MULTIFUNCTIONAL BALLOON DILATATION CATHETER FOR INTRACORPOREAL MEMBRANE OXYGENATION AND USAGE METHOD THEREFOR

Abstract

Disclosed is a multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation, comprising: a catheter hub, a dilatation balloon, and M channels. The M channels comprise at least a balloon dilatation channel for dilating the narrowed part of the airway, a positioning & detection channel for positioning or detecting while inserting, a supply channel for continuous oxygen supply or drug administration to the patient, and a secretion removal channel for removing secretions from the airway. The catheter hub is a multi-channel connection device, through which the M channels are respectively connected to the external therapeutic devices of the catheter. The catheter is inserted into a bronchiole of the lungs. When using the catheter for emergency treatment of patients with pneumonia, especially COVID-19, measures such as airway dilatation, oxygen supply, sputum suction and biopsy can be simultaneously performed, thereby improving the survival rate of patients and reducing lung damage.

Claims

1. A multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation, comprising: a catheter hub located at the proximal end of the catheter, a dilatation balloon located at the distal end of the catheter, and M channels located in the catheter; M channels comprising at least a balloon dilatation channel, a positioning & detection channel, a supply channel and a secretion removal channel; M is an integer greater than or equal to four; the catheter hub is a multi-channel connection device, through which M channels are respectively connected to the external therapeutic devices of the catheter; and the catheter is inserted into a bronchiole of the lungs, the balloon dilatation channel is used for dilating the narrowed part of the airway, the positioning & detection channel is used for positioning or detecting while inserting, the supply channel is used for continuous oxygen supply or drug administration to the patient, and the secretion removal channel is used for removing secretions from the airway.

2. The multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation according to claim 1, wherein the balloon dilatation channel is connected to a balloon inflation device through the catheter hub, and the dilatation balloon has a dilatation port; the secretion removal channel is connected to a sputum aspirator or a pressure syringe through the catheter hub, and has a lavage port; the supply channel is connected to the supply device through the catheter hub, and has a supply port; and the positioning & detection channel runs through both ends of the catheter, and can be used for guiding wire, biopsy forceps or fiber optic endoscope to pass through.

3. The multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation according to claim 2, wherein the cross-sectional area of the secretion removal channel is larger than that of the balloon dilatation channel and the supply channel.

4. The multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation according to claim 1, wherein the positioning & detection channel is a cylindrical channel with an inner diameter greater than 0.1 mm and less than or equal to 5.0 mm.

5. The multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation according to claim 1, wherein the dilatation balloon is a 3-stage dilatation balloon with the dilatation pressure within the range of 3-18 atm, and the outer diameter of 3-24 mm under inflation.

6. The multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation according to claim 1, wherein the dilatation balloon is a single-stage dilatation balloon with the dilatation pressure within the range of 3-30 atm, and the outer diameter of 3-30 mm under inflation.

7. The multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation according to claim 1, wherein the catheter is a catheter made from a polymer material, which is the same as the isolation material of M channels inside the catheter.

8. The multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation according to claim 1, wherein a Luer connector is connected to the catheter hub, and the Luer connector and the catheter hub are used for connecting M channels and corresponding external therapeutic devices.

9. A method for intracorporeal membrane oxygenation using the catheter according to claim 1, comprising the following steps: S01, inserting the catheter into a bronchus of the lungs through endotracheal intubation or through an airway endoscopy. When inserting, the positioning & detection channel is used for guiding the catheter to advance, and the balloon dilatation channel controls the balloon to dilate the narrowed part; S02, after the catheter reaches the designated position, using the supply channel to supply oxygen or medicine to the designated position; and S03, after the catheter reaches the designated position, using the secretion removal channel to perform lavage and sputum suction in the designated position.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG. 1 is the structural schematic diagram of the catheter of the present invention;

[0030] FIG. 2 is the schematic diagram of each channel in the catheter of the present invention;

[0031] FIG. 3 is the schematic diagram of the balloon part in the catheter of the present invention;

[0032] FIG. 4 is the schematic diagram of the position of the balloon when the catheter in the present invention is inserted into the lower respiratory tract;

[0033] FIG. 5 is the physical diagram of the catheter hub in the present invention;

[0034] FIG. 6 is the physical diagram of the catheter in the present invention.

