CN115624413B

CN115624413B - Adjustable sheath tube

Info

Publication number: CN115624413B
Application number: CN202210614667.5A
Authority: CN
Inventors: 魏达; 谢鑫强; 吴忠
Original assignee: APT MEDICAL Inc
Current assignee: APT MEDICAL Inc
Priority date: 2022-05-31
Filing date: 2022-05-31
Publication date: 2023-08-29
Anticipated expiration: 2042-05-31
Also published as: CN115624413A

Abstract

The embodiment of the disclosure provides an adjustable sheath pipe, including the sheath pipe the proximal end of sheath pipe sets up the joint portion, the joint portion includes interconnect's joint main part and gland cap set up the cavity in the joint main part with set up the hemostasis valve between the gland cap, the hemostasis valve includes first valve body and second valve body, first valve body with the second valve body sets gradually in the cavity the inside of gland cap sets up the boss, and it is right the second valve body realizes pressing. The embodiment of the disclosure can realize the control of hemostasis when instruments such as a guide wire, a catheter and the like pass through and can effectively reduce the pressing resistance.

Description

Adjustable sheath tube

Technical Field

The present disclosure relates to the field of medical devices, and in particular to an adjustable sheath.

Background

Heart valve disease is a common heart disease in our country, with valve damage caused by rheumatic fever being the most common. With the aggravation of aging population, valvular disease caused by coronary heart disease and myocardial infarction is more and more common. The four valves of the human body are respectively called mitral valve, tricuspid valve, aortic valve and pulmonary valve, and the valves are diseased due to rheumatic fever, mucous degeneration, degenerative change, congenital malformation, ischemic necrosis, infection or trauma, and the like, so that the normal flow of blood flow is affected, and the abnormal heart function is caused, and finally the single-valve or multi-valve disease of heart failure is caused.

The treatment of heart valve disease includes medical treatment such as medicines, surgical treatment and interventional treatment. Wherein, in the internal medicine treatment, diuretics are applied to heart failure manifestations such as sodium water retention, digoxin, beta receptor blocker, non-dihydropyridine calcium antagonist and the like are applied to control the ventricular rate of the patients with rapid atrial fibrillation, and anticoagulation treatment such as warfarin and the like is applied to the patients with thrombus danger and complications, and simultaneously, factors which induce heart failure such as fatigue and emotional agitation are emphasized, sodium water intake is properly limited, infection is prevented and the like are avoided; in surgical operation, the surgical treatment such as artificial heart valve replacement or valve forming is a radical treatment method of heart valve diseases, and for heart valve patients with heart failure symptoms, surgical indications and contraindications should be evaluated actively to strive for opportunities of surgical treatment; in interventional therapy, mainly for the balloon dilatation and valve replacement of stenotic valves, for severe simple mitral valve stenosis, aortic valve stenosis and congenital pulmonary valve stenosis, percutaneous valve balloon dilatation and transcatheter valve replacement can be selected, and the purposes of expanding the valve orifice area, relieving valve stenosis, improving hemodynamics and clinical symptoms can be achieved, including Transcatheter Aortic Valve Replacement (TAVR), transcatheter mitral valve repair/replacement (TMVr/TMVr), transcatheter tricuspid valve repair and transcatheter pulmonary valve implantation replacement.

The catheter sheath is an instrument that establishes access for the valve into the body vessel to the lesion, and thus several clinical needs must be met: 1. the catheter enters the blood vessel through the femoral artery, the arterial blood vessel pressure is high, and the catheter sheath group has good hemostatic effect; 2. the compatibility of the instrument can pass through a guide wire with the minimum diameter of 0.035 "(0.89 mm) and a catheter with the maximum diameter of 30F (10 mm), and the instrument has the advantages of good smoothness and small resistance; 3. the catheter is soft, and has to have good flexibility for ensuring the safety of blood vessels because of the very large size (14F-30F); 4. easy to use, the operator must operate simply and conveniently, will not operate by mistake.

