Sheath seat with built-in hemostasis valve structure and catheter sheath
By inserting a sheath seat with a hemostasis valve structure into the catheter sheath, the problems of blood reflux and frictional damage during interventional surgery are solved, and a sealing and low frictional sheath seat design is achieved, reducing the risk of infection and device damage.
Patent Information
- Application Number
- CN202421556306.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-07-03
- Publication Date
- 2025-07-25
- Estimated Expiration
- 2034-07-03
AI Technical Summary
During interventional surgery, existing catheter sheaths are prone to cause blood reflux and frictional damage during the withdrawal of the dilator and medical devices, increasing the risk of infection and device damage.
A sheath seat with built-in hemostatic valve structure is designed, including a hemostatic valve that accommodates the cavity and the central cavity, which can be kept sealed in the dilator or sheath puncture or removal state, reduce blood reflux, and reduce friction through the cavity.
Effectively prevent blood reflux, reduce friction during the evacuation of dilators and medical devices, and reduce the risk of infection and device damage.
Smart Images
Figure CN223143926U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the technical field of medical devices, and particularly relates to a sheath base and a catheter sheath with an internal hemostatic valve structure. Background Art
[0002] A catheter sheath is an important auxiliary guiding device in minimally invasive peripheral and intracardiac interventional surgeries. It is used to establish a connection channel between the human blood vessel and the outside world during interventional surgeries such as thrombectomy, percutaneous coronary intervention, and percutaneous interventional occlusion, so as to assist the delivery tube in delivering medical devices to the lesion site. Currently, the commonly used catheter sheath in interventional treatment consists of a sheath base and a dilator. During use, first, the catheter sheath is inserted into the human blood vessel by guiding the dilator and the guide wire, then the dilator tube is withdrawn, and the medical device to be inserted, such as a catheter, is sent into the human blood vessel through the sheath tube. After use, the medical device can be withdrawn from the human blood vessel through the sheath tube, then the sheath base is twisted off, and the sheath tube is torn and completely withdrawn from the body, which provides convenience for the intubation process and reduces the damage to the blood vessel at the same time, and is applicable to various interventional surgical operations.
[0003] During the process of withdrawing the dilator and the medical device, blood reflux may occur, which may lead to an increased risk of infection and bleeding hematoma. At the same time, the existing hemostatic valve rubs during the process of withdrawing the dilator and the medical device, which may cause damage to the dilator and the medical device. Summary of the Utility Model
[0004] In view of the above technical problems, this application provides a sheath base and a catheter sheath with an internal hemostatic valve structure, including a sheath base body and a hemostatic valve. The sheath base body is provided with a receiving cavity for receiving the hemostatic valve. A cavity is provided in the central region of the hemostatic valve. A through diameter is preset along the central axis direction of the sheath base body. The dilator or the sheath tube can penetrate through the hemostatic valve along the through diameter. The hemostatic valve can seal the sheath base in both the puncture or removal state of the dilator or the sheath tube.
[0005] Preferably, the hemostatic valve is a conical cylinder, which is composed of a cone and a cylinder. The conical cylinder is composed of a conical part and a cylindrical part. The connection between the bottom surface of the conical part and the top surface of the cylindrical part is a continuous surface. One end of the bottom surface of the cylindrical part of the conical cylinder is the embedding end, and one end of the apex angle of the conical part of the conical cylinder is the stress end. The hemostatic valve is embedded into the inner wall of the receiving cavity of the sheath base body through the embedding end.
[0006] Preferably, the inner wall of the sheath base body is provided with a centrally symmetric first groove a and a positioning protrusion b. The embedding end of the hemostatic valve is provided with a centrally symmetric positioning groove c and a first protrusion d. The first groove a and the first protrusion d cooperate with each other, and the positioning protrusion b and the positioning groove c cooperate with each other.
[0007] Preferably, the cavity is composed of at least one cavity sub - part, and the central axes of the cavity sub - part, the hemostatic valve, and the sheath base body are collinear.
[0008] Preferably, the cavity sub - part is a conical cylinder, and the conical - cylinder cavity sub - part is composed of a conical - part cavity sub - part and a cylindrical - part cavity sub - part. The connection between the bottom surface of the conical - part cavity sub - part and the top surface of the cylindrical - part cavity sub - part is a continuous surface.
[0009] Preferably, the conical - cylinder cavity is composed of at least 2 conical - cylinder cavity sub - parts. The cone heads of the conical - cylinder cavity sub - parts face the force - receiving end, and the conical - cylinder cavity sub - parts are connected end to end.
