Catheter sheath circumferential closer

Abstract

The application discloses a catheter sheath circumferential closer, and relates to the technical field of medical devices. The closer comprises a valve body, a rotating disc, a tightening member, an elastic sealing tube and a fixing disc arranged in the valve body; the fixing disc is provided with a radial guide groove, and the rotating disc is provided with a driving groove at an angle with the guide groove; the tightening member is composed of multiple moving members, and a shifting pin on each moving member is inserted into the guide groove and the driving groove; when the rotating disc is rotated, the driving groove drives the moving members to move radially along the guide groove, so that the diameter of the central hole surrounded by the multiple moving members changes, thereby the elastic sealing tube is pressed or released, and the opening and closing of the channel are realized. The application can accurately convert the rotating motion into the radial linear motion, has a simple structure and is convenient to operate, can be self-adapted to devices with different diameters, and is reliable in sealing.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a catheter sheath circumferential closure device for use in interventional surgery, which enables reliable sealing of the tubing and convenient operation. Background Technology

[0002] In minimally invasive medical surgery, closure devices are widely used in catheter sheaths. Their core function is to effectively block the lumen of the sheath when interventional instruments (such as catheters and guidewires) are inserted into or withdrawn from blood vessels, preventing blood from flowing out of the body through the sheath and ensuring the safety and cleanliness of the surgery.

[0003] Traditional closure mechanisms mainly employ three structures: The first type uses a flat membrane or gasket made of elastic material with incisions or slits, relying on the material's own elasticity to form a seal around the instrument. However, this structure has significant limitations when adapting to instruments of different diameters. When the instrument diameter does not match the incision size, effective closure is often not achieved, and blood leakage is likely to occur.

[0004] The second type is an inflatable or water-filled sealing structure, which achieves a seal by inflating or filling the sealing bladder with air to enclose the instrument. However, this structure requires an additional inflation or water filling device, which is cumbersome to operate and makes it difficult to precisely control the inflation volume, affecting the stability and convenience of the seal.

[0005] The third type is a closure device that uses multiple flexible components to compress the tubular body. By rotating the shell, the flexible components are twisted, causing the tubular body to contract or release. However, this type of structure has problems such as a large number of flexible components, complex structure, and difficulty in assembly.

[0006] Therefore, there is an urgent need for a catheter sheath closure device that is simple in structure, easy to operate, and has a reliable seal, which can adapt to interventional devices of different sizes and achieve rapid and stable closure after the device is withdrawn. Summary of the Invention

[0007] In view of the above-mentioned defects or deficiencies in the prior art, the present invention provides a catheter sheath circumferential closure device, which aims to solve the technical problems of existing closure devices having complex structure, inconvenient operation, poor adaptability to instruments of different sizes, and insufficient sealing reliability.

[0008] One aspect of the present invention provides a circumferential closure device for a catheter sheath, comprising: Valve body 1 and rotating disc 2, tightening component 5, elastic sealing tube 7, and fixed disc 8 disposed inside valve body 1; The valve body 1 has an axially penetrating channel, and the elastic sealing tube 7 passes through the rotating disk 2, the tightening member 5, and the fixed disk 8 along the channel; the fixed disk 8 is fixedly disposed inside the valve body 1, and has a plurality of circumferentially evenly distributed, center-pointing, and radially extending guide grooves on it; the rotating disk 2 is rotatably disposed inside the valve body 1, and has a plurality of driving grooves on it that are the same number as the guide grooves and correspond one-to-one, the driving grooves forming a predetermined angle with the guide grooves; the tightening member 5 is disposed between the fixed disk 8 and the rotating disk 2; When the rotating disk 2 rotates relative to the fixed disk 8 to the first position, the tightening member 5, driven by the driving groove, radially contracts along the guide groove toward the elastic sealing tube 7, thereby closing or narrowing the internal channel of the elastic sealing tube 7; when the rotating disk 2 rotates relative to the fixed disk 8 to the second position, the tightening member 5, driven by the driving groove, radially expands along the guide groove toward the direction away from the elastic sealing tube 7, thereby opening or expanding the internal channel of the elastic sealing tube 7.

[0009] Furthermore, the valve body 1 includes a main housing and a three-way connector 3, one end of the three-way connector 3 is fixedly connected to the main housing, and the elastic sealing tube 7 is sealed to one end of the three-way connector 3.

[0010] Furthermore, it also includes: a torsion spring 4, which is sleeved on the outer periphery of the rotating disk 2, the first end of the torsion spring (4) is fixedly connected to the rotating disk 2, the second end of the torsion spring 4 is fixedly connected to the valve body 1, and the torsion spring 4 is used to apply a biasing force to the rotating disk 2 to keep it in the first position.

[0011] Furthermore, the rotating disk 2 is provided with an operating handle 10, which extends from the side wall of the valve body 1 and is used to drive the rotating disk 2 to rotate.

