A hemostatic valve

Abstract

The present invention provides a hemostatic valve, belonging to the field of medical device technology, which solves the problems of blood leakage and inconvenient operation of hemostatic valves. The hemostatic valve of the present invention includes: a main housing; a rolling housing, which rotates between a first position and a second position relative to the main housing; a gasket, wherein a first tubular body is provided between the first end and the second end of the gasket, the first tubular body being elastic and having an inner cavity; and a plurality of flexible members, wherein the first ends of the plurality of flexible members are fixedly connected to the main housing, and the second ends of the plurality of flexible members are fixedly connected to the rolling housing. When the rolling housing is in the first position, the plurality of flexible members squeeze the first tubular body, closing or narrowing the inner cavity of the first tubular body. When the rolling housing is in the second position, the plurality of flexible members release the first tubular body, opening the inner cavity of the first tubular body. The hemostatic valve of the present invention can adapt to interventional instruments of different sizes or shapes, and has strong compatibility and excellent 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 U.S. Patent No. 18 / 797,449, filed on August 7, 2024, the disclosures of which are incorporated herein by reference in their entireties. Technical Field

[0003] The present 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, preventing blood from leaking. In some traditional hemostatic valves, a flat membrane or gasket made of an elastic material is typically 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 cutout 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 accommodate the diameter of the inserted instrument. However, such hemostatic valves require an inflation mechanism that is inconvenient to operate. Summary of the Invention

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

[0006] In order to solve the above technical problems, the technical solutions of the present invention are 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 washer is provided in the rolling housing, wherein a first end of the washer is fixedly connected to a first end of the main housing, a second end of the washer is fixedly connected to a second end of the main housing, a first tubular body is provided between the first end and the second end of the washer, and the first tubular body has an elastic interior and an inner cavity;

[0011] a plurality of flexible members, wherein a first end portion of each of the plurality of flexible members is fixedly connected to the main shell, and a second end portion 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 members and the main shell are evenly distributed circumferentially.

[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 cause deformation and contraction.

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

[0022] Optionally, the gasket further includes an annular band extending outward 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 housing further comprises a first protruding piece component located on a side wall of the rolling housing, and the first protruding piece component extends from an opening of the main housing.

[0028] Optionally, the main shell further includes a second protrusion member.

[0029] Optionally, the hemostatic valve further 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 the first position.

[0030] Optionally, the hemostatic valve further includes 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 includes: 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 disposed in the rolling housing, wherein the first end of the gasket is fixedly connected to the first end of the main housing, and the second end of the gasket is fixedly connected to the second end of the main housing, and a first tubular body is disposed between the first end and the second end of the gasket, the first tubular body having an elastic interior and an inner lumen; a plurality of flexible members, wherein the first ends of the plurality of flexible members are fixedly connected to the main housing, and the second ends of the plurality of flexible members are fixedly connected to the rolling housing; when the rolling housing is in the first position, the plurality of flexible members squeeze the first tubular body to close or narrow the inner lumen of the first tubular body, and when the rolling housing is in the second position, the plurality of flexible members release the first tubular body to open the inner lumen of the first tubular body; the hemostatic valve can accommodate interventional instruments of different sizes and shapes that are inserted into the hemostatic valve, and has a high degree of adaptability / compatibility and an 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 member 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, with the flexible member omitted in the figure;

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

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

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

[0045] Figure 12 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, and the rolling housing and gasket are omitted in the figure;

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

[0047] Figure 14 1 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, and the main housing, rolling housing, and gasket are omitted in the figure;

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

[0049] Figure 16 2 is another cross-sectional side view of the hemostatic valve provided by an embodiment of the present invention, in which the hemostatic valve is in a closed state, and the main housing, rolling housing, and gasket are omitted in the figure;

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

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

[0052] Figure 19 is a side view of a gasket provided in an embodiment of the present invention;

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

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

[0055] Figure 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 housing; 104, rolling housing; 106, gasket; 108, connector; 110, tension spring; 112, spring housing; 114, cover member; 116, second end of main housing; 118, first end of main housing; 120, main housing side wall; 122, first opening; 124, second opening; 126, third opening; 131-136, main housing positioning hole; 138, base member; 139, second protruding tab member; 141-146, rolling housing positioning hole; 148, rolling housing side wall; 149, first protruding tab member; 160, second end of gasket; 162, first end of gasket ; 164. First tubular body; 164a. First portion of first tubular body; 164b. Second portion of first tubular body; 166. Inner cavity; 167. First flange; 168. Second flange; 170. Annular band; 172. First end portion of connector; 174. Second end portion 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. Center channel; 190. Lock; 192. Locking clip; 194. Leg member. DETAILED DESCRIPTION

