CN116271426A - Catheter sheath - Google Patents

Abstract

The invention provides a catheter sheath, which comprises a sheath tube and a sheath tube seat connected to one end of the sheath tube, wherein an interventional instrument channel which is integrally communicated is arranged in the sheath tube and the sheath tube seat, a hemostatic sealing assembly is arranged on the sheath tube seat and used for sealing the interventional instrument channel, the hemostatic sealing assembly comprises an outer balloon wall and an inner balloon wall, the end parts of the outer balloon wall and the inner balloon wall are combined with each other, a balloon part space is formed between the outer balloon wall and the inner balloon wall, and the outer balloon wall and the inner balloon wall are both cylindrical and have a bent shape with a waist recessed towards the inner side of the interventional instrument channel. The catheter sheath according to the invention can have high reliability and versatility.

Description

Catheter sheath

Technical Field

The invention relates to the field of medical instruments, in particular to a catheter sheath with high reliability and stability.

Background

In the field of treatment of cardiovascular diseases, interventional therapy is commonly adopted due to the advantages of less bleeding, less trauma, less complications, safety, reliability, quick postoperative recovery and the like. The catheter sheath is an auxiliary medical instrument which plays an important role in interventional therapy, and is required to be used in almost all vascular interventional operations. Through the catheter sheath, a connection channel can be established between the human blood vessel and the outside to assist the delivery system in delivering diagnostic and/or therapeutic devices (collectively referred to as interventional devices) to the target lesion site.

The catheter sheath provides a passageway for the interventional device to enter the body while also creating an outlet for blood or other body fluids to flow out. To prevent blood loss, it is often necessary to provide a hemostatic valve within the catheter sheath.

At present, the existing catheter sheath generally adopts a conventional hemostatic valve, and the main principle of the conventional hemostatic valve is that a certain-shaped incision is formed on a silicone valve, so that an interventional instrument enters from the incision and is wrapped around the interventional instrument by the elasticity of silicone, and the sealing effect is achieved. Thereby reducing hemostasis and reducing the risk of blood splatter.

However, there are a number of problems with such existing catheter sheaths. Specifically, on one hand, the sealing effect of the structure is limited, blood leakage is easy to cause, on the other hand, because the sealing element of the silicone valve structure realizes sealing by self elasticity, if the sealing silicone element is too soft, a gap is reserved when the interventional instrument is pulled out, the sealing effect can be reduced, if the strength of the sealing silicone element is improved, the hemostatic effect can be improved, but the resistance of the interventional instrument entering is increased, a plurality of soft interventional catheters can be difficult to insert into the incision, or even if the interventional catheters can enter the incision, the problem that the interventional catheters are clamped flat exists, and the risk of invalidation of the interventional catheters is caused.

Disclosure of Invention

One of the main objects of the present invention is to provide a catheter sheath with high reliability.

Aiming at the purposes, the invention provides the following technical scheme:

according to an aspect of the present invention, there is provided a catheter sheath including a sheath tube and a sheath hub connected to one end of the sheath tube, an interventional instrument channel integrally communicating inside the sheath tube and the sheath hub, and a hemostatic seal assembly provided on the sheath hub for sealing the interventional instrument channel, the hemostatic seal assembly including an outer balloon wall and an inner balloon wall whose ends are bonded to each other, and a balloon portion space formed between the outer balloon wall and the inner balloon wall, the outer balloon wall and the inner balloon wall each being cylindrical and having a curved shape with a waist portion recessed toward an inside of the interventional instrument channel.

The outer and inner walls may have different thicknesses from each other, and the outer and inner walls may have different moduli of elasticity from each other.

The thickness of the outer bladder wall may be greater than the thickness of the inner bladder wall, and the modulus of elasticity of the outer bladder wall may be greater than the modulus of elasticity of the inner bladder wall.

The outer bladder wall may have a hardness greater than the inner bladder wall, and the outer bladder wall and the inner bladder wall may be formed from silicone rubber or elastomeric plastic.

The outer and inner bladder walls may each be elastically deformed in a state in which a bladder space between the outer bladder wall and the inner bladder wall is inflated or filled, wherein a radius of curvature of a waist portion of the outer bladder wall may be increased and a radius of curvature of a waist portion of the inner bladder wall may be decreased relative to a state in which the outer bladder wall is not inflated or filled.

The sheath hub may include an adapter portion and a terminating portion separated from each other, both end portions of the adapter portion may be connected to the one end of the sheath and one end of the hemostatic seal assembly, respectively, the other end of the hemostatic seal assembly may be connected to the terminating portion, and the one end and the other end of the hemostatic seal assembly may be embedded in the adapter portion and the terminating portion, respectively.

An outer inflation port may be provided on a side of the adapter, the end of the hemostatic seal assembly connected to the adapter may be provided with an inner inflation port, the outer and inner inflation ports may be disposed in overlying relation to one another for direct communication and for inflation or filling of the balloon space defined by the outer and inner balloon walls by the outer inflation assembly.

