Improved hydrophilic coating guide sheath
By introducing a locking structure between the sheath core seat and the sheath tube seat and an inflatable balloon design in the guide sheath, the problem of axial movement between the sheath core and the sheath tube is solved, achieving a highly efficient seal of the guide sheath, which is suitable for preventing blood backflow in vascular interventional surgery.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2026-03-05
- Publication Date
- 2026-04-03
AI Technical Summary
Existing hydrophilic coated guide sheaths exhibit axial movement between the sheath core and the sheath tube, affecting sealing reliability.
An improved hydrophilic coating guide sheath was designed. By setting a locking structure between the sheath core seat and the sheath tube seat, and setting an inflatable air bladder at the proximal end of the sheath tube, the synergistic effect of axial locking and radial sealing is used to prevent axial movement of the sheath core within the sheath tube and to form a tight radial seal between the sheath core and the sheath tube.
It significantly improves the sealing reliability of the guide sheath, prevents blood backflow, ensures effective sealing of the instrument channel, and meets the needs of vascular interventional surgery.
Smart Images
Figure CN224070945U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of guidance sheath technology, and in particular to an improved hydrophilic coating guidance sheath. Background Technology
[0002] In interventional vascular procedures, guide sheaths are widely used as a key device to establish percutaneous access to the vascular system, facilitating the subsequent delivery of interventional devices such as stents to the target lesion site. An ideal guide sheath needs to effectively prevent blood backflow through the proximal end of the sheath.
[0003] Several solutions to blood reflux exist in the prior art. For example, the hydrophilic coating guide sheath disclosed in patent CN220213677U includes a sheath tube and a balloon disposed at the proximal end of the sheath tube. The idea behind this solution is that when the sheath core or other instruments are inserted into the instrument channel inside the sheath tube, a medium is injected into the balloon to inflate it, thereby radially gripping the sheath core and sealing the gap between the sheath core and the sheath tube to prevent blood from flowing out.
[0004] However, in actual clinical applications, axial movement between the sheath core and the sheath tube can adversely affect the sealing reliability between them. Utility Model Content
[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing an improved hydrophilic coating guide sheath that enhances sealing reliability.
[0006] To achieve the above objectives, this utility model provides the following technical solution:
[0007] An improved hydrophilic coated guiding sheath, comprising:
[0008] A sheath, wherein the proximal end of the sheath is provided with a sheath seat and at least one air bladder, the air bladder being connected between the sheath seat and the sheath;
[0009] The sheath core has a sheath core seat at its proximal end, and the sheath core is sequentially passed through the sheath tube seat, the air bladder, and the sheath tube, and the sheath core seat and the sheath tube seat are lockably connected;
[0010] Guide wire, the guide wire passing through the sheath core seat and the sheath core;
[0011] The airbag can be inflated after being filled with a filling medium and then tightly grips the sheath core.
[0012] In a preferred embodiment, the outer wall of the sheath core seat is provided with a buckle;
[0013] The inner wall of the sheath seat is provided with a first annular boss, a second annular boss and a notch. The first annular boss and the second annular boss are spaced apart along the axial direction of the sheath seat, and the notch is connected to the first annular boss.
[0014] When the sheath core seat is inserted into the sheath tube seat, the buckle enters between the first annular boss and the second annular boss through the notch. By rotating the sheath core seat, the buckle is displaced from the notch.
[0015] As a preferred embodiment, it also includes:
[0016] An interface is provided, which is connected between the sheath and the air bladder, and is in communication with the sheath and the sheath core.
[0017] In a preferred embodiment, each airbag is connected to a valve.
[0018] In a preferred embodiment, the number of airbags is two, and they are spaced apart along the axial direction of the sheath.
[0019] Compared with existing technologies, this technical solution has the following advantages:
[0020] The locking mechanism between the sheath core seat and the sheath tube seat effectively prevents axial movement of the sheath core within the sheath tube. After inserting this assembled guide sheath into the blood vessel, the inflated balloon creates a radial seal between the sheath core and the proximal end of the sheath tube, preventing blood from flowing backward through the instrument channel inside the sheath tube to the proximal end outside the body. This design significantly improves the reliability of the seal through the synergistic effect of axial locking to prevent movement and radial pressure sealing. Attached Figure Description
[0021] Figure 1 This is a schematic diagram of the structure of the improved hydrophilic coating guide sheath described in this utility model;
[0022] Figure 2 This is a schematic diagram of the sheath core of the present invention;
[0023] Figure 3 This is a schematic diagram of the guidewire described in this utility model;
[0024] Figure 4 This is a schematic diagram of the structure of the sheath seat described in this utility model;
[0025] Figure 5 This is a schematic diagram of the structure of the sheath core seat described in this utility model;
[0026] Figure 6 This is a schematic diagram showing the usage state of the improved hydrophilic coating guide sheath described in this utility model.