[0035] Reference numerals: 1. Secretion removal channel; 2. Supply channel; 3. Balloon dilatation channel; 4. Positioning & detection channel; 5. Catheter hub; 6. Dilatation balloon; 7. Catheter end; 8. Supply port; 9. Dilatation port; 10. Lavage port; 11. Trachea; 12. Main bronchus; 13. Bronchiole.

DETAILED DESCRIPTION OF THE INVENTION

[0036] The invention will be further described below with reference to the drawings and specific embodiments:

[0037] Referring to FIGS. 1-5, a multifunctional balloon dilatation catheter for intracorporeal membrane oxygenation comprises a catheter hub 5 located at the proximal end of the catheter, a dilatation balloon 6 located at the distal end of the catheter and M channels located in the catheter. The catheter hub is a multi-channel connection device, through which M channels are respectively connected to the external therapeutic devices of the catheter. As shown in FIG. 5, a Luer connector can also be connected to the catheter hub. The Luer connector and the catheter hub are used for connecting M channels and corresponding external therapeutic devices, and enable switching between the external corresponding therapeutic devices. In the present invention, M channels comprise at least a balloon dilatation channel 3, a positioning & detection channel 4, a supply channel 2 and a secretion removal channel. M is an integer greater than or equal to four. FIG. 6 is the physical diagram of the catheter in the present invention comprising four channels. In the specific embodiments, the number of channels and their functions can be increased or replaced according to the function of the catheter and the purpose of treatment, which can cover channels with any function during the treatment of bronchioles.

[0038] The balloon dilatation channel is connected to the balloon inflation device through the catheter hub. The balloon dilatation channel 3 is communicated with the dilatation balloon 6, which has a dilatation port. The balloon inflation device inflates the gas to the dilatation balloon via the balloon dilatation channel and the dilatation port, so that the dilatation balloon 6 is dilated under certain conditions to open the blocked or narrowed part in the human body, so as to advance the catheter smoothly. The positioning & detection channel in the present invention is used for guiding during insertion, and it can also be used for biopsy or fiberoptic endoscope insertion. Specifically, the positioning & detection channel 4 can be used as a guide wire channel, a biopsy channel, or an endoscopic channel. A guide wire can be inserted into the positioning & detection channel 4 to guide the insertion of the catheter. A visualization system can also be connected to the positioning & detection channel 4 through the catheter hub to insert the catheter under the instruction. Biopsy forceps can also be inserted into the positioning & detection channel 4, which is connected to the detection system through the catheter hub, and the lung tissue sample is obtained after the catheter is inserted into the lung. The positioning & detection channel is a cylindrical channel with an inner diameter greater than 0.1 mm and less than or equal to 5.0 mm. When the positioning & detection channel 4 is connected to the visualization system, it is used for navigating the advancing of the catheter (direction and position). When the positioning & detection channel 4 is connected to the detection system, it is used for removing a piece of tissue at the distal end of the catheter, so as to know the condition of the patient at any time.

[0039] The supply channel is connected to the supply device through the catheter hub. The supply device can be an oxygen source or a drug source. The supply channel has a supply port, which is generally provided at the proximal end of the catheter. The supply channel and the supply port are used for oxygen supply and/or drug administration. Specifically, the supply channel can nebulize oxygen and then spray it into the bronchi accurately. For patients who require drug therapy, the drug can be nebulized together with oxygen for topical administration to minimize the damage caused by the drug to the system.

[0040] The secretion removal channel 1 is connected to a sputum aspirator or a pressure syringe through the catheter hub. It is used for bronchial or alveolar lavage and sputum aspiration.

[0041] The catheter of the present invention and the channels inside the catheter can be of any shape, as long as the purpose of treating the bronchioles in the present invention can be achieved. As a preferred embodiment, the example in FIG. 2 is a schematic diagram of the internal section corresponding to Section A in FIG. 1: The catheter can be provided as a cylindrical catheter, the positioning & detection channel 4 is a cylindrical channel, and the secretion removal channel 1, the supply channel 2 and the balloon dilatation channel 3 are distributed between the positioning & detection channel 4 and the outer surface of the catheter, similar to a fan-shaped distribution. The cross-sectional area of the secretion removal channel 1 is generally larger than that of the balloon dilatation channel 3 and the supply channel 2. The lavage port 10, the dilatation port 9 and the supply port 8 are all located on the outer surface of the catheter.

