Sealing system and delivery sheath

Abstract

The application provides a sealing system, comprising a connecting seat and a sealing assembly in the connecting seat, the sealing assembly is convex to a distal end, and the distal end of the sealing assembly comprises a polygonal cutting surface. The sealing system provided by the application comprises the polygonal cutting surface which is convex to the distal end, so that the blood impact force can be dispersed, the force can be unloaded quickly, the collapse or folding of the sealing assembly caused by the fact that the distal end surface of the sealing assembly cannot unload force in time due to too large instantaneous force can be prevented, the support force can be provided to the sealing assembly, the folding of the sealing assembly caused by the retreat of other instruments can be prevented, the sealing property of the sealing assembly can be ensured, blood leakage can be prevented, the operation risk can be reduced, and the operation safety can be improved.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to a sealing system and delivery sheath. Background Technology

[0002] Delivery sheaths, commonly used medical devices in cardiovascular interventional procedures, are primarily used to establish a connection between the body's blood vessels and the external environment, facilitating the entry and exit of other instruments such as sheath cores, guidewires, and catheters. The delivery sheath must include a sealing system to ensure a tight seal after insertion and during the connection established by other instruments, preventing blood leakage; it must also allow for easy insertion of other instruments along the delivery sheath.

[0003] Existing delivery sheaths, when used as connecting channels during surgery, are prone to folding of the sealing gaskets inside due to blood impact or the back-and-forth transport of other instruments. This compromises the sealing of the delivery sheath during surgery, leading to blood leakage and compromising surgical safety. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to address the defect in the prior art where the sealing gasket is easily folded due to blood impact or the back and forth transport of other instruments, resulting in insufficient sealing. The present invention provides a sealing system and a transport sheath.

[0005] The technical solution adopted by this invention to solve its technical problem is:

[0006] On one hand, one embodiment of the present invention provides a sealing system including a connector and a sealing component located within the connector, the sealing component protruding toward a distal end, and the distal end of the sealing component including a polygonal cut surface.

[0007] In addition, the sealing system according to the present invention may also have the following additional technical features:

[0008] In some embodiments of the present invention, the polygonal cut surface includes a triangular cut surface.

[0009] In some embodiments of the invention, the included angle formed by two adjacent polygonal cut surfaces on the distal side is greater than 180°.

[0010] In some embodiments of the present invention, the sealing assembly includes a first sealing gasket and a second sealing gasket, the second sealing gasket being located at the distal end of the first sealing gasket, the first sealing gasket including a distal plane abutting against the second sealing gasket, the second sealing gasket including an abutting portion and a buffer portion arching distally from the abutting portion, the abutting portion abutting against the distal plane of the first sealing gasket, and the polygonal cut surface being disposed at the distal end of the buffer portion.

[0011] In some embodiments of the present application, the sealing system is formed with an axial channel, the sealing assembly is provided with a through hole in communication with the axial channel, the through hole comprises a cutout provided at the first sealing gasket and the second sealing gasket.

[0012] In some embodiments of the present application, the cutout length of the second sealing gasket is greater than the cutout length of the first sealing gasket.

[0013] In some embodiments of the present application, the cutout of the first sealing gasket comprises a first cutting line and a second cutting line located at the distal end plane, the first cutting line intersects with the second cutting line, and the intersection point penetrates the first sealing gasket.

[0014] In some embodiments of the present application, the buffer portion comprises a connecting surface arranged in a radial direction, the cutout of the second sealing gasket comprises a third cutting line and a fourth cutting line located at the connecting surface, the third cutting line intersects with the fourth cutting line, and the intersection point penetrates the second sealing gasket.

[0015] In some embodiments of the present application, the cutout of the first sealing gasket and the cutout of the second sealing gasket are not in the same axial plane.

[0016] In some embodiments of the present application, the proximal end of the buffer portion comprises a smooth circular arc surface.

[0017] In some embodiments of the present application, the second sealing gasket is a whole-arched silica gel gasket, the abutting portion of the second sealing gasket is annular, the proximal end of the buffer portion is a smooth circular arc surface, the height of the circular arc surface defining the proximal end of the buffer portion is H, and the inner diameter of the annular abutting portion is L, then H and L satisfy: 1 / 4≤H / L≤1.

