of the body 25 toward the inside of the body 25. The flow passage 23 has a substantially rectangular longitudinal section. A plurality of suction holes 24 are formed on the side wall of the body 25 and located inside the flow passage 23, the axial lines of the plurality of suction holes 24 extend in the radial direction of the body 25, and an inner orifice of each of the plurality of suction holes 24 communicates with the second passage 21 and an outer orifice communicates with the flow passage 23. The collar 29 has a mounting hole 22 formed in a side wall thereof and communicating with the flow passage 23, and the duct 41 is connected to the body 25 through the mounting hole 22.

In this embodiment, the blocking portion 27 is formed on the inner wall of the body 25, and the blocking portion 27 is located at the proximal ends of the plurality of suction holes 24, and the blocking portion 27 is also a smoothly-transiting arc surface. When the hemostatic valve 31 is moved distally with the instrument into contact with the stop 27, the hemostatic valve 31 remains distally of the suction port 24 to ensure that in this condition, air within the mount 2 is still conveniently sucked out through the conduit 41.

The longitudinal cross-sectional area of the flow channel 23, the total cross-sectional area of the openings of the plurality of suction holes 24, the number of suction holes 24, the distance between the blocking portion 27 and the hemostatic valve 31, and the like in this embodiment are the same as those in the embodiment shown in fig. 1 to 10, and will not be described again.

In addition to the sheath 1 shown in the above embodiment being a common catheter, the sheath 1 may also be a controllable bending sheath to increase the bending function of the sheath 1. For example, as shown in the embodiment of fig. 17, the catheter sheath further includes a bending adjustment assembly disposed within the sheath 1, and a handle connected to the bending adjustment assembly and capable of controlling the distal bending of the sheath 1. The specific structure of the bending adjustment assembly and the handle is not the protection key point of the application, and the existing bending adjustment assembly and the handle can be adopted.

The catheter sheath of the application has the following advantages:

1. the suction is simple, bubbles in the tail end of the proximal end of the mounting seat 2 can be easily extracted when the catheter 41 faces any position, and the tightness of the hemostatic valve 31 can not be damaged when the suction negative pressure is large, so that the possibility of changing a suction catheter sheath when air is carelessly introduced in the operation can be realized;

2. when a doctor pushes the instrument or the internal catheter, the syringe is prevented from being used for sealing the hemostatic valve 31 by water, and the use is simpler;

3. the sealing effect is excellent, and when only the single-layer hemostatic valve 31 is used, no leakage exists when pushing and extracting the internal instrument; compared with the structure of the multi-layer hemostatic valve 31, the structure is simplified, the assembly is simpler, and the whole length of the catheter sheath is not influenced.

The following tests were performed on the catheter sheaths of the embodiments shown in fig. 1 to 10:

test 1: the test was performed with three sheaths, each having a bubble in the mount 2. To the three-way valve 42, a 50mL syringe was connected, and suction was performed at a rate of 5mL/s, and the test results were shown in Table 1 below.

Meanwhile, the conventional catheter sheath (i.e., the catheter sheath without the guide ring 26) was tested according to the method of test 1, and suction was performed when the catheter 41 of the side branch assembly 4 was placed downward, and the air bubbles in the mount 2 could not be extracted. By increasing the suction strength, the hemostatic valve 31 is deformed at the tear angle, but even when the suction strength is increased to the tear angle of the hemostatic valve 31, the air bubbles in the mount 2 cannot be extracted.

Test 2:

(1) Evacuating the catheter sheath, hanging a saline bag on the implantation system (content) and confirming that liquid drips out from the head, immersing the head of the sheath tube 1 of the catheter sheath into a basin, and confirming that no air bubble enters the interior after evacuating the sheath tube 1;

(2) The head of the implant system was fed into the catheter sheath, and the seal was observed to be broken, and the implant system was fed into the proximal end by about 30 mm. Sucking the catheter sheath until no air bubbles are present;

(3) Repeating the step (2) for 4 times, and sucking the catheter sheath until no continuous bubbles exist;

(4) Pushing the implantation system to the far end until the implantation system exposes out of the head, recording whether bubbles emerge from the head, and recording whether the proximal end of the catheter sheath is in air inlet in the pushing process;

(5) Fixing the implantation system on the bracket, pushing the delivery sheath 10 times along the direction of the proximal end and the distal end respectively by using a knob, recording whether bubbles enter the proximal end of the catheter sheath, and recording the direction of the hemostatic valve 31 in the pushing process;

(6) Slowly sucking the catheter sheath by using a 20mL syringe, and observing whether water is sucked out;

(7) The implantation system was withdrawn, the catheter sheath was aspirated, and no leakage of the hemostatic valve 31 was confirmed.

Five catheter sheaths were tested and the test results of each step of test 2 are shown in table 2.

The above embodiments are provided to illustrate the technical concept and features of the present application and are intended to enable those skilled in the art to understand the content of the present application and implement the same, and are not intended to limit the scope of the present application. Equivalent changes are made according to the spirit of the application.

