# US 2014/0190479 A1 · Speaking valve with saturation indication > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0190479 A1 - Document ID: US20140190479A1 - Status: Published application - Kind: A1 - Application number: 13/738,834 - Filed: 2013-01-10 - Published: 2014-07-10 - Earliest claimed: 2013-01-10 - Assignees: Nellcor Puritan Bennett LLC - Applicants: Nellcor Puritan Bennett LLC - Inventors: Kamlesh Sethiya; Emmet Bolger - Web page: https://patentgrep.com/patent/US20140190479A1 ## CPC - A61M 16/0468: {with valves at the proximal end limiting exhalation, e.g. during speaking or coughing (air passages from trachea to oesophagus or to pharynx, artificial epiglottis A61F2/203)} - A61M 16/105: {Filters (A61M16/047, A61M16/22 take precedence; water traps A61M16/08)} - A61M 16/161: {with means for measuring the humidity} - A61M 16/0051: {with alarm devices} - A61M 16/0434: {Cuffs} - A61M 16/0472: {Devices for performing a tracheostomy} - A61M 16/0497: {Tube stabilizer} - A61M 16/14: by mixing different fluids, one of them being in a liquid phase - A61M 16/20: Valves specially adapted to medical respiratory devices - A61M 2205/584: having a color code - 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 speaking valve includes a hollow body configured to be secured to a connector of a tracheostomy system disposed in a patient. The speaking valve further includes a cap that houses a valve member, which enables the speaking valve to act as a one-way check valve. The valve member, hollow body, or other components of the valve may include a material that undergoes a chemical changed when exposed to moisture, i.e., a hydrosensitive material. Particularly, the hydrosensitive material may exhibit a color change when exposed to moisture. As such, the hydrosensitive material may be useful in providing a visual indication of the saturation and/or moisture level of the speaking valve. ## Claims ### Claim 1 A tracheostomy speaking valve, comprising: a hollow body configured to be mounted to a tracheostomy tube connector; a cap fitted over an end of the hollow body, the cap having ribs and openings between the ribs; and a valve member disposed in the cap and occluding the openings to allow air to enter the tracheostomy tube during inhale cycles but to be forced through the larynx during exhale cycles; wherein at least one of the hollow body, the cap and the valve member are made of a hydrosensitive material that undergoes a color change over time with exposure to moisture. ### Claim 2 (depends on 1) The valve of claim 1, wherein the valve member comprises multiple membranes arranged generally parallel to one another. ### Claim 3 (depends on 2) The valve of claim 2, wherein the valve membranes are configured to be removed successively as the membranes become moisture saturated. ### Claim 4 (depends on 1) The valve of claim 1, wherein the cap is hinged to the hollow body to permit opening of the cap and removal and/or replacement of the valve member. ### Claim 5 (depends on 1) The valve of claim 1, wherein the color change is irreversible. ### Claim 6 (depends on 1) The valve of claim 1, wherein the hydrosensitive material comprises a temperature responsive polymer, a pH sensitive polymer, a halochromic material, a chromogenic material, a hydrogel, a thermochromic material, a lichens based material, or any combination thereof. ### Claim 7 (depends on 1) The valve of claim 1, wherein the valve member has a thickness of from approximately 10 microns to approximately 100 microns. ### Claim 8 (depends on 1) The valve of claim 1, wherein the hollow body is configured to fit a 15 mm connector. ### Claim 9 A tracheostomy system, comprising: a tracheostomy tube assembly comprising a cannula configured to be disposed in the patient trachea, a flange configured to fit against the neck, and a connector extending from the flange; and a speaking valve fitted to the connector and comprising a hydrosensitive material that undergoes a color change over time with exposure to moisture. ### Claim 10 (depends on 9) The system of claim 9, wherein the speaking valve comprises hollow body, a cap fitted over an end of the hollow body, the cap having ribs and openings between the ribs, and a valve member disposed in the cap and occluding the openings to allow air to enter the tracheostomy tube during inhale cycles but to be forced through the larynx during exhale cycles. ### Claim 11 (depends on 10) The system of claim 10, wherein the hollow body is at least partially made of the hydrosensitive material. ### Claim 12 (depends on 10) The system of claim 10, wherein the cap is at least partially made of the hydrosensitive material. ### Claim 13 (depends on 10) The system of claim 10, wherein the valve member is at least partially made of the hydrosensitive material. ### Claim 14 (depends on 9) The system of claim 9, wherein the speaking valve is removably secured to the connector. ### Claim 15 (depends on 9) The system of claim 9, wherein the tracheostomy tube assembly does not comprise an inflatable cuff. ### Claim 16 A method comprising: installing a valve member in a tracheostomy speaking valve, the valve member being at least partially made of a hydrosensitive material that undergoes a color change over time with exposure to moisture, the speaking valve being configured to be secured to a connector of a tracheostomy tube assembly; and providing at least one replacement valve member that can replace the installed valve member as the installed valve member becomes saturated as indicated by the color change. ### Claim 17 (depends on 16) The method of claim 16, wherein the replacement valve member is made of the same material as the installed valve member. ### Claim 18 (depends on 16) The method of claim 16, wherein the color change is irreversible. ### Claim 19 (depends on 16) The method of claim 16, wherein the hydrosensitive material comprises a temperature responsive polymer, a pH sensitive polymer, a halochromic material, a chromogenic material, a hydrogel, a thermochromic material, a lichens based material, or any combination thereof ### Claim 20 (depends on 16) The method of claim 16, wherein the installed and the replacement valve members have a thickness of from approximately 10 microns to approximately 100 microns.