Hemostasis valve and introducer sheath system

Abstract

The invention relates to the field of medical instruments, and discloses a hemostasis valve and an introducer sheath system comprising the same. The hemostasis valve comprises a fixed piece, a rotating piece and a conical sealing piece. The rotating piece is arranged on the fixed piece in a sleeving mode and can do spiral motion around the fixed piece, and the rotating piece is coupled with the conical sealing piece so that the conical sealing piece can longitudinally move in the channel of the fixed piece. The fixing piece is provided with a conical face, and the far end of the conical sealing piece is suitable for being in sealing fit with the conical face. When the rotating piece does spiral motion around the fixed piece, the rotating piece can drive the conical sealing piece to move between the first position and the second position, and then the channel is closed or opened. The hemostasis valve is convenient and fast to operate, and dynamic sealing of the hemostasis valve can quickly act by rotating the rotating piece.

Description

Technical Field

[0001] This invention relates generally to the field of medical device technology. Specifically, this invention relates to a hemostatic valve and a guiding sheath system comprising the same. Background Technology

[0002] In clinical practice, when using interventional medical devices (interventional instruments), it is often necessary to first establish a pathway using a guide sheath system before maneuvering the interventional device through the guide sheath system into the patient's body. The guide sheath system is equipped with a hemostatic valve, which provides a seal for the interventional device entering the guide sheath system. Simultaneously, this hemostatic valve also provides a seal for the guide sheath system after the interventional device is withdrawn.

[0003] When interventional devices are withdrawn, the hemostatic valve typically closes the pathway of the guiding sheath system completely through a dynamic seal to prevent blood leakage. The design of the dynamic sealing structure of the hemostatic valve and how to ensure its rapid activation while maintaining ease of operation are pressing issues in this field. Summary of the Invention

[0004] To solve the above-mentioned technical problems, this disclosure provides a hemostatic valve and a guiding sheath system including the same.

[0005] The first aspect of this disclosure discloses a hemostatic valve comprising a fixed member, a rotating member, and a conical seal. The fixed member is configured to have a longitudinally extending channel defined by at least a conical surface, and its proximal end is provided with an external thread. The rotating member is sleeved on the fixed member and has an internal thread that mates with the external thread of the fixed member. The conical seal is coupled to the rotating member and is configured to move within the channel of the fixed member, with its distal end configured to seal against the conical surface. When the rotating member undergoes helical motion relative to the fixed member, it drives the conical seal to move axially, thereby closing or opening the channel of the fixed member.

[0006] Specifically, the conical seal has a longitudinally extending channel, and the conical seal includes a cone portion located at the distal end, the cone portion having a longitudinally extending conical channel, the cone portion having a plurality of circumferentially arranged slits, the slits penetrating the cone portion wall and extending longitudinally, the cone portion sealingly engaging with the conical surface.

[0007] Specifically, the conical seal includes a conical sealing portion disposed at the distal end and a connecting body connected to the conical sealing portion. The conical portion is disposed within the conical sealing portion, and the connecting body is coupled to a rotating component. The material of the conical sealing portion is compressible and elastic, while the material of the connecting body is rigid.

[0008] Specifically, one of the connector and the fixing member is provided with an anti-rotation portion, and the other is provided with a longitudinal groove adapted to receive the anti-rotation portion, which is movable along the longitudinal groove. Preferably, the outer periphery of the connector is provided with a longitudinal groove, the hemostatic valve includes an anti-rotation block, and the anti-rotation portion is disposed on the anti-rotation block. The fixing member is provided with a connecting groove adapted to receive the anti-rotation block, and the anti-rotation portion is configured to extend radially into the longitudinal groove.

[0009] Optionally, the hemostatic valve includes a sealing handle rotatably connected to a fixed member. The distal end of the sealing handle is fitted onto the fixed member, and the proximal end of the sealing handle is fitted onto a rotating member. The rotating member is coupled to the sealing handle such that when the sealing handle is rotated, the rotating member undergoes a helical motion around the fixed member. Specifically, the hemostatic valve includes a first pin detachably connected to the rotating member, and a first annular groove is provided on the outer periphery of the proximal end of the connecting body, with the first pin at least partially located in the first annular groove. Alternatively, the hemostatic valve includes a second pin detachably connected to the sealing handle, and a second annular groove is provided on the outer periphery of the middle portion of the fixed member, with the second pin at least partially located in the second annular groove.

[0010] Optionally, the hemostatic valve also includes a connecting seat and a static seal. The connecting seat has a longitudinally extending main channel. The connecting seat is detachably connected to the fixing member. The main channel communicates with the channel of the fixing member. The static seal is disposed between the connecting seat and the fixing member.

[0011] A second aspect of this disclosure discloses a guiding sheath system, comprising a sheath tube, a control handle, and a hemostatic valve according to the first aspect of this disclosure. The control handle has a rotatable spool, and the hemostatic valve is located at the proximal end of the control handle. The hemostatic valve has a main cavity, which includes at least a cavity formed by the channel of a fixing member. The sheath tube extends through the control handle and connects to the hemostatic valve, communicating with the main cavity of the hemostatic valve. The sheath tube has a control line connected to a distal region of the sheath tube, with the proximal end of the control line connected to the spool. When the spool rotates in a first direction, the control line can be wound onto the spool, causing the sheath tube to bend; when the spool rotates in a second direction, the control line unwinds from the spool, causing the sheath tube to return to a straight position.

