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Publication Number
US-10080582-B2
Publication Date
2018-09-25
Expiration Date
Abstract
A skin insertion mechanism includes a needle fixedly positioned in a needle holder with a connector (or connective means) to an injection or analysis system having a skin attachment plate coated with an adhesive layer and a spacer mechanism kept in the ready-to-use position, the skin attachment plate is spaced away from a needle support covering the needle. Subcutaneous insertion of the needle is effected by attachment of the adhesive layer to the skin and releasing the spacer mechanism by applying a pre-set trigger point pressure against the skin.
Core Innovation
The invention describes a skin insertion mechanism in which a needle fixedly positioned in a needle holder is inserted into a patient’s skin using a connector to an injection or analysis system. The mechanism includes a skin attachment plate coated with an adhesive layer and having a hole allowing the passage of the needle. A spacer mechanism connected to and guiding an axial movement relative to each other is arranged so the needle holder and the skin attachment plate are kept in a ready-to-use position with an axially fixed spacing away from each other to cover the needle.
A withholder structure is releasably connected to the needle holder and the skin attachment plate and keeps the ready-to-use axial fixed spacing between the needle holder and the skin attachment plate. The withholder structure is releasably released in a direction of axial movement by a coupling element that keeps the needle holder and the withholder structure in the axial position by releasable connecting elements requiring a pre-set trigger point pressure to be released. The coupling element moves axially in the direction of axial movement of the needle holder when released.
A release element movably linked to the spacer mechanism is provided with pressure exerting elements. The pressure exerting elements produce pressure onto the connecting elements by axial movement towards the needle holder to release the withholder structure from the ready-to-use position, and then allow the axial movement of the needle holder towards the skin attachment plate with sufficient velocity to pierce the skin by the needle and insert the needle into the skin.
Claims Coverage
Independent claim clm-00001 is directed to a skin insertion mechanism integrating an adhesive-coated skin attachment plate, a spacer/withholder/coupling/release actuation sequence, and an axial needle-holder movement triggered by a pre-set trigger-point pressure to achieve skin piercing and insertion for an injection or analysis system.
Adhesive-coated skin attachment plate with needle passage
A skin attachment plate coated with an adhesive layer for attachment to a patient's skin and having a hole allowing the passage of the needle.
Spacer mechanism with withholder structure and coupling requiring pre-set trigger point pressure
A spacer mechanism connected to and guiding an axial movement of the needle holder and the skin attachment plate relative to each other, the spacer mechanism comprising a withholder structure releasably connected to the needle holder and the skin attachment plate and keeping the needle holder and the skin attachment plate in a ready-to-use position axially fixedly spaced away from each other to cover the needle, and the withholder structure axially moving in a direction relative to the needle holder when released; and a coupling element keeping the needle holder and the withholder structure in the axial position by releasable connecting elements requiring a pre-set trigger point pressure to be released, and the coupling element axially moving in a direction of the axial movement of the needle holder when released.
Movably linked release element with pressure exerting elements for sufficient-velocity needle insertion
A release element movably linked to the spacer mechanism and provided with pressure exerting elements producing pressure onto the connecting elements by axial movement towards the needle holder to release the withholder structure from the ready-to-use position, and allowing the axial movement of the needle holder towards the skin attachment plate with sufficient velocity to pierce the skin by the needle and insert the needle into the skin.
Across the independent claim, the claim coverage centers on combining an adhesive skin attachment plate with a needle-passing hole, a spacer mechanism that keeps the needle covered in a ready-to-use axially fixed spacing, and a trigger-point-pressure release sequence using a coupling element and a movably linked release element so the needle holder moves with sufficient velocity to pierce and insert the needle into the skin for an injection or analysis connector.
Stated Advantages
Cost-effective, user-friendly insertion behavior.
Smooth but sufficient insertion behavior.
Enables patient self-application as compared to manual or spring-driven insertion.
Documented Applications
Subcutaneous injection using the connector to an injection system.
Analyte measurement/analysis using the connector to an analysis system, including use of the needle as a diagnostic probe and measuring/analyte determination in subcutaneous tissue.
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