Intravascular administration set needle safety device

Details Intravascular administration set needle safety device Intravascular administration set needle safety device

2002-10-24

2004-01-13

Casler, Brian L. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S174000, C604S177000, C604S263000, C604S264000, C604S272000

Reexamination Certificate

active

06676633

ABSTRACT:

FIELD OF THE INVENTION
The invention relates in general to intravascular administration sets. More particularly, the invention relates to a needle safety device adapted for use with an intravascular administration set.
BACKGROUND OF THE INVENTION
The use of intravascular administration sets to access implanted ports in the art of drug therapy is well known. As known, the access port is implanted beneath the subcutaneous layers of a patient's skin and accessed by the intravascular administration set. This is accomplished by percutaneous needle insertion into the access port through a penetrable septum, or by other conventional or known means, and is accomplished by using a non-coring hypodermic needle, for example a Huber needle.
Intravascular administration sets are designed to provide duration access to the implanted port. The use of these devices reduces the trauma otherwise associated with multiple punctures of the venous system, or the inconvenience of an externalized catheter for patient treatment purposes. Accordingly, and as known, intravascular administration sets are oftentimes used to access implanted ports to facilitate frequent blood sampling, or provide for the delivery of medications, nutritions, blood products, and imaging solutions into the blood stream, or to a treatment site within the patient.
Intravascular administration sets are supplied as sterile devices, and are provided for single patient use only. They are available in a variety of materials, including PVC, and other plastics. The non-coring needles are typically formed of stainless steel. Intravascular administration sets are comprised, therefore, of a non-coring needle, a device to secure the needle to the skin after it is inserted into the port, usually wings made of plastic, tubing to transport the fluids, and a connecting device, usually a luer type of connector fitting, used to connect the set to the fluid delivery device, i.e., a syringe. A clamp is placed on the tubing to stop the flow of fluids, and an injection site may be added to the set to allow for the infusion of additional fluids other than those fluids which are administered from the luer fitting.
A major problem with the known intravascular administration sets, however, is accidental sharps injuries, also referred to as “needle sticks.” These are usually caused when the port is de-accessed, i.e., when the needle is explanted. To remove the needle from the intravascular administration set, the health care worker places two fingers from their off hand on the skin above the port to stabilize the port, the health care worker then removing the non-coring needle from the port with the other hand. Some force is required to remove the needle from the septum of the access port such that when the needle exits the port the natural reaction is to stop the upward motion. The body overreacts however, to stop this upward motion, and the needle sometimes sticks the health care worker. This is commonly referred to as a rebound injury. Due to the fact that the needles have been exposed to the patient's blood, any blood borne pathogen from the patient may therefore be transferred to the health care worker during this type of injury.
What is needed, therefore, is a device that will prevent a sharps injury or an accidental needle stick to health care workers, and which will also reduce the opportunity for the transmission of communicable diseases while de-accessing the treatment needles from an access port.
SUMMARY OF THE INVENTION
The present invention is an intravascular administration set incorporating a needle safety device adapted to prevent accidental needle sticks to health care workers and others during needle explant from a patient.
In a first embodiment, the invention comprises a winged hub, a needle holder, and a safety handle. In preparation for needle explant, the safety handle of the device is raised from a first position in which it is positioned parallel to the surface of the winged hub into a position in which the safety handle is perpendicular with respect to the winged hub. The safety handle is provided with an elongate internal slot, channel or track that is constructed and arranged to align with and receive a correspondingly shaped fitting on the needle holder therein when the safety handle is in its explant, or upright, position.
In this embodiment, as the needle is withdrawn from an implanted subcutaneous access port, for example, a finger from the user's off hand will be used to hold the safety handle down using a flat finger tab or area formed at the distal end of the safety handle. Applying downward force on the handle holds the infusion set winged hub next to the patient's skin and secures the access port in position around the needle. The needle holder provides a handle for the needle to be pulled upwards, for example toward the distal end of the safety handle. The infusion set winged hub also has a guide hole through which the needle is passed as it is extracted from the access port. Due to the specific shape of the Huber point needle, and the positioning of the guide hole within the winged hub such that it is axially offset with respect to the axis of the needle, the guide hole will allow the needle to be extracted, but will not allow the needle to return through the guide hole defined within the winged hub.
Accordingly, as the needle holder is pulled upwards, the needle exits the septum of the access port and the patient's epidermal skin layer. Once the needle clears the skin layer it is offset with respect to the guide hole, and is thus captured by and within the track of the safety handle held by the user's off hand. The needle cannot thereafter be re-extended, nor can it be used once again. The needle safety device will therefore cover or otherwise render unusable the point of the needle when the access port is de-accessed in order to prevent an accidental needle stick.
In a second embodiment, the intravascular administration set comprises a needle stick guard, a winged needle holder, and a needle trap. In preparation for needle explant using this embodiment of the device, the needle trap of the device is raised from a first position in which it is positioned parallel to the surface of the winged needle holder into a second position in which the needle trap is positioned perpendicular with respect to the winged needle holder. The needle stick guard and the needle trap together define a continuous elongate internal slot, channel or track that will align with and receive a correspondingly shaped head or track member on the winged needle holder therein when the needle trap is in the explant, or upright, position.
As the needle is withdrawn from the access port, the index finger and the thumb from the user's off hand are used to hold the needle stick guard down. Applying a downward force on the needle stick guard holds the safety assembly next to the patient's skin and secures the port in position around the needle. The winged needle holder also functions as a handle for use in moving the needle upwards, for example toward the distal end of the needle trap. The needle stick guard has a guide hole defined therein and through which the needle is passed as it is extracted from the access port. Due to the specific shape of the Huber point needle and the off center position of the hinge points of the needle trap on the needle stick guard, such that the needle stick guard may be rotated or offset into a safe position about the end of the needle trap, the guide hole will allow the needle to be extracted, but will not allow the needle to return through the needle stick guard.
Accordingly, as the needle holder is pulled upwards, the needle exits the septum of the access port and the patient's epidermal skin layer. Once the needle clears the skin layer and the needle stick guard, the needle is entrapped by and within the needle trap while the needle stick guard is held by the user's off hand, and cannot thereafter be re-extended nor used. The needle safety device will capture or other

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