Balloon catheter assembly

Abstract

The balloon catheter assembly comprises a balloon catheter and a three-way pipe, the balloon catheter comprises a catheter body and a sealing piece, the catheter body comprises an opening formed in the near end, the three-way pipe comprises a first port, a pressurizing port and a second port opposite to the first port, the opening is contained in the first port, the near end of the catheter body is connected with the first port in a sealed mode, and the pressurizing port is contained in the second port. The far end of the sealing piece is contained in the second port and is in sealing connection with the second port, the pressurizing port is connected with the pressurizer to pressurize the catheter, and the sealing piece is used for moving towards the opening after the catheter is pressurized, so that at least part of the sealing piece is inserted into the opening to seal the opening. The sealing element is arranged at the second port and the near-end opening of the catheter is arranged at the first port, so that after pressurization is completed, the sealing element moves towards the catheter and is inserted into the opening to seal the opening, pressure maintaining of the catheter is achieved, then the three-way pipe is pulled out from the catheter and the sealing element, and then the bronchoscope is pulled out. Operation is simple, and use is convenient.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a balloon catheter assembly. Background Technology

[0002] With rising incomes and changing dietary habits, various diseases have emerged, including bronchial-related diseases. Patients with bronchial-related diseases require examination to understand their condition. Current examination methods include inserting a bronchoscope into the affected bronchus. However, to prevent tracheal obstruction and suffocation caused by massive bleeding during bronchoscopy, a balloon catheter can be used during the procedure.

[0003] Existing balloon catheters are inserted into the target location through the bronchoscope's cavity. The catheter is then inflated to allow the balloon to expand and anchor within the bronchus, blocking any diseased or bleeding bronchus. The bronchoscope is then removed, and a pusher tube is used to advance the implanted medical device along the balloon catheter to the intended location. However, existing balloon catheters have several drawbacks. For example, after the balloon inflates and anchors within the bronchus, it is difficult to maintain pressure on the balloon, making detachment from the catheter challenging. This necessitates first depressurizing the balloon, then detaching the bronchoscope from the catheter and removing it from the body, followed by re-inflating the balloon catheter to re-anchor it within the bronchus. This process is cumbersome, inconvenient, and impacts surgical efficiency and safety. Utility Model Content

[0004] In order to overcome the above-mentioned technical problems, this utility model provides a balloon catheter assembly that can maintain pressure on the balloon and facilitate the detachment of the bronchoscope from the balloon catheter for removal from the human body.

[0005] Based on the above concept, the technical solution adopted by this utility model is as follows:

[0006] A balloon catheter assembly includes a balloon catheter and a three-way stopcock. The balloon catheter includes a conduit and a seal. The conduit includes an opening at its proximal end. The three-way stopcock includes a first port, an inflation port, and a second port opposite to the first port. The opening is received within the first port. The proximal end of the conduit is sealed to the first port. The distal end of the seal is received within and sealed to the second port. The inflation port is used to connect to an inflator to inflate the conduit. The seal is used to move toward the opening when the conduit is fully inflated, such that at least a portion of the seal is inserted into the opening to seal it.

[0007] Preferably, the tee includes a first sealing ring, which is disposed between the inner circumferential surface of the first port and the outer circumferential surface of the proximal end of the conduit.

[0008] Preferably, the tee pipe further includes a second sealing ring, which is disposed between the inner circumferential surface of the second port and the outer circumferential surface of the sealing element.

[0009] Preferably, the tee further includes a first sealing cap, which covers the first port and is threadedly connected thereto. The first sealing cap includes a first protrusion that abuts against the first sealing ring. The inner diameter of the first sealing ring is larger than the outer diameter of the proximal end of the conduit, such that the first protrusion presses against the first sealing ring until the inner circumferential surface of the first sealing ring abuts against the outer surface of the conduit.

[0010] Preferably, the tee further includes a second sealing cap, the second sealing cap covers the second port and is threadedly connected thereto, the second sealing cap includes a second protrusion that abuts against the second sealing ring, the inner diameter of the second sealing ring is larger than the outer diameter of the seal, so that the second protrusion presses the second sealing ring until the inner circumferential surface of the second sealing ring abuts against the outer surface of the seal.

[0011] Preferably, the three-way tube further includes an indicator balloon, which is disposed at the first port, the second port, or the inflator.

[0012] Preferably, the catheter includes a first portion at the proximal end, a second portion at the distal end, and a third portion connecting the first portion and the second portion, wherein the hardness of the third portion is greater than that of the first portion and the second portion.

[0013] Preferably, the seal includes an insertion portion disposed at the distal end and a handle portion disposed at the proximal end, wherein the maximum diameter of the insertion portion is greater than the diameter of the handle portion; and / or, the hardness of the insertion portion is less than the hardness of the handle portion; and / or, the handle portion is curved.

[0014] Preferably, the balloon catheter further includes a balloon with a U-shaped cross-section, the distal end of the catheter being located inside the balloon and fixedly connected thereto, wherein an arc surface is provided between the distal end face of the catheter and the circumferential surface of the catheter; and / or, the outer surface of the balloon is provided with a wear-resistant layer.

[0015] Preferably, the balloon includes a connecting portion, a head, and a bulge disposed between the connecting portion and the head, wherein the length t1 of the head satisfies 1mm≤t1≤3mm; and / or, the distance t2 between the distal end face of the catheter and the head satisfies 0mm≤t2≤1mm; and / or, the wall thickness of the bulge is greater than the wall thickness of the connecting portion.

