Biopsy and hemostasis integrated balloon catheter for bronchoscope

Abstract

The biopsy and hemostasis integrated balloon catheter for the bronchoscope comprises a catheter body, and a working hole channel, a balloon channel and a guide wire channel which are independent of one another are integrally arranged on the catheter body; wherein the working hole channel is used as a channel when the freezing probe performs biopsy operation; a hemostasis balloon communicated with the balloon channel is arranged at the catheter head end of the catheter body, hemostasis medicine is arranged on the outer surface of the hemostasis balloon, and the hemostasis balloon is inflated and expanded through the balloon channel to achieve compression hemostasis; a guide wire is arranged in the guide wire channel, and the catheter body is guided to reach a target position in the trachea through the guide wire. According to the application, the functions of freezing biopsy and instant hemostasis are integrated.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and in particular relates to a biopsy and hemostasis integrated balloon catheter for bronchoscopy. BACKGROUND

[0002] Transbronchial Lung Biopsy (TBLB) and Transbronchial Cryobiopsy (TBCB) are two key techniques used in clinical practice for the diagnosis of lung diseases, allowing physicians to obtain lung tissue samples for pathological examination. In the TBLB procedure, which is usually performed under local anesthesia, the physician inserts a bronchoscope into the patient's airway and uses a biopsy forceps to obtain a sample at the target lung tissue for pathological analysis. However, TBLB usually only obtains small tissue samples, limiting the accuracy and completeness of pathological analysis. TBCB usually requires patients to undergo surgery under general anesthesia, and by using a cryoprobe, physicians can obtain larger and more complete lung tissue samples, which are then thawed and subjected to pathological diagnosis. With the increasing detection rate of pulmonary ground-glass nodules and solid small nodules, there is a higher demand for transbronchial diagnostic techniques. However, both TBLB and TBCB have certain limitations, as follows:

[0003] Because TBLB usually only obtains small tissue samples, it limits the depth and accuracy of pathological analysis, resulting in a relatively low positive rate of diagnosis. Currently, bronchoscopic biopsy forceps lack scale markings, and operators usually rely on experience to judge the distance between the lesion and the bronchoscope mouth, or measure the relative distance outside the bronchoscope, which is relatively inaccurate for precise positioning of the lesion site; and inserting the biopsy forceps too deeply also significantly increases the risk of bleeding. Moreover, post-biopsy bleeding requires the replacement of operating instruments for hemostasis, which is a complex operation procedure.

[0004] In contrast, the TBCB technique can provide larger tissue samples, but it has a higher risk of bleeding, especially when using larger diameter cryoprobes. In order to reduce the risk of massive bleeding, clinicians are required to perform a pre-procedural chest CT scan to identify the location of the lesion and the distance from the bronchial opening, and to select a cryoprobe with a diameter that is appropriate for the size of the lesion. However, this approach is time-consuming and requires additional equipment and expertise. Moreover, the use of a cryoprobe with a larger diameter increases the risk of bleeding, and the procedure itself is more complex and time-consuming.

[0005] Generally, a hemostatic balloon is pre-positioned in a bronchus near the target bronchus with the support of a rigid bronchoscope. After the TBCB operation is completed, the cryoprobe needs to be removed first, and the balloon is inflated quickly to perform compression hemostasis. In addition, in order to accurately determine the target lesion site, TBCB needs to be accurately positioned under the guidance of cone beam computed tomography (CBCT). This shows that the operation process of TBCB is relatively complex, the requirements for equipment and operation technology are higher, and general anesthesia is usually required, which undoubtedly increases the complexity and risk of the operation. In addition, TBCB technology often uses 2.4mm and 1.9mm outer diameter probes, but there are still limitations in obtaining biopsy samples from the apical region of the lung, and biopsy samples cannot be obtained in this area.

[0006] In summary, the bronchoscope in the prior art has the problems of complicated steps for replacing the operating instrument for hemostasis after biopsy, poor hemostasis effect, inaccurate biopsy positioning or complex biopsy positioning operation, and difficulty in obtaining biopsy samples from the apical region of the lung. Practical new type content

[0007] In view of the above analysis, the embodiments of the present application aim to provide a bronchoscope biopsy and hemostasis integrated balloon catheter to solve at least one of the above problems in the prior art.

