Hemostasis valve

Abstract

The invention provides a hemostasis valve, belongs to the technical field of medical instruments, and solves the problems of blood leakage and inconvenience in operation of the hemostasis valve. The hemostasis valve of the present invention comprises: a main housing; the rolling shell rotates between a first position and a second position relative to the main shell; a first tubular body is arranged between the first end part of the gasket and the second end part of the gasket, and the first tubular body has elasticity and is internally provided with an inner cavity; the first ends of the multiple flexible components are fixedly connected with the main shell, and the second ends of the multiple flexible components are fixedly connected with the rolling shell; when the rolling shell is located at the first position, the multiple flexible components extrude the first tubular body to enable the inner cavity of the first tubular body to be closed or narrowed, and when the rolling shell is located at the second position, the multiple flexible components release the first tubular body to enable the inner cavity of the first tubular body to be opened. The hemostasis valve can adapt to interventional instruments of different sizes or shapes, and is high in universality and excellent in sealing effect.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 581,531, filed on September 8, 2023, and priority to U.S. Patent No. 18 / 797,449, filed on August 7, 2024, the disclosures of which are incorporated herein by reference in their entirety. Technical Field

[0003] The invention relates to the technical field of medical devices, in particular to a hemostatic valve. Background Art

[0004] Hemostatic valves can be used in a variety of medical procedures to facilitate the passage of diagnostic or therapeutic instruments while minimizing blood loss. When in use, the sealing mechanism in the hemostatic valve provides a secure seal around the inserted instrument to prevent blood leakage. In some traditional hemostatic valves, a flat membrane or gasket made of an elastic material is generally used. The flat membrane or gasket contains cutouts or slits that can expand to accommodate instruments of different sizes. When no instrument is inserted, the slits close to prevent blood flow. However, flat membranes or gaskets with geometric cutting patterns cannot effectively close around the inserted instrument and often leak. In other traditional hemostatic valves, an inflatable seal is used to prevent leakage by adjusting the seal to adapt to the diameter of the inserted instrument, but this type of hemostatic valve requires an inflatable mechanism that is inconvenient to operate. Summary of the invention

[0005] The invention provides a hemostatic valve, which solves the problems of blood leakage and inconvenient operation of the current hemostatic valve.

[0006] In order to solve the above technical problems, the technical solution of the present invention is as follows:

[0007] A hemostatic valve, comprising:

[0008] a main housing having a first end and a second end;

[0009] a rolling housing that rotates relative to the main housing between a first position and a second position;

[0010] A gasket is arranged in the rolling housing, wherein the first end of the gasket is fixedly connected to the first end of the main housing, the second end of the gasket is fixedly connected to the second end of the main housing, a first tubular body is arranged between the first end of the gasket and the second end of the gasket, and the first tubular body has an elastic interior and an inner cavity;

[0011] A plurality of flexible members, wherein a first end of each of the plurality of flexible members is fixedly connected to the main shell, and a second end of each of the plurality of flexible members is fixedly connected to the rolling shell; when the rolling shell is in a first position, the plurality of flexible members squeeze the first tubular body to close or narrow the inner cavity of the first tubular body, and when the rolling shell is in a second position, the plurality of flexible members release the first tubular body to open the inner cavity of the first tubular body.

[0012] Optionally, the rotation angle of the rolling shell relative to the main shell is 30 degrees to 330 degrees.

[0013] Optionally, the first ends of the plurality of flexible members are all fixedly connected in a first plane of the main shell, and the second ends of the plurality of flexible members are all fixedly connected in a second plane of the rolling shell.

[0014] Optionally, the plurality of flexible members are disposed between the rolling shell and the first tubular body, and surround the first tubular body.

[0015] Optionally, the fixed connection points between the first ends of the plurality of flexible components and the main shell are evenly distributed around the circumference.

[0016] Optionally, the fixed connection points between the second ends of the plurality of flexible members and the rolling shell are evenly distributed in the circumferential direction.

[0017] Optionally, the first ends of the plurality of flexible members are connected to the main housing at unevenly spaced positions, and / or the second ends of the plurality of flexible members are connected to the rolling housing at unevenly spaced positions.

[0018] Optionally, the plurality of flexible members includes 3 to 12 flexible members.

[0019] Optionally, when the rolling shell is in the second position, the middle sections of the multiple flexible components are at the smallest distance from the central axis of the inner cavity, and the ends of the multiple middle sections are adjacent to each other in sequence to form a first channel, which allows the first tubular body to pass through without being squeezed and deformed.

[0020] Optionally, when the rolling shell is in the first position, the plurality of flexible members form a cross section, and the cross section squeezes the first tubular body to generate deformation and contraction.

[0021] Optionally, the gasket further includes an annular band extending outward from the first tubular body, wherein the annular band is disposed close to the intersection.

[0022] Optionally, the gasket further comprises an annular band extending outwardly from the first tubular body.

[0023] Optionally, the annular belt and the first tubular body are integrally formed.

[0024] Optionally, when the rolling shell is in the second position, the diameter of the inner cavity ranges from 4 mm to 15 mm.

[0025] Optionally, the main shell includes a cylindrical side wall, the side wall is used to accommodate the rolling shell, and the side wall is provided with an opening.

[0026] Optionally, the rolling shell includes a cylindrical side wall, and the central axis of the rolling shell side wall coincides with the central axis of the main shell side wall.

[0027] Optionally, the rolling shell further comprises a first protruding piece component located on a side wall of the rolling shell, and the first protruding piece component extends from an opening of the main shell.

[0028] Optionally, the main housing further comprises a second protrusion member.

