A lung lobe ventilation detection balloon catheter and a lung lobe ventilation function detection device

Abstract

The utility model relates to a kind of lobe ventilation detection balloon catheter, involve lobe ventilation detection technical field, the lobe ventilation detection balloon catheter includes catheter and balloon, catheter includes first passage and second passage, first passage and second passage are the cavity for gas passing, balloon includes balloon body and the installation part respectively arranged in the both ends of balloon body, balloon body is fixedly connected with catheter end by installation part, installation part near catheter end is recessed in balloon body, balloon is communicated with first passage, balloon body is formed sealed cavity with catheter by installation part, balloon is inflated after occluding trachea by first passage, catheter end is recessed in balloon interior along the direction of catheter axis. The utility model is in by the end of catheter is inshrunk to balloon recessed area along the direction of catheter axis, balloon body carries out certain protection to the circumference of catheter end, avoid the direct contact of catheter end and bronchial mucosa.

Description

Technical Field

[0001] This utility model relates to the field of lobar ventilation detection technology, and specifically to a lobar ventilation detection balloon catheter. Background Technology

[0002] Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease characterized by chronic respiratory symptoms caused by airway and / or alveolar abnormalities. Among existing medical lung volume reduction techniques for treating COPD, the most widely used and technically mature technique is endobronchial one-way valve placement. This technique involves placing an airway stent with one-way valve function into the target lung lobe, blocking the target lobe's bronchus. During expiration, gas is expelled; during inspiration, the valve closes to prevent airflow in, ultimately causing atelectasis in the target lung lobe, achieving the goal of "volume reduction." However, before valve placement, a pulmonary ventilation function test must be performed to check for bypass ventilation in the target lung lobe.

[0003] In existing technologies, bronchial occlusion is commonly achieved using a balloon-filled catheter for lobular ventilation function testing. Pressure and airflow changes are then measured through a central lumen. Specifically, the catheter balloon inflates to block the target bronchus, while the central lumen allows air to enter the control device from the isolated lung cavity. However, during testing, the central lumen at the end of the catheter furthest from the control device often comes into close contact with the bronchial mucosa. This can cause mucus blockage of the central lumen or bronchial mucosal adhesion to the distal end of the central lumen, forcing airflow interruption and leading to testing interruption. This prolongs testing time and significantly impacts testing efficiency.

[0004] There is an urgent need to design a balloon catheter for detecting lobar ventilation to solve the above-mentioned technical problems. Utility Model Content

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide a balloon catheter for detecting lobular ventilation.

[0006] To achieve the above objectives, in a first aspect, this utility model provides a balloon catheter for detecting lobar ventilation, employing the following technical solution:

[0007] A balloon catheter for lobular ventilation monitoring includes a catheter and a balloon. The catheter includes a first channel and a second channel, which are lumens through which gas passes. The balloon includes a balloon body and mounting portions respectively disposed at both ends of the balloon body. The balloon body is fixedly connected to the end of the catheter through the mounting portions. The mounting portions near the end of the catheter are recessed into the balloon body. The balloon communicates with the first channel. The balloon body and the catheter form a sealed cavity through the mounting portions. After the balloon is inflated through the first channel, it blocks the trachea. The end of the catheter is recessed into the balloon along the direction of the catheter axis.

[0008] Furthermore, the extension direction of the catheter axis is set as the first direction. When the balloon is in an inflated state, the distance between the farthest end of the balloon body near the end of the catheter in the first direction and the distance between the farthest end of the catheter in the first direction is greater than or equal to 1 mm.

[0009] Furthermore, the first channel is provided with a balloon inflation port, and the balloon inflation volume is 3-6 ml.

[0010] Furthermore, when the balloon is in an inflated state, the direction perpendicular to the first direction is set as the second direction, and the distance between the balloon body and the first direction in the second direction is less than or equal to 6 mm.