[0008] The purpose of the present application is achieved as follows:

[0009] A bronchoscope biopsy and hemostasis integrated balloon catheter, comprising a catheter main body, the catheter main body is integrally provided with a respective independent working channel, a balloon channel and a guide wire channel; wherein the working channel serves as a channel for the cryoprobe during biopsy operation; the catheter head end of the catheter main body is provided with a hemostatic balloon in communication with the balloon channel, the outer surface of the hemostatic balloon is provided with a hemostatic drug, and the hemostatic balloon is inflated and expanded through the balloon channel to achieve compression hemostasis; a guide wire is arranged in the guide wire channel, and the guide wire guides the catheter main body to reach the target position in the trachea.

[0010] Further, the working channel inlet of the working channel is detachably connected with a hemostatic drug injection device, which can spray the hemostatic drug into the hemostatic site in the airway through the working channel.

[0011] Further, the channel inlet of the balloon channel is connected with a gas suction device, and the channel outlet of the balloon channel is in communication with the hemostatic balloon.

[0012] The gas suction device controls the inflation and deflation of the hemostatic balloon.

[0013] Further, the channel inlet of the balloon channel is connected with the gas suction device through an adapter.

[0014] Further, the outer surface of the hemostatic balloon is uniformly provided with a plurality of hemostatic particles.

[0015] Further, the outer surface of the catheter head is provided with a scale mark.

[0016] Further, the scale mark has uniformly arranged scale lines, and the scale interval of the scale lines is 1cm.

[0017] Further, the working channel of the catheter head is provided with a one-way check valve configured to prevent liquid reverse flow in the airway.

[0018] Further, the one-way check valve, the hemostatic balloon and the scale mark are sequentially arranged along the direction from the catheter head to the catheter tail of the catheter body.

[0019] Further, the outer diameter of the cryoprobe is 1.1mm.

[0020] Compared with the prior art, the bronchoscope biopsy and hemostasis integrated balloon catheter integrates the functions of cryobiopsy and instant hemostasis, can effectively control bleeding during biopsy, reduce the risk of complications, and at the same time obtain high-quality lung tissue samples, and simplifies the operation steps and reduces the risk of surgery. By integrating the hemostatic balloon at the catheter head, and controlling the inflation and deflation of the hemostatic balloon through the suction and discharge device in the balloon channel, promoting the release of hemostatic particles on the surface of the hemostatic balloon, efficient hemostasis is realized while biopsy, improving the safety and efficiency of lung disease diagnosis, through precise depth control and instant hemostasis mechanism, significantly improving the accuracy of the operation and the comfort of the patient. Moreover, by providing a one-way check valve at the catheter head, not only can effectively prevent liquid reverse flow in the airway, but also can connect a hemostatic drug injection device at the inlet of the working channel, and use the hemostatic drug injection device to uniformly spray the hemostatic drug to the surface of the airway through the working channel, significantly improving the safety of the operation, especially when using a 1.1mm cryoprobe for biopsy, which can quickly stop bleeding in the biopsy area, greatly reducing the risk of bleeding, solving the common bleeding problem in TBCB, and improving the safety of the operation. BRIEF DESCRIPTION OF DRAWINGS

[0021] DETAILED DESCRIPTION

[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present specification or the prior art, the drawings needed to be used in the embodiments or prior art description will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments described in the present specification, and other drawings can also be obtained by those skilled in the art based on these drawings.

