CN111374732A

CN111374732A - Hemostatic valve and delivery system

Info

Publication number: CN111374732A
Application number: CN201811642824.3A
Authority: CN
Inventors: 吴洪远; 丁雯; 王国旭; 朱磊; 谭家宏
Original assignee: Shanghai Microport Longmai Medical Equipment Co ltd
Current assignee: Shanghai Microport Longmai Medical Equipment Co ltd
Priority date: 2018-12-29
Filing date: 2018-12-29
Publication date: 2020-07-07

Abstract

The present invention provides a hemostatic valve comprising: the valve seat is provided with a pipe cavity, and the outer surface of the valve seat is provided with at least one tearing groove; the hemostatic valve block is arranged in the cavity of the valve seat and used for limiting the medium from flowing from the far end of the hemostatic valve block to the near end of the hemostatic valve block, and at least one cutting seam is formed in the hemostatic valve block; and the positioning piece is used for limiting the rotation of the hemostatic valve plate relative to the valve seat and limiting the hemostatic valve plate to move in the radial direction of the valve seat. In the invention, the positions of the cutting seam in the hemostatic valve sheet and the tearing groove in the valve seat are relatively fixed on the plane vertical to the axial direction of the valve seat, so that the hemostatic valve sheet can be conveniently torn in the process of tearing the valve seat, and the hemostatic valve can be torn.

Description

Hemostatic valve and delivery system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a hemostatic valve and a delivery system.

Background

Currently, pacemaker implants are typically performed by puncturing the internal jugular vein, femoral vein, or subclavian vein to create a surgical access for insertion of an electrode lead. Among them, subclavian venipuncture is a favored puncture method for doctors because it is easier to enter the heart. The process of establishing the surgical access by subclavian venipuncture is as follows: firstly, puncturing by adopting a puncture needle with an injector; secondly, after confirming the blood vessel, taking down the injector; then, feeding a short guide wire and pulling out the puncture needle; thereafter, inserting the delivery sheath and dilator along the guidewire; the dilator is then withdrawn, and the surgical tunnel is completed. Typically, after the surgical tunnel is established, an electrode lead may be inserted through the surgical tunnel. The electrode lead is inserted into the electrode sheath, the conveying sheath needs to be withdrawn, even if the conveying sheath is separated from the electrode lead, the conveying sheath cannot be directly withdrawn from the proximal end of the electrode lead to realize the separation of the conveying sheath and the electrode lead because the proximal end of the electrode lead is connected with medical equipment outside a patient body, and the conveying sheath and the electrode lead can be separated only by completely tearing the conveying sheath. Thus, the delivery sheaths of delivery systems used in cardiac pacemaker implants are typically tearable delivery sheaths.

However, after the dilator is withdrawn, the delivery sheath left in the body forms a path from the inside of the blood vessel to the outside of the body, which is likely to cause bleeding or air embolism, and if the delivery sheath is left in the body for a long time due to blood flow, it is also likely to cause blood coagulation, and emboli enter the pulmonary artery. To reduce the risk of these phenomena, the physician presses with the thumb on the proximal port of the sheath in the delivery sheath.

There are also delivery systems in the prior art that employ a combination of a hemostatic valve and a delivery sheath that can be torn to reduce the risk of these phenomena. With such a delivery system, both the hemostatic valve and the delivery sheath need to be provided in a tearable form. However, the hemostatic valve and the delivery sheath in these delivery systems are all integrally arranged, and it cannot be guaranteed that the hemostatic valve and the delivery sheath can be torn gently, so that when the hemostatic valve is torn, the delivery sheath is easy to shake, the electrode lead arranged in the lumen of the delivery sheath is affected, the treatment effect is affected, and even some hemostatic valves cannot be torn, so that the hemostatic valves can only be taken out from the far end of the electrode lead.

Disclosure of Invention

The invention aims to provide a hemostatic valve and a delivery system, which aim to solve the problem that the hemostatic valve is not easy to tear in the existing hemostatic valve and delivery system.