[0010] Preferably, the volume of the cavity does not exceed 48.6% of the volume of the hemostatic valve.
[0011] Preferably, the angle of the apex angle of the conical part of the hemostatic valve is between 90° and 180°.
[0012] According to the second aspect of one or more embodiments of the present application, a catheter sheath is provided, and the catheter sheath uses an optional sheath base with the built - in hemostatic valve structure.
[0013] In the present application, by arranging a hemostatic valve inside the sheath base, the possible blood back - flow during the process of withdrawing the dilator and medical device through the catheter sheath is avoided. At the same time, by providing a cavity inside the hemostatic valve, the friction during the process of withdrawing the dilator and medical device is reduced. BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The following further describes the present application with reference to the drawings.
[0015] Figure 1 It is a schematic cross - sectional view of a sheath base with a built - in hemostatic valve structure according to an exemplary embodiment of the present application;
[0016] Figure 2 It is a schematic cross - sectional view of a sheath base with a built - in hemostatic valve structure according to another exemplary embodiment of the present application;
[0017] Figure 3 It is a schematic cross - sectional view of a sheath base with a built - in hemostatic valve structure according to another exemplary embodiment of the present application;
[0018] Figure 4 It is a schematic diagram showing the relationship between the cavity volume ratio, friction force, and pressure resistance according to an exemplary embodiment of the present application.
[0019] The numbers in the figures represent:
[0020] 1 - Sheath base body, 2 - Hemostatic valve, 21 - Through diameter, 22 - Cavity, 221 - First cavity section, 222 - Second cavity section. Detailed implementation manner
[0021] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present application.
[0022] In the description of the present application, it should be understood that the orientation or positional relationship indicated by the terms "front", "rear", "left", "right", "upper", "lower", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.
[0023] As Figure 1 -4 shows, the present application provides a sheath base with an internal hemostatic valve structure, including:
[0024] The present application provides a sheath base with an internal hemostatic valve structure, including a sheath base body 1 and a hemostatic valve 2. The sheath base body 1 is provided with a receiving cavity 11 for receiving the hemostatic valve 2. A cavity 22 is provided in the central region of the hemostatic valve 2. A through diameter 21 is preset along the central axis direction of the sheath base body 1. An introducer or a sheath tube can penetrate through the hemostatic valve 2 along the through diameter 21. The hemostatic valve 2 can seal the sheath base in both the state of the introducer or the sheath tube being punctured or removed.
[0025] When the sheath base with an internal hemostatic valve structure provided by the present application is applied to a catheter sheath for work, medical staff hold the sheath base body 1 and insert the dilator into the sheath base body 1 along a predetermined path, i.e., the through diameter 21. At this time, the dilator passes through the hemostatic valve 2. The hemostatic valve 2 has self-sealing properties, that is, the hemostatic valve 2 has the characteristic of being able to automatically flow and fill into irregular surfaces or gaps, and finally form a smooth and uniform surface after standing still. This characteristic seals the contact point between the dilator and the hemostatic valve 2, avoiding liquid leakage or infection. After the dilator completes the puncture, the dilator and the guide wire are withdrawn, and then the corresponding medical device is introduced through the sheath tube. After the medical device is placed, the connection with the external treatment environment can be opened by rotating the three-way valve to inject contrast agent, normal saline or other medicaments. After the operation is completed, rotate the three-way valve to close the connection with the external treatment, and withdraw the medical device through the sheath tube. The medical device passes through the hemostatic valve 2. The self-sealing property of the hemostatic valve 2 causes the withdrawal channel to be automatically closed after the medical device is withdrawn, preventing blood reflux and avoiding the infection risk caused by body fluids being carried out of the catheter sheath by the medical device. When the medical device passes through the hemostatic valve 2 and is withdrawn, the cavity 22 in the hemostatic valve 2 reduces the friction between the medical device and the hemostatic valve 2, avoiding kinking and damage to the medical device when the medical staff withdraws it. After the medical device is withdrawn, the sheath base body 1 is broken off, and then starting from the fracture position, the sheath tube is torn and withdrawn. Therefore, the present application avoids possible blood reflux during the process of withdrawing the dilator and the medical device through the catheter sheath by arranging the hemostatic valve 2 in the accommodation cavity 11 of the sheath base body 1, and at the same time, by providing the cavity 22 in the hemostatic valve 2, the friction occurring during the process of withdrawing the dilator and the catheter or other medical devices can be reduced. Theoretically, the larger the volume of the cavity 22, the smaller the frictional resistance for the sheath tube and the dilator tube to enter or exit
