A mechanical ventilation device for tracheostomy patients based on BiPAP ventilator

By designing a BiPAP ventilator mechanical ventilation device suitable for tracheostomy patients, the problem of matching the BiPAP ventilator with the cannula of tracheostomy patients was solved. It enables close-range oxygen supply, airway humidification and sputum dilution, improves the patient's oxygenation and ventilation efficiency, reduces hospitalization time, and meets the rehabilitation needs of some patients who have difficulty weaning off the ventilator.

CN115738002BActive Publication Date: 2025-11-14SHANGHAI YANXIN MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202211272353.8
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-10-18
Publication Date
2025-11-14
Estimated Expiration
2042-10-18

AI Technical Summary

Technical Problem

Existing BiPAP ventilators cannot be used with tracheostomy tubes, which means these patients need to use large medical invasive ventilators and cannot undergo further rehabilitation or be discharged. In addition, existing invasive connection devices are limited in function, expensive and incompatible.

Method used

A mechanical ventilation device for tracheostomy patients based on a BiPAP ventilator was designed, including a hollow integrated valve body. One end of the valve body is connected to the patient's tracheostomy port, and the other end is connected to the BiPAP ventilator. The side wall is equipped with an oxygen connection interface, a nebulizer inhalation connection interface, and a secretion suction port, and is equipped with an adjustable exhaust mechanism, which realizes close-range oxygen supply, airway humidification and sputum dilution, as well as adjustable gas flow control.

Benefits of technology

It improved oxygenation, enhanced airway humidification and sputum management, provided more appropriate individualized respiratory support, reduced hospital stays, increased the likelihood of weaning, and met the ventilation needs of some patients who had difficulty weaning.

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Abstract

This invention relates to a mechanical ventilation device for tracheostomy patients based on a BiPAP ventilator, belonging to the field of medical device technology. It includes a hollow, integrated valve body. One end of the valve body has a cannula connector for communicating with the patient's tracheostomy port, and the other end connects to the BiPAP ventilator. The side wall of the valve body is sequentially provided with an oxygen connection interface, a nebulizer inhalation connection interface, a tubing for connecting to the BiPAP ventilator, and a secretion aspiration port. The tubing connected to the BiPAP ventilator is equipped with an adjustable exhaust mechanism. Using this invention can avoid long-term hospitalization or ICU stays for tracheostomy patients, helping them to undergo further rehabilitation treatment or be discharged to return home.
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Description

Technical Field

[0001] This invention relates to a mechanical ventilation device for tracheostomized patients based on a BiPAP ventilator, belonging to the field of medical device technology. Background Technology

[0002] BiPAP ventilators employ a non-invasive positive pressure ventilation method, Bi-Level Positive Airway Pressure (BiPAP). Essentially, it combines pressure support ventilation with positive end-expiratory pressure (PSV+PEEP) or inspiratory positive airway pressure with expiratory positive airway pressure (IPAP+EPAP). During each breath, the ventilator delivers different levels of positive airway pressure to the patient during the inspiratory and expiratory phases based on pre-set parameters, ensuring effective inspiratory support and positive pressure support during the expiratory phase, thus guaranteeing effective oxygenation and ventilation. With continuous improvements in BiPAP technology and its application by more ventilator manufacturers, the term "BiPAP ventilator" is commonly used to refer to any non-invasive ventilator with BiPAP functionality. Currently, BiPAP ventilators primarily provide pressure support ventilation through non-invasive human-machine interface methods (such as nasal masks or nasal pillows, face masks, or mouthpieces) using BiPAP, rather than through invasive connections (i.e., endotracheal tubes or tracheostomies). BiPAP ventilators are an important means of treating respiratory failure induced by chronic obstructive pulmonary disease (COPD), obstructive sleep apnea-hypopnea syndrome (OSAHS), central nervous system and respiratory muscle diseases (cerebrovascular disease, Guillain-Barré syndrome), early-stage mild cases of acute respiratory distress syndrome (ARDS), and cardiogenic pulmonary edema. Positive airway pressure ventilation is a first-line treatment. During inspiration, it provides a higher inspiratory pressure to help patients overcome airway resistance, increase alveolar ventilation, reduce inspiratory muscle load, and decrease the work and oxygen consumption of the respiratory muscles, allowing them to rest. During expiration, the machine automatically switches to a lower expiratory pressure, equivalent to positive end-expiratory pressure, which counteracts intrinsic positive end-expiratory pressure, acting as a mechanical bronchodilator to prevent airway collapse in the bronchioles, increase ventilation, increase functional residual capacity, prevent alveolar collapse, improve ventilation / perfusion ratio, increase PaO2, and effectively remove CO2 from the alveoli, thereby achieving the goal of increasing PaO2 and decreasing PaCO2.