[0029] Optionally, the hemostatic valve further comprises a tension spring, a first end of the tension spring is fixedly connected to the rolling shell, a second end of the tension spring is fixedly connected to the main shell, and when the tension spring contracts, the rolling shell is in a first position.

[0030] Optionally, the hemostatic valve further comprises a locking mechanism, and the locking mechanism is used to lock the rolling shell in the second position.

[0031] Optionally, the hemostatic valve also includes a connector fixedly connected to the second end of the main shell, the connection includes a second tubular body and a side port, the second tubular body is provided with a channel connected to the inner cavity, and the side port is used to connect a vacuum source or a flushing source.

[0032] The above solution of the present invention includes at least the following beneficial effects:

[0033] The hemostatic valve proposed by the present invention comprises: a main shell, the main shell having a first end and a second end; a rolling shell, the rolling shell rotates between a first position and a second position relative to the main shell; a gasket arranged in the rolling shell, the first end of the gasket is fixedly connected to the first end of the main shell, the second end of the gasket is fixedly connected to the second end of the main shell, a first tubular body is arranged between the first end of the gasket and the second end of the gasket, and the first tubular body has an elastic interior and an inner cavity; a plurality of flexible members, the first ends of the plurality of flexible members are fixedly connected to the main shell, and the second ends of the plurality of flexible members are fixedly connected to the rolling shell; when the rolling shell is in the first position, the plurality of flexible members squeeze the first tubular body to close or narrow the inner cavity of the first tubular body, and when the rolling shell is in the second position, the plurality of flexible members release the first tubular body to open the inner cavity of the first tubular body; it can adapt to interventional instruments of different sizes and shapes that penetrate into the hemostatic valve, has a high degree of adaptability / strong universality, and excellent sealing effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is a perspective view of a hemostatic valve provided by an embodiment of the present invention;

[0035] Figure 2 is an exploded view of a hemostatic valve provided by an embodiment of the present invention;

[0036] Figure 3 is another exploded view of the hemostatic valve provided by an embodiment of the present invention, in which the flexible component is omitted;

[0037] Figure 4 is a top view of a hemostatic valve provided by an embodiment of the present invention;

[0038] Figure 5 is a cross-sectional view of the hemostatic valve provided by an embodiment of the present invention taken along line AA, in which the flexible member is omitted;

[0039] Figure 6 is a cross-sectional view of the hemostatic valve provided by an embodiment of the present invention taken along line BB, in which the flexible member is omitted;

[0040] Figure 7 is a cross-sectional side view of a hemostatic valve provided by an embodiment of the present invention, wherein the hemostatic valve is in an open state;

[0041] Figure 8 is another cross-sectional side view of the hemostatic valve provided by an embodiment of the present invention, wherein the hemostatic valve is in a closed state;

[0042] Fig. 9 is a cross-sectional top view of a hemostatic valve provided by an embodiment of the present invention, wherein the hemostatic valve is in an open state;

[0043] Fig.10 is another cross-sectional top view of the hemostatic valve provided by an embodiment of the present invention, in which the hemostatic valve is in a closed state;

[0044] Fig.11 is a cross-sectional top view of a hemostatic valve provided by an embodiment of the present invention, the hemostatic valve is in an open state, and the rolling housing and the gasket are omitted in the figure;

[0045] Fig.12 is another cross-sectional top view of the hemostatic valve provided by an embodiment of the present invention, the hemostatic valve is in a closed state, and the rolling housing and the gasket are omitted in the figure;

[0046] Fig.13 is a cross-sectional top view of the hemostatic valve provided by an embodiment of the present invention, the hemostatic valve is in an open state, and the main housing, rolling housing and gasket are omitted in the figure;

[0047] Fig.14 is another cross-sectional top view of the hemostatic valve provided by an embodiment of the present invention, the hemostatic valve is in a closed state, and the main housing, the rolling housing and the gasket are omitted in the figure;

[0048] Fig.15 is a cross-sectional side view of a hemostatic valve provided by an embodiment of the present invention, the hemostatic valve is in an open state, and the main housing, rolling housing and gasket are omitted in the figure;

[0049] Fig.16 is another cross-sectional side view of the hemostatic valve provided by an embodiment of the present invention, the hemostatic valve is in a closed state, and the main housing, the rolling housing and the gasket are omitted in the figure;

[0050] Fig.17 is a cross-sectional top view of the hemostatic valve provided by an embodiment of the present invention, in which the rolling housing, the gasket and the flexible member are omitted;

[0051] Fig.18 is a perspective view of a gasket provided by an embodiment of the present invention;

[0052] Fig.19 is a side view of a gasket provided by an embodiment of the present invention;

[0053] Fig. 20 is a top view of a gasket provided in an embodiment of the present invention;

[0054] Fig.21 is a cross-sectional top view of the hemostatic valve provided by an embodiment of the present invention, in which the rolling housing is omitted;

[0055] Fig. 22 is a perspective view of a hemostatic valve including a locking mechanism provided by an embodiment of the present invention;

[0056] Among them, 100, hemostatic valve; 101, central axis; 102, main shell; 104, rolling shell; 106, gasket; 108, connector; 110, tension spring; 112, spring shell; 114, cover member; 116, second end of main shell; 118, first end of main shell; 120, main shell side wall; 122, first opening; 124, second opening; 126, third opening; 131-136, main shell positioning hole; 138, base member; 139, second protruding piece member; 141-146, rolling shell positioning hole; 148, rolling shell side wall; 149, first protruding piece member; 160, second end of gasket; 162, first end of gasket ; 164, first tubular body; 164a, first part of the first tubular body; 164b, second part of the first tubular body; 166, inner cavity; 167, first flange; 168, second flange; 170, annular band; 172, first end of connector; 174, second end of connector; 176, second tubular body; 178, channel; 179, side port; 181~186, multiple flexible members; 181a~186a, first ends of multiple flexible members; 181b~186b, second ends of multiple flexible members; 181m~186m, middle sections of multiple flexible members; 188, central channel; 190, lock; 192, locking clip; 194, leg member. DETAILED DESCRIPTION

[0057] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present invention and to enable the scope of the present invention to be fully communicated to those skilled in the art.

