US-12623029-B2 - Safety device for preventing needle stick injury with a needle of a medical injection device

US12623029B2US 12623029 B2US12623029 B2US 12623029B2US-12623029-B2

Abstract

A safety device for preventing needle stick injury comprises a ring configured to be attached to the distal tip of a medical injection device, a first hinge portion, and a protective shield. The protective shield comprises a second hinge portion pivotally coupled to the first hinge portion and is configured to adopt successively a storage position covering the needle tip, a retracted position uncovering the needle tip and a safety position covering the needle tip. In the safety position, the protective shield is locked on the ring by engagement of a locking member with a lug on the ring. The locking member is configured to engage the lug when the protective shield transitions from the retracted position to the safety position, passing from one side of the lug to the other, and remaining engaged with the lug for maintaining the protective shield in the safety position.

Inventors

Franck Carrel
Freddy Mills

Assignees

BECTON DICKINSON FRANCE

Dates

Publication Date: 20260512
Application Date: 20200619
Priority Date: 20190621

Claims (16)

1 . A safety device for a medical injection device, comprising: a ring configured to be attached to a distal tip of a medical injection device and comprising a first hinge portion; and a protective shield comprising a second hinge portion pivotally coupled to the first hinge portion, the protective shield configured to adopt successively a storage position in which the protective shield covers the needle tip, a retracted position in which the protective shield uncovers the needle tip, and a safety position in which the protective shield covers the needle tip; wherein: the ring comprises a lug, the lug extending distally and comprising an internal side and an external side opposite to the internal side, wherein the internal side is closer to a center point of the ring than the external side; the protective shield comprises at least one proximal locking member; in the safety position, the protective shield is locked on the ring by engagement of the locking member with the lug; the locking member is a flexible tab, wherein the flexible tab extends primarily axially and proximally directly from the body of the protective shield, wherein an axial direction is defined as a longitudinal axis of the protective shield; and the locking member is configured to: engage the lug when the protective shield transitions from the retracted position to the safety position, so that the locking member abuts against the external side of the lug and deflects radially outwardly, relative to the axis of the ring wherein the axis of the ring extends through the center point of the ring in a manner that is perpendicular to a radius of the ring, from a body of the protective shield when the protective shield passes from the external side of the lug to the internal side of the lug, and remain engaged with the internal side of the lug for maintaining the protective shield in the safety position.
2 . The safety device according to claim 1 , wherein the locking member comprises a single flexible tab.
3 . The safety device according to claim 2 , wherein: the flexible tab comprises an inner surface provided with a rib, and the ring comprises a protrusion provided with a cam member, the protrusion extending radially from the ring and comprising a distal side and a proximal side located proximally relative to the distal side, the flexible tab is configured to deform in flexion by engagement of the rib with the cam member when the protective shield transitions from the storage position to the retracted position, so that the rib passes from the distal side of the lug to the proximal side of the lug, and the rib is configured to remain engaged with the cam member for maintaining the protective shield in the retracted position.
4 . The safety device according to claim 3 , wherein the rib and the cam member are configured to maintain the protective shield at an angle equal to or greater than 80° relative to an axis of the ring when the protective shield is in the retracted position.
5 . The safety device according to claim 1 , wherein the locking member comprises two flexible tabs separated by a slot.
6 . The safety device according to claim 5 , wherein each flexible tab comprises a free end separated from the body of the protective shield by a respective groove opposite the slot.
7 . The safety device according to claim 1 , wherein the flexible tab protrudes proximally from the lug when the protective shield is in the storage position and/or in the safety position.
8 . The safety device according to claim 1 , wherein the flexible tab extends toward the second hinge portion.
9 . The safety device according to claim 1 , wherein: the first hinge portion comprises a groove defining a pivot axis of the protective shield, and the protective shield comprises an axle clipped into the groove.
10 . The safety device according to claim 1 , wherein: the first hinge portion comprises two colinear pins defining a pivot axis of the protective shield, and the protective shield comprises two proximal legs provided with an opening, each colinear pin engaging a respective opening of the two proximal legs.
11 . The safety device according to claim 1 , further comprising a protective cap configured to be mounted onto a distal tip of a medical injection device to cover a needle tip thereof, wherein the protective shield is interlocked with the protective cap when the protective shield is in the storage position.
12 . The safety device according to claim 1 , further comprising: a medical injection device comprising a barrel, a distal tip extending distally from the barrel, and a needle mounted onto the distal tip, wherein the ring is around the distal tip of the medical injection device.
13 . The safety device according to claim 1 , wherein: the flexible tab comprises an inner surface provided with a rib, and the ring comprises a protrusion provided with a cam member, the protrusion extending radially from the ring and comprising a distal side and a proximal side located proximally relative to the distal side, the flexible tab is configured to deform in flexion by engagement of the rib with the cam member when the protective shield transitions from the storage position to the retracted position, so that the rib passes from the distal side of the lug to the proximal side of the lug, and the rib is configured to remain engaged with the cam member for maintaining the protective shield in the retracted position.
14 . The safety device according to claim 13 , wherein the rib and the cam member are configured so that, when the protective shield is in the retracted position, the distal end of the protective shield does not protrude from the needle tip.