[0027] In the diagram: 100 sheath, 110 sheath seat, 111 first annular protrusion, 112 second annular protrusion, 113 notch, 120 airbag, 200 sheath core, 210 sheath core seat, 211 buckle, 300 guidewire, 400 interface, 500 valve, 600 syringe, 700 blood vessel. Detailed Implementation
[0028] The following description is intended to disclose the present invention so that those skilled in the art can implement it. The preferred embodiments described below are merely examples, and other obvious variations will occur to those skilled in the art. The basic principles of the present invention defined in the following description can be applied to other embodiments, modifications, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the present invention.
[0029] Please refer to Figures 1 to 3 An embodiment of this utility model provides an improved hydrophilic coated guiding sheath, comprising:
[0030] The sheath 100 has a sheath seat 110 and at least one air bladder 120 at its proximal end, the air bladder 120 being connected between the sheath seat 110 and the sheath 100.
[0031] The sheath core 200 has a sheath core seat 210 at its proximal end. The sheath core 200 is sequentially connected to the sheath tube seat 110, the air bladder 120, and the sheath tube 100. The sheath core seat 210 is lockably connected to the sheath tube seat 110.
[0032] Guide wire 300, the guide wire 300 passing through the sheath core seat 210 and the sheath core 200;
[0033] The airbag 120 can be injected with a filling medium, expand, and hold the sheath core 200 tightly.
[0034] During assembly, the distal end of the sheath core 200 is sequentially inserted through the sheath tube seat 110, the air bladder 120, and the sheath tube 100. The locking of the sheath core seat 210 with the sheath tube seat 110 effectively prevents axial movement of the sheath core 200 within the sheath tube 100. Subsequently, a filling medium is injected into the air bladder 120, causing it to expand radially. The expanded air bladder 120 then circumferentially grips the outer wall of the sheath core 200, forming a tight radial seal.
[0035] The distal end of the sheath 100 is used for insertion into a blood vessel, while the proximal end of the sheath 100 is located outside the body.
[0036] When this assembled guide sheath is inserted into a blood vessel, the inflated balloon 120 forms a radial seal between the proximal end of the sheath 100 and the sheath core 200, preventing blood from flowing backward through the instrument channel inside the sheath 100 to the proximal end outside the body. This design significantly improves the reliability of the seal through the synergistic effect of axial locking to prevent movement and radial pressure sealing.
[0037] like Figure 1 As shown, the sheath 100 is a hollow cylindrical tube, and its wall can be made of a multi-layer composite material structure. For example, the base layer can be made of polyamide elastomer or polyurethane to provide good flexibility, and embedded with stainless steel wire or flat steel wire for braiding reinforcement to give it support.
[0038] The outer surface of the sheath 100 is coated with a hydrophilic coating, which can be made of biocompatible polymer materials such as polyvinylpyrrolidone, polyacrylamide or their copolymers. When in contact with water or saline, the coating becomes extremely smooth, effectively reducing the resistance when the sheath 100 enters the blood vessel.
[0039] like Figure 1 As shown, the air bladder 120 expands into a ring shape after being injected with a filling medium (such as physiological saline) and tightly surrounds and hugs the outer wall of the sheath core 200. The air bladder 120 is preferably made of highly elastic medical-grade silicone or thermoplastic polyurethane. Its two ends are sealed to the sheath tube 100 and the sheath tube seat 110 respectively by medical-grade adhesive or heat fusion.
[0040] Each of the airbags 120 is connected to a valve 500 via a conduit. The valve 500 is preferably a diaphragm valve with a self-sealing function, such as a common Luer lock connector diaphragm or a silicone diaphragm sealing plug that can be punctured by a syringe needle.
[0041] The diaphragm of valve 500 remains sealed under its natural state. When it is necessary to inject a filling medium (such as saline) into the air bladder 120, refer to... Figure 6 The operator uses a syringe 600 with the needle removed, screwing it into or pressing it onto the Luer connector of the valve 500, thereby opening the diaphragm and establishing a passage. After injection, the syringe is withdrawn, and the diaphragm of the valve 500 automatically resets due to its own elasticity, resealing the pipeline to prevent backflow or leakage of the filling medium, thus maintaining the inflation state and sealing pressure of the air bladder 120. (Reference) Figure 1 The number of airbags 120 is two, and they are spaced apart along the axial direction of the sheath tube 100. By increasing the number of airbags 120, the ability to fix the sheath core 200 is improved.