The two ends of the hemostatic sealing assembly may be formed with protrusions and/or grooves, the end portions of the adapter and the termination portion connected with the hemostatic sealing assembly may include a clamping receiving groove, and the inner wall of the clamping receiving groove may be formed with grooves and/or protrusions corresponding to the protrusions and/or grooves of the hemostatic sealing assembly.

The adapter may include a filling joint seat, an adapter and a catheter seat which are sequentially arranged, one end of the catheter seat may be connected to the sheath tube, the other end may be connected to a lower end of the adapter, the filling joint seat is arranged at a periphery of an upper end of the adapter, the lower end of the filling joint seat may be connected to an outer wall of the adapter through groove/protrusion fitting, and the upper end of the filling joint seat and the adapter may be spaced apart from each other, thereby forming a clamping accommodation groove of the adapter to accommodate the one end of the hemostatic sealing assembly.

The terminating portion may include an outer wall connecting seat and a clip cover, upper ends of the outer wall connecting seat and the clip cover may be engaged with each other through a groove/protrusion, and lower ends of the outer wall connecting seat and the clip cover may be spaced apart from each other, from a clip receiving groove forming the terminating portion, to receive the other end of the hemostatic sealing assembly.

The catheter sheath can remarkably improve the sealing hemostatic effect, so that the catheter sheath has higher reliability.

The catheter sheath can prevent the catheter of the interventional instrument from being deformed under pressure, so that the catheter sheath has higher stability.

The catheter sheath provided by the invention can be suitable for interventional instruments with different diameters, and therefore has higher universality.

The catheter sheath can effectively reduce the resistance of the interventional instrument to enter and exit, so that the catheter sheath has good trafficability, thereby reducing the operation difficulty and improving the operation experience of users.

Drawings

The foregoing and/or other objects and advantages of the invention will become more apparent from the following description of embodiments taken in conjunction with the accompanying drawings in which:

fig. 1 shows a schematic assembly view of a catheter sheath according to an exemplary embodiment of the present invention.

Fig. 2 shows a schematic partial cross-sectional view of a catheter sheath according to an exemplary embodiment of the invention.

Fig. 3 shows a schematic partial cross-sectional view of a use state of the catheter sheath according to an exemplary embodiment of the present invention.

Reference numerals illustrate:

100-catheter sheath, 1-dilator joint, 2-dilator knob cover, 3-outer wall connecting seat, 4-outer wall, 5-inflation joint seat, 6-adapter, 7-catheter seat, 8-sheath, 9-dilator, 10-inflation tee, 11-inflation tube, 12-flush tube, 14-clip cover, 15-inner wall, 16-inflation or fluid-filled space, 17-interventional instrument channel, 20-adapter, 30-termination, 40-hemostatic seal assembly, 41-inner inflation hole, 51-outer inflation hole, 80-sheath seat.

Detailed Description

Example embodiments will now be described more fully with reference to the accompanying drawings. However, the embodiments of the present invention should not be construed as limited to the embodiments set forth herein. The same reference numerals in the drawings denote the same or similar structures, and thus detailed descriptions thereof will be omitted.

The construction and method of operation of the device are described using terms of azimuth upper and lower, respectively, for convenience of description, referring to the positive and negative directions in the Z direction of the drawing. The Z direction in the drawing may be an axial direction, a length direction, or a thickness direction, and the Y direction and the X direction are perpendicular to the Z direction and may be radial directions. However, the configuration of the device is not limited by the above directional terms, and the direction of the device may be adjusted, for example, the device may be flipped back and forth, flipped up and down, or positioned in other angular orientations.

Fig. 1 shows a schematic assembly view of a catheter sheath according to an exemplary embodiment of the present invention.

Fig. 2 shows a schematic partial cross-sectional view of a catheter sheath according to an exemplary embodiment of the invention.

Fig. 3 shows a schematic partial cross-sectional view of a use state of the catheter sheath according to an exemplary embodiment of the present invention.

As shown in fig. 1 to 3, the catheter sheath 100 according to an embodiment of the present invention may mainly include a sheath tube 8 and a sheath hub 80 connected to one end of the sheath tube 8. The sheath tube 8 and the sheath tube seat 80 are provided with an interventional instrument channel 17 which is communicated integrally.

Additionally, a hemostatic seal assembly 40 (described in detail below) may be provided on the sheath hub 80 for sealing the interventional instrument channel 17.

The hemostatic seal assembly 40 may include an outer and an inner balloon wall 4, 15 joined to each other at their ends, and a balloon space may be formed between the outer and inner balloon walls 4, 15, each of the outer and inner balloon walls 4, 15 being cylindrical and having a curved shape with a waist portion recessed toward the inside of the interventional instrument channel 17.

According to the catheter sheath 100 of the present embodiment, the hemostatic seal assembly 40 has a simple structure and excellent sealing effect, and can significantly improve the reliability and stability of use of the catheter sheath 100. In addition, the structure of the catheter hub 80 is simple and compact and the connection reliability is high, and therefore, the manufacturing cost can be reduced and the operation reliability of the catheter sheath 100 can be further improved.

