TT Medical's Globally First-in-Class Respiratory Balloon Dilation Catheter for COVID-19 Emergency Care Receives Market Approval

Recently, TT Medical globally exclusively developed the "Respiratory Balloon Dilation Catheter" and received approval from Guangdong Province.Approved for marketing by the regulatory authority.

It is reported that the respiratory balloon dilation catheter is also known as the "Respiratory Emergency Multifunctional Balloon Dilation Catheter" (trade name:LifeSupport™)，Specifically used for emergency treatment of patients with respiratory obstruction caused by various reasons, such as COVID-19, drowning, etc.,By TT Medical after nearlyCompleted in 3 years of independent development.

DongGuan TT Medical, Inc. is a company focused onA national high-tech enterprise specializing in the full-chain innovation of interventional devices, possessing the Guangdong Provincial Medical Polymer Materials Engineering Center and Guangdong.Provincial Innovation and Entrepreneurship Leading Team, with capabilities in analyzing clinical issues- Product Design - Sample Manufacturing - Development Verification, to Scale-upThe capability of full-chain innovation in production. The company has established material engineering and processing, balloon and balloon catheter, catheter weaving and coating.Integration, coating and drug-device combination, stent design and production five major technology platforms, in the field of medical polymer materials engineering and applicationField, with full technical capabilities ranging from precision extrusion of polymer materials, injection molding, balloon forming, catheter braiding to various welding and assembly processes.With the underlying technology reserve of the process.

As of now, TT Medical has laid out in the fields of cardiovascular, cerebrovascular, peripheral vascular, digestion and respiration, etc.More Than Ten Products.

TT Medical stated: "The multifunctional balloon catheter for respiratory emergency is the company's third approved product in the field of respiratory intervention."Products, the other two products are respiratory tertiary dilation balloon catheters and guidewires. Based on the above three innovative products, the companyIn the field of respiratory and pulmonary vascular, a series of characteristic products are gradually taking shape. The companyA total of 7 interventional products were approved in 2022.

It is reported that the multifunctional balloon dilation catheter for respiratory emergency has multi-channel and multi-stage expansion balloons. The multi-channel allows for dilation,Clinical emergency measures such as suctioning, oxygen administration, and biopsy can be performed simultaneously within the first response time. The multi-stage dilation balloon encompasses8-20mm in various specifications, meeting nearly all demands for airway dilation.

Among them, the first channel is a tertiary dilation balloon, whose main function is to keep the airway open. The second channel is used for sputum drainage, which can remove foreign objects from the patient's lungs. Meanwhile, this channel can be used to deliver saline or medication to irrigate the patient’s lungs. The third channel functions to supply oxygen. The fourth channel, located in the middle of the three channels, allows a fiber optic endoscope to pass through, enabling doctors to observe the condition of the patient’s lungs. Additionally, samples can be collected using the equipment for further examination.

In the emergency treatment of severe pneumonia such as COVID-19, the catheter is connected to a ventilator, suction machine, and other devices through a specially designed four-way adapter.Oxygen delivery equipment connection, via fiber optic inner diameter orUnder X-ray guidance, insert through tracheal intubation or directly into the lung base for multiple and repeated emergency treatments, including:

First, the multifunctional balloon dilation catheter for respiratory emergency can keep the patient's airway open.Connecting the pressure pump with three-level dilationBalloon channel connection can dilate and clear narrowed airways. The balloon is located at the distal end of the catheter and is made of special material.Made of material, corresponding to three different expansion diameters under three different expansion pressures, saving both doctors' time andPatient costs. Balloon diameter from6.0mm-20mm, length covering 30mm-55mm, capable of clearing stenosis or mucus blockage anywhere in the expanded respiratory tract.