[0042] like Figure 1 As shown, the sheath seat 110 is typically an annular rigid plastic component, which can be injection molded from materials such as polycarbonate.
[0043] like Figure 2 As shown, the sheath core 200 has a sheath core seat 210 at its proximal end. The sheath core 200 can be made of a flexible medical polymer material, such as polycarbonate or polypropylene. The sheath core seat 210 is typically made of rigid plastic injection molding, such as polycarbonate or medical-grade ABS, to facilitate the fabrication of a locking structure. The sheath core seat 210 and the sheath core 200 are typically bonded together using medical-grade adhesives or thermoforming welding to achieve a strong and sealed connection.
[0044] In a preferred embodiment, the sheath core seat 210 has a columnar structure, and its outer diameter is adapted to the inner cavity of the sheath tube seat 110, so that it can be inserted into the sheath tube seat 110 and locked and unlocked.
[0045] Specifically, refer to Figure 4 and Figure 5 The outer wall of the sheath core seat 210 is provided with a buckle 211;
[0046] The inner wall of the sheath seat 110 is provided with a first annular boss 111, a second annular boss 112 and a notch 113. The first annular boss 111 and the second annular boss 112 are spaced apart along the axial direction of the sheath seat 110, and the notch 113 is connected to the first annular boss 111.
[0047] When the sheath core seat 210 is inserted into the sheath tube seat 110, the buckle 211 enters between the first annular boss 111 and the second annular boss 112 through the notch 113. By rotating the sheath core seat 210, the buckle 211 is displaced from the notch 113.
[0048] Due to the axial limiting effect of the first annular boss 111 and the second annular boss 112, the sheath core seat 210 is reliably locked inside the sheath tube seat 110 and cannot be accidentally dislodged, effectively preventing axial movement of the sheath core during operation. To unlock, rotate the sheath core seat 210 in the opposite direction so that the latch 211 is realigned with the notch 113, and it can be pulled out axially.
[0049] refer to Figure 2 The sheath core seat 210 is partially inserted into the sheath tube seat 110, while its proximal portion is exposed outside the sheath tube seat 110, making it easy for the operator to hold and rotate.
[0050] To visually indicate the correct locking and unlocking directions and avoid misoperation, directional indicator icons can be added to the outer wall of the exposed portion of the sheath core seat 210 and the corresponding outer wall of the sheath tube seat 110. For example, an arrow mark can be set on the sheath core seat 210, and locking and unlocking image icons and corresponding directional indicator symbols can be set on the sheath tube seat 110.
[0051] When the operator needs to lock the sheath core, simply rotate the sheath core seat 210 so that the arrow on it aligns with the locking image mark on the sheath tube seat 110. This ensures that the internal latch 211 is misaligned with the notch 113, achieving a reliable lock. Conversely, when it is necessary to unlock and remove the sheath core assembly, simply rotate the arrow to the unlocking image mark.
[0052] like Figure 1 As shown, the improved hydrophilic coating guide sheath further includes:
[0053] Interface 400, preferably a three-way valve, is connected between the sheath 100 and the airbag 120, and the interface 400 communicates with the sheath 100 and the sheath core 200.
[0054] Because the interface 400 is located on the side of the balloon 120 facing the distal end of the sheath 100 and communicates with the sheath 100 and the sheath core 200, when the distal end of the sheath 100 is inserted into an artery, pressurized arterial blood will rush from the distal opening of the sheath 100 into the annular gap between the inner wall of the sheath 100 and the outer wall of the sheath core 200. At this time, the proximal end of the sheath 100 is sealed by the inflated balloon 120, and the sheath core seat 210 and the sheath seat 110 are locked, so blood cannot leak from the proximal end. Thus, arterial blood will flow along the annular gap inside the sheath 100 and eventually flow out through the interface 400. Therefore, by opening the interface 400 and observing blood flowing out of the interface 400, it can be confirmed that the distal end of the sheath 100 has accurately entered the target artery.
[0055] Both the sheath core 200 and the sheath core seat 210 are provided with through hollow channels, allowing the guide wire 300 to pass smoothly through the sheath core 200 and the sheath core seat 210.
[0056] It should be noted that, since the sheath core 200 itself is made of a flexible polymer material with a certain degree of elasticity, it will undergo slight compression deformation under the radial pressure of the air bladder 120. Even if the distal end of the sheath tube 100 is under arterial high pressure, blood cannot flow back from the inside of the sheath core 200.