[0012] The features and advantages of this disclosure include:

[0013] The hemostatic valve disclosed herein includes a fixed element, a rotating element, and a conical seal. The rotating element is fitted onto the fixed element and can rotate helically around the fixed element. The rotating element is coupled to the conical seal, allowing the conical seal to move longitudinally within the channel of the fixed element. The fixed element has a conical surface, and the distal end of the conical seal is adapted to seal against the conical surface. When the rotating element rotates helically around the fixed element, it can drive the conical seal to move between a first position and a second position, thereby closing or opening the channel. Attached Figure Description

[0014] To more clearly illustrate the technical solutions in the embodiments of this disclosure, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this disclosure. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0015] Figure 1 A three-dimensional schematic diagram of the guiding sheath system of this disclosure is shown;

[0016] Figure 2 An explosion schematic diagram of the guiding sheath system of this disclosure is shown;

[0017] Figure 3 A cross-sectional schematic diagram of the guiding sheath system of this disclosure is shown;

[0018] Figure 4 A schematic diagram of the mounting base, reel, ratchet, etc., in the guide sheath system of this disclosure is shown;

[0019] Figure 5 A cross-sectional schematic diagram of the hemostatic valve of this disclosure is shown;

[0020] Figure 6 An explosion diagram of the hemostatic valve of this disclosure is shown;

[0021] Figure 7 A three-dimensional schematic diagram of the conical seal in the hemostatic valve of this disclosure is shown, illustrating the features of the proximal end of the conical seal;

[0022] Figure 8 A three-dimensional schematic diagram of a conical seal in a hemostatic valve of the present disclosure is shown, illustrating the features of the distal end of the conical seal;

[0023] Figure 9 A cross-sectional schematic diagram of the conical seal in the hemostatic valve of this disclosure is shown;

[0024] Figure 10 A perspective view of one embodiment of the fixing member in the hemostatic valve of this disclosure is shown;

[0025] Figure 11 It shows Figure 10 A cross-sectional view of the fasteners in the diagram;

[0026] Figure 12 , Figure 13 A schematic diagram of another embodiment of the fixing member and connecting seat in the hemostatic valve of this disclosure is shown; wherein Figure 12 The proximal features of the connector are shown. Figure 13 The distal features of the fastener are shown;

[0027] Figure 14A cross-sectional schematic diagram of the guiding sheath system of this disclosure is shown, wherein the conical seal of the hemostatic valve is in the second position;

[0028] Figure 15 A cross-sectional schematic diagram of the guiding sheath system of this disclosure is shown, wherein the conical seal of the hemostatic valve is in the first position;

[0029] Figure 16 A partial cross-sectional schematic diagram of the interventional device of this disclosure extending through the guide sheath system is shown.

[0030] Explanation of reference numerals in the attached figures: 10-Guidance sheath system, 11-Sheath tube, 12-Control line, 20-Control handle, 31-Interventional device; 100-Hemostatic valve, 101-Second pin, 102-First pin, 103-Connecting block, 103a-Anti-rotation part, 103b-Circumferential extension part, 104-Static seal, 105-Flush tube, 106-Two-way valve, 107-Ring hoop, 108-Sealing ring; 110 - Sealing handle, 112 - Pin hole, 114 - Opening; 120 - Rotating component, 122 - Internal thread, 124 - Longitudinal protrusion, 126 - Pin hole; 130-Conical seal, 131-Channel, 131a-Conical channel, 131b-Cylindrical channel, 132-Conical sealing part, 132a-Conical part, 132b-Circular tube part, 133-Connector, 134-Slit, 135-Sealing body, 136-Annular groove, 137-Longitudinal groove; 140-Fixed component, 141-Channel, 142-Conical surface, 143-External thread, 144-Connecting groove, 145-Annular groove, 146-Internal thread, 147-Seal mounting groove, 148-Grip part, 149-Longitudinal engagement groove, 161-Annular engagement groove; 150-Connecting seat, 151-Main channel, 152-External thread, 153-Fixed seat connecting part, 154-Branch channel, 155-Flush pipe protrusion, 156-Proximal pipe section, 157-Annular fastening part, 158-Longitudinal fastening block; 210-Housing housing, 210a-First housing, 210b-Second housing, 211-Circumferential groove, 212-Circumferential tooth, 214-Toggle arrow indicator, 215-Unlock indicator; 220 - distal end cap, 221 - tube body, 222 - conical shell; 230-Fixed seat, 232-Sheath groove, 233-Circumferential groove, 234-Circumferential tooth, 235-Cone, 236-Connecting seat mating groove, 237-Support part; 241-Scroll, 242-Knob, 243-Pointer, 244-Ratchet, 245-Pawl, 246-Toggle button. Detailed Implementation

[0031] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them. Based on the embodiments of this disclosure, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this disclosure.

