An adaptive guide sheath

Abstract

This invention discloses an adaptive guiding sheath, including a sheath seat with a button on its side and a first hemostatic valve with a through hole inside. The first hemostatic valve includes an upper hemostatic valve part and a lower hemostatic valve part with an integral symmetrical structure. The upper hemostatic valve part has a first section and a second section arranged sequentially along the axial direction. The first section is a cylindrical section with a first diameter, and the second section has a second diameter larger than the first diameter. A contraction line is sleeved on the outside of the first section and is linked to the button. This invention, through a two-section aperture design, significantly reduces the frictional resistance of catheter insertion and removal by utilizing the larger inner diameter of the second section; at the same time, the contraction line only acts on the first section with a smaller initial inner diameter, requiring only minimal radial contraction to achieve a tight seal, effectively avoiding the risk of material wrinkling and blood leakage caused by excessive compression of the hemostatic valve and the risk of catheter collapse, thus achieving a balance between low resistance and high reliable hemostasis.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to an adaptive guidance sheath. Background Technology

[0002] As an auxiliary guiding device for interventional procedures, the guiding sheath plays a crucial role in interventional treatment. Through vascular puncture techniques, the guiding sheath establishes a channel from outside the body to the lumen of the blood vessel, serving as a percutaneous access route for other instruments.

[0003] To effectively prevent bleeding during instrument insertion and withdrawal from the guide sheath, the guide sheath must possess extremely high hemostatic reliability. Existing guide sheaths suitable for procedures such as EVAR typically control the orifice size by applying external force, such as pressing or rotating, to compress the hemostatic valve as a whole, thus covering the instrument surface to achieve hemostasis. However, this traditional design, relying on the "proportional contraction of the entire hemostatic valve," suffers from the following insurmountable technical drawbacks in actual clinical practice: Firstly, it is difficult to balance insertion / removal resistance with hemostasis. To ensure hemostasis and sealing for catheters of different sizes, current technology typically designs the initial orifice diameter of the hemostatic valve to be smaller than the outer diameter of the catheter to be inserted. When the instrument is inserted, the inner wall of the hemostatic valve forms a long-distance, large-area interference contact with the catheter surface, resulting in significant frictional resistance. This makes it extremely difficult for physicians to advance or withdraw the catheter, lacking adaptive matching capability.

[0004] Secondly, large deformation can cause material wrinkling, leading to bleeding. For example, Chinese invention patent CN111295221B discloses a scheme that uses a contraction mechanism to compress the inner lumen together. When this type of hemostatic structure is applied to catheters with small outer diameters, the large-aperture hemostatic valve needs to be forcibly and significantly contracted radially. This inevitably leads to localized accumulation, folding, or irregular compression of the silicone material in the hemostatic valve. These wrinkles create tiny, unhealable gaps at their intersections, making it impossible to achieve a complete hemostatic seal on small catheters.

[0005] Third, drastic changes in contraction force can easily cause catheter collapse. In the aforementioned large deformation contraction mechanism, due to the forced and significant compression of the inner diameter, the contraction force exhibits a non-linear and drastic change. This crude force application method makes it difficult to precisely control the clamping force. Once the stress is concentrated on the catheter surface with low tube strength, it can easily cause excessive compression, leading to serious risks such as catheter lumen collapse, directly affecting surgical safety.

[0006] In summary, overcoming the leakage problem caused by irregular material wrinkles during large radial contraction of existing hemostatic valves, and achieving stable and precise control of hemostatic contraction force to avoid catheter collapse while effectively reducing the frictional resistance of instrument insertion and removal, are technical challenges that urgently need to be solved in this field. Summary of the Invention

[0007] The purpose of this invention is to provide an adaptive guide sheath that is not only simple to operate, but also adaptively controls the size of the hemostatic valve to match different sizes of inserted catheters and prevent blood leakage; at the same time, it can effectively control the degree of change in contraction force to avoid excessive compression of the catheter and achieve good hemostasis; and finally, it reduces the resistance of other instruments entering and exiting the guide sheath.