[0012] Furthermore, the tightening member 5 is composed of a plurality of circumferentially arranged and overlapping movable members 50, the number of which is the same as the number of the guide grooves, and the plurality of movable members 50 form a central hole through which the elastic sealing tube 7 passes. Each of the moving parts 50 has a first actuating pin on the side facing the fixed disk 8 and a second actuating pin on the side facing the rotating disk 2; the first actuating pin of each of the moving parts 50 is aligned with and inserted into the corresponding guide groove on the fixed disk 8, and the second actuating pin of each of the moving parts 50 is aligned with and inserted into the corresponding drive groove on the rotating disk 2. When the rotating disk 2 rotates relative to the fixed disk 8 toward the first position, each driving groove drives the corresponding moving part 50 to move toward the direction closer to the elastic sealing tube 7 through the corresponding second actuating pin. At the same time, the first actuating pin on each moving part 50 moves along the corresponding guide groove toward the direction closer to the center of the fixed disk 8, so that the overlap of adjacent moving parts 50 increases and the diameter of the central hole decreases. When the rotating disk 2 rotates relative to the fixed disk 8 to the second position, each driving groove drives the corresponding moving part 50 to move away from the elastic sealing tube 7 through the corresponding second actuating pin. At the same time, the first actuating pin on each moving part 50 moves along the corresponding guide groove away from the center of the fixed disk 8, so that the overlap of adjacent moving parts 50 becomes smaller and the diameter of the central hole becomes larger.

[0013] Furthermore, the elastic sealing tube 7 is a sponge-like silicone tube, a foam-like silicone tube, or a polyurethane tube.

[0014] Furthermore, the fixing plate 8 is integrally formed with the valve body 1 or detachably connected, and the fixing plate 8 is located inside the valve body 1 and perpendicular to the axis of the valve body 1.

[0015] Furthermore, it also includes a locking mechanism for locking the rotating disk 2 in the second position.

[0016] Furthermore, the locking mechanism includes a hook disposed on the operating handle 10 and a slot disposed on the valve body 1, wherein the hook and the slot are detachably engaged.

[0017] Furthermore, it also includes a pressure tube 9, one end of which is inserted into the valve body 1 and sealed to the elastic sealing tube 7.

[0018] Furthermore, the rotating disk 2 is a gear-type rotating disk with gear teeth on its outer periphery; the valve body 1 has a slot 12 for the pressing member 11 to pass through, and the pressing member 11 has a rack portion 111 that meshes with the gear teeth; when the pressing member 11 is pressed, the rack portion 111 drives the rotating disk 2 to rotate to the second position; when the pressing member 11 is released, the rotating disk 2 rotates back to the first position under the biasing force of the torsion spring 4, and the pressing member 11 returns to the initial position under the drive of the gear teeth.

[0019] Furthermore, there are two slots 12, which are symmetrically arranged on both sides of the valve body 1. Two pressing members 11 are respectively arranged in the corresponding slots 12. The rack portions 111 of the two pressing members 11 are located on the radially opposite sides of the rotating disk 2 and mesh with the gear teeth on the radially opposite sides of the rotating disk 2.

[0020] Furthermore, the inner wall of the elastic sealing tube 7 is provided with a sealing structure. When the tightening member 5 radially contracts and squeezes the elastic sealing tube 7, the sealing structure can undergo elastic deformation to tightly fit the outer peripheral wall of the interventional device inserted in the elastic sealing tube 7, thereby sealing the gap between the interventional device and the inner wall of the elastic sealing tube.

[0021] Furthermore, the sealing structure includes any one of the following structures: Multiple grooves are arranged circumferentially and spirally along the inner wall of the elastic sealing tube 7; Alternatively, multiple protrusions are arranged circumferentially along the inner wall of the elastic sealing tube 7 and extend axially in a spiral manner; Alternatively, a plurality of protrusions are arranged at intervals in both the circumferential and axial directions along the inner wall of the elastic sealing tube 7, with one end of each protrusion disposed on the inner wall of the elastic sealing tube 7 and the other end pointing towards the central axis of the elastic sealing tube 7. Alternatively, multiple grooves are arranged circumferentially and spirally along the inner wall of the elastic sealing tube 7; and multiple protrusions are arranged circumferentially and axially along the inner wall of the elastic sealing tube 7, with one end of each protrusion disposed on the inner wall of the elastic sealing tube 7 and the other end pointing to the central axis of the elastic sealing tube 7. Alternatively, multiple first grooves are arranged circumferentially and spirally extending along the inner wall of the elastic sealing tube 7, and multiple second grooves are arranged circumferentially and spirally extending along the inner wall of the elastic sealing tube 7, wherein the spiral directions of the first grooves and the second grooves are opposite.

[0022] The circumferential closure device for a catheter sheath provided by this invention has the following beneficial effects: (1) Through the coordinated operation of the rotating disk, the fixed disk and the tightening component, the radial contraction and expansion of the elastic sealing tube can be precisely controlled by a simple rotation action, which replaces the complex multi-component traction, compression or inflation device in traditional technology, reduces the difficulty of manufacturing and assembly, and improves the overall reliability of the product.

[0023] (2) The circumferential closure device for the catheter sheath employs multiple circumferentially arranged and overlapping moving parts to form a tightening element. Driven by a rotating and fixed disc, it synchronously and uniformly contracts or expands radially, ensuring surface contact between the tightening element and the elastic sealing tube. The compressive force is evenly distributed circumferentially, avoiding the drawback of traditional traction wire structures where excessive linear shear force necessitates a metal mesh layer for buffering. This invention can directly achieve uniform, gentle, and reliable radial closure of the elastic sealing tube without the need for an additional metal mesh layer. It ensures excellent sealing performance on the surfaces of interventional instruments of different sizes, significantly reduces local stress damage to the elastic sealing tube, extends its service life, and further simplifies the structure, reducing manufacturing costs and assembly complexity.

