Abstract
Provided is an article for protection configured with at least one perforable, modifiable access point positioned to allow airway management procedures. Also provided is a method for maintaining the sterile environment during airway management procedures by covering a subject in need thereof with the article for protection.
Claims
1. An article for protection on a subject in need thereof, said article comprising a covering adapted to cover at least a portion of head and upper trunk of the subject, wherein said covering includes at least one transparent portion and at least one access point designated for introducing instrument therethrough, and wherein the covering is substantially impermeable to bodily fluid of the subject.
2. The article of claim 1, wherein the at least one access point on the covering is designated at a position to allow conducting a procedure with the instrument introduced therethrough while maintaining coverage of the head and upper trunk of the subject.
3. The article of claim 1, wherein the at least one access point is located at a designated area on the covering made of a same material as other parts of the covering.
4. The article of claim 3, wherein the at least one access point is configured with a precut slit.
5. The article of claim 4, wherein the precut slit is reinforced with an additional layer of material around the slit.
6. The article of claim 4, wherein the precut slit is covered with an additional layer of flexible material substantially impermeable to the bodily fluid.
7. The article of claim 6, wherein the additional layer of flexible material is a polymeric film.
8. The article of claim 2, wherein the at least one access point is an opening configured with a cover allowing opening or closing of the access point reversibly.
9. The article of claim 2, wherein the at least one access point is a valve.
10. The article of claim 1, wherein the covering is at least one layer sheet or film made of at least one of polypropylene, polystyrene, polycarbonate, polyethylene, polyester and polypropene.
11. The article of claim 1, wherein the covering is a one-piece sheet or film integrally made with a pre-defined line of perforation configured to run across the sheet or film and through the access point.
12. A method for protecting an airway procedure, comprising: covering the article of claim 1 over the at least a portion of head and upper trunk of the subject; and introducing the instrument through the at least one access point of the covering.
13. The method of claim 12, further comprising making a slit at the at least one access point of the covering before introducing the instrument.
14. The method of claim 12, further comprising covering the at least one access point with an adhesive tape before introducing the instrument.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
[0022] The drawings accompanying and forming part of this specification are included to depict certain aspects of the disclosure. A clearer impression of the disclosure, and of the components and operation provided with the disclosure, will become more readily apparent by referring to the exemplary, and therefore non-limiting, embodiments illustrated in the drawings. It is noted that the features illustrated in the drawings are not necessarily drawn to scale.
[0023] FIG. 1 is a front view showing an embodiment of the article for protection of the present disclosure with two areas (shown as rectangles) designated as access points or windows allowing intubation or any other airway procedures or instruments.
[0024] FIG. 2 is a front view showing another embodiment of the article for protection of the present disclosure with three areas (shown as rectangles) designated as access points or windows allowing intubation or any other airway procedure or instruments.
[0025] FIG. 3 illustrates the transparent article for protection as placed over the patient with one of the access points allowing entry and exit created to accommodate various sizes of endotracheal tubes (ETTs) or video-assisted intubating stylet, with either direct visualization via the transparent article for protection or using a camera (fiberoptic or electrical) in conjunction with the ETT for placement.
[0026] FIG. 4A shows a double layered-plastic sheet with two windows or access points marked in rectangles with tape.
[0027] FIG. 4B shows the windows or access points marked with crosses and covered with adhesive tapes.
[0028] FIG. 4C shows the adhesive tape punctured with the camera module of the video laryngoscope.
[0029] FIG. 5A is a photograph showing an embodiment of the article for protection of the present disclosure in use with a facial mask orifice connector.
[0030] FIG. 5B is a photograph showing an embodiment of the article for protection of the present disclosure in another use with a laryngeal mask airway tube/connector.
[0031] FIG. 5C is a photograph showing an embodiment of the article for protection of the present disclosure in still another use with an intubating stylet/endotracheal tube.
[0032] FIG. 6A is a photograph showing an embodiment of the article for protection of the present disclosure in use with a facial mask ventilation. In this embodiment, a plastic sheet is draped on patient's head, face and upper trunk with a facial mask underneath the plastic sheet. Ventilation through the facial mask can be performed easily without air leak.