[0008] To achieve the above objectives, the present invention adopts the following technical solution: an adaptive guiding sheath, including a sheath seat, on which at least one button is slidably disposed, and a first hemostatic valve having a through hole is fixed inside the sheath seat; The first hemostatic valve includes an upper hemostatic valve part and a lower hemostatic valve part that are integrally symmetrical in structure; The upper hemostatic valve is provided with a first section and a second section in sequence along the axial direction. The first section is a first cylindrical section with a first diameter. The second section includes a transition section and a second cylindrical section. The second cylindrical section has a second diameter, which is larger than the first diameter. The transition section connects the first cylindrical section and the second cylindrical section. It also includes a shrink cord, which is sleeved on the outside of the first segment, and one or both ends of the shrink cord are fixedly connected to the at least one button.

[0009] Furthermore, the upper hemostatic valve portion also includes a third segment and a fourth segment extending radially, and a second transition segment located between the third segment and the fourth segment; the third segment is planar and has a third diameter larger than the second diameter; the fourth segment is planar and has a fourth diameter larger than the third diameter.

[0010] Furthermore, the sheath seat includes a first sealing member and a second sealing member that are fixed together. The mating surfaces of the first sealing member and the second sealing member form a hemostatic valve groove and a wire hole that is laterally connected to the hemostatic valve groove. The first hemostatic valve is positioned in the hemostatic valve groove, and the shrinking wire passes through the wire hole.

[0011] Furthermore, the first seal and the second seal together form a movable slot and a fixed position located on the side of the movable slot; the button is slidably disposed in the movable slot, and the button has a pressure groove inside; it also includes a compression spring, the two ends of which abut against the fixed position and the inner wall of the pressure groove, respectively.

[0012] Furthermore, the at least one button is a single button, and the number of the movable card slot and the fixed position is a set; The shrinkage line includes a ring, a spiral segment, and a first section of the line; the spiral segment is sleeved on the outside of the first section of the first hemostatic valve, and the spiral segment has 2 to 5 turns; the ring is fixed to the head end of the spiral segment, the first section of the line extends from the end of the spiral segment, the first section of the line passes through the ring, and its end is fixedly connected to the single button.

[0013] Furthermore, the at least one button is a single button, and the number of the movable card slot and the fixed position is a set; The shrinkage line includes a spiral segment sleeved on the outside of the first section of the first hemostatic valve, and a first section and a second section of the line extending from both ends of the spiral segment; the spiral segment has 2 to 5 turns; the ends of the first section and the second section of the line are both fixedly connected to the single button.

[0014] Furthermore, the at least one button includes a first button and a second button; the number of movable slots and fixed positions are both two sets, and the two sets of movable slots and fixed positions are arranged symmetrically with respect to the central axis of the first seal. The first button and the second button are respectively slidably disposed in the two sets of movable slots. The shrinkage liner includes a spiral segment sleeved on the outside of the first section of the first hemostatic valve, and a first section and a second section of the liner extending from both ends of the spiral segment; the first section and the second section of the liner both extend in a straight line, and the first section and the second section of the liner are parallel to each other and extend in opposite directions; the end of the first section of the liner is fixedly connected to the first button, and the end of the second section of the liner is fixedly connected to the second button.

[0015] Furthermore, the central axis of the first segment of the line is coplanar in a first imaginary plane, and the first imaginary plane is tangent to the outer circumference of the head end of the spiral segment; the central axis of the second segment of the line is coplanar in a second imaginary plane, and the second imaginary plane is tangent to the outer circumference of the end of the spiral segment; the first imaginary plane and the second imaginary plane are coplanar.

[0016] Furthermore, the sheath seat also includes a connector, the lower part of which is provided with a first thread; the adaptive guiding sheath also includes a base and a second hemostatic valve, the upper part of which is provided with a second thread that is screwed and fixed to the first thread, and the interior of the base is provided with a hemostatic cavity, a catheter cavity and a sheath cavity in sequence from top to bottom; the second hemostatic valve is positioned in the hemostatic cavity.

