Bronchoscope guiding sheath tube with balloon

Abstract

The bronchoscope guiding sheath tube comprises a bendable sheath tube body, a channel in the center of the sheath tube body is an operation channel, and the bronchoscope guiding sheath tube is characterized in that the sheath tube body is at least composed of an inner-layer tube and an outer-layer tube which are concentrically arranged, and a gap exists between the inner-layer tube and the outer-layer tube; an outer annular notch and an inner annular notch are formed in the pipe wall of the outer layer pipe and the pipe wall of the inner layer pipe close to the front end of the sheathing canal body respectively, an outer balloon is arranged around the outer annular notch, an inner balloon is arranged around the inner annular notch, an air injection hole is formed in the pipe wall of the outer layer pipe corresponding to the rear end of the sheathing canal body, and the air injection hole is connected with an air injection device through an air injection pipe. Gas is injected into the gap between the outer-layer tube and the inner-layer tube of the sheathing canal body, so that the inner balloon and the outer balloon swell, and the aim of stopping bleeding is achieved. The hemostat can realize rapid hemostasis, and avoids the risk of suffocation death of a patient.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, relates to a bronchoscope sheath, and particularly relates to a bronchoscope guiding sheath with a balloon. Background Art

[0002] Bronchoscope technology is of great value for the diagnosis and treatment of lung diseases. With the development of ultra-thin bronchoscopes, ultrasound probes and navigation technology, the application field of bronchoscopes in the diagnosis and treatment of peripheral lung diseases has been expanded, making the diagnosis and treatment of subsegmental and more distal pulmonary micro-lesions a reality.

[0003] During operation, under the guidance of navigation, the bronchoscope is delivered to the target bronchus, and then a guiding sheath containing a radial ultrasound probe is introduced through the operating channel of the bronchoscope. When the EBUS image confirms that the probe in the guiding sheath has reached the lesion, the ultrasound probe is removed and the guiding sheath remains in place. At this time, the guiding sheath can be used as an extension tube of the operating channel, so that biopsy forceps, brushes, curettes, etc. can pass through to perform tissue biopsy sampling, cytology brushing and etiological examination. The implantation of the guiding sheath can ensure that the diagnostic and treatment instruments passing in and out of the guiding sheath are accurately located within the lesion, thus eliminating the need to search for and confirm the lesion again, ensuring the consistency of the sampling position and reducing the sampling time.

[0004] However, during bronchoscope biopsy sampling, bleeding is the most common complication. At the same time, to ensure the accuracy of the examination, the number of tissue samples should be as large as possible, which undoubtedly increases the risk of bleeding. When there is a small amount of bleeding in the airway, the guiding sheath and bronchoscope can be used for compression hemostasis; when the bleeding is obvious, it can be treated with ice saline, hemostatic drugs, etc.; and when there is massive bleeding in the airway, the existing treatment method is to pull out the guiding sheath and insert a balloon for compression hemostasis. The operation is complex and time-consuming, and the rapid bleeding rate is likely to cause the blood to quickly fill the bilateral bronchi in a short time, and the patient is at risk of suffocation and death due to bleeding. Summary of the Invention

[0005] Aiming at the above deficiencies existing in the prior art, the purpose of the utility model is to provide a bronchoscope guiding sheath with a balloon, which can achieve rapid hemostasis and avoid the risk of suffocation and death of patients.

[0006] The technical solution of the utility model is realized as follows:

[0007] Bronchoscope guiding sheath with balloon, comprising a flexible sheath body, the channel in the center of the sheath body being an operation channel. The sheath body is at least composed of an inner layer tube and an outer layer tube arranged concentrically, with a gap between the inner layer tube and the outer layer tube. An outer annular notch and an inner annular notch are respectively provided on the tube walls of the outer layer tube and the inner layer tube near the front end of the sheath body, an outer balloon is arranged around the outer annular notch, and an inner balloon is arranged around the inner annular notch. An air injection hole is provided on the tube wall of the outer layer tube corresponding to the rear end of the sheath body, and the air injection hole is connected to an air injection device through an air injection tube to inject gas into the gap between the outer layer tube and the inner layer tube of the sheath body, so that the inner balloon and the outer balloon bulge to achieve the purpose of hemostasis.