Claims

1. A catheter sheath for interventional therapy, comprising a sheath tube (1) with a first channel (11) inside, a mounting seat (2) mounted at the proximal end of the sheath tube (1) and with a second channel (21) inside, a hemostatic valve assembly (3) mounted at the proximal end of the mounting seat (2) and a side branch assembly (4); the first channel (11) and the second channel (21) are communicated; the method is characterized in that: the side branch assembly (4) comprises a conduit (41) which is internally provided with a third channel (43) and one end of which is arranged on the side wall of the mounting seat (2), the conduit sheath also comprises a flow channel (23) which is arranged on the mounting seat (2) and is communicated with the third channel (43), and a plurality of suction holes (24) which are arranged on the mounting seat (2); the flow channel (23) surrounds along the circumferential direction of the mounting seat (2), a plurality of suction holes (24) are respectively communicated with the flow channel (23) and the second channel (21), and the plurality of suction holes (24) are distributed along the circumferential direction of the mounting seat (2); the mounting seat (2) comprises a body (25), a guide ring (26) which is positioned inside the body (25) and fixedly connected with the body (25) or integrally formed, the flow channel (23) is formed between the body (25) and the guide ring (26), and a plurality of suction holes (24) are formed in the guide ring (26).

2. The catheter sheath for interventional therapy of claim 1, wherein: the longitudinal cross-sectional area of the flow passage (23) is 1.5 times or less the cross-sectional area of the third passage (43).

3. The catheter sheath for interventional therapy of claim 2, wherein: the longitudinal cross-sectional area of the flow passage (23) is 0.2 times or more the cross-sectional area of the third passage (43).

4. The catheter sheath for interventional therapy of claim 1, wherein: the total cross-sectional area of the orifices of the plurality of suction holes (24) is 1.5 times and less than the cross-sectional area of the third passage (43).

5. The catheter sheath for interventional therapy of claim 4, wherein: the total cross-sectional area of the orifices of the plurality of suction holes (24) is 0.2 times and more the cross-sectional area of the third passage (43).

6. The catheter sheath for interventional therapy of any one of claims 1, 4 and 5, wherein: an aperture area of a suction hole (24) close to the third passage (43) among the plurality of suction holes (24) is smaller than an aperture area of a suction hole (24) far from the third passage (43).

7. The catheter sheath for interventional therapy of any one of claims 1, 4 and 5, wherein: the plurality of suction holes (24) are circumferentially offset from each other and axially aligned with each other.

8. The catheter sheath for interventional therapy of any one of claims 1, 4 and 5, wherein: a plurality of the suction holes (24) are uniformly distributed in the circumferential direction; and/or one of the plurality of suction holes (24) is located at the junction of the conduit (41) and the mount (2); and/or each suction hole (24) of the plurality of suction holes (24) is equal in cross-sectional area in the axial direction thereof; and/or the number of the plurality of the suction holes (24) is 2-10.

9. The catheter sheath for interventional therapy of claim 1, wherein: the hemostasis valve assembly (3) comprises a hemostasis valve (31), and the catheter sheath further comprises a blocking portion (27) formed on an inner wall of the mounting base (2) and capable of contacting the hemostasis valve (31) to prevent the hemostasis valve (31) from continuing to move distally with the instrument.

10. The catheter sheath for interventional therapy of claim 9, wherein: the distance between the blocking part (27) and the hemostatic valve (31) is 0.5-2 times the thickness of the hemostatic valve (31).

11. The catheter sheath for interventional therapy of claim 9, wherein: at least part of the suction aperture (24) is located distally of the barrier (27); and/or the surface of the blocking part (27) is an arc surface.

12. The catheter sheath for interventional therapy according to any one of claims 9 to 11, wherein: the side wall of the body (25) is provided with a mounting hole (22) communicated with the flow channel (23), and the guide pipe (41) is connected with the body (25) through the mounting hole (22).

13. The catheter sheath for interventional therapy of claim 12, wherein: the flow channel (23) is a groove formed on the side wall of the guide ring (26) and recessed inwards from the outer side wall of the guide ring (26), a plurality of suction holes (24) are respectively formed on the distal end surface and the proximal end surface of the guide ring (26), and a blocking part (27) which can be in contact with the hemostatic valve (31) to prevent the hemostatic valve (31) from continuously moving along with the instrument to the distal end is formed on the inner wall of the guide ring (26) at the proximal end.

14. The catheter sheath for interventional therapy of claim 12, wherein: a blocking surface (28) contacting with the distal end surface of the deflector ring (26) is formed on the inner wall of the body (25), and a gap is formed between the blocking surface (28) and the suction hole (24) formed on the distal end surface of the deflector ring (26).

15. The catheter sheath for interventional therapy of claim 1, wherein: the hemostasis valve assembly (3) comprises hemostasis valves (31), and the number of the hemostasis valves (31) is one; and/or, the side branch assembly (4) further comprises a three-way valve (42) mounted on the other end of the conduit (41); and/or the material of the mounting seat (2) is transparent.

16. The catheter sheath for interventional therapy of claim 1, wherein: the catheter sheath further comprises a bending adjusting assembly arranged in the sheath tube (1) and a handle which is connected with the bending adjusting assembly and can control the bending of the distal end of the sheath tube (1).