[0017] Furthermore, the catheter lumen includes a conical hole and a cylindrical hole that are connected vertically. The diameter of the conical hole on the side closer to the hemostasis lumen is larger than the diameter on the other side. The diameter of the conical hole gradually decreases downward along the axial direction and connects to the cylindrical hole. The second hemostasis valve is cylindrical in shape. Each of the upper and lower surfaces of the second hemostasis valve is provided with a non-penetrating cross-shaped incision. The cross-shaped incision on the upper surface and the cross-shaped incision on the lower surface form a 45-degree angle in the circumferential direction.

[0018] Compared with the prior art, the present invention has the following beneficial effects: 1. When the catheter is inserted into the first hemostatic valve, the large gap between the second section and the first hemostatic valve can avoid excessive contact between them and reduce the resistance to passage.

[0019] 2. Reducing the inner diameter of the first hemostatic valve to a certain size, without reducing it to zero, helps control the contraction force of the contraction line. At the same time, the inner diameter of the first section is smaller than that of the second section, making the range of contraction force variation smaller, which helps to avoid excessive compression of the catheter and cause the inner lumen to collapse, thus ensuring the hemostatic effect.

[0020] 3. The shrink line adopts a shrink line with a circular ring structure at the head end, which is equivalent to keeping one end stationary while tightening / releasing the shrink line at the other end, which facilitates quick tightening / releasing of the shrink line and can quickly respond to the operation process.

[0021] 4. When in use, the catheter is covered by both the first and second hemostatic valves to achieve double-layer hemostasis. When removing the catheter, the first hemostatic valve needs to be opened and the catheter pulled out. At this time, the second hemostatic valve covers the catheter. Continue to pull out the catheter until the catheter is pulled out of the second hemostatic valve. The second hemostatic valve will automatically close to prevent blood leakage. The second hemostatic valve can supplement the hemostatic effect. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the guide sheath structure in an embodiment of the present invention; Figure 2 is a schematic diagram of the sheath seat in an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the first hemostatic valve in an embodiment of the present invention; Figure 4 This is a schematic diagram of the sheath cap structure in an embodiment of the present invention; Figure 5 is a schematic diagram of the structure of the first sealing element and the second sealing element in an embodiment of the present invention; Figure 6 This is a schematic diagram of the structure of the shrinkage line in an embodiment of the present invention; Figure 7 This is a schematic diagram of the button structure in an embodiment of the present invention; Figure 8 This is a schematic diagram of the connector structure in an embodiment of the present invention; Figure 9 This is a schematic diagram of the base structure in an embodiment of the present invention; Figure 10 This is a schematic diagram of the structure of the second hemostatic valve in an embodiment of the present invention; Figure 11 This is a schematic diagram of the structure of the shrinkage line in an embodiment of the present invention; Figure 12 This is a schematic diagram of the structure of a single shrinkage line in an embodiment of the present invention; Figure 13 This is a schematic diagram of the structure of the two contraction lines in an embodiment of the present invention. Explanation of reference numerals in the attached drawings: 10. Adaptive guiding sheath; 100. Sheath seat; 1011. Positioning platform; 1012. Boss; 102. First seal; 1021. Positioning groove; 1022. Seal slot; 1023. Hemostatic valve groove; 1024. Wire hole; 1025. Fixed position; 1026. Moving slot; 1027. Pin; 103. Connector; 1032. Connector boss; 1033. First thread; 104. First hemostatic valve; 1041. First section; 1042. Second section; 10421. Transition section; 1043. Third section; 1044. Fourth section; 1045. Upper hemostatic valve part; 1046. Lower hemostatic valve part; 1047. Through hole; 105. Second hemostatic valve. Blood valve, 1051, cross-shaped incision, 106, second seal, 107, contraction line, 1071, ring, 1072, spiral section, 1073, first section, 108, button, 1081, pressure groove, 1082, line groove, 109, compression spring, 110, base, 1101, second thread, 1102, hemostatic cavity, 1103, catheter lumen, 1104, sheath lumen, 1105, locking position, 1106 infusion channel, 113, contraction line, 1131, spiral section, 1132, first section of the line, 1133, second section of the line, 114, contraction line, 1141, spiral section, 1142, first section of the line, 1143, second section of the line, 200 sheath, 300 dilator. Detailed Implementation