[0018] In some embodiments of the present application, H and L satisfy: H / L = 1 / 2.

[0019] In some embodiments of the present application, the buffer portion comprises a connecting surface and a plurality of oblique cutting surfaces, the connecting surface is located at the central region of the distal end side of the buffer portion, the oblique cutting surfaces connect the connecting surface and the abutting portion, the thickness of the abutting portion of the second sealing gasket is defined as d1, the thickness of the oblique cutting surface is defined as d2, and the thickness of the connecting surface is defined as d3, then d1, d2, and d3 satisfy: d1>d2>d3.

[0020] In some embodiments of the present application, the connecting seat comprises, in sequence from proximal end to distal end, a gland, a connecting joint, and a front end cover, the gland is fixedly connected to the proximal end of the connecting joint, the front end cover is fixedly connected to the distal end of the connecting joint, the proximal end of the gland is provided with a first through hole, the distal end of the front end cover is provided with a second through hole, an axial channel is formed between the first through hole and the second through hole, a replaceable joint is arranged on one side of the connecting seat close to the distal end, and the sealing assembly is located between the gland and the connecting joint.

[0021] In another aspect, the present application also provides a delivery sheath comprising the sealing system and a sheath tube extending distally from the sealing system.

[0022] The sealing system can not only disperse the blood impact force to achieve rapid force relief and prevent the collapse or folding of the sealing assembly due to the failure of the distal surface of the sealing assembly to relieve force in time under too large instantaneous force, but also provide support force to the sealing assembly to prevent the folding of the sealing assembly caused by the retreat of other instruments, thereby ensuring the sealing property of the sealing assembly, preventing blood leakage, reducing the risk of surgery, and improving the safety of surgery. BRIEF DESCRIPTION OF DRAWINGS

[0023] The present application will be further described below in conjunction with the drawings and examples, in which:

[0024] Figure 1 is a structural schematic diagram of a delivery sheath according to an embodiment of the present application;

[0025] Figure 2 is a structural schematic diagram of a sealing system according to an embodiment of the present application;

[0026] Figure 3 is an exploded view of Figure 2 ;

[0027] Figure 4 is a plan view of Figure 2 ;

[0028] Figure 5 is a sectional view of Figure 4 ;

[0029] Figure 6 is a structural schematic diagram of a first sealing gasket according to an embodiment of the present application;

[0030] Figure 7 is a schematic diagram of a distal end face of the first sealing gasket according to an embodiment of the present application;

[0031] Figure 8 is a sectional view along the central direction of Figure 7 ;

[0032] Figure 9 is a schematic view of a distal end face of a second sealing gasket according to an embodiment of the present application;

[0033] Figure 10 is a perspective view of Figure 9 ;

[0034] Figure 11a is a cross-sectional view along the central direction of Figure 10 ;

[0035] Figure 11b is a schematic view of an arch distance definition of a buffer portion of a second sealing gasket according to an embodiment of the present application;

[0036] Figure 12 is a schematic view of a structure of a delivery sheath being penetrated by a sheath core according to an embodiment of the present application;

[0037] Figure 13 is a schematic view of a structure of a sealing system being penetrated by a sheath core according to an embodiment of the present application;

[0038] Figure 14 is a cross-sectional view of Figure 13 ;

[0039] Figure 15 is a schematic view of a structure of a sealing assembly being penetrated by a sheath core according to an embodiment of the present application;

[0040] Figure 16 is a schematic view of another angle of a structure of a sealing assembly being penetrated by a sheath core according to an embodiment of the present application. DETAILED DESCRIPTION

[0041] In order to make the above objectives, features and advantages of the present application more clear and comprehensible, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, a lot of specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be implemented in many different ways other than those described herein, and one of ordinary skill in the art can make similar improvements without departing from the scope of the present application, and therefore the present application is not limited to the specific embodiments disclosed below.

[0042] It should be noted that when an element is referred to as being "on" or "fixed to" another element, it can be directly on the other element or there can be an intervening element. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or there can be an intervening element. The terms "vertical", "horizontal", "left", "right", and similar expressions used herein are used for illustrative purposes only and are not intended to be limiting. In the description of the present application, the meaning of "a plurality of" is at least two, for example, two, three, etc., unless otherwise specifically defined.

