Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
1998-10-20
2001-02-13
O'Connor, Cary (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
C604S110000, C604S195000
Reexamination Certificate
active
06186960
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to medical instruments, and more particularly to a specialized medical test tube holder assembly that is used in the collection of blood or other body fluids via evacuated test tubes. Still more particularly, the present invention relates firstly to a disposable article, a medical test tube holder with modifications that permit an attached needle or other medical sharps device to be quickly and safely detached from the holder after use, and secondly, to an accessory article, an evacuated chamber that captures the detached needle and retracts it into the chamber, all actions being accomplished in a safe manner with one hand. The disposable medical test tube holder assembly of the present invention is fitted with a detachable needle port hub and a wedging hub release ring that positions the detachable needle port hub within the interior wall of the holder at the distal (towards the needle) end of the holder. The detachable needle port hub of the holder may have the needle pre-molded into the hub as an integral component of the holder or, as in the preferred embodiment, may be a needle hub interface that is compliant for use with specialized needle devices or other similar medical devices, The disposable holder may be of any particular shape to accomplish a specific purpose or, as in the preferred embodiment, may be of a generally tubular shape with varying interior diameter from proximal end to distal end with flanges fitted on the proximal end to assist the operator to hold the device during use. The evacuated accessory consists of a hollow chamber fitted with a specialized combination part mounted on the distal end of the evacuated accessory. The specialized combination part contains a needle port hub capturing device; it has an air release/vacuum seal mechanism to readily introduce and hold a pressure differential within the hollow chamber of the evacuated accessory; and, it has gasket seals which maintain a pressure differential between the hollow chamber of the evacuated accessory and the atmosphere. The hollow chamber of the evacuated accessory may be constructed in the form of a test tube, false plunger or other chamber of appropriate size, shape and density capable of holding and maintaining a pressure differential when fitted with a specialized combination part. The specialized combination part functions to capture a detachable target contrivance, allows introduction of a pressure differential within the hollow chamber, and seals the pressure differential between the hollow chamber and the atmosphere.
A problem for doctors, nurses and other health care personnel who use or handle medicinal blood collection devices is the accidental puncture of the skin by the needle. The problem can be very serious if the needle has been used. Potentially fatal diseases, such as hepatitis or Acquired Immune Deficiency Syndrome (AIDS), can be contracted if the needle has been used on an infected subject.
The needle used in the collection of blood or other body fluids is typically covered with a removable sheath prior to and following use to prevent accidental contact, but the act of replacing the sheath after use can still result in accidental skin puncture. Also, if the sheath is not securely repositioned, the danger exists that personnel subsequently involved in disposal of the device may become infected by accidental puncture.
2. Description of Related Art
U.S. Pat. No. 3,008,570 discloses the use of a removable cap for the purposes of enclosing and protecting a sterilized syringe in a transport.
Solutions that attempt to better protect the health care worker include that disclosed in U.S. Pat. No. 4,790,822. The '822 patent discloses a disposable syringe in which the needle can be first captured by the plunger and then withdrawn into the barrel in a position with the needle completely protected by the barrel. The plunger can then be broken off, leaving the broken end flush with the end of the barrel, so that the needle cannot be accidentally pushed out from the barrel and exposed.
U.S. Pat. No. 4,747,830 discloses a similar system with a plunger that can be broken off once the needle is retracted into the barrel. U.S. Pat. Nos. 4,692,156 and 4,643,200 disclose similar systems, used with a blood donor assembly, which allows retraction of a needle into a barrel.
U.S. Pat. No. 4,425,120 discloses a needle guard movable on the syringe barrel between an extended position in which the needle guard shields the needle and a retracted position in which the needle is exposed for use.
U.S. Pat. No. 4,816,022 discloses a syringe with a sliding cap for preventing accidental puncture. The '022 patent utilizes a nub and backseat for engagement of a nose-piece for securing the cap around the syringe for safety purposes. U.S. Pat. No. 4,840,619 discloses a syringe assembly that has a transport held in telescoping position over a syringe by flanges. Other and various means of sheathing or shielding a syringe are shown in the following U.S. Pat. Nos.: 4,738,663; 4,723,943; 4,666,435; 4,655,751; 4,639,249; 4,592,744; 4,356,822; 4,300,678; 3,976,069; 3,895,633; 3,107,785.
U.S. Pat. Nos. 4,826,483 discloses a non-reusable syringe with one-way movable position.
U.S. Pat. Nos. 5,000,736 and 5,125,898 to Kaufhold et al show disposable syringes with automatic needle retraction. The Kaufhold patents allow the used needle or other medical sharps device to be encapsulated within an evacuated plunger of the syringe and be rendered safe for handling immediately after use and throughout subsequent disposal procedures, as well as rendering the syringe unsuitable for further use. The Kaufhold patents do not address the safety issues associated with disposal of needles or other medical sharps devices when used with those specialized blood collection devices that do not have and do not use plungers as part of normal operation.
SUMMARY OF THE INVENTION
This invention relates to a disposable medical collection tube holder with retractable needle designed for use in blood and other body fluid collection procedures. The first article of the present invention includes a collection tube holder similar to that sold under the Vacutainer™ trademark. The collection tube holder is a tubular member with a proximal end and a distal end. The distal end (towards the needle) is fitted with an orifice that surrounds a detachable needle port hub; the needle port hub in turn accepts a bi-directional needle, or other similar medical sharps device, used in the collection of blood or other body fluids. The detachable needle port hub is secured within the interior of the collection tube holder at the distal end by a hub release ring that is wedged between the detachable needle port hub and the interior wall of the holder. An annular channel is also molded into the distal end of the collection tube holder. At the time of detachment of the needle port hub and affixed needle, the hub release ring will advance into this annular channel. During typical use, the bi-directional needle assembly is secured within the opening of the needle port hub, one needle end is exposed to the exterior environment and the other needle end is contained within the interior of the collection tube holder. The operator skillfully guides and inserts the exterior needle into a subject's vein, then inserts an evacuated test tube into the interior of the collection tube holder and presses the rubber stopper of an evacuated test tube onto the interior needle. The negative pressure in the evacuated test tube causes blood to be collected in the test tube. When the collection of the blood is complete, the test tube is withdrawn from the interior needle and then the exterior needle is withdrawn from the vein. At this point the exterior needle is exposed and individuals are at greatest risk from accidental puncture; the interior needle is shielded within the interior of the holder.
The present invention further includes a second article, an accessory, an appropriately sized ev
Janecka, Jr. Joseph J.
Tripp Martha J.
Duke Jackie Lee
O'Connor Cary
Texas Applied Biomedical Services, Inc.
Wingood Pamela
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