The currently mainly used catheter sheath group is a hydrophilic coating guiding sheath of a certain company, as shown in fig. 1 and 2, wherein the hydrophilic coating guiding sheath comprises a sheath tube a with a hemostatic valve, a dilator b and a syringe c, the sheath tube a is a polyethylene tube with a conical front end, the tip of the polyethylene tube a is provided with a marking belt d which is embedded in sheath tube material so as to be easily identified under perspective, the tail end of the marking belt d is provided with a connector e, and the connector e is embedded with a hemostatic valve; the hemostatic valve consists of a siliceous outer tube g1 and a thin film inner tube g2, wherein the siliceous outer tube g1 and the thin film inner tube g2 can be pressurized by injecting physiological saline through a syringe c, so that the thin film inner tube g2 can be expanded, and the hemostatic effect can be achieved. The hydrophilic coating guiding sheath has good hemostatic effect, the hemostatic valve is expanded for plugging by pressure injection, but the hemostatic valve is not easy to use, an operator needs to connect a valve port through a syringe c, and the valve port and a side tube three-way switch are easy to be confused to cause misuse; in terms of instrument compatibility, the hemostatic valve can control the resistance of the hemostatic valve when passing through an instrument by controlling the pressure of the syringe c, and the injection pressure can be higher when passing through an instrument with a very small outer diameter, such as a guide wire; while the injection pressure can be reduced by means of instruments with a very large outer diameter, such as catheters. .

Disclosure of Invention

An object of an embodiment of the present disclosure is to provide an adjustable sheath tube, so as to solve the problems existing in the prior art, and in order to solve the technical problems, an embodiment of the present disclosure adopts the following technical scheme:

the embodiment of the disclosure provides an adjustable sheath pipe, including the sheath pipe the proximal end of sheath pipe sets up the joint portion, the joint portion includes interconnect's joint main part and gland cap set up the cavity in the joint main part with set up the hemostasis valve between the gland cap, the hemostasis valve includes first valve body and second valve body, first valve body with the second valve body sets gradually in the cavity the inside of gland cap sets up the boss, and it is right the second valve body realizes pressing.

In some embodiments, the connector portion further includes a snap for press-fitting the first valve body and the second valve body in the cavity.

In some embodiments, the first valve body is disposed proximate the fitting body and the second valve body is disposed proximate the gland cap.

In some embodiments, the first valve body and the second valve body are flat disc-shaped and are each made of an elastomer.

In some embodiments, the first valve body and the second valve body are made of silicone rubber, and the second valve body has a hardness less than the hardness of the first valve body.

In some embodiments, a positioning member is fixedly disposed on the connector body, and the positioning member is used in cooperation with the gland cap.

In some embodiments, a straight cut is arranged on the first valve body in a way of a single-groove opening, and a circular groove is arranged in the center of the second valve body.

In some embodiments, the two surfaces of the first valve body are respectively provided with a notch with the same or different shapes, the notch of each surface is not cut through to the other surface, and the shape of the notch is at least one of a straight shape, a cross shape, a rice shape or a multi-flap shape.

In some embodiments, the first and second faces of the first valve body are each provided with a cross-shaped cutout.

In some embodiments, the second valve body adopts a gear shape, the second valve body comprises a circular main body, a plurality of teeth are arranged at the edge of the main body at equal intervals, a through hole is arranged in the middle of the main body, and the end parts of the teeth exceed the end face of the main body, which is close to the first valve body.

In some embodiments, a plurality of first buckles are provided along an outer edge of the connector body, a groove is provided between adjacent first buckles, and the connector body is connected with the buckle piece through the first buckles and the groove.

In some embodiments, a second buckle is arranged on the buckle piece, a button elastic piece is arranged on the end face of the buckle piece, and the button elastic piece slides on the groove; and the button elastic sheet is also provided with a compression buckle.

In some embodiments, an assembly slot and a compression slot 24 are provided on the pressure cap, the assembly slot and the second buckle cooperate with each other, the compression slot and the compression buckle cooperate with each other, the second valve body is extruded by the boss while the second buckle moves in the assembly slot, and the button elastic sheet moves in the groove, so as to form different pressing effects.

In some embodiments, a marker band is disposed at the distal end of the sheath.

In some embodiments, the connector portion is connected to a dilator.

In some embodiments, the seal is achieved between the sheath and the hub by a suture loop.