[0016] Preferably, the balloon catheter further includes a support guidewire, which includes a first support portion disposed within the second portion and a second support portion disposed within the third portion, wherein the insertion portion is fixedly connected to the end of the second support portion opposite to the first support portion.

[0017] This utility model has at least the following beneficial effects:

[0018] This utility model's balloon catheter assembly has a sealing element located at the second port and the proximal opening of the catheter located at the first port. This allows the catheter to be pressurized by an inflator. After pressurization, the sealing element moves toward the catheter and inserts into the opening to seal it, thus maintaining pressure on the catheter. Then, the three-way tube is removed from the catheter and the sealing element, and the bronchoscope is withdrawn. The operation is simple and convenient, ensuring the efficiency and safety of the surgery. Attached Figure Description

[0019] Figure 1 This is a perspective view of the balloon catheter assembly of this utility model;

[0020] Figure 2 This is a cross-sectional view of the balloon catheter assembly of this utility model;

[0021] Figure 3 yes Figure 1 A cross-sectional view of the first embodiment of the three-way tube of the balloon catheter assembly shown;

[0022] Figure 4 yes Figure 1 A cross-sectional view of a second embodiment of the three-way valve of the balloon catheter assembly shown;

[0023] Figure 5 yes Figure 1 A cross-sectional view of the third embodiment of the three-way valve of the balloon catheter assembly shown;

[0024] Figure 6 yes Figure 1 A cross-sectional view of the fourth embodiment of the three-way valve of the balloon catheter assembly shown;

[0025] Figure 7 It is a cross-sectional view of an existing bronchoscope;

[0026] Figure 8 yes Figure 1 A front view of a first embodiment of the balloon catheter of the balloon catheter assembly shown;

[0027] Figure 9 yes Figure 1 A front view of a second embodiment of the balloon catheter of the balloon catheter assembly shown;

[0028] Figure 10yes Figure 1 A front view of a third embodiment of the balloon catheter of the balloon catheter assembly shown;

[0029] Figure 11 yes Figure 1 Front view of the seal of the balloon catheter assembly shown;

[0030] Figure 12 yes Figure 1 A cross-sectional view of one embodiment of the balloon in the balloon catheter assembly shown;

[0031] Figure 13 yes Figure 12 A partial enlarged view of the balloon catheter assembly shown;

[0032] Figure 14 yes Figure 1 A front view of one embodiment of the support guidewire of the balloon catheter assembly shown;

[0033] Figure 15 yes Figure 1 A front view of another embodiment of the support guidewire of the balloon catheter assembly shown;

[0034] Figure 16 yes Figure 15 The diagram shows a cross-sectional view of the guidewire after it has been implanted into the catheter.

[0035] Reference numerals: 100-Balloon catheter assembly; 1-T-stop tube; 11-First port; 12-Second port; 13-Inflation port; 14-First sealing ring; 15-Second sealing ring; 16-First sealing cap; 161-First channel; 162-First protrusion; 17-Second sealing cap; 171-Second channel; 172-Second protrusion; 18-Indicating balloon; 2-Balloon catheter; 20-Opening; 21-First... Part 1; 22-Second Part; 221-Curved Surface; 23-Third Part; 24-Balloon; 25-Support Guidewire; 251-First Support Part; 252-Second Support Part; 3-Seal; 31-Insert Part; 32-Handle Part; 4-Balloon; 41-Connecting Part; 42-Head; 43-Inflated Part; 200-Bronchoscope; 201-First Chamber; 202-Second Chamber; 203-Outlet; 204-Inlet. Detailed Implementation

[0036] The balloon catheter assembly provided by the present invention will now be clearly and completely described with reference to the accompanying drawings. It is to be understood that the described embodiments are merely some, not all, embodiments of the present invention, and the present invention can be implemented in many other ways different from those described herein.

[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention.

[0038] It should be noted that all directional indications in the embodiments of this specification are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indications will also change accordingly.

[0039] The technical solutions of the various embodiments of the present invention can be combined with each other, but only if they are based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by the present invention.

[0040] In this specification, axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the component; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0041] In one embodiment, the present invention provides a balloon catheter assembly 100, comprising a balloon catheter and a three-way connector 1. The balloon catheter includes a conduit 2 and a sealing element 3. The conduit 2 includes an opening 20 disposed at its proximal end. Figure 1 and Figure 2 As shown.

[0042] Preferably, the balloon catheter includes a catheter 2, which is used to extend into the bronchus along the lumen of the bronchoscope 200, thereby achieving bronchial occlusion and anchoring, and facilitating bronchial detection.

[0043] More preferably, the conduit 2 can be a flexible tube, such as one made of latex, silicone or other materials.

[0044] Preferably, the sealing element 3 is disposed at the proximal end of the conduit 2. During pressurization, the sealing element 3 disengages from the conduit 2 to allow pressurization into the conduit 2 through the opening 20. This pressurization is achieved by injecting gas or liquid. After pressurization is complete, at least a portion of the sealing element 3 is inserted into the conduit 2, thereby maintaining pressure on the conduit 2 and facilitating the removal of the three-way tube 1 and the bronchoscope 200. Furthermore, the sealing element 3 can be made of metal or non-metallic materials, such as silicone or rubber, to meet certain flexibility requirements. Users can configure it according to their needs, and no specific limitation is made here.