[0003] Approximately 10-15% of mechanically ventilated patients undergo tracheostomy, and this proportion has been gradually increasing over the past 20 years. The main indications for tracheostomy include prolonged mechanical ventilation due to various causes, difficulty in weaning, or delayed weaning. The main causes include acute respiratory failure, neuromuscular diseases, or trauma. Some of these cases are due to respiratory drive and / or muscle weakness caused by neuromuscular diseases, making weaning impossible. Examples include decreased excitability of the respiratory center (damage to the medullary respiratory center caused by traumatic brain injury, high spinal cord injury, high CO2 depression of the respiratory center due to COPD, etc.); weakened respiratory muscle contraction strength and endurance (neuromuscular junction-related diseases such as muscle weakness, periodic paralysis, malnutrition anemia, and disuse atrophy of respiratory muscles due to excessive ventilator support, etc.); and increased respiratory muscle load due to various reasons. These patients do not have high dependence on or requirements for oxygen concentration; they only need a certain level of respiratory drive and low support pressure. However, because current BIPAP ventilators cannot be used for tracheostomy patients, these patients still require large invasive medical ventilators to be used in conjunction with tracheostomy cannulas. Small, portable BiPAP ventilators currently provide positive pressure ventilation primarily through non-invasive human-machine interface methods (such as nasal masks or nasal pillows, face masks or mouthpieces), rather than invasive connections. Invasive connections require various auxiliary devices, such as platform valves and leak valves, but these are often limited in function, expensive, and prone to incompatibility, leading to prolonged hospitalizations or ICU stays for many tracheostomy patients, preventing further rehabilitation or discharge. While small BiPAP ventilators can theoretically provide some respiratory drive and pressure, meeting the needs of some patients, their flexibility and effectiveness offer doctors and patients' families a more direct option for treatment. However, there is currently no dedicated BiPAP ventilator breathing tubing or respiratory support method for use with tracheostomy cannulas. Summary of the Invention

[0004] The purpose of this invention is to solve the technical problem of how to use a small BiPAP ventilator for tracheotomy patients.

[0005] To address the aforementioned problems, the present invention provides a mechanical ventilation device for tracheostomy patients based on a BiPAP ventilator, comprising a hollow, integrated valve body. One end of the valve body is provided with a cannula connector for communicating with the patient's tracheostomy port, and the other end is connected to the BiPAP ventilator. The side wall of the valve body is sequentially provided with an oxygen connection interface, a nebulized inhalation connection interface, a pipe connected to the BiPAP ventilator, and a secretion aspiration port. An adjustable exhaust mechanism is provided on the pipe connected to the BiPAP ventilator.

[0006] Preferably, the valve body includes a horizontal tube, one end of which is provided with a cannula connector for communicating with the patient's tracheostomy, and the other end is provided with a secretion aspiration port; the side wall of the horizontal tube is provided with an oxygen connection interface, a nebulizer inhalation connection interface and a pipe for connecting to a BiPAP ventilator in sequence.

[0007] Preferably, the secretion suction port is provided with a sealing interface.

[0008] Preferably, the adjustable exhaust mechanism includes a valve inside the pipe, a movable bushing outside the pipe, and a retaining ring; the pipe connected to the BiPAP ventilator is provided with a valve for adjusting the gas flow rate in the pipe, the valve is connected to the bushing sleeve outside the pipe, and retaining rings are provided on the upper and lower sides of the bushing for fixing the position of the bushing.

[0009] Preferably, the valve is a circular, flat butterfly valve with a rotating shaft along its diameter; both ends of the rotating shaft are connected to the pipe wall along the pipe diameter; a rotating gear is provided at one end of the rotating shaft through the pipe wall; a groove is provided on the bushing outside the pipe along the outer circumference of the pipe; the rotating gear is located in the groove, and a rack is provided on the groove to mesh with the rotating gear for rotating the rotating gear.