[0058] The embodiment of the present invention provides a hemostatic valve, which uses a plurality of flexible members that are connected in series between a main housing and a rolling housing to generate a folding intersection, thereby contracting a first tubular body passing through the center of the plurality of flexible members. The rolling housing can be rotated to allow the flexible members to loosen or release the first tubular body, thereby opening the valve. The valve contraction and closing method adopted by the present invention eliminates the disadvantages of the expansion method adopted in the traditional hemostatic valve, and can effectively avoid the occurrence of leakage or minimize the leakage.

[0059] like Figures 1 to 17 As shown, the embodiment of the present invention provides a hemostatic valve 100, including a main housing 102, a rolling housing 104, a gasket 106 (such as Figures 2 to 3 ) and a plurality of flexible members 181 to 186 (as shown Figure 2 and Figures 7 to 17As shown); the hemostatic valve 100 may also include a connector 108, a tension spring 110, a spring housing 112 and a cover member 114, such as Figures 2 to 3 As shown. Figures 9 to 16 As shown, each flexible member 181-186 includes a first end 181a-186a connected to the main housing 102 and a second end 181b-186b connected to the rolling housing 104. Each flexible member 181-186 extends in the space between the rolling housing 104 and the gasket 106, as shown in FIG. Figures 7 to 10 The rolling housing 104 can be rotated to open or close the hemostatic valve 100. In the closed state of the hemostatic valve 100, as shown in FIG. Figure 8 , 10 , 12, 14 and 16, the plurality of flexible members 181-186 contract the gasket 106, thereby closing or narrowing the inner cavity of the gasket 106 to seal the instrument passing through the inner cavity of the gasket 106. Figure 1 , 7 As shown in FIGS. 9 , 11 , 13 and 15 , the plurality of flexible members 181 - 186 do not constrain or loosen the gasket 106 , thereby allowing the inner cavity of the gasket 106 to open.

[0060] like Figures 1 to 10 As shown, an embodiment of the present invention provides a hemostatic valve 100 in which a main housing 102 provides structural support and / or assembly points for the hemostatic valve 100. The main housing 102 provides or defines a space for receiving or holding a rolling housing 104, and includes a mechanism for fixing a gasket 106. The main housing 102 includes a second end 116, a first end 118, and a side wall 120 extending between the second end 116 and the first end 118, as shown in FIG. Figures 2 to 3 In this embodiment, the main housing 102 is a cylindrical structure that provides an internal space for receiving or holding the rolling housing 104. The first opening 122 is provided in the first end 118 of the main housing 102 or the cover member 114 for introducing an instrument (not shown) into the valve 100. Figure 1 As shown. A second opening 124 is provided in the second end 116 of the main housing 102 to allow an instrument to pass through the hemostatic valve 100. The instrument inserted into and sealed by the hemostatic valve 100 of the present invention may be any diagnostic and therapeutic instrument, including a catheter, a guidewire, or any other device having a variety of regular or irregular cross-sectional shapes. The central axis 101 of the first opening 122 and the second opening 124 passing through between the second end 116 and the first end 118 of the main housing 102 defines the central axis of the hemostatic valve 100.

[0061] The embodiment of the present invention provides a hemostatic valve 100 in which the side wall 120 of the main housing 102 is provided with a third opening 126 to allow the user to twist or rotate the rolling housing 104 during the operation of the hemostatic valve 100. In this embodiment, the side wall 120 of the main housing 102 may be provided with two or more third openings 126 to help the user rotate the rolling housing 104 when operating the hemostatic valve 100. The third openings 126 in the side wall 120 of the main housing 102 may be in the form of a window or a slot. In this embodiment, the third openings 126 in the side wall 120 of the main housing 102 may define or limit the angular range of rotation of the rolling housing 104 relative to the main housing 102. For example, the third openings 126 may be configured to allow the rolling housing 104 to rotate from 30 degrees to 330 degrees around the longitudinal axis 101 of the hemostatic valve 100.

[0062] In an embodiment of the present invention, a hemostatic valve 100 is provided in which a main housing 102 provides a plurality of positioning holes 131-136, and first ends 181a-186a of a plurality of flexible members 181-186 can be connected to the main housing 102 through these positioning holes. Figure 2 , 11 , as shown in 12. For example, the main housing 102 may include a base member 138 provided with a plurality of positioning holes 131-136. Each positioning hole may be configured to allow a flexible member to pass through, and a first end of the flexible member may be connected to the base member 138. The connection of the first ends 181a-186a of the plurality of flexible members 181-186 to the base member 138 may be achieved by melting each first end 181a-186a of the plurality of flexible members 181-186 to form a ball with an increased diameter, forming a knot at each first end 181a-186a of the plurality of flexible members 181-186, and combining them by bonding. In an embodiment using metal flexible members 181-186 such as nitinol or stainless steel, the connection to the base member 138 may be achieved by welding the first ends 181a-186a into a ball or by welding through an additional sleeve.

