Catheter sheath set
By combining the inner and outer capsules, and using gas or liquid to regulate the pressure, the sealing and friction issues of the catheter sheath hemostatic valve when adapted to different instruments are solved, achieving stable sealing and low friction, and reducing the difficulty of surgery.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SHANGHAI ENDOVAS MEDICAL TECH CO LTD
- Filing Date
- 2023-07-11
- Publication Date
- 2026-05-19
AI Technical Summary
The hemostatic valves used on existing catheter sheaths have insufficient sealing and high friction when adapted to instruments of different sizes and shapes, increasing the difficulty of the operation.
The structure consists of an inner and an outer capsule. The pressure of the regulating chamber is adjusted by gas or liquid, so that the inner capsule can fit or expand when different instruments pass through, achieving stable sealing and low friction.
It achieves good sealing and low friction for instruments of different sizes and shapes, reduces surgical difficulty, and improves the applicability and ease of operation of the catheter sheath.
Smart Images

Figure CN116899082B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the technical field of medical devices, specifically to a catheter sheath assembly. Background Technology
[0002] As an auxiliary guiding device in peripheral and intracardiac minimally invasive interventional procedures, catheter sheaths play a crucial role in percutaneous coronary intervention, percutaneous interventional closure, and atrial septal puncture. They establish a connection between the body's blood vessels and the external environment, assisting in the delivery system to transport diagnostic or therapeutic instruments to the target lesion site. A hemostatic valve is an essential component of the catheter sheath during use, typically installed proximally to prevent blood loss, reduce bleeding, prevent air from entering the blood vessel and forming a thrombus, and minimize patient complications.
[0003] Currently, the hemostatic valves used on existing catheter sheaths have significant deficiencies in maintaining a tight seal when adapted to instruments of different sizes and shapes. Furthermore, the passage of surgical instruments or delivery devices through the hemostatic valve generates high friction, increasing the difficulty of the surgery.
[0004] Therefore, a new type of catheter sheath assembly is needed that can be used with instruments of various sizes and shapes, maintain good sealing during use to achieve excellent hemostasis, and reduce friction between the instrument and the hemostatic valve, thereby reducing the difficulty of the operation. Summary of the Invention
[0005] In view of this, the embodiments of this specification provide a catheter sheath assembly that is applicable to instruments of various sizes and shapes, and can maintain good sealing during use to achieve excellent hemostasis. At the same time, it can also reduce the friction between the instrument and the hemostatic valve, thereby reducing the difficulty of the operation.
[0006] The embodiments in this specification provide the following technical solutions:
[0007] This specification provides an embodiment of a catheter sheath assembly, including a balloon, a first valve body, a drain valve, a catheter sheath, and a dilator;
[0008] The cyst includes an inner cyst and an outer cyst, the inner cyst being disposed inside the outer cyst, and the outer side of the inner cyst and the inner side of the outer cyst forming a closed adjustment cavity.
[0009] The first valve body is connected to the distal end of the bladder body and includes a first channel and a second channel;
[0010] The first channel is connected to the interior of the regulating cavity and is used to deliver gas or liquid into the interior of the regulating cavity;
[0011] The vent valve and the catheter sheath are connected sequentially to the end of the first valve body away from the outer capsule;
[0012] The dilator is inserted from the proximal end of the inner capsule, passes sequentially through the internal channel of the inner capsule, the second channel, the internal channel of the emptying valve, and the internal channel of the catheter sheath, and exits from the distal end of the catheter sheath.
[0013] When gas or liquid enters the regulating chamber, it compresses the inner bladder, causing the internal channel of the inner bladder to contract and adhere to the surface of the expander, thereby closing the internal channel of the inner bladder.