[0024] (3) The rotary operating structure uses an operating handle extending from the side wall of the valve body on the rotary disc to convert the doctor's turning action into the radial linear motion of the tightening element, achieving a smooth transmission, clear feel, and intuitive operation experience with a direct correspondence between the angle and the degree of sealing. This structure requires no additional power source; the opening and closing of the channel can be completed with just a slight flick of the thumb or forefinger. The operating angle can be flexibly adjusted according to different instrument diameters, providing progressive sealing control. Combined with the normally closed bias force of the torsion spring, the rotary disc automatically resets after the handle is released, ensuring immediate sealing after the instrument is removed.

[0025] (4) The press-type operation structure achieves balanced force and stable operation by symmetrically setting press parts on both sides of the valve body and meshing the racks on the radially opposite sides of the rotating disk. This design eliminates the need for the traditional handle to operate; the channel can be opened with a light press and automatically closed when released. It is especially suitable for single-handed operation scenarios, with concentrated movements and rapid response, significantly improving the smoothness and convenience of surgical operations.

[0026] (5) The inner wall of the elastic sealing tube has a specially designed sealing structure. When the tightening component radially squeezes the elastic sealing tube, the groove and other structures on the inner wall provide reserved filling space and deformation guidance for the tube wall material, so that the inner diameter of the tube wall can be reduced more uniformly, thereby achieving a tighter circumferential wrapping of the interventional device and further improving the sealing effect. Attached Figure Description

[0027] Other features, objects, and advantages of this application will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings: Figure 1 This is a schematic diagram of the overall structure of the catheter sheath provided by existing technology; Figure 2 This is an axial cross-sectional view of a catheter sheath circumferential closure device with a toggle-type drive structure provided in one embodiment of this application; Figure 3This is a first-view exploded view of a catheter sheath circumferential closure device with a toggle-type drive structure provided in one embodiment of this application; Figure 4 This is a second-view exploded view of a catheter sheath circumferential closure device with a toggle-type drive structure provided in one embodiment of this application; Figure 5 This is a schematic diagram of the structure of the tightening member in a contracted (closed) state according to an embodiment of this application; Figure 6 This is a schematic diagram of the structure of a tightening member in an expanded (open) state according to an embodiment of this application; Figure 7 This is an exploded view of a catheter sheath circumferential closure device with a press-driven structure provided in another embodiment of this application; Figure 8 This is a cross-sectional schematic diagram of the engagement state of the pressing element and the rotating disk, and a side view of the catheter sheath circumferential closure device with a pressing drive structure provided in another embodiment of this application; Figure 9 This is a schematic diagram of a structure with a spiral groove on the inner wall of an elastic sealing tube provided in another embodiment of this application; Figure 10 This is a schematic diagram of a structure with spiral protrusions on the inner wall of an elastic sealing tube provided in another embodiment of this application; Figure 11 This is a schematic diagram of a structure provided in another embodiment of the present application, showing an array of protrusions on the inner wall of an elastic sealing tube; Figure 12 This is a schematic diagram of a structure provided in another embodiment of the present application, showing that the inner wall of the elastic sealing tube is provided with both spiral grooves and arrayed protrusions; Figure 13 This is a schematic diagram of a structure provided in another embodiment of the present application, showing a bidirectional spiral groove on the inner wall of an elastic sealing tube with opposite directions. Figure 14 This is an axial schematic diagram of the elastic sealing tube provided in another embodiment of this application after being radially compressed by the tightening member. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] This application provides a circumferential catheter sheath closure device for interventional surgery, capable of achieving rapid and reliable closure and opening of the catheter. The invention utilizes the synergistic action of a rotating disc and grooves on a fixed disc to drive the radial movement of a tightening element composed of multiple moving parts, thereby compressing and releasing the elastic sealing tube. Simultaneously, combined with the normally closed bias force of a torsion spring, it ensures automatic and rapid closure of the catheter after instrument withdrawal, improving surgical safety and ease of operation.

[0030] In the prior art, catheter sheaths, as devices for establishing and maintaining vascular access, typically consist of multiple functional components working in tandem. See also Figure 1 The catheter sheath typically includes, but is not limited to, a closure device 110, a sheath 120, a dilator 130, and a connecting tube 140.

[0031] The main function of the closure device 110 is to act as a hemostatic valve to control the outflow of blood during surgery. When interventional instruments (such as catheters or guidewires) are inserted into blood vessels through a sheath, the elastic sealing tube inside the closure device tightly wraps around the instrument to prevent blood from leaking from the sheath interface. When the instrument is withdrawn, the closure device can quickly close itself to block blood flow and maintain the airtight state of the vascular access.

[0032] Sheath 120 is the only part of the catheter sheath that enters the human body. It is a slender, flexible, and biocompatible hollow tube. During surgery, sheath 120 is inserted into the body through a skin puncture point, serving as a working channel for interventional instruments to enter and exit the body, protecting the blood vessel wall from damage caused by repeated instrument insertion and removal, and providing a stable operating platform.

[0033] The dilator 130 is a solid or slender probe with a cavity, typically used in conjunction with the sheath 120. In the initial stage of establishing vascular access, the dilator 130 passes through the closure device 110 and the sheath 120, its tip slightly longer and tapered than the sheath 120. It is used to progressively dilate the subcutaneous tissue and vascular puncture site after skin puncture, guiding the sheath 120 smoothly into the blood vessel and avoiding tearing or damage to the vessel caused by direct puncture of the sheath 120. Once the sheath 120 is in place, the dilator 130 is withdrawn, leaving the sheath 120 as a channel for subsequent procedures.

