Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Reexamination Certificate
1999-11-15
2002-03-12
Seidel, Richard K. (Department: 3763)
Surgery
Container for blood or body treating material, or means used...
Having hollow needle or spike for piercing container or...
C604S905000, C604S533000
Reexamination Certificate
active
06355023
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
The invention relates generally to a device for the administration of transactions involving bodily fluids, and particularly, to a housing with an encased needle which, when used in conjunction with any one of a variety of common access devices, minimizes or eliminates the health care professional's risk of needle stick while protecting the patient against needle contamination during the collection and transfer of bodily fluids and the injection of medication and the like.
2. Description of Prior Art
Increased occurrence of blood-borne pathogens such as HIV and hepatitis have led healthcare institutions to search for safety devices which decrease an employee's risk of exposure to patient blood. The prevalence of needles in traditional phlebotomy and other procedures subjects health care workers to a significant threat of such exposure through sharps incidents, i.e. needlesticks. Each year, throughout the nation's healthcare facilities, thirty sharps injuries occur per one hundred occupied hospital beds. Seventyfour percent of ‘high risk’ sharps injuries, those injuries associated with blood filled needles, are incurred by health care practitioners in relation to blood drawing procedures.
Traditional blood drawing procedures involve various apparatus and methods. One common method entails the use of a hypodermic syringe. A conventional hypodermic syringe includes a syringe body, a piston member, a hypodermic needle, and a needle cap. With the piston member in a decompressed position, blood is drawn through the needle into the syringe body while the needle is inserted directly into the vein or into a tube connected to a second needle that is inserted in the vein. A second common method of drawing blood involves a blood bag system. A conventional blood bag system consists of a length of tubing connected to a first needle at one end and to a bag at the other. The first needle is inserted into a vein to draw blood from the vein, through the tube, into the bag or test tube or other collection device.
Due to the spread of infectious diseases, most syringes and needle assemblies used today are designed for one use only and immediate disposal. Although disposal of syringes and needle assemblies immediately after they are used reduces human exposure to contaminated needles, it does not eliminate all of the problems associated with traditional blood draw methods. Contact with a needle before it is used can contaminate the needle and hence any medication which passes through it, thus threatening the patient. Contact with a needle after it is used can result in the transmission of disease from patient to health care practitioner. Contact with toxic or hazardous medication contained in the needle, syringe, or tube threatens the safety of both practitioner and patient.
Various technologies have addressed the need to protect health care practitioners and patients from the risks associated with the use of exposed needles in phlebotomy procedures. A safety syringe, discussed fully in U.S. Pat. No. 5,088,985 ('985) and incorporated herein by reference, describes a syringe device having a safety apparatus for shielding the needle and another apparatus for removing said needle after use. A blood collecting apparatus, discussed in U.S. Pat. No. 4,943,283 ('283) and incorporated herein by reference, describes a tube arrangement to be used with a blood bag wherein needles used for piercing a vein and for filling test tubes with blood for various screening tests are safety shielded. U.S. Pat. No. 4,576,211 ('211), incorporated herein by reference, teaches a device which facilitates the safe withdrawal of toxic or otherwise hazardous medicine from a bottle into a syringe.
These and other technologies fail to adequately protect patients and practitioners from the hazards associated with needle use in phlebotomy procedures. Despite their safety features, the devices referred to above still require the practitioner to handle needles before and after usage and also expose both the practitioner and patient to the risk of contact with hazardous medicine and bodily fluids. The device described in the '985 patent provides a member for ‘hands-free’ removal of a used needle, however, the health care employee still encounters the risk of needlestick when inserting a used needle into the removing member. Both devices of the '985 and '283 patents provide needle shields to protect the user from unintended needle contact. However, these shields are slidably mounted and thus are only effective when engaged. When the needle is disengaged the practitioner is subject to needlestick and the patent is endangered by the threat of needle contamination. Further, neither the '985 nor the '283 patents provide protection against contact with medicine which may be toxic or hazardous in nature. The device discussed in the '
211
patent allows for the safe drawing of such medicine into a syringe but no protection is offered in transferring the medicine to the patient and injecting it into a vein.
Thus the need has arisen for a device to be used in venous transactions which protects both health care practitioners and patients from the risks inherent in phlebotomy procedures by protecting against needlestick, ensuring the sterility of needles, and preventing contact with dangerous medicines.
Summary of the Invention
The above-discussed and other drawbacks and deficiencies of prior art are overcome or alleviated by the closed system access device of the present invention. The closed system access device provides a tool for managing fluid transactions that ensures the sterility of a needle, prevents exposure to toxic or hazardous medicines, and protects against needle stick by completely encasing the needle in a housing. The device allows for a protected needle withdrawal of blood, injection of medicine and transfer of fluids by use of an unexposed, internal needle which inhibits contamination and prevents contact with the transferred blood and/or medicine. In an exemplary embodiment, the device comprises a protective shielding assembly including a housing having an outer wall and an intermediate wall extending between the outer wall of the housing. The intermediate wall partitions the housing into a first section and a second section. A first needle extends from the first section to the second section of the housing through the intermediate wall, wherein the first needle having a first portion disposed in the first section and a second portion disposed in the second section. The assembly also includes a first connector disposed in the second section about the first needle for connecting a first member to the first needle in the second section and a second needle is disposed at least partially in the first section of the housing and extends through the outer wall of the housing. The second needle preferably terminates in a needle-less fluid port in which the fluid port is for fluid connection to a second member. The assembly further includes a removable guide liner having a body including a first end, an opposing second end, and an outer wall complementary to the outer wall of the housing so that the removable guide liner is intimately received within the first section of the housing. The body has a guide slot formed therein where the guide slot extends from the first end to an end wall proximate the second end. The end wall includes an opening formed therein for receiving the first portion of the first needle and a portion of the second needle so that the first portion and the second needle extend into the guide slot. The guide slot receives a third member which is fluidly connected to the first and second needles so that a fluid transfer may occur between the third member and at least one of the first and second members where the first and second needles are fully encased within the housing so as to protect the user from contact therewith.
REFERENCES:
patent: 3826261 (1974-07-01), Killinger
patent: 3993063 (1976-11-01), La
Gibbons Susan
Roth Lindsay
Colburn LLP Cantor
Gaylord Hospital
Rodriquez Cris
Seidel Richard K.
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