[0043] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0044] In this application, "proximal end" refers to the end closer to the operator, "proximal side" refers to the side closer to the operator, "distal end" refers to the end furthest from the operator, and "distal side" refers to the side furthest from the operator.

[0045] Please see Figures 1-5 This invention provides an adjustable delivery sheath 100, comprising a sealing system 10, a handle housing 20, and a sheath tube 30. The sealing system 10 is disposed within the handle housing 20. The sheath tube 30 communicates with the sealing system 10, extends distally, and exits from the distal end of the handle housing 20. Specifically, the proximal end of the sheath tube 30 is connected to the distal end of the sealing system 10 so that when the sheath tube 30 is inserted into the human body, the sealing system 10 forms a sealed cavity to prevent blood leakage. The handle housing 20 also includes an adjustment system for adjusting the bending of the sheath tube 30, which will not be described in detail here.

[0046] Please see Figures 2-5 The present invention provides a sealing system 10, such as Figures 3-4 Combination Figure 5 As shown, the sealing system 10 includes a connecting seat 11, a sealing assembly 12, and an axial channel 13. The sealing assembly 12 is located within the connecting seat 11. The connecting seat 11 and the sealing assembly 12 cooperate to form an axial channel 13 communicating with the sheath 30. The axial channel 13 allows other instruments to pass through from the proximal end to the distal end of the delivery sheath 100, thereby delivering other instruments to the human body. The sealing assembly 12 protrudes distally, and the distal end of the sealing assembly 12 also includes a polygonal cut surface located distally.

[0047] like Figure 3 and Figure 5As shown, the connecting seat 11 comprises, from proximal end to distal end, a gland 111, a connecting joint 112, a replaceable joint 113 and a front end cover 114. The gland 111 is fixedly connected to the proximal end of the connecting joint 112 so as to press the sealing assembly 12 between the gland 111 and the connecting joint 112, and the front end cover 114 is fixed to the distal end of the connecting joint 112. The proximal end of the gland 111 is provided with a first through hole 1111, and the distal end of the front end cover 114 is provided with a second through hole 1141, and an axial channel 13 is formed between the first through hole 1111 and the second through hole 1141 for other instruments to pass through. However, since the axial channel 13 is provided with the sealing assembly 12 made of silicone, and the sealing assembly 12 is provided with an incomplete opening notch, a sealing system with good sealing performance is formed between the connecting seat 11 and the sealing assembly 12.

[0048] In the embodiment, the connecting joint 112 is a T-shaped joint, as shown in Figure 3 The proximal end of the T-shaped joint is fixedly connected to the gland 111 by screwing, the distal end of the T-shaped joint is fixedly connected to the front end cover 114 by screwing, and the bottom joint of the T-shaped joint is connected with a three-way valve. The replaceable joint 113 is provided with a small hole 1131 corresponding to the position of the bottom joint of the T-shaped joint, as shown in Figure 5 so as to facilitate other operations such as drainage or injection during the operation. The bottom joint of the T-shaped joint is connected with the three-way valve 15 through the hose 14, as shown in Figure 5 In combination with Figure 1 When the delivery sheath 100 penetrates into the human body, the bottom joint of the T-shaped joint is closed through the three-way valve 15 so that the sealing system 10 remains sealed, as shown in Figure 5 In combination with Figure 1 As shown.

[0049] As shown in combination with Figure 3 As shown in combination with Figure 5 The side of the connecting seat 11 close to the distal end is also provided with a hollow replaceable joint 113, and the replaceable joint 113 is fixedly connected to the connecting joint 112 by interference fit.

[0050] As shown in combination with Figures 4-5 The side of the proximal end of the sheath tube 30 is bonded in the second through hole 1141 of the front end cover 114 and communicates with the axial channel 13 of the sealing system 10, and since the sheath tube 30 is subjected to a force along the axial direction towards the proximal end when it enters the human body, the proximal end face of the sheath tube 30 abuts against the distal end face of the replaceable joint 113 so as to support the sheath tube 30 along the axial direction.