[0063] In an embodiment of the present invention, a hemostatic valve 100 is provided in which the first ends 181a-186a of the plurality of flexible members 181-186 are connected to the plurality of positioning holes 131-136 of the main housing 102 and are evenly spaced along the circumference. Figures 11 to 12As shown. For example, if three flexible members are included in the hemostatic valve 100, the positioning holes in the base member 138 can be spaced about 120 degrees apart, about 90 degrees apart if four flexible members are used, about 60 degrees apart if six flexible members are used, or about 40 degrees apart if nine flexible members are used, and so on. Alternatively, the first ends 181a-186a of the plurality of flexible members 181-186 connected to the plurality of positioning holes 131-136 of the main housing 102 can also be unevenly spaced. In one embodiment, the first ends 181a-186a of the plurality of flexible members 181-186 connected to the plurality of positioning holes 131-136 of the main housing 102 can be in the same plane in the base member 138.

[0064] like Figures 1 to 10 As shown, an embodiment of the present invention provides a hemostatic valve 100 in which a rolling housing 104 can be used as an actuator for opening or closing the hemostatic valve 100. The rolling housing 104 can rotate relative to the main housing 102. In this embodiment, the rolling housing is accommodated in the main housing 102. The rolling housing 104 can accommodate a gasket 106, such as Figures 2 to 3 The rolling housing 104 provides a plurality of positioning holes 141-146, such as Figures 9 to 10 As shown, the second ends 181b-186b of the plurality of flexible members 181-186 can be connected to the rolling housing 104 through the plurality of positioning holes 141-146. When the rolling housing 104 rotates relative to the main housing 102, the positions of the plurality of positioning holes 141-146 for connecting the second ends 181b-186b of the plurality of flexible members 181-186 are changed, so that the plurality of flexible members 181-186 contract or release the gasket 106 to close or open the hemostatic valve 100.

[0065] The embodiment of the present invention provides a hemostatic valve 100, in which the rolling housing 104 is a cylindrical structure, including a side wall 148 for providing a space for accommodating a gasket 106. In this embodiment, the cylindrical structure of the rolling housing 104 is arranged concentrically with the cylindrical structure of the main housing 102. In this embodiment, the side wall 148 of the rolling housing 104 is provided with a plurality of positioning holes 141-146, which define a plurality of positions, and the second ends 181b-186b of a plurality of flexible members 181-186 are connected to the rolling housing 104 at these positions. Each hole 141-146 has a flexible member passing therethrough, and allows the second end of the flexible member to be connected to the rolling housing 104 at the positioning hole. The connection of the second ends 181b-186b of the plurality of flexible members 181-186 to the rolling housing 104 at the plurality of positioning holes 141-146 can be achieved by melting each second end 181b-186b of the plurality of flexible members 181-186 to form a ball with an increased diameter, forming a knot at each second end 181b-186b of the plurality of flexible members 181-186, and combining them by bonding. In an embodiment using metal flexible members 181-186 such as nitinol or stainless steel, the connection to the rolling housing 104 can be achieved by welding the second ends 181b-186b into a ball or by welding through an additional sleeve.

[0066] An embodiment of the present invention provides a hemostatic valve 100 in which a plurality of positioning holes 141-146 in a side wall 148 of a rolling shell 104 are evenly spaced around a circumference. For example, if three flexible members are included in the hemostatic valve, the plurality of positioning holes 141-146 may be spaced about 120 degrees, about 90 degrees if four flexible members are used, or about 60 degrees if six flexible members are used, or about 40 degrees if nine flexible members are used, and so on. Alternatively, the plurality of positioning holes 141-146 in which the second ends 181b-186b of the plurality of flexible members 181-186 are connected to the main shell 102 may be spaced unevenly. In one embodiment, the plurality of positioning holes 141-146 on the side wall 148 of the rolling shell 104 are located in the same plane. The plane is perpendicular to the central axis 101 of the hemostatic valve 100.

[0067] The embodiment of the present invention provides a hemostatic valve 100 in which the rolling housing 104 includes a first tab member 149 to facilitate the user to operate the hemostatic valve 100. When assembled, the first tab member 149 can protrude outward from the side wall 148 of the rolling housing 104 and extend out of the third opening 126 in the main housing 102. The first tab member 149 is used for the user to apply torque to the rolling housing 104 when operating the hemostatic valve 100. In this embodiment, the main housing 102 also includes a second tab member 139, which extends outward from the side wall 120 adjacent to the third opening 126 of the main housing 102. The second tab member 139 on the main housing 102 and the first tab member 149 on the rolling housing 104 allow the user to hold or grasp the hemostatic valve 100 with one hand, for example, when the rolling housing 104 is rotated relative to the main housing 102 to open the valve 100, the user can insert an instrument into the valve 100 with the other hand. The second tab member 139 on the main housing 102 and the first bump member 149 on the rolling housing 104 also allow the hemostatic valve 100 to be locked in an open state to facilitate sterilization of the hemostatic valve 100. In this embodiment, the rolling housing 104 may include two or more tab members to facilitate the user to operate the hemostatic valve 100.

[0068] In an embodiment of the present invention, a hemostatic valve 100 is provided, wherein the rolling housing 104 may include a positioning point for supporting the tension spring 110. Figures 2 to 3 As shown, the rolling housing 104 may include a circular flange protruding inwardly from the inner surface of the side wall 148 for receiving and supporting the tension spring 110. The rolling housing 104 may be provided with a slot in the side wall 148 for connecting the first end of the tension spring 110. The second end of the tension spring 110 may be connected to the first end 118 of the main housing 102, or to the spring housing 112 of the second end 116 of the main housing 102. The tension spring 110 may provide a biasing force to the rolling housing 104. In this embodiment, when the rolling housing 104 is in the default closed position of the hemostatic valve 100, the tension spring 110 is configured to be in a low energy state; when the rolling housing 104 is rotated relative to the main housing 102 to open the hemostatic valve 100, the tension spring 110 will be in a stretched or stressed state, thereby generating a biasing force to pull the rolling housing 104 back to the default closed position.