[0026] In a specific embodiment, such as Figure 1As shown in FIG. 4, the hemostatic valve 2 is a conical cylinder, which is composed of a conical part and a cylindrical part. The connection between the bottom surface of the conical part and the top surface of the cylindrical part is a continuous surface. One end of the bottom surface of the cylindrical part of the conical cylinder is the embedding end, and one end of the apex angle of the conical part of the conical cylinder is the stress end. The hemostatic valve 2 is embedded in the inner wall of the accommodation cavity 11 of the sheath seat body 1 through the embedding end. The embedding end of the conical cylinder of the hemostatic valve 2 is the bottom surface of the cylindrical part. The bottom diameter of the conical part of the hemostatic valve 2 has a proper interference with the diameter inside the accommodation cavity 11. The hemostatic valve 2 is made of a soft material and can be squeezed and embedded in the inner wall of the accommodation cavity 11 of the sheath seat body 1 to form a seal. When the hemostatic valve 2 is inserted into the accommodation cavity 11 during assembly, the side surface of the cylindrical part will fit the side wall of the accommodation cavity 11 of the sheath seat body 1 to prevent body fluid from flowing out through the gap between the hemostatic valve 2 and the sheath seat body 1. One end of the apex angle of the conical part of the hemostatic valve 2 is the stress end. When the medical device is withdrawn, the conical outer surface is the stress surface, and the body fluid is blocked on the conical outer surface, serving the purpose of preventing body fluid backflow.
[0027] In a specific embodiment, as Figure 1As shown in FIG. -3, a first symmetrically centered groove a and a positioning protrusion b are provided on the inner wall of the sheath base body 1. A positioning groove c and a first protrusion d that are symmetrically centered are provided at the insertion end of the hemostatic valve 2. The first groove a and the first protrusion d are respectively located on the side wall of the accommodation cavity 11 of the sheath tube body 1 and the side surface of the insertion end of the hemostatic valve 2. The cooperation of the first groove a and the first protrusion d can limit the movement of the hemostatic valve 2 in the horizontal direction. The positioning protrusion b and the positioning groove c are respectively located on the front wall of the accommodation cavity 11 of the sheath base body 1 and the top surface of the insertion end of the hemostatic valve 2. The cooperation of the positioning protrusion b and the positioning groove c can limit the movement of the hemostatic valve 2 in the vertical direction. The cooperation of the two makes the hemostatic valve 2 firmly embedded in the accommodation cavity 11 of the sheath base body 1, and it will not move in the direction of the sheath tube under the action of friction when inserting a medical device, nor will it move in the vertical direction to cause the central axis to shift. In another specific embodiment, a symmetrically centered positioning groove g and a second protrusion h are provided on the inner wall of the sheath base body 1. A symmetrically centered positioning protrusion i and a second groove j are provided at the insertion end of the hemostatic valve 2. The second protrusion h and the second groove j are respectively located on the side wall of the accommodation cavity 11 of the sheath base body 1 and the side surface of the insertion end of the hemostatic valve 2. The cooperation of the second protrusion h and the second groove j can limit the movement of the hemostatic valve 2 in the horizontal direction. The positioning groove g and the positioning protrusion i are respectively located on the front wall of the accommodation cavity 11 of the sheath base body 1 and the top surface of the insertion end of the hemostatic valve 2. The cooperation of the positioning groove g and the positioning protrusion i can limit the movement of the hemostatic valve 2 in the vertical direction. The cooperation of the two makes the hemostatic valve 2 firmly embedded in the accommodation cavity 11 of the sheath base body 1. There can also be other mortise and tenon structures that can achieve the above functions, and this application does not limit this.
[0028] In a specific embodiment, the cavity 22 is composed of at least one cavity sub - part, and the central axes of the cavity sub - part, the hemostatic valve 2, and the sheath base body 1 are collinear. As Figure 1 shown, the cavity 22 includes one cavity sub - part, and the cavity sub - part is in the shape of a conical cylinder; as Figure 2 shown, the cavity 22 includes 2 cavity sub - parts, specifically a first cavity sub - part 221 and a second cavity sub - part 222. Both the first cavity sub - part 221 and the second cavity sub - part 222 are conical cylinders. As Figure 3 shown, the cavity 22 includes 3 cavity sub - parts. On the basis of maintaining the pressure resistance and sealing performance of the hemostatic valve 2, the width occupied by the cavity 22 should be as large as possible to reduce the friction between the medical device / sheath tube / dilator when entering or exiting the hemostatic valve 2 and the hemostatic valve 2 as much as possible. The central axes of the cavity sub - part, the hemostatic valve 2, and the sheath base body 1 are collinear to facilitate the quick and accurate insertion and removal of the medical device.