[0042] In the present invention, the inner diameter of the positioning & detection channel 4 is greater than 0.1 mm and less than or equal to 5.0 mm, so that the guide wire with a diameter of more than 0.05 mm and less than 5.0 mm can pass through the positioning & detection channel. A visualization system is connected at the starting end of the positioning & detection channel to observe the position of the catheter in the human body at any time. The visualization system and the positioning & detection channel are used for navigating the insertion and positioning of the catheter, or a fiber optic endoscope is embedded in the positioning & detection channel to guide the insertion of the catheter. The positioning & detection channel 4 can also be connected to a detection device through the catheter hub to remove a piece of tissue at the distal end of the catheter, so as to know the condition of the patient at any time.

[0043] Referring to FIG. 3, the balloon dilatation channel 3 also has a dilatation port 9, which is located inside the balloon 6, and an air pump is connected at the front end of the balloon dilatation channel 3. The balloon 6 is located in the middle of the catheter near the end. The outer diameter of the balloon is larger than that of other parts of the catheter under inflation. The balloon can be dilated to different sizes under different inflation pressures for the purpose of dilating a narrowed or blocked part of the body. In practice, the dilatation balloon may be a 3-stage dilatation balloon with the dilatation pressure within the range of 3-18 atm, and the outer diameter of 3-24 mm under inflation. The dilatation balloon may also be a single-stage dilatation balloon with the dilatation pressure within the range of 3-30 atm, and the outer diameter of 3-30 mm under inflation. The position and number of the dilatation ports in the balloon can be designed according to specific requirements.

[0044] The catheter in the present invention can be, but is not limited to, a polymer catheter, and the isolation material of M channels inside the catheter is the same as the catheter material. The hardness of the polymer catheter is higher than that of the balloon, so that the guide wire leads the catheter, and the catheter leads the ball to a bronchus of the lungs. Preferably, the balloon in the present invention comprises two bridging portions, a gradual portion and a cylindrical portion. The bridging portions are located at both ends of the balloon and fixedly connected to the outer surface of the catheter. The gradual portion connects the bridging portion and the cylindrical portion, the outer diameter of the gradual portion increases successively from the bridging portion to the cylindrical portion, and the outer diameter of the cylindrical portion is larger than that of the bridging portion. The outer diameter of the bridging portion is the same as that of the catheter, and the outer diameter of the cylindrical portion needs to be larger than that of the catheter. The specific size can be determined according to the inflation state of the balloon. When the balloon is not inflated, the outer diameter of the balloon only needs to be slightly larger than that of the catheter. In order to ensure a better opening effect of the balloon during the insertion of the catheter into the bronchiole, the length of the bridging portion:the length of the gradual portion:the length of the cylindrical portion should be 1:2:7 in the advancing direction of the catheter. This length ratio can ensure that the balloon is firmly fixed to the outer surface of the catheter. When the narrowed part is opened, the gradual portion can play a buffer role to the narrowed part to avoid human tissue damage due to the dash of the cylindrical portion on the narrowed part.

[0045] The function of the balloon is to open the narrowed or blocked part of the human body. During the normal advancement of the catheter, the balloon does not need to be inflated. Only when an obstacle or a narrowed part is encountered during the advancement of the catheter, it is necessary to inflate the balloon using the air pump. Since the dilatation port is located inside the balloon, the balloon can be dilated by inflation to open the narrowed or blocked part, so that the catheter can continue to advance. The balloon may be made from materials including but not limited to nylon and its copolymers, polyethylene terephthalate (PET), polyether block polyamide (PEBAX) and one of other polymers or copolymers.

