Patent Application
20160317832
The present invention is a method and apparatus to provide therapeutic doses of non-ultraviolet light and/or sterilizing doses of non-ultraviolet light to stimulate healthy cell growth causing a healing effect and/or to inactivate infectious agents residing on, within, or generally around an endotracheal tube while said endotracheal tube is residing within a body cavity.
Endotracheal tubes are medical devices used to provide mechanical ventilation for incapacitated patients. Unfortunately, they commonly cause hospital-acquired pneumonia (HAP). These devices cause infections in 91,000-126,000 patients every year and are the leading cause of death among hospital-acquired infections (Scheld W M. Developments in the pathogenesis, diagnosis and treatment of nosocomial pneumonia. Surg Gynecol Obstet 1991; 172 Suppl:42).
The current first-line standard of care treatment is antibiotics (American Thoracic Society, Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med 2005; 171:388). However, establishing the diagnosis of ventilator-associated pneumonia (VAP) can be difficult due to concomitant etiologies and symptoms, leading to increased mortality. Additionally, the prevalence of drug-resistant bacteria often necessitates a more toxic second-line antibiotic treatment and, due to a greater side-effect profile, further increases the risk to patient safety.
Endotracheal tubes are known that function only to secure the airway and provide ventilation for the intubated patient. Various hydrophobic, antibiotic, and/or anti-inflammatory coatings for endotracheal tubes are also known. Examples of these coatings include antibiotic agents like chlorhexidine or silver. This coating is intended to inhibit bacterial and fungal colonization of the device. However, these proposals are only marginally effective in-vivo and are unable to prevent numerous infections and deaths.
There are also known methods for providing visualization at the tip of the endotracheal tube. While possibly helpful for the device insertion, this has not become a standard of care due to simpler methods being developed. This also does nothing to reduce the infection rates.
The use of ultraviolet (UV) light to reduce the prevalence of infection is known. Unfortunately, UV light is well known to cause damage to living cells (Riffle. “UV-light-induced signal cascades and skin aging.” Ageing research reviews 1.4 (2002): 705-720).
Unfortunately, these methods and solutions fail to offer a reduction in hospital-acquired infections. This is due not only to the difficulty in diagnosing HAP in the midst of concomitant etiologies, but also to the high clinical prevalence of drug resistant microorganisms. Accordingly, there exists a need for a method and apparatus for delivering non-antibiotic, bactericidal therapeutics in-vivo, and for such a method and apparatus to use novel technology in delivering safe, effective, and reproducible disinfection.
The invention of the present disclosure comprises of a method and apparatus for delivering therapeutic doses in-vivo to stimulate healthy cell growth causing a healing effect and/or to inactivating infectious agents on or within an endotracheal tube. In particular, the exemplary embodiments of this disclosure allow for therapeutic treatments that stimulate healthy cell growth enhancing healing and/or that inactivate infectious agents while the endotracheal tube is residing within a patient's body cavity. Generally, this disclosure relates to an endotracheal tube assembly that incorporates the delivery of electromagnetic radiation (EMR) therapy in addition to the functions of existing standard of care endotracheal tubes (securing airway, providing a passage for mechanical ventilation, etc.). The endotracheal tube assembly includes an endotracheal tube with an associated EMR source that provides non-ultraviolet, therapeutic EMR of sufficient fluency to inactivate one or more infectious agents and/or to stimulate healthy cell growth causing a healing effect.
For the purposes of this disclosure the use of the term “therapeutic” should be understood to mean of or relating to the treatment of disease, including infectious agents, as well as serving or performed to maintain health, including enhancing healthy cell growth.
It should also be understood that the exemplary embodiments of this disclosure include retrofitting a EMR delivery system to an existing standard endotracheal tube where the EMR delivery system is permanently attached to the endotracheal tube or where the EMR delivery system is removably insertable into the endotracheal tube, as well as including the use of a custom-made endotracheal tube that incorporates the EMR delivery system into the structure of the endotracheal tube. For a rapid, retrofit connection of the EMR delivery system onto the endotracheal tube a quick-connect coupling may be used and/or the insertable portion of the EMR delivery system may move freely and axially relative to the endotracheal tube.
This disclosure also provides methods and apparatuses for effectively sterilizing the body surface for the area in, on, or around the endotracheal tube. This is done through use of EMR at sufficient intensities capable of inactivation of infectious agents. This source can be from a single or group of EMR sources including, but not limited to, a light emitting diode, a semiconductor laser, a diode laser, an incandescent and fluorescent light source. This EMR source provides non-ultraviolet, sterilizing EMR providing one or more wavelengths in the range of approximately 380 nm to approximately 900 nm. In order to provide sufficient inactivation of infectious species each EMR wavelength should be of a narrow spectrum and centered around one wavelength from the group, and has intensity sufficient to inactivate one or more infectious agents. This group includes several wavelengths centered about: 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 455 nm, 470 nm, 475 nm, 660 nm, and 808 nm.
