A sealing sheet and hemostatic valve

Abstract

The present invention belongs to the technical field of medical devices, and in particular, relates to a sealing sheet and a hemostatic valve. The sealing sheet is used to cooperate with a structural member, and the structural member is provided with a pipeline, and the pipeline has a pipe opening located on the surface of the structural member. The sealing sheet is made of elastic material and covers the pipe opening. The sealing sheet has a first end face set away from the structural member and a second end face pressed on the pipe opening. The first end face is provided with a first slit, and the depth of any point of the first slit is less than the thickness of the sealing sheet at this point along the depth direction of the first slit. The second end face is provided with a second slit, and the depth of any point of the second slit is less than the thickness of the sealing sheet at this point along the depth direction of the second slit. The first slit and the second slit are arranged crosswise, and the first slit and the second slit are connected at the intersection. This valve improves the sealing of the instrument and also improves the sealing performance of the sealing sheet.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a sealing sheet and a hemostatic valve. Background Art

[0002] At present, as an auxiliary access device for arteriovenous interventional surgery, the catheter sheath plays an important role in interventional treatment. The catheter sheath device is mainly used as an auxiliary device for cardiovascular interventional diagnosis and treatment. In PTCA and PCI angioplasty, the catheter sheath uses a guidewire to guide the catheter sheath into the blood vessel through vascular puncture technology to establish a pathway from the outside to the blood vessel, which can be used for intervention of other devices, injection of drugs or hemodynamic monitoring, etc.; the rear end of the sheath usually contains an important anti-leakage device, which is mainly used to prevent blood loss and provide insertion of the tube body after the sheath is inserted. The anti-leakage device is generally embodied in the form of a hemostatic valve. On the one hand, the hemostatic valve should be able to meet the smooth entry of subsequent diagnostic and treatment catheters and diagnose and treat patients. On the other hand, it should have a good sealing effect to prevent blood loss after the sheath is inserted, or to prevent air embolism caused by air entering during the catheter withdrawal.

[0003] The existing hemostatic valve includes a sealing sheet for inserting instruments. Usually, a slit is opened on the outer surface of the sealing sheet, and the slit extends along the thickness direction of the sealing sheet to the inner surface of the sealing sheet, so that the instrument can be inserted into the hemostatic valve from the slit, and the instrument is wrapped by the elasticity of the sealing sheet. However, since the entire slit extends from the outer surface of the sealing sheet to the inner surface of the sealing sheet, the sealing effect of the instrument when the instrument is inserted into the slit will be unsatisfactory. After long-term use or when the sealing sheet is not inserted by an instrument, its sealing performance is likely to decline, which increases the risk of surgery to a certain extent. Summary of the invention

[0004] The purpose of the embodiments of the present application is to provide a sealing sheet, aiming to solve the problem of how to improve the sealing performance of the sealing sheet of the hemostatic valve during use.

[0005] To achieve the above-mentioned purpose, the technical solution adopted in the present application is: providing a sealing sheet, cooperating with a structural member, the structural member is provided with a pipe, the pipe has a pipe opening located on the surface of the structural member, the sealing sheet is made of an elastic material and covers the pipe opening, the sealing sheet has a first end face arranged away from the structural member and a second end face pressed on the pipe opening, the first end face is provided with a first slit, the depth of any point of the first slit is less than the thickness of the sealing sheet at this point along the depth direction of the first slit, the second end face is provided with a second slit, the depth of any point of the second slit is less than the thickness of the sealing sheet at this point along the depth direction of the second slit, the first slit and the second slit are arranged crosswise, and the first slit and the second slit are connected at the intersection.

[0006] In one embodiment, a first groove is formed on the first end surface, the bottom of the first groove is an arc surface and is convex toward the pipe opening, and the first slit is formed at the bottom of the first groove.

[0007] In one embodiment, a second groove is formed on the second end surface, the bottom of the second groove is an arc surface and is convex toward the first end surface, and the second slit is formed on the bottom of the second groove.

[0008] In one embodiment, the edge of the pipe mouth is arranged in a plane, the position where the second end face abuts the edge of the pipe mouth is an arc surface and is convex toward the pipe mouth, and two structural members are provided, and the other structural member abuts the first end face and presses the first end face toward the pipe mouth.

[0009] In one embodiment, the position where the second end face abuts against the edge of the pipe mouth is a conical surface; and the first end face is arranged in a plane, and the angle between any generatrix on the second end face and the first end face is in the range of 3 to 8 degrees.