[0023] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0024] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0025] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0026] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0027] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator. Axial direction refers to the direction parallel to the line connecting the center of the distal and proximal ends of the medical device; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0028] like Figure 1 As shown, an adaptive guiding sheath 10 includes: a sheath seat 100, a sheath tube 200, and a dilator 300. A first hemostatic valve 104 with a through hole 1047 is installed inside the sheath seat 100, and a button 108 is slidably disposed on the side of the sheath seat 100. The centerline of the through hole 1047 coincides with the central axis of the sheath seat 100.

[0029] The first hemostatic valve 104 is made of silicone or other elastic polymer materials. Its overall wall thickness is uniform, ranging from 0.1 mm to 1.0 mm. The first hemostatic valve 104 has an "hourglass" structure, meaning it is symmetrical with larger ends and a smaller middle section. Specifically, the first hemostatic valve 104 includes an integrated, symmetrical upper hemostatic valve portion 1045 and a lower hemostatic valve portion 1046.

[0030] like Figure 3 As shown, taking the upper hemostatic valve 1045 as an example, the lower hemostatic valve 1046 has the same structure as the upper hemostatic valve 1045 and is symmetrical in position. The upper hemostatic valve 1045 is provided with a first section 1041 and a second section 1042 in sequence along the axial direction. It can be understood that the axial direction refers to the direction from the center to the end.

[0031] The first segment 1041 is a first cylindrical segment with a first diameter D1 and an axial height of 2-5mm. The first diameter D1 is larger than the outer diameter of the fitting conduit, with a difference range of 0.2-1.0mm.

[0032] The second segment 1042 includes a transition segment 10421 and a second cylindrical segment. The transition segment 10421 connects the first cylindrical segment and the second cylindrical segment. The second cylindrical segment has a second diameter D2, which is larger than the first diameter D1. In a preferred embodiment, the second segment 1042 is frustum-shaped, meaning the second diameter D2 increases radially uniformly away from the first segment 1041. In an alternative embodiment, the second segment 1042 may also be a cylinder with a uniform inner diameter.

[0033] Furthermore, the upper hemostatic valve portion 1045 also includes a radially extending third segment 1043 and a fourth segment 1044, and a second transition segment located between them. The third segment 1043 is planar and has a third diameter D3 larger than the second diameter D2; the fourth segment 1044 is planar and has a fourth diameter D4 larger than the third diameter D3. In other embodiments, adhesive layers are distributed on both the upper and lower end faces of the radially extending third segment 1043 and fourth segment 1044. This achieves multiple layers of water resistance and leak prevention, not only through mechanical interference sealing but also by utilizing surface-contact adhesive layers to reduce assembly gaps.

[0034] When the catheter is inserted into the first hemostatic valve 104, the second diameter D2 of the second segment 1042 is larger, which avoids excessive contact with the catheter, thereby significantly reducing the frictional resistance of catheter insertion and withdrawal; while the first diameter D1 of the first segment 1041 is smaller, and the contraction line 107 can achieve tight clamping by applying a small deformation, which is conducive to precise control of contraction force, ensuring hemostasis effect and avoiding excessive compression of the catheter that would cause its inner lumen to collapse.