[0014] The above technical solution involves a capsule consisting of an inner and an outer capsule. When hemostasis is required during the operation of dilators or other instruments, gas or liquid is introduced into the regulating chamber, causing the inner capsule to contract until its internal channel adheres to the surface of the dilator or other instrument. This forms a closure and achieves hemostasis. Because the pressure provided by the gas and liquid is relatively stable, the closure remains stable during hemostasis, maintaining good sealing and restricting blood flow. Furthermore, when instruments or dilators of different sizes or types need to pass through the internal channel of the inner capsule, the gas or liquid in the regulating chamber is withdrawn, creating a negative pressure state within the chamber. This causes the inner capsule to expand outward. The expanded internal channel of the inner capsule provides excellent passage for instruments or dilators of different sizes and types, without excessive contact or high friction during passage, thus effectively reducing surgical difficulty.
[0015] Preferably, the first valve body includes a lower cover structure and a side connection portion, the proximal end of the lower cover structure is connected to the distal end of the bladder body, and the side connection portion is vertically disposed on the side of the lower cover structure;
[0016] The second channel penetrates the lower cover structure along the distribution direction of the proximal and distal ends of the capsule;
[0017] The first channel is located at the side connection part, the axial direction of the first channel is perpendicular to the axial direction of the second channel, and the first channel and the second channel are connected.
[0018] Preferably, the distal ends of both the outer and inner capsules extend into and connect to the proximal end of the second channel, and the internal channel of the inner capsule communicates with the second channel;
[0019] The outer capsule has a connecting port on its distal side, and the first channel is connected to the interior of the adjustment cavity through the connecting port.
[0020] Preferably, the vent valve includes a vent connection and a conduit seat;
[0021] The proximal end of the catheter seat is connected to the distal end of the lower cover structure;
[0022] The catheter seat is provided with a connecting channel, the proximal end of the connecting channel is connected to the distal end of the second channel, and the axial direction of the connecting channel coincides with the axial direction of the second channel;
[0023] The venting connection is vertically disposed on the side of the conduit seat, and a venting channel is provided on the venting connection, which is connected to the connecting channel.
[0024] Preferably, the proximal end of the catheter sheath is detachably connected to the distal end of the catheter seat.
[0025] Preferably, the proximal end of the catheter sheath is threadedly connected to the distal end of the catheter seat.
[0026] Preferably, the proximal end of the capsule is provided with a top cover structure, and the top cover structure is provided with a first turn structure;
[0027] The expander is fixed to an expander tube seat at its proximal end, and the expander tube seat is provided with a second turn structure for cooperating with the first turn structure;
[0028] The expander achieves a detachable connection relative to the upper cover structure through the cooperation of the first turn structure and the second turn structure.
[0029] Preferably, both the first turn structure and the second turn structure are male-female or female-female buckles.
[0030] Preferably, the outer capsule is rigid, and when the outer capsule is pressed by an external force, it can deform and compress the inner capsule.
[0031] Preferably, the distal end of the dilator is provided with a side hole, and the surface of the dilator and / or the surface of the catheter sheath are provided with graduations.
[0032] Compared with the prior art, the beneficial effects that at least one technical solution adopted in the embodiments of this specification can achieve include at least:
[0033] 1. By setting up a sac, which consists of an inner sac and an outer sac, when hemostasis is required during the operation of the dilator or other instruments, gas or liquid is introduced into the regulating cavity, causing the inner sac to contract until the internal channel of the inner sac fits against the surface of the dilator or other instruments. At this time, a closure can be formed and hemostasis can be completed. Since the pressure provided by the gas and liquid is relatively stable, the closure can remain stable during the hemostasis process to maintain good sealing and restrict blood flow.
