Polymeric catheter needle tip shielding device

Inventors

Knutsson, Per

Assignees

Greiner Bio One GmbH Austria

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Publication Number

US-9522255-B2

Patent

Publication Date

2016-12-20

Expiration Date


Abstract

The present invention discloses a catheter instrument (1000) comprising a needle tip shielding device (100), a needle (303), a needle carrying unit, and a catheter unit, said catheter unit comprising a catheter hub (200) and a catheter (201), and said needle tip shielding device (100) and said catheter hub (200) being separable from one another, wherein said needle tip shielding device (100) is kept in contact with said catheter unit upon withdrawal of said needle (303) via at least one interface surface between said needle tip shielding device (100) and said catheter unit, and wherein said at least one interface surface of said needle tip shielding device (100) being at least partly of a first polymeric material and said at least one interface surface of said catheter unit being at least partly of a second polymeric material.

Core Innovation

The invention relates to a catheter instrument that includes a hollow needle with a needle tip, a needle carrying unit configured to hold the needle, and a catheter unit having a catheter hub and a catheter with proximal and distal ends defining an axis. The needle carrying unit is removably mounted within a proximal end of the catheter hub, so the needle is slidable along the axis to be projected distally and retracted proximally. A needle tip shielding device is removably mounted within the catheter hub and includes front and rear surfaces, an elevation with a hole for passage of the needle, and at least one interface surface configured to attach to the catheter hub interface surface.

The needle tip shielding device further includes a self-biased resilient needle tip shielding arm. The arm includes a first arm portion projecting from the front surface in a direction along the axis, with a proximal end attached to the front surface and a distal end, and a second arm portion extending transverse to the first arm portion. When the needle is projected distally, the arm is pushed away from the axis by the needle, and when the needle is retracted proximally the arm moves proximally under its own self-bias and resiliency, shielding the needle tip from subsequent distal projection.

To prevent malfunction from the attraction effect during automatic release, the invention uses different polymeric materials on interface surfaces and/or surface features to control detachment force and detachment behavior. The interface surface of the needle tip shielding device is made at least partly of a first polymeric material, while the interface surface of the catheter hub is made at least partly of a second polymeric material that is different from the first polymeric material. When the needle is fully retracted to a fully retracted position, the first and second polymeric materials are configured to facilitate removal of at least the needle tip shielding device from the catheter hub.

The invention additionally provides a stop member on the needle shaft configured to prevent the needle tip shielding device from distal movement relative to the needle when the needle is retracted in the proximal direction. Structural embodiments include a round body with an elevation including a hole, resilient arm geometries and features, and interface arrangements between the needle tip shielding device and the catheter hub to achieve the shielding and removal functions described above.

Claims Coverage

The provided content includes two independent claims (clm-00001 and clm-00012). Both cover a catheter instrument with a removable needle tip shielding device having a self-biased or biased resilient arm that shields during needle retraction, together with an interface between the shielding device and the catheter hub that uses different polymeric materials to facilitate removal; clm-00001 additionally specifies a stop member to prevent distal movement during retraction, and both define that the shielding device is removable when the needle is fully retracted.

Catheter instrument with removable needle tip shielding device and self-biased resilient shielding arm

A catheter instrument comprising a hollow needle with a needle tip, a needle carrying unit removably mounted within a proximal end of a catheter hub to allow distal projection and proximal retraction along an axis, and a needle tip shielding device removably mounted within the catheter hub. The shielding device includes a round body with front and rear surfaces, an elevation with a hole positioned along the axis for needle passage, and at least one interface surface removably attached to the catheter hub interface surface. A self-biased resilient needle tip shielding arm has a first arm portion projecting from the front surface along the axis and a second arm portion extending transverse to the first arm portion; the arm is pushed away from the axis when the needle is projected and moves in the proximal direction under its own self-bias and resiliency when the needle is retracted, shielding the needle tip from subsequent distal projection.

Stop member preventing distal movement of shielding device relative to the needle during retraction

A stop member on the needle shaft configured to prevent the needle tip shielding device from distal movement relative to the needle when the needle is retracted in the proximal direction.

Different polymeric materials on shielding-device and catheter-hub interface surfaces to facilitate removal

The interface surface of the needle tip shielding device is made at least partly of a first polymeric material, and the interface surface of the catheter hub is made at least partly of a second polymeric material different from the first polymeric material. When the needle is fully retracted to a fully retracted position, the first and second polymeric materials are configured to facilitate removal of at least the needle tip shielding device from the catheter hub.

Biased needle tip shielding arm that shields during fully retracted position with sliding needle in shielding device

A catheter instrument where the needle is movable along the axis in a proximal direction and a distal direction, and includes a needle tip shielding device removably mounted within the catheter hub. When the needle is in a ready position with the needle projecting into the catheter, the needle is at least partly disposed in and slidable within the needle tip shielding device. When the needle is in a fully retracted position, the needle tip shielding arm made of the first polymeric material shields the needle tip from movement in the distal direction by moving across the axis.

Polymeric-material-dependent facilitation of removal using first and second interface surfaces

The needle tip shielding device contacts the catheter hub via at least one interface surface between the needle tip shielding device and the catheter hub, defined by a first interface surface on the shielding device and a second interface surface on the catheter hub. The first interface surface is made at least partly of the first polymeric material and the second interface surface is made at least partly of the second polymeric material, different from the first. When the needle is in the fully retracted position, the first and second polymeric materials are configured so that the facilitation of removal of at least the needle tip shielding device from the catheter hub results from the different first and second polymeric materials.

Across clm-00001 and clm-00012, the claim coverage centers on a catheter instrument that automatically shields a hollow needle tip using a removable needle tip shielding device with a biased or self-biased resilient arm, prevents unwanted distal movement via a stop member, and facilitates removal using different polymeric materials on the interface surfaces between the shielding device and the catheter hub.

Stated Advantages

Improved automatic shielding in a standard hub without special obstruction.

Reduced scraping noise and vibrations.

Reduced risk of particle release.

Reduced risk of high release force due to the attraction effect.

Easier manufacturing/molding and color-coding.

Documented Applications

Automatic shielding of a hollow needle tip in a standard hub configuration during needle projection and retraction.

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