Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2002-11-20
2004-11-09
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S187000, C604S264000, C604S272000
Reexamination Certificate
active
06814725
ABSTRACT:
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates in general, to intravascular (I.V.) catheter assemblies, and in particular, to a new and useful I.V. catheter assembly that prevents blood from accidentally leaking from the catheter.
A typical I.V. catheter assembly requires the user to remove and then dispose of a contaminated needle after the needle tip and the catheter are properly located in a blood vessel of a patient. Once the needle is withdrawn from the catheter, the user immediately discards the needle. The user then urgently attempts to attach a male adapter to the catheter. The adapter can be of various types but almost always has a self-closing plug or member into or through which the needle of a supply tube or a needless system can be passed for drawing blood from the patient or for supplying appropriate fluids to the patient.
The user is trying to prevent the patients' blood from accidentally leaking out of the catheter hub and onto the user, the patient, the bed and/or the floor. Once the male adapter is attached to the catheter hub, the user then has time to secure the catheter and draw blood and/or provide the patient with I.V. fluids.
The main concern during this entire attachment sequence which starts with injection of the catheter and needle into the patients blood vessel, and ends with the attachment of a fluid receiving or supplying tube to the adapter, is protecting the user, the patient and everyone else involved, against exposure to blood borne pathogens such as hepatitis and HIV/AIDS. Often, typical I.V. catheter assemblies come with some sort of needle guard to help prevent accidental self-inflicted needle injuries. Unfortunately they do not efficiently prevent blood from leaking out of the catheter prior to attachment of the adaptor.
See for example, U.S. Pat. No. 5,000,740 to Ducharme et al. which is incorporated here by reference for disclosing a needle guard which covers and locks the catheter needle of the prior art when the needle has been withdrawn from the catheter. This and other catheter assemblies are sold by Ethicon. This and other catheter assemblies can be adapted for use with the present invention.
Other needle point covering means of the needle guard type are disclosed in U.S. Pat. Nos. 4,917,669 and 4,655,750. These and other needle point covering means can be adapted for use with the present invention.
Other types of needle point cover means which can also be used with the present invention include a spring cover mechanism disclosed in U.S. Pat. Nos. 6,117,108 and 6,287,278 to Woehr et al. This and other catheter assemblies are sold by B. Braun Melsungen, AG. and can be adapted for use with the present invention.
Several types of I.V. catheters that prevent accidental blood leak have been proposed. They typically work via either a valve mechanism and/or alternative site with a stopcock device. The first type generally are either expensive, inconsistent and/or do not perform the desired function. The latter types are also expensive, inconsistent and often are cumbersome and awkward.
See, for example, U.S. Pat. No. 4,245,635 to Kontos; U.S. Pat. No. 4,512,766 to Vailancourt; U.S. Pat. No. 4,883,461 to Sawyer; U.S. Pat. No. 5,053,014 to VanHeugten; U.S. Pat. No. 5,098,396 to Taylor, et al.; U.S. Pat. No. 5,376,071 to Henderson; U.S. Pat. No. 5,954,698 to Pike; U.S. Pat. No. 6,221,050 to Ishida; and U.S. Pat. No. 6,413,250 to Smith; and U.S. Pat. No. 6,322,537 to Chang.
Various other technologies have also been developed for shielding the point of a catheter needle when it is extracted from the catheter of a catheter assembly. See for example, U.S. Pat. No. 4,762,516 to Luther, et al.; U.S. Pat. No. 5,013,304 to Russell, et al.; U.S. Pat. No. 5,573,510 to Isaacson; U.S. Pat. No. 5,575,777 to Cover, et al.; U.S. Pat. No. 5,685,855 to Erskine; U.S. Pat. No. 5,695,474 to Daugherty; and U.S. Pat. No. 6,436,070 to Botich, et al. They can also be adapted for use with the present invention.
Also see U.S. Pat. No. 5,009,642 to Sahi for a self blunting needle and additional valve systems of U.S. Pat. No. 4,525,157 and U.S. Pat. No. 4,655,750 to Vaillancourt; U.S. Pat. No. 4,917,668 to Haindl; U.S. Pat. No. 5,092,845 to Chang; U.S. Pat. No. 5,156,792 to Holdaway, et al.; U.S. Pat. No. 5,405,323 to Rogers, et al.; U.S. Pat. No. 5,419,766 to Chang, et al.; and U.S. Pat. No. 5,851,196 to Arnett.
Many of these known catheter assemblies and others not yet known can benefit by use of the present invention.
SUMMARY OF THE INVENTION
In accordance with the present invention an I.V. catheter assembly has an adapter with self-closing plug member already attached to the catheter hub. The single needle of the prior art is, in effect, divided into two parts that are provided on either side of the adaptor. Just prior to its use, the user will advance the proximal or outer needle thru the plug member of the adaptor and into coupling engagement with the distal or inner needle. The distal end of the outer needle is shaped to engage and firmly couple with the proximal end of the inner needle to, in effect, form one needle again. The I.V. catheter assembly of the invention is then ready for use.
The distal needle extends through a catheter of the assembly as in the prior art, and has a distal point that is inserted in the blood vessel of the patient along with a length of the catheter. Once the catheter is in place in the patient's blood vessel, the distal needle is withdrawn from the catheter and is pulled back and out through the self-closing plug by the proximal needle which is pulled back out through the plug.
In a preferred embodiment of the invention, the distal point of the distal needle is automatically covered when the coupled needles are pulled out of the catheter for protection against inadvertently being stuck by the needle point.
The great advantage of the present invention is that the plug member never allows blood to leak from the catheter assembly during any phase of its use.
Besides the objects and advantages of a bloodless I.V. catheter, the invention has several other objects and advantages including:
Providing an I.V. catheter assembly that reliably prevents accidental blood exposure to the user, the patient, and everyone involved and/or nearby;
Providing an environment which the user, the patient, the other medical staff, the janitorial staff and the linen cleaning staff will all benefit from and appreciate;
Providing an I.V. catheter assembly that is easy to manufacture;
Providing an I.V. catheter assembly that is inexpensive and cost efficient;
Providing an I.V. catheter assembly that can be applied to other I.V. catheter assemblies that have needle guards; and
Providing an I.V. catheter that is not cumbersome and/or awkward.
Accordingly, another object of the invention is to provide an I.V. catheter assembly comprised of a catheter with a distal needle therein for insertion into a blood vessel along with a portion of the catheter, an adapter with a self-sealing or self-closing plug connected to the catheter, proximally of the distal needle, a proximal needle that can couple to the distal needle in a guard tube on the proximal side of the plug, the proximal needle being movable through the plug and into coupling engagement with the distal needle so the distal needle can be inserted into a blood vessel and the coupled needles can be withdrawn into the guard tube.
The guard tube advantageously shields the coupled needles when the coupled needles are withdrawn.
The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which a preferred embodiment of the invention is illustrated.
REFERENCES:
patent: 4245635 (1981-01-01), Kontos
patent: 4468224 (1984-08-01), Enzmann et al.
patent: 4512766 (1985-04-01), Vailancourt
patent: 4525157 (
Casler Brian L.
Notaro & Michalos P.C.
Thompson Kathryn L
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