[0010] In one embodiment, a depth direction of the first slit is arranged to be the same as a depth direction of the second slit.

[0011] In one embodiment, the second end surface is further provided with a third slit, the depth of any point of the third slit is less than the thickness of the sealing sheet at that point along the depth direction of the third slit, the third slit is arranged to cross the first slit, and the third slit passes through the intersection of the first slit and the second slit and is connected to the second slit.

[0012] In one embodiment, the end surface is arranged in a plane, and the depth direction of the first slit, the depth direction of the second slit, and the depth direction of the third slit are all perpendicular to the first end surface.

[0013] Another object of the present application is to provide a hemostatic valve, which includes the sealing plate, the hemostatic valve also includes a sheath tube seat and a sheath pressure cover, the sheath tube seat is provided with the pipeline, the inner wall of the tube mouth is provided with a positioning groove in an annular structure, the second end face abuts the bottom of the positioning groove, the sheath pressure cover is connected to the sheath tube seat at the tube mouth and presses the first end face toward the bottom of the positioning groove, and the sheath pressure cover is provided with a through hole corresponding to the position of the tube mouth.

[0014] In one embodiment, the sheath pressure cover is provided with a fixing groove, the extension path of the fixing groove is arranged in a ring shape, and a fixing ring is protruded from the edge of the pipe opening toward the fixing groove, and the fixing ring is adapted to the fixing groove.

[0015] The beneficial effects of the present application are as follows: by opening a first slit on the first end face and the first slit does not extend to the second end face, and opening a second slit on the second end face and the second slit does not extend to the first end face, the first slit and the second slit are cross-arranged and connected at the intersection, so that the first end face and the second end face of the sealing plate are only connected at the intersection of the first slit and the second slit, thereby improving the sealing of the sealing plate during use; the instrument is inserted into the first slit and inserted into the second slit from the intersection of the first slit and the second slit and then enters the interior of the pipeline, thereby improving the sealing of the instrument and improving the sealing performance of the sealing plate. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0017] Figure 1 A schematic diagram of the three-dimensional structure of the hemostatic valve provided in an embodiment of the present application;

[0018] Figure 2 yes Figure 1 A cross-sectional view of the hemostatic valve along the depth direction of the first slit;

[0019] Figure 3 yes Figure 2 A schematic structural diagram of a sealing sheet in another embodiment of the present invention;

[0020] Figure 4 yes Figure 2 A schematic structural diagram of a sealing sheet in yet another embodiment of the present invention;

[0021] Figure 5 yes Figure 2 A cross-sectional schematic diagram of the sealing sheet in a natural state.

[0022] Among them, the reference numerals in the figure are:

[0023] 100, hemostatic valve; 101, sheath tube seat; 102, sheath pressure cover; 103, sealing sheet; 21, pressure cover body; 22, pressure sleeve; 24, pipeline; 23, through hole; 111, first end face; 113, first groove; 11, first slit; 13, third slit; 112, second end face; 12, second slit; 114, second groove. DETAILED DESCRIPTION

[0024] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application more clearly understood, the present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0025] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

[0026] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0027] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0028] See also Figure 1 and Figure 3 , the embodiment of the present application provides a sealing sheet 103 for use with a structural member. A pipe 24 is provided inside the structural member, and the pipe 24 has a pipe opening located on the surface of the structural member. The sealing sheet 103 is made of an elastic material and covers the pipe opening. Optionally, the sealing sheet 103 is cylindrical. Specifically, the sealing sheet 103 is preferably a highly elastic polymer, such as silicone rubber, or a thermoplastic elastomer, such as TPU, TPE, etc.; that is, it has a certain elastic variable to meet the sealing characteristic requirements. Please refer to Figure 4 and Figure 5The sealing sheet 103 has a first end face 111 which is arranged away from the structural member and a second end face 112 which is pressed at the pipe mouth and arranged toward the structural member. Optionally, the first end face 111 is arranged in a plane. The first end face 111 is provided with a first slit 11, and the depth of any point of the first slit 11 is less than the thickness of the sealing sheet 103 at this point along the depth direction of the first slit 11, that is, the first slit 11 does not extend to the second end face 112 along the thickness direction of the sealing sheet 103, and there is a certain distance between the bottom of the first slit 11 and the second end face 112. The second end face 112 is provided with a second slit 12, and the depth of any point of the second slit 12 is less than the thickness of the sealing sheet 103 at this point along the depth direction of the second slit 12, that is, the second slit 12 does not extend to the first end face 111 along the thickness direction of the sealing sheet 103, and there is a certain distance between the bottom of the second slit 12 and the first end face 111. The first slit 11 and the second slit 12 are arranged crosswise, that is, the depth of the first slit 11 and the depth of the second slit 12 overlap, and the first slit 11 and the second slit 12 are connected at the intersection. The angle between the first slit 11 and the second slit 12 is in the range of 45° to 75°.

