Balloon catheter and components thereof

Abstract

This invention provides a balloon catheter, comprising a catheter, a sealing element, and a balloon. The catheter includes a channel and an opening, with the opening located at the proximal end of the catheter and the balloon located at the distal end. One end of the channel communicates with the opening, and the other end of the channel communicates with the balloon. The opening is connected to an inflator to inflate the channel. The sealing element is used to at least partially insert into the opening to seal it after the catheter is fully inflated. This invention inflates the balloon by inflating the opening of the catheter to block and anchor it within the bronchus. Simultaneously, after inflation, the sealing element is inserted into the opening to seal it, thus maintaining pressure on the balloon. This allows for the smooth removal and withdrawal of the bronchoscope from the balloon catheter, simplifying the balloon catheter operation process, improving ease of use, and enhancing surgical efficiency and safety.

Description

Technical Field

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

[0002] With the improvement of people's living standards and changes in dietary structure, various diseases have gradually increased, including bronchial diseases. Patients with bronchial diseases usually need to undergo examinations, such as inserting a bronchoscope into the diseased bronchus to examine its internal condition, thereby facilitating an understanding of the disease. However, during the bronchoscopy procedure, to prevent airway obstruction and suffocation caused by massive bleeding, a balloon catheter can be used during the operation.

[0003] Existing balloon catheters are inserted into the target location through the bronchoscope's cavity. The balloon is then inflated to anchor the catheter within the bronchus and block any diseased or bleeding bronchi. At this point, the bronchoscope should be withdrawn. However, sometimes the balloon catheter fails to allow the bronchoscope to be withdrawn smoothly after inflation, or the balloon cannot maintain pressure during withdrawal. This necessitates deflating the balloon before withdrawing the bronchoscope, followed by re-inflating the balloon catheter to anchor it within the bronchus. This process is cumbersome, inconvenient, and affects surgical efficiency and safety. Utility Model Content

[0004] To overcome the above-mentioned technical problems, this utility model provides a balloon catheter and its components for maintaining balloon pressure when the bronchoscope is withdrawn from the human body.

[0005] In a first aspect, the present invention provides a balloon catheter, comprising a catheter, a seal, and a balloon. The catheter includes a channel and an opening, the opening being disposed at the proximal end of the catheter, and the balloon being disposed at the distal end of the catheter. One end of the channel communicates with the opening, and the other end of the channel communicates with the balloon. The opening is connected to an inflator to inflate the channel, and the seal is used to at least partially insert into the opening to seal the opening when the catheter is fully inflated.

[0006] Preferably, the conduit includes a first portion at the proximal end, at least a portion of which is a flexible tube to seal the opening by bending the tube before the seal is inserted.

[0007] Preferably, the catheter further includes a second portion at the distal end and a third portion between the first portion and the second portion, the third portion having a harderness than the first portion and the second portion; and / or, the catheter further includes a cavity penetrating the proximal end face and the distal end face of the catheter.

[0008] Preferably, the first part includes a first sub-part, a third sub-part, and a second sub-part arranged sequentially from the distal end to the proximal end. The end of the first sub-part facing away from the third sub-part is connected to the third part, wherein the third sub-part is a flexible tube; and / or, the third sub-part has an elastic element inside, one end of the elastic element is fixedly connected to the first sub-part, and the other end of the elastic element is fixedly connected to the second sub-part.

[0009] Preferably, the sealing element includes an insertion portion inserted into the opening and a handle portion located outside the conduit, 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.

[0010] Preferably, the balloon has a U-shaped cross-section, and the distal end of the catheter is located inside the balloon and fixedly connected to it.

[0011] Preferably, an arc surface is provided between the distal end face of the catheter and the circumferential surface of the catheter; and / or, a wear-resistant layer is provided on the outer surface of the balloon.

[0012] 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.

[0013] Preferably, the balloon catheter further includes a support guidewire disposed within the catheter, the support guidewire including a first support portion disposed within the second portion and a second support portion disposed within the third portion, the insertion portion being fixed to the end of the second support portion opposite to the first support portion.

[0014] Secondly, the present invention provides a balloon catheter assembly, the balloon catheter assembly including the balloon catheter and the two-way tube as described in any of the above claims, the two-way tube including a first port and a second port, the proximal end of the catheter being housed in and sealed to the first port, and the second port being connected to an inflator to inflate the balloon catheter.

[0015] Preferably, the first port of the two-way tube is provided with a first sealing ring and a sealing cap. The first sealing ring is disposed between the inner circumferential surface of the first port and the outer circumferential surface of the proximal end of the conduit. The sealing cap is fitted onto the first port and threadedly connected thereto. The sealing cap is provided with a compression portion that abuts against the first sealing ring.