[0034] The connecting tube 140 is typically a flexible medical plastic tube, with one end connected to the side port of the tee connector of the closure device 110, and the other end connectable to other medical devices. The primary function of the connecting tube 140 is to provide an auxiliary access point for surgery, such as: injecting saline solution into the blood vessel to prevent thrombosis, injecting contrast agents for vascular visualization, monitoring intravascular pressure, or using a syringe connected to the connecting tube 140 to aspirate thrombi from the blood vessel without requiring additional puncture sites on the patient.

[0035] This invention features a completely redesigned structure for the catheter sheath closure device. By coordinating the rotating disc, the fixed disc, and the tightening component, it replaces the traditional complex sealing structure of diaphragm, inflatable, or multi-flexible components, achieving a simplified, convenient, and reliable radial compression closure function.

[0036] See Figure 2 , Figure 3 and Figure 4 One example of this application provides a circumferential closure device for a catheter sheath, comprising: a valve body 1 and a rotating disc 2, a tightening member 5, an elastic sealing tube 7, and a fixing disc 8 disposed inside the valve body 1.

[0037] The valve body 1 serves as the outer shell and support structure of the entire closure device. It has an axially penetrating channel inside, which accommodates and secures other internal components and serves as a pathway for interventional instruments and blood flow. In some embodiments, to enhance functionality, the valve body 1 may include a main housing 6 and a three-way connector 3. The three-way connector 3 is fixedly connected to the main housing 6, with its first port communicating with the channel of the main housing, its second port connecting to a sheath, and its third port connecting to a connecting tube.

[0038] The elastic sealing tube 7 passes through the rotating disk 2, the tightening member 5, and the fixed disk 8 along the axial channel of the valve body 1. The elastic sealing tube 7 is a key component that directly contacts the interventional device and achieves a seal. It is made of a biocompatible and elastic material, such as silicone or polyurethane. This type of material can elastically deform under radial pressure, tightly wrapping the internal interventional device to form an effective seal; when the pressure is released, it can return to its original shape due to its elasticity, keeping the channel unobstructed. One end of the elastic sealing tube 7 can be sealed to the first port of the tee connector 3, and the other end can be sealed to the pressure tube at the other end of the axial channel of the valve body 1.

[0039] The fixing disc 8 is fixedly disposed inside the valve body 1, preferably integrally formed with the valve body 1 to ensure absolute positional stability. The fixing disc 8 is perpendicular to the axis of the valve body 1, and has multiple circumferentially evenly distributed, center-pointing, and radially extending guide grooves 80. The function of these guide grooves 80 is to provide a precise, radially linear motion trajectory for the movement of the tightening member 5 and to limit it, ensuring that each part of the tightening member 5 moves accurately toward or away from the center, thereby uniformly compressing or releasing the elastic sealing tube 7.

[0040] The rotating disk 2 is rotatably disposed inside the valve body 1. The rotating disk 2 serves as the operation input end of this invention, and has multiple drive grooves 20, the same number as and corresponding one-to-one with the guide grooves 80. The drive grooves 20 and the guide grooves 80 form a predetermined angle. This angle design is crucial; when the rotating disk 2 rotates, the change in the trajectory of the drive grooves 20 forces the actuating component of the tightening member 5 embedded therein to produce radial displacement, thereby converting the circular motion of the rotating disk 2 into the linear motion of the tightening member 5. Specifically, when the predetermined angle is designed to be small (i.e., the drive grooves 20 are nearly parallel to the guide grooves 80): a small rotation of the rotating disk 2 can drive the moving member 50 to produce a large radial displacement, thus quickly opening or closing the elastic sealing tube 7. This design features a short operating stroke and rapid response; the doctor only needs to slightly actuate the handle to switch channels, making it suitable for surgical scenarios requiring high operating speed. However, due to the highly sensitive transmission ratio, more precise control is required during operation to avoid excessive pressure on the elastic sealing tube 7 or interventional instruments due to excessive rotation. When the predetermined angle is designed to be relatively large (i.e., the drive groove 20 is nearly perpendicular to the guide groove 80), the rotary disk 2 needs to rotate a large angle to produce the same radial displacement of the moving part 50. This design features a long operating stroke and a stable transmission ratio, allowing the surgeon to obtain a wider operating angle range, facilitating precise control of the sealing tube's contraction and enabling progressive and refined compression of instruments of different diameters. Simultaneously, because the restoring force of the torsion spring 4 is amplified after passing through a larger transmission ratio, this design provides stronger closure retention force, ensuring a more reliable seal when not in use. Furthermore, the longer operating stroke provides the surgeon with better tactile feedback, allowing them to intuitively perceive the current sealing status through the handle position. Therefore, the specific value of the predetermined angle can be optimized according to actual application needs to achieve a balance between operational sensitivity, sealing force, and operational feel, enabling the closure device to better adapt to the operating habits of different surgeons and the needs of different surgical scenarios.

[0041] The tightening member 5 is an actuator that physically compresses and releases the elastic sealing tube 7. In a preferred embodiment, the tightening member 5 consists of a plurality of circumferentially arranged, overlapping movable members 50. The number of movable members 50 is the same as the number of guide grooves 80 or drive grooves 20 (the number of guide grooves 80 is the same as the number of drive grooves 20). The plurality of movable members 50 together form a central hole for the elastic sealing tube 7 to pass through.