In some embodiments, the adjustable sheath further comprises a side tube connected to the connector portion.

In some embodiments, a side tube port is provided on the joint portion, the side tube being connected to the side tube port.

In some embodiments, a three-way seat is provided at the end of the side pipe, and a three-way valve is provided on the three-way seat, through which the cleaning liquid is introduced into the side pipe.

The embodiment of the disclosure can realize the control of hemostasis when instruments such as a guide wire, a catheter and the like pass through and can effectively reduce the pressing resistance.

Drawings

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

FIG. 1 is a schematic structural view of a hydrophilic coating introducer sheath according to the prior art;

FIG. 2 is a schematic structural view of a hydrophilic coating introducer sheath according to the prior art;

FIG. 3 is an assembled schematic view of an adjustable sheath according to a first embodiment of the present disclosure;

FIG. 4 is a schematic view of a first valve body in an adjustable sheath according to a first embodiment of the present disclosure;

FIG. 5 is a schematic view of a first valve body in an adjustable sheath according to a first embodiment of the present disclosure;

FIG. 6 is a schematic illustration of a second valve body in an adjustable sheath according to a first embodiment of the present disclosure;

FIG. 7 is a schematic structural view of an adjustable sheath according to a second embodiment of the present disclosure;

FIG. 8 is an assembled schematic view of an adjustable sheath according to a second embodiment of the present disclosure;

FIG. 9 is a schematic structural view of an adjustable sheath according to a second embodiment of the present disclosure;

FIG. 10 is a schematic structural view of an adjustable sheath according to a second embodiment of the present disclosure;

FIG. 11 is a schematic structural view of an adjustable sheath according to a second embodiment of the present disclosure;

FIG. 12 is a schematic view of the structure of a first valve body in an adjustable sheath according to a second embodiment of the present disclosure;

FIG. 13 is a schematic view of a first valve body in an adjustable sheath according to a second embodiment of the present disclosure;

FIG. 14 is a schematic view of a second valve body in an adjustable sheath according to a second embodiment of the present disclosure;

fig. 15 is a schematic view of the force applied in an adjustable sheath according to a second embodiment of the present disclosure.

Reference numerals:

1-an adjustable sheath; 2-sheath; 3-side tube; 4-pressing the cap; 6-a clamping piece; 8-a three-way seat; 9-a three-way valve; 10-joint part; 11-positioning pieces; 12-a joint body; 13-a first valve body; 14-a second valve body; 141-a body; 142-teeth; 143-a through hole; 15-side tube ports; a 16-slit coil; 17-a first catch; 18-grooves; 19-a second catch; 20-dilators; 21-a button shrapnel; 22-compression snap; 23-assembling a clamping groove; 24-compressing the clamping groove; 25-boss.

Detailed Description

Various aspects and features of the disclosure are described herein with reference to the drawings.

It should be understood that various modifications may be made to the embodiments of the application herein. Therefore, the above description should not be taken as limiting, but merely as exemplification of the embodiments. Other modifications within the scope and spirit of this disclosure will occur to persons of ordinary skill in the art.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above and the detailed description of the embodiments given below, serve to explain the principles of the disclosure.

These and other characteristics of the present disclosure will become apparent from the following description of a preferred form of embodiment, given as a non-limiting example, with reference to the accompanying drawings.

It should also be understood that, although the present disclosure has been described with reference to some specific examples, a person skilled in the art will certainly be able to achieve many other equivalent forms of the present disclosure, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

The above and other aspects, features and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings.

Specific embodiments of the present disclosure will be described hereinafter with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Well-known and/or repeated functions and constructions are not described in detail to avoid obscuring the disclosure in unnecessary or unnecessary detail. Therefore, specific structural and functional details disclosed herein are not intended to be limiting, but merely serve as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

The specification may use the word "in one embodiment," "in another embodiment," "in yet another embodiment," or "in other embodiments," which may each refer to one or more of the same or different embodiments in accordance with the disclosure.