[0034] 2. When other instruments or dilators of different sizes and types need to pass through the internal channel of the inner capsule, by removing the gas or liquid in the regulating cavity, the regulating cavity can be made into a negative pressure state, allowing the inner capsule to expand outward. After the internal channel of the inner capsule expands, it has good passability, allowing instruments or dilators of different sizes and types to pass through. Moreover, during the passage, there will be no excessive contact with the instruments or dilators and no high friction, thus effectively reducing the difficulty of the operation. Attached Figure Description
[0035] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0036] Figure 1 This is a schematic diagram of the overall structure of a catheter sheath assembly according to this application;
[0037] Figure 2 This is a schematic diagram of the internal capsule structure in this application;
[0038] Figure 3 This is a schematic diagram of the structure of the external capsule in this application;
[0039] Figure 4 This is a schematic diagram of the internal capsule structure in other embodiments of this application;
[0040] Figure 5 This is a schematic diagram of the structure of the first valve body in this application;
[0041] Figure 6 This is a schematic diagram of the structure of the vent valve in this application;
[0042] Figure 7 This is a schematic diagram of the structure of the catheter sheath in this application;
[0043] Figure 8 This is a schematic diagram of the expander in this application;
[0044] Figure 9 This is a schematic diagram of the expander tube seat in this application.
[0045] Reference numerals: 1. Capsule body; 101. Inner capsule; 102. Outer capsule; 103. Connecting port; 2. First valve body; 201. Lower cover structure; 202. Side connection part; 203. First channel; 204. Second channel; 3. Drain valve; 301. Drain connection part; 302. Catheter seat; 303. Connecting channel; 304. Drain channel; 4. Catheter sheath; 5. Dilator; 6. Dilator seat; 7. Upper cover structure; 8. Side hole. Detailed Implementation
[0046] The embodiments of this application will now be described in detail with reference to the accompanying drawings.
[0047] The following specific examples illustrate the implementation of this application. Those skilled in the art can easily understand other advantages and effects of this application from the content disclosed in this specification. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. This application can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of this application. It should be noted that, in the absence of conflict, the following embodiments and features in the embodiments can be combined with each other. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.
[0048] It should be noted that various aspects of embodiments within the scope of the appended claims are described below. It will be apparent that the aspects described herein can be embodied in a wide variety of forms, and any particular structure and / or function described herein is merely illustrative. Based on this application, those skilled in the art will understand that one aspect described herein can be implemented independently of any other aspect, and two or more of these aspects can be combined in various ways. For example, any number and aspects set forth herein can be used to implement the device and / or practice the method. Additionally, this device and / or method can be implemented using structures and / or functionalities other than one or more of the aspects set forth herein.
[0049] It should also be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of this application. The drawings only show the components related to this application and are not drawn according to the actual number, shape and size of the components in the actual implementation. In the actual implementation, the form, quantity and proportion of each component can be arbitrarily changed, and the layout of the components may also be more complex.
[0050] Additionally, specific details are provided in the following description to facilitate a thorough understanding of the examples. However, those skilled in the art will understand that practice can be carried out without these specific details.
[0051] like Figure 1 As shown in the figure, this specification provides a catheter sheath assembly, including a capsule 1, a first valve body 2, a drain valve 3, a catheter sheath 4, and a dilator 5.
[0052] The capsule 1, the first valve body 2, the drain valve 3, and the catheter sheath 4 are arranged sequentially on the same axis.
[0053] like Figures 1 to 3 As shown, the capsule 1 includes an inner capsule 101 and an outer capsule 102. Both the outer capsule 102 and the inner capsule 101 are straight tube structures. The inner capsule 101 is coaxially fixed inside the outer capsule 102, and a closed adjustment cavity is formed between the outer side of the inner capsule 101 and the inner side of the outer capsule 102.
[0054] In some other embodiments, such as Figure 4 As shown, the inner bladder 101 can also be a male and female valve tubular structure with both ends protruding radially outward and the middle section recessed radially inward.