The construction and connection of the sheath hub 80 and hemostatic seal assembly 40 will be described in detail below.

The sheath hub 80 may include, for example, an adapter portion 20 and a termination portion 30 (to be described in detail later). The hemostatic seal assembly 40 may be interposed between the adapter 20 and the termination 30, and both ends of the hemostatic seal assembly 40 may be connected and fixed by the adapter 20 and the termination 30, respectively. In this case, the internal passage of the hemostatic seal assembly 40 and the internal passages of the adapter 20 and the termination 30 communicate with each other, constituting the passage portion of the sheath hub 80.

The sheath 8 may be hollow. The channel portion of the sheath 8 and the channel portion in the sheath hub 80 communicate integrally with each other to serve as a guide channel (i.e., an interventional instrument channel 17) through which an interventional instrument passes during an interventional procedure. The hemostatic seal assembly 40 may be used to seal the passageway as the interventional instrument is passed through the passageway or after the interventional instrument is withdrawn to prevent blood leakage.

In addition, a dilator assembly may be provided on the catheter sheath 100, such as a dilator hub 1 and a dilator knob cover 2 at the upper end of the catheter sheath 100 (i.e., the upper end of the sheath hub 80) and a dilator 9 at the lower end of the catheter sheath 100 (i.e., the lower end of the sheath tube 8).

In the actual use state, the end of the sheath tube 8 provided with the dilator 9 is insertable into the human body. The hemostatic seal assembly 40 may be connected to the other end of the sheath 8 in the length direction, i.e., the inlet end of the insertion interventional instrument, by a sheath hub 80 to achieve a hemostatic seal during an interventional procedure.

Specifically, as the insertion and/or extraction of the interventional instrument is performed, the interventional instrument may reach the target site via the hemostatic seal assembly 40 on the sheath hub 80 and the sheath 8 in sequence.

As an example, the hemostatic seal assembly 40 may cover the outer circumferential surface of the interventional instrument when the interventional instrument is inserted into the catheter sheath 100, and the hemostatic seal assembly 40 may completely close the interventional instrument channel 17 after the interventional instrument is withdrawn, thereby achieving a sealed hemostatic effect.

Referring to fig. 2 and 3, the hemostatic sealing assembly 40 has protrusions and/or grooves formed at both ends thereof, and the ends of the adapter 20 and the terminal 30 connected to the hemostatic sealing assembly 40 include a clamping receiving groove having grooves and/or protrusions formed on an inner wall thereof to be correspondingly engaged with the protrusions and/or grooves of the hemostatic sealing assembly 40.

The snap receiving groove may be in the form of an annular open cavity to receive and retain the end of the hemostatic seal assembly 40, and the annular open cavity may be formed with protrusions and/or recesses near the bottom to engage with protrusions and/or recesses on the end of the hemostatic seal assembly 40 to improve the reliability of the coupling.

Specifically, the hub 20 includes one end connected to the sheath 8 and another end connected to the hemostatic seal assembly 40. Accordingly, the lower end of the hemostatic seal assembly 40 may be connected to the upper end of the sheath 8 in the length direction by being connected to the adapter 20.

In addition, an inflation or filling port (inflation hole) may be further disposed on the adaptor 20, and the inflation hole may be used to inflate or fill the inflation or filling space of the balloon portion of the hemostatic sealing assembly 40 with the connected three-way valve and pipeline, so that the inflated or filled balloon portion may have an excellent elastic sealing effect, and may be easily adapted to the sealing of the interventional instrument channels 17 with different diameters by the inflation or filling amount, and may also easily control the sealing pressure, thereby avoiding the damage of the interventional instrument such as difficult passing or deformation caused by the excessive pressure, and significantly improving the experience of the operator.

The specific construction of the adapter 20 and hemostatic seal assembly 40 will be described in detail below.

As for the constituent components of the adapter 20, as an example, the adapter 20 may include a filling hub 5, an adapter 6, and a catheter hub 7 disposed in order to firmly connect the hemostatic seal assembly 40 and the sheath 8 to each other.

One end of the catheter hub 7 may be connected to the sheath tube 8, the other end may be connected to the lower end of the adapter connector 6, the filling connector hub 5 may be disposed at the periphery of the upper end of the adapter connector 6, the lower end of the filling connector hub 5 may be connected to the outer wall of the adapter connector 6 through a groove/protrusion fitting, and the upper end of the filling connector hub 5 may be spaced apart from the adapter connector 6 to form a clamping receiving groove of the adapter 20 to receive one end (lower end in fig. 2-3) of the hemostatic seal assembly 40.

In this case, the joint receiving groove is formed by the combination of the filling joint seat 5 and the adapter joint 6, so that the manufacturing difficulty is reduced, and the disassembly and the reassembly can be easily performed, thereby being beneficial to cleaning and checking the internal condition, or performing replacement and repair of the components. In addition, since the inner shape of the clamping receiving groove can be more easily controlled, the degree of matching with the end shape of the hemostatic sealing assembly 40 can be improved, thereby ensuring the sealing effect.