[0035] like Figure 5c As shown, the sheath seat 100 includes a first sealing element 102 and a second sealing element 106. In other embodiments, the first sealing element 102 and the second sealing element 106 can also be fixed to each other by ultrasonic welding, gluing, or snap-fitting. The mating surfaces of the first sealing element 102 and the second sealing element 106 form a hemostatic valve groove 1023 and a wire hole 1024 that communicates laterally with the hemostatic valve groove 1023. The first hemostatic valve 104 is positioned within the hemostatic valve groove 1023. To ensure the stability of the fastening, a pin 1027 protrudes from the outer side of the first sealing element 102, and a corresponding pin groove is provided on the second sealing element 106. The two are engaged by an interference fit.

[0036] like Figure 4 , Figure 5b and Figure 7 As shown, it also includes a sheath cap 101. The tops of both the first seal 102 and the second seal 106 are provided with positioning grooves 1021 and seal slots 1022. The sheath cap 101 extends downwards and is provided with a positioning platform 1011 and a boss 1012 located on its inner side. The positioning platform 1011 is fixedly engaged with the positioning groove 1021, and the boss 1012 is engaged with the seal slot 1022. This ensures the compressive strength of the seal and prevents the seal from separating under high-pressure blood flow impact.

[0037] The sheath seat 100 also includes a connector 103, with a connector boss 1032 in the middle of the connector 103. The bottom of the first seal 102 and the second seal 106 are provided with connector slots, and the connector boss 1032 is engaged and fixed with the connector slots.

[0038] In other embodiments, the first hemostatic valve 104, the sheath cap 101, and the connector 103 are integrally formed. Specifically, insert injection molding is preferred, so that a seamless material fusion interface is formed between the outer periphery of the first hemostatic valve 104, which is made of elastomeric material, and the inner wall of the sheath cap 101 and the connector 103, which are made of rigid material.

[0039] A movable slot 1026 and a fixed position 1025 located on its side are also formed between the first sealing member 102 and the second sealing member 106. The button 108 is slidably disposed in the movable slot 1026, and a pressure groove 1081 is formed in the center of the button 108. Figure 2b As shown, the two ends of the compression spring 109 abut against the inner walls of the fixed position 1025 and the pressure groove 1081 respectively, providing the button 108 with a radially outward reset force.

[0040] The shrink cord 107 is preferably made of nickel-titanium alloy or stainless steel wire, which needs to be heat-set. The shrink cord 107 is sleeved on the outside of the first section 1041 of the first hemostatic valve, and its spiral center line coincides with the center line of the through hole 1047. One or both ends pass through the wire hole 1024 and are connected to the button 108.

[0041] like Figure 6 and Figure 7 As shown, the retraction line 107 consists of a ring 1071, a spiral section 1072, and a first section 1073. The spiral section 1072 is fitted around the outside of the first section 1041, with 2 to 5 turns. The ring 1071 is located at the head end of the spiral section 1072 and in the middle of the overall height. The first section 1073 extends from the end of the spiral section 1072, passes through the ring 1071, and is fixed in the groove 1082 at the center of the button 108. This structure is equivalent to one end being fixed and the other end being tightened, resulting in a fast response time during operation.

[0042] The number of contraction lines 113 is single, and a single button 108 is correspondingly arranged on the sheath seat 100. The single contraction line 113 is sleeved at the axial center position of the first section 1041 of the first hemostatic valve and is controlled by the single button, thereby forming a concentrated radial constraint band on the outer periphery of the first hemostatic valve 104 to meet the conventional hemostasis requirements.

[0043] In other embodiments, to achieve high-pressure redundant sealing, the number of contraction lines 113 is expanded to two or more. Simultaneously, the linkage receiving structure assembly of the sheath seat 100 is correspondingly configured with two or more buttons 108 with independent pressing strokes. Spatially, the two contraction lines 113 are arranged axially spaced along the central axis of the first segment 1041 of the first hemostatic valve.