[0029] In a specific embodiment, the cavity is divided into a conical cylinder, and the conical cylinder cavity is composed of a conical part cavity and a cylindrical part cavity. The connection between the bottom surface of the conical part cavity and the top surface of the cylindrical part cavity is a continuous surface. In a specific embodiment, the conical cylinder cavity is composed of at least two conical cylinder cavity parts, and the cone heads of the conical cylinder cavity parts face the stress end, and the conical cylinder cavity parts are connected end to end. As Figure 2 shown in FIG. - 3, the cone heads of multiple conical cylinder cavity parts face the stress end, and the hemostatic valve 2 body between the cavity parts plays a role in blocking the backflow of liquid section by section. As Figure 2 shown, even if liquid is brought into the first cavity part 221 when the medical device is withdrawn from the sheath tube, because the through - diameter 21 left by the cone head of the second cavity part 222 is narrow and self - sealing, the liquid is easily blocked by the spacer between the first cavity part 221 and the second cavity part 222 and cannot enter the second cavity part 222 anymore. Compared with a single cavity part, the hemostatic effect can be further improved.
[0030] In a specific embodiment, the volume of the cavity 22 does not exceed 48.6% of the volume of the hemostatic valve 2. As Figure 4 shown, the larger the volume ratio of the cavity 22, the smaller the frictional resistance for the sheath tube and the dilator to enter or exit the hemostatic valve 2. The test hemostatic valve 2 is a conical cylinder, which is composed of a conical part and a cylindrical part. The connection between the bottom surface of the conical part and the top surface of the cylindrical part is a continuous surface. The diameter of the cylindrical part is 10 mm, and the length along the central axis direction of the sheath base body 1 is 5 mm. When there is no cavity 22 at all, the frictional resistance is the largest, with an average value of 5.09 N. When it is completely penetrated, that is, when the volume ratio of the cavity 22 is 100%, the instrument can penetrate without resistance. However, the increase in the volume ratio of the cavity 22 will cause the pressure resistance value of the whole system to decrease. In this application, the leakage situation of the system under 300 kPa for 20 s is used as the detection standard, that is, if there is no leakage in the system within 20 s under 300 kPa, the pressure resistance test is considered qualified, otherwise it is unqualified. As Figure 4 shown, when the volume ratio of the cavity 22 increases to 48.6%, the pressure resistance test is unqualified.
[0031] On the basis of passing the pressure resistance test, the volume ratio of the cavity 22 should be increased as much as possible to reduce the frictional resistance. When the hemostatic valve 2 is a conical main body, and the diameter of the cylindrical part is 10 mm and the length along the central axis direction of the sheath seat main body 1 is 5 mm, the cavity 22 can be composed of a conical cylinder cavity sub-division. At this time, the optimal dimensions of the conical cylinder cavity sub-division are: OD = 8 mm, L = 3 mm, where OD is the outer diameter of the cylindrical part cavity sub-division, and L is the length along the central axis direction of the sheath seat main body 1; the cavity 22 can be composed of 2 conical cylinder cavity sub-divisions. At this time, the optimal dimensions of the conical cylinder cavity sub-division are: OD = 7 mm, L = 2 mm; the cavity 22 can also be composed of 3 conical cylinder cavity sub-divisions. At this time, the optimal dimensions of the conical cylinder cavity sub-division are: OD = 9 mm, L = 1 mm; the cavity 22 can also be composed of 4 conical cylinder cavity sub-divisions. At this time, the optimal dimensions of the conical cylinder cavity sub-division are: OD < 8 mm, L = 1 mm.
[0032] In another specific embodiment, the bottom diameters of the conical parts of multiple conical cylinder cavity sub-divisions increase sequentially in the direction from the cone head close to the hemostatic valve 2 to the cone head far from the hemostatic valve 2.
[0033] In another specific embodiment, the cavity 22 is composed of at least one conical cavity sub-division, and the central axes of the conical cavity sub-division, the hemostatic valve 2 and the sheath seat main body 1 are collinear. When the cavity 22 is composed of 2 conical cavity sub-divisions, the cone heads of the conical cavity sub-divisions face the force-receiving end, and the conical cavities are connected end to end. The total volume of the conical cavity sub-divisions does not exceed 48.6% of the volume of the hemostatic valve 2. In another specific embodiment, the bottom diameters of multiple conical cavity sub-divisions increase sequentially in the direction from the cone head close to the hemostatic valve 2 to the cone head far from the hemostatic valve 2.