Regarding the connection of the upper and lower channels of the adapter 20, the channel lower port of the hemostatic seal assembly 40 (i.e., the channel lower port of the inner balloon wall 15) may be in communication with the channel upper port of the adapter 20 (i.e., the channel upper port of the inflation hub 5), and the upper port of the sheath 8 may be in communication with the channel lower port of the adapter 20 (i.e., the channel lower port of the catheter hub 7).

By way of example, the lower end of the hemostatic seal assembly 40 may be flush-connected to the upper end of the hub 20 by an interference fit and/or adhesive, and the upper end of the sheath 8 may be flush-connected to the lower end of the passage of the hub 20 by an interference fit and/or adhesive.

With respect to the internal channel structure of the adapter 20, the internal channels of the adapter 6 and the catheter hub 7 are in communication end-to-end in sequence. That is, the lower port of the passage of the adapter 6 may communicate with the upper port of the passage of the catheter hub 7, thereby forming an access instrument passage therethrough up and down. In addition, the filler neck 5 may be disposed at the periphery of the adapter 6, and thus may not directly form an internal passage.

The adapter 6 may be used to engage individual pipes. For example, the upper end, the central section and the lower end of the adapter 6 can each be used for connecting different pipes.

The inner wall of the lower end portion of the adapter 6 may be formed with threads to be coupled with external threads on the outer circumference of the upper end portion of the catheter hub 7. In addition, a sealing ring or a fastening structure can be arranged between the adapter connector 6 and the conduit seat 7 to improve the connection reliability and the sealing effect.

The central section of the adapter 6 may be formed with a tube joint protruding outwards from the side surface, the channels in the tube joint being in communication with each other with the interventional instrument channel 17. Therefore, it is possible to connect to the flushing pipe 12 and the flushing tee 13 through pipe joints. The flushing tube 12 and the flushing tee 13 can be used for injecting flushing liquid into the interventional instrument channel 17, so that flushing of the interventional instrument channel 17 can be achieved.

The outer wall of the upper end of the adapter 6 near the central section may be provided with a snap-fit structure (protrusion or recess) to connect the filling nipple 5 by means of a snap-fit or a snap-in/adhesive combination, and correspondingly the inner wall of the filling nipple 5 may be provided with a snap-fit structure (recess or protrusion) to the outer wall of the adapter 6.

The above connection is merely a preferred example, and embodiments of the present invention are not limited thereto, but may be connected by other connection fixing means known to those skilled in the art.

In addition, the side of the filling nipple seat 5 may be provided with an outer filling hole 51 and the hemostatic sealing assembly 40 may be provided with an inner filling hole 41. As an example, the inner filling hole 41 may be provided on a side of the outer balloon wall 4 (which will be described in detail later).

Referring to fig. 2 and 3, the outer inflation port 51 of the inflation nipple mount 5 and the inner inflation port 41 of the hemostatic seal assembly 40 may overlap one another and communicate directly (coaxially disposed).

The side of the inflation nipple 5 may be provided with a nipple extending outwardly from the outer inflation port 51, into which the outer inflation tube 11 may be directly inserted such that the outer inflation tube 11 may be directly connected to the outer inflation port 51 of the inflation nipple 5, and thus the inflation tee 10 and inflation tube 11 may be in communication with the balloon portion (e.g., an air or liquid balloon, the construction and manner of use of which will be described in detail below) of the hemostatic seal assembly 40 to inflate (fill) the balloon portion of the hemostatic seal assembly 40 or deflate (discharge the filled fluid therefrom).

As described above, the hemostatic seal assembly 40 may include the outer and inner balloon walls 4 and 15 joined at their ends to each other, and a balloon space may be formed between the outer and inner balloon walls 4 and 15. Thus, the elastic portions of the outer and inner balloon walls 4, 15 that constitute the balloon space may be referred to as a balloon. That is, the balloon portion may be constructed primarily by combining the outer balloon wall 4 and the inner balloon wall 15.

Both the outer and inner balloon walls 4, 15 are made of an elastic material such that the balloon portion of the hemostatic seal assembly 40 has contractible and inflatable properties, and thus the sealing effect of the interventional instrument channel 17 can be elastically controlled by controlling the amount of inflation or filling.

As an example, the elastic deformability of the outer and inner balloon walls 4, 15 may be different from each other, and thus, it may be more effective to prevent excessive pressure from being applied to the access instrument within the access instrument channel 17 after inflation or filling of the balloon, and it may be convenient to adjust the balloon inflation/fluid state or deformation state by squeezing the outer balloon wall 4.

For example, referring to FIG. 3, when the balloon is inflated or filled via inflation tee 10 and inflation tube 11, the interstitial space between outer balloon wall 4 and inner balloon wall 15 may serve as an inflated or filled interior space.