[0057] Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although 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. Rather, these embodiments are provided to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0058] Embodiments of the present invention provide a hemostatic valve that utilizes multiple flexible components connected in series between a main housing and a rolling housing to create a folding intersection, thereby contracting a first tubular body extending through the center of the multiple flexible components. The rolling housing can rotate, allowing the flexible components to release or unwind the first tubular body, thereby opening the valve. This valve contraction-based closure method employed by the present invention eliminates the drawbacks of the expansion method employed in conventional hemostatic valves, effectively preventing or minimizing 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 As shown) and a plurality of flexible members 181 to 186 (as shown Figure 2 and Figures 7 to 17As shown); the hemostatic valve 100 may further include a connector 108, a tension spring 110, a spring housing 112 and a cover member 114, as shown 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. Figures 7 to 10 As shown. The rolling shell 104 can be rotated to open or close the hemostatic valve 100. In the closed state of the hemostatic valve 100, as shown Figure 8 、 10 , 12, 14 and 16, the plurality of flexible members 181-186 contract the gasket 106, thereby closing or narrowing the lumen of the gasket 106 to seal the instrument passing through the lumen of the gasket 106. Figure 1 、 7 , 9, 11, 13 and 15, the plurality of flexible members 181-186 do not constrain or release 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 retaining a rolling housing 104 and includes a mechanism for securing a gasket 106. The main housing 102 includes a second end 116, a first end 118, and a sidewall 120 extending between the second end 116 and the first end 118. 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. A 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 can be any diagnostic or 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 hemostatic valve 100 is defined by the central axis 101 of the first opening 122 and the second opening 124 between the second end 116 and the first end 118 of the main housing 102.

[0061] An embodiment of the present invention provides a hemostatic valve 100 in which the sidewall 120 of the main housing 102 is provided with a third opening 126 to allow a user to twist or rotate the rolling housing 104 during operation of the hemostatic valve 100. In this embodiment, the sidewall 120 of the main housing 102 may be provided with two or more third openings 126 to facilitate user rotation of the rolling housing 104 during operation of the hemostatic valve 100. The third openings 126 in the sidewall 120 of the main housing 102 may be in the form of windows or slots. In this embodiment, the third openings 126 in the sidewall 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 about 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 to 136, and first ends 181a to 186a of a plurality of flexible members 181 to 186 can be connected to the main housing 102 through these positioning holes. Figure 2 、 11 , 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 the 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 the hemostatic valve 100 includes three flexible members, the positioning holes in the base member 138 can be spaced approximately 120 degrees apart, if four flexible members are used, then approximately 90 degrees apart, if six flexible members are used, then approximately 60 degrees apart, if nine flexible members are used, then approximately 40 degrees apart, 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 to open or close the hemostatic valve 100. The rolling housing 104 can rotate relative to the main housing 102. In this embodiment, the rolling housing is housed in the main housing 102. The rolling housing 104 can house a gasket 106, such as Figures 2 to 3 The rolling shell 104 provides a plurality of positioning holes 141 to 146, as shown in FIG. 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, thereby closing or opening the hemostatic valve 100.

[0065] An embodiment of the present invention provides a hemostatic valve 100 in which the rolling housing 104 is a cylindrical structure including a sidewall 148 for accommodating a gasket 106. In this embodiment, the cylindrical structure of the rolling housing 104 is concentric with the cylindrical structure of the main housing 102. In this embodiment, the sidewall 148 of the rolling housing 104 is provided with a plurality of positioning holes 141-146. These positioning holes define a plurality of locations at which the second ends 181b-186b of a plurality of flexible members 181-186 are connected to the rolling housing 104. Each hole 141-146 allows a flexible member to pass through, allowing the second end of the flexible member to connect to the rolling housing 104 at the positioning hole. The second ends 181b-186b of the plurality of flexible members 181-186 can be connected to the rolling housing 104 at the plurality of positioning holes 141-146 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 bonding them together. In embodiments 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 to form a ball or by welding an additional sleeve.