[0016] This invention has at least the following beneficial effects: by inflating the opening of the catheter to inflate the balloon, it is sealed and anchored in the bronchus. After inflation, a sealing element is inserted into the opening to seal the opening of the catheter, thus maintaining the pressure of the balloon. At this point, the bronchoscope can be smoothly removed from the balloon catheter and withdrawn from the body, simplifying the balloon catheter operation process, making it convenient to use, and improving the efficiency and safety of surgery. Attached Figure Description

[0017] Figure 1 This is a front view of the first embodiment of the balloon catheter of this utility model;

[0018] Figure 2 This is a front view of the second embodiment of the balloon catheter of this utility model;

[0019] Figure 3 This is a front view of the third embodiment of the balloon catheter of this utility model;

[0020] Figure 4 yes Figure 1 A front view of a first embodiment of the sealing element of the balloon catheter shown;

[0021] Figure 5 yes Figure 1 A front view of a second embodiment of the sealing element of the balloon catheter shown;

[0022] Figure 6 yes Figure 1 The diagram shows a cross-sectional view of the soft tip of the balloon catheter.

[0023] Figure 7 yes Figure 1 The diagram shows a partial structural schematic of the balloon catheter.

[0024] Figure 8 yes Figure 7 The diagram shows the balloon catheter in its in-use state after balloon inflation.

[0025] Figure 9 It is a cross-sectional view of an existing bronchoscope;

[0026] Figure 10 This is a schematic diagram of the fourth embodiment of the balloon catheter of this utility model after inflation;

[0027] Figure 11 yes Figure 10 The diagram shown illustrates the balloon catheter during pressure maintenance.

[0028] Figure 12 yes Figure 11 The diagram shown illustrates the balloon catheter during inflation.

[0029] Figure 13This is a schematic diagram of the fifth embodiment of the balloon catheter of this utility model;

[0030] Figure 14 yes Figure 13 The diagram shows a cross-sectional view of a portion of the structure of the balloon catheter.

[0031] Figure 15 This is a cross-sectional view of another embodiment of the balloon of the balloon catheter of this utility model;

[0032] Figure 16 yes Figure 15 A magnified view of a portion of the balloon catheter shown;

[0033] Figure 17 This is a schematic diagram of the sixth embodiment of the balloon catheter of this utility model;

[0034] Figure 18 This is a front view of the support guidewire of the balloon catheter of this utility model;

[0035] Figure 19 This is a front view of another embodiment of the support guidewire of the balloon catheter of this utility model;

[0036] Figure 20 yes Figure 19 The figure shown is a cross-sectional view of the support guidewire of the balloon catheter of this utility model after it has been implanted into the catheter.

[0037] Figure 21 This is a schematic diagram of the balloon catheter assembly of this utility model.

[0038] Reference numerals: 100 - Balloon catheter; 1 - First part; 11 - First sub-part; 12 - Second sub-part; 13 - Third sub-part; 14 - Elastic element; 2 - Second part; 21 - Through hole; 22 - Curved surface; 3 - Third part; 4 - Soft tip; 41 - Protrusion; 42 - Covering part; 5 - Seal; 51 - Insertion part; 52 - Handle part; 6, 6' - Balloon; 61 - End; 61' - Connecting part; 62' - Head; 63 '-Bulging part; 7-Support guide wire; 71-First support part; 72-Second support part; 8-Pressure pressurizer; 81-Pressure port; 200-Two-way tube; 201-Switch; 202-First port; 203-Second port; 204-First sealing ring; 205-Sealing cap; 206-Squeezing part; 300-Bronchi; 400-Bronchoscope; 401-First cavity; 402-Second cavity; 403-Inlet; 404-Outlet. Detailed Implementation

[0039] The balloon catheter and its components provided by the present invention will be clearly and completely described below with reference to the accompanying drawings.

[0040] In one embodiment, the present invention provides a balloon catheter 100, comprising a catheter, a sealing element 5, and a balloon 6, as shown below. Figures 1 to 4 As shown.

[0041] Preferably, the sealing element 5 is disposed at the proximal end of the catheter to seal the opening 20 at the proximal end of the catheter, thereby maintaining pressure on the catheter and facilitating the removal of the bronchoscope from the balloon catheter. Furthermore, the sealing element 5 can be made of a metallic material or a non-metallic material, such as silicone or rubber.

[0042] In a further preferred embodiment, the balloon 6 inflates upon inflation, thereby anchoring itself within the bronchus and blocking it.

[0043] 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.

[0044] In one embodiment, the catheter includes a channel 10 and an opening 20, the opening 20 being disposed at the proximal end of the catheter, and a balloon 6 being disposed at the distal end of the catheter. One end of the channel 10 communicates with the opening 20, and the other end of the channel 10 communicates with the balloon 6. Figure 10 As shown.

[0045] Preferably, the channel 10 is the inner lumen of the catheter so that gas or liquid can be transmitted into the balloon 6 through the channel 10 to inflate the balloon 6.

[0046] More preferably, the opening 20 is provided at the proximal end of the conduit for connection with the inflator 8 so as to inflate through the opening 20, etc. The opening 20 may be provided on the end face or side of the proximal end, etc.

[0047] More preferably, the balloon is placed over the distal end of the catheter, thereby extending into the bronchus along with the distal end of the catheter to achieve bronchial occlusion and anchoring. The balloon has various embodiments, such as in one embodiment... Figure 15 and Figure 16 As shown, balloon 6' is fitted over the distal end face of the catheter. In another embodiment, as... Figure 1 , Figure 7 , Figure 8 and Figure 10 As shown, balloon 6 is fitted onto the non-end face of the distal end of the catheter.

