WO2014023997A2

WO2014023997A2 - Biomimetic artificial secured airway

Info

Publication number: WO2014023997A2
Application number: PCT/IB2012/003140
Authority: WO
Inventors: Eric Robert WEBER
Original assignee: Weber Eric Robert
Priority date: 2012-05-11
Filing date: 2012-05-11
Publication date: 2014-02-13
Also published as: WO2014023997A3

Abstract

Disclosed herein is a biomimetic artificial secured airway for use with a patient ventilating system that reduces the incidence of ventilator-associated patient infections when compared with the infection rate attributable to existing endotracheal and tracheostomy tubes.

Description

BIOMIMETIC ARTIFICIAL SECURED AIRWAY

This utility patent application is being submitted as a PCT application with the USPTO as the chosen receiving office and claims priority from provisional application 61485221 filed by the inventor in the USPTO on 12-MAY-2011 , the entire contents of which are incorporated herein by reference.

SPECIFICATION

FIELD OF THE INVENTION

The instant invention relates to a secured artificial airway for mechanically ventilating a medical patient, whether for long-term ventilation support or short-term ventilation, and whether in a critical care environment like an Intensive Care Unit (ICU) or in a sub-acute or home care situation. More specifically the invention is related to providing a device that closely approximates the native airway physiology and reduces associated infections. It includes a secured airway from the trachea to the exterior of the body, a method of drainage and secretion removal, and controller that regulates the actuation of short fibers on the surface of the airway and removal of accumulated debris and secretions.

REFERENCES CITED

Document Number Title Filing date

EP1120124 Ventilator Dec 5, 2000

EP0982043 Ventilator Aug 9, 1999

US7219666 Ventilator Jul 15, 2004

EP1179354 Ventilator Jun 15, 2001

US6516800 Neonatal patient ventilator circuit Aug 25, 2000

US6369838 Graphic user interface for a patient ventilator May 19, 1999

US20090194110 Mechanical ventilator Jan 30, 2009

US7017574 System for automatically weaning a patient from a Nov 17, 2003 ventilator, and method thereof

EP1 767235 Ventilator Sep 1 8, 2006

US6082357 Mechanical ventilator Mar 25, 1 998

US200803081 04 Ventilator Jun 9, 2005

US20090071 478 Ventilator Sep 1 7, 2008

US691 0480 Patient-ventilator synchronization using dual phase Sep 1 4, 2000

sensors

US6547825 Artificial trachea Apr 3, 2002

EP1 1 201 24 discloses and claims a ventilator for respi ratory care, i ntended for connection to a patient, stating further that need less alarms, caused by a patient's attempts to speak and needless sufferi ng because of the patient's inabil ity to trigger an alarm, are some of the problems occurring. These problems are solved according to the invention when a sound detector is devised and arranged to detect and identify sou nds made by the patient, preferably intentional ly, and a control unit is operatively connected to the sound detector and devised to act on at least one fu nction in the ventilator on the basis of sounds identified by the sound detector

EP0982043 discloses and clai ms a ventilator designed for connection to a patient to provide assisted breathing, comprising a gas flow generator, a pressure meter, a flow meter and a control u nit, devised to determine a gas pressure, on the basis of a pre-set tidal volume for the patient and measurement signals from the pressure meter and flow meter, for each breath and to regulate the gas flow generator so it generates the gas pressure. Fu rther claimed is an improved breathing mode, better tai lored to the patient, achieved when the control unit is also devised to determine the gas pressure to be generated by the gas flow generator on the basis of mechanical resistances and a variable corresponding to the aggregate effect of the resistance and elastance of the lu ngs. US721 9666 d iscloses and claims a ventilator which has a compact block made of plastic or metal and includes an electrical computer i nterface, in which rigid pipes and a gas supply container are integrated, resulting in a more compact device than conventional su perstructures and improved therapy gas delivery and nebulization.