[0008] Further, the sheath body is composed of a first layer tube, a second layer tube, a third layer tube and a fourth layer tube that are concentric and have gradually increasing diameters. There are gaps between the first layer tube and the second layer tube, and between the second layer tube and the third layer tube. The outer annular notch and the inner annular notch are respectively arranged on the fourth layer tube and the first layer tube, the air injection hole is arranged on the fourth layer tube, and a first ventilation hole corresponding to the air injection hole is provided on the third layer tube to facilitate gas to enter the gap between the second layer tube and the third layer tube through the air injection hole and the first ventilation hole. The second layer tube is made of a woven mesh, and gas can enter the inner balloon through the second layer tube. A plurality of second ventilation holes are evenly arranged on the circumference of the third layer tube corresponding to the outer annular notch to facilitate gas to enter the outer balloon through the second ventilation holes.

[0009] Further, the first layer tube is made of polytetrafluoroethylene, the third layer tube is made of platinum-iridium alloy; the fourth layer tube is made of an elastomer.

[0010] Further, the outer annular notch is 1 - 2 cm away from the front end of the sheath body.

[0011] Further, the size of the outer balloon gradually increases from the front end to the rear end of the sheath body.

[0012] Further, the air injection device includes a cylinder body with an open end at one end, an air outlet is provided at the other end of the cylinder body, the air outlet is connected to the air injection hole through an air injection tube, and a push-pull rod that can reciprocate longitudinally along the cylinder body is arranged in the cylinder body to facilitate pushing and pulling the push-pull rod to send the gas in the cylinder body into the sheath body.

[0013] Further, scale lines are provided on the surface of the cylinder body to facilitate observing the scale lines when pushing and pulling the push-pull rod to inject different volumes of gas, so as to be applicable to bronchi with different diameters.

[0014] Further, the inner balloon and the outer balloon are made of fluororubber.

[0015] Compared with the prior art, the utility model has the following beneficial effects:

[0016] The utility model is provided with an inner balloon and an outer balloon inside and outside the sheath tube body respectively, and the sheath tube body itself is used as an air injection channel. When massive bleeding occurs, it is not necessary to take out the bronchoscope, and gas can be directly injected, so that the outer balloon and the inner balloon are expanded simultaneously, thereby blocking the root bronchus, avoiding blood from blocking the bilateral bronchi and causing the patient to suffocate and die, and preventing the secretion containing tumor cells in the bronchus from entering other bronchi and causing tumor metastasis in the airway. At the same time, while the inner balloon and the outer balloon block the blood, the outer balloon can also compress the blood vessels around the bronchus to achieve the purpose of rapid hemostasis. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 - Schematic structural diagram of the utility model.

[0018] Figure 2 - Figure 1 Cross-sectional view.

[0019] Figure 3 - Figure 2 Enlarged view of part A in.

[0020] Wherein: 1 - sheath tube body; 11 - air injection hole; 12 - first layer tube; 13 - second layer tube; 14 - third layer tube; 15 - fourth layer tube; 16 - second ventilation hole; 21 - outer balloon; 22 - inner balloon; 3 - air injection device; 4 - air injection tube. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0021] The present utility model will be further described in detail below with reference to the drawings and specific embodiments.

[0022] See Figure 1 、 Figure 2 and Figure 3 ,The bronchoscope guiding sheath tube with a balloon includes a bendable sheath tube body 1. The channel in the center of the sheath tube body 1 is an operation channel. The sheath tube body 1 is at least composed of a concentric inner layer tube and an outer layer tube, and there is a gap between the inner layer tube and the outer layer tube; an outer annular notch and an inner annular notch are respectively provided on the tube walls of the outer layer tube and the inner layer tube near the front end of the sheath tube body 1, an outer balloon 21 is arranged around the outer annular notch, an inner balloon 22 is arranged around the inner annular notch, an air injection hole 11 is provided on the tube wall of the outer layer tube corresponding to the rear end of the sheath tube body 1, and the air injection hole 11 is connected to an air injection device 3 through an air injection tube 4 to inject gas into the gap between the outer layer tube and the inner layer tube of the sheath tube body 1, so that the inner balloon 22 and the outer balloon 21 bulge to achieve the purpose of hemostasis. The inner balloon 22 and the outer balloon 21 are made of fluororubber.