[0051] The sealing assembly 12 is located in the connecting seat 11, and the sealing assembly 12 comprises a first sealing gasket 121 and a second sealing gasket 122, and the second sealing gasket 122 is located at the distal end of the first sealing gasket 121. In the embodiment, as shown inFigures 6-8 As shown in Figure 5 The first sealing gasket 121 is a flat silica gel gasket, and a first groove 1211 is formed in a center region of the proximal end of the first sealing gasket 121, as shown in Figure 8 The first sealing gasket 121 is a flat silica gel gasket, and a first groove 1211 is formed in a center region of the proximal end of the first sealing gasket 121, as shown in

[0052] As shown in Figures 9-11b As shown in Figure 5 The second sealing gasket 122 is an arched silica gel gasket, and the second sealing gasket 122 includes an abutting portion 1221 and a buffer portion 1222, as shown in Figure 11a The abutting portion 1221 is arranged on the proximal end side of the buffer portion 1222 in the circumferential direction, and the proximal end of the abutting portion 1221 abuts against the distal end plane 1212 of the first sealing gasket 121 in the circumferential direction, and the distal end of the abutting portion 1221 abuts against the proximal end face of the T-shaped joint in the circumferential direction.

[0053] The buffer portion 1222 is an arched structure extending from the proximal end of the abutting portion 1221 to the distal end in the circumferential direction, and a space is formed between the arched structure and the first sealing gasket 121, and the proximal end of the buffer portion 1222 includes a support segment 12221 arranged in the circumferential direction around the axial direction and a buffer segment 12222 connected by a plurality of polygonal cutting surfaces, as shown in Figure 10 As shown in Figure 11a The support segment 12221 is used to transitionally connect the buffer segment 12222 and the abutting portion 1221, and to support the buffer segment 12222 in the axial direction. The distal end face of the buffer portion 1222 includes polygonal cutting surfaces protruding toward the distal end, and the included angle between two adjacent polygonal cutting surfaces formed on the distal end side is greater than 180°, that is, the common side between the two adjacent polygonal cutting surfaces protrudes toward the distal end side, as shown in Figures 10-11a As shown in

[0054] In the present implementation, asFigures 9-10 As shown, the distal side of the buffer section 12222 includes a hexagonal connecting surface 12222a arranged radially in the central region and a plurality of triangular cutting surfaces 12222b arranged obliquely for connecting the support section 12221 and the connecting surface 12222a. The triangular cutting surfaces 12222b are stable in structure and can provide stable support when the instrument being delivered is retracted or the distal surface of the second sealing gasket is impacted by blood, so as to more stably dissipate the impact force or prevent folding, thereby providing better sealing and preventing blood from overflowing.

[0055] During the operation, different instruments need to be delivered multiple times, which can easily cause the first sealing gasket 121 as a flat gasket to fold. The buffer section 12222 of the second sealing gasket 122 can timely dissipate the force due to the distal end being divided into polygonal cutting surfaces protruding toward the distal end, so as not to easily fold or collapse, and can make the sealing system continue to maintain good sealing.

[0056] In the present embodiment, the proximal end of the buffer section 1222 further includes a smooth circular arc surface. When the second sealing gasket 122 is impacted by blood, the arc can more quickly dissipate the force to ensure the sealing of the sealing assembly 12 and prevent blood leakage. Meanwhile, the arc provides certain support to the distal surface of the second arc gasket to prevent folding. The proximal end of the second sealing gasket 122 is arranged as a smooth circular arc surface or a hemispherical surface, which reduces the thickness of the central region of the second sealing gasket 122 (corresponding to the connecting surface with a cutting mark) so that the medical instrument can be more easily and labor-savingly pushed along the delivery sheath 100 to enter the diseased site, thereby shortening the operation time, reducing the pain of the patient, and improving the operation efficiency.