[0069] The embodiment of the present invention provides a hemostatic valve 100 in which a plurality of positioning holes 131 to 136 of a base member 138 are arranged circumferentially around a rolling housing 104, or are arranged between the rolling housing 104 and a gasket 106. Figures 7 to 12As shown, the circumferential diameter of the plurality of positioning holes 131-136 connected can be smaller than the circumferential diameter of the plurality of positioning holes 141-146 connected in the rolling shell 104, but larger than the diameter of the first tubular body 164 of the gasket 106 in the natural state. Therefore, the flexible member can pass through the positioning hole in the base member 138 of the main shell 102. For example, the first end 181a of the flexible member 181 is fixedly connected to the base member 138 and extends upward in the space between the rolling shell 104 and the gasket 106, and then passes through the positioning hole in the rolling shell 104. The second end 181b of the flexible member 181 is connected to the rolling shell 104. Figures 7 to 10 In this embodiment, the plurality of positioning holes 131-136 of the base member 138 are located outside the plurality of positioning holes 141-146 in the rolling shell 104. This allows a flexible member, such as the flexible member 181, to circumferentially or partially circumferentially surround the first tubular body 164 between its first end 181a and second end 181b.

[0070] like Figure 2 , 3 , 5, 6, 18 to 20, the gasket 106 provides a safe seal around the instrument inserted into the hemostatic valve 100. The gasket 106 includes a first end 162, a second end 160 and a first tubular body 164, and the first tubular body 164 includes an inner cavity 166 between the first end 162 and the second end 160. The first tubular body 164 of the gasket 106 is elastically foldable, and the inner cavity 166 of the first tubular body 164 is closed or narrowed when the first tubular body 164 contracts, and the first tubular body 164 opens the inner cavity 166 in a natural state. Materials used to make the gasket 106 include silicone, polyurethane, ethylene vinyl acetate, natural or synthetic rubber, and other polymers known in the art. In the present embodiment, the gasket 106 is made of silicone.

[0071] The gasket 106 can be disposed in the rolling housing 104. The second end 160 of the gasket 106 can be fixed to the second end 116 of the main housing 102. The first end 162 of the gasket 106 can be fixed to the first end 118 of the main housing 102. In this embodiment, the second end 160 of the gasket 106 includes a first flange 167 extending outwardly, and the first flange 167 is fixedly connected to the base member 138 and / or is compressed between the main housing 102 and the connector 108, as shown in FIG. Figure 2 , 3, 5, and 6. For example, the bottom surface of the base member 138 and the upper surface of the connector 108 are provided with a component for connecting the first flange 167, so that the first flange 167 is allowed to be compressed between the main housing 102 and the connector 108 when the hemostatic valve 100 is assembled, and thus fixed to the second end 116 of the main housing 102. In this embodiment, the first end 162 of the gasket 106 includes a second flange 168 extending outward, and the second flange 168 is compressed between the spring housing 112 and the cover member 114, as shown in FIG. Figure 2 , 3 , 5, and 6. For example, the upper surface of the spring housing 112 and the bottom surface of the cover member 114 are provided with a component for connecting the second flange 168, so that the second flange 168 is allowed to be compressed between the spring housing 122 and the cover member 114 when assembled in the hemostatic valve 100, and thus fixed to the first end 118 of the main housing 104. In this embodiment, the inner cavity 166 of the gasket 106 is aligned with the central axis 101 of the hemostatic valve 100.

[0072] Embodiments of the present invention provide a hemostatic valve 100 in which the size and shape of the first tubular body 164 or the inner cavity 166 can accommodate an instrument sealed by the hemostatic valve 100. For example, the diameter of the inner cavity 166 can range from 4 mm to 15 mm. In this embodiment, the inner cavity 166 can accommodate an instrument with a maximum cross-sectional size ranging from 0.1 mm to 14.5 mm. It should be noted that the above dimensions are provided for the purpose of illustrating and understanding the embodiments of the present invention. A person of ordinary skill in the art can easily scale the size of the inner cavity 166 based on a specific application scenario without being limited to a specific size.

[0073] like Figures 18 to 21 As shown, in an embodiment of the present invention, a hemostatic valve 100 is provided, wherein the gasket 106 includes an annular band 170 extending outwardly from the outer surface of the first tubular body 164. When the gasket 106 is contracted by the flexible members 181-186 to close the hemostatic valve 100, the annular band 170 can prevent the first tubular body 164 from folding and / or twisting. Fig.21As shown, the annular band 170 may be located above the connection position of the second end portions 181b-186b of the plurality of flexible members 181-186 and the rolling housing 104. When the hemostatic valve 100 is in a closed state, the plurality of flexible members 181-186 contract or squeeze the first tubular body 164 under the annular band 170. When the second portion 164b of the first tubular body 164 under the annular band 170 contracts, the annular band 170 may prevent the first portion 164a of the first tubular body 164 above the annular band 170 from folding. In the present embodiment, the annular band 170 is one of the integral parts of the first tubular body 164 and is made of the same material as the gasket 106. Alternatively, the annular band 170 may be a separate part bonded to the first tubular body 164 by any suitable means. According to an alternative embodiment of the present invention, the gasket 106 may be provided with a plurality of rib members on the outer surface of the first tubular body 164 to prevent the first tubular body 164 from folding during the operation of the hemostatic valve 100.