A first embodiment of the present disclosure relates to an adjustable sheath for guiding movement of a wire, catheter or the like in a patient, wherein the adjustable sheath 1 comprises a sheath 2, as shown in fig. 3, and wherein the sheath 2 may be a nylon composite tube with a tapered front end, and wherein during a surgical procedure on the patient, a device such as a wire, catheter or the like is passed through the sheath 2 to reach an operative position in the patient under the guidance of the adjustable sheath 1. In particular, a marker band which is easily identifiable in a perspective view may be provided at the distal end of the sheath 2, which marker band may be provided embedded in the end face of the sheath 2 for indicating the position of the sheath 2 within the patient, wherein the distal end here refers to the end remote from the operator. Of course the adjustable sheath 1 described herein may also be used in conjunction with a dilator.

Further, a connector 10 is provided at the proximal end of the sheath 2, where the proximal end is the end near the operator, and the connector 10 may be connected to a dilator for use with the sheath 2, for example. In addition, the sealing between the sheath tube 2 and the joint 10 is achieved by a slit coil 16.

Further, the joint part 10 comprises a joint main body 12 and a gland cap 4, wherein the joint main body 12 can be made of injection molding; a cavity is provided in the joint body 12, the gland cap 4 can be engaged with or screwed or connected to the joint body 12, and when the gland cap 4 is pressed, the gland cap 4 has a certain pressing stroke relative to the joint body 12.

In one embodiment, the adjustable sheath 1 further comprises a side tube 3, the side tube 3 is used for cleaning the interior of the sheath 2 after the cleaning liquid is introduced, the side tube 3 is connected with the joint part 10, for example, a side tube port 15 can be provided on the joint part 10, and the side tube 3 is connected to the side tube port 15; further, a three-way seat 8 is provided at the distal end of the side pipe 3, and a three-way valve 9 is provided on the three-way seat 8, whereby the input of the cleaning liquid into the side pipe 3 can be controlled by the three-way valve 9.

Further, a hemostatic valve for hemostasis is provided between the joint body 12 and the gland cap 4, and as further shown in fig. 3, the hemostatic valve herein includes a first valve body 13a and a second valve body 14a, and since the joint body 12 has a cavity structure in which the first valve body 13a and the second valve body 14a are sequentially provided, the first valve body 13a is provided close to the joint body 12, and the second valve body 14a is provided close to the gland cap 4 and away from the joint body 12.

Here, in order to facilitate the setting of the hemostatic valve and to play a hemostatic role, the first valve body 13a and the second valve body 14a are flat disc-shaped and made of an elastomer, so as to be capable of achieving compression deformation of themselves, and the first valve body 13a and the second valve body 14a may be made of silicone rubber, for example. In some embodiments, the second valve body 14a has a relatively low hardness and the first valve body 13a has a relatively high hardness.

Further, in order to achieve the hemostatic effect by the hemostatic valve, as shown in fig. 4 and 5, a through, for example, a straight incision is provided on the first valve body 13a through a single slot opening, where the incision cuts through the first valve body 13a, and as shown in fig. 6, a circular groove is provided at the center of the second valve body 14a, and the incision and the circular groove are mutually communicated so as to pass through a guide wire, a catheter, or the like during the operation.

In this way, the first valve body 13a and the second valve body 14a are accommodated in the hollow structure of the joint body 12, and by pressing the capping cap 4, a certain compression of the hemostatic valve can be achieved by the cooperation of the in-line slit and the circular groove, for hemostatic operation.

Specifically, a boss is provided inside the gland cap 4 here, which can facilitate the operator to press the second valve body 14a in the hemostatic valve. Specifically, when the operator presses the cap 4, the second valve body 14a receives the pressing force from the boss and transmits the pressing force to the first valve body 13a, and the size of the slit after pressing through the first valve body 13a is changed to achieve the hemostatic effect.

Further, as shown in fig. 3, the joint portion 10 further includes a fastener 6, where the fastener 6 is used to press-fix the first valve body 13a and the second valve body 14a in the cavity structure of the joint main body 12. In this way, when instruments such as catheters or guide wires with different sizes pass through the adjustable sheath tube 1, the compression amount of the first valve body 13a and the second valve body 14a can be controlled through the cooperation of the clamping piece 6 and the gland cap 4, and specifically, the extrusion force of the incision center of the first valve body 13a and the size of the circular groove positioned at the center of the second valve body 14a can be changed, so that the hemostatic effect is achieved.

