Patent Application
20210330922
The present invention relates generally to personal protective equipment for health care workers and, more particularly, to personal protective equipment worn by a patient for protecting the heath care worker.
Viruses, such as the Coronavirus (COVID-19), and other airborne pathogens may be highly concentrated in the nose of an infected patient. At times, a patient may be infected with, or recently exposed to, the virus but not yet exhibit symptoms of invention. During this time, it is possible that the patient may inadvertently expose nearby persons to the virus.
While societal practices during pandemic periods require social distancing or wearing of a facial covering to minimize potential for exposure, such practices are not possible or feasible during medical emergencies or medical procedures. For example, if a patient requires oral, nasal, sinus, or other similar surgery, it is possible the patient, being an infected person, could expose surgeons or other medical personnel assisting in the surgery to the virus. While pre-operative examinations and physicals may include testing for infectious diseases, false negatives or very recent exposures may provide a false sense of security.
Beyond the operation room, first responders are called to treat patients of unknown exposure status. Often there is not time to triage the patient, perform a basic physical, or test for infectious diseases. Thus, the potential for first responders to be exposed to airborne pathogens remains very high.
There exists a need for devices and methods that may be utilized to reduce or eliminate the potential for exposing healthcare providers to airborne pathogens.
The present invention overcomes the foregoing problems and other shortcomings, drawbacks, and challenges of limiting the exposure of health care workers while treating a patient of unknown exposure status. While the invention will be described in connection with certain embodiments, it will be understood that the invention is not limited to these embodiments. To the contrary, this invention includes all alternatives, modifications, and equivalents as may be included within the spirit and scope of the present invention.
According to one embodiment of the present invention a negative pressure surgical apparatus that includes a mask configured to cover a portion of the face of a patient and that includes a first port and an instrument port. Both ports extend through the mask. The first port is configured to draw negative pressure from between the mask and the face of the patient. The instrument port is configured to receive a medical instrument therethrough and form a seal therewith. The instrument port is positioned on the mask so as to permit surgery at a surgical site.
Another embodiment of the present invention includes a negative pressure surgical apparatus that includes a mask configured to cover a portion of the face of a patient. First, second, and third ports extend through the mask and are configured to draw a negative pressure, provide gas to a patient, and exhaust exhaled breath, respectively. An instrument port extends through the mask and is configured to receive a medical instrument therethrough and form a seal therewith, the instrument port positioned on the mask so as to permit surgery at a surgical site.
Still another embodiment of the present invention is directed to a method of performing oronasal surgery by positioning a negative pressure surgical apparatus on the face of a patient. The negative pressure surgical apparatus includes a mask configured to cover a portion of the face of a patient. A first port extends through the mask. An instrument port also extends through the mask and is configured to receive a medical instrument therethrough. The instrument port is also configured to form a seal with the medical instrument. The instrument port is positioned on the mask so as to permit surgery at a surgical site. A seal is formed between the face of the patient and the mask by drawing negative pressure through the first port. A medical instrument is inserted through the instrument port to the surgical site.
Additional objects, advantages, and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
It should be understood that the appended drawings are not necessarily to scale, presenting a somewhat simplified representation of various features illustrative of the basic principles of the invention. The specific design features of the sequence of operations as disclosed herein, including, for example, specific dimensions, orientations, locations, and shapes of various illustrated components, will be determined in part by the particular intended application and use environment. Certain features of the illustrated embodiments have been enlarged or distorted relative to others to facilitate visualization and clear understanding. In particular, thin features may be thickened, for example, for clarity or illustration.
Referring now to figures, and in particular to
A perimeter 56 of the mask 52 may include a cuff 58 that is configured to form a seal between the mask 52 and the patient 54. The cuff 58 may be constructed from an open cell foam material (such as polyurethane), silicone, gel, foam, memory foam, and so forth. In some embodiments, the cuff 58 may be an adhesive tape or an inflatable bladder. The inflatable bladder embodiment may be constructed from polyurethane, latex, or other flexible and expandable plastic that may be filled with gas to expand and conform to the patient's face and form a seal therewith.