[0032] In this disclosure, "proximal" refers to the side closer to the surgeon, and "distal" refers to the side closer to the surgical target location.

[0033] See Figures 1 to 3 The guide sheath system 10 disclosed herein includes a sheath 11 and a control handle 20. The sheath 11 is provided with a control line 12 connected to the distal region of the sheath. The proximal end of the sheath 11 extends through or connects to the control handle 20, and the proximal end of the control line 12 is connected to the control handle 20. Operating the control handle can tension the control line 12, thereby bending the sheath 11 to facilitate the establishment of a channel within the body, allowing interventional instruments used for treatment to pass through. Specifically, tensioning the control line 12 can be achieved by pulling the control line 12 proximally or by winding the control line 12. A detailed description will follow using the winding of the control line 12 as an example.

[0034] See also Figure 1 , Figure 2 The control handle 20 includes a base 230, a reel 241, and a hemostatic valve 100. The reel 241 is rotatably connected to the base 230, and the proximal end of the control line 12 is connected to the reel 241. When the reel 241 rotates in a first direction, the control line 12 is wound onto the reel 241, causing the sheath 11 to bend; when the reel 241 rotates in a second direction, the control line 12 unwinds from the reel 241, causing the sheath 11 to return to a straight position. The hemostatic valve 100 includes a longitudinally extending main lumen that provides a passage for an interventional device to enter the body; the hemostatic valve 100 provides a dynamic seal and / or a static seal for the interventional device entering the main lumen. The sheath 11 is connected to the hemostatic valve 100 and communicates with the main lumen. The interventional device can extend through the hemostatic valve 100 into the sheath 11, and the hemostatic valve 100 provides a seal for the interventional device passing through it to prevent leakage of blood or other substances. Specifically, the distal end of the hemostatic valve 100 is fixed to the proximal end of the fixing seat 230. The proximal end of the fixing seat 230 is provided with a connecting seat groove 236 suitable for accommodating the distal end of the hemostatic valve 100.

[0035] Specifically, the mounting base 230 has a sheath groove 232 extending longitudinally through the mounting base 230, and the sheath 11 extends through the sheath groove 232 to connect to the hemostatic valve 100. The reel 241 is constructed as a transversely extending column, spanning the sheath groove 232. Specifically, the mounting base 230 has two support portions 237, which are respectively disposed on two longitudinal sidewalls defining the sheath groove 232. The support portions 237 have connecting holes, and the reel 241 extends through the connecting holes of the two support portions 237 to rotatably connect the reel 241 to the mounting base 230. The portion of the reel 241 located between the two support portions 237 is used for winding the control line 12. Optionally, one end of the reel 241 has a pointer 243, and the other end has a knob 242. The pointer 243 is fixed to the reel 241, and when the reel 241 rotates, the pointer 243 rotates synchronously to indicate the curvature of the sheath 11. A knob 242 is provided to facilitate the operator in rotating the scroll 241.

[0036] Optionally, the spool 241 is provided with a ratchet 244, and the control handle includes a pawl 245. When the pawl 245 engages with the ratchet teeth of the ratchet 244, it prevents the spool 241 from rotating in the unwinding direction, keeping the control line 12 under tension and the sheath in a bent state. Specifically, the ratchet 244 is coaxially arranged with the spool 241, and the ratchet 244 is located near the knob 242. The pawl 245 is rotatably connected to the fixed base 230. More specifically, the pawl 245 is connected to an elastic element, which gives the pawl 245 a tendency to remain locked with the ratchet 244. When it is necessary to rotate the spool 241, the elastic force of the elastic element must be overcome to allow the pawl 245 to rotate and release the lock, thereby allowing the spool 241 to rotate. Optionally, the control handle is provided with a toggle button 246 connected to the pawl 245. Toggling the toggle button 246 causes the pawl 245 to rotate synchronously.

[0037] See also Figure 1 , Figure 2Optionally, the control handle 20 includes a housing 210, a fixing seat 230, a ratchet 241, a pawl 245, and an elastic element disposed within the cavity of the housing 210, while a pointer 243 and a knob 242 are disposed outside the housing 210. A toggle button 246 is disposed inside the housing 210 and partially extends outside the housing 210 for easy operation. Specifically, the housing 210 includes a radially arranged and detachably connected first housing 210a and second housing 210b, with the housing 210 and the fixing seat 230 fixedly connected by a toothed groove. The distal ends of the inner walls of the first housing 210a and the second housing 210b are provided with longitudinally spaced circumferential grooves 211, forming circumferential teeth 212 between adjacent circumferential grooves 211. Correspondingly, the distal outer periphery of the fixing seat 230 is provided with longitudinally spaced circumferential grooves 233, which are configured to accommodate the circumferential teeth 212. Circumferential teeth 234 are formed between adjacent circumferential grooves 233, and the circumferential teeth 234 are configured to be received in the circumferential grooves 211. Optionally, the outer periphery of the mounting base 230 with circumferential grooves 233 and circumferential teeth 234 is provided with longitudinally extending reinforcing ribs, which helps to increase the strength of the mounting base 230. Specifically, the reinforcing ribs can be provided on the lower outer periphery of the mounting base 230. Optionally, the second housing 210b is provided with an unlocking indicator, which includes a toggle arrow indicator 214 and an unlocking indicator 215. The toggle arrow indicator 214 is used to indicate the direction of toggle of the button 245 when the pawl lock is released.