[0055] like Figure 2 and Figure 3 As shown, the inner capsule 101 is made of an elastic material, specifically silicone. The outer capsule 102 is made of a polymer material and has a certain degree of rigidity. In actual application, when the regulating cavity is under positive pressure, the internal channel of the inner capsule 101 will undergo elastic deformation, contracting radially inward. When the regulating cavity is under negative pressure, the internal channel of the inner capsule 101 will undergo elastic deformation, expanding radially outward. The outer capsule 102 does not undergo significant deformation when the regulating cavity is under positive or negative pressure, but when subjected to external force, such as manual pressure by an operator, it can undergo significant deformation and compress the inner capsule 101.
[0056] like Figure 1 and Figure 5 As shown, the first valve body 2 is connected to the distal end of the bladder body 1, and includes a first channel 203 and a second channel 204.
[0057] The first channel 203 is connected to the interior of the regulating cavity and is used to deliver gas or liquid into the interior of the regulating cavity.
[0058] The internal channels of the inner capsule 101, the second channel 204, the internal channel of the vent valve 3, and the internal channel of the catheter sheath 4 are arranged sequentially along the same axis. The dilator 5 is inserted from the proximal end of the inner capsule 101, passes sequentially through the internal channels of the inner capsule 101, the second channel 204, the internal channel of the vent valve 3, and the internal channel of the catheter sheath 4, and exits from the distal end of the catheter sheath 4.
[0059] Specifically, the first valve body 2 includes a lower cover structure 201 and a side connection portion 202.
[0060] The lower cover structure 201 is a cylindrical structure, and the side connecting part 202 is a stepped cylindrical structure. The proximal end of the lower cover structure 201 is connected to the distal end of the capsule 1, and the side connecting part 202 is vertically arranged on the side of the lower cover structure 201.
[0061] The second channel 204 extends through the lower cover structure 201 along the distribution direction of the proximal and distal ends of the capsule 1. That is, the axial direction of the second channel 204 coincides with the axial direction of the internal channel of the inner capsule 101, and the second channel 204 extends through both ends of the lower cover structure 201 along the axial direction.
[0062] The first channel 203 is opened in the side connection part 202. The axial direction of the first channel 203 is perpendicular to the axial direction of the second channel 204, and the first channel 203 and the second channel 204 are connected.
[0063] The distal ends of both the outer capsule 102 and the inner capsule 101 extend into and connect to the proximal end of the second channel 204, and the internal channel of the inner capsule 101 communicates with the second channel 204. The outer side of the outer capsule 102 and the inner side of the second channel 204 can be connected by any of the following fixing methods: interference fit, ultrasonic welding, or bonding.
[0064] A connecting port 103 is provided on the distal side of the outer capsule 102, through which the first channel 203 communicates with the interior of the regulating cavity. In practical applications, gas or liquid is introduced and discharged into the regulating cavity via the first channel 203 and the connecting port 103, resulting in a positive pressure state and a negative pressure state respectively. When the regulating cavity is under positive pressure, the gas or liquid compresses the inner capsule 101, causing its internal channel to contract and adhere to the surface of the dilator 5, forming a closure that closes the internal channel of the inner capsule 101, thus achieving hemostasis. When the regulating cavity is under negative pressure, the internal channel of the inner capsule 101 expands radially outward, allowing the dilator 5 to contact the internal channel of the inner capsule 101, reducing friction and facilitating easy insertion of the dilator 5 into the internal channel of the inner capsule 101.
[0065] It should be noted that in practical applications, the internal channels of the capsule 1, the first valve body 2, the vent valve 3, and the catheter sheath 4 are not only for the insertion of the dilator 5, but can also be used as guides for other delivery devices, diagnostic instruments, and surgical instruments. When delivery devices, diagnostic instruments, and outer shell instruments of different shapes and sizes are inserted, the gas or liquid in the regulating cavity can be withdrawn to create a negative pressure state, increasing the diameter of the internal channel of the inner capsule 101. This reduces the contact between the internal channel of the inner capsule 101 and the delivery device, diagnostic instrument, and outer shell instrument, thereby reducing friction during insertion, improving compatibility with different instruments, and reducing the difficulty of surgical procedures. When hemostasis is required, gas or liquid is introduced into the regulating cavity, causing the gas or liquid to compress the inner capsule 101, resulting in the internal channel of the inner capsule 101 contracting and adhering to the external surface of the dilator 5, delivery device, diagnostic instrument, or outer shell instrument, forming a closed portion, thereby achieving hemostasis.