[0044] In other embodiments, such as Figure 11As shown, the shrinking thread 113 includes a spiral segment 1131 with 2 to 5 turns, and a first thread segment 1132 and a second thread segment 1133 extending from both ends of the spiral segment 1131. The first thread segment 1132 extends tangentially from the beginning of the spiral segment, and the second thread segment 1133 extends tangentially from the end, and both are fixedly connected within the thread groove 1082 of the same button 108. This structure allows for simultaneous relaxation of both ends of the shrinking thread by pressing a single button, resulting in more even force distribution.

[0045] In other embodiments, such as Figure 12 and Figure 13 As shown, the number of contraction lines 114 can be two or one. The first segment 1142 and the second segment 1143 of the line are located in the same horizontal plane and are parallel to each other and in opposite directions. The first segment 1142 is fixedly connected to the first button, and the second segment 1143 is fixedly connected to the symmetrically arranged second buttons.

[0046] The main body of the contraction line 114 consists of a spiral segment 1141 located in the middle, and a first section 1142 and a second section 1143 extending from both ends of the spiral segment 1141. The spiral segment 1141 has a tightly wound spiral configuration, and to ensure the rationality of the clamping area and stress distribution, the number of winding turns is between 2 and 5. In the assembly position, the spiral segment 1141 is coaxially sleeved on the outer periphery of the first section 1041 of the first hemostatic valve; when the system is under pressure, the inner diameter of the spiral segment 1141 is designed to be larger than the outer diameter of the first section 1041 of the first hemostatic valve.

[0047] To accommodate different sheath housing internal space designs, the first segment 1142 of the line extends tangentially from the head end of the spiral segment 1141 (which can be understood as the top loop), and the axis of this straight segment is completely flush with the height of the plane where the head end of the spiral segment 1141 is located; the second segment 1143 extends tangentially from the end of the spiral segment 1141 (which can be understood as the bottom loop), and the axis of this straight segment is completely flush with the height of the plane where the end of the spiral segment 1141 is located.

[0048] In other embodiments, to optimize the coplanarity of the force applied to the dual buttons, the first segment 1142 and the second segment 1143 of the line, after being led out from their ends, can also be guided to the middle position of the overall axial height of the contraction line 114 for lateral extension. Specifically, the first segment 1142 extends in a straight line, and the central axes of all parts of its straight segment are coplanar in a first imaginary plane, and the first imaginary plane is tangent to the outer circumference of the lead end of the spiral segment 1141; similarly, the second segment 1143 extends in a straight line, and the central axes of all parts of its straight segment are coplanar in a second imaginary plane, and the second imaginary plane is tangent to the outer circumference of the end of the spiral segment 1141.

[0049] In terms of overall spatial orientation, the final straight extensions of the first segment 1142 and the second segment 1143 of the line are both on the same horizontal plane, and their extension directions are parallel to each other and 180 degrees apart.

[0050] The ends of the first segment 1142 and the second segment 1143 of the thread are rigidly fixedly connected to two oppositely arranged buttons 108. When the operator releases the buttons 108 on both sides simultaneously, the reverse parallel tensile force line applied by the rebound assembly acts directly on both ends of the spiral segment 1141, realizing the radial uniform contraction of the spiral segment 1141 with its center as the reference, fundamentally eliminating the uneven force on the hemostatic valve that may be caused by unidirectional pulling.

[0051] like Figure 8 and Figure 9 As shown, the outer peripheral surface below the positioning platform of the connector 103 is provided with a first thread 1033. The inner side of the top of the base 110 is provided with a second thread 1101, which is screwed and fixed to the first thread 1033. The lower outer edge of the base 110 is provided with an annular groove 1105, which is connected from top to bottom to a hemostasis chamber 1102, a catheter chamber 1103, and a sheath chamber 1104, and is laterally connected to an infusion channel 1106.

[0052] The hemostatic cavity 1102 is a circular groove used to accommodate the second hemostatic valve 105. After the second hemostatic valve 105 is installed, its top surface is flush with the lower surface of the second thread 1101 and is axially limited by the connector 103.