[0038] Optionally, the control handle 20 includes a distal end cap 220, which includes a longitudinally extending tube 221 and a conical housing 222 adjacent to the distal side of the tube 221. The tube 221 communicates with the cavity of the conical housing 222, and the sheath 11 can extend through the distal end cap 220. Specifically, the tube 221 is configured to accommodate the distal end of the housing 210, and the conical housing 222 is configured to accommodate the distal end of the mounting base 230. The distal end of the mounting base 230 is configured as a tapered portion with external threads, and the conical housing 222 has matching internal threads. The distal end cap 220 further integrates the housing 210 and the mounting base 230 into a single unit.

[0039] Specifically, see [link to relevant documentation] Figure 2 and Figure 5 The hemostatic valve 100 includes a fixing member 140, a rotating member 120, and a conical sealing member 130. See also... Figure 10 and Figure 11The fixing member 140 is configured to have a longitudinally extending channel 141, which is at least partially defined by a tapered surface 142. The main cavity of the hemostatic valve 100 includes the cavity formed by the longitudinally extending channel 141 of the fixing member 140. A rotating member 120 is sleeved on the fixing member 140. The proximal end of the fixing member 140 has an external thread 143, and the rotating member 120 has an internal thread 122 that mates with the external thread 143 of the fixing member 140. A tapered seal 130 is coupled to the rotating member 120. The tapered seal 130 is configured to move axially within the channel of the fixing member 140, and the distal end of the tapered seal 130 is configured to seal against the tapered surface 142. When the rotating member 120 helically moves about the fixing member 140, the rotating member 120 can drive the tapered seal 130 to move axially between a first position and a second position, thereby closing or opening the channel 141, wherein the first position is closer to the distal end of the fixing member 140. When the conical seal 130 is in the first position, the conical seal 130 engages with the conical surface of the fixing member 140, and the channel is closed; the conical seal 130 moves in the direction pointing to the second position (i.e., moves towards the proximal end) until the conical seal 130 disengages from the conical surface 142 of the fixing member 140, and the channel is opened.

[0040] Specifically, see Figure 10 and Figure 11 The fixation member 140 has a proximal channel with a circular cross-section, and a channel defined by a tapered surface 142 abuts the distal end of the proximal channel. The tapered surface 142 is configured such that its diameter gradually decreases distally. Specifically, the hemostatic valve 100 includes a connector 150 to which the proximal end of the sheath 11 is fixed, and the proximal end of the connector 150 is detachably connected to the fixation member 140. The distal end of the fixation member 140 is sleeved onto the connector 150, the proximal end of the connector 150 having an external thread, and the distal end of the fixation member 140 having an internal thread 146 adapted to engage the external thread of the connector 150. In some embodiments, the hemostatic valve 100 includes a static seal 104 disposed between the connector 150 and the fixation member 140, the static seal 104 providing a static seal for interventional instruments extending through the hemostatic valve 100. The fixing member 140 is provided with a sealing element placement groove 147 adjacent to the internal thread 146, and the outer peripheral portion of the static seal 104 is disposed within the sealing element placement groove 147. See also Figure 5 The two end faces of the outer peripheral portion of the static seal 104 are abutted by the connecting seat 150 and the fixing member 140, respectively. Preferably, the static seal 104 is configured as a four-leaf valve. This will be described in detail later. In some embodiments, see [reference needed]. Figure 5 and Figure 11 A transition channel is provided between the channels defined by the sealing groove 147 and the conical surface 142, and the cross-section of the transition channel is constructed to be circular.

[0041] Specifically, the conical seal 130 has a longitudinally extending channel 131 suitable for the passage of interventional instruments. Optionally, in some applications, the conical seal 130 can seal interventional instruments extending through it. When the interventional instrument is removed from the hemostatic valve 100, moving the conical seal 130 to a first position can completely close the main cavity of the hemostatic valve 100. Specifically, see Figure 9 The channel 131 includes a tapered channel 131a disposed at the far end, and a cylindrical channel 131b adjacent to the tapered channel 131a.

[0042] The distal end of the conical seal 130 is configured as a cone 132a, the outer diameter of which gradually decreases distally, and the inner diameter of which also gradually decreases distally, resulting in a generally uniform wall thickness. Optionally, the wall thickness of the cone 132a decreases slightly from the proximal end to the distal end. An opening is formed at the distal end of the cone 132a to facilitate the passage of interventional instruments. A conical channel 131a is defined by the inner wall of the cone 132a, and a cylindrical channel 131b extends from the proximal end of the conical channel 131a to the proximal end of the conical seal 130. Specifically, the cone 132a has a plurality of circumferentially arranged slits 134 that penetrate the cone wall and extend longitudinally, and the cone wall between adjacent slits 134 forms a sealing body 135. When the sealing body 135 is pressed inward by the conical surface 142, the sealing body 135 moves inward to close the channel. When the interventional device extends through the conical seal 130, the seal 135 can expand outward to increase the distal channel of the conical seal 130, facilitating the passage of the interventional device. Preferably, see Figure 8 The conical portion 132a has four slits 134 evenly arranged circumferentially, forming four sealing bodies 135. See also Figure 14 Optionally, in some embodiments, when the conical seal 130 is in the second position, the cone 132a is located in the proximal channel of the retainer 140. The cone 132a is made of a compressible and elastic material (e.g., silicone) to facilitate sealing the conduit.