[0048] More preferably, one end of the channel 10 is connected to the opening 20, so that gas or liquid injected through the opening 20 enters the channel 10.

[0049] Furthermore, the other end of the channel 10 is connected to the balloon 6, allowing gas or liquid from the channel 10 to enter the balloon 6, thus inflating the balloon 6 and sealing or anchoring it within the bronchus. Specifically, the catheter has a through-hole 21 that penetrates both the inner and outer surfaces of the catheter. The through-hole 21 is connected to both the channel 10 and the balloon 6, allowing gas or liquid from the channel 10 to enter the balloon 6 through the through-hole 21.

[0050] It should be noted that: such as Figure 1 , Figure 7 , Figure 8 and Figure 10 As shown, when the balloon 6 is fitted onto the non-end face of the distal end of the catheter, the ends 61 on both sides of the balloon 6 are fixedly connected to the outer peripheral surface of the distal end of the catheter. This fixed connection is achieved through bonding or other methods. Furthermore, the axial length of the bonding area between one end of the balloon 6 and the outer peripheral surface of the second part 2 is any value between 0.3 mm and 2 mm, such as 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, etc., thereby improving the sealing effect of the balloon 6. Furthermore, when the balloon 6 is inflated, its outer surface is wavy, and the distance between the crest and trough is any value between 0.5mm and 2mm, such as 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 1.5mm, 2mm, etc., so that the outer surface of the balloon 6 is in close contact with the inner wall of the bronchus 300 and embedded in the inner wall of the bronchus, and the two interlock and anchor better.

[0051] It should be further explained that: Figure 6As shown, when the balloon 6 is fitted onto the non-end face of the distal end of the catheter, the distal end face of the second part 2 is provided with a soft tip 4. The soft tip 4 is made of a soft material, such as silicone or rubber, thereby reducing damage to the inner wall of the bronchus. Furthermore, the angle at the distal tip of the soft tip 4 is any value between 15 and 45 degrees, such as 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, or 45 degrees, making the distal end of the soft tip 4 more flexible than the proximal end, effectively reducing the risk of puncturing the inner wall of the bronchus 300. Furthermore, the flexible tip 4 includes a protrusion 42 and a covering portion 41. The protrusion 42 is housed inside the second part 2, and its outer peripheral surface abuts against the inner peripheral surface of the second part 2. Simultaneously, the covering portion 41 covers the outer peripheral surface of the second part 2, and its inner peripheral surface abuts against the outer peripheral surface of the second part 2, thereby fixing the flexible tip 4 to the distal end of the second part 2. Preferably, the protrusion 42 and the second part 2, and the covering portion 41 and the second part 2, are fixedly connected by means of bonding or other methods. Furthermore, the axial length of the protrusion 42 and the covering portion 41 is any value between 3mm and 10mm, such as 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, etc., thereby enhancing the structural strength of the flexible tip 4 fixed to the second part 2.

[0052] In one embodiment, opening 20 is connected to pressurizer 8 to pressurize channel 10, and seal 5 is used to at least partially insert into opening 20 to seal opening 20 when the conduit is fully pressurized. Figures 1 to 10 As shown.

[0053] Preferably, the pressurizer 8 is a conventional syringe or other pressurizing structure, where pressurization can be achieved by injecting gas or liquid to increase the pressure.

[0054] More preferably, the pressurizer 8 is provided with a pressurizing port 81, through which the pressurizer 8 discharges the gas or liquid inside it. The pressurizing port 81 is a hollow cylinder or other geometric shape.

[0055] Preferably, the opening 20 is connected to the pressurizer 8, specifically, the pressurizing port 81 is inserted into the opening 20 to pressurize towards the opening 20. Furthermore, the opening 20 is funnel-shaped, which allows the pressurizing port 81 to be inserted into the opening 20 more smoothly and quickly, improving operational efficiency.

[0056] More preferably, after the inflator 8 has inflated the catheter, the balloon 6 is anchored in the bronchus. Then, the sealing element 5 is inserted into the opening to seal the opening 20, thereby maintaining the pressure on the balloon 6 and keeping it anchored in the bronchus. The bronchoscope can be easily removed from the balloon catheter and withdrawn from the body.

[0057] Furthermore, the sealing element 5 can be inserted into the opening 20 in part or in its entirety to achieve a seal on the opening 20; no specific limitation is made here.

[0058] It should be noted that: when the catheter is pressurized, the seal 5 disengages from the opening 20 so that the pressurizing port 81 of the pressurizer 8 can be inserted into the opening 20 to pressurize the catheter; when the catheter is fully pressurized, the balloon 6 is anchored in the bronchus. When the pressurizing port 81 is removed from the opening 20, the seal 5 is inserted into the opening 20 to seal the opening 20 and maintain the pressure of the balloon 6.

[0059] Furthermore, the inner diameter of the first part 1 is smaller than the outer diameter of the charging port 81 of the pressurizer 8, so that when the charging port 81 extends into the opening 20, an interference seal is formed, thereby preventing air or liquid leakage.

[0060] In one embodiment, the catheter includes a first portion 1 at its proximal end, at least a portion of which is a flexible tube to achieve a seal on the opening 20 before the insertion of the seal 5 by means of a flexible tube bend. Figures 10 to 14 As shown.

