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Publication Number

US-11413405-B2

Patent

Publication Date

2022-08-16

Expiration Date


Abstract

An assembly for forming an injection device, comprising: a foot to be placed on a skin; a body comprising at least one needle, the body being movably mounted to the foot for allowing movement of the needle towards the skin, the needle extending out of a second contact surface by a predefined distance for limiting a penetration depth of the needle; first friction means for preventing movement of the body relative to the foot for causing a sudden acceleration; the assembly further comprising second friction means for creating a dynamic friction when the needle is moving towards the skin for keeping the skin stretched.

Core Innovation

The invention provides an assembly for forming an injection device for administering a fluid to a subject. The assembly includes a foot having a first contact surface adapted to be placed on skin, and a tubular-shaped foot configured to receive a body. The body comprises at least one needle fixedly mounted to the body and includes a channel in fluid communication with the at least one needle for delivering the fluid to the subject. The body is movably mounted to the foot to move the needle from a first position to a second position in order to limit penetration depth by a predefined distance.

The assembly uses a first friction means that inhibits movement of the body relative to the foot when the body is in the first position, until a predefined static friction force is overcome. After the predefined static friction force is overcome, the first friction means causes or allows a sudden acceleration of the body towards the foot to increase the speed of the needle and increase the chance of penetration. This friction behavior enables reliable insertion beginning from a retracted position in which the needle is not accessible from outside of the assembly.

The assembly further includes a second friction means that creates a predefined dynamic friction force between the foot and the body while the body moves towards the foot. The predefined dynamic friction force is smaller than the predefined static friction force. The dynamic friction maintains contact between the first contact surface of the foot and the skin and maintains the skin in a stretched state after the predefined static friction force is overcome, during the needle movement that extends out of the contact surface by the predefined distance. Structural embodiments include protrusions and grooves configured for static friction via radial clamping and optionally at least partly spiral grooves for needle rotation.

Claims Coverage

The independent claim covers an injection-device assembly built around a foot-and-body structure with a predefined needle protrusion distance for limiting penetration depth. It further adds two-stage friction control using a predefined static friction force that is exceeded to trigger sudden acceleration, followed by a smaller predefined dynamic friction force that maintains contact and a stretched skin state during needle movement.

Foot and movable needle-bearing body for penetration-depth limiting protrusion

A foot having a first contact surface adapted to be placed on a skin of the subject, the foot having a tubular shape for receiving a body; the body comprising at least one needle fixedly mounted to the body with a channel in fluid communication with the at least one needle for delivering the fluid; the body movably mounted to the foot to allow movement from a first position where the needle is in a retracted position not extending out of the first contact surface and not accessible from outside of the assembly, to a second position where the needle extends out of the first contact surface and extends out of a second contact surface by a predefined distance for limiting a penetration depth of the needle.

Static-friction threshold that enables sudden acceleration towards the foot

A first friction means for inhibiting movement of the body relative to the foot when the body is in the first position, until a predefined static friction force is overcome, and for causing or allowing a sudden acceleration of the body towards the foot for increasing a speed of the needle for increasing chance of penetration.

Dynamic-friction maintenance of contact and stretched skin state after static friction is overcome

A second friction means for creating a predefined dynamic friction force between the foot and the body when the body is moving towards the foot for maintaining contact between the first contact surface of the foot and the skin and for maintaining the skin in a stretched state after the predefined static friction force is overcome, the predefined dynamic friction force being smaller than the predefined static friction force.

Across the independent claim, the coverage centers on an injection-device assembly where needle penetration depth is limited by a predefined needle protrusion distance, and reliable needle movement is enabled by a two-stage friction scheme: an initial static friction threshold that triggers sudden acceleration, followed by a smaller dynamic friction force that maintains foot-skin contact and keeps the skin stretched during needle extension.

Stated Advantages

Reliable insertion by enabling movement from a retracted, non-accessible position to an extended position with increased chance of penetration.

Accurate limitation of penetration depth by extending the needle by a predefined distance.

Reduced risk of failed penetration/non-penetration through sudden acceleration after a static-friction threshold is exceeded.

Maintains contact between the foot and the skin and maintains the skin in a stretched state during needle movement.

Allows single-hand self-administration.

Enables reduced non-penetration risk and increased accuracy of penetration depth especially for short needles.

Provides modular/customizable needle configurations.

Documented Applications

Intradernal (ID) injection to administer a fluid to a subject.

Administering a fluid using an injection device formed by the described assembly, including embodiments compatible with a syringe via a cavity/conical channel with standard Luer dimensions.

Needle arrays, including microneedle arrays, as part of the needle-bearing body configuration.

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