COVID Airway Patents for Purchase or License

Critical Opportunity Timing

The COVID Airway patents are for the first all-in-one tracheostomy device consisting of an integral introducer and tracheostomy tube. This device has the potential to reduce complications such as insertion trauma, infection, ventilator time, and medical waste. Due to the novel coronavirus (COVID-19) global pandemic, the timing of the COVID Airway intellectual property offering is optimal because the:

  • COVID-19 impact on tracheostomy tube market expansion is predicted to be persistent during 2019-2038;
  • Tracheostomy products market is to set for phenomenal growth by 2025;
  • Favorable reimbursement policies and rising prevalence of respiratory disorders are adding market growth;
  • North America market is expected to witness the largest global market share for tracheostomy products due to the presence of key market players, prevalence of respiratory disorders (e.g. COPD), growing incidence of respiratory diseases (COPD and COVID), presence of a highly developed healthcare system, favorable reimbursement policies in the US and Canada (Rasor COVID Airway patents are US, Canada, and Australia), rise in the number of long-term ventilation care, rise in the bed ridden geriatric population, increasing number of emergency department visits, high adoption of innovative tracheostomy devices among medical professionals, and wide availability of advanced tracheostomy devices;
  • Dearth of skilled surgeons has been a challenge to tracheostomy – the COVID Airway has a simplified procedure requiring less training and less skilled clinicians;
  • COVID-related government funding is available as well as expertise and core services to support development projects for COVID-related medical devices, tracheostomy tubes are ventilator related devices and are life-saving equipment;
  • “Tracheostomy Related Devices” are listed under “Ventilation-Related Products” in the list of device types that FDA believes are critical to the public health during the COVID-19 pandemic under section 506J(a)(1).

Read more about the COVID Airway offering in section Purchase or License COVID Airway Patents on this page below.

What is the Role of Tracheostomy in COVID-19 Respiratory Insufficiency and Artificial Ventilation?

In the United States, before the pandemic,

  • Tracheostomy was the most common surgical procedure performed on critically ill patients;
  • The primary Intensive Care Unit (ICU) admitting diagnosis was respiratory insufficiency/failure.

Now with the COVID-19 novel coronavirus global pandemic the majority of most severely ill patients initially present with single organ failure i.e., respiratory insufficiency, therefore,

Ventilators and their associated airway devices are in high demand.

COVID-19 is characterized by rapid respiratory decompensation and subsequent need for artificial airway insertion with mechanical ventilation in severe cases: initially, an endotracheal intubation via the mouth and, if ventilation of greater than 7 to 14 days is required, a tracheostomy tube insertion via an incision in the lower neck area. Invasive mechanical ventilation is frequently required for prolonged periods,

A significant proportion of COVID-19 patients require mechanical ventilation for more than 21 days which is an indication for tracheostomy.

The major indication for tracheostomy remains the facilitation of mechanical ventilation for a long period, while minimising complications from a translaryngeal endotracheal tube and weaning from ventilation. Tracheostomy might also be required for actual or threatened airway obstruction, laryngeal edema, which might be an emerging feature of COVID-19, or unsuccessful extubation due to weakness, poor cough, tenacious secretions, or a combination of these factors.

Tracheostomy has become particularly important in treating patients with COVID-19 where resource capacity is already stretched to the brink, earlier tracheostomy could:

  • free up ICU beds
  • free up ventilators
  • free up staff
  • reduce PPE use.

Recently, some centers in New York City have found early tracheostomy has improved management of COVID-19 patients. In July 2020, based on a strong consensus,

An expert panel recommends the consideration of tracheostomy in patients with COVID-19 if clinicians anticipate mechanical ventilation will be required.

The current literature suggests the tracheostomy procedure may confer better outcomes, such as ventilator-free days, shorter hospital stays, shorter stays in the ICU, and reduced hospital-acquired pneumonia incidence compared with prolonged mechanical ventilation with endotracheal intubation. Tracheostomy decreases the work of breathing and improves patient comfort when compared to an endotracheal tube.

Poor survival rates have been published for intubated critical patients without tracheostomy infected with COVID-19 admitted to ICUs, with mortality rates in large case reports of 26–54.4%. Comparatively, in a large collaborative study where 1,616 tracheostomies were performed the overall COVID-19-associated mortality was 23.7%.

Recent results in 2,081 COVID-19 patients undergoing tracheostomy suggest that tracheostomy could be effective in the weaning and decannulation of COVID-19 patients.