Of particular interest to this endotracheal tube assembly is the use of light between 380 and 900 nm wavelengths. Additionally, the intensity and power of the light emitted is particularly suitable for the inactivation of infectious agents, thus a range of fluency covering 0.1 J/cm2 to 1 kJ/cm2 and a range of powers from 0.005 mW to 1 W, and power density range covering 1 mW/cm2 and 1 W/cm2 are of interest for these device assemblies and methods.
The EMR delivery system directs the EMR lengthwise along the wall of said flexible tube in the plane of the flexure thereof for emission of the EMR internal and/or external to the endotracheal tube body. In most cases, EMR delivery system may be inserted such that its forward end terminates toward the forward end of the flexible, endotracheal tube body.
For each exemplary embodiment, the endotracheal tube assembly and method for disinfection could be utilized in an adjustable or predetermined duty cycle. If treatments began immediately after sterile procedure was initiated, device related infections may be inhibited. This includes device related biofilm growth.
These and other features and advantages of the present disclosure will become more readily appreciated by referring to the following detailed description of exemplary embodiments when considered in connection with the accompanying drawings, which are not necessarily drawn to scale. It will be understood that said drawings depict exemplary embodiments and, therefore, are not to be considered as limiting the scope with regard to other embodiments which the invention is capable, wherein:
Various exemplary embodiments of the present disclosure are described more fully hereafter with reference to the accompanying drawings. These drawings illustrate some, but not all of the embodiments of the present disclosure. It will be readily understood that the components of the exemplary embodiments, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the exemplary embodiments of the apparatus, system, and method of the present disclosure, as represented in
The phrases “connected to,” “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to each other even though they are not in direct contact with each other. The term “abutting” refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together.
The word “exemplary” is used exclusively herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.
While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
Referring now to
In the exemplary embodiment of
The exemplary embodiment of
The EMR delivery system 13 comprises an EMR source 36 for emitting non-ultraviolet, therapeutic EMR having intensity sufficient to activate desired therapeutic properties within the patient, an EMR conduction line 37 (shown in phantom lines) conducive to the propagation of EMR from the EMR source 36 along the endotracheal tube 12, and an EMR coupling 38 to connect the EMR source 36 to a coupling end 39 of the EMR conduction line 37. Such desired therapeutic properties within the patient may include stimulating healthy cell growth or sterilizing one or more target organisms or infectious agents.
The EMR source 36 may comprise an optical element (not shown) such as light emitting diodes, lasers, filtered fluorescents, filtered incandescents, and any combination thereof. The EMR source 36 may provide non-ultraviolet, sterilizing EMR at one or more wavelengths in the range of approximately 380 nm to approximately 900 nm. In order to provide sufficient inactivation of infectious agents, each EMR wavelength should be of a narrow spectrum centered about a wavelength that has demonstrated sterilization when applied at an intensity sufficient to inactivate one or more infectious agents. Several exemplary wavelengths have demonstrated desirable sterilization, including those wavelengths centered about: 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 455 nm, 470 nm, 475 nm, 660 nm, and 808 nm.
Of particular interest to this endotracheal tube assembly 10 is the use of light between 380 and 900 nm wavelengths. Additionally, the intensity and power of the light emitted is particularly suitable for the inactivation of infectious agents, thus a range of fluency covering 0.1 J/cm2 to 1 kJ/cm2 and a range of powers from 0.005 mW to 1 W, and power density range covering 1 mW/cm2 and 1 W/cm2 are of interest for these device assemblies and methods.
Also of interest to this endotracheal tube assembly 10 is the use of use of different wavelengths between 532 and 1064 nm for stimulating tissue healing properties. Exemplary wavelengths have demonstrated desirable tissue healing properties, including those wavelengths centered about 633 nm, 808 nm, and 830 nm. Doses ranging from 0.09 to 90 J/cm2 have been demonstrated to be effective, with the predominating values from 1 to 5 J/cm2. However, doses 150 J/cm2 are of particular interest for the applications contemplated by this disclosure.
For each exemplary embodiment described herein, the endotracheal tube assembly 10 and method for disinfection could be utilized in an adjustable or predetermined duty cycle. If treatments began immediately after sterile procedure was initiated, device related infections may be inhibited. This includes device related biofilm growth.
A treatment may include at least one wavelength of therapeutic EMR that acts as a predominant wavelength selected to sterilize one or more target organisms and selected from the group of wavelengths centered about 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 455 nm, 470 nm, 475 nm, 660 nm, and 808 nm. Another treatment may include alternating the predominant wavelength between a first predominant wavelength and a second predominant wavelength (differing from the first predominant wavelength) in a selected treatment pattern. Further, sterilizing EMR and EMR that stimulates healthy cell growth may be transmitted simultaneously in tandem or alternatively.