[0042] Furthermore, each movable component 50 is ingeniously designed, with a first actuating pin 51 on the side facing the fixed disk 8 and a second actuating pin 52 on the side facing the rotating disk 2. In the assembled state, the first actuating pin 51 of each movable component 50 is aligned and inserted into the corresponding guide groove 80 on the fixed disk 8, thereby limiting the movement trajectory of the movable component 50 to only move along the extension direction (i.e., radially) of the guide groove 80. At the same time, the second actuating pin 52 of each movable component 50 is aligned and inserted into the corresponding drive groove 20 on the rotating disk 2, forming a drive engagement.

[0043] Furthermore, when the operator drives the rotary disk 2 to rotate, the groove wall of the drive groove 20 applies a tangential force to the moving member 50 through the second actuating pin 52. Since the first actuating pin 51 is constrained by the guide groove 80 to move only radially, the tangential force is decomposed into a radial component, forcing the moving member 50 to move radially under the guidance of the guide groove 80.

[0044] Specifically: See Figure 5 When the rotating disk 2 rotates relative to the fixed disk 8 to the first position (i.e., the closed position), the driving groove 20 drives the moving part 50 to move towards the elastic sealing tube 7 (i.e., radially inward) via the second actuating pin 52. At the same time, the first actuating pin 51 moves along the guide groove 80 towards the center of the fixed disk 8. This increases the overlap between adjacent moving parts 50, and the diameter of the central hole they form decreases accordingly. The smaller diameter of the central hole causes the end face of the moving part 50 to uniformly press the elastic sealing tube 7 passing through it in a surface contact manner, causing the elastic sealing tube 7 to radially contract, ultimately closing or narrowing its internal channel, thereby achieving hemostasis or tightly wrapping interventional instruments of different diameters.

[0045] See Figure 6 When the rotating disk 2 rotates relative to the fixed disk 8 to the second position (i.e., the open position), the driving groove 20 drives the moving part 50 to move away from the elastic sealing tube 7 (i.e., radially outward) via the second actuating pin 52. At the same time, the first actuating pin 51 moves along the guide groove 80 away from the center of the fixed disk 8. This reduces the overlap of adjacent moving parts 50, and the diameter of the central hole increases accordingly. The increased central hole relieves the radial pressure on the elastic sealing tube 7, allowing the elastic sealing tube 7 to return to its original shape due to its elasticity, and its internal channel opens or expands, thus allowing interventional instruments to pass through without resistance.

[0046] The core advantage of this tightening component 5, which consists of multiple moving parts 50, is that: First, it provides a uniform, gentle, and precisely controllable radial force. Traditional closure structures involving reverse traction and overall compression of fine filaments are prone to damaging the elastic sealing tube 7, reducing its service life. To achieve uniform, flexible, and reliable closure of the elastic sealing tube 7, a buffer metal mesh is often required on its outer surface. The traction wire or compression part must first act on the metal mesh before acting on the outer surface of the elastic sealing tube 7, increasing the assembly complexity of the closure device. The overlapping arrangement of multiple moving parts 50 in this invention allows each moving part 50 to apply a more balanced force to the elastic sealing tube 7, avoiding localized stress concentration. Therefore, uniform, gentle, and reliable radial closure of the elastic sealing tube can be achieved without the need for a metal mesh.

[0047] Secondly, the above structure can adaptively wrap interventional instruments of different diameters. Regardless of the size of the instrument, the tightening member 5 can make it fit tightly with the elastic sealing tube 7 through radial contraction, which effectively solves the leakage problem caused by the mismatch of instrument diameter in traditional slit-type hemostatic valves.

[0048] Finally, compared to the closure device composed of multiple flexible components in the prior art, which requires a large number of flexible components and relies on a complex shell torsion mechanism for drive, resulting in problems such as bulky structure, many parts, and complex assembly, increasing costs and affecting reliability, the present invention transforms rotational motion into precise radial linear motion through the coordinated cooperation of the moving part 50, the guide groove 80 and the drive groove 20. It has fewer parts and is easier to assemble. At the same time, the movement of all moving parts 50 is constrained and driven by the guide groove 80 and the drive groove 20, ensuring synchronicity and consistency, and realizing uniform and stable compression of the elastic sealing tube 7, resulting in higher sealing reliability.

[0049] To further enhance operational safety and convenience, this invention also incorporates a normally closed function. See also Figure 2-4 The closure device also includes a torsion spring 4, which is sleeved on the outer periphery of the rotating disk 2. Its first end is fixedly connected to the rotating disk 2, and its second end is fixedly connected to the valve body 1. The torsion spring 4 is in a pre-tensioned state, continuously applying a biasing force to the rotating disk 2 to keep it in the first position (closed position). This means that without any external force, the rotating disk 2 will automatically return to the first position under the action of the torsion spring 4, keeping the tightening member 5 in a radially contracted state, thereby ensuring that the internal channel of the elastic sealing tube 7 is always closed or narrowed. This achieves automatic and rapid closure after instrument withdrawal, requiring no additional operation by the doctor, effectively preventing blood backflow, and greatly improving the safety of the surgery.

