# US 12,111,309 B2 · Point of care devices and methods for detecting infection status of a wound > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,111,309 B2 - Document ID: US12111309B2 - Status: Granted - Kind: B2 - Application number: 17/128,938 - Filed: 2020-12-21 - Published: 2021-06-24 - Granted: 2024-10-08 - Earliest claimed: 2019-12-23 - Assignees: Convatec Limited - Applicants: ConvaTec Limited - Inventors: Manjunath L. Penagondla; Daniel G. Metcalf; Philip G. Bowler - Web page: https://patentgrep.com/patent/US12111309B2 ## CPC - A61B 10/0045: {Devices for taking samples of body liquids} - G01N 33/525: {Multi-layer analytical elements} - B01L 3/5029: {using swabs} - G01N 1/02: Devices for withdrawing samples {(sampling of foundation soil E02D1/04; collecting or conveying radioactive samples G01T7/00, e.g. G01T7/02, G01T7/08)} - G01N 21/78: producing a change of colour - G01N 27/3275: {Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction} - G01N 31/22: using chemical indicators (G01N31/02 takes precedence) - A61B 2010/0006: {involving a colour change} - A61B 2010/008: {Interstitial fluid} - A61B 2010/0216: {Sampling brushes} - B01L 2300/0663: Whole sensors - B01L 2300/0672: Integrated piercing tool - B01L 2400/0683: mechanically breaking a wall or membrane within a channel or chamber - G01N 21/80: Indicating pH value - G01N 2001/028: {Sampling from a surface, swabbing, vaporising} - G01N 2021/7759: {Dipstick; Test strip} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE ## Abstract Wound sampling devices for detecting infection status may be used for point-of-care devices that can be placed at a wound site and detect an infection marker, infection status, or wound healing status by displaying a visible signal such as a color change. ## Claims ### Claim 1 A device for detecting an infection in a wound, comprising: a) an indicator unit; wherein the indicator unit comprises: i. a sensor tube having an open proximal end; and ii. a sensor positioned in the sensor tube; and b) a swab unit, wherein the swab unit comprises: i. a swab shaft having a proximal end and a distal end; ii. a swab tip positioned at the distal end of the swab shaft; and iii. a swab handle connected to the swab shaft at the proximal end of the swab shaft, the swab handle being configured to sealingly engage the open proximal end of the sensor tube, the swab handle comprising (i) a retaining element that defines a cavity and attaches to the sensor tube, (ii) a moveable element retained within the cavity and moveable relative to the retaining element, the moveable element comprising a liquid chamber and a liquid chamber seal that retains liquid within the liquid chamber, and (iii) a piercing member fixedly attached to the retaining element, movement of the moveable element from a proximal position to a distal position causing the piercing member to pierce the liquid chamber seal to release the liquid into the sensor tube. ### Claim 2 (depends on 1) The device of claim 1, wherein the sensor comprises a carrier material and at least one substrate that is operable to undergo a visible color change in response to expression of a specific infection marker present in wound fluid. ### Claim 3 (depends on 2) The device of claim 2, wherein the sensor comprises at least two substrates, each substrate operable to undergo a visible color change in response to expression of a different marker present in wound fluid. ### Claim 4 (depends on 2) The device of claim 2, wherein the carrier material comprises at least one material selected from the group consisting of paper, cellulose, cellulose derivatives, viscose, polyamide, polyester, polyacrylate, fabric, sodium carboxymethylcellulose fiber, and cardboard. ### Claim 5 (depends on 1) The device of claim 1, wherein the indicator unit further comprises a sensor retaining insert sealingly engaged to a distal end of the sensor tube, and wherein the sensor is affixed to the sensor retaining insert. ### Claim 6 (depends on 5) The device of claim 5, wherein the sensor retaining insert defines a cavity configured to receive the swab tip when the swab unit is sealingly engaged to the indicator unit. ### Claim 7 (depends on 5) The device of claim 5, wherein the sensor retaining insert comprises at least one structural feature in or adjacent to the cavity to guide the swab tip as it enters the sensor retaining insert into a desired juxtaposition with the sensor. ### Claim 8 (depends on 7) The device of claim 7, wherein the at least one structural feature is selected from rib features, inclined cavity walls and combinations thereof. ### Claim 9 (depends on 1) The device of claim 1, wherein the swab tip comprises cellulose, modified cellulose, polyurethane foam, polyester, silk, wool, nylon, polypropylene, elastane, or mixtures thereof. ### Claim 10 (depends on 1) The device of claim 1, wherein the sensor comprises a member selected from the group consisting of an enzyme-reactive indicator, a reagent that is a source of peroxide, an enzyme that is able to transform color reactions, a pH indicator, a total protein-detecting reagent, a moisture-detecting reagent and combinations thereof. ### Claim 11 (depends on 10) The device of claim 10, wherein the sensor comprises the pH indicator, and wherein the pH indicator comprises a pH-sensitive reagent. ### Claim 12 (depends on 10) The device of claim 10, wherein the sensor comprises the enzyme-reactive indicator, and wherein