# US 10,307,217 B2 · Facial protection and thermoregulation for patients undergoing surgery > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,217 B2 - Document ID: US10307217B2 - Status: Granted - Kind: B2 - Application number: 14/737,880 - Filed: 2015-06-12 - Published: 2015-10-01 - Granted: 2019-06-04 - Earliest claimed: 2013-05-17 - Assignees: Doma Patient Safety Products, LLC - Applicants: Michael Dimitri Sparkuhl - Inventors: Michael Dimitri Sparkuhl - Web page: https://patentgrep.com/patent/US10307217B2 ## CPC - A61B 90/04: {Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery (protection of eyes against laser radiation A61F9/022)} - A61M 16/06: Respiratory or anaesthetic masks - A61M 16/0627: {with sealing means on a part of the body other than the face, e.g. helmets, hoods or domes} - A61M 16/1075: {by influencing the temperature (A61M16/1045 takes precedence)} - A61B 2090/0436: {Shielding} - A61B 2090/0463: {against cooling or freezing} - A61B 2090/049: {against light, e.g. laser} - A61M 16/04: Tracheal tubes (catheters in general A61M25/00) - A61M 16/0683: {Holding devices therefor} - A61M 2205/362: by gas flow - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A mask suitable for protecting the face of a patient during surgery comprises a transparent plastic shield which includes a transverse cutout that provides access to the nose and mouth, and a vertical gap which runs from the cutout to the shield's perimeter. Padding affixed to the perimeter of the shield's underside provides a cushion between the shield and face. The padding is preferably arranged such that the mask can be installed or removed without dislodging tubing inserted into the patient's nose or mouth via the transverse cutout. An attachment mechanism secures the shield to the face. A warming hood may be coupled to the protective mask. The hood preferably comprises outer and inner layers, with an access point at which air can be introduced between the layers; perforations on the inner layer permit warm air to be dispersed onto the patient. ## Claims ### Claim 1 A protective mask suitable for protecting the face of a patient during surgery, comprising: a molded transparent plastic shield adapted to protect the face of a patient, including the patient's eyes, when said protective mask is installed on the face of said patient, said molded transparent plastic shield having a convex topside and an underside and including: a transverse cutout through said molded transparent plastic shield capable of providing access to the patient's nose and mouth and arranged to be over the patient's mouth when said protective mask is installed on said patient's face; and a continuous, pre-cut vertical gap in said molded transparent plastic shield which runs from said transverse cutout to the lower perimeter of said mold transparent plastic shield; padding affixed to the perimeter of the underside of said molded transparent plastic shield adapted to contact said patient's face and provides a cushion between said molded transparent plastic shield and said face when said protective mask is installed on the face of said patient, said padding arranged to allow said patient's face to remain substantially visible through said molded transparent plastic shield when said protective mask is installed on the face of said patient; and an attachment mechanism adapted to secure said protective mask to the face of said patient. ### Claim 2 (depends on 1) The mask of claim 1, wherein said padding is discontinuous in the area of said continuous, pre-cut vertical gap. ### Claim 3 (depends on 1) The mask of claim 1, wherein said padding is perforated or scored in the area of said continuous, pre-cut vertical gap. ### Claim 4 (depends on 1) The mask of claim 1, wherein said padding is pre-cut in the area of said continuous, pre-cut vertical gap, with the padding on one side of the cut kept in contact with the padding on the other side of the cut by a securing means. ### Claim 5 (depends on 4) The mask of claim 4, wherein said securing means comprises glue, tape, a hook and loop system, or Velcro. ### Claim 6 (depends on 1) The mask of claim 1, wherein said transverse cutout is sized to permit passage of at least two of an endotracheal tube, a laryngeal mask airway tube, and a nasogastric or orogastric tube. ### Claim 7 (depends on 6) The mask of claim 6, wherein said protective mask is provided with transverse cutouts of various sizes. ### Claim 8 (depends on 6) The mask of claim 6, wherein said protective mask is arranged such that the transverse cutout has