[0010] Preferably, the bushing is an open cylindrical shape, and the bushing rotates around the tubing connected to the BiPAP ventilator.

[0011] Preferably, the oxygen connection interface and the nebulizer inhalation connection interface are provided with protective covers.

[0012] Compared with the prior art, the present invention has the following beneficial effects:

[0013] ① The location of the oxygen source and exhaust valve is more reasonable. When the ventilator provides a large positive airflow, the actual oxygen concentration inhaled by the patient is diluted. If the oxygen source is far away from the tracheostomy port, the patient's oxygenation will not improve significantly. Placing the oxygen source as close as possible to the artificial airway opening and as far away from the exhaust valve can effectively improve ventilation while ensuring appropriate oxygen supply.

[0014] ②The integrated valve can adjust the effective area of ​​the exhaust valve by longitudinally rotating the open-type bushing according to the arterial carbon dioxide partial pressure level in the patient's blood gas, thereby adjusting the amount of air leakage and further regulating the blood gas results.

[0015] ③ The integrated valve adds an independent humidification device, which is beneficial to improve airway humidification for tracheostomy patients.

[0016] ④ The integrated valve increases the number of nebulizer inhalation connection points without disconnecting the device, which is beneficial for sputum thinning, airway despasm relief, and treatment of respiratory infections.

[0017] ⑤ The tube is opened at the suction end to draw out secretions and is kept relatively sealed to prevent secretions from splashing.

[0018] ⑥ To provide more and more suitable individualized respiratory support options for some patients who have difficulty weaning off mechanical ventilation in clinical practice. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of a mechanical ventilation device for tracheostomized patients based on a BiPAP ventilator.

[0020] Figure 2 This is a schematic diagram of the oxygen connection interface structure.

[0021] Figure 3 This is a schematic diagram of the connection interface for atomized inhalation.

[0022] Figure 4 This is a schematic diagram of the secretion suction port structure.

[0023] Figure 5 Schematic diagram of exhaust mechanism structure Figure 1 .

[0024] Figure 6 Schematic diagram of exhaust mechanism structure Figure 2 .

[0025] Figure A is a schematic diagram of the rear view structure, and Figure B is a top view of the cross section of the pipe at the exhaust mechanism.

[0026] Figure 7 This is a schematic diagram of the structure when the present invention is in use.

[0027] Reference numerals: 1. Sleeve connector; 2. Oxygen connection port protective cover; 3. Oxygen connection port; 4. Nebulizer inhalation connection port protective cover; 5. Nebulizer inhalation connection port; 6. Secretion suction port; 7. Exhaust mechanism; 8. Fixing ring one; 9. Bushing; 10. Fixing ring two; 11. Pipe; 12. Butterfly valve; 13. Rotating gear. Detailed Implementation

[0028] To make the present invention more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings:

[0029] like Figure 1-7As shown, this invention provides a mechanical ventilation device for tracheostomy patients based on a BiPAP ventilator, comprising a hollow, integrated valve body. One end of the valve body has a cannula connector 1 for communicating with the patient's tracheostomy port, and the other end is connected to the BiPAP ventilator. The side wall of the valve body is sequentially provided with an oxygen connection interface 3, a nebulized inhalation connection interface 5, a conduit 11 for connecting to the BiPAP ventilator, and a secretion aspiration port 6. The conduit 11 connected to the BiPAP ventilator is provided with an adjustable exhaust mechanism 7. The valve body includes a horizontal straight tube, one end of which has a cannula connector 1 for communicating with the patient's tracheostomy port, and the other end has a secretion aspiration port 6. The side wall of the horizontal straight tube is sequentially provided with an oxygen connection interface 3, a nebulized inhalation connection interface 5, and a conduit 11 for connecting to the BiPAP ventilator. The secretion aspiration port 6 has a sealing interface. The adjustable exhaust mechanism 7 includes a valve inside the pipe, a movable bushing 9 outside the pipe, and a retaining ring. The pipe 11, connected to the BiPAP ventilator, is equipped with a valve for adjusting the gas flow rate. The valve is connected to the bushing 9, which is fitted outside the pipe. The upper and lower sides of the bushing 9 are equipped with a retaining ring 1 (8) and a retaining ring 2 (10) for fixing the position of the bushing 9. The valve is a circular, flat butterfly valve 12, with a rotating shaft along its diameter. Both ends of the rotating shaft are connected to the pipe wall along the pipe diameter. One end of the rotating shaft passes through the pipe wall and is equipped with a rotating gear 13. The bushing 9 outside the pipe has a groove along its outer circumference. The rotating gear 13 is located in the groove, and a rack meshes with the rotating gear 13 to rotate it. The bushing 9 is an open cylindrical shape that rotates around the pipe 11 connected to the BiPAP ventilator. When the bushing 9 rotates, the rack on the groove of the bushing 9 drives the rotating gear 13 to rotate, which in turn drives the rotating shaft in the pipeline 11 to rotate, and then drives the butterfly valve 12 to flip, thereby reducing or expanding the cross-sectional area of ​​the fluid passage in the pipeline 11, thus regulating the flow rate. The oxygen connection interface 3 and the nebulizer inhalation connection interface 4 are equipped with protective covers. These are the oxygen connection interface protective cover 2 and the nebulizer inhalation connection interface protective cover 4, respectively.