[0029] By opening the first slit 11 on the first end face 111 and the first slit 11 does not extend to the second end face 112, opening the second slit 12 on the second end face 112 and the second slit 12 does not extend to the first end face 111, the first slit 11 and the second slit 12 are arranged crosswise and connected at the intersection, so that the first end face 111 and the second end face 112 of the sealing sheet 103 are only connected at the intersection of the first slit 11 and the second slit 12, thereby improving the sealing performance of the sealing sheet 103 during use; the instrument is inserted into the first slit 11 and inserted into the second slit 12 from the intersection of the first slit 11 and the second slit 12 and then enters the interior of the pipe 24, thereby improving the sealing of the instrument and the sealing performance of the sealing sheet 103. Moreover, when the sealing sheet 103 is not inserted by the instrument, since the first end face 111 and the second end face 112 are only connected at the intersection of the first slit 11 and the second slit 12, the sealing inside the pipe 24 is improved.

[0030] Optionally, the length range of the first slit 11 and the second slit 12 is 3.2-4.4 mm.

[0031] In one embodiment, the first end surface 111 is provided with a first groove 113, the bottom of the first groove 113 is an arc surface and convexly arranged toward the pipe mouth, and the first slit 11 is provided at the bottom of the first groove 113. Specifically, the groove depth at any point of the bottom of the first groove 113 ranges from 0.4 to 0.6 mm, preferably 0.5 mm.

[0032] In one embodiment, the second end surface 112 is provided with a second groove 114, the bottom of the second groove 114 is an arc surface and is convex toward the first end surface 111, and the second slit 12 is provided at the bottom of the second groove 114. Specifically, the groove depth at any point of the bottom of the second groove 114 ranges from 0.15 to 0.3 mm, preferably 0.2 mm.

[0033] See also Figure 3 and Figure 5 Optionally, the cross-sectional shapes of the pipe 24 , the first groove 113 and the second groove 114 are all circular, and the diameters of the first groove 113 and the second groove 114 are not greater than the diameter of the pipe 24 .

[0034] In one embodiment, the edge of the pipe mouth is arranged in a plane, and the position where the second end face 112 abuts against the edge of the pipe mouth is an arc surface and is arranged to bulge toward the pipe mouth. When the first end face 111 is arranged horizontally, the edge of the second end face 112 is tilted upward, and the edge of the second end face 112 is closer to the first end face 111 than the center position of the second end face 112. That is, the intersection line of the cross section passing through the center position of the second end face 112 and the second end face 112 is a parabola. Two structural members are provided, and the two structural members respectively abut against the first end face 111 and the second end face 112, and the sealing sheet 103 is pressed between the two structural members, so that the second end face 112 is deformed from the original curved surface to fit the edge of the pipe mouth. Since the edge of the pipe mouth is arranged in a plane, the second end face 112 is also arranged in a plane after deformation, thereby pulling the first end face 111 to deform toward the second end face 112, that is, the first end face 111 expands outward to increase the surface area, so that the slit of the first slit 11 is slightly enlarged, which is conducive to the insertion of the instrument into the first slit 11 and improves the insertability of the first slit 11, that is, it is convenient for instruments of different sizes to be inserted into the first slit 11.