[0074] like Figures 7 to 16 As shown, in an embodiment of the present invention, a plurality of flexible members 181-186 can be used to compress the first tubular body 164 to close or narrow the inner cavity 166. The plurality of flexible members 181-186 can also be used to release the first tubular body 164 to allow the first tubular body 164 to return to a natural state and open the inner cavity 166.

[0075] The plurality of flexible members 181-186 may be filaments, ropes, flat wires, ribbons, etc. The plurality of flexible members 181-186 may be made of a single strand of material, such as a monofilament. In the present embodiment, the plurality of flexible members 181-186 may also be made of multiple strands of wire, which are grouped, twisted, or braided to form the flexible members. Suitable materials for making the flexible members 181-186 include polymers and / or metals. For example, the plurality of flexible members 181-186 may be made of polypropylene, nylon, nitinol, stainless steel, etc. Figures 7 to 16 Six flexible members 181 to 186 are shown. It should be noted that the hemostatic valve 100 of the present invention may also include less than or more than six flexible members, for example, 3 to 12.

[0076] The first ends 181a-186a of the plurality of flexible members 181-186 are fixedly connected to the main housing 102, and the second ends 181b-186b are fixedly connected to the rolling housing 104. In this embodiment, the first ends 181a-186a and the second ends 181b-186b of the plurality of flexible members 181-186 are located in the space between the rolling housing 104 and the first tubular body 164, as shown in FIG. Figures 9 to 10 shown.

[0077] like Fig.15 , 16As shown, an embodiment of the present invention provides a hemostatic valve 100 in which the first ends 181a-186a of the plurality of flexible members 181-186 are fixedly connected to the main housing 102, and the second ends 181b-186b are fixedly connected to the rolling housing 104. In this embodiment, the connection points of the first ends 181a-186a of the plurality of flexible members 181-186 and the main housing 102 are located in the same plane, for example, on the base member 138. In this embodiment, the connection points of the second ends 181b-186b of the plurality of flexible members 181-186 and the rolling housing 104 are located in the same plane.

[0078] In an embodiment of the present invention, a hemostatic valve 100 is provided, wherein first ends 181a-186a of a plurality of flexible members 181-186 are fixedly connected to a main housing 102 through a plurality of positioning holes 131-136, wherein the plurality of positioning holes 131-136 are uniformly spaced in the circumferential direction on the main housing 102, such as Figures 11 to 12 As shown, for example, if the hemostatic valve includes three flexible members, the plurality of positioning holes in the main housing 102 for connecting the first ends 181a-186a of the plurality of flexible members 181-186 may be spaced about 120 degrees apart, about 90 degrees apart if four flexible members are used, or about 60 degrees apart if six flexible members are used, or about 40 degrees apart if nine flexible members are used, and so on. Similarly, the second ends 181b-186b of the plurality of flexible members 181-186 are fixedly connected to the rolling housing 104 through the plurality of positioning holes 141-146, wherein the plurality of positioning holes 141-146 are uniformly spaced circumferentially on the rolling housing 104, as shown in FIG. Figures 9 to 10 As shown, for example, if the hemostatic valve 100 includes three flexible members, the plurality of positioning holes in the rolling housing 104 for connecting the second ends 181b-186b of the plurality of flexible members 181-186 may be spaced about 120 degrees apart, if four flexible members are used, the plurality of positioning holes may be spaced about 90 degrees apart, or if six flexible members are used, the plurality of positioning holes may be spaced about 60 degrees apart, or if nine flexible members are used, the plurality of positioning holes may be spaced about 40 degrees apart, and so on. Alternatively, the plurality of positioning holes of the first ends 181a-186a of the plurality of flexible members 181-186 may also be arranged on the main housing 102 at uneven intervals; similarly, the plurality of positioning holes of the second ends 181b-186b of the plurality of flexible members 181-186 may also be arranged on the rolling housing 104 at uneven intervals.

[0079] The positions of the second ends 181b-186b of the plurality of flexible members 181-186 change as the rolling housing 104 rotates, for example, the rolling housing 104 rotates between the first position where the hemostatic valve 100 is closed by default and the second position where the hemostatic valve 100 is open. The position of the second end 182b of the flexible member 182 changes as shown in FIG. Fig.17 As shown, when the rolling shell 104 rotates to the second position to open the hemostatic valve 100, the flexible member 182 (shown in dotted lines) extends from the first end 182a to the second end 182b in the space between the rolling shell 104 and the gasket 106, and circumferentially surrounds the first tubular body 164. The length of the flexible member 182 can be set so that when the flexible member 182 circumferentially surrounds the first tubular body 164, the flexible member 182 does not compress the first tubular body 164, so that the first tubular body 164 is in a natural state and the gasket 106 is in a state of opening the inner cavity; when the rolling shell 104 rotates to the first position, the position of the second end 182b of the flexible member 182 changes, and the flexible member 182 (shown in solid lines) is stretched and compresses the first tubular body 164. In general, the plurality of flexible members 181-186 form a cross point, which contracts, folds or tightens the first tubular body 164 to close or narrow the inner cavity 166. Therefore, as the rolling shell 104 rotates between the first position and the second position, the plurality of flexible members 181-186 are "rotated" or "reversely rotated" to close or open the hemostatic valve 100. In this embodiment, the hemostatic valve 100 includes a tension spring 110 coupled to the rolling shell 104 and the main shell 102. When the rolling shell 104 is in the default first position, the tension spring 110 is in a low energy or natural state, in which the plurality of flexible members 181-186 form a cross point to contract or tighten the first tubular body 164; when the rolling shell 104 is in the second position, the tension spring 110 will be in a stretched or stressed state, in which the plurality of flexible members 181-186 release the first tubular body 164 to open the hemostatic valve 100. The rolling shell 104 is restored from the second position to the default first position by the tension or biasing force generated by the tension spring 110.