[0043] Specifically, one of the conical seal 130 and the rotating member 120 is provided with a circumferentially extending annular groove, and the other is provided with mating teeth at least partially located within the annular groove, allowing relative rotation but synchronous axial movement between the two. In some embodiments, the conical seal 130 has an annular groove on its proximal outer periphery, and the rotating member 120 has radially extending mating teeth on its proximal inner side. The mating teeth can be one or more independent teeth arranged circumferentially, or they can be annular teeth that surround the circumference. The mating teeth extend into the annular groove and engage with it. More specifically, the rotating member 120 can be configured as two radially arranged and detachably connected parts for easy installation.

[0044] See Figures 5 to 7In other embodiments, the conical seal 130 has an annular groove 136 on its proximal outer periphery, and the rotating member 120 has a detachably connected first pin 102. The first pin 102 extends laterally through the annular groove 136, and a portion of the first pin 102 is located within the annular groove 136, allowing the conical seal 130 to move axially synchronously with the rotating member. In this case, the first pin 102 detachably connected to the rotating member 120 is a mating tooth, and the rotating member 120 can be constructed as a single unit. Specifically, the proximal end of the rotating member 120 has two sets of opposing first pin holes 126 that extend laterally through the rotating member 120, with the two first pins 102 located within one set of first pin holes 126 respectively. Constructing the mating teeth as the first pin 102 detachably connected to the rotating member 120 facilitates the installation and production of the hemostatic valve 100.

[0045] Preferably, the conical seal 130 includes a conical sealing portion 132 and a connecting body 133. The conical portion 132a is disposed in the conical sealing portion 132, and the annular groove is disposed at the proximal end of the connecting body 133. The connecting body 133 is made of a different material than the conical sealing portion 132; the connecting body 133 is made of a rigid material, which can increase the rigidity of the annular groove 136. For example, the specific material of the connecting body 133 can be one or more of polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), high-density polyethylene (HDPE), and polyamide (Nylon). The conical sealing portion 132 and the connecting body 133 can be integrally formed by processes such as bonding, overmolding, or injection molding. The conical sealing portion 132 includes a circular tube portion 132b disposed near the conical portion 132a, and the distal end of the connecting body 133 is connected to the circular tube portion 132b. Optionally, when the conical seal 130 moves between a first position and a second position, the circular tube portion 132b is located within the proximal channel of the fixing member 140. Preferably, see Figure 5 The outer diameter of the round tube 132b is slightly larger than the inner diameter of the proximal channel of the fixing member 140, so that the gap between the round tube 132b and the proximal channel wall of the fixing member 140 can be sealed, and the conical seal 130 can move smoothly axially.

[0046] Preferably, one of the connector 133 and the fixing member 140 is provided with an anti-rotation part, and the other is provided with a longitudinal groove suitable for receiving the anti-rotation part, which can move along the longitudinal groove. Providing the anti-rotation part and the longitudinal groove can keep the conical seal 130 axially movable and restrict the rotation of the conical seal 130 relative to the fixing member 140, thereby facilitating the smooth axial movement of the conical seal 130.

[0047] In some embodiments, see Figures 6 to 11The connector 133 has two circumferentially opposite longitudinal grooves 137 on its outer periphery, and an anti-rotation portion 103a is disposed on the fixing member 140. More specifically, the hemostatic valve 100 includes an anti-rotation block 103, the anti-rotation portion 103a being provided by the anti-rotation block 103, which is detachably connected to the fixing member 140. The anti-rotation portion 103a extends radially inward into the longitudinal grooves 137. More specifically, the fixing member 140 has a connecting groove 144 at its proximal end, which is configured to accommodate the anti-rotation block 103 and restrict longitudinal movement of the anti-rotation block 103, thereby guiding the axial movement of the conical seal 130. In other embodiments, a radially outwardly extending anti-rotation portion may be provided on the outer periphery of the connector 133, and a longitudinally extending longitudinal groove may be provided on the inner sidewall of the proximal end of the fixing member 140, with the anti-rotation portion extending into and engaging with the longitudinal groove. In this embodiment, the fastener 140 may include two radially arranged and detachably connected parts for easy installation.