[0057] In other embodiments, as shown in FIG. 6, the distal end of the buffer section 12222 includes a hexagonal connecting surface 12222a arranged radially in the central region and a plurality of triangular cutting surfaces 12222b arranged obliquely for connecting the support section 12221 and the connecting surface 12222a. Figures 11a-11b In combination with the above embodiments, the second sealing gasket 122 can be arranged as shown in FIG. 7. Figures 9-10As shown, the second sealing gasket is an overall arched silica gel gasket, the abutting portion of the second sealing gasket is annular, the proximal end of the buffer portion is a smooth circular arched surface, the height of the circular arch defining the proximal end of the buffer portion is H, and the inner diameter of the annular abutting portion is L, then H and L satisfy: 1 / 4≤H / L≤1. In this embodiment, H / L=1 / 2, that is, the circular arch is hemispherical, and the support force of the arched portion as the buffer portion is better. When H / L<1 / 4 or even tends to 0, the buffer portion may even not be able to provide support, thereby reducing the sealing effect of the second sealing gasket, and the second sealing gasket is equivalent to a flat gasket. At this time, the sealing assembly composed of the second sealing gasket and the flat first sealing gasket increases the thickness of the flat gasket, making it difficult for the sealing assembly to be punctured. When the puncture point (where the notch is arranged) of the second sealing gasket is far away from the abutting portion along the axial direction (when H / L is greater than 1), the proportion of the buffer portion to the overall second sealing gasket is too large, and the abutting portion is difficult to be fixed and compressed. When the instrument is withdrawn, the abutting portion of the second sealing gasket is easy to be separated from the fixed position, and the buffer portion is too long along the axial direction, the distance between the connecting surface and the abutting portion is farther, and the abutting portion and the buffer portion provide smaller support to the connecting surface along the axial direction.

[0058] Since the blood impacts the second sealing gasket from the distal end to the proximal end, the thickness of the abutting portion of the second sealing gasket is defined as d1, the thickness of the triangular cutting surface (oblique cutting surface) is defined as d2, and the thickness of the connecting surface is defined as d3, then d1, d2 and d3 satisfy: d1>d2>d3. The connecting surface in the central region is the thinnest, and the instrument is convenient to push and withdraw when passing through the connecting surface; the thickness of the triangular cutting surface is moderate and greater than the thickness of the connecting surface, so that the triangular cutting surface can provide better support to the connecting surface (the top of the arch) when the instrument is pushed (the connecting surface is punctured). That is, when the instrument is pushed (the instrument is inserted from the proximal end to the distal end), the connecting surface is folded towards the distal end to wrap the instrument, and the instrument has a pulling force towards the distal end on the connecting surface, so that the connecting surface pulls the triangular cutting surface towards the distal end. Since the thickness of the triangular cutting surface is greater than the thickness of the connecting surface, the triangular cutting surface can provide a certain counterforce to the connecting surface, so that the connecting surface better wraps the instrument and has better sealing performance. When the instrument is withdrawn (the instrument is withdrawn from the distal end to the proximal end), the polygonal cutting surface provides support to the connecting surface to prevent the connecting surface from being folded towards the proximal end. Figure 11b As shown, the sealing assembly 12 is provided with a through hole 123 communicating with the axial channel 13. In this embodiment, the through hole 123 includes a notch arranged in the central region of the first sealing gasket 121 and the second sealing gasket 122 and not fully opened. The sealing assembly can wrap the sheath core, guide wire or catheter and other instruments of different specifications and effectively seal the instruments.

[0059] As shown, Figure 7 In combinationFigure 8 As shown, the cut of the first sealing gasket 121 includes a first cutting line 1231 and a second cutting line 1232 on the distal end plane 1212 of the first sealing gasket 121, wherein the first cutting line 1231 intersects the second cutting line 1232 and the intersection point penetrates the first sealing gasket 121. As shown, the first cutting line 1231 and the second cutting line 1232 are straight lines. Figure 9 In combination with Figure 10 As shown, the cut of the second sealing gasket 122 includes a third cutting line 1233 and a fourth cutting line 1234 on the connecting surface 12222a, wherein the third cutting line 1233 intersects the fourth cutting line 1234 and the intersection point penetrates the second sealing gasket 122. Since the sealing assembly 12 is composed of two silicone gaskets, the cut with penetration only at the intersection of the cutting lines can ensure that the sealing assembly 12 can close the proximal end of the sealing system 10 when the sealing system 10 is in a natural state. In other embodiments, the length of the cut of the distal second sealing gasket 122 is greater than the length of the cut of the proximal first sealing gasket 121, so that when the instrument penetrates the sealing assembly, it is more convenient for the instrument to advance distally with less force, and at the same time, the length of the cut of the proximal first sealing gasket is smaller, which is more convenient for further leakage prevention.