One or more straps (one strap 60 is shown in
The mask 52 may include a plurality of operable ports 64, 66, 68, each configured for a particular function during use of the mask 52. A first port 64 may be configured to be operably coupled to a medical vacuum (not shown) or other similar negative pressure device. The medical vacuum may be coupled to the first port 64 by way of a tube 70 and, optionally, a filter cartridge 72. The filter cartridge 72 may include a filter (not shown) configured to remove pathogens from air flowing through the tube 70 from the mask 52. Suitable filters may include but are not limited to N95, N99, N100, R95, P95, P99, and P100. In this way, after the mask 52 is positioned on the face of the patient 54 and the medical vacuum activated, air is pulled from between the patient 54 and the mask 52, through the tube 70 and filter cartridge 72 to form the seal and remove airborne pathogens from the pulled air. According to some embodiments, the filter cartridge 72 may further incorporate a sensor 74 operable to detect airborne pathogens and to alert the physician of such detection. Such sensors are commercially available.
A second port 66 of the mask 52 may be operably coupled to an oxygen or air supply (not shown) by way of a supply tube 76 and, optionally, a valve 78 (such as a check-valve, one-way valve, or flutter valve) so as to prevent reverse flow of air. In this way, oxygen may flow to the patient 54 and not in reverse. The second port 66 enables oxygen flow to the patient 54 while the negative pressure is applied to the mask 52. As with the tube 70 of the first port 64, the supply tube 76 may include a filter 80 operable to remove potentially harmful pathogens from the airflow to the patient 54.
A third port 68 of the mask 52 may be configured as an exhaust for removal of carbon dioxide not otherwise vented by way of the first port 64. This third port 68, like the second port 66, may include a valve 82 (such as a check-valve, one-way valve or flutter valve) configured to permit venting of carbon dioxide and to prevent inhalation of unfiltered air. The port 68 may further include a filter 84 configured to remove airborne pathogens from the vented air. In this way, the health care worker is protected from exposure. According to some embodiment, the third port 68 may include a positive end expiratory pressure valve in lieu of the one-way valve 82. The positive end expiratory pressure valve is operable to regulate the pressure in the lungs of the patient 54 to improve lung inflation. Specifically, the positive end expiratory pressure valve may be used to maintain pressure on the lower airways at the end of the breathing cycle, which prevents alveoli collapse during expiration.
Referring still to
As specifically shown in
The cap 92 may be shaped and sized so as to be received by the protrusion 90 and constructed from rigid material. Suitable materials may include those listed above with respect to the mask 25. In some embodiments, the cap 92 may be secured to the protrusion 90 by friction fit, may include a rail (not shown) configured to snap fit with a channel (not shown) of the protrusion 90, or may include tabs (not shown) that are received by recesses (not shown) of the protrusion 90. Still other methods of securing the cap 92 to the protrusion 90 would be known to those of ordinary skill in the art having the benefit of the disclosure made herein. In the illustrated embodiment, although not required, the cap 92 may further incorporate a seal 99 on a distal end 100 thereof and that is configured to form a seal with the mask 52. Suitable sealant materials are known and may include, for example, silicon.
The cap 92 includes a port (two ports 102, 104 are shown) that coincide or align with instrument ports 94, 96 of the protrusion 90. In some embodiments, the ports 102, 104 of the cap 92 may be coaxial to the instrument ports 94, 96 of the protrusion 90. Each port 102, 104, such as those of the illustrated embodiment, includes a valve 106, 108 (such as a check-valve, one-way valve, or a flutter valve) configured to permit advancement and retraction of the medical instrument but not otherwise permitting exchange of air therethrough. Accordingly, the valves 106, 108 are configured to form a seal with the medical instrument, when present, and otherwise seal the ports 102, 104 when the medical instrument is not present.
With particular reference now to
A medical vacuum may then be operably coupled to the first port 64 while an air or oxygen supply may be coupled to the second port 66. Activating the medical vacuum draws a slight vacuum between the mask 52 and the face of the patient 54, which draws the cuff 58 to the face to form a seal. If exhalation exhaust beyond the third port 68 and filter 84, then tubing or other devices may be operably coupled through the third port 68.