Second, the multifunctional balloon dilation catheter for respiratory emergency can achieve lavage and sputum drainage at the level of small bronchi and alveoli..The suction channel is connected to the sputum suction machine, which can extract secretions from the inflamed areas of the small bronchi in the lungs. This channel can also be used to repeatedly flush the inflamed area, providing a localized anti-inflammatory effect. Meanwhile, the blocking balloon can also prevent the ventilator from affecting the inflamed area.Mechanical compression to prevent the accumulation of inflammation in deeper layers.

Third, the multifunctional balloon dilation catheter for respiratory emergency can achieve positive pressure oxygen delivery in the lungs.Connect the oxygen channel to the oxygen machine.When the balloon is inflated, it blocks the distal bronchus to form a sealed high-pressure oxygen chamber, with the distal oxygen outlet directly facing the inflamed area.The tissue in the field is continuously supplied with oxygen under positive pressure, while the proximal opening directly supplies oxygen to the alveoli in other areas.

Fourth, the multifunctional balloon dilation catheter for respiratory emergency can achieve biopsy of small bronchi and alveolar tissue.Biopsy ChannelLocated in the middle of the catheter, it allows the fiber optic endoscope, guidewire, or biopsy forceps to pass through easily, enabling doctors to better understand the patient's lungs.The situation, and can use the equipment to take samples for detailed observation.

It is worth mentioning that the multiple channels of the multifunctional balloon dilation catheter for respiratory emergency can be used as needed, either individually or...Using a single channel or multiple channels simultaneously can make clinical rescue safer, more efficient, and more convenient.

Clinical experts said: "Through four channels, the multifunctional balloon dilation catheter for respiratory emergency can quickly synchronize at the bedside."The needs for foot airway dilation, sputum drainage, oxygen supply, and endoscopic sampling are of great significance in the treatment of COVID-19 patients.”

The multifunctional balloon dilation catheter for respiratory tract can be applied to emergency treatment of airway obstruction caused by any other reasons, such as drowning.The elimination and emergency treatment of water accumulation in the respiratory tract and alveoli of patients with hydrops have broad market prospects due to numerous application scenarios.。

Clinically, most patients infected with the novel coronavirus are asymptomatic or present with fever, dry cough, and fatigue. Such patients only requireSymptomatic treatment is sufficient. However, some patients may develop acute respiratory distress syndrome (ARDS), commonly known as"Big White Lung".

Wu Zunyou, the chief epidemiology expert of the Chinese Center for Disease Control and Prevention, previously stated: "The changes in China's COVID-19 situation over the past three years are,The proportion of severe and critical cases fromDecreased from 16.47% in 2020 to 3.32% in 2021. As of December 5, 2022Year is0.18%。”

Tong Zhaohui, Vice President of Chaoyang Hospital affiliated to Capital Medical University, said: "According to the admission situation of Beijing's designated hospital for COVID-19 treatment,The proportion of patients with "white lung" among the inpatients in designated hospitals is currently3%-4%。”

It should be noted that different hospitals have different technical levels, and the severity and base number of patients' conditions they admit vary, soThe severe case rate varies significantly across different hospitals. Meanwhile, some mild and moderate cases do not seek medical attention at hospitals currently.The accurate proportion of "white lung" patients among all COVID-19 infected individuals cannot yet be determined.

Nevertheless,Based on the terrifying transmission power of the novel coronavirus and China's large population base, it is estimated that China will still have a significant number of cases.A significant number of "ground-glass lung" patients that cannot be ignored。

Clinical experts said: Acute respiratory distress syndrome is an acute, diffuse inflammatory lung disease that occurs within a short period of time.Injury, caused by severe infection, trauma, and other pathogenic factors, presents clinically as respiratory distress, refractory hypoxemia, and...Respiratory failure.

