Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-08-18
2001-08-14
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S164080, C604S164050
Reexamination Certificate
active
06273874
ABSTRACT:
CROSS-REFERENCE TO RELATED APPLICATIONS
(Not Applicable)
STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT
(Not Applicable)
BACKGROUND OF THE INVENTION
The present invention generally relates to medical devices, and more particularly to a peelable introducer that prevents inadvertent needle sticks.
In the medical arts, catheters are used to deliver medicament to a prescribed location within a patient's body. Such catheters are inserted into the lumen of an anatomical passageway (e.g., an artery or vein) with a peelable introducer. Typically, the introducer comprises a tubular piercing stylet with a beveled distal tip. The stylet is formed with two weakened areas along a longitudinal axis thereof. Additionally, attached to a proximal end of the stylet are two tab members that facilitate tearing of the stylet along the weakened areas, as will be further explained below. A flash chamber is removably attached and in fluid communication with the proximal end of the stylet. The flash chamber is fabricated from a translucent material and contains a hollow interior such that fluid (e.g. blood) flowing into the distal tip of the stylet is detected within the interior of the chamber.
The introducer is used by piercing the artery or vein with the distal tip of the stylet and thereby advancing such into the artery or vein of the patient. A proper insertion of the stylet into the vein or artery of the patient is indicated when blood is detected in the flash chamber. After blood is detected, the flash chamber is removed from the proximal end of the stylet and the catheter is then inserted into the stylet and snaked through the patient's artery or vein until the distal end of the catheter is in a desired location within the patient's body. Once the catheter is in a desired location, the introducer is removed from within the blood vessel of the patient and torn along the weakened areas into two halves with the tab members to remove the stylet from the catheter. As a result of the tearing of the introducer, the stylet is separated into two halves which are unprotected and can lead to inadvertent needle trauma to health care workers.
Increasingly, health care workers are at a risk of inadvertent needle trauma (i.e., needle sticks) when handling needles with sharpened tips. In recent years, such inadvertent needle trauma has become a cause for heightened concern in view of the increase in the incidents of serious or potentially fatal blood-born pathogens such as human immunodeficiency virus (HIV) and the hepatitis B virus. Therefore there exists an ongoing motivation to provide safety devices and apparatus for preventing health care workers from incurring inadvertent needle trauma when handling sharpened needles.
The present invention provides a peelable introducer which prevents inadvertent needle trauma after removal from the patient. In this respect, the present invention protects the health care worker by covering the tips of the stylet after removal from the patient and separation into two halves.
BRIEF SUMMARY OF THE INVENTION
In accordance with the preferred embodiment of the present invention there is provided a peelable introducer for insertion into an anatomical passageway containing a fluid such as blood. The introducer comprises a needle assembly having a U-wing member and a stylet having a sharpened distal tip. The stylet is attached in fluid communication with the U-wing member such that blood flowing into the stylet may enter the interior of the U-wing member. The introducer further comprises a protective sheath cooperatively engaged to the U-wing member. The protective sheath is movable between a non-operative position whereat the distal tip is exposed and an operative position whereat the distal tip is covered by the sheath. In the preferred embodiment of the present invention, the sheath is separable into two halves when the sheath is in the operative position such that when the needle assembly is separated, the distal tips of the stylet remain covered by the separated sheath. Furthermore, the introducer may include a flashback chamber removably attachable to and in fluid communication with the U-wing member. The flashback chamber allows detection of blood entering the stylet and U-wing member.
The needle assembly of the introducer defines a longitudinal axis and is configured to be separable along such axis. The stylet therefore includes a slit formed along the longitudinal axis for separation thereof. Additionally, a groove may be formed opposite the slit along the longitudinal axis thereof for separation of the stylet. In this respect, the stylet is separable into two halves and each half has a sharpened distal tip that is covered by the sheath when the introducer is separated.
In accordance with the preferred embodiment of the present invention, there is provided a method of using a peelable protected introducer constructed in accordance with the present invention. The method comprises the step of inserting the stylet of the needle assembly into the patient's blood vessel. Next, a catheter is inserted through the stylet into the patient's blood vessel. The stylet is then removed from the patient's blood vessel. As the stylet is being removed, the sheath is advanced from a non-operative position to the operative position such that the distal tip of the stylet is covered. Once the stylet is removed from the patient's blood vessel and the sheath is advanced over the distal tip of the stylet, the U-wing member with stylet is separated into two halves in order to be removed from the catheter. Since the sheath is separable into two halves, the distal tip of the stylet is covered and therefore will not cause inadvertent needle sticks. In the preferred embodiment of the present invention, the flashback chamber is fluidly attached to the U-wing member prior to insertion of the stylet into the patient's blood vessel. After the stylet is inserted into the patient's blood vessel and blood is detected within the flashback chamber, the flashback chamber is removed from the U-wing member such that the catheter can be inserted through the stylet and the patient.
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Becton Dickinson and Company
Lam Ann Y.
Lee Eric M.
Nguyen Anhtuan T.
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