[0046] Referring now to FIG. 3, the supply channel 2 also has a supply port 8, which is located at the front and/or rear end of the balloon in the catheter. The oxygen source is connected at the front end of the supply channel 2. A mechanical ventilator may be connected at the front end of the supply channel to deliver nebulized oxygen to specific parts of the human body. A drug source may also be connected at the front end of the supply channel to supply the drug to the lungs. For patients who require drug therapy, the drug can be nebulized together with oxygen for topical administration to minimize the damage caused by the drug to the system. The position and number of the supply ports can be designed according to specific requirements. Usually, supply ports must be provided at the lower end of the balloon, and supply ports can be selectively provided at the upper end of the balloon.

[0047] Referring now to FIG. 3, the secretion removal channel 1 also has a lavage port 10, which is located at the distal end of the balloon in the catheter. A sputum aspirator or a pressure syringe is connected at the front end of the secretion removal channel for the purpose of lavage and sputum aspiration. When there is inflammation at the site where the catheter reaches, there may be inflammatory secretions, etc. The secretions can be aspirated from the body by the sputum aspirator and through the secretion removal channel, and the cleaning solution such as normal saline can be pumped into the designated part through the secretion removal channel for lavage. Timely lavage of the inflammatory sites of patients with COVID-19, and removal of fluid in the bronchi and alveoli can effectively alleviate the respiratory distress due to the cytokine storm.

[0048] In order to keep the distal end of the catheter better inserted into the human body, the distal end 7 of the catheter can be designed with a suitable hardness, which will not damage the human tissue, and can be smoothly inserted into the bronchioles under the guidance of a guide wire or a fiberoptic endoscope. The perimeter of the outer diameter of the catheter is about 2-10 mm. As shown in FIG. 4, the catheter can be easily passed through the trachea 11 and the main bronchus 12 and enter any bronchiole 13 of the lungs or alveolus through endotracheal intubation or through an airway endoscopy at the bedside under the guidance of the guide wire or fiber optic endoscope at the bedside due to its small outer diameter. The insertion is less invasive and easy to operate, which not only shortens the exposure time of medical staff to the viruses, but also reduces the pain of patients caused by intubation. The catheter is especially suitable for bronchiolar dilatation.

[0049] A method for intracorporeal membrane oxygenation using the catheter includes the following steps:

[0050] S01, inserting the catheter into a bronchus of the lungs through endotracheal intubation or through an airway endoscopy, the guide wire in the positioning & detection channel is used for guiding the catheter to advance and the balloon in the balloon dilatation channel is used for dilating the narrowed part;

[0051] S02, after the catheter reaches the designated position, using the oxygen source to nebulize and supply oxygen to the designated position through the supply channel, so as to spray the nebulized oxygen into the bronchi accurately, and the drug can be nebulized together with oxygen for topical administration to minimize the damage caused by the drug to the system; and

[0052] S03, after the catheter reaches the designated position, using a sputum aspirator or a pressure syringe to connect to the secretion removal channel for lavage and removal of inflammatory secretions, and timely lavage of the inflammatory sites of patients with COVID-19 and removal of fluid in the bronchi and alveoli can effectively alleviate the respiratory distress due to the cytokine storm.

[0053] The present invention integrates the dilatation balloon and the multi-lumen catheter, and presents a small outer diameter, so that the catheter can be directly inserted into a bronchiole under the guidance of a bronchoscope or a fiber optic endoscope. During emergency treatment, on the one hand, the blocked airway is opened up by the dilatation and contraction of the dilatation balloon; on the other hand, the inflammatory excretions on the surface of the membranes can be aspirated and washed through the secretion removal channel to restore the oxygenation function of the membranes. Continuous oxygen supply using the supply channel, nebulization therapy or artificial ventilator are used to ensure maximum oxygen supply for patients, so as to achieve the emergency treatment of all sites (bronchi, bronchioles, and alveoli) and all directions (tracheal dilatation, sputum excretion, oxygen supply and drug administration) using a single catheter. This product is also suitable for the treatment of pneumonia caused by various reasons (such as mycoplasma pneumonia, airway stenosis and pneumonia caused by tuberculosis), silicosis, etc.

[0054] For those skilled in the art, various other corresponding changes and variants may be made according to the technical scheme and concepts described above, and all these changes and variants should fall within the protection scope of the claims of the present invention.