[0023] In this way, when gas is injected into the gap between the outer tube and the inner tube of the sheath body, the inner balloon expands towards the operation channel at the center of the sheath body to form an annular plug in the operation channel to seal the operation channel, and the outer balloon expands towards the outside of the sheath body to form an annular balloon around the circumference of the sheath body. When severe bleeding occurs, there is no need to remove the bronchoscope. Gas can be directly injected to simultaneously expand the outer balloon and the inner balloon, thereby blocking the bronchus, avoiding asphyxiation and death of the patient caused by bilateral bronchial blockage by blood, and preventing the secretion containing tumor cells in the bronchus from entering other bronchi, resulting in tumor metastasis in the airway. At the same time, while the inner balloon and the outer balloon block the blood, the outer balloon can also compress the blood vessels around the bronchus to achieve the purpose of rapid hemostasis.

[0024] Fluororubber has good high-temperature resistance and corrosion resistance, and also has a certain elasticity, which enables strict medical disinfection by means of high-temperature sterilization or soaking in disinfectant after each use of the guide sheath tube, ensuring that the guide sheath tube can be reused multiple times.

[0025] In specific implementation, the sheath body 1 is composed of a first layer tube 12, a second layer tube 13, a third layer tube 14, and a fourth layer tube 15 that are concentric and have gradually increasing diameters. There are gaps between the first layer tube 12 and the second layer tube 13, and between the second layer tube 13 and the third layer tube 14. The outer annular notch and the inner annular notch are respectively arranged on the fourth layer tube 15 and the first layer tube 12. The air injection hole 11 is arranged on the fourth layer tube 15. The third layer tube 14 is provided with a first ventilation hole corresponding to the air injection hole 11, facilitating the entry of gas into the gap between the second layer tube 13 and the third layer tube 14 through the air injection hole 11 and the first ventilation hole. The second layer tube 13 is made of SUS304 high-density woven mesh, and gas can enter the inner balloon 22 through the second layer tube 13. A plurality of second ventilation holes 16 are evenly arranged on the circumference of the third layer tube 14 corresponding to the outer annular notch, facilitating the entry of gas into the outer balloon 21 through the second ventilation holes 16. The first layer tube 12 is made of polytetrafluoroethylene, the third layer tube is made of Ptlr platinum-iridium alloy; the fourth layer tube 15 is made of Pebax elastomer.

[0026] Pebax elastomer enables the sheath body to bend freely. Ptlr platinum-iridium alloy can visually confirm the puncture depth under direct vision and X-ray imaging. SUS304 high-density woven mesh can ensure that the sheath body has good bending performance and supports multiple puncture angles. The first layer tube made of polytetrafluoroethylene can ensure high passability of the instruments inside the sheath. At the same time, setting the outer balloon and the inner balloon on such a sheath body can achieve the purpose of rapid hemostasis without affecting the performance of the sheath body.

[0027] In specific implementation, the outer annular notch is 1 - 2 cm away from the front end of the sheath body 1.

[0028] During specific implementation, the size of the outer balloon 21 gradually increases from the front end to the rear end of the sheath body 1.

[0029] To a certain extent, the trachea gradually narrows. Here, the outer balloon is arranged in a gradually narrowing structure, which can effectively avoid the rupture of the smaller distal trachea while not affecting the occlusion.

[0030] During specific implementation, the gas injection device 3 includes a cylinder body with an open end, an air outlet is provided at the other end of the cylinder body, the air outlet is connected to the air injection hole 11 through an air injection pipe 4, and a push-pull rod that can reciprocate longitudinally along the cylinder body is arranged in the cylinder body. By conveniently pushing and pulling the push-pull rod, the gas in the cylinder body can be sent into the sheath body 1.