EP1 1 79354 discloses and claims a ventilator consisting of an inspiratory unit and an expiratory valve for regulating a flow of breathing gas and a control unit for controlling the inspiratory unit and the expiratory valve. Further, in order to facilitate the opening of collapsed alveoli i n the lungs, the control unit is devised to control the inspiratory unit and the expiratory valve in generating a recru itment phase with an elevated basic pressure for the flow of breathing gas upon which a nu mber of breaths is superimposed at a faster breathing rate.

US651 6800 discloses and claims a disposable neonatal patient ventilator circuit for an automatic ventilator. All components that are exposed to contamination from the patient are packaged together i n a disposable unit external to the automatic venti lator. The automatic ventilator has a receptacle with a pressu rized breathable gas supply port, a breathing control circuit port, and preferably a patient monitoring port. The disposable neonatal resuscitator unit matches the ports on the automatic ventilator with a removable plug having a pressurized breathable gas su pply connector mating the gas su pply port of the receptacle.

US6369838 discloses and clai ms a ventilation control system for controlling the ventilation of a patient. The ventilation control syste m utilizes a user-friendly user interface for the display of patient data and venti lator status, as well as for entering values for ventilation settings to be used to control the ventilator.

US200901 941 1 0 discloses and claims an entrainment-based mechanical ventilator that may be initially set to approximate the patient's spontaneous respiratory frequency, enabling the patient to entrai n to the venti lator if the venti lator frequency matches the patient's spontaneous breathing frequency or is within a reasonable range from it. If the preset frequency of the venti lator is set too high or too low from the spontaneous frequency, the patient wil l fall out of phase and "fight" the venti lator. The ventilator phase relative to the patient's breathing effort i ndicates the difference between the ventilator frequency and spontaneous frequency. Based on the phase difference, a closed-loop control mechanism may continuou sly adjust the venti lator frequency to match the patient breathing frequency until the phase shift is within a preset li mit.

US701 7574 discloses and claims a medical mechanical ventilator device adapted for use in wean ing a patient from mechanical ventilation. In one embod iment, the device measures the patient's minute volu me, breath frequency, and detects a patient's spontaneous breath. The device compares the patient's minute volume and the patient breath rate to a predeterm ined mi nute volume and a predeterm ined breath rate entered by a clinician. In a pressure support mode, the device decreases patient pressure support level if the patient's spontaneous breath ing rate falls within the predetermined range of breathi ng and the patient's minute volume exceeds the predetermi ned minute volume.

EP1 767235 discloses and claims a ventilator for ventilati ng a patient, the ventilator having the means built-in for carrying out a determ ination of the fu nctional residual capacity of the patient using an inert gas wash in/wash out techn ique. Accordingly, the ventilator operates to alter the inert gas content of breathing gases provided to the patient.

US6082357 discloses and clai ms a mechanical ventilator for ventilating a patient that employs an ai r displacement member mou nted for oscillating motion i n a chamber, preferably the chamber is semi-cylindrical and the air displacement member is a vane mounted for oscillating movement about an axis of rotation such that a free outer edge su rface of the vane is maintained in closely spaced apart relationship with the interior wall of the cham ber throughout the oscillating. The ventilator perm its significant variation in the ventilation flow waveform. US200803081 04 discloses and claims a ventilator, intended to be connected to a patient for breathing therapy, which has a control u nit having an in put for receiving EMG signals from an EMG detector and an output for an EMG based control signal and a pneumatic unit for generating breathing gas flows dependent on the EMG based control signal is described. The ventilator has a detector for determining a parameter related to breathing dynamics for the patient, the detector being connected to the control unit and control u nit controlling the pneu matic un it dependent on the parameter related to breathing dynamics in the case of loss of EMG signals at the input.

