Injection or infusion device comprising an improved release liner
Inventors
Burren, Stefan • Bernhard, Mario • Bigler, Bernhard • Schenker, Susanne • Mellenberger, Andres • Schrul, Christian • Tschirren, Markus
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12083314-B2
Publication Date
2024-09-10
Expiration Date
Abstract
An injection device configured for attachment to the skin of a patient using an adhesive layer includes a release liner covering the adhesive layer thereby preventing skin attachment. The release liner comprises a sheet of material where a first surface contacts the adhesive layer, and an aperture defining a passage for a film connected to a first sterile barrier film located within the injection device. An end of the film is connected to a second surface of the sheet of material that is opposite to the first surface, and the release liner is covered by a strengthening sheet connected to the second surface and covering the aperture and the end of the film.
Core Innovation
The invention relates to an adhesive skin-attachable injection device or infusion device having a housing with an adhesive layer and a release liner that prevents skin attachment. Within the housing, a first sterile barrier film is provided, and a film connected to the first sterile barrier film is received through an aperture in a sheet of material forming the release liner. An end of the film connected to the first sterile barrier film is connected to a second surface of the sheet of material opposite the adhesive-contacting first surface.
A strengthening sheet is connected to the second surface of the sheet of material. The strengthening sheet covers at least a portion of the release liner and one or more features selected from an aperture of the release liner and the end of the film. The disclosure also includes strengthening sheet embodiments that cover one or more additional sterile barrier films, including a removable sterile barrier for a hollow needle aperture, to address tear damage and stress concentration during liner removal.
The disclosure further provides an internal sterile barrier arrangement in which the strengthening sheet and the film connected to the sterile barrier film cooperate to enable simultaneous removal of sterile barriers to form a sterile connection. Optional electrical sensing is described, using a conductive layer on or part of the release liner or counter-layer to electrically shield a capacitive sensor and detect proper liner removal via capacitance change.
Claims Coverage
Two independent claims are identified, and they share the core structure of a skin-attachable adhesive injection device with an internal sterile barrier film arrangement protected by a release liner that includes an aperture and is covered by a strengthening sheet. Across the independent claims, the inventive features include the aperture-and-film relationship, the strengthening sheet coverage, and the manner in which sterile barrier films and optional internal second sterile barrier arrangements are connected and/or located relative to the aperture passage.
Adhesive skin attachment with internal sterile barrier film and film through release liner aperture
An injection device for attachment to the skin using an adhesive layer in a housing, with a first sterile barrier film within the housing, a film connected to the first sterile barrier film, and a release liner covering the adhesive layer, wherein the release liner comprises a sheet of material with a first surface contacting the adhesive layer and a first aperture configured for receiving the film connected to the first sterile barrier film, with an end of the film connected to a second surface of the sheet opposite the first surface.
Strengthening sheet covering aperture and film end
A strengthening sheet connected to the second surface covering at least a portion of the release liner and one or more of the first aperture and the end of the film.
Passage aperture in release liner for connected film and internal or attached second sterile barrier film
An injection device with a release liner comprising a sheet of material having an aperture defining a passage through which at least the first film passes, wherein the at least first film is connected to the first sterile barrier film and an end of the at least first film is connected to a second surface of the sheet opposite the first surface, and further comprising a second sterile barrier film that is connected to the second surface of the sheet of material or located within the injection device and connected to a second film, with an end of the second film extending through the aperture passage and connected to the second surface when the second sterile barrier film is located within the injection device.
Strengthening sheet covering selected release liner and sterile barrier features
At least a first strengthening sheet connected to the second surface and covering the release liner, wherein the at least first strengthening sheet covers one or more features selected from the group consisting of: the aperture, the end of the at least first film, a portion of the second sterile barrier film located on the second surface of the sheet of material, and the end of the second film.
The independent claims focus on a skin-attachable adhesive injection device using a release liner with a sheet and aperture that receives a film connected to an internal sterile barrier film, combined with a strengthening sheet that covers at least portions of the release liner and selected features such as the aperture and film ends. One independent claim further specifies an aperture passage and an internal or attached second sterile barrier film arrangement, where film ends extend through the aperture passage and are connected to the release liner sheet, with strengthening sheet coverage selected among the aperture, film ends, and portions of the second sterile barrier film.
Stated Advantages
Addresses tear/stress concentration problems during liner removal.
Enables simultaneous removal of sterile barriers to form a sterile connection.
Conductive layer shielding enables electrical sensing by shielding a capacitive sensor and detecting proper liner removal via capacitance change.
Documented Applications
Skin-attachable injection device attachment using an adhesive layer and a release liner with internal sterile barrier films and strengthening sheet coverage.
Skin-attachable infusion device using the same adhesive skin-attachable injection/infusion device concept with internal sterile barrier films, release liner aperture, and strengthening sheet.
Interested in licensing this patent?