[0035] Furthermore, since the edge of the second end face 112 is pressed against the edge of the tube mouth, and the center of the second end face 112 is subjected to an upward force with the tube mouth as a support point and shrinks toward the first end face 111, the opening of the second slit 12 shrinks slightly, thereby improving the closing force of the opening of the second slit 12 and further improving the sealing performance. This arrangement of the first end face 111 expanding outward and the second end face 112 shrinking inward not only facilitates the insertion of a long body such as a catheter or a guide wire into the first slit 11 and improves the insertion performance, but also facilitates the second slit 12 to be more tightly closed and improve the sealing performance after the second end face 112 is squeezed inward by the upward force. Specifically, on the one hand, it can ensure that during the process of pulling out the catheter, guide wire and other long strips from the second slit 12, the slit opening of the second slit 12 is prevented from turning inward, causing leakage in the pipe 24 or air entering the pipe 24; on the other hand, after the catheter, guide wire and other long strips are finally pulled out, the second slit 12 is tightly closed, which can ensure the sealing of the pipe 24 by the sealing piece 103, thereby improving the sealing performance of the final sealing piece 103 and extending the service life of the sealing piece 103.

[0036] In one embodiment, the second end surface 112 is a conical surface at the position where it abuts against the edge of the pipe opening; and the first end surface 111 is a plane, and the angle between any generatrix on the second end surface 112 and the first end surface 111 is in the range of 3° to 8°. That is, the intersection line of the cross section through the center of the second end surface 112 and the second end surface 112 is V-shaped.

[0037] See also Figure 2 and Figure 4 In one embodiment, the second end surface 112 is further provided with a third slit 13, the depth of any point of the third slit 13 is less than the thickness of the sealing sheet 103 at that point along the depth direction of the third slit 13, the third slit 13 is arranged crosswise with the first slit 11, and the third slit 13 passes through the intersection of the first slit 11 and the second slit 12 and connects with the second slit 12. The length direction of the third slit 13 is arranged in an X shape with the length direction of the first slit 11, and the angle between the first slit 11 and the third slit 13 is in the range of 30° to 90°, preferably 60°. The angle between the third slit 13 and the second slit 12 is in the range of 45° to 75°.

[0038] Optionally, the angle between the first slit 11 and the second slit 12 , the angle between the first slit 11 and the third slit 13 , and the angle between the second slit 12 and the third slit 13 are all 60°.

[0039] It is understandable that when the first end surface 111 expands outward, the opening of the second slit 12 is also slightly enlarged, thereby further improving the penetration of the sealing sheet 103. Optionally, the length of the third slit 13 ranges from 3.2 to 4.4 mm.

[0040] Optionally, the depth of the first slit 11 and the third slit 13 ranges from 0.7 to 1.4 mm, preferably 1 mm, and the depth of the second slit 12 ranges from 0.5 to 1.2 mm, preferably 1 mm.

[0041] In one embodiment, the depth direction of the first slit 11 is arranged in the same direction as the depth direction of the second slit 12. Optionally, the first end surface 111 is arranged in a plane, and the angle between the depth direction of the first slit 11 or the depth direction of the second slit 12 and the first end surface 111 is greater than zero and less than ninety degrees.

[0042] In one embodiment, the first end surface 111 is arranged in a plane, and the depth directions of the first slit 11 , the second slit 12 , and the third slit 13 are all perpendicular to the first end surface 111 .

[0043] The present application also proposes a hemostatic valve 100, which includes a sealing plate 103. The specific structure of the sealing plate 103 refers to the above-mentioned embodiment. Since the hemostatic valve 100 adopts all the technical solutions of all the above-mentioned embodiments, it also has all the beneficial effects brought by the technical solutions of the above-mentioned embodiments, which will not be described one by one here.

[0044] See also Figure 2 and Figure 4 In one embodiment, the hemostatic valve 100 further includes a sheath tube seat 101 and a sheath pressure cover 102. The sheath tube seat 101 is provided with a pipeline 24. The inner wall of the tube mouth is provided with a positioning groove in an annular structure. The second end face 112 abuts against the bottom of the positioning groove. The sheath pressure cover 102 is connected to the sheath tube seat 101 at the tube mouth and presses the first end face 111 toward the bottom of the positioning groove. The sheath pressure cover 102 is provided with a through hole 23 at the position corresponding to the tube mouth. Optionally, the sheath pressure cover 102 and the sheath tube seat 101 can be connected by welding or gluing. When the sealing sheet 103 is not compressed, there will be an excess amount of pressing. After the sheath pressure cover 102 and the sheath tube seat 101 are pressed together, the outer peripheral edge of the sealing sheet 103 is deformed and compressed toward the sheath tube seat 101.

[0045] In one embodiment, the sheath pressure cover 102 is provided with a fixing groove, the extension path of the fixing groove is arranged in a ring shape, and a fixing ring is protruded from the edge of the tube opening toward the inside of the fixing groove, and the fixing ring is adapted to the fixing groove.