Specifically, when an instrument such as a guide wire having a very small outer diameter is passed through the adjustable sheath 1, the user can press down the cap 4 to press the first valve body 13a through the second valve body 14a, and seal the incision by pressing the incision of the first valve body 13a to make the incision smaller, thereby achieving a hemostatic effect; however, when an instrument such as a catheter having a large outer diameter is passed through the adjustable sheath 1, the pressing force on the cap 4 can be removed, so that the first valve body 13a of the hemostatic valve can restore the opening size of the incision to achieve sealability to achieve hemostasis.

The adjustable sheath tube 1 of the embodiment of the disclosure has very good usability and can realize one-hand operation of an operator; in addition, the compression amount of the hemostatic valve can be controlled by the cooperation of the buckle piece 6 and the gland cap 4 so as to achieve the hemostatic effect.

However, the structural design of the hemostatic valve in this embodiment using two disc-shaped valve bodies has drawbacks, such as that the first valve body 13a adopts a single slot opening to form a straight incision, which may not achieve a good hemostatic effect for some instruments; in addition, since the second valve body 14a adopts a disc shape so that it is in transition fit with the cavity structure of the joint body 12, in the process of realizing extrusion through the boss of the gland cap 4, since the surface contact area between the boss and the second valve body 14a is large, and the second valve body 14a has no radial deformation space in the inner cavity, a large pressing force is required when the gland cap 4 is pressed down and a large instrument passing resistance is caused.

In a second embodiment of the present disclosure, in order to overcome the above drawbacks of the adjustable sheath 1 of the first embodiment, another adjustable sheath 1 is provided, as shown in fig. 7 to 10, where the adjustable sheath 1 may be used in combination with a dilator 20, which is different from the first embodiment in that a positioning member 11 is fixedly provided on the joint main body 12, where the positioning member 11 may be used in combination with the gland 4 in the joint portion 10, and an operator may press the positioning member 11 with his fingers to raise the pressing force against the gland 4 when pressing the gland 4.

Further, in the present embodiment, the shapes of the first valve body 13b and the second valve body 14b in the hemostatic valve are also improved, wherein, as shown in fig. 12, slits of the same or different shapes are provided on both sides of the first valve body 13b, the shape of the slits here is, for example, a one-sided, cross, rice or multi-flap shape, wherein the slits on each side of the first valve body 13b have a certain depth but are not cut through to the other side, but the slits on both sides are made to communicate after pressing to facilitate passage of the instrument, so that it is ensured that the first valve body 13b can expand in the radial direction, i.e., the outer periphery of the instrument can be wrapped by the first valve body 13b when the slits of the first valve body 13b are expanded by the instrument or the like. For example, the first surface of the first valve body 13b may be provided with a straight slit, and the second surface of the first valve body 13b may be provided with a straight slit, so that the shape of the cross is formed together, and any one surface is not cut through, but the centers of the straight slits on both surfaces are communicated.

Further, considering that the in-line cut on either side of the first valve body 13b increases the resistance to passage of the device, the multi-flap cut may cause the hemostatic valve to not wrap around the device, resulting in leakage of blood flow. Preferably, a cross-shaped incision is used here, as shown in fig. 12 and 13, the first surface of the first valve body 13b may be provided as a cross-shaped incision, and the second surface of the first valve body 13b may also be provided as a cross-shaped incision, where the cross-shaped incision may be arc-shaped, which corresponds to a shape that forms a m shape together, and any one side is not cut through, but the centers of the cross-shaped incisions on both sides after extrusion form a communication, and the incision intersection naturally forms a channel for inserting an instrument such as a catheter, so that the cross-shaped incision may make the wrapping property for the instrument better after the instrument passes. Furthermore, in order to control the hemostatic effect, the incisions on both sides of the first valve body 13b are related to the diameter of the passable instrument, for example by the size of the instrument to adjust the depth of the incision on either side as required.