[0053] The catheter lumen 1103 consists of an upper conical orifice and a lower through-hole. The conical orifice has the largest diameter near the hemostasis lumen 1102 and gradually decreases in diameter downwards along the axial direction, smoothly transitioning to the through-hole with a uniform inner diameter. The inner diameter of the sheath lumen 1104 is larger than the inner diameter of the through-hole. This smoothly transitioning flow path effectively prevents jamming during catheter insertion.

[0054] like Figure 10As shown, the second hemostatic valve 105 is cylindrical, with an unpenetrated cross-shaped incision 1051 on each of its upper and lower surfaces. The cross-shaped incision on the upper surface and the cross-shaped incision on the lower surface form a 45-degree angle in the circumferential direction, thus creating a misaligned seal.

[0055] Furthermore, the wire hole 1024, the fixed position 1025, and the movable slot 1026 are interconnected and cooperate with each other in spatial position, together forming a linkage receiving structure group for accommodating and guiding the button.

[0056] Regarding the number and arrangement of these structural groups, the first seal 102 may have only one set of the aforementioned linkage receiving structural groups, for example, adapted to the aforementioned single-button drive. Alternatively, in a preferred alternative embodiment, the first seal 102 may have two sets of the aforementioned linkage receiving structural groups, for example, adapted to the aforementioned dual-button drive.

[0057] When two sets of layouts are adopted, the two sets of linked receiving structures are respectively opened on opposite sides of the first sealing element 102, and with the central axis of the first sealing element 102 as the symmetry reference, the two sets of structures are arranged symmetrically in space, which can be understood as being symmetrically distributed at 180-degree intervals along the circumference.

[0058] The method of using this invention is as follows: 1. Preparation for insertion: The operator presses down on button 108 against the elastic force of spring 109. At this time, the tension of retraction line 107 (or 113 / 114) linked to the button is released, and the first hemostatic valve 104 returns to its initial inner diameter state due to the elasticity of the silicone itself.

[0059] 2. Catheter advancement: The catheter is smoothly passed through the through hole of the first hemostatic valve 104 and the staggered cross incision of the second hemostatic valve 105, and then smoothly enters the sheath through the inner cavity of the base.

[0060] 3. Locking and Hemostasis: Release button 108. The spring 109 drives the button to reset outward, causing the contraction line 107 to contract radially. The spiral section applies a uniform circumferential clamping force to the first section 1041 of the first hemostatic valve, making it fit tightly against the outer wall of the catheter, achieving the first main seal.

[0061] 4. Catheter removal and secondary leakage prevention: Press button 108 again to release the restraint of the first hemostatic valve 104 and pull the catheter outward. At this time, the second hemostatic valve 105 maintains the covering of the catheter. When the catheter is completely pulled out of the second hemostatic valve 105, the incision of the second hemostatic valve 105 closes actively under its own stress, realizing a second supplementary seal and preventing blood splashing at the moment of catheter removal.

[0062] The above description is merely a preferred embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, structural improvements, etc., made within the technical concept and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. An adaptive guiding sheath, comprising a sheath base, wherein at least one button is slidably disposed on the sheath base, and a first hemostatic valve having a through hole is fixed inside the sheath base; characterized in that: The first hemostatic valve includes an upper hemostatic valve part and a lower hemostatic valve part that are integrally symmetrical in structure; The upper hemostatic valve is provided with a first section and a second section in sequence along the axial direction. The first section is a first cylindrical section with a first diameter. The second section includes a transition section and a second cylindrical section. The second cylindrical section has a second diameter, which is larger than the first diameter. The transition section connects the first cylindrical section and the second cylindrical section. It also includes a shrink cord, which is sleeved on the outside of the first segment, and one or both ends of the shrink cord are fixedly connected to the at least one button.

2. The adaptive guidance sheath according to claim 1, characterized in that: The upper hemostatic valve portion further includes a third segment and a fourth segment extending radially, and a second transition segment located between the third segment and the fourth segment; the third segment is planar and has a third diameter larger than the second diameter; the fourth segment is planar and has a fourth diameter larger than the third diameter.