[0061] Preferably, the first part 1 is located at the proximal end of the catheter and is outside the body during use, making it convenient for the user to hold it and insert the distal end of the catheter into the bronchus through a bronchoscope.

[0062] More preferably, the first part 1 can be entirely made of flexible tubing, such as... Figures 10 to 12 As shown, it can also be partially a flexible tube, such as the middle section or the end portion, for example... Figure 13 and Figure 14 As shown, the first part 1 can be initially sealed by bending the hose portion.

[0063] It should be noted that the above-mentioned hoses are preferably made of materials such as rubber and silicone, so that they have the function of being flexible and sealing, and have good resilience.

[0064] More preferably, the bending angle of the hose is sufficient to seal the first part 1, such as bending at 90 degrees, 120 degrees, or 150 degrees, etc.

[0065] More preferably, after the sealing element 5 is inserted into the opening 20, the tubing can also be reset and no longer bend, thereby facilitating the removal of the bronchoscope from the first part 1 and achieving smooth pressure maintenance of the balloon 6.

[0066] It should be noted that after the catheter is pressurized, the pressurization port 81 of the pressurizer 8 is pulled out by bending the tubing. At this time, the first part 1 is initially sealed. Then, the sealing element 5 is inserted into the opening 20 to reset the tubing. Then, the bronchoscope is pulled out from the first part 1, which effectively prevents gas or liquid leakage from the catheter and balloon 6.

[0067] In one embodiment, the catheter further includes a second portion 2 at the distal end and a third portion 3 between the first portion 1 and the second portion 2, wherein the hardness of the third portion 3 is greater than that of the first portion 1 and the second portion 2, such as... Figures 1 to 3 , Figure 7 , Figure 10 As shown.

[0068] Preferably, the second part 2 is located at the distal end of the catheter. When the catheter is in use, the second part 2 is located inside the bronchus, and the balloon 6 is fitted onto the second part 2 so that the balloon 6 can be inserted into the required bronchus.

[0069] More preferably, the second part 2 is a cone shape with a proximal diameter greater than the distal diameter. For example, the difference between the proximal and distal diameters of the second part 2 is 0.4 mm to 1.5 mm, and the length of the second part 2 is 5 mm to 20 mm. Thus, when the second part 2 extends into the bronchus with a smaller diameter, it can conform to the change in the diameter of the bronchus, reduce excessive dilation of the bronchus, and reduce the effect of damaging the bronchus.

[0070] More preferably, one end of the third part 3 is connected to the first part 1, and the other end is connected to the second part 2. Preferably, the first part 1, the second part 2 and the third part 3 are integrally formed, which can simplify the process and improve the structural stability.

[0071] Preferably, the diameter of the third part 3 is larger than the diameter of the second part 2. Specifically, the diameter of the third part 3 is h1, and the diameter of the balloon 6 on the second part 2 in the uninflated state is h2, where h1 is larger than h2. Figure 7 As shown, this allows the second part 2 and the balloon 6 to smoothly extend into the bronchus with a smaller diameter, and facilitates the smooth pushing of the third part 3 into the required bronchus.

[0072] More preferably, the coefficient of friction of the outer surface of the first part 1 is greater than that of the outer surfaces of the second part 2 and the third part 3. Thus, during use, the implantation device needs to pass through the opening 20 of the first part 1 and through the catheter. The larger coefficient of friction of the first part 1 is beneficial for the doctor to grasp the first part 1 and prevents the relative movement between the doctor's hand and the catheter due to a loose grip. The outer surface of the first part 1 can be sandblasted or have anti-slip textures to increase its coefficient of friction.

[0073] Furthermore, the hardness of the third part 3 is greater than that of the first part 1 and the second part 2, thereby allowing the catheter to pass smoothly through the tortuous channel inside the bronchoscope 400.

[0074] Furthermore, such as Figure 9As shown, the bronchoscope 400 includes a first cavity 401 and a second cavity 402. The lower end of the first cavity 401 has an outlet 404, and the upper end of the second cavity 402 has an inlet 403. The first cavity 401 and the second cavity 402 are connected and are bent at the connection. When the catheter is inserted into the bronchoscope 400, the distal end of the second part 2 passes through the inlet 403 into the second cavity 402, then passes through the bent connection between the second cavity 402 and the first cavity 401 and enters the first cavity 401. It then continues to move downward and extends from the outlet 404 to the outside of the bronchoscope 400. It is precisely because the second part 2 has less rigidity that it bends smoothly into the first cavity 401 when it enters from the second cavity 402, so as to play a traction and guiding role, and then the third part... 3 and the first part 1 then smoothly enter and pass through the first cavity 401; after the balloon 6 is inflated and anchored, the bronchoscope 400 needs to be withdrawn. When the bronchoscope 400 is withdrawn, the first part 1 moves into the second cavity 402, and then passes through the bend between the second cavity 402 and the first cavity 401 before being moved out through the first cavity 401. Therefore, the design of the first part 1 with low hardness allows it to pass smoothly through the second cavity 402 and the first cavity 401, preventing the first part 1 from being too hard and causing blockage inside the second cavity 402 and the first cavity 401.