When the interventional instrument is inserted, after the internal space of the balloon portion is filled with an appropriate amount of gas or liquid (e.g., physiological saline), the inner balloon wall 15 may cover the external surface of the inserted interventional instrument with a predetermined pressure, and when the interventional instrument is withdrawn, at least a portion of the inner balloon wall 15 may be directly contact-bonded with each other (see fig. 3), so that the effect of sealing the interventional instrument channel 17 may be achieved.

In addition, during use, the outer capsule wall 4 can be directly exposed to the outside, so that a user can directly touch and squeeze the state of the capsule part, and the user can also directly judge the pressure state in the capsule part and the sealing state of the inner capsule wall 15. For example, the determination may be made based on the state of elastic deformation of the exposed outer bladder wall 4, if the degree of elastic deformation of the outer bladder wall 4 is insufficient, indicating that the pressure is insufficient, the sealing effect may be insufficient, further inflation or filling may be required, if the degree of elastic deformation of the outer bladder wall 4 is excessive, indicating that the pressure is excessive, and at this time, if the resistance to insertion of an interventional instrument is excessive, the inflation or filling state of the bladder should be appropriately adjusted.

Referring to fig. 2 and 3, the thicknesses of the outer and inner capsule walls 4 and 15 may be different from each other. In particular, the thickness of the outer balloon wall 4 may be greater than the thickness of the inner balloon wall 15, for example, the outer balloon wall 4 may have a certain thickness and thus a certain rigidity to maintain the overall shape of the balloon portion, while the inner balloon wall 15 may be a thinner flexible film.

In the non-inflated or liquid-filled state, inner bladder wall 15 may generally conform to the inside of outer bladder wall 4. At this time, the outer and inner capsule walls 4 and 15 each have a curved shape with a waist portion concave inward toward the passage. By having the concave shape, not only the inflation or filling time can be shortened and the inflation or filling efficiency can be improved, but also the stress can be dispersed by the change of the concave shape after the inflation or filling, thereby preventing the excessive movement resistance of the interventional instrument caused by the excessive inflation or filling.

In the non-inflated or liquid-filled state, the inner bladder wall 15 is almost adhered to the inner side surface of the outer bladder wall 4, and therefore, at this time, it can be considered that the radii of curvature of the concave curved portions of the outer bladder wall 4 and the inner bladder wall 15 are substantially the same (for example, refer to fig. 2).

After inflation or filling, both outer and inner balloon walls 4, 15 may elastically deform.

Specifically, in a state in which the balloon portion space between the outer balloon wall 4 and the inner balloon wall 15 is inflated or filled, the concave curvature of the outer balloon wall 4 moves outwardly away from the interventional instrument channel 17, i.e., the radius of curvature of the waist portion of the outer balloon wall 4 becomes larger relative to the state in which it is not inflated or filled, while the inner balloon wall 15 expands inwardly of the interventional instrument channel 17, i.e., the radius of curvature of the waist portion of the inner balloon wall 15 becomes smaller relative to the state in which it is not inflated or filled.

After inflation or filling, a certain pressure is formed in the balloon portion, so that the elastic inner balloon wall 15 can easily cover the interventional instrument or the inner balloon wall 15 can easily contact each other, thereby effectively sealing the interventional instrument channel 17, and compared with the catheter sheath in the prior art, the hemostatic sealing effect can be remarkably improved, and the catheter sheath has higher reliability.

In addition, the pressure in the bag portion can be adjusted by adjusting the inflation or liquid filling amount, so that the elastic inner bag wall 15 can be easily coated with interventional instruments or consumable materials with different diameters, and the universality of the catheter sheath is effectively improved.

Although both outer and inner balloon walls 4, 15 may elastically deform when inflated or filled, the degree of deformation of inner balloon wall 15 may be substantially greater than the degree of deformation of outer balloon wall 4. The outer capsule wall 4 and the inner capsule wall 15 with different deformation degrees can effectively disperse the pressure in the capsule part so as to avoid overlarge resistance of the interventional instrument caused by overlarge pressure in the capsule part, and the internal pressure state can be easily judged through the deformation of the outer capsule wall 4 so as to avoid overlarge pressure caused by excessive inflation or liquid filling.

The components with different deformability can be realized by adjusting the characteristics of material types, component shapes, component thicknesses, component elastic modulus and the like.

As an example, the outer capsule wall 4 and the inner capsule wall 15 may be formed using materials of different hardness. For example, the outer bladder wall 4 may have a hardness that is greater than the hardness of the inner bladder wall 15. Specifically, the outer capsule wall 4 may be formed using a material such as silicone rubber, elastomer plastic, etc., and the outer capsule wall 4 may be formed to have a housing of a predetermined thickness with a low elastic expansion rate. The inner bladder wall 15 may be formed as a flexible membrane to have a high elastic modulus of elasticity. However, the embodiment is not limited thereto, and the inner wall 15 may be formed of the same material as the outer wall 4 as long as a sufficient elastic modulus of the inner wall 15 can be ensured.

The outer capsule wall 4 may have a higher stiffness than the inner capsule wall 15, thereby giving both elastic deformability and shape retention. The inner capsule wall 15 may have better flexibility and elasticity than the outer capsule wall 4 to have excellent elastic deformability and compliance.