[0033] FIG. 6B is a photograph showing an embodiment of the article for protection of the present disclosure in use with a video-assisted intubating stylet using double-layered plastic sheet. The designated area for access point on the plastic sheet is covered and reinforced with a transparent adhesive tape through which the intubating stylet passes through the article for protection.
[0034] FIGS. 7A and 7B show the simulation model of water mist produced by a nebulizer to mimic water droplets caused by coughing or bucking. FIG. 7A shows the spreading of mist in the absence and FIG. 7B shows the spreading of mist in the presence of plastic sheet coverage onto a mannequin's head and upper trunk. An intubating stylet was inserted into mannequin's airway.
[0035] FIGS. 8A and 8B show simulation model of water spray to mimic coughing and bucking in the mannequin. FIG. 8A shows the result without coverage of plastic sheet over the mannequin's head and neck, and FIG. 8B shows the result with coverage of plastic sheet over the mannequin's head and neck. Tracheal intubation was performed with intubating stylet technique. Arrows indicate the spreading of the water spray. Imaging was acquired by an infrared thermography machine.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0036] The detailed description set forth below is intended as a description of the presently exemplified methods, devices and compositions provided in accordance with aspects of the present disclosure, and is not intended to represent the only form in which the present disclosure may be practiced or utilized. It is to be understood, however, that the same or equivalent functions and components may be accomplished by different embodiments that are also intended to be encompassed within the scope of the disclosure.
[0037] Referring now specifically to the drawings, a transparent and soft sheet for protection according to the present disclosure is shown generally in FIG. 1. The article for protection can be made of a plastic sheet with a size adequate to cover the head and entire upper trunk of a patient. The size of the plastic sheet can be a square of 1 m on each side, or any other shape or size that can efficiently cover the head and upper trunk of a patient. The size of the plastic sheet provides a coverage that could significantly reduce the chance of accidental splash of sputum, saliva, or secretion from the patient onto the surrounding sterile environment or the clinicians in operation during the tracheal intubation procedure. Two windows or access points are designated on the article for protection as depicted in FIG. 1. In other embodiments, there can be three windows or access points designated as depicted in FIG. 2.
[0038] Referring now to FIG. 3, the article for protection provides an adequate coverage of the patient while allowing an intubating stylet inserting through the plastic sheet without any constrain of the clinician's movement. The plastic sheet is transparent and can be used in single or double layered. To carry out the airway management procedures with the article for protection, the plastic sheet is placed over the subject receiving the procedures to cover the entire head and upper trunk. Then, the designated windows or access points are decided to allow subsequent passage of device to be in contact with nose or mouth of the subject, while allowing adequate coverage of the plastic sheet over the entire upper trunk and head of the subject. The designated windows or access points can be marked and reinforced with colored tape in rectangles as shown in FIGS. 4A to 4C. To each layer of the sheet, a set of two crosses cut within the designated windows or access points. A larger cross at 3 cm×3 cm is designated for passage of laryngoscope blade, and the smaller cross at 2 cm×2 cm is designated for passage of endotracheal tube, as shown in FIG. 4A. In order to minimize the leak from the openings, adhesive tape is used to cover the cross areas as shown in FIG. 4B. Subsequently, a needle is used to puncture a small hole in the adhesive tape to allow the laryngoscope or endotracheal tube to pass through with ease. In order to avoid an unnecessarily large defect in the plastic sheet, the disposable video laryngoscope blade is placed under the plastic sheet prior to induction. At time of laryngoscopy, the adhesive tape is punctured with the camera module of the video laryngoscope, and then connected the laryngoscope blade to the camera underneath the plastic sheet, as shown in FIG. 4C.