[0048] Preferably, the anti-rotation block 103 further includes a circumferential extension 103b, which cooperates with the connecting groove 144 to restrict the longitudinal movement of the anti-rotation block 103. There are gaps between the circumferential extension 103b and the inner wall of the rotating member 120 and the outer peripheral wall of the connecting body 133. Specifically, the anti-rotation block 103 is configured in an L-shape, with the circumferential extension 103b connected to the distal side of the anti-rotation portion 103a, and the circumferential extension 103b is configured as an arc-shaped plate extending circumferentially. The connecting groove 144 is located in the external threaded section of the fixing member 140 and is staggered from the external threads. The connecting groove 144 is configured as an L-shaped groove suitable for accommodating the anti-rotation block 103. Preferably, the proximal end of the connecting groove 144 has an opening, exposing the proximal sidewall of the anti-rotation block 103 located therein. An opening is provided at the proximal end of the connecting groove 144 to facilitate the installation of the anti-rotation block 103 into the connecting groove 144 or the removal of the anti-rotation block 103 from the connecting groove 144. Preferably, the hemostatic valve 100 is provided with two anti-rotation blocks 103, and the fixing member 140 is provided with two connecting grooves 144.

[0049] Preferably, in some embodiments, the hemostatic valve 100 further includes a sealing handle 110, which is rotatably connected to the fixing member 140. The sealing handle 110 is configured as a cylinder, with its distal end sleeved on the fixing member 140 and its proximal end sleeved on the rotating member 120. The rotating member 120 is coupled to the sealing handle 110 such that when the sealing handle 110 is rotated, the rotating member 120 undergoes a helical motion relative to the fixing member 140. Specifically, the rotatable connection between the sealing handle 110 and the fixing member 140 can be referenced to the rotatable connection between the conical seal 130 and the rotating member 120, i.e., an annular groove and mating teeth. Specifically, see [link to documentation]. Figure 10The outer periphery of the fixing member 140 is provided with an annular groove 145. The sealing handle 110 is provided with a detachably connected second pin 101. The second pin 101 extends laterally through the annular groove 145. Part of the second pin 101 is located within the annular groove 145, allowing relative rotation between the sealing handle 110 and the fixing member 140, while limiting axial movement between them. The proximal end of the sealing handle 110 is provided with two sets of opposing second pin holes 112 that laterally penetrate the sealing handle 110. The two second pins 101 are respectively located within one set of second pin holes 112.

[0050] The sealing handle 110 has an opening 114 at its proximal end, allowing interventional instruments to enter the hemostatic valve 100 through the opening 114. One of the sealing handle 110 and the rotating member 120 has a longitudinally extending longitudinal protrusion, and the other has a longitudinally extending engagement groove adapted to accommodate the longitudinal protrusion. By providing the longitudinal protrusion and the engagement groove, the sealing handle 110 and the rotating member 120 can rotate synchronously, and both can move axially relative to each other. Specifically, see... Figure 6 The outer periphery of the rotating component 120 is provided with four longitudinally spaced protrusions 124, and the inner wall of the sealing handle 110 is provided with four longitudinally extending engagement grooves suitable for accommodating the longitudinal protrusions 124.

[0051] The hemostatic valve 100 has two sealing layers. The first layer, a four-leaf valve seal, serves as the first blood flow seal, preventing most of the blood from leaking out. The second layer is a conical movable sealing structure, including a fixed member 140, a conical seal 130, a rotating member 120, pins 101 / 102, and a sealing handle 110. The fixed member 140 is fixed relative to the connecting seat 150, which does not move relative to the entire system. The sealing handle 110 is axially fixed to the fixed member 140 via the second pin 101 but can rotate radially. The rotating member 120 and the sealing handle 110 are radially fixed but axially movable. The rotating member 120 is threadedly connected to the fixed member 140, and is also axially fixed to the conical seal 130 but radially rotatable. When the sealing handle 110 is rotated, it causes the rotating member 120 to rotate. Simultaneously, the rotating member 120 undergoes axial displacement on the fixed member 140 via the threads, causing the conical portion of the conical seal 130 to also undergo axial displacement synchronously. When the conical portion of the conical seal 130 moves toward the distal end of the fixation member 140, the conical surface of the fixation member 140 and the conical portion of the conical seal 130 interfere radially, squeezing the conical portion of the conical seal 130 to completely block the portion of the channel defined by the conical surface; when the conical portion of the conical seal 130 moves toward the proximal end along the channel of the fixation member 140, the conical portion moves into the proximal channel of the fixation member 140, where sufficient space can be provided for the conical portion to expand, which can effectively reduce the friction between the conical seal 130 and the interventional device that enters it.

[0052] The hemostatic valve 100 provided by this invention has a conical channel in the conical seal 130. A rotating member 120 is rotated by a sealing handle 110. The connecting body 133 and the rotating member 120 of the conical seal 130 are axially fixed but radially rotatable, allowing the conical seal 130 to move axially towards the proximal or distal end. This structure allows for a larger contact area for the conical seal 132 during compression, resulting in a shorter required compression stroke and thus achieving compression of the conical seal 132 with a smaller axial force. Furthermore, the active moving component of the hemostatic valve 100 is the conical seal 130. When the conical portion of the hemostatic valve 100 needs to expand, it can be moved to a region with a larger inner diameter within the channel of the fixed member, allowing the conical seal 132 to expand without external pressure and reducing the resistance of interventional instruments passing through the conical seal 132.