In order to solve the above technical problems, the present invention provides a hemostatic valve, including: the valve seat is provided with a pipe cavity, and the outer surface of the valve seat is provided with at least one tearing groove; the hemostatic valve block is arranged in the cavity of the valve seat, and at least one cutting seam is formed on the hemostatic valve block; and the positioning piece is used for limiting the rotation of the hemostatic valve plate relative to the valve seat and limiting the hemostatic valve plate to move in the radial direction of the valve seat.

Optionally, at least one of the slits is aligned with at least one of the tear slots.

Optionally, the setting element includes at least one setting element body and at least one first location portion, first location portion sets up on the setting element body, the setting element body with first location portion sets up in the lumen of disk seat, the setting element body with disk seat fixed connection, hemostasis valve block includes at least one second location portion, first location portion with second location portion is mutually supported.

Optionally, the first positioning portion is a positioning protrusion, the second positioning portion is a positioning groove or a positioning through hole, and the positioning groove or the positioning through hole is sleeved in the positioning protrusion.

Optionally, the positioning element body is an annular protrusion extending inwards from the inner surface of the valve seat, the positioning protrusion is positioning pins arranged on the annular protrusion, and the number of the positioning pins is two.

Optionally, the first positioning portion is a positioning groove or a positioning through hole, the second positioning portion is a positioning protrusion, and the positioning groove or the positioning through hole is sleeved in the positioning protrusion.

Optionally, the tear groove extends in an axial direction of the valve seat.

Optionally, the number of the tearing grooves is one.

The invention also provides a delivery system, which comprises a dilator, a delivery sheath and the hemostatic valve, wherein the proximal end of the hemostatic valve is detachably connected with the dilator, and the proximal end of the delivery sheath is detachably connected with the distal end of the hemostatic valve.

Optionally, the conveying system has a first state and a second state: in a first state, the proximal end of the hemostasis valve is detachably connected with the dilator, and the proximal end of the delivery sheath is detachably connected with the distal end of the hemostasis valve; in a second state, the proximal end of the delivery sheath is detachably connected to the dilator.

Optionally, the proximal end of the hemostasis valve is threadedly connected to the dilator, and the proximal end of the delivery sheath is threadedly connected to the distal end of the hemostasis valve.

Optionally, the dilator includes a dilator seat, a screw cap and a dilator tube, the distal end of the dilator seat communicates with the proximal end of the dilator tube, the screw cap is sleeved on the outer surface of the dilator seat, the screw cap is clamped with the dilator seat, and the screw cap is used for connecting with the hemostatic valve or the delivery sheath through threads.

The hemostatic valve and delivery system provided by the invention have the following beneficial effects:

firstly, because the outer surface of the valve seat is provided with at least one tearing groove, the hemostatic valve plate is arranged in the tube cavity of the valve seat, the hemostatic valve plate is provided with at least one cutting slit, and the positioning piece is used for limiting the rotation of the hemostatic valve plate relative to the valve seat and limiting the radial movement of the hemostatic valve plate on the valve seat, therefore, the cutting slit in the hemostatic valve plate and the tearing groove in the valve seat are relatively fixed at the position on the axial plane vertical to the valve seat, so that the hemostatic valve plate can be conveniently torn in the process of tearing the valve seat, even if the hemostatic valve is torn.

Secondly, because at least one said incision with at least one said tear groove aligns, like this, make the in-process of valve seat tearing, can roughly exert oneself along same direction in order to tear hemostasis valve block and valve seat to can be convenient for the operator to tear hemostasis valve block and valve seat, even be convenient for tear the hemostasis valve.

Thirdly, because the setting element is the follow the internal surface of disk seat is to the location arch of interior extension, set up on the hemostasis valve block with location arch matched with positioning groove or positioning hole, positioning groove or positioning hole cover are established in the location arch, and the setting element is used for the restriction the hemostasis valve block rotates for the disk seat, and is used for the restriction the hemostasis valve block is in the radial of disk seat is removed, consequently can avoid the rotation of hemostasis valve block to make the joint-cutting not align with tearing the groove, and then is unfavorable for the operator to tear hemostasis valve block and disk seat. In addition, when tearing the disk seat, the location arch can with exert power transmission on the disk seat give hemostatic valve piece to can tear hemostatic valve piece when tearing the disk seat, can further be convenient for tear hemostatic valve.