If the patient 54 was prepped for surgery, then a procedure may be performed through the ports 94, 96102, 104 of the protrusion 90 and the cap 92. If one embodiment of the cap 92 is insufficient, then another embodiment may be used. In some instances, the cap 92 may be removed and the procedure accomplished through the ports 94, 96 of the protrusion 90. Use of the apparatus 50 protects the healthcare workers during a procedure from potential exposure of undiagnosed airborne pathogens.
Otherwise, the apparatus 50 may be used on any patient that engages medical attention and that may have infections transmitted by airborne particulates. As such, no operation or procedure need be performed by way of the protrusion 90, with or without the cap 92.
With reference now to
The particular embodiment of
The intubation aperture 170 may be configured to receive a window 176 comprising a frame 178 and a sheath 180 stretched within the frame 178. The window 176, as more particularly shown in
An advantage of the particular arrangement of
The particular embodiment of
For the particular embodiment of
An advantage of the particular arrangement of
The embodiment illustrated in
Advantages of the illustrative embodiment of
Each mask 286, 288, 290 further includes, similar to other embodiments, a first port (not shown in
The mask 286 of
The mask 288 of
In
The facemasks 418, 420, as shown, include first ports 422, 424 configured to be operably coupled to a medical vacuum (with tubing 426, 428 and a filter 430, 432), second ports 434, 436 configured to be operably coupled to an air or oxygen supply (with a supply tube 438, 440 and a valve 442, 444), and third ports 446, 448 configured to be operated as an exhaust (with a filter 450, 452 and a valve 454, 456).
The facemasks 418, 420 include a protrusion (not shown) having a port (not shown) and cap 462, 463 (having two ports 464, 466, 468, 470 and associated filters 472, 474, 476, 478). The ports 464, 466, 468, 470 of the respective caps 462, 463 are configured to receive a medical instrument for conducting a medical procedure therethrough (one instrument 480, 482 is shown in each figure).
The particular embodiment of
While not specifically illustrated herein, it would be readily appreciated that another embodiment of a negative pressure hood (not shown) may incorporate instrument ports 226, 228 fabricated in a manner similar to the mask 192 of
The illustrated embodiments herein show valves at the surface of the masks; however, it would be understood by the skilled artisan that valve may be positioned along a tubing and proximate to the respective mask. For some of these embodiments, a distal end of the tubing may be molded for affixed to the surface of the respective mask while a proximal end of the tubing may include an adaptor configured to receive the valve.
Furthermore regarding valves, it would be understood that other valves may be incorporated into one or more embodiments and that the number and types of valves are not limited to those particularly disclosed herein. For example, ports associated with exhalation may include a positive end expiratory pressure valve that is configured to regulate a pressure within the patient's lung to improve lung inflation. This particular valve may have particular benefit in maintaining pressure on lower airways and an end of the breathing cycle to prevent alveoli collapse.
Additionally, it would be understood that the ports, windows, and other structures may be shaped or sized according to a particular surgical or fabrication need or requirement. For instance, the window 176 of
Moreover, it would be understood that the sensor for airborne pathogens may be limited to a position within the filters of ports associated within air inflow or exhalation. Instead, the sensor may be incorporated into the mask, associated with the third port through which exhaled air is exhausted, and so forth.
Shapes and sizes of the various embodiments may vary from the illustrated examples provided here. For example, pediatric oronasal apparatuses may require one arrangement of ports while geriatric oronasal apparatuses require another.
While the present invention has been illustrated by a description of one or more embodiments thereof and while these embodiments have been described in considerable detail, they are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and method, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope of the general inventive concept
Pursuant to 37 C.F.R. § 1.78(a)(4), this application claims the benefit of and priority to prior filed co-pending Provisional Application Ser. No. 63/013,991, filed Apr. 22, 2020, which is expressly incorporated herein by reference in its entirety.
The invention described herein may be manufactured and used by or for the Government of the United States for all governmental purposes without the payment of any royalty.
| Number | Date | Country | |
|---|---|---|---|
| 63013991 | Apr 2020 | US |
