Balloon catheter with flow-directed sampling

Abstract

This utility model relates to a balloon catheter capable of diverting fluid for sampling, comprising a double-lumen tube, a core tube, a handle assembly, a soft tip, and a sampling balloon. The sampling balloon includes a balloon body and multiple longitudinal grooves, which are disposed on the sidewall of the balloon body and connect the front and rear ends of the balloon body. This balloon catheter capable of diverting fluid for sampling can perform pathological sampling in natural body cavities, allows for both air and fluid permeation, offers enhanced safety, and is simple and convenient to operate.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, specifically to a balloon catheter that can be used for pathological sampling, local compression hemostasis, and control of fluid flow rate in natural human cavities (such as the respiratory tract, blood vessels, digestive tract, urinary tract, etc.). Background Technology

[0002] Rapid economic growth has led to lifestyle changes, including unhealthy habits and dietary variations, resulting in various diseases such as infections, cancer, and atherosclerosis affecting the body's natural cavities. These diseases seriously impact patients' health and lives. To determine the specific nature of these conditions, doctors first take samples from the affected areas and then analyze the samples.

[0003] There are many methods for sample collection. Currently, the main instruments on the market are sampling forceps and sampling brushes. Sampling forceps use the closed forceps to grasp tissue from the lesion site. This sampling method is more invasive and may cause bleeding or perforation. Sampling brushes, on the other hand, use bristles to collect cell samples from the lesion site. This sampling method causes less tissue damage, has a lower risk of bleeding, but requires a smaller sample volume and may need to be repeated. There is also a risk of bristle shedding.

[0004] In addition, existing sampling devices have limited functionality, cannot immediately apply pressure to stop bleeding after sampling, and do not have the ability to control the flow rate of gas or liquid in environments such as the airway, blood vessels, or ureters.

[0005] Therefore, there is an urgent need for a multifunctional medical device that can simultaneously satisfy the requirements of safe sampling, effective hemostasis, and controllable drainage. Utility Model Content

[0006] The technical problem to be solved by this utility model is to overcome the shortcomings of the prior art and provide a balloon catheter that can guide sampling, thereby solving the technical problem that the current sampling devices have limited functions and do not have the ability to control the flow rate of gas or liquid in environments such as airways, blood vessels or ureters.

[0007] The technical solution adopted by this utility model to solve its technical problem is:

[0008] First aspect:

[0009] A balloon catheter capable of guiding and sampling is provided, including...

[0010] The device comprises a dual-lumen tube, a core tube, a handle assembly, a front soft tip, and a sampling balloon, wherein the sampling balloon is disposed between the front soft tip and the dual-lumen tube.

[0011] The sampling balloon includes a balloon body and multiple longitudinal grooves. The longitudinal grooves are disposed on the sidewall of the balloon body, and the two ends of the longitudinal grooves are connected to the front and rear ends of the balloon body.

[0012] A balloon flap is formed between adjacent longitudinal grooves. When the sampling balloon is injected with fluid, the balloon flap expands and bulges. The sampling balloon rotates at the lesion site through the rotating catheter, generating friction with the lesion site. During rotation, the dislodged pathological sample is introduced into the longitudinal groove. After sampling is completed, when the fluid in the sampling balloon is aspirated, the balloon flap contracts and folds in the center to form a flap. The flap is suitable for wrapping the pathological sample in the longitudinal groove.

[0013] Furthermore, the longitudinal groove is a straight groove, and the balloon flap body is a straight strip structure.

[0014] Furthermore, the longitudinal groove is a helical groove, so that the balloon flap body has a helical structure.

[0015] Furthermore, the balloon flap body is provided with multiple transverse grooves, and each transverse groove is distributed along the length of the balloon flap body.

[0016] Furthermore, the longitudinal groove has an arc-shaped structure.

[0017] Furthermore, the transverse groove has a V-shaped structure.