[0034] In a specific embodiment, the hemostatic valve 2 is made of silicone. Silicone material has a very dense structure, which can effectively prevent the penetration of external substances such as water, air and microorganisms, thus achieving a good sealing effect, that is, strong self-sealing property. At the same time, silicone is also a very soft material, which can maintain its elasticity and softness at different temperatures and environments. This enables the silicone material to flexibly adapt to various shapes and sizes of items. The silicone material also has good high-temperature resistance and can operate stably for a long time in a high-temperature environment. Materials with the same self-sealing and soft properties also include: Fluororubber (FKM): Fluororubber is a high-performance rubber with excellent self-sealing and chemical stability. It can be used for a long time in high-temperature, high-pressure and corrosive environments. Ethylene-propylene rubber (EPDM): EPDM is a synthetic rubber with good self-sealing and weather resistance. Butyl rubber (NBR): Butyl rubber is a general-purpose rubber with good oil resistance and heat resistance. The present application does not specifically limit the materials of the hemostatic valve 2 and the sheath seat body 1, as long as they meet the conditions such as high self-sealing, high softness, non-toxic and harmless, etc.
[0035] In a specific embodiment, the angle of the apex angle of the conical part of the hemostatic valve 2 is between 90° and 180°. The side surface of the obtuse cone is relatively gentle, without the sharp characteristics of the acute cone and is relatively stable.
[0036] The present application also provides a catheter sheath, which uses the sheath seat with the built-in hemostatic valve structure in the above specific embodiment.
[0037] Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application.
Claims
1. A sheath base with an internal hemostatic valve structure, characterized in that, It includes a sheath base body (1) and a hemostatic valve (2). The sheath base body (1) is provided with a receiving cavity (11) for receiving the hemostatic valve (2). A cavity (22) is provided in the central region of the hemostatic valve (2). A through diameter (21) is preset along the central axis direction of the sheath base body (1). An introducer or a sheath can penetrate through the hemostatic valve (2) along the through diameter (21). The hemostatic valve (2) can seal the sheath base in both the state of the introducer or the sheath being punctured and removed.
2. The sheath base with an internal hemostatic valve structure according to claim 1, characterized in that, The hemostatic valve (2) is a conical cylinder, which is composed of a conical part and a cylindrical part. The connection between the bottom surface of the conical part and the top surface of the cylindrical part is a continuous surface. One end of the bottom surface of the cylindrical part of the conical cylinder is the embedding end, and one end of the apex angle of the conical part of the conical cylinder is the stress end. The hemostatic valve (2) is embedded into the inner wall of the receiving cavity (11) of the sheath base body (1) through the embedding end.
3. The sheath base with an internal hemostatic valve structure according to claim 2, characterized in that, The inner wall of the sheath base body (1) is provided with a centrally symmetric first groove a and a positioning protrusion b. The embedding end of the hemostatic valve (2) is provided with a centrally symmetric positioning groove c and a first protrusion d. The first groove a and the first protrusion d are matched with each other, and the positioning protrusion b and the positioning groove c are matched with each other.
4. The sheath base with a built-in hemostatic valve structure according to claim 3, characterized in that, The cavity (22) is composed of at least one cavity branch. The cavity branch, the hemostatic valve (2) and the central axis of the sheath base body (1) are collinear.
5. The sheath base with an internal hemostatic valve structure according to claim 4, characterized in that The cavity branch is a conical cylinder, which is composed of a conical part cavity branch and a cylindrical part cavity branch. The connection between the bottom surface of the conical part cavity branch and the top surface of the cylindrical part cavity branch is a continuous surface.
6. The sheath base with a built-in hemostatic valve structure according to claim 4, characterized in that, The cavity (22) is composed of at least 2 conical cylinder cavity branches. The cone heads of the conical cylinder cavity branches face the stress end, and the conical cylinder cavity branches are connected end to end.
7. The sheath base with a built-in hemostatic valve structure according to claim 1, characterized in that, The volume of the cavity (22) does not exceed 48.6% of the volume of the hemostatic valve (2).
8. The sheath base with an internal hemostatic valve structure according to claim 2, characterized in that, The angle of the apex angle of the conical part of the hemostatic valve (2) is between 90° and 180°.
9. A catheter sheath, characterized in that, The catheter sheath uses the sheath base with the built-in hemostatic valve structure as described in any one of claims 1 to 8.