[0075] Furthermore, the first part 1 is wavy, such as... Figure 2 As shown, this gives it better flexibility, facilitating its passage through the first cavity 401 and the second cavity 402 of the bronchoscope 400; or, the first part 1 is curved, as shown... Figure 3 As shown, this allows it to pass smoothly through the first cavity 401 and the second cavity 402 of the bronchoscope 400. In other embodiments, the second part 2 may also be wavy or curved.

[0076] In one embodiment, the first portion 1 includes a first sub-portion 11, a third sub-portion 13, and a second sub-portion 12 arranged sequentially from distal to proximal. The end of the first sub-portion 11 facing away from the third sub-portion 13 is connected to the third portion 3. Figure 13 and Figure 14 As shown.

[0077] Preferably, the first sub-part 11, the second sub-part 12, and the third sub-part 13 are integrally formed.

[0078] More preferably, the first sub-part 11 is located between the third sub-part 13 and the third part 3. One end of the first sub-part 11 is connected to the third part 3, and the other end is connected to the third sub-part 13. Preferably, the third sub-part 13, the first sub-part 11 and the third part 3 are integrally formed, which can simplify the production process and improve the structural strength.

[0079] In one embodiment, the third sub-part 13 is a flexible tube, such as... Figure 13 and Figure 14 As shown.

[0080] Preferably, the third sub-part 13 is a flexible tube, which facilitates the initial sealing of the opening 20 of the first part 1 by bending the third sub-part 13 after pressurization and before removing the pressurization port 81 of the pressurizer 8 from the opening, so as to facilitate the insertion of the sealing member 5 into the opening 20, thereby achieving pressure maintenance of the catheter and balloon 6.

[0081] More preferably, the third sub-part 13 is wavy, which facilitates its rapid bending and sealing.

[0082] It should be noted that the third sub-part 13 is located in the middle region of the first part 1. In other embodiments, the third sub-part 13 may also be located at the proximal end of the first part 1 or at the distal end of the first part 1, so as to meet different needs. No specific limitation is made here.

[0083] It should also be noted that Part 2 can also be entirely made of flexible tubing; no specific limitation is made here.

[0084] In one embodiment, the third sub-part 13 is provided with an elastic member 14, one end of which is fixedly connected to the first sub-part 11, and the other end of which is fixedly connected to the second sub-part 12. Figure 13 and Figure 14 As shown.

[0085] Preferably, the elastic element 14 is located between the first sub-part 11 and the second sub-part 12, and after the third sub-part 13 is bent, it is conducive to returning to its natural state and enhancing its restoring force.

[0086] More preferably, the elastic element 14 is a spring, but it can also be other elastic elements, which are not specifically limited here.

[0087] More preferably, one end of the elastic member 14 is fixedly connected to the first sub-part 11, for example, the end of the elastic member 14 is embedded in the first sub-part 11; the other end of the elastic member 14 is fixedly connected to the second sub-part 12, for example, the end of the elastic member 14 is embedded in the second sub-part 12.

[0088] More preferably, the third sub-part 13 covers the radially outer side of the elastic member 14, or is located on the radially inner side of the elastic member 14, so as to achieve a stable connection between the two.

[0089] Furthermore, the third sub-part 13 is injection molded onto the elastic element 14.

[0090] In one embodiment, the seal 5 includes an insertion portion 51 within the insertion opening 20 and a handle portion 52 located outside the conduit, wherein the maximum diameter of the insertion portion 51 is larger than the diameter of the handle portion 52, such as... Figure 4 and Figure 5 As shown.

[0091] Preferably, the insertion part 51 has a tapered structure, and the diameter of the distal end of the insertion part 51 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.

[0092] More preferably, the insertion part 51 is inserted into the opening 20, and the outer peripheral surface of the insertion part 51 abuts against the inner peripheral surface of the opening 20 to seal the opening 20, prevent air or liquid leakage, and play an effective pressure-maintaining role.

[0093] Preferably, the handle portion 52 is located outside the catheter, and the handle portion 52 is designed to facilitate the doctor's grip and operation.

[0094] More preferably, the insertion part 51 and the handle part 52 are fixedly connected, such as by bonding, or by integral injection molding, which can simplify the production process and improve the structural stability.

[0095] Furthermore, the maximum diameter of the insertion part 51 is greater than the diameter of the handle part 52 to prevent the handle part 52 from being pulled out of the catheter when the bronchoscope 400 is withdrawn, thus ensuring that the bronchoscope 400 is withdrawn smoothly.

[0096] Furthermore, the insertion part 51 is softer, making it easier to deform to meet the sealing of the opening 20. Also, the hardness of the insertion part 51 and the handle part 52 is less than that of the first part 1. That is, the insertion part 51 and the handle part 52 are softer than the first part 1, making it easier for them to pass through the inside of the bronchoscope 400.

[0097] In one embodiment, the hardness of the insertion portion 51 is less than the hardness of the handle portion 52, such as... Figure 4 and Figure 5 As shown.

[0098] Preferably, the hardness of the insertion part 51 is less than that of the handle part 52, which facilitates the insertion of the insertion part 51 into the opening 20 and helps to enhance the sealing effect of the opening 20.