[0018] The second aspect:

[0019] A sampling method is provided, using the aforementioned divertable sampling balloon catheter, as follows:

[0020] Under X-ray monitoring or direct endoscopic visualization, the balloon catheter is guided by a guidewire to the lesion site and left in place. Once the sampling balloon is confirmed to be positioned at both ends of the lesion, a pressure pump with a gauge is connected to the injection chamber of the balloon catheter's handle assembly. Fluid is slowly injected into the balloon to inflate it. Inflation is stopped once the expansion pressure is reached. By rotating the catheter, the balloon's valve body rotates at the lesion site, creating friction. During rotation, detached cell samples or mucus are introduced into the longitudinal groove. After sampling, the fluid in the sampling balloon is aspirated completely, and the balloon slowly contracts, encasing the pathological sample within the longitudinal groove. The balloon catheter is then withdrawn from the body's natural cavities, and the pathological sample is retrieved for pathological examination.

[0021] The beneficial effects of this utility model are:

[0022] This utility model of a balloon catheter capable of diverting and sampling can perform pathological sampling in the natural cavities of the human body. It can be ventilated and circulated with fluid, making it safer and simple and convenient to operate.

[0023] Within a human body cavity, a rotating sampling balloon can guide pathological samples into a longitudinal groove. The pathological sample is then successfully removed by wrapping the longitudinal groove with a flap.

[0024] When bleeding occurs at the site of a lesion within a cavity, a balloon is placed at the bleeding site to dilate it, and the balloon can compress and stop the bleeding in the axial direction. Attached Figure Description

[0025] The present invention will be further described below with reference to the accompanying drawings.

[0026] Figure 1 This is a three-dimensional diagram of the first type of balloon catheter capable of diverting and sampling.

[0027] Figure 2 This is the front view of the first type of balloon catheter capable of diverting and sampling;

[0028] Figure 3 This is a side view of the balloon body of the first type of balloon catheter.

[0029] Figure 4 This is a schematic diagram of the balloon body after it has contracted;

[0030] Figure 5 This is a three-dimensional diagram of the second type of balloon catheter capable of diverting and sampling.

[0031] Figure 6 This is the front view of the second type of balloon catheter capable of diverting samples;

[0032] Figure 7 This is a side view of the balloon body of the second type of balloon catheter;

[0033] Among them, 1. front soft tip, 2. imaging marker, 3. core tube, 4. dual-lumen tube, 5. handle assembly, 6. sampling balloon, 61. longitudinal groove, 62. balloon flap, 63. transverse groove, 64. flap. Detailed Implementation

[0034] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0035] This application provides a balloon catheter capable of diverting and sampling, which will be described in detail below. It should be noted that the order of description of the following embodiments is not intended to limit the preferred order of the embodiments of this application. Furthermore, the descriptions of each embodiment have their own emphasis; parts not described in detail in a certain embodiment can be referred to in the relevant descriptions of other embodiments.

[0036] To address the technical problem that existing sampling devices have limited functionality and lack the ability to control gas or liquid flow rates in environments such as airways, blood vessels, or ureters, one embodiment of this application provides a balloon catheter capable of guiding sampling. This is described in detail below.

[0037] like Figures 1 to 4 As shown, a balloon catheter capable of diverting and sampling includes...

[0038] The sample balloon 6 consists of a dual-lumen tube 4, a core tube 3, a handle assembly 5, a front soft tip 1, and a sampling balloon 6, wherein the sampling balloon 6 is disposed between the front soft tip 1 and the dual-lumen tube 4.

[0039] The handle assembly 5 is located at the rear end of the dual-lumen tube 4, and a sheath tube is provided at the rear end of the dual-lumen tube 4. One chamber of the dual-lumen tube 4 is connected to the sampling balloon 6, and the other chamber is provided with the core tube 3. The rear end of the core tube 3 is connected to the guide wire cavity of the handle assembly 5, and the sampling balloon 6 is connected to the injection cavity.

[0040] Two imaging markers 2 are set on the core tube 3. The imaging markers 2 are located inside the sampling balloon 6. The imaging markers 2 mark the position of the sampling balloon 6 in the human body.

[0041] The front ends of the sampling balloon 6 and the core tube 3 are both connected to the front soft tip 1.