The inner capsule wall 15 is formed by soft elastic materials, so that the shape adaptability is good, interventional instruments or consumables with different diameters can be fully coated, and even a softer interventional catheter can effectively pass through the inner capsule wall, so that the problems of compression deformation, even collapse and the like of the interventional catheter are avoided.

In addition, because the outer capsule wall 4 and the inner capsule wall 15 can be supported by elastic materials, the deformation degree can be intuitively judged, so that the operation difficulty of using a catheter sheath is reduced.

As an example, the outer and inner balloon walls 4, 15 according to embodiments of the present invention may be manufactured separately, respectively, to more easily control physical properties (such as thickness, elastic modulus, etc.) of the two, and then assembled together.

The thickness of the outer capsule wall 4 and the inner capsule wall 15 may be different from each other. For example, the thickness of the outer bladder wall 4 may be greater than the thickness of the inner bladder wall 15 to meet different stiffness and deformation requirements.

The modulus of elasticity of the outer and inner capsule walls 4, 15 may be different from each other. For example, the modulus of elasticity of the outer bladder wall 4 may be greater than the modulus of elasticity of the inner bladder wall 15 to meet different elastic deformation requirements, in particular, the outer bladder wall 4 may have a smaller elastic deformation to maintain overall structural and shape stability, while the inner bladder wall 15 needs to have a larger elastic deformation to ensure excellent over-seal.

Specifically, in the original state of non-inflated or liquid-filled deformation, the outer balloon wall 4 may have a centrally concave cylindrical shape, in other words, the diameter of the outer balloon wall 4 may become smaller and larger in the length direction. As an example, the outer capsule wall 4 may have an approximately hourglass-like or dumbbell-like shape.

By way of example, in the original state of non-inflated or liquid-filled deformation, the inner bladder wall 15 may have the same shape as the outer bladder wall 4. Embodiments are not so limited and alternatively the inner bladder wall may have a cylindrical shape with a diameter that is substantially uniform from top to bottom.

With respect to the assembly of the outer and inner capsule walls 4, 15, the outside of the upper port of the inner capsule wall 15 may be bonded to the inside of the upper port of the outer capsule wall 4, and the outside of the lower port of the inner capsule wall 15 bonded to the inside of the lower port of the outer capsule wall 4.

As an example, the bonding between the outer capsule wall 4 and the inner capsule wall 15 may be achieved by means of, for example, adhesive bonding. The combination of the outer and inner capsule walls 4, 15 may be mounted to the adapter 20 after the two have been joined. The embodiments are not limited thereto and the outer capsule wall 4 and the inner capsule wall 15 may be combined or mounted in other ways.

Referring to fig. 2 and 3, the lower end of the hemostatic seal assembly 40 (outer and inner balloon walls 4, 15) may be embedded in the adapter 20. In particular, the lower ends of the outer and inner capsule walls 4, 15 may be interposed between the inflation nipple 5 and the adapter 6, and may be clamped and fixed by the inflation nipple 5 and the adapter 6. In this case, the lower ends of the outer and inner capsule walls 4, 15 may overlap with the upper ends of the filler neck 5 and the adapter 6 in the radial direction.

The manner of fixing the inner bag wall 15 is not limited to clamping, but as another example, the inner wall of the inner bag wall 15 may be bonded to the outer surface of the adapter 20 (the filling joint seat 5) by adhesive.

The inner wall of the lower end of the filling joint seat 5 is buckled on the outer wall of the upper end of the adapter joint 6, and the two can be buckled with each other through a convex/concave clamping connection structure. In addition, a stepped outer wall may be provided on the upper end of the adapter 6, and the stepped outer wall may include a first outer wall located below and a second outer wall located above, the first outer wall having a diameter greater than that of the second outer wall.

The first outer wall may be coupled to the lower end of the inflation nipple mount 5 (e.g., by a groove/protrusion snap-fit connection) and the second outer wall may be coupled to the lower end of the hemostatic seal assembly 40 (outer and inner balloon walls 4, 15).

As an example, the inner wall of the lower end portion of the outer capsule wall 4 may have a protrusion portion, and on the second outer wall on the upper end portion of the adapter joint 6 may have a corresponding groove portion, and the protrusion portion of the outer capsule wall 4 and the groove portion of the second outer wall on the upper end portion of the adapter joint 6 may have a ring shape or an arc shape, and be fitted to each other.

In this case, the inner bladder wall 15 may be interposed between the protruding portion of the outer bladder wall 4 and the recessed portion of the second outer wall on the upper end portion of the adapter 6 to further enhance the connection reliability of the hemostatic seal assembly 40 and the sealing reliability of the inflation or charging space 16 of the bladder portion by the radial clamping force of the two.