[0045] Preferably, the three-way tube 1 is used to connect the catheter 2 and the sealing element 3. After the catheter 2 is pressurized, the sealing element 3 is moved so that it is inserted into the catheter 2 to maintain the pressure of the catheter 2, which makes it convenient to pull out the three-way tube 1 and the bronchoscope 200 from the catheter 2.

[0046] More preferably, the opening 20 is located at the proximal end of the conduit 2, so as to facilitate pressurization towards the conduit 2 through the opening 20. After pressurization is completed, at least a portion of the sealing member 3 extends into the opening 20 to seal the opening 20, thereby achieving the purpose of maintaining pressure on the conduit 2.

[0047] In one embodiment, the three-way tube 1 includes a first port 11, a pressurization port 13, and a second port 12 opposite to the first port 11. The opening 20 is received within the first port 11. The proximal end of the conduit 2 is sealed to the first port 11, and the distal end of the sealing element 3 is received within and sealed to the second port 12. Figure 1 and Figure 2 As shown.

[0048] Preferably, the first port 11 and the second port 12 are arranged opposite to each other, that is, the first port 11 and the second port 12 are on a straight line, so as to facilitate the movement of the sealing element 3 in the second port 12 toward the first port 11 so as to be inserted into the opening 20 of the conduit 2, thereby achieving sealing and pressure maintenance of the conduit 2.

[0049] More preferably, the pressurization port 13 is disposed on one side of the first port 11 and the second port 12, and the pressurization port 13 is connected to the first port 11 and the second port 12, so that the gas or liquid charged through the pressurization port 13 enters the first port 11 and the second port 12.

[0050] More preferably, the shapes of the first port 11, the second port 12, and the pressurization port 13 can be circular, elliptical, or polygonal, etc.

[0051] More preferably, the opening 20 passes through the first port 11 and is housed within the first port 11, thereby enabling the opening 20 to communicate with the interior of the tee pipe 1.

[0052] Furthermore, the proximal end of the conduit 2 is housed within the first port 11, and the outer peripheral surface of the proximal end of the conduit 2 is sealed to the inner surface of the first port 11, thereby preventing gas or liquid in the three-way tube 1 from flowing out through the gap between the outer peripheral surface of the proximal end of the conduit 2 and the inner surface of the first port 11.

[0053] Furthermore, the distal end of the seal 3 extends into the second port 12 and is sealed to the second port 12, thereby preventing gas or liquid in the tee tube 1 from flowing out through the gap between the outer circumferential surface of the seal 3 and the inner circumferential surface of the second port 12. Furthermore, the seal 3 can move relative to the opening 20 of the conduit 2 within the second port 12, so that after pressurization, the distal end of the seal 3 can be inserted into the opening 20.

[0054] In one embodiment, the inflator 13 is connected to a pressurizer to pressurize the conduit 2, and the seal 3 is configured to move toward the opening 20 when the conduit 2 is fully pressurized, such that at least a portion of the seal 3 is inserted into the opening 20 to seal the opening 20. Figure 1 and Figure 2 As shown.

[0055] Preferably, the pressurizer can be a syringe or other existing pressurizing device, which is used to pressurize the conduit 2 by filling gas or liquid into the three-way tube 1 through the pressurizing port 13.

[0056] More preferably, the connector of the pressurizer extends into the pressurizing port 13 and is sealed to it, so that the gas or liquid in the pressurizer can smoothly enter the pressurizing port 13 through the connector.

[0057] Preferably, when the pressurizer pressurizes the conduit 2, the seal 3 disengages from the opening 20, allowing gas or liquid injected into the tee tube 1 by the pressurizer to enter the conduit 2 through the opening 20. When the pressurizer finishes pressurizing the conduit 2, the proximal end of the seal 3 is manually moved so that the seal 3 moves toward the opening of the conduit 2, and the seal 3 and the second port 12 maintain a sealed connection. This not only effectively prevents gas or liquid leakage, but also allows the distal end of the seal 3 to be smoothly inserted into the opening 20, thereby achieving sealing and pressure maintenance of the opening 20.

[0058] It should be noted that the proximal end is the end closer to the operator, and the distal end is the end farther away from the operator.

[0059] In one embodiment, the tee tube 1 includes a first sealing ring 14, which is disposed between the inner circumferential surface of the first port 11 and the outer circumferential surface of the proximal end of the conduit 2, such as... Figures 2 to 6 As shown.

[0060] Preferably, the first sealing ring 14 is annular, thereby achieving a 360-degree all-round seal on the proximal end of the conduit 2 and ensuring the sealing effect.

[0061] More preferably, the first sealing ring 14 is fixedly connected to the first port 11, such as by bonding or interference fit, so as to fix the first sealing ring 14 in the first port 11 and enhance the structural stability.

[0062] Preferably, the port of the internal cavity of the first sealing ring 14 is provided with a flared guide port, so that the opening 20 of the conduit 2 can be smoothly and quickly inserted into the first sealing ring 14 through the flared guide port.

[0063] More preferably, the first sealing ring 14 is made of a soft material, such as rubber or silicone, to ensure a seal on the proximal opening 20 of the conduit 2 and effectively prevent air or liquid leakage.

[0064] Furthermore, after the proximal end of the conduit 2 passes through the first sealing ring 14, and in the sealed state, the inner surface of the first sealing ring 14 abuts against the outer surface of the proximal end of the conduit 2, thereby achieving an effective sealing effect and effectively preventing air or liquid leakage.

[0065] Furthermore, the inner surface of the first sealing ring 14 is slidably connected to the outer surface of the proximal end of the conduit 2, thereby facilitating the insertion of the conduit 2 into or from the first sealing ring 14.