[0042] like Figures 1 to 4 As shown, the sampling balloon 6 includes a balloon body and multiple longitudinal grooves 61. The longitudinal grooves 61 are disposed on the side wall of the balloon body, and the two ends of the longitudinal grooves 61 are connected to the front and rear ends of the balloon body.

[0043] like Figure 3 and Figure 4 As shown, a balloon flap 62 is formed between adjacent longitudinal grooves 61. When fluid is injected into the sampling balloon 6, the balloon flap 62 inflates. The rotating catheter causes the sampling balloon 6 to rotate at the lesion site, generating friction. During rotation, detached pathological samples are introduced into the longitudinal grooves 61. After sampling is completed, when the fluid in the sampling balloon 6 is aspirated, the balloon flap 62 contracts and folds to form a flap 64. Figure 4 As shown, the segmented flap 64 is adapted to enclose the pathological sample within the longitudinal groove 61.

[0044] like Figure 4 As shown, the flap 64 is formed by the balloon flap body 62 after it contracts. The flap 64 rotates with the catheter and can form a coiled structure to wrap the pathological sample in the longitudinal groove 61.

[0045] like Figure 3 and Figure 4 As shown, the longitudinal groove 61 is a straight groove, and the balloon flap 62 is a straight strip structure.

[0046] In this embodiment, the longitudinal groove 61 has an arc-shaped structure.

[0047] Specifically, as an optional implementation method in this embodiment, such as Figure 2 As shown, the balloon flap body 62 is provided with a plurality of transverse grooves 63, and each transverse groove 63 is distributed along the length of the balloon flap body 62.

[0048] By setting multiple transverse grooves 63 on the balloon valve body 62, the balloon valve body 62 forms a tooth-like structure. When each "tooth" on the balloon valve body 62 cooperates with the human body cavity, it is easier to introduce cell samples or mucus into the longitudinal groove 61. The transverse grooves 63 on the balloon valve body 62 also facilitate the introduction of pathological samples into the longitudinal groove 61.

[0049] Specifically, as an optional implementation method in this embodiment, such as Figure 2 As shown, the horizontal groove 63 has a V-shaped structure.

[0050] Another embodiment of this application, such as Figures 5 to 7 As shown, a balloon catheter capable of diverting and sampling is provided, and this embodiment is based on the above embodiment.

[0051] The only difference between the balloon catheter in this embodiment and the balloon catheter in the above embodiment is that the sampling balloon 6 has a longitudinal groove 61 that is a spiral groove, so that the balloon valve body 62 has a spiral structure.

[0052] By designing the longitudinal groove 61 as a spiral structure, compared to the straight structure described above, the sampling balloon 6 can easily introduce pathological samples into the longitudinal groove 61 during rotation.

[0053] The sampling balloon 6 of this invention is made of non-compliant material and is formed by blow molding, which is simple and has high production efficiency.

[0054] The blow-molded balloon body is then assembled and divided into wings and a roll-up mechanism. This gives it a certain memory effect when it expands and retracts, allowing it to roll up and retain its shape after fluid aspiration.

[0055] A method for pathological sampling of natural human cavities (such as the respiratory tract, blood vessels, digestive tract, urinary tract, etc.) using the aforementioned drainable sampling balloon catheter is described below:

[0056] Under X-ray monitoring or direct endoscopic visualization, the balloon catheter is guided by a guidewire to the lesion site and left in place. The sampling balloon 6 is confirmed to be located at both ends of the lesion site by the contrast marker 2. The pressure pump with gauge is connected to the injection chamber of the balloon catheter handle assembly 5, and liquid is slowly injected into the balloon to inflate the sampling balloon 6. When the expansion pressure is reached, the expansion is stopped. By rotating the catheter, the balloon valve 62 rotates at the lesion site and generates friction with the lesion site. During rotation, detached cell samples or mucus are introduced into the longitudinal groove 61. After sampling is completed, the liquid in the sampling balloon 6 is aspirated and the sampling balloon 6 slowly contracts. The pathological sample is wrapped in the longitudinal groove 61. The balloon catheter is then withdrawn from the body's natural cavity, and the pathological sample is taken out for pathological examination.