[0046] In one embodiment, the sheath pressure cover 102 includes a pressure cover body 21 with the fixing groove and the through hole 23, and a pressure sleeve 22 connected to the pressure cover body 21 and connected to the through hole 23. The end surface of the pressure sleeve 22 abutting the first end surface 111 is set in a conical surface and protrudes toward the first end surface 111, so that when the pressure sleeve 22 presses the first end surface 111, the edge of the first end surface 111 can be better driven to expand outward, thereby making the first end surface 111 expand outward as a whole, which is conducive to the insertion of the instrument into the first slit 11. The inner wall of the pressure sleeve 22 is set obliquely to guide the instrument through the sheath pressure cover 102.

[0047] The above are only preferred embodiments of the present application and are not intended to limit the present application. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A sealing sheet, used for matching a structural member, wherein the structural member is provided with a pipe, and the pipe has a pipe opening located on the surface of the structural member, characterized in that: The sealing sheet is made of elastic material and covers the pipe opening. The sealing sheet has a first end face that is arranged away from the structural member and a second end face that covers the pipe opening. The first end face is provided with a first slit, and the depth of any point of the first slit is less than the thickness of the sealing sheet at the point along the depth direction of the first slit. The second end face is provided with a second slit, and the depth of any point of the second slit is less than the thickness of the sealing sheet at the point along the depth direction of the second slit. The first slit and the second slit are arranged crosswise, and the first slit and the second slit are connected at the intersection. The first end surface is provided with a first groove, the groove bottom of the first groove is an arc surface and is convexly arranged toward the pipe mouth, and the first slit is provided at the groove bottom of the first groove; the second end surface is provided with a second groove, the groove bottom of the second groove is an arc surface and is convexly arranged toward the first end surface, and the second slit is provided at the groove bottom of the second groove; the edge of the pipe mouth is provided with a plane, the position where the second end surface abuts against the edge of the pipe mouth is an arc surface and is convexly arranged toward the pipe mouth, two structural members are provided, and the other structural member abuts against the first end surface and presses the first end surface toward the pipe mouth; The sealing sheet is pressed tightly between the two structural members, so that the second end surface is deformed from the original curved surface to fit the edge of the pipe opening, and the second end surface is deformed to be arranged in a plane, and the first end surface is pulled to deform toward the second end surface; Since the edge of the second end face is pressed against the edge of the pipe mouth, the center position of the second end face is subjected to an upward force with the pipe mouth as a support point and shrinks toward the first end face, causing the opening of the second slit to shrink slightly, thereby increasing the closing force of the opening of the second slit and further improving the sealing performance.

2. The sealing sheet according to claim 1, characterized in that: The position where the second end face abuts against the edge of the pipe mouth is a conical surface; and the first end face is arranged in a plane, and the angle between any generatrix on the second end face and the first end face is in the range of 3 to 8 degrees.

3. The sealing sheet according to claim 1, characterized in that: The depth direction of the first slit is arranged to be the same as the depth direction of the second slit.

4. The sealing sheet according to claim 1, characterized in that: The second end surface is also provided with a third slit, the depth of any point of the third slit is less than the thickness of the sealing sheet at that point along the depth direction of the third slit, the third slit is arranged to cross the first slit, and the third slit passes through the intersection of the first slit and the second slit and is connected to the second slit.

5. The sealing sheet according to claim 4, characterized in that: The first end surface is arranged in a plane, and the depth direction of the first slit, the depth direction of the second slit, and the depth direction of the third slit are all perpendicular to the first end surface.

6. A hemostatic valve, characterized in that: include: According to the sealing sheet as described in any one of claims 1-5, the hemostatic valve also includes a sheath tube seat and a sheath pressure cover, the sheath tube seat is provided with the pipeline, the inner wall of the tube mouth is provided with a positioning groove in an annular structure, the second end face abuts the bottom of the positioning groove, the sheath pressure cover is connected to the sheath tube seat at the tube mouth and presses the first end face toward the bottom of the positioning groove, and the sheath pressure cover is provided with a through hole corresponding to the position of the tube mouth.

7. The hemostatic valve according to claim 6, characterized in that: The sheath pressure cover is provided with a fixing groove, the extension path of the fixing groove is arranged in a ring shape, and a fixing ring is protruded from the edge of the pipe opening toward the fixing groove, and the fixing ring is adapted to the fixing groove.

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