[0060] In order to achieve better sealing effect, the cut of the first sealing gasket 121 and the cut of the second sealing gasket 122 are not in the same axial plane. In this embodiment, the first cutting line 1231 and the second cutting line 1232 intersect to form a positive "cross" shape, as shown in Figure 6 As shown, the third cutting line 1233 and the fourth cutting line 1234 intersect to form an "X" shape, as shown in Figure 9 As shown, it is easier to penetrate than a straight cut, and it is not difficult to push because the sealing assembly 12 is a double-layer gasket. That is, when they are moved to the same radial plane along the axial direction, they form a "rice" shape, so that the cutting lines of the first sealing gasket 121 and the cutting lines of the second sealing gasket 122 are not in the same axial plane, that is, from the axial direction, the cutting straight lines on the first sealing gasket 121 and the cutting straight lines on the second sealing gasket 122 do not overlap. The position of the distal end of the second sealing gasket 122 subjected to blood impact corresponds to the position of the first sealing gasket 121 along the axial direction without cutting lines. The sealing assembly 12 formed by the cooperation of the first sealing gasket 121 and the second sealing gasket 122 has better sealing security, and the arrangement of the cutting lines makes the sealing assembly 12 easier to push in while still maintaining good sealing performance.

[0061] For example, the sheath core 200 (the instrument to be delivered) is inserted into the delivery sheath 100 along the axial channel, as shown in Figures 12-16As shown, when the sheath core 200 pierces into the sealing system 10 through the first through hole 1111 near the end of the gland 111 and the cut of the sealing assembly 12 (the sheath core 200 moves axially from the proximal end to the distal end), the sheath core 200 passes through the intersection of the cuts of the first sealing gasket 121 and the second sealing gasket 122. After being pierced, the silicone gasket wraps around the sheath core 200, as... Figures 15-16 As shown. When blood flows along Figure 15 When the arrow in the direction of c impacts the distal end face of the second sealing gasket, since both the first sealing gasket 121 and the second sealing gasket 122 tightly wrap around the sheath core 200, and the distal end of the second sealing gasket 122 is provided with a polygonal cut surface, it can quickly dissipate the impact force of the blood, preventing the second sealing gasket 122 from collapsing or folding due to excessive instantaneous force on the distal surface of the second sealing gasket 122 and failure to dissipate the force in time. At the same time, the polygonal cut surfaces support each other, which can further buffer the blood flow and prevent the second sealing gasket 122 from collapsing or folding. Thus, the sealing system can still maintain an effective seal when other instruments are transported during the operation.

[0062] Since the sheath core 200 or other instruments need to be retracted after being inserted through the delivery sheath (the sheath core 200 moves axially from the distal end to the proximal end), during retraction, the polygonal cut surface on the distal side of the buffer 1222 convexes to the distal end, and there is good support between the polygonal cut surfaces. This can prevent the frictional force towards the proximal end caused by the retraction of the sheath core 200 from causing the buffer 1222 of the second sealing gasket 122 to fold over, thereby preventing blood leakage, ensuring sealing, and helping to improve the safety and success rate of the operation. Since the gasket is made of silicone, and the second sealing gasket 122 is bonded to the first sealing gasket 121, and then together they are threaded to the proximal end of the connecting joint 112 with the pressure cap 111, thereby pressing and fixing the sealing assembly 12. When the instrument is withdrawn, the sealing gasket in the prior art is subjected to greater force, which may cause the gasket to fold significantly. In addition, the fixed part of the gasket may detach from the connecting seat and be taken out of the sealing system with the instrument due to excessive deformation. The second sealing gasket 122 provided in this embodiment has a polygonal cut surface at its distal end, which makes the buffer part 1222 of the second sealing gasket 122 less prone to folding. This can prevent the second sealing gasket 122 from detaching from the proximal end of the first sealing gasket 121 and the T-joint and being taken out of the sealing system 10 by the instrument, thereby ensuring the sealing performance of the sealing system 10.

[0063] The sealing system provided by the present application is convex towards the distal end, and the distal end of the sealing assembly comprises a polygonal cutting surface, so that the sealing assembly can unload force in time when encountering blood impact, to avoid folding or collapse caused by blood impact, and the support provided between the polygonal cutting surface can reduce the folding caused by the retraction of the instrument, to ensure the sealing property of the sealing system. The delivery sheath provided by the present application comprises the sealing system described above, so that the sealing assembly can still maintain good sealing property as a whole during the process of blood impact and instrument delivery, to prevent blood leakage caused by poor sealing property due to blood impact or instrument delivery during the operation, thereby improving the safety and success rate of the operation.