US20090071 478 discloses and claims a ventilator to replace or supplement a patient's breathing includes a control valve in the form of a proportional obstacle valve (POV) to provide improved air flow control and ventilator operation rel iability. The POV includes an inlet, an outlet and a bypass. A stopcock controlled by a stepper motor directs the flow of air through the bypass and outlet permitting the turbine to operate a constant RPM yet allowing control of the airflow to a patient. The ventilator also includes inhalation and exhalation valve assemblies which improve air flow control and are easy to manufacture. The inhalation valve includes an orifice disk to allow pressure sensors to move accurately measure ai r flow. The exhalation valve assembly includes wings to reduce turbulence and enhance sensor accuracy. The exhalation valve assembly is arranged to have warm air from cooling the turbine blow over the assem bly to reduce the possibility of condensation forming therein. The venti lator also i ncludes an improved power supply with redundant sources of power.

US691 0480 discloses and claims an improved venti lator which delivers ventilation su pport that is synchronized with the phase of the patient's respiratory efforts and guarantees a targeted minimum ventilation. Improved synchronization is achieved through an instantaneous respiratory phase determination process based upon measu red respiratory airflow as well as measured respiratory effort using an effort sensor accessory, preferably a suprasternal notch sensor.

US6547825 discloses and claims an artificial trachea that is able to be used safely in the clinical application, and especially an artificial trachea for the intra-thoracic trachea, and the artificial trachea comprises a polypropylene mesh tube for the base material, around the outer periphery of which a polypropylene filamentous stent is wound in a spiral shape, an amorphous collagen thin layer formed on the surface of the base material, and a fine fibrous collagen layer formed on the inner and outer surface of the amorphous collagen thin layer, to which thermal dehydration crosslinking is performed.

BACKGROUND OF THE INVENTION

A medical mechanical ventilation system consists of a mechanical ventilator, a ventilator circuit that may include filters or humidifiers, and a secured airway, either through the nasal or oral cavities or through a surgically inserted tracheostomy opening into the trachea. The mechanical ventilator is a mechanical pump for moving air or gas through the system. The ventilator circuit provides a conduit for the air to move from the mechanical pump into the artificial airway and into the lungs. The secured airway is most commonly a PVC endotracheal tube, but may be an alternate form of nasotracheal or orotracheal airway or tracheostomy tube.

Mechanical ventilators can operate on a set cycle of inspiratory and expiratory pressures and volumes, and may include an occasional increase in pressure to open closed alveoli. The ventilator circuits are generally composed of a plastic tube with ports for sensors and medication administration. Filters or humidifiers placed as part of the ventilator circuit involve air moving through a membrane and introduction of fluid or humidified air to the circuit space.

Patients who are undergoing ventilator therapy may have an endotracheal tube placed to maintain the airway under mechanical ventilation. The artificial airway consists of a polyvinyl ch loride tube that introduced through the oral cavity through the pharynx and larynx and terminates in the trachea below the larynx. The tube i ncludes an inflatable cuff that is i nflated to sufficient pressu re to provide a seal at the tracheal end , and the distal end of the tube is secu red at the mouth.

Artificial cilia formed from long chains of spherical superparamagnetic particles which self-assemble in a microflu id ic device are known. Until this i nvention, however, no artificial ciliary capabi lity appropriate for medical applications had been developed.

Although there have been recent advancements i n structu red antim icrobial and antibiotic therapy, nursing protocols, patient positioning, and endotracheal tube design, ventilator-associated infection continues to be a significant clinical problem with severe i mplications for patients with an al ready critical underlyi ng co-morbidity factor that necessitates mechanical ventilation. The endotracheal tube acts as a conduit for infectious agents because it bypasses the host defense system of the trachea and provides a reservoir for bacteria to colonize where they exhibit increased resistance to antimicrobial agents. DETAILED DESCRIPTION OF THE INVENTION

One skil led in the art knows that despite recent improvements in medical mechanical ventilation systems, there has not been a concomitant decrease in the incidence of ventilator associated infection. This lack of improvement regarding the incidence of i nfection most likely results from the lack of previous ventilator system designs to include a biomimetic artificial airway designed to replicate or replace the native host immune system bypassed by the artificial system. The instant invention will overcome this shortcoming by providing a biomimetic solution to maintenance of an artificial secured airway.