Drawings

FIG. 1 is a schematic diagram of a hemostatic valve according to a first embodiment of the invention;

FIG. 2 is a partial cross-sectional view of a hemostatic valve according to a first embodiment of the invention;

FIG. 3 is a partially exploded view of a hemostatic valve according to a first embodiment of the invention;

FIG. 4 is a schematic structural diagram of a conveying system according to a second embodiment of the present invention;

FIG. 5 is a partial cross-sectional view of a delivery system in accordance with a second embodiment of the present invention;

FIG. 6 is a schematic view of a swivel cap mounted on the dilator tube according to a second embodiment of the present invention;

FIG. 7 is a schematic view of the arrangement of the swivel cap captured in the expander mount according to a second embodiment of the present invention;

FIG. 8 is a schematic structural view of a delivery sheath according to a second embodiment of the present invention;

fig. 9 is a schematic structural view of the delivery sheath and the dilator in the second embodiment of the present invention after being connected.

Description of reference numerals:

100-a hemostatic valve;

110-sheathing cap;

120-hemostatic valve sheet; 121-cross cutting and sewing; 122-a limiting through hole; 123-a limiting through hole;

130-a housing; 131-a valve seat; 131 a-an annular projection; 131 b-the outer surface of the valve seat; 131 c-the inner surface of the valve seat;

132-a first handle; 133-a first handle; 134-a tear groove; 135-locating pins; 136-locating pin; 137-first thread; 138-second thread;

140-side branch hose; 150-three-way valve;

200-a dilator; 210-an expander seat; 211-limit groove; 212-a conical portion; 213-a handle portion;

220-screwing the cap; 221-a limit protrusion; 222-third thread; 230-a dilator tube;

300-a delivery sheath; 310-sheath seat; 311-fourth thread; 320-sheath tube; 330-a second handle; 340-second handle.

Detailed Description

The hemostatic valve and delivery system of the present invention are described in further detail below with reference to the figures and the examples. Advantages and features of the present invention will become apparent from the following description and from the claims. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

Example one

The present embodiments provide a hemostatic valve. Referring to fig. 1, 2 and 3, fig. 1 is a schematic structural view of a hemostatic valve according to a first embodiment of the present invention, fig. 2 is a partial cross-sectional view of the hemostatic valve according to the first embodiment of the present invention, and fig. 3 is a partial exploded schematic view of the hemostatic valve according to the first embodiment of the present invention, wherein the hemostatic valve 100 includes an upper sheath cap 110, a hemostatic valve sheet 120, a housing 130, a side branch hose 140 and a three-way valve 150.

The housing 130 includes a valve seat 131, two

first handles

132, 133, a tear groove 134, two locating

pins

135, 136, first threads 137, and second threads 138.

The valve seat 131 has a lumen.

The two

first handles

132, 133 are symmetrically arranged on the outer surface 131b of the valve seat and fixedly connected with the pipe wall of the valve seat 131. The

first handles

132, 133 can facilitate application of force to the valve seat 131 to facilitate tearing of the valve seat 131.

The tear groove 134 opens on the outer surface 131b of the valve seat. Since the tearing groove 134 is formed in the outer surface 131b of the valve seat, the wall of the valve seat 131 where the tearing groove 134 is formed is thinner than the wall of the other valve seat where the tearing groove 134 is not formed, and when the valve seat 131 is pulled, the wall of the tearing groove 134 where the valve seat 131 is weak is easily torn first.

As shown in fig. 3, the tear groove 134 is preferably formed along the axial direction of the valve seat 131 to minimize the tear path of the valve seat 131, thereby facilitating the tearing of the valve seat 131.

The inner surface 131c of the valve seat extends inward to form an annular protrusion 131a, and the two

positioning pins

135, 136 are symmetrically fixed on the proximal end surface of the annular protrusion 131 a. Two of the positioning pins 135, 136 are disposed in the lumen of the valve seat 131 along the axial direction of the valve seat 131. The annular protrusion 131a can also be used to limit the proximal to distal movement of the hemostatic valve blade.