[0011] Furthermore, the mounting portion near the end of the catheter is a first mounting portion, and the balloon has a bent portion at one end near the first mounting portion. The bent portion is recessed inside the balloon body and extends toward the end away from the end of the catheter. The first mounting portion is connected to the bent portion and extends toward the end near the end of the catheter.

[0012] Furthermore, the mounting part and the conduit are connected by welding.

[0013] Furthermore, the thickness of the mounting portion is greater than or equal to the thickness of the balloon body.

[0014] Furthermore, the mounting part and the balloon body are integrally formed.

[0015] Furthermore, the outer wall of the catheter is coated with a hydrophilic coating.

[0016] Secondly, this utility model provides a lung ventilation function testing device, which adopts the following technical solution:

[0017] A device for detecting lobular ventilation function includes a lobular ventilation detection balloon catheter as described in the first aspect. A handle assembly is provided at one end of the catheter away from the balloon. The handle assembly includes a main handle and a balloon pressurization handle. The main handle is provided with an air delivery tube communicating with a second channel, and the balloon pressurization handle is provided with an injection tube communicating with the first channel.

[0018] The present invention provides a balloon catheter for detecting lobar ventilation, which has the following beneficial technical effects:

[0019] This utility model provides a balloon catheter for lobular ventilation testing. By retracting the catheter tip into the concave area of ​​the balloon, the balloon body provides circumferential protection for the catheter tip, avoiding direct contact between the catheter tip and the bronchial mucosa. This reduces the likelihood of mucus clogging the central lumen of the catheter or bronchial mucosa adhering to and blocking the distal end of the central lumen, significantly reducing the risk of airflow obstruction and improving the accuracy of lobular ventilation testing. Furthermore, it avoids scratching the bronchial mucosa by the catheter, reducing patient discomfort and potential damage risks. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the lung ventilation function testing device according to a specific embodiment of the present invention.

[0022] Figure 2 This is a partial structural cross-sectional view of the balloon catheter for lobar ventilation detection according to a specific embodiment of the present invention.

[0023] Figure 3 This is a schematic diagram of the three-dimensional structure of the balloon of this utility model;

[0024] Figure 4 This is a cross-sectional view of the balloon structure of this utility model.

[0025] In the figure, 100 is the catheter; 110 is the first channel; 120 is the second channel; 101 is the catheter tip; 200 is the balloon; 210 is the balloon body; 211 is the bend; 220 is the mounting part; 221 is the first mounting part; 300 is the balloon inflator; 400 is the handle assembly; 410 is the main handle; 420 is the balloon inflator handle; 500 is the air delivery tube; and 600 is the inflation tube. Detailed Implementation

[0026] The following is in conjunction with the appendix Figure 1 - Appendix Figure 4 The technical solutions in the embodiments of this application are clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0027] It should be noted that all directional indicators (such as up, down, left, right, front, back, etc.) in the embodiments of this application are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indicator will also change accordingly.

[0028] Furthermore, the use of terms such as "first," "second," etc., in this application is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0029] In this application, unless otherwise expressly specified and limited, the terms "connection," "fixed," etc., should be interpreted broadly. For example, "fixed" can mean a fixed connection, a detachable connection, or an integral part; it can mean a mechanical connection or an electrical connection; it can mean a direct connection or an indirect connection through an intermediate medium; it can mean the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0030] Furthermore, the technical solutions of the various embodiments of this application 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 this application.

[0031] like Figures 1 to 4 As shown in the figure, this utility model discloses a balloon catheter for lobular ventilation detection, including a catheter 100 and a balloon 200. The catheter 100 includes a first channel 110 and a second channel 120, which are cavities for gas passage. The balloon 200 includes a balloon body 210 and mounting portions 220 respectively disposed at both ends of the balloon body 210. The balloon body 210 is fixedly connected to the catheter tip 101 through the mounting portions 220. The mounting portions 220 near the catheter tip 101 are recessed inside the balloon body 210. The balloon 200 communicates with the first channel 110. The balloon body 210 and the catheter 100 form a sealed cavity through the mounting portions 220. After the balloon 200 is inflated through the first channel 110, it blocks the trachea. The catheter tip 101 is recessed inside the balloon 200 along the axis of the catheter 100.