[0023] Figure 1The utility model provides a bronchoscope is with the structure diagram of the integrated balloon catheter of biopsy and hemostasis of the utility model,

[0024] Figure 2 The utility model provides a bronchoscope is with the cross section schematic drawing of the integrated balloon catheter of biopsy and hemostasis of the utility model's catheter main part,

[0025] Figure 3 The utility model provides a bronchoscope is with the structure diagram of the integrated balloon catheter of biopsy and hemostasis of the utility model,

[0026] Figure 4 The utility model provides a bronchoscope is with the structure diagram of the integrated balloon catheter of biopsy and hemostasis of the utility model,

[0027] Figure 5 The utility model provides a bronchoscope is with the structure diagram of the integrated balloon catheter of biopsy and hemostasis of the utility model,

[0028] Figure 6 The utility model provides a bronchoscope is with the structure diagram of the integrated balloon catheter of biopsy and hemostasis of the utility model,

[0029] Reference signs:

[0030] 1, working hole; 2, balloon channel; 3, guide wire channel; 4, hemostatic balloon; 401, gasbag main part; 402, folding part; 5, hemostatic medicine particle; 6, one-way check valve; 7, hemostatic medicine spraying mouth; 8, scale mark; 9, adapter; 10, gas extraction device; 11, guide wire inlet; 12, working hole inlet. DETAILED DESCRIPTION

[0031] To make the purpose, technical scheme and advantage of the embodiment of the application more clear, the technical scheme in the embodiment of the application will be clearly and completely described below in conjunction with the drawings in the embodiment of the application. Obviously, the described embodiment is a part of the embodiment of the application, not all the embodiment of the application. It should be noted that the embodiment in the disclosure and the feature in the embodiment can be combined, separated, interchanged and / or rearranged without conflict. Based on the embodiment in the application, all other implementation descriptions obtained by the person skilled in the art without creative labor belong to the protection scope of the application

[0032] Example, all belong to the protection scope of the application.

[0033] In the drawings, the size and relative size of components can be exaggerated for clarity and / or descriptive purposes. When the exemplary embodiments can be implemented differently, the specific process sequence can be performed in an order different from the described order. For example, two continuously described processes can be performed substantially simultaneously or in an order opposite to the described order. In addition, the same reference signs represent the same components.

[0034] The terminology used herein is for the purpose of describing particular embodiments and is not intended to be limiting. As used herein, unless the context clearly indicates otherwise, the singular forms “a” and “the” are intended to include the plural forms as well. Furthermore, when the terms “comprising” and / or “including” and variations thereof are used in this specification, it indicates the presence of the stated features, integrals, steps, operations, parts, components, and / or groups thereof, but does not exclude the presence or addition of one or more other features, integrals, steps, operations, parts, components, and / or groups thereof. It should also be noted that, as used herein, the terms “substantially,” “about,” and other similar terms are used as approximate terms rather than as terms of degree, thus explaining the inherent biases in measurements, calculated values, and / or provided values ​​that would be recognized by one of ordinary skill in the art.

[0035] Example 1

[0036] A specific embodiment of this utility model is as follows: Figures 1 to 6 As shown, a bronchoscopic biopsy and hemostasis integrated balloon catheter, hereinafter referred to as "integrated balloon catheter", is disclosed. It includes a catheter body with a catheter tip and a catheter tail. The catheter body is equipped with independent working channels 1, balloon channels 2, and guidewire channels 3. The working channel 1 is configured as a channel for biopsy operations using a cryoprobe. The catheter tip is equipped with a hemostasis balloon 4, the outer surface of which is covered with hemostatic drugs. The hemostasis balloon 4 is connected to the balloon channel 2, and hemostasis is achieved by inflating the hemostasis balloon 4. A guidewire is provided in the guidewire channel 3 to guide the catheter body to the target position in the trachea.

[0037] In this embodiment, the working channel 1 is also configured as a channel for spraying hemostatic drugs onto the hemostatic site within the airway. Specifically, the working channel 1 has a working channel inlet 12 and a working channel outlet. (See instruction manual ZSU240783CN)

[0038] The inlet 12 of the working channel is detachably connected to a hemostatic drug injection device, which allows hemostatic drugs to be sprayed through the working channel 1. At this time, the outlet of the working channel serves as the hemostatic drug spray port 7. The spraying status is shown in the figure. Figure 6 Optionally, a syringe can be used as the hemostatic drug injection device. By integrating the working channel 1 and the hemostatic drug injection device into the catheter body as a hemostatic drug delivery system, hemostatic drugs or other therapeutic drugs can be delivered directly to the biopsy area during or after the biopsy to enhance hemostasis or provide additional therapeutic benefits.