In addition, the outer wall of the lower end portion of the outer bag wall 4 may have an inwardly stepped structure so as to constitute a groove portion together with the first outer wall on the upper end portion of the adapter 6, and accordingly, a corresponding protrusion portion may be formed in the middle section of the inner wall of the filling joint seat 5, which are engaged with each other so as to improve the coupling stability of the filling joint seat 5, and the connection reliability of the hemostatic seal assembly 40 and the sealing reliability of the inflation or filling space 16 of the bag portion may be further improved by the external fastening force applied to the outer bag wall 4 by the filling joint seat 5.

In addition, the upper end surface of the filling nipple seat 5 may have a chamfer shape to accommodate the concave curved shape of the outer and inner bladder walls 4, 15 and to prevent breakage of the inner bladder wall 15.

The coupling structure of the upper end portions of the hemostatic seal assembly 40 (outer and inner balloon walls 4, 15) may be similar to the coupling structure of the lower end portions.

Referring to fig. 2 and 3, the upper end of the hemostatic seal assembly 40 (outer and inner balloon walls 4 and 15) may be connected with a termination 30.

The terminating portion 30 includes one end connected to the hemostatic seal assembly 40 and another end having an opening. The opening may serve as an inlet for the interventional instrument channel 17.

Specifically, the terminating portion 30 may include an outer wall connecting seat 3 and a clip cover 14, upper end portions of the outer wall connecting seat 3 and the clip cover 14 may be engaged with each other by grooves/protrusions, and lower end portions of the outer wall connecting seat 3 and the clip cover 14 may be spaced apart from each other, from a clip receiving groove forming the terminating portion 30, to receive the other end (upper end in fig. 2 to 3) of the hemostatic seal assembly 40.

In this case, the clamping receiving groove is formed by the combination of the outer capsule wall connecting seat 3 and the clamping cover 14, so that the manufacturing difficulty is reduced, and the assembly and disassembly can be easily performed, thereby being beneficial to cleaning and checking the internal condition, or performing replacement and repair of components. In addition, since the inner shape of the clamping receiving groove can be more easily controlled, the degree of matching with the end shape of the hemostatic sealing assembly 40 can be improved, thereby ensuring the sealing effect.

Therefore, by embedding the upper end portions of the hemostatic seal assembly 40 (the outer and inner capsule walls 4 and 15) in the terminal portion 30, not only the feeling of use experience can be improved, but also the reliability and stability of use can be ensured.

In terms of the fitting structure of the outer capsule wall connecting seat 3 and the clip cover 14, the inner wall of the upper end portion of the outer capsule wall connecting seat 3 is fastened to the outer wall of the upper end portion of the clip cover 14, and the two can be combined and connected with each other by the fastening structure such as a groove/protrusion.

The upper ends of the outer capsule wall 4 and the inner capsule wall 15 can be interposed between the outer capsule wall connecting seat 3 and the clamping cover 14, and can be clamped and fixed by the two. In other words, the upper end portions of the outer and inner capsule walls 4 and 15 may overlap at least a portion of the outer capsule wall connecting seat 3 and the clip cover 14 in the radial direction.

In addition, the card cover 14 may have a stepped outer wall, which may include a first outer wall located above and a second outer wall located below, the first outer wall having a diameter greater than that of the second outer wall.

The first outer wall may be coupled to the upper end of the outer wall coupling seat 3 (e.g., by a groove/protrusion snap-fit connection) and the second outer wall may be coupled to the upper end of the hemostatic seal assembly 40 (outer wall 4 and inner wall 15).

As an example, the inner wall of the upper end portion of the outer capsule wall 4 may have a protruding portion, and between the first outer wall and the second outer wall of the clip cover 14, a corresponding groove portion, and the protruding portion of the outer capsule wall 4 and the groove portion of the clip cover 14 may have a ring shape or an arc shape, and be fitted to each other.

In this case, the inner bladder wall 15 may be interposed between the protruding portion of the outer bladder wall 4 and the recessed portion of the second outer wall of the cartridge cover 14 to further enhance the connection reliability of the hemostatic seal assembly 40 and the sealing reliability of the inflation or charging space 16 of the bladder portion by the radial clamping force of the two.

As described above, the upper end portions of the hemostatic seal assembly 40 (the outer and inner capsule walls 4 and 15) can be fixed and sealed by the terminating portion 30, and the lower end portions of the hemostatic seal assembly 40 (the outer and inner capsule walls 4 and 15) can be fixed and sealed by the transit portion 20. Accordingly, it is possible to provide the catheter sheath with excellent structural reliability and sealing reliability.

In addition, through above-mentioned pipeline communication structure, can make the simple structure and the volume of catheter sheath compacter, reduce manufacturing and assembly degree of difficulty to portable.

The catheter sheath can remarkably improve the sealing hemostatic effect, so that the catheter sheath has higher reliability.

The catheter sheath can prevent the catheter of the interventional instrument from being deformed under pressure, so that the catheter sheath has higher stability.

The catheter sheath provided by the invention can be suitable for interventional instruments with different diameters, and therefore has higher universality.

The catheter sheath can effectively reduce the resistance of the interventional instrument to enter and exit, so that the catheter sheath has good trafficability, thereby reducing the operation difficulty and improving the operation experience of users.