In other embodiments, other positioning members may be used to limit the rotation of the hemostatic valve plate 120 relative to the valve seat 131 and the radial movement of the valve seat 131. For example, the positioning member includes at least one positioning member body and at least one first positioning portion. The first positioning part is arranged on the positioning part body, the positioning part body and the first positioning part are arranged in a tube cavity of the valve seat, and the positioning part body is fixedly connected with the valve seat. The hemostasis valve block includes at least one second location portion. The first positioning part and the second positioning part are matched with each other to limit the rotation of the hemostatic valve plate relative to the valve seat and limit the radial movement of the hemostatic valve plate on the valve seat.

Specifically, the first positioning portion is a positioning protrusion, the second positioning portion is a positioning groove or a positioning through hole, and the positioning groove or the positioning through hole is sleeved in the positioning protrusion; or the first positioning part is a positioning groove or a positioning through hole, the second positioning part is a positioning bulge, and the positioning groove or the positioning through hole is sleeved in the positioning bulge. In this embodiment, the positioning member body is an annular protrusion 131c extending inward from the inner surface of the valve seat, the number of the positioning member bodies is one, while in other embodiments, the positioning member body may be a plurality of protrusions arranged along the circumferential direction, the plurality of protrusions may have the same or different shapes, and the plurality of protrusions may be uniformly distributed. In other embodiments, one or more first positioning portions may be provided on one of the positioning bodies, or only a part of the positioning bodies may be provided with the first positioning portions.

The first thread 137 is provided on the inner surface of the distal end of the valve seat 131 for connection with a thread structure in the delivery sheath 300.

The second thread 138 is provided on the outer surface of the proximal end of the valve seat 131 for connection with a threaded structure in the dilator 200.

The hemostatic valve sheet 120 is disposed in the lumen of the valve seat 131, and the hemostatic valve sheet 120 is configured to limit the medium (blood) from flowing from the distal end of the hemostatic valve sheet 120 to the proximal end of the hemostatic valve sheet 120, and to limit the medium from flowing from the proximal end of the hemostatic valve sheet to the distal end of the hemostatic valve sheet, that is, to limit the medium from leaking from the lumen of the valve seat 131 to the outside of the lumen, and to limit the medium from entering the lumen of the valve seat 131 from the outside of the lumen.

The hemostatic valve sheet 120 has a cross-shaped slit 121. Preferably, one of the cross slits 121 is aligned with a tear groove 134 in the valve seat 131 of the housing 130, so that an operator can apply force in substantially the same direction when tearing the hemostatic valve sheet 120 and the valve seat 131, thereby facilitating the operator to tear the hemostatic valve sheet 120 and the valve seat 131. In other embodiments, the hemostatic valve member 120 may have a slit, or slits, and the hemostatic valve member 120 has at least one slit that aligns with the tear groove 134 in the valve seat 131 of the housing 130.

The hemostatic valve plate 120 is further provided with two limiting through

holes

122 and 123. Two the dowel pins 135, 136 with two spacing through-

holes

122, 123 cooperate in order to restrict hemostatic valve block 120 and be in follow in the valve seat 131 the axial of valve seat 131 rotates to can avoid hemostatic valve block 120 to rotate and make two kerfs in the cross kerf all not align with tearing groove 134, and then be unfavorable for the operator to tear hemostatic valve block 120 and valve seat 131 open. In addition, because the two

positioning pins

135 and 136 are matched with the two limiting through

holes

122 and 123, the hemostatic valve sheet 120 can be further limited to move in the radial direction of the valve seat 131, when an operator tears the valve seat 131, the positioning pins 135 and 136 can transmit the force applied to the valve seat 131 to the hemostatic valve sheet 120, so that the valve seat 131 can be torn, the hemostatic valve sheet 120 can be torn, and the operator can further tear the hemostatic valve 100 conveniently.

The hemostatic valve plate 120 is preferably a self-lubricating silica gel valve plate, so that an electrode wire can pass through the hemostatic valve plate 120 smoothly, and the pushing force is reduced.

The upper sheath cap 110 is used to further limit the movement of the hemostatic valve sheet 120 in the axial direction of the valve seat 131. Specifically, as shown in fig. 2 and 3, the upper sheath cap 110 is disposed in the lumen of the valve seat 131 and is in interference fit with the valve seat 131, and the distal end surface of the upper sheath cap 110 is attached to the proximal end surface of the hemostatic valve plate 120. The upper sheath cap 110 has a circular ring shape.