[0039] In this embodiment, the channel inlet of the balloon channel 2 is connected with the air extraction device 10, and the channel outlet of the balloon channel 2 is communicated with the hemostatic balloon 4, and the inflation and deflation of the hemostatic balloon 4 is controlled through the air extraction device 10. The size of the hemostatic balloon 4 is adjustable, allowing the doctor to adjust the size of the hemostatic balloon according to the needs of the operation to adapt to different operation situations, providing more flexibility. Alternatively, the air extraction device 10 can adopt a syringe to perform the inflation operation of the hemostatic balloon 4 to achieve the hemostatic function. Further, the channel inlet of the balloon channel 2 is connected with the air extraction device 10 through the adapter 9. Further, the adapter 9 has a valve, which is closed after the hemostatic balloon is inflated to disconnect the balloon channel 2 from the syringe, so that the inflated hemostatic balloon is in a continuous filling state.

[0040] In this embodiment, the hemostatic medicine on the outer surface of the hemostatic balloon 4 is in the form of medicine particles or medicine coating. Preferably, a plurality of hemostatic medicine particles 5, such as hemocoagulase, are uniformly arranged on the outer surface of the hemostatic balloon 4. The hemostatic balloon 4 can be used to embed the target sub-lung segment bronchus, and the hemostatic medicine particles 5 on the surface of the hemostatic balloon 4 can increase the contact friction between the hemostatic balloon 4 and the inner wall of the airway, which is beneficial to the fixation of the hemostatic balloon 4; when the hemostatic balloon 4 is inflated through the balloon channel 2, the inflated and unfolded hemostatic balloon 4 can compress the hemostasis, and the release of the hemostatic medicine particles 5 can further increase the hemostatic effect.

[0041] In one optional embodiment, the hemostatic balloon 4 has a balloon main body part 401 and a plurality of folded parts 402 connected with the balloon main body part 401, the balloon main body part 401 and the folded parts 402 are both made of medical elastic material, and the outer surfaces of the balloon main body part 401 and the folded parts 402 are both provided with hemostatic medicine particles 5; the balloon main body part 401 is sealingly connected to the outer wall of the catheter head end and forms a sealed space with the outer wall of the catheter head end, and the sealed space is communicated with the channel outlet of the balloon channel 2 and the inner space of the folded parts 402; when not inflated, referring to Figure 4 , the balloon main body part 401 and the folded parts 402 are both in a contracted state; when inflated, referring to

[0042] , the folded parts 402 and the balloon main body part 401 can both be inflated and unfolded to be in a spherical state. Figure 5

[0043] In one optional embodiment, the hemostatic medicine particles 5 are in a protruding structure, and the protruding structure has a sharp end; when the medicine balloon 4 is inflated and unfolded, the sharp end of the hemostatic medicine particles 5 can be inclined towards the direction of the catheter tail end, and be in a barb shape. With this structure, the sharp end of the hemostatic medicine particles 5 will not cause damage to the inner wall tissue of the trachea, but can further improve the connection stability of the medicine balloon 4 and the inner wall of the trachea, thereby preventing the position of the medicine balloon 4 from moving before the hemostatic medicine particles 5 take effect, and ensuring the reliability of the hemostatic effect.​

[0044] In this embodiment, the outer surface of the catheter head end is provided with a scale mark 8. The scale mark 8 provides the doctor with an intuitive visual reference, so that the operator can determine the depth of the target bronchus from the catheter head end in combination with the preoperative chest imaging examination, thereby intuitively and accurately controlling the depth of the biopsy during the operation, ensuring the quality of the sample and the safety of the operation, and reducing the risk of complications. Further, the scale mark 8 has uniformly arranged scale lines with a scale interval of 1 cm.