[0080] The embodiment of the present invention provides a structure of a plurality of flexible components 181-186 of a hemostatic valve 100 as shown in FIG. Figures 9 to 16 When the hemostatic valve 100 is in an open state, a cross-sectional top view of multiple flexible members 181 to 186 is shown Fig. 9 When the hemostatic valve 100 is in a closed state, the cross-sectional top view of the plurality of flexible components 181 to 186 is as shown in FIG. Fig.10 As shown. Figure 11-12 In the figure, the rolling housing 104 and the gasket 106 of the hemostatic valve 100 are omitted for clarity. Figure 13-16 In the figure, only the plurality of flexible members 181 to 186 in the open and closed positions are shown, and the main housing 102 , the rolling housing 104 and the gasket 106 of the hemostatic valve 100 are omitted for clarity.

[0081] like Fig. 9 , 11As shown in FIGS. 13 and 15 , when the hemostatic valve 100 is in the open state, the middle sections 181m to 186m of the plurality of flexible members 181 to 186 are at the smallest distance from the first tubular body 164 or the smallest distance from the central axis 101 of the inner cavity 166. The lengths of the plurality of flexible members 181 to 186 are set so that the middle sections 181m to 186m of the plurality of flexible members 181 to 186 do not compress the first tubular body 164, thereby allowing the first tubular body 164 to be in a natural state. Therefore, the middle sections 181m to 186m of the plurality of flexible members 181 to 186 form a central channel 188 as shown in FIG. Fig.11 As shown, the passage has a minimum size, allowing the first tubular body 164 or a portion of the first tubular body 164 to pass through without any compression. In this embodiment, the middle sections 181m-186m of the plurality of flexible members 181-186 are generally located in a plane perpendicular to the central axis 101 of the hemostatic valve 100.

[0082] like Fig.10 , 12 As shown in Figures 14 and 16, when the hemostatic valve 100 is in the closed state, the positions of the second ends 181b-186b of the multiple flexible members 181-186 change, so that the multiple flexible members 181-186 stretch and compress the first tubular body 164, and the multiple flexible members 181-186 form an intersection, thereby compressing or tightening the first tubular body 164.

[0083] like Figures 1 to 3 As shown in FIGS. 5 to 6, the embodiment of the present invention provides a hemostatic valve 100, which also includes a connector 108. The connector 108 includes a first end 172, a second end 174, and a second tubular body 176. The second tubular body 176 has a channel 178 between the first end 172 and the second end 174. Figures 5 to 6 As shown. The first end 172 of the connector 108 is provided with a bayonet assembly for connecting to the second end 116 of the main housing 102. The first end 172 of the connector 108 can also be provided with a recess or groove for connecting the second end 160 of the gasket 106 and / or securing it to the main housing 102. When assembled, the channel 178 is in communication with the inner cavity 166, and the channel 178 can accommodate instruments used in conjunction with the hemostasis valve 100. In this embodiment, the connector 108 includes one or more side ports 179 in communication with the channel 178. For example, the connector 108 can include a side port 179 for connecting a vacuum source or an irrigation line used in an aspiration medical procedure to reduce the formation of clots.

[0084] like Fig. 22As shown, an embodiment of the present invention proposes a hemostatic valve 100, which also includes a lock 190, and the lock 190 is used to keep the hemostatic valve 100 in an open state. The lock 190 may include a restraining element, such as a locking clip 192 for connecting to the hemostatic valve 100. The lock 190 may also include a leg member 194 arranged at intervals, and the leg member 194 is used to restrain the first protruding member 149 and the second protruding member 139 together when the hemostatic valve 100 is opened, thereby preventing the rolling shell 104 from returning to its default closed position under the action of the tension spring 110. The open state of the hemostatic valve 100 is locked, so that the inner cavity 166 remains open, which is helpful for sterilizing the first tubular body 164 or other parts of the hemostatic valve 100.

[0085] It should be noted that the description in conjunction with a specific embodiment is not necessarily limited to this embodiment, and can be implemented in any other embodiment. These drawings are intended to illustrate embodiments, but are not intended to be exhaustive descriptions or to limit the scope of protection of the present invention. Without departing from the principles of the present invention, alternative structures, components and materials will be considered feasible. For example, although various embodiments of the contraction mechanism with six flexible members are described in conjunction with the drawings, the contraction mechanism can include different numbers of flexible members, such as three, four, five, seven, eight, nine, ten, eleven, twelve, etc. Although the number of flexible members is small, it may cause less concentric contraction of the gasket tubular body or poor sealing effect, the less desirable effect can be compensated by a greater degree of rotation of a longer flexible member and a rolling shell. For example, the rolling shell is rotated at an angle of 250 degrees or more so that a longer flexible member surrounds or wraps around the gasket tubular body, thereby improving the less concentric contraction effect caused by, for example, three flexible members that rotate only at 45 degrees. When the rolling shell needs to be rotated to a greater extent, it can be achieved by a gear mechanism. On the other hand, although using a larger number of flexible members (e.g., nine) may complicate the assembly of the hemostatic valve, this can result in a better concentric contraction of the gasket, a shorter flexible member, and a smaller degree of rotation of the rolling shell (e.g., 45 degrees). Generally speaking, the length of the flexible member should be set so as not to affect the ability of the flexible member to rotate around the center or to compress the gasket. A person of ordinary skill in the art can optimize the hemostatic valve design by appropriately selecting the number and length of the flexible members and the degree of rotation of the rolling shell.