[0066] In one embodiment, the tee pipe 1 further includes a second sealing ring 15, which is disposed between the inner circumferential surface of the second port 12 and the outer circumferential surface of the sealing member 3, such as... Figures 2 to 6 As shown.

[0067] Preferably, the second sealing ring 15 is annular, thereby achieving a 360-degree all-round seal on the distal end of the sealing element 3 and ensuring the sealing effect.

[0068] More preferably, the second sealing ring 15 is fixedly connected to the second port 12, such as by bonding or interference fit, so as to fix the second sealing ring 15 in the second port 12 and enhance the structural stability.

[0069] Preferably, the port of the internal cavity of the second sealing ring 15 is provided with a horn guide port, so that the distal end of the sealing element 3 can be quickly inserted into the second sealing ring 15 through the horn guide port, reducing the difficulty of operation.

[0070] More preferably, the second sealing ring 15 is made of a soft material, such as rubber or silicone, to ensure the sealing of the sealing element 3 and effectively prevent air or liquid leakage.

[0071] Furthermore, after the distal end of the seal 3 passes through the second sealing ring 15, and in the sealed state, the inner surface of the second sealing ring 15 abuts against the outer surface of the distal end of the seal 3, effectively preventing air or liquid leakage.

[0072] Furthermore, the inner surface of the second sealing ring 15 is slidably connected to the outer surface of the distal end of the sealing element 3, thereby facilitating the insertion or removal of the distal end of the sealing element 3 into or from the second sealing ring 15, so as to meet the requirements for removing the three-way tube 1 and the bronchoscope 200.

[0073] In one embodiment, the tee tube 1 further includes a first sealing cap 16, which covers and is threadedly connected to the first port 11. The first sealing cap 16 includes a first protrusion 162 that abuts against the first sealing ring 14. The inner diameter of the first sealing ring 14 is larger than the outer diameter of the proximal end of the conduit 2, such that the first protrusion 162 presses against the first sealing ring 14 until the inner circumferential surface of the first sealing ring 14 abuts against the outer surface of the conduit 2. Figure 2 and Figure 4 As shown.

[0074] Preferably, the first sealing cover 16 is fitted onto the first port 11, and the inner circumferential surface of the first sealing cover 16 is threadedly connected to the outer circumferential surface of the first port 11, thereby achieving a stable connection between the two. Moreover, the first sealing cover 16 can be effectively tightened onto the first port 11 or unscrewed from the first port 11 by rotating it.

[0075] More preferably, the first protrusion 162 is disposed inside the first sealing cover 16, and the first protrusion 162 is fixedly connected to the first sealing cover 16, such as by bonding or integral molding.

[0076] More preferably, the first protrusion 162 is received within the first port 11 and moves axially out or in with the first sealing cover 16 within the first port 11 so as to abut against the first sealing ring 14.

[0077] More preferably, the inner diameter of the first sealing ring 14 is the diameter of the inner circumferential surface of the first sealing ring 14, and the outer diameter of the proximal end of the conduit 2 is the diameter of the outer circumferential surface of the proximal end. In the natural state, the inner diameter of the first sealing ring 14 is larger than the outer diameter of the proximal end of the conduit 2, so that the proximal end of the conduit 2 can pass smoothly and quickly through the interior of the first sealing ring 14, and the opening 20 can extend into the interior of the three-way tube 1.

[0078] Furthermore, when the first sealing cap 16 is tightened on the first port 11, the first protrusion 162 moves toward the first sealing ring 14 inside the first port 11, thereby squeezing the first sealing ring 14 and reducing the inner diameter of the first sealing ring 14 until the inner surface of the first protrusion 162 abuts against the outer surface of the proximal end of the conduit 2, thus achieving an effective seal and preventing air or liquid leakage during pressurization. It also facilitates the insertion of the proximal end of the conduit 2 into or out of the first sealing ring 14, simplifying the operation.

[0079] Furthermore, the first sealing cap 16 is provided with a first channel 161, which is connected to the first sealing ring 14, so that the proximal end of the conduit 2 passes through the first channel 161 and the first sealing ring 14, and the opening 20 is received in the three-way tube 1.

[0080] In one embodiment, the tee pipe 1 further includes a second sealing cap 17, which covers the second port 12 and is threadedly connected thereto. The second sealing cap 17 includes a second protrusion 172 that abuts against the second sealing ring 15. The inner diameter of the second sealing ring 15 is larger than the outer diameter of the sealing member 3, such that the second protrusion 172 presses against the second sealing ring 15 until the inner circumferential surface of the second sealing ring 15 abuts against the outer surface of the sealing member 3. Figure 2 and Figure 4 As shown.

[0081] Preferably, the second sealing cap 17 is fitted onto the second port 12, and the inner circumferential surface of the second sealing cap 17 is threadedly connected to the outer circumferential surface of the second port 12, thereby achieving a stable connection between the two. Furthermore, by rotating the second sealing cap 17, it can be effectively tightened onto the second port 12 or unscrewed from the second port 12.

[0082] More preferably, the second protrusion 172 is disposed inside the second sealing cover 17, and the second protrusion 172 is fixedly connected to the second sealing cover 17, such as by bonding or integral molding.

[0083] More preferably, the second protrusion 172 is received within the second port 12 and moves axially out or in with the second sealing cover 17 within the second port 12 so as to abut against the second sealing ring 15.