3. The adaptive guidance sheath according to claim 2, characterized in that: The sheath seat includes a first sealing element and a second sealing element that are fixed together. The mating surfaces of the first sealing element and the second sealing element form a hemostatic valve groove and a wire hole that is laterally connected to the hemostatic valve groove. The first hemostatic valve is positioned in the hemostatic valve groove, and the shrinking wire passes through the wire hole.

4. The adaptive guidance sheath according to claim 3, characterized in that: The first seal and the second seal further enclose a movable slot and a fixed position located on the side of the movable slot; the button is slidably disposed in the movable slot, and the button has a pressure groove inside; it also includes a compression spring, the two ends of which abut against the inner wall of the fixed position and the pressure groove, respectively.

5. The adaptive guidance sheath according to claim 4, characterized in that: The at least one button is a single button, and the number of the movable card slot and the fixed position is a set; The shrinkage line includes a ring, a spiral segment, and a first section of the line; the spiral segment is sleeved on the outside of the first section of the first hemostatic valve, and the spiral segment has 2 to 5 turns; the ring is fixed to the head end of the spiral segment, the first section of the line extends from the end of the spiral segment, the first section of the line passes through the ring, and its end is fixedly connected to the single button.

6. The adaptive guidance sheath according to claim 4, characterized in that: The at least one button is a single button, and the number of the movable card slot and the fixed position is a set; The shrinkage line includes a spiral segment sleeved on the outside of the first section of the first hemostatic valve, and a first section and a second section of the line extending from both ends of the spiral segment; the spiral segment has 2 to 5 turns; the ends of the first section and the second section of the line are both fixedly connected to the single button.

7. The adaptive guidance sheath according to claim 4, characterized in that: The at least one button includes a first button and a second button; the number of movable slots and fixed positions are both two sets, and the two sets of movable slots and fixed positions are arranged symmetrically with the central axis of the first seal as the symmetry reference; the first button and the second button are respectively slidably disposed in the two sets of movable slots. The shrinkage liner includes a spiral segment sleeved on the outside of the first section of the first hemostatic valve, and a first section and a second section of the liner extending from both ends of the spiral segment; the first section and the second section of the liner both extend in a straight line, and the first section and the second section of the liner are parallel to each other and extend in opposite directions; the end of the first section of the liner is fixedly connected to the first button, and the end of the second section of the liner is fixedly connected to the second button.

8. The adaptive guidance sheath according to claim 7, characterized in that: The central axis of the first segment of the line is coplanar in a first imaginary plane, and the first imaginary plane is tangent to the outer circumference of the head end of the spiral segment; the central axis of the second segment of the line is coplanar in a second imaginary plane, and the second imaginary plane is tangent to the outer circumference of the end of the spiral segment; the first imaginary plane and the second imaginary plane are coplanar.

9. The adaptive guidance sheath according to any one of claims 1 to 8, characterized in that: The sheath seat also includes a connector, the lower part of which is provided with a first thread; the adaptive guiding sheath also includes a base and a second hemostatic valve, the upper part of which is provided with a second thread that is screwed and fixed to the first thread, and the interior of the base is provided with a hemostatic cavity, a catheter cavity and a sheath cavity in sequence from top to bottom; the second hemostatic valve is located in the hemostatic cavity.

10. The adaptive guidance sheath according to claim 9, characterized in that: The catheter lumen includes a conical hole and a cylindrical hole that are connected vertically. The diameter of the conical hole on the side closer to the hemostasis lumen is larger than the diameter on the other side. The diameter of the conical hole gradually decreases downward along the axial direction and connects to the cylindrical hole. The second hemostasis valve is cylindrical. Each of the upper and lower surfaces of the second hemostasis valve is provided with a non-penetrating cross-shaped incision. The cross-shaped incision on the upper surface and the cross-shaped incision on the lower surface form a 45-degree angle in the circumferential direction.

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