[0032] like Figure 2 As shown, the catheter 100 has two independent channels inside: a first channel 110 and a second channel 120. The first channel 110 is used to inject air into the balloon 200, causing it to expand and close the target bronchus. The second channel 120 serves as an airflow channel, allowing gas to enter the control device from the isolated lung cavity. The end of the catheter 100 furthest from the handle is the catheter tip 101. The balloon 200 is fixedly mounted on the outer surface of the catheter tip 101 and communicates with the first channel 110. When the balloon 200 is inflated, the balloon body 210 expands and closes the bronchus. The end of the balloon 200 near the catheter tip 101 contracts along the axis of the catheter 100 to form a concave area, completely retracting the catheter tip 101 within this concave area. This design avoids direct contact between the catheter tip 101 and the bronchial mucosa, thereby reducing the risk of airflow interruption due to mucosal adhesion.

[0033] By retracting the catheter tip 101 into the recessed area of ​​the balloon 200, the balloon body 210 provides circumferential protection for the catheter tip 101, avoiding direct contact between the catheter tip 101 and the bronchial mucosa. This reduces the likelihood of mucus clogging the central lumen of the catheter 100 or bronchial mucosa adhering to and blocking the distal end of the central lumen, significantly reducing the risk of airflow obstruction, improving the accuracy of lobar ventilation detection, and reducing the time required to readjust the position of the catheter 100 due to airflow interruption. This significantly shortens the overall operation time and saves manpower and medical resource costs. Furthermore, it avoids scratching the lung components by the catheter tip 101, reducing patient discomfort and potential damage risks, and improving clinical acceptance.

[0034] In a preferred embodiment of the present invention, the extension direction of the axis of the catheter 100 is set as the first direction. When the balloon 200 is in an inflated state, the distance between the farthest end of the balloon body 210 near the catheter end 101 in the first direction and the distance between the farthest end of the catheter end 101 in the first direction is greater than or equal to 1 mm.

[0035] like Figure 1 , Figure 2 As shown, in order to prevent the catheter tip 101 from contacting the bronchial mucosa when the balloon 200 is in the inflated state, i.e. when the balloon 200 blocks the bronchus, the catheter tip 101 is recessed into the balloon body 210 along the axis of the catheter 100, and the horizontal distance of the catheter tip 101 in the first direction from the side of the balloon body 210 near the catheter tip 101 is greater than or equal to 1 mm.

[0036] In one embodiment of this utility model, the first channel 110 is provided with a balloon pressurization hole 300, and the balloon 200 is inflated to a volume of 3-6 ml.

[0037] To ensure that the trachea of ​​the lung lobe ventilation detection balloon catheter of this invention can be sealed off within the lung lobe tissue, and that the distal end 101 of the catheter does not come into direct contact with the bronchial mucosa, the first channel 110 can inflate the balloon 200 through the balloon pressure port 300. The inflation volume of the balloon 200 is not less than 3 ml. Furthermore, to prevent the distal end of the balloon 200 from closing due to excessive inflation, which could affect the ventilation volume of the second channel 120, the maximum inflation volume of the balloon 200 in this invention does not exceed 6 ml. Through multiple experiments, the lung lobe ventilation detection balloon catheter of this invention has been verified that when the inflation volume reaches 3 ml, the distal end of the balloon 200 maintains unobstructed airflow without self-closure.

[0038] In a preferred embodiment of the present invention, when the balloon 200 is in an inflated state, the direction perpendicular to the first direction is set as the second direction, and the distance between the balloon body 210 and the first direction in the second direction is less than or equal to 6 mm.