[0066] An embodiment of the present invention provides a hemostatic valve 100 in which the plurality of positioning holes 141-146 in the sidewall 148 of the rolling housing 104 are evenly spaced around the circumference. For example, if the hemostatic valve includes three flexible members, the plurality of positioning holes 141-146 may be spaced approximately 120 degrees apart, if four flexible members are used, approximately 90 degrees apart, if six flexible members are used, approximately 60 degrees apart, if nine flexible members are used, approximately 40 degrees apart, and so on. Alternatively, the plurality of positioning holes 141-146 where the second ends 181b-186b of the plurality of flexible members 181-186 connect to the main housing 102 may be unevenly spaced. In one embodiment, the plurality of positioning holes 141-146 in the sidewall 148 of the rolling housing 104 lie in the same plane. This plane is perpendicular to the central axis 101 of the hemostatic valve 100.

[0067] In an embodiment of the present invention, a hemostatic valve 100 is provided in which the rolling housing 104 includes a first tab member 149 to facilitate user operation of the hemostatic valve 100. When assembled, the first tab member 149 can protrude outward from the sidewall 148 of the rolling housing 104 and extend beyond the third opening 126 in the main housing 102. The first tab member 149 is used by 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 extending outward from the sidewall 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 grip the hemostatic valve 100 with one hand, for example, while the rolling housing 104 is rotated relative to the main housing 102 to open the valve 100, allowing the user to insert an instrument into the valve 100 with the other hand. The second tab member 139 on the main housing 102 and the first projection member 149 on the rolling housing 104 also allow the hemostatic valve 100 to be locked in the open position, so as to facilitate sterilization of the hemostatic valve 100. In this embodiment, the rolling housing 104 may include two or more tab members to facilitate user operation of the hemostatic valve 100.

[0068] In an embodiment of the present invention, a hemostatic valve 100 is provided in which 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 sidewall 148 for receiving and supporting the tension spring 110. The rolling housing 104 may be provided with a slot in the sidewall 148 for connecting a 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 at 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 is in a stretched or stressed state, thereby generating a biasing force to pull the rolling housing 104 back to the default closed position.

[0069] In an embodiment of the present invention, a hemostatic valve 100 is provided in which a plurality of positioning holes 131 to 136 of a base member 138 are arranged circumferentially around a rolling shell 104, or between the rolling shell 104 and a gasket 106. Figures 7 to 12As shown, the circumferential diameter of the plurality of positioning holes 131-136 connected thereto can be smaller than the circumferential diameter of the plurality of positioning holes 141-146 connected thereto in the rolling housing 104, but larger than the diameter of the first tubular body 164 of the gasket 106 in its natural state. Therefore, the flexible member can pass through the positioning holes in the base member 138 of the main housing 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 housing 104 and the gasket 106, then passes through the positioning holes in the rolling housing 104. The second end 181b of the flexible member 181 is connected to the rolling housing 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 As shown in Figures 5, 6, and 18 to 20, the gasket 106 provides a secure seal around an 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. 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. The inner cavity 166 of the first tubular body 164 closes or narrows when the first tubular body 164 contracts. The first tubular body 164 opens the inner cavity 166 in its natural state. Materials used to manufacture the gasket 106 include silicone, polyurethane, ethylene vinyl acetate, natural or synthetic rubber, and other polymers known in the art. In this 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 an outwardly extending first flange 167, which is fixedly connected to the base member 138 and / or is compressed between the main housing 102 and the connector 108, as shown. 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, thereby allowing the first flange 167 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 an outwardly extending second flange 168, 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 member for connecting the second flange 168, thereby allowing the second flange 168 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 first tubular body 164 or lumen 166 is sized and shaped to accommodate the device sealed by the hemostatic valve 100. For example, the diameter of the lumen 166 can range from 4 mm to 15 mm. In this embodiment, the lumen 166 can accommodate devices with a maximum cross-sectional dimension ranging from 0.1 mm to 14.5 mm. It should be noted that the above dimensions are provided for illustration and understanding of the embodiments of the present invention. Those skilled in the art can readily scale the dimensions of the lumen 166 based on specific application scenarios and are not limited to specific dimensions.

[0073] like Figures 18 to 21 As shown, in an embodiment of the present invention, a hemostatic valve 100 is provided in which 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 to 186 to close the hemostatic valve 100, the annular band 170 can prevent the first tubular body 164 from folding and / or twisting. Figure 21As shown, the annular band 170 can be located above the connection between the second ends 181b-186b of the plurality of flexible members 181-186 and the rolling housing 104. When the hemostatic valve 100 is in the closed position, the plurality of flexible members 181-186 contract or squeeze the first tubular body 164 below the annular band 170. When the second portion 164b of the first tubular body 164 below the annular band 170 contracts, the annular band 170 prevents the first portion 164a of the first tubular body 164 above the annular band 170 from folding. In this embodiment, the annular band 170 is an integral part of the first tubular body 164 and is made of the same material as the gasket 106. Alternatively, the annular band 170 can be a separate part bonded to the first tubular body 164 by any suitable means. According to alternative embodiments of the present invention, the gasket 106 can include a plurality of ribs on the outer surface of the first tubular body 164 to prevent the first tubular body 164 from folding during operation of the hemostatic valve 100.