[0086] Unless otherwise clearly defined, all technical and scientific terms used herein have the meanings commonly understood by those of ordinary skill in the art. As used in the specification and the appended claims, the term "or" refers to a non-exclusive "or" unless the context clearly states otherwise. For ease of describing various embodiments, relative terms such as "above", "below", "upper", "lower", "top", "bottom" and the like are used, but do not necessarily indicate the direction used during manufacture or use. The terms "first" and "second" and the like are used to distinguish one element from another when describing various similar elements. The terms "first" and "second" may include references to two or more. In addition, unless the context clearly states otherwise, the use of the terms "first" and "second" should not be interpreted as being in a specific order. All numerical values ​​are provided for illustration, and the term "approximately" generally refers to a series of numbers that a person skilled in the art considers to be equivalent to the quoted value, such as having the same function or result. The term "approximately" may include numbers rounded to the nearest significant figure. The expression of a numerical range by an endpoint includes all numbers within the range.

[0087] The above are preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A hemostatic valve, characterized in that: include: a main housing having a first end and a second end; a rolling housing that rotates relative to the main housing between a first position and a second position; A gasket is arranged in the rolling housing, wherein the first end of the gasket is fixedly connected to the first end of the main housing, the second end of the gasket is fixedly connected to the second end of the main housing, a first tubular body is arranged between the first end of the gasket and the second end of the gasket, and the first tubular body has an elastic interior and an inner cavity; A plurality of flexible members, wherein a first end of each of the plurality of flexible members is fixedly connected to the main shell, and a second end of each of the plurality of flexible members is fixedly connected to the rolling shell; When the rolling shell is in the first position, the multiple flexible members squeeze the first tubular body to close or narrow the inner cavity of the first tubular body. When the rolling shell is in the second position, the multiple flexible members release the first tubular body to open the inner cavity of the first tubular body.

2. The hemostatic valve according to claim 1, characterized in that: The rotation angle of the rolling housing relative to the main housing is 30 degrees to 330 degrees.

3. The hemostatic valve according to claim 1, characterized in that: The first ends of the plurality of flexible members are all fixedly connected in a first plane of the main shell, and the second ends of the plurality of flexible members are all fixedly connected in a second plane of the rolling shell.

4. The hemostatic valve according to claim 3, characterized in that: The plurality of flexible members are disposed between the rolling housing and the first tubular body, and surround the first tubular body.

5. The hemostatic valve according to claim 3, characterized in that: The fixed connection points between the first ends of the plurality of flexible members and the main shell are evenly distributed in the circumferential direction.

6. The hemostatic valve according to claim 3, characterized in that: The fixed connection points between the second ends of the plurality of flexible members and the rolling shell are evenly distributed in the circumferential direction.

7. The hemostatic valve according to claim 3, characterized in that: The first ends of the plurality of flexible members are connected to the main housing at unevenly spaced locations, and / or the second ends of the plurality of flexible members are connected to the rolling housing at unevenly spaced locations.

8. The hemostatic valve according to claim 3, characterized in that: The plurality of flexible members includes 3 to 12 flexible members.

9. The hemostatic valve according to claim 3, characterized in that: When the rolling shell is in the second position, the middle sections of the multiple flexible members are at the smallest distance from the central axis of the inner cavity, and the ends of the multiple middle sections are adjacent to each other in sequence to form a first channel, which allows the first tubular body to pass through without being squeezed and deformed.

10. The hemostatic valve according to claim 9, characterized in that: When the rolling shell is in the first position, the plurality of flexible members form a cross section, and the cross section squeezes the first tubular body to generate deformation and contraction.

11. The hemostatic valve according to claim 10, characterized in that: The gasket also includes an annular band extending outwardly from the first tubular body, the annular band being disposed proximate the intersection.

12. The hemostatic valve according to claim 1, characterized in that: The gasket also includes an annular band extending outwardly from the first tubular body.

13. The hemostatic valve according to claim 11, characterized in that: The annular belt and the first tubular body are integrally formed.

14. The hemostatic valve according to claim 1, characterized in that: When the rolling housing is in the second position, the diameter of the inner cavity ranges from 4 mm to 15 mm.

15. The hemostatic valve according to claim 1, characterized in that: The main housing comprises a cylindrical side wall, the side wall is used to accommodate the rolling housing, and an opening is arranged on the side wall.

16. The hemostatic valve according to claim 15, characterized in that: The rolling housing comprises a cylindrical side wall, and the central axis of the rolling housing side wall coincides with the central axis of the main housing side wall.

17. The hemostatic valve according to claim 16, characterized in that: The rolling housing further comprises a first protruding piece member located on a side wall of the rolling housing, wherein the first protruding piece member extends from an opening of the main housing.

18. The hemostatic valve according to claim 17, characterized in that: The main housing also includes a second tab member.

19. The hemostatic valve according to claim 1, characterized in that: The hemostatic valve also includes a tension spring, a first end of the tension spring is fixedly connected to the rolling shell, a second end of the tension spring is fixedly connected to the main shell, and when the tension spring contracts, the rolling shell is in a first position.

20. The hemostatic valve according to claim 19, characterized in that The hemostatic valve further comprises a locking mechanism for locking the rolling housing in a second position.

21. The hemostatic valve according to claim 1, characterized in that The hemostatic valve also includes a connector fixedly connected to the second end of the main shell, the connection includes a second tubular body and a side port, the second tubular body is provided with a channel connected to the inner cavity, and the side port is used to connect a vacuum source or a flushing source.

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