Benefits of early tracheostomy to patients are:

Decreased:

  • time on mechanical ventilation by 8.5 days
  • ICU length of stay
  • mortality in some studies 
  • work of breathing
  • dead space and resistance
  • subglottic stenosis
  • use of sedation and paralytics
  • cumulative effects of sedation (less delirium)
  • laryngeal injury, trauma, or dysfunction
  • risk of transmission of infection to healthcare workers
  • ventilator-associated pneumonia
  • ventilator-associated respiratory muscle atrophy
  • re-intubation when early extubating attempts fail.

Improved:

  • liberalization from the ventilator 
  • pulmonary and dental hygiene
  • expedited participation in rehabilitation
  • tracheal secretion control
  • ability to communicate
  • patient comfort and autonomy.

Tracheostomy Procedure

Today, standard percutaneous dilatational tracheostomy (PDT) requires numerous steps, but in general there are four basic steps that require four different devices: 1) incision into the neck with a scalpel; 2) dissection of skin and pretracheal tissues with the fingers and/or forceps; 3) dilation of the wound with a tracheostomy tube introducer(s); and 4) insertion of a tracheostomy tube airway through the surgical wound.

In 2020, and expert panel determined that standard PDT has a learning curve and at least 10 assisted PDTs must be done under supervision before performing the procedure independently.

The COVID Airway patents (Rasor invention) are for the first all-in-one PDT device. It simplifies the procedure with a single integral device. A comparison video of the standard dilation method for tracheostomy tube insertion vs. the COVID Airway platform shows the dramatic difference in insertion force between the two methods.

Complications Due to Friction

Friction is a primary problem with insertion of existing PDT devices (both tracheostomy tubes and tracheostomy tube introducers) – a coating or lubricant is used in an attempt to lower insertion friction – the COVID Airway does not require a coating or application of a lubricant as it uses radial dilation (read Julia’s Special Feature article ‘The Science of Friction’).  The leading marketed device has numerous shortcomings, it uses high force axial and wedge friction to dilate and insert that results in complications including many deaths.

The Rasor all-in-one everting tracheostomy tube and introducer invention, COVID Airway, is an advancement beyond the standard devices as it uses radial dilation with blunt dissection resulting in a friction free insertion without force vastly reducing tissue damage and other complications.

In addition, there is the potential for less postoperative hemorrhage, because blood vessels are compressed with radial dilation. While in situ in a trachea, the COVID Airway film sheath surrounding the tracheostomy tube also reduces tissue trauma such as rubbing frictional and pressure necrosis, scarring, and granulation which can lead to infection at the tracheostomy site or stoma.

Complications Due to Infection

Critically ill patients with COVID-19 who are intubated are at risk for developing Ventilator-Associated Pneumonia or VAP and other infections typical of all critically ill and/or intubated patients. Some of the most severely ill COVID-19 patients who initially present with single respiratory insufficiency progress to more systemic disease and multiple organ dysfunction. One of the most significant poor prognostic features in those patients is the development of coagulopathy.

In patients who develop sepsis from various infectious agents, development of coagulopathy is one of the key and persistent features which is associated with poor outcomes therefore, it is vital to prevent other infections and sepsis in COVID-19 patients.

The COVID Airway device may reduce infections introduced: 1) by current percutaneous dilatational tracheostomy (PDT) device insertion methods; 2) at the insertion site (stoma); and 3) in the trachea while the device is in place. Also,

Increased safety to healthcare workers is provided by using a tracheostomy airway with a ventilator as breathing by the patient is contained in a closed system.

Procedures such as endotracheal intubation and extubation, airway suctioning, manipulation of oxygen face masks, and tracheostomy are aerosol-generating procedures that increase the risk of transmission of infection to healthcare workers. Endotracheal intubation is especially hazardous because the clinician is close to the patient’s airway before, during, and after the procedure, however,

tracheostomy is less likely to transmit disease to healthcare workers.

The COVID Airway everting film sheath surrounding the tracheostomy tube prevents microbe tracking into the patient upon insertion and the snugly fitting stomal tissue tract around the tracheostomy tube is less prone to stomal infection and aerosolized leakage of virus to healthcare workers. One of the absolute contraindications with standard tracheostomy is infection at the site of tracheostomy. The COVID Airway could then be the only solution for these patients as it does not advance microbes upon insertion.

