Disposable kit for securing an I.V. catheter

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C128SDIG008, C602S057000

Reexamination Certificate

active

06302867

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to a taping kit and needle disposal apparatus, and more specifically to a kit which reduces the risks of contamination, infection and injury during I.V. insertion and needle disposal procedures. The kit facilitates secure application of a catheter by a medical technician to a site on a patient and disposal of a contaminated I.V. needle, all with a preferably single gloved hand.
BACKGROUND OF THE INVENTION
In a typical I.V. catheter insertion procedure, the I.V. catheter is inserted into a patient after preparation and sterilization of the insertion or wound site. Thereafter, the catheter is held in place by a plurality of tapes which are typically torn from a roll of surgical tape. The first tape is typically or preferably twisted around the catheter in a butterfly-like fashion and subsequent strips are then torn from the roll and applied to the ends of the butterfly tape and over the catheter to hold it in place. Often, an adhesive patch, or wound barrier, is applied directly over the catheter, with tape strips subsequently used to additionally secure the catheter. This typical procedure has a number of disadvantages.
Since the tape is not applied until after the catheter is inserted into the vein and, since the tape is typically torn from tape rolls, it is clear that the technician must frequently let go or release the catheter so that both hands can be used for the taping operation. This catheter release is required to either tear the strips from the roll of tape or, in the alternative, for the removal of pre-torn strips and their placement around the catheter. Any time the catheter is released after it has been inserted, it is in danger of falling out, thus requiring a reinsertion, at the least.
In one typical mode of operation then, a technician will tear off a number of tape strips and place them on the bed rail, on the bedside cabinet, or some other structure. These surfaces are mostly non-sterile.
After the insertion of the catheter, the technician still must use two hands in forming the strip around the catheter, particularly where a butterfly wrap is used, and the catheter is then in danger of falling out when not held in place during the use of both hands to handle the tape. The use of both hands in tearing off the tape and placing it on a non-sterile surface introduces the possibility of contamination of the underside of the tape, resulting in a non-sterile application. Moreover, because the tape must be torn and because it is much easier to tear the tape with an ungloved hand, frequently technicians will carry out at least this part of the procedure without using gloves at all. Use of bare or ungloved hands presents contamination problems to both patients and technicians. Additionally, potential contamination may arise from placing tape strips on non-sterile surfaces such as bed rails or cabinets just prior to their application to the patient.
A second problem that arises from this typical method, apart from the problems incurred with taping, concerns needle disposal. Following the insertion of an I.V. catheter into a patient, the needle used for the catheter insertion is removed, leaving the catheter in the patient's vein. The technician involved in inserting the catheter must now dispose of a contaminated needle, all the while maintaining pressure on the I.V. wound site so the catheter does not become loose and/or fall out before taping. This increases the difficulty of disposal of the needle, and often results in the contaminated needle being placed on a table tray or other surface near the area where the technician is at work securing the catheter. There, it has the potential to inadvertently puncture and infect other persons such as hospital personnel, the patient, family members or others. This also increases the chances that the contaminated needle may be lost prior to disposal and therefore pose an ongoing risk to other persons. Since the technician cannot usually release pressure on the catheter to take the needle to a disposal unit (which may be across the room or the like), disposal of the needle may be effected by bringing a disposal unit to the technician. This results in a disposal unit containing several contaminated articles being brought into close proximity with the patient, and is undesirable.
Another problem with the typical method of reinserting the needle in the protection sheath prior to its disposal is that the technician must hold the sheath in one hand while placing the used needle inside with the other hand. This brings the needle into very close proximity with the skin of the sheath-holding hand of the technician and constitutes risk of an inadvertent “stick” or puncture with a contaminated needle. All of the above problems increase the opportunities for either patient, technician or others to become infected. It has been estimated that each year, almost two million individuals who enter hospitals in this country acquire infections they did not have when they went there, and of these, eighty thousand die. (Jeffrey A. Fisher, The Plague Makers; NY: Simon & Schuster, 1994).
Accordingly, and in view of the above background, there is a need for a sterile I.V. catheter securing system and/or for a needle disposal system which overcomes at least some of the problems noted above. It is also desirable to provide a system to facilitate the sterile handling of sterile wound barriers and tape strips. It is also desirable to provide a system which allows for the safe disposal of contaminated needles.
SUMMARY OF THE INVENTION
This invention solves the heretofore mentioned problems and perhaps others associated with known methods and apparatuses used for dressing I.V. wound sites by the provision of a kit having components which can be completely manipulated preferably with one hand so that it is not necessary for the technician to release his hold of the catheter once it has been inserted into a vein. At the same time, the kit provides for easy grasping of a sterile wound barrier, which is an adhesive patch used to cover the wound site, and sterile tape strips used to hold the catheter in place, preferably with a single gloved hand, while the other hand is continually uninterruptedly used to hold the catheter. Additionally, the technician may safely dispose of the contaminated catheter needle with the same operative hand while maintaining pressure on the I.V. wound site with the other and thus not exposing it to the contaminated needle tip and an accidental “stick.”
In one embodiment, the kit invention comprises a base and carrier sheet, on the top of which are mounted a number of removable adhesive tapes. One of these is a patch referred to as a wound barrier for holding the catheter in place over the wound site. The remaining tapes are strips sized to be wrapped around the catheter or to otherwise hold it in place. In one embodiment, the wound barrier and the strips each may have a non-adhesive and/or raised tab for the purpose of easy grasping by a single gloved hand, so that each of the strips on the top of the carrier sheet can be easily removed from the base of the unit with a preferably single gloved hand while the base remains secured near the site by virtue of adhesive on its rear side.
The bottom of the base is provided with a mounting substrate, which includes an adhesive patterned on the underside of the base carrier for securing the entire unit to a nearby surface. In use, a removable backing releasably applied to the mounting substrate to protect the adhesive is removed.
Moreover the apparatus is provided in this embodiment with a relatively stiff adhesive sheath carrier attached to the base and covered by a releasable liner which is removed so the needle sheath can be attached to the unit as will be discussed.
In use, the kit would preferably be distributed in a sterile package or overwrap, also including an antibacterial wipe, etc. and removed from its package and the removable backing or liner on the underside of the mounting substrate is removed. The exposed mount

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