[0030] like Figure 1-7 As shown, this invention provides a mechanical ventilation device for tracheostomized patients based on a dedicated BiPAP ventilator, including a valve body with an integrated valve. The side wall of the valve body is provided with an oxygen connection interface 3, a nebulizer inhalation connection interface 5, a sealable secretion suction port 6, and a rotatable and sliding adjustable exhaust structure 7. It includes:

[0031] The cannula connector 1 connects the head end of the integrated valve to the patient's tracheostomy cannula;

[0032] The oxygen connection interface protective cover 2 is located on the side wall of the integrated valve horizontal tube near the patient's tracheostomy port;

[0033] The integrated valve has an oxygen connection interface 3 located on the side wall of the horizontal and vertical tube near the patient's tracheostomy port, which can independently humidify and deliver oxygen.

[0034] The side wall of the integrated valve's horizontal tube is equipped with an independent protective cover for the atomization inhalation connection interface;

[0035] The integrated valve has an independent atomization inhalation connection interface 5 on the side wall of the horizontal and vertical tube;

[0036] The end of the horizontal tube of the integrated valve is equipped with a secretion suction port 6, which allows secretions to be suctioned through the opening of the suction port 6 without detaching the tube and to be kept relatively sealed to prevent secretions from splashing.

[0037] The outer wall of the vertical pipe of the integrated valve is equipped with a rotatable and adjustable exhaust structure 7;

[0038] Fixing ring 8 is used to fix the rotating part to one side, serving as an axial and longitudinal fixation for the rotating part.

[0039] Self-lubricating open-type bushing 9, a longitudinally rotating sliding part, where the exhaust valve's exhaust volume is adjusted by rotation.

[0040] Fixing ring 2 10 is fixed to one side of the rotating part for axial and longitudinal fixation of the rotating part, providing double fixation to prevent displacement of bushing 9;

[0041] The mechanical ventilation device for tracheostomized patients based on a dedicated small BiPAP ventilator provided by this invention offers a respiratory support method that ensures respiratory drive, a certain pressure support, and guaranteed oxygen supply for patients who are unable to wean off the ventilator due to respiratory drive and / or muscle weakness caused by neuromuscular diseases, such as decreased excitability of the respiratory center (damage to the medullary respiratory center caused by traumatic brain injury, high spinal cord injury, high CO2 depression of the respiratory center caused by COPD, etc.); weakened respiratory muscle contraction strength and endurance (neuromuscular junction-related diseases such as myasthenia gravis, periodic paralysis, etc., malnutrition and anemia, and respiratory muscle disuse atrophy caused by excessive ventilator support, etc.); and increased respiratory muscle load caused by various reasons, thus making weaning difficult. This provides patients with respiratory drive, a certain pressure support, and guaranteed oxygen supply, while meeting their ventilation needs and creating the possibility of leaving the ICU as early as possible to carry out further professional rehabilitation exercises or be discharged from the hospital.

[0042] The present invention provides a mechanical ventilation device for tracheostomized patients based on a BiPAP ventilator, the preferred embodiment of which is as follows: Figure 1 As shown;

[0043] The oxygen connection interface protective cover 2 located near the patient's tracheostomy port on the side wall of the integrated valve's horizontal tube can be opened to provide independent humidified oxygen delivery for patients with slightly poor oxygen reserves.