[0050] To facilitate the doctor in overcoming the elastic force of the torsion spring 4 and manually opening the passage, the rotating disk 2 is equipped with an operating handle 10. The operating handle 10 extends from the side wall of the valve body 1, providing the doctor with a convenient grip point for applying force. The doctor only needs to use their fingers to flick the operating handle 10 to drive the rotating disk 2 to rotate to the second position (open position) against the elastic force of the torsion spring 4, thereby opening the passage.

[0051] In scenarios requiring prolonged channel opening, such as when long-term indwelling devices are needed, the present invention may further include a locking mechanism (not shown in the accompanying drawings). This locking mechanism is used to lock the rotating disk 2 in the second position, eliminating the need for continuous force application by the physician. In a simplified embodiment, the locking mechanism may include a hook disposed on the operating handle 10 and a slot disposed on the valve body 1. When the operating handle 10 is moved to the open position, the hook can engage with the slot, achieving self-locking. When closure is required, a slight movement of the handle disengages the hook from the slot, and the rotating disk 2 automatically resets under the action of the torsion spring 4.

[0052] Furthermore, to facilitate the use of instruments such as dilators in actual surgery, the present invention may also include a pressure tube 9. One end of the pressure tube 9 is inserted into the valve body 1 and sealed with the elastic sealing tube 7. The dilator can pass through the pressure tube 9 and the elastic sealing tube 7, and finally exit from the other port of the tee connector 3, for dilating blood vessels or surgical openings, establishing a channel for the introduction of subsequent interventional instruments.

[0053] The catheter sheath circumferential closure device provided in this embodiment achieves precise and uniform control of the radial pressure of the elastic sealing tube through a unique linkage structure of a rotating disc, a fixed disc, and a tightening element, thereby obtaining a stable and reliable sealing effect. The normally closed torsion spring design simplifies the operation process and improves safety. The entire device has a compact structure, few parts, is easy to assemble, and has controllable costs. It effectively solves many technical problems existing in hemostatic valves and has high clinical application value.

[0054] Based on the above embodiments, this application also provides a variant embodiment of another driving method, which replaces the direct rotation operation with a linear pressing operation to provide a different operating feel and ergonomic design. The structure, connection relationship, and interaction principle of the core components of the catheter sheath circumferential closure device in this embodiment, such as the valve body 1, rotating disk 2, tightening element 5, elastic sealing tube 7, fixed disk 8, and torsion spring 4, are the same as in the aforementioned embodiments. The main improvement of this embodiment lies in the driving mechanism of the rotating disk 2.

[0055] See Figure 7-8The rotating disk 2 is a gear-type rotating disk with teeth on its outer circumference. The valve body 1 has a slot 12 for the pressing member 11 to pass through, and the pressing member 11 has a rack portion 111 that meshes with the teeth. When the pressing member 11 is pressed, the rack portion 111 drives the rotating disk 2 to rotate to a second position (at which position the internal channel of the elastic sealing tube 7 is opened or expanded). When the pressing member 11 is released, the rotating disk 2 rotates back to the first position under the biasing force of the torsion spring 4 (at which position the internal channel of the elastic sealing tube 7 is closed or narrowed), and the pressing member 11 returns to its initial position before pressing under the drive of the teeth.

[0056] More preferably, the number of slots 12 can be set to two, with the two slots 12 symmetrically arranged on both sides of the valve body 1, and the two pressing members 11 respectively arranged in the corresponding slots 12. The rack portions 111 of the two pressing members 11 are respectively located on the radially opposite sides of the rotating disk 2 and mesh with the gear teeth on the outer periphery of the rotating disk 2.

[0057] The working process of the push-type drive structure is as follows: Initial state: When no external force is applied, the biasing force of the torsion spring 4 keeps the rotating disk 2 in the first position, the tightening member 5 is in a contracted state, the elastic sealing tube 7 is compressed, and the channel is closed. At the same time, the return spring keeps the pressing member 11 in the initial position of extending out of the slot 12.

[0058] Opening Operation: When it is necessary to open the channel for insertion of interventional instruments, the operator presses the press element 11 with their finger. The press element 11 moves into the valve body 1, and its rack part 111 drives the gear teeth to rotate the rotating disk 2 to the second position. The rotation of the rotating disk 2, through the cooperation of the drive groove 20 and the second actuating pin 52, drives all moving parts 50 to move radially outward along the guide groove 80 of the fixed disk 8, the central hole of the tightening part 5 expands, thereby releasing the compression on the elastic sealing tube 7, and the channel opens.

[0059] Automatic closure: When the operator releases the pressing element 11, the return spring pushes the pressing element 11 outward to return to the initial position; more importantly, the biasing force of the torsion spring 4 drives the rotating disk 2 to rotate back to the first position. These two processes work together to cause the tightening element 5 to contract radially, re-squeezing the elastic sealing tube 7, so that the channel automatically and quickly returns to the closed state, achieving reliable immediate hemostasis.

[0060] This embodiment's press-type drive structure converts linear pressing into rotational operation, making it more in line with doctors' operating habits. This design is particularly convenient for single-handed operation in confined spaces. Doctors can hold the catheter sheath with the same hand and open it by pressing with their thumb or forefinger, closing it upon release, resulting in a smooth and quick operation. At the same time, it retains all the core advantages of the original device, including precise radial contraction / expansion control through rotational motion and the normally closed torsion spring and automatic reset.