[0064] It can be understood that the sealing system provided by the present application can also be applied to other delivery sheaths.

[0065] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, all possible combinations of the technical features in the above-described embodiments are not described, however, as long as the combinations of the technical features do not contradict each other, they should be considered as the scope of the present application.

[0066] The above-described embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, however, it should not be understood as a limitation on the scope of the patent. It should be pointed out that, for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A sealing system, characterized in that, It includes a connector and a sealing assembly located within the connector, the sealing assembly protruding toward a distal end, and the distal end of the sealing assembly including a polygonal cut surface; The sealing assembly includes a first sealing gasket and a second sealing gasket, the second sealing gasket being located at the distal end of the first sealing gasket, the first sealing gasket including a distal plane abutting against the second sealing gasket, the second sealing gasket including an abutting portion and a buffer portion arching distally from the abutting portion, the abutting portion abutting against the distal plane of the first sealing gasket, and the polygonal cut surface being located at the distal end of the buffer portion. The buffer portion includes a connecting surface and multiple oblique cut surfaces. The connecting surface is located in the central region of the distal side of the buffer portion. The oblique cut surfaces connect the connecting surface and the abutting portion. The thickness of the abutting portion of the second sealing gasket is defined as d1, the thickness of the oblique cut surfaces is defined as d2, and the thickness of the connecting surface is defined as d3. Then d1, d2, and d3 satisfy the condition that d1 > d2 > d3.

2. The sealing system according to claim 1, characterized in that, The polygonal cut surface includes a triangular cut surface.

3. The sealing system according to claim 2, characterized in that, The angle formed by two adjacent polygonal cut surfaces on the distal side is greater than 180°.

4. The sealing system according to claim 1, characterized in that, The sealing system forms an axial channel, and the sealing assembly has a through hole communicating with the axial channel. The through hole includes cuts provided on the first sealing gasket and the second sealing gasket.

5. The sealing system according to claim 4, characterized in that, The cut length of the second sealing gasket is greater than that of the first sealing gasket.

6. The sealing system according to claim 4, characterized in that, The first sealing gasket has a cut including a first cutting line and a second cutting line located on the distal plane, the first cutting line intersecting the second cutting line and penetrating the first sealing gasket at the intersection point.

7. The sealing system according to claim 4 or 6, characterized in that, The buffer portion includes a connecting surface arranged radially, and the cut of the second sealing gasket includes a third cutting line and a fourth cutting line located on the connecting surface. The third cutting line intersects the fourth cutting line, and the intersection point penetrates the second sealing gasket.

8. The sealing system according to claim 7, characterized in that, The cut on the first sealing gasket and the cut on the second sealing gasket are not in the same plane along the axial direction.

9. The sealing system according to claim 1, characterized in that, The near end of the buffer section includes a smooth, arched surface.

10. The sealing system according to claim 1, characterized in that, The second sealing gasket is an arched silicone gasket. The abutting part of the second sealing gasket is annular. The proximal end of the buffer part is a smooth arched surface. The height of the arched part at the proximal end of the buffer part is defined as H, and the inner diameter of the annular part of the abutting part is defined as L. Then, H and L satisfy: 1 / 4≤H / L≤1.

11. The sealing system according to claim 10, characterized in that, H and L satisfy: H / L=1 / 2.

12. The sealing system according to claim 1, characterized in that, The connector includes a pressure cap, a connecting joint, and a front end cap in sequence from the proximal end to the distal end. The pressure cap is fixedly connected to the proximal end of the connecting joint, and the front end cap is fixedly connected to the distal end of the connecting joint. The proximal end of the pressure cap has a first through hole, and the distal end of the front end cap has a second through hole. An axial channel is formed between the first through hole and the second through hole. A replaceable joint is provided on the side of the connector closer to the distal end. The sealing assembly is located between the pressure cap and the connecting joint.

13. A delivery sheath, characterized in that, It includes a sealing system as described in any one of claims 1-12 and a sheath that communicates with the sealing system and extends distally.

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