[0099] More preferably, the handle portion 52 is less hard than the first portion 1, that is, the handle portion 52 is softer than the first portion 1, so that when the bronchoscope 400 is withdrawn from the first portion 1 of the catheter, the handle portion 52 can adapt to the shape of the cavity inside the bronchoscope 400 and deform accordingly, thereby allowing the bronchoscope 400 to be withdrawn smoothly and preventing the seal 5 from detaching from the opening 20 of the catheter.

[0100] In one embodiment, the handle portion 52 is curved, such as... Figure 5 As shown.

[0101] Preferably, the handle portion 52 is curved, which helps to adapt to the tortuous cavity inside the bronchoscope 400, so as to more smoothly withdraw the bronchoscope 400 and prevent the seal 5 from detaching from the opening 20 of the catheter.

[0102] It should be noted that the handle 52 can also be other geometric shapes, such as wavy shapes, so that the seal 5 will not detach from the opening 20 of the bronchoscope 400 when it is withdrawn from the bronchus.

[0103] like Figure 15 and Figure 16 As shown, this is another structural form of the balloon. The cross-section of the balloon 6' is U-shaped, and the distal end of the catheter is located inside the balloon 6' and fixedly connected to it.

[0104] Preferably, the balloon 6' is made of a soft material, such as latex or silicone.

[0105] More preferably, the cross-section of the balloon 6' is U-shaped, which facilitates the distal end of the catheter to be inserted into the interior of the balloon 6' through the opening to complete the inflation of the balloon 6'.

[0106] More preferably, the distal end of the second part 2 extends into the interior of the balloon 6', and the inner circumferential surface of the proximal end of the balloon 6' is fixedly connected to the outer circumferential surface of the second part 2, such as by bonding, thereby fixing the balloon 6' to the distal end of the catheter.

[0107] In one embodiment, an arc surface 22 is provided between the distal end face of the catheter and the circumferential surface of the catheter, such as... Figure 16 As shown.

[0108] Preferably, the distal end of the catheter is the distal end of the second part 2, such as... Figure 16 As shown, the distal end face of the second part 2 is its right surface, and the channel 10 penetrates the end face, so that the channel 10 communicates with the interior of the balloon 6' so as to pressurize towards the interior of the balloon 6'.

[0109] More preferably, the outer peripheral surface of the second part 2 is arc-shaped, and when the balloon 6' is in its natural state, the outer peripheral surface of the second part 2 fits against the inner surface of the balloon 6', thereby providing support for the balloon 6'.

[0110] More preferably, the distal end face of the second part 2 has an arc surface 22 between it and the outer peripheral surface of the second part 2 to prevent scratching or puncturing the inner wall of the balloon 6'.

[0111] In one embodiment, the outer surface of the balloon 6' is provided with a wear-resistant layer.

[0112] Preferably, the wear-resistant layer can be a talc layer or other wear-resistant materials. When the wear-resistant layer uses talc, the talc can form a fine powdery surface layer on the outer surface of the balloon 6', reducing the friction between the outer surface of the balloon 6' and other objects.

[0113] More preferably, the wear-resistant layer covers the entire outer surface of the balloon 6', or covers part of the outer surface of the balloon 6', etc.

[0114] In one embodiment, the balloon 6' includes a connecting portion 61', a head 62', and a bulge 63' disposed between the connecting portion 61' and the head 62', wherein the length t1 of the head 62' satisfies 1mm ≤ t1 ≤ 3mm. Figure 15 As shown.

[0115] Preferably, the connecting part 61' is disposed at the proximal end of the balloon 6', and the connecting part 61' covers the outer surface of the second part 2 and is fixedly connected to it, such as by bonding, so as to achieve the purpose of fixing the balloon 6' to the second part 2, thereby achieving the sealing of the balloon 6' and preventing gas or liquid from leaking out of the balloon 6'.

[0116] More preferably, the head 62' is located on one side of the second part 2. The head 62' is solid. When the second part 2 of the catheter is inserted into the bronchus, the head 62' acts as a buffer to prevent scratching or puncturing the inner wall of the bronchus and to protect the bronchus.

[0117] More preferably, the bulge 63' is disposed between the connecting part 61' and the head 62', one end of the bulge 63' is fixedly connected to the connecting part 61', and the other end is fixedly connected to the head 62'. The fixed connection can be adhesive or the like. In other embodiments, the connecting part 61', the head 62' and the bulge 63' are injection molded together.

[0118] More preferably, the bulge 63' is used to inflate the balloon 6' when it is inflated.

[0119] Furthermore, the length t1 of the head 62' 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., without any specific limitation here.

[0120] It should be noted that the limitation on the length of the head 62' serves as a buffer when the second part 2 extends into the bronchus, preventing scratching of the inner wall of the bronchus. At the same time, it eliminates the need for a soft tip, simplifying the structure.

[0121] In one embodiment, the distance t2 between the distal end face of the catheter and the head 62' satisfies 0mm ≤ t2 ≤ 1mm, such as... Figure 15 As shown.

[0122] Preferably, the distance between the distal end face of the catheter and the head 62' 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.