the enzyme-reactive indicator comprises a moiety capable of producing a visible color or detectable electronic change upon interaction with one or more target enzymes. ### Claim 13 (depends on 12) The device of claim 12, wherein the moiety is selected from the group consisting of a peroxidase substrate, arylamine, an amino phenol, an indoxyl, a neutral dye, a charged dye, a nanoparticle, a colloidal gold particle, and combinations or analogs thereof. ### Claim 14 (depends on 1) The device of claim 1, wherein the seal comprises a member selected from the group consisting of a metallic foil and a plastic film. ### Claim 15 (depends on 1) The device of claim 1, wherein the swab shaft is fixedly attached to the retaining element such that a proximal end of the swab shaft extends into the cavity, and wherein the piercing member comprises the proximal end of the swab shaft. ### Claim 16 (depends on 15) The device of claim 15, wherein the swab shaft comprises a tube defining a longitudinal passageway therethrough, and wherein, after the liquid chamber seal is pierced, the liquid chamber is in fluid communication with the sensor tube through the passageway. ### Claim 17 (depends on 16) The device of claim 16, wherein the swab shaft defines a radial aperture at its distal end near the swab tip, and wherein, after the liquid chamber seal is pierced, the liquid chamber is in fluid communication with the sensor tube through the passageway and the aperture. ### Claim 18 (depends on 1) The device of claim 1, further comprising a locking mechanism that is operable to prevent the movable element from moving in a proximal direction after the liquid chamber seal is pierced. ### Claim 19 (depends on 1) The device of claim 1, wherein the liquid in the liquid chamber is in an amount of about 500 uL, 1 mL, 1.5 mL, 2 mL, 2.5 mL, 3 mL, 3.5 mL, or 4 mL. ### Claim 20 A device for detecting an infection in a wound, comprising: a) an indicator unit; wherein the indicator unit comprises: i. a sensor tube having an open proximal end; and ii. a sensor positioned in the sensor tube; and b) a swab unit, wherein the swab unit comprises: i. a swab shaft having a proximal end and a distal end; ii. a swab tip positioned at the distal end of the swab shaft; and iii. a swab handle connected to the swab shaft at the proximal end of the swab shaft, the swab handle being configured to sealingly engage the open proximal end of the sensor tube, the swab handle defining a liquid chamber and the swab handle containing a liquid in the liquid chamber to automatically release the liquid into the sensor tube with the swab tip positioned within the sensor tube and the swab handle sealingly engaged to the open proximal end of the sensor tube, and the swab handle comprising a liquid chamber seal positioned at a distal end of the liquid chamber, the indicator unit further comprising a piercing member fixedly attached to the sensor tube at a location whereby the piercing member contacts the liquid chamber seal only when a distal end of the swab handle is inserted into the sensor tube, and inserting the distal end of the swab handle into the sensor tube causing the piercing member to pierce the liquid chamber seal to release the liquid into the sensor tube. ### Claim 21 (depends on 20) The device of claim 20, wherein the piercing member is a piercing ring. ### Claim 22 A device for detecting an infection in a wound, comprising: a) an indicator unit; wherein the indicator unit comprises: i. a sensor tube having an open proximal end; and ii. a sensor positioned in the sensor tube; and b) a swab unit, wherein the swab unit comprises: i. a swab shaft having a proximal end and a distal end; ii. a swab tip positioned at the distal end of the swab shaft; and iii. a swab handle connected to the swab shaft at the proximal end of the swab shaft, the swab handle being configured to sealingly engage the open proximal end of the sensor tube, wherein the swab handle defines a liquid chamber and wherein the swab handle contains a liquid in the liquid chamber and is structured to automatically release the liquid into the sensor tube after the swab tip is positioned within the sensor tube and the swab handle is sealingly engaged to the open proximal end of the sensor tube, and wherein the swab handle comprises a liquid chamber seal positioned at a distal end of the liquid chamber, wherein the indicator unit further comprises a piercing ring attached to the sensor tube at a location whereby the piercing ring contacts the liquid chamber seal only when a distal end of the swap handle is inserted into the sensor tube, and wherein the piercing ring is positioned within the sensor tube such that insertion of the distal end of the swap handle into the sensor tube causes the piercing ring to pierce the liquid chamber seal to release the liquid into the sensor tube. ### Claim 23 (depends on 22) The device of claim 22, wherein a proximal edge of the piercing ring comprises at least one sharp piercing edge that contacts and pierces the liquid chamber seal when the swab unit is inserted into the indicator unit. ### Claim 24 (depends on 22) The device of claim 22, wherein the piercing ring is affixed to an inner wall of the sensor tube. ### Claim 25 (depends on 22) The device of claim 22, wherein the piercing ring comprises a plurality of piercing edges that contact and pierce the liquid chamber seal when the swab unit is inserted into the indicator unit.