[0066] Furthermore, the operator can press the outer capsule 102 with their hands to deform the outer capsule 102 and squeeze the inner capsule 101, thereby achieving a better hemostatic effect.
[0067] like Figure 1 and Figure 6 As shown, the vent valve 3 includes a vent connection part 301 and a conduit seat 302. Both the vent connection part 301 and the conduit seat 302 are stepped circular tube structures and are made of nylon or ABS material.
[0068] The proximal end of the catheter seat 302 is connected to the distal end of the lower cover structure 201, and the connection between the proximal end of the catheter seat 302 and the distal end of the lower cover structure 201 is an interference fit.
[0069] The catheter seat 302 is provided with a connecting channel 303, the proximal end of the connecting channel 303 is connected to the distal end of the second channel 204, and the axial direction of the connecting channel 303 coincides with the axial direction of the second channel 204.
[0070] The venting connection 301 is vertically disposed on the side of the catheter seat 302, and the venting connection 301 has a venting channel 304, which is connected to the connecting channel 303. In practical applications, gas and liquid can be drawn back from the catheter sheath 4 through the venting channel 304 and the connecting channel 303.
[0071] like Figure 1 , Figure 6 and Figure 7 As shown, the proximal end of the catheter sheath 4 and the distal end of the catheter seat 302 are detachably connected.
[0072] Furthermore, the proximal end of the catheter sheath 4 is threadedly connected to the distal end of the catheter seat 302. Specifically, the distal end of the connecting channel 303 is provided with internal threads, and the proximal end of the catheter sheath 4 is provided with external threads.
[0073] In some other embodiments, the proximal end of the catheter sheath 4 and the distal end of the catheter seat 302 can also be connected by a male-female or female-female fastener.
[0074] like Figure 1 , Figure 8 and Figure 9 As shown, a top cover structure 7 is fixedly connected to the proximal end of the capsule 1. The connection between the capsule 1 and the top cover structure 7 can be any one of interference fit, ultrasonic welding, or bonding.
[0075] The upper cover structure 7 has a first turn structure at the end away from the bladder body 1.
[0076] The expander 5 is fixed to the proximal end with an expander tube seat 6. Specifically, the inner ring of the expander tube seat 6 is provided with several interference fit buckles, which are engaged with the outer ring of the expander 5 to achieve an interference connection between the expander 5 and the expander tube seat 6.
[0077] The expander tube seat 6 is provided with a second turn structure for mates with the first turn structure. Both the first and second turn structures are either male-female or female-female snap fasteners. In this embodiment, both the first and second turn structures are female-female snap fasteners.
[0078] In practical applications, the expander 5 achieves a detachable connection relative to the upper cover structure 7 through the cooperation of the first turn structure and the second turn structure.
[0079] Specifically, after the dilator 5 passes sequentially through the internal channel of the inner capsule 101, the second channel 204, the internal channel of the vent valve 3, and the internal channel of the catheter sheath 4, and exits from the distal end of the catheter sheath 4, rotating the dilator 5 causes the dilator seat 6 to rotate, causing the first turn structure and the second turn structure to rotate and lock together, thereby achieving rapid locking and release of the dilator 5. Simultaneously, other instruments, such as delivery devices, can also be equipped with turn structures that cooperate with the first turn structure to achieve rapid locking and release. This ensures that each component can move independently without interfering with each other.