the smallest possible size capable of accommodating a known tube or combination of tubes so as to minimize exposure of the face. ### Claim 9 (depends on 1) The mask of claim 1, further comprising a membrane over said transverse cutout, said membrane slit to permit the passage of tubing through said protective mask while providing a partial seal around said tubing and preventing at least some operative debris and/or fluids from reaching the patient's mouth by flowing around said tubing. ### Claim 10 (depends on 9) The mask of claim 9, wherein said membrane is affixed to either the topside or underside of said mold transparent plastic shield. ### Claim 11 (depends on 9) The mask of claim 9, wherein said membrane is also over said continuous, pre-cut vertical gap. ### Claim 12 (depends on 1) The mask of claim 1, wherein said protective mask is arranged such that, when installed on the face of said patient, said transverse cutout is adapted to be over said patient's mouth and said continuous, pre-cut vertical gap runs from said transverse cutout to the perimeter of said molded transparent plastic shield over said patient's chin, such that said transverse cutout and said continuous, pre-cut vertical gap form a T-shaped opening through said molded transparent plastic shield. ### Claim 13 (depends on 1) The mask of claim 1, wherein said molded transparent plastic shield, said transverse cutout, said continuous, pre-cut vertical gap and said padding are arranged such that said protective mask can be installed on or removed from the face of said patient without dislodging tubing inserted into said patient's nose or mouth. ### Claim 14 (depends on 1) The mask of claim 1, wherein said mold transparent plastic shield is made from FDA-approved medical grade plastic. ### Claim 15 (depends on 1) The mask of claim 1, wherein said mold transparent plastic shield is fabricated with impregnated or film barriers to protect said face, including the eyes, from ultraviolet rays, X-rays, and/or laser light. ### Claim 16 (depends on 1) The mask of claim 1, wherein said padding is pre-cut to provide said discontinuity in the area of said continuous, pre-cut vertical gap. ### Claim 17 (depends on 1) The mask of claim 1, wherein said padding is FDA-approved, latex-free hypoallergenic medical grade foam padding. ### Claim 18 (depends on 1) The mask of claim 1, wherein said padding is a latex-free flexible plastic bladder containing air or a conformable material. ### Claim 19 (depends on 1) The mask of claim 1, wherein said padding comprises disposable cotton padding. ### Claim 20 (depends on 1) The mask of claim 1, wherein said protective mask is intended for a single use. ### Claim 21 (depends on 1) The mask of claim 1, wherein said attachment mechanism is affixed to said plastic shield. ### Claim 22 (depends on 1) The mask of claim 1, wherein said attachment mechanism comprises elastic ear loop retainers. ### Claim 23 (depends on 1) The mask of claim 1, wherein said attachment mechanism comprises a behind-head elastic strap. ### Claim 24 (depends on 1) The mask of claim 1, wherein said attachment mechanism comprises a behind-head hook-and-loop strap. ### Claim 25 (depends on 1) The mask of claim 1, wherein said attachment mechanism comprises a four point head strap harness. ### Claim 26 (depends on 1) The mask of claim 1, wherein said attachment mechanism comprises a low tack skin adhesive. ### Claim 27 (depends on 1) The mask of claim 1, wherein said attachment mechanism comprises an electron beam cure synthetic polymer adhesive. ### Claim 28 (depends on 1) The mask of claim 1, wherein said molded transparent plastic shield includes a flange extending circumferentially from the perimeter of said molded transparent plastic shield, said flange substantially forming a right angle with the topside of said molded transparent plastic shield. ### Claim 29 (depends on 28) The mask of claim 28, wherein said padding comprises first and second pieces of foam padding which are sandwiched on and affixed to either side of said flange. ### Claim 30 (depends on 28) The mask of claim 28, wherein said padding comprises a single piece of foam padding affixed to the underside of said flange. ### Claim 31 (depends on 29) The mask of claim 29, wherein said attachment mechanism comprises elastic ear loop retainers, each of which passes through said sandwiched foam padding and is affixed to said mold transparent plastic shield. ### Claim 32 (depends on 1) The mask of claim 1, further comprising a warming hood arranged to be coupled to said protective mask