[0039] As shown in FIGS. 5A to 5C, the designated window or access points are used to allow passage of different devices. FIG. 5A shows the use of facial mask orifice connector; FIG. 5B shows the use of a laryngeal mask airway tube/connector; and FIG. 5C shows an intubating stylet or endotracheal tube. As shown in FIGS. 5A to 5C, the plastic sheet coverage does not interfere with insertion of the laryngeal mask or video-assisted intubating stylet at all. After the airway management procedure required is completed, the plastic sheet can be carefully rolled over, folded, packed and discarded.
[0040] FIG. 6A shows the use of a plastic sheet as the article for protection on a patient after anesthesia is induced. The coverage of the plastic sheet does not interfere with facial mask ventilation. The facial mask ventilation can be used in its original setting without any adjustment due to the use of the article for protection.
[0041] Alternatively, as shown in FIG. 6B, a video-assisted intubating stylet is used for tracheal intubation by passing through the article for protection at the designated access point. The stylet or endotracheal tube can easily pass the access point with a small aperture on the plastic sheet, and the article for protection as used does not interfere with the tracheal intubation procedure. Under the coverage of a piece of the plastic sheet, the tracheal intubation using an intubating stylet can be accomplished without any constraint to the hands of the clinicians while providing substantial protection against the secretion from accidental cough of the patient that is usually confronted during an intubation procedure. Using this intubating stylet technique, the intubator could keep a reasonable “social distance” from the patient as shown in FIG. 6B. Maintaining as much distance as possible from the subject's airway, together with protective equipment worn by the intubator and the plastic sheet barrier, reduces the chance of viral transmission from the patient's airway droplets and secretions. The use of the plastic sheet was found to not hinder the intubator's maneuvers of the video stylet. To show the effectiveness of a plastic sheet, a medical nebulizer is used to simulate aerosol production from the patient's airway. Then, the reservoir is filled with hot water, and the water is then nebulized into mist (which is composed of small droplets of water suspending in air). In some embodiments, a bag valve mask can be used to propel the mist through the mannequin's airway in order to simulate the episodes of coughing and bucking. As shown in FIG. 7A, without a plastic sheet, a visible mist was observed from the mannequin's nose and mouth. In contrast, when the mannequin's head and upper trunk were covered with a plastic sheet, the mist was not appreciated above the sheet as shown in FIG. 7B.
[0042] The plastic sheet is also shown to prevent spreading of larger respiratory droplets during periods of coughing, sneezing, or bucking. Hot water spray with the mannequin was used as a validation model. Hot water spray was detectable by an infrared thermography machine. FIG. 8A shows that the hot water spray was easily detected by infrared imaging, and as shown in FIG. 8B, the spray is prevented from entering the environment with application of the plastic sheet of the present disclosure.
[0043] The present disclosure has been described with embodiments thereof, and it is understood that various modifications, without departing from the scope of the present disclosure, are in accordance with the embodiments of the present disclosure. Hence, the embodiments described are intended to cover the modifications within the scope of the present disclosure, rather than to limit the present disclosure. The scope of the claims therefore should be accorded the broadest interpretation so as to encompass all such modifications.
REFERENCE
[0044] Canelli R., Connor C. W., Gonzalez M., Nozari A., and Ortega R. Barrier enclosure during endotracheal intubation. N. Engl. J. Med. (2020) 382:1957-1958. [0045] Chen X., Liu Y, Gong Y, Guo X., Zuo M., Li J., Shi W., Li H., Xu X., and Mi W. Perioperative management of patients infected with the novel coronavirus: Recommendation from the Joint Task Force of the Chinese Society of Anesthesiology and the Chinese Association of Anesthesiologists. Anesthesiology (2020) 133(3):693. [0046] Luo M., Cao S., Wei L., Tang R., Hong S., Liu R., and Wang Y. Precautions for intubating patients with COVID-19. Anesthesiology (2020) 132(6):1616-1618. [0047] Meng L., Qiu H., Wan L., Ai Y, Xue Z., Guo Q., Deshpande R., Zhang L., Meng J., Tong C., Liu H., and Xiong L. Intubation and ventilation amid the COVID-19 outbreak: Wuhan's experience. Anesthesiology (2020) April 8: 10.