[0053] See Figure 5 and Figure 6 The connecting seat 150 is described in detail below. The connecting seat 150 has a longitudinally extending main channel 151, and the proximal end of the sheath 11 extends into the distal end of the main channel 151 and is fixed to the connecting seat 150. The main cavity of the hemostatic valve 100 also includes a cavity formed by the longitudinally extending main channel 151. The sheath 11 can be fixed to the connecting seat 150 by means of bonding or other methods. Optionally, the connecting seat 150 may have a radially extending through hole connected to the distal end of the main channel 151, which communicates with the main channel to facilitate the assembly of the connecting sheath 11. The static seal 104 includes a main body and an abutment ring disposed on the outer periphery of the main body, the abutment ring abutting between the proximal end of the connecting seat 150 and the fixing member 140. The proximal end of the main channel 151 is formed into a tapered channel, and the main body of the static seal 104 is located within the tapered channel and forms a gap with the inner wall defining the main channel 151. More specifically, the outer periphery of the main body of the static seal 104 is configured as a cone, and the proximal end of the main channel 151 is configured to have two cone-shaped channels with different tapers, wherein the first cone-shaped channel is located at the proximal end and its taper is consistent with the taper of the outer periphery of the main body of the static seal 104, and the second cone-shaped channel is adjacent to the distal end of the first cone-shaped channel.

[0054] More specifically, the connecting seat 150 is also provided with a branch channel 154 communicating with the main channel 151, through which the hemostatic valve 100 and the sheath 11 can be flushed. The connecting seat 150 is provided with a flushing tube protrusion 155, and the branch channel 154 extends radially to the flushing tube protrusion 155. For example, the flushing tube protrusion 155 is located at the upper part of the connecting seat 150, and the branch channel 154 extends upward to the flushing tube protrusion 155. The hemostatic valve 100 also includes a flushing tube 105 and a two-way valve 106. The flushing tube 105 extends through the flushing tube protrusion 155 and communicates with the branch channel 154, and external flushing fluid can enter the hemostatic valve 100 through the two-way valve 106 and the flushing tube 105.

[0055] The distal end of the connector 150 is provided with a fixing seat connecting portion 153 adapted to be disposed in the connector mating groove 236, so that the control handle 20 and the hemostatic valve 100 are connected as a whole. In some embodiments, the hemostatic valve 100 can be regarded as part of the control handle 20.

[0056] Optionally, see Figure 2 , Figure 3 , Figure 5 , Figure 6 The hemostatic valve 100 also includes a ring clamp 107, which is fitted onto the connecting seat 150 and is adjacent to the fixing member 140. The ring clamp 107 is constructed as a ring, and its outer diameter, the distal outer diameter of the fixing member 140, and the outer diameter of the sealing handle 110 are substantially the same, ensuring that the outer circumferential dimensions of the hemostatic valve 100 are consistent. Furthermore, the outer diameter of the ring clamp 107 is consistent with the proximal outer diameter of the housing 210, resulting in a smooth transition of the outer contour of the handheld portion of the guide sheath system 10. Optionally, see... Figure 5 The distal outer periphery of the fixing member 140 is provided with a grip portion 148, which can be configured as an annular groove for easy gripping by the operator. The grip portion 148 may also be provided with anti-slip features.

[0057] Alternatively, the fastener 140 and the connector 150 can be connected by other means, such as bonding, ultrasonic welding, or snap-fitting. See also Figure 12 , Figure 13 This disclosure provides another embodiment of the fastener 140 and the connecting seat 150, which are connected by a snap-fit ​​connection. Specifically, the proximal end of the connecting seat 150 is provided with a proximal tube segment 156, and the outer periphery of the proximal tube segment 156 is provided with an annularly extending snap-fit ​​portion 157 and four longitudinally arranged snap-fit ​​blocks 158. The distal end of the fastener 140 is configured to accommodate the proximal end of the connecting seat 150. The inner sidewall of the distal end of the fastener 140 is provided with an annularly extending snap-fit ​​groove 161 and four longitudinally arranged snap-fit ​​grooves 149. The annular snap-fit ​​groove 161 cooperates with the annular snap-fit ​​portion 157 to achieve axial limiting, and the longitudinal snap-fit ​​grooves 149 cooperate with the longitudinal snap-fit ​​blocks 158 to achieve circumferential limiting.

[0058] See Figures 14 to 16 , Figure 14 and Figure 15 Cross-sectional schematic diagrams of the guiding sheath system 10 are shown below. Figure 16 A partial cross-sectional schematic diagram shows the interventional device extending through the guidance sheath system 10. Among them, Figure 14 The cone seal 130 is shown in the second position, i.e., the cone seal 130 is in the initial position. At this time, the outer periphery of the cone 132a is not restrained, and the cone 132a can expand outward to facilitate the passage of interventional instruments through the cone seal 130. Figure 15The conical seal 130 is shown in the first position, with the conical portion 132a being pressed by the conical surface 142 to completely close the channel 141 of the fixation member, thereby completely closing the hemostatic valve 100.

