# US 10,369,314 B2 · Customizable cushion utilizing fitted plug inserts > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,369,314 B2 - Document ID: US10369314B2 - Status: Granted - Kind: B2 - Application number: 14/431,310 - Filed: 2013-09-26 - Published: 2015-08-27 - Granted: 2019-08-06 - Earliest claimed: 2012-10-02 - Assignees: Koninklijke Philips N.V. - Applicants: Koninklijke Philips N.V. - Inventors: Lauren Patricia Chodkowski - Web page: https://patentgrep.com/patent/US10369314B2 ## CPC - A61M 16/0622: {having an underlying cushion} - A61M 16/06: Respiratory or anaesthetic masks - A61M 16/0616: {with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure} - A61M 2016/0661: {with customised shape} - 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 respiratory interface device provides a support cushion (15) including a cushion body (20) and at least two inserts (50). The cushion body has a plurality of stiffener passages (22). The at least two inserts are stiffening inserts shaped to correspond to the stiffener passages. The cushion body is made from a first material having a first hardness. One of the at least two inserts is made from a first material, having substantially the same first hardness as the cushion body, and the second insert is made from a second material having a second hardness, the second hardness being different than the first hardness. ## Claims ### Claim 1 A support cushion for a respiratory interface, the interface having a cross-sectional shape similar to the interface peripheral contour, the cushion comprising: a cushion body and at least two inserts, the cushion body having a cross-sectional shape similar to the mask peripheral contour, the cushion body defining a passage, the cushion body comprising: a distal member, a sidewall, and a proximal member, the cushion body distal member and cushion body proximal member are maintained in a spaced relation by the cushion body sidewall, the cushion body sidewall having an inner side and an outer side, the cushion body sidewall having at least one stiffener passage with an opening, wherein the at least one stiffener passage is one of an axial stiffener passage with an opening adjacent both distal member and the proximal member, or a radial stiffener passage with an opening in one of the cushion body inner side or the cushion body outer side, wherein the at least two inserts are shaped to correspond to the at least one stiffener passage, wherein the cushion body is made from a first material having a cushion body hardness, wherein the at least two inserts are made from either the first material having the first hardness, or, a second material having a second hardness, wherein the second hardness is different than the first hardness, and wherein one insert may be inserted into each of the stiffener passages and wherein selection of the insert as being of the first material or the second material selectively determines the localized hardness of the cushion. ### Claim 2 (depends on 1) The support cushion of claim 1, wherein the at least one stiffener passage has a general cross-sectional shape selected from the group including circular, oval, hexagonal, rhombus, and wave. ### Claim 3 (depends on 2) The support cushion of claim 2, wherein: the at least one stiffener passage includes a plurality of stiffener passages; each stiffener passage has generally the same shape as any other stiffener passage. ### Claim 4 (depends on 1) The support cushion of claim 1, wherein one of the at least two inserts being made from the first material having a first indicia and the other of the at least two inserts being made from the second material having a second indicia. ### Claim 5 (depends on 1) The support cushion of claim 1, wherein at least one stiffener passage is a through hole. ### Claim 6 (depends on 1) The support cushion of claim 1, wherein the cushion body includes a sealing flap, the sealing flap being coupled to the cushion body. ### Claim 7 (depends on 1) The support cushion of claim 1, wherein the cushion body includes an insert retaining device. ### Claim 8 (depends on 7) The support cushion of claim 7, wherein the cushion body includes a sealing flap, the sealing flap being coupled to the cushion body, and wherein the sealing flap includes at least one retaining band, the retaining band extending over one of the inner side of cushion body sidewall or the outer side of cushion body sidewall, the retaining band being the insert retaining device. ### Claim 9 (depends on 8) The support cushion of claim 8, wherein: the sealing flap includes the at least one retaining band; the at least one retaining band includes an inner retaining band and an outer retaining band, the inner retaining band extending over the cushion body sidewall inner side; and the outer retaining band extending over the cushion body sidewall outer side. ### Claim 10 (depends on 7) The support cushion of claim 7, wherein the insert retaining device is a retaining band, the retaining band extending over the cushion body sidewall outer side. ### Claim 11 (depends on 7) The support cushion of claim 7, wherein the at least one stiffener passage is tapered. ### Claim 12 (depends on 11) The support cushion of claim 11, wherein each tapered at least one stiffener passage has a smaller cross-sectional area adjacent the cushion body inner side. ### Claim 13 (depends on 7) The support cushion of claim 7, wherein the insert retaining device is an insert stop disposed within the at least one stiffener passage. ### Claim 14 (depends on 7) The support cushion of claim 7, wherein the insert retaining device is a membrane extending over the cushion body inner side. ### Claim 15 (depends on 1) The support cushion of claim 1, wherein the at least one stiffener passage includes a plurality of passages which extend substantially about the cushion body sidewall. ### Claim 16 (depends on 1) The support cushion of claim 1, wherein the at least one stiffener passage extends generally axially. ### Claim 17 (depends on 1) The support cushion of claim 1, wherein the at least one stiffener passage extends generally radially. ### Claim 18 A method of using a support cushion for a respiratory interface device mask, the mask having a faceplate with a peripheral contour, the cushion including a cushion body and at least two inserts, the cushion body having a cross-sectional shape similar to the mask peripheral contour, the cushion body defining a passage, the cushion body having an distal member, a sidewall, and a proximal member wherein the cushion body distal member and cushion body proximal member are maintained in a spaced relation by the cushion body sidewall, the cushion body sidewall having an inner side and an outer side, the cushion body sidewall having at least one stiffener passage with an opening, wherein the at least one stiffener passage is one of an axial stiffener passage with an opening adjacent both distal member and the proximal member, or a radial stiffener passage with an opening in one of the cushion body inner side or the cushion body outer side, the at least two inserts shaped to correspond to the at least one stiffener passage, the cushion body made from a first material having a cushion body hardness, the at least two inserts made from either the first material, or, a second material having a second hardness, the second hardness being different than the first hardness, wherein one insert may be inserted into each of the at least one stiffener passages and wherein selection of the insert as being of the first material or the second material selectively determines the localized hardness of the cushion, the method including the steps of: selectively inserting one insert in each at least one axial stiffener passage through the opening in one of the distal member or the proximal member, or, in at least one radial stiffener passage through the opening in one of the cushion body inner side or the cushion body outer side; and positioning the mask over the user's face. ### Claim 19 (depends on 18) The method of claim 18, wherein the step of inserting one insert in each at least one stiffener passage includes the steps of: determining if the mask is providing a generally continuous seal between the user's face and the cushion; determining the location of a gap in the generally continuous seal; placing an insert of a different material in an at least one stiffener passage adjacent the location of a gap; and determining if the gap has been reduced thereby providing a more complete seal between the user's face and the cushion. ### Claim 20 (depends on 18) The method of claim 18, wherein the at least one stiffener passage includes a plurality of stiffener passages and wherein the step of inserting one insert in each at least one stiffener passage includes the steps of: placing an insert of a first material in each stiffener passage; determining if the mask is providing a generally continuous seal between the user's face and the cushion; determining the location of a gap in the generally continuous seal; placing an insert of a second material in an at least one stiffener passage adjacent the location of a gap; determining if the gap has been reduced thereby providing a more complete seal between the user's face and the cushion.