Pen needle hub injection depth optimization

Inventors

Rini, ChristopherKlug, RichardRoberts, BruceMorel, DidierPettis, Ronald

Assignees

Embecta Corp

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Publication Number

US-11511053-B2

Patent

Publication Date

2022-11-29

Expiration Date


Abstract

A needle hub (10) for a pen needle is provided with an enlarged surface for contact with the skin of a patient. The enlarged surface is provided with a surface having a dimension and shape to enable a needle or cannula to penetrate the skin to a desired depth and permit substantially the entire exposed length of the needle or cannula to penetrate the skin to the desired depth. The surface of the needle hub can be formed by an inner cone shaped member (26) forming a first contact surface with a surface area of about 1-5 mm2 and an outer ring (28) at a peripheral edge forming a second contact surface with a combined surface area of about 15 to 50 mm2.

Core Innovation

The invention provides a needle hub configured for coupling to a pen needle delivery device and includes a body with a proximal end and a distal end, a post extending from the distal end, and a cannula coupled to and extending from the post. The post has an end wall that forms a contact surface for contacting a surface of skin of a patient upon insertion of the cannula. The contact surface includes an inner annular ring forming a first contact surface portion surrounding the cannula and a second portion surrounding and spaced radially outward from the first portion forming an outer annular ring.

An annular recess extends between the inner annular ring and the outer annular ring, creating a shaped interface at the cannula tip region. The inner annular ring and the outer annular ring are dimensioned by specified surface areas so that the first contact surface and second contact surface have a combined surface area of about 15-50 mm2 and provide consistent delivery over a range of insertion forces. The shaped face at the end wall is configured to limit depressing and deforming of the skin to control a depth of penetration of the cannula.

Stabilization and mechanical support are integrated into the needle hub. The end wall includes an inner post extending from a second inner surface toward the proximal end of the body, and a plurality of ribs extend between the inner post and the first inner surface for stabilizing the inner post.

Claims Coverage

The document includes two independent claims. Each independent claim is centered on controlling cannula penetration depth using a needle hub having a shaped skin-contact contact surface defined by inner and outer annular rings separated by an annular recess, and further includes an inner post stabilized by ribs (device claim) or applies the same hub structure in a medication injection method (method claim).

Needle hub with inner and outer annular rings separated by an annular recess

A needle hub configured for coupling to a pen needle delivery device, comprising a body, a post extending from the distal end, and a cannula coupled to and extending from the post, where the end wall forms a contact surface for contacting skin upon insertion; the contact surface includes a first portion surrounding the cannula forming an inner annular ring and a second portion surrounding and spaced radially outward forming an outer annular ring, with an annular recess extending between the inner annular ring and the outer annular ring; the first contact surface and second contact surface have a combined surface area of about 15-50 mm2 and provide consistent delivery over a range of insertion forces.

Inner post stabilization by ribs in the needle hub

The needle hub further includes an inner post extending from the second inner surface toward the proximal end of the body, and a plurality of ribs extending between the inner post and the first inner surface for stabilizing the inner post.

Injecting medication by using dual annular skin contact surfaces to limit skin deformation and control penetration depth

A method for injecting a medication to a subject using a pen body and a pen needle having a needle hub with an end wall forming a contact surface; the contact surface includes an inner annular ring and an outer annular ring separated by an annular recess, with a combined surface area of about 15-35 mm2; inserting the cannula into the skin where the first and second contact surfaces contact the subject's skin to limit depressing and deforming of the skin to control a depth of penetration of the cannula.

Stabilizing the inner post with ribs during the injection method

The method includes the needle hub where the end wall has an inner post extending from the second inner surface toward the proximal end of the body, and a plurality of ribs extend between the inner post and the first inner surface for stabilizing the inner post.

Across both independent claims, the central inventive approach is a needle hub that uses inner and outer annular ring contact surfaces separated by an annular recess, with specified contact surface areas configured to limit skin depression and deformation so that cannula penetration depth is controlled with consistent delivery over a range of insertion forces; in addition, an inner post is stabilized by a plurality of ribs.

Stated Advantages

Provides consistent delivery over a range of insertion forces.

Limits depressing and deforming of the skin.

Controls a depth of penetration of the cannula.

Documented Applications

Injecting a medication to a subject using a pen body and a pen needle with the described needle hub.

The hub and method are used for injections involving skin penetration depth control, including subcutaneous insulin injections and intradermal/intramuscular penetration control as discussed in the document summary.

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