The EMR conduction line 37 has the coupling end 39 and a distal end 41 and may be insertable into the endotracheal tube 12 to deliver non-ultraviolet, therapeutic EMR within the patient at sufficient intensity to activate desired therapeutic properties. The EMR conduction line 37 may comprise one or more optical features such as a reflective surface, an optically transmissible material, a lens, a fiber optic filament, a gradient modification, light emitting portions, opaque portions, or any combination thereof. The EMR conduction line 37 may also comprise plastic, silica, or other polymeric optical fiber capable of transmission and dispersion of light over a given distance.
Also, at least a portion of the endotracheal tube 12 may be optically clear or translucent. These portions of clearness or translucency permit the EMR emitted from the EMR conduction line 37 to deliver therapeutic EMR to the inside of the tube wall 16 and to body tissue external to the tube wall 16 and proximate the clear or translucent portions. In most cases, the endotracheal tube 12 will be an off-the-shelf (rather than custom made) item and the entire length of the endotracheal tube 12 will be clear or translucent. However, it should be understood that custom made endotracheal tubes 12 may have portions that are not clear or translucent so not to permit the emission of the EMR from the endotracheal tubes 12 at those opaque portions.
The EMR conduction line 37 may comprise at least one optical feature selected from a group of optical features such as a reflective surface, an optically transmissible material, a lens, a fiber optic filament, and any combination thereof. It also may be capable of transmitting more than one wavelength or intensity EMR. Multiple wavelengths may be transmitted simultaneously, one after another or in tandem, or a combination thereof (for example, one constantly on and the other wavelength pulsed). Multiple intensities may be transmitted through the same element simultaneously. Alternating patterns of light treatments may also be transmitted.
The optical conduit 32 may be incorporated onto, into, or through the endotracheal tube body 12 at optical joinder site 40 and the cuff inflation conduit 30 may be incorporated onto, into, or through the endotracheal tube body 20 at inflation joinder site 42, as shown in
The ventilator collar 18 depicted in
The endotracheal adapter 68 of
The EMR port 70 may have either an optical conduit 32 (as shown) or may receive the EMR conduction line 37 directly so long as the port is adequately sealed so that the ventilation operation will not be compromised. The form of seal may be any suitable seal known by those in the art, such as a rubber diaphragm that may be penetrated by the EMR conduction line 37 or O-rings positioned within the EMR port 70, or the like.
The endotracheal adapter 68, as retrofitted, enables the removable insertion of the EMR conduction line 37 to whatever depth within or through the tube body 20 is desired. The EMR conduction line 37 is shown in
By way of example,
Referring now to
Referring now to
In the cross-sectional view of
In
Referring now to
In another exemplary embodiment, the EMR source 36 may also be incorporated into the ventilator itself, using the ventilator tubing as a conduit for passing the optical conduit 32 to the endotracheal tube body 20. The ventilator connection on the proximal end 22 of the endotracheal tube body 20 could then serve as a combined ventilator and optical conduit coupling apparatus. These connections could also be individual at the point of coupling with the endotracheal tube body 20.
In another embodiment, EMR is transmitted directly down the endotracheal tube wall 16 using the tube wall 16 as an optical conduit. This may be done in conjunction with any of the other EMR source 36 configurations specifically mentioned above or that would be understood by those skilled in the art armed with this disclosure.
The ventilator collar 18 has a first inner diameter 80 and a first outer diameter 82 that differs from the second inner diameter 84 and second outer diameter 86 of the secondary port 78 of the tripartite port adapter 68 so that the tripartite port adapter 68 can accommodate connection to ventilators having different-sized connectors. Of course, if any of the ventilator collar 18, EMR port 70, and secondary port 78 is not needed or is between uses, they may be capped so not to compromise ventilation of the patient.
As shown in
While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the invention is not limited to the precise configuration and components disclosed as exemplary embodiments herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present invention disclosed herein without departing from the spirit and scope of the invention.
This application claims the benefit of U.S. Provisional Application No. 62/154,789 that was filed Apr. 30, 2015, for an invention titled METHODS AND APPARATUS TO INACTIVATE INFECTIOUS AGENTS ON AN ENDOTRACHEAL TUBE, which is hereby incorporated in its entirety by this reference. This application also claims the benefit of U.S. Provisional Application No. 62/292,028 that was filed Feb. 5, 2016, for an invention titled METHOD AND APPARATUS FOR REMOVABLE CATHETER VISUAL LIGHT STERILIZATION SYSTEM, which is hereby incorporated in its entirety by this reference. This application is related to a co-pending application entitled METHODS AND APPARATUS TO INACTIVATE INFECTIOUS AGENTS ON A CATHETER RESIDING IN A BODY CAVITY, U.S. application Ser. No. 13/801,750, filed Mar. 13, 2013.
| Number | Date | Country | |
|---|---|---|---|
| 62154789 | Apr 2015 | US | |
| 62292028 | Feb 2016 | US |