[0045] In one alternative embodiment, a one-way check valve 6 is provided in the working channel 1 of the catheter head end, which is configured to prevent the reverse flow of liquid in the airway. When the hemostatic drug injection device is used to quickly inject hemostatic drugs mixed with air from the working channel inlet 12, the mist of hemostatic drugs can be uniformly sprayed from the hemostatic drug spray port 7 of the catheter head end. Specifically, the one-way check valve 6, the hemostatic balloon 4 and the scale mark 8 are arranged in sequence along the direction from the catheter head end to the catheter tail end. The hemostatic drugs sprayed through the working channel 1 can pass through the one-way check valve 6 located inside the catheter head end, which can also prevent the reverse flow of liquid, reducing the risk of reverse flow of liquid in the airway into the integrated balloon catheter due to the patient's severe cough.

[0046] In this embodiment, the catheter body of the integrated balloon catheter simultaneously integrates a separate guide wire channel 3, which can be used to accurately and flexibly guide the catheter body to the difficult-to-reach position in the target bronchus (such as the upper lobe tip segment, the posterior segment) without affecting the working channel 1. After the catheter body is in place, a stable biopsy passage is established, improving the success rate of biopsy in difficult positions. The biopsy position can be accurately positioned before the operation, and the introduction of a separate guide wire channel further improves the flexibility of operation, fully meeting the requirements of the specification ZSU240783CN

[0047] There is a clinical demand for efficient and safe lung biopsy technology. The guide wire channel 3 has a guide wire inlet 11 connected to the catheter tail end for introducing a guide wire to guide the catheter body to the target position, improving the flexibility of operation and enabling complex path guidance operation.

[0048] In this embodiment, the outer diameter of the cryoprobe is 1.1 mm, and the inner diameter of the working channel 1 is matched with the outer diameter of the cryoprobe. By using the working channel 1 with an outer diameter of 1.1 mm cryoprobe, the cryoprobe can be guided into the lung segment and subsegment under the guidance of the bronchoscope and the guide wire, which can obtain larger size lung tissue samples and ensure the integrity of the samples, thereby improving the accuracy of pathological analysis. Moreover, the use of a 1.1 mm diameter cryoprobe not only reduces the risk of bleeding, but also improves the flexibility of operation, especially when the bronchoscope needs to be bent at a larger angle, making the biopsy process safer and more effective.

[0049] The specific use process of the bronchoscope biopsy and hemostasis integrated balloon catheter is as follows:

[0050] (1) Preoperative preparation: determine the target biopsy site through CT imaging, and measure the distance from the adjacent lung segment and subsegment bronchus, so as to accurately control the biopsy depth during operation.

[0051] (2) Bronchoscope positioning: send the bronchoscope to the adjacent lung subbronchus opening of the target lung segment to provide accurate guidance for the placement of the catheter.

[0052] (3) Catheter placement: place the integrated balloon catheter from the working channel of the bronchoscope into the target lung segment, adjust the depth of the catheter according to the preoperative measurement distance, and introduce a guide wire through the guide wire inlet 11 as a guide to ensure that the catheter accurately reaches the target position.

[0053] (4) Inflation of hemostatic balloon 4: inflate the hemostatic balloon 4 through the air extraction device 10, embed the target sub-lung segment bronchus, release the hemostatic particles 5 on the surface of the hemostatic balloon 4 to prevent bleeding during biopsy and achieve immediate hemostasis.

[0054] (5) Cryobiopsy: insert a 1.1mm cryoprobe through the working channel inlet 12 into the working channel 1 to perform cryobiopsy and obtain high-quality lung tissue samples.

[0055] (6) Postoperative treatment: after biopsy, if necessary, hemostatic drugs can be injected through the working channel inlet 12 and uniformly sprayed into the airway through the spray port 7 to enhance the hemostatic effect and ensure the safety of the operation.

[0056] Compared with the prior art, the bronchoscope biopsy and hemostasis integrated balloon catheter ZSU240783CN

[0057] The catheter can at least achieve one of the following beneficial effects:

[0058] 1. The application integrates cryobiopsy and immediate hemostasis functions, and can be applied to the diagnosis and treatment of various respiratory system diseases, especially in the field of interventional respiratory medicine, for biopsy of lung tissue and real-time hemostasis treatment.