[0074] like Figures 7 to 16 As shown, in an embodiment of the present invention, a hemostatic valve 100 is provided in which a plurality of flexible members 181-186 can be used to compress the first tubular body 164 to close or narrow the inner lumen 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 its natural state and open the inner lumen 166.

[0075] The plurality of flexible members 181-186 may be filaments, ropes, flat wires, ribbons, and the like. The plurality of flexible members 181-186 may be made from a single strand of material, such as a monofilament. In this embodiment, the plurality of flexible members 181-186 may also be made from multiple strands of wire that are grouped, twisted, or braided to form the flexible member. 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 from polypropylene, nylon, nitinol, stainless steel, and the like. Figures 7 to 16 Six flexible members 181 to 186 are shown in FIG. 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 flexible members.

[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 Figure 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 with 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 with the rolling housing 104 are located in the same plane.

[0078] In an embodiment of the present invention, a hemostatic valve 100 is provided in which the first ends 181a to 186a of the plurality of flexible members 181 to 186 are fixedly connected to the main housing 102 through the plurality of positioning holes 131 to 136, wherein the plurality of positioning holes 131 to 136 are evenly spaced on the main housing 102 in the circumferential direction. 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 can be spaced approximately 120 degrees apart, or approximately 90 degrees apart if four flexible members are used, or approximately 60 degrees apart if six flexible members are used, or approximately 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 evenly 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 can be spaced approximately 120 degrees apart, or approximately 90 degrees apart if four flexible members are used, or approximately 60 degrees apart if six flexible members are used, or approximately 40 degrees apart if nine flexible members are used, and so on. Alternatively, the plurality of positioning holes of the first ends 181a-186a of the plurality of flexible members 181-186 can also be arranged at uneven intervals on the main housing 102; similarly, the plurality of positioning holes of the second ends 181b-186b of the plurality of flexible members 181-186 can also be arranged at uneven intervals on the rolling housing 104.

[0079] The positions of the second ends 181b to 186b of the plurality of flexible members 181 to 186 change as the rolling housing 104 rotates, for example, when the rolling housing 104 rotates between the first position in which the hemostatic valve 100 is closed by default and the second position in which the hemostatic valve 100 is open. The position of the second end 182b of the flexible member 182 changes as shown in FIG. Figure 17 As shown, when the rolling housing 104 rotates to the second position to open the hemostatic valve 100, the flexible member 182 (shown in dotted lines) extends from a first end 182a to a second end 182b in the space between the rolling housing 104 and the gasket 106, circumferentially surrounding 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, thereby keeping the first tubular body 164 in a natural state and the gasket 106 in an open lumen state. When the rolling housing 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 that contracts, folds, or tightens the first tubular body 164 to close or narrow the lumen 166. Thus, as the rolling housing 104 rotates between the first and second positions, the plurality of flexible members 181-186 are "rotated" or "counter-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 housing 104 and the main housing 102. When the rolling housing 104 is in the default first position, the tension spring 110 is in a low-energy or neutral 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 housing 104 is in the second position, the tension spring 110 is 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 tension or biasing force generated by the tension spring 110 restores the rolling housing 104 from the second position to the default first position.

[0080] The embodiment of the present invention provides a structure of multiple flexible components 181-186 of a hemostatic valve 100 as follows: Figures 9 to 16 When the hemostatic valve 100 is in the open state, a cross-sectional top view of the plurality of flexible members 181 to 186 is shown. Figure 9 When the hemostatic valve 100 is in the closed state, the cross-sectional top view of the multiple flexible components 181 to 186 is as shown in FIG. Figure 10 As shown. Figure 11-12 In FIG, the rolling housing 104 and the gasket 106 of the hemostatic valve 100 are omitted for clarity. Figure 13-16 , only the plurality of flexible members 181 - 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 Figure 9 、 11As shown in Figures 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 at the smallest distance from the central axis 101 of the lumen 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 Figures 13 and 15. Figure 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 Figure 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 to 186b of the multiple flexible members 181 to 186 change, so that the multiple flexible members 181 to 186 stretch and compress the first tubular body 164, and the multiple flexible members 181 to 186 form an intersection, thereby compressing or tightening the first tubular body 164.