The side branch hose 140 is disposed between the valve seat 131 and the three-way valve 150, one end of the side branch hose 140 communicates with the lumen of the valve seat 131, and the other end of the side branch hose 140 communicates with the three-way valve 150.

When the hemostatic valve 100 is torn, the

first handles

132, 133 of the hemostatic valve 100 are held and the valve seat 131 is torn, and meanwhile, the positioning pins 135, 136 drive the hemostatic valve sheet 120 to tear, so that the hemostatic valve 100 is torn integrally.

Example two

The present embodiments provide a conveying system. Referring to fig. 4 and 5, fig. 4 is a schematic structural view of a delivery system in a second embodiment of the present invention, and fig. 5 is a partial cross-sectional view of the delivery system in the second embodiment of the present invention, which includes a dilator 200, a delivery sheath 300, and the hemostatic valve 100 in the first embodiment. The hemostatic valve 100 is sleeved on the outer surface of the dilator 200, the proximal end of the hemostatic valve 100 is detachably connected with the dilator 200, the delivery sheath 300 is sleeved on the outer surface of the dilator 200, and the proximal end of the delivery sheath 300 is detachably connected with the distal end of the hemostatic valve 100.

The dilator 200 includes a dilator seat 210, a swivel cap 220, and a dilator tube 230.

The expander seat 210 is tubular. The distal end of the dilator seat 210 communicates with the proximal end of the dilator tube 230. The screw cap 220 is sleeved on the outer surface of the expander seat 210, and the screw cap 220 is clamped with the expander seat 210.

The expander seat 210 includes a limiting portion disposed on an outer surface of the expander seat 210, and the limiting portion is used to limit the movement of the screw cap 220 in an axial direction of the expander seat 210.

Specifically, as shown in fig. 6 and 7, fig. 6 is a schematic structural view of the second embodiment of the present invention in which the screw cap 220 is sleeved on the dilator tube 230, fig. 7 is a schematic structural view of the second embodiment of the present invention in which the screw cap 220 is clamped in the dilator seat 210, the limiting portion is a limiting groove 211 disposed on the outer surface of the dilator seat 210, and the limiting groove 211 is an annular groove disposed on the outer tube wall of the dilator seat 210. The screw cap 220 includes a limiting protrusion 221, and the limiting protrusion 221 is an annular protrusion extending inward from the inner tube wall of the screw cap 220. The limiting protrusion 221 is clamped in the limiting groove 211, and the screw cap 220 can only rotate under the action of the limiting protrusion 221 and the limiting groove 211. In other embodiments, an outward extending limiting protrusion 221 may be disposed on the outer surface of the expander seat 210, a limiting groove 211 may be disposed on the tube wall of the screw cap 220, and the screw cap 220 may be limited from moving in the axial direction of the expander 200 by the combined action of the limiting protrusion 221 and the limiting groove 211.

The expander seat 210 further includes a tapered portion 212, the tapered portion 212 is disposed on the distal outer surface of the expander seat 210, the large end of the tapered portion 212 is connected to the stopper groove 211, and the small end of the tapered portion 212 is disposed away from the stopper groove 211. The large end of the conical part 212 is in interference fit with the annular protrusion.

The expander base 210 further comprises a handle portion 213, the handle portion 213 being disposed on the outer surface of the proximal end of the expander base 210, the distal end of the handle portion 213 being connected to the stopper groove 211, and the proximal end of the handle portion 213 being disposed away from the stopper groove 211.

The screw cap 220 is tubular, and the screw cap 220 is used for being connected with one of the hemostatic valve 100 or the delivery sheath 300 in a threaded manner. The inner pipe wall of the screw cap 220 is provided with a third thread 222. The third threads 222 are adapted to cooperate with the second threads 138 to secure the hemostatic valve 100 to the dilator 200.