Pathologically, acute respiratory distress syndrome caused by coronavirus infection presents with inflammatory responses and pulmonary edema in the lungs, along with a large amount ofThe inflammatory secretions cover the alveoli, similar to dust covering an air conditioner filter, thereby obstructing normal alveolar oxygenation.Function, leading to a severe lack of oxygen saturation in the blood, ultimately causing difficulty in breathing for the patient.Therefore, regarding the COVID-19 infectionAcute respiratory distress syndrome caused by infection requires early clearance of inflammatory secretions from the airway to maintain airway patency.Dryness in the lungs.

At present, the clinical treatment mainly relies on ventilators and extracorporeal membrane oxygenation (ECMO) for emergency treatment of such patients. However, forPatients with severe COVID-19 pneumonia, these two treatment methods both have certain limitations.

A ventilator uses external machinery to create a positive pressure difference between the patient's airway opening and alveoli, passively completing the inhalation process; then removes it.External mechanical drive causes the thorax and lung elastic recoil, generating a passive positive pressure difference between the alveoli and airway opening, passively completing exhalation.Pneumatic action.

However, during the positive pressure ventilation process, inflammatory substances are also delivered to the bottom of the lungs along with the airflow. The longer the ventilator is used,The longer the duration, the more inflammatory substances accumulate in the patient's lungs, potentially leading to more severe consequences. Additionally, the patient's use of a ventilator requiresInserting a catheter, and if the patient needs to expel phlegm, the catheter must be removed again, making the procedure very cumbersome, and medical staff are also at risk of...The risk of infection.

ECMO is a technique that draws blood from the large veins of the body, oxygenates it outside the body, and then returns the oxygenated blood to the large arteries.Or large venous vessels, to partially or completely replace heart and lung functions, alleviating pulmonary pressure. However,ECMO can only alleviate bloodThe lack of oxygen in the liquid does not fundamentally solve the problem of the pulmonary membrane being sealed, and therefore it is a temporary solution rather than a permanent one. Additionally, the deviceExpensive cost, complex operation, and difficult to popularize.

In response to the pain points of ventilators and ECMO, TT Medical's team, based on its innovative strength and rich experience,Time has considered developing a multifunctional interventional treatment product to fundamentally solve the issue of pulmonary oxygenation in pneumonia patients.Title. Dr. TianGen Wu, founder of TT Medical, stated:"We hope to develop a multifunctional interventional catheter product that integrates functions such as airway dilation, sputum drainage, oxygen delivery, and endoscopic sampling, allowing patients to drain sputum at any time without delaying oxygen supply."

The respiratory emergency multifunctional balloon dilation catheter approved this time is a globally unique product independently developed by TT Medical.Innovative products and treatment methods. The product utilizes a four-lumen balloon catheter to rapidly and easily administer treatment from inside the airway at the bedside.Eliminate inflammatory accumulations in the respiratory tract economically and efficiently, thereby restoring the alveoli's own oxygenation function.。

Currently, TT Medical has obtained numerous patents and product approval certificates for this globally pioneering product.

TT Medical (Dongguan) - A Wholly-Owned Subsidiary of Wuxi TianGuang Tai, is a national high-tech enterprise driven by clinical needs and focused on full-chain innovation in interventional devices. It possesses the Guangdong Provincial Medical Polymer Materials Engineering Center and the Guangdong Pearl River Talent Innovation and Entrepreneurship Leading Team. In the field of interventional devices, the company has full-chain innovation capabilities spanning from analyzing clinical source problems to product design, prototype production, development validation, and large-scale manufacturing. TT Medical has established five major technology platforms: polymer materials engineering, balloon and balloon catheters, catheter braiding and composites, coatings and drug-device combinations, and stent design and production. In the field of medical polymer materials and applications, it holds comprehensive underlying technologies and processes, including precision extrusion, injection molding, balloon forming, catheter braiding, and various welding and assembly techniques. To date, TT Medical has developed a portfolio of thirty products across cardiovascular, cerebrovascular, peripheral vascular, gastrointestinal, and respiratory fields. For more information, please visit the TT Medical official website:https://cn.ttmedicalinc.com