and which covers the head, neck and shoulders when so coupled. ### Claim 33 (depends on 32) The mask of claim 32, wherein said warming hood comprises a blanket having an outer layer and an inner layer, said outer and inner layers heat sealed to each other at their respective perimeters, said blanket having at least one access point at which air can be introduced into the blanket between the outer and inner layers, said inner layer comprising a plurality of micro-perforations through which air introduced via said access points is dispersed onto said patient. ### Claim 34 (depends on 33) The mask of claim 33, wherein said outer and inner layers are Mylar sheets. ### Claim 35 (depends on 33) The mask of claim 33, wherein said outer and inner layers are further heat sealed to each other at a plurality of points within the perimeter of said blanket. ### Claim 36 (depends on 35) The mask of claim 35, wherein said plurality of heat sealed points within the perimeter of said blanket form a plurality of linked chambers through which air introduced via said access points is distributed around the interior of said blanket. ### Claim 37 (depends on 33) The mask of claim 33, wherein said warming hood is arranged to be used with a thermal blanket to be used for warming portions of the patient's body other than the head. ### Claim 38 (depends on 37) The mask of claim 37, wherein said thermal blanket has at least one access point at which air can be introduced into the thermal blanket, wherein said warming hood and thermal blanket are arranged to be coupled together such that warm air introduced into the thermal blanket at said at least one access point also flows into the warming hood. ### Claim 39 (depends on 1) The mask of claim 1, wherein said transverse cutout is 4 inches wide by 1 inch high, and said vertical gap is approximately 0.75 inches wide by 3 inches high. ### Claim 40 (depends on 1) The mask of claim 1, wherein said protective mask is provided in various sizes to fit a variety of face sizes. ### Claim 41 (depends on 1) The mask of claim 1, wherein said protective mask is sized to provide a perimeter large enough to protect the entire face without extending beyond the face. ### Claim 42 (depends on 41) The mask of claim 41, wherein said protective mask is provided in small, medium and large sizes, and/or in pediatric and adult sizes. ### Claim 43 A protective mask suitable for protecting the face of a patient during surgery, comprising: a molded transparent plastic shield adapted to protect the face of a patient, including the patient's eyes, when said protective mask is installed on the face of said patient, said molded transparent plastic shield having a convex topside and an underside and including: a transverse cutout through said molded transparent plastic shield capable of providing access to the patient's nose and mouth and arranged to be over the patient's mouth when said protective mask is installed on said patient's face; and a continuous, pre-cut vertical gap in said transparent plastic shield which runs from said transverse cutout to the lower perimeter of said molded transparent plastic shield; padding affixed to the perimeter of the underside of said molded transparent plastic shield adapted to contact said patient's face and provides a cushion between said molded transparent plastic shield and said face when said protective mask is installed on the face of said patient, said padding arranged to allow said patient's face to remain substantially visible through said molded transparent plastic shield when said protective mask is installed on the face of said patient; and an attachment mechanism adapted to secure said protective mask to the face of said patient. wherein said protective mask is arranged such that, when installed on the face of said patient, said transverse cutout is adapted to be over said patient's mouth and nose, and said continuous, pre-cut vertical gap runs from said transverse cutout to the perimeter of said molded transparent plastic shield over said patient's chin, such that said transverse cutout and said continuous pre-cut vertical gap form a T-shaped opening through said molded transparent plastic shield; wherein said padding is discontinuous in the area of said continuous pre-cut vertical gap such that, when said continuous pre-cut vertical gap is widened, said padding separates along said discontinuity and said protective mask can be removed from the face of said patient without disturbing any tubing passing through said transverse cutout to said patient's mouth or nose.