[0057] like Figure 3 As shown, the guidewire 300 is typically made of a metallic material with good shape memory and flexibility, such as nickel-titanium alloy or stainless steel. The distal end of the guidewire 300 is pre-shaped into a flexible J-shaped tip, a design that helps to bypass branch openings during intravascular navigation.
[0058] The improved hydrophilic coating guide sheath is used as follows:
[0059] S100: The distal end of the sheath core assembly is sequentially passed through the sheath seat 110 and the air bladder 120, ultimately placing the sheath core 200 into the inner cavity of the sheath tube 100. The sheath core seat 210 is rotated to lock it with the sheath seat 110, thereby preventing axial movement of the sheath core 200. Subsequently, a filling medium such as physiological saline is injected into the air bladder 120 through a syringe, causing it to expand and radially tighten around the sheath core 200, forming a seal at the proximal end of the sheath tube.
[0060] S200: Puncture the assembled guide sheath as a whole, and insert the distal end of the sheath 100 into the blood vessel 700. At this time, the sheath seat 110, the balloon 120, the interface 400, and the sheath core seat 210 are all located outside the body. Open the interface 400; if blood is observed flowing out, it can be confirmed that the distal end of the sheath 100 has successfully entered the arterial vessel. After confirming the vessel location, close the interface 400.
[0061] S300: After confirming the location of the blood vessel, insert the distal end of the guidewire 300 into the sheath core seat 210, allowing it to pass through the channel inside the sheath core 200 and extend from the distal end of the sheath tube 100 into the blood vessel. The guidewire 300 is usually made of a metal with good rigidity (such as stainless steel or nickel-titanium alloy), whose rigidity is much greater than that of the flexible material sheath core 200. Therefore, the guidewire 300 can overcome the clamping force of the balloon 120 on the sheath core 200, smoothly pass through the internal channel of the sheath core 200 deformed by pressure, and extend from the distal end of the sheath tube 100 into the deep part of the blood vessel.
[0062] S400: Unlock the sheath core seat 210 from the sheath tube seat 110, and then pull the sheath core 200 and sheath core seat 210 out of the sheath tube 100 along the guide wire 300. At this time, the guide wire 300 remains inside the sheath tube 100 and in the blood vessel.
[0063] After completing the above steps, other interventional devices such as stents can be delivered to the target lesion site through the channel established by the indwelling guidewire 300 and the sheath 100 for treatment.
[0064] The embodiments described above are only used to illustrate the technical ideas and features of this utility model. Their purpose is to enable those skilled in the art to understand the content of this utility model and implement it accordingly. The scope of patent application of this utility model should not be limited by these embodiments. That is, any equivalent changes or modifications made in accordance with the spirit disclosed in this utility model still fall within the patent scope of this utility model.
Claims
1. An improved hydrophilic coated introducer sheath characterized in that, The application relates to a sheath device, which comprises: a sheath (100), the proximal end of which is provided with a sheath seat (110) and at least one air bag (120) connected between the sheath seat (110) and the sheath (100); a sheath core (200), the proximal end of which is provided with a sheath core seat (210), the sheath core (200) is sequentially arranged in the sheath seat (110), the air bag (120) and the sheath (100), and the sheath core seat (210) is lockably connected with the sheath seat (110); a guide wire (300), which is arranged in the sheath core seat (210) and the sheath core (200); the air bag (120) can be inflated and tightly wrapped around the sheath core (200) after being filled with a filling medium.
2. The modified hydrophilically coated introducer sheath of claim 1, wherein, The outer wall of the sheath core seat (210) is provided with a buckle (211); the inner wall of the sheath seat (110) is provided with a first annular boss (111), a second annular boss (112) and a gap (113), the first annular boss (111) and the second annular boss (112) are arranged along the axial direction of the sheath seat (110) and are spaced apart from each other, and the gap (113) is connected with the first annular boss (111); when the sheath core seat (210) is inserted into the sheath seat (110), the buckle (211) enters the space between the first annular boss (111) and the second annular boss (112) through the gap (113), and the buckle (211) is disengaged from the gap (113) by rotating the sheath core seat (210).
3. The modified hydrophilically coated introducer sheath of claim 1, wherein, The application further comprises: an interface (400), which is connected between the sheath (100) and the air bag (120) and is in communication with the sheath (100) and the sheath core (200).
4. The modified hydrophilically coated introducer sheath of claim 3, wherein, Each air bag (120) is connected with a valve (500).
5. The modified hydrophilically coated introducer sheath of claim 4, wherein, The number of the air bags (120) is two, and the air bags (120) are arranged along the axial direction of the sheath (100) and are spaced apart from each other.