Surgery – Instruments – External pressure applicator
Reexamination Certificate
1999-11-24
2004-01-06
Reip, David O. (Department: 3731)
Surgery
Instruments
External pressure applicator
C600S201000, C604S116000
Reexamination Certificate
active
06673091
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to tools and methods for accessing and deaccessing a medical device implanted under the skin of a patient, and particularly tools and methods which reduce the risk of a nurse accidentally sticking herself or himself or a patient with a needle.
2. Background Discussion
Implanted medical devices, such as vascular access devices, are commonly used to allow medication to be administered to patients. One such implant device is sold under the trademark “BardPort” by C. R. Bard, Inc. These devices include a housing enclosing a chamber which has an inlet covered with a silicone or latex seal. An outlet in communication with the chamber allows fluid in the chamber to flow through the outlet into a tube which, typically, is inserted into the vein of a patient.
These devices are accessed periodically by a nurse who inserts a needle through the patient's skin overlying the device and then into and through the seal. The nurse palpates, or feels, the device through the skin overlying the implanted device, and presses downward to locate the position of the implanted device. While holding or pressing against the device through the skin with one hand, the nurse with the other hand inserts the needle through the skin, and into and through the seal. Once properly inserted through the skin, the tip of the needle penetrates the seal and is lodged within the chamber. A “click” sound can sometimes be heard when the tip of the needle touches the bottom of the chamber, or the nurse can feel the tip contact the bottom of the chamber. Typically, the needle penetrates a depth of from about ¼ inch to about 1 inch. Medication now flows through the needle into the chamber and then out the outlet through the tube into the vein of the patient. Sometimes, however, the nurse, while attempting to introduce the needle into the seal of the implanted device, accidently sticks herself or himself with the needle. These accidental needle sticks occur while either accessing or deaccessing the implanted device with the needle.
Needle sticks occur most frequently while deaccessing the needle. The needle sometimes remains in the implanted medical device for several hours, and sometimes even for several days.
These needles must be periodically flushed and removed from the device. The removal is accomplished by the nurse, with one hand, pressing against the skin overlying and around the device, and, with the other hand, grasping the needle and withdrawing it from the device. Frequently, there is an involuntary muscular recoil as the needle escapes from the implanted medical device as it is withdrawn. It is thought that this recoil is due to proprioceptive neuro-muscular activity. The recoil sometimes results in the nurse accidentally sticking a finger of the hand which is pressing against the skin adjacent to the implanted medical device. If the source patient has an infectious and or contagious disease such as disseminated TB, Hepatitis B or C, or is HIV positive or has AIDS, the nurse may contract the disease directly from this needle stick.
After such a needlestick, even if the source patient has no communicable and/or infectious disease or condition identified at the time of the needlestick, the nurse must undergo intensive and expensive follow-up testing intermittently for up to 1 year. The source patient must be tested, if they consent, for infectious or communicable disease as set forth in the OSHA regulations and CDC (Center for Disease Control) recommendations, under Employee Exposure to Bloodborne Pathogens. The nurse must also be counseled as to certain restrictions in his or her own lifestyle, particularly sex practices, until his or her own freedom from communicable/infectious disease or condition is determined. This places an incredible strain on the nurse's marital relationships and lifestyle. The partner often demands that the nurse quit nursing rather than face the risks.
Needle sticks also occur while accessing the implanted device. The problem of contracting an infectious, contagious disease also is sometimes encountered. For example, the needle, which is typically sterile initially, has in some reported instances completely penetrated the finger of the nurse and entered the body of the patient. The now contaminated needle can only be removed by withdrawing it from the patient's body into and through the nurse's finger, possibly infecting the nurse.
Recent guidelines promulgated by the CDC prohibits medical acts which require manipulating needles using both hands in the act, or any other technique that involves directing the point of a needle toward any part of the health care workers body. Under the current protocols for using the implanted device, the nurse's hand which secures the implanted device in place during accessing and deaccessing is always in direct line with the needle during accessing, and also in line with the needle tip during deaccessing when one considers the frequency of the known recoil phenomenon.
The problem of needle sticks while deaccessing the needle has been recognized by workers at the University Hospital in Antwerp, Belgium, who published an article in Infection Control and Hospital Epidemiology, Volume 14, No. 10 (October 1993). In this article it is suggested to use a tool, rather than the nurse's hand, to hold the implanted device during removal of the needle. The suggested tool includes a guard with a slot in it. The guard has a relatively small area. It appears to be less than 1 square inch, and it appears to be made of an opaque material. There is a short handle attached to the guard used to grasp the tool which does not permit the hand of the nurse to be located far enough away from the needle to insure avoiding needle sticks if a recoil occurs.
SUMMARY OF THE INVENTION
It is the objective of this invention to provide tools and methods which allow a nurse to access and deaccess safely a needle used with an implanted medical device. This invention has several features, no single one of which is solely responsible for its desirable attributes. Without limiting the scope of this invention as expressed by the claims which follow, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled, “DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS,” one will understand how the features of this invention provide its benefits, which include low cost manufacture, simplicity of use, and, most importantly, nurse and patient safety by avoiding accidental needle sticks and the ensuing medical costs and risks such as, for example, loss of health or life, ability to work, and sometimes spousal support.
The first feature of the tool of this invention is that it may be used for assisting in both accessing and deaccessing a needle used with a medical device implanted under the skin of a patient. In one embodiment it has the general configuration of a spatula and it includes an elongated body having a handle section and an enlarged guard section. There is an elongated slot extending from an edge of the guard section into the guard section, terminating at an internal portion of the guard section. The guard section has an area of 1.00 square inch or more, typically the area is from about 1.00 square inch to about 18 square inches. This relatively large guard area prevents the patient from being stuck with the needle, if there is a recoil during removal of the needle from the implanted medical device.
The second feature is the dimensions and other physical characteristics of the guard section. The guard section has a forward edge terminating at opposed ends and side edges at each opposed end which extend rearward to the handle section. The guard section has a floor including the forward edge, opposed sides, and a rear end. There is a raised rear wall connected to the rear of end of the floor, and a pair of raised side walls, each connected to one side of the floor. Preferably, the side walls taper dow
Burns Robert
Perlick Jeanette
Shaffer Terry
Connors John J.
Connors & Associates, Inc.
Reip David O.
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