[0039] By ensuring that the distance between the balloon 200 in the second direction and the first direction is less than or equal to 6 mm, it is guaranteed that the balloon 200 matches the normal diameter of the bronchus after inflation, avoiding airway damage (such as mucosal tearing, vascular rupture, etc.) caused by over-expansion of the balloon 200. Furthermore, since the working channel of a bronchoscope is usually limited, restricting the size of the balloon 200 in the second direction prevents situations where the catheter tip 101 and the balloon 200 are difficult to bronchoscope, ensuring the compatibility of the balloon catheter and bronchoscope for lobar ventilation testing and facilitating clinical operation.

[0040] In a preferred embodiment of the present invention, the mounting portion 220 near the catheter tip 101 is a first mounting portion 221, and the balloon 200 is provided with a bent portion 211 at one end near the first mounting portion 221. The bent portion 211 is recessed inside the balloon body 210 and extends toward the end away from the catheter tip 101. The first mounting portion 221 is connected to the bent portion 211, and the first mounting portion 221 extends toward the end near the catheter tip 101.

[0041] like Figure 3 , Figure 4As shown, by providing the bending portion 211, the balloon 200 can be guided to expand into a predetermined shape during inflation, ensuring that the balloon 200 maintains an ideal geometric shape during use. This facilitates the recessing of the first mounting portion 221 and the catheter tip 101 within the balloon body 210, which is particularly important for applications requiring precise expansion. Simultaneously, the design of the bending portion 211 creates a more robust connection structure between the balloon body 210 and the first mounting portion 221, helping to resist inflation pressure and preventing stress concentration points at the connection point, thus reducing the risk of balloon 200 rupture. Furthermore, the bending portion 211 provides additional visual or tactile reference points for the relative distance between the catheter tip 101 and the balloon body 210, helping medical personnel better determine the position and status of the balloon 200.

[0042] In a preferred embodiment of this utility model, the mounting part 220 and the conduit 100 are connected by welding.

[0043] By welding the mounting part 220 to the catheter 100, a seamless connection can be formed between the mounting part 220 and the catheter 100, effectively preventing gas or liquid leakage from the connection point, ensuring a firm bond between the mounting part 220 and the catheter 100, and improving the safety and reliability of the overall device. When welding the balloon 200 and the catheter 100 of this invention, the first mounting part 221 near the catheter end 101 can be welded to the catheter end 101 first. Before welding the first mounting part 221 to the catheter 100, the first mounting part 221 is pulled out from the recess in the balloon body 210. After welding is completed, the first mounting part 221 and the balloon body 210 are reset. At this time, the bending part 211 can provide additional positioning reference for the relative distance between the first mounting part 221 and the recess inside the balloon body 210. Subsequently, the mounting part 220 away from the catheter end 101 is welded to the outer wall of the catheter 100.

[0044] It should be noted that this utility model does not limit the connection method between the mounting part 220 and the conduit 100. In the second embodiment of this utility model, the mounting part 220 and the conduit 100 can be connected by ultrasonic welding, laser welding, or other methods. Similarly, the mounting part 220 and the conduit 100 can also be connected by heat fusion, bonding, or other methods. This utility model does not limit the material of the balloon 200. In one embodiment, the balloon 200 is made of PEBAX material, and in another embodiment, the balloon 200 is made of TPU material.

[0045] In a preferred embodiment of this invention, the thickness of the mounting portion 220 is greater than or equal to the thickness of the balloon body 210. As the connection area between the balloon 200 and the catheter 100, the mounting portion 220 must withstand the expansion pressure during balloon inflation. To enhance the strength and sealing of the connection structure between the balloon 200 and the catheter 100, a thicker mounting portion 220 can increase the tensile strength of the local material, preventing tearing or seal failure at the connection due to excessive pressure, and also preventing gas leakage from the balloon 200. Furthermore, the thickened design of the mounting portion 220 enhances the shape memory capability of the recessed area formed by the distal end of the balloon 200 contracting towards the axis of the catheter 100. When the inner surface of the distal end of the balloon 200 is fixed to the catheter tip 101, the thicker material prevents the recessed area from over-expanding or deforming due to insufficient material after inflation, ensuring that the catheter tip 101 is completely retracted into the recessed area, thus helping to maintain the morphological stability of the balloon 200. Furthermore, the increased thickness of the mounting section 220 reduces material fatigue failure caused by repeated inflation and deflation (such as multiple ventilation tests), meeting the durability requirements of medical devices.