Further, as shown in fig. 14, the second valve body 14b adopts a gear shape, specifically, the second valve body 14b includes a circular main body 141, a plurality of teeth 142 are provided at an edge of the main body 141 at equal intervals, a through hole 143 is provided at a middle portion of the main body 141, and an end portion of the teeth 142 exceeds an end surface of the main body 141, which is close to the first valve body 13b, so that the outer edge of the first valve body 13b is pressed by the teeth 142 when the second valve body 14b presses the first valve body 13b, so that the compression amount can be reduced and the compression deformation space can be increased by providing the teeth 142 at the edge of the main body 141 under the same compression stroke, and the pressing resistance and the resistance of the passage of the instrument can be reduced. The gear-shaped second valve body 14b can reduce the contact area between the hemostatic valve surface and the boss of the gland cap 4 in a limited manner, and the deformation amount can be transmitted to the gap between the adjacent teeth 142 of the second valve body 14b during the compression of the hemostatic valve, thereby effectively reducing the compression resistance.

Furthermore, in order to enable fixation of the hemostatic valve by the snap 6 and pressing the capping cap 4 to press the hemostatic valve, as shown in fig. 9, a plurality of first snaps 17 are provided along the outer edge of the joint body 12, a groove 18 is provided between adjacent first snaps 17, and the joint body 12 is connected to the snap 6 by the first snaps 17 and the groove 18; as shown in fig. 10, a second buckle 19 is arranged on the buckle element 6, and a button elastic piece 21 is arranged on the end surface of the buckle element 6, wherein the button elastic piece 21 of the buckle element 6 slides on the groove 18, so that the groove 18 on the joint main body 12 forms a reserved pressing stroke of the button elastic piece 21 of the buckle element 6; the button shrapnel 21 is also provided with a compression buckle 22.

On the other hand, as shown in fig. 11, the fastener 6 needs to be fitted to the cap 4 to be mounted on the joint body 12, for this purpose, an assembling slot 23, a compressing slot 24 and a boss 25 are provided on the cap 4, wherein the assembling slot 23 is fitted to the second fastener 19, the compressing slot is fitted to the compressing slot 22, and when the cap 4, the fastener 6 and the joint body 12 are mounted in sequence, the second valve body 14b is pressed by the boss 25 according to the pressing force for pressing the cap 4, and the second fastener 19 moves in the assembling slot 23, and the button spring piece 21 moves in the groove 18, thereby forming different pressing effects.

In the process of using the adjustable sheath 1, as shown in fig. 15, when the joint main body 12, the first valve body 13b, the second valve body 14b, the fastener 6 and the gland cap 4 are assembled in sequence, the gland cap 4 generates a vertical pressure F0 on the second valve body 14b, and since the first valve body 13a is made of a silicone rubber which is usually an elastomer, that is, the second valve body 14b is less hard than the first valve body 13b, the F0 can cause the second valve body 14b to receive a force F1, and further generate a force F2 with smaller pressure on the first valve body 13b through the second valve body 14b, and simultaneously, because the edge of the second valve body 14b transmits an inward force F3, the first valve body 13b is pressed inward through F3, so that the first valve body 13b, for example, is pressed inward, at the middle of the first valve body 13b, for example, so that the pressing force F3 is formed inward, at the center of the first valve body 13 b; meanwhile, since the hardness of the second valve body 14b is small, when the second valve body 14b is subjected to the action of F0, an inward acting force F4 is generated, so that the through hole 143 of the second valve body 14b is pressed less. Thus, when the instrument is inserted, the sealing can be kept under the pressure of 0-380mmHg by virtue of the pressing force F3 of the first valve body 13b to the center of the incision and the pressing force F4 of the second valve body 14b to the through hole 143; when no instrument is inserted, the sealing is kept from leaking blood under the pressure of 0-380mmHg by means of the hardness of the first valve body 13b and the extrusion force F3.

When a large catheter (for example, the outer diameter is larger than the inner diameter of the through hole 143 of the second valve body 14 b) is inserted into the adjustable sheath tube 1, the catheter passes through the center of the slit of the first valve body 13b, the catheter presses the silicone rubber to deform from the center to the periphery, F0 is increased by the reaction force, F0 is increased to be shown as the silicone rubber surrounding the center of the slit of the first valve body 13b wraps the catheter, so that the blood leakage can be kept under the pressure of 0-380mmHg, and since the first valve body 13b adopts a m-shaped slit, the silicone rubber at the center of the slit is easy to swing along with the insertion or extraction of the catheter, so that the resistance is small when the catheter passes.