[0084] More preferably, the inner diameter of the second sealing ring 15 is the diameter of the inner circumferential surface of the second sealing ring 15, and the outer diameter of the sealing element 3 is the diameter of the outer circumferential surface of the sealing element 3. In the natural state, the inner diameter of the second sealing ring 15 is larger than the outer diameter of the sealing element 3, so that the sealing element 3 can pass smoothly and quickly through the interior of the second sealing ring 15, and the distal end of the sealing element 3 can extend into the interior of the tee pipe 1, which is simple to operate and convenient to use.

[0085] Furthermore, when the second sealing cap 17 is screwed onto the second port 12, the second protrusion 162 moves toward the second sealing ring 15 inside the second port 12, thereby squeezing the second sealing ring 15 and reducing the inner diameter of the second sealing ring 15 until the inner surface of the second protrusion 172 abuts against the outer surface of the sealing member 3, thereby achieving an effective seal and facilitating the insertion of the distal end of the sealing member 3 into or from the interior of the second sealing ring 15.

[0086] Furthermore, the second sealing cover 17 is provided with a second channel 171, which is connected to the second sealing ring 15, so that the distal end of the sealing member 3 passes through the second channel 171 and the second sealing ring 15, and the distal end of the sealing member 3 is received in the tee tube 1.

[0087] In one embodiment, the three-way tube 1 further includes an indicator balloon 18, which is disposed at the first port 11, the second port 12, or the inflation port 13, such as... Figure 5 and Figure 6 As shown.

[0088] Preferably, the indicator balloon 18 is made of a soft material, such as silicone or latex, so that it can inflate when the internal pressure of the three-way tube 1 is high during inflation, so as to observe whether any depressurization has occurred.

[0089] More preferably, the indicator balloon 18 is disposed at the first port 11, the second port 12, or the inflation port 13.

[0090] More preferably, the indicator balloon 18 is fixedly connected to the three-way tube 1, such as by bonding or integral molding, so as to ensure structural stability and improve structural strength and sealing effect.

[0091] More preferably, the shape of the indicator balloon 18 can be spherical, polygonal, or other geometric shapes.

[0092] It should be noted that in clinical use, after the balloon catheter is inserted into the target bronchus, it is inflated to inflate the balloon and anchor and block the bronchus. Because the balloon is located deep within the bronchus, its position cannot be directly visualized by the endoscope. Furthermore, the balloon may deflate due to operational errors with the sealing element 3 or poor adhesion between the balloon ends and the catheter 2. In such cases, the balloon catheter may fail to anchor and block the bronchus, leading to surgical failure if the surgeon proceeds unknowingly. Therefore, the indicator balloon 18 is designed to maintain pressure at the opening 20 of the catheter 2 after the sealing element 3 is in place. By observing the volume change of the indicator balloon 18, it can be determined whether there is any deflation in the catheter 2 and the balloon. Only after confirming there is no deflation should the next step be performed, thus ensuring the success rate and safety of the surgery.

[0093] In one embodiment, the catheter 2 includes a first portion 21 at a proximal end, a second portion 22 at a distal end, and a third portion 23 connecting the first portion 21 and the second portion 22, wherein the hardness of the third portion 23 is greater than that of the first portion 21 and the second portion 22, such as... Figures 8 to 10 As shown.

[0094] Preferably, the second part 22 is located at the distal end of the catheter 2. When the catheter 2 is in use, the second part 22 is located inside the bronchus, and the balloon 24 is fitted onto the second part 22 so that the balloon 24 can be inserted into the required bronchus.

[0095] It should be noted that the catheter 2 has a cavity, one end of which is connected to the opening 20 and the other end of which is connected to the balloon 24. This allows gas or liquid injected from the opening 20 to enter the balloon 24 through the cavity, thereby inflating the balloon 24 and causing it to bulge and collide to anchor and block the bronchus.

[0096] More preferably, the second part 22 is a cone shape with a proximal diameter larger than the distal diameter. For example, the difference between the proximal and distal diameters of the second part 22 is 0.4 mm to 1.5 mm, and the length of the second part 22 is 5 mm to 20 mm. The aforementioned cone shape and size limitation conform to the characteristic that the deeper the bronchus, the smaller the diameter. When the second part 22 extends into the bronchus with a smaller diameter, it can adapt to the change in the diameter of the bronchus, reduce excessive dilation of the bronchus, and reduce the effect of damaging the bronchus.

[0097] More preferably, the third part 23 is located between the first part 21 and the second part 22, with one end of the third part 23 connected to the first part 21 and the other end connected to the second part 22. Preferably, the first part 21, the second part 22 and the third part 23 are integrally formed.

[0098] Preferably, the diameter of the third part 23 is larger than the diameter of the second part 22. Specifically, the diameter of the third part 23 is h1, and the diameter of the balloon 24 on the second part 2 in the uninflated state is h2. Since h1 is larger than h2, the second part 22 and the balloon 24 can be smoothly inserted into the bronchus with a smaller diameter, and the third part 23 can smoothly push the second part 22 into the required bronchus.

[0099] More preferably, the coefficient of friction of the outer surface of the first part 21 is greater than that of the outer surfaces of the second part 22 and the third part 23. Therefore, during use, the implantation device needs to pass through the opening 20 of the first part 21 and then through the catheter 2. The higher coefficient of friction of the first part 21 helps the doctor grip it better, preventing a loose grip that could cause relative movement between the doctor's hand and the catheter, leading to misjudgment of catheter 2 displacement or the catheter's position, thus affecting the accuracy and safety of the surgery. The outer surface of the first part 21 can be sandblasted or have anti-slip textures added to increase its coefficient of friction.