[0046] In a preferred embodiment of this invention, the mounting portion 220 and the balloon body 210 are integrally formed. By making the mounting portion 220 and the balloon 200 an integral structure, the stress distribution of the mounting portion 220 and the balloon body 210 can be more uniform through the continuity of the materials, reducing local weak points and preventing the risk of rupture due to uneven pressure. In addition, it simplifies the manufacturing process, reduces costs, and improves the consistency of the balloon 200.

[0047] In a preferred embodiment of this invention, the outer wall of the catheter 100 is coated with a hydrophilic coating. By applying this hydrophilic coating to the outer wall of the catheter 100, the coating absorbs moisture and forms a lubricating film on the surface of the catheter 100. This film significantly reduces the coefficient of friction between the catheter 100 and surrounding tissues such as the bronchi; it reduces the risk of mechanical damage to the bronchial walls and other contact areas, greatly alleviating patient discomfort and even pain, and to a certain extent enhancing the biocompatibility and safety of the catheter 100. These improvements make medical procedures safer and more effective, while also improving the overall treatment outcome.

[0048] This utility model also provides a device for detecting lobular ventilation function, including the lobular ventilation detection balloon catheter described in the first aspect. The end of the catheter 100 away from the balloon 200 is provided with a handle assembly 400. The handle assembly 400 includes a main handle 410 and a balloon pressurization handle 420. The main handle 410 is provided with an air guide tube 500 communicating with the second channel 120. The balloon pressurization handle 420 is provided with an air injection tube 600 communicating with the first channel 110.

[0049] like Figure 1As shown, by setting the balloon pressure handle 420 and the air inlet tube 600 to communicate with the first channel 110, medical personnel can pressurize the balloon 200 through the balloon pressure handle 420 to inflate it and block the bronchus; by setting the main handle 410 and the air inlet tube 500 to communicate with the second channel 120, it can be ensured that the gas in the bronchus can be discharged through the second channel 120 and the air inlet tube 500. At the same time, the end of the main handle 410 away from the catheter 100 is connected to the detection unit to detect whether there is gas discharge in the air inlet tube 500.

[0050] This pulmonary ventilation function testing device has broad applicability and can be used for the diagnosis and treatment monitoring of various respiratory diseases such as chronic obstructive pulmonary disease (COPD) and emphysema, and is especially suitable for cases with complex airway structures. By setting a unique recessed balloon 200 at the catheter tip 101, which is far from the handle assembly 400, the catheter tip 101 is recessed into the balloon body 210 relative to the balloon 200, which solves many shortcomings of the prior art, significantly improves the testing efficiency and patient experience, and has broad application prospects and important clinical value.

[0051] The steps for using the lung lobar ventilation function testing device of this utility model are as follows:

[0052] First, prepare by checking that the aseptic packaging is intact and confirming that the catheter 100, handle assembly 400, and detection unit are undamaged. Use a syringe to test the seal of the balloon 200 to ensure it can retain injected air.

[0053] Next, the catheter 100 is inserted. In a standard diagnostic bronchoscopy procedure, the catheter 100 is carefully inserted into the working channel of the bronchoscope until the target airway is reached. At this time, the balloon 200 is in a vacuum state and can be closely attached to the outer wall of the catheter 100 to ensure that it will not be relatively displaced from the end of the catheter 101 when it enters the working channel of the bronchoscope along with the catheter 100.