[0044] The protective cover 4 of the independent nebulization inhalation connection interface on the side wall of the integrated valve can be opened to provide nebulization inhalation treatment for patients with thick sputum, airway spasm, and airway inflammation.

[0045] The secretion suction port 6 at the end of the horizontal tube of the integrated valve is open to attract secretions and keep them relatively sealed to prevent secretions from splashing.

[0046] After the BIPAP ventilator has been running for 30 minutes, the effective area of ​​the exhaust valve is adjusted by longitudinally rotating the open-type bushing 9 according to the patient's arterial carbon dioxide partial pressure level in the blood gas, and the amount of leakage is adjusted. The bushing 9 is double-fixed to prevent displacement. The blood gas results are then checked again to adjust to an appropriate level.

[0047] Use of this invention:

[0048] This invention provides a mechanical ventilation device for tracheostomized patients based on a BiPAP ventilator, the optimal usage of which is as follows: Figure 7 As shown, it includes an integrated valve body, with the head end connected to the patient's tracheostomy cannula, and an oxygen connection interface 3, a nebulizer inhalation connection interface 5, a sealable secretion suction port 6, and a rotatable sliding adjustable exhaust structure 7 on the side wall of the valve body.

[0049] In clinical practice, some patients who have difficulty weaning from mechanical ventilation due to respiratory center lesions or neuromuscular junction-related diseases, but whose ventilation needs can be met by the ventilator providing a certain amount of respiratory drive and a low pressure, can use a mechanical ventilation device for tracheostomy patients based on a dedicated BiPAP ventilator provided by this invention in conjunction with the tracheostomy cannula.

[0050] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention. Any modifications, alterations, and equivalent changes made by those skilled in the art based on the above-disclosed technical content without departing from the spirit and scope of the present invention are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A mechanical ventilation device for tracheostomized patients based on a BiPAP ventilator, characterized in that, It includes a hollow, integrated valve body. One end of the valve body is equipped with a cannula connector for communicating with the patient's tracheostomy port, and the other end is connected to a BiPAP ventilator. The side wall of the valve body is provided with an oxygen connection interface, a nebulizer inhalation connection interface, a tubing for connecting to the BiPAP ventilator, and a secretion aspiration port. An adjustable exhaust mechanism is provided on the tubing connected to the BiPAP ventilator. The adjustable exhaust mechanism includes a valve inside the pipe for adjusting the gas flow rate, a movable bushing outside the pipe, and a retaining ring. The valve is connected to the bushing outside the pipe, and retaining rings are provided on the upper and lower sides of the bushing to fix the position of the bushing. The valve is a circular, flat butterfly valve with a rotating shaft along its diameter. Both ends of the rotating shaft are connected to the pipe wall along the pipe diameter. A rotating gear is provided at one end of the rotating shaft through the pipe wall. A groove is provided on the bushing outside the pipe along the outer circumference of the pipe. The rotating gear is located in the groove, and a rack meshes with the rotating gear to rotate it. The bushing is an open cylindrical shape and rotates around the pipe connected to the BiPAP ventilator. The adjustable exhaust mechanism also includes an exhaust valve with an exhaust hole, and the effective area of ​​the exhaust valve can be adjusted by rotating the bushing to regulate the amount of air leakage; The adjustable exhaust mechanism regulates the flow rate by adjusting the valves inside the pipe to reduce or increase the cross-sectional area of ​​the fluid passage.

2. The mechanical ventilation device for tracheostomized patients based on a BiPAP ventilator according to claim 1, characterized in that, The valve body includes a horizontal tube, one end of which is provided with a cannula connector for communicating with the patient's tracheostomy, and the other end is provided with a secretion aspiration port; the side wall of the horizontal tube is provided with an oxygen connection interface, a nebulizer inhalation connection interface and a pipe for connecting to a BiPAP ventilator in sequence.

3. The mechanical ventilation device for tracheostomized patients based on a BiPAP ventilator according to claim 1, characterized in that, The secretion suction port is equipped with a sealed interface.

4. A mechanical ventilation device for tracheostomized patients based on a BiPAP ventilator according to claim 1, characterized in that, The oxygen connection interface and the nebulizer inhalation connection interface are equipped with protective covers.

Citation Information

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