[0061] In some preferred embodiments of the present invention, the inner wall of the elastic sealing tube 7 may also be provided with a sealing structure to further improve the sealing adaptability during radial contraction. The principle is as follows: when the tightening member 5 drives the moving member 50 to radially contract and squeeze the elastic sealing tube 7, the grooves, protrusions or bumps on the inner wall provide reserved filling space and orderly deformation guidance for the compression deformation of the tube wall material, so that the inner diameter of the tube wall can be reduced more uniformly, avoiding irregular wrinkles caused by material accumulation, thereby ensuring that a tight and continuous contact interface is formed between the tube wall and the outer peripheral wall of the interventional device, effectively sealing the gap and preventing blood leakage.

[0062] Specifically, see Figures 9-13 The sealing structure may take any of the following forms: like Figure 9 As shown, the sealing structure includes multiple grooves 70 arranged circumferentially and spirally extending axially along the inner wall of the elastic sealing tube 7. When the tightening member 5 radially compresses the elastic sealing tube 7, the groove wall of the groove 70 tightly wraps the interventional instrument as the tube wall deforms. The groove 70 itself provides deformation guidance and buffer space, so that the tube wall is subjected to uniform force and conforms to the outer contour of the instrument.

[0063] like Figure 10 As shown, the sealing structure includes multiple protrusions 71 arranged circumferentially and spirally extending axially along the inner wall of the elastic sealing tube 7. When radially contracted, the protrusions 71 directly press against the outer wall of the interventional device, and fill the tiny unevenness on the surface of the device through the elastic deformation of the protrusions 71 themselves, forming multiple circumferential closed barriers.

[0064] like Figure 11 As shown, the sealing structure includes multiple protrusions 72 spaced apart circumferentially and axially along the inner wall of the elastic sealing tube 7. One end of each protrusion 72 is located on the inner wall of the elastic sealing tube 7, and the other end points towards the central axis of the elastic sealing tube 7. Each protrusion 72 undergoes independent elastic deformation under radial compression, flexibly conforming to the outer wall of the interventional device. This is particularly suitable for scenarios where multiple interventional devices are inserted simultaneously, and can fully fill the gaps between the devices.

[0065] like Figure 12As shown, the sealing structure includes multiple grooves 70 arranged circumferentially and spirally extending axially along the inner wall of the elastic sealing tube 7, and multiple protrusions 72 arranged circumferentially and axially at intervals along the inner wall of the elastic sealing tube 7. One end of each protrusion 72 is located on the inner wall of the elastic sealing tube 7, and the other end points towards the central axis of the elastic sealing tube 7. The grooves 70 and protrusions 72 cooperate to conform to the instrument surface from different dimensions during contraction, and the double sealing barrier further enhances the sealing effect.

[0066] like Figure 13 As shown, the sealing structure includes multiple first grooves 73 arranged circumferentially and spirally extending axially along the inner wall of the elastic sealing tube 7, and multiple second grooves 74 arranged circumferentially and spirally extending axially along the inner wall of the elastic sealing tube 7. The spiral directions of the first grooves 73 and the second grooves 74 are opposite (i.e., opposite rotation directions). The bidirectional spiral pattern can deform and fit the instrument simultaneously from two directions during contraction, which can not only fully wrap and fill the gaps between the instruments, but also cancel out the local stress generated by torsional deformation, making the tube wall fit more uniform and the sealing stability better.

[0067] Figure 14 The image shows the sealing state of the elastic sealing tube 7 after it has been radially compressed by the tightening member 5.

[0068] All of the above-mentioned sealing structures can work in conjunction with the radial contraction mechanism of the tightening element 5 without the need for an additional metal mesh layer, significantly enhancing the circumferential sealing ability of the elastic sealing tube 7 to enclose and seal the interventional device.

[0069] The above description is merely a preferred embodiment of the present invention. Those skilled in the art should understand that the scope of disclosure in this invention is not limited to the specific combination of the above-described technical features, but should also cover other technical solutions formed by any combination of the above-described technical features or their equivalents without departing from the above-described concept. For example, technical solutions formed by substituting the above features with (but not limited to) technical features with similar functions disclosed in this invention.

Claims

1. A circumferential closure device for a catheter sheath, characterized in that, include: Valve body (1) and rotating disc (2), tightening member (5), elastic sealing tube (7), and fixed disc (8) disposed inside valve body (1); The valve body (1) has an axially penetrating channel, and the elastic sealing tube (7) passes through the rotating disk (2), the tightening member (5), and the fixed disk (8) along the channel; the fixed disk (8) is fixedly disposed inside the valve body (1), and has a plurality of circumferentially evenly distributed, center-pointing, and radially extending guide grooves on it; the rotating disk (2) is rotatably disposed inside the valve body (1), and has a plurality of drive grooves on the rotating disk (2) that are the same number as the guide grooves and correspond one-to-one, and the drive grooves form a predetermined angle with the guide grooves; the tightening member (5) is disposed between the fixed disk (8) and the rotating disk (2); When the rotating disk (2) rotates to the first position relative to the fixed disk (8), the tightening member (5) is driven by the driving groove and radially contracts along the guide groove toward the elastic sealing tube (7), causing the end face of the tightening member (5) to contact the surface of the elastic sealing tube (7), so that the internal channel of the elastic sealing tube (7) is closed or narrowed; when the rotating disk (2) rotates to the second position relative to the fixed disk (8), the tightening member (5) is driven by the driving groove and radially expands along the guide groove toward the direction away from the elastic sealing tube (7), so that the internal channel of the elastic sealing tube (7) is opened or expanded.