15 . A safety device for a medical injection device, comprising: a ring configured to be attached to a distal tip of a medical injection device and comprising a first hinge portion; and a protective shield comprising a second hinge portion pivotally coupled to the first hinge portion, the protective shield configured to adopt successively a storage position in which the protective shield covers the needle tip, a retracted position in which the protective shield uncovers the needle tip, and a safety position in which the protective shield covers the needle tip; wherein: the ring comprises a lug, the lug extending distally and comprising an internal side and an external side opposite to the internal side, wherein the internal side is closer to a center point of the ring than the external side; the protective shield comprises at least one proximal locking member; in the safety position, the protective shield is locked on the ring by engagement of the locking member with the lug; the locking member is a flexible tab, wherein the flexible tab extends primarily axially and proximally directly from the body of the protective shield, wherein an axial direction is defined as a longitudinal axis of the protective shield; and the locking member is configured to: engage the lug when the protective shield transitions from the retracted position to the safety position, so that the locking member abuts against the external side of the lug and deflects radially outwardly, relative to the axis of the ring wherein the axis of the ring extends through the center point of the ring in a manner that is perpendicular to a radius of the ring, from a body of the protective shield when the protective shield passes from the external side of the lug to the internal side of the lug, and remain engaged with the internal side of the lug for maintaining the protective shield in the safety position by abutment of the flexible tab against the internal side of the lug such that the locking member undergoes buckling deformation.
16 . The safety device according to claim 15 , further comprising a protective cap configured to be mounted onto a distal tip of a medical injection device to cover a needle tip thereof, wherein in the storage position: the protective shield is interlocked with the protective cap, and the needle tip is embedded in the protective cap, the protective cap is configured to engage with both the protective shield and the needle tip to maintain the storage position, such that removal of the protective cap in a distal direction causes the protective shield to transition into the retracted position.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is the United States national phase of International Application No. PCT/EP2020/067181 filed Jun. 19, 2020, and claims priority to European Patent Application No. 19305817.9 filed Jun. 21, 2019, the disclosures of which are hereby incorporated by reference in their entirety. BACKGROUND Technical Field The present disclosure relates to a safety device for preventing needle stick injury with a needle of a medical injection device. The present disclosure also relates to a safety assembly comprising the safety device and a medical injection device. Technical Background Medical devices provided with sharp pointed needles are of daily practice among the medical community in order to perform injections or to take samples into or from muscles, veins or arteries. The medical devices may include injection devices such as syringes, pen-injectors, catheters or blood collection devices. Sharp pointed needles present an inherent risk of needle stick injury for the medical staff and the patients and are thus usually provided with a needle cap covering the needle before use. This cap not only preserves the needle from contamination, but also from undesired contacts or punctures that could occur during transport and delivery by the medical staff. Such a cap needs to be removed immediately before use of the medical device. Replacing the needle cap onto the needle after use is strictly prohibited as it is regarded as a major cause of accidents and contamination for the medical staff. Indeed, the whole medical device or at least the used needle should be disposed of after use in an appropriate needle collector. However, a risk of needle stick injury still exists as the medical staff handles the bare, contaminated needles before disposal. Safety devices have thus been designed to prevent needle stick injury with the needle of such medical devices after use, i.e. between the end of the injection or collection and the proper disposal of the device. Usually, such safety systems are designed to be locked automatically or manually on at least the needle tip when the medical act is finished. Examples of such safety devices are given in EP0702973 and CA3046821. Nevertheless, many of these safety systems require a triggering step in order to expose the needle tip before use, which slows down the pace of the medical act and decreases the safety level of the medical device. In addition, the majority of such safety systems increase the overall size of the device leading to difficult handling but also to storage concerns, particularly for prefilled syringes. Finally, most of these systems do not achieve a complete exposure of the needle tip and impede the medical act by preventing direct view and access to the needle tip. Additionally, pre-fillable syringes are transported in sterile packaging after manufacturing in order to be filled by the pharmaceutical companies with a pharmaceutical product before the final delivery to the medical staff. The sterile packaging is adapted to the length and diameter of the syringe closed with a usual needle cap and may not accept oversized safety devices as currently available. SUMMARY According to non-limiting embodiments or aspects of the present disclosure, provided is a safety device which prevents the user, the patient, or any person around the device, from coming into contact with the needle of the medical injection before and after use of the device, that is, before and after the injection has been performed. In that way, the needle, especially the needle tip, is not physically accessible, and the risk of accidental pricks or wounds generally caused by contact of the needle with a person close to the device is nullified. The present disclosure aims also to provide a safety device that is readily usable, which presents a simplified structure compared to the known devices, and a size suitable for the transport in sterile packaging. To this end, according to non-limiting embodiments or aspects of the present disclosure, provided is a safety device for preventing needle stick injury with a needle extending from a distal tip of a medical injection device. The safety device may include a ring configured to be attached to the distal tip of the medical injection device. The ring may include a first hinge portion. The safety device may include a protective shield comprising a second hinge portion pivotally coupled to the first hinge portion. The protective shield is configured to adopt successively a storage position wherein the protective shield covers the needle tip, a retracted position wherein the protective shield uncovers the needle tip and a safety position wherein the protective shield covers the needle tip. The ring may include a lug, the lug extending distally and comprising a radially inward side and a radially outward side opposite to the radially inward side relative to the axis of the ring. The protective shield may include at least one