[0083] like Figures 1 to 3 As shown in Figures 5 to 6, an embodiment of the present invention provides a hemostatic valve 100, which further 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 may also be provided with a recess or groove for connecting to 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 may include a side port 179 for connecting to a vacuum source or an irrigation line used in an aspiration medical procedure to reduce clot formation.

[0084] like Figure 22As shown, an embodiment of the present invention provides a hemostatic valve 100 that further includes a lock 190 for maintaining the hemostatic valve 100 in an open state. The lock 190 may include a restraining element, such as a locking clip 192 for connection to the hemostatic valve 100. The lock 190 may also include spaced leg members 194 that, when the hemostatic valve 100 is open, restrain the first tab member 149 and the second tab member 139 together, thereby preventing the rolling housing 104 from returning to its default closed position under the action of the tension spring 110. Locking the hemostatic valve 100 in an open state keeps the inner cavity 166 open, facilitating sterilization of the first tubular body 164 or other portions of the hemostatic valve 100.

[0085] It should be noted that the descriptions described with reference to a specific embodiment are not necessarily limited to that embodiment and may be implemented in any other embodiment. The figures are intended to illustrate embodiments and are not intended to be exhaustive or to limit the scope of the present invention. Alternative structures, components, and materials are contemplated without departing from the principles of the present invention. For example, while various embodiments of a contraction mechanism having six flexible members are described in conjunction with the figures, the contraction mechanism may include a different number of flexible members, such as three, four, five, seven, eight, nine, ten, eleven, or twelve. While a smaller number of flexible members may result in less concentric contraction of the gasket tubular body or a poorer sealing effect, this less-than-ideal effect can be compensated for by longer flexible members and a greater degree of rotation of the rolling shell. For example, rotating the rolling shell by 250 degrees or more allows the longer flexible member to wrap around or around the gasket tubular body, thereby ameliorating the less-than-concentric contraction effect caused by, for example, three flexible members rotating only 45 degrees. When a greater degree of rotation of the rolling shell is desired, this can be achieved using a gear mechanism. On the other hand, while using a larger number of flexible members (e.g., nine) may complicate the assembly of the hemostatic valve, it can result in better concentric contraction of the gasket, shorter flexible members, and a smaller degree of rotation of the rolling shell (e.g., 45 degrees). Generally, the length of the flexible members should be set so as not to affect their ability to rotate about their center or to compress the gasket. Those skilled 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 expressly 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 dictates otherwise. To facilitate the description of various embodiments, relative terms such as "above," "below," "upper," "lower," "top," and "bottom" are used, but do not necessarily indicate directions used during manufacture or use. Terms such as "first" and "second" 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. Furthermore, unless the context clearly dictates otherwise, the use of the terms "first" and "second" should not be construed to imply a specific order. All numerical values ​​are provided for illustrative purposes, and the term "approximately" generally refers to a range of numbers that one skilled in the art would consider equivalent to the cited value, e.g., to have the same function or result. The term "approximately" may include numbers rounded to the nearest significant figure. Representations of numerical ranges by endpoints include all numbers within that range.

[0087] The above is a preferred embodiment 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 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 washer disposed in the rolling housing, wherein a first end of the washer is fixedly connected to a first end of the main housing, and a second end of the washer is fixedly connected to a second end of the main housing, and a first tubular body is disposed between the first end and the second end of the washer, the first tubular body being elastic and having an inner cavity; a plurality of flexible members, wherein a first end portion of each of the plurality of flexible members is fixedly connected to the main housing, and a second end portion of each of the plurality of flexible members is fixedly connected to the rolling housing; 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 along the circumference.

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 along the circumference.

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 cause deformation and contraction.

11. The hemostatic valve according to claim 10, characterized in that: The gasket further 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 includes a cylindrical side wall, the side wall is used to accommodate the rolling housing, and an opening is provided on the side wall.

16. The hemostatic valve according to claim 15, characterized in that The rolling housing includes 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 includes a first tab member located on a side wall of the rolling housing, wherein the first tab 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 further 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 the first position.

20. The hemostatic valve according to claim 19, characterized in that The hemostatic valve further includes a locking mechanism for locking the rolling housing in the 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 connector 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 to a vacuum source or a flushing source.

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