[0059] 2. The application realizes biopsy and hemostasis on the same device, reduces the need to switch different tools during operation, thereby eliminating the use of rigid bronchoscopes, simplifying the operation steps and improving the diagnosis efficiency; moreover, the application is easy to operate, so that the doctor can operate under local anesthesia, reducing the dependence on general anesthesia and rigid bronchoscopes, not only improving the operation efficiency and patient comfort, but also reducing the patient's economic burden and hospitalization time.

[0060] 3、By integrating the 1.1mm outer diameter cryopulmonary biopsy probe and the hemostatic balloon, hemostatic drug spraying port into one catheter body, multiple hemostatic mechanisms are integrated, the local hemostatic effect is enhanced, the risk of complications is effectively reduced, the safety and efficiency of the operation are significantly improved, and the complexity of replacing the operation instrument for hemostatic steps after biopsy in TBLB or TBCB is solved.

[0061] 4、By providing scale marks at the catheter head end, the doctor is provided with an intuitive visual reference, so that the depth of biopsy can be accurately controlled during the biopsy process. The scale mark helps to improve the accuracy and consistency of sample acquisition, and also avoids the risk of increasing pneumothorax by blindly inserting the biopsy probe too deep.

[0062] 5、By providing a one-way check valve at the catheter head end, the risk of occupational exposure of the operator can be effectively prevented.

[0063] The above specific embodiments further illustrate the purpose, technical solutions and beneficial effects of the present application. It should be understood that the above description is only a specific embodiment of the present application and is not intended to limit the protection scope of the present application. Any modification, equivalent replacement, improvement, etc. within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A bronchoscope biopsy and hemostasis integrated balloon catheter, characterized in that, The catheter body is integrally provided with a working channel, a balloon channel and a guide wire channel; the working channel is used as a channel for biopsy operation of a cryoprobe; the catheter head of the catheter body is provided with a hemostatic balloon in communication with the balloon channel; the outer surface of the hemostatic balloon is provided with a hemostatic drug; the hemostatic balloon is inflated to achieve compression hemostasis through the balloon channel; a guide wire is arranged in the guide wire channel; and the catheter body is guided to a target position in the trachea through the guide wire.

2. The bronchoscopic integrated biopsy and hemostasis balloon catheter of claim 1, wherein, A hemostatic drug injection device is detachably connected to the working channel inlet of the working channel, and the hemostatic drug injection device can spray the hemostatic drug into the airway through the working channel.

3. The bronchoscope integrated biopsy and hemostasis balloon catheter of claim 1, wherein, The channel inlet of the balloon channel is connected with a gas suction device, the channel outlet of the balloon channel is in communication with the hemostatic balloon, and the inflation and deflation of the hemostatic balloon are controlled through the gas suction device.

4. The bronchoscopic integrated biopsy and hemostasis balloon catheter of claim 3, wherein, The channel inlet of the balloon channel is connected with a gas suction device through an adapter.

5. The bronchoscopic integrated biopsy and hemostasis balloon catheter according to claim 3 or 4, characterized in that, The outer surface of the hemostatic balloon is uniformly provided with a plurality of hemostatic drug particles.

6. The bronchoscope integrated biopsy and hemostasis balloon catheter of claim 1, wherein, The outer surface of the catheter head is provided with a scale mark.

7. The bronchoscopic integrated biopsy and hemostasis balloon catheter of claim 6, wherein, The scale mark is uniformly provided with scale lines, and the scale interval of the scale lines is 1 cm.

8. The bronchoscopic integrated biopsy and hemostasis balloon catheter of claim 7, wherein, A one-way check valve is arranged in the working channel of the catheter head, and the one-way check valve is configured to prevent reverse flow of liquid in the airway.

9. The bronchoscopic integrated biopsy and hemostasis balloon catheter of claim 8, wherein, The one-way check valve, the hemostatic balloon and the scale mark are sequentially arranged along the direction from the catheter head to the catheter tail of the catheter body.

10. The bronchoscope integrated biopsy and hemostasis balloon catheter of claim 1, wherein, The outer diameter of the cryoprobe is 1.1 mm.

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