[0123] 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 2 and the head 62' will move relative to each other and rush toward the head 62'. Because the aforementioned distance is short, the second part 2 cannot form an acceleration distance, that is, the second part 2 hits the head 62' at the lowest possible speed, thereby reducing the impact damage of the second part 2 to the balloon 6'.

[0124] In one embodiment, the wall thickness of the bulge 63' is greater than the wall thickness of the connecting portion 61'.

[0125] Preferably, the wall thickness of the bulge 63' is greater than that of the connecting portion 61', thereby increasing the rupture resistance of the bulge 63' and further preventing the end of the second part 2 from puncturing the balloon 6'.

[0126] More preferably, the wall thickness of the bulge 63' is greater than the wall thickness of the connecting portion 61' to prevent the bulge 63' from breaking.

[0127] It should be noted that in other embodiments, the wall thickness of the bulge 63' can also be equal to the wall thickness of the connecting portion 61', such as... Figure 15 As shown, the wall thickness of the bulge 63' is less than the wall thickness of the connecting part 61'.

[0128] In one embodiment, the catheter further includes a cavity 30 that extends through the proximal end face and the distal end face of the catheter, such as... Figure 17 As shown.

[0129] Preferably, the cavity 30 extends through the proximal and distal ends of the catheter, and is used to deliver liquids, gases, or other necessary substances to the target location, simplifying the operation and improving the treatment effect.

[0130] More preferably, the cavity 30 and the channel 10 are arranged side by side, such as in parallel arrangement.

[0131] In one embodiment, the balloon catheter further includes a support guidewire 7, which is disposed within the catheter to provide support for the catheter. Figures 1 to 3 and Figure 17 As shown.

[0132] Preferably, the support guidewire 7 can be fixed inside the catheter or movably disposed inside the catheter.

[0133] More preferably, the support guidewire 7 is made of metal materials with good support such as nickel-titanium or stainless steel, so as to effectively support the catheter and allow it to extend smoothly into the bronchus.

[0134] More preferably, the proximal end of the support guidewire 7 is located between the first part 1 and the second part 2, thereby providing good support for the third part 3, making it easier to push the catheter to the required position.

[0135] In one embodiment, the support guide wire 7 includes a first support portion 71 disposed within the second portion 2 and a second support portion 72 disposed within the third portion 3. The insertion portion 52 is fixed to the end of the second support portion 72 opposite to the first support portion 71. Figures 18 to 20 As shown.

[0136] Preferably, the first support portion 71 is movably disposed inside the second part 2 so that it can be removed or implanted into the inside of the catheter, and the first support portion 71 is used to support the second part 2.

[0137] More preferably, the second support 72 is movably disposed inside the third part 3 so that it can be removed or implanted into the inside of the catheter, and the second support 72 is used to support the airway of the third part 3.

[0138] More preferably, the first support portion 71 and the second support portion 72 are fixedly connected, such as by bonding or integral molding, which simplifies the process and improves the structural stability.

[0139] More preferably, the insertion part 52 is fixedly connected to the end of the second support part 72 that is away from the first support part 71, such as by bonding or integral molding, so as to achieve a fixed connection between the support guide wire 7 and the sealing element 5.

[0140] It should be noted that the mutual fixation between the sealing element 5 and the supporting guide wire 7 allows the sealing element 5 and the supporting guide wire 7 to be removed together during pressurization. After pressurization is completed, the supporting guide wire 7 is inserted into the inside of the conduit to support the conduit, and the insertion part 51 of the sealing element 5 is then inserted into the conduit to achieve sealing and pressure maintenance of the conduit.

[0141] In one embodiment, the present invention also discloses a balloon catheter assembly, which includes a balloon catheter 100 and a two-way tube 200 as described above. The two-way tube 200 includes a first port 202 and a second port 203. The proximal end of the catheter is received within and sealed to the first port 202, and the second port 203 is connected to an inflator 8 to inflate the balloon catheter. Figure 21 As shown.

[0142] Preferably, the structure of the balloon catheter 100 refers to the balloon catheter described in any of the above embodiments, and will not be repeated here.

[0143] More preferably, the two-way tube 200 includes a first port 202 and a second port 203 opposite to each other. The first port 202 is connected to the second port 203. The first port 202 is used to connect to the balloon catheter, and the second port 203 is used to connect to the inflator 8, so as to realize the connection between the balloon catheter and the inflator 8.

[0144] Preferably, a switch 201 is provided between the first port 202 and the second port 203. The switch 201 has two working states: open and closed. When the switch 201 is in the open state, the first port 202 and the second port 203 are connected. When the switch 201 is in the closed state, the first port 202 and the second port 203 are not connected. The switch 201 of the two-way tube 200 is the prior art and will not be described in detail here.

[0145] More preferably, the proximal end of the catheter passes through the first port 202 and extends into the interior of the two-way tube 200. The proximal end of the catheter is sealed to the first port 202, so that gas or liquid entering the two-way tube 200 enters the catheter through the opening 20 at the proximal end of the catheter, thereby achieving the purpose of pressurizing the catheter.

[0146] Furthermore, the charging port 81 of the pressurizer 8 extends into the second port 203 and is sealed to the second port 203, thereby allowing the pressurizer 8 to smoothly pressurize into the two-way pipe 200 through the charging port 81.