2. The circumferential closure device for a catheter sheath according to claim 1, characterized in that, The valve body (1) includes a main housing and a three-way connector (3). One end of the three-way connector (3) is fixedly connected to the main housing, and the elastic sealing tube (7) is sealed to one end of the three-way connector (3).

3. A circumferential closure device for a catheter sheath according to claim 1, characterized in that, Also includes: A torsion spring (4) has its first end fixedly connected to the rotating disk (2) and its second end fixedly connected to the valve body (1). The torsion spring (4) is used to apply a biasing force to the rotating disk (2) to keep it in the first position.

4. A circumferential closure device for a catheter sheath according to claim 3, characterized in that: The tightening member (5) is composed of multiple circumferentially arranged and overlapping movable members (50). The number of movable members (50) is the same as the number of guide grooves. The multiple movable members (50) form a central hole through which the elastic sealing tube (7) passes. Each of the moving parts (50) has a first actuating pin on the side facing the fixed disk (8) and a second actuating pin on the side facing the rotating disk (2); the first actuating pin of each of the moving parts (50) is aligned with and inserted into the corresponding guide groove on the fixed disk (8), and the second actuating pin of each of the moving parts (50) is aligned with and inserted into the corresponding drive groove on the rotating disk (2). When the rotating disk (2) rotates relative to the fixed disk (8) toward the first position, each driving groove drives the corresponding moving part (50) to move toward the direction close to the elastic sealing tube (7) through the corresponding second detonating pin. At the same time, the first detonating pin on each moving part (50) moves along the corresponding guide groove toward the direction close to the center of the fixed disk (8), so that the overlap of adjacent moving parts (50) increases and the diameter of the central hole decreases. When the rotating disk (2) rotates relative to the fixed disk (8) to the second position, each driving groove drives the corresponding moving part (50) to move away from the elastic sealing tube (7) through the corresponding second actuating pin. At the same time, the first actuating pin on each moving part (50) moves along the corresponding guide groove towards the center of the fixed disk (8), so that the overlap of adjacent moving parts (50) becomes smaller and the diameter of the central hole becomes larger.

5. A circumferential closure device for a catheter sheath according to claim 1, characterized in that, The fixing plate (8) is integrally formed with the valve body (1) or detachably connected. The fixing plate (8) is located inside the valve body (1) and is perpendicular to the axis of the valve body (1).

6. A circumferential closure device for a catheter sheath according to any one of claims 1-5, characterized in that, The rotating disk (2) is provided with an operating handle (10), which extends from the side wall of the valve body (1) and is used to drive the rotating disk (2) to rotate.

7. A circumferential closure device for a catheter sheath according to claim 3, characterized in that: The rotating disk (2) is a gear-type rotating disk with teeth on its outer circumference; The valve body (1) has a slot (12) for the pressing member (11) to pass through, and the pressing member (11) has a rack (111) that meshes with the gear teeth. When the pressing member (11) is pressed, the rack part (111) drives the rotating disk (2) to rotate to the second position; when the pressing member (11) is released, the rotating disk (2) rotates back to the first position under the biasing force of the torsion spring (4), and the pressing member (11) returns to the initial position under the drive of the gear teeth.

8. A circumferential closure device for a catheter sheath according to claim 7, characterized in that: The number of the slots (12) is two, and the two slots (12) are symmetrically arranged on both sides of the valve body (1). The two pressing parts (11) are respectively arranged in the corresponding slots (12). The rack parts (111) of the two pressing parts (11) are respectively located on the radially opposite sides of the rotating disk (2) and mesh with the gear teeth on the outer periphery of the rotating disk (2).

9. A circumferential closure device for a catheter sheath according to claim 1, characterized in that: The inner wall of the elastic sealing tube (7) is provided with a sealing structure. When the tightening member (5) radially contracts and squeezes the elastic sealing tube (7), the sealing structure can undergo elastic deformation to tightly fit the outer peripheral wall of the interventional device inserted in the elastic sealing tube (7), thereby sealing the gap between the interventional device and the inner wall of the elastic sealing tube.

10. A circumferential closure device for a catheter sheath according to claim 9, characterized in that, The sealing structure includes any one of the following structures: Multiple grooves are arranged circumferentially along the inner wall of the elastic sealing tube (7) and extend axially in a spiral manner; Alternatively, multiple protrusions are arranged circumferentially along the inner wall of the elastic sealing tube (7) and extend axially in a spiral manner; Alternatively, a plurality of protrusions are arranged at intervals in both the circumferential and axial directions along the inner wall of the elastic sealing tube (7), with one end of each protrusion disposed on the inner wall of the elastic sealing tube (7) and the other end pointing towards the central axis of the elastic sealing tube (7). Alternatively, multiple grooves are arranged circumferentially and spirally along the inner wall of the elastic sealing tube (7); and multiple protrusions are arranged circumferentially and axially along the inner wall of the elastic sealing tube (7), with one end of the protrusion disposed on the inner wall of the elastic sealing tube (7) and the other end pointing to the central axis of the elastic sealing tube (7). Alternatively, multiple first grooves are arranged circumferentially and spirally extending along the inner wall of the elastic sealing tube (7), and multiple second grooves are arranged circumferentially and spirally extending along the inner wall of the elastic sealing tube (7), wherein the spiral directions of the first grooves and the second grooves are opposite.

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