[0100] Furthermore, the third part 23 is harder than the first part 21 and the second part 22, which allows the catheter 2 to pass smoothly through the tortuous channel inside the bronchoscope 200 and extend smoothly into the required bronchus.

[0101] Furthermore, such as Figure 7 As shown, the bronchoscope 200 includes a first cavity 201 and a second cavity 202. The lower end of the first cavity 201 has an outlet 203, and the upper end of the second cavity 202 has an inlet 204. The first cavity 201 and the second cavity 202 are connected and are bent. When the catheter 2 is inserted into the bronchoscope 200, the distal end of the second part 22 passes through the inlet 204 into the second cavity 202. After passing through the bent connection between the second cavity 202 and the first cavity 201, it enters the first cavity 201. It then continues to move downwards and extends from the outlet 203 to the outside of the bronchoscope 200. The lower rigidity of the second part 22 allows it to bend smoothly when entering the first cavity 201 from the second cavity 202, thus providing traction and guidance. Then, the third part 23 and the first part 21 smoothly enter and pass through the first cavity 201; when the bronchoscope 200 needs to be withdrawn after the balloon 24 is inflated and anchored, the first part 21 moves into the second cavity 202, and then passes through the bend between the second cavity 202 and the first cavity 201 before being moved out through the first cavity 201. Therefore, the design of the first part 21 with low hardness allows it to pass smoothly through the second cavity 202 and the first cavity 201, preventing the first part 21 from being too hard and causing blockage inside the second cavity 202 and the first cavity 201.

[0102] Furthermore, the first part 21 is wavy, as... Figure 9 As shown, this allows for better flexibility. Similarly, the second part 22 can also be wavy, which facilitates its passage through the first cavity 201 and the second cavity 202 of the bronchoscope 200; or, the first part 21 can be curved, as shown... Figure 10As shown, this allows it to pass smoothly through the first cavity 201 and the second cavity 202 of the bronchoscope 200.

[0103] In one embodiment, the seal 3 includes an insertion portion 31 disposed at a distal end and a handle portion 32 disposed at a proximal end, wherein the maximum diameter of the insertion portion 31 is larger than the diameter of the handle portion 32, such as... Figure 11 As shown.

[0104] Preferably, the insertion part 31 has a tapered structure, and the diameter of the distal end of the insertion part 31 is smaller than the diameter of its proximal end, which facilitates insertion into the opening 20 of the catheter and achieves a seal on the opening 20.

[0105] More preferably, the insertion part 31 is inserted into the opening 20, and the outer peripheral surface of the insertion part 31 abuts against the inner peripheral surface of the opening 20, thereby sealing the opening 20 and preventing air or liquid leakage.

[0106] Preferably, the handle portion 32 is located outside the catheter 2. The handle portion 32 is designed to make it easy for doctors to hold and operate, thus improving the ease of use.

[0107] More preferably, the insertion part 31 and the handle part 32 are fixedly connected, such as by bonding, or they can be integrally injection molded, thereby simplifying the production process and improving the structural stability.

[0108] Furthermore, the maximum diameter of the insertion part 31 is greater than the diameter of the handle part 32, thereby preventing the handle part 32 from being pulled out of the catheter when the bronchoscope 200 is withdrawn, and ensuring that the bronchoscope 200 is withdrawn smoothly.

[0109] Furthermore, the insertion part 31 is softer, making it easier to deform to meet the sealing of the opening 20. The hardness of the insertion part 31 and the handle part 32 is less than that of the first part 21, making the insertion part 31 and the handle part 32 softer than the first part 21, which makes it easier for them to pass through the inside of the bronchoscope 200.

[0110] In one embodiment, the hardness of the insertion portion 31 is less than the hardness of the handle portion 32;

[0111] Preferably, the hardness of the insertion part 31 is less than that of the handle part 32, so that the insertion part 31 can be easily inserted into the opening 20.

[0112] More preferably, the hardness of the handle portion 32 is less than that of the first portion 21, that is, the handle portion 32 is relatively softer than the first portion 21, so that when the bronchoscope 200 is withdrawn from the first portion 21 on the catheter, the handle portion 32 can adapt to the shape of the cavity inside the bronchoscope 200 and deform accordingly, thereby allowing the bronchoscope 200 to be withdrawn smoothly and preventing the seal 3 from detaching from the opening 20 of the catheter.

[0113] In one embodiment, the handle portion 32 is curved, such as... Figure 11 As shown.

[0114] Preferably, the handle portion 32 is curved, which helps to adapt to the bends or curves in the bronchoscope 200, so as to more smoothly withdraw the bronchoscope 200.

[0115] It should be noted that the handle part 32 can also be other geometric shapes, such as wavy shapes. The specific shape can be set as needed, so that the seal 3 will not detach from the opening 20 of the bronchoscope 200 when it is withdrawn from the catheter 2.

[0116] In one embodiment, the balloon catheter further includes a balloon 4, the balloon 4 having a U-shaped cross-section, and the distal end of the catheter 2 being located inside and fixedly connected to the balloon 4, such as... Figure 12 and Figure 13 As shown.

[0117] Preferably, the balloon 4 is made of a soft material, such as latex or silicone, so that it can expand when inflated to block and anchor in the bronchus.

[0118] More preferably, the cross-section of the balloon 4 is U-shaped, so that it has only one opening, which allows the distal end of the catheter 2 to be inserted into the interior of the balloon 4 to complete the inflation of the balloon 4.