[0147] In one embodiment, a first sealing ring 204 is provided inside the first port 202 of the two-way tube 200. The first sealing ring 204 is disposed between the inner peripheral surface of the first port 202 and the outer peripheral surface of the proximal end of the conduit. Figure 21 As shown.

[0148] Preferably, the first sealing ring 204 is annular, with its outer circumferential surface abutting against the inner circumferential surface of the first port 202, and its inner circumferential surface abutting against the outer circumferential surface of the proximal end of the conduit, thereby achieving a sealed connection between the two and effectively preventing leakage.

[0149] More preferably, the internal channel of the first sealing ring 204 is funnel-shaped, so that the proximal end of the catheter can quickly pass through the first sealing ring 204, which is convenient for doctors to operate.

[0150] In one embodiment, the first port of the two-way pipe is further provided with a sealing cap 205. The sealing cap 205 is fitted onto the first port 202 and threadedly connected thereto. The sealing cap 205 has a pressing portion 206 that abuts against the first sealing ring 204. Figure 21 As shown.

[0151] Preferably, the sealing cap 205 is fitted onto the first port 202, and the inner circumferential surface of the sealing cap 205 is in contact with the outer circumferential surface of the first port 202 and is threadedly connected thereto, so that the sealing cap 205 can be rotated to tighten it onto the first port 202 or unscrew it from the first port 202.

[0152] The sealing cap 205 is provided with a compression part 206. When the first sealing ring 204 is not compressed, the diameter of the inner circumferential surface of the first sealing ring 204 is larger than the diameter of the outer circumferential surface of the proximal end of the conduit. When the sealing cap 205 is tightened at the first port 202, the compression part 206 compresses the first sealing ring 204, reducing the inner diameter of the first sealing ring 204 and causing it to abut against the outer circumferential surface of the proximal end of the conduit, thus achieving a seal. When it is necessary to disconnect the two-way tube 200, the sealing cap 205 is removed from the first port 202, and the first sealing ring 204 returns to its natural state. The diameter of the inner circumferential surface of the first sealing ring 204 is larger than the diameter of the outer circumferential surface of the proximal end of the conduit, thereby allowing the proximal end of the conduit to be removed from the first port 202.

[0153] It should be noted that after the catheter is pressurized, the first part 1 is bent to achieve a preliminary seal on the catheter. Then, the sealing cap 205 is unscrewed to remove it from the first port 202. Then, the sealing element 5 is inserted into the opening 20 of the catheter to achieve a seal. Then, the first part 1 is restored to its natural state, and then the bronchoscope 400 is withdrawn.

Claims

1. A balloon catheter, characterized by, The device includes a catheter, a seal, and a balloon. The catheter includes a channel and an opening. The opening is located at the proximal end of the catheter, and the balloon is located at the distal end of the catheter. One end of the channel communicates with the opening, and the other end of the channel communicates with the balloon. The opening is connected to an inflator to inflate the channel. The seal is used to at least partially insert into the opening to seal the opening when the catheter is fully inflated.

2. The balloon catheter of claim 1, wherein, The catheter includes a first portion at its proximal end, at least a portion of which is a flexible tube to seal the opening by bending the tube before the seal is inserted.

3. The balloon catheter of claim 2, wherein, The catheter further includes a second portion at the distal end and a third portion between 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; And / or, the catheter further includes a lumen extending through the proximal end face and the distal end face of the catheter.

4. The balloon catheter of claim 3, wherein, The first part includes a first sub-part, a third sub-part, and a second sub-part arranged sequentially from distal to proximal. The end of the first sub-part facing away from the third sub-part is connected to the third part. The third sub-part is a flexible tube; And / or, the third sub-part is provided with an elastic element inside, one end of the elastic element is fixedly connected to the first sub-part, and the other end of the elastic element is fixedly connected to the second sub-part.

5. The balloon catheter of claim 3, wherein, The sealing element includes an insertion portion inserted into the opening and a handle portion located outside the conduit, 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.

6. The balloon catheter of claim 1, wherein, The balloon has a U-shaped cross-section, and the distal end of the catheter is located inside the balloon and is fixedly connected to it.

7. The balloon catheter of claim 6, 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.

8. The balloon catheter of claim 7, wherein, 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.

9. The balloon catheter of claim 5, wherein, The balloon catheter further includes a support guidewire disposed within the catheter. The support guidewire includes a first support portion disposed within the second part and a second support portion disposed within the third part. The insertion portion is fixed to the end of the second support portion opposite to the first support portion.

10. A balloon catheter assembly characterized by, The balloon catheter assembly includes a balloon catheter and a two-way tube as described in any one of claims 1 to 9, the two-way tube including a first port and a second port, the proximal end of the catheter being received in and sealed to the first port, and the second port being connected to an inflator to inflate the balloon catheter.

11. The balloon catheter assembly of claim 10, wherein, The first port of the two-way pipe is provided with a first sealing ring and a sealing cover. The first sealing ring is arranged between the inner circumferential surface of the first port and the outer circumferential surface of the proximal end of the catheter. The sealing cover is sleeved on the first port and is screwed with the first port. The sealing cover is provided with a pressing part abutting against the first sealing ring.

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