When a guide wire or a smaller catheter is inserted into the adjustable sheath 1 (for example, the size is smaller than the inner diameter of the through hole 143 of the second valve body 14 b), after the gland cap 4 is pressed down to a certain stroke, the compression buckle 22 on the buckle piece 6 is locked, and then F0 is increased, and F1 and F2 are increased simultaneously, and then the silicone rubber at the center of the opening of the first valve body 13b is tightly wrapped by the action of F2, so that the blood leakage is kept under the pressure of 0-380 mmHg.

Moreover, although operations are depicted in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order. In certain circumstances, multitasking and parallel processing may be advantageous. Likewise, while several specific implementation details are included in the above discussion, these should not be construed as limiting the scope of the present disclosure. Certain features that are described in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination.

Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are example forms of implementing the claims.

While various embodiments of the present disclosure have been described in detail, the present disclosure is not limited to these specific embodiments, and various modifications and embodiments can be made by those skilled in the art on the basis of the concepts of the present disclosure, which modifications and modifications should fall within the scope of the claims of the present disclosure.

Claims

1. The utility model provides an adjustable sheath, includes the sheath the proximal end of sheath sets up the joint portion, the joint portion includes interconnect's joint main part and gland cap set up the cavity in the joint main part connect the main part with set up the hemostasis valve between the gland cap, its characterized in that, the hemostasis valve includes first valve body and second valve body, first valve body with the second valve body sets gradually in the cavity set up the boss in the inside of gland cap, it is right the second valve body realizes pressing down set up the incision respectively on two faces of first valve body, every face the incision does not cut through to the another side, the second valve body adopts the gear form, the second valve body includes circular shape main part the equidistant a plurality of teeth that set up in edge in order to increase compression deformation space and reduce the resistance that presses resistance and apparatus passed through of main part set up the through-hole in the middle part of main part, the tip of tooth surpass the main part with the terminal surface that first valve body is close to.

2. The adjustable sheath of claim 1, wherein the connector portion further comprises a clip for press-fitting the first valve body and the second valve body in the cavity.

3. The adjustable sheath of claim 1, wherein the first valve body is disposed proximate the connector body and the second valve body is disposed proximate the gland cap.

4. The adjustable sheath of claim 1, wherein the first valve body and the second valve body are flat disk-shaped and are each made of an elastomer.

5. The adjustable sheath of claim 1, wherein the first valve body and the second valve body are made of silicone rubber, and the second valve body has a hardness less than the hardness of the first valve body.

6. The adjustable sheath of claim 1, wherein a positioning member is fixedly disposed on the connector body, the positioning member being configured to cooperate with the gland cap.

7. The adjustable sheath of claim 1, wherein a straight cut is provided through the first valve body by means of a single slot opening, and a circular recess is provided in the center of the second valve body.

8. The adjustable sheath of claim 1, wherein the cuts are of the same or different shapes, the shape of the cuts being at least one of a one-piece, a cross, a rice, or a multiple-piece.

9. The adjustable sheath of claim 8, wherein the first face and the second face of the first valve body are each provided with a cross-shaped cutout.

10. The adjustable sheath of claim 2, wherein a plurality of first catches are provided along an outer edge of the connector body, a groove is provided between adjacent ones of the first catches, and the connector body is connected to the catch member by the first catches and the groove.

11. The adjustable sheath of claim 10, wherein a second clip is provided on the clip member, a button spring is provided on an end face of the clip member, the button spring sliding over the groove; and the button elastic sheet is also provided with a compression buckle.

12. The adjustable sheath of claim 11, wherein an assembly slot and a compression slot are provided on the pressure cap, the assembly slot and the second clip cooperate with each other, the compression slot and the compression clip cooperate with each other, the second valve body is pressed by the boss while the second clip moves in the assembly slot, and the button spring moves in the groove to form different pressing effects.