[0080] like Figure 1 and Figure 8 As shown, the distal end of the dilator 5 is also provided with a side hole 8, and the surface of the dilator 5 and / or the surface of the catheter sheath 4 are provided with graduations (not shown in the figure). Blood flow can be observed through the side hole 8, and the relative position between the dilator 5 and the catheter sheath 4 can be determined by observing the graduations, thus determining the distance the catheter sheath 4 has entered the blood vessel.
[0081] The various embodiments in this specification are described in a progressive manner. The same or similar parts between the various embodiments can be referred to each other. Each embodiment focuses on describing the differences from other embodiments.
[0082] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.
Claims
1. A catheter sheath assembly, characterized in that, Includes a capsule, a first valve body, a drain valve, a catheter sheath, and a dilator; The cyst includes an inner cyst and an outer cyst, the inner cyst being disposed inside the outer cyst, and the outer side of the inner cyst and the inner side of the outer cyst forming a closed adjustment cavity. The first valve body is connected to the distal end of the bladder body and includes a first channel and a second channel; The first channel is connected to the interior of the regulating cavity and is used to deliver gas or liquid into the interior of the regulating cavity; The vent valve and the catheter sheath are connected sequentially to the end of the first valve body away from the outer capsule; The dilator is inserted from the proximal end of the inner capsule, passes sequentially through the internal channel of the inner capsule, the second channel, the internal channel of the emptying valve, and the internal channel of the catheter sheath, and exits from the distal end of the catheter sheath. When gas or liquid enters the regulating chamber, it squeezes the inner bladder, causing the internal channel of the inner bladder to contract and adhere to the surface of the expander, thereby closing the internal channel of the inner bladder. The outer capsule is rigid, and it can deform and compress the inner capsule when pressed by an external force.
2. The catheter sheath assembly according to claim 1, characterized in that, The first valve body includes a lower cover structure and a side connection portion. The proximal end of the lower cover structure is connected to the distal end of the bladder body, and the side connection portion is vertically disposed on the side of the lower cover structure. The second channel penetrates the lower cover structure along the distribution direction of the proximal and distal ends of the capsule; The first channel is located at the side connection part, the axial direction of the first channel is perpendicular to the axial direction of the second channel, and the first channel and the second channel are connected.
3. The catheter sheath assembly according to claim 2, characterized in that, The distal ends of both the outer and inner capsules extend into and connect to the proximal end of the second channel, and the internal channel of the inner capsule communicates with the second channel. The outer capsule has a connecting port on its distal side, and the first channel is connected to the interior of the adjustment cavity through the connecting port.
4. The catheter sheath assembly according to claim 2, characterized in that, The vent valve includes a vent connection and a conduit seat; The proximal end of the catheter seat is connected to the distal end of the lower cover structure; The catheter seat is provided with a connecting channel, the proximal end of the connecting channel is connected to the distal end of the second channel, and the axial direction of the connecting channel coincides with the axial direction of the second channel; The venting connection is vertically disposed on the side of the conduit seat, and a venting channel is provided on the venting connection, which is connected to the connecting channel.
5. The catheter sheath assembly according to claim 4, characterized in that, The proximal end of the catheter sheath is detachably connected to the distal end of the catheter seat.
6. The catheter sheath assembly according to claim 5, characterized in that, The proximal end of the catheter sheath is threadedly connected to the distal end of the catheter seat.
7. The catheter sheath assembly according to claim 2, characterized in that, The proximal end of the capsule is provided with a top cover structure, and the top cover structure is provided with a first rotating structure; The expander is fixed to an expander tube seat at its proximal end, and the expander tube seat is provided with a second rotating structure for cooperating with the first rotating structure. The expander achieves a detachable connection relative to the upper cover structure through the cooperation of the first rotating structure and the second rotating structure.
8. The catheter sheath assembly according to claim 7, characterized in that, Both the first and second rotating structures are male-female or female-female buckles.
9. The catheter sheath assembly according to claim 1, characterized in that, The distal end of the dilator is provided with a side hole, and the surface of the dilator and / or the surface of the catheter sheath are provided with graduations.