[0057] With the increasing number of patients suffering from respiratory diseases, airway airflow velocity needs to be controlled in some pathological conditions. If the flow rate is too fast (e.g., during wheezing), the gas does not stay in the alveoli long enough, leading to excessive CO2 expulsion (hypocapnia) or insufficient O2 absorption. If the flow rate is too slow (e.g., due to respiratory muscle weakness), ventilation is insufficient, causing hypercapnia and hypoxemia. An appropriate flow rate can maintain effective gas exchange. High-speed airflow (e.g., during violent coughing or mechanical ventilation) may also cause airway mucosal damage, inflammation, or edema, especially in patients with pre-existing conditions (e.g., asthma, tracheal stenosis). To ensure effective ventilation and reduce airway damage, airway airflow velocity needs to be controlled. In this case, the balloon catheter of this patent application can be used. Depending on the patient's condition, the balloon is placed in a suitable position so that it expands and adheres to the trachea. After adhering, ventilation is achieved through the longitudinal groove 61 on the balloon. This structural design can limit the airflow velocity.

[0058] When it is necessary to restrict blood flow within a blood vessel, the balloon catheter of this patent application can be used. Depending on the patient's condition, the balloon is placed in a suitable position so that it expands and adheres to the blood vessel. After the balloon is adhered, blood can only flow through the groove, thus restricting the blood flow rate.

[0059] When it is necessary to control the flow rate of urine in the ureter, the balloon catheter of this patent application can be used. Depending on the patient's condition, the balloon is placed in a suitable position so that it expands and fits against the ureter. After fitting, urine can only flow through the groove, which can limit the flow rate of urine.

[0060] All the devices (parts whose specific structures are not specified) selected in this application are general standard parts or parts known to those skilled in the art. Their structures and principles can be learned by those skilled in the art through technical manuals or conventional experimental methods.

[0061] In the description of the embodiments of this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0062] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0063] In the several embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. The apparatus embodiments described above are merely illustrative. For example, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. Furthermore, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Additionally, the shown or discussed mutual couplings, direct couplings, or communication connections may be through some communication interfaces; indirect couplings or communication connections between devices or units may be electrical, mechanical, or other forms.

[0064] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0065] In addition, in the various embodiments of this utility model, each functional unit can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit.

[0066] Based on the above-described preferred embodiments of this utility model, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the technical concept of this utility model. The technical scope of this utility model is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A balloon catheter capable of diverting and sampling, characterized in that it comprises: The device comprises a dual-lumen tube, a core tube, a handle assembly, a front soft tip, and a sampling balloon, wherein the sampling balloon is disposed between the front soft tip and the dual-lumen tube. The sampling balloon includes a balloon body and multiple longitudinal grooves. The longitudinal grooves are disposed on the sidewall of the balloon body, and the two ends of the longitudinal grooves are connected to the front and rear ends of the balloon body. A balloon flap is formed between adjacent longitudinal grooves. When the sampling balloon is injected with fluid, the balloon flap expands and bulges. The sampling balloon rotates at the lesion site through the rotating catheter, generating friction with the lesion site. During rotation, the dislodged pathological sample is introduced into the longitudinal groove. After sampling is completed, when the fluid in the sampling balloon is aspirated, the balloon flap contracts and folds in the center to form a flap. The flap is suitable for wrapping the pathological sample in the longitudinal groove.

2. The flow-directable, sampleable balloon catheter of claim 1, wherein, The longitudinal groove is a straight groove, and the balloon flap body is a straight strip structure.

3. The balloon catheter capable of diverting and sampling according to claim 1, characterized in that, The longitudinal groove is a spiral groove, so that the balloon valve body has a spiral structure.

4. The balloon catheter capable of diverting samples according to claim 2 or 3, characterized in that, The balloon valve body is provided with multiple transverse grooves, and each transverse groove is distributed along the length of the balloon valve body.

5. The balloon catheter capable of diverting and sampling according to claim 1, characterized in that, The longitudinal groove has an arc-shaped structure.

6. The balloon catheter capable of diverting and sampling according to claim 4, characterized in that, The transverse groove has a V-shaped structure.

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