In addition, while in situ in a trachea, the COVID Airway resists surface adherence of fibrin, minerals and platelets minimizing biofilm build-up that leads to colonization, local, then systemic infection.

Pandemic Shortages

During the COVID-19 pandemic public health emergency, ventilators and their associated airway devices are in high demand. Use of the COVID Airway reduces infection and thus ventilator time freeing up ventilators for others. Tracheostomy has become particularly important in treating patients with COVID-19 where resource capacity is already stretched to the brink, earlier tracheostomy could free up ICU beds, ventilators and staff and reduce PPE use.

Medical Waste Reduction

Record amounts of medical waste are being generated with the COVID-19 global pandemic. Standard tracheostomy devices require numerous dilation steps, auxiliary kit devices, and large mass disposables. The COVID Airway all-in-one integral device simplified procedure reduces the number of components required for tracheostomy thus offering an eco-friendly solution by reducing medical waste.

Purchase or License COVID Airway Patents

The Rasor COVID Airway patents patents are for an Everting Device and Method for Tracheostomy. The invention relates to an improved method and related devices for percutaneous placement of airway tubes into the tracheas of living bodies, a procedure known as a tracheostomy, and subsequent supportive maintenance tracheostomy. The objects of the invention are as follows:

  • Simplify the procedure and reduce the number of components required for tracheostomy;
  • Provide a device and method that require less axial force to dilate patient tissue and less shear and frictional force to insert an airway into the patient’s trachea;
  • Provide a device and method that reduce the potential of infection and other complications as a result of a tracheostomy;
  • Provide a device and method that reduce tissue trauma such a rubbing frictional and pressure necrosis, scarring, and granulation produced by a tracheostomy tube while in situ in a trachea.

The Rasor intellectual property available for purchase or license consists of a collection of a large volume of information that provides turn-key development, approval, and commercialization of the device:

  • Three issued patents in the US, Canada, and Australia (The Americas is expected to hold the largest share of the global tracheostomy products market. This is owing to the presence of key market players, the growing incidence of respiratory diseases (COPD and COVID), and favorable reimbursement policies in the US and Canada)
  • Trade Secrets on manufacturing, materials, venders, etc. (not in the public domain)
  • Solidworks® drawings of device and insertion steps
  • Full detailed business plan
  • In vitro, in vivo, and clinical trial designs
  • Established regulatory 510(k) and reimbursement paths
  • 3D printed demo device
  • Inventor available to consult to transfer know-how
  • Top tracheostomy clinical opinion leader contacts who want the device developed and available for use.

Are There Coronavirus (COVID-19) Government Funds Available for Medical Devices? Yes.

At this time, there are government funds available as well as expertise and core services to support development projects for devices like the COVID Airway:

  • The recent Coronavirus Preparedness and Response Supplemental Appropriations Act authorized federal funds to prevent, prepare for, and respond to COVID-19. More than $3 billion has been allocated to the development of necessary countermeasures and vaccines and the purchasing of vaccines, therapeutics, and diagnostics, as well as other medical supplies.
  • As part of the government-wide effort to mitigate the spread of COVID-19 in U.S. communities, the U.S. Department of Health and Human Services (HHS) has updated a broad agency announcement (BAA) to focus specifically on products to diagnose, prevent or treat coronavirus infections. The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), issued the BAA, BAA-18-100-SOL-00003-Amendment 13, to solicit proposals.
  • BARDA will provide funding as well as expertise and core services to support development projects selected through this BAA. These products include diagnostic tests (assays); vaccines; therapeutics; medications to help regulate or normalize the immune system (immunomodulators); therapeutics targeting lung repair; medicines that prevent infections either before or after exposure to the virus (pre-exposure or post-exposure prophylaxis); respiratory protective devices; and ventilators.
  • National Science Foundation (NSF) also has COVID-19 related funding.

These government funds are available for medical devices like the COVID Airway which is the first all-in-one tracheostomy device consisting of an integral introducer and tracheostomy tube vs the standard that uses separate devices. Patents for the device are issued to inventors Julia S. Rasor and Ned S. Rasor and are now for sale or license. Due to the novel coronavirus (COVID-19) global pandemic, the COVID Airway patents are a timely offering as they cover an airway device, a medical supply, respiratory protective device, that is used with a ventilator that offers infection prevention to both the patient and the healthcare worker. 

Contact Julia S. Rasor, 408-395-3335 for more information.