As shown in FIG. 6, with the cap 220 fitted over the outer surface of dilator tube 230, the cap 220 may be moved proximally from the distal end of dilator tube 230 and pushed into the retaining groove 211 to capture the cap 220 in the retaining groove 211 by the engagement of the annular protrusion with the retaining groove 211. Since the large end of the tapered part 212 is in interference fit with the annular protrusion, the annular protrusion of the screw cap 220 can be pushed into the limiting groove 211 with proper force, and the structure of the screw cap 220 clamped in the expander seat 210 is schematically shown in fig. 7. Since the screw cap 220 can be rotated, the valve seat 131 in the hemostatic valve 100 can be screwed into the lumen of the screw cap 220 by rotating the screw cap 220 under the action of the second thread 138, thereby achieving the fixed connection of the hemostatic valve 100 and the dilator 200.

The proximal end of the dilator tube 230 is in fixed communication with the distal end of the dilator seat 210, and the distal end of the dilator tube 230 is pointed.

Referring to fig. 8, fig. 8 is a schematic structural view of a delivery sheath 300 according to a second embodiment of the present invention, wherein the delivery sheath 300 includes a sheath holder 310, a sheath 320 and two symmetrically disposed

second handles

330, 340. The sheath seat 310 is connected with the sheath tube 320, and the lumen of the sheath seat 310 is communicated with the lumen of the sheath tube 320. The sheath seat 310 may tear. A fourth thread 311 is disposed on an outer surface of the sheath seat 310, and the fourth thread 311 is configured to cooperate with the first thread 137 or the third thread 222.

In other embodiments, the distal end of the hemostatic valve 100 may be connected to the proximal end of the delivery sheath 300 by a snap fit, the proximal end of the hemostatic valve 100 may be connected to the dilator 200 by a snap fit, and the dilator 200 may be directly connected to the proximal end of the delivery sheath 300 by a snap fit. The clamping structure of the far end of the hemostatic valve 100 and the near end of the delivery sheath 300 and the clamping structure of the dilator 200 and the near end of the hemostatic valve 100 can be the same or two different clamping structures, and when the clamping structure of the far end of the hemostatic valve 100 and the near end of the delivery sheath 300 is the same as the clamping structure of the dilator 200 and the near end of the hemostatic valve 100, the dilator 200 can be directly clamped with the delivery sheath 300. Of course, the distal end of the hemostatic valve 100 may be connected to the proximal end of the delivery sheath 300 by a tapered interference fit, and the proximal end of the hemostatic valve 100 may be connected to the dilator 200 by a tapered interference fit. And the dilator 200 can also be directly connected with the proximal end of the delivery sheath 300 by means of a conical interference fit.

The sheath 320 may be made of an axially tearable PTFE material. Since the PTFE material is difficult to bond, the delivery sheath 300 is formed by double-side through injection molding in this embodiment.

Because the delivery sheath 300 and the hemostatic valve 100 can be detachably connected through the first thread 137 and the fourth thread 311, that is, the delivery sheath 300 and the hemostatic valve 100 are designed in a split manner, after the hemostatic valve 100 is unscrewed from the delivery sheath 300, the hemostatic valve 100 can be separated from the electrode lead by tearing the hemostatic valve 100, and the electrode lead in the delivery sheath 300 is not easily affected.

Since the fourth thread 311 can be mated with either the first thread 137 or the third thread 222, and the second thread 138 can be mated with the third thread 222, the delivery system can have the following two operating states. In a first state, the proximal end of the hemostatic valve 100 is threadedly connected to the dilator 200 and the proximal end of the delivery sheath 300 is threadedly connected to the distal end of the hemostatic valve 100; in the second state, the proximal end of the delivery sheath 300 is threadedly coupled to the dilator 200. Thus, the delivery sheath 300, the hemostatic valve 100, and the dilator 200 can be freely combined according to clinical needs, so that a doctor has more choices, thereby improving the flexibility of the delivery system. If the operation time is long or the bleeding is more, the doctor can adopt the hemostatic valve 100 to avoid the bleeding and the air embolism in the pacemaker implantation operation process, and simultaneously, the hemostatic valve 100 can be quickly fixed with the dilator 200 and the delivery sheath 300, and the hemostatic valve 100 can be quickly separated from the dilator 200 and the delivery sheath 300, so that the operation is convenient. If the operation time is short, the hemostatic valve 100 is not needed, and the dilator 200 can be directly fixed with the delivery sheath 300, and bleeding is not easy to occur. As shown in fig. 9, fig. 9 is a schematic structural view of the delivery sheath 300 and the dilator 200 according to the second embodiment of the present invention, when the third thread 222 in the screw cap 220 is matched with the fourth thread 311 in the delivery sheath 300, the hemostatic valve 100 is not disposed between the delivery sheath 300 and the dilator 200.