[0054] Subsequently, the balloon 200 is inflated, and an appropriate amount of air is injected into the balloon 200 through the first channel 110 via the balloon pressurization handle 420, causing the balloon 200 to expand and close the target bronchial segment.

[0055] Finally, the airflow is measured, and the changes in airflow are monitored in real time using the second channel 120 to determine whether bypass ventilation is needed. After the measurement is completed, the air is deflated using the balloon inflator handle 420, and then the catheter 100 is removed.

[0056] The above description is merely a preferred embodiment of this application and does not limit the patent scope of this application. Any equivalent structural transformations made based on the inventive concept of this application and the contents of the specification and drawings of this application, or direct / indirect applications in other related technical fields, are included within the patent protection scope of this application.

Claims

1. A balloon catheter for detecting lobar ventilation, characterized in that, include: The catheter (100) includes a first channel (110) and a second channel (120), wherein the first channel (110) and the second channel (120) are lumens through which gas passes; A balloon (200) includes a balloon body (210) and mounting portions (220) respectively disposed at both ends of the balloon body (210). The balloon body (210) is fixedly connected to the end of the catheter (101) through the mounting portions (220). The mounting portion (220) near the end of the catheter (101) is recessed inside the balloon body (210). The balloon (200) communicates with the first channel (110). The balloon body (210) and the catheter (100) form a sealed cavity through the mounting portion (220). After the balloon (200) is inflated through the first channel (110), it blocks the trachea. The end of the catheter (101) is recessed inside the balloon (200) along the direction of the axis of the catheter (100).

2. The balloon catheter for detecting lobar ventilation according to claim 1, characterized in that, The extension direction of the catheter (100) axis is set as the first direction. When the balloon (200) is in an inflated state, the distance between the farthest end of the balloon body (210) near the catheter tip (101) in the first direction and the distance between the farthest end of the catheter tip (101) in the first direction is greater than or equal to 1 mm.

3. The balloon catheter for detecting lobar ventilation according to claim 1, characterized in that, The first channel (110) is provided with a balloon pressurization port (300), and the balloon (200) is inflated to a volume of 3-6 ml.

4. The balloon catheter for detecting lobar ventilation according to claim 2, characterized in that, When the balloon (200) is in an inflated state, the direction perpendicular to the first direction is set as the second direction, and the distance between the balloon body (210) and the first direction in the second direction is less than or equal to 6 mm.

5. The balloon catheter for detecting lobar ventilation according to claim 1, characterized in that, The mounting portion (220) near the end of the catheter (101) is a first mounting portion (221). The balloon (200) has a bent portion (211) near the first mounting portion (221). The bent portion (211) is recessed inside the balloon body (210) and extends toward the end away from the end of the catheter (101). The first mounting portion (221) is connected to the bent portion (211). The first mounting portion (221) extends toward the end near the end of the catheter (101).

6. The balloon catheter for detecting lobar ventilation according to claim 1, characterized in that, The mounting part (220) and the conduit (100) are connected by welding.

7. The pulmonary ventilation detection balloon (200) catheter (100) according to claim 1, characterized in that, The thickness of the mounting portion (220) is greater than or equal to the thickness of the balloon body (210).

8. The balloon catheter for detecting lobar ventilation according to claim 1, characterized in that, The mounting part (220) and the balloon body (210) are integrally formed.

9. The balloon catheter for detecting lobar ventilation according to claim 1, characterized in that, The outer wall of the conduit (100) is coated with a hydrophilic coating.

10. A device for detecting pulmonary lobar ventilation function, characterized in that, The device includes a pulmonary ventilation detection balloon (200) catheter (100) according to any one of claims 1-9, wherein a handle assembly (400) is provided at one end of the catheter (100) away from the balloon (200), the handle assembly (400) includes a main handle (410) and a balloon pressurization handle (420), the main handle (410) is provided with an air delivery tube (500) communicating with the second channel (120), and the balloon pressurization handle (420) is provided with an air injection tube (600) communicating with the first channel (110).

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