[0059] See Figure 16 The interventional device 31 extends through the hemostatic valve 100 and into the sheath 11. The sealing handle 110 can be driven to rotate, which in turn causes the rotating component 120 to helically move relative to the fixed seat 140, thereby moving the conical seal 130 from its initial position (second position) to a position between the first and second positions, so that the outer wall of the cone portion 132a contacts the conical surface 142. At this time, the cone portion 132a is compressed by the conical surface 142, causing the outer wall of the cone portion 132a to be tightly pressed against the conical surface 142, and the inner wall of the cone portion 132a to be tightly pressed against the outer wall of the interventional device 31, thereby sealing the interventional device 31. Additionally, the interventional device 31 extends through the static seal 104, which also provides a seal for the interventional device 31. When it is necessary to remove the interventional device 31 from the guide sheath system 10, the sealing handle 110 can be rotated in the opposite direction, causing the rotating component 120 to make a helical movement in the opposite direction relative to the fixed seat 140, thereby moving the sealing component 130 to the second position or close to the second position, so that the outer wall of the cone portion 132a separates from the cone surface 142, facilitating the removal of the interventional device 31. After the interventional device 31 is withdrawn, the sealing handle 110 can be quickly rotated to move the cone seal 130 to the first position, such as... Figure 15 As shown, this completely closes the hemostatic valve 100.

[0060] The above descriptions are merely a few embodiments of this disclosure. Those skilled in the art can make various modifications or variations to the embodiments of this disclosure based on the content disclosed in the application documents without departing from the spirit and scope of this disclosure.

Claims

1. A hemostatic valve characterized by, include: A fastener, the fastener being configured to have a longitudinally extending channel, the channel being defined by at least a tapered surface, and the proximal end of the fastener having an external thread. A rotating component, which is sleeved on the fixed component, and the rotating component is provided with an internal thread that mates with the external thread of the fixed component; and A conical seal, coupled to the rotating member, the conical seal being configured to move within a channel of the fixed member, and the distal end of the conical seal being configured to seal against the conical surface. When the rotating component moves in a spiral motion relative to the fixed component, the rotating component drives the conical seal to move axially, thereby closing or opening the channel of the fixed component.

2. The hemostatic valve of claim 1, wherein, The conical seal has a longitudinally extending channel and includes a conical portion at the distal end. The conical portion has a longitudinally extending conical channel and a plurality of circumferentially arranged slits that penetrate the wall of the conical portion and extend longitudinally. The conical portion seals against the conical surface.

3. The hemostatic valve according to claim 2, characterized in that, The conical seal includes a conical sealing portion disposed at the distal end and a connecting body connected to the conical sealing portion, wherein the conical portion is disposed at the conical sealing portion and the connecting body is coupled to the rotating member; The material of the conical sealing part is compressible and elastic, while the material of the connecting body is a rigid material.

4. The hemostatic valve according to claim 3, characterized in that, One of the connector and the fixing member is provided with an anti-rotation part, and the other is provided with a longitudinal groove suitable for receiving the anti-rotation part, and the anti-rotation part can move along the longitudinal groove.

5. The hemostatic valve according to claim 4, characterized in that, The outer periphery of the connector is provided with a longitudinal groove, and the hemostatic valve includes an anti-rotation block, with the anti-rotation part disposed on the anti-rotation block; The fastener is provided with a connecting groove adapted to accommodate the anti-rotation block, and the anti-rotation portion is configured to extend radially into the longitudinal groove.

6. The hemostatic valve according to any one of claims 3 to 5, characterized in that, Includes a sealing handle, which is rotatably connected to the fixing member, the distal end of which is sleeved on the fixing member. The proximal end of the sealing handle is sleeved on the rotating component; The rotating component is coupled to the sealing handle, such that when the sealing handle is rotated, the rotating component moves in a spiral motion around the fixed component.

7. The hemostatic valve according to claim 6, characterized in that, The connector includes a first pin detachably connected to the rotating member, and the outer periphery of the proximal end of the connector is provided with a first annular groove, the first pin being at least partially located in the first annular groove.

8. The hemostatic valve according to claim 6, characterized in that, The device includes a second pin detachably connected to the sealing handle, and the fixing member has a second annular groove on its central outer periphery, with the second pin at least partially located in the second annular groove.

9. The hemostatic valve according to claim 6, characterized in that, It also includes a connecting seat and a static seal. The connecting seat has a longitudinally extending main channel. The connecting seat is detachably connected to the fixing member. The main channel communicates with the channel of the fixing member. The static seal is disposed between the connecting seat and the fixing member.

10. A guiding sheath system, characterized in that, The device includes a sheath, a control handle, and a hemostatic valve according to any one of claims 1 to 9. The control handle is provided with a rotatable spool, the hemostatic valve is disposed at the proximal end of the control handle, and the hemostatic valve is provided with a main cavity, the main cavity including at least the cavity formed by the channel of the fixing member. The sheath extends through the control handle and connects to the hemostatic valve, and the sheath communicates with the main cavity of the hemostatic valve; The sheath is provided with a control line connected to the distal region of the sheath, and the proximal end of the control line is connected to the reel; When the spool rotates in the first direction, the control line can be wound onto the spool to bend the sheath; when the spool rotates in the second direction, the control line unwound from the spool to straighten the sheath.

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