The hemostatic valve 100 is sleeved on the outer surface of the dilator 200, the proximal end of the hemostatic valve 100 is detachably connected with the dilator 200, the delivery sheath 300 is sleeved on the outer surface of the dilator 200, and the proximal end of the delivery sheath 300 is detachably connected with the distal end of the hemostatic valve 100.

The "proximal" and "distal" in the above embodiments are relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a physician using the medical device, although "proximal" and "distal" are not intended to be limiting, but "proximal" generally refers to the end of the medical device that is closer to the physician during normal operation, and "distal" generally refers to the end that is first introduced into the patient. Furthermore, the term "or" in the above embodiments is generally used in the sense of comprising "and/or" unless otherwise explicitly indicated. In the above embodiments, "both ends" refer to the proximal end and the distal end.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims

1. A hemostatic valve, comprising:

the valve seat is provided with a pipe cavity, and the outer surface of the valve seat is provided with at least one tearing groove;

the hemostatic valve block is arranged in the cavity of the valve seat, and at least one cutting seam is formed on the hemostatic valve block; and

and the positioning piece is used for limiting the rotation of the hemostatic valve plate relative to the valve seat and limiting the hemostatic valve plate to move in the radial direction of the valve seat.

2. The hemostatic valve according to claim 1, wherein at least one of the slits is aligned with at least one of the tear slots.

3. The hemostatic valve according to claim 2, wherein the positioning member comprises at least one positioning member body and at least one first positioning portion, the first positioning portion is disposed on the positioning member body, the positioning member body and the first positioning portion are disposed in the lumen of the valve seat, the positioning member body is fixedly connected to the valve seat, the hemostatic valve plate comprises at least one second positioning portion, and the first positioning portion and the second positioning portion are engaged with each other.

4. The hemostatic valve according to claim 3, wherein the first positioning portion is a positioning protrusion, the second positioning portion is a positioning groove or a positioning through hole, and the positioning groove or the positioning through hole is sleeved in the positioning protrusion.

5. The hemostatic valve according to claim 4, wherein the retainer body is an annular protrusion extending inwardly from the inner surface of the valve seat, the retainer protrusion being two retainer pins disposed on the annular protrusion.

6. The hemostatic valve according to claim 3, wherein the first positioning portion is a positioning groove or a positioning through hole, the second positioning portion is a positioning protrusion, and the positioning groove or the positioning through hole is sleeved in the positioning protrusion.

7. The hemostasis valve of claim 3, further comprising an over-sheath cap for limiting axial movement of the hemostasis valve blade in the valve seat.

8. The hemostatic valve according to claim 1, wherein the tear groove extends in an axial direction of the valve seat.

9. The hemostatic valve according to claim 1, wherein the tear groove is one in number.

10. A delivery system comprising a dilator, a delivery sheath, and a hemostatic valve according to any one of claims 1 to 8, the hemostatic valve having a proximal end detachably connected to the dilator and a proximal end detachably connected to a distal end of the hemostatic valve.

11. The delivery system of claim 10, wherein the delivery system has a first state and a second state:

in a first state, the proximal end of the hemostasis valve is detachably connected with the dilator, and the proximal end of the delivery sheath is detachably connected with the distal end of the hemostasis valve;

in a second state, the proximal end of the delivery sheath is detachably connected to the dilator.

12. The delivery system of claim 10, wherein the proximal end of the hemostasis valve is threadably coupled to the dilator and the proximal end of the delivery sheath is threadably coupled to the distal end of the hemostasis valve.

13. The delivery system of claim 12, wherein the dilator comprises a dilator seat, a screw cap and a dilator tube, the distal end of the dilator seat is in communication with the proximal end of the dilator tube, the screw cap is sleeved on the outer surface of the dilator seat, and the screw cap is in snap fit with the dilator seat, the screw cap is used for being in threaded connection with the hemostasis valve or the delivery sheath.