In the present disclosure, the terms "first," "second," and "second" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implying a number of technical features being 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 present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.

In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

The described features, structures, or characteristics of the invention may be combined in any suitable manner in one or more embodiments. In the above description, numerous specific details are provided to give a thorough understanding of embodiments of the invention. One skilled in the relevant art will recognize, however, that the inventive aspects may be practiced without one or more of the specific details, or with other methods, components, materials, and so forth. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the invention.

Claims (10)

1. A catheter sheath (100), characterized in that the catheter sheath (100) comprises a sheath tube (8) and a sheath hub (80) connected to one end of the sheath tube (8),

an interventional instrument channel (17) is integrally communicated inside the sheath tube (8) and the sheath tube seat (80), and a hemostatic sealing assembly (40) is arranged on the sheath tube seat (80) for sealing the interventional instrument channel (17),

the hemostatic seal assembly (40) comprises an outer balloon wall (4) and an inner balloon wall (15) with ends bonded to each other, and a balloon space is formed between the outer balloon wall (4) and the inner balloon wall (15), and the outer balloon wall (4) and the inner balloon wall (15) are both cylindrical and have a curved shape with a waist recessed toward the inside of the interventional instrument channel (17).

2. The catheter sheath (100) of claim 1, wherein,

the outer and inner capsule walls (4, 15) have different thicknesses from each other, and the outer and inner capsule walls (4, 15) have different elastic moduli from each other.

3. The catheter sheath (100) of claim 2, wherein,

the thickness of the outer capsule wall (4) is greater than the thickness of the inner capsule wall (15), and the elastic modulus of the outer capsule wall (4) is greater than the elastic modulus of the inner capsule wall (15).

4. The catheter sheath (100) of claim 3, wherein,

the hardness of the outer capsule wall (4) is greater than that of the inner capsule wall (15),

the outer and inner capsule walls (4, 15) are formed from silicone rubber or elastomeric plastic.

5. The catheter sheath (100) of claim 3, wherein,

in a state in which a balloon portion space between the outer balloon wall (4) and the inner balloon wall (15) is inflated or filled with liquid, both the outer balloon wall (4) and the inner balloon wall (15) are elastically deformed,

wherein the radius of curvature of the waist of the outer balloon wall (4) is increased and the radius of curvature of the waist of the inner balloon wall (15) is decreased relative to the non-inflated or fluid-filled state.

6. The catheter sheath (100) of any one of claims 1-5, wherein,

the sheath hub (80) includes an adapter portion (20) and a termination portion (30) that are separate from each other,

two ends of the adapter part (20) are respectively connected to the one end of the sheath tube (8) and one end of the hemostatic seal assembly (40), the other end of the hemostatic seal assembly (40) is connected to the terminating part (30),

the one end and the other end of the hemostatic seal assembly (40) are embedded in the adapter portion (20) and the termination portion (30), respectively.

7. The catheter sheath (100) of claim 6, wherein,

an outer filling hole (51) is arranged on the side part of the switching part (20), an inner filling hole (41) is arranged at the end of the hemostatic sealing assembly (40) connected to the switching part (20),

the outer and inner inflation ports (51, 41) are disposed in overlying relation to one another for direct communication and for inflation or filling of the balloon space defined by the outer and inner balloon walls (4, 15) by an outer inflation assembly.

8. The catheter sheath (100) of claim 6, wherein,

the hemostatic seal assembly (40) has protrusions and/or grooves formed on both ends thereof,

the end parts of the switching part (20) and the terminating part (30) connected with the hemostatic sealing assembly (40) comprise clamping accommodating grooves, and groove parts and/or protruding parts which are correspondingly embedded with the protruding parts and/or the groove parts of the hemostatic sealing assembly (40) are formed on the inner walls of the clamping accommodating grooves.

9. The catheter sheath (100) of claim 8, wherein,

the adapter part (20) comprises a filling joint seat (5), an adapter joint (6) and a catheter seat (7) which are sequentially arranged,

one end of the catheter seat (7) is connected to the sheath tube (8), the other end is connected to the lower end part of the adapter connector (6),

the filling joint seat (5) is arranged at the periphery of the upper end part of the adapter joint (6),

the lower end of the filling joint seat (5) is connected to the outer wall of the adapter joint (6) through a groove/protrusion fit, and the upper end of the filling joint seat (5) and the adapter joint (6) are spaced apart from each other, thereby forming a clamping receiving groove of the adapter part (20) to receive the one end of the hemostatic sealing assembly (40).

10. The catheter sheath (100) of claim 8, wherein,

the termination part (30) comprises an outer capsule wall connecting seat (3) and a clamping cover (14),

the upper ends of the outer capsule wall connecting seat (3) and the clamping cover (14) are connected with each other in a jogged way through grooves/protrusions,

the lower ends of the outer wall connecting seat (3) and the clamping cover (14) are spaced apart from each other, and form a clamping accommodating groove of the terminating part (30) so as to accommodate the other end of the hemostatic sealing assembly (40).

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