[0119] Preferably, the distal end of the second part 22 extends into the interior of the balloon 4, and the inner peripheral surface of the proximal end of the balloon 4 is fixedly connected to the outer peripheral surface of the second part 22, such as by bonding, so that the balloon 4 is fixed to the distal end of the catheter 2, resulting in better structural stability.

[0120] In one embodiment, an arc surface 221 is provided between the distal end face of the catheter 2 and the circumferential surface of the catheter 2, such as... Figure 12 and Figure 13 As shown.

[0121] Preferably, the distal end of the catheter 2 is the distal end of the second part 22, which extends into the interior of the balloon 4 and is fixedly connected to the balloon 4.

[0122] More preferably, such as Figure 13 As shown, the distal end face of the second part 22 is its right surface, and the outer peripheral surface of the second part 22 is arc-shaped. When the balloon 4 is in its natural state, the outer peripheral surface of the second part 22 fits against the inner surface of the balloon 4 to achieve the supporting effect on the balloon 4.

[0123] Preferably, the distal end face of the second part 22 has an arc surface 221 between it and the outer peripheral surface of the second part 22 to prevent scratching or puncturing the inner wall of the balloon 4 and to ensure the normal use of the balloon 4.

[0124] In one embodiment, the outer surface of the balloon 4 is provided with a wear-resistant layer.

[0125] Preferably, the wear-resistant layer can be a talc layer, or it can be made of other wear-resistant materials, etc. The user can set it according to needs, and there is no specific limitation here. When the wear-resistant layer is made of talc, the talc can form a fine powdery surface layer on the outer surface of the balloon 4, reducing the friction between the outer surface of the balloon 4 and other objects. Especially when the balloon catheter enters the internal cavity of the bronchoscope 200, the balloon 4 is sandwiched between the relatively hard inner wall of the bronchoscope 200 and the catheter 2, preventing damage to the balloon 4 caused by friction from relative movement, and extending the service life of the balloon 4.

[0126] More preferably, the wear-resistant layer may cover the entire outer surface of the balloon 4, or it may cover part of the outer surface of the balloon 4, etc., without specific limitation.

[0127] In one embodiment, the balloon 4 includes a connecting portion 42, a head 42, and a bulge 43 disposed between the connecting portion 42 and the head 42, wherein the length t1 of the head 42 satisfies 1mm ≤ t1 ≤ 3mm, as shown below. Figure 12 and Figure 13 As shown.

[0128] Preferably, the connecting part 41 is disposed at the proximal end of the balloon 4, and the connecting part 41 covers the outer surface of the second part 22 and is fixedly connected to it, such as by bonding, so as to achieve the purpose of fixing the balloon 4 to the second part 22, thereby sealing the balloon 4 and preventing gas or liquid from leaking out of the balloon 4.

[0129] More preferably, the head 42 is solid, and when the second part 22 of the catheter 2 is inserted into the bronchus, the head 42 acts as a buffer to prevent scratching or puncturing the inner wall of the bronchus.

[0130] More preferably, the bulge 43 is disposed between the connecting part 41 and the head 42. One end of the bulge 43 is fixedly connected to the connecting part 41, and the other end is fixedly connected to the head 42. The fixed connection can be bonding or the like. In other embodiments, the connecting part 41, the head 42 and the bulge 43 are integrally injection molded, which can simplify the production process and improve the structural stability.

[0131] More preferably, the bulge 43 is designed to expand when the balloon 4 is inflated, thereby achieving the function of blocking and anchoring the bronchus.

[0132] Furthermore, the length t1 of the head 42 can be any value between 1mm and 3mm, such as 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.5mm, 3mm, etc., which can be set by the user as needed, and no specific limitation is made here.

[0133] It should be noted that the aforementioned limitation on the length of the head 42 allows the second part 22 to effectively buffer the airflow when it extends into the bronchus, preventing scratches to the inner wall of the bronchus. At the same time, it simplifies the structure and makes it more stable.

[0134] In one embodiment, the distance t2 between the distal end face of the catheter 2 and the head 42 satisfies 0mm ≤ t2 ≤ 1mm, such as... Figure 12 and Figure 13 As shown.

[0135] Preferably, the distance between the distal end face of the catheter 2 and the head 42 is any value between 0mm and 1mm, such as 0mm, 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, etc. The user can set it as needed, and no specific limitation is made here.

[0136] More preferably, it is precisely because of the aforementioned distance limitation that when the distal end of the catheter is inserted into the bronchus and encounters resistance, the second part 22 and the head 42 will move relative to each other and rush toward the head 42. Because the aforementioned distance is short, the second part 22 cannot form an acceleration distance, that is, the second part 22 hits the head 42 at the lowest possible speed, thereby reducing the impact damage of the second part 22 to the balloon 4.

[0137] In one embodiment, the wall thickness of the bulge 43 is greater than the wall thickness of the connecting portion 41.

[0138] Preferably, the wall thickness of the bulge 43 is greater than the wall thickness of the connecting portion 41, thereby increasing the rupture resistance of the bulge 43 and further preventing the end of the second part 22 from puncturing the balloon 4.

[0139] More preferably, the wall thickness of the bulge 43 is greater than the wall thickness of the connecting part 41, thereby increasing its structural strength, enabling it to expand effectively, and preventing the bulge 43 from breaking.