[0031] This is an implementation manner of the gas injection device. The gas injection device here is similar to a syringe. At the same time, scale lines can be set on the surface of the cylinder body, which are divided into grades, and each grade corresponds to the size of the bronchi of a corresponding level. For example, the first gear is the maximum gear number and can block the size of the lobar bronchi.

[0032] Finally, it should be noted that the above embodiments of the present invention are only examples for explaining the present invention, and are not limitations on the implementation manners of the present invention. For those of ordinary skill in the art, other different forms of changes and variations can be made on the basis of the above description. It is impossible to list all the implementation manners here. Any obvious changes or variations derived from the technical solutions of the present invention still fall within the protection scope of the present invention.

Claims

1. A bronchoscope guide sheath with a balloon, comprising a bendable sheath body, wherein the channel in the center of the sheath body is an operation channel, and is characterized in that: The sheath body is composed of at least an inner tube and an outer tube arranged concentrically, with a gap between the inner tube and the outer tube; an outer annular notch and an inner annular notch are respectively provided on the walls of the outer tube and the inner tube near the front end of the sheath body, and an outer balloon is provided around the outer annular notch, and an inner balloon is provided around the inner annular notch; an air injection hole is provided on the wall of the outer tube corresponding to the rear end of the sheath body, and the air injection hole is connected to the air injection device through an air injection tube to inject gas into the gap between the outer tube and the inner tube of the sheath body, so that the inner balloon and the outer balloon swell, thereby achieving the purpose of hemostasis.

2. The bronchoscope guide sheath with a balloon according to claim 1, characterized in that: The sheath tube body is composed of a first layer tube, a second layer tube, a third layer tube and a fourth layer tube which are concentric and have increasing tube diameters in sequence. There are gaps between the first layer tube and the second layer tube, and between the second layer tube and the third layer tube. The outer annular notch and the inner annular notch are respectively arranged on the fourth layer tube and the first layer tube. The gas injection hole is arranged on the fourth layer tube. The third layer tube is provided with a first ventilation hole corresponding to the gas injection hole, so that gas can enter the gap between the second layer tube and the third layer tube through the gas injection hole and the first ventilation hole. The second layer tube is made of a woven mesh, and gas can enter the inner balloon through the second layer tube. The third layer tube corresponding to the outer annular notch is evenly provided with a plurality of second ventilation holes on the circumference, so that gas can enter the outer balloon through the second ventilation holes.

3. The bronchoscope guide sheath with a balloon according to claim 2, characterized in that: The first tube layer is made of polytetrafluoroethylene, the third tube layer is made of platinum-iridium alloy; and the fourth tube layer is made of elastomer.

4. The bronchoscope guide sheath with a balloon according to claim 1, 2 or 3, characterized in that: The outer annular notch is 1 to 2 cm away from the front end of the sheath body.

5. The bronchoscope guide sheath with a balloon according to claim 1, 2 or 3, characterized in that: The size of the outer balloon gradually increases from the front end of the sheath body to the rear end of the sheath body.

6. The bronchoscope guide sheath with a balloon according to claim 1, 2 or 3, characterized in that: The gas injection device includes a cylinder with an open end and a gas outlet at the other end of the cylinder. The gas outlet is connected to the gas injection hole through an injection pipe. A push-pull rod that can move back and forth along the longitudinal direction of the cylinder is provided in the cylinder, so that the gas in the cylinder can be sent into the sheath body by pushing and pulling the push-pull rod.

7. The bronchoscope guide sheath with a balloon according to claim 6, characterized in that: The surface of the cylinder is provided with scale lines, which is convenient for observing the scale lines when pushing and pulling the push-pull rod to inject different volumes of gas, so as to be suitable for bronchi of different diameters.

8. The bronchoscope guide sheath with a balloon according to claim 1, characterized in that: The inner balloon and the outer balloon are made of fluororubber.

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