The instant invention consists essentially of a secu red airway tube that has an i nternal su rface modification that approximates cil ia and ci liary movement with a drain for removing biofilm and particles cleared from the airway by the ciliary action, as well as an electronic control ler that varies the cycles of actuation of fibers on the interior surface of the airway and controls drainage and suction within the device . It wil l be readily understood by those skilled in the art that the heretofore unprecedented feature of this biom imetic airway, the ability to mimic the hu man body's natural airway clearing function, has the potential to decrease the occurrence of hospital-acquired infections, a major threat to pu blic health as identified by the Centers for Disease Control and Prevention. As a successfu l preventive intervention, the instant invention will reduce reliance on antibiotic agents to treat infections and will therefore decrease the development of antibiotic resistant respiratory pathogen strai ns. The net result will be a healthier hospital environment both for patients and providers.

Additionally, this artificial ci lia technology offers the potential for use as a cross- discipli ne platform for future i nnovation in the life sciences, being used for example in fabricating replacement devices for other tissues having natu rally occurring ci lia, including but not limited to the lining of the gastrointestinal system .

BRIEF DESCRIPTION OF THE DRAWINGS FIGURE 1 is an overall view of the i nvention.

FIGURE 2 shows a longitudinal section of the interior surface of the i nvention.

FIGURE 3 shows a longitudinal section of the i nterior surface of the invention at two different time points.

DETAILED DESCRIPTION OF THE DRAWINGS

FIGURE 1 is an overall outside view of the biomimetic artificial airway. Feature A is a universal adapter that connects the tube to standard airway ci rcuitry. Featu re B is the tubing of the air injection port that i nflates the tracheal cuff. Featu re C is a smal l balloon for optimizing cuff inflation. Feature D is a tracheal cuff balloon. Feature E is a drainage port that connects to suction or other drainage. Featu re F is a wi re bundle that connects to the electronic control ler. Featu re G is the mai n body of the tu be. Feature H is the beveled tracheal end of the tube that includes a Murphy eye. FIGURE 2 illustrates a longitudi nal section of the interior su rface of the invention (where left and right are the long axis of the tube). Feature A is short fiber with the free end in the lu men of the airway and the other end attached to the body of the device. Feature B is a thin film for attachment of the fiber to the body of the device. Feature C is a longitudinal conductive ci rcuit that connects circu mferential circuits to the wire bu nd le leaving the device and to other circumferential circuits. Feature D is the bulk tube and may contain an air-injection passage from the air-injection port to the inflatable tracheal cuff balloon. Feature E is a ci rcumferential conductive circu it.

FIGURE 3 illustrates a longitudinal section of the interior su rface of the invention at two different time points (where up and down are the long axis of the tube). Featu res A and C are the lumen of the airway. Feature B is energized circu mferential circuits i n the tube at one time point while feature D is the energizi ng of sequential circumferential ci rcuits in the same tu be at a second time point, with the thick arrow showing a corresponding longitudinal wave in the interior fibers.

Claims

What is claimed is:

[Claim 1] A biomimetic artificial secured airway that reduces the incidence of ventilator- associated patient infections when compared with the infection rates attributable to the use of endotracheal and tracheostomy tubes presently available.

[Claim 2] An airway as in claim 1 further comprising the means to enable its interior surface to emulate the human body's natural defense mechanism against respiratory system infections by artificial cilia-like longitudinal wave action to move debris and pathogenic bacteria out of the patient's respiratory tract.

[Claim 3] An airway as in claim 2 further comprising a means to empty the collected debris and pathogenic bacteria from the secured airway structure.