Safety angled indwelling needle and a protective shield for...

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S192000, C604S263000

Reexamination Certificate

active

06500155

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention relates generally to hypodermic needles, and more particularly to safety indwelling angled needles, e.g., right angle Huber needles, and protective shields for such needles, to prevent accidental sticking when inserting or removing angled needles from the body of a living being.
As is known implanted ports for the delivery of drugs or other liquid materials are commonly utilized in the medical field today. Such ports are typically placed in a subcutaneous pocket, e.g., the anterior upper chest wall below the clavicle, and typically include a chamber for the drug or other liquid and a pierceable, e.g., rubber, septum for receipt of a needle to either fill or empty the chamber. Special non-coring needles (sometimes referred to as “Huber” needles) are commonly used with such ports to minimize the damage to the septum resulting from repeated piercing by the needle. Such damage may lead to infusion of the septum fragment(s) into the patient's vascular system or into any catheter or other device having access to the port, thereby occluding the port. In U.S. Pat. No. 2,748,759 (Huber) there is shown a Huber type safety needle.
As is known, Huber needles may be straight or angled and may be of various lengths depending upon the application, e.g., drawing blood, filling the chamber, flushing chamber, etc. In order to hold the needle in place in the port Huber needles frequently include a pair of flanges which are arranged to be secured, e.g., taped, to the patient's skin at the location of the port.
As will be recognized by those skilled in the art removal of a Huber needle from a port, particularly, a right angle shaped Huber needle, frequently results in an accidental piercing or “needle-stick” of the person removing the needle.
U.S. Pat. No. 5,505,711 (Arakawa et al.) discloses an indwelling injector needle device constructed to reduce the risk of accidental needle-sticks. The device includes a pair of wings and a cannula or needle body, a hub supporting a proximal end of the needle body, a tube in fluid communication with the needle body, a cylindrical holder having a distal end from which the wings protrude, and a latching mechanism. The hub can slide along an inner periphery of the holder between a first position near the distal end of the holder and a second position near a proximal end of the holder. A latching mechanism is formed in and disposed between the hub and the holder so that the hub is inhibited from moving from the first position toward the second position, and vice versa. The needle edge can be retracted within the holder while its wings remain fixed to a patient's skin.
U.S. Pat. No. 5,879,330 (Bell) discloses a needle retraction device for removing a needle, such as a right angled “Huber” needle, from a patient without danger of an accidental needle-stick. The device basically comprises an exterior housing having an interior compartment and a slidable member. The housing has an exterior wall which defines an interior compartment. The slidable member has a pair of spaced apart movable legs separated from one another by an elongate slot and is located within the interior compartment. The pair of spaced apart movable legs are also spaced from a remainder of the slidable member by a cavity or area which is sized to receive the needle. The slidable member is movable from a first position, in which the pair of spaced apart movable legs are located outside of the interior compartment of the needle retraction device for receiving a needle, and a second retracted position, in which the pair of spaced apart movable legs along with a supported needle, are completely retracted inside the interior compartment of the housing to prevent an inadvertent needle stick.
U.S. Pat. No. 5,921,969 (Vallenunga et al.) discloses a device for shielding a butterfly needle, such as a straight or right angled “Huber” needle, to protect the user against accidental needle-stick injuries. The device basically comprises a hollow box-like member having a pair of engaging complementary shield sections which are adapted to be secured together to form a cavity for receipt of the needle therein.
U.S. Pat. No. 5,951,522 (Rosato et al.) also discloses a device whose intent is to reduce accidental needle-sticks caused by right angled Huber type needles. To that end the device of this patent is in the form of hypodermic needle safety enclosure for a right angle shaped hypodermic needle. A wing assembly is mounted on the hypodermic needle. The wing assembly may be either a single integral member having a plurality of spaced apart fold lines which permits the integral member to be folded between a mounting position and a protective position or a pair of wing members which are mounted in a scissors arrangement which is movable between a mounting position and a protective position. Upon withdrawing of the needle from the installed position within the body of a human, the wing assembly is automatically positioned to encase the sharpened point of the needle, thereby preventing undesired injury by the needle to the medical practitioner that is installing and removing of the enclosure.
While the devices of the aforementioned patents appear suitable for their intended purposes, the still leave much to be desired from various standpoints, such as simplicity of construction, intuitiveness of operation and ease of use.
SUMMARY OF THE INVENTION
A safety angled indwelling needle device and a protective shield for a safety angled indwelling needle. The safety device comprises the combination of an angled indwelling, e.g., Huber type, needle and a protective shield. The protective shield can be a separate unit for use with an angled Huber needle.
The needle is a hollow member having a distal end portion and a proximal end portion, with the distal end portion extending at an angle to the proximal end portion and terminates in a piercing tip.
The protective shield comprises a central hub and a pair of wing members, e.g., an integrally molded unit. The central hub has a longitudinal central axis, a distal end, a proximal end and a passageway extending through the central hub along the horizontal axis. The proximal end portion of the needle extends through said passageway, e.g., is connected to a tube thereat. The distal end portion of the needle extends out of the passageway in the central hub and extends at an angle, e.g., approximately perpendicularly, to the passageway.
Each of the wing members of the protective shield are generally planar. Each wing member is mounted to the central hub, e.g., secured by a living hinge, on opposite sides of the central hub and is arranged to be moved, e.g., flexed, from an open state, wherein the wing members are generally coplanar with each other, to a closed state, wherein the wing members abut each other with the distal portion of the needle disposed between them, to enclose the needle's piercing tip. Each of the wing members also includes at least one connector, e.g., respective projections and apertures, for holding the wing members in the closed state.
In accordance with one exemplary, but not exclusive embodiment, of this invention each wing member includes include a linear channel therein. The channels conjoin when the wing members are in their closed state to form an enclosed recess for receipt of the needle's piercing tip. Each channel is generally linear and extends within its associated wing member from a first end point adjacent the central hub to a second end point more remote from the hub. The use of the linear channels while not mandatory, desirable, to further ensure that persons contacting the device will not be pierced by the enclosed needle.
In accordance with the aforementioned exemplary embodiment, one of the channels of one of the wing members includes an arrowhead-shaped recess located at the second end point of that wing member. The other of the channels includes an arrowhead shaped projection located at the second end point of the other of the wing member. The arrowhead shaped recess and the arr

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