[0140] It should be noted that in other embodiments, the wall thickness of the bulge 43 can also be equal to the wall thickness of the connecting portion 41, such as... Figure 13 As shown, the wall thickness of the bulge 43 may be less than the wall thickness of the connecting part 41, thereby meeting different usage requirements. No specific limitation is made here.

[0141] In one embodiment, the balloon catheter further includes a support guidewire 25, the support guidewire 25 including a first support portion 251 disposed within the second portion 22 and a second support portion 252 disposed within the third portion 23, such as... Figure 14 As shown.

[0142] Preferably, the support guidewire 25 is fixed inside the catheter 2, or is movably disposed inside the catheter 2; furthermore, the support guidewire 25 is made of metal materials with good support such as nickel-titanium or stainless steel, so as to effectively support the catheter 2 and allow it to extend smoothly into the bronchus.

[0143] More preferably, the first support portion 251 is housed within the second portion 22, thereby providing support for the second portion 22 so that the second portion 22 can be smoothly implanted into the bronchus; further, the second support portion 252 is housed within the third portion 23, thereby providing support for the third portion 23.

[0144] In one embodiment, the insertion portion 31 is fixedly connected to the end of the second support portion 252 opposite to the first support portion 251, such as... Figure 15 and Figure 16 As shown.

[0145] Preferably, when the first support portion 251 and the second support portion 252 are movably disposed within the conduit 2, the insertion portion 31 and the end of the second support portion 252 opposite to the first support portion 251 are fixedly connected, such as by bonding or integral injection molding, thereby simplifying the structure.

[0146] It should be noted that the mutual fixation between the insertion part 31 and the second support part 252 allows the sealing member 3 and the support guide wire 25 to be removed together during pressurization. After pressurization is completed, the support guide wire 25 is inserted into the inside of the catheter 2 to support the catheter 2. The insertion part 31 of the sealing member 3 then extends into the opening 20 of the catheter 2 to seal and maintain pressure on the catheter.

Claims

1. A balloon catheter assembly, characterized in that, The device includes a balloon catheter and a three-way valve. The balloon catheter includes a catheter and a seal. The catheter includes an opening at its proximal end. The three-way valve includes a first port, an inflation port, and a second port opposite to the first port. The opening is received within the first port. The proximal end of the catheter is sealed to the first port. The distal end of the seal is received within and sealed to the second port. The inflation port is used to connect to an inflator to inflate the catheter. The seal is used to move toward the opening when the catheter is fully inflated, such that at least a portion of the seal is inserted into the opening to seal it.

2. The balloon catheter assembly according to claim 1, characterized in that, The tee includes a first sealing ring, which is disposed between the inner circumferential surface of the first port and the outer circumferential surface of the proximal end of the conduit.

3. The balloon catheter assembly according to claim 2, characterized in that, The tee also includes a second sealing ring, which is disposed between the inner circumferential surface of the second port and the outer circumferential surface of the sealing element.

4. The balloon catheter assembly according to claim 3, characterized in that, The tee also includes a first sealing cap, which covers the first port and is threadedly connected thereto. The first sealing cap includes a first protrusion that abuts against the first sealing ring. The inner diameter of the first sealing ring is larger than the outer diameter of the proximal end of the conduit, such that the first protrusion squeezes the first sealing ring until the inner circumferential surface of the first sealing ring abuts against the outer surface of the conduit.

5. The balloon catheter assembly according to claim 4, characterized in that, The tee also includes a second sealing cap, which covers the second port and is threadedly connected to it. The second sealing cap includes a second protrusion that abuts against the second sealing ring. The inner diameter of the second sealing ring is larger than the outer diameter of the seal, so that the second protrusion presses the second sealing ring until the inner circumferential surface of the second sealing ring abuts against the outer surface of the seal.

6. The balloon catheter assembly according to claim 5, characterized in that, The three-way tube also includes an indicator balloon, which is disposed at the first port, the second port, or the inflatable port.

7. The balloon catheter assembly according to claim 6, characterized in that, The catheter includes a first portion at the proximal end, a second portion at the distal end, and a third portion connecting the first portion and the second portion, wherein the hardness of the third portion is greater than that of the first portion and the second portion.

8. The balloon catheter assembly according to claim 7, characterized in that, The sealing element includes an insertion portion disposed at the distal end and a handle portion disposed at the proximal end, wherein the maximum diameter of the insertion portion is greater than the diameter of the handle portion; And / or, the hardness of the insertion portion is less than the hardness of the handle portion; And / or, the handle portion is curved.

9. The balloon catheter assembly according to claim 8, characterized in that, The balloon catheter also includes a balloon with a U-shaped cross-section. The distal end of the catheter is located inside the balloon and is fixedly connected to it. An arc surface is provided between the distal end face of the catheter and the circumferential surface of the catheter. And / or, the outer surface of the balloon is provided with a wear-resistant layer.

10. The balloon catheter assembly according to claim 9, characterized in that, The balloon includes a connecting part, a head, and a bulge disposed between the connecting part and the head, wherein the length t1 of the head satisfies 1mm≤t1≤3mm; And / or, the distance t2 between the distal end face of the catheter and the head satisfies 0mm≤t2≤1mm; And / or, the wall thickness of the bulge is greater than the wall thickness of the connecting portion.

11. The balloon catheter assembly according to claim 8, characterized in that, The balloon catheter further includes a support guidewire, which includes a first support portion disposed in the second part and a second support portion disposed in the third part. The insertion portion is fixedly connected to the end of the second support portion opposite to the first support portion.

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